Fish and Fishery Products Hazards and Controls Guidance Fourth Edition

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Fish and Fishery Products Hazards and Controls Guidance Fourth Edition – APRIL 2011

DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR FOOD SAFETY AND APPLIED NUTRITION OFFICE OF FOOD SAFETY

Fish and Fishery Products Hazards and Controls Guidance Fourth Edition – April 2011

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You may submit electronic or written comments regarding this guidance at any time. Submit electronic comments to http://www.regulations. gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identiﬁed with the docket number listed in the notice of availability that publishes in the Federal Register.

U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition (240) 402-2300

April 2011

Table of Contents: Fish and Fishery Products Hazards and Controls Guidance

• Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance ...... 1 • CHAPTER 1: General Information ...... 19 • CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan ...... 21 • CHAPTER 3: Potential Species-Related and Process-Related Hazards ...... 29 • CHAPTER 4: Pathogens From the Harvest Area ...... 75 • CHAPTER 5: Parasites ...... 91 • CHAPTER 6: Natural Toxins ...... 99 • CHAPTER 7: Scombrotoxin (Histamine) Formation ...... 113 • CHAPTER 8: Other Decomposition-Related Hazards ...... 153 • CHAPTER 9: Environmental Chemical Contaminants and Pesticides ...... 155 • CHAPTER 10: Methylmercury ...... 181 • CHAPTER 11: Aquaculture Drugs ...... 183 • CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse ...... 209 • CHAPTER 13: Clostridium botulinum Toxin Formation ...... 245 • CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying ...... 293 • CHAPTER 15: Staphylococcus aureus Toxin Formation in Hydrated Batter Mixes ...... 309 • CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization ...... 315 • CHAPTER 17: Pathogenic Bacteria Survival Through Processes Designed to Retain Raw Product Characteristics ...... 331 • CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes ...... 345 • CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives ...... 355 • CHAPTER 20: Metal Inclusion...... 385 • CHAPTER 21: Glass Inclusion ...... 395 • APPENDIX 1: Forms ...... 405 • APPENDIX 2: Sample Product Flow Diagram ...... 411 • APPENDIX 3: Critical Control Point Decision Tree ...... 413 • APPENDIX 4: Bacterial Pathogen Growth and Inactivation ...... 417 • APPENDIX 5: FDA and EPA Safety Levels in Regulations and Guidance ...... 439 • APPENDIX 6: Japanese and Hawaiian Vernacular Names for Fish Eaten Raw ...... 443 • APPENDIX 7: Bacterial and Viral Pathogens of Greatest Concern in Seafood Processing - Public Health Impacts ...... 451 • APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products ... 455 NOTES: Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisﬁes the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.

I. INTRODUCTION II. DISCUSSION

This guidance is intended to assist processors A. Scope and Limitations of fish and fishery products in the development of their Hazard Analysis Critical Control Point The control strategies and practices provided in (HACCP) plans. Processors of fish and fishery this guidance are recommendations to the fish products will find information in this guidance and fishery products industry unless they are that will help them identify hazards that are required by regulation or statute. This guidance associated with their products, and help them provides information that would likely result in a formulate control strategies. The guidance will HACCP plan that is acceptable to FDA. Processors help consumers and the public generally to may choose to use other control strategies, as understand commercial seafood safety in terms long as they comply with the requirements of of hazards and their controls. The guidance does the applicable food safety laws and regulations. not specifically address safe handling practices by However, processors that chose to use other consumers or by retail establishments, although control strategies (e.g., critical limits) should many of the concepts contained in this guidance scientifically establish their adequacy. are applicable to both. This guidance is also The information contained in the tables in intended to serve as a tool to be used by federal Chapter 3 and in Chapters 4 through 21 provide and state regulatory officials in the evaluation of guidance for determining which hazards are HACCP plans for fish and fishery products. “reasonably likely to occur” in particular fish and fishery products under ordinary circumstances. FDA’s guidance documents, including this However, the tables should not be used separately guidance, do not establish legally enforceable for this purpose. The tables list potential hazards responsibilities. Instead, guidance describe the for specific species and finished product types. Agency’s current thinking on a topic and should This information should be combined with be viewed only as recommendations, unless the information in the subsequent chapters to specific regulatory or statutory requirements are determine the likelihood of occurrence. cited. The use of the word should in Agency guidance means that something is suggested or The guidance is not a substitute for the recommended, but not required. performance of a hazard analysis by a processor of fish and fishery products, as required by FDA’s regulations. Hazards not covered by this guidance may be relevant to certain products under certain circumstances. In particular, processors should be alert to new or emerging problems (e.g., the occurrence of natural toxins in fish not previously associated with that toxin).

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition 1 FDA announced its adoption of final regulations This guidance does not cover the sanitation to ensure the safe and sanitary processing of fish controls required by the Seafood HACCP and fishery products in the Federal Register of Regulation. However, the maintenance of a December 18, 1995 (60 FR 65096) (hereinafter sanitation monitoring program is an essential referred to as the Seafood HACCP Regulation). prerequisite to the development of a HACCP This guidance, the Seafood HACCP Regulation program. When sanitation controls are necessary (21 CFR 123),and the Control of Communicable for food safety, but are not included in a Diseases regulation (21 CFR 1240) apply to sanitation monitoring program, they must be all aquatic animal life, other than birds and included in the HACCP plan (21 CFR 123.6). mammals, used as food for human consumption. This guidance does not describe corrective action For example, in addition to fresh and saltwater or verification records, because these records finfish and crustaceans, this guidance applies are not required to be listed in the HACCP plan. to echinoderms such as sea cucumbers and sea Nonetheless, such records must be maintained, urchins; reptiles such as alligators and turtles; where applicable, as required in § 123.7 and § amphibians such as frogs; and to all mollusks, 123.8. Additionally, this guidance does not restate including land snails (escargot). It also applies the general requirements for records that are set to extracts and derivatives of fish, such as eggs out in § 123.9(a). (roe), oil, cartilage, and fish protein concentrate. In addition, this guidance applies to products This guidance does not cover reassessment of the that are mixtures of fish and non-fish ingredients, HACCP plan and/or the hazard analysis or review such as tuna sandwiches and soups. Appendix 8, of consumer complaints, as mandated by § 123.8. § 123.3, lists the definitions for “fish” and “fishery This guidance also does not provide specific product” used in the Seafood HACCP Regulation. guidance to importers of fish and fishery This guidance covers safety hazards associated products for the development of required with fish and fishery products only. It does importer verification procedures. However, not cover most hazards associated with non- the information contained in the text, and, in fishery ingredients (e.g., Salmonella enteritidis particular, in Appendix 5 (“FDA and EPA Safety in raw eggs). However, where such hazards are Levels in Regulations and Guidance”), should presented by a fishery product that contains non- prove useful for this purpose. fishery ingredients, control must be included in the HACCP plan (§ 123.6). Processors may use the principles included in this guidance for assistance in developing appropriate controls for these hazards. This guidance does not cover the hazard associated with the formation of Clostridium botulinum (C. botulinum) toxin in low-acid canned foods (LACFs) or shelf-stable acidified foods. Mandatory controls for this hazard are contained in the Thermally Processed Low- Acid Foods Packaged in Hermetically Sealed Containers regulation (hereinafter referred to as the LACF Regulation, 21 CFR 113) and the Acidified Foods regulation (21 CFR 114). Such controls may be, but are not required to be, included in HACCP plans for these products.

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition 2 B. Changes in This Edition • Additional information that is broadly applicable to these tasks, also contained in Following is a summary of the most signiﬁcant the companion document to this guidance, changes in this edition of the guidance “HACCP: Hazard Analysis Critical Control document. In addition to using this summary list, Point Training Curriculum,” developed by the you should carefully review the chapters that are Seafood HACCP Alliance for Training and applicable to your product and process. Education, is now included.

The information contained throughout this The information in Chapter 3 for identifying guidance document is changed as follows: potential species-related and process-related The elements of a control strategy (i.e., critical hazards is changed as follows: limits, monitoring procedures, corrective action • Information is now provided on how illicit procedures, recordkeeping system, and verification species substitution can impact on the procedures) are now consolidated for each control identification of potential species-related strategy. In most cases, an example of a HACCP hazards. plan follows the discussion of each control strategy; The information contained in Table 3-2 • A bibliography is now located at the end of (“Potential Vertebrate Species-Related most chapters. References have been added Hazards”) is changed as follows: and deleted for many of the chapters; • Information on the mechanics of completing • There are several scientific name changes to a HACCP plan, previously repeated in reflect changes in taxonomic conventions; Chapters 4 through 21, is now contained in • Aholehole (Kuhlia spp.) is no longer listed as Chapter 2; having a potential ciguatera fish poisoning • Information on the potential public health (CFP) hazard; consequences (i.e., illness or injury) of • Amberjack or Yellowtail, Aquacultured seafood safety hazards is now provided; (Seriola lalandi), is no longer listed as having • Recommendations for specific job positions a potential CFP hazard; are no longer listed for “Who should perform • Barramundi (Lates calcarifer) is now listed as the monitoring?” in Chapters 4 through 21; a species that is aquacultured; • Additional information is now provided on • Basa or Bocourti (Pangasius bocourti) is now the performance of accuracy checks and listed as a species in U.S. commerce; calibration of temperature-indicating devices • Bass, Sea (Dicentrarchus labrax) is now (e.g., thermometers) and temperature- listed as a species that is aquacultured; recording devices (e.g., recording • Bata (Labeo bata) is now listed as a species thermometers); and in U.S. commerce; • Reference is no longer made to the • Bream (Abramis brama) is now listed as a intended issuance by FDA of guidance on species that is aquacultured; the development of Sanitation Standard Operating Procedures (SSOPs) and sanitation • Caparari (Pseudoplatystoma tigrinum) is monitoring or guidance on the development now listed as a market name for a species of importer verification procedures. previously referred to as catfish; • Carp (Barbonymus spp., Hypophthalmichthys The recommendations in Chapter 2 for nobilis, and Carassius carassius) is now conducting a hazard analysis and developing a listed as a species in U.S. commerce; HACCP plan are changed as follows: • Carp (Hypophthalmichthys nobilis and

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition 3 Carassius carassius) is now listed as a • Goatfish (Mulloidichthys spp., Pseudupeneus species that is aquacultured; spp., and Upeneichthys lineatus) is no longer • Cascarudo (Callichthys callichthys) is now listed as having a potential CFP hazard; listed as a market name for a species • Goby (Neogobius melanostomus) is now previously referred to as catfish; listed as a species in U.S. commerce; • Characin (Leporinus obtusidens) is now listed • Grouper (Anyperodon spp., Caprodon as a species in U.S. commerce; schlegelii, and Diplectrum formosum) is • Charal (Chirostoma jordani) is now listed as no longer listed as having a potential CFP a species in U.S. commerce; hazard; • Chiring (Apocryptes bato) is now listed as a • Grouper, or Coral Grouper (Plectropomus species in U.S. commerce; spp.), is now listed as a species in U.S. commerce; • Clarias Fish, or Walking Clarias Fish (Clarias anguillaris and Clarias gariepinus), is • Grouper, or Jewfish (Epinephelus itajara), is now listed as a market name for a species no longer listed as a having a potential CFP previously referred to as catfish, and is now hazard; listed as a species that is aquacultured; • Herring, or Sea Herring, or Sild (Clupea • Cobia (Rachycentron canadum) is now listed spp.), is no longer listed as having a potential as a species that is aquacultured; scombrotoxin (histamine) hazard associated with its roe; • Coroata (Platynematichthys notatus) is now listed as a market name for a species • Hind (Epinephelus drummondhayi) is no previously referred to as catfish; longer listed as having a potential CFP hazard; • Curimbata or Guramata (Prochilodus lineatus) is now listed as a species in U.S. commerce; • Jack (Carangoides bartholomaei) is now listed as having a potential CFP hazard; • Cusk-eel (Brotula clarkae) is now listed as a species in U.S. commerce; • Jack (Selene spp., Urapsis secunda, and Oligoplites saurus) is no longer listed as • Dace (Rhinichthys spp.) is now listed as a having a potential CFP hazard; species that is aquacultured; • Jack or Crevalle (Alectis indicus) is no longer • Eel, Moray (Muraena retifera), is no longer listed as having a potential CFP hazard; listed as having a potential CFP hazard; • Jack or Roosterfish (Nematistius pectoralis) • Featherback (Notopterus notopterus) is now is no longer listed as having a potential CFP listed as a species in U.S. commerce; hazard; • Flathead (Platycephalus conatus) is now • Jobfish (Aprion spp.) is now listed, and listed as a species in U.S. commerce; Aprion virescens is deleted because it is • Flatwhiskered Fish (Pinirampus pirinampu) included in Aprion spp.; is now listed as a market name for a species • Jobfish (Aphareus spp., Aprion spp., and previously referred to as catfish; Pristipomoides spp.) is no longer listed as • Frog (Rana spp.) is now listed as having a having a potential scombrotoxin (histamine) parasite hazard; hazard; • Gillbacker, or Gilleybaka (Aspistor parkeri), • Kahawai (Arripis spp.) is no longer listed as is now listed as a market name for a species having a potential CFP hazard; previously referred to as catfish; • Loach (Somileptus gongota) is now listed as a • Goatfish (Mulloidichthys vanicolenis) is now species in U.S. commerce; listed as a species in U.S. commerce;

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition 4 • Mackerel, narrow-barred Spanish • Salmon and roe (wild) (freshwater) (Scomberomorus commerson), is now listed (Oncorhynchus spp. and Salmo salar) is now as having a potential CFP hazard; listed as having a potential parasite hazard; • Menhaden (Brevoortia spp. and Ethmidium • Scad (Trachurus spp.) is now listed as having maculatum) is now listed as having a potential scombrotoxin (histamine) hazard; a potential scombrotoxin (histamine) • Scad or Horse Mackerel (Trachurus trachurus) hazard for products intended for direct is now listed as a market name for a species human consumption of the muscle and previously referred to as only scad; for aqueous components, such as fish • Shad (Alosa spp.) is no longer listed as having protein concentrates, that are to be used a potential scombrotoxin (histamine) hazard as food additives. It is also listed as associated with its roe; having a potential environmental chemical contaminant and pesticide hazard when • Shad, Hilsa (Tenualosa ilisha), is now listed the food products are intended for human as a species in U.S. commerce; consumption, such as oil extracts used as • Snapper (Etelis spp. and Pristipomoides spp.) dietary ingredients; is no longer listed as having a potential CFP • Oreo Dory (Neocyttus spp.)is now listed as a hazard; species in U.S. commerce; • Snapper (Pristipomoides spp.) is no longer • Oreo Dory (Pseudocyttus spp.) is now listed, listed as having a potential scombrotoxin and Pseudocyttus maculates is deleted (histamine) hazard; because it is included in Pseudocyttus spp; • Snapper (Symphorus nematophorus) is now • Pangasius or Shortbarbel (Pangasius listed as having a potential CFP hazard; micronemus) is now listed as a market name • Sorubim, or Surubi (Pseudoplatystoma for a species previously referred to as catfish; corruscans), is now listed as a market name • Parrotfish (Bolbometopon spp.) is now listed for a species previously referred to as catfish; as a species in U.S. commerce; • Spearfish (Tetrapturus spp.) is now listed as • Piramutaba or Laulao Fish (Brachyplatystoma having a potential scombrotoxin (histamine) vaillanti) is now listed as a market name for hazard; a species previously referred to as catfish; • Squirrelfish (Holocentrus spp.) is no longer • Puffer (Fugu spp., now Takifugu spp.) is now listed as having a potential CFP hazard; listed as an aquacultured species; • Sutchi or Swai (Pangasius hypophthalmus) • Puffer (Sphoeroides annulatus, Sphoeroides are now listed as market names for a species nephelus, Sphoeroides spengleri, and previously referred to as catfish and are now Sphoeroides testudineus, Tetraodon spp.) is listed as species that are aquacultured; now listed as a species in U.S. commerce; • Tang (Naso spp.) is now listed as a species in • Puffer (Fugu spp., now Takifugu spp.) is now U.S. commerce; listed as having a potential Paralytic Shellfish • Tang (Tenthis spp.) is no longer listed. Poisoning (PSP) hazard; • Tang (Zebrasoma spp.) is no longer listed as • Rita (Rita rita) is now listed as a species in a having a potential CFP hazard; U.S. commerce; • Tigerfish (Datnioides microlepis and • Rohu (Labeo rohita) is now listed as a Datnioides polota) is now listed as a species species in U.S. commerce; in U.S. commerce; • Sailfish (Istiophorus platypterus) is now listed • Tinfoil (Barbonymus altus) is now listed as a as a species in U.S. commerce; species in U.S. commerce;

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition 5 • Trahira (Hoplias malabaricus) is now listed The information contained in Table 3-3 as a species in U.S. commerce; (“Potential Invertebrate Species-Related • Triggerfish (Canthidermis sufflamen and Hazards”) is changed as follows: Melichthys niger) is no longer listed as having • There are several scientific name changes to a potential CFP hazard; reflect changes in taxonomic conventions; • Tuna (Thunnus spp.) is now listed as a genus • Abalone (Haliotis spp.) is now listed as that is aquacultured; having a natural toxin hazard; • Turbot (Scophthalmus maximus, now Psetta • Conch (Lambis lambis) is now listed as a maxima) is now listed as a species that is species in U.S. commerce; aquacultured; • Crab, all species are now listed as having • Turtle (Malaclemys spp., Chelydra spp., a potential environmental chemical Apalone spp., and Trachemys spp.) is now contaminant and pesticide hazard; listed as a species in U.S. commerce; • Crab, Blue (Callinectes sapidus), is now listed • Turtle, Aquacultured (Malaclemys spp., as a species that is aquacultured; Chelydra spp., Apalone spp., and Trachemys • Crab, Japanese Freshwater (Geothelphusa spp.), is now listed as a species in U.S. dehaani), is now listed as a species in U.S. commerce; commerce; • Unicornfish (Naso unicornis) is now listed as • Crab, Sheep (Loxorhynchus grandis), is now a species in U.S. commerce; listed as a species in U.S. commerce; • Weakfish (Cynoscion spp.) is now listed as • Crab, Swamp (Scylla serrata), is now listed as having a potential environmental chemical a species in U.S. commerce; contaminant and pesticide hazard; • Murex, or Merex (Murex brandaris), is now • Weakfish, or Bangamary (Macrodon ancylodon), listed as a species in U.S. commerce; is now listed as a market name for a species • Oyster (Spondylus spp.) is now listed as a previously referred to as only weakfish; species in U.S. commerce; • Whiskered Fish (Arius spp.) is now listed • Sea Squirt (Styela spp.) is now listed as a as a market name for a species previously species in U.S. commerce; referred to as sea catfish; • Shrimp (Pleoticus muelleri) is now listed as a • Whiskered Fish, or Gafftopsail Fish (Bagre species in U.S. commerce; marinus), is now listed as a market name for • Snail, Moon (Polinices spp.), is now listed as a species previously referred to as sea catfish; a species in U.S. commerce; • Whiskered Fish, or Hardhead Whiskered • Whelk (Busycon spp.) is now listed as having Fish (Ariopsis felis), is now listed as a market a potential natural toxin hazard. name for a species previously referred to as sea catfish; The information contained in Table 3-4 • Wrasse (Cheilinus undulatus) is now listed as (“Potential Process-Related Hazards”) is a species in U.S. commerce; changed as follows: • Yellowtail Amberjack (Seriola lalandi) is now • Fish oil is now listed as a food category; listed as a species that is aquacultured and • Changes have been made to be consistent is no longer listed as having a potential CFP with changes in Chapters 13, 16, and 17. hazard; • Zander (Sander lucioperca) is now listed as a species that is aquacultured.

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition 6 The recommendations in Chapter 4 for the The recommendations in Chapter 6 for the control of pathogens from the harvest area are control of natural toxins are changed as follows: changed as follows: • Azaspiracid Poisoning (AZP) is now • Hydrostatic pressure, individual quick described, and an action level of 0.16 mg/kg freezing (IQF) with extended storage, is now provided; and irradiation are now identified as • Information regarding potential molluscan processes that are designed to retain shellfish toxins, pectenotoxins (PTXs) raw product characteristics and that can and yessotoxins (YTXs), is now provided, be used to reduce Vibrio vulnificus (V. although FDA has no specific expectations vulnificus) and Vibrio parahaemolyticus (V. for control of YTXs; parahaemolyticus) to non-detectable levels; • An example of a HACCP plan is now • It is now recognized that a tag on a container provided for control of natural toxins in of shellstock (in-shell molluscan shellfish) molluscan shellfish; received from another dealer need not • The action level for Diarrhetic Shellfish identify the harvester; Poisoning (DSP) is now listed as 0.16 ppm • Critical limits relating to control of pathogen total okadaic acid equivalents; growth prior to receipt of raw molluscan • Action levels for CFP are now listed as 0.01 shellfish by the primary processor are now ppb for Pacific ciguatoxin and 0.1 ppb for linked to monitoring the time that the Caribbean ciguatoxin; shellfish are exposed to air (i.e., by harvest or receding tide) rather than to the time that • It is now noted that in 2008, FDA advised the shellfish are harvested; against the consumption of lobster tomalley because unusually high levels of PSP toxins • Reference is now made to the role of the were detected in that organ in lobsters Federal, state, tribal, territorial and foreign caught in the waters of New England during government shellfish control authorities a red tide event; in determining whether the hazard of V. parahaemolyticus is reasonably likely to occur in • CFP is now described as being associated raw molluscan shellfish and in the development with consumption of toxin-contaminated fish of a V. parahaemolyticus control plan that will found in tropical or subtropical areas around dictate, at least to some extent, the nature of the the world between 35° north latitude and 35° controls for this pathogen in HACCP plans; south latitude, particularly the Caribbean Sea, • The control strategy examples are Pacific Ocean, and Indian Ocean and in the restructured for improved clarity: one for Flower Garden Banks area in the northern source controls (e.g., tagging, labeling, Gulf of Mexico; source waters, harvester licensure, and raw • Gempylotoxin is now described as being consumption advisory) and a second for time associated with orange roughy (Hoplostethus from harvest to refrigeration controls. atlanticus) and oreo dory (Allocyttus spp., Pseudocyttus spp. and Neocyttus spp.) The recommendations in Chapter 5 for the although in lesser amounts than escolar. control of parasites are changed as follows: • It is now recognized that the parasite hazard The recommendations in Chapter 7 for the may be reasonably likely to occur in fish control of scombrotoxin (histamine) formation raised in freshwater containing larvae of are changed as follows: pathogenic liver, lung and intestinal flukes • Information is now provided about the because these parasites enter the fish potential for scombrotoxin (histamine) through the skin rather than in the food.

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition 7 formation in products like tuna salad • The lower anterior portion of the loin is that have been allowed to become now identified as the best place to collect a recontaminated and then subjected to time sample from large fish for histamine analysis; and temperature abuse; • Fermenting, pickling, smoking, and drying • The recommendations regarding on-board are now identified as likely critical control chilling of scombrotoxin-forming species of points (CCPs) for this hazard; fish are now listed as follows: • When fish are checked for internal Fish exposed to air or water temperatures temperature at off-loading, it is now above 83°F (28.3°C) should be placed in recommended that: ice, or in refrigerated seawater, ice slurry, For fish held iced or refrigerated (not or brine of 40°F (4.4°C) or less, as soon frozen) onboard the vessel and off- as possible during harvest, but not more loaded from the vessel by the processor than 6 hours from the time of death, or 24 or more hours after death, the internal Fish exposed to air and water temperature should be 40°F (4.4°C) or temperatures of 83°F (28.3°C) or less below, should be placed in ice, or in refrigerated OR seawater, ice slurry, or brine of 40°F For fish held iced or refrigerated (not (4.4°C) or less, as soon as possible frozen) onboard the vessel and off- during harvest, but not more than 9 loaded from the vessel by the processor hours from the time of death, or from 15 to less than 24 hours after death, Fish that are gilled and gutted before the internal temperature should be 50°F chilling should be placed in ice, or (10°C) or below, in refrigerated seawater, ice slurry, or OR brine of 40°F (4.4°C) or less, as soon as possible during harvest, but not more For fish held iced or refrigerated (not than 12 hours from the time of death, or frozen) onboard the vessel and off- loaded from the vessel by the processor Fish that are harvested under conditions from 12 to less than 15 hours after death, that expose dead fish to harvest waters the internal temperature should be 60°F of 65°F (18.3°C) or less for 24 hours or (15.6°C) or below; less should be placed in ice, refrigerated seawater, ice slurry, or brine of 40°F • The recommended level at which a lot (4.4°C) or less, as soon as possible after should be rejected based on sensory harvest, but not more than the time limits examination when 118 fish are examined listed above, with the time period starting is now corrected to be no more than 2 fish when the fish leave the 65°F (18.3°C) or to coincide with the goal of less than 2.5% less environment; decomposition in the lot; • Cautions are now provided that handling • It is now recommended that the number of practices and processing controls that are fish subjected to sensory examination be recommended as suitable for preventing increased if there is likely to be greater than the formation of scombrotoxin may not normal variability in the lot, and that only be sufficient to prevent fish from suffering one species constitute a lot for sampling quality or shelf-life degradation (i.e., purposes; decomposition) in a way that may otherwise • When histamine analysis is performed as a render it adulterated under the Federal Food, corrective action, it is now recommended Drug, and Cosmetic Act; that any fish found to exceed the internal

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition 8 temperature at receiving critical limit be or internal product temperatures are used included in the sample; at receipt of fish from another processor, it • When the sensory critical limit has not is now recommended that the number of been met, it is now recommended that containers examined and the number of the processor perform histamine analysis containers in the lot be recorded; of a minimum of 60 fish, collected • Control of scombrotoxin (histamine) representatively from throughout the lot, formation during processing and storage are including all fish in the lot that show now provided as separate control strategy evidence of decomposition, and reject the lot examples, and examples of HACCP plans are if any fish are found with a histamine level now provided for both strategies; greater than or equal to 50 ppm; • The extended exposure times during • Subdividing and retesting for histamine is no processing (more than 12 hours, longer recommended after an initial failed cumulatively, if any portion of that time is at histamine test; temperatures above 70°F (21.1°C); or more • It is now recommended that employees who than 24 hours, cumulatively, as long as no conduct sensory screening receive adequate portion of that time is at temperatures above training; 70°F (21.1°C)) previously recommended for fish that have been previously frozen are • It is now recommended that for shipments now also recommended for fish that have of scombrotoxin-forming species received been previously heat treated sufficiently under ice on open-bed trucks be checked for to destroy scombrotoxin-forming bacteria both sufficiency of ice and internal product and are subsequently handled in a temperature; manner where there is an opportunity for • It is now recommended that shipments of recontamination with scombrotoxin-forming scombrotoxin-forming species received under bacteria; gel packs be checked for both adequacy of • It is now acknowledged that it may be gel packs and internal product temperature; possible to control scombrotoxin formation • It is now recommended that if only the during unrefrigerated processing using a internal temperature of fish is checked at critical limit that is time of exposure only receipt by a secondary processor because (i.e., no temperature component), if it is the transit time is no more than 4 hours, developed with an assumption that worst- calculation of transit time should include case temperatures (e.g., in excess of 70°F all time outside a controlled temperature (21.1°C)) may occur; environment; • Chemical coolants (e.g., gel packs) are • It is now recommended that if only the no longer recommended for control of internal temperature of fish is checked at temperature during in-plant storage; receipt by a secondary processor because • For control of time and temperature during the transit time is no more than 4 hours, refrigerated storage, it is now noted that a temperature-indicating device (e.g., a critical limits that specify a cumulative time thermometer) should be used to determine and temperature of exposure to temperatures internal product temperatures in a minimum above 40°F (4.4°C) are not ordinarily suitable of 12 fish, unless there are fewer than 12 fish because of the difficulty in determining in a lot, in which case all of the fish should when specific products have entered and be measured; left the cooler and the time and temperature • When checks of the sufficiency of ice or exposures to which they were subjected. chemical cooling media, such as gel packs, However, there may be circumstances where

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition 9 this approach is suitable. It is also noted • When testing for environmental chemical that minor variations in cooler temperature contaminants and pesticides is used as the measurements can be avoided by control measure, it is now recommended submerging the sensor for the temperature- that the adequacy of the testing methods recording device in a liquid that mimics the and equipment be verified periodically (e.g., characteristics of the product; by comparing results with those obtained • High-temperature alarms are no longer using an Association of Official Analytical recommended for monitoring temperatures Chemists (AOAC) or equivalent method, or in coolers or processing areas; by analyzing proficiency samples). • When the adequacy of ice is established as Chapter 10, which covers the control of the critical limit for refrigerated storage, it methylmercury, has been rewritten to is now recommended that monitoring be acknowledge that FDA is receiving comments performed with sufficient frequency to ensure on a draft quantitative risk assessment control rather than at least twice per day. for methylmercury, which may result in a The recommendations in Chapter 8 related reassessment of its risk management strategies. to other decomposition-related hazards are changed as follows: The recommendations in Chapter 11 for the control of aquaculture drugs are changed as • It is now noted that FDA has received follows: consumer complaints concerning illnesses associated with the consumption of • The potential for this hazard to occur during decomposed salmon, attributable to the transportation of live fish is now recognized, production in the fish of toxins other than and recommended controls are provided; histamine (e.g., biogenic amines, such as • An explanation of extra-label use of drugs is putrescine and cadaverine); now provided, and a list of drugs prohibited • It is now noted that there are also some for extra-label use is now listed; indications that chemicals formed when fats • FDA high enforcement priority aquaculture and oils in foods oxidize may contribute to drugs are now listed; long-term detrimental health effects. • Aquaflor® Type A Medicated Article (florfenicol) is now listed as an approved The recommendations in Chapter 9 for the drug for catfish and salmonids; control of environmental chemical contaminants ® and pesticides are changed as follows: • Aquaflor CA1 is now listed as an approved drug for catfish or in fingerling to food fish • Toxic element guidance levels for arsenic, as the sole ration for 10 consecutive days. cadmium, lead, and nickel are no longer listed; • 35% PEROX-AID® (hydrogen peroxide) • Tolerance levels for endothall and its is now listed as an approved drug for monomethyl ester in fish and carbaryl in freshwater-reared salmonids and freshwater- oysters are now listed; reared cool water finfish and channel catfish; • The collection of soil samples from • Terramycin® 200 for Fish (oxytetracycline aquaculture production sites is no longer dihydrate) Type C, is now listed as an approved listed as a preventive measure; drug for catfish, salmonids; and lobster; • An example of a HACCP plan is now • OxyMarine™, Oxytetracycline HCl Soluble provided for control of environmental Powder-343, Terramycin-343, TETROXY Aquatic chemical contaminants in molluscan is now listed as an approved drug for all finfish shellfish; fry and fingerlings as an aid in identification;

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition 10 • Quarterly raw material, in-process, • For control of transit conditions at receipt or finished product testing is now of ready-to-eat fish or fishery products recommended as a verification step for delivered refrigerated (not frozen), it is now control strategies involving review of recommended that all lots be accompanied suppliers’ certificates at receipt of raw by transportation records that show that materials, review of records of drug use at the fish were held at or below an ambient receipt of raw materials, and on-farm visits; or internal temperature of 40°F (4.4°C) • When testing for aquaculture drugs is throughout transit or, for transit times of 4 used as the control measure, it is now hours or less, that the internal temperature recommended that the adequacy of the of the fish at time of receipt was at or below testing methods and equipment be verified 40°F (4.4°C); periodically (e.g., by comparing results with • For control of time and temperature those obtained using an AOAC or equivalent during refrigerated storage and refrigerated method, or by analyzing proficiency processing, it is now noted that critical samples). limits that specify a cumulative time and temperature of exposure to temperatures The recommendations in Chapter 12 for the above 40°F (4.4°C) are not ordinarily suitable control of pathogenic bacteria growth and because of the difficulty in determining toxin formation (other than C. botulinum) as when specific products have entered and a result of time and temperature abuse are left the cooler and the time and temperature changed as follows: exposures to which they were subjected. • It is now recognized that V. vulnificus, V. However, there may be circumstances where parahaemolyticus, and Vibrio cholarae this approach is suitable. It is also noted non-O1 and non-0139 are generally that minor variations in cooler temperature associated with marine and estuarine species measurements can be avoided by of fish and may not be reasonably likely to submerging the sensor for the temperature- occur in freshwater species or non-fishery recording device in a liquid that mimics the ingredients, unless they have been cross- characteristics of the product; contaminated; • It is now recommended that if only the • It is now clarified that products that are internal temperature of the fishery product partially cooked to set the batter or breading is checked at receipt, because the transit or stabilize the product shape (e.g., fish balls, time is no more than 4 hours, calculation of shrimp egg rolls, and breaded fish portions) transit time should include all time outside a are not considered to be ready to eat; controlled temperature environment; • Information is now provided on the • It is now recommended that if only the determination of CCPs for products that are a internal temperature of product is checked combination of raw, ready-to-eat and cooked, at receipt by a secondary processor because ready-to-eat fishery ingredients; the transit time is no more than 4 hours, • Control of time and temperature abuse a temperature-indicating device (e.g., a at receipt, during cooling after cooking, thermometer) should be used to determine during unrefrigerated processing, and during internal product temperatures in a minimum refrigerated storage and processing are now of 12 containers (e.g., cartons and totes), provided as four separate control strategy unless there are fewer than 12 containers examples. Examples of HACCP plans are in a lot, in which case all of the containers now provided for all four strategies; should be measured;

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition 11 • When checks of the sufﬁciency of ice or Alternatively, the product is held at chemical cooling media, such as gel packs, ambient air temperatures below 50°F or internal product temperatures are used (10°C) throughout processing; at receipt of ﬁsh from another processor, it is now recommended that the number of For cooked, ready-to-eat products: containers examined and the number of If at any time the product is held at containers in the lot be recorded; internal temperatures above 80°F • Chemical coolants (e.g., gel packs) are (27.2°C), exposure time (i.e., time at no longer recommended for control of internal temperatures above 50°F (10°C) temperature during in-plant storage; but below 135ºF (57.2ºC)) should be • Recommended cumulative exposure times limited to 1 hour (3 hours if S. aureus is and temperatures (i.e., critical limits) are now the only pathogen of concern), listed as follows: OR

For raw, ready-to-eat products: Alternatively, if at any time the product is held at internal temperatures above If at any time the product is held at 80°F (26.7°C), exposure time (i.e., time at internal temperatures above 70°F internal temperatures above 50°F (10°C) (21.1°C), exposure time (i.e., time but below 135ºF (57.2ºC)) should be at internal temperatures above 50°F limited to 4 hours, as long as no more (10°C) but below 135ºF (57.2ºC)) than 1 of those hours is above 70°F should be limited to 2 hours (3 hours if (21.1°C), Staphylococcus aureus (S. aureus) is the only pathogen of concern), OR OR If at any time the product is held at internal temperatures above 70°F Alternatively, exposure time (i.e., time at (21.1°C), but never above 80°F (26.7°C), internal temperatures above 50°F (10°C) exposure time at internal temperatures but below 135ºF (57.2ºC)) should be above 50°F (10°C) should be limited to limited to 4 hours, as long as no more 2 hours (3 hours if S. aureus is the only than 2 of those hours are between 70°F pathogen of concern), (21.1°C) and 135ºF (57.2ºC), OR OR Alternatively, if the product is never held at If the product is held at internal internal temperatures above 80°F (26.7°C), temperatures above 50°F (10°C), but never exposure times at internal temperatures above 70°F (21.1°C), exposure time at above 50°F (10°C) should be limited to 4 internal temperatures above 50°F (10°C) hours, as long as no more than 2 of those should be limited to 5 hours (12 hours if S. hours are above 70°F (21.1°C), aureus is the only pathogen of concern), OR OR If the product is held at internal The product is held at internal temperatures above 50°F (10°C), but never temperatures below 50°F (10°C), above 70°F (21.1°C), exposure time at OR internal temperatures above 50°F (10°C) should be limited to 5 hours (12 hours if S. aureus is the only pathogen of concern),

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition 12 OR spoilage organisms have been eliminated or The product is held at internal significantly reduced by such processes as temperatures below 50°F (10°C), high pressure processing and (2) refrigeration is the sole barrier to toxin formation. The OR generally recommended 10,000 cc/m2/24 Alternatively, the product is held at hours at 24ºC oxygen transmission rates may ambient air temperatures below 50°F not be suitable in this case; (10°C) throughout processing; • High-temperature alarms are no longer • High-temperature alarms are no longer recommended for monitoring temperatures recommended for monitoring temperatures in coolers or processing areas; in coolers or processing areas; • Chemical coolants (e.g., gel packs) are • When the adequacy of ice is established as no longer recommended for control of the critical limit for refrigerated storage, it temperature during in-plant storage; is now recommended that monitoring be • When the adequacy of ice is established performed with sufficient frequency to ensure as the critical limit for refrigerated storage, control rather than at least twice per day; it is now recommended that monitoring • It is now recommended that monitoring be performed with sufficient frequency to shipments received under gel packs include ensure control rather than at least twice per both adequacy of gel packs and internal day; product temperature. • It is now recommended that a water phase salt level of 20% be achieved in shelf-stable, The recommendations in Chapter 13 for the reduced oxygen packaged products in which control of C. botulinum toxin formation are salt is the only barrier to pathogenic bacteria changed as follows: growth and toxin formation; • Information is now provided on Time- • It is now recommended that monitoring Temperature Indicator (TTI) performance shipments received under gel packs include and suitability; both adequacy of gel packs and internal • A control strategy is now provided for product temperature; application of TTIs on each of the smallest • It is now recommended that if only the package units (i.e., the unit of packaging that internal temperature of the fishery product will not be distributed any further, usually is checked at receipt, because the transit consumer or end-user package), where time is no more than 4 hours, calculation of refrigeration is the sole barrier to prevent transit time should include all time outside a toxin formation; controlled temperature environment; • It is no longer recommended that • It is now recommended that if only the consideration be given to whether the internal temperature of product is checked finished product will be stored and at receipt by a secondary processor because distributed frozen when determining whether the transit time is no more than 4 hours, the hazard is significant. A control strategy is a temperature-indicating device (e.g., a now provided to ensure that frozen products thermometer) should be used to determine are properly labeled when freezing is the internal product temperatures in a minimum sole barrier to prevent toxin formation; of 12 containers (e.g., cartons and totes), • Processors are now advised to take particular unless there are fewer than 12 containers care in determining the safety of a packaging in a lot, in which case all of the containers material for a product in which (1) the should be measured;

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition 13 • A control strategy example is now provided • The separate chapters that previously for receipt by a secondary processor of covered pathogen survival through cooking refrigerated reduced oxygen packaged and pathogen survival through pasteurization products that may be stored and further are now combined; distributed or used as an ingredient for • Pasteurization is now defined as a heat further processing; treatment applied to eliminate the most • It is now clarified that brining time should be resistant pathogen of public health concern monitored during the processing of smoked that is reasonably likely to be present in fish; food; • It is now recommended that brine be • Information is now provided for an option treated to minimize microbial contamination to monitor End-Point Internal Product or be periodically replaced as a good Temperature, instead of continuous time manufacturing practice control. and temperature monitoring during cooking or pasteurization, when a scientific study The recommendations in Chapter 14 for the has been conducted to validate that it will control of pathogenic bacteria growth and provide a 6D process for the target pathogen; toxin formation as a result of inadequate drying are changed as follows: • For surimi-based products, soups, or sauces, the following pasteurization process is now • It is no longer recommended that consideration recommended: a minimum cumulative, be given to whether the finished product total lethality of F194°F (F90°C) = 10 minutes, will be stored and distributed frozen (in the where z = 12.6°F (7°C) for temperatures less case of reduced oxygen packaged products) than 194°F (90°C), and z = 18°F (10°C) for or refrigerated (in the case of aerobically temperatures above 194°F (90°C); packaged products) when determining whether • For dungeness crabmeat, the following the hazard is significant. A control strategy pasteurization process is now recommended: to ensure that refrigerated dried products are a minimum cumulative total lethality of F properly labeled when refrigeration is the sole 194°F (F ) = 57 minutes, where z = 15.5°F (8.6°C); barrier to toxin formation is now provided. A 90°C control strategy to ensure that frozen products • Information concerning levels of Listeria are properly labeled when freezing is the sole monocytogenes (L. monocytogenes) in foods barrier to toxin formation is now provided in is now updated based on the final FDA/U.S. Chapter 13. Department of Agriculture L. monocytogenes risk assessment. The recommendations in Chapter 15 for the control of S. aureus toxin formation in hydrated Chapter 17 is a new chapter that contains batter mixes are changed as follows: guidance for the control of pathogen survival through processes designed to retain raw • The number of S. aureus organisms normally product characteristics, including high needed to produce toxin is now listed as hydrostatic pressure processing, mild heat 500,000 to 1,000,000 per gram; processing, IQF with extended frozen storage, • High-temperature alarms are no longer and irradiation. At present, the chapter applies recommended for monitoring temperatures exclusively to the processing of molluscan in processing areas. shellfish products for which there is a desire to retain raw product characteristics. However, The recommendations in Chapter 16 for the these technologies may have other applications control of pathogenic bacteria survival through as well. cooking are changed as follows:

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition 14 The recommendations in Chapter 18 for the • The use of sulfiting agents in conch meat is control of the introduction of pathogenic now identified as a reasonably likely hazard. bacteria after pasteurization and specialized cooking processes are changed as follows: The recommendations in Chapter 20 for the control of metal inclusion are changed as • It is no longer recommended that consideration follows: be given to whether the finished product will be stored and distributed frozen when • Foreign objects less than 0.3 inch (7 mm) determining whether the hazard is significant. are now identified as having a potential for A control strategy to ensure that frozen causing trauma or serious injury to persons products are properly labeled when freezing is in special risk groups, such as infants, the sole barrier to prevent C. botulinum toxin surgery patients, and the elderly; formation is now provided in Chapter 13. • Additional information on calibration and validation of electronic metal detectors is The recommendations in Chapter 19 for the now provided; control of undeclared food allergens and • Wire mesh baskets are no longer used as intolerance substances and prohibited food an example of an unlikely source of metal and color additives are changed as follows: fragments; • Additional explanatory material on food • The recommended critical limit for the metal allergens is now included, with information detection or separation control strategy has on the Food Allergen Labeling and been expanded to read, “All product passes Consumer Protection Act of 2004 and its through an operating metal detection or impact on preventive controls for allergens; separation device,” and “No detectable metal • Additional information is now provided on fragments in a product passing through the factors to be considered in judging when the metal detection or separation device.” the presence of certain food intolerance As a result, the recommended monitoring substances and prohibited food and color procedures are also expanded so that they additives is or is not reasonably likely to now are designed to also ensure that the occur, such as the historical use of the processes are in place and operating; substance and the expected level of sulfiting • It is now recommended that when metal agent in the formulated finished food; fragments are found in a product by a metal • Additional information is now provided on detector or separated from the product stream regulatory requirements for food additives. by magnets, screens, or other devices, the • Corrective actions are now expanded to source of the fragment is located and corrected. include steps that should be taken to regain The recommendations in Chapter 21 for the control over the operation after a critical limit control of glass inclusion are changed as follows: deviation, for consistency with guidance in the other chapters; • This chapter is no longer identified as a draft; • It is now recommended that finished product • The use of x-ray detection devices is no labels be checked at time of labeling rather longer recommended as a reliable method for than at time of label receiving; controlling glass inclusion; • It is now recommended that finished product • The recommended critical limit for the glass testing be included as a verification step container cleaning and visual inspection when review of suppliers’ labeling is used as control strategy has been expanded to read, a monitoring procedure for the presence of “All container pass through an operating sulfiting agents; glass container inspection or cleaning

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition 15 process,” and “No detectable glass fragments exposure times for Bacillus cereus are now in glass containers passing the CCP.” As listed as follows: 5 days at temperatures of a result, the recommended monitoring 39.2 to 43°F (4 to 6°C); 1 day at temperatures procedures are also expanded so that they of 44 to 59°F (7 to 15°C); 6 hours at now are designed to also ensure that the temperatures of 60 to 70°F (16 to 21°C); and processes are in place and operating; 3 hours at temperatures above 70°F (21°C); • The monitoring procedures for the • The maximum cumulative exposure times for glass container cleaning and visual E. coli, Salmonella, and Shigella spp. are now inspection control strategy now include a listed as follows: 2 days for temperatures recommendation that a representative sample from their minimum growth temperature of the cleaned or inspected containers be 41.4 to 50°F (10°C); 5 hours for temperatures examined at the start of processing, every of 51 to 70°F (11 to 21°C); and 2 hours for 4 hours during processing, at the end of temperatures above 70°F (21°C); processing, and after any breakdowns; • The maximum cumulative exposure times • It is now recommended that monitoring for for Listeria monocytogenes are now listed the presence of glass be performed at the as follows: 7 days for temperatures of 31.3 start of each production day and after each to 41ºF (-0.4 to 5ºC); 1 day for temperatures shift change. of 42 to 50°F (6 to 10°C); 7 hours for • It is now recommended that a temperatures of 51 to 70°F (11 to 21°C); 3 representative sample of cleaned or hours for temperatures of 71 to 86°F (22 to inspected glass containers be examined 30°C); and 1 hour for temperatures above daily, at the start of processing, every 4 86°F (30°C); hours during processing, at the end of • The maximum cumulative exposure times processing, and after any breakdowns. for Vibrio cholerae, V. vulnificus, and V. parahaemolyticus are now listed as follows: The Hazard Analysis Worksheet in Appendix 21 days for temperatures from their minimum 1 has been changed for consistency with the growth temperature to 50°F (10°C); 6 hours worksheet in the “HACCP: Hazard Analysis for temperatures of 51 to 70°F (11 to 21°C); Critical Control Point Training Curriculum,” 2 hours at temperatures of 71 to 80°F (22 to developed by the Seafood HACCP Alliance for 26.7°C); and 1 hour at temperatures above Training and Education. 80°F (26.7°C), with the last temperature range The recommendations in Appendix 4 for applying only to cooked, ready-to-eat products. bacterial pathogen growth and inactivation are The safety levels listed in Appendix 5, Table changed as follows: A-5, “FDA and EPA Safety Levels in Regulations • Recommended summary cumulative and Guidance,” are changed as follows: exposure times and temperatures are now • Toxic element guidance levels for arsenic, listed as described above for Chapter 12; cadmium, lead, and nickel are no longer • The maximum water phase salt level for listed; growth of Campylobacter jejuni is now listed • Tolerance levels for endothall and its as 1.7%; monomethyl ester in fish and carbaryl in • The maximum level of acidity (pH) for oysters are now listed; growth of pathogenic strains of Escherichia • A tolerance level for Florfenicol in channel coli (E. coli) is now listed as 10; catfish and freshwater-reared salmonids is • The maximum recommended cumulative now listed;

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition 16 • The tolerance for oxytetracycline is now corrected to apply to all finfish and lobster; • The tolerance for sulfamerazine is now corrected to apply to trout; • A list of drugs prohibited for extra-label use is now provided; • V. parahaemolyticus and V. vulnificus levels are now listed for post-harvest processed molluscan shellfish. Appendix 6 no longer lists food allergens. It now contains a table of Japanese and Hawaiian vernacular names and their corresponding U.S. market names.

Appendix 7 no longer lists the bibliography. It now contains information regarding the public health impacts of bacterial and viral pathogens of greatest concern in seafood processing.

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition 17 NOTES:

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition 18 CHAPTER 1: General Information

THE GUIDANCE

This is the fourth edition of the Food and Drug Copies of the training document may be Administration’s (FDA’s) “Fish and Fishery Products purchased from: Hazards and Controls Guidance.” This guidance Florida Sea Grant relates to FDA’s Fish and Fishery Products IFAS - Extension Bookstore regulation (called the Seafood HACCP Regulation, University of Florida 21 CFR 123, in this guidance document) and the P.O. Box 110011 Control of Communicable Diseases regulation, Gainesville, FL 32611-0011 21 CFR 1240, that require processors of fish (800) 226-1764 and fishery products to develop and implement HACCP systems for their operations. Those final Or regulations were published in the Federal Register www.ifasbooks.com on December 18, 1995, and became effective on December 18, 1997. The codified portion of the Or you may download a copy from: regulations is included in Appendix 8. http://www.fda.gov/FoodGuidances This guidance is being issued as a companion document to “HACCP: Hazard Analysis Critical Control Point Training Curriculum,” which was developed by the Seafood HACCP Alliance for Training and Education. The Alliance is an organization of federal and state regulators, including FDA, academia, and the seafood industry. FDA recommends that processors of fish and fishery products use the two documents together in the development of a HACCP system. This guidance document will be maintained on the FDA.GOV website, which should be consulted for subsequent updates.

CHAPTER 1: General Information 19 NOTES:

CHAPTER 1: General Information 20 CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan

THE HACCP PLAN FORM THE HAZARD ANALYSIS WORKSHEET

This guidance document is designed to walk In order to complete the HACCP Plan Form, you through a series of 18 steps that will yield a you will need to perform a process called completed Hazard Analysis Critical Control Point hazard analysis. The Seafood HACCP Regulation (HACCP) plan. A blank HACCP Plan Form is requires that all seafood processors conduct, contained in Appendix 1. Note that this is a two- or have conducted for them, a hazard analysis page form, with the second page to be used if to determine whether there are food safety your process has more critical control points than hazards that are reasonably likely to occur in can be listed on one page. The Procedures for their product and to the preventive measures that the Safe and Sanitary Processing and Importing a processor can apply to control those hazards of Fish and Fishery Products regulation, 21 CFR (21 CFR 123.6(a)). FDA has found that the use 123 (hereinafter, the Seafood HACCP Regulation), of a standardized Hazard Analysis Worksheet requires that you prepare a HACCP plan for fish assists with this process. A blank Hazard Analysis and fishery products that you process if there are Worksheet is contained in Appendix 1. Note that significant food safety hazards associated with the this is also a two-page form, with the second page products. The regulation does not require that you to be used if your process has more processing use the form included in Appendix 1. However, steps than can be listed on one page. The Seafood using this standardized form may help you develop HACCP Regulation does not require that the an acceptable plan and will expedite regulatory hazard analysis be kept in writing. However, review. A separate HACCP plan should be FDA expects that a written hazard analysis will developed for each location where fish and fishery be useful when you perform mandatory HACCP products are processed and for each kind of fish plan reassessments and when you are asked by and fishery product processed at that location. You regulators to justify why certain hazards were or may group products together in a single HACCP were not included in your HACCP plan. plan if the food safety hazards and controls are the same for all products in the group.

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan 21 THE STEPS PRELIMINARY STEPS

Following is a list of the steps that this guidance STEP 1: Provide general information. uses in HACCP plan development: Record the name and address of your processing • Preliminary Steps facility in the spaces provided on the first page Provide general information; of both the Hazard Analysis Worksheet and the Describe the food; HACCP Plan Form (Appendix 1). Describe the method of distribution and storage; STEP 2: Describe the food. Identify the intended use and consumer; Identify the market name or Latin name (species) Develop a flow diagram. of the fishery component(s) of the product.

• Hazard Analysis Worksheet Examples: Set up the Hazard Analysis Worksheet; • Tuna (Thunnus albacares); Identify potential species-related hazards; • Pandals spp.); Identify potential process-related hazards; • Jack ma Understand the potential hazard; Fully describe the ﬁnished product food. Determine whether the potential hazard Examples: is signiﬁcant; • Individually quick frozen, cooked, peeled Identify critical control points. shrimp;

• HACCP Plan Form • Fresh tuna steaks; Set up the HACCP Plan Form; • Frozen, surimi-based, imitation king crab legs; Set critical limits; • Fresh, raw drum, in-the-round; Establish monitoring procedures: • Raw shrimp, in-shell; • What, • Raw, shucked clams; • How, • Fresh seafood salad, with shrimp and blue • Frequency, crabmeat; • Frozen, breaded pollock sticks; • Who; • Frozen crab cakes. Establish corrective action procedures; Describe the packaging type. Establish a recordkeeping system; Establish veriﬁcation procedures. Examples: • Vacuum-packaged plastic bag; • Aluminum can; • Bulk, in wax-coated paperboard box; • Plastic container with snap lid. Record this information in the space provided on the ﬁrst page of both the Hazard Analysis Worksheet and the HACCP Plan Form.

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan 22 STEP 3: Describe the method of distribution STEP 5: Develop a flow diagram. and storage. The purpose of the diagram is to provide a Identify how the product is distributed and stored clear, simple description of the steps involved in after distribution. the processing of your fishery product and its associated ingredients as they “flow” from receipt Examples: to distribution. The flow diagram should cover • Stored and distributed frozen; all steps in the process that your firm performs. • Distributed on ice and then stored under Receiving and storage steps for each of the refrigeration or on ice. ingredients, including non-fishery ingredients, Record this information in the space provided should be included. The flow diagram should be on the first page of both the Hazard Analysis verified on-site for accuracy. Worksheet and the HACCP Plan Form. Figure A-1 (Appendix 2) is an example of a flow diagram. STEP 4: Identify the intended use and consumer. HAZARD ANALYSIS WORKSHEET Identify how the product will be used by the end user or consumer. STEP 6: Set up the Hazard Analysis Examples: Worksheet. • To be heated (but not fully cooked) and Record each of the processing steps (from served; the flow diagram) in Column 1 of the Hazard • To be eaten with or without further cooking; Analysis Worksheet. • To be eaten raw or lightly cooked; STEP 7: Identify the potential species-related • To be fully cooked before consumption; hazards. • To be further processed into a heat and serve product. Biological, chemical, and physical hazards can Identify the intended consumer or user of the affect the safety of fishery products. Some food product. The intended consumer may be the safety hazards are associated with the product general public or a particular segment of the (e.g., the species of fish, the way in which the population, such as infants or the elderly. The fish is raised or caught, and the region of the intended user may also be another processor that world from which the fish originates). These will further process the product. hazards are introduced outside the processing plant environment before, during, or after Examples: harvest. This guidance refers to these as “species- • By the general public; related hazards.” Other food safety hazards are • By the general public, including some associated with the way in which the product distribution to hospitals and nursing homes; is processed (e.g., the type of packaging, the • By another processing facility. manufacturing steps, and the kind of storage). These hazards are introduced within the Record this information in the space provided processing plant environment. This guidance on the first page of both the Hazard Analysis refers to these as “process-related hazards.” They Worksheet and the HACCP Plan Form. are covered in Step 8. Find in Table 3-2 (Chapter 3) or Table 3-3 (Chapter 3) the market name (Column 1) or

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan 23 Latin name (Column 2) of the product that you You may need to include potential hazards for identified in Step 2. Use Table 3-2 for vertebrates more than one finished product food category (animals with backbones) such as finfish. Use from Table 3-4, which will happen when your Table 3-3 for invertebrates (animals without product fits more than one description. For backbones) such as shrimp, oysters, crabs, and example, if you cook shrimp and use it to prepare lobsters. Determine whether the species has a a finished product salad, you should look at both potential species-related hazard by looking for the “cooked shrimp” and the “salads … prepared a “√” mark (or one- or three-letter codes for a from ready-to-eat fishery products” categories in natural toxin) in the right-hand columns of the Table 3-4, Column 1. Potential hazards from both table. If it does, record the potential species- finished product food categories apply to your related hazard(s) in Column 2 of the Hazard product and should be listed in Column 2 of the Analysis Worksheet, at every processing step. Hazard Analysis Worksheet. Tables 3-2 and 3-3 include the best information Table 3-4 includes the best information currently currently available to FDA concerning hazards that available to FDA concerning hazards that are are specific to each species of fish. You should use related to specific processing techniques. You your own expertise, or that of outside experts, as should use your own expertise, or that of outside necessary, to identify any hazards that may not experts as necessary, to identify any hazards be included in the table (e.g., those that may be that may not be included in the table (e.g., those new or unique to your region). You may already that are new or unique to your physical plant, have effective controls in place for a number of equipment, or process). these hazards as part of your routine or traditional handling practices. The presence of such controls STEP 9: Understand the potential hazard. does not mean that the hazard is not significant. Consult the hazards and controls chapters of The likelihood of a hazard occurring should be this guidance document (Chapters 4 through 7, judged in the absence of controls. For example, the 9, and 11 through 21) for each of the potential fact that scombrotoxin (histamine) development hazards that you entered in Column 2 of the in a particular species of fish has not been noted Hazard Analysis Worksheet. These chapters offer may be the result of (1) the inability of the fish to guidance for completing your hazard analysis produce histamine or (2) the existence of controls and developing your HACCP plan. Each chapter that are already in place to prevent its development contains a section, “Understand the Potential (e.g., harvest vessel time and temperature controls). Hazard,” that provides information about the In the first case, the hazard is not reasonably significance of the hazard, the conditions under likely to occur. In the second case, the hazard is which it may develop in a fishery product, and reasonably likely to occur, and the controls should methods available to control the hazard. be included in the HACCP plan. STEP 10: Determine whether the potential STEP 8: Identify potential process-related hazard is significant. hazards. Narrow the list of potential hazards that you Find in Table 3-4 (Chapter 3) the finished product entered in Column 2 of the Hazard Analysis food (Column 1) and package type (Column 2) Worksheet to those that are significant or, in that most closely match the information that you other words, “reasonably likely to occur.” The developed in Steps 2 and 3. Record the potential Seafood HACCP Regulation defines a food safety hazard(s) listed in the table for that product in hazard that is reasonably likely to occur as “one Column 2 of the Hazard Analysis Worksheet, at for which a prudent processor would establish every processing step. controls because experience, illness data,

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan 24 scientific reports, or other information provide STEP 11: Identify critical control points. a basis to conclude that there is a reasonable possibility that it will occur in the particular type For each processing step where a significant of fish or fishery product being processed in the hazard is identified in Column 3 of the Hazard absence of those controls.” Analysis Worksheet, determine whether it is necessary to exercise control at that step The hazards and controls chapters of this in order to control the hazard. Figure A-2 guidance (Chapters 4 through 7, 9, and 11 (Appendix 3) is a critical control point (CCP) through 21) each contain a section, “Determine decision tree that can be used to aid you in Whether this Potential Hazard Is Significant,” your determination. that provides information about how to assess the significance of potential hazards. You should The hazards and controls chapters of this evaluate the significance of a potential hazard guidance (Chapters 4 through 7, 9, and 11 independently at each processing step. It may through 21) each contain a section, “Identify be significant at one step but not at another. A Critical Control Points (CCPs),” which provides potential hazard is significant at the processing information about where control should be or handling step if (1) it is reasonably likely that exercised. Each chapter discusses one or more the hazard can be introduced at an unsafe level “control strategy example(s)” for how the hazard at that processing step; or (2) it is reasonably can be controlled, because there are often more likely that the hazard can increase to an unsafe ways than one to control a hazard. CCP(s) for level at that processing step; or (3) it is significant one control strategy example often differ from at another processing or handling step and it those of another example for the same hazard. can be prevented, eliminated, or reduced to The control strategies contain preventive measure an acceptable level at the current processing or information. Record the preventive measure(s) in handling step. When evaluating the significance Column 5 of the Hazard Analysis Worksheet for of a hazard at a processing step, you should each “Yes” answer in Column 3. consider the method of distribution and storage For every significant hazard, there must be at and the intended use and consumer of the least one CCP where the hazard is controlled product, which you developed in Steps 3 and 4. (21 CFR 123.6(c)(2)). In some cases, control may If you determine that a potential hazard is be necessary at more than one CCP for a single significant at a processing step, you should hazard. In other cases, a processing step may answer “Yes” in Column 3 of the Hazard Analysis be a CCP for more than one hazard. CCPs are Worksheet. If you determine that a potential points in the process (i.e., processing steps) hazard is not significant at a processing step, you where the HACCP control activities will occur. should answer “No” in that column. You should Control activities at a CCP can effectively prevent, record the reason for your “Yes” or “No” answer eliminate, or reduce the hazard to an acceptable in Column 4. You need not complete Steps 11 level (21 CFR 123.3(b)). through 18 for a hazard for those processing If you determine that a processing step is a CCP steps where you have recorded a “No.” for a significant hazard, you should enter “Yes” in It is important to note that identifying a hazard Column 6 of the Hazard Analysis Worksheet. If as significant at a processing step does not mean you determine that a processing step is not a CCP that it must be controlled at that processing step. for a significant hazard, you should enter “No” Step 11 will help you determine where in the in that column. You need not complete Steps 12 process the critical control point is located. through 18 for a hazard for those processing steps where you have recorded a “No.”

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan 25 HACCP PLAN FORM met, but before a critical limit deviation would require you to take corrective action. You should set operating limits based on your experience STEP 12: Set up the HACCP Plan Form. with the variability of your operation and with Find the processing steps that you have identified the closeness of typical operating values to the as CCPs in Column 6 of the Hazard Analysis critical limit. Worksheet. Record the names of these processing Consider that the critical limit should directly steps in Column 1 of the HACCP Plan Form. relate to the parameter that you will be Enter the hazard(s) for which these processing monitoring. For example, if you intend to steps were identified as CCPs in Column 2 of monitor the temperature of the water in the the HACCP Plan Form. This information can cooker and the speed of the belt that carries the be found in Column 2 of the Hazard Analysis product through the cooker (because you have Worksheet. determined that these factors result in the desired Complete Steps 13 through 18 for each of the internal product temperature for the desired significant hazards. These steps involve setting time), you should specify water temperature critical limits, establishing monitoring procedures, and belt speed as critical limits, not the internal establishing corrective action procedures, temperature of the product. establishing a recordkeeping system, and Enter the critical limit(s) in Column 3 of the establishing verification procedures. HACCP Plan Form. STEP 13: Set critical limits. STEP 14: Establish monitoring procedures.

For each processing step where a significant For each processing step where a significant hazard is identified on the HACCP Plan Form, hazard is identified on the HACCP Plan Form, identify the maximum or minimum value to describe monitoring procedures that will ensure which a parameter of the process must be that critical limits are consistently met (21 CFR controlled in order to control the hazard. Each 123.6(c)(4)). The hazards and controls chapters control strategy example provided in the hazards of this guidance document (Chapters 4 through and controls chapters of this guidance (Chapters 7, 9, and 11 through 21) each contain a section, 4 through 7, 9, and 11 through 21) each contain “Establish Monitoring Procedures,” that provides a section, “Set Critical Limits,” that provides information about appropriate monitoring information about appropriate critical limits for procedures for each of the control strategy each of the control strategy example(s) discussed. example(s) discussed. You should set a critical limit at such a value that To fully describe your monitoring program, you if it is not met, the safety of the product may be should answer four questions: (1) What will be questionable. If you set a more restrictive critical monitored? (2) How will monitoring be done? (3) limit, you could, as a result, be required to take How often will monitoring be done (frequency)? corrective action when no safety concern actually and (4) Who will do the monitoring? exists. On the other hand, if you set a critical It is important for you to keep in mind that the limit that is too loose, you could, as a result, monitoring process should directly measure allow an unsafe product to reach the consumer. the parameter for which you have established As a practical matter, it may also be advisable a critical limit. The necessary frequency of to set an operating limit that is more restrictive monitoring is dependent upon the circumstances. than the critical limit. In this way, you can adjust Continuous monitoring is always desirable, and the process when the operating limit is not in some cases necessary. In other cases, it may not be necessary or practical. You should monitor

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan 26 often enough that the normal variability in the through 21) each contain a section, “Establish values you are measuring will be detected. This Corrective Action Procedures,” that provides is especially true if these values are typically information about appropriate corrective action close to the critical limit. Additionally, the greater procedures for each of the control strategy the time span between measurements, the example(s) discussed. An appropriate corrective more products you are putting at risk should a action procedure must accomplish two goals: (1) measurement show a deviation from a critical ensure that an unsafe product does not reach limit has occurred, because you should assume the consumer and (2) correct the problem that that the critical limit had not been met since caused the critical limit deviation (21 CFR 123.7). the last “good” value. Even with continuous If the corrective action involves testing the monitoring, the paper or electronic record of the finished product, the limitations of the sampling continuous monitoring should be periodically plan should be understood. Because of these checked in order to determine whether limitations, microbiological testing is often not a deviations from the critical limit have occurred. suitable corrective action. The Seafood HACCP The frequency of that check should be at least Regulation requires that corrective actions be fully daily, and more frequent if required in order to documented in records (21 CFR 123.7(d)). Note implement an appropriate corrective action. that if a critical limit deviation occurs repeatedly, the adequacy of that CCP for controlling the Enter the “What,” “How,” “Frequency,” and “Who” hazard should be reassessed. Remember that monitoring information in Columns 4, 5, 6, and 7, deviations from operating limits do not need to respectively, of the HACCP Plan Form. result in formal corrective actions. STEP 15: Establish corrective action Enter the corrective action procedures in Column procedures. 8 of the HACCP Plan Form. A corrective action must be taken whenever there STEP 16: Establish a recordkeeping system. is a deviation from a critical limit at a CCP (21 CFR 123.7((a)). For each processing step where For each processing step where a significant a significant hazard is identified on the HACCP hazard is identified on the HACCP Plan Form, list Plan Form, describe the procedures that you the records that will be used to document the will use when your monitoring indicates that accomplishment of the monitoring procedures the critical limit has not been met. Note that the discussed in Step 14 (21 CFR 123.9(a)(2)). Seafood HACCP Regulation does not require The hazards and controls chapters of this that you predetermine your corrective actions. guidance (Chapters 4 through 7, 9, and 11 You may instead elect to follow the prescribed through 21) each contain a section, “Establish corrective action procedures listed at 21 CFR a Recordkeeping System,” that provides 123.7(c). However, a predetermined corrective information about appropriate records for each action has the following advantages: (1) It of the control strategy example(s) discussed. provides detailed instructions to the processing Records must document monitoring of the employee that can be followed in the event of a CCP and shall contain the actual values and critical limit deviation; (2) it can be prepared at a observations obtained during monitoring (21 time when an emergency situation is not calling CFR 123.6(b)(7)) The Seafood HACCP Regulation for an immediate decision; and (3) it removes lists specific requirements about the content of the obligation to reassess the HACCP plan in the records (21 CFR 123.9(a)). response to a critical limit deviation. Enter the names of the HACCP monitoring The hazards and controls chapters of this records in Column 9 of the HACCP Plan Form. guidance (Chapters 4 through 7, 9, and 11

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan 27 STEP 17: Establish verification procedures. that of the most responsible individual on-site at your processing facility or a higher level official For each processing step where a significant (21 CFR 123.6(d)(1)). It signifies that the HACCP hazard is identified on the HACCP Plan Form, plan has been accepted for implementation by describe the verification procedures that will your firm. ensure that the HACCP plan is (1) adequate to address the hazard and (2) consistently being followed (21 CFR 123.6(c)(6)). The hazards and controls chapters of this guidance (Chapters 4 through 7, 9, and 11 through 21) each contain a section, “Establish Verification Procedures,” that provides information about appropriate verification activities for each of the control strategy example(s) discussed. The information covers validation of the adequacy of critical limits (e.g., process establishment); calibration (including accuracy checks) of CCP monitoring equipment; performance of periodic end-product and in-process testing; and review of monitoring, corrective action, and verification records. Note that the Seafood HACCP Regulation does not require product testing (21 CFR 123.8(a)(2)(iii)). However, it can be a useful tool, especially when coupled with a relatively weak monitoring procedure, such as reliance upon suppliers’ certificates. When calibration or an accuracy check of a CCP monitoring instrument shows that the instrument is not accurate, you should evaluate the monitoring records since the last instrument calibration to determine whether the inaccuracy would have contributed to a critical limit deviation. For this reason, HACCP plans with infrequent calibration or accuracy checks can place more products at risk than those with more frequent checks should a problem with instrument accuracy occur. Enter the verification procedures in Column 10 of the HACCP Plan Form.

STEP 18: Complete the HACCP Plan Form.

When you have finished these steps for all significant hazards that relate to your product, you will have completed the HACCP Plan Form. You should then sign and date the first page of the HACCP Plan Form. The signature must be

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan 28 CHAPTER 3: Potential Species-Related and Process-Related Hazards

INTRODUCTION It is important to note that the tables provide lists of potential hazards. You should use the tables, together with the information • Purpose provided in Chapters 4 through 21, and your The purpose of this chapter is to identify own expertise or that of outside experts, to potential food safety hazards that are species determine whether the hazard is significant related and process related. It also provides for your particular product and, if so, how it information on how the illicit substitution of should be controlled. one species for another can impact on the identification of species-related hazards. • Species substitution To assist in identifying species-related and Illicit substitution of one species for another process-related hazards, this chapter contains may constitute economic fraud and/or three tables: misbranding violations of the Federal Food, Drug, and Cosmetic Act. Furthermore, species • Table 3-2, “Potential Vertebrate substitution may cause potential food safety Species-Related Hazards,” contains a hazards to be overlooked or misidentified by list of potential hazards that are associated processors or end users, as shown in Table with specific species of vertebrates 3-1, “The Effect of Misbranding Through (species with backbones). These hazards Species Substitution on the Identification of are referred to as species-related hazards; Potential Species-Related Hazards.” These • Table 3-3, “Potential Invertebrate examples are based on actual incidents of Species-Related Hazards,” contains a species substitution or misbranding. list of potential hazards that are associated with specific species of invertebrates (species without backbones). These hazards are also referred to as species- related hazards; • Table 3-4, “Potential Process-Related Hazards,” contains a list of potential hazards that are associated with specific finished fishery products, as a result of the finished product form, the package type, and the method of distribution and storage. These hazards are referred to as process-related hazards.

CHAPTER 3: Potential Species-Related and Process-Related Hazards 29 TABLE 3-1

THE EFFECT OF MISBRANDING THROUGH SPECIES SUBSTITUTION ON THE IDENTIFICATION OF POTENTIAL SPECIES-RELATED HAZARDS

POTENTIAL POTENTIAL SPECIES-RELATED HAZARDS SPECIES- RELATED HAZARDS ACTUAL MARKET NAME PRODUCT THAT WOULD BE IDENTIFIED BASED ON ASSOCIATED WITH OF PRODUCT INAPPROPRIATELY LABELED AS INAPPROPRIATE SPECIES LABELING THE ACTUAL PRODUCT (FROM TABLE 3-2) (FROM TABLE 3-2)

Gempylotoxin Escolar Sea bass Parasites Histamine

Tetrodotoxin Puffer fish Monkfish Parasites Paralytic Shellfish Poisoning

Parasites Spanish mackerel Histamine Kingﬁsh None Ciguatera Fish Poisoning

Environmental Basa Parasites chemical contaminants Grouper Ciguatera Fish Poisoning and pesticides

Parasites Grouper Cod Parasites Ciguatera Fish Poisoning

CHAPTER 3: Potential Species-Related and Process-Related Hazards 30 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

Note: You should identify pathogens from the harvest area as a potential species-related hazard if you know or have reason to know that the ﬁsh will be consumed without a process sufﬁcient to kill pathogens, or if you represent, label, or intend for the product to be so consumed. (See Chapter 4 for guidance on controlling pathogens from the harvest area.)

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Kuhlia spp. AHOLEHOLE

Alosa pseudoharengus √√ ALEWIFE OR RIVER HERRING

Beryx spp. ALFONSINO Centroberyx spp. Alligator √ ALLIGATOR mississipiensis Alligator sinensis √ Alligator √√ ALLIGATOR, mississipiensis AQUACULTURED Alligator sinensis √√ Seriola spp. CFP √ AMBERJACK

Seriola lalandi √ AMBERJACK OR YELLOWTAIL

Seriola lalandi √√√ AMBERJACK OR YELLOWTAIL, AQUACULTURED

Anchoa spp. ASP5 √ Anchoviella spp. ASP5 √ Cetengraulis ASP5 √ ANCHOVY mysticetus Engraulis spp. ASP5 √ Stolephorus spp. ASP5 √ Holacanthus spp. ANGELFISH Pomacanthus spp. Argentina elongata ARGENTINE QUEENFISH

Sphyraena spp. CFP √ BARRACUDA S. barracuda CFP √ S. jello CFP √ Lates calcarifer √ BARRAMUNDI

CHAPTER 3: Potential Species-Related and Process-Related Hazards 31 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Lates calcarifer √√ BARRAMUNDI AQUACULTURED

Pangasius bocourti √ BASA OR BOCOURTI8

Pangasius bocourti √√ BASA OR BOCOURTI8, AQUACULTURED

Ambloplites spp. √ Micropterus spp. √ BASS Morone spp. √ Stereolepis gigas √ Synagrops bellus √ Morone spp. √√ BASS, AQUACULTURED Centropristis spp. √√

Acanthistius √3 brasilianus Centropristis spp. √3 Dicentrarchus labrax √3 Lateolabrax japonicus √3 BASS, SEA Paralabrax spp. √3 Paranthias furcifer √3 Polyprion americanus √3 Polyprion oxygeneios √3 Polyprion yanezi √3 Dicentrarchus labrax √3 √√ BASS, SEA, AQUACULTURED

Labeo bata √ BATA

Priacanthus arenatus BIGEYE Pristigenys alta Pomatomus saltatrix √√ BLUEFISH

Lepomis macrochirus √ BLUEGILL

CHAPTER 3: Potential Species-Related and Process-Related Hazards 32 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Hyperoglyphe BLUENOSE antarctica Harpadon nehereus √ BOMBAY DUCK

Cybiosarda elegans √ Gymnosarda unicolor √ BONITO Orcynopsis unicolor √ Sarda spp. √ Amia calva √ BOWFIN AND ROE

Abramis brama Acanthopagrus spp.7 Argyrops spp. Gymnocranius BREAM grandoculis7 Monotaxis spp. Sparus aurata Wattsia spp. Abramis brama √√ BREAM, AQUACULTURED

Boops boops BREAM OR BOGUE

Nemipterus japonicus BREAM, THREADFIN

Ictiobus spp. √ BUFFALOFISH

Ameiurus spp. √ BULLHEAD

Lota lota √ BURBOT

Odax pullus √ BUTTERFISH8 Peprilus spp. √ Pampus cinereus √ Pseudoplatystoma √ 8 CAPARARI tigrinum Mallotus villosus √3 CAPELIN AND ROE

CHAPTER 3: Potential Species-Related and Process-Related Hazards 33 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Barbonymus spp. √ Cyprinus carpio √ Hypophthalmichthys √ CARP molitrix Hypophthalmichthys √ nobilis Carassius carassius √ Cyprinus carpio √√ Hypophthalmichthys √√ CARP, molitrix AQUACULTURED Hypophthalmichthys √√ nobilis. Carassius carassius √√ Callichthys callichthys √√ CASCARUDO8

Ameiurus catus √ CATFISH Ictalurus spp. √ Pylodictis oliveris √ Ictalurus spp. √√ CATFISH, AQUACULTURED

Salvelinus alpinus √ CHAR

Salvelinus alpinus √√ CHAR, AQUACULTURED

Leporinus obtusidens √ CHARACIN

Chirostoma jordani CHARAL

Harriota raleighana CHIMAERA Hydrolagus spp. Apocryptes bato CHIRING

Coregonus kiyi √ Kyphosus spp. √ CHUB Semotilus √ atromaculatus

CHAPTER 3: Potential Species-Related and Process-Related Hazards 34 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Coregonus alpenae √ CISCO OR CHUB Coregonus reighardi √ Coregonus zenithicus √ Coregonus artedi7 √ CISCO OR TULLIBEE

Clarias spp. √ CLARIAS FISH OR WALKING CLARIAS FISH8

Clarias anguillaris √√

CLARIAS FISH Clarias gariepinus √√ OR WALKING CLARIAS FISH, AQUACULTURED8

Rachycentron √3 COBIA canadum Rachycentron √3 √√ COBIA, canadum AQUACULTURED

Arctogadus spp. √3 Boreogadus saida √3 COD Eleginus gracilis √3 Gadus spp. √3 Gadus macrocephalus √3 COD OR ALASKA COD

Lotella rhacina √3 Mora moro √3 COD, MORID Psendophycis barbata7 √3 Pseudophycis spp. √3 Platynematichthys √3 √ 8 COROATA notatus Cilus gilberti7 √3 CORVINA Micropogonias √3 undulates7 Pomoxis spp. √ CRAPPIE

CHAPTER 3: Potential Species-Related and Process-Related Hazards 35 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Argyrosomus spp. √ Bairdiella spp. √ Cheilotrema saturnum √ Genyonemus lineatus √ Micropogonias spp. √ Nebris microps √ Nibea spp. √ Pachypops spp. √ CROAKER Pachyurus spp. √ Paralonchurus spp. √ Plagioscion spp. √ Pseudotolithus spp. √ Pterotolithus spp. √ Roncador stearnsii7 √ Umbrina roncador √ Odontoscion dentex √ Cynoscion spp. √ CROAKER OR CORVINA

Argyrosomus regius √ CROAKER OR SHADEFISH

Larimichthys polyactis7 √ CROAKER OR YELLOWFISH

Prochilodus lineatus CURIMBATA OR GURAMATA

Brosme brosme CUSK

Lepophidium spp. CUSK-EEL Brotula clarkae Aphanopus carbo CUTLASSFISH Lepidopus caudatus Trichiurus spp. Rhinichthys ssp. √ DACE

CHAPTER 3: Potential Species-Related and Process-Related Hazards 36 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Rhinichthys ssp. √√ DACE, AQUACULTURED

Cyttus novaezealandiae DORY Zenopsis spp. Zeus spp. Hyperoglyphe spp. DRIFTFISH

Equetus punctatus √ Larimus spp. √ Pogonias cromis √ DRUM Stellifer spp. √ Totoaba macdonaldi √ Umbrina coroides √ Pareques umbrosus7 √ DRUM OR CUBBYU

Aplodinotus grunniens √ DRUM, FRESHWATER

Collichthys spp. √ DRUM OR LION FISH

Argyrosomus regius7 √ DRUM OR MEAGRE

Seriphus politus √ DRUM OR QUEENFISH

Sciaenops ocellatus √ DRUM OR REDFISH

Sciaenops ocellatus √√ DRUM OR REDFISH, AQUACULTURED

Anguilla spp. EEL

Anguilla Anguilla √√

EEL, Anguilla australis √√ AQUACULTURED Anguilla dieffenbachii √√ Anguilla japonica7 √√

CHAPTER 3: Potential Species-Related and Process-Related Hazards 37 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Ariosoma balearicum √ Conger spp. √ Gnathophis cinctus √ EEL, CONGER Rhynchoconger spp. √ Paraconger √ caudilimbatus Anguilla rostrata √ EEL, FRESHWATER

Anguilla rostrata √√ EEL, FRESHWATER, AQUACULTURED

Gymnothorax funebris CFP EEL, MORAY Lycodontis javanicus CFP Muraena retifera Notacanthus EEL, SPINY chemnitzii Zoarces americanus √3 EELPOUT Zoarces viviparus √3 Callorhynchus millii ELEPHANT FISH

Lethrinus spp. EMPEROR

Lepidocybium G√ ESCOLAR OR ﬂavobrunneum OILFISH Ruvettus pretiosus G√ Notopterus notopterus FEATHERBACK

Platycephalus conatus FLATHEAD

Pinirampus √ FLATWHISKERED pirinampu FISH8

CHAPTER 3: Potential Species-Related and Process-Related Hazards 38 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Ancylopsetta dilecta √3 √1 Arnoglossus scapha √3 √1 Reinhardtius √3 √1 evermanni Bothus spp. √3 √1 Chascanopsetta √3 √1 crumenalis Cleisthenes pinetorum √3 √1 Colistium spp. √3 √1 Cyclopsetta chittendeni √3 √1 Hippoglossoides √3 √1 robustus Limanda ferruginea √3 √1 Liopsetta glacialis √3 √1 Microstomus achne √3 √1 FLOUNDER Paralichthys albigutta √3 √1 Hippoglossina oblonga √3 √1 Paralichthys olivaceus √3 √1 Paralichthys √3 √1 patagonicus Paralichthys √3 √1 squamilentus Pelotretis ﬂavilatus √3 √1 Peltorhampus √3 √1 novaezeelandiae Platichthys spp. √3 √1 Pseudorhombus spp. √3 √1 Rhombosolea spp. √3 √1 Samariscus √3 √1 triocellatus Scophthalmus spp. √3 √1

CHAPTER 3: Potential Species-Related and Process-Related Hazards 39 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Ancylopsetta dilecta √3,4 √√ Arnoglossus scapha √3,4 √√ Reinhardtius √3,4 √√ evermanni Bothus spp. √3,4 √√ Chascanopsetta √3,4 √√ crumenalis Cleisthenes pinetorum √3,4 √√ Colistium spp. √3,4 √√ Cyclopsetta chittendeni √3,4 √√ Hippoglossoides √3,4 √√ robustus FLOUNDER, AQUACULTURED Limanda ferruginea √3,4 √√ Liopsetta glacialis √3,4 √√ Microstomus achne √3,4 √√ Paralichthys spp. √3,4 √√ Pelotretis ﬂavilatus √3,4 √√ Peltorhampus √3,4 √√ novaezeelandiae Pseudorhombus spp. √3,4 √√ Rhombosolea spp. √3,4 √√ Samariscus √3,4 √√ triocellatus Scophthalmus spp. √3,4 √√ Limanda limanda7 √3 √1 Limanda proboscidea7 √3 √1 FLOUNDER OR DAB Limanda √3 √1 punctatissima7 Paralichthys dentatus √3 √1 Paralichthys √3 √1 FLOUNDER OR lethostigma FLUKE Paralichthys microps √3 √1 Platichthys ﬂesus7 √3 √1 Reinhardtius √3 FLOUNDER, hippoglossoides ARROWTOOTH

CHAPTER 3: Potential Species-Related and Process-Related Hazards 40 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Cypselurus spp. Exocoetus spp. Fodiator acutus Hirundichthys spp. FLYINGFISH Oxyporhamphus AND ROE micropterus Parexocoetus brachypterus Prognichthys gibbifrons Rana spp. √3 √ FROG

Lepisosteus spp. √ GAR

Epinnula magistralis Nesiarchus nasutus GEMFISH Lepidocybium G√ ﬂavobrunneum Rexea solandri GEMFISH OR BARRACOUTA Thyrsites atun

Thyrsites lepidopoides GEMFISH OR CABALLA

Aspistor parkeri GILLBACKER OR GILLEYBAKA8

Mulloidichthys spp. Mulloidichthys vanicolenis Mullus auratus GOATFISH Parupeneus spp. Pseudupeneus spp. Upeneichthys lineatus Upeneus spp. Neogobius √ GOBY melanostomus Thymallus arcticus √ GRAYLING

CHAPTER 3: Potential Species-Related and Process-Related Hazards 41 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Odax pullus7 GREENBONE

Hexagrammos spp. GREENLING

Coryphaenoides spp. Lepidorhynchus denticulatus GRENADIER Macruronus spp7 Nezumia bairdii7 Trachyrhynchus spp.7 Anyperodon spp. √3 Caprodon schlegelii √3 Cephalopholis spp. √3 CFP C. argus √3 CFP C. miniata √3 CFP Diplectrum formosum √3 Epinephelus spp. √3 CFP GROUPER E. fuscoguttatus √3 CFP E. lanceolatus √3 CFP E. morio √3 CFP Mycteroperca spp. √3 CFP M. venenosa √3 CFP M. bonaci √3 CFP Variola spp. √3 CFP Variola louti √3 CFP Plectropomus spp. CFP GROUPER OR √3 CORAL GROUPER

Mycteroperca √3 CFP GROUPER OR GAG microlepis Epinephelus guttatus √3 CFP GROUPER OR HIND

Epinephelus itajara √3 GROUPER OR JEWFISH

Leuresthes tenuis GRUNION

CHAPTER 3: Potential Species-Related and Process-Related Hazards 42 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Anisotremus interruptus Conodon nobilis GRUNT Haemulon spp. Orthopristis chrysoptera Pomadasys crocro Anisotremus taeniatus GRUNT OR CATALINA

Haemulon album GRUNT OR MARGATE Anisotremus surinamensis7 Plectorhinchus spp. GRUNT OR SWEETLIPS

Melanogrammus HADDOCK aegleﬁnus Urophycis spp. HAKE

Hippoglossus spp. √3 HALIBUT

Hippoglossus spp. √3,4 √√ HALIBUT, AQUACULTURED

Paralichthys √3 HALIBUT OR californicus CALIFORNIA HALIBUT

Alphestes afer 7 HAMLET, MUTTON

Etrumeus teres √3 √√ Harengula thrissina √3 √√ Ilisha spp. √3 √√ HERRING Opisthopterus tardoore √3 √√ Pellona ditchela √3 √√ Alosa spp. √√ Clupea spp. √3 √ HERRING OR SEA HERRING OR SILD

CHAPTER 3: Potential Species-Related and Process-Related Hazards 43 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Clupea spp. √3 HERRING OR SEA HERRING OR SILD ROE

Opisthonema spp. √√ HERRING, THREAD

Epinephelus guttatus √3 CFP Epinephelus √3 CFP HIND adscensionis Epinephelus √3 drummondhayi Lachnolaimus √3 CFP HOGFISH maximus Trachurus trachurus √3 √ HORSE MACKEREL OR SCAD

Caranx spp. √3 CFP √ C. ignobilis √3 CFP √ C.melampygus √3 CFP √ C.latus √3 CFP √ C. lugubris √3 CFP √ C. ruber √3 CFP √ JACK Carangoides √3 CFP √ bartholomaei Oligoplites saurus √3 √ Selene spp. √3 √ Seriola rivoliana √3 CFP √ Urapsis secunda √3 √ Caranx crysos √3 CFP √ JACK OR BLUE RUNNER

Alectis indicus7 √3 √ JACK OR CREVALLE

Elagatis bipinnulata √3 CFP √ JACK OR RAINBOW RUNNER

Nematistius pectoralis √3 √ JACK OR ROOSTERFISH

CHAPTER 3: Potential Species-Related and Process-Related Hazards 44 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Aphareus spp. √3 CFP JOBFISH Aprion spp. √3 CFP Pristipomoides spp. √3 CFP Arripis spp. √3 √ KAHAWAI

Menticirrhus spp. KINGFISH6

Genypterus spp. KINGKLIP

Elops spp. LADYFISH

Molva spp. LING

Molva LING, macrophthalma7 MEDITERRANEAN

Ophiodon elongatus LINGCOD

Synodus spp. LIZARDFISH

Somileptus gongota LOACH

Cyclopterus lumpus LUMPFISH ROE

Gasterochisma √3 √ melampus

3 MACKEREL Grammatorcynus spp. √ √ Rastrelliger kanagurta √3 √ Scomber scombrus √3 √ Pleurogrammus √3 MACKEREL, ATKA monopterygius Scomber spp. √3 √ MACKEREL, CHUB

Trachurus spp. √3 √ MACKEREL, JACK

Scomberomorus spp. √3 √ MACKEREL, SPANISH

CHAPTER 3: Potential Species-Related and Process-Related Hazards 45 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Scomberomorus CFP √ MACKEREL, commerson NARROW-BARRED SPANISH

Scomberomorus √3 CFP √ MACKEREL, SPANISH cavalla OR KING

Coryphaena spp. √ MAHI-MAHI

Coryphaena spp. √√√ MAHI-MAHI, AQUACULTURED

Makaira spp. √ MARLIN Tetrapturus spp. √ Brevoortia spp. √9 √10 MENHADEN Ethmidium √9 √10 maculatum Chanos chanos √ MILKFISH

Chanos chanos √√ MILKFISH, AQUACULTURED

Lophius spp. √3 MONKFISH

Aplodactylus arctidens7

MORWONG Cheilodactylus spp. Goniistius spp. Nemadactylus spp. Agonostomus √3 √ monticola Aldrichetta forsteri √3 √ Crenimugil crenilabis √3 √ MULLET Mugil spp. √3 √ Mullus spp. √3 √ Mugil cephalus7 √3 √ Mugil thoburni √3 √ Esox masquinongy √ MUSKELLUNGE

CHAPTER 3: Potential Species-Related and Process-Related Hazards 46 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Lampris guttatus OPAH

Girella nigricans OPALEYE

Allocyttus niger OREO DORY Neocyttus spp. Pseudocyttus spp. Astronotus ocellatus √ OSCAR

Astronotus ocellatus √√ OSCAR, AQUACULTURED

Myleus pacu PACU

Polyodon spp. √ PADDLEFISH AND ROE

Polyodon spp. √√ PADDLEFISH AND ROE, AQUACULTURED

Pangasius gigas √ PANGASIUS, GIANT8

Pangasius √ PANGASIUS micronemus SHORTBARBEL8

Scarus spp. CFP2 PARROTFISH Bolbometopon spp. Dissostichus √3 PATAGONIAN eleginoides7 TOOTHFISH OR CHILEAN SEA BASS

Hermosilla azurea √ PERCH Perca ﬂuviatilis √ Perca ﬂavescens √ PERCH, LAKE OR YELLOW

Lates niloticus √ PERCH, NILE

Lates niloticus √√ PERCH, NILE, AQUACULTURED

CHAPTER 3: Potential Species-Related and Process-Related Hazards 47 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Sebastes spp. √3 PERCH, OCEAN

Rhacochilus vacca √ PERCH, PILE

Bairdiella chrysoura √ PERCH, SILVER

Morone americana √ PERCH, WHITE

Spicara maena √ PICAREL

Esox spp. √ PICKEREL

Esox lucius √ PIKE

Sardina pilchardus √ PILCHARD OR SARDINE Sardinops spp. √

Brachyplatystoma √ PIRAMUTABA OR vaillantii LAULAO FISH8

Hippoglossoides √3 platessoides PLAICE Pleuronectes platessa √3 Pleuronectes √3 quadrituberculatus Pollachius pollachius √3 POLLOCK Pollachius virens √3 Theragra √3 POLLOCK OR chalcogramma ALASKA POLLOCK

Brama spp. POMFRET Parastromateus spp. Taractes rubescens Alectis ciliaris CFP POMPANO Parastromateus niger Trachinotus spp. Trachinotus kennedyi POMPANO OR PERMIT Trachinotus falcatus

CHAPTER 3: Potential Species-Related and Process-Related Hazards 48 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Trachinotus rhodopus POMPANO OR POMPANITO

Calamus spp. Chrysophrys auratus Dentex spp. Diplodus spp. PORGY Lagodon rhomboides Pagrus spp. Pterogymnus laniarus Stenotomus caprinus Stenotomus chrysops PORGY OR SCUP

Arothron spp. T, PSP Lagocephalus spp. T, PSP Sphoeroides annulatus T, PSP Sphoeroides nephelus T, PSP Sphoeroides maculatus T, PSP PUFFER Sphoeroides spengleri T, PSP Sphoeroides T, PSP testudineus Takifugu spp.7 T, PSP Tetraodon spp. T, PSP Takifugu spp.7 T, PSP √ √ PUFFER, AQUACULTURED

Congiopodus RACEHORSE leucopaecilus Rita rita RITA

Scorpaena papillosus √3 ROCKFISH Scorpaena cardinalis √3 Sebastes spp. √3 Ciliata spp. ROCKLING Enchelyopus cimbrius Labeo rohita √ ROHU

CHAPTER 3: Potential Species-Related and Process-Related Hazards 49 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Helicolenus ROSEFISH dactylopterus Paratrachichthys trailli ROUGHY

Hoplostethus ROUGHY, ORANGE atlanticus Hoplostethus ROUGHY, SILVER mediterraneus mediterraneus7 Anoplopoma ﬁmbria √3 SABLEFISH

Istiophorus platypterus √ SAILFISH

Oncorhynchus spp. √3,4 √√ SALMON AND ROE, AQUACULTURED Salmo salar √3,4 √√

Oncorhynchus spp. √3 √ SALMON AND ROE (WILD)(FRESHWATER) Salmo salar √3 √

Oncorhynchus spp. √3 SALMON AND ROE, (WILD) (OCEAN) Salmo salar √3

Citharichthys sordidus √ SANDDAB

Mugiloides chilensis SANDPERCH Parapercis spp. Harengula spp. √ SARDINE Sardinella spp. √ Atule mate7 SAUGER

Cololabis saira √ SAURY Scomberesox saurus √ Atule mate7 √3 Decapterus spp. √3 SCAD Selar √3 crumenophthalmus Trachurus spp. √3 √ Trachurus trachurus √3 √ SCAD OR HORSE MACKEREL

CHAPTER 3: Potential Species-Related and Process-Related Hazards 50 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Hemitripterus americanus Myoxocephalus SCULPIN polyacanthocephalus Scorpaenichthys marmoratus Archosargus rhomboidalis SEA BREAM Chrysophrys auratus7 Pagellus spp. Chelidonichthys spp. Peristedion miniatum SEAROBIN Prionotus carolinus Pterygotrigla picta Cynoscion spp. √3 SEATROUT

Alosa spp. √√ SHAD

Alosa spp. √ SHAD ROE

Dorosoma spp. √√ SHAD, GIZZARD Nematalosa vlaminghi √√ Tenualosa ilisha √ SHAD, HILSA

Carcharhinus spp. Cetorhinus maximus Galeocerdo cuvier Galeorhinus spp. Hexanchus griseus Lamna ditropis SHARK Negaprion brevirostris Notorynchus cepedianus Prionace glauca Sphyrna spp. Triaenodon obesus Triakis semifasciata

CHAPTER 3: Potential Species-Related and Process-Related Hazards 51 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Lamna nasus SHARK OR PORBEAGLE

Mustelus spp. SHARK OR SMOOTHHOUND

Squatina spp. SHARK, ANGEL

Centrophorus spp.

SHARK, DOGFISH Mustelus spp. OR CAPE SHARK Scyliorhinus spp. Squalus spp. Isurus spp. SHARK, MAKO

Alopias spp. SHARK, THRESHER

Semicossyphus pulcher √ SHEEPHEAD Archosargus √ probatocephalus Notropis spp. √ SHINER

Atherinops spp. √ SILVERSIDE Basilichthys australis √ Menidia menidia √ Bathyraja spp. √ SKATE Raja spp. √ Erilepis zonifer SKILLFISH

Allosmerus elongatus √ Argentina spp. √ Hypomesus spp. √ Osmerus spp. √ SMELT Plecoglossus altivelis √ altivelis7 Retropinna retropinna √ Spirinchus spp. √ Thaleichthys paciﬁcus √

CHAPTER 3: Potential Species-Related and Process-Related Hazards 52 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Channa striata SNAKEHEAD Parachanna obscura7 Apsilus dentatus Etelis spp. Lutjanus spp. CFP L. bohar CFP L. gibbus CFP L. sebae CFP L. buccanella CFP L. cyanopterus CFP SNAPPER L. jocu CFP Symphorus CFP nematophorus Macolor spp. Ocyurus chrysurus Pristipomoides spp. √3 Rhomboplites aurorubens Symphorichthys spilurus Centropomus spp. √ SNOOK

CHAPTER 3: Potential Species-Related and Process-Related Hazards 53 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Aseraggodes spp. √3 Austroglossus spp. √3 Buglossidium luteum √3 Clidoderma √3 asperrimum Embassichthys √3 bathybius Lyopsetta exilis7 √3 Eopsetta jordani √3 Glyptocephalus √3 zachirus7 Glyptocephalus spp. √3 Gymnachirus melas √3

3 SOLE OR FLOUNDER Hippoglossina spp. √ Lepidopsetta bilineata √3 Microchirus spp. √3 Microstomus kitt √3 Microstomus paciﬁcus √3 Pseudopleuronectes √3 americanus7 Parophrys vetulus7 √3 Psettichthys √3 melanostictus Solea solea7 √3 Brachirus orientalis7 √3 Trinectes spp. √3 Xystreurys liolepis √3

CHAPTER 3: Potential Species-Related and Process-Related Hazards 54 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Aseraggodes spp. √3,4 √√ Austroglossus spp. √3,4 √√ Buglossidium luteum √3,4 √√ Clidoderma √3,4 √√ asperrimum Embassichthys √3,4 √√ bathybius Lyopsetta exilis 7 √3,4 √√ Eopsetta jordani √3,4 √√ Glyptocephalus √3,4 √√ zachirus 7 Glyptocephalus spp. √3,4 √√

3,4 SOLE OR FLOUNDER, Gymnachirus melas √ √√ AQUACULTURED Hippoglossina spp. √3,4 √√ Lepidopsetta bilineata √3,4 √√ Microchirus spp. √3,4 √√ Pseudopleuronectes √3,4 √√ americanus 7 Parophrys vetulus 7 √3,4 √√

Psettichthys √3,4 √√ melanostictus Solea solea 7 √3,4 √√ Brachirus orientalis7 √3,4 √√ Trinectes spp. √3,4 √√ Xystreurys liolepis √3,4 √√ √ SORUBIM Pseudoplatystoma OR SURUBI8 corruscans

Chaetodipterus spp. SPADEFISH

Tetrapturus spp. √ SPEARFISH

Leiostomus xanthurus √ SPOT

Sprattus spp. √3 √ SPRAT OR BRISTLING

CHAPTER 3: Potential Species-Related and Process-Related Hazards 55 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Holocentrus spp. SQUIRRELFISH Myripristis spp. Sargocentron spp. Acipenser spp. √ Huso huso √ STURGEON AND ROE Pseudoscaphirhynchus √ spp. Scaphirhynchus spp. √ Acipenser spp. √√

STURGEON Huso huso √√ AND ROE, Pseudoscaphirhynchus √√ AQUACULTURED spp. Scaphirhynchus spp. √√ Carpiodes spp. √ Catostomus √ SUCKER commersonii Cycleptus elongatus √ Moxostoma √ SUCKER OR macrolepidotum REDHORSE

Archoplites interruptus √ SUNFISH (NOT MOLA MOLA) Lepomis spp. √

Amphistichus spp. √ Cymatogaster √ aggregata SURFPERCH Embiotoca spp. √ Hyperprosopon √ argenteum Rhacochilus toxotes √ Pangasius √ 8 SUTCHI OR SWAI hypophthalmus Pangasius √√ 8 SUTCHI OR SWAI , hypophthalmus AQUACULTURED

Xiphias gladius SWORDFISH

CHAPTER 3: Potential Species-Related and Process-Related Hazards 56 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Acanthurus spp. CFP2 Ctenochaetus spp CFP2 TANG Naso spp. CFP2 Zebrasoma spp. Megalops atlanticus √ TARPON

Tautoga onitis √ TAUTOG

Sebastolobus spp. √3 √ THORNYHEAD

Eleutheronema tetradactylum Galeoides THREADFIN decadactylus Gnathanodon spp. Polydactylus spp. Polynemus spp. Datnioides microlepis √ TIGERFISH Datnioides polota √ Tilapia spp. √ TILAPIA Oreochromis spp. √ Sarotherodon spp √ Oreochromis spp. √√ TILAPIA, Sarotherodon spp. √√ AQUACULTURED Tilapia spp. √√ Caulolatilus spp. Lopholatilus TILEFISH chamaeleonticeps Malacanthus plumieri Prolatilus jugularis Barbonymus altus TINFOIL

Microgadus spp. √3 TOMCOD

Cynoglossus spp. √3 TONGUESOLE

Hoplias malabaricus TRAHIRA

CHAPTER 3: Potential Species-Related and Process-Related Hazards 57 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Caranx spp. √3 CFP √ TREVALLY

Balistes spp. CFP Canthidermis TRIGGERFISH sufﬂamen Melichthys niger Navodon spp. Datnioides TRIPLETAIL quadrifasciatus Lobotes spp Oncorhynchus mykiss √√ aguabonita Oncorhynchus clarkii √√ Oncorhynchus gilae √√ Oncorhynchus mykiss √√ TROUT, AQUACULTURED Salmo trutta √√ Salvelinus fontinalis √√ Salvelinus malma √√ Salvelinus namaycush √√ Stenodus leucichthys √√ Oncorhynchus mykiss √3 TROUT, RAINBOW OR STEELHEAD

Latridopis spp. √ TRUMPETER Latris lineata √ Allothunnus fallai √3 √ Auxis spp. √3 √ TUNA (SMALL) Euthynnus spp. √3 √ Katsuwonus pelamis √3 √ Thunnus tonggol √3 √ Thunnus alalunga √ Thunnus albacares √ Thunnus atlanticus √ TUNA (LARGE) Thunnus maccoyii √ Thunnus obesus √ Thunnus thynnus √

CHAPTER 3: Potential Species-Related and Process-Related Hazards 58 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Thunnus spp. √3,4 √√√ TUNA, AQUACULTURED

Pleuronichthys √3 guttulatus7 Pleuronichthys spp. √3 TURBOT Psettodes spp. √3 Reinhardtius √3 hippoglossoides Psetta maxima7 √3 Psetta maxima √√ TURBOT, AQUACULTURED

Malaclemys spp. √ Chelydra spp. TURTLE Apalone spp. Trachemys spp. Malaclemys spp. √√ TURTLE, Chelydra spp. AQUACULTURED Apalone spp. Trachemys spp. Naso unicornis UNICORNFISH

Acanthocybium √ WAHOO solandri Sander spp.7 √ WALLEYE

Seriolella spp. WAREHOU

Cynoscion spp. √ WEAKFISH

Macrodon ancylodon WEAKFISH OR BANGAMARY

Arius spp. √ WHISKERED FISH8

Bagre marinus √ WHISKERED FISH OR GAFFTOPSAIL FISH8

Ariopsis felis √ WHISKERED FISH OR HARDHEAD WHISKERED FISH8

CHAPTER 3: Potential Species-Related and Process-Related Hazards 59 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 Coregonus spp. √ WHITEFISH Prosopium √ cylindraceum Merluccius gayi WHITING Merluccius hubbsi Merluccius merluccius Micromesistius spp. WHITING, BLUE

Merluccius productus WHITING OR PACIFIC WHITING

Macruronus WHITING, novaezelandiae NEW ZEALAND

Cheilinus CFP WRASSE undulatus Anarhichas spp. √3 WOLFFISH

Seriola lalandi √ YELLOW TAIL OR AMBERJACK

Seriola lalandi7 √√√ YELLOWTAIL AMBERJACK, AQUACULTURED

Sander lucioperca7 √ ZANDER

Sander lucioperca7 √√ ZANDER, AQUACULTURED

CHAPTER 3: Potential Species-Related and Process-Related Hazards 60 TABLE 3-2

POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PARASITES TOXINS (HISTAMINE) CHEMICALS DRUGS

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11

ASP = Amnesic Shellfish Poisoning; CFP = Ciguatera Fish Poisoning; G = gempylotoxin; PSP = Paralytic Shellfish Poisoning; and T = tetrodotoxin. 1. This hazard does not apply to offshore catch (e.g., areas not subject to shore side contaminant discharges). 2. Indicates that the ciguatera hazard is associated with this species only in the tropical Pacific Ocean. 3. This hazard applies where the processor has knowledge or has reason to know that the parasite-containing fish or fishery product will be consumed without a process sufficient to kill the parasites, or where the processor represents, labels, or intends for the product to be so consumed. 4. This hazard, when caused by consuming infected feed, only applies if fish processing waste, fresh fish, or plankton is used as feed. 5. This hazard only applies if the product is marketed uneviscerated. 6. Amberjack, yellowtail, Spanish mackerel, king mackerel and other scombrotoxin-forming fish are sometimes marketed incorrectly as kingfish. 7. The scientific name for this species has changed since the previous edition of this guidance. 8. The market name for this species has been changed since the previous edition of this guidance. 9. This hazard does not apply to products intended for animal feed or fish oil products, but does apply to products intended for direct human consumption of the muscle and to aqueous components, such as fish protein concentrates that are to be used as food additives. 10. This hazard only applies to food products for human consumption, such as oil extracts used as dietary ingredients.

CHAPTER 3: Potential Species-Related and Process-Related Hazards 61 TABLE 3-3

POTENTIAL INVERTEBRATE SPECIES-RELATED HAZARDS

Note: You should identify pathogens from the harvest area as a potential species-related hazard if you know, or have reason to know, that the ﬁsh will be consumed without a process sufﬁcient to kill pathogens or if you represent, label, or intend for the product to be so consumed. (See Chapter 4 for guidance on controlling pathogens from the harvest area.)

HAZARDS

NATURAL ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PATHOGENS PARASITES TOXINS CHEMICALS DRUGS

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11 Haliotis spp √√ Marinauris roei √ ABALONE Haliotis ruber √ Haliotis laevigata √ Anadara subcrenata √√√ ARKSHELL Arca spp. √√√ Macoma nasuta √√√ CLAM, BENTNOSE

Saxidomus spp. √√√ CLAM BUTTER

Macrocallista maculata √√√ CLAM, CALICO

Panopea abrupta √√√ CLAM, GEODUCK Panopea bitruncata √√√ Arctica islandica √√√ CLAM, HARD Meretrix spp. √√√ Venus mortoni √√√ Protothaca thaca √√√ CLAM, HARDSHELL OR QUAHOG Mercenaria spp. √√√

Protothaca staminea √√√ Protothaca tenerrima √√√ Tapes variegata √√√ CLAM, LITTLENECK Tapes virginea √√√ Venerupis aurea4 √√√ Venerupis decussata4 √√√ Venerupis philippinarum √√√ Corbicula japonica √√√ CLAM, MARSH

Tivela stultorum √√√ CLAM, PISMO

Ensis spp. √√√ Siliqua spp. √√√ CLAM, RAZOR Solen spp. √√√ Tagelus spp. √√√ Sanguinolaria spp. √√√ CLAM, SANGUIN

CHAPTER 3: Potential Species-Related and Process-Related Hazards 62 TABLE 3-3

POTENTIAL INVERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PATHOGENS PARASITES TOXINS CHEMICALS DRUGS

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11 Mya arenaria √√√ CLAM, SOFTSHELL

Mactrellona alata √√√ Mactromeris spp. √√√ Mactra spp. √√√ CLAM, SURF OR Mactrotomas spp. √√√ SURFCLAM Simomactra spp. √√√ Spisula spp. √√√ Tresus spp. √√√ Mactra schalinensis √√√ CLAM, SURF AQUACULTURED

Chione spp. √√√ CLAM, VENUS Chionista spp.4 √√√ Macrocallista nimbosa √√√ Paphies spp. √√√ CLAM, WEDGE

Cardium spp. √√√ Clinocardium spp. √√√ COCKLE Dinocardium robustum √√√ Serripes groenlandicus √√√ Strombus spp. √√ CONCH Lambis lambis √√ Donax spp. √√√ COQUINA

Iphigenia brasiliana √√√ COQUINA, FALSE

√ Callinectes sapidus √ CRAB, BLUE, AQUACULTURED

Callinectes sapidus √ CRAB, BLUE

Chaceon fenneri4 √ CRAB, BROWN

Lithodes aequispinus4 √ CRAB, BROWN KING

CHAPTER 3: Potential Species-Related and Process-Related Hazards 63 TABLE 3-3

POTENTIAL INVERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PATHOGENS PARASITES TOXINS CHEMICALS DRUGS

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11 Lithodes antarcticus √ CRAB, CENTOLLA Lithodes murrayi √ Paralomis granulosa √ CRAB, DEEPSEA

Cancer magister √2 √ CRAB, DUNGENESS

Geothelphusa dehaani √1 √ CRAB, JAPANESE FRESHWATER

Cancer borealis √2 √ CRAB, JONAH

Paralithodes camtschaticus √ CRAB, KING Paralithodes platypus √ Paralithodes brevipes √ CRAB, KING OR HANASAKI

Erimacrus isenbeckii √ CRAB, KOREAN OR KEGANI

Neolithodes brodiei √ CRAB, LITHODES

Chaceon quinquedens4 √ CRAB, RED

Cancer productus √2 √ CRAB, RED ROCK

Cancer irroratus √ CRAB, ROCK Cancer pagurus √ Loxorhynchus grandis √ CRAB, SHEEP

Chionoecetes angulatus √ Chionoecetes bairdi √ CRAB, SNOW Chionoecetes opilio √ Chionoecetes tanneri √ Jacquinotia edwardsii √ CRAB, SPIDER Maja squinado √ Menippe spp.4 √ CRAB, STONE

Scylla serrata √ CRAB, SWAMP

CHAPTER 3: Potential Species-Related and Process-Related Hazards 64 TABLE 3-3

POTENTIAL INVERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PATHOGENS PARASITES TOXINS CHEMICALS DRUGS

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11 Scylla serrata √√ CRAB, SWAMP, AQUACULTURED

Callinectes arcuatus √ CRAB, SWIMMING Callinectes toxotes √ Portunus spp. √ Cambarus spp. √ Cherax spp. √ Euastacus armatus √ CRAWFISH OR Pacifastacus spp. √ CRAYFISH Paranephrops spp. √ Procambarus spp. √ Astacus spp. √ Cambarus spp. √√ Cherax spp. √√ Euastacus armatus √√ CRAWFISH OR CRAYFISH, Pacifastacus spp. √√ AQUACULTURED Paranephrops spp. √√ Procambarus spp. √√ Astacus spp. √√ Sepia spp. CUTTLEFISH

Rhopilema spp. JELLYFISH

Euphausia spp. Meganyctiphanes KRILL norvegica Thysandoessa inermis Cervimunida johni LANGOSTINO Munida gregaria Pleuroncodes spp.

CHAPTER 3: Potential Species-Related and Process-Related Hazards 65 TABLE 3-3

POTENTIAL INVERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PATHOGENS PARASITES TOXINS CHEMICALS DRUGS

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11 Tectura testudinalis4 Cellana denticulata Diodora aspera LIMPET Fissurella maxima Lottia gigantea Patella caerulea Homarus spp. √3 LOBSTER

Nephrops norvegicus LOBSTER, NORWAY

Jasus spp. LOBSTER, ROCK

Palinurus spp. LOBSTER, ROCK OR SPINY Panulirus spp.

Ibacus ciliatus LOBSTER, SLIPPER Scyllarides spp. Thenus orientalis Metanephrops spp. LOBSTERETTE Nephropsis aculeata Murex brandaris MUREX OR MEREX

Modiolus spp. √√√ MUSSEL Mytilus spp. √√√ Perna canaliculus √√√ Eledone spp. √1 OCTOPUS Octopus spp. √1 Crassostrea spp. √√√ Ostrea spp. √√√ OYSTER Spondylus spp. √√√ Tiostrea spp. √√√ Atrina pectinata √√√ PEN SHELL

Littorina littorea PERIWINKLE

CHAPTER 3: Potential Species-Related and Process-Related Hazards 66 TABLE 3-3

POTENTIAL INVERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PATHOGENS PARASITES TOXINS CHEMICALS DRUGS

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11 Aequipecten spp. √2 √2 √ Amusium spp. √2 √2 √ Argopecten nucleus √2 √2 √ Chlamys spp. √2 √2 √ SCALLOP Euvola spp.4 √2 √2 √ Patinopecten yessoensis √2 √2 √ Pecten spp. √2 √2 √ Placopectin magellanicus √2 √2 √ Aequipecten spp. √2 √2 √ Amusium spp. √2 √2 √ Argopecten nucleus √2 √2 √

2 2 SCALLOP Chlamys spp. √ √ √ AQUACULTURED Euvola spp.4 √2 √2 √ Patinopecten yessoensis √2 √2 √ Pecten spp. √2 √2 √ Placopectin magellanicus √2 √2 √ Argopecten irradians √2 √2 √ SCALLOP OR BAY SCALLOP

Argopecten gibbus √2 √2 √ SCALLOP, CALICO

Patinopecten caurinus √2 √2 √ SCALLOP OR WEATHERVANE

Cucumaria spp. √ Holothuria spp. √ SEA CUCUMBER Parastichopus spp. √ Stichopus spp. √ Echinus esculentus √ Evechinus chloroticus √ Heliocidaris spp. √ SEA URCHIN ROE Loxechimus spp. √ Paracentrotus spp. √ Pseudocentrotus spp. √ Strongylocentrotus spp. √ Xiphopenaeuskroyeri SEABOB

CHAPTER 3: Potential Species-Related and Process-Related Hazards 67 TABLE 3-3

POTENTIAL INVERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PATHOGENS PARASITES TOXINS CHEMICALS DRUGS

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11 Styela spp. √ SEA SQUIRT

Crangon spp. Farfantepenaeus spp.4 Fenneropenaeus spp.4 Litopenaeus spp.4 Marsupenaeus spp.4 Melicertus spp.4

SHRIMP Metapenaeus afﬁnis Palaemon serratus Palaemonetes vulgaris Pandalopsis dispar Pandalus spp. Penaeus spp. Pleoticus muelleri Plesionika martia Crangon spp. √√ Exopalaemon styliferus √√ Farfantepenaeus spp.4 √√ Fenneropenaeus spp.4 √√ Litopenaeus spp.4 √√ Marsupenaeus spp.4 √√ SHRIMP, AQUACULTURED Macrobrachium spp. √√ Melicertus spp.4 √√ Metapenaeus spp. √√ Palaemon serratus √√ Palaemonetes vulgaris √√ Pandalopsis dispar √√ Pandalus spp. √√ Penaeus spp. √√ Plesionika martia √√ Crangon spp. √√ Macrobrachium spp. SHRIMP, FRESHWATER

CHAPTER 3: Potential Species-Related and Process-Related Hazards 68 TABLE 3-3

POTENTIAL INVERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PATHOGENS PARASITES TOXINS CHEMICALS DRUGS

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11 Macrobrachium spp. √√ SHRIMP, FRESHWATER, AQUACULTURED

Sicyonia brevirostris SHRIMP, ROCK

Pleoticus robustus SHRIMP, ROYAL

Pandalus borealis SHRIMP OR PINK SHRIMP Pandalus jordani

Hymenopenaeus sibogae SHRIMP OR PRAWN

Otala spp. √ SNAIL Helix pomatia √ OR ESCARGOT Achatina fulica √1 Polinices spp. √ SNAIL, MOON

Berryteuthis magister √1 Dosidicus gigas √1 Illex spp. √1 Loligo spp. √1 Loligo media4 √1 Lolliguncula spp. √1 SQUID Nototodarus spp. √1 Ommastrephes spp. √1 Rossia macrosoma √1 Sepiola rondeleti √1 Sepioteuthis spp. √1 Todarodes sagittatus √1 Turbo cornutus TOP SHELL Monodonta turbinata4 Buccinum spp. WHELK Busycon spp. √ OR SEA SNAIL Neptunea spp. √2

CHAPTER 3: Potential Species-Related and Process-Related Hazards 69 TABLE 3-3

POTENTIAL INVERTEBRATE SPECIES-RELATED HAZARDS

HAZARDS

NATURAL ENVIRONMENTAL AQUACULTURE MARKET NAMES LATIN NAMES PATHOGENS PARASITES TOXINS CHEMICALS DRUGS

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11

1. This hazard applies where the processor has knowledge or has reason to know that the parasite-containing fish or fishery product will be consumed without a process sufficient to kill the parasites, or where the processor represents, labels, or intends for the product to be so consumed. 2. This hazard only applies if the product is marketed uneviscerated. 3. This hazard only applies if the lobsters are held in pounds. 4. The scientific name for this species has changed since the last edition of this guidance.

CHAPTER 3: Potential Species-Related and Process-Related Hazards 70 TABLE 3-4

POTENTIAL PROCESS-RELATED HAZARDS

HAZARDS

FINISHED PACKAGE PRODUCT FOOD1 TYPE ADDITIVES ALLERGENS/ PASTEURIZATION METAL INCLUSION METAL GLASS INCLUSION TEMPERATURE ABUSE TEMPERATURE C. BOTULINUM TOXIN COOKING PROCESSES PATHOGENIC BACTERIA PATHOGENIC S. AUREUS TOXIN - BATTER PROCESSES DESIGNED TO S. AUREUS TOXIN - DRYING PATHOGENIC BACTERIA GROWTH - PATHOGENIC SURVIVAL THROUGH COOKING OR SURVIVAL RETAIN RAW PRODUCT CHARACTERISTICS RAW RETAIN AFTER PASTEURIZATION AND SPECIALIZED AFTER PASTEURIZATION PATHOGENIC BACTERIA CONTAMINATION BACTERIA CONTAMINATION PATHOGENIC PATHOGENIC BACTERIA SURVIVAL THROUGH BACTERIA SURVIVAL PATHOGENIC

CHP CHP CHP CHP CHP CHP CHP CHP CHP CHP 12 13 14 15 16 17 18 19 20 21

Cooked shrimp, Reduced oxygen √√ √ √√ crab, lobster, packaged (e.g., and other fish, mechanical vacuum, including cooked steam flush, hot meat, sections, fill, MAP, CAP, and whole fish, hermetically sealed, and surimi-based or packed in oil) analog products Cooked shrimp, Other than reduced √√√√ crab, lobster, oxygen packaged and other fish, including cooked meat, sections, and whole fish, and surimi-based analog products Pasteurized crab, Reduced oxygen √√ √ √ √√ lobster, and other packaged (e.g., fish, including mechanical vacuum, pasteurized steam flush, hot surimi-based fill, MAP, CAP analog products hermetically sealed, or packed in oil) Pasteurized crab, Other than reduced √√√√√ lobster, and other oxygen packaged fish, including pasteurized surimi-based analog products Smoked fish Reduced oxygen √√ √√ packaged (e.g., mechanical vacuum, steam flush, hot fill, MAP, CAP, hermetically sealed, or packed in oil)

CHAPTER 3: Potential Species-Related and Process-Related Hazards 71 TABLE 3-4

POTENTIAL PROCESS-RELATED HAZARDS

HAZARDS

CHP CHP CHP CHP CHP CHP CHP CHP CHP CHP 12 13 14 15 16 17 18 19 20 21

Smoked fish Other than reduced √√√ oxygen packaged Salads, Reduced oxygen √√ √√√ sandwiches, packaged (e.g., dips, cocktails, mechanical vacuum, and similar steam flush, hot seafood products fill, MAP, CAP, prepared from hermetically sealed, ready-to-eat or packed in oil) fishery products

Salads, Other than reduced √√√√ sandwiches, oxygen packaged dips, cocktails, and similar seafood products prepared from ready-to-eat fishery products Battered or All √√√ breaded (including surface-browned) raw shrimp, finfish, oysters, clams, squid, and other fish Stuffed crab, All √√√ shrimp, finfish, and other fish Dried fish All √√√ √√

CHAPTER 3: Potential Species-Related and Process-Related Hazards 72 TABLE 3-4

POTENTIAL PROCESS-RELATED HAZARDS

HAZARDS

CHP CHP CHP CHP CHP CHP CHP CHP CHP CHP 12 13 14 15 16 17 18 19 20 21

Raw oysters, Reduced oxygen √√ √ √√√ clams, and packaged (e.g., mussels mechanical vacuum, steam flush, hot fill, MAP, CAP, hermetically sealed, or packed in oil) Raw oysters, Other than reduced √√√√√ clams, and oxygen packaged mussels Raw fish other Reduced oxygen √2 √√√ than oysters, packaged (e.g. clams, and mechanical vacuum, mussels (finfish steam flush, hot and non-finfish) fill, MAP, CAP, hermetically sealed, or packed in oil) Raw fish other Other than reduced √2 √√ than oysters, oxygen packaged clams, and mussels (finfish and non-finfish) Partially cooked Reduced oxygen √√ √√√ or uncooked packaged (e.g., prepared foods mechanical vacuum, steam flush, hot fill, MAP, CAP, hermetically sealed, or packed in oil) Partially cooked Other than reduced √√√√ or uncooked oxygen packaged prepared foods

CHAPTER 3: Potential Species-Related and Process-Related Hazards 73 TABLE 3-4

POTENTIAL PROCESS-RELATED HAZARDS

HAZARDS

CHP CHP CHP CHP CHP CHP CHP CHP CHP CHP 12 13 14 15 16 17 18 19 20 21

Fully cooked Reduced oxygen √√ √ √√√ prepared foods packaged (e.g., mechanical vacuum, steam flush, hot fill, MAP, CAP, hermetically sealed, or packed in oil) Fully cooked Other than reduced √√√√√ prepared foods oxygen Fermented, All √√3 √√ √ acidified, pickled, salted, and LACFs Fish oil All √4

C. botulinum = Clostridium botulinum; S. aureus = Staphylococcus aureus; MAP = modified atmosphere packaging; CAP = controlled atmosphere packaging; and LACF = low-acid canned food. 1. You should include potential hazards from more than one finished product food category if your product fits more than one description. 2. This hazard only applies if you have knowledge, or have reason to know, that the fish will be consumed without a process sufficient to kill pathogens or if you represent, label, or intend for the product to be so consumed. 3. Controls for this hazard need not be included in HACCP plans for shelf-stable acidified and LACFs. See Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113), called the LACF Regulation in this guidance document, and Acidified Foods regulation (21 CFR 114) for mandatory controls. 4. This hazard does not apply to highly refined fish oil.

CHAPTER 3: Potential Species-Related and Process-Related Hazards 74 CHAPTER 4: Pathogens From the Harvest Area

UNDERSTAND THE POTENTIAL HAZARD • Managing the amount of time that food is exposed to temperatures that are favorable This chapter covers the control of pathogens from for pathogenic bacteria growth and toxin the harvest area for both molluscan shellfish and production (covered generally in Chapter 12; fish other than molluscan shellfish. for Clostridium botulinum, in Chapter 13; and for Staphylococcus aureus in hydrated batter • Strategies for control of pathogens mixes, in Chapter 15); There are a number of strategies for the control • Killing pathogenic bacteria by cooking or of pathogens in fish and fishery products. They pasteurization (covered in Chapter 16) or include: retorting (covered by the Thermally Processed • Controlling the source (i.e., harvest waters) Low-Acid Foods Packaged in Hermetically of molluscan shellfish and the time from Sealed Containers regulation (hereinafter, the exposure to air (i.e., by harvest or receding Low-Acid Canned Foods (LACF) Regulation), tide) to refrigeration to control pathogens from 21 CFR 113); the harvest area (covered in this chapter); • Killing pathogenic bacteria by processes that • Controlling the amount of moisture that is retain raw product characteristics (covered in available for pathogenic bacteria growth Chapter 17). (water activity) in the product by drying • Molluscan shellfish (covered in Chapter 14); Pathogens found in waters from which molluscan • Controlling the amount of moisture that is shellfish are harvested can cause disease in available for pathogenic bacterial growth consumers. For the purposes of this guidance, (water activity) in the product by formulation molluscan shellfish include: (covered in Chapter 13); • Controlling the amount of salt or (1) oysters; (2) clams; (3) mussels; and (4) scallops, preservatives, such as sodium nitrite, in the except where the final product is the shucked product (covered in Chapter 13); adductor muscle only. The pathogens of concern include both bacteria (e.g., Vibrio spp., Salmonella • Controlling the level of acidity (pH) in the spp., Shigella spp., and Campylobacter jejuni (C. product (covered by the Acidified Foods jejuni)) and viruses (e.g., hepatitis A virus and regulation, 21 CFR 114, for shelf-stable norovirus). See Appendix 7 for a description of the acidified products, and by Chapter 13, for public health impacts of these pathogens. refrigerated acidified products); Pathogens from the harvest area are of particular • Controlling the introduction of pathogenic concern in molluscan shellfish because (1) bacteria after the pasteurization process environments in which molluscan shellfish grow (covered in Chapter 18); are commonly subject to contamination from

CHAPTER 4: Pathogens From the Harvest Area 75 sewage, which may contain pathogens, and harvest location, and the date of harvest (21 CFR contamination from naturally occurring bacteria, 123.28(c)); (2) molluscan shellfish harvesters be which may also be pathogens; (2) molluscan licensed (note that licensing may not be required shellfish filter and concentrate pathogens that in all jurisdictions); (3) processors that ship, may be present in surrounding waters; and (3) reship, shuck, or repack molluscan shellfish be molluscan shellfish are often consumed whole, certified; and (4) containers of shucked molluscan either raw or partially cooked. shellfish bear a label with the processor’s name, address, and certification number. Certain pathogens generally originate from human or animal fecal sources (e.g., The controls listed above serve to minimize the Vibrio cholerae (V. cholerae) O1 and O139, risk of molluscan shellfish containing pathogens Salmonella spp., Shigella spp., C. jejuni, Yersinia of human or animal origin, but do not fully enterocolitica (Y. enterocolitica), hepatitis A virus, eliminate the risk. As a result, consumption and norovirus). Other pathogens are naturally of raw or undercooked molluscan shellfish occurring in certain waters (e.g., Vibrio vulnificus may not be safe for individuals with certain (V. vulnificus), Vibrio parahaemolyticus (V. health conditions, such as liver disease; chronic parahaemolyticus), and V. cholerae non-O1 and alcohol abuse; diabetes; and stomach, blood, non-O139), and their presence is not associated and immune disorders. For this reason, shellfish with human or animal fecal sources. control authorities require that shellstock intended for raw consumption bear a tag that See Appendix 7 for a description of the public instructs retailers to inform their customers that health impacts of these pathogens. consuming raw or undercooked shellfish may Control of pathogens of human or animal origin increase the risk of foodborne illness, especially To minimize the risk of molluscan shellfish for individuals with certain medical conditions. containing pathogens of human or animal fecal You can also eliminate the hazard of pathogens origin (e.g., V. cholerae O1 and O139, Salmonella from the harvest area by properly cooking, spp., Shigella spp., C. jejuni, hepatitis A virus, pasteurizing, or retorting the product. Guidance and norovirus), Federal, state, tribal, territorial on cooking and pasteurizing to control and foreign government agencies, called shellfish pathogenic bacteria is provided in Chapter 16. control authorities, classify waters in which Mandatory retorting controls are described in molluscan shellfish are found, based, in part, the LACF Regulation (21 CFR 113). It should be on an assessment of water quality. As a result noted that neither cooking, nor pasteurizing, nor of these classifications, molluscan shellfish retorting will eliminate the hazards of natural harvesting is allowed from some waters, not toxins or environmental chemical contaminants from others, and only at certain times or under and pesticides that also may be associated with certain conditions from others. Shellfish control molluscan shellfish. Appropriate control strategies authorities exercise control over the molluscan for these hazards are provided in Chapters 6 and shellfish harvesters to ensure that harvesting 9. Additionally, the laws and regulations of states takes place only when and where it has been that participate in the National Shellfish Sanitation determined to be safe. Program administered by FDA require that all molluscan shellfish be harvested from waters Other significant elements of shellfish control authorized for harvesting by the shellfish control authorities’ efforts to control the safety of authority, regardless of how it will be processed. molluscan shellfish include requirements that (1) containers of in-shell molluscan shellfish Control of naturally occurring pathogens (shellstock) bear a tag that identifies the type To minimize the risk of illness from the and quantity of shellfish, the harvester, the consumption of molluscan shellfish containing

CHAPTER 4: Pathogens From the Harvest Area 76 naturally occurring pathogens such as V. As with pathogens of sewage origin, the above vulnificus, V. parahaemolyticus, and V. cholerae controls for naturally occurring pathogens help non-O1 and non-O139, shellfish control minimize the risk from these pathogens in authorities place certain controls on the harvest molluscan shellfish but do not fully eliminate of molluscan shellfish. the risk. For this same reason, shellfish control authorities require that shellstock intended Naturally occurring pathogens may be present in for raw consumption bear a tag containing relatively low numbers at the time that molluscan an advisory relative to raw and undercooked shellfish are harvested but may increase to more consumption (described above). hazardous levels if they are exposed to time and temperature abuse. To minimize the risk of The controls for Vibrio spp. discussed in this growth of Vibrio spp., shellfish control authorities chapter apply only to molluscan shellfish if they place limits on the time from exposure to air (i.e., are intended for raw consumption. For example, by harvest or receding tide) to refrigeration. The they would not be applied to oyster shellstock length of time is dependent upon the Average if tags on the containers of shellstock indicate Monthly Maximum Air Temperature (AMMAT) or that they must be shucked before consumption. the Average Monthly Maximum Water Temperature Vibrio spp. can be eliminated or reduced to non- (AMMWT) at the time of harvest, which is detectable levels by cooking, pasteurizing, and determined by the shellfish control authority. retorting. These control mechanisms are widely used in the processing of fishery products for the In addition to the above, control for V. control of pathogens. Guidance for these control parahaemolyticus in oysters involves (1) a risk mechanisms can be found in Chapter 16 (cooking evaluation by the shellfish control authority to and pasteurization to control pathogenic bacteria) determine whether the risk of V. parahaemolyticus and the LACF Regulation, 21 CFR 113 (retorting). illness from the consumption of oysters harvested Other mechanisms for control of Vibrio spp. include from a growing area(s) in a state is reasonably processes that are designed to retain the raw likely to occur; and (2) a determination by characteristics of the food, including individual quick shellfish control authorities about whether a freezing (IQF) with extended storage, mild heat, growing area(s) in a state has average monthly high hydrostatic pressure, and irradiation. These daytime water temperatures that exceed 60°F control mechanisms are covered in Chapter 17. for waters bordering the Pacific Ocean or 81°F Appropriate controls to prevent further growth for waters bordering the Gulf of Mexico and the of these pathogenic bacteria during processing, Atlantic Ocean (New Jersey and south) at times storage, and transportation between processors during which harvesting occurs. If either of these are discussed in Chapter 12. conditions is met, the shellfish control authority develops and implements a V. parahaemolyticus • Fish other than molluscan shellfish control plan intended to reduce the incidence of Pathogens from the harvest area may also be a V. parahaemolyticus illnesses. As part of the plan, potential hazard for fish other than molluscan shellfish control authorities may (1) temporarily shellfish. Pathogens may be found on raw close some waters to the harvesting of oysters; (2) fish as a result of near-shore harvest water limit the time from exposure to air (i.e., by harvest contamination, poor sanitary practices on the or receding tide) to refrigeration; (3) temporarily harvest vessel, and poor aquacultural practices. permit harvesting of oysters for products that will The pathogens of concern include those be labeled “For Shucking Only” from some waters; described above for molluscan shellfish, but also or (4) temporarily permit harvesting of oysters for include Listeria monocytogenes and Escherichia processes that retain raw product characteristics coli. See Appendix 7 for a description of the (covered in Chapter 17) only from some waters. public health impacts of these pathogens.

CHAPTER 4: Pathogens From the Harvest Area 77 Control of pathogens DETERMINE WHETHER THIS POTENTIAL The processor can control pathogens by proper HAZARD IS SIGNIFICANT. cooking, pasteurizing, or retorting. Guidance for these control mechanisms can be found in The following guidance will assist you in Chapter 16 (cooking and pasteurizing to kill determining whether pathogens from the harvest pathogenic bacteria) and the LACF Regulation, 21 area are a significant hazard at a processing step: CFR 113 (retorting). 1. Is it reasonably likely that an unsafe level For many products (e.g., raw fish fillets), there of pathogens from the harvest area will be is no cooking, pasteurizing, or retorting step introduced at this processing step (e.g., are performed by the processor. For most of these pathogens present in the raw material at an products, cooking is performed by the consumer unsafe level)? or end user before consumption. FDA is not Under ordinary circumstances, it would be aware of any Hazard Analysis Critical Control reasonably likely that pathogens of human Point (HACCP) controls that exist internationally or animal origin from the harvest area could for the control of pathogens in fish and fishery enter the process at an unsafe level at the products that are customarily fully cooked by receiving step for the following types of fish: the consumer or end user before consumption other than a rigorous sanitation regime as part • Raw oysters; of a prerequisite program or as part of HACCP • Raw clams; itself. The Fish and Fishery Products regulation (21 CFR 123.11, “Sanitation control procedures”) • Raw mussels; requires such a regime. The proper application • Raw scallops (see information of sanitation controls is essential because of the provided under “Intended use”). likelihood that pathogens in seafood products can be introduced through poor handling In addition: practices by the aquaculture producer, the • Under ordinary circumstances, it would harvester, or the processor. be reasonably likely that an unsafe level of V. vulnificus (a naturally occurring For some products (e.g., raw fish intended for pathogen) could enter the process sushi), there is no cooking performed by either the from oysters harvested from areas that processor, or the consumer, or the end user. When have been confirmed as the original the processor has knowledge or has reason to source of oysters associated with two know that the product will be consumed without or more V. vulnificus illnesses (e.g., a process sufficient to kill pathogens of public states bordering the Gulf of Mexico); health concern or where the processor represents, labels, or intends for the product to be so • Under ordinary circumstances, it consumed, the processor should control time and would be reasonably likely that an temperature exposure of the product to prevent unsafe level of V. parahaemolyticus growth of bacterial pathogens and formation of could enter the process from oysters toxins by any bacterial pathogens that may be harvested from an area that meets any present in the product. Guidance for these controls one of the following conditions: can be found in Chapter 12 and in Chapter 13 (for The shellfish control authority those products where the packaging technique has conducted a risk evaluation creates a reduced oxygen environment). and determined that the risk of V. parahaemolyticus illness from the Note: The guidance contained in the remainder of this chapter applies to receiving controls for molluscan shellfish only. consumption of oysters harvested

CHAPTER 4: Pathogens From the Harvest Area 78 from that growing area is reasonably • Making sure that incoming molluscan likely to occur. Specific guidance for shellfish are supplied by a licensed determining risk can be found in the harvester (where licensing is required “National Shellfish Sanitation Program by law) or by a certified dealer; Guide for the Control of Molluscan • Killing pathogenic bacteria by Shellfish 2007 Revision”; cooking or pasteurizing (covered in The shellfish control authority has Chapter 16) or retorting (covered by determined that harvesting occurs the LACF Regulation, 21 CFR 113). It in the growing area at a time when should be noted that neither cooking average monthly daytime water nor retorting will eliminate the temperatures exceed 60°F for waters hazards of natural toxins or chemical bordering the Pacific Ocean and contamination that also may be 81°F for waters bordering the Gulf of associated with molluscan shellfish; Mexico and the Atlantic Ocean (New • Killing Vibrio spp. by IQF with Jersey and south), except where a extended storage, mild heat, more rigorous risk evaluation has irradiation, or high hydrostatic led the shellfish control authority pressure (covered in Chapter 17); to conclude that the risk of V. • Minimizing the growth of V. parahaemolyticus illness from the cholerae, V. parahaemolyticus, and V. consumption of oysters harvested vulnificus by limiting the time from from that growing area is not exposure to air (i.e., by harvesting reasonably likely to occur; or receding tide) to refrigeration; The growing area has been confirmed • Including an advisory on tags on as the original source of oysters containers of molluscan shellstock associated with two or more V. intended for raw consumption or parahaemolyticus illnesses in the past on containers of shucked molluscan 3 years. shellfish that instructs retailers to 2. Can an unsafe level of pathogens from the inform their customers that consuming harvest area that was introduced at the receiving raw or undercooked shellfish may step be eliminated or reduced to an acceptable increase the risk of foodborne level at this processing step? illness, especially for individuals with certain medical conditions. Pathogens from the harvest area should also be considered a significant hazard at • Intended use any processing step where a measure is For most raw molluscan shellfish products, or can be used to eliminate the pathogens you should assume that the product will be that had been introduced at a previous step consumed raw. You should, therefore, identify or is adequate to reduce the likelihood of the hazard as significant if it meets the criteria in occurrence of the hazard to an acceptable the previous section. level. Measures to eliminate pathogens or to Where the product consists of scallop adductor reduce the likelihood of occurrence of the muscle only, it may be reasonable to assume that hazard from the harvest area include: the product will be cooked before consumption. • Checking incoming molluscan In this case, you would not need to identify shellfish to ensure that they are pathogens from the harvest area as a significant properly tagged or labeled; hazard. However, if you have knowledge, or have

CHAPTER 4: Pathogens From the Harvest Area 79 reason to know, that the scallop adductor muscle Additionally, the laws and regulations will be consumed without a process sufficient to of states that participate in the National kill pathogens of public health concern or where Shellfish Sanitation Program require that the processor represents, labels, or intends for the all molluscan shellfish be harvested from product to be so consumed, you should control waters authorized for harvesting by the time and temperature exposure of the product shellfish control authority, regardless of to prevent growth of bacterial pathogens and how it will be processed. formation of toxins by any bacterial pathogens that Example: may be present in the product. Guidance for these A canned clam chowder processor controls can be found in Chapter 12 and in Chapter should set the CCP for pathogens from 13 (for those products where the packaging the harvest area at the retorting step, technique creates a reduced oxygen environment). and would not identify the receiving The controls for V. vulnificus and V. step as a CCP for this hazard. parahaemolyticus that are discussed in this chapter do not need to be applied to molluscan shellfish b. If the product will not be cooked, that are not marketed for raw consumption. For pasteurized, or retorted sufficiently to kill example, they need not be applied to oyster bacterial pathogens during processing shellstock from the Gulf of Mexico if tags on the in your facility, you should identify the containers of shellstock indicate that they must be receiving step as a CCP where you can shucked before consumption. exercise control over the source of the molluscan shellfish and the time from IDENTIFY CRITICAL CONTROL POINTS. exposure to air (i.e., by harvest or receding tide) to refrigeration in order to control pathogens from the harvest area. If the The following guidance will assist you in finished product is shellstock intended for determining whether a processing step is a raw consumption, you should also identify critical control point (CCP) for pathogens from the labeling step or the label (tag) receiving the harvest area: step as a CCP, because you can ensure that 1. Will the product be cooked, pasteurized, or the raw consumption advisory is on the tag. retorted sufficiently to kill all bacterial pathogens Example: of public health concern during processing in your A processor that shucks raw oysters facility? and ships a raw product should a. If it will be, you should identify the cook check the tags of incoming shellstock step, pasteurization step, or retorting step (in-shell oysters), the license of the as the CCP. In this case, you would not harvesters that supply the shellstock, need to identify the receiving step as a and the length of time between CCP for the hazard of pathogens from exposure to air (i.e., by harvest or the harvest area. However, note that receding tide) and refrigeration. The neither cooking, nor pasteurizing, nor processor should identify the receiving retorting will eliminate the hazards of step as the CCP for this hazard. natural toxins or environmental chemical contaminants and pesticides that also may be associated with molluscan shellfish. Chapters 6 and 9 provide appropriate control strategies for these hazards.

CHAPTER 4: Pathogens From the Harvest Area 80 Example: characteristics as the CCP for control of A processor that ships oyster shellstock V. vulnificus. In this case, you would not should check the tags of incoming need to identify the receiving step as a shellstock, the license of the harvesters CCP for the control of V. vulnificus. that supply the shellstock, the Example: harvest location, and the length of A Gulf of Mexico oyster processor time between exposure to air (i.e., should set the CCP for V. vulnificus by harvest or receding tide) and at the mild heat processing step and refrigeration. The processor should would not identify the receiving step identify the receiving step as a CCP as a CCP for that pathogen. for this hazard. The processor should also identify the labeling step as a CCP If you choose to follow this approach, for this hazard and would check for you should refer to Chapter 17 for further the presence of the raw consumption guidance. advisory on the label or tag. b. If the finished product will not be This control approach includes two subjected to a process that is designed control strategies referred to in this to retain raw product characteristics and chapter as “Control Strategy Example 1 is sufficient to kill V. vulnificus during - Source Control” and “Control Strategy processing in your facility, you should Example 2 - Shellstock Temperature identify the receiving step as a CCP, Control.” Refer to Control Strategy because you can exercise control over Example 2 - Shellstock Temperature the time from exposure to air (i.e., by Control” when controls for V. vulnificus harvest or receding tide) to refrigeration or V. parahaemolyticus are needed.” in order to control V. vulnificus. Conditions that warrant control for these pathogens are described below. Example: A Gulf of Mexico oyster processor 2. If the finished product is raw oyster shellstock should set the CCP for V. vulnificus at intended for raw consumption and is harvested the receiving step. from a state that has been confirmed as the original source of oysters associated with two or more V. This control strategy is referred to as vulnificus illnesses (e.g., the Gulf of Mexico), will it be “Control Strategy Example 2 - Shellstock subjected in your plant to a process that is designed Temperature Control” Refer to “Control to retain raw product characteristics (e.g., mild Strategy Example 2 - Shellstock heat processing, IQF with extended storage, high Temperature Control” when controls for hydrostatic pressure processing, or irradiation) and is V. vulnificus are needed.” These controls sufficient to kill V. vulnificus during processing in your should be considered in addition to the facility (i.e., reduced to a non-detectable level of less controls contained in “Control Strategy than 30 Most Probable Number per gram (herein Example 1 - Source Control.” If your referred to as 30 MPN/gram), as defined in the shellfish control authority has developed “National Shellfish Sanitation Program Guide for the a V. vulnificus control plan, you should Control of Molluscan Shellfish 2007 Revision”)? develop a HACCP plan that is based on the requirements of that plan. Elements a. If the finished product will be subjected of the control strategy example provided to such a process in your facility, you in this chapter and in Chapter 17 may be should identify the processing step useful for development of such a plan. that is designed to retain raw product

CHAPTER 4: Pathogens From the Harvest Area 81 3. If the finished product is raw oyster shellstock b. If the finished product will not be intended for raw consumption and is harvested subjected in your facility to a process from an area where: (1) The shellfish control that is designed to retain raw product authority has conducted a risk evaluation and characteristics and is sufficient to kill V. determined that the risk of V. parahaemolyticus parahaemolyticus during processing, illness from the consumption of oysters harvested you should identify the receiving step from that growing area is reasonably likely as a CCP, because you can exercise to occur; (2) the shellfish control authority control over the time from exposure has determined that harvesting occurs in the to air (i.e., by harvest or receding tide) growing area at a time when average monthly to refrigeration in order to control V. daytime water temperatures exceed 60°F for parahaemolyticus or exercise other waters bordering the Pacific Ocean and 81°F controls as determined by your state’s V. for waters bordering the Gulf of Mexico and the parahaemolyticus control plan. Atlantic Ocean (New Jersey and south); or (3) Example: the waters of the state have been confirmed as An oyster processor should set the the original source of oysters associated with two CCP for V. parahaemolyticus at the or more V. parahaemolyticus illnesses in the past receiving step. 3 years, will it be subjected in your facility to a process that is designed to retain raw product This control strategy is referred to as characteristics (e.g., mild heat processing, IQF “Control Strategy Example 2 - Shellstock with extended storage, high hydrostatic pressure Temperature Control.” Refer to “Control processing, or irradiation) and is sufficient to Strategy Example 2 - Shellstock kill V. parahaemolyticus (i.e., reduced to a non- Temperature Control” when controls for detectable level of less than 30 MPN/gram, V. parahaemolyticus are needed.” These as defined in the “National Shellfish Sanitation controls should be considered in addition Program Guide for the Control of Molluscan to the controls contained in “Control Shellfish 2007 Revision”)? Strategy Example 1 - Source Control.” If your shellfish control authority has If the finished product will be subjected to a. developed a V. parahaemolyticus control such a process in your facility, you should plan, you should develop a HACCP plan identify the processing step designed to that is based on the requirements of that retain raw product characteristics as the plan. Elements of the control strategy CCP for the control of V. parahaemolyticus. examples provided in this chapter In this case, you would not need to and in Chapter 17 may be useful for identify the receiving step as a CCP for the development of such a plan. control of V. parahaemolyticus. Only the primary processor (the processor who Example: takes possession of the molluscan shellfish An oyster processor should set the CCP from the harvester) should apply the time-to- for V. parahaemolyticus at the mild refrigeration controls for Vibrio spp. that are heat processing step and would not discussed in this chapter, because this processor identify the receiving step as a CCP is in the best position to control the time from for that pathogen. exposure to air (i.e., by harvest or receding tide) If you choose to follow this approach, to refrigeration. you should refer to Chapter 17 for further guidance.

CHAPTER 4: Pathogens From the Harvest Area 82 DEVELOP A CONTROL STRATEGY. accompanied by a bill of lading or similar shipping document that contains the same The following guidance provides three examples information; of control strategies for pathogens from the Note: The source controls listed in this critical limit are required under harvest area. You may select a control strategy 21 CFR 123.28(c). that is different from those which are suggested, OR provided it complies with the requirements of the • All containers of shellstock received from applicable food safety laws and regulations, except a processor must bear a tag that discloses that some parts of “Control Strategy Example 1 - the date and place they were harvested Source Control” are specifically required by the (by state and site), the type and quantity of Procedures for the Safe and Sanitary Processing shellfish, and the certification number of the and Importing of Fish and Fishery Products processor; regulation, 21 CFR 123 (called the Seafood HACCP Regulation in this guidance document). OR • All containers of shucked molluscan shellfish The following are examples of control strategies must bear a label that identifies the name, included in this chapter: address, and certification number of the packer or repacker of the product; MAY APPLY TO MAY APPLY TO CONTROL STRATEGY PRIMARY SECONDARY AND PROCESSOR PROCESSOR • All molluscan shellfish must have been Source control harvested from waters authorized for Shellstock temperature harvesting by a shellfish control authority. control For U.S. federal waters, no molluscan shellfish may be harvested from waters that • CONTROL STRATEGY EXAMPLE 1- are closed to harvesting by an agency of the SOURCE CONTROL federal government; Note: The following controls should be considered in addition to AND those in “Control Strategy Example 2 - Shellstock Temperature Control.” • All molluscan shellfish must be from a harvester that is licensed as required (note Set Critical Limits. that licensing may not be required in all • All containers of shellstock (in-shell jurisdictions) or from a processor that is molluscan shellfish) received from a certified by a shellfish control authority; harvester must bear a tag that discloses the AND date and place they were harvested (by • All finished product shellstock intended state and site), type and quantity of shellfish, for raw consumption must bear a tag that and information on the harvester or the instructs retailers to inform their customers harvester’s vessel (i.e., the identification that consuming raw or undercooked shellfish number assigned to the harvester by the may increase the risk of foodborne illness, shellfish control authority, where applicable, especially for individuals with certain or if such identification numbers are not medical conditions. assigned, the name of the harvester or the name or registration number of the Note: Only the primary processor, the processor that takes possession harvester’s vessel). For bulk shipments of the molluscan shellfish from the harvester, needs to apply controls relative to the identification of the harvester, the harvester’s license, or of shellstock where the shellstock is not the approval status of the harvest waters. containerized, the shellstock must be

CHAPTER 4: Pathogens From the Harvest Area 83 Establish Monitoring Procedures. • For checking incoming labels: At least three containers randomly » What Will Be Monitored? selected from every lot; • Information contained on tags on containers of incoming shellstock or on the bill AND of lading or similar shipping document • For checking licenses: accompanying bulk shipments of shellstock; Every delivery; AND AND • Information on whether the harvest area is • For checking the raw consumption advisory authorized for harvest by a shellfish control on finished product tags or labels: authority or information on whether federal Each container of finished product harvest waters are closed to harvesting by an shellstock intended for raw consumption agency of the federal government; or at least three containers randomly OR selected from every lot of shucked • Information contained on labels on molluscan shellfish. containers of incoming shucked molluscan » Who Will Do the Monitoring? shellfish; • Any person who has an understanding of the AND nature of the controls. • The harvester’s license, where applicable; Establish Corrective Action Procedures. AND • The raw consumption advisory on tags on Take the following corrective action to a product containers of finished product shellstock involved in a critical limit deviation: intended for raw consumption or the • Reject the lot; raw consumption advisory on labels on OR containers of shucked molluscan shellfish. • Relabel finished product shellstock intended » How Will Monitoring Be Done? for raw consumption that does not bear a tag • Perform visual checks; that contains the raw consumption advisory or relabel shucked molluscan shellfish that AND does not bear a label that contains the raw • Ask the shellfish control authority of the consumption advisory; state in which your shellstock are harvested OR whether the harvest area is authorized for harvest. • Reject any incoming tags to be used on finished product shellstock intended for » How Often Will Monitoring Be Done (Frequency)? raw consumption that do not contain the • For checking incoming tags: raw consumption advisory or reject any Every container; incoming labels to be used on shucked molluscan shellfish that do not contain the OR raw consumption advisory. • For checking the bill of lading or similar AND shipping document: Every delivery; OR

CHAPTER 4: Pathogens From the Harvest Area 84 Take the following corrective action to regain control Quantity and type of shellfish; over the operation after a critical limit deviation: AND • Discontinue use of the supplier until Name and certification number of the evidence is obtained that harvesting, tagging, packer or repacker; and/or label manufacturing practices have changed; AND Presence of the raw consumption OR advisory. • Modify labeling practices. Establish Verification Procedures. Establish a Recordkeeping System. • Review monitoring and corrective action records For shellstock: within 1 week of preparation to ensure they are • Receiving record that documents: complete and any critical limit deviations that Date of harvest; occurred were appropriately addressed. AND Location of harvest by state and site; AND Quantity and type of shellfish; AND Name of the harvester, name or registration number of the harvester’s vessel, or an identification number issued to the harvester by the shellfish control authority (for shellstock received directly from the harvester only); AND Number and date of expiration of the harvester’s license, where applicable; AND Certification number of the shipper, where applicable; AND For shellstock intended for raw consumption, the presence of the raw consumption advisory, when received from a certified dealer.

For shucked molluscan shellﬁsh: • Receiving record that documents: Date of receipt; AND

CHAPTER 4: Pathogens From the Harvest Area 85 Review Review 1 week of 1 week preparation records within monitoring and corrective action corrective record record record Receiving Receiving Receiving Receiving Receiving Receiving rates how a primary processor (processor hapter 3) for other potential hazards (e.g., harvesters Temperature Control.” Temperature Reject the lot Reject Reject lots from Reject unapproved waters unapproved thogens from the harvest area. It is provided for has secured a license CORRECTIVE ACTION(S) RECORDS VERIFICATION Discontinue use of the Discontinue use of the Discontinue use of the supplier until evidence supplier until evidence practices have changed practices have practices have changed practices have is obtained that tagging obtained that harvesting obtained that harvesting supplier until evidence is supplier until evidence supplier until evidence is supplier until evidence obtained that the harvester obtained that the harvester Reject lots from unlicensed Reject Receiving Receiving employee employee employee Every Every delivery Every lotEvery Receiving Every sackEvery Receiving TABLE 4-1 TABLE Example Only Visual Visual checks checks checks MONITORING See Text for Full Recommendations See Text tags WHAT HOW FREQUENCY WHO Information on CONTROL STRATEGY EXAMPLE 1 - SOURCE CONTROL CONTROL STRATEGY Ask the shellfish Harvester’s license Harvester’s Visual whether the area is control authority of Harvest site on tags Harvest incoming shellstock the state in which authorized for harvest authorized for shellstock are harvested shellstock are harvested MEASURE harvester All incoming control authority EACH PREVENTIVE shellstock must be be from a licensed All shellstock must CRITICAL LIMITS FOR type and quantity of by the state shellfish tagged with the date the harvester’s vessel the harvester’s and place of harvest, and place of harvest, All shellstock must be from waters approved approved from waters shellfish, and name or shellfish, registration number of from the Pathogens Pathogens HAZARD(S) harvest area harvest SIGNIFICANT natural toxins, environmental chemical contaminants and pesticides, pathogens during processing). Pathogens from the harvest area may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (C Pathogens from the harvest area may be only one of several significant hazards for this product. Refer to Tables that takes possession of the oysters from the harvester) of shellstock oysters, that is, the shellstock shipper, can control pa that takes possession of the oysters from harvester) of shellstock oysters, that is, the shipper, This control strategy should be considered in addition to “Control Strategy Example 2 - Shellstock illustrative purposes only. This table is an example of a portion of a HACCP plan using “Control Strategy Example 1 - Source Control.” This example illust (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) POINT CRITICAL CONTROL Receiving Receiving shellstock

CHAPTER 4: Pathogens From the Harvest Area 86 • CONTROL STRATEGY EXAMPLE 2 - SHELLSTOCK 12 hours; TEMPERATURE CONTROL OR Note: The following controls should be considered in addition to those in “Control Strategy Example 1 - Source Control.” For AMMAT of greater than 80°F (greater than 27°C): 10 hours. Set Critical Limits. Note: AMMAT is determined by the shellfish control authority. The • When controls for neither V. vulnificus nor V. shellfish control authority may implement time to temperature controls parahaemolyticus are needed: that are more stringent than those described here. Processors should consult with their shellfish control authority for current requirements. For AMMAT of less than 66°F (less than Note: Only the primary processor, the processor that takes possession 19°C): 36 hours; of the molluscan shellfish from the harvester, should apply controls for the time from exposure to air (i.e., by harvest or receding tide) to OR refrigeration. For AMMAT of 66 to 80°F (19 to 27°C): 24 hours; Establish Monitoring Procedures. OR » What Will Be Monitored? For AMMAT of greater than 80°F (greater • The time shellfish was exposed to air (i.e., by than 27°C): 20 hours; harvest or receding tide); Note: AMMAT is determined by the shellfish control authority. AND OR • The time shellstock was placed under • When controls for V. vulnificus are needed: refrigeration; For AMMWT of less than 65°F (less than » How Will Monitoring Be Done? 18°C): 36 hours; • For the time from exposure to air (i.e., by OR harvest or receding tide) to refrigeration: For AMMWT of 65 to 74°F (18 to 23°C): Obtain information from the shellfish 14 hours; control authority; OR OR For AMMWT of greater than 74 to 84°F Check the harvester’s log or tags; (greater than 23 to 29°C): 12 hours; OR OR Note the time of departure from and For AMMWT of greater than 84°F (greater return to dock; than 29°C): 10 hours; OR Note: AMMWT is determined by the shellfish control authority. The shellfish control authority may implement time to temperature controls Ask the harvester. that are more stringent than those described here. Processors should consult with their shellfish control authority for current requirements. » How Often Will Monitoring Be Done (Frequency)? OR • Every delivery.

• When controls for V. parahaemolyticus are » Who Will Do the Monitoring? needed: • Any person who has an understanding of For AMMAT of less than 66°F (less than the nature of the controls may perform the 19°C): 36 hours; monitoring. OR For AMMAT of 66 to 80°F (19 to 27°C):

CHAPTER 4: Pathogens From the Harvest Area 87 Establish Corrective Action Procedures. Take the following corrective action to a product involved in a critical limit deviation: • Reject lots that do not meet the critical limit; OR • Subject the shellstock to a cooking, pasteurization, retorting, or other process that reduces pathogens of public health concern to acceptable levels. See Chapters 16 and 17 and LACF Regulation (21 CFR 113) for further guidance; OR • Destroy the product; OR • Divert the product to a non-food use. AND

Take the following corrective action to regain control over the operation after a critical limit deviation: • Discontinue use of the supplier until evidence is obtained that harvesting practices have changed.

Establish a Recordkeeping System. • Receiving record that documents: Time shellstock is exposed to air (i.e., by harvest or receding tide); AND Time shellstock was placed under refrigeration; AND AMMWT.

Establish Veriﬁcation Procedures. • Review monitoring and corrective action records within 1 week of preparation to ensure they are complete and any critical limit deviations that occurred were appropriately addressed.

CHAPTER 4: Pathogens From the Harvest Area 88 action Review Review corrective corrective 1 week of 1 week preparation records within monitoring and record RECORDS VERIFICATION Receiving Receiving until practices Reject lot Reject s example illustrates how a primary ACTION(S) harvesting harvesting evidence is evidence hapter 3) for other potential hazards (e.g., CORRECTIVE obtained that have changed have of the supplier Discontinue use Strategy Example 1 - Source Control.” can control the pathogen from the harvest area, V. can control the pathogen from harvest area, V. Receiving Receiving Receiving Receiving employee employee delivery delivery TABLE 4-2 TABLE MONITORING Example Only (V. VULNIFICUS MODEL) (V. Visual checksVisual Every Harvester’s logHarvester’s Every See Text for Full Recommendations See Text AMMWT = Average Monthly Maximum Water Temperature Monthly Maximum Water AMMWT = Average Time Time WHAT HOW FREQUENCY WHO harvest Time of Time placed in refrigeration CONTROL STRATEGY EXAMPLE 2 - SHELLSTOCK TEMPERATURE CONTROL EXAMPLE 2 - SHELLSTOCK TEMPERATURE CONTROL STRATEGY LIMITS 36 hours 10 hours CRITICAL MEASURE FOR EACH PREVENTIVE refrigeration: AMMWT 65 to Maximum time from harvest to from harvest 74°F: 14 hours AMMWT >84ºF: AMMWT >84ºF: AMMWT >74 to 84°F: 12 hours; AMMWT < 65°F: AMMWT < 65°F: HAZARD(S) SIGNIFICANT Pathogens from Pathogens the harvest area the harvest (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Shellstock Temperature Control.” Thi This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Shellstock Temperature processor (one that takes possession of the oysters from harvester) of shellstock oysters, that is, the shipper, This control strategy should be considered in addition to “Control vulniﬁcus. It is provided for illustrative purposes only. 3-3 and 3-4 (C Pathogens from the harvest area may be only one of several signiﬁcant hazards for this product. Refer to Tables natural toxins, environmental chemical contaminants and pesticides, pathogens during processing). POINT CRITICAL CONTROL Receiving Receiving shellstock

CHAPTER 4: Pathogens From the Harvest Area 89 BIBLIOGRAPHY. • U.S. Centers for Disease Control and Prevention. 2001. “Norwalk-like viruses: We have placed the following references on Public health consequences and outbreak display in the Division of Dockets Management, management. Morb. Mortal. Wkly. Rep. 50:1-18. Food and Drug Administration, 5630 Fishers Lane, • U.S. Centers for Disease Control and rm. 1061, Rockville, MD 20852. You may see Prevention. February 2010 Norovirus: them at that location between 9 a.m. and 4 p.m., Technical Fact Sheet. Atlanta, GA. http://www. Monday through Friday. As of March 29, 2011, cdc.gov/ncidod/dvrd/revb/gastro/norovirus- FDA had verified the Web site address for the factsheet.htm. references it makes available as hyperlinks from • U.S. Food and Drug Administration. 2007. the Internet copy of this guidance, but FDA is not National Shellfish Sanitation Program Guide responsible for any subsequent changes to Non- for the control of molluscan shellfish 2007 FDA Web site references after March 29, 2011. revision. Department of Health and Human • Cook, D. W., J. C. Bowers, and A. DePaola. Services, Public Health Service, Food and 2002. Density of total and pathogenic (tdh+) Drug Administration, Division of Seafood Vibrio parahaemolyticus in Atlantic and Gulf Safety, College Park, MD. http://www.fda.gov/ Coast molluscan shellfish at harvest. J. Food Food/FoodSafety/Product-SpecificInformation/ Prot. 65:1873-1880. Seafood/FederalStatePrograms/ • DePaola, A., L. H. Hopkins, J. T. Peeler, NationalShellfishSanitationProgram/ B. Wentz, and R. M. McPhearson. 1990. ucm046353.htm. Incidence of Vibrio parahaemolyticus in U.S. coastal waters and oysters. Appl. Environ. Microbiol. 56:2299-2302. • Frankhauser, R. L., S. S. Monroe, J. S. Noel, C. D. Humphrey, J. S. Bresee, U. D. Parashar, T. Ando, and R. I. Glass. 2002. Epidemiologic and molecular trends of “Norwalk-like viruses” associated with outbreaks of gastroenteritis in the United States. J. Infect. Dis. 186:1-7. • Motes, M. L., A. DePaola, D. W. Cook, J. E. Veazey, J. C. Hunsucker, W. E. Garthright, R. J. Blodgett, and S. J. Chirtel. 1998. Influence of water temperature and salinity on Vibrio vulnificus in northern Gulf and Atlantic Coast oysters (Crassostrea virginica). Appl. Environ. Microbiol. 64:1459-1465. • Nishibuchi, M., and A. DePaola. 2005. Vibrio species, p. 251-271. In P. M. Fratamico, A. K. Bhunia, and J. L. Smith (ed.), Foodborne pathogens: microbiology and molecular biology. Caister Academic Press, Norfolk, UK. • Rippey, S. R. 1994. Infectious diseases associated with molluscan shellfish consumption. Clin. Microbiol. Rev. 7:419-425.

CHAPTER 4: Pathogens From the Harvest Area 90 CHAPTER 5: Parasites

UNDERSTAND THE POTENTIAL HAZARD and other ingredients); green herring (lightly brined herring); drunken crabs (crabs marinated in wine Parasites (in the larval stage) consumed in and pepper); cold-smoked fish; and, undercooked uncooked or undercooked seafood can present grilled fish. A survey of U.S. gastroenterologists a human health hazard. Among parasites, the confirmed that seafood-borne parasitic infections nematodes or roundworms (Anisakis spp., occur in the United States with sufficient frequency Pseudoterranova spp., Eustrongylides spp., and to recommend preventive controls during the Gnathostoma spp.), cestodes or tapeworms processing of parasite-containing species of fish that (Diphyllobothrium spp.), and trematodes or flukes are intended for raw consumption. (Chlonorchis sinensis (C. sinensis), Opisthorchis • Controlling parasites spp., Heterophyes spp., Metagonimus spp., The process of heating raw fish sufficiently Nanophyetes salmincola, and Paragonimus spp.) to kill bacterial pathogens is also sufficient to are of most concern in seafood. Most of these kill parasites. Guidance concerning cooking parasites cause mild-to-moderate illness, but and pasteurizing to kill bacterial pathogens is severe symptoms can occur. Roundworms may provided in Chapters 13 (hot smoking) and embed in the intestinal wall and cause nausea, 16 (cooking and pasteurization). Regulatory vomiting, diarrhea, and severe abdominal pain requirements for retorting (i.e., thermal processing and sometimes may penetrate the intestine. of low acid canned foods) are contained in the Tapeworms can cause abdominal swelling and Thermally Processed Low-Acid Foods Packaged abdominal cramps and may lead to weight loss in Hermetically Sealed Containers regulation, and anemia. Intestinal flukes (Heterophyes spp., 21 CFR 113 (hereinafter, the Low-Acid Canned Metagonimus spp., and Nanophyetes salmincola) Foods (LACF) Regulation). This guidance does not may cause abdominal discomfort and diarrhea. provide further information on retorting. Some intestinal flukes may also migrate to and damage the heart and central nervous system. The effectiveness of freezing to kill parasites Liver flukes (C. sinensis and Opisthorchis spp.) and depends on several factors, including the lung flukes (Paragonimus spp.) may migrate to temperature of the freezing process, the length of the liver and lung and sometimes cause serious time needed to freeze the fish tissue, the length of problems in other vital organs. time the fish is held frozen, the species and source of the fish, and the type of parasite present. The Some products that have been implicated in human temperature of the freezing process, the length parasite infection are the following: ceviche (fish and of time the fish is held frozen, and the type of spices marinated in lime juice); lomi lomi (salmon parasite appear to be the most important factors. marinated in lemon juice, onion, and tomato); For example, tapeworms are more susceptible to poisson cru (fish marinated in citrus juice, onion, freezing than are roundworms. Flukes appear to tomato, and coconut milk); herring roe; sashimi be more resistant to freezing than roundworms. (slices of raw fish); sushi (pieces of raw fish with rice

CHAPTER 5: Parasites 91 Freezing and storing at an ambient temperature that the fish will be consumed without of -4°F (-20°C) or below for 7 days (total time), thorough cooking by the end user or if you or freezing at an ambient temperature of -31°F represent, label, or intend for the product to (-35°C) or below until solid and storing at an be consumed in that manner. ambient temperature of -31°F (-35°C) or below for Species of fish not listed with a parasite 15 hours, or freezing at an ambient temperature of hazard in Tables 3-2 and 3-3 may have a -31°F (-35°C) or below until solid and storing at an parasite hazard that has not been identified ambient temperature of -4°F (-20°C) or below for if these fish are not customarily consumed 24 hours are sufficient to kill parasites. Note that raw or undercooked, or if the hazard occurs these conditions may not be suitable for freezing in certain localized harvest areas that are not particularly large fish (e.g., thicker than 6 inches). known commercial sources of fresh fish for Brining and pickling may reduce the parasite the U.S. You should consider this possibility hazard in a fish, but they do not eliminate it, in your hazard analysis. nor do they minimize it to an acceptable level. Species that normally have a parasite hazard as Nematode larvae have been shown to survive a result of consuming infected prey apparently 28 days in an 80° salinometer brine (21% salt do not have the same parasite hazard when by weight). raised only on pelleted feed in an aquaculture Fish that contain parasites in their flesh may also operation. You need not consider such contain parasites within their egg sacs (skeins), but aquacultured fish as having a parasite hazard. generally not within the eggs themselves. For this On the other hand, aquacultured fish that are reason, eggs that have been removed from the sac fed processing waste, fresh fish, or plankton and rinsed are not likely to contain parasites. may have a parasite hazard, even when wild- caught fish of that species do not normally Trimming away the belly flaps of fish or have a parasite hazard. Pellet fed fish that candling and physically removing parasites are sometimes depend on wild-caught prey to effective methods for reducing the numbers supplement their diet may have a parasite of parasites. However, they do not completely hazard. In addition, fish raised in freshwater eliminate the hazard, nor do they minimize it to may have a parasite hazard from trematodes an acceptable level. because these parasites enter the fish through the skin rather than in the food. You should DETERMINE WHETHER THE POTENTIAL verify the culture methods used by your HAZARD IS SIGNIFICANT. aquaculture producers before eliminating parasites as a significant hazard. The following guidance will assist you in determining whether parasites are a significant If the finished product is fish eggs that have hazard at a processing step: been removed from the sac (skein) and rinsed, the fish eggs are not reasonably likely to 1. Is it reasonably likely that parasites will be contain parasites and you need not consider introduced at the receiving step (e.g., do they such product as having a parasite hazard. come in with the raw material)? However, unrinsed fish eggs or fish eggs Tables 3-2 and 3-3 (Chapter 3) list those that remain in the sac ordinarily will have a species for which FDA has information that parasite hazard if the species is identified in a potential parasite hazard exists. Ordinarily, Table 3-2 or 3-3 as having a parasite hazard. you should identify the receiving step for If you receive the fish frozen and have these species as having a significant parasite documented assurance from your supplier hazard if you know or have reason to know that the fish are frozen in a way that will

CHAPTER 5: Parasites 92 kill the parasites (e.g., consistent with the primary processor would not need to identify guidance in this chapter), you do not need to parasites as a significant hazard. identify the hazard of parasites as reasonably likely to occur in your product. IDENTIFY CRITICAL CONTROL POINTS. It is not reasonably likely that parasites will enter the process at other processing steps. The following guidance will assist you in determining whether a processing step is a 2. Can the parasite hazard that was introduced at critical control point (CCP) for parasites: an earlier step be eliminated or reduced to an acceptable level at this processing step? 1. Does the process contain a heating step, such as retorting, cooking, or pasteurizing that is Parasites should be considered a significant designed to kill bacterial pathogens? hazard at any processing step where a preventive measure is, or can be, used to a. If the process contains a heating step, eliminate the hazard that was introduced at an you should identify the heating step as earlier step or to reduce to an acceptable level the CCP and would not need to identify the likelihood of occurrence of the hazard. receiving as a CCP for this hazard. Preventive measures for parasites can include: See Chapters 13 (Clostridium botulinum • Retorting (covered in 21 CFR toxin formation) and 16 (Pathogen 113, the LACF Regulation); bacteria survival through cooking or pasteurization), and the LACF Regulation • Hot smoking (covered in Chapter 13); (21 CFR 113) for further information on • Cooking and pasteurization this control strategy. (covered in Chapter 16); Example: • Freezing (covered in this chapter). A hot-smoked salmon processor should set the CCP for parasites at the • Intended use hot-smoking step and would not need If the consumer intends to cook the fish to identify the receiving step as a CCP thoroughly before consumption, then you do for this hazard. not need to consider the hazard significant, even if Table 3-2 or 3-3 lists the species as having a b. If the process does not contain a heating potential parasite hazard. In order to eliminate step, you should identify a freezing parasites as a significant hazard when you are step as the CCP, and would not need to unsure of the product’s intended use, you should identify receiving as a CCP for this hazard. obtain documented assurance from the subsequent Example: processor, restaurateur, or institutional user (e.g., A salmon processor that sells the prison or nursing home) that the fish will be finished product for raw consumption processed in a way that will kill the parasites. should identify a freezing step as the Example: CCP for parasites. The processor would A primary processor receives whole salmon not need to identify the receiving step from the harvest vessel and re-ices the fish as a CCP for this hazard. for shipment to a second processor. The This control approach is a control second processor butchers the fish for sale strategy referred to in this chapter as to the sushi market. The primary processor “Control Strategy Example 1 - Freezing.” has documented assurance that the second processor freezes the fish before sale. The

CHAPTER 5: Parasites 93 DEVELOP A CONTROL STRATEGY. For 7-day freezing critical limit: • Starting time of freezing and ending The following guidance provides an example of time of the frozen storage period; a control strategy for parasites. It is important OR to note that you may select a control strategy that is different from that which is suggested, For 15-hour and 24-hour freezing critical provided it complies with the requirements of the limits: applicable food safety laws and regulations. • Time when all ﬁsh are solid The following is an example of the control frozen and ending time of strategy included in this chapter: the frozen storage period. » How Will Monitoring Be Done? MAY APPLY TO MAY APPLY TO CONTROL STRATEGY PRIMARY SECONDARY • Use a continuous temperature-recording PROCESSOR PROCESSOR device (e.g., a recording thermometer); Freezing AND • Perform a visual check of time and physical • CONTROL STRATEGY EXAMPLE - FREEZING check of solid frozen condition, as appropriate. Set the Critical Limits. » How Often Will Monitoring Be Done (Frequency)? • Freezing and storing at an ambient temperature • For temperature: of -4°F (-20°C) or below for 7 days (total time); Continuous monitoring, with a visual OR check of the recorded data at least once • Freezing at an ambient temperature of -31°F during each freezing or storage period, (-35°C) or below until solid and storing at but no less than once per day; an ambient temperature of -31°F (-35°C) or AND below for 15 hours; • For time: OR Each batch, at the beginning and end • Freezing at an ambient temperature of -31°F of the freezing or storage period, as (-35°C) or below until solid and storing at an appropriate. ambient temperature of -4°F (-20°C) or below for 24 hours. » Who Will Do the Monitoring?

Note: These conditions may not be suitable for freezing particularly • The device itself performs the monitoring. Any large fish (e.g., thicker than 6 inches). It may be necessary for you person who has an understanding of the nature to conduct a study to determine effective control parameters specific of the controls may perform the visual check of to your freezing method, fish thickness, fish species, method of the data generated by this device to ensure that preparation, and target parasites. the critical limits have been met consistently. Establish Monitoring Procedures. Establish Corrective Action Procedures. » What Will Be Monitored? Take the following corrective action to a product • Freezer temperature; involved in a critical limit deviation: AND • Refreeze and store the product at an ambient • Length of time fish is held at freezer temperature temperature of -4°F (-20°C) or below for 7 or held solid frozen, as appropriate: days (total time), or refreeze it at an ambient temperature of -31°F (-35°C) or below until solid

CHAPTER 5: Parasites 94 and store at an ambient temperature of -31°F known accurate reference device (e.g., (-35°C) or below for 15 hours, or refreeze it at an a thermometer traceable to the National ambient temperature of -31°F (-35°C) or below Institute of Standards and Technology until solid and store at an ambient temperature (NIST) standards) under conditions that of -4°F (-20°C) or below for 24 hours. Note that are similar to how it will be used (e.g., these conditions may not be suitable for freezing product internal temperature) within the particularly large fish (e.g., thicker than 6 inches); temperature range at which it will be used; OR AND • Destroy or divert the product to a non-raw or • Once in service, check the temperature- non-food use. recording device daily before the beginning of operations. Less frequent accuracy checks may AND be appropriate if they are recommended by Take the following corrective action to regain control the instrument manufacturer and the history over the operation after a critical limit deviation: of use of the instrument in your facility has • Make repairs or adjustments to the freezer; shown that the instrument consistently remains accurate for a longer period of time. In addition OR to checking that the device is accurate by one • Move some or all of the product in the of the methods described above, this process freezer to another freezer. should include a visual examination of the sensor and any attached wires for damage or Establish a Recordkeeping System. kinks. The device should be checked to ensure • Record of continuous temperature monitoring; that it is operational and, where applicable, has sufficient ink and paper; AND • Record of visual checks of recorded data. AND • Calibrate the temperature-recording device AND against a known accurate reference device (e.g., • Record of notation of the start time and end a NIST-traceable thermometer) at least once a time of the freezing periods; year or more frequently if recommended by AND the device manufacturer. Optimal calibration frequency is dependent upon the type, condition, • Record of notation of the time the fish is past performance, and conditions of use of the solid frozen (if appropriate). device. Consistent temperature variations away from the actual value (drift) found during checks Establish Verification Procedures. and/or calibration may show a need for more • Before a temperature-recording device (e.g., frequent calibration or the need to replace the a recording thermometer) is put into service, device (perhaps with a more durable device). check the accuracy of the device to verify Calibration should be performed at a minimum that the factory calibration has not been of two temperatures that bracket the temperature affected. This check can be accomplished by: range at which it is used; Immersing the sensor in an ice slurry AND (32°F (0°C)) if the device will be used at • Review monitoring, corrective action, or near refrigeration temperature; and verification records within 1 week of OR preparation to ensure they are complete and Comparing the temperature reading any critical limit deviations that occurred on the device with the reading on a were appropriately addressed.

CHAPTER 5: Parasites 95 at the Review Review that it is per year recorder corrective corrective 1 week of 1 week Check the verification verification action, and action, operational monitoring, monitoring, preparation into service; for accuracy for and damage beginning of thermometer and to ensure check it daily, check it daily, before putting before records within operations; and calibrate it once period RECORDS VERIFICATION for visual for and time at check, time check, temperature solid frozen, solid frozen, with notations end of storage Recorder chartRecorder product Refreeze Refreeze Adjust or Adjust ACTION(S) CORRECTIVE repair freezer zing.” This example illustrates how a proces- r processors for the production of refrigerated otential hazards (e.g., environmental chemical Freezer operator period process freezing check of with visual Continuous, Continuous, recorded data Each batch, at Each batch, at end of each end of storage beginning and TABLE 5-1 TABLE MONITORING Example Only Recorder Recorder Visual and Visual thermometers physical checks See Text for Full Recommendations See Text CONTROL STRATEGY EXAMPLE - FREEZING CONTROL STRATEGY blast WHAT HOW FREQUENCY WHO period and time at freezer and solid frozen Time when all Time end of storage storage freezer Temperature of Temperature fish are visually hours MEASURE FOR EACH PREVENTIVE below for 24 below for CRITICAL LIMITS hold at -4°F or -31°F or below until solid, and until solid, HAZARD(S) SIGNIFICANT (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) This table is an example of a portion of a Hazard Analysis Critical Control Point plan using “Control Strategy Example 1 - Free sor can control parasites in frozen salmon fillets with pin bones removed, where the finished product will be distributed to othe lox. It is provided for illustrative purposes only. 3-2, and 3-4 (Chapter 3) for other p Parasites may be only one of several significant hazards for this product. Refer to Tables contaminants and pesticides, aquaculture drugs, food color additives, metal fragments). POINT CRITICAL Freezing Parasites Blast freeze at CONTROL

CHAPTER 5: Parasites 96 BIBLIOGRAPHY. Prevalence of larval Anisakis simplex in pen- reared and wild-caught salmon (Salmonidae) We have placed the following references on from Puget Sound, Washington. J. Wildl. Dis. - display in the Division of Dockets Management, 25:416 419. Food and Drug Administration, 5630 Fishers • Deardorff, T. L., and R. M. Overstreet. 1990. Lane, rm. 1061, Rockville, MD 20852. You may Seafood-transmitted zoonoses in the United see them at that location between 9 a.m. and 4 States: the fish, the dishes and the worms, p. p.m., Monday through Friday. As of March 29, 211-265. In D. Ward and C. R. Hackney (ed.). 2011, FDA had verified the Web site address for Microbiology of marine food products, Van the references it makes available as hyperlinks Nostrand Reinhold, New York, NY. from the Internet copy of this guidance, but FDA • Deardorff, T. L., and R. Throm. 1988. is not responsible for any subsequent changes Commercial blast-freezing of third-stage to Non-FDA Web site references after March 29, Anisakis simplex larvae encapsulated in 2011. salmon and rockfish. J. Parasitol. 74(4):600- • Adams, A. M., K. D. Murrell, and J. H. 603. Cross. 1997. Parasites of fish and risks to • Deardorff, T. L., M. J. Klicks, M. E. Rosenfeld, public health. Rev. Sci. Tech. Off. Int. Epiz. R. A. Rychlinski, and R. S. Desowitz. 1982. 16(2):652-660. Larval ascaroid nematodes from fishes near • Adams, A. M., M. N. Ton, M. M. Wekell, the Hawaiian Islands, with comments on A. P. MacKenzie, and F. M. Dong. 2005. pathogenicity experiments. Pac. Sci. 36:187- Survival of Anisakis simplex in arrowtooth 201. flounder (Atheresthes stomia) during frozen • Deardorff, T. L., R. B. Raybourne, and R. S. storage. J. Food Prot. 68(7):1441-1446. Desowitz. 1984. Behavior and viability of • American Gastroenterological Association. third-stage larvae of Terranova sp. (Type 2000. Determination of the incidence of HA) and Anisakis simplex (type I) under gastrointestinal parasitic infections from the coolant conditions. J. Food Prot. 47(1):49-52. consumption of raw seafood in the U.S. • Edgerton, B. F., L. H. Evans, F. J. Stephens, [Report under FDA Contract 223-97-2328 and R. M. Overstreet. 2002. Synopsis of with Life Sciences Research Office, American freshwater crayfish diseases and commensal Society for Nutritional Sciences]. AGA, organisms. Aquaculture 206:57-135. Bethesda, MD. • Eslami, A., and B. Mokhayer. 1997. Nematode • Berland, B. 1961. Nematodes from some larvae of medical importance found in Norwegian marine fishes. Sarsia 2:1-50. market fish in Iran. Pahlavi Med. J. 8:345-348. • Bier, J. W. 1988. Anisakiasis. In A. Balows, W. • Freeman, R. S., P. F. Stuart, S. J. Cullen, J. Hausler, Jr., M. Ohashi, and A. Turano (ed.), A. C. Ritchie, A. Mildon, B. J. Fernandes, Laboratory diagnosis of infectious diseases, and R. Bonin. 1976. Fatal human infection vol. I. Springler-Verlag, New York, NY. with mesocercariae of the trematode Alaria • Bouree, P., A. Paugam, and J. C. Petithory. americana, Am. J. Trop. Med. Hyg. 25(6):803- 1995. Review - Anisakidosis: report of 25 807. cases and review of the literature. Comp. • Gardner, M. A. 1990. Survival of Anisakis in Immunol. Microbiol. Infect. Dis. 18(2):75-84. cold-smoked salmon. Can. Inst. Food Sci. • Daniel, R. J. 1950. A guide to marketable fish. Technol. J. 23:143-144. Proc. Lpool. Biol. Soc. 57:App1, 68 pp. • Hauck, A. K. 1977. Occurrence and survival • Deardorff, T. L., and M. L. Kent. 1989. of the larval nematode Anisakis sp. in the

CHAPTER 5: Parasites 97 flesh of fresh, frozen, brined, and smoked • Templeman, W., H. J. Squires, and A. M. Pacific herring, Clupea harengus pallasi, J. Fleming. 1957. Nematodes in the fillets of Parasitol. 63:515-519. cod and other fishes in Newfoundland and • Jensen, T., K. Andersen, and S. des Clers. neighbouring areas. J. Fish. Res. Bd. Can. 1994. Sealworm (Pseudoterranova decipiens) 14:831-897. infections in demersal fish from two areas in • Verhamme, M. A. M., and C. H. R. Ramboer. Norway. Can. J. Zool. 72:598-608. 1988. Anisakiasis caused by herring in • Karl, H., and M. Leinemann. 1989. Viability vinegar: a little known medical problem. Gut. of nematode larvae (Anisakis sp.) in frozen 29:843-847. herrings. Archiv fur Lebensmittelhygiene. • Williamson, H. C. 1910. Nematodes in the 40(1):14-16 (in German). muscle of the cod (Gadus callarias). Rep. • Lile, N. K., O. Halvorsen, and W. Fish. Bd. Scot. 28:61-62. Hemmingsen. 1994. Zoogeographical • Williamson, H. C. 1919. The distribution of classification of the macroparasite faunas of parasite-infected fish. Ann. App. Biol. 6:48- four flatfish species from the northeastern 52. Atlantic. Polar Biol. 14(2):137-141. • World Health Organization. 1995. Control of • Margolis, L., and J. R. Arthur. 1979. Synopsis foodborne trematode infections: report of of the parasites of fishes of Canada. Fish. a WHO study group. WHO, Geneva. WHO Res. Board Can. Bull. Canadian Department Technical Report Series No. 849. of Fisheries and Oceans. 199:1-269. • McClelland, G., R. K. Misra, and D. J. Martell. 1990. Larval anisakine nematodes in various fish species from Sable Island Bank and vicinity, p. 83-118. In W. D. Bowen (ed.), Population biology of sealworm (Pseudoterranova decipiens) in relation to its intermediate and seal hosts. Can. Bull. Fish. Aquat. Sci., vol. 222:83-118. • Ogawa, K. 1996. Marine parasitology with special reference to Japanese fisheries and mariculture. Vet. Parasitol. 64:95-105. • Polyanskii, Y. 1966. The parasitology of fish of northern waters of the U.S.S.R. Parasites of the fish of the Barents Sea, p. 158. Transactions of the Zoological Institute of the Academy of Sciences of the U.S.S.R., vol. 19 (Translated from Russian by the Israel Program for Scientific Translations, Jerusalem). • Punt, A. 1941. Recherches sur quelques nematodes parasites des poissons de la Mer du Nord. Mem. Mus. Hist. Nat. Belg. 98:1-110. • Sakanari, J. A., and J. H. McKerrow. 1989. Anisakiasis. Clin. Microbiol. Rev. 2:278-284.

CHAPTER 5: Parasites 98 CHAPTER 6: Natural Toxins

UNDERSTAND THE POTENTIAL HAZARD. Paralytic Shellfish Poisoning (saxitoxin) in the U.S. is generally associated with the consumption Contamination of fish with natural toxins from the of molluscan shellfish from its northeast and harvest area can cause consumer illness. Most of northwest coastal regions. PSP in other parts of these toxins are produced by species of naturally the world has been associated with molluscan occurring marine algae (phytoplankton). They shellfish from environments ranging from tropical accumulate in fish when they feed on the algae to temperate waters. Certain gastropods (e.g., or on other fish that have fed on the algae. There conch, snails and whelk) are also known to are also a few natural toxins that are normal accumulate PSP toxins. They may accumulate constituents of certain species of fish. toxins by feeding on molluscs that are toxic. In particular, moon snails and whelk are commonly For fish products in the United States (U.S.) found to contain PSP toxins off the northeast commerce there are six recognized fish poisoning coast of the U.S. Abalone from South Africa and syndromes that can occur from the consumption Spain have been reported to contain PSP toxins, of fish or fishery products contaminated with although there have been no reports of PSP toxins natural toxins: Paralytic shellfish poisoning in abalone off the coast of the U.S. Similarly, (PSP), neurotoxic shellfish poisoning (NSP), PSP toxins have been reported in sea cucumbers, diarrhetic shellfish poisoning (DSP), amnesic octopi and a variety of echinoderms, targeted shellfish poisoning (ASP), ciguatera fish poisoning for human consumption in sub-tropical regions (CFP) and azaspiracid shellfish poisoning (AZP). of Australia, but to date no reports have been Scombrotoxin (histamine) poisoning, that can shown in these species in U.S. waters. In the U.S., occur as a result of scombrotoxin formation PSP toxin has been reported from the viscera of in time and temperature abused fish, is not lobster and crabs are often eaten whole, therefore considered a natural toxin, and is covered in it is important to include toxin loads contained Chapter 7. in the viscera and flesh for these animals. The • Species and geographic areas involved levels of PSP toxins found in lobster tomalley and crab viscera may pose a health hazard if eaten This section provides information about species of from a heavily contaminated area. In 2008, FDA fish and geographic areas that have been linked advised against the consumption of American to one of the five fish poisoning syndromes by lobster tomalley because unusually high levels historical occurrence of the syndrome. However, of PSP toxins were detected in that organ in it is important to note that historical occurrence lobsters caught in the waters of New England. In may be an inadequate guide to future occurrence 2002, PSP from the consumption of the flesh of in the case of natural toxins, because the puffer fish was first reported in the U.S. All cases distribution of the source algae may vary over to date have been due to fish harvested from time. You should be alert to the potential for central east coast Florida. PSP toxins have been emerging problems.

CHAPTER 6: Natural Toxins 99 confirmed in southern (Sphoeroides nephelus), the first time in several locations along the Texas checkered (Sphoeroides testudineus), and bandtail Gulf Coast during a large marine algae bloom. (Sphoeroides spengleri) puffer fish. There is DSP is characterized by gastrointestinal currently a ban on the harvesting of all puffer symptoms, including: nausea, vomiting, diarrhea, fish in the Florida counties of Volusia, Brevard, abdominal pain, headache, and fever. Symptoms Indian River, St. Lucie, and Martin. develop from 30 minutes to 3 hours after The effects of PSP are primarily neurological consumption and last for up to 4 days. DSP is and can include: tingling, burning, numbness, generally not considered life threatening but drowsiness, incoherent speech, and respiratory complications could occur as a result of severe paralysis. Respiratory paralysis can result in dehydration in some patients. death if respiratory support is not provided in a Amnesic shellfish poisoning (from domoic acid) timely manner. PSP toxin is an extremely potent is generally associated with the consumption toxin with a high mortality rate. The symptoms of molluscan shellfish from the northeast and develop from ½ to 2 hours after consumption. northwest coasts of North America. In these Neurotoxic shellfish poisoning (from brevetoxin) regions, domoic acid has been identified in in the U.S. is generally associated with the the viscera of Dungeness (Cancer magister), consumption of molluscan shellfish from the tanner, and red rock crab. Domoic acid has also coast of the Gulf of Mexico, and, sporadically, been identified in several fish species including along the southern Atlantic coast. NSP has also anchovies (Engraulis mordax), Pacific sanddab been linked to gastropods (whelk) harvested off (Citharichthys sordidus), chub mackerel (Scomber the Florida Gulf Coast. In addition, there has japonicas), albacore tuna (Thunnas alalunga), been a significant occurrence of toxins similar jack smelt (Atherinopsis californiensis), and to NSP in New Zealand and some suggestions of market squid (Loligo opalescens) along the west occurrence elsewhere. coast of the U.S. It has not yet been a problem in the Gulf of Mexico, although the planktonic NSP is characterized by gastrointestinal and algae that produce the toxin have been reported neurological symptoms, including: tingling in coastal waters, and more recently detected in and numbness of the lips, tongue, and menhaden (Brevoortia partonus) collected from throat; muscular aches; dizziness; reversal Louisiana. Although this planktivorous species is of sensations of hot and cold; diarrhea; and not currently commercially harvested for human vomiting. Symptoms develop from a few food in the Gulf of Mexico, it is used in dietary minutes to a few hours after consumption. supplements, feed products, and occasionally There are few, if any, after effects and there caught recreationally and eaten by locals. have been no reported fatalities. ASP is characterized by gastrointestinal Diarrhetic shellfish poisoning (from okadaic acid symptoms, including: nausea, vomiting, and dinophysistoxins) is generally associated abdominal cramps, and diarrhea. These with the consumption of molluscan shellfish. symptoms develop within 24 hours of There have been no documented occurrences consumption. In severe cases, neurological of illness to date in the U.S. however reports of symptoms also appear, including: dizziness, this illness can be misidentified as a bacterial or headache, seizures, disorientation, short-term viral source and is expected to be highly under- memory loss, respiratory difficulty, and coma. reported. Outbreaks have been documented These symptoms usually develop within 48 in Japan, Southeast Asia, Scandinavia, Western hours of consumption. These marine toxins Europe, Chile, New Zealand, and eastern Canada. described above are not ordinarily a problem in However, in 2008, okadaic acid levels in excess scallops if only the adductor muscle is consumed. of the 0.16 ppm guidance level were recorded for

CHAPTER 6: Natural Toxins 100 However, products such as roe-on scallops and Netherlands, linked to consumption of mussels whole scallops do present a potential hazard for harvested in Ireland. Since then, several outbreaks natural toxins. of AZP have been reported in various regions in Europe. In 2008, two cases of AZP were reported Ciguatera fish poisoning (from ciguatoxin in the US, and linked to consumption of an (CTX)) is associated with consumption of toxin- imported mussel product from Ireland confirmed contaminated subtropical and tropical reef fish. to contain AZP toxins in excess of guidance levels. The toxin is introduced to the marine food chain To date, AZP toxins have not been confirmed in by microscopic algae and moves up the food any product harvested in the US. chain as small plant-eating reef fish eat the toxic algae and are then eaten by larger reef fish. AZP is characterized by severe gastrointestinal The toxin accumulates in the flesh of certain disorders including abdominal pain, nausea, predatory reef fish species. Although ciguatera vomiting, and diarrhea. Symptoms develop hotspots are well recognized, there is not an within minutes to hours after consumption of the even distribution of toxic fish within a given contaminated shellfish and last for several days. reef; fish caught side by side may have widely There have been no reported fatalities. differing contamination levels. Ciguatoxic fish A number of additional toxins that have been may be found in tropical or subtropical areas identified in molluscan shellfish have shown around the world between 35° north latitude and toxicity in mouse studies but have not been 35° south latitude and are common in several linked to human illness. Pectenotoxins (PTX) areas in the Caribbean Sea, Pacific Ocean, Indian have been detected in phytoplankton and/ Ocean, and in the Flower Garden Banks area in or molluscan shellfish in Australia, Italy, Japan, the northern Gulf of Mexico. Reef fish associated New Zealand, Norway, Portugal, and Spain. with CFP include: barracuda (Sphyraenidae), Yessotoxins (YTX) have been detected in amberjack (Seriola), grouper (Family: Serranidae), phytoplankton and/or molluscan shellfish in snapper (Family: Lutjanidae), po’ou (Chelinus Australia, Canada, Italy, Japan, New Zealand, spp.), jack (Family: Carangidae), travelly (Caranx Norway, the United Kingdom, and the U.S. Cyclic spp.), wrasse (Family: Labridae), surgeon fish imines have been found in phytoplankton and/ (Family: Acanthuridae), moray eel (Family: or molluscan shellfish in Canada, Denmark, New Muraenidae), roi (Cephalopholis spp.), and parrot Zealand, Norway, Scotland, Tunisia, and the fish (Family: Scaridae). U.S. PTX and YTX have been found to occur in CFP is characterized by numbness and tingling shellfish along with the DSP toxins okadaic acid of the lips and tongue, which may spread to the and dinophysistoxins. At this time, FDA makes extremities; nausea; vomiting; diarrhea; joint pain; no recommendations in this guidance and has no muscle pain; headache; reversal of sensation of specific expectations with regard to controls for hot and cold; acute sensitivity to temperature PTX, YTX and cyclic imines in processors’ Hazard extremes; vertigo; muscular weakness; irregular Analysis Critical Control Point (HACCP) plans. heartbeat, and reduced blood pressure. • Natural toxin detection Gastrointestinal symptoms may develop within 2 hours following consumption of toxic fish while The FDA has established action levels for natural neurological and cardiovascular symptoms will toxins as follows: usually emerge within 6 hours post-ingestion. • PSP - 0.8 ppm (80 ug/100 g) saxitoxin equivalents; Azaspiracid shellfish poisoning (AZP) is caused by the consumption of molluscan shellfish • NSP - 0.8 ppm (20 mouse units/100 g) contaminated with azaspiracids (AZA). AZP was brevetoxin-2 equivalents; first recognized following a 1995 outbreak in the • DSP - 0.16 ppm total okadaic acid

CHAPTER 6: Natural Toxins 101 equivalents (i.e., combined free okadaic acid, and quantity of shellfish, the harvester, harvest dinophysistoxins, acyl-esters of okadaic acid location, and the date of harvest (21 CFR and dinophysistoxins); 123.28(c)); (2) molluscan shellfish harvesters be • ASP - 20 ppm domoic acid, except in the licensed (note that licensing may not be required viscera of dungeness crab, where the action in all jurisdictions); (3) processors that ship, level is 30 ppm; reship, shuck, or repack molluscan shellfish be certified; and (4) containers of shucked molluscan • CFP - 0.01 ppb P-CTX-1 equivalents for shellfish bear a label with the processor’s name, Pacific ciguatoxin and 0.1 ppb C-CTX-1 address, and certification number. equivalent for Caribbean ciguatoxin; • AZP - 0.16 ppm azaspiracid equivalents. An established water classification system similar to that in use for the molluscan shellfish system There are currently no NSSP-accepted rapid test is not in place for controlling CFP in finfish. methods for NSP, ASP, DSP, CFP or AZP, and only However, some states issue advisories regarding one rapid test method has been validated (for PSP). reefs that are known to be toxic. In areas where • Natural toxin control there is no such advisory system, fishermen and processors must depend on their own knowledge Natural toxins cannot be reliably eliminated by of local reporting of illnesses associated with heat. However, severe heating processes, such as reefs from which they obtain fish. retorting, may be effective at reducing the levels of some natural toxins. Where PSP or ASP has become a problem in finfish or crustaceans, states generally have To minimize the risk of molluscan shellfish closed or restricted the appropriate fisheries or containing natural toxins from the harvest area, have issued consumption advisories. In addition, state and foreign government agencies, called removal and destruction of the viscera will shellfish control authorities, classify waters in eliminate the hazard, and this is at times required which molluscan shellfish are found, based, by state public health authorities. In 2008, FDA in part, on the presence of natural toxins in advised against the consumption of American shellfish meats. Shellfish control authorities lobster tomalley, but not the lobster meat itself, may also use cell counts of the toxin-forming because unusually high levels of PSP toxins were algae in the harvest waters to classify shellfish detected in the lobster tomalley of lobsters caught harvest areas. As a result of these classifications, in the waters of New England. molluscan shellfish harvesting is allowed from some waters, not from others, and only at certain • Escolar, puffer fish, and whelk times, or under certain conditions, from others. There are naturally occurring toxins in some Shellfish control authorities then exercise control species that do not involve marine algae. Escolar over the molluscan shellfish harvesters to ensure or oilfish (i.e., Lepidocybium flavobrunneum or that harvesting takes place only when and where Ruvettus pretiosus) contains a strong purgative oil it has been permitted. In this context, molluscan (wax ester), called gempylotoxin, that may cause shellfish include oysters, clams, mussels, and diarrhea, abdominal cramps, nausea, headache, scallops, except where the scallop product and vomiting when consumed. FDA advises contains the shucked adductor muscle only. against importation and interstate marketing Other significant elements of shellfish control of these fish. Additional deep sea fish species, authorities’ efforts to control the harvesting of such as orange roughy (Hoplostethus atlanticus), molluscan shellfish include requirements that and, oreo dory (Allocyttus spp., Pseudocyttus (1) containers of in-shell molluscan shellfish spp., Oreosoma spp., and Neocyttus spp.) are (shellstock) bear a tag that identifies the type known to contain lesser amounts of the same indigestible wax esters. Sensitive individuals may

CHAPTER 6: Natural Toxins 102 also experience symptoms from the consumption Tetramine is a toxin that is found in the salivary of these fish. Improperly handled escolar glands of Neptunia spp., a type of whelk. The and oilfish also have been associated with hazard can be controlled by removing the glands. scombrotoxin (histamine) poisoning (Covered in Symptoms of tetramine poisoning include: Chapter 7). double vision, temporary blindness, difficulty in focusing, tingling of the fingers, prostration, Puffer fish (also known as fugu, swellfish, bok, nausea, vomiting, diarrhea, and loss of muscle blowfish, globefish, balloonfish, or sea squab) control. Symptoms usually develop within 1 may contain tetrodotoxin. Poisonings from hour of consumption. tetrodotoxin have usually been associated with the consumption of puffer fish from waters of the FDA makes no recommendations in this guidance Indo-Pacific Ocean regions. However, several document and has no specific expectations with reported cases of poisonings, including fatalities, regard to controls for gempylotoxin in processors’ involved puffer fish from the Atlantic Ocean, Gulf HACCP plans. Additionally, FDA makes no of Mexico, and Gulf of California. There have specific recommendation in this guidance for been no confirmed cases of poisonings from control of tetrodotoxin and tetramine. northern puffer fish (Sphoeroides maculatus), which was once harvested and marketed as “sea DETERMINE WHETHER THE POTENTIAL squab” on the U.S. east coast, but there is still HAZARD IS SIGNIFICANT. reason for concern. There is a restriction on importation of all species of puffer fish and fishery The following guidance will assist you in products containing puffer fish. See Import determining whether natural toxins are a Alert #16-20 at the internet location http://www. significant hazard at a processing step: accessdata.fda.gov/cms_ia/importalert_37.html. Some puffer fish are also subject to contamination 1. Is it reasonably likely that unsafe levels of natural with PSP toxins, covered earlier in this chapter. toxins will be introduced at this processing step (e.g., does the toxin come in on the raw material Tetrodotoxin has been implicated in illnesses at an unsafe level)? from the consumption of additional species besides puffer fish, for example, certain species Tables 3-2 and 3-3 (Chapter 3) identify the of xanthid crabs, marine gastropods, and goby species of fish for which natural toxins are fish. Reports of these illnesses have been mainly known to be a potential hazard. Under limited to Asia, and involve species unlikely to be ordinary circumstances, it would be imported into the U.S. reasonably likely to expect that, without proper controls, natural toxins from the Tetrodotoxin poisoning is characterized by harvest area could enter the process at slight numbness of the lips and tongue, tingling unsafe levels at the receiving step for those sensation in the face and extremities, headache, species. There may be circumstances in abdominal pain, nausea, diarrhea, vomiting, your geographic area that would allow you difficulty in walking, paralysis, respiratory to conclude that it is not reasonably likely for distress, difficulty in speech, shortness of breath, a particular natural toxin to occur at unsafe blue or purplish discoloration of the lips and levels in fish from your area. You should be skin, lowering of blood pressure, convulsions, guided by the information provided above mental impairment, irregular heartbeat, and death. and the historical occurrence of the toxin Symptoms usually develop between 30 minutes in the fish, at levels above the established and 3 hours after consumption and may last for guidance levels, in your geographic area. 20 minutes to 8 hours. If respiratory aid is not However, you should remain alert to the provided, death may occur within 4 to 6 hours. potential for emerging problems. Examples

CHAPTER 6: Natural Toxins 103 of natural toxin hazards that had not until • Intended use recently been known to exist are PSP in In most cases, it is unlikely that the intended puffer fish and domoic acid in anchovies. use of the product would determine whether If you are receiving fish, other than the hazard is significant. One exception is with molluscan shellfish, from another processor, certain products for which only the muscle tissue you would not need to identify natural toxins will be consumed. For example, where the as a significant hazard. This hazard should finished product is only the shucked adductor have been fully controlled by the primary muscle of the scallop, it is reasonable to assume (first) processor. that the product as consumed will not contain natural toxins. In this case, you may not need to 2. Can natural toxins that were introduced at unsafe identify natural toxins as a significant hazard. levels at an earlier step be eliminated or reduced to an acceptable level here? IDENTIFY CRITICAL CONTROL POINTS. Natural toxins should also be considered a significant hazard at any processing step The following guidance will assist you in where a preventive measure is, or can be, determining whether a processing step is a used to eliminate the natural toxin hazard, critical control point (CCP) for natural toxins. which had been introduced at a previous Where preventive measures, such as those step, or is adequate to reduce the likelihood described above, are available to you the hazard of occurrence of the hazard to an acceptable of natural toxins can best be controlled at the level. Preventive measures for natural toxins receiving step. This control approach consists of can include: two control strategies referred to in this chapter as “Control Strategy Example 1 - Source Control for For molluscan shellfish: Molluscan Shellfish” and “Control Strategy Example • Checking incoming molluscan 2 - Source Control for Fish Other Than Molluscan shellfish to ensure that they are Shellfish” (for primary (first) processors only). properly tagged or labeled; DEVELOP A CONTROL STRATEGY. • Making sure that incoming molluscan shellfish are supplied by a licensed The following guidance provides two control harvester (where licensing is required strategies for natural toxins. You may select a by law) or by a certified dealer. control strategy that is different from those which For finfish other than molluscan shellfish: are suggested, provided it complies with the • Making sure that incoming fish have requirements of the applicable food safety laws not been caught in an area from which and regulations. harvesting is prohibited or restricted The following are examples of control strategies because of a natural toxin problem; included in this chapter: • Making sure that incoming finfish have not been caught in an area for which MAY APPLY TO MAY APPLY TO CONTROL STRATEGY PRIMARY SECONDARY there is a CFP advisory or for which you PROCESSOR PROCESSOR have knowledge there is a CFP problem. Source control for These preventive measures are ordinarily molluscan shellfish employed at the receiving step. Source control for fish other than molluscan shellfish

CHAPTER 6: Natural Toxins 104 • CONTROL STRATEGY EXAMPLE 1 - SOURCE that licensing may not be required in all CONTROL FOR MOLLUSCAN SHELLFISH jurisdictions) or from a processor that is certified by a shellfish control authority. Set Critical Limits. Note: Only the primary processor, the processor that takes • All containers of shellstock (in-shell molluscan possession of the molluscan shellfish from the harvester, should apply shellfish) received from a harvester must controls relative to the identification of the harvester, the harvester’s bear a tag that discloses the date and place license, or the approval status of the harvest waters. they were harvested (by state and site), type and quantity of shellfish, and information on Establish Monitoring Procedures. the harvester or the harvester’s vessel (i.e., the identification number assigned to the » What Will Be Monitored? harvester by the shellfish control authority, • Information contained on tags on containers where applicable, or if such identification of incoming shellstock or on the bill numbers are not assigned, the name of of lading or similar shipping document the harvester or the name or registration accompanying bulk shipments of shellstock; number of the harvester’s vessel). For bulk AND shipments of shellstock where the shellstock is not containerized, the shellstock must be • Information on whether the harvest area is accompanied by a bill of lading or similar authorized for harvest by a shellfish control shipping document that contains the same authority or information on whether federal information; harvest waters are closed by an agency of the federal government. Note: The source controls listed in this critical limit are required under 21 CFR 123.28(c). OR OR • Information contained on labels on • All containers of shellstock received from a containers of incoming shucked molluscan processor must bear a tag that discloses the shellfish; date and place they were harvested (by state AND and site), type and quantity of shellfish, and the certification number of the processor; • The harvester’s license. OR » How Will Monitoring Be Done? • All containers of shucked molluscan shellfish • Perform visual checks; must bear a label that identifies the name, AND address, and certification number of the packer or repacker of the product; • Ask the shellfish control authorities of the state or country in which your shellstock AND are harvested whether the harvest area is • All molluscan shellfish must have been authorized for harvest. harvested from waters authorized for harvesting by a shellfish control authority. » How Often Will Monitoring Be Done (Frequency)? For U.S. federal waters, no molluscan • For checking incoming tags: shellfish may be harvested from waters that Every container; are closed to harvesting by an agency of the federal government; OR • For checking the bill of lading or similar AND shipping document: • All molluscan shellfish must be from a Every delivery; harvester that is licensed as required (note

CHAPTER 6: Natural Toxins 105 OR Number and date of expiration of the • For checking incoming labels: harvester’s license, where applicable; At least three containers randomly AND selected from every lot; Certification number of the shipper, AND where applicable. • For checking licenses: For shucked molluscan shellfish: Every delivery. • Receiving record that documents: Date of receipt; » Who Will Do the Monitoring? • Any person who has an understanding of the AND nature of the controls. Quantity and type of shellfish; AND Establish Corrective Action Procedures. Name and certification number of the Take the following corrective action to a product packer or repacker. involved in a critical limit deviation: • Reject the lot. Establish Verification Procedures. AND • Review monitoring and corrective action records within 1 week of preparation Take the following corrective action to regain control of to ensure they are complete and any the operation after a critical limit deviation: critical limit deviations that occurred were • Discontinue use of the supplier until appropriately addressed. evidence is obtained that harvesting and/or tagging practices have changed.

Establish a Recordkeeping System. For shellstock: • Receiving record that documents: Date of harvest; AND Location of harvest by state and site; AND Quantity and type of shellfish; AND Name of the harvester, name or registration number of the harvester’s vessel, or an identification number issued to the harvester by the shellfish control authority (for shellstock received directly from the harvester only); AND

CHAPTER 6: Natural Toxins 106 within Review Review 1 week of 1 week monitoring preparation action records and corrective and corrective record RECORDS VERIFICATION Receiving Receiving Reject Reject .” This example illustrates how a primary ACTION(S) er potential hazards (e.g., natural toxins, CORRECTIVE untagged sacks Reject lots from Reject Reject lots from Reject unapproved waters unapproved has secured a license unlicensed harvesters Example Only Discontinue use of the Discontinue use of the Discontinue use of the supplier until evidence supplier until evidence practices have changed practices have changed practices have is obtained that tagging obtained that harvesting obtained that harvesting supplier until evidence is supplier until evidence supplier until evidence is supplier until evidence obtained that the harvester obtained that the harvester ipper, can control natural toxins from the harvest ipper, Receiving Receiving Receiving Receiving Receiving employee employee employee lot sack Every Every Every Every Every delivery TABLE 6-1 TABLE MONITORING Visual Visual checks checks See Text for Full Recommendations See Text for harvest for Visual checks Visual authority of the state the area is authorized are harvested whether are harvested in which the shellstock Ask the shellfish control on tags WHAT HOW FREQUENCY WHO license on tags incoming shellstock Harvester’s Harvester’s Harvest site Harvest Information environmental chemical contaminants and pesticides, pathogens during processing). CONTROL STRATEGY EXAMPLE 1 - SOURCE CONTROL FOR MOLLUSCAN SHELLFISH CONTROL STRATEGY LIMITS vessel must be CRITICAL licensed authority MEASURE harvester approved approved be tagged FOR EACH number of PREVENTIVE registration of shellfish, of shellfish, by the state from waters from waters and place of and quantity harvest, type harvest, and name or with the date All shellstock All shellstock the harvester’s the harvester’s must be from a shellstock must shellfish control HAZARD(S) SIGNIFICANT Natural toxins All incoming Natural toxins may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for oth Natural toxins may be only one of several significant hazards for this product. Refer to Tables This table is an example of a portion of a HACCP plan using “Control Strategy Example 1 - Source Control for Molluscan Shellfish processor (processor that takes possession of the oysters from harvester) of shellstock oysters, that is, the sh It is provided for illustrative purposes only. area in shellstock oysters received directly from a harvester. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) POINT CRITICAL CONTROL Receiving Receiving shellstock

CHAPTER 6: Natural Toxins 107 • CONTROL STRATEGY EXAMPLE 2 - SOURCE Establish Corrective Action Procedures. CONTROL FOR FISH OTHER THAN MOLLUSCAN Take the following corrective action to a product SHELLFISH involved in a critical limit deviation: This guidance applies to primary (first) • Reject the lot. processors only. AND Set Critical Limits. Take the following corrective action to regain control of • No fish may be received that has been the operation after a critical limit deviation: harvested from: • Discontinue use of the supplier until An area that is closed to fishing by evidence is obtained that harvesting practices foreign, federal, state, tribal, territorial or have changed. local authorities (e.g., certain counties in Florida for puffer fish); Establish a Recordkeeping System. OR • Receiving record that documents the location An area that is the subject of a CFP or and status (e.g., prohibited, restricted, or ASP consumption advisory; unrestricted) of the harvest area. OR Establish Verification Procedures. An area for which you have knowledge that there is a CFP problem. • Review monitoring and corrective action records within 1 week of preparation to ensure they are complete and any deviations Establish Monitoring Procedures. that occurred were addressed appropriately. » What Will Be Monitored? • The location and status (e.g., prohibited, restricted, or unrestricted) of the harvest area.

» How Will Monitoring Be Done? • Ask the harvesters for the harvest site at the time of receipt, or obtain the information from the harvester’s catch record, where applicable.

» How Often Will Monitoring Be Done (Frequency)? • Every lot.

» Who Will Do the Monitoring? • Any person who has an understanding of the nature of the controls.

CHAPTER 6: Natural Toxins 108 Review Review corrective corrective action records within 1 week within 1 week of preparation monitoring and record RECORDS VERIFICATION Receiving Receiving lluscan Shellfish.” This example illustrates changed Reject lot Reject ACTION(S) is obtained CORRECTIVE until evidence until evidence practices have practices have that harvesting that harvesting of the supplier er potential hazards (e.g., environmental Discontinue use ative purposes only. ative purposes only. employee Every lotEvery Receiving TABLE 6-2 TABLE MONITORING Example Only Ask the location the harvest the harvest fisherman for See Text for Full Recommendations See Text WHAT HOW FREQUENCY WHO Location and status of the harvest area the harvest EACH CRITICAL problem MEASURE LIMITS FOR PREVENTIVE that there is which there No fish may No fish may be harvested be harvested from an area from a valid a current CFP is information by a state CFP that is covered that is covered advisory or for scientific source CONTROL STRATEGY EXAMPLE 2 - SOURCE CONTROL FOR FISH OTHER THAN MOLLUSCAN SHELLFISH CONTROL STRATEGY Natural HAZARD(S) toxins - CFP SIGNIFICANT (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) fish how a fish processor in Hawaii that receives locally harvested barracuda can control natural toxins. It is provided for illustr 3-2 and 3-4 (Chapter 3) for oth Natural toxins may be only one of several significant hazards for this product. Refer to Tables chemical contaminants and pesticides). This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Source Control for Fish Other Than Mo POINT CRITICAL CONTROL Receiving fresh Receiving

CHAPTER 6: Natural Toxins 109 BIBLIOGRAPHY. • Dickey, R.W and S.M. Plakas. 2009. Ciguatera: A public health perspective. We have placed the following references on Toxicon In Press xxx:1-14. display in the Division of Dockets Management, • European Communities. 2002. Commission Food and Drug Administration, 5630 Fishers Lane, Decision of 15 March 2002. Laying down rm. 1061, Rockville, MD 20852. You may see rules for the implementation of Council them at that location between 9 a.m. and 4 p.m., Directive 91/492/EEC as regards the Monday through Friday. As of March 29, 2011, maximum levels and the methods of analysis FDA had verified the Web site address for the of certain marine biotoxins in bivalve references it makes available as hyperlinks from molluscs, echinoderms, tunicates and the Internet copy of this guidance, but FDA is not marine gastropods. Off. J. Eur. Communities. responsible for any subsequent changes to Non- (2002./225/EC) L 75:62-63. FDA Web site references after March 29, 2011. • Food and Agriculture Organization. • Arakawa, O., T. Noguchi, and Y. Onoue. 2004. In, FAO (ed), FAO Food and Nutrition 1995. Paralytic shellfish toxin profiles of Paper 80. Risk Assessment of Toxins xanthid crabs Zosimus aeneus and Atergatis Associated with PSP, DSP, and ASP in floridus collected on reefs of Ishigaki Island. Seafood, pp 56-95. 3. Diarrhoeic Shellfish Fish. Sci. 61(4):659-662. Poisoning (DSP). Food and Agriculture Organization of the United Nations, Rome. • Bakes, M. J., N. G. Elliott, G. J. Green, and P. D. Nichols. 1995. Variation in lipid • Food and Agriculture Organization. 2004. composition of some deep-sea fish (Teleostei: Marine biotoxins FAO food and nutrition Oreosomatidae and Trachichthyidae). Comp. paper 80. Food and Agriculture Organization Biochem. Physiol B. 111(4):633-642. of the United Nations, Rome, Italy. • Bravo, I., J. M. Franco, A. Alonzo, R. Dietrich, • Food Safety Authority of Ireland. August and P. Molist. 2001. Cytological study and 2006. Risk assessment of azaspiracids (AZAs) immunohistochemical location of PSP in shellfish. Food Safety Authority of Ireland, toxins in foot skin of the ormer, Haliotis Dublin, Ireland. tuberculata, from the Galacian coast (NW • Friedman, M. A., L. E. Fleming, M. Spain). Mar. Biol. 138:709-715. Fernandez, P. Bienfang, K. Schrank, R. • Bravo, I., M. I. Reyero, E. Cacho, and J. M. Dickey, M. Y. Bottein, L. Backer, R. Ayyar, Franco. 1999. Paralytic shellfish poisoning in R. Weisman, S. Watkins, R. Granade, and Haliotis tuberculata from the Galician coast: A. Reich. 2008. Ciguatera fish poisoning: geographical distribution, toxicity by lengths and treatment, prevention and management. Mar. parts of the mollusc. Aquat. Toxicol. 46:79-85. Drugs 6:456-479. • Clifford, M. N., R. Walker, P. Ijomah, • Hall, S., and G. Strichartz (ed.). 1990. Marine J. Wright, C. K. Murray, R. Hardy, E. P. toxins: origin structure, and molecular Martlbauer, E. Usleber, and G. Terplan. 1993. pharmacology. ACS Symposium Series 418. Do saxitoxin-like substances have a role in American Chemical Society, Washington, DC. scombrotoxicosis? Food Addit. Contamin. • Halstead, B. W. 1967. Poisonous and 9(6):657-667. venomous marine animals of the world, vol. • Dickey, R. W. 2008. Ciguatera toxins: chemistry, 2 - invertebrates. U.S. Government Printing toxicology and detection, p. 479-500. In L. M. Office, Washington, DC. Botana (ed.), Seafood and freshwater toxins: • Halstead, B. W. 1988. Poisonous and pharmacology, physiology, and detection, 2nd venomous marine animals of the world, 2nd ed. CRC Press/Taylor & Francis. rev. ed. The Darwin Press, Inc., Princeton, NJ.

CHAPTER 6: Natural Toxins 110 • Hess, P., L. Nguyen, J. Aasen, M. Keogh, • Lehane, L., R. J. Lewis. 2000. Ciguatera: N. Keogh, J. Kilcoyne, P. McCarron, and recent advances but the risk remains. Int. J. T. Aune. 2005. Tissue distribution, effects Food Microbiol. 61:91–125. on cooking and parameters affecting the • Ling, K. H., C. W. Cheung, S. W. Cheng, L. extraction of azaspiracids from mussels, Cheng, S-L. Li, P. D. Nichols, R. D. Ward, Mytilus edulis, prior to analysis by A. Graham, and P. P-H. But. 2008. Rapid liquid chromatography coupled to mass detection of oilfish and escolar in fish steaks: spectrometry. Toxicon. 46:62-71. a tool to prevent keriorrhea episodes. Food • Hwang, D-F., and Y-H. Tsai. 1999. Toxins in Chem. 110:538-546. toxic Taiwanese crabs. Food. Rev. 15(2):145-162. • Martinez, A., J. M. Franco, I. Bravo, M. • Hwang, D-F., Y-H. Tsai, T-J. Chai, and S-S Mazoy, and E. Cacho. 1993. PSP toxicity in Jeng. 1996. Occurrence of tetrodotoxin and Haliotis tuberculata from NW Spain, p. 419- paralytic shellfish poison in Taiwan crab 423. In T. J. Smayda and Y. Shimizu (ed.), Zosimus aeneus. Fish. Sci. 62(3):500-501. Toxic phytoplankton blooms in the sea. • James, K. A. C., and B. P. Treloar. 1984. Elsevier, Amsterdam, Netherlands. Comparative effects of orange roughy • Nichols, P. D., B. D. Mooney, and N. (Hoplostethus atlanticus) and snapper G. Elliott. 2001. Unusually high levels (Chrysophrys auratus) in the diets of growing of non-saponifiable lipids in the fishes rats. New Zealand J. Sci. 27:295-305. escolar and rudderfish. Identification • James, K. A. C., D. R. Body, and W. C. Smith. by gas chromatography and thin-layer 1986. A nutritional evaluation of orange chromatography. J. Chromatogr A 936:183-191. roughy (Hoplostethus atlanticus) using • Noguchi, T., and Y. Hashimoto. 1973. growing pigs. New Zealand J. Tech. 2:219-223. Isolation of tetrodotoxin from a goby Gobius • James, K. J., A. Furey, M. Lehane, H. criniger. Toxicon. 11:305-307. Ramstad, T. Aune, P. Hovgaard, S. Morris, • Ochiai, Y., S. Watabe, K. Hashimoto, H. W. Higman, M. Satake, and T. Yasumoto. Narita, Y. Ukishima, and M. Nara. 1984. 2002. First evidence of an extensive northern Biochemical identification of two gempylid European distribution of azaspiracid fish causative of a food poisoning. Bull. poisoning (AZP) toxins in shellfish. Japan. Soc. Sci. Fish. 50:721-725. • Toxicon. 40:909-915. • Perez-Zarza, M. C., V. Ruiz-Gutierrez, and • Kawai, N., Y. Nakayama, S. Matsuoka, and L. Bravo. 1993. Lipid composition of two T. Mori. 1985. Lipid composition of various purgative fish: Ruvettus pretiosus and tissues of Lepidocybium flavobrunneum. Lepidocybium flavobrunneum. Grasas y Yukagaku 34:25-31. Aceites 44:47-52. • Lawrence, J. F., M. Maher, and W. Watson- • Pitcher, G. C., M. Franco, G. J. Doucette, C. Wright. 1994. Effect of cooking on the L. Powell, and A. Mouton. 2001. Paralytic concentration of toxins associated with shellfish poisoning in abalone Haliotis midae paralytic shellfish poison in lobster on the west coast of South Africa. J. Shellfish hepatopancreas. Toxicon. 33(12):1669-1673. Res. 20(2):895-904. • Lehane, L. 2000. Paralytic shellfish poisoning: • Poli, M., S. Musser, R. Dickey, P. Ellers, and a review. National Office of Animal and Plant S. Hall. 2000. Neurotoxic shellfish poisoning Health Agriculture, Fisheries and Forestry, and brevitoxin metabolites: a case study from Canberra, Australia. Florida. Toxicon. 38:981-993.

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CHAPTER 6: Natural Toxins 112 CHAPTER 7: Scombrotoxin (Histamine) Formation This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisﬁes the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.

UNDERSTAND THE POTENTIAL HAZARD. that the methods of control used to inhibit the bacteria that result in histamine formation will Scombrotoxin (histamine) formation as a result also inhibit the bacteria that produce other of time and temperature abuse of certain species biogenic amines. of fish can cause consumer illness. The illness Symptoms of scombrotoxin poisoning include is closely linked to the development of histamine tingling or burning in or around the mouth or in these fish. In most cases, histamine levels in throat; rash or hives on the upper body; drop in illness-causing fish have been above 200 ppm, blood pressure; headache; dizziness; itching of the often above 500 ppm. However, there is some skin; nausea; vomiting; diarrhea; asthmatic-like evidence that other chemicals (e.g., biogenic constriction of the air passage; heart palpitation; amines such as putrescine and cadaverine) may and respiratory distress. Symptoms usually also play a role in the illness. The possible role of occur within a few minutes to a few hours of these chemicals in consumer illness is the subject consumption and last from 12 hours to a few days. of Chapter 8. • Scombrotoxin (histamine) formation Seafood-related scombrotoxin poisoning is Certain bacteria produce the enzyme histidine primarily associated with the consumption of decarboxylase during growth. This enzyme reacts tuna, mahi-mahi, marlin, and bluefish. Table 3-2 with histidine, a naturally occurring amino acid (Chapter 3) identifies other species that are also that is present in larger quantities in some fish capable of developing elevated levels of histamine than in others. The result is the formation of when temperature abuse occurs. scombrotoxin (histamine). The illness caused by the consumption of fish Histamine-forming bacteria are capable of growing in which scombrotoxin has formed is most and producing histamine over a wide temperature appropriately referred to as “scombrotoxin range. Growth of histamine is more rapid, however, poisoning.” The illness has historically been at high-abuse temperatures (e.g., 70°F (21.1°C) known by other names. Originally, the illness or higher) than at moderate-abuse temperatures was termed “scombroid poisoning” because of its (e.g., 45°F (7.2°C)). Growth is particularly rapid association with fish in the families Scombridae at temperatures near 90°F (32.2°C). Histamine is and Scomberesocidae. However, other species more commonly the result of high temperature of fish are now known to cause the illness. The spoilage than of long-term, relatively low- terms “histamine poisoning” and “histamine fish temperature spoilage, which is commonly associated poisoning” have also been applied to the illness. with organoleptically detectable decomposition. However, because biogenic amines other than Nonetheless, there are a number of opportunities histamine have been associated with the illness, for histamine to form under more moderate-abuse these terms also present difficulties. Nonetheless, temperature conditions. this chapter refers to control measures to prevent the formation of histamine. It is expected

CHAPTER 7: Scombrotoxin (Histamine) Formation 113 Once the enzyme histidine decarboxylase is species that generate heat, resulting in internal present in the fish, it can continue to produce temperatures that may exceed environmental histamine in the fish even if the bacteria are not temperatures and increasing the likelihood active. The enzyme can be active at or near of conditions favorable to growth of enzyme- refrigeration temperatures. The enzyme remains forming bacteria. stable while in the frozen state and may be The potential for histamine formation is increased reactivated very rapidly after thawing. when the scombrotoxin-forming fish muscle is in Freezing may inactivate some of the enzyme- direct contact with the enzyme-forming bacteria. forming bacteria. Both the enzyme and This direct contact occurs when the fish are the bacteria can be inactivated by cooking. processed (e.g., butchering or filleting) and can However, once histamine is produced, it cannot be particularly problematic when the surface-to- be eliminated by heat (including retorting) or volume ratio of the exposed fish muscle is large, freezing. After cooking, recontamination of such as minced tuna for salads. Even when such the fish with the enzyme-producing bacteria products are prepared from canned or pouch is necessary for additional histamine to form. retorted fish, recontamination can occur during For these reasons, histamine development is salad preparation, especially with the addition of more likely in raw, unfrozen fish but should raw ingredients. The mixing in of the bacteria not be discounted in other product forms of throughout the product and the high surface-to- scombrotoxin-forming fish species. volume ratio can result in substantial histamine formation if time and temperature abuse occurs. The kinds of bacteria that are associated with histamine development are commonly present in At least some of the histamine-forming bacteria the saltwater environment. They naturally exist are halotolerant (salt tolerant) or halophilic (salt on the gills, on external surfaces, and in the gut loving). Some are more capable of producing of live, saltwater fish, with no harm to the fish. histamine at elevated acidity (low pH). As a Upon death, the defense mechanisms of the fish result, histamine formation is possible during no longer inhibit bacterial growth in the muscle processes such as brining, salting, smoking, tissue, and histamine-forming bacteria may start drying, fermenting, and pickling until the product to grow, resulting in the production of histamine. is fully shelf-stable. Refrigeration can be used Evisceration and removal of the gills may reduce, to inhibit histamine formation during these but not eliminate, the number of histamine- processes. forming bacteria. Packing of the visceral cavity A number of the histamine-forming bacteria are with ice may aid in chilling large fish in which facultative anaerobes that can grow in reduced internal muscle temperatures are not easily oxygen environments. As a result, reduced reduced. However, when done improperly, these oxygen packaging (e.g., vacuum packaging, steps may accelerate the process of histamine modified atmosphere packaging, and controlled development in the edible portions of the fish by atmosphere packaging) should not be viewed as spreading the bacteria from the visceral cavity to inhibitory to histamine formation. the flesh of the fish. Histamine is water soluble (dissolves in water) With some harvesting practices, such as and would not be expected in significant longlining and gillnetting, death may occur many quantity in products such as fish oil that do not hours before the fish is removed from the water. have a water component. However, histamine Under the worst conditions, histamine formation could be present in products such as fish protein can already be underway before the fish is concentrate that are prepared from the muscle or brought onboard the vessel. This condition aqueous (water-based) components of fish tissue. can be further aggravated with certain tuna

CHAPTER 7: Scombrotoxin (Histamine) Formation 114 • Controlling scombrotoxin (histamine) formation Rapid chilling of scombrotoxin-forming fish immediately after death is the most important element in any strategy for preventing the formation of scombrotoxin (histamine), especially for fish that are exposed to warm waters or air, and for tunas which generate heat in their tissues. Some recommendations follow: • Fish exposed to air or water temperatures above 83°F (28.3°C) should be placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not more than 6 hours from the time of death; or • Fish exposed to air and water temperatures of 83°F (28.3°C) or less should be placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not more than 9 hours from the time of death; or • Fish that are gilled and gutted before chilling should be placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not more than 12 hours from the time of death; or • Fish that are harvested under conditions that expose dead fish to harvest waters of 65°F (18.3°C) or less for 24 hours or less should be placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not more than the time limits listed above, with the time period starting when the fish leave the 65°F (18.3°C) or less environment.

Note: If the actual time of death is not known, an estimated time of the ﬁrst ﬁsh death in the set may be used (e.g., the time the deployment of a longline begins).

CHAPTER 7: Scombrotoxin (Histamine) Formation 115 ONBOARD LANDING IS… THE TIME OF… ext above. 1 TIME OF DEATH IS… TIME OF DEATH THEN, THE MAXIMUM TIME IN HOURS TO GET FISH INTO CHILLING MEDIUM (≤ 40°F) FROM TABLE 7-1 TABLE FOR UNEVISCERATED FISH: FOR UNEVISCERATED SCOMBROTOXIN FORMATION FOR FISH EVISCERATED ONBOARD BEFORE CHILLING: FOR FISH EVISCERATED Any -- 12 ≤ 83 -- 9 > 83 -- 6 AND THE AIR TEMPERATURE (°F) IS…AND THE AIR TEMPERATURE OF THE FISH OR EARLIEST ESTIMATED DEATH WHEN… 2 2 2 > 65> 65 > 83 Any 6 12 -- -- > 83 Any 6 -- ≤ 65 ≤ 65 ≤ 65 THE WATER THE WATER > 65, but ≤ 83> 65, ≤ 83 9 -- TEMPERATURE (°F) IS… TEMPERATURE 1. This table is a summary of the preceding recommendations. For complete understanding recommendations, refer to t 2. Provided exposure of the ﬁsh in water at 65°F or less is ≤ 24 hours. RECOMMENDED MAXIMUM TIME TO GET SCOMBROTOXIN-FORMING FISH INTO CHILLING MEDIUM ONBOARD HARVEST VESSELS PREVENT

CHAPTER 7: Scombrotoxin (Histamine) Formation 116 The controls listed above for onboard chilling • The size of the fish; will prevent the rapid formation of the enzyme • The chilling method: histidine decarboxylase. Once this enzyme is Ice alone takes longer to chill fish formed, control of the hazard is unlikely. It is than does an ice slurry or recirculated important to recognize that the parameters listed refrigerated seawater or brine, a above are intended to control scombrotoxin consequence of reduced contact area formation; these criteria may not effectively control and heat transfer; the activity of other spoilage organisms, raising the possibility that fish may become adulterated The quantity of ice or ice slurry and because of decomposition (not a food safety the capacity of refrigerated seawater or hazard covered by the Procedures for the Safe and brine systems, as well as the physical Sanitary Processing and Importing of Fish and arrangement of the fish in the chilling Fishery Products regulation, 21 CFR 123, called media, should be suitable for the the Seafood Hazard Analysis Critical Control Point quantity of catch. (HACCP) Regulation in this guidance document) Once chilled, the scombrotoxin-forming fish before scombrotoxin (histamine) is formed. should be maintained as close as possible to the Further chilling toward the freezing point is also freezing point (or held frozen) until it is consumed. desirable to safeguard against the less common, Exposure to temperatures above 40°F (4.4°C) longer term, lower temperature development of should be minimized. The amount of post-harvest histamine. Additionally, the shelf life and quality time at elevated temperatures (after proper chilling of the fish are significantly compromised when onboard the harvest vessel) to which a fish can product temperature is not rapidly dropped to be exposed (e.g., during processing, storage, and near freezing. distribution) without adverse effects is dependent primarily upon whether the fish was previously Although it may be possible for a harvest vessel frozen (e.g., onboard the harvest vessel) or heat to completely avoid onboard chilling and still processed sufficiently to destroy scombrotoxin- deliver fish to the processor within the time and forming bacteria. temperature limitations recommended above for chilling the fish, this practice is discouraged. Extended frozen storage (e.g., 24 weeks) or Failure to chill onboard may permit bacteria and cooking minimizes the risk of additional enzymes, including those that form scombrotoxin histamine development by inactivating the (histamine), to increase unnecessarily. enzyme-forming bacteria and, in the case of cooking, the enzyme itself. As previously The time required to lower the internal mentioned, recontamination with enzyme- temperature of fish after capture will be forming bacteria and significant temperature dependent upon a number of factors, including: abuse is necessary for histamine formation • The harvest method: following cooking. Such recontamination may Delays in removing fish from the water not be likely if the fish is processed under a after capture, such as those captured by conscientious sanitation program. However, a longline, may significantly limit the addition of raw ingredients, employee contact, amount of time left for chilling and may or poor sanitary conditions could reintroduce allow some fish to heat up; contamination. Further guidance is provided below: Large quantities of fish captured in a single fishing set, such as those captured • Scombrotoxin-forming fish that have not on a purse seiner, may exceed a vessel’s been previously frozen or heat processed ability to rapidly chill the product; sufficiently to destroy scombrotoxin- forming bacteria should not be exposed to

CHAPTER 7: Scombrotoxin (Histamine) Formation 117 temperatures above 40°F (4.4°C) for: More than 4 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1°C); or More than 8 hours, cumulatively, as long as no portion of that time is at temperatures above 70°F (21.1°C). • Scombrotoxin-forming fish that have been previously frozen, or heat processed sufficiently to destroy scombrotoxin-forming bacteria and are subsequently handled in a manner in which there is an opportunity for recontamination with scombrotoxin- forming bacteria (e.g., contact with fresh fish, employees, or introduction of raw ingredients), should not be exposed to temperatures above 40°F (4.4°C) for: More than 12 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1°C); or More than 24 hours, cumulatively, as long as no portion of that time is at temperatures above 70°F (21.1°C); • Scombrotoxin-forming fish that have been heat processed sufficiently to destroy scombrotoxin-forming bacteria and enzymes and are not subsequently handled in a manner in which there is an opportunity for recontamination with scombrotoxin-forming bacteria (e.g., no contact with fresh fish, employees, or raw ingredients) are at low risk for further scombrotoxin (histamine) development.

CHAPTER 7: Scombrotoxin (Histamine) Formation 118

exposed to possible recontamination), is… exposed to possible recontamination), 1 Previously frozen fish, or heat processed fish (that has been frozen fish, Previously xt above. … ≤ 4≤ 8 ≤ 12 ≤ 24 TABLE 7-2 TABLE or previously frozen) is or previously Fresh fish (not heat processed EXPOSURE AND PREVIOUS PROCESSING CONDITIONS > 70 AT ANY TIME > 70 AT ≤ 70 DURING ENTIRE EXPOSURE RECOMMENDED MAXIMUM HOURS OF EXPOSURE OF SCOMBROTOXIN-FORMING FISH TO AMBIENT TEMPERATURES GREATER THAN GREATER RECOMMENDED MAXIMUM HOURS OF EXPOSURE SCOMBROTOXIN-FORMING FISH TO AMBIENT TEMPERATURES 40°F TO PREVENT SCOMBROTOXIN FORMATION AFTER PROPER ONBOARD HARVEST VESSEL CHILLING, FOR DIFFERING TEMPERATURE AFTER PROPER ONBOARD HARVEST VESSEL CHILLING, FOR DIFFERING TEMPERATURE 40°F TO PREVENT SCOMBROTOXIN FORMATION 1. This table is a summary of the preceding recommendations. For complete understanding recommendations, refer to te WHEN THE AMBIENT TEMPERATURE (°F) OF EXPOSURE IS…WHEN THE AMBIENT TEMPERATURE THEN, THE MAXIMUM HOURS OF EXPOSURE TIME FOR…

CHAPTER 7: Scombrotoxin (Histamine) Formation 119 • Detection histamine testing is dependent upon the design Sensory evaluation of the sampling plan. The amount of sampling required to accommodate such variability of Sensory evaluation is generally used to screen distribution is necessarily quite large. The fish for indicators of spoilage that develop when method of collection of the fish sample is also the fish is exposed to time and temperature critical. In large scombrotoxin-forming fish, the abuse. Odor in particular is an effective means lower, anterior (forward) portion of the fish loin of detecting fish that have been subjected to a (not the belly flap) is likely to provide the best variety of abusive conditions. However, odors of information about the histamine content of the decomposition that are typical of relatively low fish. The number of samples (i.e., scombrotoxin- temperature spoilage may not be present if the forming fish) necessary to make a judgment fish has undergone high temperature spoilage. about a lot depends on the anticipated variability, This condition makes sensory examination but should not be fewer than 18 samples per lot, alone an ineffective control for preventing unless the lot contains less than 18 fish, in which scombrotoxin (histamine) formation. case a sample should be collected from each fish. It is important to recognize that the Federal Where samples are composited to reduce the Food, Drug, and Cosmetic Act (the FFD&C Act) number of analyses needed on a lot, it should prohibits interstate commerce of adulterated be done in a manner that ensures meaningful foods (21 U.S.C. 331). Under the FFD&C results. No more than three samples should be Act, a food that is decomposed is considered composited, in order to minimize masking of adulterated (21 U.S.C 342). Accordingly, a fish problematic fish. Furthermore, the analytical or fishery product that is decomposed in whole method and instrument used should be capable or in part is prohibited from entering interstate of reliably detecting histamine at the lower levels commerce even if the type of decomposition that are necessary for composited samples (e.g., may not lead to scombrotoxin (histamine) 17 ppm histamine in a three-sample composite, formation. You should distinguish between rather than 50 ppm in an uncomposited sample ). recommendations in this chapter for sensory screening, as a component of a HACCP control Combining additional indicators of conditions strategy for scombrotoxin formation, and your that can lead to histamine formation, such as obligation to avoid otherwise violating the sensory examination and internal temperature FFD&C Act with regard to the distribution of measurement, with histamine testing can provide decomposed food. better assurance of product safety. Observation for the presence of honeycombing (voids in Chemical testing the fish flesh) in cooked tuna loins intended Chemical testing is an effective means of for canning is a valuable means of screening detecting the presence of histamine in fish flesh. for fish that have been exposed to the kinds of However, the variability in histamine levels temperature abuse that can lead to histamine between fish and within an individual fish can be development. Any scombrotoxin-forming fish large, even in fish from the same harvest vessel. that demonstrate the trait should be destroyed or For this reason, a guidance level has been set of diverted to a non-food use. 50 ppm histamine in the edible portion of fish. If 50 ppm is found in one section of a fish or lot, there is the possibility that other sections may exceed 500 ppm. Because histamine is generally not uniformly distributed in a fish or a lot, the validity of

CHAPTER 7: Scombrotoxin (Histamine) Formation 120 DETERMINE WHETHER THE POTENTIAL a refrigerated (not frozen) raw or cooked HAZARD IS SIGNIFICANT. product from another processor (see Chapter 12). The in-transit controls for secondary The following guidance will assist you in processors recommended in Chapter 12 are determining whether scombrotoxin (histamine) similar to those recommended in this chapter. formation is a significant hazard at a processing 2. Is it reasonably likely that unsafe levels of step: histamine will form at this processing step? 1. Is it reasonably likely that unsafe levels of To answer this question, you should consider histamine will be introduced at this processing step the potential for time and temperature abuse (do unsafe levels come in with the raw material)? in the absence of controls. You may already Table 3-2 (Chapter 3) lists those species of have controls in your process that minimize fish that are generally known to be capable the potential for time and temperature abuse of producing elevated levels of histamine if that could result in unsafe levels of histamine. temperature abused. Such species of fish This guidance will help you determine have this capability because they contain whether those or other controls should be naturally high levels of histidine. They also included in your HACCP plan. have this capability because they are marine Time and temperature abuse that occurs fish that are likely to harbor the kinds of at successive processing and storage steps bacteria that produce histidine decarboxylase. may be sufficient to result in unsafe levels It is, therefore, reasonable to assume that of histamine, even when abuse at one without proper onboard vessel controls, these step alone would not result in such levels. species of fish will contain unsafe levels of For this reason, you should consider the histamine upon receipt by the primary (first) cumulative effect of time and temperature processor. abuse during the entire process. Information However, if the worst case environmental is provided above to help you assess the conditions (i.e., air and water temperatures) significance of time and temperature abuse during the harvest season in a particular that may occur in your process. region would not permit the formation of 3. Can unsafe levels of histamine formation that are histamine during the time necessary to reasonably likely to occur be eliminated or reduced harvest and transport the fish to the primary to an acceptable level at this processing step? processor, onboard controls may not be necessary. For example, such conditions Scombrotoxin (histamine) formation should might exist if the fish are harvested when air also be considered a significant hazard at any and water temperatures do not exceed 40°F processing or storage step where a preventive (4.4°C), as evidenced by supporting data. measure is or can be used to eliminate the hazard if it is reasonably likely to occur. It is also reasonable to assume that without Preventive measures for scombrotoxin proper controls during refrigerated (not (histamine) formation can include: frozen) transportation between processors, scombrotoxin-forming species of fish will • Examining harvest vessel records contain unsafe levels of histamine upon to ensure that incoming fish were receipt by the secondary processor (including properly handled onboard the warehouses). In addition, you may need harvest vessel, including: to exercise control to prevent pathogen Rapidly chilling the fish immediately growth or toxin formation when receiving after death;

CHAPTER 7: Scombrotoxin (Histamine) Formation 121 Controlling onboard refrigeration IDENTIFY CRITICAL CONTROL POINTS. (other than frozen storage) temperatures; The following guidance will assist you in Performing proper onboard icing; determining whether a processing step is a • Testing incoming fish for critical control point (CCP) for scombrotoxin histamine levels; (histamine) formation: • Ensuring that incoming fish 1. If scombrotoxin (histamine) formation is a were handled properly during significant hazard at the receiving step, you refrigerated transportation from the should identify receiving as a CCP for this previous processor, including: hazard. Controlling refrigeration temperatures a. If you are the primary processor of the during transit; scombrotoxin-forming fish (i.e., if you Performing proper icing during receive the fish directly from the harvest transit; vessel) and have a relationship with the • Checking incoming fish to ensure operator of the harvest vessel(s) from that they are not at an elevated which you purchase fish that enables temperature at time of receipt; you to obtain documentation of onboard practices, you should identify the • Checking incoming fish to ensure following preventive measures for control that they are properly iced or of this hazard: refrigerated at time of receipt; • Examining harvest vessel records • Performing sensory examination on to ensure that incoming fish incoming fish to ensure that they do were properly handled onboard not show signs of decomposition; the harvest vessel, including: • Controlling refrigeration Rapidly chilling the fish temperatures in your plant; immediately after death; • Performing proper icing in your plant; Controlling onboard refrigeration (other than frozen storage) • Controlling the amount of time that the temperatures; product is exposed to temperatures that would permit histamine Performing proper onboard icing; formation during processing. • Checking incoming fish to ensure These preventive measures are ordinarily employed that they are not at an elevated at receiving, processing, and storage steps. temperature at time of receipt; and, • Performing sensory examination of • Intended use incoming fish to ensure that they do Because of the heat stable nature of histamine, not show signs of decomposition. the intended use of the product is not likely to affect the significance of this hazard. Example: A mahi-mahi processor that regularly purchases from the same harvest vessels should require harvest vessel records as a condition of purchase.

CHAPTER 7: Scombrotoxin (Histamine) Formation 122 The processor should also check you should identify the following the internal temperatures of preventive measures for control of this incoming fish and perform sensory hazard: examination of these fish. The • Ensuring that incoming fish were processor should then set a CCP for properly refrigerated during histamine formation at receiving. transportation from the previous This control approach is a control strategy processor, by controlling refrigeration referred to in this chapter as “Control temperatures during transit or, Strategy Example 1 - Harvest Vessel • Checking incoming fish to Control.” ensure that they are properly b. If you are the primary processor of the iced at time of receipt. scombrotoxin-forming fish (i.e., if you Example: receive the fish directly from the harvest A tuna processor that receives fish vessel) and do not have a relationship from another processor should require with the operator of the harvest vessel(s) evidence of temperature control that enables you to obtain documentation throughout transit as a condition of of onboard practices, you should identify receipt. The processor should then the following preventive measures for set a CCP for histamine formation at control of this hazard: receiving. • Testing incoming fish for This control approach is a control strategy histamine levels; referred to in this chapter as “Control • Checking incoming fish to ensure Strategy Example 3 - Transit Control.” that they are not at an elevated This control strategy, in addition to temperature at time of receipt and, “Control Strategy Example 1 - Harvest Vessel Control” or “Control Strategy • Performing sensory examination of Example 2 - Histamine Testing,” may incoming fish to ensure that they do also be applicable if you are a primary not show signs of decomposition. processor and transport the fish by truck Example: from your harvest vessel unloading site to A canned tuna processor that your processing facility. purchases from a variety of harvest vessels should subject incoming fish 2. If scombrotoxin (histamine) formation is a from each harvest vessel to histamine significant hazard at one or more processing testing, internal temperature checks, steps, you should identify the processing step(s) and sensory examination. The as a CCP for this hazard. processor should then set a CCP for a. The preventive measure for this type of histamine formation at receiving. control is: This control approach is a control strategy • Controlling the amount of time referred to in this chapter as “Control that the scombrotoxin-forming Strategy Example 2 - Histamine Testing.” product is exposed to temperatures c. If you are a secondary processor of the that would permit histamine scombrotoxin-forming fish (i.e., if you formation during processing. receive the fish from another processor),

CHAPTER 7: Scombrotoxin (Histamine) Formation 123 Example: • Receiving; A mahi-mahi processor should • Processing, such as: control histamine formation Thawing; by limiting exposure time and temperature of the product during Brining and salting; processing. The processor should Smoking; then set CCPs for histamine Heading and gutting; formation at the processing steps. Manual filleting and steaking; This control approach is a control strategy Fermenting; referred to in this chapter as “Control Pickling; Strategy Example 4 - Processing Control.” Drying; This control strategy is intended for processing at ambient and air-conditioned Stuffing; temperatures. “Control Strategy Mixing (e.g., salad preparation); Example 5 - Storage Control” may be Portioning; more appropriate for processing under • Packaging; refrigerated conditions. • Final chilling after processing 3. If scombrotoxin (histamine) formation is a and packaging; significant hazard at a storage step for raw material, in-process product, or finished product, • Storing raw material, in-process product, you should identify the storage step(s) as a CCP and finished product under refrigeration. for this hazard. Note: Rather than identify each processing step as an individual CCP when the controls are the same at those steps, it may be more a. The preventive measures for this type of convenient to combine into one CCP those processing steps that control are: together contribute to a cumulative time and temperature exposure. • Controlling refrigeration • Unlikely CCPs temperatures in your plant or, Time and temperature controls will usually not be needed at processing steps that meet • Performing proper icing the following conditions: in your plant. • Continuous, mechanical processing Example: steps that are brief, such as: A mahi-mahi processor should control histamine formation by icing the Mechanical filleting; product during raw material, in-process • Processing steps that are brief and product, and finished product storage. unlikely to contribute significantly The processor should then set CCPs for to the cumulative time and histamine formation at the storage steps. temperature exposure, such as: This control approach is a control strategy Date code stamping; referred to in this chapter as “Control Case packing; Strategy Example 5 - Storage Control.” • Processing steps where the product • Likely CCPs is held in a frozen state, such as: Following is further guidance on processing Assembly of orders for distribution; steps that are likely to be identified as CCPs Frozen product storage; for this hazard:

CHAPTER 7: Scombrotoxin (Histamine) Formation 124 • Retorting and post-retorting steps (if the • Sensory examination; product is covered by the Thermally • Internal temperature measurements. Processed Low-Acid Foods Packaged in Hermetically Sealed Containers Harvest vessel records: regulation, 21 CFR 113 (called the • All scombrotoxin-forming fish lots received Low-Acid Canned Foods Regulation are accompanied by harvest vessel records in this guidance document)); that show: Fish exposed to air or water temperatures DEVELOP A CONTROL STRATEGY. above 83°F (28.3°C) were placed in ice, or in refrigerated seawater, ice slurry, or The following guidance provides examples of five brine of 40°F (4.4°C) or less, as soon control strategies for scombrotoxin (histamine) as possible after harvest, but not longer formation. It may be necessary to select more than 6 hours from the time of death; than one control strategy in order to fully control OR the hazard, depending upon the nature of your Fish exposed to air and water temperatures operation. You may select a control strategy of 83°F (28.3°C) or less were placed in that is different from those which are suggested, ice, or in refrigerated seawater, ice slurry, provided it complies with the requirements of the or brine of 40°F (4.4°C) or less, as soon as applicable food safety laws and regulations. possible after harvest, but not longer than 9 The following are examples of control strategies hours from the time of death; included in this chapter: OR Fish that were gilled and gutted before chilling were placed in ice, or MAY APPLY TO MAY APPLY TO CONTROL STRATEGY PRIMARY SECONDARY in refrigerated seawater, ice slurry, or PROCESSOR PROCESSOR brine of 40°F (4.4°C) or less, as soon Harvest vessel control as possible after harvest, but not longer Histamine testing than 12 hours from the time of death; Transit control OR Processing control Fish that were harvested under Storage Control conditions that expose dead fish to harvest waters of 65°F (18.3°C) or less for 24 hours or less were placed in ice, or in refrigerated seawater, ice slurry, or • CONTROL STRATEGY EXAMPLE 1 - HARVEST brine of 40°F (4.4°C) or less, as soon VESSEL CONTROL as possible after harvest, but not more It may be necessary to select more than one than the time limits listed above, with the control strategy in order to fully control the time period starting when the fish left the hazard, depending upon the nature of your 65°F (18.3°) or less environment; operation. OR Set Critical Limits. Other critical limits for onboard handling (e.g., maximum refrigerated brine or The critical limits for this control strategy should seawater temperature, maximum fish include three components: size, maximum fish to brine/seawater/ • Harvest vessel records; ice ratio, maximum initial temperature of

CHAPTER 7: Scombrotoxin (Histamine) Formation 125 the fish) necessary to achieve a cooling (10°C) or below; rate that will prevent development of OR an unsafe level of histamine in the specific species, as established through a • For fish held iced or refrigerated (not frozen) scientific study. onboard the vessel from 12 to less than 15 hours after death: Note: If the actual time of death is not known, an estimated time of the first fish death in the set may be used (e.g., the time the The internal temperature should be 60°F deployment of a longline begins). Table 7-1 provides a summary of (15.6°C) or below; the preceding recommended critical limits. OR AND • For fish held iced or refrigerated (not frozen) For fish held refrigerated (not frozen) onboard the vessel less than 12 hours after onboard the vessel: death: • The fish were stored at or below The internal temperature should 40°F (4.4°C) after cooling; be sufficiently below water and air OR temperatures to indicate that appropriate chilling methods were implemented • The fish were stored completely onboard the harvest vessel. Chilling and continuously surrounded of the fish should begin on the harvest by ice after cooling; vessel regardless of the time from death AND until off-loading from the vessel by the processor unless the environmental Sensory examination: conditions (e.g., air and water • Sensory examination of a representative temperatures) are below 40°F (4.4°C) sample of scombrotoxin-forming fish shows from the time of death until off-loading decomposition (persistent and readily from the vessel by the processor; perceptible) in less than 2.5% of the fish in OR the sample. For example, no more than 2 fish in a sample of 118 fish may show signs • For fish held iced or refrigerated (not frozen) of decomposition. Note that the FFD&C onboard the vessel: Act prohibits interstate commerce of any Elapsed time from death and internal decomposed fish whether or not the HACCP temperatures at the time of off-loading critical limit has been exceeded; from the vessel by the processor should be consistent with cooling curves that AND will prevent development of an unsafe Internal temperature measurements: level of histamine in the specific species, • For fish held iced or refrigerated (not frozen) as established through a scientific study. onboard the vessel 24 or more hours after death: Establish Monitoring Procedures. The internal temperature should be 40°F » What Will Be Monitored? (4.4°C) or below; Harvest vessel records containing the following OR information: • For fish held iced or refrigerated (not frozen) • Method of capture*; onboard the vessel from 15 to less than 24 hours after death: AND The internal temperature should be 50°F • Where applicable to the critical limit, the

CHAPTER 7: Scombrotoxin (Histamine) Formation 126 date and time of landing the fish onboard • The presence of ice that completely the harvest vessel; and continuously surrounds the fish. AND (*These items may be documented by the primary (first) processor, on the receiving records, rather than by the harvest vessel operator, • Where applicable to the critical limit, the on the harvest vessel records, provided the primary processor has estimated earliest date and time of death for direct knowledge about those aspects of the harvesting practices and fish brought onboard in the fishing set (e.g., has made first-hand observations for each lot received. The vessel operator should document other onboard handling information. The trawl, gillnet, longline, or purse seine); primary processor should maintain all relevant information.) AND AND • Where applicable to the critical limit, the Sensory examination: air and water temperatures at the time of landing the fish onboard the harvest vessel*; • Amount of decomposition in the lot; AND AND • Where applicable to the critical limit, the Internal temperature measurement: water temperature at the depth where dead • For fish held iced or refrigerated (not frozen) fish may remain until harvest; onboard the vessel: AND The internal temperature of a • Where applicable to the critical limit, the representative number of the largest method of cooling* and temperature of the fish in the lot at the time of off-loading cooling medium; from the harvest vessel, concentrating on any fish that show signs of having been AND mishandled (e.g., inadequately iced); • Where applicable to the critical limit, the AND date and time cooling began and/or the date and time when the last fish in a fishing set Date and time of off-loading. (e.g., trawl, gillnet, longline, or purse seine) Example: was placed in the cooling medium; A primary processor receives AND bluefish from several day-boats that catch the fish when the air • Where applicable to the critical limit, those and water temperatures are below factors of the cooling process that have been 83°F (28.3°C). The day-boats take established through a scientific study as critical on ice at the processor’s facility to achieving the cooling rate critical limits (e.g., immediately before setting out for the refrigerated brine or seawater temperature, fish day and return within 9 hours to the size, fish to brine/seawater/ice ratio, maximum processor’s facility with the iced catch. initial temperature of the fish); The processor monitors and records AND the date and time of departure of • For fish held iced or refrigerated (not frozen) the vessels after they take on ice; the onboard the vessel: date and time of the return of the The storage temperature, as evidenced by: vessels; the ambient water and air temperatures of the fishing grounds; • The temperature of refrigerated and the adequacy of icing of the seawater or brine in which catch at the time of off-loading. The the fish are stored; processor also conducts sensory OR evaluations and checks the internal

CHAPTER 7: Scombrotoxin (Histamine) Formation 127 temperature of the catch upon arrival. of the fish. Randomly select fish from The harvest vessel operators perform throughout the lot. Lots that show a high no monitoring or record keeping. level of temperature variability or lots of very small fish may require a larger » How Will Monitoring Be Done? sample size; • For harvest vessel records: AND Review controls documented in the Visually determine the date and time of records; off-loading. AND • For sensory examination: » How Often Will Monitoring Be Done (Frequency)? • Every lot of scombrotoxin-forming fish Examine at least 118 fish, collected received. representatively throughout each lot (or the entire lot, for lots smaller than 118 fish). » Who Will Do the Monitoring? Additional fish should be examined if • For sensory examination: variability in fish-to-fish histamine content is expected to be high. Lots should Any person who is qualified by consist of only one species of fish; for experience or training to perform the vessels delivering multiple species, testing examination; should generally be done separately on AND each species. All fish within a lot should • For other checks: have a similar history of harvest. If the Any person who has an understanding of fish are received frozen, this monitoring the nature of the controls. procedure may be performed by a sensory examination on the warmed flesh produced by drilling the frozen fish (drill Establish Corrective Action Procedures. method). It may also be performed after Take the following corrective actions to a product thawing, rather than at receipt; involved in a critical limit deviation: AND • In the absence of harvest vessel records or when one of the harvester-related critical • For fish held iced or refrigerated (not frozen) limits has not been met, or when the internal onboard the vessel: temperature critical limit at receiving has not Use a temperature-indicating device been met: (e.g., a thermometer) to measure the Chill and hold the affected lot (i.e., internal temperature of a representative fish of common origin) until histamine number of the largest fish in each analysis is performed on a minimum lot, concentrating on any that show of 60 fish representatively collected signs of having been mishandled (e.g., from throughout the lot, including any inadequately iced). For example, fish measured to have temperatures when receiving 10 tons or more of fish, that exceeded the critical limit (or the measure a minimum of one fish per ton, entire lot for lots smaller than 60 fish). and when receiving less than 10 tons of Reject the lot if any fish are found with fish, measure a minimum of one fish per histamine greater than or equal to 50 1,000 pounds. Measure a minimum of ppm. The fish collected for analysis 12 fish, unless there are fewer than 12 may be composited for analysis if the fish in the lot, in which case measure all action point is reduced accordingly. For

CHAPTER 7: Scombrotoxin (Histamine) Formation 128 example, a sample of 60 fish may be Establish a Recordkeeping System. composited into 20 units of 3 fish each, • Harvest vessel records containing the provided the action point is reduced information described above; from 50 ppm to 17 ppm for each unit; AND OR • Receiving records showing the date and time Reject the lot; of off-loading; AND AND • When the sensory examination critical limit • Results of sensory examination; has not been met: AND Chill and hold the affected lot (i.e., fish of common origin) until histamine • For fish held iced or refrigerated (not frozen) analysis is performed on a minimum onboard the vessel: of 60 fish representatively collected Internal temperatures of the fish. from throughout the lot, including all fish in the lot that show evidence of Establish Verification Procedures. decomposition (persistent and readily • Collect a representative sample of the raw perceptible odors) (or the entire lot for material, in-process product, or finished lots smaller than 60 fish), and reject the product, and analyze it for histamine at least lot if any fish is found with histamine quarterly; greater than or equal to 50 ppm; AND AND • Ensure that new sensory examiners receive If any fish in the lot are to proceed training to calibrate their ability to identify into commerce for food use, perform decomposed fish and that all sensory a sensory examination of all fish in the examiners receive periodic refresher training; lot to ensure that no decomposed fish proceed; AND • Where histamine testing is part of a AND corrective action plan, periodically verify Any individual fish found to be the findings (e.g., by comparing results with decomposed (persistent and readily those obtained using an Association of perceptible) should be destroyed or Official Analytical Chemists (AOAC) method); diverted to a non-food use; AND OR • Before a temperature-indicating device (e.g., Reject the lot. a thermometer) is put into service, check AND the accuracy of the device to verify that the factory calibration has not been affected. Take the following corrective action to regain control This check can be accomplished by: over the operation after a critical limit deviation: Immersing the sensor in an ice slurry • Discontinue use of the supplier until (32°F (0°C)), if the device will be used at evidence is obtained that the identified or near refrigeration temperature; harvesting and onboard practices and controls have been improved. OR Comparing the temperature reading on the device with the reading on a

CHAPTER 7: Scombrotoxin (Histamine) Formation 129 known accurate reference device (e.g., • Review monitoring, corrective action, a thermometer traceable to the National and veriﬁcation records within 1 week of Institute of Standards and Technology preparation to ensure they are complete and (NIST) standards) under conditions that any critical limit deviations that occurred are similar to how it will be used (e.g., were appropriately addressed. product internal temperature) within the temperature range at which it will be used; OR Following the manufacturer’s instructions; AND • Once in service, check the temperature- indicating device daily before the beginning of operations. Less frequent accuracy checks may be appropriate if they are recommended by the instrument manufacturer and the history of use of the instrument in your facility has shown that the instrument consistently remains accurate for a longer period of time. In addition to checking that the device is accurate by one of the methods described above, this process should include a visual examination of the sensor and any attached wires for damage or kinks. The device should be checked to ensure that it is operational; AND • Calibrate the temperature-indicating device against a known accurate reference device (e.g., a NIST-traceable thermometer) at least once a year or more frequently if recommended by the device manufacturer. Optimal calibration frequency is dependent upon the type, condition, past performance, and conditions of use of the device. Consistent temperature variations away from the actual value (drift) found during checks and/or calibration may show a need for more frequent calibration or the need to replace the device (perhaps with a more durable device). Calibration should be performed at a minimum of two temperatures that bracket the temperature range at which it is used; AND

CHAPTER 7: Scombrotoxin (Histamine) Formation 130 per year examiners (18 fish per sample) daily, at the beginning of daily, Provide sensoryProvide training annual trainingall fish for perform these same checks for new fish examiners and for for accuracy for and damage to ensure that it is operational Check the digital thermometer within 1 week of preparation within 1 week within 1 week of preparation within 1 week within 1 week of preparation within 1 week Review monitoring, corrective corrective monitoring, Review Review monitoring, corrective corrective monitoring, Review Review monitoring, corrective corrective monitoring, Review Perform histamine analysis on Perform before putting it into operation;before 1 incoming lot every 3 months 1 incoming lot every operations; and calibrate it once action, and verification records and verification action, action, and verification records and verification action, action, and verification records and verification action, vessel vessel record record records RECORDS VERIFICATION Harvester Harvester Receiving Receiving Receiving Receiving that and and until Reject Reject the lot controls supplier onboard practices evidence evidence improved e illustrates how a fresh mahi-mahi processor that use of the ACTION(S) harvesting harvesting have been have is obtained CORRECTIVE Discontinue l scombrotoxin formation. It is provided for illustrative on the nature of your operation. r other potential hazards (e.g., metal fragments). staff control Quality Receiving Receiving Receiving Receiving supervisor supervisor lot lot lot Every Every Every Every Every Every received received received MONITORING lot) fish) Digital Sensory controls pounds; TABLE 7-3 TABLE Review of Review 12 fish per in the lot if examination minimum of (118 fish per documented (1 fish/1,000 less than 118 thermometer lot; or all fish Example Only in the records of lot See Text for Full Recommendations See Text WHAT HOW FREQUENCY WHO time of records Internal Amount off-loading from vessel; from vessel; temperature of the fish at of off-loading Harvest vessel vessel Harvest Date and time decomposition in the incoming

≤ 50° ≤ 60° CONTROL STRATEGY EXAMPLE 1 - HARVEST VESSEL CONTROL CONTROL STRATEGY ≤ 40° below ambient LIMITS CRITICAL MEASURE FOR EACH of the fish: PREVENTIVE time since death >24 hours in the incoming lot (2) The fish were stored (2) The fish were 12 to < 15 hours 15 to < 24 hours temperature 83°F; exceeds air and water temperatures air and water (1) placement of fish on ice completely and continuously < 12 hours within 9 hours of death if the Less than 2.5% decomposition Internal temperatures of all fish surrounded by ice after capture hours if the maximum exposure maximum exposure temperature are to meet the following criteria are to meet the following does not exceed 83°F or within 6 does not exceed All lots received are accompanied All lots received based on the time since death (persistent and readily perceptible) by harvest vessel records that show vessel by harvest commensurate with size of fish and formation HAZARD(S) SIGNIFICANT Scombrotoxin (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) fresh mahi- POINT vessels harvest harvest CRITICAL mahi on ice from CONTROL Receiving Receiving Histamine formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) fo Histamine formation may be only one of several significant hazards for this product. Refer to Tables purposes only. It may be necessary to select more than one control strategy in order fully the hazard, depending up purposes only. receives the fish on ice directly from harvest vessels that use a hook and line technique (fish brought onboard alive) can contro This table is an example of a portion of a HACCP plan using “Control Strategy Example 1 - Harvest Vessel Control.” This exampl This table is an example of a portion of a HACCP plan using “Control Strategy Example 1 - Harvest Vessel

CHAPTER 7: Scombrotoxin (Histamine) Formation 131 • CONTROL STRATEGY EXAMPLE 2 - HISTAMINE The internal temperature should be 50°F TESTING (10°C) or below; It may be necessary to select more than one OR control strategy in order to fully control the • For fish held iced or refrigerated (not frozen) hazard, depending upon the nature of your onboard the vessel from 12 to less than 15 operation. hours after death: Set Critical Limits. The internal temperature should be 60°F (15.6°C) or below; The critical limits for this control strategy should include three components: OR • Histamine testing; • For fish held iced or refrigerated (not frozen) onboard the vessel less than 12 hours after • Sensory examination; death: • Internal temperature measurements. The internal temperature should Histamine testing: be sufficiently below water and air • Analysis of a representative sample of temperatures to indicate that appropriate scombrotoxin-forming fish shows less than chilling methods were implemented 50 ppm histamine in all fish in the sample; onboard the harvest vessel. Chilling of the fish should begin on the harvest AND vessel regardless of the time from death Sensory examination: until off-loading from the vessel by the • Sensory examination of a representative processor, unless the environmental sample of scombrotoxin-forming fish shows conditions (e.g. air and water decomposition (persistent and readily temperatures) are below 40°F (4.4°C) perceptible) in less than 2.5% of the fish in from the time of death until off-loading the sample. For example, no more than 2 from the vessel by the processor; fish in a sample of 118 fish may show signs OR of decomposition. Note that the FFD&C • For fish held iced or refrigerated (not frozen) Act prohibits interstate commerce of any onboard the vessel: decomposed fish whether or not the HACCP critical limit has been exceeded; Elapsed time from death and internal temperatures at the time of off-loading AND from the vessel by the processor should Internal temperature measurements: be consistent with cooling curves that will prevent development of an unsafe • For fish held iced or refrigerated (not frozen) level of histamine in the specific species, onboard the vessel 24 or more hours after as established through a scientific study. death: The internal temperature should be 40°F Establish Monitoring Procedures. (4.4°C) or below; OR » What Will Be Monitored? • For fish held iced or refrigerated (not frozen) Histamine testing: onboard the vessel from 15 to less than 24 • Histamine content in the scombrotoxin- hours after death: forming fish flesh; AND

CHAPTER 7: Scombrotoxin (Histamine) Formation 132 Sensory examination: • For sensory examination: • Amount of decomposition in the Examine at least 118 fish, collected scombrotoxin-forming fish lot; representatively throughout each lot (or the entire lot, for lots smaller than AND 118 fish). Additional fish should be Internal temperature measurement: examined if variability in fish-to-fish • For scombrotoxin-forming fish held iced or histamine content is expected to be high. refrigerated (not frozen) onboard the vessel: Lots should consist of only one species The internal temperature of a of fish; for vessels delivering multiple representative number of the largest species, testing should generally be fish in the lot at the time of off-loading done separately on each species. If the from the harvest vessel by the processor, fish are received frozen, this monitoring concentrating on any fish that show procedure may be performed by a signs of having been mishandled (e.g., sensory examination on the warmed inadequately iced); flesh produced by drilling the frozen fish (drill method). It may also be performed AND after thawing, rather than at receipt; Date and time of off-loading. AND » How Will Monitoring Be Done? • For fish held iced or refrigerated (not frozen) • For histamine analysis: onboard the vessel: Test a minimum of 18 fish, collected Use a temperature-indicating device representatively throughout each lot (or (e.g., a thermometer) to measure the the entire lot when there are fewer than internal temperature of a representative 18 fish in the lot). Additional fish should number of the largest fish in each be examined if variability in fish-to-fish lot, concentrating on any that show histamine content is expected to be high. signs of having been mishandled (e.g., Lots should consist of only one species inadequately iced). For example, of fish; for vessels delivering multiple when receiving 10 tons or more of fish, species, testing should generally be done measure a minimum of one fish per ton, separately on each species. Reject the and when receiving less than 10 tons of lot if any fish are found with histamine fish, measure a minimum of one fish per greater than or equal to 50 ppm. The 1,000 pounds. Measure a minimum of fish collected for analysis may be 12 fish, unless there are fewer than 12 composited if the critical limit is reduced fish in the lot, in which case measure all accordingly. For example, a sample of of the fish. Randomly select fish from 18 fish may be composited into 6 units throughout the lot. Lots that show a high of 3 fish each, provided the critical limit level of temperature variability or lots is reduced from 50 ppm to 17 ppm for of very small fish may require a larger each unit; sample size; AND AND Visually determine the date and time of off-loading.

CHAPTER 7: Scombrotoxin (Histamine) Formation 133 » How Often Will Monitoring Be Done (Frequency)? OR • Every lot of scombrotoxin-forming ﬁsh received. • Reject the lot;

» Who Will Do the Monitoring? AND • For sensory examination and histamine • When the sensory examination critical limit testing: has not been met: Any person who is qualified by If histamine did not exceed 50 ppm in experience or training to perform the the initial testing: work; • Chill and hold the affected lot AND (i.e., fish of common origin) until • For other checks: histamine analysis is performed on a minimum of 60 fish representatively Any person who has an understanding of collected from throughout the lot, the nature of the controls. including all fish in the lot that show evidence of decomposition Establish Corrective Action Procedures. (persistent and readily perceptible Take the following corrective actions to a product odors) (or the entire lot for lots involved in a critical limit deviation: smaller than 60 fish). Reject the • When the histamine-level critical limit at the lot if any fish are found with receiving step has not been met, reject the lot; histamine greater than or equal to 50 ppm. The fish collected for AND analysis may be composited for • When the internal temperature critical limit analysis if the action point is reduced has not been met: accordingly. For example, a sample If histamine did not exceed 50 ppm in of 60 fish may be composited into the initial testing: 20 units of 3 fish each, provided the action point is reduced from • Chill and hold the affected lot 50 ppm to 17 ppm for each unit; (i.e., fish of common origin) until histamine analysis is performed on a AND minimum of 60 fish representatively If any fish in the lot are to proceed collected from throughout the lot, into commerce for food use, perform including any fish measured to a sensory examination of all fish in the have temperatures that exceeded lot to ensure that no decomposed fish the critical limit (or the entire lot proceed; for lots smaller than 60 fish). Reject AND the lot if any fish are found with histamine greater than or equal Any individual fish found to be to 50 ppm. The fish collected for decomposed (persistent and readily analysis may be composited for perceptible) should be destroyed or analysis if the action point is reduced diverted to a non-food use; accordingly. For example, a sample OR of 60 fish may be composited into Reject the lot. 20 units of 3 fish each, provided the action point is reduced from AND 50 ppm to 17 ppm for each unit;

CHAPTER 7: Scombrotoxin (Histamine) Formation 134 Take the following corrective action to regain control traceable thermometer) under conditions over the operation after a critical limit deviation: that are similar to how it will be used (e.g., • Discontinue use of the supplier until evidence product internal temperature) within the is obtained that the identified harvesting and temperature range at which it will be used; onboard practices have been improved. OR Following the manufacturer’s instructions; Establish a Recordkeeping System. AND • Receiving records showing: • Once in service, check the temperature- Date and time of off-loading; indicating device daily before the beginning AND of operations. Less frequent accuracy checks • Results of histamine analysis; may be appropriate if they are recommended by the instrument manufacturer and the history AND of use of the instrument in your facility has • Results of sensory examination; shown that the instrument consistently remains AND accurate for a longer period of time. In • For fish held iced or refrigerated (not frozen) addition to checking that the device is accurate onboard the vessel: by one of the methods described above, this process should include a visual examination of Internal temperatures of the fish. the sensor and any attached wires for damage or kinks. The device should be checked to Establish Verification Procedures. ensure that it is operational; • Periodically verify histamine findings (e.g., by AND comparing results with those obtained using an AOAC method or by analyzing proficiency • Calibrate the temperature-indicating device samples); against a known accurate reference device (e.g., a NIST-traceable thermometer) at AND least once a year or more frequently if • Ensure that new sensory examiners receive recommended by the device manufacturer. training to calibrate their ability to identify Optimal calibration frequency is dependent decomposed fish and that all sensory upon the type, condition, past performance, examiners receive periodic refresher training; and conditions of use of the device. AND Consistent temperature variations away from the actual value (drift) found during checks • Before a temperature-indicating device (e.g., and/or calibration may show a need for more a thermometer) is put into service, check frequent calibration or the need to replace the accuracy of the device to verify that the the device (perhaps with a more durable factory calibration has not been affected. device). Calibration should be performed at This check can be accomplished by: a minimum of two temperatures that bracket Immersing the sensor in an ice slurry the temperature range at which it is used; (32°F (0°C)), if the device will be used at or near refrigeration temperature; AND • Review monitoring, corrective action, OR and verification records within 1 week of Comparing the temperature reading on preparation to ensure they are complete and the device with the reading on a known any critical limit deviations that occurred accurate reference device (e.g., a NIST- were appropriately addressed.

CHAPTER 7: Scombrotoxin (Histamine) Formation 135 Review Review method monitoring, monitoring, preparation preparation Do a quarterly within 1 week of within 1 week within 1 week of within 1 week all fish examiners verification records verification verification records verification Review monitoring, monitoring, Review corrective action, and action, corrective corrective action, and action, corrective test results with AOAC test results with AOAC for new fish examiners for and annual training for Provide sensoryProvide training comparison of histamine record analysis Sensory histamine Reports of examination ustrates how a canned tuna processor that r other potential hazards (e.g., Clostridium oses only. It may be necessary to select more than oses only. Reject the lot; Reject CORRECTIVE ACTION(S) RECORDS VERIFICATION and if all fish <50 ppm was <50 ppm, perform <50 ppm, was histamine analysis on a histamine analysis on a min, of 60 fish, collected collected of 60 fish, min, until evidence is obtained until evidence until evidence is obtained until evidence and reject the lot if any fish and reject the lot if any fish that harvesting and onboard that harvesting that harvesting and onboard that harvesting representatively from the lot from the lot representatively contains ≥50 ppm histamine; contains ≥50 ppm histamine; practices have been improved practices have practices have been improved practices have If the initial histamine sample If the initial histamine sample Conduct sensory of evaluation destroying all decomposed fish Discontinue use of the supplier Discontinue use of the supplier all fish in the lot, removing and removing all fish in the lot, staff staff Quality Quality assurance assurance TABLE 7-4 TABLE received received Example Only Every lot Every lot Every See Text for Full Recommendations See Text MONITORING Sensory detected histamine) vessels with vessels of histamine between fish between or when 1 of of 18 fish per than 118 fish) on a minimum 977.13 method high variability the first 18 fish fish if lot is less using the AOAC using the AOAC lot (36 fish from exceeds 30 ppm exceeds Histamine testing examination (118 fish per lot, or all fish per lot, CONTROL STRATEGY EXAMPLE 2 - HISTAMINE TESTING EXAMPLE 2 - HISTAMINE CONTROL STRATEGY in the WHAT HOW FREQUENCY WHO content histamine Amount of incoming lot Fish flesh for for Fish flesh decomposition fish LIMITS sample sample 50 ppm CRITICAL MEASURE Less than FOR EACH (persistent PREVENTIVE Less than 3 and readily perceptible) histamine in in a 118-fish decomposed all fish in the formation HAZARD(S) SIGNIFICANT Scombrotoxin

This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Histamine Testing.” This example ill This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Histamine Testing.” receives frozen tuna directly from the harvest vessel can control scombrotoxin formation. It is provided for illustrative purp botulinum growth and toxin formation). one control strategy in order to fully the hazard, depending upon nature of your operation. 3-2 and 3-4 (Chapter 3) fo Histamine formation may be only one of several signiﬁcant hazards for this product. Refer to Tables (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) POINT frozen vessels harvest harvest CRITICAL CONTROL Receiving Receiving tuna from

CHAPTER 7: Scombrotoxin (Histamine) Formation 136 • CONTROL STRATEGY EXAMPLE 3 - TRANSIT a controlled temperature environment) of 4 CONTROL hours or less (optional control strategy): It may be necessary to select more than one Time of transit does not exceed 4 hours; control strategy in order to fully control the hazard, AND depending upon the nature of your operation. Internal temperature of the fish at the Set Critical Limits. time of delivery does not exceed 40°F (4.4°C). • For fish delivered refrigerated (not frozen): All lots received are accompanied by Note: Processors receiving fish with transit times of 4 hours or less may elect to use one of the controls described for longer transit times instead. transportation records that show that the fish were held at or below an ambient Establish Monitoring Procedures. or internal temperature of 40°F (4.4°C) throughout transit. Note that allowance » What Will Be Monitored? for routine refrigeration defrost cycles may • For scombrotoxin-forming fish delivered be necessary; refrigerated (not frozen): OR The internal temperature of the fish • For fish delivered under ice: throughout transportation; Fish are completely surrounded by ice at OR the time of delivery; The ambient temperature within the truck OR or other carrier throughout transportation; • For fish delivered under ice on an open-bed OR truck: • For scombrotoxin-forming fish delivered under Fish are stored completely surrounded by ice: ice; The adequacy of ice surrounding the AND product at the time of delivery; The internal temperature of the fish at the OR time of delivery is 40°F (4.4°C) or below; • For scombrotoxin-forming fish delivered under OR ice on an open-bed truck: • For fish delivered under chemical cooling The adequacy of ice surrounding the media such as gel packs: product at the time of delivery; There is an adequate quantity of AND cooling media that remain frozen to The internal temperature of the fish at have maintained product at an internal time of delivery; temperature of 40°F (4.4°C) or below throughout transit; OR • For scombrotoxin-forming fish held under AND chemical cooling media such as gel packs: The internal temperature of the fish at the The quantity and frozen status of cooling time of delivery is 40°F (4.4°C) or below; media at the time of delivery; OR AND • For fish delivered refrigerated (not frozen) The internal temperature of the fish at the with a transit time (including all time outside time of delivery;

CHAPTER 7: Scombrotoxin (Histamine) Formation 137 OR Make visual observations of the • For scombrotoxin-forming fish delivered adequacy and frozen state of the cooling refrigerated (not frozen) with a transit time of media in a representative number of 4 hours or less: containers (e.g., cartons and totes) from throughout the shipment; The date and time fish were removed from a controlled temperature AND environment before shipment and the Use a temperature-indicating device (e.g., date and time delivered; a thermometer) to determine internal AND product temperatures in a representative number of fish from throughout the The internal temperature of a representative shipment, at delivery; number of fish at the time of delivery. OR » How Will Monitoring Be Done? • For fish delivered refrigerated (not frozen) • For fish delivered refrigerated (not frozen): with a transit time of 4 hours or less: Use a continuous temperature-recording Review carrier records to determine the device (e.g., a recording thermometer) date and time fish were removed from for internal product temperature or a controlled temperature environment ambient air temperature monitoring before shipment and the date and time during transit; delivered; OR AND • For fish delivered under ice: Use a temperature-indicating device (e.g., Make visual observations of the adequacy a thermometer) to determine internal of ice in a representative number of product temperatures in a representative containers (e.g., cartons and totes) from number of fish randomly selected from throughout the shipment, at delivery; throughout the shipment, at delivery. OR Measure a minimum of 12 fish, unless there are fewer than 12 fish in a lot, in • For fish delivered under ice on an open-bed which case measure all of the fish. Lots truck: that show a high level of temperature Make visual observations of the variability or lots of very small fish may adequacy of ice surrounding the product require a larger sample size. in a representative number of containers (e.g., cartons and totes) from throughout » How Often Will Monitoring Be Done (Frequency)? the shipment, at delivery; • Every scombrotoxin-forming fish lot received. AND » Who Will Do the Monitoring? Use a temperature-indicating device (e.g., • For continuous temperature-recording a thermometer) to determine internal devices: product temperatures in a representative Monitoring is performed by the device itself. number of fish from throughout the The visual check of the data generated shipment, at delivery; by the device, to ensure that the critical OR limits have consistently been met, may • For fish delivered under chemical cooling be performed by any person who has an media such as gel packs: understanding of the nature of the controls;

CHAPTER 7: Scombrotoxin (Histamine) Formation 138 OR • The number of containers examined • For other checks: and the sufficiency of ice for each; Any person who has an understanding of AND the nature of the controls. • The number of containers in the lot; Establish Corrective Action Procedures. OR For chemical cooling media checks: Take the following corrective action to a product involved in a critical limit deviation: • The number of containers • Chill and hold the affected lot until histamine examined and the frozen status analysis is performed on a minimum of of the cooling media for each; 60 fish representatively collected from AND throughout the lot, including any with temperatures that exceeded a critical limit • The number of containers in the lot; and any fish observed to have been exposed AND to inadequate cooling media (or the entire lot Results of internal product temperature for lots smaller than 60 fish). Reject the lot if monitoring, where applicable, including: any fish is found with histamine greater than or equal to 50 ppm. • The number of containers examined and the internal The fish collected for analysis may be temperatures observed for each; composited if the action point is reduced accordingly. For example, a sample of 60 fish AND may be composited into 20 units of 3 fish • The number of containers in the lot; each, provided the action point is reduced AND from 50 ppm to 17 ppm for each unit; Date and time fish were initially OR removed from a controlled temperature • Reject the lot. environment and the date and time fish AND were delivered, when applicable.

Take the following corrective action to regain control Establish Veriﬁcation Procedures. over the operation after a critical limit deviation: • Before a temperature-indicating device (e.g., • Discontinue use of the supplier or carrier a thermometer) is put into service, check until evidence is obtained that the identiﬁed the accuracy of the device to verify that the transportation-handling practices have been factory calibration has not been affected. improved. This check can be accomplished by: Immersing the sensor in an ice slurry Establish a Recordkeeping System. (32°F (0°C)), if the device will be used at • Receiving records showing: or near refrigeration temperature; For continuous temperature monitoring: OR • Printouts, charts, or readings from Comparing the temperature reading on temperature-recording devices (e.g., the device with the reading on a known temperature recorder); accurate reference device (e.g., a NIST- OR traceable thermometer) under conditions For ice checks: that are similar to how it will be used

CHAPTER 7: Scombrotoxin (Histamine) Formation 139 (e.g., product internal temperature) the device with the reading on a known within the temperature range at which it accurate reference device (e.g., a NIST- will be used; traceable thermometer) under conditions that are similar to how it will be used (e.g., air OR temperature) within the temperature range at Following the manufacturer’s instructions; which it will be used; AND AND • Once in service, check the temperature- • When visual checks of ice are used, indicating device daily before the beginning periodically measure internal temperatures of operations. Less frequent accuracy checks of fish to ensure that the ice are sufficient may be appropriate if they are recommended to maintain product temperatures at 40°F by the instrument manufacturer and the (4.4°C) or less; history of use of the instrument in your facility has shown that the instrument AND consistently remains accurate for a longer • Review monitoring, corrective action, period of time. In addition to checking that and verification records within 1 week the device is accurate by one of the methods of preparation are complete and any described above, this process should include critical limit deviations that occurred were a visual examination of the sensor and any appropriately addressed. attached wires for damage or kinks. The device should be checked to ensure that it is operational; AND • Calibrate the temperature-indicating device against a known accurate reference device (e.g., a NIST-traceable thermometer) at least once a year or more frequently if recommended by the device manufacturer. Optimal calibration frequency is dependent upon the type, condition, past performance, and conditions of use of the device. Consistent temperature variations away from the actual value (drift) found during checks and/or calibration may show a need for more frequent calibration or the need to replace the device (perhaps with a more durable device). Calibration should be performed at a minimum of two temperatures that bracket the temperature range at which it is used; AND • Check the accuracy of temperature-recording devices that are used for monitoring transit conditions upon receipt of each lot. The accuracy of the device can be checked by comparing the temperature reading on

CHAPTER 7: Scombrotoxin (Histamine) Formation 140 year Review Review Check the monitoring, monitoring, ensure that it accuracy and is operational perform these before putting before into operation; and verification and verification damage, and to damage, records within 1 thermometer for at the beginning corrective action, action, corrective same checks daily of operations, and of operations, calibrate it once per week of preparation week record record Receiving Receiving Receiving Receiving improved improved Reject the lot Reject Reject the lot Reject r other potential hazards (e.g., metal fragments). trates how a fresh mahi-mahi secondary processor that practices have been practices have practices have been practices have CORRECTIVE ACTION(S) RECORDS VERIFICATION Discontinue use of the Discontinue use of the supplier or carrier until supplier or carrier until ive purposes only. It may be necessary to select more than ive purposes only. transportation-handling transportation-handling evidence is obtained that evidence evidence is obtained that evidence clerk clerk Receiving Receiving Receiving Receiving received received Every lot Every Every lot Every TABLE 7-5 TABLE Example Only MONITORING containers) for internal for containers) See Text for Full Recommendations See Text temperature of has less than 12 25% of shipping containers in the lot but not fewer lot but not fewer of a minimum 12 containers (or one fish in 25% of Visual observationVisual than 12 containers all containers if lot but not fewer than but not fewer (or all containers if lot has less than 12 shipping containers Digital thermometer and a CONTROL STRATEGY EXAMPLE 3 - TRANSIT CONTROL CONTROL STRATEGY WHAT HOW FREQUENCY WHO Quantity gel packs and frozen of each fish temperature temperature condition of near-surface Internal core LIMITS Internal CRITICAL packs to MEASURE Adequate Adequate FOR EACH frozen gel product at quantity of PREVENTIVE throughout transit; and 40°F or less delivery are delivery of all fish at maintain the temperatures 40°F or below formation HAZARD(S) SIGNIFICANT (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) POINT CRITICAL CONTROL Receiving Scombrotoxin receives the product by air under chemical coolant (gel packs) can control scombrotoxin formation. It is provided for illustrat one control strategy in order to fully the hazard, depending upon nature of your operation. 3-2 and 3-4 (Chapter 3) fo Histamine formation may be only one of several significant hazards for this product. Refer to Tables This table is an example of a portion of a HACCP plan using “Control Strategy Example 3 - Transit Control.” This example illus This table is an example of a portion of a HACCP plan using “Control Strategy Example 3 - Transit

CHAPTER 7: Scombrotoxin (Histamine) Formation 141 • CONTROL STRATEGY EXAMPLE 4 - PROCESSING The fish are not exposed to ambient CONTROL temperatures above 40°F (4.4°C) for It may be necessary to select more than one more than 12 hours, cumulatively, if any control strategy in order to fully control the portion of that time is at temperatures hazard, depending upon the nature of your above 70°F (21.1°C); operation. OR Set Critical Limits. The fish are not exposed to ambient temperatures above 40°F (4.4°C) for • During processing (e.g., butchering, more than 24 hours, cumulatively, as cleaning, brining, salting, smoking, drying, long as no portion of that time is at fermenting, pickling, mixing, fermenting, temperatures above 70°F (21.1°C). stuffing, packing, labeling, and staging) of scombrotoxin-forming fish that have not Note: Only one of the two limits above should be selected. They should not be added for a total exposure of 36 hours. been previously frozen or heat processed sufficiently to destroy scombrotoxin-forming Establish Monitoring Procedures. bacteria: The fish are not exposed to ambient » What Will Be Monitored? temperatures above 40°F (4.4°C) for • The length of time the scombrotoxin-forming more than 4 hours, cumulatively, if any fish are exposed to unrefrigerated conditions portion of that time is at temperatures (i.e., above 40°F (4.4°C)); above 70°F (21.1°C); AND OR • The ambient temperatures during the The fish are not exposed to ambient exposure periods. temperatures above 40°F (4.4°C) for Note: If the critical limit is based on an assumption that temperatures more than 8 hours, cumulatively, as may exceed 70°F (21.1°C), then only the length of exposure may long as no portion of that time is at need to be monitored. temperatures above 70°F (21.1°C). » How Will Monitoring Be Done? Note: Only one of the two limits above should be selected. They • Make visual observations of the length of should not be added for a total exposure of 12 hours. time of product exposure to unrefrigerated OR conditions (i.e., above 40°F (4.4°C)); • During processing (e.g., thawing, butchering, AND cleaning, brining, mixing, fermenting, • Measure ambient air temperature, using: stuffing, packing, labeling, and staging) of scombrotoxin-forming fish or fishery A continuous temperature-recording products that have been (1) previously device (e.g., a recording thermometer) frozen or (2) heat processed sufficiently to located in the processing area; destroy scombrotoxin-forming bacteria and OR are processed in a manner where there is A temperature-indicating device (e.g., a an opportunity for recontamination with thermometer) located in the processing scombrotoxin-forming bacteria (e.g., contact area. with fresh fish, employees, or introduction of raw ingredients), such as in a tuna salad Note: Where multiple processing locations are combined in a cumulative exposure control strategy, temperature monitoring may be made from canned tuna with added raw needed in each of the processing locations. ingredients:

CHAPTER 7: Scombrotoxin (Histamine) Formation 142 Example: » Who Will Do the Monitoring? A fresh tuna processor using raw • For a continuous temperature-recording device: material that was not previously Monitoring is performed by the device frozen has identified a series of itself. The visual check of the data processing steps (i.e., from raw generated by the device, to ensure that material cooler to finished product the critical limits have consistently been cooler) as CCPs for scombrotoxin met, may be performed by any person formation. The processor establishes who has an understanding of the nature a critical limit of no more than 4 of the controls; cumulative hours of exposure to unrefrigerated temperatures in OR excess of 40°F (4.4°C) during these • For other checks: processing steps. The processor uses Any person who has an understanding of a marked product to monitor the the nature of the controls. progress of the product through the processing steps. The time that the Establish Corrective Action Procedures. marked product is removed from refrigeration to the time the last of Take the following corrective action to a product the marked product is placed in the involved in a critical limit deviation: finished product cooler is monitored • Chill and hold the affected product until visually and recorded. It is not histamine analysis is performed on a necessary for the processor to measure minimum of 60 fish representatively collected temperature because the critical limit from throughout the affected lot. Destroy is based on an assumption that the the lot or divert it to a non-food use if any product temperature may exceed 70°F fish is found with histamine greater than (21.1°C). or equal to 50 ppm. The fish collected for analysis may be composited if the action » How Often Will Monitoring Be Done (Frequency)? plan is reduced accordingly. For example, • For exposure time: a sample of 60 fish may be composited into At least every 2 hours; 20 units of 3 fish each, provided the action point is reduced from 50 ppm to 17 ppm for AND each unit; • For temperature measurements: OR For a continuous temperature-recording device: • Destroy the product; • Continuous monitoring during OR processing operations is • Divert the product to a non-food use. accomplished by the device itself, AND with a visual check of the device at least once per lot or batch, but Take the following corrective actions to regain control no less often than once per day; over the operation after a critical limit deviation: • Add ice to the product; OR For a temperature-indicating device: OR • Return the affected product to the cooler; • At least every 2 hours. AND

CHAPTER 7: Scombrotoxin (Histamine) Formation 143 • Modify the process as needed to reduce the by the instrument manufacturer and the time and temperature exposure. history of use of the instrument in your facility has shown that the instrument Establish a Recordkeeping System. consistently remains accurate for a longer • Processing records showing the results period of time. In addition to checking that of time and temperature exposure the device is accurate by one of the methods measurements. described above, this process should include a visual examination of the sensor and any Establish Verification Procedures. attached wires for damage or kinks. The device should be checked to ensure that it is • Before a temperature-indicating device (e.g., operational and has sufficient ink and paper, a thermometer) or a temperature-recording where applicable; device (e.g., a recording thermometer) is put into service, check the accuracy of the AND device to verify that the factory calibration • Calibrate the temperature-indicating device has not been affected. This check can be or temperature-recording device against a accomplished by: known accurate reference device (e.g., a Immersing the sensor in an ice slurry NIST-traceable thermometer) at least once a (32°F (0°C)), if the device will be used at year or more frequently if recommended by or near refrigeration temperature; the device manufacturer. Optimal calibration OR frequency is dependent upon the type, condition, past performance, and conditions Immersing the sensor in boiling water of use of the device. Consistent temperature (212°F (100°C)) if the device will be used variations away from the actual value (drift) at or near the boiling point. Note that found during checks and/or calibration may the temperature should be adjusted to show a need for more frequent calibration compensate for altitude, when necessary; or the need to replace the device (perhaps OR with a more durable device). Calibration Doing a combination of the above if should be performed at a minimum of two the device will be used at or near room temperatures that bracket the temperature temperature; range at which it is used; OR AND Comparing the temperature reading on • Review monitoring, corrective action, the device with the reading on a known and verification records within 1 week of accurate reference device (e.g., a NIST- preparation to ensure they are complete and traceable thermometer) under conditions any critical limit deviations that occurred that are similar to how it will be used (e.g., were appropriately addressed. air temperature) within the temperature range at which it will be used; AND • Once in service, check the temperature- indicating device or temperature-recording device daily before the beginning of operations. Less frequent accuracy checks may be appropriate if they are recommended

CHAPTER 7: Scombrotoxin (Histamine) Formation 144 Review Review corrective corrective 1 week of 1 week verification verification action, and action, monitoring, monitoring, preparation records within record RECORDS VERIFICATION Processing the cooler 50 ppm Perform Perform exceeds exceeds histamine histamine lustrates how a fresh bluefish processor if any fish ACTION(S) process, if process, Modify the Destroy the CORRECTIVE entire batch minimum of r other potential hazards (e.g., metal Ice and hold necessary, to necessary, analysis on a 60 fish in the reduce delays affected batch affected batch affected ation. in raw material ded for illustrative purposes only. It may be ded for illustrative purposes only. supervisor Quality control fish processing raw material removed from removed Every batch of Every cold storage for TABLE 7-6 TABLE MONITORING Example Only storage of time for a of time for product cold material cold of product to marked batch marked Visual tracking Visual storage to final move from raw move See Text for Full Recommendations See Text WHAT HOW FREQUENCY WHO during conditions operations processing exposure to unrefrigerated Time of product Time CONTROL STRATEGY EXAMPLE 4 - PROCESSING CONTROL CONTROL STRATEGY LIMITS CRITICAL for more for MEASURE FOR EACH PREVENTIVE refrigeration is not out of The product cumulatively than 4 hours formation HAZARD(S) SIGNIFICANT Scombrotoxin (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) This table is an example of a portion of a HACCP plan using “Control Strategy Example 4 - Processing Control.” This example il that butchers, cleans, packs, labels, and boxes the fish at ambient temperature can control scombrotoxin formation. It is provi necessary to select more than one control strategy in order fully the hazard, depending upon nature of your oper 3-2 and 3-4 (Chapter 3) fo Histamine formation may be only one of several significant hazards for this product. Refer to Tables fragments). POINT boxing) CRITICAL cleaning, CONTROL Processing packaging, (butchering, (butchering, labeling, and labeling,

CHAPTER 7: Scombrotoxin (Histamine) Formation 145 • CONTROL STRATEGY EXAMPLE 5 - STORAGE Establish Monitoring Procedures. CONTROL » What Will Be Monitored? It may be necessary to select more than one control strategy in order to fully control the • For refrigerated storage of scombrotoxin- hazard, depending upon the nature of your forming fish: operation. The temperature of the cooler; Set Critical Limits. OR • For storage under ice of scombrotoxin- • For refrigerated (not frozen) storage or forming fish: processing of raw material, in-process product, or finished product: The adequacy of ice surrounding the product. The product is held at a cooler temperature of 40°F (4.4°C) or » How Will Monitoring Be Done? below. Note that allowance for • For refrigerated storage: routine refrigeration defrost cycles Measure cooler temperature using a may be necessary. On the other continuous temperature-recording device hand, minor variations in cooler (e.g., a recording thermometer); temperature measurements can be avoided by submerging the sensor OR for the temperature-recording device • For storage under ice: (e.g., temperature-recorder) in a liquid Make visual observations of the that mimics the characteristics of the adequacy of ice in a representative product. Also note that critical limits number of containers (e.g., cartons and during refrigerated storage that specify totes) from throughout the cooler. a cumulative time and temperature of exposure to temperatures above » How Often Will Monitoring Be Done (Frequency)? 40°F (4.4°C) are not ordinarily suitable • For continuous temperature-recording devices: because of the difficulty in tracking Continuous monitoring during storage is the specific products and the specific accomplished by the device itself, with a cumulative temperature exposures visual check of the recorded data at least that those products experience. The once per day; cumulative exposure for each product OR would then need to be determined prior to shipping. If you chose this approach, • For storage under ice: the critical limit for cumulative exposure Monitoring with sufficient frequency to to temperatures above 40°F (4.4°C) ensure control. should include time during transit, refrigerated storage, and refrigerated and » Who Will Do the Monitoring? unrefrigerated processing; • For continuous temperature-recording devices: Monitoring is performed by the device OR itself. The visual check of the data • For raw material, in-process product, or generated by the device, to ensure that finished product stored under ice: the critical limits have consistently been The product is completely and met, may be performed by any person continuously surrounded by ice who has an understanding of the nature throughout the storage time. of the controls;

CHAPTER 7: Scombrotoxin (Histamine) Formation 146 OR OR • For other checks: Make adjustments to the ice application Any person who has an understanding of operations. the nature of the controls. Establish a Recordkeeping System. Establish Corrective Action Procedures. • For refrigerated storage: Take the following corrective action to a product Printouts, charts, or readings from involved in a critical limit deviation: continuous temperature-recording devices; • Chill and hold the product until it can be evaluated based on its total time and AND temperature exposure, including exposures Record of visual checks of recorded data; during prior processing operations. OR OR • For storage under ice: • Chill and hold the affected product until The number of containers examined and histamine analysis is performed on a the sufficiency of ice for each; minimum of 60 fish collected from throughout each affected lot. Destroy the lot or divert AND it to a non-food use if any fish is found The approximate number of containers with histamine greater than or equal to 50 in the cooler. ppm. The fish collected for analysis may be composited if the action point is reduced Establish Verification Procedures. accordingly. For example, a sample of 60 fish • Before a temperature-recording device (e.g., may be composited into 20 units of 3 fish a recording thermometer) is put into service, each, provided the action point is reduced check the accuracy of the device to verify that from 50 ppm to 17 ppm for each unit; the factory calibration has not been affected. OR This check can be accomplished by: • Destroy the product; Immersing the sensor in an ice slurry (32°F (0°C)), if the device will be used at OR or near refrigeration temperature; • Divert the product to a non-food use. OR AND Comparing the temperature reading on Take the following corrective actions to regain control the device with the reading on a known over the operation after a critical limit deviation: accurate reference device (e.g., a NIST- • Prevent further deviation: traceable thermometer) under conditions Add ice to the product; that are similar to how it will be used (e.g., air temperature) within the temperature OR range at which it will be used; Move some or all of the product in the AND malfunctioning cooler to another cooler; • Once in service, check the temperature- AND recording device daily before the beginning • Address the root cause: of operations. Less frequent accuracy checks Make repairs or adjustments to the may be appropriate if they are recommended malfunctioning cooler; by the instrument manufacturer and the

CHAPTER 7: Scombrotoxin (Histamine) Formation 147 history of use of the instrument in your facility has shown that the instrument consistently remains accurate for a longer period of time. In addition to checking that the device is accurate by one of the methods described above, this process should include a visual examination of the sensor and any attached wires for damage or kinks. The device should be checked to ensure that it is operational and, where applicable, has sufficient ink and paper; AND • Calibrate the temperature-recording device against a known accurate reference device (e.g., a NIST-traceable thermometer) at least once a year or more frequently if recommended by the device manufacturer. • Optimal calibration frequency is dependent upon the type, condition, past performance, and conditions of use of the device. Consistent temperature variations away from the actual value (drift) found during checks and/or calibration may show a need for more frequent calibration or the need to replace the device (perhaps with a more durable device). Calibration should be performed at a minimum of two temperatures that bracket the temperature range at which it is used; AND • When visual checks of ice are used, periodically measure internal temperatures of fish to ensure that the ice is sufficient to maintain product temperatures at 40°F (4.4°C) or less; AND • Review monitoring, corrective action, and verification records within 1 week of preparation to ensure they are complete and any critical limit deviations that occurred were appropriately addressed.

CHAPTER 7: Scombrotoxin (Histamine) Formation 148 Review Review corrective corrective 1 week of 1 week Check the verification verification action, and action, monitoring, monitoring, preparation ensure that it accuracy and is operational once per year once per year the beginning of operations; perform these before putting before records within data logger for data logger for into operation; and calibrate it damage and to checks daily, at checks daily, Data logger printout RECORDS VERIFICATION Check reliably product affected affected Perform Perform of 60 fish histamine trates how a fresh fish processor can ACTION(S) Destroy all CORRECTIVE r other potential hazards (e.g., metal is functioning two times per two representative representative of the affected of the affected on a minimum on the product day until cooler day affected product affected exceeds 50 ppm exceeds Ice and hold the inside the cooler sufficiency of ice cooler as needed Adjust and repair Adjust histamine analysis product if any fish ntrol strategy in order to fully control the hazard, supervisor Production check of Continuous, Continuous, with a visual once per day recorded data TABLE 7-7 TABLE MONITORING Example Only Time and Time data logger temperature See Text for Full Recommendations See Text WHAT HOW FREQUENCY WHO Cooler temperature CONTROL STRATEGY EXAMPLE 5 - STORAGE CONTROL CONTROL STRATEGY 40°F LIMITS cooler CRITICAL MEASURE FOR EACH Maximum PREVENTIVE temperature of formation HAZARD(S) SIGNIFICANT Scombrotoxin (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) This table is an example of a portion of a HACCP plan using “Control Strategy Example 5 - Storage Control.” This example illus control scombrotoxin formation. It is provided for illustrative purposes only. It may be necessary to select more than one co control scombrotoxin formation. It is provided for illustrative purposes only. depending upon the nature of your operation. 3-2 and 3-4 (Chapter 3) fo Histamine formation may be only one of several significant hazards for this product. Refer to Tables fragments). POINT cooler) CRITICAL CONTROL and finished product cold Raw material Raw storage (shared

CHAPTER 7: Scombrotoxin (Histamine) Formation 149 BIBLIOGRAPHY. seafood science). Elsevier, New York, NY. • Fletcher, G. C., G. Summers, and P. W. C. We have placed the following references on van Veghel. 1998. Levels of histamine and display in the Division of Dockets Management, histamine-producing bacteria in smoked fish Food and Drug Administration, 5630 Fishers from New Zealand markets. J. Food Prot. Lane, rm. 1061, Rockville, MD 20852. You may 61(8):1064-1070. see them at that location between 9 a.m. and 4 • Frank, H. A., and D. H. Yoshinaga. 1984. p.m., Monday through Friday. As of March 29, Histamine formation in tuna, p. 443-451. In 2011, FDA had verified the Web site address for E. Ragelis (ed.), Seafood toxins. American the references it makes available as hyperlinks Chemical Society, Washington, DC. from the Internet copy of this guidance, but FDA • Frank, H. A., D. H. Yoshinaga, and W. is not responsible for any subsequent changes Nip. 1981. Histamine formation and to Non-FDA Web site references after March 29, honeycombing during decomposition of 2011. skipjack tuna. Katsuwonus pelamis, at • Arnold, S., and D. Brown. 1978. Histamine elevated temperatures. Mar. Fisheries Rev. toxicity from fish products. Adv. Food Res. 43(10):9-14. 24:113-154. • Hernández-Herrero, M. M., A. X. Roig-Sagués, • Baranowski, J. D., H. A. Frank, P. A. Brust, J. J. Rodríguez-Jerez, and M. T. Mora-Ventura. M. Chongsiriwatana, and R. J. Premaratne. 1999. Halotolerant and halophilic histamine- 1990. Decomposition and histamine content forming bacteria isolated during the ripening in mahimahi (Coryphaena hippurus). J. Food of salted anchovies (Engraulis encrasicholus). Prot. 53(3):217222. J. Food Prot. 62(5):509-514. • Behling, A. R., and S. L. Taylor. 1982. • Inestia, C. 1973. Significance and detection Bacterial histamine production as a function of histamine in food, p. 327-347. In of temperature and time of incubation. J. Microbiological safety of food. Academic Food Sci. 47:1311-1317. Press, New York, NY. • Bjeldanes, L. F., D. E. Schultz, and M. M. • Lehane, L., and J. Olley. 2000. Review: Morris. 1978. On the aetiology of scombroid histamine fish poisoning revisited. Int. J. poisoning: cadaverine potentiation of Food Microbiol. 58:1-37. histamine toxicity in the guinea pig. Food • Predy, G., L. Honish, W. Hohn, and S. Jones. Cosmet. Toxicol. 16:157-159. 2003. Was it something she ate? Case report • Brillantes, S., S. Paknol, and A. Totakien. and discussion of scombroid poisoning. Can. 2002. Histamine formation in fish sauce Med. Assoc. J. 168(5):587-588. production. J. Food Sci. 67:2090-2094. • Silva, C. C. G., J. B. Da Ponte, and M. L. N. • Concon, J. (ed.), 1988. Food toxicology, p. Enes Dapkevicius. 1998. Storage temperature 511-605. Marcel Dekker, Inc., New York, NY. effect on histamine formation in big eye tuna • Eitenmiller, R., and S. DeSouza. 1984. and skipjack. J. Food Sci. 63(4):644-647. Enzymatic mechanisms for amine formation • Staruszkiewicz, W. F. April 2007. Report in fish, p. 431-442. In E. Ragelis (ed.), on the 2005 Hawaii Bigeye Tuna Research Seafood toxins. American Chemical Society, Project. Effects of onboard fish handling on Washington, DC. the formation of histamine. • Farn, G., and C. Sims. 1987. Chemical indices • Staruszkiewicz, W. F., J. D. Barnett, P. L. of decomposition in tuna, p. 175-184. In D. Rogers, R. A. Benner, Jr., L. L. Wong, and Kramer and J. Liston (ed.), Seafood quality J. Cook. 2004. Effects of on-board and determination (Book 15 of Developments in

CHAPTER 7: Scombrotoxin (Histamine) Formation 150 dockside handling on the formation of biogenic amines in mahimahi (Coryphaena hippurus), skipjack tuna (Katsuwonus pelamis), and yellowfin tuna (Thunnus albacares). J. Food Prot. 67(1):134-141. • Stratton, J., and S. Taylor. 1991. Scombroid poisoning, p. 331-351. In D. Ward and C. Hackney (ed.), Microbiology of marine food products. Van Nostrand Reinhold, New York, NY. • Taylor, S. 1985. Histamine poisoning associated with fish, cheese, and other foods, p. 1-47. World Health Organization, VPH/ FOS/85.1. Geneva, Switzerland. • Taylor, S. 1988. Marine toxins of microbial origin. Food Technol. 42:94-98. • Taylor, S., and S. Summer. 1987. Detection of histamine, cadaverine, and putrescine, p. 235-246. In D. Kramer and J. Liston (ed.), Seafood quality determination (Book 15 of Developments in seafood science). Elsevier, New York, NY. • Taylor, S. L., J. Y. Hui, and D. E. Lyons. 1984. Toxicology of scombroid poisoning, p. 417-430. In E. Ragelis (ed.), Seafood toxins. American Chemical Society, Washington, DC. • van Spreckens, K. 1987. Histamine production by psychrophilic flora, p. 309-318. In D. Kramer and J. Liston (ed.), Seafood quality determination (Book 15 of Developments in seafood science). Elsevier, New York, NY. • Yongsawatdigul, J., Y. J. Choi, and S. Udomporn. 2004. Biogenic amines formation in fish sauce prepared from fresh and temperature-abused Indian anchovy (Stolephourus indicus). J. Food Sci. 69(4):312-319.

CHAPTER 7: Scombrotoxin (Histamine) Formation 151 NOTES:

CHAPTER 7: Scombrotoxin (Histamine) Formation 152 CHAPTER 8: Other Decomposition-Related Hazards

Chapter 7 covers scombrotoxin poisoning in certain species of fish. This poisoning occurs as a result of the formation of high levels of histamine during decomposition of the fish at improper holding temperatures. There are indications that decomposition can result in the production of other toxins (e.g., biogenic amines, such as putrescine and cadaverine) that have the potential to cause illness, even in the absence of histamine formation. Such illnesses have been reported with consumption of a number of fish species. FDA also has received a number of consumer complaints concerning illnesses that are associated with the consumption of decomposed shrimp and salmon. There are also some indications that chemicals formed when fats and oils in foods oxidize may contribute to long-term detrimental health effects.

CHAPTER 8: Other Decomposition-Related Hazards 153 BIBLIOGRAPHY. Food Microbiol. 58:1-37. • Parrot, J., and G. Nicot. 1986. Absorption We have placed the following references on de l’histamine par l’appareil digestif, p. display in the Division of Dockets Management, 148-161. In Handbuch der Experimentellen Food and Drug Administration, 5630 Fishers Pharmakologie, Vol. 18. Springer-Verlag, New Lane, rm. 1061, Rockville, MD 20852. You may York, NY. see them at that location between 9 a.m. and 4 • Quakenbush, F. W. 1945. Toxicity of rancid p.m., Monday through Friday. As of March 29, fats. Oil & Soap. 22:336-338. 2011, FDA had verified the Web site address for • Stratton, J., and S. Taylor. 1991. Scombroid the references it makes available as hyperlinks poisoning, p. 331-351. In D. Ward and C. from the Internet copy of this guidance, but FDA Hackney (ed.), Microbiology of marine food is not responsible for any subsequent changes products. Van Nostrand Reinhold, New York, to Non-FDA Web site references after March 29, NY. 2011. • Taylor, S. 1985. Histamine poisoning • Arnold, S. H., and D. W. Brown. 1978. associated with fish, cheese, and other foods, Histamine toxicity from fish products. Adv. p. 1-47. World Health Organization, VPH/ - Food Res. 24:113 154. FOS/85.1. Geneva, Switzerland. • Bjeldanes, L. F., D. E. Schultz, and M. M. • Taylor, S. 1988. Marine toxins of microbial Morris. 1978. On the aetiology of scombroid origin. Food Technol. 42:94-98. poisoning: cadaverine potentiation of • Taylor, S., and S. Summer. 1987. histamine toxicity in the guinea pig. Food Determination of histamine, putrescine, and Cosmet. Toxicol. 16:157-159. cadaverine, p. 235-246. In D. Kramer and J. • Concon, J. 1988. Food toxicology. Part A. Liston (ed.), Seafood quality determination - Principles and concepts, p. 626 627. Marcel (Book 15 of Developments in food science). Dekker, Inc., New York, NY. Elsevier, New York, NY. • Eitenmiller, R., and S. DeSouza. 1984. Enzymatic mechanisms for amine formation • Taylor, S. L., J. Y. Hui, and D. E. Lyons. in fish, p. 431-442. In Ragelis, E. (ed.), 1984. Toxicology of scombroid poisoning, p. - Seafood toxins. American Chemical Society, 417 430. In E. Ragelis (ed.), Seafood toxins. Washington, DC. American Chemical Society, Washington, DC. • Farn, G., and C. Sims. 1987. Chemical indices of decomposition in tuna, p. 175-184. In D. Kramer and J. Liston (ed.), Seafood quality determination (Book 15 of Developments in food science). Elsevier, New York, NY. • Guillén, M. D., and E. Goicoechea. 2008. Toxic oxygenated alpha, beta-unsaturated aldehydes and their study in foods: a review. Crit. Rev. Food Sci. Nutr. 48:119-136. • Kubow, S. 1992. Routes of formation and toxic consequences of lipid oxidation products in foods. Free Radic. Biol. Med. 12:63-81. • Lehane, L., and J. Olley. 2000. Review: histamine fish poisoning revisited. Int. J.

CHAPTER 8: Other Decomposition-Related Hazards 154 CHAPTER 9: Environmental Chemical Contaminants and Pesticides

UNDERSTAND THE POTENTIAL HAZARD. and used according to conditions described on the label (40 CFR 180 and the “Guide to Drug, Vaccine, Environmental chemical contaminants and and Pesticide Use in Aquaculture,” the Federal Joint pesticides in fish pose a potential human health Subcommittee on Aquaculture (http://aquanic.org/ hazard. Fish can be harvested from waters that jsa/wgqaap/drugguide/drugguide.htm)). are contaminated by varying amounts of industrial Many contaminants accumulate in the edible fatty chemicals, including heavy metals and pesticides. tissues of fish. Concentrations of these contaminants These contaminants may accumulate in fish at can vary considerably in individual fish of the same levels that can cause human health problems species from the same location, depending on factors (e.g., carcinogenic and mutagenic effects). The such as their fat content, size, age, and gender. hazard is most commonly associated with In the case of components or extracts of whole exposure over a prolonged period of time (chronic fish (e.g., dietary supplements, dietary ingredients, exposure). Illnesses related to a single exposure and flavors), the component or extract may contain (one meal) are very rare. Concern for these higher or lower concentrations of environmental contaminants primarily focuses on fish harvested chemical contaminants and pesticides than from aquaculture ponds, freshwater bodies, the whole fish from which it was derived. For estuaries, and near-shore coastal waters (e.g., areas example, organochlorine contaminants, such as subject to shoreside contaminant discharges), PCBs, are oil soluble. When producing fish oil rather than from the open ocean. Environmental and fish meal, any PCBs present will become chemicals and pesticides may also accumulate more concentrated in the oil fraction and less in aquacultured fish through contaminated feed concentrated in the water fraction, as compared ingredients (e.g., pesticides in oil-containing feed with the levels in the whole fish. ingredients derived from near-shore bait fish). Although some pesticides have not been produced • Control of chemical contaminants or used in the United States for many years (e.g., Federal tolerances and action levels are dichloro-diphenyl-trichloroethane (DDT) and established for some of the most toxic and polychlorinated biphenyls (PCBs)), many are very persistent contaminants that can be found in persistent and tend to accumulate in soil and fish. These levels are listed in Table 9-1. State, sediments. Once pesticides are introduced into the tribal, local, or foreign authorities may use the environment, they may travel beyond their point federal tolerances or action levels to decide of application or discharge. whether to issue local advisories to consumers recommending limits on consumption of all or Certain pesticides are applied directly to the water in certain species of locally harvested fish (some of aquaculture ponds to control weeds and algae and which may be commercially important) or to close to eliminate fish and invertebrates. These products waters for commercial harvesting of all or certain can be used legally only if they are registered with species of fish. the U.S. Environmental Protection Agency (US EPA)

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 155 In the case of molluscan shellfish, state, tribal, • Tolerance and action levels territorial and foreign government agencies, Table 9-1, “Environmental Chemical Contaminants called shellfish control authorities, consider the and Pesticides Tolerance and Action Levels,” degree of chemical contamination as part of their lists the tolerance and action levels that have classification of harvesting waters. As a result of been established for environmental chemical these classifications, molluscan shellfish harvesting contaminants and pesticides in the edible portion is allowed from some waters and not from others. of fish (wet weight). Shellfish control authorities then exercise control over the molluscan shellfish harvesters to ensure that harvesting takes place only when and where it has been permitted. In this context, molluscan shellfish include oysters, clams, mussels, and scallops. Other significant elements of shellfish control authorities’ efforts to control the harvesting of molluscan shellfish include requirements that (1) containers of in-shell molluscan shellfish (shellstock) bear a tag that identifies the type and quantity of shellfish, the harvester, harvest location, and the date of harvest (21 CFR 123.28(c)); (2) molluscan shellfish harvesters be licensed (note that licensing may not be required in all jurisdictions); (3) processors that ship, reship, shuck, or repack molluscan shellfish be certified; and (4) containers of shucked molluscan shellfish bear a label with the processor’s name, address, and certification number. Processors of seafood components and extracts may choose to control environmental chemical contaminants and pesticides at receipt (e.g., by screening raw materials). If contaminants in the raw material are present at unacceptable levels, processors may reject the product or choose to implement refining steps that reduce the contaminants to acceptable levels in the finished product. These steps may include distillation, absorption, and steam deodorization. You should validate the effectiveness of these refining steps at reducing environmental and chemical contaminants to an acceptable level and include appropriate controls in your Hazard Analysis Critical Control Point (HACCP) plan. No further information on these control measures is provided in this guidance document.

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 156 TABLE 9-1

ENVIRONMENTAL CHEMICAL CONTAMINANTS AND PESTICIDES TOLERANCE AND ACTION LEVELS

Tolerance Levels

DELETERIOUS LEVEL IN FOOD COMMODITY REFERENCE SUBSTANCE EDIBLE TISSUE PCBs 2 ppm All fish 21 CFR 109.30 Carbaryl 0.25 ppm Oysters 40 CFR 180.169 Diquat 2 ppm Fish 40 CFR 180.226 Diquat 20 ppm Shellfish 40 CFR 180.226 Diuron and its 2 ppm Farm-raised, 40 CFR 180.106 metabolites freshwater finfish Endothall and 0.1 ppm All fish 40 CFR 180.293 its monomethyl ester Fluridone 0.5 ppm Finfish and 40 CFR 180.420 crayfish Glyphosate 0.25 ppm Fish 40 CFR 180.364 Glyphosate 3 ppm Shellfish 40 CFR 180.364 2,4-D 0.1 ppm Fish 40 CFR 180.142 2,4-D 1 ppm Shellfish 40 CFR 180.142 Action Levels

DELETERIOUS LEVEL IN FOOD COMMODITY REFERENCE SUBSTANCE EDIBLE TISSUE Aldrin and 0.3 ppm All fish “Compliance Policy Guide,” Sec. 575.100 dieldrin1 Benzene 0.3 ppm Frog legs “Compliance Policy Guide,” Sec. 575.100 hexachloride Chlordane 0.3 ppm All fish “Compliance Policy Guide,” Sec. 575.100 Chlordecone2 0.3 ppm All fish “Compliance Policy Guide,” Sec. 575.100 Chlordecone2 0.4 ppm Crabmeat “Compliance Policy Guide,” Sec. 575.100 DDT, TDE, 5 ppm All fish “Compliance Policy Guide,” Sec. 575.100 and DDE3 Methylmercury4 1 ppm All fish “Compliance Policy Guide,” Sec. 540.600 Heptachlor and 0.3 ppm All fish “Compliance Policy Guide,” Sec. 575.100 Heptachlorepoxide5 Mirex 0.1 ppm All fish “Compliance Policy Guide,” Sec. 575.100

1. The action level for aldrin and dieldrin is for residues of the pesticides individually or in combination. However, in calculating a total, amounts of aldrin or dieldrin found at below 0.1 ppm are not counted. 2. Previously listed as Kepone, the trade name of chlordecone. 3. The action level for DDT, TDE, and DDE is for residues of the pesticides individually or in combination. However, in calculating a total, amounts of DDT, TDE, and DDE found below 0.2 ppm are not counted. 4. See Chapter 10 for additional information. 5. The action level for heptachlor and heptachlor epoxide is for the pesticides individually or in combination. However, in calculating a total, amounts of heptachlor and heptachlor epoxide found below 0.1 ppm are not counted.

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 157 DETERMINE WHETHER THE POTENTIAL 2. Can unsafe levels of environmental chemical HAZARD IS SIGNIFICANT. contaminants and pesticides that were introduced earlier be eliminated or reduced to an acceptable The following guidance will assist you in level at this processing step? determining whether environmental chemical Environmental chemical contaminants and contaminants and pesticides are a significant pesticides should be considered a significant hazard at a processing step: hazard at any processing step where a 1. Is it reasonably likely that unsafe levels of preventive measure is or can be used environmental chemical contaminants or to eliminate the hazard or to reduce the pesticides will be introduced at this processing likelihood of its occurrence to an acceptable step (e.g., do such contaminants and pesticides level. Preventive measures for environmental come in on the raw material)? chemical contaminants and pesticides can include: Tables 3-2 and 3-3 (Chapter 3) identify the species of fish for which environmental For wild-caught fish other than molluscan chemical contaminants and pesticides shellfish: are a potential hazard. Under ordinary • Making sure that incoming fish have circumstances, it would be reasonably likely not been harvested from waters that are to expect that, without proper controls, closed to commercial harvest because of unsafe levels of environmental chemical concentrations of environmental chemical contaminants and pesticides could enter contaminants or pesticides exceeding the process at the receiving step from the federal tolerance or action levels; those species. However, there may be • Making sure that incoming fish have circumstances that would allow you to not been harvested (for commercial conclude that it is not reasonably likely for purposes) from the same waters that unsafe levels of environmental chemical are under a consumption advisory contaminants and pesticides to occur in by a state, tribal, territorial, local, or fish harvested from your area. You should foreign regulatory authority based be guided by the historical occurrence of on a determination by the authority environmental contaminants and pesticides, that fish harvested from these waters at levels above established tolerance and are reasonably likely to contain action levels, in fish from the area in which contaminants above the federal your fish are caught. This information may be tolerance or action levels. Note that available from federal, state, tribal, territorial, many consumption advisories are not local, or foreign health or environmental based on such a determination. authorities in the area where your fish are caught. For aquacultured fish other than molluscan shellfish: If you are receiving fish, other than molluscan shellfish, from another processor, you would • Reviewing, at time of receipt, the not need to identify environmental chemical producer’s lot-by-lot certification that contaminants and pesticides as a significant harvest is from uncontaminated waters, hazard. This hazard should have been fully coupled with appropriate verification; controlled by the primary (first) processor. • Reviewing, at time of receipt, test results of fish tissue samples or production site water for those contaminants that

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 158 are reasonably likely to be present, and firm, it may be possible and desirable to obtaining information on present land exercise preventive measures early in the use practices in the area immediately process (ideally when the cultivation site is surrounding the production area (tests selected), rather than at receipt of the fish and monitoring may be performed by at the processing plant. Such preventive the aquacultural producer, a state, tribal, measures will not be covered in this territorial, local, or foreign authority, guidance document. or a third-party organization); • Intended use • Conducting on-farm visits to the For environmental chemical contaminants and aquacultural producer to collect and pesticides, it is unlikely that the intended use of the analyze water or fish samples for those product will affect the significance of the hazard. environmental chemical contaminants and pesticides that are reasonably likely IDENTIFY CRITICAL CONTROL POINTS. to be present, and to review present land use practices in the area immediately The following guidance will assist you in surrounding the production area; determining whether a processing step is a • Reviewing, at time of receipt, evidence critical control point (CCP) for the hazard of (e.g., a third-party certificate) that environmental chemical contaminants and the producer operates under a third- pesticides: party-audited Quality Assurance (QA) program for environmental chemical Is the raw material an aquacultured product other than contaminants and pesticides (e.g., the molluscan shellfish? National Aquaculture Association’s Fish 1. If the raw material is an aquacultured product Producers Quality Assurance Program); other than molluscan shellfish, do you have a • Conducting, at time of receipt, relationship with the producer that enables you to environmental chemical contaminant visit the farm before receipt of the fish? and pesticide testing of fish tissue a. If you have such a relationship with for those contaminants that are the producer, then you should identify reasonably likely to be present. the pre-harvest step as the CCP for For molluscan shellfish, both aquacultured environmental chemical contaminants and wild caught: and pesticides. The preventive measure for this type of control is: • Checking incoming molluscan shellfish to ensure that containers • Conducting on-farm visits to the are properly tagged or labeled; aquacultural producer to collect • Screening incoming molluscan shellfish and analyze water or fish samples to ensure that they are supplied by a for those environmental chemical licensed harvester (where licensing is contaminants and pesticides that required by law) or by a certified dealer. are reasonably likely to be present, and to review present land use These preventive measures are ordinarily practices in the area immediately employed either at the receiving step or surrounding the production area. at the pre-harvest step. In the case of an integrated operation, where fish cultivation Example: and processing are performed by the same An aquacultured catfish processor that regularly purchases from the same

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 159 producers should visit the producers verification and should set the CCP before the fish are harvested. The at receiving. processor should collect and analyze This control approach is a control water or fish samples for those strategy referred to in this chapter environmental chemical contaminants as “Control Strategy Example 2 - and pesticides that are reasonably likely Supplier’s Certification.” to be present and should review present land use at the pond site and in the • Reviewing, at time of receipt, adjacent areas. The processor should test results of water or fish tissue then set the CCP for environmental samples for those contaminants that chemical contaminants and pesticides are reasonably likely to be present at the pre-harvest step. and obtaining information on the present land use practices in the This control approach is a control area immediately surrounding the strategy referred to in this chapter as production area (the aquaculture “Control Strategy Example 1 - On- producer, a state, tribal, territorial, Farm Visits.” local or foreign authority, or a b. If no such relationship exists with the third-party organization may producer, then you should identify perform tests and monitoring). the receiving step as the CCP for Example: environmental chemical contaminants A farm-raised catfish processor and pesticides. At the receiving step, you purchases catfish from producers should exercise one of the following with which the processor has no preventive measures: long-term relationship. The processor • Reviewing, at time of receipt, requires all new suppliers to provide the supplier’s lot-by-lot the test results of water samples or certification of harvesting from fish tissue for those contaminants uncontaminated waters, coupled that are reasonably likely to be with appropriate verification. present and reports on present agricultural and industrial land use Example: at and near the pond site. The land An aquacultured shrimp processor use reports are updated annually that purchases raw material through and whenever information on the various brokers should receive lot- land use change warrants a more by-lot certificates from the suppliers. frequent update (the aquaculture The certificates would state that producer, a state, tribal, territorial, shrimp were not harvested from local or foreign authority, or a third- contaminated waters that would party organization may perform cause the levels in shrimp to exceed tests and monitoring). The processor the established tolerance or action should set the CCP at receiving. levels. The processor should combine this monitoring procedure with This control approach is a control quarterly raw material testing strategy referred to in this chapter for those environmental chemical as “Control Strategy Example 3 - contaminants and pesticides that are Records of Testing and Monitoring.” reasonably likely to be present for

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 160 • Conducting, at time of receipt, Is the raw material molluscan shellfish (aquacultured or analysis of fish tissue for wild caught) or wild caught fish other than molluscan those environmental chemical shellfish? contaminants and pesticides that are reasonably likely to be present. 1. If the raw material is molluscan shellfish or wild- caught fish other than molluscan shellfish, you Example: should identify the receiving step as the CCP An aquacultured shrimp processor for environmental chemical contaminants and that purchases raw material pesticides. At the receiving step, you should through various brokers should exercise the following preventive measures: screen all incoming lots of shrimp for those environmental chemical a. For wild-caught fish other than contaminants and pesticides that molluscan shellfish: are reasonably likely to be used in the production area. The processor • Making sure that incoming fish have should set the CCP at receiving. not been harvested from waters that are closed to commercial This control approach is a control harvest because of concentrations of strategy referred to in this chapter environmental chemical contaminants as “Control Strategy Example 4 - or pesticides exceeding the federal Chemical Contaminant Testing.” tolerance or action levels; • Reviewing, at time of receipt, • Making sure that incoming fish have evidence (e.g., a continuing or not been harvested from waters that lot-by-lot third- party certificate) are under a consumption advisory that the producer operates under by a state, tribal, territorial, local, a third-party-audited QA program or foreign regulatory authority that covers environmental chemical based on a determination by the contaminants and pesticides. authority that fish harvested from The certificate should outline the audit steps and summarize the the waters are reasonably likely to water and/or fish test results. contain contaminants above the federal tolerance or action levels. Example: Example: An aquacultured trout processor that A processor purchases bluefish directly regularly purchases raw trout from the from the harvester. The processor same producer should obtain a third- asks the harvester where the fish were party certificate, valid for 1 year (i.e., caught. The processor then compares a continuing certificate), that attests the harvest area location with the areas that the producer operates under a QA that are closed to commercial fishing by program that controls environmental state or local regulatory authorities or chemical contaminants and pesticides that are under consumption advisories or should receive a lot-by-lot certificate that include bluefish and that are issued by the third party. The processor based on the reasonable likelihood that should set the CCP at receiving. a contaminant level in fish tissue will This control approach is a control exceed a federal tolerance or action strategy referred to in this chapter level. The processor should set the CCP as “Control Strategy Example 5 - QA at receiving. Program.”

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 161 This control approach is a control MAY APPLY TO MAY APPLY TO strategy referred to in this chapter as CONTROL STRATEGY PRIMARY SECONDARY PROCESSOR PROCESSOR “Control Strategy Example 6 - Source On-farm visit Control for wild caught Fish Other Than Molluscan Shellfish.” Supplier’s certification Records of testing and b. For molluscan shellfish: monitoring • Checking incoming molluscan Chemical contaminant testing shellfish to ensure that they are QA program properly tagged or labeled; Source control for wild • Checking incoming molluscan caught fish other than shellfish to ensure that they are molluscan shellfish supplied by a licensed harvester Source control for molluscan shellfish (where licensing is required by law) or by a certified dealer. Example: • CONTROL STRATEGY EXAMPLE 1 - ON-FARM A processor purchases oysters directly VISIT from the harvesters. The processor Set Critical Limits. should check the harvest location on the tags attached to the sacks of • Environmental chemical contaminants oysters. The processor should then and pesticides that are reasonably likely compare the harvest area location to be present in farm water may not be with information on closed waters at levels so high that they are reasonably and check the harvesters’ state likely to result in concentrations in fish licenses. The processor should set the tissue above the established tolerance or CCP at receiving. action levels (refer to Table 9-1). Elevated concentrations of chemical contaminants This control approach is a control in water can be an indication that they are strategy referred to in this chapter as reasonably likely to be present in the fish “Control Strategy Example 7 - Source tissue. Note that US EPA has developed water Control for Molluscan Shellfish.” quality guidance documents that may be suitable for evaluating water quality in local DEVELOP A CONTROL STRATEGY. situations (U.S. EPA Water Quality Standards Handbook, Appendix I); The following guidance provides seven control strategies for environmental chemical OR contaminants and pesticides. It is important to • The levels of environmental contaminants note that you may select a control strategy that and pesticides in fish tissue samples that is different from those which are suggested, are reasonably likely to be present may not provided it complies with the requirements of the exceed the established tolerance or action applicable food safety laws and regulations. levels (refer to Table 9-1); The following are examples of control strategies AND included in this chapter: • Agricultural and industrial practices in the area near the production site must not be reasonably likely to cause contamination

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 162 of the ﬁsh tissue above the established » Who Will Do the Monitoring? tolerance or action levels (refer to Table 9-1). • Any person who has an understanding of the nature of the controls. Establish Monitoring Procedures. Establish Corrective Action Procedures. » What Will Be Monitored? • The levels of environmental chemical Take the following corrective action to a product contaminant and pesticide residues found in involved in a critical limit deviation: water or in ﬁsh tissue for those contaminants • Do not have the product shipped from the that are reasonably likely to occur; production site for processing. AND AND

• Agricultural and industrial practices in the Take the following corrective action to regain control area near the production site. over the operation after a critical limit deviation: » How Will Monitoring Be Done? • Discontinue use of the supplier until • Collect and analyze water samples or ﬁsh evidence is obtained that the cause of the tissue samples from each production site; chemical contamination has been eliminated.

AND Establish a Recordkeeping System. • Ask questions about and observe agricultural • Test results; and industrial practices in the area near the production site, such as: AND Which types of crops, if any, are grown • On-site audit report. in the area near the production site? Establish Veriﬁcation Procedures. What pesticides, if any, are used on these crops, how are they applied, and at what • Review monitoring and corrective action time of year? records within 1 week of preparation to ensure they are complete and any What industrial and urban discharges, if critical limit deviations that occurred were any, enter the watershed surrounding the appropriately addressed. production site?

» How Often Will Monitoring Be Done (Frequency)? • For testing water: Before ﬁrst delivery from each production site; OR • For testing ﬁsh tissue: Before each delivery; AND • For evaluating agricultural and industrial practices: At least once per year for each production site.

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 163 Review Review Review monitoring monitoring action records action records within 1 week within 1 week within 1 week of preparation of preparation and correction and correction Test Test Field agent report results RECORDS VERIFICATION

ACTION(S) CORRECTIVE the cause of the cause of the chemical the chemical until evidence until evidence until evidence until evidence for processing for for processing for of the supplier of the supplier is obtained that is obtained that Discontinue use been eliminated Discontinue use been eliminated Do not have the Do not have product shipped product shipped contamination has contamination has les 3-2 and 3-4 (Chapter 3) for other potential ates how an aquacultured catﬁsh processor can hich analysis will be conducted, the protocol for sample collection, laboratory to the contract Field agent will submit samples onmental chemical contaminants and pesticides that are reasonably likely to harvest Before each Before Once per year Field agent the Do not have

* MONITORING TABLE 9-2 TABLE Example Only practices chemical agricultural and observe and observe contaminants and industrial Ask questions environmental and pesticides and analyze for and analyze for Collect samples See Text for Full Recommendations See Text * WHAT HOW FREQUENCY WHO that are present chemical the pond reasonably likely to be likely Agricultural contaminant levels in fish levels contaminants and pesticide and industrial practices near Environmental tissue for those tissue for CONTROL STRATEGY EXAMPLE 1 - ON-FARM VISITS EXAMPLE 1 - ON-FARM CONTROL STRATEGY LIMITS CRITICAL Levels of Levels chemical MEASURE FOR EACH of the fish PREVENTIVE tissue above tissue above action levels action levels to be present* environmental tissue may not tissue may tolerances and the established levels for those for levels Agricultural and pesticides in fish contaminants and contaminants that pond must not be industrial practices exceed established exceed reasonably likely to reasonably likely in the area near tolerance and action cause contamination are reasonably likely are reasonably likely chemical HAZARD(S) SIGNIFICANT contaminants and pesticides be present and the critical limits to applied each contaminant; (2) in Monitoring columns: contaminants for w and the analytical method to be used for each contaminant. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) hazards (e.g., aquaculture drugs, food and color additives, metal fragments). This table is an example of a portion of a HACCP plan using “Control Strategy Example 1 - On-Farm Visits.” This example illustr * An actual plan should specify (1) in the Critical Limits column: envir Note: This plan is for illustrative purposes only. control environmental chemical contaminants and pesticides. It is provided for illustrative purposes only. control environmental chemical contaminants and pesticides. It is provided for illustrative purposes only. Environmental chemical contaminants and pesticides may be only one of several significant hazards for this product. Refer to Tab CRITICAL Pre-harvest Environmental CONTROL POINT

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 164 • CONTROL STRATEGY EXAMPLE 2 - SUPPLIER’S Establish a Recordkeeping System. CERTIFICATION • Copy of the certificate; Set Critical Limits. AND • A certificate accompanying all lots received • Receiving record showing lots received and (lot by lot) that indicates that fish were not the presence or absence of a certificate. harvested from contaminated waters that could cause the levels in fish tissue to exceed Establish Verification Procedures. the established federal tolerance and action • Visit all new aquacultured fish producers levels (refer to Table 9-1). within the year and all existing fish suppliers at a predetermined frequency (e.g., 25% per Establish Monitoring Procedures. year) to collect and analyze water or fish » What Will Be Monitored? tissue samples, as appropriate, for those environmental chemical contaminants • Presence of a certificate indicating harvesting and pesticides that are reasonably likely from uncontaminated waters. to be present, and review agricultural and » How Will Monitoring Be Done? industrial practices in the production area; • Visual check for the presence of a certificate. OR • Collect a representative sample of the raw » How Often Will Monitoring Be Done (Frequency)? material, in-process product, or finished • Each lot received. product at least quarterly, and analyze it for » Who Will Do the Monitoring? those environmental chemical contaminants and pesticides that are reasonably likely to • Any person who has an understanding of the be present; nature of the controls. AND Establish Corrective Action Procedures. • Review monitoring, corrective action, Take the following corrective action to a product and verification records within 1 week of involved in a critical limit deviation: preparation to ensure they are complete and any critical limit deviations that occurred • Reject the lot; were appropriately addressed. OR • Hold the lot until a certificate can be provided; OR • Hold and analyze the lot for those environmental chemical contaminants and pesticides that are reasonably likely to be present. AND

Take the following corrective action to regain control over the operation after a critical limit deviation: • Discontinue use of the supplier until evidence is obtained that the supplier will comply with the certiﬁcation controls.

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 165 Review Review existing the area corrective corrective 1 week of 1 week verification verification action, and action, and review and review agricultural and 25% of practices in monitoring, monitoring, preparation and analyze Visit all new Visit aquacultured and industrial year to collect year fish producers records within suppliers each water samples, samples, water within the year within the year

record RECORDS VERIFICATION Receiving Receiving certificate Copy of the controls with the Reject lot Reject ACTION(S) certification will comply CORRECTIVE the supplier until evidence until evidence of the supplier is obtained that Discontinue use les 3-3 and 3-4 (Chapter 3) for other potential e illustrates how an aquacultured shrimp employee Receiving dock Receiving Each lot received TABLE 9-3 TABLE MONITORING Example Only check Visual See Text for Full Recommendations See Text of a WHAT HOW FREQUENCY WHO Presence certificate CONTROL STRATEGY EXAMPLE 2 - SUPPLIER’S CERTIFICATION CONTROL STRATEGY LIMITS federal CRITICAL MEASURE FOR EACH Certificate waters that waters PREVENTIVE action levels levels in fish levels fish were not fish were indicates that contaminated tolerance and accompanying the established harvested from harvested all lots received all lots received could cause the tissue to exceed tissue to exceed chemical HAZARD(S) SIGNIFICANT contaminants and pesticides (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) processor can control environmental chemical contaminants and pesticides. It is provided for illustrative purposes only. processor can control environmental chemical contaminants and pesticides. It is provided for illustrative purposes only. Environmental chemical contaminants and pesticides may be only one of several significant hazards for this product. Refer to Tab hazards (e.g., aquaculture drugs, food and color additives, metal fragments). This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Supplier’s Certification.” This exampl This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Supplier’s CRITICAL Receiving Environmental CONTROL POINT

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 166 • CONTROL STRATEGY EXAMPLE 3 - RECORDS OF pesticides that are reasonably likely to be TESTING AND MONITORING present; Set Critical Limits. AND • Reports of analyses of the water from all • Monitoring results for agricultural and new suppliers that show that levels of those industrial practices. environmental chemical contaminants » How Will Monitoring Be Done? and pesticides that are reasonably likely • Visual check of test results and monitoring to be present are not so high that they are reports. reasonably likely to result in levels in the fish tissue that exceed the established federal » How Often Will Monitoring Be Done (Frequency)? tolerance and action levels (refer to Table 9-1). • For results of water testing: (The aquaculture producer, a state, tribal, territorial, local, or foreign authority, or a All new suppliers; third-party organization may perform tests.) OR Note that US EPA has developed water quality • For results of fish tissue testing: documents that may be suitable for evaluating Each delivery; water quality in local situations (U.S. EPA Water Quality Standards Handbook, Appendix I); AND OR • For reports of evaluation of agricultural and industrial practices: • Reports of analyses of fish tissue for each delivery that show that levels of those At least once every year. environmental chemical contaminants » Who Will Do the Monitoring? and pesticides that are reasonably likely to be present are below the established • Any person who has an understanding of the federal tolerance and action levels (the nature of the controls. aquaculture grower, a state, tribal, territorial, local, or foreign authority, or a third-party Establish Corrective Action Procedures. organization may perform tests); Take the following corrective action to a product AND involved in a critical limit deviation: • Reports from all suppliers that show that • Reject the lot. agricultural and industrial practices in the AND area near the aquaculture production site are Take the following corrective action to regain control not reasonably likely to cause contamination over the operation after a critical limit deviation: of fish tissue above the established federal tolerance or action levels (the aquaculture • Discontinue use of the supplier until producer, a state, tribal, territorial, local, evidence is obtained that the supplier will or foreign authority, or a third-party comply with the testing and evaluation organization may perform monitoring). controls.

Establish Monitoring Procedures. Establish a Recordkeeping System. • Test results; » What Will Be Monitored? AND • Test results of water or ﬁsh tissue for those environmental chemical contaminants and • Reports of evaluation of agricultural and industrial practices.

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 167 and and action action within Review Review Review Review records records week of week within 1 corrective corrective corrective corrective 1 week of 1 week monitoring monitoring preparation preparation and Test Test results practices RECORDS VERIFICATION industrial Reports of agricultural

controls controls. ACTION(S) evaluation evaluation evaluation evaluation testing and testing and CORRECTIVE Reject the lot Reject Reject the lot Reject until evidence until evidence until evidence until evidence of the supplier of the supplier is obtained that is obtained that Discontinue use Discontinue use the supplier will the supplier will comply with the comply with the his example illustrates how a farm-raised catfish les 3-2 and 3-4 (Chapter 3) for other potential Quality control staff control staff hich analysis will be conducted, the protocol for sample collection, onmental chemical contaminants and pesticides that are reasonably likely to At first delivery Once per year Quality MONITORING check check Visual Visual TABLE 9-4 TABLE Example Only * See Text for Full Recommendations See Text WHAT HOW FREQUENCY WHO analyses present chemical for those for Reports of Reports of agricultural likely to be likely area near the contaminants and industrial water samples water are reasonably showing levels showing levels production site practices in the and pesticides in of environmental contaminants that * LIMITS CRITICAL MEASURE FOR EACH PREVENTIVE action levels action levels CONTROL STRATEGY EXAMPLE 3 - RECORDS OF TESTING AND MONITORING CONTROL STRATEGY established federal reasonably likely to reasonably likely in the area near cause contamination result in levels in fish result in levels that they are likely to that they are likely tissue that exceed the tissue that exceed Reports of analyses and pesticides that are reasonably likely to be reasonably likely chemical contaminants the water from all new the water production site are not of fish tissue above the of fish tissue above and industrial practices present are not so high levels of environmental levels established tolerance or suppliers that show Reports from all suppliers that show agricultural tolerance or action levels chemical HAZARD(S) SIGNIFICANT contaminants and pesticides be present and the critical limits to applied each contaminant; (2) in Monitoring columns: contaminants for w and the analytical method to be used for each contaminant. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) hazards (e.g., aquaculture drugs, food and color additives, metal fragments). This table is an example of a portion of a HACCP plan using “Control Strategy Example 3 - Records of Testing and Monitoring.” T This table is an example of a portion of a HACCP plan using “Control Strategy Example 3 - Records Testing * An actual plan should specify (1) in the Critical Limits column: envir Note: This plan is for illustrative purposes only. processor can control environmental chemical contaminants and pesticides. It is provided for illustrative purposes only. processor can control environmental chemical contaminants and pesticides. It is provided for illustrative purposes only. Environmental chemical contaminants and pesticides may be only one of several significant hazards for this product. Refer to Tab POINT CRITICAL CONTROL Receiving Environmental

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 168 Establish Verification Procedures. the chemical contamination has been • Review monitoring and corrective action eliminated. records within 1 week of preparation to ensure they are complete and any Establish a Recordkeeping System. critical limit deviations that occurred were • Test results. appropriately addressed. Establish Verification Procedures. • CONTROL STRATEGY EXAMPLE 4 - CHEMICAL • Periodically verify the adequacy of the CONTAMINANT TESTING testing methods and equipment (e.g., by Set Critical Limits. comparing results with those obtained • No lot may exceed the federal tolerance using an Association of Official Analytical or action levels for those environmental Chemists, or equivalent method, or by chemical contaminants and pesticides that analyzing proficiency samples); are reasonably likely to be present (refer to AND Table 9-1). • Review monitoring, corrective action and verification records within 1 week of Establish Monitoring Procedures. preparation to ensure they are complete and any critical limit deviations that occurred » What Will Be Monitored? were appropriately addressed. • Fish tissue for those environmental chemical contaminants and pesticides that are reasonably likely to be present.

» How Will Monitoring Be Done? • Obtain samples and analyze for environmental chemical contaminants and pesticides.

» How Often Will Monitoring Be Done (Frequency)? • Each lot received.

» Who Will Do the Monitoring? • Any person who is qualiﬁed by training or experience to perform the analyses.

Establish Corrective Action Procedures. Take the following corrective action to product involved in a critical limit deviation: • Reject the lot. AND

Take the following corrective action to regain control over the operation after a critical limit deviation: Discontinue use of the supplier until evidence is obtained that the cause of

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 169 of Annual Review Review methods monitoring preparation action records and corrective and corrective within 1 week within 1 week comparison to AOAC methods AOAC Test Test results RECORDS VERIFICATION

has been ACTION(S) eliminated CORRECTIVE the cause of the chemical Reject the lot Reject until evidence until evidence contamination xample illustrates how an aquacultured shrimp of the supplier is obtained that Discontinue use les 3-3 and 3-4 (Chapter 3) for other potential hich analysis will be conducted, the protocol for sample collection, to quality Receiving Receiving control staff employee will employee submit sample onmental chemical contaminants and pesticides that are reasonably likely to Each lot received

* TABLE 9-5 TABLE MONITORING Example Only and chemical analyze for analyze for contaminants environmental and pesticides Obtain samples See Text for Full Recommendations See Text * WHAT HOW FREQUENCY WHO present Chemical in shrimp reasonably likely to be likely residue levels residue levels tissue that are * CONTROL STRATEGY EXAMPLE 4 - CHEMICAL CONTAMINANT TESTING EXAMPLE 4 - CHEMICAL CONTAMINANT CONTROL STRATEGY LIMITS action that are CRITICAL present chemical No lot of MEASURE levels for for levels FOR EACH reasonably exceed the exceed PREVENTIVE established likely to be likely shrimp may shrimp may tolerance or contaminants and pesticides environmental chemical HAZARD(S) SIGNIFICANT contaminants and pesticides be present and the critical limits to applied each contaminant; (2) in Monitoring columns: contaminants for w and the analytical method to be used for each contaminant. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) hazards (e.g., aquaculture drugs, food and color additives, metal fragments). This table is an example of a portion of a HACCP plan using “Control Strategy Example 4 - Chemical Contaminant Testing.” This e This table is an example of a portion of a HACCP plan using “Control Strategy Example 4 - Chemical Contaminant Testing.” * An actual plan should specify (1) in the Critical Limits column: envir Note: This plan is for illustrative purposes only. processor can control environmental chemical contaminants and pesticides. It is provided for illustrative purposes only. processor can control environmental chemical contaminants and pesticides. It is provided for illustrative purposes only. Environmental chemical contaminants and pesticides may be only one of several signiﬁcant hazards for this product. Refer to Tab Receiving Environmental TROL POINT CRITICAL CON-

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 170 • CONTROL STRATEGY EXAMPLE 5 - QA AND PROGRAM Take the following corrective action to regain control Set Critical Limits. over the operation after a critical limit deviation: • A certificate indicating that the producer • Discontinue use of the supplier until operates under a third-party-audited QA evidence is obtained that the supplier will program that covers environmental chemical comply with the certification controls. contaminants and pesticides. The certificate may accompany each lot of incoming Establish a Recordkeeping System. aquacultured fish or may be issued for each • Third-party certificates; producer of incoming aquacultured fish as a AND continuing certification. • Records showing lots received and the Establish Monitoring Procedures. presence or absence of a certificate.

» What Will Be Monitored? Establish Veriﬁcation Procedures. • Certiﬁcate indicating operation under a third- • Review the third-party-audited QA program party-audited QA program. and results of audits annually;

» How Will Monitoring Be Done? AND • Visual check for the presence of a certificate. • Review monitoring, corrective action, and verification records within 1 week of » How Often Will Monitoring Be Done (Frequency)? preparation to ensure they are complete and • Each lot received is checked for the presence any critical limit deviations that occurred of a certificate. Certificates may be issued on were appropriately addressed. continuing (not less often than annually) or lot-by-lot basis.

» Who Will Do the Monitoring? • Any person who has an understanding of the nature of the controls.

Establish Corrective Action Procedures. Take the following corrective action to a product involved in a critical limit deviation: • Reject the lot; OR • Hold the lot until a certiﬁcate can be provided; OR • Hold and analyze the lot for those environmental chemical contaminants and pesticides that are reasonably likely to be present.

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 171 Review Review annually corrective corrective 1 week of 1 week verification Review the Review action, and action, third-party- audited QA audited QA monitoring, monitoring, preparation program and records within results of audits record RECORDS VERIFICATION Receiving Receiving Certificate controls with the ACTION(S) certification CORRECTIVE will comply the supplier Reject the lot Reject until evidence until evidence how an aquacultured trout processor can of the supplier is obtained that Discontinue use les 3-2 and 3-4 (Chapter 3) for other potential employee Each lot dock Receiving TABLE 9-6 TABLE MONITORING Example Only a certificate the presence of Visual check for check for Visual See Text for Full Recommendations See Text WHAT HOW FREQUENCY WHO CONTROL STRATEGY EXAMPLE 5 - QA PROGRAM CONTROL STRATEGY certificate third-party Presence of a LIMITS covers covers CRITICAL chemical MEASURE FOR EACH Certificate PREVENTIVE audited QA audited QA the producer program that a third-party- contaminants and pesticides indicating that environmental operates under chemical HAZARD(S) SIGNIFICANT contaminants and pesticides (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) control environmental chemical contaminants and pesticides. It is provided for illustrative purpose only. Environmental chemical contaminants and pesticides may be only one of several significant hazards for this product. Refer to Tab hazards (e.g., aquaculture drugs, food and color additives, metal fragments). This table is an example of a portion of a HACCP plan using “Control Strategy Example 5 - QA Program.” This example illustrates CRITICAL Receiving Environmental CONTROL POINT

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 172 • CONTROL STRATEGY EXAMPLE 6 - SOURCE Establish Corrective Action Procedures. CONTROL FOR WILD CAUGHT FISH OTHER THAN Take the following corrective action to a product MOLLUSCAN SHELLFISH involved in a critical limit deviation: Set Critical Limits. • Reject the lot; • No fish may be harvested from an area that is OR closed to commercial harvesting by state, tribal, • For fish harvested from an area under a territorial, local, or foreign authorities because consumption advisory based on federal of concentrations of environmental chemical tolerance or action levels: contaminants or pesticides exceeding the federal tolerance or action levels; Sample the lot and analyze it for the appropriate environmental chemical AND contaminant or pesticide. Reject the lot if • No fish may be harvested from an area that the results exceed the federal tolerance is under a consumption advisory by a, state, or action level. tribal, territorial, local, or foreign regulatory AND authority based on a determination by the authority that fish harvested from the waters Take the following corrective action to regain control are reasonably likely to contain contaminants over the operation after a critical limit deviation: above the federal tolerance or action levels. • Discontinue use of the supplier until Note that many consumption advisories are evidence is obtained that harvesting practices not based on such a determination. have changed.

Establish Monitoring Procedures. Establish a Recordkeeping System. » What Will Be Monitored? • Receiving records that document the location and whether the harvest area is subject to • Location of harvest and whether the closure or consumption advisory. harvest area is subject to closure or consumption advisory. Establish Verification Procedures. » How Will Monitoring Be Done? • Review monitoring and corrective action • Ask the harvester for the harvest site at time records within 1 week of preparation of receipt, or obtain the information from the to ensure they are complete and any harvester’s catch record, where applicable; critical limit deviations that occurred were appropriately addressed. AND • Ask the state, tribal, territorial, local, or foreign authorities in which your fish are harvested whether there are closures or consumption advisories that apply to the areas from which your fish are harvested.

» How Often Will Monitoring Be Done (Frequency)? • Every lot received.

» Who Will Do the Monitoring? • Any person who has an understanding of the nature of the controls.

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 173 and action within Review Review records corrective corrective 1 week of 1 week monitoring preparation record RECORDS VERIFICATION Receiving Receiving that until have supplier changed practices evidence evidence use of the ACTION(S) harvesting harvesting is obtained CORRECTIVE Discontinue Reject the lot Reject ther Than Molluscan Shellfish.” This example Refer to Tables 3-2 and 3-4 (Chapter 3) for other Refer to Tables dock for illustrative purposes only. for illustrative purposes only. Receiving Receiving employee Each lot received MONITORING area Ask the ask state and local the harvest the harvest status of the harvester for for harvester location, and location, authorities the TABLE 9-7 TABLE Example Only WHAT HOW FREQUENCY WHO advisory closure or Location of harvest and harvest is subject to harvest area harvest whether the consumption See Text for Full Recommendations See Text CONTROL STRATEGY EXAMPLE 6 - SOURCE CONTROL CONTROL STRATEGY FOR WILD CAUGHT FISH OTHER THAN MOLLUSCAN SHELLFISH LIMITS CRITICAL MEASURE FOR EACH PREVENTIVE by a state, local, or local local, by a state, tolerance or action levels No fish may be harvested be harvested No fish may chemical contaminants or that fish harvested from the that fish harvested No fish may be commercially No fish may from an area that is closed to harvested from an area that is harvested or local authorities because of determination by the authority waters are reasonably likely to are reasonably likely waters under a consumption advisory commercial harvesting by state, by state, commercial harvesting regulatory authority based on a contain contaminants above the contain contaminants above pesticides exceeding the federal pesticides exceeding concentrations of environmental federal tolerance or action levels tolerancefederal or action levels chemical HAZARD(S) SIGNIFICANT contaminants and pesticides (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) potential hazards (e.g., scombrotoxin (histamine), metal fragments). illustrates how a wild caught bluefish processor can control environmental chemical contaminants and pesticides. It is provided Environmental contaminants and pesticides from the harvest area may be only one of several significant hazards for this product. This table is an example of a portion of a HACCP plan using “Control Strategy Example 6 - Source Control for Wild Caught Fish O CRITICAL Receiving Environmental CONTROL POINT

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 174 • CONTROL STRATEGY EXAMPLE 7 - SOURCE • All molluscan shellfish must be from a CONTROL FOR MOLLUSCAN SHELLFISH harvester that is licensed as required (note that licensing may not be required in all Set Critical Limits. jurisdictions) or from a processor that is • All containers of shellstock (in-shell certified by a shellfish control authority. molluscan shellfish) received from a Note: Only the primary processor (the processor that receives harvester must bear a tag that discloses the molluscan shellfish directly from the harvester) needs to apply controls date and place they were harvested (by state relative to the identification of the harvester, the harvester’s license, or and site), the type and quantity of shellfish, the approval status of the harvest waters. and the harvester’s or harvester’s vessel information (i.e., the identification number Establish Monitoring Procedures. assigned to the harvester by the shellfish » What Will Be Monitored? control authority, where applicable, or if • The information contained on tags on such identification numbers are not assigned, containers of incoming shellstock or on the name of the harvester or the name or the bill of lading or other similar shipping registration number of the harvester’s vessel). document accompanying bulk shipments of For bulk shipments of shellstock, where the shellstock and whether the harvest area is shellstock is not containerized, the shellstock authorized for harvest by a shellfish control must be accompanied by a bill of lading authority; or other similar shipping document that contains the same information; AND Note: The source controls listed in this critical limit are required under • The license of the harvester; 21 CFR 123.28(c). OR OR • The information contained on labels on • All containers of shellstock received from containers of incoming shucked molluscan a processor must bear a tag that discloses shellfish. the date and place they were harvested (by state and site), the type and quantity of » How Will Monitoring Be Done? shellfish, and the certification number of the • Perform visual checks; processor; AND OR • Ask the relevant shellfish control authority • All containers of shucked molluscan shellfish whether the harvest area is authorized for must bear a label that identifies the name, harvest. address, and certification number of the packer or repacker of the product; » How Often Will Monitoring Be Done (Frequency)? • For checking tags: AND Every container; • All molluscan shellfish must have been harvested from waters authorized for AND harvesting by a shellfish control authority. • For checking harvester licenses: For U.S. federal waters, no molluscan Every delivery; shellfish may be harvested from waters that are closed to harvesting by an agency of the OR federal government; AND

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 175 • For checking labels: For shucked molluscan shellfish: At least three containers randomly • Receiving record that documents: selected from throughout every lot. Date of receipt; » Who Will Do the Monitoring? AND • Any person who has an understanding of the Quantity and type of shellfish; nature of the controls. AND Establish Corrective Action Procedures. Name and certification number of the packer or repacker. Take the following corrective action to a product involved in a critical limit deviation: Establish Verification Procedures. • Reject the lot. • Review monitoring and corrective action AND records within 1 week of preparation to ensure they are complete and any Take the following corrective action to regain control critical limit deviations that occurred were over the operation after a critical limit deviation: appropriately addressed. • Discontinue use of the supplier until evidence is obtained that harvesting and/or tagging practices have changed.

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 176 and action within Review Review records corrective corrective 1 week of 1 week monitoring preparation record RECORDS VERIFICATION Receiving Receiving Reject Reject harvesters ACTION(S) unlicensed CORRECTIVE have changed have changed have until evidence until evidence until evidence until evidence until evidence until evidence of the supplier of the supplier of the supplier the harvester is the harvester untagged sacks is obtained that is obtained that is obtained that Reject lots from Reject Discontinue use Discontinue use Discontinue use tagging practices properly licensed unapproved waters waters unapproved harvesting practicesharvesting .” The example illustrates how a processor of Refer to Tables 3-3 and 3-4 (Chapter 3) for other Refer to Tables vided for illustrative purposes only. vided for illustrative purposes only. employee Every Every delivery Every lotEvery lots from Reject MONITORING checks harvest Perform Perform TABLE 9-8 TABLE whether authority the area is and ask the Example Only visual checks Visual checksVisual sack Every Receiving authorized for authorized for Perform visual Perform shellfish control See Text for Full Recommendations See Text tags WHAT HOW FREQUENCY WHO harvester License of Information on incoming shellstock tags Harvest site on Harvest LIMITS CRITICAL authority MEASURE FOR EACH harvesters PREVENTIVE from waters from waters from licensed shellfish control CONTROL STRATEGY EXAMPLE 7 - SOURCE CONTROL FOR MOLLUSCAN SHELLFISH CONTROL STRATEGY type and quantity of tagged with the date the harvester’s vessel the harvester’s and place of harvest, and place of harvest, approved by the state approved All shellstock must be All shellstock must be All shellstock must be shellfish, and name or shellfish, registration number of chemical HAZARD(S) SIGNIFICANT contaminants and pesticides (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) potential hazards (e.g., natural toxins and pathogens from the harvest area). shellstock oysters received directly from a harvester can control environmental chemical contaminants and pesticides. It is pro Environmental contaminants and pesticides from the harvest area may be only one of several significant hazards for this product. This table is an example of a portion of a HACCP plan using “Control Strategy Example 7 - Source Control for Molluscan Shellfish CRITICAL Receiving Environmental CONTROL POINT

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 177 BIBLIOGRAPHY. • U.S. Environmental Protection Agency. 1992. Water quality standards – Establishment of We have placed the following references on numeric criteria for priority toxic pollutants; - display in the Division of Dockets Management, states’ compliance, p. 60848 60923. In Federal Food and Drug Administration, 5630 Fishers Lane, Register, vol. 57, no. 246. U.S. Government rm. 1061, Rockville, MD 20852. You may see Printing Office, Washington, DC. them at that location between 9 a.m. and 4 p.m., • U.S. Environmental Protection Agency. 1994. Monday through Friday. As of March 29, 2011, Appendix I: list of EPA water quality criteria FDA had verified the Web site address for the documents. In Water quality standards references it makes available as hyperlinks from handbook: second edition. http://www.epa. the Internet copy of this guidance, but FDA is not gov/waterscience/standards/handbook/. responsible for any subsequent changes to Non- • U.S. Environmental Protection Agency. 1995. FDA Web site references after March 29, 2011. Final water quality guidance for the Great • Catfish Farmers of America. 1993. Catfish Lakes System. In Federal Register, vol. 60, quality assurance. Cooperative Extension no. 56. U.S. Government Printing Office, Service Publication 1873. Mississippi State Washington, DC. University, Mississippi State, MS. • U.S. Environmental Protection Agency. • Federal Joint Subcommittee on Aquaculture. Updated February 2011. Residue Analytical 2007. Guide to drug, vaccine, and pesticide Methods (RAM). http://www.epa.gov/ use in aquaculture. http://aquanic.org/jsa/ pesticides/methods/ramindex.htm. wgqaap/drugguide/drugguide.htm. • U.S. Environmental Protection Agency. • Gutenmann, W. H., J. G. Ebel, Jr., H. T. Revised July 2006. Tolerances and exemptions Kuntz, K. S. Yourstone, and D. J. Lisk. 1992. from tolerances for pesticide chemicals in Residues of p,p’-DDE and mercury in lake or on raw agricultural products. In Code trout as a function of age. Arch. Environ. of Federal Regulations, 40 CFR 180. U.S. Contam. Toxicol. 22(4):452-455. Government Printing Office, Washington, • Karl, H., I. Lehmann, and K. Oetjen. 1998. DC. http://www.access.gpo.gov/nara/cfr/ Levels of chlordane compounds in fish waisidx_05/40cfr180_05.html. muscle, -meal, -oil and -feed. Chemosphere. • U.S. Food and Drug Administration. 36(13):2819-2832. Updated July 2009. Pesticide Analytical • Ruus, A., K. I. Ugland, and J. U. Skaare. Manual (PAM). http://www.fda.gov/Food/ 2002. Influence of trophic position on ScienceResearch/LaboratoryMethods/ organochlorine concentrations and PesticideAnalysisManualPAM/default.htm. compositional patterns in a marine food web. • U.S. Food and Drug Administration. Updated Environ. Toxicol. Chem. 21(11):2356-2364. January 2008. Pesticide chemical residues in • Smith, A. G., and S. D. Grangolli. 2002. food - enforcement criteria. In Compliance Organochlorine chemicals in seafood: policy guides, sect. 575.100. Department of occurrence and health concerns. Food Chem. Health and Human Services, Public Health Toxicol. 40:767-779. Service, Food and Drug Administration, Center for Food Safety and Applied • Striped Bass Growers Association. 1996. Nutrition, Washington, DC. http://www.fda. The hybrid striped bass industry from fish gov/downloads/ICECI/ComplianceManuals/ farmer to consumer. Striped Bass Growers CompliancePolicyGuidanceManual/ Association, P.O. Box 11280, Columbia, SC. UCM186872.pdf.

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 178 • U.S. Food and Drug Administration. Revised April 2009. Fish and fishery products. In Code of Federal Regulations, 21 CFR 123.3. U.S. Government Printing Office, Washington, DC. http://www.access.gpo.gov/ nara/cfr/waisidx_06/21cfr123_06.html. • U.S. Food and Drug Administration. Revised April 2009. Unavoidable contaminants in food for human consumption and food-packaging material. In Code of Federal Regulations, 21 CFR 109. U.S. Government Printing Office, Washington, DC. http://www.access.gpo.gov/nara/cfr/ waisidx_06/21cfr109_06.html. • U.S. Trout Farmer’s Association. 1994. Trout producers quality assurance program. USTFA, P.O. Box 220, Charles Town, WV.

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 179 NOTES:

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 180 CHAPTER 10: Methylmercury

As with previous editions of the “Fish and Fishery Products Hazards and Controls Guidance,” this fourth edition does not contain advice on Hazard Analysis Critical Control Point (HACCP) controls for methylmercury, except where federal, state, local, or foreign authorities close certain waters to commercial harvesting as described in Chapter 9.

CHAPTER 10: Methylmercury 181 NOTES:

CHAPTER 10: Methylmercury 182 CHAPTER 11: Aquaculture Drugs

UNDERSTAND THE POTENTIAL HAZARD. general-purpose chemicals, or approved drugs in a manner that deviates from the labeled instructions. Use of unapproved drugs or misuse of approved When a drug is approved by CVM, the conditions drugs in aquacultured ﬁsh poses a potential of the approval are listed on its label or in the human health hazard. These substances may labeling (21 CFR 514.1). These conditions specify be toxic, allergenic, or carcinogenic, and/or may the species for which the drug is approved for use; cause antibiotic resistance in pathogens that indications (disease or other circumstances) for affect humans. use; dosage regimen; and other limitations, such To control this hazard, drugs for use in food as route of administration and withdrawal time. animals, whether they are for direct medication or Labeled withdrawal times must be followed to for addition to feed, generally must be approved, ensure that no harmful drug residues are present conditionally approved or index listed by FDA in the edible tissue of the animal when harvested (Federal Food, Drug, and Cosmetic Act Section for human consumption and offered for sale. 512). Under certain conditions authorized by FDA, Tolerances for some drug residues in the edible unapproved new animal drugs may be used in tissue have been established (21 CFR 556). conformance with the terms of an Investigational Only a licensed veterinarian may legally prescribe New Animal Drug (INAD) application (21 CFR 511 a drug under conditions that are not listed on and FDA’s Center for Veterinary Medicine (CVM) the label (extra-label use). This includes: use in Guide 1240.3025). Off label use in animals of species not listed on the label; use for indications approved human or animal drugs is permissible (disease or other conditions) not listed on the in certain circumstances. Drugs on the Index label; use at dosage levels, frequencies, or routes of Legally Marketed Unapproved New Animal of administration other than those stated on the Drugs for Minor Species (the Index) may not be label; and deviation from the labeled withdrawal used in food animals except in early nonfood life time. A veterinarian is a person licensed by a stages of food producing minor species in certain state, territory, or foreign government to practice circumstances. veterinary medicine. Reasons for the use of drugs in aquaculture The extra-label use restrictions are fully include the need to (1) treat and prevent disease, explained in 21 CFR 530. Information on the (2) control parasites, (3) affect reproduction and new animal drug approval process and for growth, and (4) provide tranquilization (e.g., other information on the laws, regulations for weighing). Relatively few drugs have been and policies pertaining to drugs can be found approved for aquaculture. This factor may lead to on FDA’s internet website, http://www.fda.gov/ the inappropriate use of unapproved drugs, AnimalVeterinary/DevelopmentApprovalProcess/ Aquaculture/default.htm.

CHAPTER 11: Aquaculture Drugs 183 • Approved aquaculture drugs spp., Costia spp., Scyphidia spp., Epistylis FDA-approved aquaculture drugs, with their spp., and Trichodina spp.) and monogenetic approved sponsor, species for which they have trematodes (Cleidodiscus spp., Gyrodactylus been approved and required withdrawal times spp., and Dactylogyrus spp.); and on the eggs are listed below. Additional details on conditions of salmon, trout, and esocids for the control of use (e.g., dosage levels) can be obtained from of fungi of the family Saprolegniaceae (21 the Code of Federal Regulations (CFR) as cited CFR 529.1030). There is no mandatory below; the labeling for the drug; the FDA CVM withdrawal time prior to harvest and Website, (http://www.fda.gov/AnimalVeterinary/ no residue tolerance (formalin does not DevelopmentApprovalProcess/Aquaculture/ bioaccumulate in animals). This drug is ucm132954.htm). approved as an over-the-counter (OTC) product, and a prescription is not required. FDA’s determination that these substances are approved aquaculture drugs does not exempt Parasite-S® , Formacide-B® and Formalin-F® facilities from complying with other federal, Parasite-S® is supplied by Western Chemical, state, tribal, territorial and local environmental Inc., Ferndale, WA. Formacide-B® is requirements. For example, in the United States, supplied by B.L. Mitchell, Inc., Leland, facilities using these substances would still be MS. Formalin-F® is supplied by Natchez required to comply with the National Pollutant Animal Supply Company, Natchez, MS. Discharge Elimination System requirements. Each is approved for use to control external protozoan parasites (Chilodonella spp., Costia Chorionic gonadotropin spp., Epistylis spp., Ichthyophthirius spp., Chorulon® Scyphidia spp., and Trichodina spp.) and monogenetic trematodes (Cleidodiscus spp., ® Chorulon , supplied by Intervet, Inc., Dactylogyrus spp., and Gyrodactylus spp.) Roseland, NJ, is approved for use as an aid on all finfish species; external protozoan in improving spawning function in male parasites (Bodo spp., Epistylis spp., and and female brood finfish. The drug may be Zoothamnium spp.) on Penaeid shrimp; and administered for up to three doses. The total fungi of the family Saprolegniaceae on the dose should not exceed 25,000 I.U. chorionic eggs of all finfish species (21 CFR 529.1030). gonadotropin in fish intended for human There is no mandatory withdrawal time consumption. Federal law restricts this prior to food animal harvest and no residue drug to use by or on the order of a licensed tolerance (formalin does not bioaccumulate in veterinarian (21 CFR 522.1081). Because animals). These drugs are approved as OTC residues are expected to be well below the products, and a prescription is not required. safe concentration in the edible portion of fish, there is no tolerance level set for residues Florfenicol of gonadotropin in fish tissue 21 CFR 556.304). Aquaflor® Type A Medicated Article Formalin solution Aquaflor® Type A is supplied by Intervet, Paracide-F® Inc., Millsboro DE/ Schering-Plough Animal Health Corporation, Roseland, NJ, and is ® Paracide-F , supplied by Argent Laboratories, approved for use in medicated feed for the Redmond, WA, is approved for use as control of mortality due to enteric septicemia follows: in salmon, trout, catfish, largemouth of channel catfish (Ictalurus punctatus) bass, and bluegill for the control of external associated with Edwardsiella ictaluri, control protozoa (Ichthyophthirius spp., Chilodonella

CHAPTER 11: Aquaculture Drugs 184 of mortality in freshwater-reared salmonids been recognized as a valuable tool for the due to coldwater disease associated with proper handling of these animals during Flavobacterium psychrophilum, and control of manual spawning (fish stripping), weighing, mortality in freshwater-reared salmonids due measuring, marking, surgical operations, and to furunculosis associated with Aeromonas transport. Use in fish intended for human salmonicida. The minimum withdrawal time consumption is restricted to the following before harvest is 12 days for catfish and 15 families: Ictaluridae (catfish), Salmonidae days for salmonids (21 CFR 558.261). The (salmon and trout), Esocidae (pike), and tolerance level for florfenicol amine (the Percidae (perch). There is a mandatory 21- marker residue) in muscle is 1 ppm (21 CFR day withdrawal time before harvest. In other 556.283). The product is restricted to use by non-food, aquatic, cold-blooded animals, or on the order of a licensed veterinarian (21 the drug should be limited to hatchery or CFR 558.261). Extra-label use of medicated laboratory use (21 CFR 529.2503). These feed containing florfenicol is prohibited (21 drugs are approved as OTC products, and CFR 558.6(a)(4) and (6)). a prescription is not required. There is no tolerance level set for residues in fish tissue. Aquaflor® CA1

® Aquaflor CA1 is supplied by Intervet, Inc./ Oxytetracycline Schering-Plough Animal Health Corporation, ® Roseland, NJ, and is approved for use in Terramycin 200 for Fish (oxytetracycline medicated feed for the control of mortality in dihydrate) Type A Medicated Article catfish due to columnaris disease associated Terramycin® 200 for Fish (oxytetracycline with Flavobacterium columnare. The drug dihydrate) Type A Medicated Article can be used at any stage of production, from is supplied by Phibro Animal Health, fingerling to food fish, as the sole ration Ridgefield Park, NJ. Terramycin® 200 for for 10 consecutive days. The minimum Fish is approved for use to treat bacterial withdrawal time before harvest is 12 days. hemorrhagic septicemia caused by The product is restricted to use by or on Aeromonas liquefaciens and pseudomonas the order of a licensed veterinarian (21 CFR disease in catfish. For salmonids, 516.1215) . Extra-label use of medicated feed Terramycin® 200 for Fish is approved containing florfenicol is prohibited (21 CFR for use to control ulcer disease caused 558.6(a)(4) and (6)). Because Aquaflor® CAI by Hemophilius piscium, furunculosis is a conditionally approved new animal drug, caused by Aeromonas salmonicida, it extra-label use is also prohibited by 21 bacterial hemorrhagic septicemia caused U.S.C. 360ccc(a)(1). by Aeromonas liquefaciens, pseudomonas disease and for control of mortality due Tricaine methanesulfonate (MS-222) to coldwater disease associated with Flavobacterium psychrophilium. This drug is Finquel® and Tricaine-S also approved for use to mark skeletal tissue. Finquel® is supplied by Argent Laboratories, For lobster, Terramycin® 200 for Fish is Redmond, WA, and Tricaine-S is supplied approved for use to control gaffkemia caused by Western Chemical, Inc., Ferndale, WA, by Aerococcus viridians. Withdrawal times Tricaine-S. This drug is approved for vary with indication as follows: for marking use to temporary immobilization of fish, skeletal tissue in Pacific salmon, 7 days; for amphibians, and other aquatic cold-blooded disease control in salmonids, 21 days; catfish, animals. Tricaine methanesulfonate has 21 days; lobster, 30 days (21 CFR 558.450).

CHAPTER 11: Aquaculture Drugs 185 OxyMarine™, Oxytetracycline Sulfamerazine HCl Soluble Powder-343, Sulfamerazine, supplied by Alpharma, Inc., Terramycin-343, TETROXY Aquatic Bridgewater, NJ, is approved for use only in OxyMarine™ is supplied by Alpharma, trout (rainbow, brook, and brown) to control Inc., Fort Lee, NJ. Oxytetracycline HCl furunculosis. It may be used for treatment Soluble Powder-343 is supplied by Teva not more than 14 days. The withdrawal time Animal Health, Inc., St. Joseph, MO. is 21 days before harvest for marketing or Terramycin-343 is supplied by Aquatic stocking in stream open to fishing (21 CFR Health Resources. TETROXY Aquatic is 558.582). A tolerance of zero is established supplied by Cross Vetpharm Group Ltd., for residues of sulfamerazine in the edible Dublin, Ireland. Each of these drugs is flesh (21 CFR 556.660). administered by immersion, approved for use to mark skeletal tissue of all finfish fry Sulfadimethoxine/ormetoprim combination and fingerlings as an aid in identification. Romet-30® These drugs are approved as OTC products, and a prescription is not required. A Romet-30®, supplied by Pharmaq AS, tolerance level of 2 ppm in muscle tissue (as Overhalla, Norway, is approved for use only the sum of tetracycline residues, including in medicated feed only for control of enteric oxytetracycline, chlortetracycline, and septicemia of catfish caused by Edwardsiella tetracycline) has been established for all ictaluri and furunculosis in salmonids finfish and lobster (21 CFR 556.500). (trout and salmon) caused by Aeromonas salmonicida. Required withdrawal times Hydrogen peroxide are as follows: salmonids, 42 days; catfish, 3 days (21 CFR 558.575). The withdrawal ® 35% PEROX-AID time for catfish is shorter because any 35% PEROX-AID®, supplied by Eka residues that might be present in the skin are Chemicals, Inc., Marietta, GA, is approved removed during processing. The tolerance for the control mortality in freshwater-reared for Sulfadimethoxine and ormetoprim in finfish eggs due to saprolegniasis; freshwater- the flesh is 0.1 ppm for each drug (21 CFR reared salmonids due to bacterial gill disease; 556.490 and 556.640). and freshwater-reared coolwater finfish and channel catfish due to external columnaris • FDA low regulatory priority aquaculture disease. This drug is approved as an OTC drugs product, and a prescription is not required. CVM has identified a number of unapproved There are no limitations on acceptable daily aquaculture drugs that are of low regulatory intake; there is no required withdrawal time; priority when used in food fish. The and no tolerance has been set for residues in following list identifies these compounds fish tissue. However, as with all new animal and provides their indicated use and usage drugs, a licensed veterinarian is required to levels (CVM’s Policy and Procedures Manual prescribe an extra-label use of 35% PEROX- Attachment: “Enforcement Priorities for Drug AID® to treat diseases or species not listed on use in Aquaculture” (Guide 1240.4200) (http:// the product label (21 CFR 529.1150). www.fda.gov/downloads/AnimalVeterinary/ GuidanceComplianceEnforcement/ PoliciesProceduresManual/UCM046931.pdf).

CHAPTER 11: Aquaculture Drugs 186 The agency does not intend to take enforcement Calcium oxide action against low regulatory priority substances Used as an external protozoacide for fingerlings if the following conditions are met: (1) the to adult fish at a concentration of 2,000 mg/L for substances are used for the stated indications; 5 seconds. (2) the substances are used at the stated levels; (3) the substances are used according to good management practices; (4) the product is of an Carbon dioxide gas appropriate grade for use in food animals; and Used for anesthetic purposes in fish. (5) use of these products is not likely to result in an adverse effect on the environment. Fuller’s earth The agency’s enforcement position on the use Used to reduce the adhesiveness of fish eggs to of these substances should not be considered an improve hatchability. approval, or an affirmation of their safety and effectiveness. The agency reserves the right to Garlic (whole form) take a different position on the use of any or all Used for control of helminth and sea lice of these substances at some time in the future. infestations in marine salmonids at all life stages. FDA’s determination that these substances are new animal drugs of low regulatory priority Ice does not exempt facilities from complying with other federal, state, tribal, territorial and local Used to reduce metabolic rate of fish during environmental requirements. For example, in transport. the United States, facilities using these substances would still be required to comply with the Magnesium sulfate National Pollutant Discharge Elimination System Used to treat external monogenic trematode requirements. infestations and external crustacean infestations in freshwater fish species at all life stages. Fish Acetic acid are immersed in a 30,000 mg MgSO4/L and 7,000 Used in a 1,000 to 2,000 ppm dip for 1 to 10 mg NaCl/L solution for 5 to 10 minutes. minutes as a parasitide for fish. Onion (whole form) Calcium chloride Used to treat external crustacean parasites and to Used to increase water calcium concentration deter sea lice from infesting the external surface to ensure proper egg hardening. Dosages used of salmonids at all life stages. would be those necessary to raise calcium Papain concentration to 10 to 20 ppm CaCO3. Used up to 150 ppm indefinitely to increase the hardness Used in a 0.2% solution to remove the gelatinous of water for holding and transporting fish in matrix of fish egg masses in order to improve order to enable fish to maintain osmotic balance. hatchability and decrease the incidence of disease.

CHAPTER 11: Aquaculture Drugs 187 Potassium chloride • FDA high enforcement priority aquaculture drugs Used as an aid in osmoregulation; relieves stress and prevents shock. Dosages used would CVM has identified a number of drugs and be those necessary to increase chloride ion families of drugs historically used in fish without concentration to 10 to 2,000 mg/L. FDA approval that are of high enforcement priority. They should not be used in fish that is to be consumed, unless a sponsor obtains Povidone iodine an approval or index listing for them. The Used in a 100 ppm solution for 10 minutes as an following list identifies these compounds egg surface disinfectant during and after water (CVM Program Policy and Procedures Manual hardening. Attachment: “Enforcement Priorities for Drug Use in Aquaculture” (Guide 1240.4200) (http:// Sodium bicarbonate www.fda.gov/downloads/AnimalVeterinary/ Used at 142 to 642 ppm for 5 minutes as a means GuidanceComplianceEnforcement/ of introducing carbon dioxide into the water to PoliciesProceduresManual/UCM046931.pdf ): anesthetize fish. • Chloramphenicol; • Nitrofurans; Sodium chloride • Fluoroquinolones and Quinolones; Used in a 0.5% to 1% solution for an indefinite • Malachite Green; period as an osmoregulatory aid for the relief • Steroid Hormones. of stress and prevention of shock; and in a 3% solution for 10 to 30 minutes as a parasitide. • Drugs prohibited for extra-label use The following drugs and families of drugs are Sodium sulfite prohibited for extra-label use in food-producing animals (21 CFR 530.41(a)): Used in a 15% solution for 5 to 8 minutes to treat eggs in order to improve their hatchability. • Chloramphenicol; • Clenbuterol; Thiamine hydrochloride • Diethylstilbestrol (DES); Used to prevent or treat thiamine deficiency in • Dimetridazole, Ipronidazole, and other salmonids. Eggs are immersed in an aqueous Nitroimidazoles; solution of up to 100 ppm for up to 4 hours • Furazolidone, and Nitrofurazone; during water hardening. Sac fry are immersed in • Fluoroquinolones; an aqueous solution of up to 1,000 ppm for up to • Glycopeptides. 1 hour. None of these drugs and families of drugs Urea and tannic acid has been approved use in fish. Additional information on aquaculture-related topics can be Used to denature the adhesive component of obtained from FDA/CVM at: http://www.fda.gov/ fish eggs at concentrations of 15g urea and cvm/aqualibtoc.htm. 20g NaCl/5 liters of water for approximately 6 minutes, followed by a separate solution of 0.75 g tannic acid/5 liters of water for an additional 6 minutes. These amounts will treat approximately 400,000 eggs.

CHAPTER 11: Aquaculture Drugs 188 DETERMINE WHETHER THE POTENTIAL measure is or can be used to eliminate the HAZARD IS SIGNIFICANT. hazard or to reduce the likelihood of its occurrence to an acceptable level. Preventive The following guidance will assist you in measures for the hazard of aquaculture drugs determining whether aquaculture drugs are a used in aquaculture operations and during significant hazard at a processing step: live transportation can include: • Conducting on-farm visits to review 1. Is it reasonably likely that unsafe levels of drug usage (other than INADs) before aquaculture drugs will be introduced at this receipt of the product, coupled with processing step? a supplier’s certificate that any INADs Under ordinary circumstances, if you used were used in conformance are a primary (first) processor, it would with the application requirements be reasonably likely that unsafe levels and appropriate verification; of aquaculture drugs could enter the • Reviewing, at time of receipt, drug usage process at the receiving step of any type of records (other than INADs), coupled aquacultured fish, including: with a supplier’s certificate that any • Finfish; INADs used were used in conformance with the application requirements • Crustaceans; and appropriate verification; • Other aquatic food animals, • Reviewing, at time of receipt, the such as alligator. producer’s lot-by-lot certification Under ordinary circumstances it would also of proper drug usage, including be reasonably likely that unsafe levels of INAD usage, coupled with aquaculture drugs could enter the process appropriate verification; during aquatic holding (e.g., live lobster in • Conducting, at time of receipt, pounds) or transport of live fish. drug residue testing; Under ordinary circumstances, it would • Reviewing, at time of receipt, evidence not be reasonably likely to expect that (e.g., a third-party certificate) that aquaculture drugs could enter the process the producer operates under a third- during the receiving of wild-caught fish. party-audited Quality Assurance (QA) Currently, FDA is not aware of drug use in program for aquaculture drug use. the grow-out of molluscan shellfish. If you are receiving fish (other than live fish) Note: INAD records are confidential unless an exception is made by the sponsor of the drug research. Thus, review of INAD drug usage from another processor, you would not need records by the processor may not be practical in certain situations. to identify aquaculture drugs as a significant Written certification, on a lot-by-lot basis, from the producer hazard. The primary (first) processor should to the processor stating that INAD usage is in accordance with authorizations from FDA/CVM is a suitable alternative. have fully controlled this hazard.

2. Can unsafe levels of aquaculture drugs that are These preventive measures are ordinarily reasonably likely to occur be eliminated or reduced employed at either the receiving step or the to an acceptable level at this processing step? pre-harvest step. Aquaculture drugs should be considered Preventive measures for the control of a signiﬁcant hazard at any processing step aquaculture drugs used during aquatic at a primary processor where a preventive holding (e.g. lobster pounds) can include

CHAPTER 11: Aquaculture Drugs 189 controlled application of animal drugs in a a. If you have such a relationship with the manner consistent with: grower, then you should identify a pre- harvest step as the CCP for aquaculture • Established withdrawal times; drugs. The preventive measure for this • Labeled instructions for use; type of control is: • Conditions for extra-label use of FDA- • Conducting on-farm visits to approved drugs, under a veterinarian’s review drug usage, coupled with supervision and in accordance with a supplier’s certificate that any FDA regulations and guidelines; INAD used is used in accordance • Conditions specified in the FDA list of with food use authorization low regulatory priority aquaculture drugs; and appropriate verification. • Conditions of an INAD application. Example: A primary processor of aquacultured These preventive measures are ordinarily catfish that regularly purchases from applied at the holding step. the same grower should visit the In the case of an integrated operation, where grower before the fish are harvested fish processing and farming, and perhaps and review drug usage practices and feed manufacture, are performed by the records. The processor should also same firm, it may be possible and desirable receive a guarantee that any INAD to exercise preventive measures early in the used is used in conformance with the process (ideally, at feed manufacture), rather food use authorization requirements. than at receipt of the fish at the processing The processor should combine this plant. Such preventive measures will not be monitoring procedure with quarterly covered in this guidance document. raw material testing for verification and should set the CCP at the pre- • Intended use harvest step. For aquaculture drugs, it is unlikely that the This control approach is a control intended use of the product will affect the strategy referred to in this document significance of the hazard. as “Control Strategy Example 1 - On- Farm Visits.” IDENTIFY CRITICAL CONTROL POINTS. b. If you have no such relationship with The following guidance will assist you in the grower, then you should identify the determining whether a processing step is a receiving step as the CCP for aquaculture critical control point (CCP) for the hazard of drugs. At the receiving step, you should aquaculture drugs. exercise one of the following preventive measures: Is the hazard the result of the use of aquaculture drugs during the raising of fish (i.e., aquaculture) or during • Reviewing, at time of receipt, the aquatic holding (e.g., lobster pounds) or transport of live producer’s lot-by-lot certification fish? of proper drug usage, coupled with appropriate verification. 1. If the hazard is the result of aquaculture, do you have a relationship with the grower that enables Example: you to visit the farm before receipt of the fish? A primary processor of aquacultured shrimp that purchases raw material

CHAPTER 11: Aquaculture Drugs 190 shrimp through various brokers This screening can be performed by should receive lot-by-lot certificates rapid analytical methods that may from the producers. The certificates indicate the presence of a family of should state that all drugs were used drugs, rather than any specific drug. in conformance with applicable FDA If the rapid screening test indicates regulations and labeled instructions. that a family of drugs is present, The processor should combine this further testing and/or follow-up with monitoring procedure with quarterly the supplier could be necessary.

raw material testing for verification Note: A limited number of drug screening tests for and should set the CCP at receiving. aquaculture drugs are available. Tests are not available to assay for all drugs that might be used in all aquacultured This control approach is a control species. Processors should be cautioned that tests that strategy referred to in this document have not been validated may be unreliable. These tests as “Control Strategy Example 2 - may fail to detect a residue or may give a false positive. Processors should ensure that the tests that they intend Supplier’s Certification.” to use have been validated and are appropriate for the • Reviewing, at time of receipt, drug species and tissue to be tested. usage records (other than INADs), Example: coupled with a supplier’s lot-by- A primary processor of aquacultured lot certificate that any INAD used shrimp that purchases raw material was used in conformance with the shrimp through various brokers use authorization requirements should screen all incoming lots of and appropriate verification. shrimp with a series of validated Example: rapid tests that target the families A primary processor of aquacultured of drugs that are reasonably likely shrimp that purchases raw material to be used during grow-out (e.g., shrimp through various brokers chloramphenicol, nitrofurans, and should receive records of drug fluoroquinolones). The processor usage (other than INADs) from should set the CCP at receiving. the producers when the product is This control approach is a control delivered. Additionally, the processor strategy referred to in this document should receive a lot-by-lot certificate as “Control Strategy Example 4 - stating that any INAD used was Drug Residue Testing.” used in conformance with the food • Reviewing, at time of receipt, use authorization requirements. evidence (e.g., continuing or lot- The processor should combine this by-lot third- party certificate) that monitoring procedure with quarterly the producer operates under a raw material testing for verification third-party-audited QA program and should set the CCP at receiving. that covers aquaculture drug use. This control approach is a control Example: strategy referred to in this document A primary processor of aquacultured as “Control Strategy Example 3 - trout that regularly purchases Records of Drug Use.” raw material trout from the same • Conducting, at time of receipt, drug grower should obtain a third-party screening on all lots for the presence certificate, valid for 1 year (i.e., of approved or unapproved drugs. continuing certification), that attests

CHAPTER 11: Aquaculture Drugs 191 that the grower operates under a QA 3. If the hazard is the result of transportation of live program that covers aquaculture fish, then you should identify the receiving step drug use. The processor should set the as the CCP for aquaculture drugs. In this case, CCP at receiving. you should refer to described in Control Strategy This control approach is a control Examples 2 through 5 for guidance. However, strategy referred to in this document if live transportation is on your own truck, you as “Control Strategy Example 5 - should identify the transportation step as the Quality Assurance Program.” CCP, and refer to Control Strategy Example 6 for guidance. 2. If the hazard is the result of aquatic holding (e.g., Example: lobster pounds), then you should identify the A primary processor that receives holding step as the CCP for aquaculture drugs. live basa from a broker on the The preventive measure for this type of control is: broker’s truck should receive lot- • Applying animal drugs in a by-lot certificates from the broker. manner consistent with: The certificates should state that all Established withdrawal times; drugs were used in conformance Labeled instructions for use; with applicable regulations and Conditions for extra-label use labeled instructions. The processor of FDA-approved drugs under a should combine this monitoring veterinarian’s supervision and in procedure with quarterly raw accordance with FDA regulations and material testing for verification guidances; and should set the CCP at Conditions specified in the FDA “low receiving. regulatory priority aquaculture drug” list; Example: A primary processor that receives Conditions of an INAD food use live catfish from the growers on authorization. the processor’s own truck and uses Example: drugs to control animal health A primary processor that uses during transportation (e.g., carbon oxytetracycline in the holding of live dioxide as an anesthetizing agent lobster in a lobster pound should at levels appropriate for the purpose) use the drug as a medicated feed in should control drug use during accordance with labeled instructions transportation and should set the CCP and should document the withdrawal at transportation. time of 30 days before selling. The processor should set the CCP at holding. This control approach is a control strategy referred to in this document as “Control Strategy Example 6 - Control During Holding.”

CHAPTER 11: Aquaculture Drugs 192 DEVELOP A CONTROL STRATEGY. AND • Verified by a certificate from the producer The following guidance provides six control indicating that any investigational new strategies for aquaculture drugs. You may select drug used is subject to an investigational a control strategy that is different from those new animal drug exemption under 21 which are suggested provided it complies with CFR Part 511, that fish intended for human the requirements of the applicable food safety consumption is subject to a food use laws and regulations. authorization, and that the INAD is used in the fish according to the food use The following are examples of control strategies authorization requirements. included in this chapter:

MAY APPLY TO MAY APPLY TO CONTROL STRATEGY PRIMARY SECONDARY Establish Monitoring Procedures. PROCESSOR PROCESSOR » What Will Be Monitored? On-farm visit • On-farm drug usage procedures; Supplier’s certiﬁcation

Records of drug use AND

Drug residue testing • Certificate indicating proper INAD usage. Quality assurance program » How Will Monitoring Be Done? Control during holding • Survey farm husbandry procedures, ask questions, and review drug usage records; • CONTROL STRATEGY EXAMPLE 1 - ON-FARM VISITS AND Set Critical Limits. • Visual check for presence of INAD certificate of proper use. Aquaculture drugs are used on food-producing fish only if they have been: » How Often Will Monitoring Be Done (Frequency)? • Approved by FDA or granted a conditional • At least once per year for each aquaculture approval by FDA and used in accordance site. with all labeled conditions; » Who Will Do the Monitoring? OR • Any person who has an understanding of the • Approved by FDA and used in an extra-label nature of the controls. manner under a veterinarian’s supervision in accordance with FDA regulations; Establish Corrective Action Procedures. OR Take the following corrective action to a product • Put on the FDA list of low regulatory priority involved in a critical limit deviation: aquaculture drugs and used according to the • Do not have the product shipped from the provisions in the list; production site for processing. OR AND • Used in food fish as an INAD subjected Take the following corrective action to regain control to an investigational new animal drug over the operation after a critical limit deviation: exemption under 21 CFR Part 511 and used • Discontinue use of the supplier until according to the requirements of the food evidence is obtained that drug treatment use authorization;

CHAPTER 11: Aquaculture Drugs 193 practices have changed.

Establish a Recordkeeping System. • On-site audit report; AND • INAD certiﬁcate of proper use.

Establish Verification Procedures. • Collect a representative sample of the raw material, in-process product, or finished product at least quarterly, and analyze for those drug residues that are reasonably likely to be present; AND • Periodically verify the adequacy of the testing methods and equipment (e.g., by comparing results with those obtained using an Association of Official Analytical Chemists (AOAC) or equivalent method, or by analyzing proficiency samples); AND • Review monitoring, verification, and corrective action records within 1 week of preparation to ensure they are complete and any critical limit deviations that occurred were appropriately addressed.

CHAPTER 11: Aquaculture Drugs 194

* Review Review (AOAC) present Collect a preparation quarterly, and quarterly, the raw material analyze for those analyze for Periodically verify verify Periodically Analytical Chemists equipment (e.g., by equipment (e.g., the adequacy of testing methods and and corrective action and corrective drug residues that are Association of Official reasonably likely to be reasonably likely comparing results with monitoring, verification, verification, monitoring, those obtained using an representative sample of representative records within 1 week of records within 1 week audit usage report On-site of INAD RECORDS VERIFICATION Certificate until have site for site for Do not product product shipped supplier changed have the have from the practices evidence evidence that drug treatment Reject the Reject use of the ACTION(S) production is obtained processing. CORRECTIVE Discontinue 1 - On-Farm Visits.” This example illustrates how other potential hazards (e.g., environmental Field Field agent agent e drugs for which analysis will be conducted, the protocol sample site site Once Once for each for for each for per year per year per year per year aquaculture aquaculture

MONITORING ask farm drug check Visual Visual Survey Survey records questions, questions, husbandry and review and review procedures, procedures, TABLE 11-1 TABLE Example Only INAD usage WHAT HOW FREQUENCY WHO proper On-farm indicating Certificate drug usage procedures See Text for Full Recommendations See Text CONTROL STRATEGY EXAMPLE 1 - ON-FARM VISITS EXAMPLE 1 - ON-FARM CONTROL STRATEGY LIMITS CRITICAL MEASURE FOR EACH PREVENTIVE the drugs have been the drugs have with all labeled conditions; accordance with FDA regulations; accordance with FDA drug exemption under 21 CFR Part 511 drug exemption Certificate from the producer indicating put on the list of low regulatory priority subject to an investigational new animal subject to an investigational fish intended for human consumption is fish intended for approved by FDA or granted conditional by FDA approved that any investigational new drug used in that any investigational approval by FDA and used in accordance by FDA approval Part 511 and used in accordance with the Aquaculture drugs are used on fish only if Aquaculture aquaculture drugs and used in accordance new animal drug exemption under 21 CFR new animal drug exemption requirements of the food use authorization requirements of the food requirements of the food use authorization requirements of the food and that the INAD is used according to fish as an INAD subject to an investigational fish as an INAD subject to investigational approved by FDA and used in an extra-label by FDA approved manner under a veterinarian’s supervision in manner under a veterinarian’s with the provisions in the list; or use in food in the list; or use food with the provisions drugs HAZARD(S) Aquaculture Aquaculture SIGNIFICANT collection, and the analytical method to be used for each drug a primary processor of farm-raised catfish can control aquaculture drugs. It is provided for illustrative purposes only. a primary processor of farm-raised catfish can control aquaculture drugs. It is provided for illustrative purposes only. 3-2 and 3-4 (Chapter 3) for Aquaculture drugs may be only one of several significant hazards for this product. Refer to Tables chemical contaminants and pesticides). This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using “Control Strategy Example * column: the aquacultur An actual plan should specify in the Verification Note: This plan is for illustrative purposes only. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) Pre- POINT harvest CRITICAL CONTROL

CHAPTER 11: Aquaculture Drugs 195 • CONTROL STRATEGY EXAMPLE 2 - SUPPLIER’S Establish a Recordkeeping System. CERTIFICATION • Copy of certificates; Set Critical Limits. AND • Certificate proper drug usage accompanying • Receiving record showing lots received and each lot of incoming aquacultured fish. presence or absence of a certificate of proper use. Establish Monitoring Procedures. Establish Verification Procedures. » What Will Be Monitored? • Collect a representative sample of the raw • Presence of a certificate indicating proper material, in-process product, or finished drug usage. product at least quarterly, and analyze for » How Will Monitoring Be Done? those drug residues that are reasonably likely • Visual check for presence of certificate of to be present; proper use. AND • Periodically verify the adequacy of the » How Often Will Monitoring Be Done (Frequency)? testing methods and equipment (e.g., by • Each lot received. comparing results with those obtained » Who Will Do the Monitoring? using an Association of Official Analytical Chemists (AOAC) or equivalent method, or • Any person who has an understanding of the by analyzing proficiency samples); nature of the controls. AND Establish Corrective Action Procedures. • Review monitoring, corrective action, Take the following corrective action to a product and verification records within 1 week of involved in a critical limit deviation: preparation to ensure they are complete and any critical limit deviations that occurred • Reject the lot; were appropriately addressed. OR • Hold the lot until a certificate can be provided; OR • Hold and analyze the lot for those aquaculture drugs that are reasonably likely to be present. AND

CHAPTER 11: Aquaculture Drugs 196 *

week of week Collect a comparing preparation representative representative Association of and verification and verification and analyze for and analyze for records within 1 corrective action, action, corrective Chemists (AOAC) results with those Official Analytical Periodically verify verify Periodically obtained using an material quarterly, material quarterly, sample of the raw that are reasonably Review monitoring, monitoring, Review those drug residues equipment (e.g., by equipment (e.g., the adequacy of testing methods and likely to be present likely record RECORDS VERIFICATION Receiving Receiving Producer’s drug Producer’s usage certificate le illustrates how a primary processor of pond- controls with the ACTION(S) other potential hazards (e.g., environmental certification will comply CORRECTIVE the supplier Reject the lot Reject until evidence until evidence of the supplier is obtained that Discontinue use dock e drugs for which analysis will be conducted, the protocol sample Receiving Receiving employee Each lot received TABLE 11-2 TABLE Example Only MONITORING check Visual See Text for Full Recommendations See Text usage WHAT HOW FREQUENCY WHO indicating a certificate Presence of proper drug CONTROL STRATEGY EXAMPLE 2 - SUPPLIER’S CERTIFICATION CONTROL STRATEGY proper MEASURE all lots of indicating FOR EACH Certificate PREVENTIVE drug usage raised shrimp CRITICAL LIMITS accompanying incoming pond- drugs HAZARD(S) SIGNIFICANT collection, and the analytical method to be used for each drug (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) chemical contaminants and pesticides). This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Supplier’s Certification.” This examp This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Supplier’s * column: the aquacultur An actual plan should specify in the Verification Note: This plan is for illustrative purposes only. raised shrimp can control aquaculture drugs. It is provided for illustrative purposes only. raised shrimp can control aquaculture drugs. It is provided for illustrative purposes only. 3-3 and 3-4 (Chapter 3) for Aquaculture drugs may be only one of several significant hazards for this product. Refer to Tables POINT CRITICAL CONTROL Receiving Aquaculture

CHAPTER 11: Aquaculture Drugs 197 • CONTROL STRATEGY EXAMPLE 3 - RECORDS OF Establish Corrective Action Procedures. DRUG USE Take the following corrective action to a product Set Critical Limits. involved in a critical limit deviation: Drug usage records for each delivery that show • Reject the lot. aquaculture drugs were used on food–producing AND fish only if the drugs have been: Take the following corrective action to regain control • Approved by FDA or granted conditional over the operation after a critical limit deviation: approval by FDA and used in accordance • Discontinue use of the supplier until with all labeled conditions; evidence is obtained that drug treatment OR practices have changed and/or the producer • Approved by FDA and used in an extra-label will comply with the certification controls. manner under a veterinarian’s supervision in accordance with FDA regulations; Establish a Recordkeeping System. OR • Producer’s drug records; • Put on the list of low regulatory priority AND aquaculture drugs and used according to the • INAD certificate of proper use; provisions in the list; AND AND • Receiving record showing lots received and Lot-by-lot certificate from the producer indicating presence or absence of a certificate. that any investigational new drug used in fish intended for human consumption is subjected to Establish Verification Procedures. an investigational new animal drug exemption • Collect a representative sample of the raw under 21 CFR Part 511 and that the INAD is used material, in-process product, or finished according to the requirements of the food use product at least quarterly, and analyze for authorization. those drug residues that are reasonably likely to be present; Establish Monitoring Procedures. AND » What Will Be Monitored? • Periodically verify the adequacy of the • Records of on-farm drug use; testing methods and equipment (e.g., by comparing results with those obtained AND using an Association of Official Analytical • Certificate indicating proper INAD usage. Chemists (AOAC) or equivalent method, or » How Will Monitoring Be Done? by analyzing proficiency samples); • Visual check of drug use records and INAD AND certificate of proper use. • Review monitoring, verification, and corrective action records within 1 week of » How Often Will Monitoring Be Done (Frequency)? preparation to ensure they are complete and • Each lot received. any critical limit deviations that occurred were appropriately addressed. » Who Will Do the Monitoring? • Any person who has an understanding of the nature of the controls.

CHAPTER 11: Aquaculture Drugs 198

* Collect a Review monitoring, monitoring, Review week of preparation week likely to be present likely Periodically verify the verify Periodically action records within 1 adequacy of the testing methods and equipment representative sample of representative an Association of Official with those obtained using the raw material quarterly, the raw material quarterly, verification, and corrective and corrective verification, (e.g., by comparing results (e.g., and analyze for those drug and analyze for Analytical Chemists (AOAC) residues that are reasonably drug usage usage record record records of INAD Grower’s Grower’s RECORDS VERIFICATION Receiving Receiving Receiving Receiving Certificate llustrates how a pond-raised shrimp processor

other potential hazards (e.g., chemical ACTION(S) CORRECTIVE comply with Reject the lot Reject requirements Reject the lot Reject have changed have until evidence until evidence of the supplier of the supplier is obtained that the certification Discontinue use Discontinue use the supplier will until evidence is until evidence obtained that drug treatment practices e drugs for which analysis will be conducted, the protocol sample supervisor supervisor Production Production Each lot Each lot received received MONITORING TABLE 11-3 TABLE Example Only check check Visual Visual See Text for Full Recommendations See Text INAD usage usage WHAT HOW FREQUENCY WHO of on- proper Records Records indicating farm drug Certificate CONTROL STRATEGY EXAMPLE 3 - RECORDS OF DRUG USE CONTROL STRATEGY MEASURE FOR EACH PREVENTIVE CRITICAL LIMITS food use authorization food producer indicating that any Lot-by-lot certificate from the a veterinarian’s supervision in a veterinarian’s approved by FDA or granted a by FDA approved fish only if the drugs have been fish only if the drugs have put on the list of low regulatory conditional approval by FDA and by FDA conditional approval intended for human consumption intended for conditions; approved by FDA and by FDA conditions; approved Part 511 and that the INAD is used that show that drugs were used on that show drugs were is subject to an investigational new is subject to an investigational used in accordance with all labeled priority aquaculture drugs and used accordance with FDA regulations; or accordance with FDA used in an extra-label manner under according to the requirements of investigational new drug used in fish investigational Drug usage records for each delivery each delivery Drug usage records for animal drug exemption under 21 CFR animal drug exemption according to the provisions on the list according to the provisions drugs HAZARD(S) SIGNIFICANT collection, and the analytical method to be used for each drug can control aquaculture drugs. It is provided for illustrative purposes only. can control aquaculture drugs. It is provided for illustrative purposes only. 3-3 and 3-4 (Chapter 3) for Aquaculture drugs may be only one of several significant hazards for this product. Refer to Tables This table is an example of a portion of a HACCP plan using “Control Strategy Example 3 - Records Drug Use.” This example i * column: the aquacultur An actual plan should specify in the Verification Note: This plan is for illustrative purposes only. contaminants). (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) POINT CRITICAL CONTROL Receiving Aquaculture

CHAPTER 11: Aquaculture Drugs 199 • CONTROL STRATEGY EXAMPLE 4 - DRUG Establish a Recordkeeping System. RESIDUE TESTING • Test results. Set Critical Limits. Establish Verification Procedures. • No fish may contain a residue of an unapproved drug (other than for those • Periodically verify the adequacy of the drugs used as an INAD and according to the testing methods and equipment (e.g., by requirements of the food use authorization comparing results with those obtained or used in accordance with the criteria using an Association of Official Analytical specified in the list of low regulatory priority Chemists (AOAC) or equivalent method, or aquaculture drugs); by analyzing proficiency samples). AND AND • No fish may contain a residue level of an • Review monitoring, corrective action and approved drug that is above FDA tolerance verification records within 1 week of for that drug. preparation to ensure they are complete and any critical limit deviations that occurred Establish Monitoring Procedures. were appropriately addressed;

» What Will Be Monitored? • Fish edible ﬂesh for those drug residues that are reasonably likely to occur.

» How Will Monitoring Be Done? • Obtain samples and test for drugs using rapid screening methods or other validated analytical methods.

» How Often Will Monitoring Be Done (Frequency)? • Each lot received.

» Who Will Do the Monitoring? • Any person who is qualiﬁed by training or experience to perform the analyses.

Establish Corrective Action Procedures. Take the following corrective action to a product involved in a critical limit deviation: • Reject the lot. AND

Take the following corrective action to regain control over the operation after a critical limit deviation: • Discontinue use of the supplier until evidence is obtained that drug treatment practices have changed.

CHAPTER 11: Aquaculture Drugs 200 Review Review (e.g., by (e.g., using an Chemists verify the verify Analytical of Official equivalent (AOAC) or (AOAC) comparing Association results with monitoring, monitoring, Periodically Periodically verification, verification, action records and corrective and corrective within 1 week within 1 week of preparation those obtained and equipment testing methods adequacy of the results RECORDS VERIFICATION Analytical

practices that drug treatment ACTION(S) is obtained CORRECTIVE Reject the lot Reject have changed have until evidence until evidence of the supplier Discontinue use illustrates how a primary processor of farm- other potential hazards (e.g., environmental Quality assurance personnel ed, the protocol for sample collection, and analytical method to aquaculture drugs that are reasonably likely to be present and the critical Each lot received * MONITORING TABLE 11-4 TABLE Example Only methods methods or and analyze for drugs using for other analytical rapid screening Obtain samples See Text for Full Recommendations See Text * WHAT HOW FREQUENCY WHO residues Fish edible ﬂesh for drug for ﬂesh CONTROL STRATEGY EXAMPLE 4 - DRUG RESIDUE TESTING CONTROL STRATEGY

* * drug drugs) MEASURE FOR EACH level of an level PREVENTIVE No fish may No fish may No fish may No fish may and according CRITICAL LIMITS of unapproved of unapproved approved drug approved 21 CFR Part511 of the food use of the food to requirements authorization or INAD subject to contain residues those used as an new animal drug tolerance that for contain a residue exemption under exemption of low regulatory an investigational an investigational drugs (other than that is above FDA FDA that is above included on the list priority aquaculture drugs HAZARD(S) SIGNIFICANT limits to be applied to each drug; and (2) in the Verification column: the aquaculture drugs for which analysis will be conduct limits to be applied each drug; and (2) in the Verification be used for each drug. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) raised catfish can control aquaculture drugs. It is provided for illustrative purposes only. raised catfish can control aquaculture drugs. It is provided for illustrative purposes only. 3-2 and 3-4 (Chapter 3) for Aquaculture drugs may be only one of several significant hazards for this product. Refer to Tables chemical contaminants and pesticides). This table is an example of a portion of a HACCP plan using “Control Strategy Example 4 - Drug Residue Testing.” This example This table is an example of a portion of a HACCP plan using “Control Strategy Example 4 - Drug Residue Testing.” * An actual plan should specify: (1) in the Critical Limits column: Note: This plan is for illustrative purposes only. POINT CRITICAL CONTROL Receiving Aquaculture

CHAPTER 11: Aquaculture Drugs 201 • CONTROL STRATEGY EXAMPLE 5 - QUALITY Take the following corrective action to regain control ASSURANCE PROGRAM over the operation after a critical limit deviation: Set Critical Limits. • Discontinue use of the supplier until evidence is obtained that the supplier will Certificate indicating that the producer operates comply with the certification controls. under a third-party-audited quality assurance (QA) program that controls aquaculture drug Establish a Recordkeeping System. use. The certificate may accompany each lot of • Third-party certificates; incoming aquacultured fish or may be issued for each producer of incoming aquacultured fish as a AND continuing certification. • Receiving record showing lots received and presence or absence of a certificate. Establish Monitoring Procedures. Establish Verification Procedures. » What Will Be Monitored? • Review the third-party QA program and • Certificate indicating operation under third- results of audits annually; party-audited QA program. AND » How Will Monitoring Be Done? • Review monitoring, corrective action, • Visual check for presence of a certificate. and verification records within 1 week of preparation to ensure they are complete and » How Often Will Monitoring Be Done (Frequency)? any critical limit deviations that occurred • Each lot received must be checked for the were appropriately addressed. presence of certificates. Certificates may be issued on a lot-by-lot (no less than annually) or continuing basis.

» Who Will Do the Monitoring? • Any person who has an understanding of the nature of the controls.

Establish Corrective Action Procedures. Take the following corrective action to a product involved in a critical limit deviation: • Reject the lot; OR • Hold the lot until a certiﬁcate can be provided; OR • Hold and analyze the lot for those aquaculture drugs that are reasonably likely to be present. AND

CHAPTER 11: Aquaculture Drugs 202

Review Review Review Review annually monitoring, monitoring, verification, verification, program and action records and corrective and corrective within 1 week within 1 week of preparation third-party QA third-party QA results of audits record RECORDS VERIFICATION Receiving Receiving certificate Third- party with the certificate ACTION(S) will comply CORRECTIVE the supplier mple illustrates how an aquacultured trout Reject the lot Reject requirements until evidence until evidence is obtained that Discontinue use other potential hazards (e.g., environmental employee TABLE 11-5 TABLE MONITORING Example Only Visual check Visual Each lot dock Receiving See Text for Full Recommendations See Text WHAT HOW FREQUENCY WHO certificate third-party Presence of a CONTROL STRATEGY EXAMPLE 5 - QUALITY ASSURANCE PROGRAM CONTROL STRATEGY operates MEASURE FOR EACH Certificate that covers that covers drug usage PREVENTIVE aquaculture QA program QA the producer party-audited under a third- indicating that CRITICAL LIMITS drugs HAZARD(S) SIGNIFICANT (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) chemical contaminants). This table is an example of a portion of a HACCP plan using “Control Strategy Example 5 - Quality Assurance Program.” This exa processor can control aquaculture drugs. It is provided for illustrative purposes only. 3-2 and 3-4 (Chapter 3) for Aquaculture drugs may be only one of several significant hazards for this product. Refer to Tables POINT CRITICAL CONTROL Receiving Aquaculture

CHAPTER 11: Aquaculture Drugs 203 • CONTROL STRATEGY EXAMPLE 6 - CONTROL OR DURING HOLDING Requirements of the INAD food use Set Critical Limits. authorization; AND Aquaculture drugs are used on fish only if the drugs have been: • Date of distribution of the finished product. • Approved by FDA or granted a conditional » How Will Monitoring Be Done? approval by FDA and used in accordance • Visually observe drug use and finished with all labeled conditions; product distribution. OR » How Often Will Monitoring Be Done (Frequency)? • Approved by FDA and used in an extra-label • Every time aquaculture drugs are used manner under a veterinarian’s supervision in during holding or transportation; accordance with FDA regulations; AND OR • Every time the finished product is • Put on the FDA list of low regulatory priority distributed. aquaculture drugs and used according to the provisions on the list; » Who Will Do the Monitoring? OR • Any person who has an understanding of • Used for use in food fish as an INAD subject the nature of the controls. to an investigational new animal drug exemption under 21 CFR Part 511 and used Establish Corrective Action Procedures. according to the requirements in the food Take the following corrective action to a product use authorization. involved in a critical limit deviation: • Destroy the product; Establish Monitoring Procedures. OR » What Will Be Monitored? • Divert the product to non-food use; • Type of aquaculture drug used; OR AND • If the drug is approved for the species in • Date and quantity of drug use; which it was used, hold the product until the AND mandatory withdrawal period (if applicable) has been met and until the drug residue • Any other conditions of drug usage that are level is below the established tolerance. relevant to: These corrective actions may be verified by Established withdrawal times; collecting and analyzing a representative Labeled instructions; sample of the product, using an appropriate Extra-label use of an FDA-approved drug analytical method. used under a veterinarian’s supervision AND in accordance with FDA regulations and guidances; Take the following corrective action to regain control Conditions specified in the FDA list over the operation after a critical limit deviation: of low regulatory priority aquaculture • Modify drug use practices. drugs;

CHAPTER 11: Aquaculture Drugs 204 Review Review monitoring action records and corrective and corrective within 1 week within 1 week of preparation record record record Shipping RECORDS VERIFICATION Drug use Drug use residues are used practices and retest ACTION(S) CORRECTIVE Modify drug use (oxytetracycline) Hold the product level is below the level tolerance (2 ppm) unapproved drugs unapproved if the drug residue Collect a sample of Hold the product if Release the product Release e illustrates how a processor that holds live the finished product and analyze for drug and analyze for Destroy the lot when exceeds the toleranceexceeds the drug residue level the drug residue level other potential hazards (e.g., environmental Shipping employee employee supervisor Production Production finished shipped product is Every time Every Every time Every Every time Every aquaculture aquaculture drugs are used drugs are used TABLE 11-6 TABLE MONITORING Example Only Visual Visual Visual Visual drug use drug use of product distribution Visual check Visual observation of observation of See Text for Full Recommendations See Text use WHAT HOW FREQUENCY WHO Type of product Date and drug used distribution aquaculture Date of finished quantity of drug CONTROL STRATEGY EXAMPLE 6 - CONTROL DURING HOLDING CONTROL STRATEGY use used No other MEASURE FOR EACH PREVENTIVE aquaculture 30 days after 30 days drugs will be directions for directions for in accordance withheld from CRITICAL LIMITS treatment with Lobster will be distribution for distribution for oxytetracycline with the labeled drug HAZARD(S) SIGNIFICANT oxytetracycline (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) lobster in a lobster pound can control aquaculture drugs. It is provided for illustrative purposes only. lobster in a pound can control aquaculture drugs. It is provided for illustrative purposes only. 3-3 and 3-4 (Chapter 3) for Aquaculture drugs may be only one of several significant hazards for this product. Refer to Tables This table is an example of a portion of a HACCP plan using “Control Strategy Example 6 - Control During Holding.” This exampl chemical contaminants, pesticides and natural toxins). POINT Holding Aquaculture CRITICAL CONTROL

CHAPTER 11: Aquaculture Drugs 205 Establish a Recordkeeping System. • Drug use records; AND • Records indicating date of distribution of the ﬁnished product.

CHAPTER 11: Aquaculture Drugs 206 BIBLIOGRAPHY. of Health and Human Services, Food and Drug Administration, Center for We have placed the following references on Veterinary Medicine. http://www.fda. display in the Division of Dockets Management, gov/downloads/AnimalVeterinary/ Food and Drug Administration, 5630 Fishers Lane, GuidanceComplianceEnforcement/ rm. 1061, Rockville, MD 20852. You may see GuidanceforIndustry/ucm052519.pdf. them at that location between 9 a.m. and 4 p.m., • U.S. Food and Administration. April 2010. Monday through Friday. As of March 29, 2011, Certain other dosage form new animal FDA had verified the Web site address for the drugs. In Code of Federal Regulations, 21 references it makes available as hyperlinks from CFR 529. U.S. Government Printing Office, the Internet copy of this guidance, but FDA is not Washington, DC. responsible for any subsequent changes to Non- • U.S. Food and Administration. April 2010. FDA Web site references after March 29, 2011. Extra label drug use in animals. In Code • Federal Joint Subcommittee on Aquaculture. of Federal Regulations, 21 CFR 530. U.S. April 2007. Guide to drug, vaccine, and Government Printing Office, Washington, DC. pesticide use in aquaculture. http://aquanic. • U.S. Food and Administration. April 2010. org/jsa/wgqaap/drugguide/drugguide.htm. Implantation or injectable dosage form • Federal Register. November 21, 2005. new animal drugs. In Code of Federal Rules and regulations: new animal drugs: Regulations, 21 CFR 522. U.S. Government florfenicol, vol. 70, no 233. U.S. Government Printing Office, Washington, DC. Printing Office, Washington, DC. • U.S. Food and Administration. April 2010. • Federal Register. February 6, 2007. Rules and New animal drug applications. In Code regulations: new animal drugs: hydrogen of Federal Regulations, 21 CFR 514. U.S. peroxide, vol. 72, no. 24. U.S. Government Government Printing Office, Washington, DC. Printing Office, Washington, DC. • U.S. Food and Drug Administration. April • Federal Register. November 26, 2007. 2010. New animal drugs for investigational Rules and regulations: new animal drugs: use. In Code of Federal Regulations, 21 florfenicol, vol. 72, no. 226. U.S. Government CFR 511. U.S. Government Printing Office, Printing Office, Washington, DC. Washington, DC. • U.S. Food and Drug Administration. February • U.S. Food and Administration. April 2010. 19, 2008. Extralabel use of approved Tolerances for residues of new animal drugs drugs in aquaculture. In Program policy in food. In Code of Federal Regulations, 21 and procedures manual guide 1240.4210. CFR 556. U.S. Government Printing Office, Department of Health and Human Services, Washington, DC. Food and Drug Administration, Center • U.S. Food and Drug Administration. April for Veterinary Medicine. http://www. 26, 2007. Enforcement priorities for drug fda.gov/downloads/AnimalVeterinary/ use in aquaculture; part B and part C. GuidanceComplianceEnforcement/ In CVM’s policy and procedures manual PoliciesProceduresManual/ucm046932.pdf. 1240.4200. Department of Health and Human • U.S. Food and Drug Administration. Services, Food and Drug Administration, October 23, 2003. Evaluating the safety Center for Veterinary Medicine. http://www. of antimicrobial new animal drugs with fda.gov/downloads/AnimalVeterinary/ regard to their microbiological effects GuidanceComplianceEnforcement/ on bacteria of human health concern. In PoliciesProceduresManual/ucm046931.pdf. Guidance for industry, no. 152. Department

CHAPTER 11: Aquaculture Drugs 207 NOTES:

CHAPTER 11: Aquaculture Drugs 208 CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse

UNDERSTAND THE POTENTIAL HAZARD. Time and temperature abuse occurs when a product is allowed to remain at temperatures Pathogenic bacteria growth and toxin formation favorable to pathogenic bacteria growth for as a result of time and temperature abuse of fish sufficient time to result in unsafe levels of and fishery products can cause consumer illness. pathogenic bacteria or their toxins in the product. This hazard is limited to bacterial pathogens since Therefore, management of time and temperature viral pathogens (viruses) are not able to grow in of product exposure is important to producing food. Of particular concern in seafood are the a safe product. Table A-1 (Appendix 4) provides pathogenic forms of Listeria monocytogenes (L. guidance concerning the conditions under which monocytogenes), Vibrio vulnificus (V. vulnificus), certain pathogenic bacteria can grow. The bacteria Vibrio parahaemolyticus (V. parahaemolyticus), listed are those of greatest concern in fish and Vibrio cholera (V. cholera), Escherichia coli (E. fishery products. coli), Salmonella spp., Shigella spp., Staphylococcus Managing time and temperature of exposure aureus (S. aureus), Clostridium perfringens Time and temperature management relies (C. perfringens), Bacillus cereus (B. cereus), on identification of time and temperature Campylobacter jejuni (C. jejuni), and Yersinia combinations that ensure the safety of your enterocolitica (Y. enterocolitica). See Appendix 7 product. The following factors should be for a description of the public health impacts of considered: these pathogens. • The types of pathogenic bacteria that are Pathogenic bacteria can enter the process on raw reasonably likely to be present; materials. They can also be introduced into foods • Whether those pathogens can grow in the during processing from the air, unclean hands, food; insanitary utensils and equipment, contaminated water, or sewage and through cross-contamination • The infective dose of the pathogenic bacteria; between raw and cooked product. The primary • The expected initial level of the pathogenic method for control is to reduce levels through bacteria in the food. cooking or other treatments, when feasible, Presence of pathogenic bacteria minimize the potential for recontamination and to maintain products at temperatures that do not It is reasonable to assume that pathogenic bacteria support growth of pathogenic bacteria. of various types that are not associated with specific food sources, including those listed in Table A-1 (Appendix 4), will be present on raw fish

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 209 and fishery products and non-fishery ingredients. Table A-1 (Appendix 4) provides guidance They might be present only at low levels or only on some conditions that limit the growth sporadically, but even such occurrences warrant of those pathogenic bacteria that are most consideration because of the potential for growth relevant to fish and fishery products. Table A-1 and toxin production under temperature abuse provides minimum and maximum values of conditions. However, certain pathogenic bacteria pathogenic bacteria growth. This table can help are associated with specific food sources, and it you to decide whether particular pathogenic may not be necessary to assume that they will be bacteria will grow in your food if it is time and present in other foods unless introduced from a temperature-abused. contaminated source. For example, V. vulnificus, Certain pathogenic bacteria grow well in time V. parahaemolyticus, and V. cholerae non-O1 and temperature-abused raw fish and fishery and non-O139 are generally associated with products (e.g., raw molluscan shellfish), and marine and estuarine species of fish and not with freshwater species or non-fishery ingredients. others do not. Those that grow well in time and temperature-abused raw fish include: V. Pathogenic bacteria can also be introduced vulnificus, V. parahaemolyticus, V. cholerae, and during processing, even after cooking. Well- L. monocytogenes. Others may grow if the natural designed sanitation programs will minimize condition of the raw fish is changed, such as their introduction. However, in most cases, through salting or reduced oxygen packaging. it is not reasonable to assume that sanitation Those that ordinarily do not grow well, because programs will fully prevent the introduction of they compete poorly with the normal spoilage pathogenic bacteria. For this reason, controls bacteria, include: C. jejuni, pathogenic strains of should be in place to minimize the risk of E. coli, Salmonella spp., Shigella spp., S. aureus, pathogenic bacteria growth. C. perfringens, B. cereus, and Y. enterocolitica. Pathogenic bacteria growth Most pathogenic bacteria will grow well in Fish and fishery products generally provide temperature-abused cooked fish if their growth is sufficient nutrients for pathogenic bacteria not controlled by means such as drying, salting, growth. However, chemical and physical or acidification, because competing bacteria are characteristics of the product and its packaging destroyed by the cooking process. could limit or enhance pathogenic bacteria Infective dose growth and toxin formation. Furthermore, these characteristics could restrict competing The infective dose or toxic dose is the total microorganism growth and provide conditions number of a pathogen, or the total amount of a favorable to pathogenic bacteria growth. toxin, that is necessary to produce human illness. The dose often varies considerably for a single Consider: pathogen based on the health of the consumer • The moisture available to support pathogenic and the virulence (infective capacity) of the bacteria growth in the product (i.e., water particular strain of the pathogen. activity); The typical infectious dose is known or • The amount of salt and preservatives in the suspected to be very low (i.e., one to several product (e.g., water phase salt and nitrates); hundred organisms can cause illness) for • The acidity of the product (i.e., pH); many of the pathogenic bacteria listed in Table • The availability of oxygen in the product A-1 (Appendix 4). These include C. jejuni, (i.e., aerobic or anaerobic conditions); E. coli, Salmonella spp., Shigella spp., and Y. • The presence of competing spoilage enterocolitica. The typical infectious dose for organisms in the food. other pathogenic bacteria is considered to be

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 210 somewhat higher (i.e., several thousand to less pathogenic bacteria that have a relatively high than 100,000). These include V. vulnificus and infective dose, the initial number of pathogenic V. parahaemolyticus. In the case of both of bacteria may be a significant consideration. these categories of pathogens, it is advisable to Practical considerations for unrefrigerated prevent any significant growth so that the typical processing infective dose is not exceeded. In other words, product temperatures should be maintained Consider the above described factors to identify below the minimum growth temperature for the the pathogen(s) that presents the greatest pathogen or should not be allowed to exceed challenge with respect to managing time and that temperature for longer than the lag growth temperature exposure in your product. This then phase (i.e., the slow growth phase during becomes the target pathogen(s) for time and which a pathogenic bacteria acclimates to its temperature control. Table A-2 (Appendix 4) can environment before proceeding to rapid growth) then be used to establish safe exposure times of the pathogenic bacteria at the exposure for the target pathogen(s) at the temperatures at temperature. which you expect your product to be exposed. Still other pathogenic bacteria require large As an alternative, you can use predictive numbers in order to cause disease. The typical microbiology models, such as the U.S. infectious dose of V. cholerae is suspected to be Department of Agriculture Pathogen Modeling 1,000,000 cells. S. aureus and B. cereus toxin do Program (http://ars.usda.gov/Services/docs. not normally produce sufficient toxin to cause htm?docid=6786) or ComBase (http://www. illness until numbers of the pathogen reach combase.cc/default.html) for product-specific 100,000 to 1,000,000/gram. time and temperature exposure calculations. However, you should validate the reliability of C. perfringens typically does not produce toxin predictions from such models for your food. in the human gut unless at least 100,000,000 bacteria are consumed. Limited growth of these Growth rates of pathogens are highly pathogens might not compromise the safety of temperature dependent. Ordinarily, pathogenic the product. However, time and temperature bacteria growth is relatively slow at temperatures controls must be adequate to prevent growth below 70°F (21.1°C). In most cases, growth is before the infectious or toxic dose is reached. very slow below 50°F (10°C), and 40°F (4.4°C) is below the minimum growth temperature of Levels of pathogenic bacteria most pathogenic bacteria, although there are The levels of a pathogen that are likely to be some exceptions. On the other hand, pathogenic present in a fish or fishery product is dependent bacteria grow relatively fast at temperatures on factors such as the quality of the harvest above 70°F (21.1°C). Product temperatures should water, how the raw material was handled be maintained below the minimum growth before it was delivered to your plant, and the temperature for the pathogen or should not be effectiveness of your sanitation control program. allowed to exceed that temperature for longer than the lag growth phase of the pathogen As a practical matter, the initial number of low- growth cycle. to-moderate infectious dose pathogenic bacteria in a food is usually of limited importance when Consider the following recommendations when you develop a time and temperature management developing a product monitoring program. Product strategy because these pathogens should be surface temperature or ambient temperature controlled by a time and temperature strategy generally should be monitored when the ambient that does not permit their growth to pass the temperature (e.g., air) is warmer than the product lag phase. On the other hand, when controlling internal temperature. Internal temperature in the

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 211 center of the thickest part of the product should acidified products, and by Chapter 13 for be monitored when the ambient temperature refrigerated acidified products); (e.g., air, ice, and brine) is cooler than the product • Controlling the introduction of pathogenic internal temperature. Similarly, when selecting a bacteria after the pasteurization process product for temperature measurement, consider (covered in Chapter 18); the location of the product selected in relation to • Controlling the source of molluscan shellfish the environment and select the likely worse case and the time from exposure to air (e.g., by product. For example, a product in the center of harvest or receding tide) to refrigeration to a pile of products will take longer to cool than a control pathogens from the harvest area product at the surface. (covered in Chapter 4). • Strategies for control of pathogenic bacteria There are a number of strategies for the control DETERMINE WHETHER THE POTENTIAL of pathogenic bacteria in fish and fishery HAZARD IS SIGNIFICANT. products. They include: The following guidance will assist you in • Managing the amount of time that food is determining whether pathogenic bacteria growth exposed to temperatures that are favorable and toxin formation as a result of time and for pathogen growth and toxin production temperature abuse is a significant hazard at a (covered generally in this chapter; for processing step: Clostridium botulinum (C. botulinum), in Chapter 13; and for S. aureus in hydrated 1. Is it reasonably likely that unsafe levels of batter mixes, in Chapter 15); pathogenic bacteria will be introduced at this • Killing pathogenic bacteria by cooking processing step (do unsafe levels come in with the or pasteurization (covered in Chapter 16) raw material or will the process introduce them)? or by retorting (covered by the Thermally It is reasonable to assume that pathogenic Processed Low-Acid Foods Packaged in bacteria of various types that are not Hermetically Sealed Containers regulation, 21 associated with specific food sources, CFR 113 (hereinafter, the Low-Acid Canned including those listed in Table A-1 (Appendix Foods (LACF) Regulation); 4), will be present on raw fish and fishery • Killing pathogenic bacteria by processes products and non-fishery ingredients. that retain the raw product characteristics However, certain pathogenic bacteria are (covered in Chapter 17); associated with specific food sources, and it • Controlling the amount of moisture that is may not be necessary to assume that they available for pathogen growth (water activity) in will be present in other foods unless they the product by drying (covered in Chapter 14); have been cross-contaminated. For example, • Controlling the amount of moisture that is V. vulnificus, V. parahaemolyticus, and V. available for pathogen growth (water activity) cholerae non-O1 and non-O139 are generally in the product by formulation (covered in associated with marine and estuarine species Chapter 13); of fish and not with freshwater species or non-fishery ingredients. • Controlling the amount of salt or preservatives, such as sodium nitrite, in the Pathogenic bacteria also could be introduced product (covered in Chapter 13); during processing, even after cooking. Well- • Controlling the level of acidity (pH) in the designed sanitation programs (prerequisite product (covered by the Acidified Foods programs) will minimize the introduction of regulation, 21 CFR 114, for shelf-stable pathogenic bacteria. However, in most cases

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 212 it is not reasonable to assume that they will In summary, under ordinary circumstances fully prevent the introduction of pathogenic (e.g., without data to the contrary), you bacteria. Additional information on this should consider that it is reasonably likely topic is presented in the previous section, that a pathogenic bacteria in Table A-1 “Understand the Potential Hazard.” (Appendix 4) will grow to an unsafe level or produce toxin in your product at a particular 2. Is it reasonably likely that pathogenic bacteria processing step if all of the following will grow to unsafe levels and/or produce toxin conditions are met: at this processing step? • It is reasonably likely to be present; In order to answer this question, you must first determine which of those pathogenic • Its growth is not prevented by bacteria that are reasonably likely to be a condition of the food; present in your product would be able • It is reasonably likely that, in the to grow under time and temperature absence of controls, cumulative time abuse conditions. Information on this and temperature abuse conditions topic is presented in the previous section, such as those described in Table A-2 “Understand the Potential Hazard.” (Appendix 4) could occur during Time and temperature abuse at one step processing of the product, and the alone might not result in an unsafe product. processing step could contribute However, time and temperature abuse significantly to that cumulative abuse. that occurs at successive processing steps 3. Can unsafe levels of pathogenic bacteria and/ (including storage steps) might be sufficient or toxin production that are reasonably likely to to result in unsafe levels of pathogenic occur be eliminated or reduced to an acceptable bacteria or toxins. For this reason, you should level at this processing step? consider the cumulative effect of time and temperature abuse during the entire process. Pathogenic bacteria growth and toxin Table A-2 (Appendix 4) provides guidance formation due to time and temperature abuse about the kinds of time and temperature should be considered a significant hazard abuse that might cause a product to be at any processing step where a preventive unsafe. A study may need to be conducted to measure is, or can be, used to eliminate determine time and temperature exposure of the hazard (or reduce the likelihood of its your seafood to temperature abuse for each occurrence to an acceptable level) if it is process step. reasonably likely to occur. The preventive measures that can be applied for pathogenic Remember that you should consider the bacteria growth and toxin formation due to potential for time and temperature abuse in time and temperature abuse include: the absence of controls. You might already have controls in your process that minimize • Refrigeration of the product and the potential for time and temperature controlling refrigeration temperatures; abuse that could result in unsafe levels of • Proper icing of the product; pathogenic bacteria or toxins. This section and subsequent sections will help you • Controlling the amount of time that the determine whether those or other controls product is exposed to temperatures should be included in your Hazard Analysis that would permit pathogenic bacteria Critical Control Point (HACCP) plan. growth or toxin production; • Rapid cooling of the product;

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 213 • Ensuring that incoming fish the processor for culinary purposes (e.g., were handled properly during setting the batter or breading, or stabilizing refrigerated transportation from the the product shape), and are customarily previous processor, including: fully cooked by the consumer or end user. Controlling refrigeration temperatures Examples include: fish balls, shrimp egg rolls, during transit; shrimp and cheese stuffed ravioli, crab cakes, and breaded fish portions. Although the Proper icing during transit. exterior of these products may appear cooked, • Intended use the interior fish protein is not coagulated, and Except as noted, it is unlikely that the the products are not ready-to-eat. intended use will affect the significance of Other products contain a combination of the hazard. raw or partially cooked, and fully cooked FDA is not aware of any HACCP controls ingredients (e.g., seafood mixture of raw that exist internationally for the control oysters, cooked shrimp, and raw or cooked of pathogenic bacteria in fish and fishery octopus). Although the protein of some of products that are customarily fully cooked the fishery ingredients is coagulated, some is by the consumer or end user before not. As a result, many of these products are consumption, other than a rigorous sanitation not ready-to-eat. However, these combination regime as part of a prerequisite program products should be considered ready-to-eat or as part of HACCP itself. The Fish and if the raw or partially cooked ingredients are Fishery Products regulation, 21 CFR 123 customarily eaten without cooking by the (called the Seafood HACCP Regulation in consumer or end user. this guidance document) requires such a Note that the toxin produced by S. aureus regime. The proper application of sanitation is not destroyed by cooking or retorting. Its controls is essential because of the likelihood formation should, therefore, be prevented that pathogenic bacteria can be introduced in all fish and fishery products. However, as into fish and fishery products through previously mentioned, S. aureus does not poor handling practices by the aquaculture grow well in raw fish, unless the growth of producer, the fisherman, or the processor. competing spoilage organisms is inhibited (e.g., FDA is interested in information regarding any by salting or vacuum packaging). B. cereus also HACCP controls beyond sanitation that could produces a heat-stable toxin and forms heat- be necessary and practical for the control resistant spores that can survive cooking. of pathogenic bacteria in fish and fishery products that are customarily fully cooked by the consumer or end user. However, the agency makes no recommendations in this guidance document and has no specific expectations with regard to such controls in processors’ HACCP plans. The agency plans to develop Good Manufacturing Practice guidelines for harvest vessels and for aquaculture in an effort to minimize the likelihood that these operations will contribute pathogens to fish and fishery products. Some products are partially cooked by

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 214 IDENTIFY CRITICAL CONTROL POINTS. identify as a CCP each processing step at which you have identified this hazard as significant. You The following guidance will assist you in should control cumulative exposure of the product determining whether a processing step is a to time and temperatures that will permit growth critical control point (CCP) for pathogenic or toxin formation at these steps. bacteria growth and toxin formation as a result of Example: time and temperature abuse: A crabmeat processor identifies a series 1. If there is a cook step, pasteurization step, or of post-cook processing and storage retorting step later in your manufacturing process, steps (e.g., backing, picking, packing, you should, in most cases, identify that step as and refrigerated storage) as presenting the CCP. You would not usually need to identify a reasonable likelihood of pathogenic processing steps prior to cooking, pasteurization, bacteria growth and toxin formation. or retorting as CCPs for this hazard. The processor does not subject the product to a final pasteurization process and Example: recognizes that it might be consumed A cooked shrimp processor should set without further cooking. The processor the critical control point for pathogenic controls the temperature during bacteria growth and toxin formation as refrigerated storage and the time of a result of time and temperature abuse exposure to unrefrigerated conditions at the cook step. The processor would not during the processing steps. The processor need to identify each of the processing should identify each of the post-cook steps prior to cooking as CCPs. processing and storage steps as CCPs for Guidance for this pathogen control strategy this hazard. is contained in Chapter 16 (for cooking and This chapter provides the following four pasteurization) and the LACF Regulation, 21 control approaches, or control strategies, each CFR 113 (for retorting). relating to a separate potential CCP or a set However, there are two important limitations of CCPs: to this strategy: • “Control Strategy Example 1 - Transit • The cooking, pasteurizing, or retorting Control.” This control strategy should process must be sufficient to eliminate be applied to the control of transit at the most resistant pathogenic bacteria receipt of chilled (i.e., refrigerated, of public health concern that are iced, or held under chemical cooling reasonably likely to be present; media, such as gel packs, and not frozen) ready-to-eat fishery products; • Certain toxins (e.g., S. aureus and B. cereus toxins) are heat stable. Heat • “Control Strategy Example 2 - treatment, including retorting, might not Refrigerated Storage and Refrigerated eliminate the toxin once it is formed. Processing Control.” This control strategy should be applied to chilled In either case, time and temperature control (i.e., refrigerated, iced, and not would be necessary at the processing steps frozen) storage and refrigerated at which growth and toxin formation could (i.e., <40ºF (4.4ºC)) processing; occur. • “Control Strategy Example 3 - Cooling 2. If there is no cook step, pasteurization step, or After Cooking Control.” This control retorting step later in the process, you should strategy should be applied to a cooling

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 215 step when there is no significant In some cases, refrigerated cooked, ready- handling during the cooling and to-eat foods (e.g., lobster meat, pasteurized there is a need to control spore- crabmeat, smoked fish, and surimi-based forming pathogenic bacteria; analog products) are received by a secondary processor and held for sale without further • “Control Strategy Example 4 - handling. In other cases, these products Unrefrigerated Processing Control.” are received by a secondary processor and This control strategy should be used as ingredients in a ready-to-eat product applied to unrefrigerated (i.e., that will not be cooked or pasteurized by ≥40ºF (4.4ºC)) processing. that processor (e.g., seafood salad). In these Following is further guidance that may help cases, the receiving and storage steps by the you determine whether these processing secondary processor should be designated steps should be identified as CCPs for this as CCPs to control the hazard of pathogenic hazard. The guidance is divided into two bacteria growth. On the other hand, if types of finished products: cooked ready-to- these ready-to-eat foods are received by the eat and raw ready-to-eat. secondary processor to be used in a product that will be cooked or pasteurized by that • Cooked, ready-to-eat products processor, the receiving and storage steps These products may be cooked by the before the cooking or pasteurization step processor, received by the processor already might not need to be designated as CCPs, cooked, or assembled by the processor from unless S. aureus or B. cereus toxin formation ready-to-eat components. They may appear is a significant hazard. Remember that these to the consumer or end user to be ready-to- toxins are not likely to be inactivated by heat. eat products and may, therefore, be eaten without further cooking. Examples include: In still other cases, ready-to-eat foods are cooked crabmeat, lobster meat, and crayfish received by a secondary processor and meat; surimi-based analog products; seafood used as ingredients in a non-ready-to-eat salads; and hot-smoked fish. Note that product (e.g., cooked octopus used by the smoked fish is also covered in Chapter 13, processor as an ingredient in a seafood mix and cooking and pasteurization are covered that is customarily eaten after cooking by the in Chapter 16. consumer or end user). Again, the receiving and storage steps might not need to be Cooked, ready-to-eat products, especially designated as CCPs, unless S. aureus or B. assembled products, might develop pathogen cereus toxin formation is a significant hazard. hazards as a result of cross-contamination and growth. Contributing factors to this The need to establish a CCP at cooling after risk are manual handling steps, multiple cooking or pasteurization depends on: ingredients, unrefrigerated processing, and • The severity of the cooking (including multiple cooling steps. Cumulative exposure hot smoking) or pasteurization step; to time and temperature abuse after the • The extent to which the product cook step should be taken into consideration is handled between the end of the when establishing CCPs based on time and cooking or pasteurization step and temperature. the end of the cooling step. Spore-forming pathogenic bacteria may survive cooking or pasteurization processes that target vegetative pathogenic bacteria.

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 216 For example, in foods that contain meat or Time and temperature controls may be rice, spores of C. perfringens and B. cereus needed at the following steps (CCPs): could be present, could survive the cooking • Receiving; process, and could grow and produce toxin in the product during cooling and subsequent • Thawing; handling. In fact, the heat from the cooking • Cooling after cooking; process might initiate growth of the surviving spores. In this case, a CCP may be needed • Processing after cooking: at product cooling. However, some cooking Slicing hot-smoked salmon; processes might be adequate to kill even the Mixing seafood salad; spores of C. perfringens and B. cereus. In this Picking crabmeat; case, a CCP at product cooling may not be necessary. • Packaging; When significant handling occurs after • In-process and finished product cooking or pasteurization, there is a risk refrigerated (not frozen) storage. that the product might be recontaminated Time and temperature controls will usually with pathogenic bacteria. Because many of not be needed at processing steps that meet the normally occurring spoilage organisms the following conditions: may have been eliminated by the cooking or pasteurization process and are no longer • Continuous, mechanical present to compete with the pathogenic processing steps that are brief: bacteria, rapid growth and toxin formation Mechanical size grading of cooked by the pathogenic bacteria are possible. It shrimp; is advisable to fully cool a product before Mechanical forming of surimi-based it is further handled, in order to minimize analog products; pathogenic bacteria growth and toxin Individual quick freezing; formation. When significant handling occurs after the heating process but before the • Processing steps that are brief and completion of the cooling process or when unlikely to contribute significantly to the cooked product comes into contact with the cumulative time and temperature equipment that was not heated along with exposure to unrefrigerated conditions: the product, time and temperature exposure Date code stamping; controls may need to start at that point. In Case packing; some processes, cooling is performed (1) • Processing steps where the product before any significant handling of the cooked is held in a frozen state: product; and (2) in the same container in which the product was cooked. Under Glazing; these conditions, cooling after cooking may Assembly of orders for distribution; not need to be identified as a CCP for this Frozen product storage; hazard. However, such a determination is dependent upon strict adherence to good • Processing steps where the sanitation practices to further minimize the product is held at temperatures risk of recontamination with pathogenic above 135°F (57.2°C): bacteria. Initial stage of cooling; Hot holding.

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 217 • Raw, ready-to-eat products Time and temperature controls will usually These products are not heated during not be needed at processing steps that meet processing to a temperature that destroys the following conditions: pathogenic bacteria. They are often • Continuous, mechanical consumed without cooking. Examples processing steps that are brief: include: cold-smoked fish, raw oysters, Mechanical filleting; clams and mussels, and raw finfish (when the processor has knowledge or has reason • Processing steps that are brief and to know that the product will be consumed unlikely to contribute significantly to without a process sufficient to kill pathogens the cumulative time and temperature of public health concern or where the exposure to unrefrigerated conditions: processor represents, labels, or intends for Date code stamping; the product to be so consumed). Case packing; Like cooked, ready-to-eat products, raw • Processing steps where the product ready-to-eat products may contain pathogenic is held in a frozen state: bacteria as a result of near-shore harvest Assembly of orders for distribution; water contamination, poor aquaculture practices, or poor sanitary practices during Frozen storage. harvesting, transportation, or processing. • Time and temperature profile For example, oysters, especially those harvested during the warm weather Preparing a diagram that depicts the months, might contain V. vulnificus or maximum times and temperatures at which V. parahaemolyticus. Raw finfish might your product will be exposed at each contain V. parahaemolyticus, Salmonella processing step may help you determine spp., or L. monocytogenes. Some of these cumulative product exposure, especially if pathogenic bacteria (e.g., V. vulnificus, V. your product is cooked, ready-to-eat. This parahaemolyticus, and L. monocytogenes) are diagram can help you identify CCPs, as capable of growth in raw fish. well as critical limits, as will be discussed later. Figures 12-1 and 12-2 are examples Time and temperature controls may be needed of time and temperature profiles for two at the following processing steps (CCPs): different crabmeat processes. Although the • Receiving; figures show similar time and temperature profiles, they demonstrate how differences in • Processing: processing operations, especially with respect Thawing; to when significant handling occurs, can have Shucking; an impact on the location of CCPs and on the Portioning; critical limits at those CCPs. • Packaging; Figure 12-1 shows a time and temperature profile for a cooked crabmeat processor that • Raw material, in-process product, significantly handles product before it is and finished product refrigerated cooled to 50°F (10°C). As a result, a CCP is (not frozen) storage. likely to be needed at backing, picking, and packing.

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 218 Figure 12-2 shows a time and temperature handling occurs. A more restrictive set of profile for a cooked crabmeat processor that critical limits is also likely for the product does not significantly handle product before depicted by Figure 12-1 than for that depicted it is cooled to 50°F (10°C). As a result, a CCP by Figure 12-2, because the former product is is not needed until the picking operation, handled while still warm. which is the first point at which significant

FIGURE 12-1: Internal Temperature Proﬁle — Blue Crabmeat Processing Partial Cooling Only After Cook With Signiﬁcant Handling Before Full Cooling

135˚F (57.2˚C)

Backing Begins Place in Cooler Picking Begins Packing Ends

80˚F (26.7˚C) 70˚F (21.1˚C)

50˚F (10˚C)

40˚F (4.4˚C)

1 HR. 2 HOURS MAX. MAX. 1 HR. MAX. FIGURE 12-2: Internal Temperature Proﬁle — Blue Crabmeat Processing Cooling After Cook in Original Container With No Signiﬁcant Handling During Cooling

135˚F (57.2˚C) Cooling in Original Container No Signiﬁcant Handling Picking Begins Packing Ends 80˚F (26.7˚C) 70˚F (21.1˚C)

50˚F (10˚C)

40˚F (4.4˚C)

5 HOURS MAX.

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 219 DEVELOP A CONTROL STRATEGY. OR • For products delivered under ice: The following guidance provides examples of four Product is completely surrounded by ice control strategies for pathogenic bacteria growth at the time of delivery; and toxin formation. It may be necessary to select OR more than one control strategy in order to fully control the hazard, depending upon the nature of • For products delivered under chemical your operation. You may select a control strategy cooling media, such as gel packs: that is different from those which are suggested, There is an adequate quantity of cooling provided it complies with the requirements of the media that remain frozen to have applicable food safety laws and regulations. maintained the product at an internal temperature of 40°F (4.4°C) or below The following are examples of control strategies throughout transit; included in this chapter: AND MAY APPLY TO MAY APPLY TO The internal temperature of the product CONTROL STRATEGY PRIMARY SECONDARY PROCESSOR PROCESSOR at the time of delivery is 40°F (4.4°C) or Transit control below;

Refrigerated storage and OR refrigerated processing control • For products delivered refrigerated (not frozen) with a transit time (including all Cooling after cooking control time outside a controlled temperature Unrefrigerated processing environment) of 4 hours or less (optional control control strategy): Time of transit does not exceed 4 hours; • CONTROL STRATEGY EXAMPLE 1 - TRANSIT AND CONTROL (FOR REFRIGERATED (NOT FROZEN) COOKED, READY-TO-EAT OR RAW, READY-TO- Internal temperature of the product at EAT FISHERY PRODUCTS TO BE STORED OR the time of delivery does not exceed PROCESSED WITHOUT FURTHER COOKING) 40°F (4.4°C). It may be necessary to select more than one Note: Processors receiving product with transit times of 4 hours or control strategy in order to fully control the less may elect to use one of the controls described for longer transit times instead. hazard, depending upon the nature of your operation. Establish Monitoring Procedures. Set Critical Limits. » What Will Be Monitored? • For ﬁsh or ﬁshery products delivered • For products delivered refrigerated (not refrigerated (not frozen): frozen): All lots received are accompanied by The internal temperature of the product transportation records that show that the throughout transportation; product was held at or below an ambient OR or internal temperature of 40°F (4.4°C) throughout transit. Note that allowance The ambient temperature within the for routine refrigeration defrost cycles truck or other carrier throughout may be necessary; transportation;

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 220 OR OR • For products delivered under ice: • For products delivered under chemical The adequacy of ice surrounding the cooling media, such as gel packs: product at the time of delivery; Make visual observations of the adequacy and frozen state of the cooling OR media in a representative number of • For products held under chemical cooling containers (e.g., cartons and totes) from media, such as gel packs: throughout the shipment at delivery; The quantity and frozen status of cooling AND media at the time of delivery; Use a temperature-indicating device (e.g., AND a thermometer) to determine internal The internal temperature of a product temperatures in a representative representative number of product units at number of product containers from time of delivery; throughout the shipment at delivery; OR OR • For products delivered refrigerated (not • For products delivered refrigerated (not frozen) with a transit time of 4 hours or less: frozen) with a transit time of 4 hours or less: The date and time product was Review carrier records to determine the removed from a controlled temperature date and time product was removed from environment before shipment and the a controlled temperature environment date and time delivered; before shipment and the date and time AND delivered; The internal temperature of a AND representative number of product Use a temperature-indicating device (e.g., containers (e.g., cartons and totes) at the a thermometer) to determine internal time of delivery. product temperatures in a representative number of product containers (e.g., » How Will Monitoring Be Done? cartons and totes) randomly selected • For products delivered refrigerated (not from throughout the shipment, at frozen): delivery. Measure a minimum of 12 Use a continuous temperature-recording product containers, unless there are device (e.g., a recording thermometer) fewer than 12 products in a lot, in which for internal product temperature or case measure all of the containers. Lots ambient air temperature monitoring that show a high level of temperature during transit; variability may require a larger sample OR size. • For products delivered under ice: » How Often Will Monitoring Be Done (Frequency)? Make visual observations of the • Every lot received. adequacy of ice in a representative number of containers (e.g., cartons and » Who Will Do the Monitoring? totes) from throughout the shipment at • For continuous temperature-recording delivery; devices:

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 221 Monitoring is performed by the device AND itself. The visual check of the data Take the following corrective action to regain control generated by the device, to ensure that over the operation after a critical limit deviation: the critical limits have consistently been met, may be performed by any person • Discontinue use of the supplier or carrier who has an understanding of the nature until evidence is obtained that the identified of the controls; transportation- handling practices have been improved. OR • For other checks: Establish a Recordkeeping System. Any person who has an understanding of • Receiving records showing: the nature of the controls. The results of continuous temperature monitoring, including: Establish Corrective Action Procedures. • Printouts, charts, or readings from Take the following corrective action to a product temperature-recording devices; involved in a critical limit deviation: AND • Chill and hold the affected product until an evaluation of the total time and temperature • Visual check of recorded data; exposure is performed (a product with OR cumulative exposures that exceed the critical The results of ice checks, including: limits recommended in “Control Strategy Example 4 - Processing Controls” should be • The number of containers (e.g., cooked or diverted to a use in which the cartons and totes) examined and critical limit is not applicable (e.g., divert the sufficiency of ice for each; crabmeat to a stuffed flounder operation), AND after giving consideration to the fact that any S. aureus or B. cereus toxin that may be • The number of containers (e.g., present may not be inactivated by heat, or cartons and totes) in the lot; destroyed or diverted to a non-food use); OR OR The results of chemical media checks, • Cook the product, after giving consideration including: to the fact that any S. aureus or B. cereus • The number of containers (e.g., toxin that may be present may not be cartons and totes) examined and the inactivated by heat; frozen status of the media for each; OR AND • Divert the product to a use in which the • The number of units in the lot; critical limit is not applicable (e.g., divert crabmeat to a stuffed flounder operation), AND/OR after giving consideration to the fact that The results of internal product any S. aureus or B. cereus toxin that may be temperature monitoring, including: present may not be inactivated by heat; • The number of containers (e.g., OR cartons and totes) examined • Reject the lot. and the internal temperatures observed for each;

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 222 AND kinks. The device should be checked to ensure that it is operational; • The number of containers (e.g., cartons and totes) in the lot; AND AND • Calibrate the temperature-indicating device against a known accurate reference device • Date and time product was (e.g., a NIST-traceable thermometer) at initially removed from a controlled least once a year or more frequently if temperature environment and recommended by the device manufacturer. date and time product was Optimal calibration frequency is dependent delivered, when applicable. upon the type, condition, past performance, and conditions of use of the device. Establish Verification Procedures. Consistent temperature variations away from • Before a temperature-indicating device (e.g., the actual value (drift) found during checks a thermometer) is put into service, check and/or calibration may show a need for more the accuracy of the device to verify that the frequent calibration or the need to replace factory calibration has not been affected. the device (perhaps with a more durable This check can be accomplished by: device). Calibration should be performed at Immersing the sensor in an ice slurry a minimum of two temperatures that bracket (32°F (0°C)) if the device will be used at the temperature range at which it is used; or near refrigeration temperature; AND OR • Check the accuracy of temperature-recording Comparing the temperature reading on devices that are used for monitoring transit the device to the reading on a known conditions upon receipt of each lot. The accurate reference device (e.g., a accuracy of the device can be checked thermometer traceable to standards of by comparing the temperature reading on the National Institute of Standards and the device with the reading on a known Technology (NIST)) under conditions that accurate reference device (e.g., a NIST- are similar to how it will be used (e.g., traceable thermometer) under conditions that product internal temperature) within the are similar to how it will be used (e.g., air temperature range at which it will be temperature) within the temperature range at used; which it will be used; AND AND • Once in service, check the temperature- • When visual checks of ice or cooling media indicating device daily before the beginning of are used, periodically measure internal operations. Less frequent accuracy checks may temperatures of fish to ensure that the ice be appropriate if they are recommended by or cooling media are sufficient to maintain the instrument manufacturer and if the history product temperatures at 40°F (4.4°C) or less; of use of the instrument in your facility has AND shown that the instrument consistently remains • Review monitoring, corrective action, accurate for a longer period of time. In addition and verification records within 1 week of to checking that the device is accurate by one preparation to ensure they are complete and of the methods described above, this process any critical limit deviations that occurred should include a visual examination of the were appropriately addressed. sensor and any attached wires for damage or

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 223 lot upon Check Review Review corrective corrective 1 week of 1 week verification verification action, and action, data logger monitoring, monitoring, preparation temperature records within receipt of each accuracy of the Data RECORDS VERIFICATION logger printout tal fragments). of the handling shipment Reject the Reject ACTION(S) supplier or evidence is evidence t is provided for illustrative purposes only. It t is provided for illustrative purposes only. carrier until CORRECTIVE 3-3 and 3-4 (Chapter 3) for other potential ur operation. rates how a processor receiving pasteurized obtained that the identified the identified practices have practices have transportation- been improved Discontinue use Receiving Receiving employee shipment with visual monitoring review and review Continuous, Continuous, temperature evaluation of evaluation records for each records for TABLE 12-1 TABLE MONITORING Example Only data logger temperature Digital time and See Text for Full Recommendations See Text WHAT HOW FREQUENCY WHO of truck refrigerated CONTROL STRATEGY EXAMPLE 1 - TRANSIT CONTROL CONTROL STRATEGY Temperature Temperature compartment are 40°F show by truck MEASURE FOR EACH PREVENTIVE at or below records that temperature accompanied CRITICAL LIMITS was maintained was All lots received All lots received and toxin formation HAZARD(S) Pathogenic Pathogenic SIGNIFICANT bacteria growth (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) crabmeat can control pathogenic bacteria growth and toxin formation as a result of time and temperature abuse during transit. I may be necessary to select more than one control strategy in order fully the hazard, depending upon nature of yo Pathogenic bacteria growth and toxin formation may be only one of several significant hazards for this product. Refer to Tables hazards (e.g., environmental chemical contaminants and pesticides, pathogen survival through cooking and pasteurization, me This table is an example of a portion of a HACCP plan using “Control Strategy Example 1 - Transit Control.” This example illust This table is an example of a portion of a HACCP plan using “Control Strategy Example 1 - Transit POINT CRITICAL crabmeat CONTROL Receiving Receiving pasteurized

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 224 • CONTROL STRATEGY EXAMPLE 2 - REFRIGERATED • For raw material, in-process product, or STORAGE AND REFRIGERATED PROCESSING ﬁnished product stored under ice: CONTROL The product is completely and It may be necessary to select more than one continuously surrounded by ice control strategy in order to fully control the throughout the storage time. hazard, depending upon the nature of your operation. Establish Monitoring Procedures.

Set Critical Limits. » What Will Be Monitored? • For refrigerated (not frozen) storage or • For refrigerated storage or processing: processing of the raw material, in-process The ambient air temperature of the product, or finished product: cooler or refrigerated processing room; The product is held at a cooler ambient OR air temperature of 40°F (4.4°C) or • For storage under ice: below. Note that allowance for routine refrigeration defrost cycles may be The adequacy of ice surrounding the necessary. On the other hand, minor product. variations in cooler temperature » How Will Monitoring Be Done? measurements can be avoided • For refrigerated storage or processing: by submerging the sensor for the temperature-recording device (e.g., a Use a continuous temperature-recording recording thermometer) in a liquid that device (e.g., a recording thermometer); mimics the characteristics of the product. OR Also note that critical limits during • For storage under ice: refrigerated storage and refrigerated Make visual observations of the processing that specify a cumulative adequacy of ice in a representative time and temperature of exposure to number of containers (e.g., cartons and temperatures above 40°F (4.4°C) are not totes) from throughout the cooler. ordinarily suitable to control the hazard because of the difficulty in tracking » How Often Will Monitoring Be Done (Frequency)? the specific products and the specific • For continuous temperature recording cumulative temperature exposures devices: that those products experience. The cumulative exposure for each product Continuous monitoring by the device would need to be determined prior to itself, with a visual check of the recorded shipping. If you chose this approach, data at least once per day; the critical limit for cumulative exposure OR to temperatures above 40°F (4.4°C) • For storage under ice: should include time during transit, Sufficient frequency to ensure the critical refrigerated storage, and refrigerated and limit is met. unrefrigerated processing; OR

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 225 » Who Will Do the Monitoring? OR • For continuous temperature-recording • Destroy the product; devices: OR Monitoring is performed by the device • Divert the product to a non-food use. itself. The visual check of the data generated by the device, to ensure that AND the critical limits have consistently been Take the following corrective actions to regain control met, may be performed by any person over the operation after a critical limit deviation: who has an understanding of the nature • Prevent further deterioration of the product: of the controls; Add ice to the product; OR OR • For other checks: Move some or all of the product in the Any person who has an understanding of malfunctioning cooler to another cooler; the nature of the controls. OR Establish Corrective Action Procedures. Freeze the product; Take the following corrective action to a product AND involved in a critical limit deviation: • Address the root cause: • Chill and hold the affected product Make repairs or adjustments to the until an evaluation of the total time and malfunctioning cooler; temperature exposure is performed. A product with cumulative exposures that OR exceed the critical limits recommended in Make adjustments to the ice application “Control Strategy Example 4 - Unrefrigerated operations. Processing Controls,” should be cooked or diverted to a use in which the critical limit Establish a Recordkeeping System. is not applicable (e.g., divert crabmeat to • For refrigerated storage: a stuffed flounder operation), after giving Printouts, charts, or readings from consideration to the fact that any S. aureus continuous temperature-recording devices; or B. cereus toxin that may be present may not be inactivated by heat, or destroyed or AND diverted to a non-food use; Record of visual checks of recorded data; OR OR • Cook the product, after giving consideration • For storage under ice: to the fact that any S. aureus or B. cereus The results of ice checks: toxin that may be present may not be inactivated by heat; • The number of containers (e.g., cartons and totes) examined and OR the sufficiency of ice for each; • Divert the product to a use in which the critical limit is not applicable (e.g., divert AND crabmeat to a stuffed flounder operation), • The approximate number after giving consideration to the fact that of containers (e.g., cartons any S. aureus or B. cereus toxin that may be and totes) in the cooler. present may not be inactivated by heat;

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 226 Establish Verification Procedures. Consistent temperature variations away from • Before a temperature-recording device (e.g., the actual value (drift) found during checks a recording thermometer) is put into service, and/or calibration may show a need for more check the accuracy of the device to verify frequent calibration or the need to replace that the factory calibration has not been the device (perhaps with a more durable affected. This check can be accomplished by: device). Calibration should be performed at a minimum of two temperatures that bracket Immersing the sensor in an ice slurry the temperature range at which it is used; (32°F (0°C)) if the device will be used at or near refrigeration temperature; AND OR • When visual checks of ice are used, periodically measure internal temperatures Comparing the temperature reading of fish to ensure that the ice is sufficient to on the device with the reading on a maintain product temperatures at 40°F (4°C) known accurate reference device (e.g., or less; a NIST-traceable thermometer) under conditions that are similar to how it will AND be used (e.g., air temperature) within • Review monitoring, corrective action, the temperature range at which it will be and verification records within 1 week of used; preparation to ensure they are complete and AND any critical limit deviations that occurred were appropriately addressed. • Once in service, check the temperature- recording device daily before the beginning of operations. Less frequent accuracy checks may be appropriate if they are recommended by the instrument manufacturer and the history of use of the instrument in your facility has shown that the instrument consistently remains accurate for a longer period of time. In addition to checking that the device is accurate by one of the methods described above, this process should include a visual examination of the sensor and any attached wires for damage or kinks. The device should be checked to ensure that it is operational and, where applicable, has sufficient ink and paper; AND • Calibrate the temperature-recording device against a known accurate reference device (e.g., a NIST-traceable thermometer) at least once a year or more frequently if recommended by the device manufacturer. Optimal calibration frequency is dependent upon the type, condition, past performance, and conditions of use of the device.

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 227 weekly Review Review corrective corrective 1 week of 1 week verification verification action, and action, monitoring, monitoring, preparation iced crabmeat records within Check internal temperature of record RECORDS VERIFICATION Ice storage tal fragments). Processing Control (Icing Model).” This product evaluate evaluate based on exposure Hold and Re-ice the Re-ice ACTION(S) e and temperature abuse during icing. It is CORRECTIVE 3-3 and 3-4 (Chapter 3) for other potential temperature total time and the hazard, depending upon nature of your employee Production before before shipping Each case immediately TABLE 12-2 TABLE MONITORING Example Only (ICING MODEL) observation See Text for Full Recommendations See Text AND REFRIGERATED PROCESSING CONTROL AND REFRIGERATED WHAT HOW FREQUENCY WHO Adequacy of iceAdequacy Visual CONTROL STRATEGY EXAMPLE 2 - REFRIGERATED STORAGE EXAMPLE 2 - REFRIGERATED CONTROL STRATEGY product with ice Finished MEASURE FOR EACH containers completely PREVENTIVE surrounded CRITICAL LIMITS and toxin formation HAZARD(S) Pathogenic Pathogenic SIGNIFICANT bacteria growth (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Refrigerated Storage and example illustrates how a blue crabmeat processor can control pathogenic bacteria growth and toxin formation as a result of tim It may be necessary to select more than one control strategy in order fully provided for illustrative purposes only. operation. Pathogenic bacteria growth and toxin formation may be only one of several significant hazards for this product. Refer to Tables hazards (e.g., environmental chemical contaminants and pesticides, pathogen survival through cooking and pasteurization, me POINT CRITICAL Finished CONTROL product cooler

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 228 Review Review check it per year per year corrective corrective 1 week of 1 week Check the veriﬁcation veriﬁcation action, and action, monitoring, monitoring, preparation daily, at the daily, beginning of ensure that it accuracy and is operational before putting before records within data logger for data logger for into operation; damage and to operations; and calibrate it once Data checks RECORDS VERIFICATION logger printout Record or visual Record

tal fragments). and Processing Control (Refrigeration Model).” Move to Move exposure Hold and f time and temperature abuse during ACTION(S) CORRECTIVE 3-3 and 3-4 (Chapter 3) for other potential temperature on total time and/or add ice evaluate based evaluate alternate cooler employee Production check of with visual Continuous, Continuous, once per day recorded data TABLE 12-3 TABLE MONITORING Example Only data logger temperature (REFRIGERATION MODEL) (REFRIGERATION Digital time and See Text for Full Recommendations See Text AND REFRIGERATED PROCESSING CONTROL AND REFRIGERATED WHAT HOW FREQUENCY WHO Cooler temperature CONTROL STRATEGY EXAMPLE 2 - REFRIGERATED STORAGE EXAMPLE 2 - REFRIGERATED CONTROL STRATEGY 40°F Cooler MEASURE FOR EACH PREVENTIVE maintained at or below CRITICAL LIMITS and toxin formation HAZARD(S) Pathogenic Pathogenic SIGNIFICANT bacteria growth (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Refrigerated Storage and This example illustrates how a blue crabmeat processor can control pathogenic bacteria growth and toxin formation as a result o refrigerated storage. It is provided for illustrative purposes only. Pathogenic bacteria growth and toxin formation may be only one of several signiﬁcant hazards for this product. Refer to Tables hazards (e.g., environmental chemical contaminants and pesticides, pathogen survival through cooking and pasteurization, me POINT CRITICAL Finished CONTROL product cooler

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 229 • CONTROL STRATEGY EXAMPLE 3 - COOLING OR AFTER COOKING CONTROL • Use appropriate instruments (e.g., a It may be necessary to select more than one temperature-indicating device, such as a control strategy in order to fully control the hazard, thermometer, a continuous temperature- depending upon the nature of your operation. recording device, such as a time and temperature data logger, a scale) and/or Set Critical Limits. visual observations as necessary to measure • The product is cooled from 135°F (57.2°C) to the critical factors of the process that affect 70°F (21.1°C) within 2 hours; the rate of cooling, as established by a cooling rate study. AND • The product is further cooled from 135°F Example: (57.2°C) to 40°F (4.4°C) within an additional A crayfish processor identifies cooling 4 hours; after the cook step as a CCP for pathogenic bacteria growth and toxin OR formation. The processor establishes a • The minimum or maximum values for the cooling critical limit of no more than critical factors of the process that affect the 2 hours from 135°F (57.2°C) to 70°F rate of cooling, as established by a cooling (21.1°C) and no more than 4 more rate study (e.g., product internal temperature hours from 70°F (21.1°C) to 40°F at the start of cooling, cooler temperature, (4.4°C). The processor uses marked quantity of ice, quantity or size of the batches of cooked product to monitor product being cooled, product formulation, the cooling process. The time that the configuration of the product in the cooler). marked batch is removed from the cooker is monitored visually, and the Establish Monitoring Procedures. internal temperature of the product in that batch 2 hours after cooking and 4 » What Will Be Monitored? more hours after cooking is monitored • The length of the cooling cycle and the with a dial thermometer. internal temperature of the product; Example: OR Another crayfish processor has similarly • The critical factors of the process that affect identified cooling after cooking as the rate of cooling, as established by a a CCP and has established the same cooling rate study. critical limit. The processor uses a digital time and temperature data logger » How Will Monitoring Be Done? to monitor the cooling rate of the cooked • Clock; product. AND Example: • Use a temperature-indicating device (e.g., a Another crayfish processor has similarly thermometer) and visual check on time of identified cooling after cooking as a CCP. cooling; This processor has performed a cooling rate study that determined that a cooling OR rate of no more than 2 hours from 135°F • Use a continuous temperature-recording device (57.2°C) to 70°F (21.1°C) and no more (e.g., time and temperature data logger); than 4 more hours from 70°F (21.1°C) to 40°F (4.4°C) can be achieved as long as

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 230 certain conditions are met in the cooling Establish Corrective Action Procedures. process. The study determined that the following critical limits must be met: Take the following corrective action to a product a cooler temperature of no more than involved in a critical limit deviation: 60°F (15.6°C) during the first 2 hours of • Recook the product, after giving cooling and no more than 40°F (4.4°C) consideration to the fact that any S. aureus during the remainder of cooling; and toxin that may be present may not be no more than 1,000 pounds of crayfish inactivated by heat; in the cooler. The processor monitors OR the cooler temperature with a recording • Divert the product to a use in which the thermometer and monitors the weight of critical limit is not applicable (e.g., divert the product at receiving with a scale. crabmeat to a stuffed flounder operation), » How Often Will Monitoring Be Done (Frequency)? after giving consideration to the fact that any • For temperature-indicating devices: B. cereus toxin that may be present may not be inactivated by heat; At least every 2 hours; OR OR • Destroy the product; • For temperature-recording devices: At least every 2 hours a device is placed OR in the product. It provides continuous • Divert the product to a non-food use. monitoring, which is visually checked at AND the end of the cooling period; Take the following corrective actions to regain control OR over the operation after a critical limit deviation: • For critical aspects of the cooling process: • Prevent further deterioration of the product: As often as necessary to ensure control Add ice to the product; of the process. AND » Who Will Do the Monitoring? • Address the root cause: • For temperature-recording devices: Make repairs or adjustments to the Monitoring is performed by the device malfunctioning cooler; itself. The visual check of the data OR generated by the device, to ensure that the critical limits have consistently been • Make adjustments to the ice application met, may be performed by any person operation. who has an understanding of the nature of the controls; Establish a Recordkeeping System. • For temperature-indicating devices: OR Cooling records showing the internal • For other checks: temperature of the product, and the Any person who has an understanding of length of time between the end of the the nature of the controls. cooking (or the time that the product internal temperature falls below 135°F (57.2°C)), and the time that the measurement was made;

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 231 OR (e.g., product internal temperature) • For temperature-recording devices: within the temperature range at which it will be used; Record of continuous temperature monitoring; AND AND • Once in service, check the temperature- indicating device or temperature-recording Record of visual checks of recorded data; device daily before the beginning of OR operations. Less frequent accuracy checks may • For the critical factors of the process that be appropriate if they are recommended by affect the rate of cooling, as established by a the instrument manufacturer and the history cooling rate study: of use of the instrument in your facility has Appropriate records (e.g., processing shown that the instrument consistently remains record showing the results of the time accurate for a longer period of time. In addition and temperature checks and/or volume to checking that the device is accurate by one of product in cooler). of the methods described above, this process should include a visual examination of the Establish Veriﬁcation Procedures. sensor and any attached wires for damage or kinks. The device should be checked to ensure • Before a temperature-indicating device (e.g., that it is operational; a thermometer) or temperature- recording device (e.g., a time and temperature data AND logger) is put into service, check the • Calibrate the temperature-indicating device accuracy of the device to verify that the or temperature-recording device against a factory calibration has not been affected. known accurate reference device (e.g., a This check can be accomplished by: NIST-traceable thermometer) at least once a Immersing the sensor in an ice slurry year or more frequently if recommended by (32°F (0°C)) if the device will be used at the device manufacturer. Optimal calibration or near refrigeration temperature; frequency is dependent upon the type, condition, past performance, and conditions OR of use of the device. Consistent temperature Immersing the sensor in boiling water variations away from the actual value (drift) (212°F (100°C)) if the device will be used found during checks and/or calibration may at or near the boiling point. Note that show a need for more frequent calibration or the temperature should be adjusted to the need to replace the device (perhaps with compensate for altitude, when necessary; a more durable device). Devices subjected to OR high temperatures for extended periods of time may require more frequent calibration. Doing a combination of the above if Calibration should be performed at a the device will be used at or near room minimum of two temperatures that bracket temperature; the temperature range at which it is used; OR AND Comparing the temperature reading on • Review monitoring, corrective action, the device with the reading on a known and veriﬁcation records within 1 week of accurate reference device (e.g., a NIST- preparation to ensure they are complete and traceable thermometer) under conditions any critical limit deviations that occurred that are similar to how it will be used were appropriately addressed.

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 232 Review Review check it that it is per year corrective corrective 1 week of 1 week verification verification action, and action, operational monitoring, monitoring, preparation daily, at the daily, for accuracy for and damage beginning of thermometer and to ensure before putting before records within Check the dial into operation; operations; and calibrate it once record RECORDS VERIFICATION Production tal fragments). Make Make cooler cooling after cooking. In this case, the example illustrates how a dungeness ACTION(S) adjustment CORRECTIVE 3-3 and 3-4 (Chapter 3) for other potential or repairs to Destroy product ses only. It may be necessary to select more than one ses only. .” supervisor Production ores of C. perfringens or B. cereus batch every 2 hours every Approximately during cooking TABLE 12-4 TABLE MONITORING Example Only Dial Clock Start marked thermometer in marked batches marked of cooked crabs of cooked See Text for Full Recommendations See Text WHAT HOW FREQUENCY WHO Cooked Cooked Length of temperature crab internal cooling cycle CONTROL STRATEGY EXAMPLE 3 - COOLING AFTER COOKING CONTROL CONTROL STRATEGY hours MEASURE FOR EACH PREVENTIVE and 70°F to Crabs cooled from 135°F to CRITICAL LIMITS 40°F in 4 more 70°F in 2 hours and toxin formation HAZARD(S) Pathogenic Pathogenic SIGNIFICANT bacteria growth (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) hazards (e.g., environmental chemical contaminants and pesticides, pathogen survival through cooking and pasteurization, me product is fully cooled, i.e., to 40°F (4.4°C), after cooking before significant handling. It provided for illustrative purpo control strategy in order to fully the hazard, depending upon nature of your operation. Pathogenic bacteria growth and toxin formation may be only one of several significant hazards for this product. Refer to Tables crabmeat processor can control pathogenic bacteria growth and toxin formation as a result of time and temperature abuse during This table is an example of a portion of a HACCP plan using “Control Strategy Example 3 - Cooling After Cooking Control.” This Note: Control during unrefrigerated processing is covered under “Control Strategy Example 4 - Unrefrigerated Processing Note: Control is necessary at this step because the processor has not established that cook is adequate to kill sp POINT cooler CRITICAL CONTROL Cooked crab Cooked

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 233 • CONTROL STRATEGY EXAMPLE 4 - OR UNREFRIGERATED PROCESSING CONTROL • CRITICAL LIMIT 3: It may be necessary to select more than one The product is held at internal control strategy in order to fully control the temperatures below 50°F (10°C) hazard, depending upon the nature of your throughout processing, operation. OR Set Critical Limits. Alternatively, the product is held at The following recommended critical limits are ambient air temperatures below 50°F intended to keep the pathogenic bacteria of (10°C) throughout processing. greatest concern in fish and fishery products For cooked, ready-to-eat products: from reaching the rapid growth phase (i.e., Note: The critical limits for cooked, ready-to-eat products are keep them in the lag phase) as a result of time intended to begin at the completion of cooling or at the time that the and temperature exposure during processing. product is first significantly handled after cooking, whichever occurs You may also wish to reference Table A-2 first. (Appendix 4), which provides cumulative time • CRITICAL LIMIT 1: and temperature combinations for the pathogenic If at any time the product is held at bacteria individually. internal temperatures above 80°F For raw, ready-to-eat products: (26.7°C), exposure time (i.e., time at internal temperatures above 50°F (10°C) • CRITICAL LIMIT 1: but below 135ºF (57.2ºC)) should be If at any time the product is held at limited to 1 hour (3 hours if S. aureus is internal temperatures above 70°F the only pathogen of concern), (21.1°C), exposure time (i.e., time at internal temperatures above 50°F (10°C) OR but below 135ºF (57.2ºC)) should be Alternatively, if at any time the product limited to 2 hours (3 hours if S. aureus is is held at internal temperatures above the only pathogen of concern), 80°F (26.7°C), exposure time (i.e., time at internal temperatures above 50°F (10°C) OR but below 135ºF (57.2ºC)) should be Alternatively, exposure time (i.e., time at limited to 4 hours, as long as no more internal temperatures above 50°F (10°C) than 1 of those hours is above 70°F but below 135ºF (57.2ºC)) should be (21.1°C); limited to 4 hours, as long as no more than 2 of those hours are between 70°F OR (21.1°C) and 135ºF (57.2ºC); • CRITICAL LIMIT 2: OR If at any time the product is held at internal temperatures above 70°F • CRITICAL LIMIT 2: (21.1°C) but never above 80°F (26.7°C), If at any time the product is held at exposure time at internal temperatures internal temperatures above 50°F (10°C) above 50°F (10°C) should be limited to but never above 70°F (21.1°C), exposure 2 hours (3 hours if S. aureus is the only time at internal temperatures above 50°F pathogen of concern), (10°C) should be limited to 5 hours (12 hours if S. aureus is the only pathogen of concern);

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 234 OR Example: Alternatively, if the product is never A crabmeat processor using a retort process held at internal temperatures above identifies a series of post-cook processing 80°F (26.7°C), exposure times at internal steps (e.g., backing, picking, and packing) temperatures above 50°F (10°C) should as CCPs for pathogenic bacteria growth be limited to 4 hours, as long as no more and toxin formation. Initial cooling takes than 2 of those hours are above 70°F place in the cooking crates and then the (21.1°C); product is first handled at temperatures of around 120°F (48.9°C). The processor sets a OR critical limit of maximum cumulative time • CRITICAL LIMIT 3: of exposure of 4 hours at product internal If at any time the product is held at temperatures above 50°F (10°C), no more internal temperatures above 50°F (10°C) than 1 of which is above 70°F (21.1°). This but never above 70°F (21.1°C), exposure critical limit is selected because the crabs time at internal temperatures above 50°F are handled while still warm (e.g., above (10°C) should be limited to 5 hours (12 80°F (26.7°C)). Cooling that takes place hours if S. aureus is the only pathogen of after the product is handled is included in concern); the limit. OR Example: Another crabmeat processor using a retort • CRITICAL LIMIT 4: process also identifies a series of post-cook The product is held at internal processing steps (e.g., backing, picking, temperatures below 50°F (10°C) and packing) as CCPs. However, this throughout processing, product is cooled fully before handling, OR and ice is used on the product during processing to control time and temperature Alternatively, the product is held at abuse. The processor sets a critical limit of ambient air temperatures below 50°F a maximum product internal temperature (10°C) throughout processing. of 50°F (10°C) at all times. Specifying a Note: The preceding recommended critical limits do not address time of exposure is not necessary in this internal product temperatures between 40°F (4.4°C), the case, because it is not reasonably likely recommended maximum storage temperature for refrigerated fish and fishery products, and 50°F (10°C). The recommended that the product would be held long critical limits do not address such temperatures because growth of enough that significant pathogen growth foodborne pathogenic bacteria is very slow at these temperatures could occur at this temperature (e.g., 2 to and the time necessary for significant growth is longer than would be reasonably likely to occur in most fish and fishery product processing 21 days, depending upon the pathogen). steps. However, if you have processing steps that occur at these temperatures that approach the maximum cumulative exposure times listed in Table A-2 (Appendix 4) for the pathogenic bacteria of concern in your product, you should consider development of a critical limit for control at these temperatures. The cumulative time and temperature critical limits above (other than the last critical limit for raw, ready-to-eat and cooked, ready-to-eat fish and fishery products) are depicted in table format below:

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 235 TABLE 12-5

CUMULATIVE TIME AND TEMPERATURE CRITICAL LIMITS

THEN THE CUMULATIVE EXPOSURE TIME AT INTERNAL WHEN THE PRODUCT INTERNAL TEMPERATURES ABOVE 50°F (10°C) IN HOURS IS1… TEMPERATURE RANGE IN ºF (ºC) IS… 12 3 512

RAW, READY TO EAT >503 XX2 (>10) Alternatively, >50 to ≤ 70 X (>10 to ≤ 21.1)

Plus X >70 (>21.1)

Alternatively, X >50 to ≤ 70 (>10 to ≤ 21.1) Plus X >70 (>21.1) >50 to ≤ 70 XX2 (>10 to ≤21.1)

COOKED, READY TO EAT >504 XX2 (>10) Alternatively, X >50 to ≤ 70 (>10 to ≤ 21.1) Plus X >704 (>21.1) >50 to ≤ 80 XX2 (>10 to ≤ 26.7) Alternatively, X >50 to ≤ 70 (>10 to ≤ 21.1) Plus X >70 to <80 (>21.1 to <26.7) Alternatively, X >50 to ≤ 70 (>10 to ≤ 21.1) Plus X >70 to <80 (>21.1 to <26.7) >50 to ≤ 70 XX2 (>10 to ≤ 21.1)

1. Time at temperatures of 135ºF (57.2ºC) and above is not counted. 2. Where S. aureus is the only pathogen of public health signiﬁcance. 3. Temperature may exceed 70ºF (21.1ºC). 4. Temperature may exceed 80ºF (26.7ºC).

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 236 Establish Monitoring Procedures. • Make visual observations of length of exposure to unrefrigerated conditions (i.e., » What Will Be Monitored? >40ºF (4.4ºC)) using a clock. • The length of time of product exposure to Example: unrefrigerated conditions (i.e., above 40°F A crabmeat processor identifies a (4.4°C)); series of processing steps (e.g., backing, The product internal temperature during picking, and packing) as CCPs for the exposure period; pathogenic bacteria growth. The processor OR establishes a critical limit of no more than 1 cumulative hour of exposure to The ambient temperature of the unrefrigerated temperature during these processing area; processing steps (Critical Limit 1). The OR processor uses marked product containers • The length of time only of product exposure to monitor the progress of the product to unrefrigerated conditions (i.e., >40°F through the three processing steps. The (4.4°C)), for critical limit 1 (raw, ready-to-eat time that the marked container is removed and cooked, ready-to-eat); from and returned to refrigeration is monitored using a clock. OR • The internal temperature only of the Example: product, when internal temperatures are held Another crabmeat processor with identical below 50°F (10°C) or above 135°F (57.2°C) CCPs establishes a more complex set of throughout processing for critical limit 3 critical limits: no more than 4 cumulative for raw, ready-to-eat or critical limit 4 for hours with product internal temperatures cooked, ready-to-eat; above 50°F (10°C), with no more than 1 of those hours above 70°F (21.1°C) OR (Critical Limit 1 Alternative). This • The ambient air temperature only, when processor also uses marked containers ambient air temperature is held below 50°F to monitor the progress of the product (10°C) throughout processing for critical limit through the process. However, in addition 3 for raw, ready-to-eat or critical limit 4 for to monitoring time using a clock, the cooked, ready-to-eat. processor also monitors product internal temperature for the marked containers » How Will Monitoring Be Done? using a thermometer. This monitoring • For product internal temperature or ambient technique provides the processor more air temperature: flexibility in processing but requires more Use a temperature-indicating device (e.g., monitoring effort. a thermometer); Example: OR A lobster meat processor identifies the • For ambient air temperature: meat removal process as a CCP for pathogenic bacteria growth. The operation Use a continuous temperature-recording is performed under near-refrigeration device (e.g., a recording thermometer); conditions (<50°F (10°C)) (Critical Limit AND/OR 4 Alternative). The processor monitors ambient air temperature with a digital data logger.

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 237 » How Often Will Monitoring Be Done (Frequency)? • Divert the product to a use in which the • For continuous temperature-recording critical limit is not applicable (e.g., divert devices: crabmeat to a stuffed ﬂounder operation), after giving consideration to the fact that Continuous monitoring during processing any S. aureus or B. cereus toxin that may be is accomplished by the device itself, with present may not be inactivated by heat; a visual check of the recorded data at least once per day; OR OR • Destroy the product; • For temperature-indicating devices and OR clocks: • Divert the product to a non-food use. At least every 2 hours; AND OR Take the following corrective actions to regain control Every batch. over the operation after a critical limit deviation:

» Who Will Do the Monitoring? • Add ice to the product; • For continuous temperature recording OR devices: • Return the affected product to the cooler; Monitoring is performed by the device AND itself. The visual check of the data • Modify the process as needed to reduce the generated by the device, to ensure that time and temperature exposure. the critical limits have consistently been met, may be performed by any person who has an understanding of the nature Establish a Recordkeeping System. of the controls; • Processing records showing the results of time and/or temperature exposure measurements. OR • For temperature-indicating devices and Establish Veriﬁcation Procedures. clocks: • Before a temperature-indicating device (e.g., Any person who has an understanding of a thermometer) or temperature-recording the nature of the controls. device (e.g., a recording thermometer) is put into service, check the accuracy of the Establish Corrective Action Procedures. device to verify that the factory calibration Take the following corrective action to a product has not been affected. This check can be involved in a critical limit deviation: accomplished by: • Chill and hold the affected product until an Immersing the sensor in an ice slurry evaluation of the total time and temperature (32°F (0°C)) if the device will be used at exposure is performed; or near refrigeration temperature; OR OR • Cook the product, after giving consideration Immersing the sensor in boiling water to the fact that any S. aureus or B. cereus (212°F (100°C)) if the device will be used toxin that may be present may not be at or near the boiling point. Note that inactivated by heat; the temperature should be adjusted to compensate for altitude, when necessary; OR

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 238 OR or the need to replace the device (perhaps Doing a combination of the above if with a more durable device). Calibration the device will be used at or near room should be performed at a minimum of two temperature; temperatures that bracket the temperature range at which it is used; OR AND Comparing the temperature reading on the device with the reading on a known • Where appropriate to the critical limit, by accurate reference device (e.g., a NIST- using a study that establishes the relationship traceable thermometer) under conditions between exposure time and product that are similar to how it will be used temperature; (e.g., air temperature and product internal AND temperature) within the temperature • Review monitoring, corrective action, range at which it will be used; and veriﬁcation records within 1 week of AND preparation to ensure they are complete and • Once in service, check the temperature- any critical limit deviations that occurred indicating device or temperature-recording were appropriately addressed. device daily before the beginning of operations. Less frequent accuracy checks may be appropriate if they are recommended by the instrument manufacturer and the history of use of the instrument in your facility has shown that the instrument consistently remains accurate for a longer period of time. In addition to checking that the device is accurate by one of the methods described above, this process should include a visual examination of the sensor and any attached wires for damage or kinks. The device should be checked to ensure that it is operational and, where applicable, has sufﬁcient ink and paper; AND • Calibrate the temperature-indicating device or temperature-recording device against a known accurate reference device (e.g., a NIST-traceable thermometer) at least once a year or more frequently if recommended by the device manufacturer. Optimal calibration frequency is dependent upon the type, condition, past performance, and conditions of use of the device. Consistent temperature variations away from the actual value (drift) found during checks and/or calibration may show a need for more frequent calibration

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 239 Review Review per year 1 week of 1 week monitoring, monitoring, preparation ensure that it accuracy and is operational before putting before records within Check the dial into operation; damage and to operations; and calibrate it once veriﬁcation, and veriﬁcation, thermometer for at check it daily, corrective action corrective the beginning of record RECORDS VERIFICATION Production

tal fragments). his example illustrates how a blue crabmeat evaluate evaluate based on exposure Hold and ACTION(S) CORRECTIVE 3-3 and 3-4 (Chapter 3) for other potential temperature Immediately total time and ice product or ormation as a result of time and temperature move to cooler move one control strategy in order to fully the Processing Control. supervisor Production container in-process and packing Start marked every 2 hours every approximately cooler, picking, picking, cooler, during backing, TABLE 12-6 TABLE MONITORING Example Only Dial Visual Visual containers of marked of marked observation thermometer using a clock See Text for Full Recommendations See Text WHAT HOW FREQUENCY WHO period internal exposure during the exposure to above 40°F) above temperature The product The length of unrefrigerated conditions (i.e., conditions (i.e., time of product CONTROL STRATEGY EXAMPLE 4 - UNREFRIGERATED PROCESSING CONTROL EXAMPLE 4 - UNREFRIGERATED CONTROL STRATEGY 70°F MEASURE (i.e., time (i.e., FOR EACH but below at internal PREVENTIVE above 50°F above as no more backing, in- backing, picking, and picking, temperatures 135ºF) during hours, as long hours, CRITICAL LIMITS Exposure time hours is above hours is above be limited to 4 process cooler, process cooler, than 1 of those packing should and toxin formation HAZARD(S) Pathogenic SIGNIFICANT bacteria growth (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) hazards (e.g., environmental chemical contaminants and pesticides, pathogen survival through cooking and pasteurization, me abuse during unrefrigerated processing. It is provided for illustrative purposes only. It may be necessary to select more than abuse during unrefrigerated processing. It is provided for illustrative purposes only. hazard, depending upon the nature of your operation. Pathogenic bacteria growth and toxin formation may be only one of several signiﬁcant hazards for this product. Refer to Tables processor that handles the crabs at beginning of backing while still hot can control pathogenic bacteria growth and toxin f This table is an example of a portion of a HACCP plan using “Control Strategy Example 4 - Unrefrigerated Processing Control.” T Note: Control during refrigerated storage is covered under “Control Strategy Example 2 - Refrigerated Storage and Note: This critical limit is necessary because the crabs are handled at internal temperatures above 80°F during backing POINT CRITICAL Backing, CONTROL in-process and packing cooler, picking, picking, cooler,

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 240 BIBLIOGRAPHY. • Gecan, J. S., R. Bandler, and W. F. Staruskiewcz. 1994. Fresh and frozen We have placed the following references on shrimp: a profile of filth, microbiological display in the Division of Dockets Management, contamination, and decomposition. J. Food Food and Drug Administration, 5630 Fishers Lane, Prot. 57:154158. rm. 1061, Rockville, MD 20852. You may see • Hood, M. A., G. E. Ness, G. E. Rodrick, and them at that location between 9 a.m. and 4 p.m., N. J. Blake. April 1983. Effects of storage Monday through Friday. As of March 29, 2011, on microbial loads of two commercially FDA had verified the Web site address for the important shellfish species, Crassostrea references it makes available as hyperlinks from virginica and Mercenaria campechiensis. the Internet copy of this guidance, but FDA is not Appl. Environ. Microbiol. 45:1221−1228. responsible for any subsequent changes to Non- • Huss, H. H., 1993. Assurance of seafood FDA Web site references after March 29, 2011. quality. FAO fisheries technical paper, no. • Ahmed, F. E. (ed.). 1991. Seafood safety. 334. FAO, Rome, Italy. 169p. National Academy Press, Washington, DC. • Huss, H. H. (ed.). 1993. Quality and quality • Baek, S-Y., S-Y. Lim, D-H. Lee, K-H. Min, changes in fresh fish. FAO fisheries technical and C-M. Kim. 2000. Incidence and paper, no. 346. FAO, Rome, Italy. characterization of Listeria monocytogenes • Huss, H. H. 1997. Control of indigenous from domestic and imported foods in Korea. pathogenic bacteria in seafood. Food J. Food Prot. 63:186−189. Control. 8:91−98. • Buchanan, R. L., and L. A. Klawitter. 1992. • Jemmi, T., and A. Keusch. 1992. Behavior of Effectiveness of Carnobacterium piscicola Listeria monocytogenes during processing LK5 for controlling the growth of Listeria and storage of experimentally contaminated monocytogenes Scott A in refrigerated foods. hot-smoked trout. Int. J. Food Microbiol. J. Food Safety 12:219−236. 15:339−346. • Duffes, F., C. Corre, F. Leroi, X. Dousset, • Huss, H. H., A. Reilly, and P. K. Ben and P. Boyaval. 1999. Inhibition of Listeria Embarek. 2000. Prevention and control monocytogenes by in situ produced and of hazards in seafood. Food Control. semipurified bacteriocins on Carnobacterium 11:149−156. spp. on vacuum-packed, refrigerated cold- • Jørgensen, L. V., and H. H. Huss. 1998. − smoked salmon. J. Food Prot. 62:1394 1403. Prevalence and growth of Listeria • Farber, J. M. 1991. Listeria monocytogenes in fish monocytogenes in naturally contaminated products. J. Food Prot. 54(12):922−924, 934. seafood. Int. J. Food Microbiol. 42:127−131. • Food and Agriculture Organization and • Leung, C. K., Y. W. Huang, and M. World Health Organization. 2005. Risk A. Harrison. 1992. Fate of Listeria assessment of Vibrio cholerae 01 and 0139 monocytogenes and Aeromonas hydrophila in warm-water shrimp in international trade. on packaged channel catfish fillets stored at Microbiological risk assessment series no. 9. 4 C. J. Food Prot. 55:728−730. FAO, Rome, Italy. • Morris, G. J., and R. E. Black. 1985. Cholera • Food and Agriculture Organization and and other vibrioses in the United States. New World Health Organization. 2005. Risk Engl. J. Med. 12:343−350. assessment of Vibrio vulnificus in raw • Nielsen, H.-J. S., and P. Zeuthen. 1984. oysters: interpretative summary and technical Growth of pathogenic bacteria in sliced report. Microbiological risk assessment series vacuum-packed bologna-type sausage no. 8. FAO, Rome, Italy, FAO.

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 241 as influenced by temperature and gas • Rosso, L., S. Bajard, J. P. Flandrois, C. permeability of packaging film. Food Microb. Lahellec, J. Fournaud, and P. Veit. 1996. 1:229−243. Differential growth of Listeria monocytogenes • Palumbo, S. A. 1986. Is refrigeration enough at 4 and 8°C: consequences for the shelf life to restrain foodbourne pathogens? J. Food of chilled products. 59:944−949. Prot. 49: 1003−1009. • Satoshi, I., A. Nakama, Y. Arai, Y. Kokubo, T. • Peixotto, S. S., G. Finne, M. O. Hanna, and Maruyama, A. Saito, T. Yoshida, M. Terao, S. C. Vanderzant. 1979. Presence, growth and Yamamoto, and S. Kumagai. 2000. Prevalence survival of Yersinia entercolitica in oysters, and contamination levels of Listeria shrimp and crab. J. Food Prot. 42:974−981. monoocytogenes in retail foods in Japan. Int. J. Food Microb. 59:73−77. • Peterson, M. E., G. A. Pelroy, R. N. Paranjpye, F. T. Poysky, J. S. Almond, and M. W. Eklund. • Son, N. T., and G. H. Fleet. December 1980. 1993. Parameters for control of Listeria Behavior of pathogenic bacteria in the oyster, monocytogenes in smoked fishery products: Crassostrea commercialis, during depuration, sodium chloride and packaging method. J relaying and storage. Appl. Environ. Food Prot. 56:938−943. Microbiol. 40(6):994−1002. • Philips, F. A., and T. Peeler. December 1972. • U.S. Food and Drug Administration. Bacteriological survey of the blue crab Foodborne pathogenic microorganisms industry. Appl. Microbiol. 24(6):958−966. and natural toxins handbook. In The bad bug book. http://www.fda.gov/ • Rahmati, T., and R. Labbe. 2007. Incidence Food/FoodSafety/FoodborneIllness/ and enterotoxigenicity of Clostridium rneIllnessFoodbornePathogensNaturalToxins/ perfringens and Bacillus cereus from retail BadBugBook/default.htm. seafood. IAFP Annual Meeting. P128. • U.S. Food and Drug Administration. 2009. • Refrigerated Foods and Microbiological Food code. Department of Health and Criteria Committee of the National Food Human Services, Public Health Service, FDA, Processors Association. 1988. Factors Center for Food Safety and Applied Nutrition, to be considered in establishing good College Park, MD. http://www.fda.gov/Food/ manufacturing practices for the production FoodSafety/RetailFoodProtection/FoodCode/ of refrigerated foods. Dairy and Food Sanit. FoodCode2009/default.htm. 8:288−291. • U.S. Food and Drug Administration. • Rivituso, C. P. and Snyder, O. P. 1981. 2005. Quantitative risk assessment on the Bacterial growth at foodservice operating public health impact of pathogenic Vibrio temperatures. J. Food Prot. 44:770−775. parahaemolyticus in raw oysters. Department • Rodríguez, Ó., V. Losada, S. P. Aubourg, of Health and Human Services, Public and J. Barros-Velázquez. 2004. Enhanced Health Service, FDA, Center for Food Safety shelf-life of chilled European hake and Applied Nutrition, College Park, MD. (Merluccius merluccius) stored in slurry http://www.fda.gov/Food/ScienceResearch/ ice as determined by sensory analysis and ResearchAreas/RiskAssessmentSafetyAssessment/ assessment of microbiological activity. Food ucm050421.htm Res. Int’l. 37(8):749−757. • U.S. Food and Drug Administration and U.S. • Rosso, L., J. R. Lobry, J. P. Flandrois. 1993 Department of Agriculture. 2003. Quantitative An unexpected correlation between cardinal assessment of the relative risk to public health temperature of microbial growth highlighted from foodborne Listeria monocytogenes among − by a new mode. J. Theor. Biol. 162:447 463. selected categories of ready-to-eat foods.

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 242 http://www.fda.gov/Food/ScienceResearch/ ResearchAreas/RiskAssessmentSafetyAssessment/ ucm183966.htm. • Wallace, B. J., J. J. Guzewich, M. Cambridge, and S. Altekruse. 1999. Seafood-associated disease outbreaks in New York, 1980-1994. Amer. J. Prev. Med. 17:48−54. • Ward, D. R, and C. R. Hackney (ed.). 1991. Microbiology of marine food products. Van Nostrand Reinhold, New York, NY. • Wentz, B. A., A. P. Duran, A. Swartzentruber, A. H. Schwab, F. D. McClure, D. Archer, and R. B. Read, Jr. 1985. Microbiological quality of crabmeat during processing. J. Food Prot. 48:44−49. • Wong, H.-C., M.-C. Chen, S.-H. Liu, and D.- P. Lin. 1999. Incidence of highly genetically diversiﬁed Vibrio parahaemolyticus in seafood imported from Asian countries. Int. J. Food Microbiol. 52:181−188.

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 243 NOTES:

CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 244 CHAPTER 13: Clostridium botulinum Toxin Formation

UNDERSTAND THE POTENTIAL HAZARD. • Controlling the amount of moisture that is available for pathogenic bacteria growth Clostridium botulinum (C. botulinum) toxin (water activity) in the product by formulation formation can result in consumer illness and (covered in this chapter); death. It is the toxin responsible for botulism. • Controlling the amount of moisture that is About 10 outbreaks of foodborne botulism occur available for pathogenic bacteria growth annually in the United States, from all sources. (water activity) in the product by drying Symptoms include: weakness, vertigo, double (covered in Chapter 14); vision, difficulty in speaking, swallowing and • Controlling the introduction of pathogenic breathing, abdominal swelling, constipation, bacteria after the pasteurization process paralysis, and death. Symptoms start from 18 and after the cooking process performed hours to 36 hours after consumption. Everyone immediately before reduced oxygen packaging is susceptible to intoxication by C. botulinum (covered in Chapter 18); toxin; only a few micrograms of the toxin can • Controlling the source of molluscan shellfish cause illness in a healthy adult. Mortality is high; and the time from exposure to air (e.g., by without the antitoxin and respiratory support, harvest or receding tide) to refrigeration death is likely. to control pathogens from the harvest area This chapter covers the hazard of C. botulinum (covered in Chapter 4); growth and toxin formation as a result of time and • Managing the amount of time that food is temperature abuse during processing, storage, and exposed to temperatures that are favorable distribution. for pathogenic bacteria growth and toxin production (covered generally in Chapter • Strategies for controlling pathogen growth 12; for C. botulinum, in this chapter; and for There are a number of strategies for the control Staphylococcus aureus (S. aureus) in hydrated of pathogens in fish and fishery products. They batter mixes, in Chapter 15); include: • Killing pathogenic bacteria by cooking or • Controlling the level of acidity (pH) in the pasteurization (covered in Chapter 16), or product (covered by the Acidified Foods retorting (covered by the Thermally Processed regulation, 21 CFR 114, for shelf-stable Low-Acid Foods Packaged in Hermetically acidified products, and by this chapter for Sealed Containers regulation, 21 CFR 113 refrigerated acidified products); (hereinafter, the Low-Acid Canned Foods • Controlling the amount of salt or (LACF) Regulation)); preservatives, such as sodium nitrite, in the • Killing pathogenic bacteria by processes that product (covered in this chapter); retain the raw product characteristics (covered in Chapter 17).

CHAPTER 13: Clostridium botulinum Toxin Formation 245 • Formation of C. botulinum toxin packaging and modified atmosphere packaging) When C. botulinum grows, it can produce a extend the shelf life of a product by inhibiting potent toxin, one of the most poisonous naturally the growth of aerobic spoilage bacteria. There occurring substances known. The toxin can be is a safety concern with these products because destroyed by heat (e.g., boiling for 10 minutes), there is an increased potential for the formation but, because of its potency, you should not rely of C. botulinum toxin before spoilage makes the on this as a means of control. product unacceptable to consumers. The strains of C. botulinum can be divided C. botulinum forms toxin more rapidly at higher into two groups, the proteolytic group (i.e., temperatures than at lower temperatures. The those that break down proteins) and the non- minimum temperature for growth and toxin proteolytic group (i.e., those that do not break formation by C. botulinum type E and non- down proteins). The proteolytic group includes proteolytic types B and F is 38°F (3.3°C). For C. botulinum type A and some of types B and F. type A and proteolytic types B and F, the The non-proteolytic group includes C. botulinum minimum temperature for growth is 50°F (10°C). type E and some of types B and F. As the shelf life of refrigerated foods is increased, more time is available for C. botulinum growth The vegetative cells of all types of C. botulinum and toxin formation. As storage temperatures are easily killed by heat. However, C. botulinum increase, the time required for toxin formation is is able to produce spores. In this state, the significantly shortened. You should expect that at pathogen is very resistant to heat. The spores some point during storage, distribution, display, of the proteolytic group are much more resistant or consumer handling of refrigerated foods, safe to heat than are those of the non-proteolytic refrigeration temperatures will not be maintained group (i.e., they require a canning process to be (especially for the non-proteolytic group). Surveys destroyed). Table A-4 (Appendix 4) provides of retail display cases indicate that temperatures guidance about the conditions under which of 45 to 50°F (7 to 10°C) are not uncommon. the spores of the most heat-resistant form Surveys of home refrigerators indicate that of non-proteolytic C. botulinum, type B, are temperatures can exceed 50°F (10°C). killed. However, there are some indications that substances that may be naturally present In reduced oxygen packaged products in which in some products (e.g., dungeness crabmeat), the spores of non-proteolytic C. botulinum such as lysozyme, may enable non-proteolytic are inhibited or destroyed (e.g., smoked fish, C. botulinum to more easily recover after heat pasteurized crabmeat, and pasteurized surimi), damage, resulting in the need for a considerably a normal refrigeration temperature of 40°F more stringent process to ensure destruction. (4.4°C) is appropriate because it will limit the growth of proteolytic C. botulinum and C. botulinum is able to produce toxin when other pathogens that may be present. Even a product in which it is present is exposed to in pasteurized products where non-proteolytic temperatures favorable for growth for sufficient C. botulinum is the target organism for the time. Table A-1 (Appendix 4) provides guidance pasteurization process, and vegetative pathogens, about the conditions under which C. botulinum such as Listeria monocytogenes, are not likely and other pathogenic bacteria are able to grow. to be present (e.g., pasteurized crabmeat and Table A-2 (Appendix 4) provides guidance about pasteurized surimi), a storage temperature of the time necessary at various temperatures for 40°F (4.4°C) is still appropriate because of the toxin formation to occur. potential for survival through the pasteurization Packaging conditions that reduce the amount process and recovery of spores of non-proteolytic of oxygen present in the package (e.g., vacuum C. botulinum, aided by naturally occurring

CHAPTER 13: Clostridium botulinum Toxin Formation 246 substances, such as lysozyme. In this case, toxin formation in reduced oxygen packaged fish refrigeration serves as a prudent second barrier. and fishery products. However, in reduced oxygen packaged products Alternatively, products of this type may be safely in which refrigeration is the sole barrier to marketed frozen, with appropriate labeling outgrowth of non-proteolytic C. botulinum and to ensure that it is held frozen throughout the spores have not been destroyed (e.g., vacuum- distribution. For some reduced oxygen packaged packaged refrigerated raw fish, vacuum-packaged products, control of C. botulinum can be refrigerated unpasteurized crayfish meat, and achieved by breaking the vacuum seal before the reduced oxygen packaged unpasteurized product leaves the processor’s control. dungeness crabmeat), the temperature should be The guidance in this chapter emphasizes maintained below 38°F (3.3°C) from packing to consumption. Ordinarily you, as a processor, can preventive measures for the control of non- ensure that temperatures are maintained below proteolytic strains of C. botulinum in products 38°F (3.3°C) while the product is in your control. that are contained in reduced oxygen packaging. However, the current U.S. food distribution As was previously described, this emphasis system does not ensure the maintenance of these is because such an environment extends the temperatures after the product leaves your control. shelf life of a refrigerated product in a way that, under moderate temperature abuse, favors C. The use of a Time-Temperature Indicator (TTI) on botulinum growth and toxin formation over each consumer package may be an appropriate aerobic spoilage. It is also possible for both means of overcoming these problems in the non-proteolytic and proteolytic C. botulinum distribution system for reduced oxygen packaged to grow and produce toxin in a product that is products in which refrigeration is the sole barrier not reduced oxygen packaged and is subjected to outgrowth of non-proteolytic C. botulinum and to severe temperature abuse. This is the case in which the spores have not been destroyed. because of the development within the product A TTI is a device that monitors the time and of microenvironments that support its growth. temperature of exposure of the package and However, this type of severe temperature abuse alerts the consumer or end user if a safe exposure of refrigerated products is not reasonably likely limit has been exceeded. If a TTI is used, it to occur in the processing environment of most should be validated to ensure that it is fit for its fish or fishery products and the Current Good intended purpose and verified that it is functional Manufacturing Practice in Manufacturing, Packing, at the time of use. It should be designed to alert or Holding Human Food regulation, 21 CFR 110, the consumer (e.g., a color change) that an unsafe requires refrigeration of foods that support the time and temperature exposure has occurred growth of pathogenic microorganisms. that may result in C. botulinum toxin formation. Additionally, the alert should remain perpetually • Sources of C. botulinum visible after it has been triggered, regardless of C. botulinum can enter the process on raw environmental conditions that could reasonably materials. The spores of C. botulinum are very be expected to occur thereafter. Skinner, G. E., common. They have been found in the gills and J. W. Larkin in “Conservative prediction of and viscera of finfish, crabs, and shellfish. C. time to Clostridium botulinum toxin formation for botulinum type E is the most common form found use with time-temperature indicators to ensure in freshwater and marine environments. Types the safety of foods,” Journal of Food Protection, A and B are generally found on land but may 61:1154-1160 (1998), describe a safe time and temperature exposure curve (“Skinner-Larkin also be occasionally found in water. It should be curve”) that may be useful in evaluating the assumed that C. botulinum will be present in any suitability of a TTI for control of C. botulinum raw fishery product, particularly in the viscera.

CHAPTER 13: Clostridium botulinum Toxin Formation 247 Because spores are known to be present in the packaging) may be rapidly depleted by the viscera, any product that will be preserved by activity of spoilage bacteria, resulting in the salting, drying, pickling, or fermentation should formation of a reduced oxygen environment. be eviscerated prior to processing (see the Packaging that provides an oxygen transmission “Compliance Policy Guide,” Sec. 540.650). Without rate (in the final package) of at least 10,000 cc/ evisceration, toxin formation is possible during the m2/24 hours at 24ºC can be regarded as an process, even with strict control of temperature. oxygen-permeable packaging material for fishery Evisceration of fish is the careful and complete products. The oxygen transmission rate of removal of all internal organs in the body cavity packaging material is listed in the packaging without puncturing or cutting them, including specifications that can be obtained from the gonads. If even a portion of the viscera or its packaging manufacturer. contents is left behind, the risk of toxin formation by C. botulinum remains. Uneviscerated small An oxygen-permeable package should provide fish, less than 5 inches in length (e.g., anchovies sufficient exchange of oxygen to allow aerobic and herring sprats), for which processing eliminates spoilage organisms to grow and spoil the product preformed toxin, prevents toxin formation during before toxin is produced under moderate abuse processing and that reach a water phase salt temperatures. Particular care should be taken in content of 10% in refrigerated finished products, determining the safety of a packaging material for a or a water activity of below 0.85 in shelf-stable product in which the spoilage organisms have been finished products, or a pH of 4.6 or less in shelf- eliminated or significantly reduced by processes stable finished products, are not subject to the such as high pressure processing. The generally evisceration recommendation. recommended 10,000 cc/m2/24 hours at 24ºC transmission rate may not be suitable in this case. Note: The water phase salt content of 10% is based on the control of C. botulinum type A and proteolytic types B and F. Use of an oxygen-permeable package may not Note: The water activity value of below 0.85 is based on the compensate for the restriction to oxygen exchange minimum water activity for toxin production of S. aureus. created by practices such as packing in oil or in • Reduced oxygen packaging deep containers from which the air is expressed or the use of oxygen scavengers in the packaging. A number of conditions can result in the creation of a reduced oxygen environment in packaged • Control of C. botulinum fish and fishery products. They include: There are a number of strategies to prevent C. • Vacuum, modified, or controlled atmosphere botulinum growth and toxin formation during packaging. These packaging methods processing, storage, and distribution of finished generally directly reduce the amount of fish and fishery products. They include: oxygen in the package; For products that do not require refrigeration • Packaging in hermetically sealed containers (i.e., shelf-stable products): (e.g., double-seamed cans, glass jars • Heating the finished product in its final with sealed lids, and heat-sealed plastic container sufficiently by retorting to destroy containers), or packing in deep containers the spores of C. botulinum types A B, E, from which the air is expressed (e.g., caviar and F (e.g., canned fish). This strategy is in large containers), or packing in oil. These covered by the LACF Regulation, 21 CFR and similar processing and packaging 113, and these controls are not required to techniques prevent the entry of oxygen into be included in your Hazard Analysis Critical the container. Any oxygen present at the Control Point (HACCP) plan; time of packaging (including oxygen that may be added during modified atmosphere

CHAPTER 13: Clostridium botulinum Toxin Formation 248 • Controlling the level of acidity (pH) in the • Controlling the amount of salt in the product finished product to 4.6 or below, to prevent to 20% water phase salt (wps) or more, to growth and toxin formation by C. botulinum prevent the growth of C. botulinum types A, types A, B, E, and F (e.g., shelf-stable B, E, and F and other pathogens that may acidified products). This strategy is covered be present in the product (e.g., shelf-stable by the Acidified Foods regulation, 21 CFR salted products). This strategy is covered 114, and these controls are not required to be in this chapter. Water phase salt is the included in your HACCP plan; concentration of salt in the water-portion of • Controlling the amount of moisture that is the fish flesh and calculated as follows: (% available in the product (water activity) to NaCl X 100)/(% NaCl + % moisture) = % NaCl 0.85 or below by drying, to prevent growth in water phase. The relationship between and toxin formation by C. botulinum types percent water phase salt and water activity in A, B, E, and F and other pathogens that may fish is described in the following graph. be present in the product (e.g., shelf-stable dried products). This strategy is covered by Chapter 14;

! ! !" !

" " " #

1. This relationship is generally valid for ﬁsh products when salt (sodium chloride) is the primary means of binding water. The speciﬁc food matrix and the use of other salts or water binding agents could affect the exact relationship. If you intend to use this relationship in your control strategy, you should determine the exact relationship in your product by conducting a study.

CHAPTER 13: Clostridium botulinum Toxin Formation 249 For products that require refrigeration: type A and proteolytic types B and F and • Heating the finished product in its final other pathogens that may be present in container sufficiently by pasteurization to the finished product through refrigerated destroy the spores of C. botulinum type storage (e.g., refrigerated dried fish). Drying E and non-proteolytic types B and F, and is covered in Chapter 14, controlling the then minimizing the risk of recontamination growth of proteolytic C. botulinum through by controlling seam closures and cooling refrigeration is covered in this chapter, and water, and next controlling the growth controlling the growth of other pathogenic of the surviving C. botulinum type A and bacteria through refrigeration is covered in proteolytic types B and F in the finished Chapter 12; product with refrigerated storage (e.g.. • Controlling the level of pH to 5 or below, salt pasteurized crabmeat and some pasteurized to 5% wps or more, moisture (water activity) surimi-based products). Pasteurization to 0.97 or below, or some combination is covered in Chapter 16, controlling of these barriers, in the finished product recontamination after pasteurization is sufficiently to prevent the growth of C. covered in Chapter 18, and controlling the botulinum type E and non-proteolytic growth of proteolytic C. botulinum through types B and F by formulation, and then refrigeration is covered in this chapter; controlling the growth of C. botulinum • Heating the product sufficiently to destroy type A and proteolytic types B and F and the spores of C. botulinum type E and other pathogens that may be present in non-proteolytic types B and F, and then the finished product with refrigerated minimizing the risk of recontamination storage (e.g., refrigerated acidified (pickled) by hot filling the product into the final products). Controlling the growth of non- container in a sanitary, continuous, closed proteolytic C. botulinum through formulation filling system and controlling seam closures is covered in this chapter, controlling the and cooling water, and next controlling growth of proteolytic C. botulinum through the growth of the surviving C. botulinum refrigeration is covered in this chapter, and type A and proteolytic types B and F and controlling the growth of other pathogenic other pathogens that may be present in the bacteria through refrigeration is covered in finished product with refrigerated storage Chapter 12; (e.g., vacuum packed soups, chowders, and • Controlling the amount of salt and sauces). Specialized cooking processes preservatives, such as sodium nitrite, in are covered in Chapter 16, prevention of the finished product, in combination with recontamination after specialized cooking other barriers, such as smoke, heat damage, processes is covered in Chapter 18, and competitive bacteria, sufficiently to controlling the growth of proteolytic C. prevent the growth of C. botulinum type botulinum through refrigeration is covered E and non-proteolytic types B and F, and in this chapter, and controlling the growth then controlling the growth of C. botulinum of other pathogenic bacteria through type A and proteolytic types B and F and refrigeration is covered in Chapter 12; other pathogens that may be present in the • Controlling the amount of moisture that finished product with refrigerated storage is available in the product (water activity) (e.g., salted, smoked, or smoke-flavored fish). to 0.97 or below to inhibit the growth of Controlling the growth of non-proteolytic C. botulinum type E and non-proteolytic C. botulinum through salting and smoking types B and F by drying, and then is covered in this chapter, controlling the controlling the growth of C. botulinum growth of proteolytic C. botulinum through

CHAPTER 13: Clostridium botulinum Toxin Formation 250 refrigeration is covered in this chapter, and In hot-smoked products, heat damage to controlling the growth of other pathogenic the spores of C. botulinum type E and non- bacteria through refrigeration is covered in proteolytic types B and F also helps prevent Chapter 12; toxin formation. In these products, control of • Controlling the amount of salt in the the heating process is critical to the safety of finished product, in combination with heat the finished product. It is important to note, damage from pasteurization in the finished however, that this same heating process also product container, sufficiently to prevent reduces the numbers of naturally occurring the growth of C. botulinum type E and spoilage organisms. The spoilage organisms nonproteolytic types B and F, and then would otherwise have competed with, and controlling the growth of C. botulinum inhibited the growth of, C. botulinum. type A and proteolytic types B and F and In cold-smoked fish, it is important that other pathogens that may be present in the product does not receive so much heat the finished product with refrigerated that the numbers of spoilage organisms storage (e.g., some pasteurized surimi- are significantly reduced. This is important based products). Controlling the growth because spoilage organisms must be present of non-proteolytic C. botulinum through to inhibit the growth and toxin formation a combination of salt and heat damage of C. botulinum type E and non-proteolytic is covered in this chapter, controlling the types B and F. This inhibition is important growth of proteolytic C. botulinum through in cold-smoked fish because the heat applied refrigeration is covered in this chapter, and during this process is not adequate to controlling the growth of other pathogenic weaken the C. botulinum spores. Control bacteria through refrigeration is covered in of the temperature during the cold-smoking Chapter 12. process to ensure survival of the spoilage Examples of C. botulinum control in specific organisms is, therefore, critical to the safety products: of the finished product. The interplay of these inhibitory effects • Refrigerated (not frozen), reduced oxygen (i.e., salt, temperature, smoke, and nitrite) packaged smoked and smoke-flavored fish is complex. Control of the brining or dry Achieving the proper concentration of salting process is clearly critical to ensure that salt and nitrite in the flesh of refrigerated, there is sufficient salt in the finished product. reduced oxygen packaged smoked and However, preventing toxin formation by C. smoke-flavored fish is necessary to prevent botulinum type E and non-proteolytic types the formation of toxin by C. botulinum type B and F is made even more complex by the E and non-proteolytic types B and F during fact that adequate salt levels are not usually storage and distribution. Salt works along achieved during brining. Proper drying with smoke and any nitrites that are added during smoking is also critical in order to to prevent growth and toxin formation by C. achieve the finished product water phase botulinum type E and non-proteolytic types salt level (i.e., the concentration of salt in B and F. Note that nitrites should be used the water portion of the fish flesh) needed only in salmon, sable, shad, chubs, and tuna, to inhibit growth and toxin formation by C. according to 21 CFR 172.175 and 21 CFR botulinum. 172.177 , and should not exceed a level of 200 ppm in salmon, sable, shad, chubs and This chapter covers the control procedures 10 ppm in tuna. described above.

CHAPTER 13: Clostridium botulinum Toxin Formation 251 You should ordinarily restrict brining, dry also serves as a prudent second barrier salting, and smoking loads to single species because of the potential survival through and to fish portions of approximately the pasteurization process and recovery of uniform size. This restriction minimizes the spores of non-proteolytic C. botulinum, aided complexity of controlling the operation. You by naturally occurring substances, such as should treat brine to minimize microbial lysozyme. Cooking and pasteurization are contamination or periodically replace it as a covered in Chapter 16, and controlling the good manufacturing practice control. growth of C. botulinum through refrigeration is covered in this chapter. The combination of inhibitory effects that are present in smoked and smoke-flavored fish In the second category of products, filling are not adequate to prevent toxin formation the product into the final container while it is by C. botulinum type A and proteolytic types still hot in a continuous, closed filling system B and F. Strict refrigeration control (i.e., at (i.e., hot filling) is also critical to the safety of or below 40°F (4.4°C)) during storage and the finished product because it minimizes the distribution should be maintained to prevent risk of recontamination of the product with growth and toxin formation by C. botulinum pathogens, including C. botulinum type E and type A and proteolytic types B and F and non-proteolytic types B and F. This control other pathogens that may be present in strategy applies to products such as soups, these products. Controlling the growth of chowders, and sauces that are filled directly proteolytic C. botulinum through refrigeration from the cooking kettle, where the risk of is covered in this chapter, and controlling the recontamination is minimized. It may not growth of other pathogenic bacteria through apply to products such as crabmeat, lobster refrigeration is covered in Chapter 12. meat, or crayfish meat or to other products that are handled between cooking and filling. • Refrigerated (not frozen), reduced oxygen Control of hot filling is covered in Chapter 18. packaged, pasteurized fishery products Chapter 18 also covers other controls that Refrigerated, reduced oxygen packaged, may be necessary to prevent recontamination, pasteurized fishery products fall into two including controlling container sealing and categories: (1) those which are pasteurized controlling contamination of container in the final container; and (2) those which cooling water. These controls may be critical are cooked in a kettle and then hot filled to the safety of both categories of products. into the final container in a continuous, closed filling system (e.g., heat-and-fill Examples of properly pasteurized products soups, chowders, and sauces). In both follow: fish and fishery products generally cases, ordinarily the heating process should (e.g., surimi-based products, soups, be sufficient to destroy the spores of C. or sauces) pasteurized to a minimum

botulinum type E and non-proteolytic types cumulative total lethality of F194°F (F90°C) B and F. In neither case is it likely that = 10 minutes, where z = 12.6°F (7°C) for the heating process will be sufﬁcient to temperatures less than 194°F (90°C), and destroy the spores of C. botulinum type A z = 18°F (10°C) for temperatures above and proteolytic types B and F. Therefore, 194°F (90°C); blue crabmeat pasteurized strict refrigeration control (i.e., at or below to a minimum cumulative total lethality of

40°F (4.4°C)) should be maintained during F185°F (F85°C) = 31 minutes, where z = 16°F storage and distribution to prevent growth (9°C); and dungeness crabmeat pasteurized and toxin formation by C. botulinum type A to a minimum cumulative total lethality of

and proteolytic types B and F. Refrigeration F194°F (F90°C) = 57 minutes, where z = 15.5°F

CHAPTER 13: Clostridium botulinum Toxin Formation 252 (8.6°C). Equivalent processes at different • Adding sufficient acid to reduce temperatures can be calculated using the z the acidity (pH) to 5.0 or below; values provided. • Reducing the amount of moisture that is available for growth (water EXAMPLES OF PROPERLY PASTEURIZED activity) to below 0.97 (e.g., by PRODUCTS adding salt or other substances that MINIMUM CUMULATIVE “bind” the available water); or PRODUCT Z VALUE TOTAL LETHALITY • Making a combination of salt, pH, Fish and fishery F194°F (F90°C) = 10 minutes 12.6°F (7°C), for products temperatures and/or water activity adjustments generally less than 194°F (e.g., surimi- (90°C) that, when combined, prevents the based products, 18°F (10°C) for growth of C. botulinum type E and soups, or temperatures sauces) above 194°F non-proteolytic types B and F (to be (90°C) established by a scientific study). Blue crabmeat F (F ) = 31 minutes 16°F (9°C) 185°F 85°C Much like smoked products, in some of these Dungeness F (F ) = 57 minutes 15.5°F (8.6°C) 194°F 90°C products the interplay of these inhibitory crabmeat effects (i.e., salt, water activity, and pH) can be complex. Control of the brining, pickling, In some pasteurized surimi-based or formulation steps is, therefore, critical to products, salt, in combination with a milder ensure that there are sufficient barriers in the pasteurization process, in the finished product finished product to prevent the growth and container works to prevent growth and toxin toxin formation of C. botulinum type E and formation by C. botulinum type E and non- non-proteolytic types B and F during storage proteolytic types B and F. An example of a and distribution. These control procedures properly pasteurized surimi-based product are covered in this chapter. in which 2.4% wps is present is one that has been pasteurized at an internal temperature You should ordinarily restrict brining and of 185°F (85°C) for at least 15 minutes. This pickling loads to single species and to fish process may not be suitable for other types of portions of approximately uniform size. products because of the unique formulation This restriction minimizes the complexity of and processing involved in the manufacture of controlling the operation. You should treat surimi-based products. brine to minimize microbial contamination or periodically replace it as a good • Refrigerated (not frozen), reduced oxygen manufacturing practice control. packaged pickled fish, salted fish, caviar, and similar products The controls discussed above are not sufficient to prevent toxin formation by C. In pickled fish, salted fish, caviar, and similar botulinum type A and proteolytic types B products that have not been preserved and F. Strict refrigeration control (i.e., at sufficiently for them to be shelf stable, or below 40°F (4.4°C)) during storage and growth and toxin formation by C. botulinum distribution should, therefore, be maintained type E and non-proteolytic types B and F is to prevent growth and toxin formation by C. controlled by one of the following: botulinum type A and proteolytic types B and • Adding sufficient salt to produce F and other pathogens that may be present a water phase salt level (i.e., the in these products. Controlling the growth of concentration of salt in the water proteolytic C. botulinum through refrigeration portion of the fish flesh) of at least 5%; is covered in this chapter, and controlling the

CHAPTER 13: Clostridium botulinum Toxin Formation 253 growth of other pathogenic bacteria through • Frozen, reduced oxygen packaged raw, refrigeration is covered in Chapter 12. unpreserved fish and unpasteurized, cooked fishery products • Refrigerated (not frozen), reduced oxygen For frozen, reduced oxygen packaged raw, packaged raw, unpreserved fish and unpreserved fish (e.g., frozen, vacuum- unpasteurized, cooked fishery products packaged fish fillets) and frozen, reduced For refrigerated, reduced oxygen packaged oxygen packaged, unpasteurized, cooked raw, unpreserved fish (e.g., refrigerated, fishery products (e.g., frozen, vacuum- vacuum-packaged fish fillets) and refrigerated, packaged, unpasteurized crabmeat, lobster reduced oxygen packaged, unpasteurized, meat, or crayfish meat), the sole barrier to cooked fishery products (e.g., refrigerated, toxin formation by C. botulinum type E vacuum-packaged, unpasteurized crabmeat, and non-proteolytic types B and F during lobster meat, or crayfish meat), the sole finished product storage and distribution barrier to toxin formation by C. botulinum is freezing. Because these products may type E and non-proteolytic types B and appear to the retailer, consumer, or end user F during finished product storage and to be intended to be refrigerated, rather than distribution is refrigeration. These types of C. frozen, labeling to ensure that they are held botulinum will grow at temperatures as low frozen throughout distribution is critical to as 38°F (3.3°C). As was previously noted, their safety. maintenance of temperatures below 38°F (3.3°C) after the product leaves your control Controls should be in place to ensure that and enters the distribution system cannot such products are immediately frozen after normally be ensured. The use of a TTI on processing, maintained frozen throughout the smallest unit of packaging (i.e., the unit storage in your facility, and labeled to of packaging that will not be distributed be held frozen and to be thawed under any further, usually consumer or end-user refrigeration immediately before use (e.g., package) may be an appropriate means of “Important, keep frozen until used, thaw overcoming these problems in the distribution under refrigeration immediately before use”). system. This chapter provides controls for the Frozen, reduced oxygen packaged products application of TTIs for packaging. that are customarily cooked by the consumer or end user in the frozen state (e.g., boil-in- If you intend to package these products in bag products and frozen fish sticks) need not a reduced oxygen package and you do not be labeled to be thawed under refrigeration. intend to apply a TTI on each consumer For purposes of hazard analysis, other frozen package, you should evaluate the effectiveness products that do not contain the “keep of other preventive measures, either singularly, frozen” statement should be evaluated as if or in combination, that may be effective in they will be stored refrigerated because the preventing growth and toxin formation by C. consumer or end user would not have been botulinum. Such evaluation is customarily warned to keep them frozen. accomplished by conducting an inoculated pack study under moderate abuse conditions. Control procedures to ensure that product A suitable protocol for the performance of is properly labeled with “keep frozen” such studies is contained in a 1992 publication instructions are covered in this chapter. by the National Advisory Committee on Microbiological Criteria for Foods, “Vacuum or modified atmosphere packaging for refrigerated, raw fishery products.”

CHAPTER 13: Clostridium botulinum Toxin Formation 254 • Control in unrefrigerated (shelf-stable), DETERMINE WHETHER THE POTENTIAL reduced oxygen packaged fishery products HAZARD IS SIGNIFICANT. Examples of shelf-stable, reduced oxygen packaged fishery products are dried fish, The following guidance will assist you in acidified fish, canned fish, and salted fish. determining whether C. botulinum toxin formation Because these products are marketed without is a significant hazard at a processing step: refrigeration, either (1) the spores of C. C. botulinum botulinum types A, B, E, and F should be 1. Is it reasonably likely that will destroyed after the product is placed in the grow and produce toxin during finished product finished product container (covered by the storage and distribution? LACF Regulation, 21 CFR 113) or (2) a barrier, The factors that make C. botulinum toxin or combination of barriers, should be in place formation during finished product storage that will prevent growth and toxin formation and distribution reasonably likely to occur by C. botulinum types A, B, E, and F, and are those that may result in the formation of other pathogens that may be present in the a reduced oxygen packaging environment. product. Suitable barriers include: These are discussed in the section • Adding sufficient salt to produce “Understand the potential hazard,” under the a water phase salt level (i.e., the heading, “Reduced oxygen packaging.” concentration of salt in the water 2. Can growth and toxin formation by C. botulinum that portion of the fish flesh) of at least is reasonably likely to occur be eliminated or reduced 20%. Note that this value is based on to an acceptable level at this processing step? the maximum salt level for growth of S. aureus, covered in this chapter; C. botulinum toxin formation should also be considered a significant hazard at any • Reducing the amount of moisture processing step where a preventive measure that is available for growth (water is, or can be, used to eliminate the hazard activity) to below 0.85 (e.g., by adding (or reduce the likelihood of its occurrence to salt or other substances that bind the an acceptable level) if it is reasonably likely available water). Note that this value to occur. is based on the minimum water activity for growth and toxin formation of S. Preventive measures for C. botulinum toxin aureus, covered in this chapter; formation during finished product distribution and storage are discussed in the section, • Adding sufficient acid to reduce the pH “Understand the potential hazard,” under the to 4.6 or below. This barrier is covered heading, “Control of C. botulinum.” by the Acidified Foods regulation, 21 CFR 114, and these controls are not required • Intended use to be included in your HACCP plan; Because of the extremely toxic nature of • Drying the product sufficiently to C. botulinum toxin, it is unlikely that the reduce the water activity to 0.85 or significance of the hazard will be affected by the below. Note that this value is based intended use of your product. on the minimum water activity for growth and toxin formation of S. aureus, covered in Chapter 14.

Note: A heat treatment, addition of chemical additives, or other treatment may be necessary to inhibit or eliminate spoilage organisms (e.g., mold) in shelf-stable products.

CHAPTER 13: Clostridium botulinum Toxin Formation 255 IDENTIFY CRITICAL CONTROL POINTS. • Products dried to control the growth of C. botulinum type E The following guidance will assist you in and non-proteolytic types B and determining whether a processing step is a F and refrigerated to control the critical control point (CCP) for C. botulinum toxin growth of C. botulinum type A and formation: proteolytic types B and F and other pathogens that may be present. 1. Is there an acidification step (equilibrium pH In these cases, you should also identify of 4.6 or below), a drying step, an in-package the finished product storage step as pasteurization step, a combination of cook and a CCP for the hazard. Control of hot-fill steps, or a retorting step (commercial refrigeration is covered in this chapter for sterility) in the process? C. botulinum and in Chapter 12 for other a. If there is, you should in most cases pathogenic bacteria. identify the acidification step, drying Additionally, some pasteurized surimi- step, pasteurization step, cook and hot- based products rely on a combination of fill steps, or retorting step as the CCP(s) salt and a relatively mild pasteurization for this hazard. Other processing steps process in the finished product container where you have identified C. botulinum for the control of C. botulinum type E toxin formation as a significant hazard and non-proteolytic types B and F. In will then not require control and will these products, you should also identify not need to be identified as CCPs for the formulation step as a CCP for the the hazard. However, control should hazard. Guidance provided in “Control be provided for time and temperature Strategy Example 4 - Pickling and Salting” exposure during finished product may be useful in developing controls at storage and distribution of the following this step. products: Guidance for the C. botulinum control • Products pasteurized in the final strategies listed above is contained in the container to kill C. botulinum type following locations: E and non-proteolytic types B • Control of cooking and hot-filling and F and refrigerated to control is covered in Chapters 16 and 18; the growth of C. botulinum type A and proteolytic types B and F • Control of pasteurization is and other pathogens that may covered in Chapters 16 and 18; be present (e.g., pasteurized • Control of drying is covered crabmeat and pasteurized surimi); in Chapter 14; • Products cooked to kill C. botulinum • Control of acidification is type E and non-proteolytic types covered in the Acidified Foods B and F, and then hot filled into regulation, 21 CFR 114; the final container, and next refrigerated to control the growth • Control of retorting is covered in of C. botulinum type A and the LACF Regulation, 21 CFR 113. proteolytic types B and F and other Note: Acidification and retorting controls for C. botulinum pathogens that may be present; required by 21 CFRs 113 and 114 need not be included in your HACCP plan.

CHAPTER 13: Clostridium botulinum Toxin Formation 256 b. If there is no acidification step and the smoking step should be identified as (equilibrium pH of 4.6 or below), drying a CCP for this hazard. The smoking step for step, pasteurization step, cooking and hot-smoked fish should be sufficient to damage hot-filling, or retorting (commercial the spores and make them more susceptible to sterility) step in the process, then decide inhibition by salt. The smoking step for cold- which of the following categories best smoked fish should not be so severe that it kills describes your product and refer to the the natural spoilage bacteria. These bacteria guidance below: are necessary so that the product will spoil before toxin production occurs. It is likely • Smoked and smoke-flavored fish; that they will also produce acid, which will • Fishery products in which further inhibit C. botulinum growth and toxin refrigeration is the sole barrier formation. to prevent toxin formation; This control approach is a control strategy • Fishery products in which freezing is referred to in this chapter as “Control Strategy the sole barrier to toxin formation; Example 1 - Smoking (1b - Cold Smoking and 1c - Hot Smoking).” • Pickled fish and similar products. 3. Is the storage temperature important to the safety • Smoked and smoke-flavored fish of the product? 1. Is the water phase salt level and, when permitted, the nitrite level, important to the safety of the Refrigerated (not frozen) finished product product? storage is critical to the safety of all products in this category and should be identified as For all products in this category, the water a CCP. Toxin formation by C. botulinum phase salt level is critical to the safety of the type A and proteolytic types B and F is not product, and the brining, dry salting and, inhibited by water phase salt levels below where applicable, drying steps should be 10%, nor by the combination of inhibitors identified as CCPs. Nitrite, when permitted, present in most smoked or smoke-flavored allows a lower level of salt to be used. Salt fish. Bacillus cereus can grow and form and nitrite are the principal inhibitors to toxin at water phase salt concentrations as C. botulinum type E and non-proteolytic high as 18%. types B and F toxin formation in these This control approach is a control strategy products. The water phase salt level needed referred to in this chapter as “Control Strategy to inhibit toxin formation is partially achieved Example 1 - Smoking (1d - Refrigerated during brining or dry salting and is partially Finished Product Storage).” achieved during drying. Control should be exercised over both operations. In some cases, salted, smoked, or smoke- flavored fish are received as ingredients This control approach is a control strategy for assembly into another product, such referred to in this chapter as “Control Strategy as a salmon paté. In other cases, they are Example 1 - Smoking (1a - Brining, Dry received simply for storage and further Salting, and Drying).” distribution (e.g., by a warehouse). In either 2. Is the temperature of the heating or smoking case, the refrigerated (not frozen) storage step process important to the safety of the product? is critical to the safety of the product and should be identified as a CCP. Control is the For both cold-smoked and hot-smoked fish same as that provided under “Control Strategy products, the temperature of smoking is critical, Example 1 - Smoking (1d - Refrigerated

CHAPTER 13: Clostridium botulinum Toxin Formation 257 Finished Product Storage).” Additionally, This control approach is a control strategy receiving of these products should be referred to in this chapter as “Control Strategy identified as a CCP, where control can be Example 2 - Refrigeration With a TTI (2e - exercised over the time and temperature Receipt of Product by Secondary Processor).” during transit. As previously noted, maintenance of This control approach is a control strategy temperatures below 38°F (3.3°C) after the referred to in this chapter as “Control product leaves your control and enters the Strategy Example 1 - Smoking (1e - Receipt of distribution system cannot normally be Products by Secondary Processor).” ensured. The use of a TTI on the smallest unit of packaging (i.e., the unit of packaging • Fishery products in which refrigeration is that will not be distributed any further, the sole barrier to prevent toxin formation usually consumer or end-user package) may 1. Is the storage temperature important to the safety be an appropriate means of overcoming these of the product? problems in the distribution system. When TTIs are used in this manner, their receipt, Refrigerated finished product storage is storage, and application and activation should critical to the safety of all products in this be identified as CCPs. category and should be identified as a CCP. These products contain no barriers (other This control approach is a control strategy than refrigeration) to toxin formation by C. referred to as “Control Strategy Example 2 - botulinum type E and non-proteolytic types Refrigeration With TTI (2a - Unactivated TTI B and F during finished product storage and Receipt, 2b - Unactivated TTI Storage, and 2c distribution. These types of C. botulinum - Application and Activation of TTI).” will grow at temperatures as low as 38°F • Fishery products in which freezing is the (3.3°C), necessitating particularly stringent sole barrier to toxin formation temperature control. 1. Is the storage temperature important to the safety This control approach is a control strategy of the product? referred to in this chapter as “Control Strategy Example 2 - Refrigeration With TTI (2d - Frozen finished product storage is critical to Refrigerated Finished Product Storage).” the safety of all products in this category. These products contain no barriers (other In some cases, these products are received as than freezing) to toxin formation by C. ingredients for assembly into another product. botulinum type E and non-proteolytic types In other cases, they are received simply for B and F during finished product storage and storage and further distribution (e.g., by a distribution. As previously noted, because warehouse). In either case, the refrigerated these products may appear to the retailer, storage step is critical to the safety of the consumer, or end user to be intended to be product and should be identified as a CCP. refrigerated, rather than frozen, labeling to Control is the same as that provided under ensure that they are held frozen throughout “Control Strategy Example 2 - Refrigeration distribution is critical to their safety and With a TTI (2d - Refrigerated Finished should be identified as a CCP. Product Storage).” Additionally, receiving of these products should be identified as a CCP, This control approach is a control strategy where control can be exercised over the time referred to in this chapter as “Control Strategy and temperature during transit. Example 3 - Frozen With Labeling.”

CHAPTER 13: Clostridium botulinum Toxin Formation 258 • Pickled and salted ﬁsh and similar products Salting (4b - Refrigerated Finished Product 1. Is the water phase salt level, water activity, and/ Storage).” Additionally, receiving of these or pH level important to the safety of the product? products should be identiﬁed as a CCP, where control can be exercised over time and For all products in this category, the water temperature during transit. phase salt level, water activity, and/or pH This control approach is a control strategy level are critical to the safety of the product referred to in this chapter as “Control Strategy because they are the principal inhibitors to Example 4 - Pickling and Salting (4c - Receipt growth and toxin formation by C. botulinum of Product by Secondary Processor).” type E and non-proteolytic type B and F. The levels of these inhibitors needed to inhibit toxin formation are achieved during the DEVELOP A CONTROL STRATEGY. pickling, brining, or formulation step. Control should be exercised over the relevant step. The following guidance provides four control strategies for C. botulinum toxin formation. You This control approach is a control strategy may select a control strategy that is different from referred to in this chapter as “Control Strategy those which are suggested, provided it complies Example 4 - Pickling and Salting (4a - with the requirements of the applicable food Brining, Pickling, Salting, and Formulation).” safety laws and regulations. Control strategies 2. Is the storage temperature important to the safety contain several elements that may need to be of the product? used in combination to result in an effective control program. Unless pickling, brining, or formulation results The following are examples of control strategies in a water phase salt level of at least 20% included in this chapter: (note that this value is based on the maximum

salt concentration for growth of S. aureus), a MAY APPLY TO MAY APPLY TO pH of 4.6 or below, or a water activity of 0.85 CONTROL STRATEGY PRIMARY SECONDARY PROCESSOR PROCESSOR or below (note that this value is based on Smoking the minimum water activity for growth of S. aureus), refrigerated ﬁnished product storage Refrigeration with TTI is critical to ensure the safety of the product Frozen with labeling

and should be identiﬁed as a CCP. Pickling and salting This control approach is a control strategy referred to in this chapter as “Control Strategy • CONTROL STRATEGY EXAMPLE 1 - SMOKING Example 4 - Pickling and Salting (4b - This control strategy should include the following Refrigerated Finished Product Storage).” elements, as appropriate:

In some cases, pickled fish or similar a. Brining, dry salting, and drying; products are received as ingredients for assembly into another product. In b. Cold smoking; other cases, they are received simply for Hot smoking; storage and further distribution (e.g., by a c. warehouse). In either case, the refrigerated d. Refrigerated finished product storage; storage step is critical to the safety of the product and should be identified as a CCP. e. Receipt of products by secondary Control is the same as that provided under processor. “Control Strategy Example 4 - Pickling and

CHAPTER 13: Clostridium botulinum Toxin Formation 259 1A. BRINING, DRY SALTING, AND DRYING • Monitor brine temperature at the start of the brining process Set Critical Limits. with a temperature- indicating • The minimum or maximum values for the device (e.g., a thermometer), critical factors of the brining, dry salting, and then monitor ambient air and/or drying processes established by a temperature using a continuous scientific study. The critical factors are those temperature-recording device that are necessary to ensure that the finished (e.g., a recording thermometer); product has not less than 3.5% wps or, where AND permitted, the combination of 3% wps and not less than 100 ppm nitrite. The critical Monitor the drying time and the input/ factors may include: brine strength; brine to output air temperature (as specified fish ratio; brining time; brining temperature; by the study) using a continuous thickness, texture, fat content, quality, and temperature-recording device (e.g., a species of fish; drying time; input/output air recording thermometer); temperature, humidity, and velocity; smoke AND density; and drier loading. Monitor all other critical factors specified by the study with equipment appropriate Establish Monitoring Procedures. for the measurement; » What Will Be Monitored? OR • The critical factors of the established brining, • Collect a representative sample of the dry salting, and/or drying processes. These finished product and conduct water phase may include: brine strength; brine to fish salt analysis and, when appropriate, nitrite ratio; brining time; brining temperature; analysis. thickness, texture, fat content, quality, and species of fish; drying time; input/output air » How Often Will Monitoring Be Done (Frequency)? temperature, humidity, and velocity; smoke • For brine strength: density; and drier loading; At least at the start of the brining OR process; • The water phase salt and, where appropriate, AND nitrite level of the finished product. • For brine time:

» How Will Monitoring Be Done? Once per batch; • For monitoring critical factors: AND Monitor brine strength with a • For manual brine temperature monitoring: salinometer; At the start of the brining process and at AND least every 2 hours thereafter; Monitor brine time with a clock; AND AND • For continuous temperature-recording devices: Monitor brine temperature using: Continuous monitoring by the device • A temperature-indicating device itself, with a visual check of the recorded (e.g., a thermometer); data at least once per batch; OR

CHAPTER 13: Clostridium botulinum Toxin Formation 260 AND that is not hermetically sealed, or an LACF, • For brine to ﬁsh ratio: or a frozen product); At the start of the brining process; OR AND • Destroy the product; • For time requirements of the drying process: OR Each batch; • Divert the product to a non-food use. AND AND

• For all other critical factors speciﬁed by the Take the following corrective action to regain control study: over the operation after a critical limit deviation: As often as necessary to maintain control; • Adjust the salt and/or nitrite concentration in OR the brine; • For water phase salt and, when appropriate, OR nitrite: • Adjust the air velocity or input air Each lot or batch of ﬁnished product. temperature to the drying chamber;

» Who Will Do the Monitoring? OR • For continuous temperature-recording • Extend the drying process to compensate devices: for a reduced air velocity or temperature or elevated humidity; Monitoring is performed by the device itself. The visual check of the data OR generated by the device, to ensure • Adjust the brine strength or brine to ﬁsh ratio; that the critical limits have been met consistently, may be performed by any OR person who has an understanding of the • Cool the brine; nature of the controls; OR OR • Move some or all of the product to another • For other checks: drying chamber; Any person who has an understanding of OR the nature of the controls. • Make repairs or adjustments to the drying chamber as necessary. Establish Corrective Action Procedures. Take the following corrective action to a product Establish a Recordkeeping System. involved in a critical limit deviation: • Printouts, charts, or readings from continuous • Chill and hold the product until its safety can temperature-recording devices; be evaluated; AND OR • Record of visual checks of recorded data; • Reprocess the product; AND OR • Appropriate records (e.g., processing record • Divert the product to a use in which the showing the results of the brine strength critical limit is not applicable (e.g., packaging and temperature, brine to ﬁsh ratio, size

CHAPTER 13: Clostridium botulinum Toxin Formation 261 and species of fish, and time of brining) as applicable, nitrite levels should be necessary to document the monitoring of taken into consideration in the process the critical factors of the brining, dry salting, establishment. A record of the process and/or drying process, as established by a establishment should be maintained; study; AND OR • Before a temperature-indicating device (e.g., • Results of the finished product water phase a thermometer) or temperature-recording salt determination and, when appropriate, device (e.g., a recording thermometer) is nitrite determination. put into service, check the accuracy of the device to verify that the factory calibration Establish Verification Procedures. has not been affected. This check can be • Process validation study (except where water accomplished by: phase salt analysis and, where appropriate, Immersing the sensor in an ice slurry nitrite analysis of the finished product are the (32°F (0°C)), if the device will be used at monitoring procedure): or near refrigeration temperature; The adequacy of the brining, dry OR salting, and drying processes should Immersing the sensor in boiling water be established by a scientific study. It (212°F (100°C)) if the device will be used should be designed to consistently at or near the boiling point. Note that achieve a water phase salt level of the temperature should be adjusted to 3.5% or 3% with not less than 100 ppm compensate for altitude, when necessary; nitrite. Expert knowledge of salting and/ or drying processes may be required OR to establish such a process. Such Doing a combination of the above if knowledge can be obtained by education the device will be used at or near room or experience, or both. Process temperature; validation study for establishment of OR brining, dry salting, and drying processes may require access to adequate facilities Comparing the temperature reading and the application of recognized on the device with the reading on a methods. The drying equipment should known accurate reference device (e.g., be designed, operated, and maintained to a thermometer traceable to National deliver the established drying process to Institute of Standards and Technology every unit of product. In some instances, (NIST) standards) under conditions that brining, dry salting, and/or drying studies are similar to how it will be used (e.g., may be required to establish minimum air temperature, brine temperature, processes. In other instances, existing product internal temperature) within the literature, which establishes minimum temperature range at which it will be processes or adequacy of equipment, used; is available. Characteristics of the AND process, product, and/or equipment • Once in service, check the temperature- that affect the ability of the established indicating device or temperature-recording minimum salting, dry salting, and drying device daily before the beginning of process to deliver the desired finished operations. Less frequent accuracy checks product water phase salt and, where may be appropriate if they are recommended

CHAPTER 13: Clostridium botulinum Toxin Formation 262 by the instrument manufacturer and the and verification records within 1 week of history of use of the instrument in your preparation to ensure they are complete and facility has shown that the instrument any critical limit deviations that occurred consistently remains accurate for a longer were appropriately addressed. period of time. In addition to checking that the device is accurate by one of the methods 1B. COLD SMOKING described above, this process should include Set Critical Limits. a visual examination of the sensor and any • The smoker temperature must not exceed attached wires for damage or kinks. The 90°F (32.2°C). device should be checked to ensure that it is operational and, where applicable, has Establish Monitoring Procedures. sufficient ink and paper; AND » What Will Be Monitored? • Calibrate the temperature-indicating device • The smoker temperature. or temperature recording device against a » How Will Monitoring Be Done? known accurate reference device (e.g., a • Measure ambient smoker chamber NIST-traceable thermometer) at least once a temperature using a continuous temperature- year or more frequently if recommended by recording device (e.g., a recording the device manufacturer. Optimal calibration thermometer). frequency is dependent upon the type, condition, past performance, and conditions » How Often Will Monitoring Be Done (Frequency)? of use of the device. Consistent temperature • Continuous monitoring by the device itself, variations away from the actual value (drift) with a visual check of the recorded data at found during checks and/or calibration may least once per batch. show a need for more frequent calibration or the need to replace the device (perhaps with » Who Will Do the Monitoring? a more durable device). Devices subjected • Monitoring is performed by the device itself. to high temperatures for extended periods of The visual check of the data generated time may require more frequent calibration. by the device, to ensure that the critical Calibration should be performed at a limits have been met consistently, may minimum of two temperatures that bracket be performed by any person who has an the temperature range at which it is used; understanding of the nature of the controls. AND Establish Corrective Action Procedures. • Perform other calibration procedures as necessary to ensure the accuracy of the Take the following corrective action to a product monitoring instruments; involved in a critical limit deviation: AND • Chill and hold the product until its safety can be evaluated; • Do finished product sampling and analysis to determine water phase salt and, where OR appropriate, nitrite analysis at least once • Divert the product to a use in which the every 3 months (except where such testing is critical limit is not applicable (e.g., packaging performed as part of monitoring); that is not hermetically sealed, or an LACF, AND or a frozen product); • Review monitoring, corrective action, OR

CHAPTER 13: Clostridium botulinum Toxin Formation 263 • Destroy the product; traceable thermometer) under conditions that are similar to how it will be used (e.g., OR air temperature) within the temperature • Divert the product to a non-food use. range at which it will be used; AND AND Take the following corrective action to regain control • Once in service, check the temperature- over the operation after a critical limit deviation: recording device daily before the beginning • Make repairs or adjustments to the smoking of operations. Less frequent accuracy checks chamber; may be appropriate if they are recommended by the instrument manufacturer and the AND/OR history of use of the instrument in your • Move some or all of the product to another facility has shown that the instrument smoking chamber. consistently remains accurate for a longer period of time. In addition to checking that Establish a Recordkeeping System. the device is accurate by one of the methods • Printouts, charts, or readings from continuous described above, this process should include temperature-recording devices; a visual examination of the sensor and any attached wires for damage or kinks. The AND device should be checked to ensure that it • Record of visual checks of recorded data. is operational and, where applicable, has sufficient ink and paper; Establish Verification Procedures. AND • Before a temperature-recording device (e.g., a recording thermometer) is put into service, • Calibrate the temperature-recording device check the accuracy of the device to verify that against a known accurate reference device the factory calibration has not been affected. (e.g., a NIST-traceable thermometer) at This check can be accomplished by: least once a year or more frequently if recommended by the device manufacturer. Immersing the sensor in an ice slurry Optimal calibration frequency is dependent (32°F (0°C)) if the device will be used at upon the type, condition, past performance, or near refrigeration temperature; and conditions of use of the device. OR Consistent temperature variations away from Immersing the sensor in boiling water the actual value (drift) found during checks (212°F (100°C)) if the device will be used and/or calibration may show a need for more at or near the boiling point. Note that frequent calibration or the need to replace the temperature should be adjusted to the device (perhaps with a more durable compensate for altitude, when necessary; device). Calibration should be performed at a minimum of two temperatures that bracket OR the temperature range at which it is used; Doing a combination of the above if the device will be used at or near room AND temperature; • Review monitoring, corrective action, and verification records within 1 week of OR preparation to ensure they are complete and Comparing the temperature reading on any critical limit deviations that occurred the device with the reading on a known were appropriately addressed. accurate reference device (e.g., a NIST-

CHAPTER 13: Clostridium botulinum Toxin Formation 264 1C. HOT SMOKING OR Set Critical Limits. • Destroy the product; • The internal temperature of the ﬁsh must OR be maintained at or above 145°F (62.8°C) • Divert the product to a non-food use. throughout the ﬁsh for at least 30 minutes. AND

Establish Monitoring Procedures. Take the following corrective action to regain control over the operation after a critical limit deviation: » What Will Be Monitored? • Make repairs or adjustments to the heating • The internal temperature at the thickest chamber; portion of three of the largest ﬁsh in the OR smoking chamber. • Move some or all of the product to another » How Will Monitoring Be Done? heating chamber. • Use a continuous temperature-recording device (e.g., a recording thermometer) Establish a Recordkeeping System. equipped with three temperature-sensing • Printouts, charts, or readings from continuous probes. temperature-recording devices;

» How Often Will Monitoring Be Done (Frequency)? AND • Continuous monitoring by the device itself, • Record of visual checks of recorded data. with visual check of the recorded data at least once per batch. Establish Veriﬁcation Procedures. • Before a temperature-recording device (e.g., » Who Will Do the Monitoring? a recording thermometer) is put into service, • Monitoring is performed by the device itself. check the accuracy of the device to verify The visual check of the data generated that the factory calibration has not been by the device, to ensure that the critical affected. This check can be accomplished limits have been met consistently, may by: be performed by any person who has an Immersing the sensor in an ice slurry understanding of the nature of the controls. (32°F (0°C)) if the device will be used at or near refrigeration temperature; Establish Corrective Action Procedures. OR Take the following corrective action to a product involved in a critical limit deviation: Immersing the sensor in boiling water (212°F (100°C)) if the device will be used • Chill and hold the product until its safety can at or near the boiling point. Note that be evaluated; the temperature should be adjusted to OR compensate for altitude, when necessary; • Reprocess the product; OR OR Doing a combination of the above if • Divert the product to a use in which the the device will be used at or near room critical limit is not applicable (e.g., packaging temperature; that is not hermetically sealed, or a LACF, or OR a frozen product);

CHAPTER 13: Clostridium botulinum Toxin Formation 265 Comparing the temperature reading on preparation to ensure they are complete and the device with the reading on a known any critical limit deviations that occurred accurate reference device (e.g., a NIST- were appropriately addressed. traceable thermometer) under conditions that are similar to how it will be used (e.g., 1D. REFRIGERATED FINISHED PRODUCT STORAGE product internal temperature) within the Set Critical Limits. temperature range at which it will be used; • For refrigerated (not frozen) finished product AND storage: • Once in service, check the temperature- The product is held at a cooler recording device daily before the beginning temperature of 40°F (4.4°C) or of operations. Less frequent accuracy checks below. Note that allowance for routine may be appropriate if they are recommended refrigeration defrost cycles may be by the instrument manufacturer and the necessary. Also note that you may history of use of the instrument in your choose to set a critical limit that specifies facility has shown that the instrument a time and temperature of exposure to consistently remains accurate for a longer temperatures above 40°F (4.4°C); period of time. In addition to checking that OR the device is accurate by one of the methods described above, this process should include • For finished product stored under ice: a visual examination of the sensor and any The product is completely and attached wires for damage or kinks. The continuously surrounded by ice device should be checked to ensure that it throughout the storage time. is operational and, where applicable, has sufficient ink and paper; Establish Monitoring Procedures.

AND » What Will Be Monitored? • Calibrate the temperature-recording device • For refrigerated finished product storage: against a known accurate reference device The temperature of the cooler; (e.g., a NIST-traceable thermometer) at least once a year or more frequently if OR recommended by the device manufacturer. • For finished product storage under ice: Optimal calibration frequency is dependent The adequacy of ice surrounding the upon the type, condition, past performance, product. and conditions of use of the device. Consistent temperature variations away from » How Will Monitoring Be Done? the actual value (drift) found during checks • For refrigerated finished product storage: and/or calibration may show a need for more Use a continuous temperature-recording frequent calibration or the need to replace device (e.g., a recording thermometer); the device (perhaps with a more durable device). Calibration should be performed at OR a minimum of two temperatures that bracket • For finished product storage under ice: the temperature range at which it is used; Make visual observations of the AND adequacy of ice in a representative number of containers (e.g., cartons and • Review monitoring, corrective action, totes) from throughout the cooler. and verification records within 1 week of

CHAPTER 13: Clostridium botulinum Toxin Formation 266 » How Often Will Monitoring Be Done (Frequency)? OR • For continuous temperature-recording Move some or all of the product in the devices: malfunctioning cooler to another cooler; Continuous monitoring by the device OR itself, with a visual check of the recorded Freeze the product; data at least once per day; AND OR • Address the root cause: • For finished product storage under ice: Make repairs or adjustments to the Sufficient frequency to ensure control. malfunctioning cooler; » Who Will Do the Monitoring? OR • For continuous temperature-recording Make adjustments to the ice application devices: operations. Monitoring is performed by the device itself. The visual check of the data Establish a Recordkeeping System. generated by the device, to ensure • For refrigerated finished product storage: that the critical limits have been met Printouts, charts, or readings from consistently, may be performed by any continuous temperature-recording person who has an understanding of the devices; nature of the controls; AND OR Record of visual checks of recorded data; • For other checks: Any person who has an understanding of OR the nature of the controls. • For finished product storage under ice: Results of ice checks: Establish Corrective Action Procedures. • The number of containers examined Take the following corrective action to a product and the sufficiency of ice for each; involved in a critical limit deviation: AND • Chill and hold the affected product until an evaluation of the total time and temperature • The approximate number of exposure is performed; containers in the cooler.

OR Establish Veriﬁcation Procedures. • Destroy the product; • Before a temperature-recording device (e.g., OR a recording thermometer) is put into service, • Divert the product to a non-food use. check the accuracy of the device to verify that the factory calibration has not been affected. AND This check can be accomplished by: Take the following corrective actions to regain control Immersing the sensor in an ice slurry over the operation after a critical limit deviation: (32°F (0°C)) if the device will be used at • Prevent further deterioration: or near refrigeration temperature; Add ice to the product; OR

CHAPTER 13: Clostridium botulinum Toxin Formation 267 Comparing the temperature reading on of fish to ensure that the ice is sufficient the device with the reading on a known to maintain product temperatures at 40°F accurate reference device (e.g., a NIST- (4.4°C) or less; traceable thermometer) under conditions AND that are similar to how it will be used (e.g., air temperature) within the temperature • Review monitoring, corrective action, range at which it will be used; and verification records within 1 week of preparation to ensure they are complete and AND any critical limit deviations that occurred • Once in service, check the temperature- were appropriately addressed. recording device daily before the beginning of operations. Less frequent accuracy checks 1E. RECEIPT OF PRODUCTS BY SECONDARY may be appropriate if they are recommended PROCESSOR by the instrument manufacturer and the Set Critical Limits. history of use of the instrument in your • For fish or fishery products delivered facility has shown that the instrument refrigerated (not frozen): consistently remains accurate for a longer period of time. In addition to checking that All lots received are accompanied by the device is accurate by one of the methods transportation records that show that described above, this process should include the product was held at or below 40°F a visual examination of the sensor and any (4.4°C) throughout transit. Note that attached wires for damage or kinks. The allowance for routine refrigeration device should be checked to ensure that it defrost cycles may be necessary; is operational and, where applicable, has OR sufficient ink and paper; • For products delivered under ice: AND Product is completely surrounded by ice • Calibrate the temperature-recording device at the time of delivery; against a known accurate reference device OR (e.g., a NIST-traceable thermometer) at • For products delivered under chemical least once a year or more frequently if cooling media, such as gel packs: recommended by the device manufacturer. Optimal calibration frequency is dependent There is an adequate quantity of cooling upon the type, condition, past performance, media that remain frozen to have and conditions of use of the device. maintained product at 40°F (4.4°C) or Consistent temperature variations away from below throughout transit; the actual value (drift) found during checks AND and/or calibration may show a need for more The internal temperature of the product frequent calibration or the need to replace at the time of delivery is 40°F (4.4°C) or the device (perhaps with a more durable below; device). Calibration should be performed at a minimum of two temperatures that bracket OR the temperature range at which it is used; • For products delivered refrigerated (not AND frozen) with a transit time (including all time outside a controlled temperature • When visual checks of ice are used, environment) of 4 hours or less (optional periodically measure internal temperatures control strategy):

CHAPTER 13: Clostridium botulinum Toxin Formation 268 Time of transit does not exceed 4 hours; containers (e.g., cartons and totes) at the time of delivery. AND Temperature of the product at the time » How Will Monitoring Be Done? of delivery does not exceed 40°F (4.4°C). • For products delivered refrigerated (not Note: Processors receiving product with transit times of 4 hours or less frozen): may elect to use one of the controls described for longer transit times. Use a continuous temperature-recording device (e.g., a recording thermometer) Establish Monitoring Procedures. for internal product temperature or ambient air temperature monitoring » What Will Be Monitored? during transit; • For products delivered refrigerated (not frozen): OR The internal temperature of the product • For products delivered under ice: throughout transportation; Make visual observations of the OR adequacy of ice in a representative number of containers (e.g., cartons and The temperature within the truck or totes) from throughout the shipment, at other carrier throughout transportation; delivery; OR OR • For products delivered under ice: • For products delivered under chemical The adequacy of ice surrounding the cooling media, such as gel packs: product at the time of delivery; Make visual observations of the OR adequacy and frozen state of the cooling • For products held under chemical cooling media in a representative number of media, such as gel packs: containers (e.g., cartons and totes) from throughout the shipment, at delivery; The quantity and frozen status of cooling media at the time of delivery; AND AND Use a temperature-indicating device (e.g., The internal temperature of a a thermometer) to determine internal representative number of product product temperatures in a representative containers (e.g., cartons and totes) at number of product containers from time of delivery; throughout the shipment, at delivery; OR OR • For products delivered refrigerated (not • For products delivered refrigerated (not frozen) with a transit time of 4 hours or less: frozen) with a transit time of 4 hours or less: The date and time ﬁsh were removed Review carrier records to determine from a controlled temperature the date and time the product was environment before shipment and the removed from a controlled temperature date and time delivered; environment before shipment and the date and time delivered; AND AND The internal temperature of a representative number of product

CHAPTER 13: Clostridium botulinum Toxin Formation 269 Use a temperature-indicating device (e.g., • Discontinue use of the supplier or carrier a thermometer) to determine internal until evidence is obtained that the identified product temperatures in a representative transportation-handling practices have been number of product containers (e.g., improved. cartons and totes) randomly selected from throughout the shipment, at Establish a Recordkeeping System. delivery. Measure a minimum of 12 • Receiving records showing: product containers, unless there are Results of continuous temperature fewer than 12 product containers in a monitoring: lot, in which case measure all of the containers. Lots that show a high level • Printouts, charts, or readings of temperature variability may require a from continuous temperature- larger sample size. recording devices; AND » How Often Will Monitoring Be Done (Frequency)? • Each lot received. • Visual check of recorded data; OR » Who Will Do the Monitoring? Results of ice checks, including: • For continuous temperature-recording devices: • The number of containers examined Monitoring is performed by the device and the sufficiency of ice for each; itself. The visual check of the data AND generated by the device, to ensure • The number of containers in the lot; that the critical limits have been met consistently, may be performed by any OR person who has an understanding of the Results of the chemical media checks, nature of the controls; including: OR • The number of containers • For other checks: examined and the frozen status of the media for each; Any person who has an understanding of the nature of the controls. AND • The number of containers in the lot; Establish Corrective Action Procedures. AND/OR Take the following corrective action to a product Results of internal product temperature involved in a critical limit deviation: monitoring, including: • Chill and hold the affected product until an • The number of containers evaluation of the total time and temperature examined and the internal exposure is performed; temperatures observed for each; OR AND • Reject the lot. • The number of containers in the lot; AND AND Take the following corrective action to regain control • Date and time fish were initially over the operation after a critical limit deviation: removed from a controlled

CHAPTER 13: Clostridium botulinum Toxin Formation 270 temperature environment recommended by the device manufacturer. and date and time fish were Optimal calibration frequency is dependent delivered, when applicable. upon the type, condition, past performance, and conditions of use of the device. Establish Verification Procedures. Consistent temperature variations away from • Before a temperature-indicating device (e.g., the actual value (drift) found during checks a thermometer) is put into service, check and/or calibration may show a need for more the accuracy of the device to verify that the frequent calibration or the need to replace factory calibration has not been affected. the device (perhaps with a more durable This check can be accomplished by: device). Calibration should be performed at Immersing the sensor in an ice slurry a minimum of two temperatures that bracket (32°F (0°C)), if the device will be used at the temperature range at which it is used; or near refrigeration temperature; AND OR • Check the accuracy of temperature-recording Comparing the temperature reading on devices that are used for monitoring transit the device with the reading on a known conditions, for all new suppliers and at accurate reference device (e.g., a NIST- least quarterly for each supplier thereafter. traceable thermometer) under conditions Additional checks may be warranted based that are similar to how it will be used on observations at receipt (e.g., refrigeration (e.g., product internal temperature) units appear to be in poor repair or readings within the temperature range at which it appear to be erroneous). The accuracy of will be used; the device can be checked by comparing the temperature reading on the device with AND the reading on a known accurate reference • Once in service, check the temperature- device (e.g., a NIST-traceable thermometer) indicating device daily before the under conditions that are similar to how it beginning of operations. Less frequent will be used (e.g., air temperature) within the accuracy checks may be appropriate if temperature range at which it will be used; they are recommended by the instrument manufacturer and the history of use of AND the instrument in your facility has shown • When visual checks of ice are used, that the instrument consistently remains periodically measure internal temperatures accurate for a longer period of time. In of fish to ensure that the ice or is sufficient addition to checking that the device is to maintain product temperatures at 40°F accurate by one of the methods described (4.4°C) or less; above, this process should include a AND visual examination of the sensor and any • Review monitoring, corrective action, attached wires for damage or kinks. The and verification records within 1 week of device should be checked to ensure that preparation to ensure they are complete and it is operational; any critical limit deviations that occurred AND were appropriately addressed. • Calibrate the temperature-indicating device against a known accurate reference device (e.g., a NIST-traceable thermometer) at least once a year or more frequently if

CHAPTER 13: Clostridium botulinum Toxin Formation 271 per year Establish a brining and drying process of the finished product ensure that it is operational accuracy and damage to within 1 week of preparation within 1 week before putting into operation; before Review monitoring, corrective corrective monitoring, Review action, and verification records and verification action, Check the dial thermometer for Monthly calibration of the scale operations; and calibrate it once check it daily, at the beginning of check it daily, Quarterly phase salt analysis water record record record record RECORDS VERIFICATION Production Production ow a processor of vacuum-packaged hot- of other pathogenic bacteria through the ter 3) for other potential hazards (e.g., brining process Add saltAdd Production Add brine Add Production ACTION(S) Extend the the product CORRECTIVE and reweigh product water product water Cool the brine based on finished Hold and evaluate Hold and evaluate Hold and evaluate Hold and evaluate phase salt analysis room room room room Brine Brine Brine Brine employee employee employee employee employee fish) brining brining process process TABLE 13-1 TABLE (10 largest (10 largest Every batch Every Example Only Start of each Every 2 hours Every MONITORING See Text for Full Recommendations See Text Dial tank Scale Each batch some fish Remove Clock Caliper Each batch Visual, to Visual, Salinometer Start of each mark on the thermometer CONTROL STRATEGY EXAMPLE 1 - SMOKING CONTROL STRATEGY Salt fish Fish Brine WHAT HOW FREQUENCY WHO process of brine brine (as thickness Start time Weight of Weight Weight of Weight determined by volume) temperature and end time concentration of the brining 2:1 3.5% 6 hours Minimum FOR EACH MEASURE* PREVENTIVE salinometer brine to fish: brining time: Minimum salt Maximum fish CRITICAL LIMITS of brining: 60° Maximum brine thickness 1½ in. thickness 1½ in. concentration of brine at the start Minimum ratio of a minimum water a minimum water temperature: 40ºF phase salt level in phase salt level the loin muscle of Note: To produce Note: To toxin product HAZARD(S) the finished formation in SIGNIFICANT aquaculture drugs, environmental chemical contaminants and pesticides, parasites, growth of other pathogenic bacteria, survival cook step, and metal fragments). This table is an example of a portion of a HACCP plan using “Control Strategy Example 1 - Smoking.” This example illustrates h smoked salmon can control C. botulinum toxin formation. It is provided for illustrative purposes only. smoked salmon can control C. botulinum toxin formation. It is provided for illustrative purposes only. 3-2 and 3-4 (Chap C. botulinum toxin formation may be only one of several significant hazards for this product. Refer to Tables (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) POINT Brining botulinum C. CRITICAL CONTROL

CHAPTER 13: Clostridium botulinum Toxin Formation 272 calibrate it once per year calibrate it once per year within 1 week of preparation within 1 week within 1 week of preparation within 1 week within 1 week of preparation within 1 week Review monitoring, corrective corrective monitoring, Review Review monitoring, corrective corrective monitoring, Review Review monitoring, corrective corrective monitoring, Review Establish a brining and drying it is operationalputting before it is operationalputting before action, and verification records and verification action, action, and verification records and verification action, action, and verification records and verification action, and damage to ensure that and damage to ensure that analysis of the finished product into operation; check it daily, at into operation; check it daily, into operation; check it daily, at into operation; check it daily, the beginning of operations; and the beginning of operations; and process Quarterly phase salt water Check the data logger for accuracy Check the data logger for Check the data logger for accuracy Check the data logger for

Data logger record Digital printout printout RECORDS VERIFICATION Production data logger ow a processor of vacuum-packaged hot- of other pathogenic bacteria through the ter 3) for other potential hazards (e.g.,

heating process process exposure the cooler ACTION(S) Extend the the product CORRECTIVE on time and product water product water temperature of Adjust or repair Adjust Make repairs or Make based on finished smoking chamber Extend the drying the product based adjustments to the Hold and evaluate Hold and evaluate Hold and evaluate Hold and evaluate phase salt analysis Hold and evaluate Hold and evaluate Smoker Smoker employee employee employee Production check of check of the batch TABLE 13-1 TABLE with visual with visual Continuous, Continuous, Continuous, Continuous, Example Only at the end of once per day recorded data recorded data MONITORING See Text for Full Recommendations See Text Clock Each batch Smoker logger spot of smoking chamber in thickest in thickest fish in cold logger with Digital data Digital data three probes CONTROL STRATEGY EXAMPLE 1 - SMOKING CONTROL STRATEGY vent WHAT HOW FREQUENCY WHO Internal Cooler air of fish and time at that temperature temperature temperature Time of open Time Internal minutes FOR EACH MEASURE* PREVENTIVE pathogens) of vegetative of vegetative CRITICAL LIMITS Minimum time held at or above held at or above Maximum cooler (based on growth temperature of fish temperature: 40°F open vent: 2 hours open vent: 145°F for at least 30 145°F for toxin toxin toxin during storage product product product finished formation formation HAZARD(S) in finished the finished formation in SIGNIFICANT C. botulinum C. C. botulinum C. aquaculture drugs, environmental chemical contaminants and pesticides, parasites, growth of other pathogenic bacteria, survival cook step, and metal fragments). This table is an example of a portion of a HACCP plan using “Control Strategy Example 1 - Smoking.” This example illustrates h *Note: The critical limits in this example are for illustrative purposes only and not related to any recommended process. smoked salmon can control C. botulinum toxin formation. It is provided for illustrative purposes only. smoked salmon can control C. botulinum toxin formation. It is provided for illustrative purposes only. 3-2 and 3-4 (Chap C. botulinum toxin formation may be only one of several significant hazards for this product. Refer to Tables (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) and POINT drying storage Heating botulinum C. product CRITICAL Finished Smoking CONTROL

CHAPTER 13: Clostridium botulinum Toxin Formation 273 • CONTROL STRATEGY EXAMPLE 2 - Performance data from the manufacturer; REFRIGERATION WITH TTI AND This control strategy should include the following • For transportation conditions: elements, as appropriate: The temperature within the truck or a. Unactivated TTI receipt; other carrier throughout transportation;

b. Unactivated TTI storage; OR Other conditions that affect the c. Application and activation of TTI; functionality of the TTI, where applicable; d. Refrigerated finished product storage; AND e. Receipt of product by secondary • For functionality at receipt: processor. The ability of the TTI to produce an 2A. UNACTIVATED TTI RECEIPT alert indicator, such as a color change of the device, when exposed to time and Set Critical Limits. temperature abuse at time of receipt. • The TTI is suitable for use. It should be designed to perform properly under the » How Will Monitoring Be Done? conditions that it will be used. It should • For suitability of use: also be designed to produce an alert Review performance data; indicator (e.g., a color change of the device) AND at a combination of time and temperature exposures that will prevent the formation of • For transportation conditions: non-proteolytic C. botulinum toxin formation Use a continuous temperature-recording (e.g., consistent with the “Skinner-Larkin device (e.g., a recording thermometer) curve”); for ambient air temperature monitoring during transit; AND • Where transportation conditions (e.g., AND temperature) could affect the functionality • For functionality at receipt: of the TTI, all lots of TTIs are accompanied Activate and then expose a TTI from by transportation records that show that they the lot to ambient air temperature for were held at conditions that do not result in sufficient time to determine whether loss of functionality throughout transit; it is functional (i.e., produces an alert AND indicator, such as a color change of the device). • The TTI functions (i.e., produces an alert indicator, such as a color change of » How Often Will Monitoring Be Done (Frequency)? the device, when exposed to time and • For suitability of use: temperature abuse) at time of receipt. The first shipment of a TTI model; Establish Monitoring Procedures. AND • For transportation conditions and » What Will Be Monitored? functionality at receipt: • For suitability of use: Every shipment.

CHAPTER 13: Clostridium botulinum Toxin Formation 274 » Who Will Do the Monitoring? Records of visual checks of recorded • For suitability of use: data; Anyone with an understanding of TTI AND validation studies and of the intended • For functionality at receipt: conditions of use; Results of a TTI challenge test (i.e., AND whether the TTI produces an alert • For transportation conditions and indicator, such as a color change of functionality at receipt: the device, when exposed to time and temperature abuse). Anyone with an understanding of the nature of the controls. Establish Verification Procedures. Establish Corrective Action Procedures. • Check the accuracy of temperature-recording devices that are used for monitoring transit Take the following corrective action to a product conditions, for all new suppliers and at involved in a critical limit deviation: least quarterly for each supplier thereafter. • Reject or return the shipment. Additional checks may be warranted based AND on observations at receipt (e.g., refrigeration units appear to be in poor repair or readings Take the following corrective actions to regain control appear to be erroneous). The accuracy of over the operation after a critical limit deviation: the device can be checked by comparing • For suitability of use: the temperature reading on the device with Discontinue use of the supplier until the reading on a known accurate reference documentation of validation has been device (e.g., a NIST-traceable thermometer) provided; under conditions that are similar to how it will be used (e.g., air temperature) within the AND temperature range at which it will be used; • For transportation conditions and functionality at receipt: AND Discontinue use of the supplier or • Review monitoring, corrective action, carrier until evidence is obtained that the and verification records within 1 week of identified production or transportation preparation to ensure they are complete and practices have been improved. any critical limit deviations that occurred were appropriately addressed.

Establish a Recordkeeping System. 2B. UNACTIVATED TTI STORAGE • For suitability of use: Set Critical Limits. Manufacturer’s performance data; • The combination of storage conditions AND (e.g., temperature) that prevent loss of • For transportation conditions: functionality throughout storage (based Printouts, charts, or readings from on manufacturer’s speciﬁcations). continuous temperature-recording devices; AND

CHAPTER 13: Clostridium botulinum Toxin Formation 275 Establish Monitoring Procedures. Establish Corrective Action Procedures.

» What Will Be Monitored? Take the following corrective action to a TTI involved in a • Storage air temperature, where temperature critical limit deviation: affects functionality of the TTI; • Destroy the lot of TTIs. AND/OR AND • Other storage conditions that affect Take the following corrective action to regain control functionality of the TTI. over the operation after a critical limit deviation: • Make repairs or adjustments to the » How Will Monitoring Be Done? malfunctioning cooler; • For temperature: AND/OR Use a continuous temperature-recording device (e.g., a recording thermometer); • Make other repairs or adjustment appropriate for the condition. AND/OR • For other conditions: Establish a Recordkeeping System. Use instruments appropriate for the • For refrigerated storage: purpose. Printouts, charts, or readings from » How Often Will Monitoring Be Done (Frequency)? continuous temperature-recording devices; • For temperature: Continuous monitoring by the device AND itself, with a visual check of the recorded Record of visual checks of recorded data; data at least once per day; AND/OR AND/OR • Storage record showing the results of • For other conditions: monitoring of other conditions. With sufﬁcient frequency to ensure control. Establish Veriﬁcation Procedures. • Before a temperature-recording device (e.g., » Who Will Do the Monitoring? a recording thermometer) is put into service, • With continuous temperature-recording check the accuracy of the device to verify that devices: the factory calibration has not been affected. Monitoring is performed by the device This check can be accomplished by: itself. The visual check of the data Immersing the sensor in an ice slurry generated by the device, to ensure (32°F (0°C)) if the device will be used at that the critical limits have been met or near refrigeration temperature; consistently, may be performed by any person who has an understanding of the OR nature of the controls; Comparing the temperature reading on the device with the reading on a known AND accurate reference device (e.g., a NIST- • For other checks: traceable thermometer) under conditions Any person who has an understanding of that are similar to how it will be used (e.g., the nature of the controls. air temperature) within the temperature range at which it will be used;

CHAPTER 13: Clostridium botulinum Toxin Formation 276 AND 2C. APPLICATION AND ACTIVATION OF TTI • Once in service, check the temperature- Set Critical Limits. recording device daily before the beginning of operations. Less frequent accuracy checks • Each consumer package has an activated may be appropriate if they are recommended TTI. by the instrument manufacturer and the history of use of the instrument in your Establish Monitoring Procedures. facility has shown that the instrument » What Will Be Monitored? consistently remains accurate for a longer • Packages for the presence of an activated period of time. In addition to checking that TTI. the device is accurate by one of the methods described above, this process should include » How Will Monitoring Be Done? a visual examination of the sensor and any • Visual examination. attached wires for damage or kinks. The device should be checked to ensure that it » How Often Will Monitoring Be Done (Frequency)? is operational and, where applicable, has • Representative number of packages from sufficient ink and paper; each lot of product. AND » Who Will Do the Monitoring? • Calibrate the temperature-recording device • Any person who has an understanding of the against a known accurate reference device nature of the controls. (e.g., a NIST-traceable thermometer) at least once a year or more frequently if recommended by the device manufacturer. Establish Corrective Action Procedures. Optimal calibration frequency is dependent Take the following corrective action to a product upon the type, condition, past performance, involved in a critical limit deviation: and conditions of use of the device. • Hold the lot below 38°F (3.3°C) until TTIs Consistent temperature variations away from are applied and activated. the actual value (drift) found during checks and/or calibration may show a need for more AND frequent calibration or the need to replace Take the following corrective action to regain control the device (perhaps with a more durable over the operation after a critical limit deviation: device). Calibration should be performed at • Identify and correct the cause of the TTI a minimum of two temperatures that bracket application or activation deficiency. the temperature range at which it is used; AND Establish a Recordkeeping System. • Perform other instrument calibration, as • Packaging control record that shows the appropriate; results of the TTI checks. AND Establish Verification Procedures. • Review monitoring, corrective action, • Review monitoring and corrective action and verification records within 1 week of records within 1 week of preparation preparation to ensure they are complete and to ensure they are complete and any any critical limit deviations that occurred critical limit deviations that occurred were were appropriately addressed. appropriately addressed.

CHAPTER 13: Clostridium botulinum Toxin Formation 277 2D. REFRIGERATED FINISHED PRODUCT STORAGE Follow the guidance for “Control Strategy Example 1 - Smoking (1d - Refrigerated Finished Product Storage),” except that the where the critical limits list 40ºF (4.4ºC), they should list 38°F (3.3°C).

2E. RECEIPT OF PRODUCTS BY SECONDARY PROCESSOR Follow the guidance for “Control Strategy Example 1 - Smoking (1e - Receipt of Products by Secondary Processor),” except that the where the critical limits list 40ºF (4.4ºC), they should list 38°F (3.3°C).

CHAPTER 13: Clostridium botulinum Toxin Formation 278 Review Review Review Review Review Review thereafter corrective corrective corrective corrective corrective corrective and for all and for suppliers at monitoring, monitoring, monitoring, monitoring, monitoring, logger for all logger for new suppliers least quarterly within 1 week within 1 week within 1 week within 1 week within 1 week within 1 week of preparation of preparation of preparation action records action records action records Check the data TTI data record record challenge Receiving Receiving performance Manufacturer’s Manufacturer’s l fragments). e illustrates how a processor of refrigerated, ter 3) for other potential hazards (e.g., shipment shipment improved Reject the Reject Reject the Reject validation is provided documentation been improved or transportation- that the identified that the identified practices have been practices have evidence is obtained evidence CORRECTIVE ACTION(S) RECORDS VERIFICATION Discontinue use of the Discontinue use of the Discontinue use of the supplier or carrier until supplier or carrier until handling practices have handling practices have transportation- handling the identified production the identified evidence is obtained that evidence supplier until appropriate staff Quality Quality Receiving Receiving assurance assurance employee supervisor First Every Every shipment shipment TTI model with visual monitoring review and review Continuous, Continuous, temperature- evaluation of evaluation shipment of a records for each records for TABLE 13-2 TABLE Example Only MONITORING data See Text for Full Recommendations See Text Review of Review whether it data logger to room air from the lot temperature performance to determine Expose a TTI changes color sufficient time temperature for Digital time and Truck Truck WHAT HOW FREQUENCY WHO CONTROL STRATEGY EXAMPLE 2 - REFRIGERATION WITH TTI EXAMPLE 2 - REFRIGERATION CONTROL STRATEGY The ability to room air temperature temperature Performance Performance of the TTI to change color manufacturer data from the when exposed are 40°F TTI is records The TTI by truck MEASURE functions at receipt that show FOR EACH PREVENTIVE at or below temperature accompanied CRITICAL LIMITS suitable for use suitable for was maintained was All lots received All lots received toxin product HAZARD(S) the finished formation in SIGNIFICANT C. botulinum C. vacuum-packaged, raw fish fillets can control C. botulinum toxin formation. It is provided for illustrative purposes only. vacuum-packaged, raw fish fillets can control C. botulinum toxin formation. It is provided for illustrative purposes only. 3-2 and 3-4 (Chap C. Botulinum toxin formation may be only one of several significant hazards for this product. Refer to Tables aquaculture drugs, environmental chemical contaminants and pesticides, parasites, growth of other pathogenic bacteria, meta This table is an example of a portionTTI.” exampl of a HACCP plan using “Control Strategy Example 2 - Refrigeration With (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) TTI POINT CRITICAL CONTROL Receipt of of Receipt

CHAPTER 13: Clostridium botulinum Toxin Formation 279 Review Review Review Review check it per year corrective corrective 1 week of 1 week 1 week of 1 week Check the action and verification verification verification verification action, and action, monitoring, monitoring, monitoring, monitoring, preparation preparation daily, at the daily, beginning of ensure that it accuracy and is operational before putting before and corrective and corrective records within records within data logger for data logger for into operation; damage and to operations; and calibrate it once Data Packaging Packaging control record logger printout l fragments). e illustrates how a processor of refrigerated, ter 3) for other potential hazards (e.g., deviation CORRECTIVE ACTION(S) RECORDS VERIFICATION Repair or adjust cooler Repair Destroy the lot of TTIs apply and activate TTIs Identify and correct the cause of TTI application Hold lot below 38°F, and Hold lot below 38°F, staff Quality assurance employee Production product check of number of each lot of with visual Continuous, Continuous, once per day recorded data Representative Representative packages from TABLE 13-2 TABLE Example Only MONITORING Visual Visual See Text for Full Recommendations See Text data logger temperature examination Digital time and of an WHAT HOW FREQUENCY WHO Cooler CONTROL STRATEGY EXAMPLE 2 - REFRIGERATION WITH TTI EXAMPLE 2 - REFRIGERATION CONTROL STRATEGY temperature Packages for for Packages the presence activated TTI Each Cooler MEASURE FOR EACH PREVENTIVE maintained below 38°F activated TTI CRITICAL LIMITS package has an toxin toxin product product HAZARD(S) the finished the finished formation in formation in SIGNIFICANT C. botulinum C. C. botulinum C. vacuum-packaged, raw fish fillets can control C. botulinum toxin formation. It is provided for illustrative purposes only. vacuum-packaged, raw fish fillets can control C. botulinum toxin formation. It is provided for illustrative purposes only. 3-2 and 3-4 (Chap C. Botulinum toxin formation may be only one of several significant hazards for this product. Refer to Tables aquaculture drugs, environmental chemical contaminants and pesticides, parasites, growth of other pathogenic bacteria, meta This table is an example of a portionTTI.” exampl of a HACCP plan using “Control Strategy Example 2 - Refrigeration With (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) TTI TTI and POINT storage CRITICAL CONTROL activation attachment

CHAPTER 13: Clostridium botulinum Toxin Formation 280 Review Review check it per year corrective corrective 1 week of 1 week Check the verification verification action, and action, monitoring, monitoring, preparation daily, at the daily, beginning of ensure that it accuracy and is operational before putting before records within data logger for data logger for into operation; damage and to operations; and calibrate it once printout Digital logger l fragments). e illustrates how a processor of refrigerated, ter 3) for other potential hazards (e.g., Hold and based on time and evaluate the product evaluate CORRECTIVE ACTION(S) RECORDS VERIFICATION Adjust or repair cooler Adjust temperature of exposure employee Production check of with visual Continuous, Continuous, once per day recorded data TABLE 13-2 TABLE Example Only MONITORING logger See Text for Full Recommendations See Text Digital data WHAT HOW FREQUENCY WHO CONTROL STRATEGY EXAMPLE 2 - REFRIGERATION WITH TTI EXAMPLE 2 - REFRIGERATION CONTROL STRATEGY Cooler air temperature 38°F cooler MEASURE FOR EACH Maximum PREVENTIVE temperature CRITICAL LIMITS toxin during storage product finished formation HAZARD(S) SIGNIFICANT C. botulinum C. vacuum-packaged, raw fish fillets can control C. botulinum toxin formation. It is provided for illustrative purposes only. vacuum-packaged, raw fish fillets can control C. botulinum toxin formation. It is provided for illustrative purposes only. 3-2 and 3-4 (Chap C. Botulinum toxin formation may be only one of several significant hazards for this product. Refer to Tables aquaculture drugs, environmental chemical contaminants and pesticides, parasites, growth of other pathogenic bacteria, meta This table is an example of a portionTTI.” exampl of a HACCP plan using “Control Strategy Example 2 - Refrigeration With *Note: The critical limits in this example are for illustrative purposes only and not related to any recommended process. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) POINT storage product CRITICAL Finished CONTROL

CHAPTER 13: Clostridium botulinum Toxin Formation 281 • CONTROL STRATEGY EXAMPLE 3 - FROZEN WITH Establish Veriﬁcation Procedures. LABELING • Review monitoring and corrective action Set Critical Limits. records within 1 week of preparation to ensure they are complete and any • All ﬁnished product labels must contain a critical limit deviations that occurred were “keep frozen” statement (e.g., “Important, appropriately addressed. keep frozen until used, thaw under refrigeration immediately before use”).

Establish Monitoring Procedures.

» What Will Be Monitored? • Finished product labels for the presence of a “keep frozen” statement.

» How Will Monitoring Be Done? • Visual examination.

» How Often Will Monitoring Be Done (Frequency)? • Representative number of packages from each lot of product.

» Who Will Do the Monitoring? • Any person who has an understanding of the nature of the controls.

Establish Corrective Action Procedures. Take the following corrective action to a product involved in a critical limit deviation: • Segregate and relabel any improperly labeled product. AND

Take the following corrective actions to regain control over the operation after a critical limit deviation: • Segregate and return or destroy any label stock or pre-labeled packaging stock that does not contain the proper statement; AND • Determine and correct the cause of improper labels.

Establish a Recordkeeping System. • Record of labeling checks.

CHAPTER 13: Clostridium botulinum Toxin Formation 282 Review Review correction action records within 1 week within 1 week of preparation monitoring and record RECORDS VERIFICATION Label receiving illustrates how a processor of frozen, proper statement ACTION(S) Determine label stock improperly relabel any contain the and correct ter 3) for other potential hazards (e.g., destroy any CORRECTIVE the cause of that does not Segregate and Segregate and improper labels labeled product Receiving Receiving employee product number of each lot of Representative Representative packages from TABLE 13-3 TABLE MONITORING Example Only Visual Visual examination See Text for Full Recommendations See Text WHAT HOW FREQUENCY WHO product Finished statement labels for the the labels for presence of a “keep frozen” frozen” “keep CONTROL STRATEGY EXAMPLE 3 - FROZEN WITH LABELING CONTROL STRATEGY “keep “keep frozen” frozen” MEASURE statement FOR EACH PREVENTIVE All finished product labels CRITICAL LIMITS must contain a toxin during storage product finished formation HAZARD(S) SIGNIFICANT C. botulinum C. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) This table is an example of a portionLabeling.” of a HACCP plan using “Control Strategy Example 3 - Frozen With vacuum-packaged, raw fish fillets can control C. botulinum toxin formation. It is provided for illustrative purposes only. vacuum-packaged, raw fish fillets can control C. botulinum toxin formation. It is provided for illustrative purposes only. 3-2 and 3-4 (Chap C. Botulinum toxin formation may be only one of several significant hazards for this product. Refer to Tables environmental chemical contaminants and pesticides, parasites, metal fragments). POINT labeling CRITICAL CONTROL Receipt of Receipt

CHAPTER 13: Clostridium botulinum Toxin Formation 283 • CONTROL STRATEGY EXAMPLE 4 - PICKLING For unrefrigerated (shelf-stable), reduced oxygen- AND SALTING packaged products: This control strategy should include the following A water phase salt level of at least 20% elements, as appropriate: (based on the maximum salt level for growth of S. aureus); a. Brining, pickling, salting, and formulation; OR A pH of 4.6 or below; b. Refrigerated finished product storage; OR c. Receipt of Product by secondary A water activity of 0.85 or below (based processor. on the minimum water activity for growth and toxin formation of S. aureus). 4A. BRINING, PICKLING, SALTING, AND FORMULATION A heat treatment, addition of chemical additives, or other treatment may be necessary to inhibit or Set Critical Limits. eliminate spoilage organisms (e.g., mold) in shelf- • The minimum or maximum values for stable products. the critical factors of the brining, pickling, or formulation process established by a Establish Monitoring Procedures. scientific study. The critical factors are those that are necessary to ensure that the finished » What Will Be Monitored? product has: • The critical factors of the established pickling, brining, or formulation process. For refrigerated, reduced oxygen-packaged These may include: brine and acid strength; fishery products: brine or acid to fish ratio; brining and A water phase salt level of at least 5%; pickling time; brine and acid temperature; OR thickness, texture, fat content, quality, and A pH of 5.0 or below; species of fish; OR OR A water activity of below 0.97; • The water phase salt, pH, and/or water activity of the finished product. OR A water phase salt level of at least » How Will Monitoring Be Done? 2.4% in surimi-based products, when • For brine strength: combined with a pasteurization process Use a salinometer; in the finished product container AND of 185°F (85°C) for 15 minutes (pasteurization controls are covered in • For acid strength: Chapter 16); Use a pH meter or titrate for acid concentration; OR A combination of water phase salt, AND pH, and/or water activity that, when • For brine/acid temperature: combined, have been demonstrated to Use a temperature-indicating device (e.g., prevent the growth of C. botulinum type a thermometer); E and non-proteolytic types B and F. AND

CHAPTER 13: Clostridium botulinum Toxin Formation 284 • For all other critical factors specified by the Establish Corrective Action Procedures. study: Take the following corrective action to a product Use equipment appropriate for the involved in a critical limit deviation: measurement; • Chill and hold the product until it can be OR evaluated based on its water phase salt, pH, • For water phase salt, pH, and/or water and/or water activity level; activity: OR Collect a representative sample of the • Reprocess the product (if reprocessing does finished product, and conduct water not jeopardize the safety of the product); phase salt, pH, and/or water activity analysis, as appropriate. OR • Divert the product to a use in which the » How Often Will Monitoring Be Done (Frequency)? critical limit is not applicable (e.g., packaging • For brine and acid strength: that is not hermetically sealed, or a LACF, or At the start of each brining, pickling, and a frozen product); formulation process; OR AND • Divert the product to a non-food use; • For brine and acid temperature: OR At the start of each brining, pickling, and • Destroy the product. formulation process and at least every 2 hours thereafter; AND AND Take the following corrective action to regain control • For brine or acid to fish ratio: over the operation after a critical limit deviation: At the start of each brining, pickling, and • Adjust the brine or acid strength or brine or formulation process; acid to fish ratio; AND OR • For other critical factors specified by the study: • Extend the brining or pickling time to compensate for an improper brine or acid As often as necessary to maintain control; temperature. OR • Water phase salt, pH, and/or water activity Establish a Recordkeeping System. analysis should be determined for each batch • Records, as necessary, to document the of finished product. monitoring of the critical factors of the brining or pickling process, as established » Who Will Do the Monitoring? by a study (e.g., a processing record showing • For water activity: the results of the brine or acid strength Any person with sufficient training to and temperature, brine or acid to fish ratio, perform the analysis; size and species of fish, time of brining or pickling); OR • For other checks: OR Any person with an understanding of the • Record of determinations of the finished nature of the controls. product water phase salt, pH, or water activity.

CHAPTER 13: Clostridium botulinum Toxin Formation 285 Establish Verification Procedures. and/or product that affect the ability • Process validation study (except where water of the established minimum pickling, phase salt, pH, or water activity analysis brining, and formulation process of the finished product is the monitoring should be taken into consideration in procedure): the process establishment. A record of the process establishment should be The adequacy of the pickling, brining, maintained; and formulation process steps should be established by a scientific study. For AND refrigerated, reduced oxygen-packaged • Before a temperature-indicating device (e.g., products, it should be designed to a thermometer) is put into service, check consistently achieve: a water phase salt the accuracy of the device to verify that the level of at least 5%; a pH of 5.0 or below; factory calibration has not been affected. a water activity of below 0.97; a water This check can be accomplished by: phase salt level of at least 2.4% in surimi- Immersing the sensor in an ice slurry based products, when combined with (32°F (0°C)) if the device will be used at a pasteurization process in the finished or near refrigeration temperature; product container of 185°F (85°C) for at least 15 minutes; or a combination OR of salt, pH, and/or water activity that, Immersing the sensor in boiling water when combined, prevent the growth of (212°F (100°C)) if the device will be C. botulinum type E and non-proteolytic used at or near the boiling point. Note types B and F (established by a scientific that the temperature should be adjusted study). For unrefrigerated (shelf-stable), to compensate for altitude, when reduced oxygen-packaged products, necessary); it should be designed to consistently OR achieve: a water phase salt level of Doing a combination of the above if at least 20% (based on the maximum the device will be used at or near room water phase salt level for the growth of temperature; S. aureus); a pH of 4.6 or below; or a water activity of 0.85 or below (based OR on the minimum water activity for the Comparing the temperature reading on growth of S. aureus). Expert knowledge the device with the reading on a known of pickling, brining, and formulation accurate reference device (e.g., a NIST- processes may be required to establish traceable thermometer) under conditions such a process. Such knowledge can be that are similar to how it will be used obtained by education or experience, or (e.g., brine temperature) within the both. Establishment of pickling, brining, temperature range at which it will be and formulation processes may require used; access to adequate facilities and the application of recognized methods. In AND some instances, pickling, brining, and • Once in service, check the temperature- formulation studies may be required to indicating device daily before the beginning establish minimum processes. In other of operations. Less frequent accuracy checks instances, existing literature, which may be appropriate if they are recommended establishes minimum processes, is by the instrument manufacturer and the available. Characteristics of the process history of use of the instrument in your

CHAPTER 13: Clostridium botulinum Toxin Formation 286 facility has shown that the instrument any critical limit deviations that occurred consistently remains accurate for a longer were appropriately addressed. period of time. In addition to checking that the device is accurate by one of the methods 4B. REFRIGERATED FINISHED PRODUCT STORAGE described above, this process should include Follow the guidance for “Control Strategy a visual examination of the sensor and any Example 1 - Smoking (1d - Refrigerated Finished attached wires for damage or kinks. The Product Storage).” device should be checked to ensure that it is 4C. RECEIPT OF PRODUCT BY SECONDARY operational; PROCESSOR AND Follow the guidance for “Control Strategy • Calibrate the temperature-indicating device Example 1 - Smoking (1e - Receipt of Product by against a known accurate reference device Secondary Processor).” (e.g., a NIST-traceable thermometer) at least once a year or more frequently if recommended by the device manufacturer. Optimal calibration frequency is dependent upon the type, condition, past performance, and conditions of use of the device. Consistent temperature variations away from the actual value (drift) found during checks and/or calibration may show a need for more frequent calibration or the need to replace the device (perhaps with a more durable device). Calibration should be performed at a minimum of two temperatures that bracket the temperature range at which it is used; AND • Perform daily calibration of pH meters against standard buffers; AND • Perform other calibration procedures as necessary to ensure the accuracy of the monitoring instruments; AND • Do ﬁnished product sampling and analysis to determine water phase salt, pH, or water activity level, as appropriate, at least once every 3 months (except where such testing is performed as part of monitoring); AND • Review monitoring, corrective action, and veriﬁcation records within 1 week of preparation to ensure they are complete and

CHAPTER 13: Clostridium botulinum Toxin Formation 287 Review Review Review Review week of week per year 1 week of 1 week monitoring, monitoring, monitoring, monitoring, preparation preparation the pH meter to ensure that before putting before records within into operation; Check the data and verification and verification and verification and verification it is operational operations; and calibrate it once records within 1 check it daily, at check it daily, the beginning of and damage corrective action, action, corrective corrective action, action, corrective Daily calibration of logger for accuracy logger for record printout RECORDS VERIFICATION Data logger Pickling control illustrates how a pickled herring processor ter 3) for other potential hazards (e.g., Adjust or Adjust exposure Hold and ACTION(S) CORRECTIVE evaluate the evaluate on time and repair cooler Continue the product based temperature of until pH meets the critical limit pickling process control Quality employee personnel Production Each cycle per day pickling check of recorded data once tank, each tank, with visual Continuous, Continuous, TABLE 13-4 TABLE Example Only MONITORING meter Collect a Time and Time tank at the data logger end of each temperature product from each pickling sample of the pickling cycle pickling cycle pH using a and analyze for and analyze for See Text for Full Recommendations See Text WHAT HOW FREQUENCY WHO Finished Cooler air temperature product pH in the loin muscle CONTROL STRATEGY EXAMPLE 4 - PICKLING AND SALTING CONTROL STRATEGY 40°F of 5.0 cooler finished MEASURE growth of FOR EACH Maximum Maximum vegetative vegetative (based on PREVENTIVE pathogens) temperature: product pH in CRITICAL LIMITS the loin muscle toxin during storage product product finished formation HAZARD(S) SIGNIFICANT C. botulinum C. in the finished toxin formation (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) can control C. botulinum toxin formation. It is provided for illustrative purposes only. can control C. botulinum toxin formation. It is provided for illustrative purposes only. 3-2 and 3-4 (Chap C. botulinum toxin formation may be only one of several significant hazards for this product. Refer to Tables histamine, environmental and chemical contaminants pesticides, parasites, metal fragments). This table is an example of a portion of a HACCP plan using “Control Strategy Example 4 - Pickling and Salting.” This example POINT Pickling botulinum C. CRITICAL Finished CONTROL product storage

CHAPTER 13: Clostridium botulinum Toxin Formation 288 BIBLIOGRAPHY. • Daniels, R. W. 1991. Applying HACCP to new-generation refrigerated foods at retail We have placed the following references on and beyond. Food Technol. 45:122, 124. display in the Division of Dockets Management, • Dufresne, I., J. P. Smith, J. N. Liu, and I. Tarte. Food and Drug Administration, 5630 Fishers Lane, 2000. Effect of films of different oxygen rm. 1061, Rockville, MD 20852. You may see transmission rate on toxin production by them at that location between 9 a.m. and 4 p.m., Clostridium botulinum type E in vacuum Monday through Friday. As of March 29, 2011, packaged cold and hot smoked trout fillets. J. FDA had verified the Web site address for the Food Saf. 20:251-268. references it makes available as hyperlinks from • Eklund, M. W., G. A. Pelroy, R. Paranjpye, M. the Internet copy of this guidance, but FDA is not E. Peterson, and F. M. Teeny. 1982. Inhibition responsible for any subsequent changes to Non- of Clostridium botulinum types A and E FDA Web site references after March 29, 2011. toxin production by liquid smoke and NaCl in hot-process smoke-flavored fish. J. Food • Association of Food and Drug Officials. 2005. Prot. 44:935-941. Cured, salted, & smoked fish establishments • Essuman, K. M., 1992. Fermented fish in good manufacturing practices, including Africa: a study on processing marketing and Listeria Control Manual. Association of Food consumption. FAO Fisheries technical paper no. and Drug Officials, York, PA. T329. FAO, Rome, Italy. ISBN: 9251032556. 80p. • Baird-Parker, A. C., and B. Freame. 1967. • European Chilled Food Federation. 1997. Combined effect of water activity, pH and Guidelines for good hygienic practice in the temperature on the growth of Clostridium manufacture of chilled foods. Kettering, NN. botulinum from spore and vegetative cell • Farber, J. M. 1991. Microbiological aspects of - inocula. J. Appl. Bact. 30:420 429. modified atmosphere packaging technology - • Betts, G. D., and J. E. Getts. 1995. Growth a review. J. Food Prot. 54:58-70. and heat resistance of psychotropic • Garren, D. M., M. A. Harrison, and Y. W. Clostridium botulinum in relation to ‘sous Huang. 1994. Clostridium botulinum type E - vide’ products. Food Control 6:57 63. outgrowth and toxin production in vacuum- • Boyd, J. W., and B. A. Southcott. 1971. Effects skin packaged shrimp. Food Microbiol. of sodium chloride on outgrowth and toxin 11:467-472. production of Clostridium botulinum type • Gould, G. W. 1999. Sous vide foods: E in cod homogenates. J. Fish. Res. Bd. conclusions of an ECFF botulinum working - Canada. 28:1071 1075. party. Food Control 10:47-51. • Brody, A. L. (ed.). 1989. Controlled/modified • Graham, A. F., D. R. Mason, and M. W. atmosphere/vacuum packaging of foods. Peck. 1996. Predictive model of the effect Food and Nutrition Press, Inc., Trumbull, CT. of temperature, pH and sodium chloride • Crisan, E.V., and A. Sands. 1975. Microflora of on growth from spores of non-proteolytic four fermented fish sauces. Appl. Microbiol. Clostridium botulinum. Int. J. Food Microbiol. 29(1): 106-108. 31:69-85. • Christiansen, L. N., J. Deffner, E. M. Foster, • Hathaway, C.L. 1993. Clostridium botulinum and H. Sugiyama. 1968. Survival and and other Clostridia that produce botulinum. outgrowth of Clostridium botulinum type In Clostridium botulinum Ecology and Control E spores in smoked fish. Appl. Microbiol. in Foods. A.H.W Hauschild and K.L. Dodds 16:133-137. (eds.), Marcel Dekker, New York. 1993.

CHAPTER 13: Clostridium botulinum Toxin Formation 289 • Hauschild, A. H. W., and R. Hilsheimer. 1979. Food Safety and Inspection Service, U.S. Effect of salt content and pH on toxigenesis Department of Agriculture, Washington, DC. by Clostridium botulinum in caviar. J. Food http://www.fsis.usda.gov/OPHS/NACMCF/past/ Prot. 42:245-248. map_fishery.htm. • Hilderbrand, K. S. 1992. Fish smoking • Peck, M. W. 1997. Clostridium botulinum and procedures for forced convection the safety of refrigerated processed foods smokehouses, Special Report 887. Oregon of extended durability. Trends Food Sci. State Extension Service, Newport, OR. Technol. 8:186-192. • Kautter, D. A., P. K. Lynt, T. Lily, and H. M. • Pelroy, G. A, M. W. Eklund, R. N. Paranjpye, Solomon. 1981. Evaluation of the botulism E. M. Suzuki, and M. E. Peterson. 1982. hazard from nitrogen-packed sandwiches. J. Inhibition of Clostridium botulinum types A Food Prot. 44:59-61. and E toxin formation by sodium nitrite and • Kornacki, J. L., and D. A. Gabis. 1990. sodium chloride in hot process (smoked) Microorganisms and Refrigeration salmon. J. Food Prot. 45:833-841. Temperatures. Dairy, Food & Environ. Sanit. • Peterson, M. E., G. A. Pelroy, R. N. Paranjpye, 10:192-195. F. T. Poysky, J. S. Almond, and M. W. Eklund. • Loha-unchit, K. 1998. How Fish Sauce 1993. Parameters for control of Listeria is Made. Kasma’s Thai Food and Travel. monocytogenes in smoked fishery products: http://www.thaifoodandtravel.com/features/ sodium chloride and packaging method. J. fishsauce1.html. Food Prot. 56:938-943. • Lerke, P., and L. Farber. 1971. Heat • Reddy, N. R., A. Paradis, M. G. Roman, H. M. pasteurization of crab and shrimp from the Solomon, and E. J. Rhodehamel. 1996. Toxin Pacific coast of the United States: public development by Clostridium botulinum in health aspects. J. Food Sci. 36:277-279. modified atmosphere-packaged fresh tilapia fillets during storage. J. Food Sci. 61:632-635. • Lyon, W. J., and C. S. Reddmann. 2000. Bacteria associated with processed • Reddy, N. R., D. J. Armstrong, E. J. crawfish and potential toxin production by Rhodehamel, and D. A. Kautter. 1992. Shelf- Clostridium botulinum type E in vacuum- life extension and safety concerns about packaged and aerobically packaged crawfish fresh fishery products packaged under tails. J. Food Prot. 63:1687-1696. modified atmospheres: a review. J. Food Saf. 12:87-118. • McClure, P. J., M. B. Cole, and J. P. P. M. Smelt. 1994. Effects of water activity and pH • Reddy, N. R., H. M. Solomon, H. Yep, M. G. on growth of Clostridium botulinum. J. Appl. Roman, and E. J. Rhodehamel. 1997. Shelf Bact. Symp. Suppl. 76:105S-114S. life and toxin development by Clostridium botulinum during storage in modified • Moody, M.W., G.J. Flick, R.E. Martin, and A.L. atmosphere-packaged fresh aquacultured Correa. 2000. Smoked, cured, and dried fish. salmon fillets. J. Food Prot. 60:1055-1063. In R.E. Martin, E.P. Carter, G.J. Flick, L.M. Davis, (eds.), Marine & Freshwater Products • Reddy, N. R., M. G. Roman, M. Villanueva, Handbook, 2000. Technomic Publishing Co. H. M. Solomon, D. A. Kautter, and E. J. Lancaster, PA Rhodehamel. 1996. Shelf life and Clostridium botulinum toxin development during storage • National Advisory Committee on of modified atmosphere-packaged fresh Microbiological Criteria for Foods. 1992. catfish fillets. J. Food Sci. 62:878-884. Vacuum or modified atmosphere packaging for refrigerated raw fishery products. • Refrigerated Foods and Microbiological Criteria Committee of the National Food

CHAPTER 13: Clostridium botulinum Toxin Formation 290 Processors Association. 1988. Safety considerations for new generation refrigerated foods. Dairy Food Sanit. 8:5-7. • Rhodehamel, E. J. 1992. FDA’s concerns with sous vide processing. Food Technol. 46:73- 76.Rhodehamel, E. J., H. M. Solomon, T. Lilly, Jr., D. A. Kautter, and J. T. Peeler. 1991. Incidence and heat resistance of Clostridium botulinum type E spores in menhaden surimi. J. Food Sci. 56:1562-1563, 1592. • Ross, T., and P. Dalgaard. 2004. Secondary Models - A3.1.3. Salt, water-phase salt, and water activity. In R. C. McKellar and L. Xuewen (ed.), Modeling microbial responses in food. CRC Press, Boca Raton, FL. • Schmidt, R. V., R. V. Lechowich, and J. F. Folinazzo. 1961. Growth and toxin production by type E Clostridium botulinum below 40°F. J. Food Sci. 26:626-630. • Segner, W. P, C. F. Schmidt, and J. K. Boltz. 1966. Effect of sodium chloride and pH on the outgrowth of spores of type E Clostridium botulinum at optimal and suboptimal temperatures. Appl. Microbiol.14:49-54. • Skinner, G. E., and J. W. Larkin. 1998. Conservative prediction of time to Clostridium botulinum toxin formation for use with time-temperature indicators to ensure the safety of foods. J. Food Prot. 61:1154-1160. • Sobel, J., et al., 2004.Foodborne botulism in the United States, 1990-2000. Emerging Infectious Diseases. 10(9): 1606-1611. • Sugiyama, H., and K. S. Rutledge. 1978. Failure of Clostridium botulinum to grow in fresh mushrooms packaged in plastic ﬁlm overwraps with holes. J. Food Prot. 41:348-350. • U.S. Food and Drug Administration. 1996. Import Alert 16-74: automatic detention of salt-cured uneviscerated ﬁsh. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park, MD.

CHAPTER 13: Clostridium botulinum Toxin Formation 291 NOTES:

CHAPTER 13: Clostridium botulinum Toxin Formation 292 CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying

UNDERSTAND THE POTENTIAL HAZARD. expected conditions of storage and distribution. Additionally, finished product package closures Pathogenic bacteria growth and toxin formation should be free of gross defects that could expose in the finished product as a result of inadequate the product to moisture during storage and drying of fishery products can cause consumer distribution. Chapter 18 provides guidance on illness. The primary pathogens of concern are control of container closures. Staphylococcus aureus (S. aureus) and Clostridium Some dried products that are reduced oxygen botulinum (C. botulinum). See Appendix 7 for a packaged (e.g., vacuum packaged, modified description of the public health impacts of atmosphere packaged) are dried only enough these pathogens. to control growth and toxin formation by C. botulinum type E and non-proteolytic types B • Control by Drying and F (i.e., types that will not form toxin with Dried products are usually considered shelf stable a water activity of below 0.97). These dried and are, therefore, often stored and distributed products are then refrigerated to control growth unrefrigerated. Examples of shelf-stable dried and toxin formation by C. botulinum type A and fish products are salmon jerky, octopus chips, proteolytic types B and F and by other pathogenic dried shrimp, stock fish, and shark cartilage. The bacteria that may be present in the product, characteristic of dried foods that makes them including S. aureus. The products might have the shelf stable is their low water activity (A ). Water w appearance of a fully dried product. Therefore, activity is the measure of the amount of water their packaging should include “keep refrigerated” in a food that is available for the growth of labeling to ensure that temperature controls are microorganisms, including pathogenic bacteria. A applied throughout distribution. water activity of 0.85 or below will prevent the growth and toxin production of all pathogenic Distributing partially dried, reduced oxygen bacteria, including S. aureus and C. botulinum, packaged products frozen also could be used and is critical for the safety of a shelf-stable dried to control these pathogens. However, labeling product. S. aureus grows at a lower water activity with “keep frozen” instructions would then be than other pathogenic bacteria, and should, important to ensure food safety. More information therefore, be considered the target pathogen for on C. botulinum and reduced oxygen packaging is drying for shelf-stable products. contained in Chapter 13. You should select a packaging material that will This chapter does not cover the growth of prevent rehydration of the product under the pathogenic bacteria, including S. aureus, which may occur as a result of time and temperature

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 293 abuse during processing, including before or of the viscera or its contents is left behind, the during the drying process. That hazard is risk of toxin formation by C. botulinum remains. covered in Chapter 12. It also does not cover the Small fish, less than 5 inches in length, that are control of C. botulinum type A and proteolytic processed in a manner that eliminates preformed types B and F and that of other pathogenic toxin and prevents toxin formation and that bacteria that may be present, including S. aureus, reach (1) a water phase salt content of 10%, a during refrigerated storage of reduced oxygen value based on the control of C. botulinum type packaged, partially dried products. That hazard A and proteolytic types B and F, in refrigerated is covered in Chapters 12 and 13, respectively. products; or (2) a water activity of 0.85 or below (note that this is a value based on the minimum Controlling pathogenic bacteria growth and toxin water activity for toxin production by S. aureus, formation by drying is best accomplished by: in shelf-stable products); or (3) a pH (acidity) • Scientifically establishing a drying process level of 4.6 or less in shelf-stable products are not that reduces the water activity to 0.85 or subject to the evisceration recommendation. below if the product will be stored and distributed unrefrigerated (shelf stable). Note • Strategies for controlling pathogenic that a heat treatment, addition of chemical bacteria growth additives, further drying, or other treatment Pathogens can enter the process on raw materials. may be necessary to inhibit or eliminate They can also be introduced into foods during spoilage organisms, for example, mold; processing, from the air, unclean hands, insanitary • Scientifically establishing a drying process utensils and equipment, contaminated water, and that reduces the water activity to below 0.97 sewage. There are a number of strategies for the if the product will be stored refrigerated (not control of pathogenic bacteria in fish and fishery frozen) in reduced oxygen packaging; products. They include: • Designing and operating the drying • Controlling the amount of moisture that is equipment so that every unit of a product available for pathogenic bacteria growth receives at least the established minimum (water activity) in the product by drying process; (covered in this chapter); • Packaging the finished product in a container • Controlling the amount of moisture that is that will prevent rehydration. available for pathogenic bacteria growth (water activity) in the product by formulation The drying operation used in the production of (covered in Chapter 13); smoked or smoke-flavored fish is not designed to result in a finished product water activity of 0.85 • Controlling the amount of salt or or below. The controls for these products are preservatives, such as sodium nitrite, in the described in Chapter 13. product (covered in Chapter 13); • Controlling the pH in the product (covered Because spores of C. botulinum are known to be by the Acidified Foods regulation, 21 CFR present in the viscera of fish, any product that 114, for shelf-stable acidified products, and will be preserved by salting, drying, pickling, by Chapter 13 for refrigerated acidified or fermentation should be eviscerated prior to products); processing (see the “Compliance Policy Guide,” Sec. 540.650). Without evisceration, toxin • Controlling the source of molluscan shellfish formation is possible during the process even and the time from exposure to air (e.g., by with strict control of temperature. Evisceration harvest or receding tide) to refrigeration to should be thorough and performed to minimize control pathogens from the harvest area contamination of the fish flesh. If even a portion (covered in Chapter 12);

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 294 • Controlling the introduction of pathogenic if drying is not properly performed. Note bacteria after the pasteurization process that drying to control toxin formation by S. (covered in Chapter 18); aureus will also control toxin formation by C. • Managing the amount of time that food is botulinum in these products. exposed to temperatures that are favorable 2. For shelf-stable, dried products, can S. aureus for pathogenic bacteria growth and toxin toxin formation that is reasonably likely to occur production (covered generally in Chapter 12; be eliminated or reduced to an acceptable level for C. botulinum, in Chapter 13; and for S. at this processing step? aureus in hydrated batter mixes, in Chapter 15); Pathogenic bacteria growth and toxin • Killing pathogenic bacteria by cooking formation as a result of inadequate drying or pasteurization (covered in Chapter 16) should also be considered a significant or by retorting (covered by the Thermally hazard at any processing step where a Processed Low-Acid Foods Packaged in preventive measure is, or can be, used to Hermetically Sealed Containers regulation, 21 eliminate the hazard of S. aureus toxin CFR 113 (called the Low-Acid Canned Foods formation (or reduce the likelihood of its Regulation in this guidance document)); occurrence to an acceptable level) if it is reasonably likely to occur. The preventive • Killing pathogenic bacteria by processes that measure that can be applied for pathogenic retain raw product characteristics (covered in bacteria growth and toxin formation as a Chapter 17). result of inadequate drying are: DETERMINE WHETHER THE POTENTIAL • Proper design and control of the drying HAZARD IS SIGNIFICANT. process (covered in this chapter); 3. For refrigerated or frozen, partially dried (i.e., The following guidance will assist you in not shelf stable) products, is it reasonably likely determining whether pathogenic bacteria growth that C. botulinum type E and nonproteolytic types and toxin formation as a result of inadequate B and F will grow and form toxin in the finished drying is a significant hazard at a processing step: product if the product is inadequately dried? 1. For shelf-stable, dried products, is it reasonably Table A-1 (Appendix 4) provides information S. aureus likely that will grow and form toxin in on the conditions under which C. botulinum the finished product if the product is inadequately type E and non-proteolytic types B and F dried? will grow. Because of the need to prevent Table A-1 (Appendix 4) provides information rehydration of dried products, these products on the conditions under which S. aureus will generally will be contained in a reduced grow. If your food that is not distributed oxygen package. If your refrigerated (not refrigerated or frozen and meets these frozen), reduced oxygen packaged food meets conditions (i.e., in Table A-1) before drying, these conditions (i.e., Table A-1) before drying, then drying will usually be important to the then drying will usually be important to the safety of the product, because it provides safety of the product, because it provides the barrier to S. aureus growth and toxin the barrier to growth and toxin formation formation. Under ordinary circumstances, it by C. botulinum type E and non-proteolytic would be reasonably likely that S. aureus will types B and F. Note that refrigeration will grow and form toxin in such products during control toxin formation by S. aureus and C. finished product storage and distribution botulinum type A and non-proteolytic types B and F in these products. Under ordinary

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 295 circumstances, it would be reasonably likely • Proper design and control of the drying that C. botulinum type E and non-proteolytic process (covered in this chapter); types B and F will grow and form toxin • Refrigeration (covered in Chapter in such products during ﬁnished product 12) and labeling to ensure that the storage and distribution if drying is not product is held refrigerated throughout properly performed. In addition, controlling distribution (covered in this chapter); labeling (e.g., “keep refrigerated” labeling) to ensure that the product is held refrigerated • Freezing (Chapter 13 provides guidance throughout distribution may be important to on labeling controls to ensure that a the safety of the product, because the product frozen product that otherwise supports may appear to retailers, consumers, and end the growth of non-proteolytic C. users to be shelf stable. botulinum is distributed frozen).

However, if your dried, reduced oxygen • Intended use packaged product is distributed frozen, then Because of the highly stable nature of S. aureus freezing may provide the barrier to growth toxin and the extremely toxic nature of C. and toxin formation by C. botulinum type botulinum toxin, it is unlikely that the intended E and non-proteolytic types B and F, rather use will affect the significance of the hazard. than drying. In this case, labeling to ensure that the product is distributed frozen may IDENTIFY CRITICAL CONTROL POINTS. be important to the safety of the product. Chapter 13 provides guidance on labeling The following guidance will assist you in controls to ensure that frozen product that determining whether a processing step is a critical supports the growth of non-proteolytic C. control point (CCP) for pathogenic bacteria growth botulinum is distributed frozen. and toxin formation as a result of inadequate drying: 4. For refrigerated or frozen, partially dried, reduced 1. If you identified the hazard of pathogenic oxygen packaged dried products, can growth bacteria growth and toxin formation as a result of and toxin formation by C. botulinum type E and inadequate drying as significant because drying non-proteolytic types B and F that are reasonably (rather than, or in addition to, refrigeration) is likely to occur be eliminated or reduced to an important to the safety of the product, you should acceptable level at this processing step? identify the drying step as a CCP for this hazard. Pathogenic bacteria growth and toxin Example: formation as a result of inadequate drying A salmon jerky processor that distributes should be considered a significant hazard the product unrefrigerated should set at any processing step where a preventive the CCP for controlling the hazard of measure is, or can be, used to eliminate pathogenic bacteria growth and toxin the hazard (or reduce the likelihood of its formation as a result of inadequate drying occurrence to an acceptable level) if it is at the drying step. The processor would reasonably likely to occur. The preventive not need to identify the processing steps measures that can be applied for pathogenic prior to drying as CCPs for that hazard. bacteria growth and toxin formation as a However, these steps may be CCPs for result of inadequate drying for refrigerated the control of other hazards, such as the or frozen, partially dried, reduced oxygen growth of pathogenic bacteria as a result packaged products are: of time and temperature abuse during processing, covered by Chapter 12.

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 296 This control approach is a control strategy DEVELOP A CONTROL STRATEGY. referred to in this chapter as “Control Strategy Example 1 - Control by Drying.” The following guidance provides examples of 2. If you identified the hazard of pathogenic two control strategies for pathogenic bacteria bacteria growth and toxin formation as a result growth and toxin formation that occurs as a of inadequate drying as significant because result of inadequate drying. It may be necessary refrigeration (in addition to drying) is important to select more than one control strategy in order to the safety of the product, you should identify to fully control the hazard, depending upon the finished product storage step and the the nature of your operation. It is important labeling step, where you will ensure that the to note that you may select a control strategy “keep refrigerated” labeling is included on every that is different from those that are suggested, package, as a CCP, for this hazard. provided it complies with the requirements of the applicable food safety laws and regulations. Example: The following are examples of control strategies A partially dried catfish processor that included in this chapter: distributes the product refrigerated and reduced oxygen packaged should set MAY APPLY TO MAY APPLY TO the CCPs for controlling the hazard of CONTROL STRATEGY PRIMARY SECONDARY pathogenic bacteria growth and toxin PROCESSOR PROCESSOR formation as a result of inadequate Control by drying

drying at the drying step, finished Control by refrigeration product labeling step, and finished with labeling product storage step. The processor would not need to identify the processing steps • CONTROL STRATEGY EXAMPLE 1 - CONTROL BY prior to drying as CCPs for that hazard. DRYING However, these steps may be CCPs for It may be necessary to select more than one the control of other hazards, such as the control strategy in order to fully control the growth of pathogenic bacteria as a result hazard, depending upon the nature of your of time and temperature abuse during operation. processing, covered by Chapter 12. The control by drying is covered in “Control Set Critical Limits. Strategy Example 1 - Control by Drying.” • The minimum or maximum values for the Control of labeling is referred to in this critical factors established by a scientific chapter as “Control Strategy Example 2 - study (i.e., for shelf-stable products, those Control by Refrigeration With Labeling.” It which must be met in order to ensure that should be used along with “Control Strategy the finished product has a water activity of Example 1 - Control by Drying.” Note that 0.85 or below; for refrigerated (not frozen), control of refrigerated finished product storage reduced oxygen packaged products, those is covered in Chapter 12. Note also that which must be met in order to ensure that Chapter 13 provides guidance on labeling the finished product has a water activity of controls to ensure that a frozen product less than 0.97). These will likely include that otherwise supports the growth of non- drying time, input/output air temperature, proteolytic C. botulinum is distributed frozen. humidity, and velocity, as well as flesh thickness. Other critical factors that affect the rate of drying of the product may also be established by the study;

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 297 OR Use a continuous temperature-recording • The minimum percent weight loss device (e.g., a recording thermometer); established by a scientific study (i.e., for AND shelf-stable products, that which must be met • For all other critical factors specified by the in order to ensure that the finished product study: has a water activity of 0.85 or below; for refrigerated (not frozen), reduced oxygen Use equipment appropriate for the packaged products, that which must be met measurement; in order to ensure that the finished product OR has a water activity of less than 0.97); • For percent weight loss: OR Weigh all, or a portion, of the batch • For shelf-stable products: before and after drying; Maximum finished product water activity OR of 0.85 or above; • For water activity analysis: OR Collect a representative sample of the • For refrigerated (not frozen), reduced oxygen finished product and conduct water packaged products: activity analysis. Maximum finished product water activity For continuous drying equipment: of less than 0.97. • For input/output air temperature: Note: A heat treatment, addition of chemical additives, further Use a continuous temperature-recording drying, or other treatment may be necessary to inhibit or eliminate spoilage organisms (e.g., mold) in shelf-stable products. device (e.g., a recording thermometer); AND Establish Monitoring Procedures. • For drying time: » What Will Be Monitored? Measure: • Critical factors of the established drying process • The revolutions per minute (RPM) that affect the ability of the process to ensure of the belt drive wheel, using the desired finished product water activity (i.e., a stopwatch or tachometer; 0.85 or below for shelf-stable products, less OR than 0.97 for refrigerated (not frozen), reduced oxygen packaged products). These may • The time necessary for a test unit include drying time, air temperature, humidity, or belt marking to pass through the and velocity, as well as flesh thickness; equipment, using a stopwatch; OR AND • Percent weight loss; • For all other critical factors specified by the study: OR Use equipment appropriate for the • Water activity of the finished product. measurement; » How Will Monitoring Be Done? OR For batch drying equipment: • For percent weight loss: • For drying time and input/output air Weigh all, or a portion, of the batch temperature: before and after drying;

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 298 OR • For water activity: • For water activity: Each lot of finished product. Collect a representative sample of the » Who Will Do the Monitoring? finished product and conduct water activity analysis. • For continuous temperature-recording devices: » How Often Will Monitoring Be Done (Frequency)? Monitoring is performed by the For batch drying equipment: equipment itself. The visual check of the data generated by this equipment, • For time and temperature: to ensure that the critical limits have Continuous monitoring, with a visual consistently been met, may be performed check of the recorded data at least once by any person who has an understanding during each batch; of the nature of the controls; AND AND • For all other critical factors specified by the • For all other critical factors specified by the study: study: As often as necessary to maintain control; Any person who has an understanding of OR the nature of the controls; • For percent weight loss: OR Each batch; • For percent weight loss: OR Any person who has an understanding of • For water activity: the nature of the controls; Each batch. OR For continuous drying equipment: • For water activity: • For temperature: Any person with sufficient training to perform the analysis. Continuous monitoring, with a visual check of the recorded data at least once per day; Establish Corrective Action Procedures. AND Take the following corrective action to a product involved in a critical limit deviation: • For time: • Redry the product (provided that redrying At least once per day, and whenever any does not present an unacceptable changes in belt speed are made; opportunity for pathogenic bacteria growth); AND OR • For all other critical factors specified by the • Chill and hold the product for an evaluation study: of the adequacy of the drying process. As often as necessary to maintain control; The evaluation may involve water activity OR determination on a representative sample of the finished product. If the evaluation • For percent weight loss: shows that the product has not received an Each lot of finished product; adequate drying process, the product should OR be destroyed, diverted to a use in which

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 299 pathogenic bacteria growth in the finished critical factors (e.g., a drying log that indicates product will be controlled by means other input/output air humidity and/or velocity); than drying, diverted to a non-food use, or OR redried; • Record of weight before and after drying; OR OR • Divert the product to a use in which the critical limit is not applicable because • Record of water activity analysis. pathogenic bacteria growth in the finished For continuous drying equipment: product will be controlled by means other • Record of continuous temperature than drying (e.g., divert inadequately dried monitoring; fish to a frozen fish operation); AND OR • Record of visual checks of recorded data; • Divert the product to a non-food use; AND OR • Drying log that indicates the RPM of the belt • Destroy the product. drive wheel or the time necessary for a test unit or belt marking to pass through the drier; AND AND Take the following corrective action to regain control • Records that are appropriate for the other over the operation after a critical limit deviation: critical factors (e.g., a drying log that indicates • Adjust the air temperature or velocity; input/output air humidity and/or velocity); OR OR • Adjust the length of the drying cycle to • Record of weight before and after drying; compensate for a temperature or velocity drop, humidity increase, or inadequate OR percent weight loss; • Record of water activity analysis. OR Establish Verification Procedures. • Adjust the belt speed to increase the length • Process validation study (except where a of the drying cycle. water activity analysis of the finished product is the monitoring procedure): Establish a Recordkeeping System. The adequacy of the drying process For batch drying equipment: should be established by a scientific • Record of continuous temperature study. For shelf-stable products, the monitoring; drying process should be designed to AND ensure the production of a shelf-stable product with a water activity of 0.85. • Record of visual checks of recorded data; For refrigerated (not frozen), reduced AND oxygen packaged products, it should be • Record of notation of the start time and end designed to ensure a finished product time of the drying periods; water activity of less than 0.97. Expert knowledge of drying process calculations AND and the dynamics of mass transfer in • Records that are appropriate for the other processing equipment may be required

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 300 to establish such a drying process. Such Doing a combination of the above if knowledge can be obtained by education the device will be used at or near room or experience or both. Establishment of temperature; drying processes may require access to OR adequate facilities and the application of recognized methods. The drying Comparing the temperature reading equipment should be designed, operated, on the device with the reading on a and maintained to deliver the established known accurate reference device (e.g., drying process to every unit of a product. a thermometer traceable to National In some instances, drying studies may Institute of Standards and Technology be required to establish the minimum (NIST) standards) under conditions that process. In other instances, existing are similar to how it will be used (e.g., literature that establishes minimum air temperature) within the temperature processes or adequacy of equipment is range at which it will be used; available. Characteristics of the process, AND product, and/or equipment that affect • Once in service, check the temperature- the ability to achive the established recording device daily before the beginning minimum drying process should be of operations. Less frequent accuracy checks taken into consideration in the process may be appropriate if they are recommended establishment. A record of the process by the instrument manufacturer and the establishment should be maintained; history of use of the instrument in your AND facility has shown that the instrument • Finished product sampling and analysis to consistently remains accurate for a longer determine water activity at least once every period of time. In addition to checking that 3 months (except where such testing is the device is accurate by one of the methods performed as part of monitoring); described above, this process should include a visual examination of the sensor and any AND attached wires for damage or kinks. The • Before a temperature-recording device (e.g., device should be checked to ensure that it a recording thermometer) is put into service, is operational and, where applicable, has check the accuracy of the device to verify sufﬁcient ink and paper; that the factory calibration has not been AND affected. This check can be accomplished by: • Calibrate the temperature-recording device against a known accurate reference device Immersing the sensor in an ice slurry (e.g., a NIST-traceable thermometer) at (32°F (0°C)) if the device will be used at least once a year or more frequently if or near refrigeration temperature; recommended by the device manufacturer. OR Optimal calibration frequency is dependent Immersing the sensor in boiling water upon the type, condition, past performance, (212°F (100°C)) if the device will be used and conditions of use of the device. at or near the boiling point. Note that Consistent temperature variations away from the temperature should be adjusted to the actual value (drift) found during checks compensate for altitude, when necessary; and/or calibration may show a need for more frequent calibration or the need to replace OR the device (perhaps with a more durable

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 301 device). For example, devices subjected to high temperatures for extended periods of time may require more frequent calibration. Calibration should be performed at a minimum of two temperatures that bracket the temperature range at which it is used; AND • Calibrate other instruments as necessary to ensure their accuracy; AND • Review monitoring, corrective action, and veriﬁcation records within 1 week of preparation to ensure they are complete and any critical limit deviations that occurred were appropriately addressed.

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 302 activity per year per year Review of Review 1 week of 1 week monitoring, monitoring, preparation Analyze the establishment to ensure that before putting before records within into operation; Check the data it is operational operations; and calibrate it once and verification, and verification, check it daily, at check it daily, finished product corrective action corrective the beginning of and damage of drying process sample once every sample once every 3 months for water water 3 months for logger for accuracy logger for RECORDS VERIFICATION Processing log Documentation slicer Re-adjust Re-adjust ACTION(S) CORRECTIVE or this product. Refer to Tables 3-2 and 3-4 or this product. Refer to Tables te drying. It is provided for illustrative purposes 1 - Control by Drying.” This example illustrates , and metal fragments). ture of your operation. Slicer operator Once per operations day before before day TABLE 14-1 TABLE MONITORING Example Only inch Preset slicer to just less than ¼ See Text for Full Recommendations See Text WHAT HOW FREQUENCY WHO Product thickness CONTROL STRATEGY EXAMPLE 1 - CONTROL BY DRYING CONTROL STRATEGY inch product MEASURE FOR EACH Maximum PREVENTIVE thickness: ¼ CRITICAL LIMITS and toxin formation HAZARD(S) Pathogenic Pathogenic SIGNIFICANT bacteria growth (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) oven) This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using “Control Strategy Example how a processor of shelf-stable salmon jerky can control pathogenic bacteria growth and toxin formation as a result of inadequa only. It may be necessary to select more than one control strategy in order fully the hazard, depending upon na only. Pathogenic bacteria growth and toxin formation as a result of inadequate drying may be only one of several significant hazards f (Chapter 3) for other potential hazards (e.g., aquaculture drugs, environmental chemical contaminants and pesticides, parasites POINT Drying (forced (forced CRITICAL CONTROL convection convection

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 303 week of week per year per year Review of Review monitoring, monitoring, preparation daily, at the daily, putting into Analyze the beginning of 3 months for 3 months for water activity water establishment Check the data Documentation operations; and calibrate it once and verification, and verification, records within 1 finished product corrective action corrective and damage of drying process to ensure that it is operational before sample once every sample once every operation; check it logger for accuracy logger for printout RECORDS VERIFICATION Data logger drying Continue ACTION(S) CORRECTIVE or this product. Refer to Tables 3-2 and 3-4 or this product. Refer to Tables te drying. It is provided for illustrative purposes 1 - Control by Drying.” This example illustrates , and metal fragments). ture of your operation. Oven Oven operator check of with visual each batch Continuous, Continuous, recorded data TABLE 14-1 TABLE MONITORING Example Only data logger temperature See Text for Full Recommendations See Text WHAT HOW FREQUENCY WHO Drying time Digital time and CONTROL STRATEGY EXAMPLE 1 - CONTROL BY DRYING CONTROL STRATEGY hours MEASURE Minimum FOR EACH PREVENTIVE CRITICAL LIMITS drying time: 5 and toxin formation HAZARD(S) Pathogenic SIGNIFICANT bacteria growth (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) oven) This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using “Control Strategy Example how a processor of shelf-stable salmon jerky can control pathogenic bacteria growth and toxin formation as a result of inadequa only. It may be necessary to select more than one control strategy in order fully the hazard, depending upon na only. Pathogenic bacteria growth and toxin formation as a result of inadequate drying may be only one of several significant hazards f (Chapter 3) for other potential hazards (e.g., aquaculture drugs, environmental chemical contaminants and pesticides, parasites POINT Drying (forced (forced CRITICAL CONTROL convection convection

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 304 week of week per year per year Review of Review monitoring, monitoring, preparation Analyze the 3 months for 3 months for water activity water establishment to ensure that before putting before into operation; Check the data Documentation it is operational operations; and calibrate it once and verification, and verification, records within 1 check it daily, at check it daily, finished product corrective action corrective the beginning of and damage of drying process sample once every sample once every logger for accuracy logger for printout RECORDS VERIFICATION Data logger for for

water water drying Extend activity process product ﬁnished than 0.85 ACTION(S) evaluation analysis on hold under performing Evaluate by CORRECTIVE or this product. Refer to Tables 3-2 and 3-4 or this product. Refer to Tables Redry if less refrigeration product and Segregate the te drying. It is provided for illustrative purposes 1 - Control by Drying.” This example illustrates , and metal fragments). ture of your operation. Oven Oven operator check of with visual each batch Continuous, Continuous, recorded data TABLE 14-1 TABLE MONITORING Example Only data logger temperature Digital time and See Text for Full Recommendations See Text WHAT HOW FREQUENCY WHO temperature Oven air input Oven CONTROL STRATEGY EXAMPLE 1 - CONTROL BY DRYING CONTROL STRATEGY

140°F or less MEASURE FOR EACH To achieve achieve To PREVENTIVE a final water a final water temperature: CRITICAL LIMITS activity of 0.85 Minimum oven Minimum oven and toxin formation HAZARD(S) Pathogenic Pathogenic SIGNIFICANT bacteria growth (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) oven) This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using “Control Strategy Example how a processor of shelf-stable salmon jerky can control pathogenic bacteria growth and toxin formation as a result of inadequa only. It may be necessary to select more than one control strategy in order fully the hazard, depending upon na only. Pathogenic bacteria growth and toxin formation as a result of inadequate drying may be only one of several significant hazards f (Chapter 3) for other potential hazards (e.g., aquaculture drugs, environmental chemical contaminants and pesticides, parasites POINT Drying (forced (forced CRITICAL CONTROL convection convection

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 305 • CONTROL STRATEGY EXAMPLE 2 - CONTROL BY AND REFRIGERATION WITH LABELING • Determine and correct the cause of improper It may be necessary to select more than one labels. control strategy in order to fully control the hazard, depending upon the nature of your Establish a Recordkeeping System. operation. • Record of labeling checks. Set Critical Limits. Establish Veriﬁcation Procedures. • All ﬁnished product labels must contain • Review monitoring and corrective action a “keep refrigerated” statement (e.g., records within 1 week of preparation “Important, keep refrigerated until used”). to ensure they are complete and any critical limit deviations that occurred were Establish Monitoring Procedures. appropriately addressed. » What Will Be Monitored? • Finished product labels for presence of “keep refrigerated” statement.

» How Will Monitoring Be Done? • Visual examination.

» How Often Will Monitoring Be Done (Frequency)? • Representative number of packages from each lot of a ﬁnished product.

» Who Will Do the Monitoring? • Any person who has an understanding of the nature of the controls.

Establish Corrective Action Procedures. Take the following corrective action to a product involved in a critical limit deviation: • Segregate and relabel any improperly labeled product. AND

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 306 Review Review correction action records within 1 week within 1 week of preparation monitoring and record RECORDS VERIFICATION Label receiving proper statement Segregate ACTION(S) Determine label stock improperly contain the and correct destroy any CORRECTIVE re-label any the cause of that does not and return or Segregate and improper labels labeled product g.” This example illustrates how a processor of or this product. Refer to Tables 3-2 and 3-4 or this product. Refer to Tables g. It is provided for illustrative purposes only. It may g. It is provided for illustrative purposes only. peration. Receiving Receiving employee receipt labels at each case of One label from TABLE 14-2 TABLE MONITORING Example Only Visual Visual examination See Text for Full Recommendations See Text WHAT HOW FREQUENCY WHO product Finished the “keep the “keep statement presence of refrigerated” refrigerated” labels for the labels for “keep “keep CONTROL STRATEGY EXAMPLE 2 - CONTROL BY REFRIGERATION WITH LABELING EXAMPLE 2 - CONTROL BY REFRIGERATION CONTROL STRATEGY MEASURE statement FOR EACH PREVENTIVE All finished refrigerated” refrigerated” product labels CRITICAL LIMITS must contain a toxin during storage product finished formation HAZARD(S) SIGNIFICANT C. botulinum C. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides metal fragments). This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Control by Refrigeration With Labelin *Note: Chapter 12 covers control of pathogenic bacteria growth at the CCP finished product storage. refrigerated, partially dried catfish can control pathogenic bacteria growth and toxin formation as a result of inadequate dryin Pathogenic bacteria growth and toxin formation as a result of inadequate drying may be only one of several significant hazards f be necessary to select more than one control strategy in order fully the hazard, depending upon nature of your o POINT labeling CRITICAL CONTROL Receipt of Receipt

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 307 BIBLIOGRAPHY.

• Hilderbrand, K. S. 1992. Fish smoking procedures for forced convection smokehouses, Special report 887. Oregon State University, Extension Service, Corvallis, OR. • Hilderbrand, K. S., Jr. 1996. Personal communication. Oregon State University, Extension Service, Corvallis, Oregon. • McClure, P. J., M. B. Cole, and J. P. P. M. Smelt. 1994. Effects of water activity and pH on growth of Clostridium botulinum. J. Appl. Bact. Symp. Suppl. 76:105S-114S. • Tatini, S. R. 1973. Inﬂuence of food environments on growth of Staphylococcus aureus and production of various enterotoxins. J. Milk Food Technol. 36:559-563.

CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 308 CHAPTER 15: Staphylococcus aureus Toxin Formation in Hydrated Batter Mixes

UNDERSTAND THE POTENTIAL HAZARD. reach levels that will cause food poisoning until the numbers of the pathogen reach 500,000 Staphylococcus aureus (S. aureus) toxin formation to 1,000,000 per gram. S. aureus will grow at in hydrated batter mixes can cause consumer temperatures as low as 44.6°F (7°C) and at a water illness. S. aureus is the bacterium responsible activity as low as 0.83 (additional information for Staphylococcal Food Poisoning (SFP). Ten on conditions favorable to S. aureus growth is to thirty outbreaks of SFP occur annually in the provided in Table A-1 (Appendix 4)). However, United States, from all sources. Symptoms include: toxin formation is not likely at temperatures lower vomiting, diarrhea, abdominal pain, nausea, than 50°F (10°C) or at water activities below 0.85. and weakness. Symptoms usually start within 4 For this reason, toxin formation can be controlled hours of consumption. Everyone is susceptible to by minimizing exposure of hydrated batter mixes intoxication by S. aureus toxin, with more severe to temperatures above 50°F (10°C). Exposure symptoms, including occasionally death, occurring times greater than 12 hours at temperatures in infants, the elderly, and debilitated persons. between 50°F (10°C) and 70°F (21.1°C) could result Generally, it is a self-limiting illness. in toxin formation. Exposure times greater than 3 hours at temperatures above 70°F (21.1°C) could This chapter covers control of S. aureus toxin also result in toxin formation. formation that occurs as a result of time and temperature abuse at the hydrated batter mix • Strategies for controlling pathogen growth storage or recirculation step. This toxin in There are a number of strategies for the control particular is a concern at this step because it is not of pathogens in fish and fishery products. They likely to be destroyed by subsequent heating steps include: that the processor or the consumer may perform. • Managing the amount of time that food is Pathogenic bacteria other than S. aureus, such as exposed to temperatures that are favorable those described in Chapter 12, are less likely to for pathogen growth and toxin production grow in hydrated batter mixes and/or are likely to (covered in this chapter for S. aureus be killed by subsequent heating. in hydrated batter mix; Chapter 13 for • Control of S. aureus in batter mixes Clostridium botulinum; and Chapter 12 for other pathogenic bacteria and conditions); S. aureus can enter the process on raw materials. It can also be introduced into foods during • Killing pathogenic bacteria by cooking or processing, from unclean hands and insanitary pasteurizing (covered in Chapter 16), or utensils and equipment. retorting (covered by the Thermally Processed Low-Acid Foods Packaged in Hermetically The hazard develops when a batter mix is Sealed Containers regulation, 21 CFR 113 exposed to temperatures favorable for S. aureus (called the Low-Acid Canned Foods Regulation growth for sufficient time to permit toxin in this guidance document)); development. S. aureus toxin does not normally

CHAPTER 15: Staphylococcus aureus Toxin Formation in Hydrated Batter Mixes 309 • Killing pathogenic bacteria by processes 2. Can the hazard of S. aureus growth and toxin that retain the raw product characteristics formation that was introduced at an earlier step (covered in Chapter 17); be eliminated or reduced to an acceptable level • Controlling the amount of moisture that is at this processing step? available for pathogenic bacteria growth S. aureus toxin formation in hydrated batter (water activity) in the product by drying mixes should be considered a significant (covered in Chapter 14); hazard at any processing step where a • Controlling the amount of moisture that is preventive measure is, or can be, used to available for pathogenic bacteria growth eliminate the hazard (or reduce the likelihood (water activity) in the product by formulation of its occurrence to an acceptable level) if it (covered in Chapter 13); is reasonably likely to occur. The preventive • Controlling the amount of salt or measure that can be applied for S. aureus preservatives, such as sodium nitrite, in the toxin formation in hydrated batter mixes is product (covered in Chapter 13); controlling the amount of time that hydrated • Controlling the level of acidity (pH) in the batter mixes are exposed to temperatures product (covered by the Acidified Foods above 50°F (10°C). regulation, 21 CFR 114, for shelf-stable • Intended use acidified products, and by Chapter 13 for Because of the highly heat-stable nature of S. refrigerated acidified products); aureus toxin, it is unlikely that the intended use • Controlling the source of molluscan shellfish will affect the significance of the hazard. and the time from exposure to air (e.g., by harvest or receding tide) to refrigeration to IDENTIFY CRITICAL CONTROL POINTS. control pathogens from the harvest area (covered in Chapter 4); If the hazard of S. aureus toxin formation in • Controlling the introduction of pathogenic hydrated batter mixes is significant, you should bacteria after the pasteurization process identify the hydrated batter mix storage or (covered in Chapter 18). recirculation step as the critical control point (CCP) for this hazard. For hand-battering DETERMINE WHETHER THE POTENTIAL operations, where hydrated batter mix is stored HAZARD IS SIGNIFICANT. at each hand-battering station, the hand-battering stations also should be identified as a CCP. The following guidance will assist you in This control approach is a control strategy determining whether S. aureus toxin formation in referred to in this chapter as “Control Strategy hydrated batter mixes is a significant hazard at a Example - Hydrated Batter Mix Control.” processing step: Example: S. aureus 1. Is it reasonably likely that will grow A mechanized breaded fish processor should and form toxin in the hydrated batter mix at the set the CCP for controlling the hazard of hydrated batter mix storage or recirculation step? S. aureus growth and toxin formation in The previous section, “Understand the Potential hydrated batter mixes at the hydrated batter Hazard,” provides information to help you mix storage or recirculation step. The decide whether the time and temperature processor would not need to identify other conditions of your hydrated batter mix storage processing steps as CCPs for that hazard. or recirculation step are favorable for S. aureus growth and toxin formation.

CHAPTER 15: Staphylococcus aureus Toxin Formation in Hydrated Batter Mixes 310 DEVELOP A CONTROL STRATEGY. » How Often Will Monitoring Be Done (Frequency)? • For continuous temperature-recording The following guidance provides an example of devices: a control strategy for S. aureus toxin formation Continuous monitoring, with a visual in hydrated batter mixes. It is important to check of the recorded data at least once note that you may select a control strategy per day; that is different from that which is suggested, OR provided it complies with the requirements of the • For temperature-indicating devices: applicable food safety laws and regulations. At least every 2 hours. The following is an example of the control strategy included in this chapter: » Who Will Do the Monitoring? • For temperature-recording devices:

MAY APPLY TO MAY APPLY TO Monitoring is performed by the device CONTROL STRATEGY PRIMARY SECONDARY itself. The visual check of the data PROCESSOR PROCESSOR generated by the device, to ensure that Hydrated batter mix control the critical limits have consistently been met, may be performed by any person who has an understanding of the nature • CONTROL STRATEGY EXAMPLE - HYDRATED of the controls; BATTER MIX CONTROL OR Set Critical Limits. • For temperature-indicating devices: • Hydrated batter mix should not be held Any person who has an understanding of for more than 12 hours, cumulatively, at the nature of the controls. temperatures between 50°F (10°C) and 70ºF (21.1ºC); Establish Corrective Action Procedures. AND Take the following corrective action to a product • Hydrated batter mix should not be held involved in a critical limit deviation: for more than 3 hours, cumulatively, at • Destroy the product and remaining hydrated temperatures above 70ºF (21.1ºC). batter mix; OR Establish Monitoring Procedures. • Divert the product and remaining hydrated » What Will Be Monitored? batter mix to a non-food use; • The temperature of the hydrated batter mix OR and the time of exposure at temperatures • Hold the product and hydrated batter until it above 50°F (10°C) and above 70ºF (21.1ºC). can be evaluated based on its total time and temperature exposure; » How Will Monitoring Be Done? OR • Use a continuous temperature-recording • Hold the product and hydrated batter device (e.g., a recording thermometer); mix until the hydrated batter mix can be OR sampled and analyzed for the presence of • Use a temperature-indicating device (e.g., staphylococcal enterotoxin. a thermometer) and observe the time of AND exposure.

CHAPTER 15: Staphylococcus aureus Toxin Formation in Hydrated Batter Mixes 311 Take the following corrective action to regain control known accurate reference device (e.g., over the operation after a critical limit deviation: a thermometer traceable to National • Add ice to the hydrated batter mix storage Institute of Standards and Technology and recirculation tank; (NIST) standards) under conditions that are similar to how it will be used (e.g., batter AND/OR temperature) within the temperature range • Make repairs or adjustments to the hydrated at which it will be used; batter mix refrigeration equipment. AND Establish a Recordkeeping System. • Once in service, check the temperature- indicating device or temperature-recording • For continuous temperature-recording device daily before the beginning of devices: operations. Less frequent accuracy checks may Recorder thermometer charts or digital time be appropriate if they are recommended by and temperature data logger printouts; the instrument manufacturer and the history AND of use of the instrument in your facility has shown that the instrument consistently remains Record of visual checks of recorded data; accurate for a longer period of time. In OR addition to checking that the device is accurate • For temperature-indicating devices: by one of the methods described above, this process should include a visual examination of Record of visual checks of devices (time the sensor and any attached wires for damage and temperature). or kinks. The device should be checked to ensure that it is operational and, where Establish Verification Procedures. applicable, has sufficient ink and paper; • Before a temperature-indicating device (e.g., AND a thermometer) or temperature-recording device (e.g., a recording thermometer) is • Calibrate the temperature-indicating device put into service, check the accuracy of the or temperature-recording device against a device to verify that the factory calibration known accurate reference device (e.g., a has not been affected. This check can be NIST-traceable thermometer) at least once a accomplished by: year or more frequently if recommended by the device manufacturer. Optimal calibration Immersing the sensor in an ice slurry frequency is dependent upon the type, (32°F (0°C)) if the device will be used at condition, past performance, and conditions or near refrigeration temperature; of use of the device. Consistent temperature OR variations away from the actual value (drift) Immersing the sensor in boiling water found during checks and/or calibration may (212°F (100°C)) if the device will be used show a need for more frequent calibration at or near the boiling point. Note that or the need to replace the device (perhaps the temperature should be adjusted to with a more durable device). Calibration compensate for altitude, when necessary; should be performed at a minimum of two temperatures that bracket the temperature OR range at which it is used; Doing a combination of the above if AND the device will be used at or near room temperature; • Review monitoring, corrective action, and verification records within 1 week of OR preparation to ensure they are complete and Comparing the temperature reading any critical limit deviations that occurred on the device with the reading on a were appropriately addressed.

CHAPTER 15: Staphylococcus aureus Toxin Formation in Hydrated Batter Mixes 312 Review Review check it that it is per year per year recorder corrective corrective 1 week of 1 week Check the veriﬁcation veriﬁcation action, and action, operational monitoring, monitoring, preparation daily, at the daily, for accuracy for and damage beginning of thermometer and to ensure before putting before records within into operation; operations; and calibrate it once chart Recorder Recorder RECORDS VERIFICATION thermometer

Destroy hydrated hydrated deviation deviation - Hydrated Batter Mix Control.” This produced ACTION(S) batter mix during the equipment CORRECTIVE any product refrigeration period of the for illustrative purposes only. for illustrative purposes only. batter mix and bles 3-2 and 3-4 (Chapter 3) for other potential Adjust hydrated hydrated Adjust employee Production day with visual Continuous, Continuous, check once per TABLE 15-1 TABLE MONITORING Example Only Recorder Recorder thermometer See Text for Full Recommendations See Text The of the WHAT HOW FREQUENCY WHO (21.1ºC) hydrated hydrated (10°C) and the time of above 70ºF above above 50°F above exposure at temperature temperatures batter mix and CONTROL STRATEGY EXAMPLE - HYDRATED BATTER MIX CONTROL BATTER EXAMPLE - HYDRATED CONTROL STRATEGY 3 hours, 3 hours, MEASURE Hydrated Hydrated 12 hours, 12 hours, FOR EACH batter mix more than PREVENTIVE nor 70°F for nor 70°F for cumulatively cumulatively, cumulatively, for more than for CRITICAL LIMITS to exceed 50°F to exceed temperature not toxin S. aureus S. formation HAZARD(S) growth and SIGNIFICANT (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) tank example illustrates how a breaded ﬁsh processor can control S. aureus toxin formation in hydrated batter mixes. It is provided S. aureus toxin formation in hydrated batter mixes may be only one of several signiﬁcant hazards for this product. Refer to Ta hazards (e.g., environmental chemical contaminants and pesticides metal fragments). This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using “Control Strategy Example POINT CRITICAL CONTROL Batter mix recirculation

CHAPTER 15: Staphylococcus aureus Toxin Formation in Hydrated Batter Mixes 313 BIBLIOGRAPHY. • Duran, A. P., B. A. Wentz, J. M. Lanier, F. D. McClure, A. H. Schwab, A. Swartzentruber, We have placed the following references on R. J. Barnard, and R. B. Read. 1983. display in the Division of Dockets Management, Microbiological quality of breaded shrimp - Food and Drug Administration, 5630 Fishers Lane, during processing. J. Food Prot. 46:974 977. rm. 1061, Rockville, MD 20852. You may see • Godwin, G. J., R. M. Grodner, and A. F. them at that location between 9 a.m. and 4 p.m., Novak. 1977. Twenty-four hour methods Monday through Friday. As of March 29, 2011, for bacteriological analyses in frozen raw FDA had verified the Web site address for the breaded shrimp. J. Food Sci. 42:750-754. references it makes available as hyperlinks from • Greenwood, M. H., E. F. C. Coetzee, B. the Internet copy of this guidance, but FDA is not M. Ford, P. Gill, W. L. Hooper, S. C. W. responsible for any subsequent changes to Non- Matthews, S. Patrick, J. V. S. Pether, and R. FDA Web site references after March 29, 2011. J. D. Scott. 1985. The bacteriological quality • Baird-Parker, A. C. 1971. Factors affecting of selected retail, ready-to-eat food products. the production of bacterial food poisoning III. Cooked crustaceans and mollusks. - toxins. J. Appl. Bact. 34:181-197. Environ. Health 93:236 239. • Beckers, H. J., F. M. van Leusden, and P. • Hughes, A., and A. Hurst. 1980. The effect D. Tips. 1985. Growth and enterotoxin of NaCl on the upper temperature limit for production of Staphylococcus aureus in growth of and enterotoxin synthesis by shrimp. J. Hyg., Camb. 95:685-693. Staphylococcus aureus. Can. J. Microbiol. 26:507-510. • Bryan, F. L. 1979. Staphylococcus aureus in food microbiology: public health and • Lotter, L. P., and L. Leistner. 1978. Minimal spoilage aspects. The Avi Publishing water activity for enterotoxin A production Company, Inc., Westport, CT. and growth of Staphylococcus aureus. Appl. Environ. Microbiol. 36:377-380. • Buchanan, R. L. 1991. Microbiological criteria for cooked, ready-to-eat shrimp and • Ostovar, K., and M. J. Bremier. 1975. Effect of crabmeat. Food Technol. 45:157-160. thawing on growth of Staphylococcus aureus in frozen convenience food items. J. Milk • Dahl Sawyer, C. A., and J. J. Pestka. 1985. Food Technol. 38:337-339. Foodservice systems: presence of injured bacteria in foods during food product flow. • Potter, L., and L. Leistner. 1978. Minimal Ann. Rev. Microbiol. 39:51-67. water activity for enterotoxin A production and growth of Staphylococcus aureus. Appl. • Deibel, K. E. 1995. Potential of Environ. Microbiol. 36:377-380. Staphylococcus aureus to produce enterotoxin in fish batter at various • Raj, H. D. 1970. Public health bacteriology of - temperatures, p. 33. In Medallion Lab (ed.), processed frozen foods. Lab. Pract. 19:374 Proceedings of the IFT Annual Meeting. 377, 394. Medallion Lab, Minneapolis, MN. • Sutherland, J. P., A. J. Bayliss, and T. A. • Dengremont, E., and J. M. Membre. 1995. Roberts. 1994. Predictive modeling of growth Statistical approach for comparison of the of Staphylococcus aureus: the effects of growth rates of five strains of Staphylococcus temperature, pH and sodium chloride. Int. J. - aureus. Appl. Environ. Microbiol. 61:4389- Food Microbiol. 21:217 236. 4395.

CHAPTER 15: Staphylococcus aureus Toxin Formation in Hydrated Batter Mixes 314 CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization

UNDERSTAND THE POTENTIAL HAZARD. Pasteurization is a treatment (usually, but not always, the application of heat) applied to The survival of pathogenic bacteria through eliminate the most resistant pathogenic bacteria cooking or pasteurization can cause consumer of public health concern that is reasonably likely illness. The primary pathogens of concern are to be present in the food for as long as the shelf- Clostridium botulinum (C. botulinum), Listeria life of the product, when stored under normal monocytogenes (L. monocytogenes), Campylobacter and moderate abuse conditions. With fishery jejuni (C. jejuni), pathogenic strains of Escherichia products, pasteurization is usually performed after coli (E. coli), Salmonella spp., Shigella spp., Yersinia the product is placed in the hermetically sealed enterocolitica (Y. enterocolitica), Staphylococcus finished product container. It is applied to fishery aureus (S. aureus), Vibrio cholera (V. cholera), products that are distributed either refrigerated or Vibrio vulnificus (V. vulnificus), and Vibrio frozen. Examples of pasteurized fishery products parahaemolyticus (V. parahaemolyticus). See are pasteurized crabmeat, pasteurized surimi-based Appendix 7 for a description of the public health analog products, and pasteurized lobster meat. impacts of these pathogens. In addition to eliminating bacterial pathogens, It is not practical to target viral pathogens in cooking and pasteurization also greatly reduce cooking or pasteurization processes because of the number of spoilage bacteria present in the their extreme heat resistance. Viral pathogens fishery product. These bacteria normally restrict should be controlled through a rigorous sanitation the growth of pathogens through competition. regime as part of a prerequisite program or as Elimination of spoilage bacteria allows rapid part of Hazard Analysis Critical Control Point growth of newly introduced pathogenic bacteria. (HACCP) itself. The Procedures for the Safe and Sanitary Processing and Importing of Fish and Pathogenic bacteria that may be introduced after Fishery Products regulation, 21 CFR 123 (called cooking or pasteurization are, therefore, a concern. the Seafood HACCP Regulation in this guidance This is especially true for pasteurization, because document) requires such a regime. that process can significantly extend the shelf-life of the fishery product, providing more time for • Types of heat processing pathogenic bacteria growth and toxin formation. Cooking is a heat treatment, usually performed Retorting is a heat treatment that eliminates all before the product is placed in the finished product food-borne pathogens and produces a product container. It is applied to fishery products that are that is shelf stable. Mandatory controls for retorting distributed either refrigerated or frozen. Generally, are provided in the Thermally Processed Low-Acid after cooking, fishery products are referred to as Foods Packaged in Hermetically Sealed Containers cooked, ready to eat. Examples of cooked, ready- to-eat fishery products are crabmeat, lobster meat, regulation, 21 CFR 113 (hereinafter, the Low Acid crayfish meat, cooked shrimp, surimi-based analog Canned Foods (LACF) Regulation), but are not products, seafood salads, seafood soups and covered in this chapter. sauces, and hot-smoked fish.

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 315 • Goal of pasteurization (38°F (3.3°C)) are not uncommon. Therefore, Selection of the target pathogen is critical to refrigeration alone cannot be relied upon for the effectiveness of pasteurization. You should control of the C. botulinum hazard. When consider the potential that C. botulinum type freezing is relied upon to control the growth of E or non-proteolytic types B and F will survive C. botulinum type E and non-proteolytic types B the pasteurization process and grow under and F, controls should be in place to ensure that normal storage conditions or moderate abuse the product is labeled with instructions that it be conditions. This is of particular concern if the kept frozen throughout distribution. product is reduced oxygen packaged (e.g., For pasteurization processes that target C. vacuum packaged or modified atmosphere botulinum type E and non-proteolytic types B and packaged), does not contain a barrier that is F, generally a reduction of six orders of magnitude sufficient to prevent growth and toxin formation (six logarithms, e.g., from 103 to 10-3) in the level by this pathogen, is not equipped with a time of contamination is suitable. This is called a 6D and temperature integrator, and is stored or process. However, lower degrees of destruction distributed refrigerated (not frozen). In such may be acceptable if supported by a scientific products, you should ordinarily select C. study of the normal levels in the food before botulinum type E and non-proteolytic types pasteurization. It is also possible that higher levels B and F as the target pathogen. For example, of destruction may be necessary in some foods, if vacuum-packaged lobster meat that is pasteurized especially high initial levels of the target pathogen to kill L. monocytogenes, but not C. botulinum are anticipated. Table A-4 (Appendix 4) provides type E or non-proteolytic types B and F, and 6D process times for a range of pasteurization is not equipped with a Time-Temperature temperatures, with C. botulinum type B (the Indicator should be frozen to prevent growth most heat resistant form of non-proteolytic C. and toxin formation by C. botulinum type E botulinum) as the target pathogen. The lethal rates and non-proteolytic types B and F, and should and process times provided in the table may not be labeled to be held frozen and to be thawed be sufficient for the destruction of C. botulinum under refrigeration immediately before use (e.g., type E and non-proteolytic types B and F in “Important, keep frozen until used, thaw under dungeness crabmeat, because of the potential that refrigeration immediately before use”). naturally occurring substances, such as lysozyme, If the product is not reduced oxygen packaged, may enable the pathogen to more easily recover or contains a barrier that is sufficient to prevent after heat damage. the growth and toxin formation by C. botulinum Examples of properly pasteurized products are type E or non-proteolytic types B and F, or fish and fishery products generally (e.g., surimi- is equipped with a time and temperature based products, soups, or sauces) pasteurized integrator, or is distributed frozen, then selection to a minimum cumulative total lethality of F of another target pathogen may be appropriate. 194°F (F90°C) = 10 minutes, where z = 12.6°F (7°C) for L. monocytogenes may be selected as the target temperatures less than 194°F (90°C) and z = 18°F pathogen for pasteurization of this type of (10°C) for temperatures above 194°F (90°C); blue product because it is the most resistant bacterial crabmeat pasteurized to a minimum cumulative pathogen of public health concern that is total lethality of F185°F (F85°C) = 31 minutes, where z reasonably likely to be present. = 16°F (9°C); and dungeness crabmeat pasteurized

Surveys of retail display cases and home to a minimum cumulative total lethality of F194°F refrigerators indicate that temperatures above the (F90°C) = 57 minutes, where z = 15.5°F (8.6°C). minimum growth temperature of C. botulinum Equivalent processes at different temperatures can type E and non-proteolytic types B and F be calculated using the z values provided.

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 316 forming unit (CFU)/g and that approximately 91% EXAMPLES OF PROPERLY are contaminated at less than 1 CFU/g. Less than PASTEURIZED PRODUCTS 1% of raw seafood are contaminated at levels MINIMUM CUMULATIVE 3 PRODUCT Z VALUE greater than 10 CFU/g and none at levels greater TOTAL LETHALITY than 106 CFU/g. FDA’s limit for L. monocytogenes

Fish and F194°F (F90°C) = 10 minutes 12.6°F (7°C), for fishery temperatures in ready-to-eat products, nondetectable, products less than 194°F corresponds to a level of less than 1 CFU/25g. generally (90°C) (e.g., surimi- Table A-3 (Appendix 4) provides 6D process based 18°F (10°C) for products, temperatures times for a range of pasteurization temperatures, soups, or above 194°F (90°C) with L. monocytogenes as the target pathogen. sauces) Lower degrees of destruction may be acceptable Blue F (F ) = 31 minutes 16°F (9°C) 185°F 85°C if supported by a scientific study of the normal crabmeat levels in the food before pasteurization. It is also Dungeness F194°F (F90°C) = 57 minutes 15.5°F (8.6°C) crabmeat possible that higher degrees of destruction may be necessary in some foods if especially high In some pasteurized surimi-based products, salt, initial levels are anticipated. in combination with a milder heat pasteurization Products that are pasteurized in the finished process in the finished product container, works product container are at risk for recontamination to prevent growth and toxin formation by C. after pasteurization. Controls, such as container botulinum type E and non-proteolytic types B seal integrity and protection from contaminated and F. An example of a properly pasteurized cooling water, are critical to the safety of these surimi-based product in which 2.4% water phase products and are covered in Chapter 18. salt is present is one that has been pasteurized at an internal temperature of 185°F (85°C) for • Goal of cooking for most products at least 15 minutes. This process may not be One reason for cooking products that will not suitable for other types of products because of be reduced oxygen packaged is to eliminate the unique formulation and processing involved vegetative cells of pathogenic bacteria (or reduce in the manufacture of surimi-based products. them to an acceptable level) that may have been Reduced oxygen-packaged foods that are introduced to the process by raw materials or pasteurized to control C. botulinum type E by processing that occurs before the cooking and non-proteolytic types B and F, but not C. step. Selection of the target pathogen is critical botulinum type A and proteolytic types B and to the effectiveness of cooking. Generally, L. F, and that do not contain barriers to its growth monocytogenes is selected as the target pathogen should be refrigerated or frozen to control C. because it is regarded as the most heat-tolerant, botulinum type A and proteolytic types B and foodborne bacterial pathogen that does not form F. Control of refrigeration is critical to the safety spores. Cooking processes are not usually designed of these products. Further information on C. to eliminate spores of bacterial pathogens. botulinum and reduced oxygen packaging is Determining the degree of destruction of the target contained in Chapter 13. pathogen is also critical. Generally, a reduction of six orders of magnitude (six logarithms, e.g., from In cases where L. monocytogenes is selected 103 to 10-3) in the level of contamination is suitable. as the target pathogen, a 6D process is also This is called a 6D process. generally suitable. FDA and U.S. Department of Agriculture’s L. monocytogenes risk assessment Table A-3 provides 6D process times for a range of indicates that approximately 8% of raw seafood cooking temperatures, with L. monocytogenes as are contaminated with from 1 to 103 colony the target pathogen. Lower degrees of destruction

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 317 may be acceptable if supported by a scientific properly cooked to eliminate C. botulinum type study of the normal levels in the food before E and non-proteolytic types B and F is a soup or pasteurization. It is also possible that higher sauce that is cooked to a minimum cumulative degrees of destruction may be necessary in some total lethality of F194°F (F90°C) = 10 minutes, where foods if especially high initial levels are anticipated. z = 12.6°F (7°C) for temperatures less than 194°F (90°C) and z = 18°F (10°C) for temperatures • Goal of cooking refrigerated, reduced above 194°F (90°C). oxygen-packaged products Reduced oxygen-packaged soups or sauces that Cooking is sometimes performed on products are cooked immediately before packaging to immediately before placement in reduced oxygen control C. botulinum type E and non-proteolytic packaging (e.g., vacuum packaging or modified types B and F, but not C. botulinum type A and atmosphere packaging). These products include proteolytic types B and F, and that do not contain cooked, hot-filled soups, chowders, or sauces barriers to its growth should be refrigerated that are filled directly from the cook kettle using or frozen to control C. botulinum type A and sanitary, automated, continuous filling systems proteolytic types B and F. Control of refrigeration designed to minimize risk of recontamination. is critical to the safety of these products. Further They are often marketed under refrigeration, information on C. botulinum and reduced oxygen which is important for the control of C. packaging is contained in Chapter 13. botulinum type A and proteolytic types B and F. Cooking processes that target C. botulinum The cooking process for these products should type E and non-proteolytic types B and F have be sufficient to eliminate the spores of C. much in common with pasteurization processes. botulinum type E and non-proteolytic types B Like products that are pasteurized in the final and F. This is the case when the product does container, products that are cooked and then not contain other barriers that are sufficient placed in the final container also are at risk to prevent growth and toxin formation by for recontamination after they are placed in this pathogen. Generally, a 6D process (six the finished product container. Controls, such logarithms, e.g., from 103 to 10-3) is suitable. as container seal integrity and protection from However, lower degrees of destruction may contaminated cooling water, are critical to the be acceptable if supported by a scientific safety of these products and are covered in study of the normal levels in the food before Chapter 18. pasteurization. It is also possible that higher degrees of destruction may be necessary in Additionally, because these products are cooked some foods if especially high initial levels are before they are packaged, they are at risk of anticipated. recontamination between cooking and packaging. The risk of recontamination may be minimized Table A-4 provides 6D process times for a range by filling the container in a sanitary, automated, of cooking temperatures, with C. botulinum type continuous filling system while the product is B (the most heat-resistant form of non-proteolytic still hot (i.e., hot filling). This is another critical C. botulinum) as the target pathogen. The lethal step for the safety of these products. This control rates and process times provided in the table strategy is suitable for products that are filled may not be sufficient for the destruction of C. directly from the cooking kettle, where the risk of botulinum type E and non-proteolytic types B recontamination is minimized. It is not ordinarily and F in soups or sauces containing dungeness suitable for products such as crabmeat, lobster crabmeat because of the potential that naturally meat, or crayfish meat that are handled between occurring substances, such as lysozyme, may cooking and filling. Hot filling is also covered in enable the pathogen to more easily recover Chapter 18. after damage. An example of a product that is

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 318 • Control by cooking or pasteurization cells of L. monocytogenes and destroying them Controlling pathogenic bacteria survival through requires an EPIPT that could be achieved only cooking or pasteurization is accomplished by: in a pressurized steam environment, making • Scientifically establishing a cooking or measurement impractical. Additional guidance pasteurization process that will eliminate on EPIPT monitoring can be found in Food pathogenic bacteria of public health concern Processors Association guidance document “FPA or reduce their numbers to acceptable levels; Guidance Document: Establishing or Verifying a Heat Process for Cooked, Ready-to-Eat • Designing and operating the cooking or Seafood Products, and Heat Process Monitoring pasteurization equipment so that every unit Considerations under HACCP,” 2nd Edition, of product receives at least the established February 2005 and purchased at the Grocery minimum process; Manufacturers Association, Washington DC 20005. • Continuously monitoring the critical process parameters to verify achievement of a • Strategies for controlling pathogenic scientifically established process (e.g., time bacteria growth and temperature). There are a number of strategies for the control You may monitor End-Point Internal Product of pathogenic bacteria in fish and fishery Temperature (EPIPT), a measurement of the products. They include: temperature of the product as it exits the heat • Killing pathogenic bacteria by cooking or process, instead of performing continuous time pasteurizing (covered in this chapter) or and temperature monitoring. This approach is retorting (covered by the LACF Regulation, 21 suitable if you have conducted a scientific study CFR 113); to validate that the EPIPT that you have selected • Killing pathogenic bacteria by processes that will provide an appropriate reduction in the retain the raw characteristics of the products numbers of the target pathogen (e.g., 6D) in the (covered in Chapter 17); slowest heating unit or portion of product under • Managing the amount of time that food is the worst set of heating conditions covered by exposed to temperatures that are favorable the scientific study. You should (1) conduct a for pathogenic bacteria growth and toxin temperature distribution study within the heating production (covered generally in Chapter system to identify any cold spots; (2) conduct 12; for C. botulinum, in Chapter 13; and a heat penetration study that accounts for the for S. aureus in hydrated batter mixes, in slowest heating product under the worst case Chapter 15); heating conditions covered by the scientific study; • Controlling the amount of moisture that is and identify other critical factors of processing available for pathogenic bacteria growth and/or packaging that affect the rate of product (water activity) in the product by drying heating when scientifically establishing a cooking (covered in Chapter 14); or pasteurization process (i.e., process validation). The EPIPT should be used as a monitoring • Controlling the amount of moisture that is technique only under those conditions that available for pathogenic bacteria growth were evaluated by the scientific study. Those (water activity) in the product by formulation conditions may need to be identified as critical (covered in Chapter 13); limits and monitored as part of the HACCP plan. • Controlling the amount of salt or preservatives, such as sodium nitrite, in the EPIPT monitoring may not be an option when product (covered in Chapter 13); the objective is control of C. botulinum type E and non-proteolytic types B and F spores. These • Controlling the level of acidity (pH) in the spores are far more heat resistant than vegetative product (covered by the Acidified Foods

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 319 regulation, 21 CFR 114, for shelf-stable of bacterial pathogens. For this reason, you acidified products, and by Chapter 13 for should consider it reasonably likely that refrigerated acidified products); low numbers of pathogenic bacteria will be • Controlling the source of molluscan shellfish present in the product. and the time from exposure to air (e.g., by 2. Can unsafe levels of pathogenic bacteria that harvest or receding tide) to refrigeration to were introduced at an earlier processing step be control pathogens from the harvest area eliminated or reduced to an acceptable level at (covered in Chapter 4); this processing step? • Controlling the introduction of pathogenic bacteria after the pasteurization process Pathogenic bacteria survival through cooking (covered in Chapter 18). or pasteurization should also be considered a significant hazard at any processing step DETERMINE WHETHER THE POTENTIAL where a preventive measure is, or can be, HAZARD IS SIGNIFICANT. used to eliminate the hazard (or reduce the likelihood of its occurrence to an acceptable level) if it is reasonably likely to occur. The The following guidance will assist you in preventive measure that can be applied determining whether pathogenic bacteria for pathogenic bacteria survival through survival through cooking and pasteurization is a cooking and pasteurization is proper design significant hazard at a processing step. and control of the cooking or pasteurization 1. Is it reasonably likely that unsafe levels of process. pathogenic bacteria will be introduced at this • Intended use processing step (do unsafe levels of pathogenic bacteria come in with the raw material, or will Because cooked or pasteurized products are the process introduce unsafe levels of pathogenic ready to eat, it is unlikely that the intended use bacteria)? will affect the significance of the hazard.

It is reasonable to assume that pathogens of IDENTIFY CRITICAL CONTROL POINTS. various types, including those listed in Table A-1 (Appendix 4), will be present on raw fish The following guidance will assist you in and fishery products. They may be present determining whether a processing step is a only at low levels or only occasionally, but critical control point (CCP) for the survival even such occurrences warrant consideration of pathogenic bacteria through cooking or because of the potential for growth and toxin pasteurization: production. Will the finished product be pasteurized in the final Pathogenic bacteria may also be introduced container? during processing, from the air, unclean hands, insanitary utensils and equipment, 1. If the finished product will be pasteurized in unsafe water, and sewage. Well-designed the final container, you should identify the sanitation programs will minimize the pasteurization step as the CCP. In this case, you introduction of pathogens. Such sanitation would not need to identify the cooking step as controls need not be part of your HACCP a CCP for the hazard of pathogenic bacteria plan if they are monitored under your survival through cooking. sanitation program (prerequisite program). Example: In most cases, it is not reasonable to assume A crabmeat processor cooks, picks, that they will fully prevent the introduction packs, and pasteurizes the crabmeat.

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 320 The processor sets the CCP for pathogenic cook or pasteurization cycle (speed of the bacteria survival through cooking and belt for a continuous cooker or pasteurizer), pasteurization at the pasteurization step temperature of the steam or water used and does not identify the cooking step as for cooking or pasteurization (or visual a CCP for this hazard. observation of minutes at a boil for cooking), initial temperature of the product, container This control approach is a control strategy size (e.g., can dimensions, pouch thickness), referred to in this chapter as “Control Strategy and product formulation. Other critical Example - Cooking and Pasteurization.” factors that affect the rate of heating of the 2. If the product will not be pasteurized, you should product may also be established by the identify the cooking step as the CCP. study; This control approach is the same as the OR one above and is a control strategy also • The EPIPT, established by a scientiﬁc referred to in this chapter as “Control Strategy study. Other critical factors that affect the Example - Cooking and Pasteurization.” For rate of heating of the product may also be products in reduced oxygen packaging for established by the study.

which the cooking process does not target Note: EPIPT monitoring may not be an option when the objective C. botulinum type E and non-proteolytic is control of C. botulinum type E and non-proteolytic types B and F types B and F, see Chapter 13 for additional spores. guidance. Establish Monitoring Procedures. DEVELOP A CONTROL STRATEGY. » What Will Be Monitored? The following guidance provides a control • The critical factors established by a scientiﬁc strategy for survival of pathogenic bacteria study. These may include length of the cook through cooking or pasteurization. You may or pasteurization cycle (speed of the belt select a control strategy that is different from that for a continuous cooker or pasteurizer) and which is suggested, provided it complies with the temperature of the steam or water used requirements of the applicable food safety laws for cooking or pasteurization (or visual and regulations. observation of minutes at a boil for cooking), initial temperature of the product, container The following is an example of the control size (e.g., can dimensions, pouch thickness), strategy included in this chapter: and product formulation; OR MAY APPLY TO MAY APPLY TO CONTROL STRATEGY PRIMARY SECONDARY • The EPIPT. PROCESSOR PROCESSOR Cooking and pasteurization » How Will Monitoring Be Done? For batch cooking or pasteurization equipment: • CONTROL STRATEGY EXAMPLE - COOKING AND • For cooking or pasteurization temperature: PASTEURIZATION Use a continuous temperature-recording Set Critical Limits. device (e.g., a recording thermometer). The device should be installed where • The minimum or maximum values for the it measures the coldest temperature of critical factors established by a scientiﬁc the cooking equipment (cold spot to be study. These may include length of the determined by a study). Where cooking

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 321 is performed at the boiling point, visual Use equipment appropriate to the critical observation of minutes at a boil may be factor (e.g., initial temperature with a an acceptable alternative; temperature-indicating device, (e.g., a thermometer); AND • For the start and end of each cooking or OR pasteurization cycle: • For the EPIPT: Visual observation; Use a temperature-indicating device (e.g., a thermometer). AND • For other critical factors: » How Often Will Monitoring Be Done (Frequency)? Use equipment appropriate to the critical For batch cooking or pasteurization equipment: factor (e.g., initial temperature with a • For cooking or pasteurization temperature: temperature-indicating device, (e.g., a thermometer); Continuous monitoring, with a visual check of the recorded data at least once OR per batch; • For the EPIPT: AND Use a temperature-indicating device (e.g., • For the start and end of each cooking or a thermometer). pasteurization cycle: For continuous cooking or pasteurization Each batch; equipment: AND • For cooking or pasteurization temperature: • For other critical factors: Use a continuous temperature-recording device (e.g., a recording thermometer). With sufﬁcient frequency to achieve The device should be installed where control; it measures the coldest temperature of OR the cooking equipment (cold spot to • For the EPIPT: be determined by a study). Because Each batch. of the extended time of operation of such equipment, it is unlikely that For continuous cooking or pasteurization visual observation of boiling will be an equipment: acceptable alternative, even if cooking is • For cooking or pasteurization temperature: performed at the boiling point; Continuous monitoring, with a visual AND check of the recorded data at least once • For cooking or pasteurization time, use: per day; A stopwatch or tachometer to monitor AND the speed of the belt drive wheel; • For cooking or pasteurization time: OR At least once per day, and whenever any A stopwatch to monitor the time changes in belt speed are made; necessary for a test unit or belt marking AND to pass through the equipment; • For other critical factors: AND With sufﬁcient frequency to achieve • For other critical factors: control;

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 322 OR AND

• For the EPIPT: Take the following corrective action to regain control At least every 30 minutes, and whenever over the operation after a critical limit deviation: any changes in product-heating critical • Adjust the steam supply to increase the factors occur. processing temperature; » Who Will Perform the Monitoring? OR • For continuous temperature-recording • Extend the length of the cooking or devices: pasteurization cycle to compensate for a Monitoring is performed by the device temperature drop, using a process developed itself. The visual check of the data by a process authority; generated by the device, to ensure that OR the critical limits have consistently been • Process at a higher temperature to met, may be performed by any person compensate for a low initial temperature, who has an understanding of the nature using a process developed by a process of the controls; authority; AND OR • For other monitoring: • Adjust the belt speed. Any person who has an understanding of the nature of the controls. Establish a Recordkeeping System.

Establish Corrective Action Procedures. For batch cooking or pasteurization equipment: • For temperature monitoring: Take the following corrective action to a product Record of continuous temperature involved in a critical limit deviation: monitoring; • Recook or repasteurize the product; AND OR Record of visual checks of recorded data; • Chill and hold the product for an evaluation of the adequacy of the cooking or OR pasteurization process. If the product has • Cooking log that indicates visual observation not received an adequate process, it should of boiling, where cooking is performed at be destroyed, diverted to a non-food use, or the boiling point; recooked or repasteurized; AND OR • Record of notation of the start time and end • Divert the product to a use in which the time of the cooking or pasteurization periods; critical limit is not applicable (e.g., divert AND improperly cooked or pasteurized shrimp to a shrimp canning operation); • Records that are appropriate for the other critical factors (e.g., a cooking or OR pasteurization log that indicates the initial • Destroy the product; temperature); OR OR • Divert the product to a non-food use. • Record of EPIPT results.

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 323 For continuous cooking or pasteurization the spores of C. botulinum type E and non- equipment: proteolytic types B and F. This is the case • Record of continuous temperature monitoring; when the product does not contain other barriers that are sufficient to prevent growth AND and toxin formation by this pathogen (e.g., • Record of visual checks of devices; refrigerated, vacuum packaged hot-filled AND soups and sauces). Generally, a 6D process is suitable, regardless of the target bacterial • Cooking or pasteurization log that indicates pathogen. However, lower degrees of the RPM of the belt drive wheel or the time destruction may be acceptable if supported necessary for a test unit or belt marking to by a scientific study of the normal levels in pass through the tank; the food. Tables A-3 and A-4 provide 6D AND process times for a range of internal product • Records that are appropriate for the other temperatures, with L. monocytogenes and C. critical factors (e.g., a cooking or pasteurization botulinum type B (the most heat-resistant log that indicates the initial temperature); form of non-proteolytic C. botulinum) as the target pathogens. The values provided OR in Table A-4 may not be sufficient for the • Record of EPIPT results. destruction of C. botulinum type E and non-proteolytic types B and F in products Establish Verification Procedures. containing dungeness crabmeat because of For cooking, process validation study (process the potential protective effect of naturally establishment): occurring substances, such as lysozyme. • The adequacy of the cooking process Expert knowledge of thermal process should be established by a scientific study. It calculations and the dynamics of heat transfer should be designed to ensure an appropriate in processing equipment may be required reduction in the number of pathogenic to establish such a cooking process. Such bacteria of public health concern. Selecting knowledge can be obtained by education or the target organism is critical. In most cases, experience, or both. Conducting a validation it will be a relatively heat-tolerant vegetative study for cooking processes may require pathogen, such as L. monocytogenes. access to suitable facilities and the application However, in some cases where outgrowth of recognized methods. The cooking of spore-forming pathogens, such as equipment should be designed, operated, Clostridium perfringens and Bacillus cereus, and maintained to deliver the established during the post-cook cooling step must be process to every unit of the product. In some prevented by eliminating these pathogens cases, thermal death time, heat penetration, during the cook step (e.g., because cooling temperature distribution, and inoculated after cooking is not controlled (see pack studies may be necessary to validate Chapter 12)), then they will be the target the minimum process. In many cases, organisms. Additionally, when cooking is establishing the minimum process may be performed immediately before reduced simplified by repetitively determining the oxygen packaging (e.g., vacuum packaging process needed to reach an internal product or modified atmosphere packaging), for temperature that will ensure the inactivation a product that will be marketed under of all vegetative bacterial pathogens of public refrigeration, it may be necessary for the health concern under the most difficult cooking process to be sufficient to eliminate heating conditions likely to be encountered

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 324 during processing. In other instances, in processing equipment may be required to existing literature or federal, state, or local determine the target bacterial pathogen and regulations that establish minimum processes to establish a pasteurization process. Such or adequacy of equipment are available. knowledge can be obtained by education Characteristics of the process, product, and/ or experience, or both. Conducting a or equipment that affect the ability of the validation study for pasteurization processes established minimum cooking process should may require access to suitable facilities and be taken into consideration in the validation the application of recognized methods. of the process. A record of the process The pasteurization equipment should be validation study should be maintained; designed, operated, and maintained to deliver the established process to every OR unit of the product. In some cases, thermal For pasteurization, process validation study death time, heat penetration, temperature (process establishment): distribution, and inoculated pack studies • The adequacy of the pasteurization process may be necessary to validate the minimum should be established by a scientific study. It process. In other instances, existing literature should be designed to ensure an appropriate or federal, state, or local regulations that reduction in the number of target bacterial establish minimum processes or adequacy pathogens. Selecting the target organism of equipment are available. Characteristics is critical. In most cases, it will be the of the process, product, and/or equipment spores of C. botulinum type E and non- that affect the adequacy of the established proteolytic types B and F. In some cases minimum pasteurization process should be (e.g., products that are distributed frozen taken into consideration in the validation of or contain other barriers to prevent growth the process. A record of the validation study and toxin formation by C. botulinum type should be maintained; E and non-proteolytic types B and F), the AND process will target another pathogen, such • Before a temperature-indicating device (e.g., as L. monocytogenes. Generally, a 6D process a thermometer) or temperature-recording is suitable, regardless of the target pathogen. device (e.g., a recording thermometer) is However, lower degrees of destruction may put into service, check the accuracy of the be acceptable if supported by a scientific device to verify that the factory calibration study of the normal levels in the food. Tables has not been affected. This check can be A-3 and A-4 provide 6D process times for accomplished by: a range of internal product temperatures, with L. monocytogenes and C. botulinum Immersing the sensor in an ice slurry type B (the most heat-resistant form of (32°F (0°C)) if the device will be used at non-proteolytic C. botulinum) as the target or near refrigeration temperature; pathogens. The values provided in Table A-4 OR may not be sufficient for the destruction of C. Immersing the sensor in boiling water botulinum type E and non-proteolytic types (212°F (100°C)) if the device will be used B and F in products containing dungeness at or near the boiling point (note that crabmeat because of the potential protective the temperature should be adjusted to effect of naturally occurring substances, such compensate for altitude, when necessary); as lysozyme. OR Expert knowledge of thermal process calculations and the dynamics of heat transfer A combination of the above if the

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 325 device will be used at or near room show a need for more frequent calibration or temperature; the need to replace the device (perhaps with a more durable device). Devices subjected to OR high temperatures for extended periods of Comparing the temperature reading time may require more frequent calibration. on the device with the reading on a Calibration should be performed at a known accurate reference device (e.g., minimum of two temperatures that bracket a thermometer traceable to National the temperature range at which it is used; Institute of Standards and Technology (NIST) standards) under conditions that AND are similar to how it will be used (e.g., • Calibrate other instruments as necessary to steam temperature, water temperature, ensure their accuracy; product internal temperature) within the AND temperature range at which it will be used; • Review monitoring, corrective action, and veriﬁcation records within 1 week of AND preparation to ensure they are complete and • Once in service, check the temperature- any critical limit deviations that occurred indicating device or temperature-recording were appropriately addressed. device daily before the beginning of operations. Less frequent accuracy checks may be appropriate if they are recommended by the instrument manufacturer and the history of use of the instrument in your facility has shown that the instrument consistently remains accurate for a longer period of time. In addition to checking that the device is accurate by one of the methods described above, this process should include a visual examination of the sensor and any attached wires for damage or kinks. The device should be checked to ensure that it is operational and, where applicable, has sufﬁcient ink and paper; AND • Calibrate the temperature-indicating device or temperature-recording device against a known accurate reference device (e.g., a NIST-traceable thermometer) at least once a year or more frequently if recommended by the device manufacturer. Optimal calibration frequency is dependent upon the type, condition, past performance, and conditions of use of the device. Consistent temperature variations away from the actual value (drift) found during checks and/or calibration may

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 326

Review Review (process 1 week of 1 week Check the validation) monitoring, monitoring, preparation accuracy and once per year before putting before data logger for data logger for it is operational the thermal process corrective action and corrective into operation; check it daily, at the beginning of daily, operations; and calibrate it damage and to ensure that Calibrate the scale monthly Scientific study establishing verification, records within verification, record record printout Cooking RECORDS VERIFICATION Data logger el).” This example illustrates how a mation during processing, food and color Refer to Tables 3-3 and 3-4 (Chapter 3) Refer to Tables rposes only. rposes only. authority processes or elevate or elevate ACTION(S) the process limit, based limit, CORRECTIVE on alternate from critical temperature provided by provided for deviation deviation for for evaluation for Chill and hold to compensate Extend process Cooker Cooker Cooker Cooker operator operator Grader operator Grading check of or grader lot change after every after every adjustment with visual adjustment Continuous, Continuous, raw material once per day and after any Once per day Once per day recorded data TABLE 16-1 TABLE Example Only (COOKING MODEL) MONITORING See Text for Full Recommendations See Text Belt speed data logger temperature measurement with stopwatch Digital time and WHAT HOW FREQUENCY WHO the cooker cook cycle of steam in Shrimp size Scale Hourly and Temperature Temperature Length of the CONTROL STRATEGY EXAMPLE - COOKING AND PASTEURIZATION CONTROL STRATEGY 210°F minutes Note: To Note: To Minimum FOR EACH Maximum MEASURE* PREVENTIVE temperature: achieve a 6D achieve count/pound CRITICAL LIMITS reduction of L. reduction of L. cook time: 2.5 Minimum cook monocytogenes shrimp size: 40 survival bacteria HAZARD(S) SIGNIFICANT (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) Pathogenic bacteria survival through cooking and pasteurization may be only one of several significant hazards for this product. additives, and metal fragments). This table is an example of a portion of a HACCP plan using “Control Strategy Example - Cooking and Pasteurization (Cooking Mod *Note: The critical limits in this example are for illustrative purposes only and not related to any recommended process. processor of wild-caught cooked shrimp can control cooking using a continuous steam cooker. It is provided for illustrative pu processor of wild-caught cooked shrimp can control cooking using a continuous steam cooker. for other potential hazards (e.g., environmental chemical contaminants and pesticides, pathogenic bacteria growth toxin POINT CRITICAL Cooking Pathogenic CONTROL

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 327 year Review Review Process Check the monitoring, monitoring, preparation temperature- establishment verification, and verification, within 1 week of within 1 week check it daily, at the check it daily, dial thermometer for recording device and recording device accuracy and damage are operational before putting into operation; and to ensure that they and calibrate it once per beginning of operations; corrective action records corrective log log chart Recorder Recorder RECORDS VERIFICATION thermometer Pasteurization Pasteurization Pasteurization Pasteurization ion Model).” This example illustrates how on during processing, recontamination after Refer to Tables 3-3 and 3-4 (Chapter 3) for Refer to Tables for for limit ly. ly. critical from the deviation deviation Segregate ACTION(S) evaluation evaluation process or Extend the elevate the elevate CORRECTIVE temperature and hold for and hold for to compensate operator operator operator Recorder Recorder check by with visual Pasteurizer pasteurizer thermometer, thermometer, Coldest of batch with visual each batch Each batch Pasteurizer can entering check at end Continuously, Continuously, TABLE 16-2 TABLE Example Only MONITORING Dial (PASTEURIZATION MODEL) (PASTEURIZATION device device recording recording See Text for Full Recommendations See Text thermometer Temperature- Temperature- Temperature- Temperature- ends Initial WHAT HOW FREQUENCY WHO 189°F and time cycle time cycle Time up to Time temperature Temperature of water bath of water CONTROL STRATEGY EXAMPLE - COOKING AND PASTEURIZATION CONTROL STRATEGY 37°F initial 189°F cycle: cycle: product length of Minimum Minimum Minimum FOR EACH MEASURE* water bath water PREVENTIVE 120 minutes temperature: temperature: pasteurization CRITICAL LIMITS survival bacteria HAZARD(S) Pathogenic Pathogenic SIGNIFICANT (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) Pathogenic bacteria survival through cooking and pasteurization may be only one of several significant hazards for this product. other potential hazards (e.g., environmental chemical contaminants and pesticides, pathogenic bacteria growth toxin formati a processor of pasteurized, refrigerated blue crabmeat can control pasteurization. It is provided for illustrative purposes on pasteurization, and metal fragments). This table is an example of a portion of a HACCP plan using “Control Strategy Example - Cooking and Pasteurization (Pasteurizat *Note: The critical limits in this example are for illustrative purposes only and not related to any recommended process. Batch POINT CRITICAL CONTROL pasteurization

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 328 BIBLIOGRAPHY. • National Advisory Committee on Microbiological Criteria for Foods. 1990. We have placed the following references on Recommendations of the National Advisory display in the Division of Dockets Management, Committee on Microbiological Criteria for Food and Drug Administration, 5630 Fishers Lane, Foods for Cooked Ready-to-Eat Shrimp and rm. 1061, Rockville, MD 20852. You may see Cooked Ready-to-Eat Crabmeat. Executive them at that location between 9 a.m. and 4 p.m., Secretariat, Food Safety and Inspection Monday through Friday. As of March 29, 2011, Service, U.S. Department of Agriculture, FDA had veriﬁed the Web site address for the Washington, DC. references it makes available as hyperlinks from • National Advisory Committee on the Internet copy of this guidance, but FDA is not Microbiological Criteria for Foods. 1990. responsible for any subsequent changes to Non- Recommendations of the National Advisory FDA Web site references after March 29, 2011. Committee on Microbiological Criteria for Foods for Refrigerated Foods Containing • Cockey, R. R., and M. C. Tatro. 1974. Survival Cooked, Uncured Meat or Poultry Products studies with spores of Clostridium botulinum that are Packaged for Extended Refrigerated type E in pasteurized meat of the blue crab Shelf Life and that are Ready-to-Eat or Callinectes sapidus. Appl. Microbiol. 27:629-633. Prepared with Little or No Additional Heat • European Chilled Food Federation. 1997. Treatment. Executive Secretariat, Food Safety Guidelines for good hygienic practice in the and Inspection Service, U.S. Department of manufacture of chilled foods. Agriculture, Washington, DC. • Frazier, J. 2005. Establishing or verifying a • National Advisory Committee on heat process for cooked, ready-to-eat seafood Microbiological Criteria for Foods. 1991. products, and heat process monitoring Listeria monocytogenes: recommendations considerations under HACCP. 2nd ed. of the National Advisory Committee on Grocery Manufacturers Association (Food Microbiological Criteria for Foods for Products Association), Washington, DC. Refrigerated Foods. Intl. J. Food Microbiol. • Hilderbrand, K. S., Jr. 1996. Personal 14:185-246. communication. Oregon State University, • Peterson, M. E., G. A. Pelroy, F. T. Poysky, R. Extension Service, Corvallis, OR. N. Paranjpye, R. M. Dong, G. M. Pigott, and M. • Lum, K. C. 1996. Personal communication. W. Eklund. 1997. Heat-pasteurization process National Food Processors Association, for inactivation of nonproteolytic types of Seattle, WA. Clostridium botulinum in picked dungeness • Lynt, R. K., D. A. Kautter, and H. M. crabmeat. J. Food Prot. 60:928-934. Solomon. 1982. Differences and similarities • Peterson, M. E., R. N. Paranjpye, F. T. among proteolytic and nonproteolytic strains Poysky, G. A. Pelroy, and M. W. Eklund. of Clostridium botulinum types A, B, E and 2002. Control of nonproteolytic Clostridium F: a review. J. Food Prot. 45:466-474. botulinum types B and E in crab analogs • Lynt, R. K., H. M. Solomon, T. Lilly, and by combinations of heat pasteurization and D. A. Kautter. 1977. Thermal death time of water phase salt. J. Food Prot. 65:130-139. Clostridium botulinum type E in meat of the • Rippen, T., C. Hackney, G. Flick, G. Knobl, blue crab. J. Food Sci. 42:1022-1025. and D. Ward. 1993. Seafood pasteurization • Mackey, B. M., and N. Bratchell. 1989. The and minimal processing manual. Virginia heat resistance of Listeria monocytogenes: a Cooperative Extension Publication 600- review. Lett. Appl. Microbiol. 9:89-94. 0061. Virginia Sea Grant Publication VSG

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 329 93-09. Virginia Seafood Research and Extension Center Publication VPI-SG-93-01. Blacksburg, VA. • U.S. Food and Drug Administration and U.S. Department of Agriculture. 2003. Quantitative assessment of the relative risk to public health from foodborne Listeria monocytogenes among selected categories of ready-to-eat foods. http://www.fda. gov/Food/ScienceResearch/ResearchAreas/ RiskAssessmentSafetyAssessment/ucm183966. htm. • U.S. Food and Drug Administration. Thermally processed low-acid foods packaged in hermetically sealed containers. In Code of Federal Regulations, 21 CFR 113. U.S. Government Printing Ofﬁce, Washington, DC.

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 330 CHAPTER 17: Pathogenic Bacteria Survival Through Processes Designed to Retain Raw Product Characteristics

UNDERSTAND THE POTENTIAL HAZARD. • Mild heat processing; • Irradiation. The survival of pathogenic bacteria through HPP, IQF with extended frozen storage, mild heat processes designed to retain raw product processing, and irradiation are processes currently characteristics can cause consumer illness. used for the treatment of raw molluscan shellfish The primary pathogens of concern are to reduce the presence of V. vulnificus and V. Vibrio vulnificus (V. vulnificus) and Vibrio parahaemolyticus to non-detectable levels. V. parahaemolyticus (V. parahaemolyticus). See vulnificus and V. parahaemolyticus are naturally Appendix 7 for a description of the public health occurring pathogens (i.e., not associated with impacts of these pathogens. human or animal sources) that may be present in • Goal of processes designed to retain raw fish and fishery products, and in particular, raw product characteristics molluscan shellfish. Non-detectable for these pathogens is defined under the National Shellfish Some processes are designed to reduce specific Sanitation Program (NSSP) as less than 30 (MPN)/ pathogens to acceptable levels while retaining gram. MPN means most probable number and it the sensory qualities (appearance, taste, and is an approximation of the bacterial population in texture) of the raw product. These processes analyzed product. Shellfish that are processed in are particularly useful in addressing the hazard a manner that achieves a non-detectable level for associated with the target pathogen in raw one or both of these pathogens may bear “added products such as raw molluscan shellfish (i.e., safety” labeling. Additionally, they need not meet oysters, clams, mussels, and whole and roe-on the time from exposure to air (e.g., by harvest or scallops) that are intended for the raw ready- receding tide) to refrigeration recommendations to-eat market. Because these processes do not specific to V. vulnificus and V. parahaemolyticus eliminate all pathogens of public health concern, described in Chapter 4. they are not considered cooking or pasteurization processes. Finished products in which the raw These processes also may have application to sensory qualities are not maintained are covered pathogens other than Vibrio spp. and to products in Chapter 16, “Pathogenic Bacteria Survival other than raw molluscan shellfish, but such Through Cooking and Pasteurization.” applications are not presently in commercial use in the U.S. fish and fishery products industry. Examples of processes designed to retain raw product characteristics include: Control of pathogenic bacteria growth and toxin • High hydrostatic pressure processing (HPP); formation during storage of these products may be important to their safety because: • Individual quick freezing (IQF) with extended frozen storage; • Pathogens that are more resistant than the target pathogen(s) may survive the process;

CHAPTER 17: Pathogenic Bacteria Survival Through Processes Designed to Retain Raw Product Characteristics 331 • These processes may reduce the number • Mild heat processing of spoilage bacteria in the food, reducing Mild heat processing involves submerging the competition for any surviving pathogenic product ﬁrst in a hot water bath for a prescribed bacteria. time period followed by dipping it in an ice Strategies for controlling pathogenic bacteria water bath. This process results in a reduction growth and toxin formation are included in in the number of heat-sensitive pathogens. Some Chapter 12 (for pathogens other than Clostridium pathogens are more sensitive to heat than are botulinum (C. botulinum)) and Chapter 13 (for others. V. parahaemolyticus and V. vulniﬁcus are C. botulinum). especially sensitive.

• High Hydrostatic Pressure Processing (HPP) • Irradiation HPP is the application of hydrostatic compression Ionizing radiation (i.e., irradiation) is used to in the range of 14,500 to 145,000 pound per eliminate or reduce the numbers of bacterial square inch (100 to 1,000 megapascal (MPa)). pathogens, parasites, and insects in food. It These pressures are capable of inactivating can also be used to delay physiological pressure-sensitive pathogens, especially processes (e.g., ripening) in fruit and vegetables. vegetative forms. Some pathogens are more Acceptable sources of ionizing radiation in sensitive to pressure than are others. For the United States include: gamma rays from example, V. parahaemolyticus and V. vulnificus sealed units of the radionuclides cobalt-60 and are particularly sensitive. However, HPP appears cesium-137; electrons generated by machine to have limited effect against bacterial spores sources (at energies not exceeding 10 million like C. botulinum unless combined with other electron volts); and, x-rays generated by machine treatments, such as heat and acidity (pH). sources (at energies not exceeding 5 or 7.5 million electron volts, depending on the target The effectiveness of the process is dependent material as set forth in 21 CFR 179.26 (a)). upon the amount of pressure applied, the process temperature, and the duration of the FDA has approved the use of ionizing radiation process. However other organoleptic changes, for the control of V. parahaemolyticus and V. such as texture, viscous liquor and a “plumper” vulnificus and other foodborne pathogens in appearance have been reported. Additionally, fresh or frozen molluscan shellfish. Mandatory the pressure facilitates oyster adductor muscle irradiation controls are described in the changes; hence, HPP may result in a shucked Irradiation in the Production, Processing and oyster. Handling of Food regulation (21 CFR 179). Irradiation of fresh and frozen molluscan • Individual quick freezing (IQF) with shellfish may not exceed an absorbed dose of 5.5 extended frozen storage kilograys (kGy) (21 CFR 179.26(b)). IQF involves the use of cryogenic or blast Some pathogens are more sensitive to ionizing freezing technology to rapidly lower the product radiation than are others. V. parahaemolyticus temperature below freezing. This process results and V. vulnificus are highly sensitive, whereas in a reduction in the number of freeze-sensitive Salmonella spp. and Listeria monocytogenes (L. pathogens. Some pathogens are more sensitive monocytogenes) are more resistant. Bacterial to freezing than are others. For example, V. spores (e.g., C. botulinum) are more resistant to parahaemolyticus and V. vulnificus are especially ionizing radiation than are bacterial vegetative sensitive. To reduce V. parahaemolyticus and/ cells (e.g., L. monocytogenes). or V. vulnificus to non-detectable levels, the IQF process is followed by a period of frozen storage, The effectiveness of the process is determined which may vary depending on organism. by the amount of the ionizing radiation absorbed

CHAPTER 17: Pathogenic Bacteria Survival Through Processes Designed to Retain Raw Product Characteristics 332 by the food. The amount of ionizing radiation If “added safety” labeling is to be used on the absorbed depends on factors associated with product or if the process is used as a substitute for the irradiator itself, for example, activity (energy the time from exposure to air (e.g., by harvest or output) of the source (e.g., x-ray intensity and receding tide) to refrigeration recommendations electron or photon energy spectrum), source specific to V. vulnificus and V. parahaemolyticus geometry (configuration or relationship between described in Chapter 4, the ability of a process to the product and the source), source-to-product reliably achieve the appropriate reduction of the distance, process path through the irradiator, target pathogen should be validated by a scientific and beam characteristics. The amount of study approved by the shellfish control authority absorption also depends on factors associated with concurrence from FDA. A scientific study is with the specific process, for example, length of conducted to initially validate the efficacy of the time irradiated, conveyor speed, environmental process and to revalidate it when there has been a temperature, product temperature, product change in the process. Additional guidance on the composition and density, packaging size, shape conduct of a validation study can be found in the and composition, and configuration of the load “National Shellfish Sanitation Program Guide for of product in the irradiator. It is important the Control of Molluscan Shellfish 2007 Revision.” that every part of the product receive the • Strategies for control of pathogens prescribed absorbed dose within a specified range. Dosimetry mapping is used to document There are a number of strategies for the control the distribution of absorbed dose throughout of pathogens in fish and fishery products. They a process load for a particular set of irradiator include: parameters. All factors listed above should be • Killing pathogenic bacteria by processes considered in the establishment of the process that retain the raw product characteristics and its verification. The parameters that could (covered in this chapter); affect the absorbed dose should be monitored. • Killing pathogenic bacteria by cooking A suitable dosimetry system should be used to or pasteurizing (covered in Chapter 16) verify the range of absorbed dose delivered to or by retorting (covered by the Thermally each lot of product. Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation, 21 • Control of processes intended to retain raw CFR 113, called the Low-Acid Canned Foods product characteristics Regulation in this guidance document); Controlling pathogenic bacteria survival through • Managing the amount of time that food is processes intended to retain raw product exposed to temperatures that are favorable characteristics is accomplished by: for pathogenic bacteria growth and toxin • Scientifically establishing and validating a production (covered generally in Chapter process that will reduce the target pathogen(s) 12; for C. botulinum, in Chapter 13; and for to an acceptable level (the scientific study may Staphylococcus aureus in hydrated batter be conducted by the processor or obtained mixes, in Chapter 15); from scientific literature); • Controlling the amount of moisture that is • Designing and operating the processing available for pathogenic bacteria growth equipment so that every unit of the product (water activity) in the product by drying receives at least the established minimum (covered in Chapter 14); process; • Controlling the amount of moisture that is • Continuously monitoring the critical process available for pathogenic bacteria growth parameters to verify achievement of a (water activity) in the product by formulation scientifically established process. (covered in Chapter 13);

CHAPTER 17: Pathogenic Bacteria Survival Through Processes Designed to Retain Raw Product Characteristics 333 • Controlling the amount of salt or • The shellfish control authority preservatives, such as sodium nitrite, in the has conducted a risk evaluation product (covered in Chapter 13); and determined that the risk of V. • Controlling the level of pH in the product parahaemolyticus illness from the (covered by the Acidified Foods regulation, consumption of oysters harvested 21 CFR 114 for shelf-stable acidified products, from that growing area is reasonably and by Chapter 13 for refrigerated acidified likely to occur. Specific guidance products); for determining risk can be found in the “National Shellfish Sanitation • Controlling the source of molluscan shellfish Program Guide for the Control of and time from exposure to air (e.g., by Molluscan Shellfish 2007 Revision”; harvest or receding tide) to refrigeration in order to control pathogens from the harvest • The shellfish control authority has area (covered in Chapter 4); determined that harvesting occurs in the • Controlling the introduction of pathogenic growing area at a time when average bacteria after the pasteurization process monthly daytime water temperatures (covered in Chapter 18). exceed 60°F for waters bordering the Pacific Ocean and 81°F for waters DETERMINE WHETHER THE POTENTIAL bordering the Gulf of Mexico and HAZARD IS SIGNIFICANT. the Atlantic Ocean (New Jersey and south), except where a more rigorous The following guidance will assist you in risk evaluation has led the shellfish determining whether pathogenic bacteria survival control authority to conclude that the through processes designed to retain raw risk of V. parahaemolyticus illness product characteristics is a significant hazard at a from the consumption of oysters processing step: harvested from that growing area is not reasonably likely to occur; 1. Is it reasonably likely that unsafe levels of • The waters of the state have been pathogenic bacteria will be introduced at this confirmed as the original source processing step (do unsafe levels of pathogenic of oysters associated with two bacteria come in with the raw material or will the or more V. parahaemolyticus process introduce unsafe levels of pathogens)? illnesses in the past 3 years. Under ordinary circumstances, it would be 2. Can unsafe levels of pathogenic bacteria that reasonably likely that an unsafe level of were introduced at an earlier processing step be V. vulnificus could enter the process from eliminated or reduced to an acceptable level at oysters harvested from states that have been this processing step? confirmed as the original source of oysters associated with two or more V. vulnificus Pathogenic bacteria survival through processes illnesses (e.g., states bordering the Gulf of designed to retain raw product characteristics Mexico). should also be considered a significant hazard Under ordinary circumstances, it would be at any processing step where a preventive reasonably likely that an unsafe level of V. measure is, or can be, used to eliminate parahaemolyticus could enter the process the hazard (or reduce the likelihood of its from oysters harvested from an area that occurrence to an acceptable level) if it is meets any one of the following conditions: reasonably likely to occur. The preventive measure that can be applied for pathogenic

CHAPTER 17: Pathogenic Bacteria Survival Through Processes Designed to Retain Raw Product Characteristics 334 bacteria survival through processes designed This control approach includes two to retain raw product characteristics is proper control strategies referred to in this chapter design and control of the process. as “Control Strategy Example 1 - High Hydrostatic Pressure Processing,” or • Intended use “Control Strategy Example 2 - IQF With The controls for V. vulnificus and V. Extended Frozen Storage.” For guidance parahaemolyticus that are discussed in this on controls for mild heat processing, see chapter are only intended to be applied to “Control Strategy Example 1 - Cooking and oysters if they are intended for raw consumption. Pasteurization,” in Chapter 16; however, You should assume that most oysters will be guidance on process validation for mild consumed raw. However, controls need not heat processing is more appropriately be applied to oyster shellstock if tags on the obtained from “Control Strategy Example 1 containers of shellstock indicate that they must - High Hydrostatic Pressure Processing,” in be shucked before consumption. this chapter. No specific guidance is given on control of irradiation. IDENTIFY CRITICAL CONTROL POINTS. b. If the product will not be subjected to a process in your facility that is designed The following guidance will assist you in to retain raw product characteristics determining whether a processing step is a and is sufficient to reduce V. vulnificus critical control point (CCP) for pathogenic or V. parahaemolyticus to acceptable bacteria survival through processes designed to levels, you should identify the receiving retain raw product characteristics: step as the CCP for V. vulnificus and/ 1. If the finished product is raw oyster shellstock or V. parahaemolyticus, as appropriate. intended for raw consumption, will it be subjected Guidance for development of this control to a process in your facility that is designed to strategy is provided in Chapter 4. retain raw product characteristics (e.g., mild heat processed, IQF with extended frozen DEVELOP A CONTROL STRATEGY. storage, high hydrostatic pressure processed, or V. vulnificus irradiated) and is sufficient to reduce The following guidance provides two control V. parahaemolyticus or to acceptable levels (i.e., strategies for pathogenic bacteria survival reduced to a non-detectable level, less than 30 through processes designed to retain raw product MPN/gram)? characteristics. You may select a control strategy that is different from those which are suggested, a. If the finished product will be subjected provided it complies with the requirements of the to a process designed to retain raw applicable food safety laws and regulations. product characteristics, you should identify that processing step as the CCP The following are examples of control strategies for the target pathogen. In this case, you included in this chapter: would not need to identify the receiving

step as a CCP for the control of the target MAY APPLY TO MAY APPLY TO pathogen. However, you may need to CONTROL STRATEGY PRIMARY SECONDARY identify the receiving step as a CCP for PROCESSOR PROCESSOR control of other non-target pathogens High hydrostatic pressure (e.g., Salmonella spp. and norovirus), as processing described in Chapter 4. IQF with extended frozen storage

CHAPTER 17: Pathogenic Bacteria Survival Through Processes Designed to Retain Raw Product Characteristics 335 • CONTROL STRATEGY EXAMPLE 1 - HIGH » How Often Will Monitoring Be Done (Frequency)? HYDROSTATIC PRESSURE PROCESSING • For time and pressure: Set Critical Limits. Continuous monitoring, with a visual check of the recorded data at least once • The minimum or maximum values for the per batch; critical factors established by conducting a scientific study to validate the process (e.g., AND minimum pressure, minimum hold time at • For initial temperature of the product: pressure, and minimum initial temperature of Each batch; the product). AND Establish Monitoring Procedures. • For other critical factors: With sufficient frequency to achieve » What Will Be Monitored? control. • Pressure; AND » Who Will Do the Monitoring? • For continuous-recording devices: • Hold time at pressure; Monitoring is performed by the device AND itself. The visual check of the data • Initial temperature of the product; generated by the device, to ensure that AND the critical limits have consistently been met, may be performed by any person • Other critical factors that affect the who has an understanding of the nature effectiveness of the process, as specified by of the controls; the study (e.g., pressurization time (step-up time), decompression time (step-down time), AND and treatment temperature). • For other checks:

» How Will Monitoring Be Done? Any person who has an understanding of the nature of the controls. • For time and pressure: Use a continuous pressure-recording Establish Corrective Action Procedures. device (e.g., a pressure recorder); Take the following corrective action to a product AND involved in a critical limit deviation: • For initial temperature of the product: • Reprocess the product; Use a temperature-indicating device (e.g., OR a thermometer); • Chill and hold the product for an evaluation AND of the adequacy of the high hydrostatic • For other critical limits: pressure process. If the product has not Use equipment appropriate to the critical received an adequate high hydrostatic limit. pressure process, the product should be destroyed, diverted to a non-food use, or reprocessed; OR • Divert the product to a use in which the

CHAPTER 17: Pathogenic Bacteria Survival Through Processes Designed to Retain Raw Product Characteristics 336 critical limit is not applicable (e.g., divert the NSSP as less than 30 MPN/gram. If improperly processed product to a canning “added safety” labeling is to be used operation); on the product or if the process is used as a substitute for the time from OR exposure to air (e.g., by harvest or • Destroy the product; receding tide) to refrigeration limitations OR described in Chapter 4, the ability • Divert the product to a non-food use or a of a post-harvest process to reliably use without the “added safety” labeling. achieve the appropriate reduction of the target pathogen should be validated AND by a study approved by the shellfish Take the following corrective action to regain control control authority with concurrence over the operation after a critical limit deviation: from FDA. A study is used to initially • Adjust or repair the processing equipment; validate the efficacy of the process and to revalidate it when there has been AND/OR a change in the process. Additional • Extend the high hydrostatic pressure process guidance on conducting a validation to compensate for a pressure drop, using a study can be found in the “National process established by a scientific study. Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish 2007 Establish a Recordkeeping System. Revision” (http://www.fda.gov/Food/ • Record of continuous pressure monitoring; FoodSafety/Product-SpecificInformation/ Seafood/FederalStatePrograms/ AND NationalShellfishSanitationProgram/ • Record of visual checks of recorded data; ucm046353.htm). AND Expert knowledge of high hydrostatic • Record of visual observations of initial pressure process calculations may be temperature of product; required to validate a high hydrostatic pressure process. Such knowledge can AND be obtained by education or experience, • Records that are appropriate for other critical or both. Validating high hydrostatic limit monitoring. pressure processes may require access to suitable facilities and the application Establish Verification Procedures. of recognized methods. The equipment • Process validation study: should be designed, operated, and The adequacy of the high hydrostatic maintained to deliver the established pressure treatment should be validated process to every unit of the product. by conducting a scientific study. It In some instances, inoculated pack should be designed to ensure an studies may be necessary to validate the appropriate reduction in the number minimum process. In other instances, of the target pathogen(s). In the case existing literature or federal, state, or of V. vulnificus or V. parahaemolyticus, local regulations that establish minimum it should be designed to reduce the processes or adequacy of equipment presence of these pathogens to non- may be available. Characteristics of detectable levels. Non-detectable for the process, product, and/or equipment these pathogens is defined under the that affect the adequacy of the

CHAPTER 17: Pathogenic Bacteria Survival Through Processes Designed to Retain Raw Product Characteristics 337 established minimum high hydrostatic attached wires for damage or kinks. The pressure process should be taken into device should be checked to ensure that it is consideration in the validation of the operational; process. A record of process validation AND studies should be maintained; • Calibrate the temperature-indicating AND device against a known accurate reference • Before a temperature-indicating device (e.g., device (e.g., NIST-traceable thermometer) a thermometer) is put into service, check at least once a year or more frequently if the accuracy of the device to verify that the recommended by the device manufacturer. factory calibration has not been affected. Optimal calibration frequency is dependent This check can be accomplished by: upon the type, condition, past performance, Immersing the sensor in an ice slurry and conditions of use of the device. (32°F (0°C)) if the device will be used at Consistent temperature variations away from or near refrigeration temperature; the actual value (drift) found during checks and/or calibration may show a need for more OR frequent calibration or the need to replace Immersing the sensor in boiling water the device (perhaps with a more durable (212°F (100°C)) if the device will be device). Calibration should be performed at used at or near the boiling point (note a minimum of two temperatures that bracket that the temperature should be adjusted the temperature range at which it is used; to compensate for altitude, when AND necessary); • Check and calibrate other monitoring OR instruments as necessary to ensure their Doing a combination of the above if accuracy; the device will be used at or near room AND temperature; • Review monitoring, corrective action, OR and veriﬁcation records within 1 week of Comparing the temperature indicated preparation to ensure they are complete and by the device with the reading on a any critical limit deviations that occurred known accurate reference device (e.g., were appropriately addressed. a thermometer traceable to National Institute of Standards and Technology (NIST) standards) under conditions that are similar to how it will be used (e.g., product internal temperature) within the temperature range at which it will be used; AND • Once in service, check the temperature- indicating device daily before the beginning of operations. In addition to checking that the device is accurate by one of the methods described above, this process should include a visual examination of the sensor and any

CHAPTER 17: Pathogenic Bacteria Survival Through Processes Designed to Retain Raw Product Characteristics 338

once per year Process validation Review monitoring, monitoring, Review 1 week of preparation 1 week corrective action, and action, corrective and to ensure that it is into operation; check it daily, at the beginning of daily, for accuracy for and damage veriﬁcation records within veriﬁcation operational putting before operations; and calibrate it Check the dial thermometer log Initial device device device device printout printout RECORDS VERIFICATION Pressure- Pressure- recording recording temperature s for this product. Refer to Tables 3-3 and s for this product. Refer to Tables 1 - High Hydrostatic Pressure Processing.” l toxins, pathogenic bacteria growth and hrough processes designed to retain raw needed ACTION(S) CORRECTIVE equipment as for evaluation evaluation for Chill and hold Adjust or repair Adjust Pressure Pressure operator operator operator equipment equipment equipment with visual with visual Each batch Pressure Continuous, Continuous, Continuous, Continuous, TABLE 17-1 TABLE check of the check of the recorded data recorded data once per batch once per batch Example Only MONITORING See Text for Full Recommendations See Text Dial device device Pressure- Pressure- recording recording thermometer Initial WHAT HOW FREQUENCY WHO period holding Pressure pressure during the of product temperature Hold time at

CONTROL STRATEGY EXAMPLE 1 - HIGH HYDROSTATIC PRESSURE PROCESSING EXAMPLE 1 - HIGH HYDROSTATIC CONTROL STRATEGY 350 MPa FOR EACH MEASURE* PREVENTIVE product: 60°F CRITICAL LIMITS Minimum hold temperature of Minimum initial time: 250 seconds Minimum pressure:

SIG- survival NIFICANT HAZARD(S) V. vulniﬁcus V. toxin formation during processing, food and color additives, metal fragments). 3-4 (Chapter 3) for other potential hazards (e.g., pathogens from the harvest area, environmental chemical contaminants, natura This example illustrates how a raw oyster processor using high hydrostatic pressure can control pathogen survival t product characteristics. It is provided for illustrative purposes only. Pathogen survival through processes designed to retain raw product characteristics may be only one of several signiﬁcant hazard This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using “Control Strategy Example *Note: The critical limits in this example are for illustrative purposes only and not related to any recommended process. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) High POINT CRITICAL pressure CONTROL processing hydrostatic hydrostatic

CHAPTER 17: Pathogenic Bacteria Survival Through Processes Designed to Retain Raw Product Characteristics 339 • CONTROL STRATEGY EXAMPLE 2 - IQF WITH » How Often Will Monitoring Be Done (Frequency)? EXTENDED FROZEN STORAGE • For the IQF freezer: Set Critical Limits. With sufficient frequency to achieve control; • There are minimum or maximum values for the critical factors established by conducting AND a scientific study to validate the process • For frozen storage temperature: (e.g., amount of time to reach frozen state, Continuous monitoring, with a visual maximum frozen storage temperature and check of the recorded data at least once minimum time) per lot; Establish Monitoring Procedures. AND • For length of frozen storage: » What Will Be Monitored? Each lot, at the beginning and end of a • IQF freezer and product parameters batch. critical to ensure that the product internal temperature is achieved within the time » Who Will Do the Monitoring? established by the scientific study. These • For temperature-recording devices: variables may include, but are not limited Monitoring is performed by the device to: initial product temperature, tunnel air itself. The visual check of the data temperature, time in tunnel, air velocity, belt generated by the device, to ensure that speed, product moisture, product size, and the critical limits have consistently been loading pattern; met, may be performed by any person AND who has an understanding of the nature • Frozen storage temperature; of the controls; AND AND • Length of frozen storage. • For other monitoring: Any person who has an understanding of » How Will Monitoring Be Done? the nature of the controls. • For the IQF freezer: Use equipment appropriate to the critical Establish Corrective Action Procedures. limit (e.g., initial temperature with a Take the following corrective action to a product temperature-indicating device (e.g., a involved in a critical limit deviation: thermometer)); • Refreeze the product; AND OR • For frozen storage temperature: • Hold the product for an evaluation of the Use a continuous temperature-recording adequacy of the freezing process. If the device (e.g., a recording thermometer); product has not received an adequate AND process, it should be destroyed, diverted to • For length of frozen storage: a non-food use or other appropriate use, or refrozen; Use a clock. OR

CHAPTER 17: Pathogenic Bacteria Survival Through Processes Designed to Retain Raw Product Characteristics 340 • Divert the product to a use in which the Establish Verification Procedures. critical limit is not applicable (e.g., divert an • Process validation study: improperly frozen product to a cooking or The adequacy of the IQF with extended canning operation); frozen storage process should be validated OR by conducting a scientific study. It should • Destroy the product; be designed to ensure an appropriate reduction in the number of the target OR pathogen(s). In the case of V. vulnificus • Divert the product to a non-food use or a or V. parahaemolyticus, it should be use without the “added safety” labeling. designed to reduce the presence of AND these pathogens to non-detectable levels. Non-detectable for these pathogens is Take the following corrective action to regain control defined under the NSSP as less than 30 over the operation after a critical limit deviation: MPN/gram. If “added safety” labeling • Make repairs or adjustments to the IQF is to be used on the product or if the freezing equipment; process is used as a substitute for the time OR from harvest to refrigeration limitations described in Chapter 4, the ability of a • Make repairs or adjustments to the frozen post-harvest process to reliably achieve storage freezer; the appropriate reduction of the target OR pathogen should be validated by a study • Move some or all of the product in the approved by the shellfish control authority frozen storage freezer to a properly with concurrence from FDA. A study is functioning freezer. performed to initially validate the efficacy of the process and to revalidate it when AND/OR there has been a change in the process. • Extend the freezing cycle or frozen storage Process verification may also be required time period to compensate for a rise in at predetermined intervals. Additional temperature, using a process developed by a guidance on conducting a validation study process authority; can be found in the “National Shellfish Sanitation Program Guide for the Control Establish a Recordkeeping System. of Molluscan Shellfish 2007 Revision.” • For the IQF freezer: Validating an IQF with extended frozen Records that are appropriate to the storage process may require access to monitoring; suitable facilities and the application of AND recognized methods. The equipment should be designed, operated, and • For frozen storage temperature: maintained to deliver the established Record of continuous temperature process to every unit of the product. monitoring; In some instances, inoculated pack AND studies may be necessary to establish the • For length of frozen storage: minimum process. In other instances, existing literature or federal, state, or Freezing log with notation of the start local regulations that establish minimum and end of frozen storage periods. processes or adequacy of equipment

CHAPTER 17: Pathogenic Bacteria Survival Through Processes Designed to Retain Raw Product Characteristics 341 may be available. Characteristics of the device is accurate by one of the methods process, product, and/or equipment that described above, this process should include affect the adequacy of the established a visual examination of the sensor and any minimum IQF with extended frozen attached wires for damage or kinks. The storage process should be taken into device should be checked to ensure that it consideration in the validation of is operational and has, where applicable, the process. A record of the process sufficient ink and paper; validation studies should be maintained; AND AND • Calibrate the temperature-indicating device • Before a temperature-indicating device (e.g., or temperature-recording device against a a thermometer) or temperature-recording known accurate reference device (e.g., a device (e.g., a recording thermometer) is NIST-traceable thermometer) at least once a put into service, check the accuracy of the year or more frequently if recommended by device to verify that the factory calibration the device manufacturer. Optimal calibration has not been affected. This check can be frequency is dependent upon the type, accomplished by: condition, past performance, and conditions Immersing the sensor in an ice slurry of use of the device. Consistent temperature (32°F (0°C)) if the device will be used at variations away from the actual value (drift) or near refrigeration temperature; found during checks and/or calibration may show a need for more frequent calibration OR or the need to replace the device (perhaps Immersing the sensor in boiling water with a more durable device). Devices (212°F (100°C)) if the device will be used used to determine the core temperature of at or near the boiling point (note that frozen fish or fishery products may require the temperature should be adjusted to more frequent calibration. Calibration compensate for altitude, when necessary); should be performed at a minimum of two OR temperatures that bracket the temperature range at which it is used; Doing a combination of the above if the device will be used at or near room AND temperature; • Review monitoring, corrective action, OR and verification records within 1 week of preparation to ensure they are complete and Comparing the temperature indicated by any critical limit deviations that occurred the device with the reading on a known were appropriately addressed. accurate reference device (e.g., a NIST- traceable thermometer) under conditions that are similar to how it will be used (e.g., air temperature, product internal temperature) within the temperature range at which it will be used; AND • Once in service, check the temperature- indicating device or temperature-recording device daily before the beginning of operations. In addition to checking that the

CHAPTER 17: Pathogenic Bacteria Survival Through Processes Designed to Retain Raw Product Characteristics 342

year year that it Review Review monitoring, monitoring, preparation beginning of operations; and for accuracy for and within 1 week of within 1 week verification records verification calibrate it once per check it daily, at the check it daily, is operational before corrective action, and action, corrective Check the data logger damage and to ensure putting into operation; Data logger record Frozen storage printout IQF record Process validation ticides, natural toxins, pathogenic bacteria sses designed to retain raw product s for this product. Refer to Tables 3-3 and s for this product. Refer to Tables 2 - IQF With Extended Storage.” This 2 - IQF With evaluation evaluation the product for the product for Adjust or repair Adjust Segregate and hold equipment as needed CORRECTIVE ACTION(S) RECORDS VERIFICATION which they will be monitored, and the frequency of monitoring. IQF ezer, actual minimum frozen storage temperature, and length ezer, operator operator operator equipment Frozen storage Frozen storage * With With check of sufficient with visual Continuous, Continuous, once per lot frequency to recorded data end of each lot achieve control achieve TABLE 17-2 TABLE Example Only MONITORING * Use limit Clock Beginning and See Text for Full Recommendations See Text equipment data logger appropriate temperature Digital time/ to the critical * of of the WHAT HOW FREQUENCY WHO frozen frozen storage storage Length of the study process, as process, specified by specified Temperature Temperature effectiveness effectiveness that affect the that affect Critical factors CONTROL STRATEGY EXAMPLE 2 - IQF WITH EXTENDED STORAGE CONTROL STRATEGY * * * The study study study FOR EACH MEASURE* PREVENTIVE CRITICAL LIMITS established by a established by a established by a The minimum or of frozen storage of frozen storage the critical factors scientific validation scientific validation scientific validation maximum values for maximum values for The minimum length maximum temperature

survival HAZARD(S) V. vulniﬁcus V. SIGNIFICANT of frozen storage. Additionally, an actual plan should specify the critical factors that will be monitored, way in of frozen storage. Additionally, example illustrates how a raw oyster processor using continuous cryogenic freezer can control pathogen survival through proce This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using “Control Strategy Example * An actual plan should specify the critical limits for IQF fre Note: This plan is for illustrative purposes only. characteristics. It is provided for illustrative purposes only. characteristics. It is provided for illustrative purposes only. Pathogen survival through processes designed to retain raw product characteristics may be only one of several signiﬁcant hazard 3-4 (Chapter 3) for other potential hazards (e.g., pathogens from the harvest area, environmental chemical contaminants and pes growth and toxin formation during processing, food and color additives, metal fragments) (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) IQF POINT freezer CRITICAL CONTROL

CHAPTER 17: Pathogenic Bacteria Survival Through Processes Designed to Retain Raw Product Characteristics 343 BIBLIOGRAPHY. • U.S. Food and Drug Administration. Irradiation in the production, processing We have placed the following references on and handling of food. In Code of Federal display in the Division of Dockets Management, Regulations, 21 CFR 179. U.S. Government Food and Drug Administration, 5630 Fishers Lane, Printing Office, Washington, DC. rm. 1061, Rockville, MD 20852. You may see • U.S. Food and Drug Administration. Ionizing them at that location between 9 a.m. and 4 p.m., radiation for the treatment of food. In Code Monday through Friday. As of March 29, 2011, of Federal Regulations, 21 CFR 179.26. U.S. FDA had verified the Web site address for the Government Printing Office, Washington, DC. references it makes available as hyperlinks from • U.S. Food and Drug Administration. 2007. the Internet copy of this guidance, but FDA is not National Shellfish Sanitation Program, responsible for any subsequent changes to Non- Guide for the Control of Molluscan Shellfish FDA Web site references after March 29, 2011. 2007 Revision. Department of Health and • Food Standards Program Codex Alimentarius Human Services, Public Health Service, Commission. 2003. Codex general standard for Food and Drug Administration, Center irradiated foods (CODEX STAN 106-1983, rev. for Food Safety and Applied Nutrition, 1-2003). Food and Agriculture Organization and College Park, MD. http://www.fda.gov/Food/ World Health Organization, Rome, Italy. FoodSafety/Product-SpecificInformation/ Seafood/FederalStatePrograms/ • Food Standards Program Codex Alimentarius NationalShellfishSanitationProgram/ Commission. 2003. Recommended ucm046353.htm. international code of practice for radiation processing of food (CAC/RCP 19-1979, rev. 2-2003). Food and Agriculture Organization and World Health Organization, Rome, Italy. • Harewood, R. S. Rippey, and M. Montesalvo. 1994. Effect of gamma irradiation on shelf life and bacterial and viral loads in hard- shelled clams (Mercenaria mercenaria). Appl. Environ. Microbiol. 60: 2666-2670. • Subcommittee E10.01 on Radiation Processing: Dosimetry and Applications. 2003. Standard guide for irradiation of finfish and aquatic invertebrates used as food to control pathogens and spoilage microorganisms. ASTM International, West Conshohocken, PA. • Subcommittee E10.01 on Radiation Processing: Dosimetry and Applications. 2004. Standards on dosimetry for radiation processing. ASTM International, West Conshohocken, PA.

CHAPTER 17: Pathogenic Bacteria Survival Through Processes Designed to Retain Raw Product Characteristics 344 CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes

UNDERSTAND THE POTENTIAL HAZARD. competition. Rapid growth of pathogenic bacteria that may be introduced after pasteurization is, The introduction of pathogenic bacteria after therefore, a concern. This chapter covers control pasteurization and certain specialized cooking of recontamination after pasteurization. processes can cause consumer illness. The For some products that are marketed refrigerated, primary pathogens of concern are Clostridium cooking is performed immediately before reduced botulinum (C. botulinum), Listeria monocytogenes, oxygen packaging (e.g., vacuum packaging, Campylobacter jejuni, pathogenic strains of modified atmosphere packaging). For these Escherichia coli, Salmonella spp., Shigella spp., products, the cooking process is targeted to Yersinia enterocolitica, Staphylococcus aureus (S. eliminate the spores of C. botulinum type E aureus), Vibrio cholerae, Vibrio vulnificus, and and non-proteolytic types B and F, particularly Vibrio parahaemolyticus. See Appendix 7 for a when the product does not contain other description of the public health impacts of barriers that are sufficient to prevent growth and these pathogens. toxin formation by this pathogen (e.g., many refrigerated, vacuum packaged hot-filled soups, • Goal of pasteurization and specialized chowders, and sauces). cooking processes Pasteurization is a heat treatment applied to These specialized cooking processes, which are eliminate the most resistant pathogenic bacteria discussed in Chapter 16, have much in common of public health concern that is reasonably likely with pasteurization processes, which are also to be present in the food. With fishery products, discussed in Chapter 16. For example, control pasteurization is usually performed after the product of recontamination after the product is placed in is placed in the hermetically sealed finished product the finished product container is critical to the container. It is applied to fishery products that are safety of these products. Additionally, because distributed either refrigerated or frozen. Examples these products are cooked before they are of pasteurized fishery products follow: pasteurized packaged, they are at risk for recontamination crabmeat, pasteurized surimi-based analog products, between cooking and packaging. The risk of this and pasteurized lobster meat. recontamination may be minimized by filling directly from the cook kettle using a sanitary, In addition to eliminating pathogenic bacteria, automated, continuous-filling system (designed to the pasteurization process also greatly reduces minimize the risk of recontamination) while the the number of spoilage bacteria present in the product is still hot (i.e., hot filling). This control fishery product. Spoilage bacteria normally strategy may not be suitable for products such as restrict the growth of pathogenic bacteria through crabmeat, lobster meat, or crayfish meat that are

CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes 345 handled between cooking and filling. Hot filling provide limited lethality for any non-proteolytic is covered in this chapter. C. botulinum spores present on the packaging material. • Control of pathogenic bacteria introduction after pasteurization and after specialized It may also be prudent to use packaging that has cooking processes been manufactured or treated to inactivate spores of C. botulinum type E and non-proteolytic There are three primary causes of types B and F (e.g., gamma irradiation and hot recontamination after pasteurization and after extrusion). FDA is also interested in comment on cooking that is performed immediately before the utility of such measures. reduced oxygen packaging: • Defective container closures; • Strategies for controlling pathogenic • Contaminated container cooling water; bacteria growth • Recontamination between cooking and There are a number of strategies for the control reduced oxygen packaging. of pathogenic bacteria in fish and fishery products. They include: Poorly formed or defective container closures • Controlling the introduction of pathogenic can increase the risk of pathogens entering the bacteria after the pasteurization process container through container handling that occurs and after the cooking process performed after pasteurization or after the cooked product is immediately before reduced oxygen filled into the reduced oxygen package. This risk packaging (covered in this chapter); is a particular concern during container cooling performed in a water bath. Contaminated • Controlling the amount of moisture that is cooling water can enter through the container available for pathogenic bacteria growth closure, especially when the closure is defective. (water activity) in the product by drying Container closure can be controlled by adherence (covered in Chapter 14); to seal guidelines that are provided by the • Controlling the amount of moisture that is container or sealing machine manufacturer. available for pathogenic bacteria growth Control is accomplished through periodic seal (water activity) in the product by formulation inspection. (covered in Chapter 13); Contamination of cooling water can be controlled • Controlling the amount of salt or either by ensuring that a measurable residual preservatives, such as sodium nitrite, in the of chlorine, or other approved water treatment product (covered in Chapter 13); chemical, is present in the cooling water or by • Controlling the level of acidity (pH) in the ensuring that ultraviolet (UV) treatment systems product (covered by the Acidified Foods for the cooling water are operating properly, regulation, 21 CFR 114, for shelf-stable particularly for systems in which the water is acidified products, and by Chapter 13 for reused or recirculated. refrigerated acidified products); Recontamination between cooking and reduced • Controlling the source of molluscan shellfish oxygen packaging in continuous filling systems, and the time from exposure to air (e.g., by where the product is packaged directly from harvest or receding tide) to refrigeration the kettle, can be controlled by hot filling at to control pathogens from the harvest area temperatures at or above 185°F (85°C). FDA (covered in Chapter 4); is interested in information on the value of • Killing pathogenic bacteria by cooking adding a time component (e.g., 3 minutes) to or pasteurization (covered in Chapter 16) this hot filling temperature recommendation to or by retorting (covered by the Thermally

CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes 346 Processed Low-Acid Foods Packaged in pathogenic bacteria after pasteurization can Hermetically Sealed Containers regulation, 21 include: CFR 113, called the Low Acid Canned Foods • Controlling container sealing; regulation in this guidance document); • Killing pathogens by processes that retain • Controlling the residual of chlorine, the raw product characteristics (covered in or other approved water treatment Chapter 17); chemical, in container cooling water; • Managing the amount of time that food is • Controlling UV light intensity of bulbs exposed to temperatures that are favorable used for treating container cooling water for pathogenic bacteria growth and toxin and the flow rate of the cooling water production (covered generally in Chapter 12; moving through the UV treatment system; for C. botulinum, in Chapter 13; and for S. • Hot filling the product into the final aureus in hydrated batter mixes, in Chapter 15). container in a continuous filling system. DETERMINE WHETHER THE POTENTIAL • Intended use HAZARD IS SIGNIFICANT. It is unlikely that the intended use will affect the significance of this hazard. The following guidance will assist you in determining whether introduction of pathogenic IDENTIFY CRITICAL CONTROL POINTS. bacteria after pasteurization is a significant hazard at a processing step: The following guidance will assist you in determining whether a processing step is a 1. Is it reasonably likely that pathogenic bacteria critical control point (CCP) for introduction of will be introduced at this processing step pathogenic bacteria after pasteurization. (consider post-pasteurization and post-cooking processing steps only)? If you identified the hazard as significant, you should identify the container sealing step, the It is reasonable to assume that in the absence water bath container cooling step, and the hot of controls, pathogens of various types may filling step (where applicable) as the CCPs for this enter the finished product container after hazard. pasteurization or after filling the cooked product into the reduced oxygen package. Example: This is a particular concern for products that A crabmeat processor that pasteurizes the are cooled in a water bath. finished product cans after filling and cools them in a water bath should set the CCPs for 2. Can the introduction of pathogenic bacteria after introduction of pathogenic bacteria after pasteurization be eliminated or reduced to an pasteurization at the can seaming and water acceptable level here? bath can cooling steps. Introduction of pathogenic bacteria after This control approach is a control strategy pasteurization should also be considered referred to in this chapter as “Control Strategy a significant hazard at any processing step Example - Control of Recontamination.” where a preventive measure is, or can be, used to eliminate the hazard (or reduce the likelihood of its occurrence to an acceptable level) if it is reasonably likely to occur. Preventive measures for introduction of

CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes 347 DEVELOP A CONTROL STRATEGY. For container cooling: • For chemical treatment: The following guidance provides a strategy to Residual chlorine, or other approved control the introduction of pathogenic bacteria water treatment chemical, in the cooling into the product after pasteurization. You may water; select a control strategy that is different from that OR which is suggested, provided it complies with the requirements of the applicable food safety laws • For UV treatment: and regulations. Intensity of UV light; The following is an example of a control strategy AND included in this chapter: Cooling water flow rate. For hot filling: MAY APPLY TO MAY APPLY TO CONTROL STRATEGY PRIMARY SECONDARY • Product temperature as the product enters PROCESSOR PROCESSOR the final container. Control of recontamination » How Will Monitoring Be Done? • CONTROL STRATEGY EXAMPLE - CONTROL OF For container sealing: RECONTAMINATION Visual examination of containers (non- Set Critical Limits. destructive): • Recommendations for visual examinations For container sealing: that ensure a reliable hermetic seal should • Container or sealing machine manufacturer’s be obtained from the container or sealing seal guidelines. machine manufacturer. They should include: For container cooling: For double-seamed metal and plastic • Measurable residual of chlorine, or other cans: approved water treatment chemical, at the • The external features of the double discharge point of the container cooling seam should be examined for tank; gross closure defects, including: OR cutovers, seam sharpness, false • Equipment manufacturer’s UV light intensity seams, deadheading, droop, damage and flow rate guidelines. to the countersink wall indicating a broken chuck, cable cuts, and For hot filling: product overlapping the flange. • Product temperature of 185°F (85°C) or In addition, visual examination higher as the product enters the final should include examination of container. the entire container for product leakage or other obvious defects; Establish Monitoring Procedures. OR » What Will Be Monitored? For pouches: For container sealing: • Visual examination should be • Container integrity. sufficient to detect gross closure defects, including: cuts, fractures,

CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes 348 non-bonding, malformation, testing (tensile strength), residual puncture, abrasion, blister, gas testing, electroconductivity contaminated seal, delamination, seal testing, and dye testing; creep, wrinkle, flex cracks, crushed OR package, or other obvious defects; For glass containers: OR • The examination should include cold For glass containers: water vacuum testing. Additional • Visual examination should be examinations may include: for sufficient to detect gross closure lug-type caps, security values (lug- and glass defects, including: cap tension) and for lug-type, twist tilt, cocked cap, crushed lug, caps, pull-up (lug position). stripped cap, cut through, and For container cooling: chipped and cracked glass finish; • For chemical treatment: AND Measure residual of chlorine, or other Detailed examination of containers (destructive): approved water treatment chemical, • Recommendations for seal evaluation at the discharge point of the container measurements that ensure a reliable hermetic cooling tank; seal should be obtained from the container OR or sealing machine manufacturer. They • For UV treatment: should include: Use a UV light meter; For double-seamed metal and plastic cans: AND • The examination should include a Use a flow rate meter. teardown examination of the can. For hot filling: If the micrometer method is used, • Use a continuous temperature-measuring three measurements, approximately instrument (e.g., a recorder thermometer). 120° apart around the double seam, should be made. Measurements » How Often Will Monitoring Be Done (Frequency)? should include: cover hook, For container sealing: body hook, width, tightness, and thickness. If the optical method Visual examination of containers: (seamscope or projector) is used, • At least one container from each sealing cuts should be made at at least two head at least every 30 minutes of sealing different locations, excluding the machine operation. At a minimum, visual side seam juncture. Measurements examinations should include those made should include body hook, at the beginning of the production day, overlap, tightness, and thickness; and immediately after a jam in the sealing machine, or after machine adjustment, repair, OR or prolonged shutdown; For pouches: AND • The examination should include burst, vacuum or bubble testing. It may also include: drop testing, peel

CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes 349 Detailed examination of containers: Establish Corrective Action Procedures. • At least one container from each sealing Take the following corrective action to a product head at least every 4 hours of sealing involved in a critical limit deviation: machine operation. At a minimum, visual examinations should include those made For container sealing: at the beginning of the production day, • Repack and recook or repasteurize the and immediately after a jam in the sealing affected product; machine, or after machine adjustment, repair, OR or prolonged shutdown. • Segregate and hold the product to evaluate For container cooling: the seriousness of the defects, which may • For chemical treatment: include, but is not limited to, 100% visual At least once every 4 hours of use; inspection of all affected containers to remove the defective containers. Any OR containers that are found to be unsafe should • For UV treatment: be destroyed, diverted to a non-food use, or At least daily. repacked and recooked; For hot ﬁlling: OR • Continuous monitoring, with a visual check • Divert the product to a use in which the of the instrument at least once per batch of critical limit is not applicable (e.g., divert to a cooked product. canning operation);

» Who Will Do the Monitoring? OR • Destroy the product; For container sealing: • Monitoring may be performed by any person OR who is trained and qualified to conduct • Divert the product to a non-food use. container examinations. For hot filling: For container cooling: • Recook the product; • Monitoring may be performed by any person OR who has an understanding of the nature of • Segregate and hold the product for a safety the controls. evaluation. If the product is found to be For hot filling: unsafe, it should be destroyed, diverted to a • For continuous temperature-measuring non-food use, or recooked; instruments: OR Monitoring is performed by the • Divert the product to a use in which the equipment itself. The visual check of critical limit is not applicable (e.g., divert to a the data generated by the equipment, canning operation); to ensure that the critical limits have consistently been met, may be performed OR by any person who has an understanding • Destroy the product; of the nature of the controls. OR • Divert the product to a non-food use. AND

CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes 350 Take one or more of the following corrective actions to For hot filling: regain control over the operation after a critical limit • Record of continuous temperature deviation: monitoring; For container sealing: AND • Identify and correct the source of the defect. • Record of visual checks of recorded data. For container cooling: • If no measurable residual chlorine, or other Establish Verification Procedures. approved water treatment chemical, is For container sealing: detected, add chlorine or adjust the chlorine- • Obtain container seal guidelines from metering system and recheck for chlorine container or sealing machine manufacturer; residual; AND OR • Review monitoring and corrective action • If UV intensity is inadequate, replace or records within 1 week of preparation clean the bulbs or shields; to ensure they are complete and any OR critical limit deviations that occurred were appropriately addressed. • If flow exceeds the critical limit, adjust or replace the pump. For container cooling: For hot filling: • Obtain UV light intensity and flow rate guidelines from the UV light manufacturer; • Adjust the cooking equipment to increase the processing temperature; AND OR • Review monitoring and corrective action records within 1 week of preparation • Adjust the post-cook process to minimize to ensure they are complete and any time delays. critical limit deviations that occurred were appropriately addressed. Establish a Recordkeeping System. For hot filling: For container sealing: • Before a temperature-recording device (e.g., • Record of visual examination of containers; a recording thermometer) is put into service, AND check the accuracy of the device to verify that • Record of detailed examination of containers. the factory calibration has not been affected. This check can be accomplished by: For container cooling: Immersing the sensor in boiling water • For chemical treatment: (212°F (100°C)) if the device will be used Record of residual chlorine, or other at or near the boiling point (note that approved water treatment chemical; the temperature should be adjusted to compensate for altitude, when necessary); OR OR • For UV treatment: Comparing the temperature reading Record of UV intensity testing; on the device with the reading on a AND known accurate reference device (e.g., Record of flow rate testing. a thermometer traceable to National

CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes 351 Institute of Standards and Technology • Review monitoring, corrective action, (NIST) standards) under conditions that and veriﬁcation records within 1 week of are similar to how it will be used (e.g., preparation to ensure they are complete and product internal temperature) within the any critical limit deviations that occurred temperature range at which it will be were appropriately addressed. used; AND • Once in service, check the temperature- recording device daily before the beginning of operations. Less frequent accuracy checks may be appropriate if they are recommended by the instrument manufacturer and the history of use of the instrument in your facility has shown that the instrument consistently remains accurate for a longer period of time. In addition to checking that the device is accurate by one of the methods described above, this process should include a visual examination of the sensor and any attached wires for damage or kinks. The device should be checked to ensure that it is operational and, where applicable, has sufﬁcient ink and paper; AND • Calibrate the temperature-recording device against a known accurate reference device (e.g., NIST-traceable thermometer) at least once a year or more frequently if recommended by the device manufacturer. Optimal calibration frequency is dependent upon the type, condition, past performance, and conditions of use of the device. Consistent temperature variations away from the actual value (drift) found during checks and/or calibration may show a need for more frequent calibration or the need to replace the device (perhaps with a more durable device). Devices subjected to high temperatures for extended periods of time may require more frequent calibration. Calibration should be performed at a minimum of two temperatures that bracket the temperature range at which it is used; AND

CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes 352 Obtain Review Review can seam guidelines monitoring from the can manufacturer action records and corrective and corrective within 1 week within 1 week of preparation seam record record record Double chlorine Residual Residual teardown Visual seam Visual examination defect defect defect necessary necessary defect, and defect, ing processing, pathogenic bacteria Evaluate the Evaluate the evaluation if evaluation hold for furtherhold for urization. It is provided for illustrative the source of the source of Add chlorine and Add l of Recontamination.” This example illustrates to Tables 3-3 and 3-4 (Chapter 3) for other to Tables seriousness of the seriousness of the Identify and correct Identify and correct further if evaluation defect, and hold for and hold for defect, recheck for residual recheck for CORRECTIVE ACTION(S) RECORDS VERIFICATION Seamer Seamer operator operator operator every 30 every after jams, after jams, prolonged prolonged shutdowns shutdowns repairs, and repairs, and repairs, startup; and adjustments, adjustments, adjustments, One can per One can per seaming head seaming head and after jams, and after jams, every 4 hours; at every minutes; at startup; TABLE 18-1 TABLE MONITORING Example Only apart using a teardown Rapid test batch Every Pasteurizer 3 points on Visual seam Visual examination See Text for Full Recommendations See Text examination, examination, Double seam micrometer at the seam, 120° the seam, bath WHAT HOW FREQUENCY WHO chlorine integrity integrity in water in water Residual Residual Container Container CONTROL STRATEGY EXAMPLE - CONTROL OF RECONTAMINATION EXAMPLE - CONTROL OF RECONTAMINATION CONTROL STRATEGY FOR EACH minimum; MEASURE* PREVENTIVE Measurable tightness 80% CRITICAL LIMITS obvious defects obvious residual chlorine deadheading, droop, droop, deadheading, Cover hook: .070 inch Cover sharpness, false seams, false seams, sharpness, overlapping the flange, the flange, overlapping wall indicating a broken indicating a broken wall thickness .052-.058 inch; product leakage, or other product leakage, No visible cutovers, seam No visible cutovers, chuck, cable cuts, product cable cuts, chuck, damage to the countersink body hook: .072-.088 inch; width: .125 inch maximum; bacteria bacteria HAZARD(S) Pathogenic Pathogenic Pathogenic Pathogenic introduction introduction SIGNIFICANT survival through cooking and pasteurization, metal fragments). potential hazards (e.g., environmental chemical contaminants and pesticides, pathogenic bacteria growth toxin formation dur This table is an example of a portion of a Hazard Analysis Critical Control Point plan using “Control Strategy Example - Contro * Note: The critical limits in this example are for illustrative purposes only and not related to any recommended process how a processor of pasteurized blue crabmeat, packed in steel cans, can control introduction pathogenic bacteria after paste purposes only. Pathogenic bacteria recontamination after pasteurization may be only one of several significant hazards for this product. Refer (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) bath Water Water POINT sealing cooling CRITICAL container CONTROL Container

CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes 353 BIBLIOGRAPHY.

CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes 354 CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives

UNDERSTAND THE POTENTIAL HAZARD. The FFD&C Act requires that the name of the food source from which a major food allergen is derived be the same as the name of the major • Food allergens food allergen itself for the following five foods: A number of foods contain allergenic proteins, milk; egg; wheat; peanuts; and soybeans (e.g., which are natural constituents of the food that can milk must be listed as “milk”). The name of the pose a health risk to certain sensitive individuals. food source that must be listed on the label for The symptoms of food allergies can include a tree nuts must be the specific type of tree nut tingling sensation in the mouth, swelling of the (e.g., almonds, pecans, or walnuts). Likewise, the tongue and throat, difficulty in breathing, hives, name of the food source that must be listed on the vomiting, abdominal cramps, diarrhea, drop in label for fish or crustacean shellfish must be the blood pressure, loss of consciousness, and, in specific type of fish (e.g., bass, cod, or flounder) or severe cases, death. crustacean shellfish (e.g., crab, lobster, or shrimp) The Food Allergen Labeling and Consumer (21 CFR U.S.C. 343(w)(2)). The “market” names Protection Act of 2004 amended the Federal Food, of species of fish and crustacean shellfish should Drug, and Cosmetic Act (FFD&C Act). The FFD&C be used to identify the food source of these two Act now requires that all foods that are not raw major food allergens. The market names are agricultural commodities and that contain a major found in the document “Guidance for Industry: food allergen be labeled to clearly identify the The Seafood List: FDA’s Guide to Acceptable name of the food source from which the allergen is Market Names for Seafood Sold in Interstate derived (21 CFR U.S.C. 343(w)(1)). The Act defines Commerce” revised 2009 ((http://www.fda.gov/ the following eight foods and any ingredients that Food/GuidanceComplianceRegulatoryInformation/ contain protein derived from these eight foods GuidanceDocuments/Seafood/ucm113260.htm). (with certain exemptions noted in section 201(qq) You may add the term “fish” to the market name (2) of the Act) as major food allergens: on the label if you believe that the market name • Milk; may not otherwise be recognized to be fish by the consumer (e.g., “gar fish”). • Eggs; • Fish (e.g., bass, cod, or flounder); To meet the requirements of the FFD&C Act, the • Crustacean shellfish (e.g., crab, lobster, or food labels of packaged fish and fishery products shrimp); that are or contain a major food allergen must declare the name of the food source for the • Tree nuts (e.g., almonds, pecans, or walnuts); allergen, either: • Peanuts; (1) Within the list of ingredients, in parentheses • Wheat; and immediately after the common or usual • Soybeans.

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 355 name of the ingredient that is a major food of rework material). Unintentional introduction of allergen, (e.g., “whey (milk)”) when its food allergenic proteins should be controlled through source name: rigorous process controls, either as part of a prerequisite program or as part of the Hazard (a) is not already included as part of that Analysis Critical Control Point (HACCP) program ingredient’s common or usual name (e.g., the itself. The Fish and Fishery Products regulation, food source name “milk” is included in the 21 CFR 123 (called the Seafood HACCP name of the ingredient “non-fat dried milk”); Regulation in this guidance document), requires or such a regime.

(b) does not appear elsewhere in the • Food and color additives ingredient list (e.g., if the food contains both Certain food and color additives can cause casein and whey and the label lists “whey hypersensitivity reactions, or food intolerances, (milk),” the term “(milk)” need not follow the in some consumers. Although in most cases term “casein”); or there are no known allergic mechanisms, (2) In a separate “Contains” statement symptoms may be similar to those caused immediately after or adjacent to the list by food allergens and can include a tingling of ingredients in a print size no smaller sensation in the mouth, swelling of the tongue than that used for the ingredient list (e.g., and throat, difficulty in breathing (e.g. asthma), “Contains shrimp and eggs”). If a “Contains” hives, vomiting, abdominal cramps, and diarrhea. statement is included on the label, it must Examples of such food and color additives that identify the food source names of all are used in fish and fishery products include major food allergens present as ingredients sulfiting agents and FD&C Yellow No. 5 (Yellow whether or not those food source names No. 5) described below. were previously mentioned within the list of • Sulfiting agents are mostly used during on- ingredients (21 CFR U.S.C. 343(w)(1)). board handling of shrimp and lobster to prevent the formation of “black spot.” They This chapter contains guidance on the kinds of are sometimes used by cooked octopus preventive controls that may be suitable to ensure processors as an antioxidant, to retain the proper labeling if your fish or fishery product is red color of the octopus skin. They are made in whole or in part of a food that is a major also sometimes used by conch processors food allergen. As a practical matter, this guidance to prevent discoloration or are used as covers all finfish and crustacean shellfish and all stabilizers in some breading meals added to other fishery products (e.g., molluscan shellfish) fish. People sensitive to sulfiting agents can that contain one or more of the other major food experience symptoms that can range from allergens. mild severity to life-threatening reactions. Labeling controls that are designed to ensure that • Yellow No. 5 is sometimes added to smoked any major food allergen that is present in a food fish to impart color. To help protect people is declared on the label are the most effective who are sensitive to Yellow No. 5, FDA’s means of controlling this hazard. However, regulation for Yellow No. 5 states that any such controls are not suitable to prevent the food for human use that contains Yellow unintentional introduction of allergenic proteins No. 5 must specifically declare the presence from foods that contain these allergens into foods of the color additive by listing it as an that are not intended to contain them, through ingredient (21 CFR 74.705(d)(2)). If Yellow cross-contact (e.g., use of common equipment, No. 5 is added to smoked fish but is not improper production scheduling, or improper use declared, the product not only is misbranded

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 356 under section 403 of the FFD&C Act, but the food injurious to health (21 U.S.C. 342(a) also is adulterated under section 402(c). (21 (1)). It is important to note that there is no GRAS U.S.C. 343(m) and 342(c)). People sensitive to status for color additives. Yellow No. 5 can experience symptoms that In addition to the statutory requirements that can range from mild to moderate severity. ensure the safety of substances added to food, Under the FFD&C Act, a use or intended use there are labeling requirements that apply to of a food or additives is deemed unsafe unless ingredients in food. Under the FFD&C Act, the use or intended use either conforms with a a food is deemed misbranded unless the regulation prescribing the conditions for safe use label bears the common or usual name of or the terms of an exemption for investigational each ingredient with the exception of spices, use. A food additive that is a food contact flavorings, and color additives not subject to substance also may be used in accordance certification by FDA (21 U.S.C. 343(i)). This list with an effective notification (21 U.S.C. 348 of ingredients on the food label is especially and 21 U.S.C. 379e). Any food that contains an important for people who need to avoid certain unsafe food additive or color additive is deemed ingredients for health reasons. adulterated under sections 402(a)(2)(C)(i) and If a substance is an incidental additive and has 402(c) of the FFD&C Act, respectively (21 U.S.C no functional or technical effect in the finished 342(a)(2)(C)(i) and 342(c)). product, then it need not be declared on the The FFD&C Act excludes from the definition label. Incidental additives are usually either of “food additive” substances that are generally processing aids present in the finished food recognized among experts qualified by or substances that have migrated to the food scientific training and experience to evaluate from packaging or equipment. Sulfiting agents, their safety as having been adequately shown which are added to food as preservatives, are through scientific procedures (or, in the case considered to be incidental only if they have of a substance used in food prior to January no technical effect in the food and are present 1, 1958, through either scientific procedures or at less than 10 parts per million (ppm) (21 CFR experience based on common use in food) to 101.100(a)(4)). be safe under the conditions of their intended Currently, there are six sulfiting agents allowed use (21 U.S.C. 321 (s)). A substance (other than a in processed food. The names by which they are food contact substance) added to food for a use listed on food labels are: that is not generally recognized as safe (GRAS) under the conditions of its intended use and is • sulfur dioxide (21 CFR 182.3862); not otherwise excluded from the food additive • sodium sulfite (21 CFR 182.3798); definition in section 201(s) of the FFD&C Act, • sodium bisulfite (21 CFR 182.3739); must be used in accordance with a food additive • sodium metabisulfite (21 CFR 182.3766); regulation permitting that specific use (21 CFR • potassium bisulfite (21 CFR 182.3616); and 348). Otherwise, the use of that substance in food makes the food adulterated under section • potassium metabisulfite (21 CFR 182.3637). 402(a)(2)(C) of the FFD&C Act. Additionally, The amount of any one or a combination of any food may be deemed adulterated if it contains of the six sulfiting agents that may be added to a poisonous or deleterious substance that may a processed food is restricted by Current Good render the food injurious to health, but if the Manufacturing Practices (CGMP) (See 21 CFR substance is not an added substance, the food is part 182, Subpart D). Under CGMP’s, the quantity not considered adulterated if the quantity of the of sulfiting agents added to food should not substance in the food does not ordinarily render exceed the amount necessary to achieve the

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 357 technical effect. If the total amount of sulfiting Certain other food and color additives are agent added to food results in a concentration specifically prohibited from use in food because of 10 ppm or greater, which is the current limit of a determination by FDA that they present a of analytical detection identified in the Code potential risk to the public health (see 21 CFR of Federal Regulation § 101.100(a)(4), then the part 189 and 21 CFR 81.10). Examples of such sulfiting agents are not exempt from FFD&C food and color additives are coumarin, safrole, Act food labeling requirements and must be and FD&C Red No. 4 (Red No. 4). listed as an ingredient on the product label (21 CFR 101.100(a)(4)). Table 19-1, “Rationale for a Finished Product Sulfiting Agent Declaration,” provides several examples of raw materials treated with sulfiting agents and the rationale for deciding whether or not the finished product requires a sulfiting agent declaration. Example: A processor receives frozen, raw, headless, shell-on shrimp that are labeled with a sulfiting agents declaration. The shrimp were treated with sulfiting agents to prevent the formation of black spot during on-board handling. The processor thaws, peels, and deveins the shrimp, and then adds it to a gumbo in which the processor has determined that the final sulfiting agents concentration is less than 10 ppm. Because the sulfiting agents no longer has a functional effect in the finished food, and because the concentration of the sulfiting agents is less than 10 ppm in the finished product, the processor is not required to have a sulfiting agents declaration on the label of the shrimp gumbo. Example: A processor receives frozen, raw, headless, shell-on shrimp that are labeled with a sulfiting agents declaration. The processor uses the shrimp to prepare a shell-on, deveined, easy-peel shrimp, which is packaged and refrozen. Because the sulfiting agents continue to have a functional (ongoing technical) effect in the finished product, the processor is required to have a sulfiting agents declaration on the finished product label, regardless of the concentration of sulfiting agents in the finished product.

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 358 1 2 YES YES SULFITING AGENT LEVEL IN FINISHED FOOD the level in finished food 1 2 o finished food such that their collective concentration in/on the el in the finished food is either ≥ 10 ppm or sulfiting agents were NO YES <10 PPM ≥10 PPM TABLE 19-1 TABLE Is a Sulfiting Agent Declaration Required? casserole) Conch meat Cooked octopus Cooked Raw, shell-on shrimp or lobster Raw, Raw, peeled shrimp or lobster meat Raw, Food containing raw, peeled shrimp or Food containing raw, lobster meat as an ingredient (e.g., seafood seafood lobster meat as an ingredient (e.g., RATIONALE FOR A FINISHED PRODUCT SULFITING AGENT DECLARATION RATIONALE of the octopus prevent discoloration prevent added to the finished food at any level. To further clarify, if a sulfiting agent or combination of agents is added t further clarify, added to the finished food at any level. To food is ≥ 10 ppm , then you must declare each by its approved label name (listed above)(21CFR101.100). 1. The sulfiting agents have an ongoing technical or functional effect on/in the finished food and must be declared regardless of 2. The sulfiting agents have no technical or functional effect in the finished food and do not to be declared unless lev EXAMPLES OF SULFITING AGENT USE EXAMPLES OF FINISHED FOOD sulfiting agents to prevent black spot sulfiting agents to prevent black spot sulfiting agents to prevent black spot sulfiting agents to prevent Sulfiting agents added to conch meat an antioxidant to retain the red skin color Raw, shell-on shrimp or lobster treated with Raw, shell-on shrimp or lobster treated with Raw, shell-on shrimp or lobster treated with Raw, Sulfiting agents added to cooked octopus as Sulfiting agents added to cooked

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 359 DETERMINE WHETHER THE POTENTIAL variation in formulation to establish that HAZARD IS SIGNIFICANT. sulfiting agents will not be present at 10 ppm or greater in the finished product; The following guidance will assist you in • Product formulation step, if your determining whether undeclared major food finished product contains one or allergens, certain food intolerance causing more of the major food allergens substances, and prohibited food and color (including non-fishery allergens) additives are a significant hazard at a processing listed in the previous section, step: “Understand the Potential Hazard.”;

1. Is it reasonably likely that an undeclared major • Product formulation step, if you have food allergen, undeclared food intolerance an ingredient that is or contains one causing substance (e.g., sulfiting agents or Yellow or more of the major food allergens No. 5), or prohibited food or color additive (including non-fishery allergens) or food (e.g., coumarin, safrole, or Red No. 4) will be intolerance causing substances in your introduced at each processing step (e.g., does it facility or use such an ingredient in the come in with the raw material or will the process formulation of any of your products; introduce it)? • Product formulation step, if your finished Under ordinary circumstances, you should product is cooked octopus or conch consider whether undeclared major food meat, because of the potential presence allergens, certain food intolerance causing of sulfiting agents. However, you may not substances, and prohibited food and color need to identify the hazard as significant additives are a significant hazard at the: if you do not have sulfiting agents in your facility and do not use it in the • Receiving step, if your finished product is formulation of any of your products; or contains finfish or crustacean shellfish, because they are major food allergens; • Product formulation step, if your finished product is a formulated fishery product • Receiving step, if your finished product (i.e., a product in which two or more contains either shrimp or lobster, ingredients are combined) because of because there is a potential for sulfiting the potential presence of Yellow No. agents to be present. However, there 5 or sulfiting agents. However, you may be circumstances that would allow may not need to identify the hazard as you to conclude that the hazard is not significant if you do not have Yellow No. reasonably likely to occur. For example, 5 in your facility and do not use it in the sulfiting agents may not be used in formulation of any of your products; and aquacultured shrimp from some regions. You should be guided by information • Ingredient receiving step, if you receive about the historical use of sulfiting ingredients in which you have reason agents in your region. Also, in some to believe prohibited food or color formulated finished products that contain additives (e.g., coumarin, safrole, or shrimp or lobster, the sulfiting agent may Red No. 4) may be present, based, for not have a functional effect and may example, on an historic occurrence not be present at 10 ppm or greater. of the additive in that ingredient. You should conduct a study that tests 2. 8huruhh qsqrpyh rqhw sq the range of concentration of sulfiting hyyr trhqpr hvsqvyr hprphvt agents in the raw material and possible ihprhq uvivrqsqhqpy

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 360 hqqvvruhr rv qprqhhrh yvr r ingredients in which you have reason irryvvhrq rqprqhhpprhiyryrry to believe the additive may be present huv prvtr4 (with appropriate veriﬁcation).

Undeclared major food allergens, food • Intended use intolerance causing substances and prohibited In the case of undeclared major food allergens food and color additives should also be and certain food intolerance causing substances considered a significant hazard at a processing and prohibited food and color additives, it is not step if a preventive measure is or can be likely that the significance of the hazard will be used to prevent or eliminate the hazard or affected by the intended use of the product. to reduce the likelihood of its occurrence to an acceptable level. Preventive measures IDENTIFY CRITICAL CONTROL POINTS. for undeclared major food allergens, food intolerance causing substances and prohibited The following guidance will assist you in food and color additives include: determining whether a processing step is a • Reviewing finished product labels critical control point (CCP) for undeclared major to ensure that the presence of food allergens, certain food intolerance causing certain food intolerance causing substances and prohibited food and color substances (e.g., sulfiting agents additives: or Yellow No. 5) is declared; 1. In the case of shrimp or lobster for which you • Testing incoming shrimp or lobster have identified sulfiting agents as a significant for residues of sulfiting agents; hazard, will the finished product label declare the • Reviewing a supplier’s certification presence of sulfiting agents? of the lack of sulfiting agent use on a. If the finished product label will declare incoming lots of shrimp or lobster the presence of sulfiting agents, you (with appropriate verification); should identify the finished product • Reviewing the labeling (or labeling step as the CCP and review the accompanying documents, in the case labels at that step. You would not need of unlabeled product) on shipments to identify the shrimp or lobster receiving of shrimp or lobster received from step as a CCP for this hazard. another processor for the presence Example: of a sulfiting agent declaration; A frozen shrimp processor labels all of • Reviewing finished product labels the finished product with a sulfiting to ensure that the presence of the agent declaration. The processor major food allergens, listed in the should set the CCP for sulfiting agents previous section, “Understand the at the finished product labeling step, Potential Hazard” is declared; where labels would be reviewed for • Testing incoming lots of ingredients the presence of the declaration. The for the presence of prohibited food processor would not need to have a and color additives that you have CCP for this hazard at the shrimp reason to believe may be present; receiving step. • Reviewing a supplier’s certification This control approach is a control of the lack of prohibited food and strategy referred to in this chapter color additive use in incoming lots of as “Control Strategy Example 1

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 361 - Finished Product Labeling for declaration. The processor should Control of Food Intolerance Causing set the CCP for sulfiting agents at Substances from Raw Materials.” the raw material receiving step and obtain certificates from the harvest If the finished product labeling will not b. vessels that sulfiting agents were not declare the presence of sulfiting agents, used on the shrimp. The processor you should identify the raw material should verify the effectiveness of the receiving step as the CCP, where you monitoring procedures by collecting could screen incoming lots for the quarterly samples of all incoming presence of sulfiting agents. Preventive shrimp and samples of incoming measures that can be applied here shrimp from all new suppliers and include: analyzing for the presence of sulfiting • Testing incoming shrimp or agents. The processor would not need lobster for residues of sulfiting to have a CCP for this hazard at agents at or above 10 ppm. finished product labeling. Example: This control approach is a control A frozen shrimp processor receives strategy referred to in this chapter shrimp directly from the harvest as “Control Strategy Example 3 - vessel and does not label the finished Review of Suppliers’ Certificates for product with a sulfiting agent Control of Food Intolerance Causing declaration. The processor should Substances and Prohibited Food and set the CCP for sulfiting agents at Color Additives from Raw Materials.” the raw material receiving step and • Reviewing the labeling (or test incoming lots of shrimp for the accompanying documents, in the presence of sulfiting agents. The case of an unlabeled product) processor would not need to have on shipments of shrimp or a CCP for this hazard at finished lobster received from another product labeling. processor for the presence of a This control approach is a control sulfiting agent declaration (with strategy referred to in this chapter as appropriate verification). “Control Strategy Example 2 - Raw Example: Material Testing for Control of Food A frozen shrimp processor receives Intolerance Causing Substances and shrimp from another processor and Prohibited Food and Color Additives does not label the finished product From Raw Materials.” with a sulfiting agent declaration. • Receiving a supplier’s certification The processor should set the CCP for of the lack of sulfiting agent use on sulfiting agents at the raw material incoming lots of shrimp or lobster receiving step and reject incoming (with appropriate verification). lots that are identified as having been treated with a sulfiting agent Example: (e.g., identified on the label or, A frozen shrimp processor receives in the case of unlabeled product, shrimp directly from the harvest on documents accompanying the vessel and does not label the finished shipment). The processor should verify product with a sulfiting agent the effectiveness of the monitoring

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 362 procedures by collecting quarterly that the appropriate label is being samples of all incoming shrimp and applied based on the results of the samples of incoming shrimp from raw material testing. The processor all new suppliers and analyzing for would not need to have a CCP for this the presence of sulfiting agents. The hazard at the raw material receiving processor would not need to have step, although controls would be a CCP for this hazard at finished exercised there by performing raw product labeling. material testing at the receiving step. This control approach is a control This control approach is a control strategy referred to in this chapter as strategy referred to in this chapter “Control Strategy Example 4 - Review as “Control Strategy Example 5 - of Suppliers’ Labeling for Control of Finished Product Labeling Based on Food Intolerance Causing Substances Raw Material Testing for Control of from Raw Materials.” Food Intolerance Causing Substances from Raw Materials.” c. If the finished product label will declare the presence of sulfiting agents only • Receiving a supplier’s certification when it is present in the raw material, of the lack of sulfiting agent use on you should identify the finished product incoming lots of shrimp or lobster labeling step as the CCP, where you (with appropriate verification) and can ensure that the appropriate label review of finished product labels. is placed on the package based on Example: the results of screening performed at A frozen shrimp processor receives the receiving step for the presence of shrimp directly from the harvest vessel sulfiting agents. You would not need to and labels the finished product with identify the shrimp or lobster receiving a sulfiting agent declaration only step as a CCP for this hazard, although if a lot of raw material shrimp is you would be exercising controls by received without a certificate attesting performing raw material tests. Preventive to the absence of sulfiting agent use. measures that can be applied here The processor should set the CCP include: for sulfiting agents at the finished • Testing incoming shrimp or lobster product labeling step and check that for detectable residues of sulfiting the appropriate label is being applied agents at or above 10 ppm and based on the presence or absence of a review of finished product labels. certificate. The processor should verify the effectiveness of the monitoring Example: procedures by collecting quarterly A frozen shrimp processor receives samples of incoming shrimp for the shrimp directly from the harvest vessel presence of sulfiting agents. The and labels the finished product with processor would not need to have a sulfiting agent declaration only a CCP for this hazard at the raw if testing at receiving step identifies material receiving step, although a residue of a sulfiting agent. The controls for the receipt of a certificate processor should set the CCP for attesting to the absence of sulfiting sulfiting agents at the finished agent use would be applied there. product labeling step and check This control approach is a control

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 363 strategy referred to in this chapter This control approach is a control as “Control Strategy Example 6 - strategy referred to in this chapter Finished Product Labeling Based on as “Control Strategy Example 7 - Review of Suppliers’ Certificates for Finished Product Labeling Based on Control of Food Intolerance Causing Review of Suppliers’ Labeling for Substances from Raw Materials.” Control of Food Intolerance Causing Substances from Raw Materials.” • Reviewing the labeling (or accompanying documents, in the 2. In the case of (1) cooked octopus or conch case of an unlabeled product) on meat for which you have identified sulfiting incoming shipments of shrimp agents as a significant hazard; (2) products or lobster received from another for which you have identified Yellow No. 5 as processor for the presence of a a significant hazard because you use one of sulfiting agent declaration (with this color additive in the product formulation; applicable verification), and review and (3) products for which you have identified of finished product labels. undeclared major food allergens as a significant Example: hazard, you should identify the finished product A frozen shrimp processor receives labeling step as the CCP, where you can ensure shrimp (as raw material) from that the appropriate label is placed on the another processor and labels the package based on the results of a review of the finished product with a sulfiting agent product formula for that product. You would not declaration only if the incoming lot need to identify the product formulation step as was identified on the labeling (or, a CCP for this hazard, although you may be in the case of unlabeled product, exercising control at that point. on documents accompanying the Example: shipment) as having been treated A smoked sablefish processor treats the with a sulfiting agent. The processor fish with Yellow No. 5 before smoking. should set the CCP for sulfiting agents The processor should set the CCP for at the finished product labeling step Yellow No. 5 at the finished product and check that the appropriate label labeling step, where the labels would is being applied based on the raw be examined to ensure that the color material label review. The processor additive is declared. The processor should verify the effectiveness of the would not need to have a CCP for monitoring procedures by collecting this hazard at the treatment (product quarterly samples of all incoming formulation) step. shrimp and collect at least one representative sample for each new Example: supplier and analyzing for the A cooked octopus processor treats presence of sulfiting agents. The the fish with a sulfiting agent. processor would not need to have The processor should set the CCP a CCP for this hazard at the raw for sulfiting agents at the finished material receiving step, although product labeling step, where the labels controls for reviewing the labeling would be examined to ensure that (or, in the case of unlabeled product, the food additive is declared. The on documents accompanying the processor would not need to have a shipment) would be applied there. CCP for this hazard at the treatment (product formulation) step.

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 364 Example: Material Testing for Control of Food A breaded fish processor uses pollock Intolerance Causing Substances and fillets and a batter mix containing Prohibited Food and Color Additives egg and wheat for some formulations from Raw Materials.” but not others listing egg, wheat, • Receiving a supplier’s certification and pollock on the label only when of the lack of prohibited food and those ingredients are included in the color additive use in the ingredient formulation. The processor should lot (with appropriate verification). set the CCP for undeclared major food allergens at the finished product Example: labeling step, where labels would A shrimp salad processor uses be reviewed for the presence of an an imported ingredient that has ingredient declaration that matches historically contained Red 4. The the current product formula. processor should set the CCP for prohibited food and color additives This control approach is a control at the ingredient receiving step and strategy referred to in this chapter obtain certificates from the supplier as “Control Strategy Example 8 - that Red No. 4 was not used in Finished Product Labeling Controls the formulation of the ingredient for Major Food Allergens and lot. The processor should verify Added Food Intolerance Causing the effectiveness of the monitoring Substances.” procedures by collecting quarterly 3. In the case of products for which you have samples of the imported ingredient for identified prohibited food and color additives the presence of Red No. 4. (e.g., coumarin, safrole, or Red No. 4) as a This control approach is the same significant hazard because you have reason to control strategy previously identified believe that it may be present in an ingredient as “Control Strategy Example 3 - used in the finished product, you should identify Review of Suppliers’ Certificates for the raw material receiving step as the CCP, Control of Food Intolerance Causing where you could screen incoming lots for the Substances and Prohibited Food and presence of the additive. Preventive measures that Color Additives from Raw Materials.” can be applied here include: • Testing the incoming ingredient for the additive. Example: A shrimp salad processor uses an imported ingredient that has historically contained Red No. 4. The processor should test the ingredient at receipt for the additive and set the CCP for prohibited food and color additives at the ingredient receiving step. This control approach is the same control strategy previously identified as “Control Strategy Example 2 - Raw

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 365 DEVELOP A CONTROL STRATEGY. • CONTROL STRATEGY EXAMPLE 1 - FINISHED PRODUCT LABELING FOR CONTROL OF FOOD The following guidance provides eight control INTOLERANCE CAUSING SUBSTANCES FROM strategies for undeclared major food allergens, RAW MATERIALS certain food intolerance causing substances, and Set Critical Limits. prohibited food and color additives. You may select a control strategy that is different from • All ﬁnished product packages must bear a those that are suggested, provided it complies label that declares the presence of a sulﬁting with the requirements of the applicable food agent. safety laws and regulations. Establish Monitoring Procedures. The following are examples of control strategies included in this chapter: » What Will Be Monitored?

MAY APPLY TO MAY APPLY TO • Labels on finished product packages for CONTROL STRATEGY PRIMARY SECONDARY presence of sulfiting agent. PROCESSOR PROCESSOR Finished product labeling for » How Will Monitoring Be Done? control of food intolerance causing substances from raw • Visual examination. materials » How Often Will Monitoring Be Done (Frequency)? Raw material testing for control of food intolerance • Representative number of packages from causing substances and each lot of a finished product; prohibited food and color additives from raw materials » Who Will Do the Monitoring? Review of suppliers’ certificates for control of food • Any person who has an understanding of the intolerance causing substances nature of the controls. and prohibited food and color additives from raw materials Establish Corrective Action Procedures. Review of suppliers’ labeling for control of food Take the following corrective action to a product intolerance causing substances involved in a critical limit deviation: from raw materials • Segregate and relabel any improperly labeled Finished product labeling based on raw material testing product. for control of food intolerance causing substances from raw AND materials Take the following corrective action to regain control Finished product labeling over the operation after a critical limit deviation: based on review of suppliers’ certificates for control of food • Modify labeling procedures, as appropriate; intolerance causing substances from raw materials OR Finished product labeling • Make corrections to the label generation based on review of suppliers’ labeling for control of food program or equipment; intolerance causing substances from raw materials OR Finished product labeling • Discontinue use of the label supplier until controls for major food evidence is obtained that the labeling will allergens and added food intolerance causing substances contain the appropriate declaration;

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 366 AND/OR • Segregate and return or destroy any label stock or pre-labeled packaging stock that does not contain the proper declaration.

Establish a Recordkeeping System. • Record of labeling checks of ﬁnished product packages.

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 367 Review Review monitoring and corrective and corrective within 1 week within 1 week of preparation action records product RECORDS VERIFICATION packages Record of Record of finished labeling checks veral significant hazards for this product. of Food Intolerance Causing Substances Segregate ACTION(S) improperly declaration evidence is evidence contain the and relabel nd metal fragments). CORRECTIVE Discontinue labeling will obtained that supplier until sulfiting agent the harvest vessel. It is provided for illustrative use of the label labeled product Quality assurance employee at the of the beginning each lot and production of hour thereafter one label every one label every TABLE 19-2 TABLE MONITORING Example Only Visual One label See Text for Full Recommendations See Text WHAT HOW FREQUENCY WHO for the for product Labels on declaration presence of the finished sulfiting agent FOOD INTOLERANCE CAUSING SUBSTANCES FROM RAW MATERIALS FROM RAW FOOD INTOLERANCE CAUSING SUBSTANCES contain product MEASURE FOR EACH declaration PREVENTIVE All finished CONTROL STRATEGY EXAMPLE 1 - FINISHED PRODUCT LABELING FOR CONTROL OF CONTROL STRATEGY sulfiting agent CRITICAL LIMITS packages must bear labels that HAZARD(S) Undeclared SIGNIFICANT sulfiting agents (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) from Raw Materials.” This example illustrates how a processor of shell-on shrimp can control sulfiting agents that are used on This table is an example of a portion of a HACCP Plan using “Control Strategy Example 1 - Finished Product Labeling for Control purposes only. Major food allergens, certain food intolerance causing substances and prohibited color additives may be only one of se Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants pesticides a Refer to Tables POINT product labeling CRITICAL Finished CONTROL

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 368 • CONTROL STRATEGY EXAMPLE 2 - RAW Establish Corrective Action Procedures. MATERIAL TESTING FOR CONTROL OF FOOD Take the following corrective action to a product INTOLERANCE CAUSING SUBSTANCES AND involved in a critical limit deviation: PROHIBITED FOOD AND COLOR ADDITIVES FROM RAW MATERIALS • Reject the lot. Set Critical Limits. AND • Incoming lots of shrimp or lobster must not Take the following corrective action to regain control of contain a detectable level of sulfiting agents the operation after a critical limit deviation: (Note that <10 ppm sulfiting agents may be • Discontinue use of the supplier until present in finished product shell-off shrimp evidence is obtained that control of sulfiting and lobster without a sulfiting agent declaration agents and/or prohibited food and color on the label if the sulfiting agents have no additives, as appropriate, has improved. functional (ongoing technical) effect in the finished food. However, if the sulfiting agents Establish a Recordkeeping System. have a functional (ongoing technical) effect in • Test results for sulfiting agents and/or finished shell-on or shell-off shrimp or lobster prohibited food and color additives, as product regardless of level, then they must be appropriate. declared as ingredients on the product label). AND/OR Establish Verification Procedures. • An incoming lot of raw materials must not • Review monitoring and corrective action contain a detectable level of prohibited food records within 1 week of preparation or color additive. to ensure they are complete and any critical limit deviations that occurred were Establish Monitoring Procedures. appropriately addressed.

» What Will Be Monitored? • Each lot at receipt for sulﬁting agent residual analysis and/or prohibited food and color additive analysis, as appropriate.

» How Will Monitoring Be Done? • Screening test for sulﬁting agents and/ or prohibited food and color additives, as appropriate.

» How Often Will Monitoring Be Done (Frequency)? • Representative sample from each incoming lot.

» Who Will Do the Monitoring? • Any person who is qualiﬁed by training or experience to perform the screening test procedure.

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 369 Review Review monitoring action records and corrective and corrective within 1 week within 1 week of preparation RECORDS VERIFICATION Test results for results for Test sulfiting agents agent veral significant hazards for this product. Food Intolerance Causing Substances ontrol sulfiting agents that are used on the of shrimp control of ACTION(S) Reject any Reject nd metal fragments). CORRECTIVE a detectable incoming lot that contains has improved until evidence until evidence of the supplier sulfiting agents is obtained that level of sulfiting level Discontinue use Receiving Receiving employee shrimp selected randomly of incoming Three shrimp from each lot TABLE 19-3 TABLE MONITORING Example Only test Malachite green See Text for Full Recommendations See Text for for WHAT HOW FREQUENCY WHO residual sulfiting agent Each lot of raw material shrimp PROHIBITED FOOD AND COLOR ADDITIVES FROM RAW MATERIALS PROHIBITED FOOD AND COLOR ADDITIVES FROM RAW must not MEASURE Incoming or greater FOR EACH PREVENTIVE lots of shrimp CRITICAL LIMITS sulfiting agents contain 10 ppm HAZARD(S) Undeclared SIGNIFICANT sulfiting agents CONTROL STRATEGY EXAMPLE 2 - RAW MATERIAL TESTING FOR CONTROL OF FOOD INTOLERANCE CAUSING SUBSTANCES AND TESTING FOR CONTROL OF FOOD INTOLERANCE CAUSING SUBSTANCES MATERIAL EXAMPLE 2 - RAW CONTROL STRATEGY (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) harvest vessel. It is provided for illustrative purposes only. harvest vessel. It is provided for illustrative purposes only. Major food allergens, certain food intolerance causing substances and prohibited color additives may be only one of se 3-2 and 3-3 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants pesticides a Refer to Tables This table is a an example of a portion of a HACCP plan using “Control Strategy Example 2 - Raw Material Testing for Control of This table is a an example of portion of a HACCP plan using “Control Strategy Example 2 - Raw Material Testing and Prohibited Food Color Additives from Raw Materials.” This example illustrates how a processor of shell-on shrimp can c POINT Shrimp CRITICAL receiving CONTROL

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 370 • CONTROL STRATEGY EXAMPLE 3 - REVIEW OF AND SUPPLIERS’ CERTIFICATES FOR CONTROL OF Take the following corrective action to regain control FOOD INTOLERANCE CAUSING SUBSTANCES over the operation after a critical limit deviation: AND PROHIBITED FOOD AND COLOR ADDITIVES • Discontinue use of the supplier until FROM RAW MATERIALS evidence is obtained that certificates will Set Critical Limits. accompany future shipments. • Incoming lots of shrimp or lobster must be accompanied by a supplier’s lot-by- Establish a Recordkeeping System. lot certificate that sulfiting agents and/ • Suppliers’ lot-by-lot certificates; or prohibited food and color additives, as AND appropriate, were not used. • Receiving records showing lots received Establish Monitoring Procedures. and the presence or absence of suppliers’ certificates. » What Will Be Monitored? • The supplier’s lot-by-lot certificate that no Establish Verification Procedures. sulfiting agents and/or prohibited food and • Collect at least one representative sample color additives, as appropriate, were used on per quarter, randomly selected from each the lot. supplier, and analyze for sulfiting agents and/or prohibited food and color additives, » How Will Monitoring Be Done? as appropriate. Additionally, collect at least • Visual examination of certificates. one representative sample from each new supplier, and analyze for sulfiting agents » How Often Will Monitoring Be Done (Frequency)? or prohibited food and color additives, as • Each incoming lot. appropriate; » Who Will Do the Monitoring? AND • Any person who has an understanding of the • Review monitoring, corrective action, nature of the controls. and verification records within 1 week of preparation to ensure they are complete and Establish Corrective Action Procedures. any critical limit deviations that occurred were appropriately addressed. Take the following corrective action to a product involved in a critical limit deviation: • Reject the lot; OR • Hold the lot until a certificate can be provided; OR • Test the lot for sulfiting agents and/or prohibited food and color additives, as appropriate, and reject the lot if 10 ppm or greater sulfating agents or a detectable levels of prohibited food and color additives are found.

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 371 Review Review least one Collect at agents; in corrective corrective 1 week of 1 week verification verification action, and action, sample per at least one monitoring, monitoring, preparation quarter and addition, test addition, new supplier lot from each representative representative records within sulfiting agents and analyze for and analyze for test for sulfiting test for records RECORDS VERIFICATION lot-by-lot Receiving Receiving Suppliers’ Suppliers’ certificates certificates or absence of suppliers’ of suppliers’ showing lots the presence received and received several significant hazards for this future hrimp can control sulfiting agents that are ACTION(S) shipments Control of Food Intolerance Causing sticides and metal fragments). agents and Test the lot Test accompany for sulfiting for CORRECTIVE reject the lot if a detectable until evidence until evidence of the supplier certificates will agents is found agents is found is obtained that level of sulfiting level Discontinue use Receiving Receiving employee employee received Every lot Every TABLE 19-4 TABLE MONITORING Example Only Visual Visual examination See Text for Full Recommendations See Text lot WHAT HOW FREQUENCY WHO lot-by-lot Suppliers’ Suppliers’ certificates the incoming were used on were stating that no sulfiting agents AND PROHIBITED FOOD AND COLOR ADDITIVES FROM RAW MATERIALS AND PROHIBITED FOOD COLOR ADDITIVES FROM RAW must be MEASURE FOR EACH stating that PREVENTIVE by a lot-by- All incoming lot certificate accompanied lots of shrimp were not used were CRITICAL LIMITS sulfiting agents HAZARD(S) Undeclared SIGNIFICANT sulfiting agents (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) CONTROL STRATEGY EXAMPLE 3 - REVIEW OF SUPPLIERS’ CERTIFICATES FOR CONTROL OF FOOD INTOLERANCE CAUSING SUBSTANCES FOR CONTROL OF FOOD INTOLERANCE CAUSING SUBSTANCES EXAMPLE 3 - REVIEW OF SUPPLIERS’ CERTIFICATES CONTROL STRATEGY Substances and Prohibited Food Color Additives from Raw Materials.” This example illustrates how a processor of shell-on s 3-2 and 3-3 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants pe product. Refer to Tables This table is an example of a portion of a HACCP plan using “Control Strategy Example 3 - Review Suppliers’ Certificates for used on the harvest vessel. It is provided for illustrative purposes only. used on the harvest vessel. It is provided for illustrative purposes only. Major food allergens and certain food intolerance causing substances and prohibited color additives may be only one of POINT Shrimp CRITICAL receiving CONTROL

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 372 • CONTROL STRATEGY EXAMPLE 4 - REVIEW OF Establish a Recordkeeping System. SUPPLIERS’ LABELING FOR CONTROL OF FOOD • Record of review of labeling or shipping INTOLERANCE CAUSING SUBSTANCES FROM documents for raw materials. RAW MATERIALS Set Critical Limits. Establish Verification Procedures. • The labeling or shipping documents for • Collect at least one representative sample incoming lots of shrimp or lobster received per quarter, randomly selected from among from another processor must not contain a your suppliers, and analyze for sulfiting sulfiting agent declaration. agents. Additionally, collect at least one representative sample for each new supplier, Establish Monitoring Procedures. and analyze for sulfiting agents; AND » What Will Be Monitored? • Review monitoring, corrective action, • Suppliers’ product labels or shipping and verification records within 1 week of documents for the presence of sulfiting agent preparation to ensure they are complete and declaration. any critical limit deviations that occurred » How Will Monitoring Be Done? were appropriately addressed. • Visual examination of labels.

» How Often Will Monitoring Be Done (Frequency)? • Every incoming lot.

» Who Will Do the Monitoring? • Any person who has an understanding of the nature of the controls.

Establish Corrective Action Procedures. Take the following corrective action to a product involved in a critical limit deviation: • Reject the lot; OR • Test the lot for sulﬁting agents and reject the lot if 10 ppm or greater of sulﬁting agents are found. AND

Take the following corrective action to regain control of the operation after a critical limit deviation: • Discontinue use of supplier until evidence is obtained that they will no longer provide a product in which sulﬁting agents have been used.

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 373 test for test for Review Review least one Collect at corrective corrective 1 week of 1 week verification verification action, and action, sample per at least one monitoring, monitoring, preparation quarter and new supplier lot from each representative representative records within sulfiting agents and analyze for and analyze for in addition, test in addition, sulfiting agents; of raw materials RECORDS VERIFICATION Record of Record labeling checks

several significant hazards for this Reject Reject the lot trol of Food Intolerance Causing Substances ACTION(S) sticides and metal fragments). is provided is provided not provide not provide CORRECTIVE Discontinue that they will sulfiting agent until evidence until evidence treated shrimp use of supplier the harvest vessel. It is provided for illustrative Receiving Receiving employee employee received Every lot Every TABLE 19-5 TABLE MONITORING Example Only Visual Visual the labels examination of See Text for Full Recommendations See Text WHAT HOW FREQUENCY WHO product Suppliers’ Suppliers’ declaration presence of labels for the labels for sulfiting agent FOOD INTOLERANCE CAUSING SUBSTANCES FROM RAW MATERIALS FROM RAW FOOD INTOLERANCE CAUSING SUBSTANCES received received MEASURE FOR EACH declaration PREVENTIVE of incoming The labeling from another not contain a lots of shrimp sulfiting agent CRITICAL LIMITS processor must CONTROL STRATEGY EXAMPLE 4 - REVIEW OF SUPPLIERS’ LABELING FOR CONTROL CONTROL STRATEGY HAZARD(S) Undeclared SIGNIFICANT sulfiting agents (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants pe product. Refer to Tables This table is an example of a portion of a HACCP plan using “Control Strategy Example 4 - Review Suppliers’ Labeling for Con from Raw Materials.” This example illustrates how a processor of shell-on shrimp can control sulfiting agents that are used on purposes only. Major food allergens and certain food intolerance causing substances and prohibited color additives may be only one of POINT Shrimp CRITICAL receiving CONTROL

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 374 • CONTROL STRATEGY EXAMPLE 5 - FINISHED » Who Will Do the Monitoring? PRODUCT LABELING BASED ON RAW MATERIAL • For finished product labeling: TESTING FOR CONTROL OF FOOD INTOLERANCE Any person who has an CAUSING SUBSTANCES FROM RAW MATERIALS understanding of the nature of the Set Critical Limits. controls; • All finished product packages processed from AND raw materials that contain a detectable level of • For raw material testing: sulfiting agents must bear a label that contains Any person who is qualified by a sulfiting agent declaration. Note that 10 ppm training or experience to perform the sulfiting agent may be present in finished screening test. product shell-off shrimp and lobster without a sulfiting agent declaration on the label. Establish Corrective Action Procedures. However, any detectable level of sulfiting agent in finished product shell-on shrimp Take the following corrective action to a product or lobster would require a sulfiting agent involved in a critical limit deviation: declaration on the label, because the sulfiting • Segregate and relabel any improperly labeled agents continue to have a functional effect. product. AND Establish Monitoring Procedures. Take the following corrective action to regain control of » What Will Be Monitored? the operation after a critical limit deviation: • Labels on finished product packages for • Modify labeling procedures, as appropriate. presence of sulfiting agent declaration; AND Establish a Recordkeeping System. • A representative sample of each lot of raw • Record of labeling checks of finished product material for the presence of sulfiting agents. packages;

» How Will Monitoring Be Done? AND • For labels on finished packages: • Record of sulfiting agent test results. Visual examination of labels; Establish Verification Procedures AND • Review monitoring and corrective action • For raw material testing: records within 1 week of preparation Screening test for sulfiting agents. to ensure they are complete and any critical limit deviations that occurred were » How Often Will Monitoring Be Done (Frequency)? appropriately addressed. • For finished product labeling: A representative number of packages from each lot of a finished product; AND • For raw material testing: Each lot of raw material shrimp received.

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 375 Review Review corrective corrective action records within 1 week within 1 week of preparation monitoring and results product RECORDS VERIFICATION packages Record of Record Analytical of finished labeling checks several significant hazards for this Raw Material Testing for Control of Food Raw Material Testing Modify labeling ACTION(S) sticides and metal fragments). improperly relabel any lfiting agents that are used on the harvest appropriate CORRECTIVE Segregate and procedures, as procedures, labeled product control control Quality Quality employee employee collected beginning of Three shrimp the production hour thereafter randomly from of each lot and each lot of raw one label every one label every material shrimp One label at the TABLE 19-6 TABLE MONITORING Example Only test Visual product of labels packages on finished examination Malachite green See Text for Full Recommendations See Text raw raw agent WHAT HOW FREQUENCY WHO for the for product residual finished packages Labels on Analysis of declaration for sulfiting for presence of a sulfiting agent material shrimp INTOLERANCE CAUSING SUBSTANCES FROM RAW MATERIALS FROM RAW INTOLERANCE CAUSING SUBSTANCES product MEASURE packages FOR EACH must bear contains a declaration PREVENTIVE a label that All finished raw materials sulfiting agent CRITICAL LIMITS that contain 10 sulfiting agents ppm or greater ppm or greater processed from HAZARD(S) Undeclared SIGNIFICANT sulfiting agents CONTROL STRATEGY EXAMPLE 5 - FINISHED PRODUCT LABELING BASED ON RAW MATERIAL TESTING FOR CONTROL OF FOOD MATERIAL EXAMPLE 5 - FINISHED PRODUCT LABELING BASED ON RAW CONTROL STRATEGY (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) product. Refer to Tables 3-2 and 3-3 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants pe product. Refer to Tables This table is a an example of portion of a HACCP plan using “Control Strategy Example 5 - Finished Product Labeling Based on Intolerance Causing Substances from Raw Materials.” This example illustrates how a processor of shell-on shrimp can control su vessel. It is provided for illustrative purposes only. Major food allergens and certain food intolerance causing substances and prohibited color additives may be only one of POINT product labeling CRITICAL Finished CONTROL

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 376 • CONTROL STRATEGY EXAMPLE 6 - FINISHED Establish Corrective Action Procedures. PRODUCT LABELING BASED ON REVIEW OF Take the following corrective action to a product SUPPLIERS’ CERTIFICATES FOR CONTROL OF involved in a critical limit deviation: FOOD INTOLERANCE CAUSING SUBSTANCES FROM RAW MATERIALS • Segregate and relabel any improperly labeled product. Set Critical Limits. AND • All finished product packages must bear a label that contains a sulfiting agent Take the following corrective action to regain control declaration unless they are processed over the operation after a critical limit deviation: from raw material shrimp or lobster that • Modify labeling procedures, as appropriate. are accompanied by a supplier’s lot-by-lot certificate that states that no sulfiting agents Establish a Recordkeeping System. were used. • Record of labeling checks;

Establish Monitoring Procedures. AND • Copy of certificates; » What Will Be Monitored? AND • Labels on finished product packages for the presence of a sulfiting agent declaration; • Receiving record showing lots received and the presence or absence of a certificate. AND • Suppliers’ lot-by-lot certificates for raw Establish Verification Procedures. material shrimp or lobster that no sulfiting • Collect at least one representative sample per agent was used on the lot. quarter from lots that are accompanied by a certificate, randomly selected from among » How Will Monitoring Be Done? your suppliers, and analyze for sulfiting • For finished product labeling: agents. Additionally, collect at least one Visual examination of the labels; representative sample for each new supplier AND and analyze for sulfiting agents; • For suppliers’ lot-by-lot certificates: AND Visual examination of the certificates. • Review monitoring, corrective action, and verification records within 1 week of » How Often Will Monitoring Be Done (Frequency)? preparation to ensure they are complete and • For finished product labeling: any critical limit deviations that occurred A representative number of packages were appropriately addressed. from each lot of a finished product; AND • For suppliers’ lot-by-lot certificates: Each incoming lot.

» Who Will Do the Monitoring? • Any person who has an understanding of the nature of the controls.

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 377 ' \ * &" % ( " % " + % \% ) " \ ) \ "

& " & \ several significant hazards for this view of Suppliers’ Certificates for Control ntrol sulfiting agents that are used on the sticides and metal fragments). % $ # CORRECTIVE ACTION(S) RECORDS VERIFICATION &" " , TABLE 19-7 TABLE Example Only ! " MONITORING See Text for Full Recommendations See Text \ \ BASED ON REVIEW OF SUPPLIERS’ CERTIFICATES FOR BASED ON REVIEW OF SUPPLIERS’ CERTIFICATES WHAT HOW FREQUENCY WHO \ \ CONTROL STRATEGY EXAMPLE 6 - FINISHED PRODUCT LABELING CONTROL STRATEGY \ \ CONTROL OF FOOD INTOLERANCE CAUSING SUBSTANCES FROM RAW MATERIALS FROM RAW CONTROL OF FOOD INTOLERANCE CAUSING SUBSTANCES MEASURE FOR EACH PREVENTIVE \ CRITICAL LIMITS \ S \ \ \ HAZARD(S) SIGNIFICANT harvest vessel. It is provided for illustrative purposes only. harvest vessel. It is provided for illustrative purposes only. Major food allergens and certain food intolerance causing substances and prohibited color additives may be only one of 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants pe product. Refer to Tables This table is an example of a portion of a HACCP plan using “Control Strategy Example 6 - Finished Product Labeling Based on Re of Food Intolerance Causing Substances from Raw Materials.” This example illustrates how a processor shell-on shrimp can co (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) POINT CRITICAL CONTROL

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 378 • CONTROL STRATEGY EXAMPLE 7 - FINISHED Establish Corrective Action Procedures. PRODUCT LABELING BASED ON REVIEW OF Take the following corrective action to a product SUPPLIERS’ LABELING FOR CONTROL OF FOOD involved in a critical limit deviation: INTOLERANCE CAUSING SUBSTANCES FROM RAW MATERIALS • Segregate and relabel any improperly labeled product. Set Critical Limits. AND • All finished product packages must bear a label that contains a sulfiting agent Take the following corrective action to regain control of declaration if they are processed from the operation after a critical limit deviation: raw material shrimp or lobster that are • Modify labeling procedures, as appropriate. labeled with a sulfiting agent declaration or accompanied by documents that contain a Establish a Recordkeeping System. sulfiting agent declaration. • Record of labeling checks of finished product packages; Establish Monitoring Procedures. AND » What Will Be Monitored? • Record of review of raw material labeling or • Labels on finished product packages for the shipping documents. presence of a sulfiting agent declaration; AND Establish Verification Procedures. • Labeling or shipping documents for each lot • Collect at least one representative sample of raw material shrimp or lobster received per quarter from lots that are not labeled from another processor for the presence of a with a sulfiting agent declaration or not sulfiting agent declaration. accompanied by documents with a sulfiting agent declaration, randomly selected from » How Will Monitoring Be Done? among your suppliers, and analyze for • Visual examination of labels and shipping sulfiting agents. Additionally, collect at least documents. one representative sample for each new supplier, and analyze for sulfiting agents; » How Often Will Monitoring Be Done (Frequency)? AND • For finished product labeling: • Review monitoring, corrective action and A representative number of packages verification records within 1 week of from each lot of a finished product; preparation to ensure they are complete and AND any critical limit deviations that occurred • For raw material labeling: were appropriately addressed. Each incoming lot.

» Who Will Do the Monitoring? • Any person who has an understanding of the nature of the controls.

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 379 \ \ ' \ * &" % ( " + % % % ) " % ) " " \ & RECORDS VERIFICATION & several signiﬁcant hazards for this view of Suppliers’ Labeling for Control ntrol sulﬁting agents that are used on the sticides and metal fragments). ACTION(S) CORRECTIVE % # $ &" " , ! " TABLE 19-8 TABLE Example Only MONITORING \ See Text for Full Recommendations See Text BASED ON REVIEW OF SUPPLIERS’ LABELING FOR WHAT HOW FREQUENCY WHO \ " \ CONTROL STRATEGY EXAMPLE 7 - FINISHED PRODUCT LABELING CONTROL STRATEGY \ CONTROL OF FOOD INTOLERANCE CAUSING SUBSTANCES FROM RAW MATERIALS FROM RAW CONTROL OF FOOD INTOLERANCE CAUSING SUBSTANCES MEASURE FOR EACH PREVENTIVE \ \ CRITICAL LIMITS \ \ \ HAZARD(S) SIGNIFICANT harvest vessel. It is provided for illustrative purposes only. harvest vessel. It is provided for illustrative purposes only. Major food allergens and certain food intolerance causing substances and prohibited color additives may be only one of 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants pe product. Refer to Tables This table is an example of a portion of a HACCP plan using “Control Strategy Example 7 - Finished Product Labeling Based on Re of Food Intolerance Causing Substances from Raw Materials.” This example illustrates how a processor shell-on shrimp can co (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) POINT CRITICAL CONTROL

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 380 • CONTROL STRATEGY EXAMPLE 8 - FINISHED Establish a Recordkeeping System. PRODUCT LABELING CONTROLS FOR MAJOR • Record of labeling checks of finished product FOOD ALLERGENS AND ADDED FOOD packages. INTOLERANCE CAUSING SUBSTANCES Set Critical Limits. Establish Verification Procedures. • All finished product labeling must accurately • Review monitoring and corrective action list any major food allergens and added records within 1 week of preparation sulfiting agents that have an on-going to ensure they are complete and any functional effect or Yellow No. 5 that are critical limit deviations that occurred were included in the product formulation. appropriately addressed.

Establish Monitoring Procedures.

» What Will Be Monitored? • Labels on finished product packages for comparison with the product formula (recipe), including the market name of any finfish or crustacean shellfish contained in the product.

» How Will Monitoring Be Done? • Visual examination of the ﬁnished product labels and product formula.

» How Often Will Monitoring Be Done (Frequency)? • A representative number of packages from each lot of a ﬁnished product.

» Who Will Do the Monitoring? • Any person who has an understanding of the nature of the controls.

Establish Corrective Action Procedures. Take the following corrective action to a product involved in a critical limit deviation: • Segregate and relabel any improperly labeled product. AND

Take the following corrective action to regain control over the operation after a critical limit deviation: • Modify label procedures, as appropriate.

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 381 Review Review corrective corrective action records within 1 week within 1 week of preparation monitoring and ﬁnished RECORDS VERIFICATION review of review Record of Record product labels

several significant hazards for this ens in the production of breaded fish Modify labeling r Major Food Allergens and Added ACTION(S) incorrectly sticides and metal fragments). relabel any appropriate CORRECTIVE procedure, as procedure, Segregate and labeled product Quality assurance staff beginning of the production hour thereafter of each lot and one label every one label every One label at the TABLE 19-9 TABLE MONITORING Example Only of the Visual Visual product finished labels on packages examination See Text for Full Recommendations See Text with WHAT HOW FREQUENCY WHO Finished product labels for comparison for product formula pollock Finished MEASURE CONTROL STRATEGY EXAMPLE 8 - FINISHED PRODUCT LABELING CONTROLS FOR CONTROL STRATEGY FOR EACH PREVENTIVE must declare MAJOR FOOD ALLERGENS AND ADDED INTOLERANCE CAUSING SUBSTANCES product labels CRITICAL LIMITS the presence of egg, wheat, and wheat, egg, allergens HAZARD(S) major food major food Undeclared SIGNIFICANT (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) Intolerance Causing Substances.” This example illustrates how a breaded fish processor can control undeclared major food allerg portions containing egg, wheat, and pollock. It is provided for illustrative purposes only. Major food allergens and certain food intolerance causing substances and prohibited color additives may be only one of 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants pe product. Refer to Tables This table is an example of a portion of a HACCP plan using “Control Strategy Example 8 - Finished Product Labeling Controls fo POINT product labeling CRITICAL Finished CONTROL

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 382 BIBLIOGRAPHY. • U.S. Food and Drug Administration. October 2003. Import sample collection assignment We have placed the following references on for undeclared sulfites - DFP #04-08. display in the Division of Dockets Management, Department of Health and Human Services, Food and Drug Administration, 5630 Fishers Lane, Public Health Service, Food and Drug rm. 1061, Rockville, MD 20852. You may see Administration, Center for Food Safety and them at that location between 9 a.m. and 4 p.m., Applied Nutrition, College Park, MD. Monday through Friday. As of March 29, 2011, • U.S. Food and Drug Administration. FDA had verified the Web site address for the Substances prohibited from use in human references it makes available as hyperlinks from food. In Code of Federal Regulations, the Internet copy of this guidance, but FDA is not CFR 21 74.1304, 74.2303, 81.10, 81.30. U.S. responsible for any subsequent changes to Non- Government Printing Office, Washington, DC. FDA Web site references after March 29, 2011. • Wade, A. D. October 2005. Final status report • U.S. Congress. Food Allergen Labeling and on import sample collection assignment Consumer Protection Act of 2004. Title II of for undeclared sulfites - DFP #04-08. Public Law 108-282. http://www.fda.gov/Food/ (Memorandum). Department of Health and LabelingNutrition/FoodAllergensLabeling/ Human Services, Public Health Service, Food GuidanceComplianceRegulatoryInformation/ and Drug Administration, Center for Food ucm106187.htm. Safety and Applied Nutrition, College Park, MD. • U.S. Food and Drug Administration. September 23, 1976. Termination of provisional listing and certification of FD&C Red No. 4 for use in maraschino cherries and ingested drugs. In Federal Register, vol. 41, no. 186. • U.S. Food and Drug Administration. July 9, 1986. Food labeling: declaration of sulfiting agents. Final rule, CFR Part 101. In Federal Register, 25012, vol. 51, no. 131. • U.S. Food and Drug Administration. May 29, 1992. Statement of policy: foods derived from new plant varieties. In Federal Register, vol. 57, no. 104. • U.S. Food and Drug Administration. 1993. Substances prohibited from use in human food (cyclamate and its derivatives). In Code of Federal Regulations, CFR 21 189.135; 100.130. U.S. Government Printing Office, Washington, DC. • U.S. Food and Drug Administration. 1997. Substances prohibited from use in human food (safrole). In Code of Federal Regulations, CFR 21 189.180. U.S. Government Printing Office, Washington, DC.

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 383 NOTES:

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 384 CHAPTER 20: Metal Inclusion

UNDERSTAND THE POTENTIAL HAZARD. Alternatively, metal fragments may be detected in the finished food by an electronic metal Ingesting metal fragments can cause injury to detector. The use of electronic metal detectors the consumer. These injuries may include dental is complex, especially with regard to stainless damage, laceration of the mouth or throat, or steel, which is difficult to detect. The orientation laceration or perforation of the intestine. FDA’s of the metal object in the food affects the ability Health Hazard Evaluation Board has supported of the equipment to detect it. For example, if a regulatory action against products with metal detector is not properly calibrated and is set to fragments 0.3 inch (7 mm) to 1 inch (25 mm) in detect a sphere 0.08 inch (2 mm) in diameter, length. The Federal Food, Drug, and Cosmetic it may fail to detect a stainless steel wire that is Act (the FFD&C Act) prohibits interstate commerce smaller in diameter but up to 0.9 inch (24 mm) of adulterated foods (21 U.S.C. 331). Under the long, depending on the orientation of the wire as FFD&C Act, a food containing foreign objects it travels through the detector. Processing factors, is considered adulterated (21 U.S.C 342). See such as ambient humidity or product acidity, FDA’s “Compliance Policy Guide,” Sec. 555.425. may affect the conductivity of the product and In addition, foreign objects that are less than 0.3 create an interference signal that may mask metal inch (7 mm) may cause trauma or serious injury inclusion unless the detector is properly calibrated. to persons in special risk groups, such as infants, You should consider these factors when calibrating surgery patients, and the elderly. and using this equipment. Metal-to-metal contact (e.g., mechanical cutting Finally, the hazard of metal inclusion may also or blending operations and can openers) and be controlled by periodically examining the equipment with metal parts that can break loose processing equipment for damage that can (e.g., moving wire mesh belts, injection needles, contribute metal fragments to the product. This screens and portion control equipment, and metal measure will not necessarily prevent metal ties) are likely sources of metal that may enter fragments from being incorporated into the food during processing. product, but it will enable you to separate products that may have been exposed to metal fragments. • Control of metal inclusion Visually inspecting equipment for damaged or Once introduced into a product, metal fragments missing parts may only be feasible with relatively may be removed from the product by passing it simple equipment, such as band saws, small orbital through a screen, magnet, or flotation tank. The blenders, and wire mesh belts. More complex effectiveness of these measures depends on the equipment that contains many parts, some of nature of the product. These measures are more which may not be readily visible, may not be likely to be effective in liquids, powders, and suitable for visual inspection and may require similar products in which the metal fragment will controls such as metal detection or separation. not become imbedded.

CHAPTER 20: Metal Inclusion 385 DETERMINE WHETHER THE POTENTIAL 2. Can the hazard of metal inclusion that was HAZARD IS SIGNIFICANT. introduced at an earlier step be eliminated or reduced to an acceptable level at this processing The following guidance will assist you in step? determining whether metal inclusion is a Metal inclusion should also be considered significant hazard at a processing step: a significant hazard at any processing step 1. Is it reasonably likely that metal fragments will be where a preventive measure is or can be introduced at this processing step (e.g., do they used to prevent or eliminate the hazard come in with the raw material or will the process (or is adequate to reduce the likelihood of introduce them)? its occurrence to an acceptable level) if it is reasonably likely to occur. Preventive For example, under ordinary circumstances, measures for metal inclusion can include: it would be reasonably likely to expect that metal fragments could enter the process from • Periodically checking equipment the following sources as a result of worn, for damaged or missing parts; damaged, or broken equipment parts: • Passing the product through metal • Mechanical crabmeat pickers; detection or separation equipment. • Wire-mesh belts used to • Control of metal inclusion convey products; In most cases, you should assume that the • Saw blades used to cut product will be consumed in a way that would portions or steaks; not eliminate any metal fragments that may be introduced during the process. However, • Wire from mechanical mixer blades; in some cases, if you have assurance that the • Blades on mechanical chopping, product will be run through a metal detector, for filleting, or blending equipment; detection of metal fragments, or through screens or a magnet, for separation of metal fragments, • Rings, washers, nuts, or bolts from by a subsequent processor, you would not need breading, batter, sauce cooling, liquid to identify metal inclusion as a significant hazard. dispensing, and portioning equipment; Example: • Injection needles; A primary processor produces frozen fish • Metal ties used to attach blocks by mechanically heading, eviscerating, tags or close bags; and filleting fish in the round. The primary processor sells exclusively to breaded fish stick • Can slivers from opening cans. processors and has been given assurance by Under ordinary circumstances, it would not these processors that the finished breaded be reasonably likely to expect that metal product will be subjected to a metal detector. fragments could enter the food from the The primary processor would not need to following sources: identify metal inclusion as a significant • Utensils used for manual blending, hazard. cutting, shucking, or gutting; • Metal processing tables or storage tanks.

CHAPTER 20: Metal Inclusion 386 IDENTIFY CRITICAL CONTROL POINTS. b. If the product will not be run through such a device, you should have The following guidance will also assist you procedures to periodically check the in determining whether a processing step is a processing equipment for damage or lost critical control point (CCP) for metal inclusion: parts at each processing step where metal inclusion is identified as a significant 1. Will the product be run through a metal detector hazard. In this case, you should identify or a separation device, such as a screen, those processing steps as CCPs. magnet, or flotation tank, on or after the last step where metal inclusion is identified as a significant Example: hazard? A processor that cuts tuna steaks from frozen loins has identified the band a. If it will be, you should identify final saw cutting step as the only step that metal detection or separation as the is reasonably likely to introduce metal CCP. Then processing steps prior to fragments into the product. The processor metal detection or separation would not should identify the band saw cutting step require controls and would not need to as the CCP for this hazard and should be identified as CCPs for the hazard of check the condition of the band saw blade metal fragments. every 4 hours to ensure that it has not been damaged. Example: A breaded fish processor uses saws, This control approach is a control strategy breading and batter machines, and referred to in this chapter as “Control wire conveyor belts. The processor Strategy Example 2 - Equipment Checks.” should choose to use a metal detector Visually inspecting equipment for on the finished product containers and damaged or missing parts may only be should set the CCP for metal inclusion feasible with relatively simple equipment, at the metal detection step for packaged such as band saws, small orbital blenders, products. The processor would not need and wire mesh belts. More complex to have CCPs for this hazard at each of equipment that contains many parts, the previous processing steps at which some of which may not be readily visible, there was a reasonable likelihood that may not be suitable for visual inspection metal fragments could be introduced. and may require controls such as metal detection or separation. This control approach is a control strategy referred to in this chapter as “Control DEVELOP A CONTROL STRATEGY. Strategy Example 1 - Metal Detection or Separation.” The following guidance provides two examples You should recognize that by setting the CCP of control strategies for metal inclusion. It is at or near the end of the process, rather than important to note that you may select a control at the point of potential metal fragment entry strategy that is different from those which into the process, you are likely to have more are suggested, provided it complies with the labor and materials invested in the product requirements of the applicable food safety laws before the problem is detected or prevented. and regulations.

CHAPTER 20: Metal Inclusion 387 The following are examples of control strategies • Continuous monitoring by the metal included in this chapter: detection or separation device itself.

» Who Will Do the Monitoring? MAY APPLY TO MAY APPLY TO CONTROL STRATEGY PRIMARY SECONDARY • Monitoring is performed by the metal PROCESSOR PROCESSOR detection or separation device itself. Visual Metal detection or separation checks to ensure that the device is in place and operating may be performed by any Equipment checks person who has an understanding of the nature of the controls. • CONTROL STRATEGY EXAMPLE 1 - METAL DETECTION OR SEPARATION Establish Corrective Action Procedures. Set Critical Limits. Take the following corrective action to a product • All of the product passes through an involved in a critical limit deviation: operating metal detection or separation • When processing occurred without an device; operating metal detector or intact or operating separation device: AND Hold all of the product produced • No detectable metal fragments are in the since controls were last confirmed as product that passes through the metal functioning properly until it can be run detection or separation device. through a metal detection or separation device; Establish Monitoring Procedures. OR » What Will Be Monitored? Hold all of the product produced • The presence of an operating metal detection since controls were last confirmed as or separation device; functioning properly until an inspection AND of the processing equipment that could • The product for the presence of metal contribute metal fragments can be fragments. completed to determine whether there are any broken or missing parts (may » How Will Monitoring Be Done? be suitable only for relatively simple • Visual examination for the presence of an equipment); operating electronic metal detector, magnet, OR intact screen, or flotation tank; Divert all of the product produced AND since controls were last confirmed as • Product monitoring is performed by the functioning properly to a use in which it metal detection or separation device itself. will be run through a properly calibrated metal detector (e.g., divert fish fillets to a » How Often Will Monitoring Be Done (Frequency)? breading operation that is equipped with • Check that the metal detection or separation a metal detector); device is in place and operating at the start OR of each production day; Destroy all of the product produced AND since controls were last confirmed as functioning properly;

CHAPTER 20: Metal Inclusion 388 OR Establish Verification Procedures. Divert all of the product produced For metal detectors: since controls were last confirmed as • Develop sensitivity standards that are based functioning properly to a non-food use. on whether the potential hazard is ferrous, AND non-ferrous, or stainless steel, or obtain such • When product is rejected by a metal detector: standards from the equipment manufacturer. Hold and evaluate the rejected product; The standards should be designed to ensure that metal fragments will be detected in OR the product. Conduct a validation study to Rework the rejected product to eliminate identify the range of values for each of the metal fragments; processing factors over which the equipment OR will detect the standards that affect its operation in your product (e.g., ambient Destroy the rejected product; humidity and product acidity), or obtain such OR a study from the equipment manufacturer. Divert the rejected product to a non-food The study should identify the appropriate use. equipment settings over the range of each of the processing factors. The study also should AND consider the range of orientations in which Take the following corrective actions to regain control the metal fragments may be present; over the operation after a critical limit deviation: AND • Correct operating procedures to ensure • Challenge the metal detector using validated that the product is not processed without sensitivity standards daily, at the start of an operating metal separation or detection production, every 4 hours during operation, device; when processing factors (e.g., ambient OR humidity and product acidity) change, and at • Attempt to locate and correct the source of the end of processing; the fragments found in the product by the AND metal detector or separated from the product For all metal detection and separation devices: stream by the magnets, screens, or other devices; • Review monitoring, corrective action, and verification records within 1 week of OR preparation to ensure they are complete and • Repair or replace the metal separation any critical limit deviations that occurred device. were appropriately addressed.

Establish a Recordkeeping System. • Record documenting that the metal detection or separation device is in place and operating.

CHAPTER 20: Metal Inclusion 389 hours Review Review detector whenever whenever 1 week of 1 week Conduct a processing monitoring, monitoring, preparation appropriate to determine standards daily, standards daily, validation study processing factors during production, during production, sensitivity standards Challenge the metal settings for the metal settings for corrective action and corrective before start-up, every 4 every start-up, before Develop metal detector Develop detector with sensitivity change, and at the end of change, verification records within verification log Metal detector RECORDS VERIFICATION operation 1 - Metal Detection or Separation.” her potential hazards (e.g., environmental ve purposes only. ve purposes only. fix the damaged detection ACTION(S) equipment Identify the CORRECTIVE product and source of the procedures to product is not metal detector rejected by the ensure that the metal detection metal detection, metal detection, metal fragments If the product is hold it for metal hold it for Correct operating from any product processed without processed without Rework to remove to remove Rework metal found in the metal found itself employee Production start of Daily, at Daily, operations Continuous Equipment TABLE 20-1 TABLE Example Only MONITORING metal Visual See Text for Full Recommendations See Text detector Electronic examination The WHAT HOW FREQUENCY WHO for the for product of metal presence operating fragments present and Metal detector CONTROL STRATEGY EXAMPLE 1 - METAL DETECTION OR SEPARATION EXAMPLE 1 - METAL CONTROL STRATEGY No metal metal metal LIMITS passes product product detector detector CRITICAL MEASURE All of the operating are in the fragments FOR EACH detectable through an PREVENTIVE passing the through the Metal inclusion HAZARD(S) SIGNIFICANT (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) This example illustrates how a frozen fish sticks processor can control metal fragment inclusion. It is provided for illustrati 3-2 and 3-4 (Chapter 3) for ot Metal inclusion may be only one of several significant hazards for this product. Refer to Tables chemical contaminants and pesticides Staphylococcus aureus toxin formation in the hydrated batter mix). This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using “Control Strategy Example Metal POINT CRITICAL detection CONTROL

CHAPTER 20: Metal Inclusion 390 • CONTROL STRATEGY EXAMPLE 2 - EQUIPMENT Establish Corrective Action Procedures. CHECKS Take the following corrective action to a product Set Critical Limits. involved in a critical limit deviation: • No broken or missing metal parts from • Hold all of the product produced since the equipment. previous satisfactory equipment check until it can be run through a metal detector; Establish Monitoring Procedures. OR » What Will be Monitored? • Divert all of the product produced since • The presence of broken or missing metal the previous satisfactory equipment check parts from equipment. to a use in which it will be run through a properly calibrated metal detector (e.g., divert » How Will Monitoring Be Done? ﬁsh ﬁllets to a breading operation that is • Visually check the equipment for broken or equipped with a metal detector); missing parts. OR Examples: • Destroy all of the product produced since the Check saw blades for missing teeth or previous satisfactory equipment check; sections; OR Check that all parts are present and • Divert all of the product produced since the secure on blending equipment; previous satisfactory equipment check to a Check for missing links or broken wires non-food use. on metal belts. AND

» How Often Will Monitoring Be Done? Take the following corrective actions to regain control • Check before starting operations each day; over the operation after a critical limit deviation: AND • Stop production; • Check every 4 hours during operation; AND AND • If necessary, adjust or modify the equipment to reduce the risk of recurrence. • Check at the end of operations each day; AND Establish a Recordkeeping System. • Check whenever there is an equipment • Records of equipment inspections. malfunction that could increase the likelihood that metal could be introduced Establish Veriﬁcation Procedures. into the food. Review monitoring and corrective action records » Who Will Do the Monitoring? within 1 week of preparation to ensure they are • Any person who has a thorough complete and any critical limit deviations that understanding of the proper condition of the occurred were appropriately addressed. equipment.

CHAPTER 20: Metal Inclusion 391 Review Review week of week within 1 monitoring preparation action records and corrective and corrective log RECORDS VERIFICATION Equipment maintenance Adjust Adjust strates how a frozen tuna steak processor product detector ACTION(S) equipment check until CORRECTIVE it can be run product since the last visual Hold all of the her potential hazards (e.g., scombrotoxin through a metal Stop production Destroy rejected Saw Saw operator jam Before Before every 4 every start-up, start-up, operation, operation, hours during at the end of day, and after day, an equipment TABLE 20-2 TABLE MONITORING Example Only check Visual See Text for Full Recommendations See Text blade WHAT HOW FREQUENCY WHO CONTROL STRATEGY EXAMPLE 2 - EQUIPMENT CHECKS CONTROL STRATEGY Check the saw Check the saw MEASURE FOR EACH PREVENTIVE the saw blade the saw No damage or CRITICAL LIMITS missing parts to Metal inclusion HAZARD(S) SIGNIFICANT (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) Fish can control metal fragment inclusion. It is provided for illustrative purposes only. can control metal fragment inclusion. It is provided for illustrative purposes only. 3-2 and 3-4 (Chapter 3) for ot Metal inclusion may be only one of several signiﬁcant hazards for this product. Refer to Tables (histamine) and parasites). This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Equipment Checks.” This example illu POINT cutting CRITICAL CONTROL

CHAPTER 20: Metal Inclusion 392 BIBLIOGRAPHY.

We have placed the following references on display in the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may see them at that location between 9 a.m. and 4 p.m., Monday through Friday. As of March 29, 2011, FDA had veriﬁed the Web site address for the references it makes available as hyperlinks from the Internet copy of this guidance, but FDA is not responsible for any subsequent changes to Non- FDA Web site references after March 29, 2011. • Olsen, A. R. 1998. Regulatory action criteria for ﬁlth and other extraneous materials. I. Review of hard or sharp foreign objects as physical hazards in food. Regul. Toxicol. Pharmacol. 28:181-189. • U.S. Food and Drug Administration. 1999. Foods - Adulteration involving hard or sharp foreign objects. In Compliance Policy Guides, Sec. 555.425. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park, MD.

CHAPTER 20: Metal Inclusion 393 NOTES:

CHAPTER 20: Metal Inclusion 394 CHAPTER 21: Glass Inclusion

UNDERSTAND THE POTENTIAL HAZARD. • Control of glass inclusion Once introduced into a product container, the Ingesting glass fragments can cause injury to the hazard of glass fragments may be controlled consumer. These injuries may include damage by (1) removing the fragments by cleaning the to teeth, laceration of the mouth and throat, or containers before filling or (2) detecting the perforation of the intestine. FDA’s Health Hazard fragments by visual inspection before or after Evaluation Board has supported regulatory action filling. Glass containers may be cleaned using against products with glass 0.3 inch (7 mm) to 1 water or compressed air and inverted during or inch (25 mm) in length. The Federal Food, Drug, after cleaning to help with glass removal. This and Cosmetic Act (the FFD&C Act) prohibits measure may be suited only to processes that do interstate commerce of adulterated foods (21 U.S.C. not use automated filling systems which include 331). Under the FFD&C Act, a food containing filled container conveyors or capping equipment, foreign objects is considered adulterated (21 U.S.C because this equipment can result in glass 342). See FDA’s “Compliance Policy Guide,” Sec. breakage after glass container cleaning. 555.425. Foreign objects that are less than 0.3 inch The effectiveness of visual inspection depends (7 mm) may cause trauma or serious injury to on the nature of the product and the process. For persons in special risk groups, such as infants, most fishery products, this measure also may be surgery patients, and the elderly. suited only to processes that do not use automated Glass inclusion can occur whenever processing filled container conveyors or capping equipment, involves the use of glass containers. Normal because visual inspection after the glass containers handling and packaging methods, especially are filled is not practical. However, for clear liquids mechanized methods, can result in breakage. Most (e.g., some fish sauces), candling may be used to products packed in glass containers are eaten with visually inspect all filled containers. Candling is a minimal handling on the part of the consumer visual inspection process in which the container is providing little opportunity to detect glass inclusion. illuminated from behind. The purpose of this chapter is to address only the Alternatively, the hazard of glass inclusion hazard of glass fragments that results from the use may be controlled by periodically checking of glass containers. Glass fragments originating the processing areas and equipment for glass from sources such as overhead light fixtures must breakage. This measure will not necessarily be addressed where applicable in a prerequisite prevent glass fragments from being incorporated sanitation program. The Procedures for the Safe into the product, but it will enable you to separate and Sanitary Processing and Importing of Fish and products that may have been exposed to glass Fishery Products regulation, 21 CFR 123 (called fragments. the Seafood HACCP Regulation in this guidance document), requires such a program.

CHAPTER 21: Glass Inclusion 395 DETERMINE WHETHER THE POTENTIAL • Periodically monitoring processing HAZARD IS SIGNIFICANT. lines for evidence of glass breakage; • Visually examining glass The following guidance will assist you in containers containing transparent determining whether glass inclusion is a liquid ﬁshery products. signiﬁcant hazard at a processing step: • Intended use 1. Is it reasonably likely that glass fragments will be In most cases, you should assume that the introduced at this processing step (e.g., do they product will be consumed in a way that would come in with the raw material or will the process not eliminate any glass fragments that may be introduce them)? introduced during the process. For example, under ordinary circumstances, it would be reasonably likely to expect that IDENTIFY CRITICAL CONTROL POINTS. glass fragments could enter the process during the processing of any product that is The following guidance will also assist you packed in a glass container. These are likely in determining whether a processing step is a areas of concern for glass containers: critical control point (CCP) for glass inclusion:

• Glass container receiving; 1. Will the containers be visually inspected for • Glass container storage, when detection of glass fragments or be cleaned (water cases are moved mechanically; or compressed air) and inverted on or after the last step where glass inclusion is identified as a • Mechanized glass container cleaning; significant hazard? • Glass container conveyor lines; a. If they will be, you should identify the • Glass container filling; final visual inspection or cleaning as the • Mechanized capping of glass containers; CCP. For example, you should visually inspect the containers for broken glass • Pasteurizing product in glass containers. or clean and invert the containers after 2. Can glass fragments that were introduced at the processing steps where breakage is an earlier step be eliminated or reduced to an reasonably likely to occur. acceptable level at this processing step? For most fishery products, this method Glass inclusion should be considered a may be suited only to processes that do significant hazard at any processing step not use automated filling systems which where a preventive measure is or can be include filled container conveyors or used to prevent or eliminate the hazard capping equipment. However, if your (or is adequate to reduce the likelihood product is a clear liquid, you should of its occurrence to an acceptable level) if visually inspect all filled containers by it is reasonably likely to occur. Preventive candling. In this case, the candling step measures for glass inclusion can include: would be designated as the CCP. • Visually examining the Example: empty glass containers; A processor that manually packs caviar into glass jars has identified • Cleaning (water or compressed air) and the glass container receiving and inverting the empty glass containers; storage steps as the only steps that are reasonably likely to introduce

CHAPTER 21: Glass Inclusion 396 glass fragments into the process. The jams. The processor should identify processor should visually inspect the finished product candling step as each jar prior to the filling process. the CCP for this hazard. The processor should also collect a This control approach is a control representative sample of inspected strategy referred to in this chapter glass jars at the start of processing, as “Control Strategy Example 1 - every 4 hours during processing, at Cleaning or Visual Inspection of the end of processing and after any Containers.” jams. The processor should identify the container inspection step as the You should recognize that by setting CCP for this hazard. the CCP at or near the end of the process, rather than at the point of Example: potential glass fragment entry into Another processor that manually the process, you are likely to have packs caviar has identified the glass more labor and materials invested container receiving and storage steps in the product before the problem is as the only steps that are reasonably detected or prevented. likely to introduce glass fragments into the process. Just before filling, b. If the containers will not be visually the empty glass jars are inverted and inspected or cleaned and inverted cleaned using filtered, compressed on or after the last step, you should air. The processor should also collect periodically check the processing areas a representative sample of cleaned and equipment for glass breakage at each glass jars at the start of processing, processing step where glass inclusion every 4 hours during processing, at is identified as a significant hazard. In the end of processing and after any this case, those processing steps should jams. The processor should identify be CCPs. It would not ordinarily be the container cleaning and inverting necessary to identify these steps as step as the CCP for this hazard. CCPs in addition to identifying a final inspection or cleaning step as a CCP. Example: A processor that bottles a transparent Example: fish sauce has identified glass A processor bottles clam juice and has container receiving and storage, identified glass container receiving mechanical conveyor lines, and storage, mechanical conveyor mechanical filling, and mechanical lines, mechanical filling, and capping as processing steps that mechanical capping as processing are reasonably likely to introduce steps reasonably likely to introduce glass fragments into the process. The glass fragments into the process. The processor should visually inspect processor should visually inspect each filled and capped bottle for all processing areas for broken visible glass fragments by candling. glass at start-up and once every 4 The processor should also collect a hours during processing. If broken representative sample of inspected glass is observed, the line should be glass jars at the start of processing, stopped, the glass removed and the every 4 hours during processing, at product that has moved through the end of processing and after any that area since the last inspection

CHAPTER 21: Glass Inclusion 397 placed on hold to be ﬁltered or Establish Monitor Procedures. destroyed. The processor should identify glass container receiving and » What Will Be Monitored? storage, mechanical conveyor lines, • The presence of an operating glass container mechanical ﬁlling, and mechanical cleaning or inspection process; capping as the CCPs for this hazard. AND This control approach is a control • Cleaned or inspected containers for the strategy referred to in this chapter presence of glass fragments. as “Control Strategy Example 2 - Equipment Checks.” » How Will Monitoring Be Done? • Visual examination for the presence of DEVELOP A CONTROL STRATEGY. equipment and employees for cleaning or inspecting glass containers; The following guidance provides examples of AND two control strategies for glass inclusion. You • Visual examination of a representative may select a control strategy that is different from sample of glass containers after cleaning or those which are suggested, provided it complies inspecting. with the requirements of the applicable food safety laws and regulations. The following are » How Often Will Monitoring Be Done? examples of control strategies included in this • Check that the glass container cleaning or chapter: inspection process is in place and operating at the start of each production day and after each shift change; MAY APPLY TO MAY APPLY TO CONTROL STRATEGY PRIMARY SECONDARY AND PROCESSOR PROCESSOR • Examine a representative sample of glass Cleaning or visual inspection of containers containers after cleaning or inspection daily, at the start of processing, every 4 hours Equipment checks during processing, at the end of processing, and after any breakdowns.

• CONTROL STRATEGY EXAMPLE 1 - CLEANING OR » Who Will Do the Monitoring? VISUAL INSPECTION OF CONTAINERS • Any person who has an understanding of the nature of the controls. Set Critical Limits. • All containers pass through an operating Establish Corrective Action Procedures. glass container inspection or cleaning Take the following corrective action to a product process; involved in a critical limit deviation: AND • Hold and evaluate all of the product • No detectable glass fragments are in glass processed since controls were last conﬁrmed containers that pass through the glass as functioning properly; container inspection or cleaning process. OR • Destroy all of the product produced since controls were last conﬁrmed as functioning properly;

CHAPTER 21: Glass Inclusion 398 OR • Divert all of the product produced since controls were last confirmed as functioning properly to a non-food use; OR • Rework all of the product produced since controls were last confirmed as functioning properly to eliminate glass fragments by visually examining for the presence of glass or by running the product through a filter or screen. AND

Take the following corrective actions to regain control over the operation after a critical limit deviation: • Correct operating procedures to ensure that the product is not processed without an operating glass container visual inspection or cleaning process; AND/OR • Stop operations and locate and correct the source of the glass fragments.

Establish a Recordkeeping System. • Record documenting that the glass container cleaning or inspection process is in place and operating; AND • Record documenting the visual examination of glass containers after cleaning or inspection.

CHAPTER 21: Glass Inclusion 399 Review Review monitoring action records and corrective and corrective within 1 week within 1 week of preparation Glass record toxin formation, and RECORDS VERIFICATION inspection Stop Correct ainers.” This example illustrates how a pro- cleaning operating processed ACTION(S) evaluation operations correct the without jar CORRECTIVE Clostridium botulinum source of the procedures to product is not product for an product for Hold all of the and locate ensure that the glass fragments her potential hazards (e.g., parasites, scombro- Quality control staff the start of every 4 every processing, processing, processing, processing, daily, at the daily, breakdowns hours during at the end of shift changes and after any after cleaning At the start of One dozen jars production and TABLE 21-1 TABLE MONITORING Example Only of a Visual Visual cleaning examination Visual check Visual representative representative sample of glass containers after See Text for Full Recommendations See Text The The WHAT HOW FREQUENCY WHO process containers in cleaned presence of glass cleaning glass fragments presence of the All process process cleaning No glass the glass MEASURE container fragments FOR EACH containers containers PREVENTIVE are in glass an operating pass through glass cleaning CRITICAL LIMITS passing through CONTROL STRATEGY EXAMPLE 1 - CLEANING OR VISUAL INSPECTION OF CONTAINERS EXAMPLE 1 - CLEANING OR VISUAL INSPECTION OF CONTAINERS CONTROL STRATEGY Glass inclusion HAZARD(S) SIGNIFICANT (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) Jar pathogen growth as a result of temperature abuse). This table is an example of a portion of a HACCP plan using “Control Strategy Example 1 - Cleaning or Visual Inspection Cont cessor of pickled herring in glass jars can control glass inclusion. It is provided for illustrative purposes only. cessor of pickled herring in glass jars can control inclusion. It is provided for illustrative purposes only. 3-2 and 3-4 (Chapter 3) for ot Glass inclusion may be only one of several signiﬁcant hazards for this product. Refer to Tables toxin (histamine), environmental chemical contaminants and pesticides, unapproved food color additives, metal fragments, POINT CRITICAL inversion CONTROL cleaning and

CHAPTER 21: Glass Inclusion 400 • CONTROL STRATEGY EXAMPLE 2 - EQUIPMENT Establish Corrective Action Procedures. CHECKS Take the following corrective action to a product Set Critical Limits. involved in a critical limit deviation: • No broken glass on or near equipment. • Hold and evaluate all of the product produced since the previous satisfactory Establish Monitoring Procedures. equipment check; » What Will Be Monitored? OR • The presence of broken glass on or near • Destroy all of the product produced since the equipment. previous satisfactory equipment check; » How Will Monitoring Be Done? OR • Visually check the glass handling areas for • Divert all of the product produced since the broken glass. previous satisfactory equipment check to a Examples: non-food use; Check pallets and packing cases OR for damage, broken jars, and glass • Rework the product packaged since the fragments; previous satisfactory equipment check by Check mechanical glass cleaning area for visually examining for the presence of glass broken glass; or by running the product through a filter or Check floors around conveyors for broken screen. glass; AND Check filling and capping equipment and surrounding floors for broken glass; Take one of the following corrective actions to regain control over the operation after a critical limit deviation: Check glass containers for breakage after exposure to heat (e.g., after heated • Stop production; product is added or after pasteurization). AND » How Often Will Monitoring Be Done (Frequency)? • If necessary, adjust or modify the materials, • Check before starting operations each day; equipment, and/or processes to reduce the risk of recurrence; AND • Check at least every 4 hours during AND operation; • Remove all broken glass from the equipment and surrounding area. AND • Check at the end of operations each day; Establish a Recordkeeping System. AND • Records of equipment and processing area • Check whenever there is an equipment inspections. malfunction that could increase the likelihood that glass containers could be damaged. Establish Verification Procedures. » Who Will Do the Monitoring? • Review monitoring and corrective action • Any person who has a thorough records within 1 week of preparation understanding of the proper condition of the to ensure they are complete and any equipment and surrounding area. critical limit deviations that occurred were appropriately addressed.

CHAPTER 21: Glass Inclusion 401 Review Review monitoring action records and corrective and corrective within 1 week within 1 week of preparation Glass record RECORDS VERIFICATION inspection area Stop l fragments). check Adjust Adjust strates how a processor of clam juice in the last Hold and necessary ACTION(S) caused the production satisfactory breakage, if breakage, CORRECTIVE evaluate the evaluate broken glass glass broken source of the product since glass from the Determine the er potential hazards (e.g., pathogens from the equipment that Remove broken broken Remove Filler Operator after of day of day equipment operations, operations, jams, and end jams, start-up, every every start-up, 4 hours during TABLE 21-2 TABLE MONITORING Example Only Visual check Visual Before See Text for Full Recommendations See Text WHAT HOW FREQUENCY WHO equipment Broken glass Broken CONTROL STRATEGY EXAMPLE 2 - EQUIPMENT CHECKS CONTROL STRATEGY on or around MEASURE FOR EACH processing equipment PREVENTIVE on or around CRITICAL LIMITS No broken glass No broken Glass inclusion HAZARD(S) SIGNIFICANT (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) bottle harvest area, environmental chemical contaminants and pesticides, natural toxins, unapproved food color additives, meta glass jars can control glass inclusion. It is provided for illustrative purposes only. glass jars can control inclusion. It is provided for illustrative purposes only. 3-3 and3-4 (Chapter 3) for oth Glass inclusion may be only one of several significant hazards for this product. Refer to Tables This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Equipment Checks.” This example illu POINT capping CRITICAL CONTROL receiving, receiving, filling, and filling, conveyors, mechanical mechanical mechanical Glass bottle

CHAPTER 21: Glass Inclusion 402 BIBLIOGRAPHY.

• Olsen, A. R. 1998. Regulatory action criteria for ﬁlth and other extraneous materials. I. Review of hard or sharp foreign objects as physical hazards in food. Regul. Toxicol. Pharmacol. 28:181-189. • U.S. Food and Drug Administration. 1999. Foods – Adulteration involving hard or sharp foreign objects. In Compliance Policy Guide, Sect. 555.425. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park, MD.

CHAPTER 21: Glass Inclusion 403 NOTES:

CHAPTER 21: Glass Inclusion 404 APPENDIX 1: Forms

This appendix contains a blank model Hazard Analysis Critical Control Point (HACCP) Plan Form and a blank model Hazard Analysis Worksheet.

APPENDIX 1: Forms 405 RECORDS VERIFICATION ACTION(S) CORRECTIVE INTENDED USE AND CONSUMER: MONITORING HACCP PLAN FORM WHAT HOW FREQUENCY WHO ______DATE: LIMITS CRITICAL MEASURE FOR EACH PREVENTIVE HAZARD(S) SIGNIFICANT (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) POINT CRITICAL CONTROL FIRM NAME:FIRM ADDRESS: PRODUCT DESCRIPTION: METHOD OF DISTRIBUTION AND STORAGE: SIGNATURE OF COMPANY OFFICIAL: OF COMPANY SIGNATURE 1 OF PAGE ______

APPENDIX 1: Forms 406 APPENDIX 1: FORMS B RECORDS VERIFICATION ACTION(S) CORRECTIVE MONITORING HACCP PLAN FORM WHAT HOW FREQUENCY WHO ______DATE: LIMITS CRITICAL MEASURE FOR EACH PREVENTIVE HAZARD(S) SIGNIFICANT (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) POINT CRITICAL CONTROL SIGNATURE OF COMPANY OFFICIAL: OF COMPANY SIGNATURE 1 OF PAGE ______

APPENDIX 1: Forms 407 POINT? (YES/NO) IS THIS STEP A CRITICAL CONTROL APPLIED FOR THE WHAT PREVENTIVE WHAT MEASURE(S) CAN BE SIGNIFICANT HAZARDS? COLUMN 3 JUSTIFY YOUR DECISION FOR INTENDED USE AND CONSUMER: (YES/NO) AT THIS STEP? AT FOOD SAFETY ARE ANY POTENTIAL HAZARDS SIGNIFICANT HAZARD ANALYSIS WORKSHEET HAZARD ANALYSIS PROCESS BIOLOGICAL, PRODUCT AND CHEMICAL, AND PHYSICAL HAZARDS IDENTIFY POTENTIAL ASSOCIATED WITH THIS ASSOCIATED (1) (2) (3) (4) (5) (6) STEP INGREDIENT/PROCESSING FIRM NAME:FIRM ADDRESS: PRODUCT DESCRIPTION: METHOD OF DISTRIBUTION AND STORAGE:

APPENDIX 1: Forms 408 POINT? (YES/NO) IS THIS STEP A CRITICAL CONTROL APPLIED FOR THE WHAT PREVENTIVE WHAT MEASURE(S) CAN BE SIGNIFICANT HAZARDS? COLUMN 3 JUSTIFY YOUR DECISION FOR (YES/NO) FOOD SAFETY HAZARDS SIGNIFI- CANT AT THIS STEP? CANT AT ARE ANY POTENTIAL HAZARD ANALYSIS WORKSHEET HAZARD ANALYSIS PROCESS BIOLOGICAL, PRODUCT AND CHEMICAL, AND PHYSICAL HAZARDS IDENTIFY POTENTIAL ASSOCIATED WITH THIS ASSOCIATED (1) (2) (3) (4) (5) (6) STEP INGREDIENT/PROCESSING 1 OF PAGE ______

APPENDIX 1: Forms 409 NOTES:

APPENDIX 1: Forms 410 APPENDIX 2: Sample Product Flow Diagram

This appendix contains a sample product ﬂow diagram that can be used as a model when you develop your own ﬂow diagram.

APPENDIX 2: Sample Product Flow Diagram 411 CONTROL STRATEGY

FIGURE A-1 SAMPLE PRODUCT FLOW DIAGRAM (SALMON FILLETS)

RECEIVING

FISH PUMP

SORT

REFRIGERATED STORAGE

HEAD

GUT

WASH

FILLET

INSPECT

FREEZE

GLAZE

WEIGH/PACKAGE

FROZEN STORAGE

SHIP

APPENDIX 2: Sample Product Flow Diagram 412 APPENDIX 3: Critical Control Point Decision Tree

This appendix contains a decision tree that may be used to assist you with the identiﬁcation of critical control points (CCPs). You should not rely exclusively on the decision tree, because error may result.

APPENDIX 3: Critical Control Point Decision Tree 413 FIGURE A-2: CCP DECISION TREE

Q1. DOES THIS STEP INVOLVE A HAZARD OF SUFFICIENT RISK AND SEVERITY TO WARRENT ITS CONTROL?

YES NO NOT A CCP

Q2. DOES CONTROL MEASURE FOR THE HAZARD EXIST AT THIS STEP?

MODIFY THIS STEP, YES NO PROCESS OR PRODUCT

IS CONTROL AT THIS STEP NECESSARY YES FOR SAFETY?

NO NOT A CCP STOP*

Q3. IS CONTROL AT THIS STEP NECESSARY TO PREVENT, ELIMINATE OR REDUCE THE RISK OF THE HAZARD TO CONSUMERS?

YES NO NOT A CCP STOP*

CCP

This decision tree is derived from one that was developed by the National Advisory Committee on Microbiological Criteria for Foods.

APPENDIX 3: Critical Control Point Decision Tree 414 BIBLIOGRAPHY.

APPENDIX 3: Critical Control Point Decision Tree 415 NOTES:

APPENDIX 3: Critical Control Point Decision Tree 416 APPENDIX 4: Bacterial Pathogen Growth and Inactivation

This appendix contains information on the growth above 50°F (10°C) but below 135ºF (57.2ºC)) and inactivation of bacterial pathogens. should be limited to 2 hours (3 hours if Staphylococcus aureus (S. aureus) is the only Table A-1 contains information on the minimum pathogen of concern), water activity (aw), acidity (pH), and temperature; the maximum, pH, water phase salt, and OR temperature; and oxygen requirements that will Alternatively, exposure time (i.e., time at sustain growth for the bacterial pathogens that are internal temperatures above 50°F (10°C) but of greatest concern in seafood processing. Data below 135ºF (57.2ºC)) should be limited to shown are the minimum or maximum values, 4 hours, as long as no more than 2 of those the extreme limits reported among the references hours are between 70°F (21.1°C) and 135ºF cited. These values may not apply to your (57.2ºC); processing conditions. OR Table A-2 contains information on maximum, cumulative time and internal temperature • If at any time the product is held at internal combinations for exposure of fish and fishery temperatures above 50°F (10°C) but never products that, under ordinary circumstances, will above 70°F (21.1°C), exposure time at internal be safe for the bacterial pathogens that are of temperatures above 50°F (10°C) should be greatest concern in seafood processing. These limited to 5 hours (12 hours if S. aureus is the maximum, cumulative exposure times are derived only pathogen of concern); from published scientific information. OR Because the nature of bacterial growth is • The product is held at internal temperatures logarithmic, linear interpolation using the below 50°F (10°C) throughout processing, time and temperature guidance may not be OR appropriate. Furthermore, the food matrix effects bacterial growth (e.g., presence of competing Alternatively, the product is held at ambient microorganisms, available nutrients, growth air temperatures below 50°F (10°C) throughout restrictive agents). Consideration of such attributes processing. is needed when using the information in Tables For cooked, ready-to-eat products: A-1 and A-2. • If at any time the product is held at internal In summary, Table A-2 indicates that: temperatures above 80°F (26.7°C), exposure time (i.e., time at internal temperatures above For raw, ready-to-eat products: 50°F (10°C) but below 135ºF (57.2ºC)) should • If at any time the product is held at internal be limited to 1 hour (3 hours if S. aureus is temperatures above 70°F (21.1°C), exposure the only pathogen of concern), time (i.e., time at internal temperatures OR

APPENDIX 4: Bacterial Pathogen Growth and Inactivation 417 Alternatively, if at any time the product is at these temperatures and the time necessary held at internal temperatures above 80°F for significant growth is longer than would be (26.7°C), exposure time (i.e., time at internal reasonably likely to occur in most fish and fishery temperatures above 50°F (10°C) but below product processing steps. However, if you have 135ºF (57.2ºC)) should be limited to 4 hours, processing steps that occur at these temperatures as long as no more than 1 of those hours is that approach the maximum cumulative exposure above 70°F (21.1°C); times listed in Table A-2 below for the pathogenic bacteria of concern in your product, you should OR consider development of a critical limit for • If at any time the product is held at internal control at these temperatures. temperatures above 70°F (21.1°C) but never above 80°F (26.7°C), exposure time at It is not possible to furnish recommendations internal temperatures above 50°F (10°C) for each pathogenic bacteria, process, type of should be limited to 2 hours (3 hours if S. fish and fishery product, and temperature or aureus is the only pathogen of concern), combination of temperatures. Programmable models to predict growth rates for certain OR pathogens associated with various foods under Alternatively, if the product is never held at differing conditions have been developed by internal temperatures above 80°F (26.7°C), the U.S. Department of Agriculture’s (Pathogen exposure times at internal temperatures Modeling Program (PMP)) and the United above 50°F (10°C) should be limited to 4 Kingdom’s (Food MicroModel (FMM) program). hours, as long as no more than 2 of those These programs can provide growth curves hours are above 70°F (21.1°C); for selected pathogens. You indicate the conditions, such as pH, temperature, and salt OR concentration that you are interested in and the • If at any time the product is held at internal models provide pathogen growth predictions temperatures above 50°F (10°C) but never (e.g., growth curve, time of doubling, time of above 70°F (21.1°C), exposure time at internal lag phase, and generation time). FDA does not temperatures above 50°F (10°C) should be endorse or require the use of such modeling limited to 5 hours (12 hours if S. aureus is programs, but recognizes that the predictive the only pathogen of concern); growth information they provide may be of OR assistance to some processors. However, you • The product is held at internal temperatures are cautioned that significant deviations between below 50°F (10°C) throughout processing, actual microbiological data in specific products and the predictions do occur, including those for OR the lag phase of growth. Therefore, you should Alternatively, the product is held at ambient validate the time and temperature limits derived air temperatures below 50°F (10°C) from such predictive models. throughout processing. Table A-3 contains information on the Note that the preceding recommended destruction of Listeria monocytogenes (L. critical limits do not address internal product monocytogenes). Lethal rate, as used in this temperatures between 40°F (4.4°C), the table, is the relative lethality of 1 minute at the recommended maximum storage temperature designated internal product temperature as for refrigerated fish and fishery products, compared with the lethality of 1 minute at the and 50°F (10°C). That is because growth of reference internal product temperature of 158°F foodborne pathogenic bacteria is very slow (70°C) (i.e., z = 13.5°F (7.5°C)). For example, 1

APPENDIX 4: Bacterial Pathogen Growth and Inactivation 418 minute at 145°F (63°C) is 0.117 times as lethal as 1 minute at 158°F (70°C). The times provided are the length of time at the designated internal product temperature necessary to deliver a 6D process for L. monocytogenes. The length of time at a particular internal product temperature needed to accomplish a six logarithm reduction in the number of L. monocytogenes (6D) is, in part, dependent upon the food in which it is being heated. The values in the table are generally conservative and apply to all foods. You may be able to establish a shorter process time for your food by conducting scientific thermal death time studies. Additionally, lower degrees of destruction may be acceptable in your food if supported by a scientific study of the normal initial levels in the food. It is also possible that higher levels of destruction may be necessary in some foods, if especially high initial levels are anticipated. Table A-4 contains information on the destruction of Clostridium botulinum (C. botulinum) type B (the most heat- resistant form of non-proteolytic C. botulinum). Lethal rate, as used in this table, is the relative lethality of 1 minute at the designated internal product temperature as compared with the lethality of 1 minute at the reference product internal temperature of 194°F (90°C) (i.e., for temperatures less than 194°F (90°C), z = 12.6°F (7.0°C); for temperatures above 194°F (90°C), z = 18°F (10°C)). The times provided are the length of time at the designated internal product temperature necessary to deliver a 6D process for C. botulinum. The values in the table are generally conservative. However, these values may not be sufficient for the destruction of non- proteolytic C. botulinum in dungeness crabmeat because of the potential protective effect of lysozyme. You may be able to establish a shorter process time for your food by conducting scientific thermal death time studies. Additionally, lower degrees of destruction may be acceptable in your food if supported by a scientific study of the normal innoculum in the food.

APPENDIX 4: Bacterial Pathogen Growth and Inactivation 419 2 4 3 3 3 4 4 4 4 4 4 4 4 4 4 micro- OXYGEN anaerobe anaerobe anaerobe anaerobe anaerobe anaerobe anaerobe anaerobe anaerobe anaerobe anaerobe anaerobe anaerobe anaerobe aerophile facultative facultative facultative facultative facultative facultative facultative facultative facultative facultative facultative facultative facultative facultative facultative REQUIREMENT

1 55°C 42°C 48°C 45°C 52°C 45°C 43°C 43°C 45°C 50°C 48°C 113°F 113°F 113°F 122°F 118°F 131°F 49.4°C 46.2°C 47.1°C 45.3°C 107.6°F 118.4°F 125.6°F 120.9°F 115.2°F 116.8°F 109.4°F 113.5°F 109.4°F 4°C 7°C 5°C 8°C 30°C 10°C 10°C 10°C 10°C 3.3°C 6.5°C 5.2°C 6.1°C -0.4°C -1.3°C MIN. TEMP. MAX. TEMP. PHASE SALT MAX. % WATER MAX. % WATER TABLE A-1 TABLE pH MAX. LIMITING CONDITIONS FOR PATHOGEN GROWTH LIMITING CONDITIONS FOR PATHOGEN pH MIN. W 0.92 4.30.970.93 9.30.95 50.92 50.94 10 40.96 9 4.40.83 39.2°F 3.7 90.85 4.8 100.97 5 9.4 40.94 9.5 4 70.96 9.3 6.5 37.9°F 5 10 4.8 10 8 50°F 9.8 5 43.7°F 5.2 31.3°F 10 11 20 41.4°F 10 10 43°F 6 44.6°F 10 50°F 5 50°F 41°F 46.4°F 0.9870.935 4.9 4.6 9.5 9 1.7 10 86°F 50°F 0.945 4.2 10 7 29.7°F MIN. A (USING SALT) VIBRIO LISTERIA GROWTH PATHOGEN PROTEOLYTIC PROTEOLYTIC SHIGELLA SPP. TYPES B AND F TYPES B AND F BACILLUS CEREUS SALMONELLA SPP. VIBRIO CHOLERAE ESCHERICHIA COLI VIBRIO VULNIFICUS TYPE E, AND NON- TOXIN FORMATION MONOCYTOGENES PARAHAEMOLYTICUS CAMPYLOBACTER JEJUNI PATHOGENIC STRAINS OF STRAINS OF PATHOGENIC TYPE A, AND PROTEOLYTIC TYPE A, AND PROTEOLYTIC CLOSTRIDIUM BOTULINUM, CLOSTRIDIUM BOTULINUM, CLOSTRIDIUM BOTULINUM, YERSINIA ENTEROCOLITICA STAPHYLOCOCCUS AUREUS STAPHYLOCOCCUS AUREUS STAPHYLOCOCCUS CLOSTRIDIUM PERFRINGENS 1. Has signiﬁcantly delayed growth (>24 hours) at 131°F (55°C). 2. Requires limited levels of oxygen. 3. Requires the absence of oxygen. 4. Grows either with or without oxygen.

APPENDIX 4: Bacterial Pathogen Growth and Inactivation 420 TABLE A-2 TIME AND TEMPERATURE GUIDANCE FOR CONTROLLING PATHOGEN GROWTH AND TOXIN FORMATION IN FISH AND FISHERY PRODUCTS

MAXIMUM CUMULATIVE POTENTIALLY HAZARDOUS CONDITION PRODUCT TEMPERATURE EXPOSURE TIME GROWTH AND TOXIN FORMATION 39.2-43°F (4-6°C) 5 days BY BACILLUS CEREUS 44-59°F (7-15°C) 1 day 60-70°F (16-21°C) 6 hours Above 70°F (21°C) 3 hours GROWTH OF CAMPYLOBACTER JEJUNI 86-93°F (30-34°C) 48 hours Above 93°F (34°C) 12 hours GERMINATION, GROWTH, AND TOXIN 50-70°F (10-21°C) 11 hours FORMATION BY CLOSTRIDIUM BOTULINUM Above 70°F (21°C) 2 hours TYPE A, AND PROTEOLYTIC TYPES B AND F GERMINATION, GROWTH, AND TOXIN 37.9-41°F (3.3-5°C) 7 days FORMATION BY CLOSTRIDIUM BOTULINUM 42-50°F (6-10°C) 2 days TYPE E, AND NON-PROTEOLYTIC 51-70°F (11-21°C) 11 hours TYPES B AND F Above 70°F (21°C) 6 hours GROWTH OF CLOSTRIDIUM PERFRINGENS 50-54°F (10-12°C) 21 days 55-57°F (13-14 °C) 1 day 58-70°F (15-21°C) 6 hours1 Above 70°F (21°C) 2 hours GROWTH OF PATHOGENIC STRAINS OF 43.7-50°F (6.6-10°C) 2 days ESCHERICHIA COLI 51-70°F (11-21°C) 5 hours Above 70°F (21°C) 2 hours GROWTH OF LISTERIA MONOCYTOGENES 31.3-41°F (-0.4-5°C) 7 days 42-50°F (6-10°C) 1 day 51-70°F (11-21°C) 7 hours 71-86°F (22-30°C) 3 hours Above 86°F (30°C) 1 hour GROWTH OF SALMONELLA SPECIES 41.4-50°F (5.2-10°C) 2 days 51-70°F (11-21°C) 5 hours Above 70°F (21°C) 2 hours GROWTH OF SHIGELLA SPECIES 43-50°F (6.1-10°C) 2 days 51-70°F (11-21°C) 5 hours Above 70°F (21°C) 2 hours GROWTH AND TOXIN FORMATION BY 50°F (7-10°C) 14 days STAPHYLOCOCCUS AUREUS 51-70°F (11-21°C) 12 hours1 Above 70°F (21°C) 3 hours GROWTH OF VIBRIO CHOLERAE 50°F (10°C) 21 days 51-70°F (11-21°C) 6 hours 71-80°F (22-27°C) 2 hours Above 80ºF (27ºC) 1 hour2 GROWTH OF VIBRIO PARAHAEMOLYTICUS 41-50°F (5-10°C) 21 days 51-70°F (11-21°C) 6 hours 71-80°F (22-27°C) 2 hours Above 80ºF (27ºC) 1 hour2 GROWTH OF VIBRIO VULNIFICUS 46.4-50°F (8-10°C) 21 days 51-70°F (11-21°C) 6 hours 71-80°F (22-27°C) 2 hours Above 80ºF (27ºC) 1 hour2 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 (21°C) 2.5 hours

1. Additional data needed. 2. Applies to cooked, ready-to-eat foods only.

APPENDIX 4: Bacterial Pathogen Growth and Inactivation 421 LETHAL RATE TIME FOR 6D PROCESS (MINUTES) TABLE A-3 TABLE INACTIVATION OF LISTERIA MONOCYTOGENES INACTIVATION TEMPERATURE (°C) TEMPERATURE INTERNAL PRODUCT 145 63 0.117 17.0 147 64 0.158 12.7 149 65 0.215 9.3 151 66 0.293 6.8 153 67 0.398 5.0 154 68 0.541 3.7 156 69 0.736 2.7 158 70 1.000 2.0 160 71 1.359 1.5 162 72 1.848 1.0 163 73 2.512 0.8 165 74 3.415 0.6 167 75 4.642 0.4 169 76 6.310 0.3 171 77 8.577 0.2 172 78 11.659 0.2 174 79 15.849 0.1 176 80 21.544 0.09 178 81 29.286 0.07 180 82 39.810 0.05 182 83 54.116 0.03 183 84 73.564 0.03 185 85 100.000 0.02 TEMPERATURE (°F) TEMPERATURE INTERNAL PRODUCT Note: z = 13.5°F (7.5°C).

APPENDIX 4: Bacterial Pathogen Growth and Inactivation 422 ness crabmeat because of the potential that substances may be naturally LETHAL RATE* TIME FOR 6D PROCESS (MINUTES) TABLE A-4 TABLE TEMPERATURE (°C) TEMPERATURE INTERNAL PRODUCT INACTIVATION OF NON-PROTEOLYTIC CLOSTRIDIUM BOTULINUM TYPE B OF NON-PROTEOLYTIC INACTIVATION 185 85 0.193 51.8 187 86 0.270 37.0 189 87 0.370 27.0 190 88 0.520 19.2 192 89 0.720 13.9 194 90 1.000 10.0 196 91 1.260 7.9 198 92 1.600 6.3 199 93 2.000 5.0 201 94 2.510 4.0 203 95 3.160 3.2 205 96 3.980 2.5 207 97 5.010 2.0 208 98 6.310 1.6 210 99 7.940 1.3 212 100 10.000 1.0 TEMPERATURE (°F) TEMPERATURE INTERNAL PRODUCT present, such as lysozyme, may enable the pathogen to more easily recover from heat damage. *Note: These lethal rates and process times may not be sufﬁcient for the destruction of non-proteolytic C. botulinum in dunge Note: For temperatures less than 194°F (90°C), z = 12.6°F (7.0°C); for above 18°F (10°C).

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APPENDIX 4: Bacterial Pathogen Growth and Inactivation 433 • Reed, G. H. 1994. Foodborne illness (Part 4): • Rusul, G., and N. H. Yaacob. 1995. Prevalence Bacillus cereus gastroenteritis. Dairy, Food, of Bacillus cereus in selected foods and Environ. San. 14:87. detection of enterotoxin using TECRA-VIA and • Reed, G. H. 1994. Foodborne illness (Part 8): BCET-RPLA. Int. J. Food Microbiol. 25:131-139. Escherichia coli Dairy, Food, Environ. San. • Schiemann, D. A. 1988. Examination of 14:329-330. enterotoxin production at low temperature • Reed, G. H. 1994. Foodborne illness (Part 11): by Yersinia enterocolitica in culture media Yersinosis. Dairy, Food, Environ. San. 14:536. and foods. J. Food Prot. 51:571-573. • Rey, C. R., H. W. Walker, and P. L. • Segner, W. P., C. F. Schmidt, and J. K. Boltz. Rohrbaugh. 1975. The inﬂuence of 1971. Minimal growth temperature, sodium temperature on growth, sporulation, and chloride tolerance, pH sensitivity, and toxin heat resistance of spores of six strains production of marine and terrestrial strains of Clostridium perfringens. J. Milk Food of Clostridium botulinum type C. Appl. Technol. 38:461-465. Microbiol. 22:1025-1029. • Richards, J. C. S., A. C. Jason, G. Hobbs, • Shaw, M. K., A. G. Marr, and J. L. Ingraham. D. M. Gibson, and R. H. Christie. 1978. 1971. Determination of the minimal Electronic measurement of bacterial growth. temperature for growth of Escherichia coli. J. J. Phys. E.: Sci. Instrum. 11:560-568. Bacteriol. 105:683-684. • Roberts, D., and R. J. Gilbert. 1979. Survival • Skinner, G. E., and J. W. Larkin. 1998. and growth of non-cholera vibrios in various Conservative prediction of time to foods. J. Hyg., Camb. 82:123-131. Clostridium botulinum toxin formation for use with time-temperature indicators to • Roberts, T. A., and A. M. Gibson. 1983. ensure the safety of foods. J. Food Protect. Chemical methods for controlling 61:1154-1160. Clostridium botulinum in processed meats. Food Technol. 40:163-171, 176. • Smith, G. R., and A. Turner. 1989. The production of Clostridium botulinum toxin • Roberts, T. A., and C. M. Derrick. 1978. in mammalian, avian, and piscine carrion. The effect of curing salts on the growth of Epidemiol. Infect. 102:467-471. Clostridium perfringens (welchii) in a laboratory medium. J. Food Technol. 13:394-353. • Smith, M. G. 1985. The generation time, lag time, and minimum temperature of growth • Roberts, T. A., and G. Hobbs. 1968. Low of coliform organisms on meat, and the temperature growth characteristics of implications for codes of practice in abattoirs. clostridia. J. Appl. Bacteriol. 31:75-88. J. Hyg., Camb. 94:289-300. • Romick, T. L., H. P. Fleming, and R. F. • Sneath, P. H. A. (ed.), 1986. Bergey’s manual McFeeters. 1996. Aerobic and anaerobic of systematic bacteriology, vol. 2. Williams & metabolism of Listeria monocytogenes in Wilkins, Baltimore, MD. deﬁned glucose medium. Appl. Environ. Microbiol. 62:304-307. • Sokari, T. 1991. Distribution of enterotoxigenic Staphylococcus aureus in • Rørvik, L. M., and M. Yndestad. 1991. Listeria ready-to-eat foods in eastern Nigeria. Int. J. monocytogenes in foods in Norway. Int. J. Food Microbiol. 12:275-279. Food Microbiol. 13:97-104. • Stern, N. J., and A. W. Kotula. 1982. Survival • Rørvik, L. M., M. Yndestad, and E. Skjerve. of Campylobacter jejuni inoculated into 1991. Growth of Listeria monocytogenes in ground beef. Appl. Environ. Microbiol. vacuum-packed, smoked salmon during storage 44(5):1150-1153. at 4°C. Int. J. Food Microbiol. 14:111-118.

APPENDIX 4: Bacterial Pathogen Growth and Inactivation 434 • Subcommittee on Microbiological Criteria. • Tatani, S. R. 1973. Influence of food 1985. An evaluation of the role of environments on growth of Staphylococcus microbiological criteria for foods and food aureus and production of various ingredients. Committee on Food Protection, enterotoxins. J. Milk Food Technol. 36:559. National Research Council. National Academy • Telzak, E. E., E. P. Bell, D. A. Kautter, L. Press, Washington, DC. 256 p. Crowell, L. D. Budnick, D. L. Morse, and • Sutherland, A. D. 1993. Toxin production by S. Schultz. 1990. International outbreak of Bacillus cereus in dairy products. J. Dairy type E botulism due to uneviscerated fish. J. Res. 60:569-574. Infect. Dis. 161:340-342. • Sutherland, J. P., and A. J. Bayliss. 1994. • Thayer, D. W., W. S. Muller, R. L. Buchanan, Predictive modeling of growth of Yersinia and J. G. Phillips. 1987. Effect of NaCl, pH, enterocolitica: the effects of temperature, pH, temperature, and atmosphere on growth of and sodium chloride. Int. J. Food Microbiol. Salmonella typhimurium in glucose-mineral 21:197-215. salts medium. Appl. Environ. Microbiol. • Sutherland, J. P., A. Aherne, and A. L. 53:1311-1315. Beaumont. 1996. Preparation and validation • Thomas, L. V., J. W. T. Wimpenny, and A. C. of a growth model for Bacillus cereus: the Peters. 1991. An investigation of the effects effects of temperature, pH, sodium chloride of four variables in the growth of Salmonella and carbon dioxide. Int. J. Food Microbiol. typhimurium using two types of gradient gel 30:359-372. plates. Int. J. Food Microbiol. 14:261-275. • Sutherland, J. P., A. J. Bayliss, and D. S. • Thomas, L. V., J. W. T. Wimpenny, and A. C. Braxton. 1995. Predictive modeling of growth Peters. 1992. Testing multiple variables on the of Escherichia coli O157:H7: the effects of growth of a mixed inoculum of Salmonella temperature, pH and sodium chloride. Int. J. strains using gradient plates. Int. J. Food Food Microbiol. 25:29-49. Microbiol. 15:165-175. • Sutherland, J. P., A. J. Bayliss, and T. A. • Tilton, R. C., and R. W. Ryan. 1987. Clinical Roberts. 1994. Predictive modeling of growth and ecological characteristics of Vibrio of Staphylococcus aureus: the effects of vulnificus in the northeastern United States. temperature, pH and sodium chloride. Int. J. Diagn. Microbiol. Infect. Dis. 6:109-117. Food Microbiol. 21:217-236. • Tipparaju, S., S. Ravishankar, and P. J. • Swartzentruber, A., A. H. Schwab, A. P. Slade. February 2004. Survival of Listeria Duran, B. A. Wents, and R. B. Read, Jr. 1980. monocytogenes in vanilla-flavored soy and Microbiological quality of frozen shrimp dairy products stored at 8 degrees C. J. Food and lobster tail in the retail market. Appl. Prot. 67(2):378-382. Environ. Microbiol. 40:765-769. • Twedt, R. M., P. L. Spaulding, and H. E. Hall. • Syndicat National des Fabricants de Plats 1969. Vibrio parahaemolyticus. J. Bacteriol. Prepares. 1995. Aide a la maitrise de 98:511-518. l’hygiene alimentaire. Collection Alesial, • U.S. Food and Drug Administration and Alesial Services, Paris, France. Food Safety and Inspection Service. 1992. • Taormina, P. J., G. W. Bartholomew, and Preventing foodborne listeriosis. Department W. J. Dorsa. 2003. Incidence of Clostridium of Health and Human Services, Food and perfringens in commercially produced cured Drug Administration, and U.S. Department raw meat product mixtures and behavior of Agriculture, Food Safety and Inspection in cooked products during chilling and Service, Washington, DC. refrigerated storage. J Food Prot. 66(1):72-81.

APPENDIX 4: Bacterial Pathogen Growth and Inactivation 435 • U.S. Food and Drug Administration and microflora in fresh cod fish treated with U.S. Department of Agriculture. 2003. lysozyme and EDTA. Food Microbiol. 9:207- Quantitative assessment of relative risk 213. to public health from foodborne Listeria • Ward, D. R. and C. R. Hackney (ed.). 1991. monocytogenes among selected categories Microbiology of marine food products. Van of ready-to-eat foods. http://www.fda. Nostrand Reinhold, New York, NY. gov/downloads/food/scienceresearch/ • Watkins, W., and S. McCarthy (ed.). 1995. researchareas/riskassessmentsafetyassessment/ Proceedings of the 1994 Vibrio vulnificus ucm197330.pdf. Workshop, second printing. Department of • U.S. Food and Drug Administration. Health and Human Services, Public Health Foodborne pathogenic microorganisms and Service, Food and Drug Administration, natural toxins handbook. In The bad bug Center for Food Safety and Applied Nutrition, book. http://www.fda.gov/Food/FoodSafety/ College Park, MD. FoodborneIllness/FoodborneIllnessFoodborne • Weagant, S. D., P. N. Sado, K. G. Colburn, PathogensNaturalToxins/default.htm. J. D. Torkelson, F. A. Stanley, M. H. Krane, • U.S. Food and Drug Administration. 2007. S. E. Shields, and C. F. Thayer. 1988. The National Shellfish Sanitation Program incidence of Listeria species in frozen guide for the control of molluscan shellfish seafood products. J. Food Prot. 51:655-657. 2007 Revision. Department of Health and • Weber, J. T., R. G. Hibbs, Jr., A. Darwish, Human Services, Public Health Service, B. Mishu, A. L. Corwin, M. Rakha, C. L. Food and Drug Administration, Center Hatheway, S. el Sharkawy, S. A. el-Rahim, for Food Safety and Applied Nutrition, and M. F. al-Hamd, et al. 1993. A massive College Park, MD. http://www.fda.gov/Food/ outbreak of type E botulism associated with FoodSafety/Product-SpecificInformation/ traditional salted fish in Cairo. J. Infect. Dis. Seafood/FederalStatePrograms/ 167:451-454. NationalShellfishSanitationProgram/ ucm046353.htm. • Weichart, D., and J. D. Oliver. 1992. Low temperature induced non-culturability and • U.S. Food and Drug Administration. killing of Vibrio vulnificus. FEMS Microbiol. 2005. Quantitative risk assessment on the Lett. 79:205-210. public health impact of pathogenic Vibrio parahaemolyticus in raw oysters. Department • West, P. A. 1989. The human pathogenic of Health and Human Services, Public Health vibrios - a public health update with Service, Food and Drug Administration, environmental perspectives. Epidemiol. - Center for Food Safety and Applied Nutrition, Infect. 103:1 34. College Park, MD. • Whiting, R. C., and K. A. Naftulin. 1992. • Venkataramaiah, N., and A. G. Kempton. Effect of headspace oxygen concentration on 1975. Bacterial growth in seafood on growth and toxin production by proteolytic restaurant premises. Can. J. Microbiol. strains of Clostridium botulinum. J. Food 21(11):1788-1797. Prot. 55:23-17. • Walker, S. J., P. Archer, and J. G. Banks. • Wright, A. C., R. T. Hill, J. A. Johnson, M. C. 1990. Growth of Listeria monocytogenes at Roghman, R. R. Colwell, and J. G. Morris, Jr. refrigeration temperatures. J. Appl. Bacteriol. 1996. Distribution of Vibrio vulnificus in the 68:157-162. Chesapeake Bay. Appl. Environ. Microbiol. 62:717-724. • Wang, C., and L. A. Shelef. 1992. Behavior of Listeria monocytogenes and the spoilage

APPENDIX 4: Bacterial Pathogen Growth and Inactivation 436 • Yang, S. E., and C. C. Chou. July 2000. Growth and survival of Escherichia coli O157:H7 and Listeria monocytogenes in egg products held at different temperatures. J. Food Prot. 63(7):907-911. • Zaika, L. L., A. H. Kim, and L. Ford, 1991. Effect of sodium nitrite on growth of Shigella flexneri. J. Food Prot. 54:424-428. • Zaika, L. L., E. Moulden, L. Weimer, J. G. Phillips, and R. L. Buchanan. 1994. Model for the combined effects of temperature, initial pH, sodium chloride and sodium nitrite concentrations on anaerobic growth of Shigella flexneri. Int. J. Food Microbiol. 23:345-358. • Zaika, L. L., J. G. Phillips, and R. L. Buchanan. 1992. Model for aerobic growth of Shigella flexneri under various conditions of temperature, pH, sodium chloride and sodium nitrite concentrations. J. Food Prot. 55:509-513. • Zaika, L. L., J. G. Phillips, J. S. Fanelli, and O. J. Scullen. 1998. Revised model for aerobic growth of Shigella flexneri to extend the validity of predictions at temperatures between 10 and 19°C. Int. J. Food Microbiol. 41:9-19.. • Zwietering, M. H., I. Jongenburger, F. M. Rombouts, and K. van’t Riet. 1990. Modeling of the bacterial growth curve. Appl. Environ. Microbiol. 56:1875-1881.

APPENDIX 4: Bacterial Pathogen Growth and Inactivation 437 NOTES:

APPENDIX 4: Bacterial Pathogen Growth and Inactivation 438 APPENDIX 5: FDA and EPA Safety Levels in Regulations and Guidance

This appendix lists 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.

APPENDIX 5: FDA and EPA Safety Levels in Regulations and Guidance 439 TABLE A-5 FDA AND EPA SAFETY LEVELS IN REGULATIONS AND GUIDANCE PRODUCT LEVEL

READY-TO-EAT FISHERY PRODUCTS Listeria monocytogenes - presence of organism in (MINIMAL COOKING BY CONSUMER) 25 gram sample. ALL FISH Salmonella spp. - presence of organism in 25 gram sample. ALL FISH 1. Staphylococcus aureus - positive for staphylococcal enterotoxin; or 2. Staphylococcus aureus - level equal to or greater than 104/g (MPN). READY-TO-EAT FISHERY PRODUCTS Vibrio cholerae - presence of toxigenic O1 or O139 or non-O1 (MINIMAL COOKING BY CONSUMER) and non-O139 in 25 gram sample. READY-TO-EAT FISHERY PRODUCTS Vibrio parahaemolyticus - levels equal to or greater than 1 x 104/g (MINIMAL COOKING BY CONSUMER) (Kanagawa positive or negative). POST-HARVEST PROCESSED CLAMS, MUSSELS, OYSTERS, Vibrio parahaemolyticus - levels less than 30/g (MPN). AND WHOLE AND ROE-ON SCALLOPS, FRESH OR FROZEN, THAT MAKE A LABEL CLAIM OF “PROCESSED TO REDUCE VIBRIO PARAHAEMOLYTICUS TO NON-DETECTABLE LEVELS” COOKED READY-TO-EAT FISHERY PRODUCTS Vibrio vulnificus - presence of organism. (MINIMAL COOKING BY CONSUMER) POST-HARVEST PROCESSED CLAMS, MUSSELS, OYSTERS, Vibrio vulnificus - levels less than 30/g (MPN). AND WHOLE AND ROE-ON SCALLOPS, FRESH OR FROZEN, THAT MAKE A LABEL CLAIM OF “PROCESSED TO REDUCE VIBRIO VULNIFICUS TO NON-DETECTABLE LEVELS” ALL FISH Clostridium botulinum - 1. Presence of viable spores or vegetative cells in products that will support their growth; or 2. Presence of toxin. CLAMS, OYSTERS, MUSSELS, AND WHOLE AND ROE-ON Microbiological - SCALLOPS, FRESH OR FROZEN 1. E. coli or fecal coliform - 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. TUNA, MAHI-MAHI, AND RELATED FISH Histamine - 500 ppm based on toxicity; 50 ppm defect action level. ALL FISH Polychlorinated Biphenyls (PCBs) - 2.0 ppm (edible portion).1 FINFISH AND SHELLFISH Aldrin and dieldrin - 0.3 ppm (edible portion). FROG LEGS Benzene Hexachloride (BHC) - 0.3 ppm (edible portion). OYSTERS Carbaryl1 - 0.25 ppm. ALL FISH Chlordane - 0.3 ppm (edible portion). ALL FISH Chlordecone - 0.4 ppm crabmeat and 0.3 ppm in other fish (edible portion). ALL FISH DDT, TDE, and DDE - 5.0 ppm (edible portion). FARM-RAISED, FRESHWATER FISH Diuron and its matabolites1 - 2.0 ppm. ALL FISH Endothall and its monomethyl ester - 0.1 ppm.1 ALL FISH Heptachlor and heptachlor epoxide - 0.3 ppm (edible portion). ALL FISH Mirex - 0.1 ppm (edible portion). ALL FISH Diquat - 0.1 ppm.1

APPENDIX 5: FDA and EPA Safety Levels in Regulations and Guidance 440 TABLE A-5 FDA AND EPA SAFETY LEVELS IN REGULATIONS AND GUIDANCE PRODUCT LEVEL

FINFISH AND CRAYFISH Fluridone - 0.5 ppm.1 FINFISH Glyphosate - 0.25 ppm.1 SHELLFISH Glyphosate - 3.0 ppm.1 FINFISH Simazine and its metabolites - 12 ppm.1 ALL FISH 2,4-D - 1.0 ppm.1 CHANNEL CATFISH AND FRESHWATER-REARED SALMONIDS Florfenicol - 1.0 ppm (muscle tissue).1 FINFISH AND LOBSTER Oxytetracycline - 2.0 ppm (muscle tissue).1 TROUT Sulfamerazine - no residue permitted.1 SALMONIDS AND CATFISH Sulfadimethoxine/ormetoprim combination - 0.1 ppm for each drug (edible tissue).1 ALL FISH Drugs prohibited for extra-label use in animals - no residue permitted: Chloramphenicol; Clenbuterol; Diethylstilbestrol (DES); Dimetridazole, Ipronidazole, and other Nitroimidazoles; Furazolidone, Nitrofurazone, and other nitrofurans; Fluoroquinilones; Glycopeptides. ALL FISH Methylmercury - 1.0 ppm.2 ALL FISH Paralytic Shellfish Poisoning - 0.8 ppm (80μg/100g) saxitoxin equivalent. CLAMS, MUSSELS, OYSTERS, AND WHOLE AND ROE-ON Neurotoxic Shellfish Poisoning - 0.8 ppm (20 mouse units/100 g) SCALLOPS, FRESH, FROZEN, OR CANNED brevetoxin-2 equivalent. CLAMS, MUSSELS, OYSTERS, AND WHOLE AND ROE-ON Diarrhetic Shellfish Poisoning - 0.2 ppm okadaic acid plus SCALLOPS, FRESH, FROZEN, OR CANNED 35-methyl okadaic acid (DTX 1). ALL FISH Amnesic Shellfish Poisoning - 20 ppm domoic acid, except in the viscera of dungeness crab, where 30 ppm is permitted. ALL FISH Ciguatera Fish Poisoning - 0.01 ppb CTX equivalent for Pacific ciguatoxin and 0.1 ppb CTX equivalent for Caribbean ciguatoxin. ALL FISH Hard or sharp foreign object - generally 0.3 (7 mm) to 1.0 (25 mm) in length.

MPN = Most probable number. CTX = ciguatoxin. 1. These values are tolerances. 2. See Chapter 10, “Methylmercury,” for additional information. Note: The term “fish” refers to fresh or saltwater finfish, crustaceans, other forms of aquatic life other than birds or mammals, and all mollusks, where such animal life is intended for human consumption , as defined in the Fish and Fishery Products, “Definitions,” 21 CFR 123.3(d).

APPENDIX 5: FDA and EPA Safety Levels in Regulations and Guidance 441 NOTES:

APPENDIX 5: FDA and EPA Safety Levels in Regulations and Guidance 442 APPENDIX 6: Japanese and Hawaiian Vernacular Names for Fish Eaten Raw

• Table A-1 contains a list of Japanese vernacular names and their corresponding U.S. market names; • Table A-2 contains a list of Hawaiian vernacular names and their corresponding U.S. market names.

APPENDIX 6: Japanese and Hawaiian Vernacular Names for Fish Eaten Raw 443 These tables are not intended to be a complete list of species consumed raw.

TABLE A-1 COMMONLY USED JAPANESE VERNACULAR NAMES FOR FISH EATEN RAW WITH CORRESPONDING U.S. MARKET NAMES

WHEN THE JAPANESE VERNACULAR NAME IS … THE U.S. MARKET NAME IS … AINAME GREENLING AJI MACKEREL, JACK AKA-GAI CLAM, ARKSHELL AKAMANBO OPAH AKAUO MONKFISH AKODAI MONKFISH AKOU-DAI ROCKFISH, RED AMADAI TILEFISH AMAEBI PRAWN, SWEET ANAGO, HAMO CONGER EEL ANKOU MONKFISH AOYAGI CLAM, SURF ASARI CLAM, SHORT NECKED AWABI ABALONE AYU SMELT BAIGAI WHELK BORA MULLET, GRAY BURL YELLOWTAIL DOJYOU LOACH EBI SHRIMP, FRESHWATER EBI SHRIMP, PINK EBODAI BUTTERFISH ESO LIZARDFISH EZOBORA WHELK FUEFUKIDAI EMPEROR FUGU PUFFER FUGU GLOBEFISH FUNA CARP GARIGANI CRAYFISH GIN-SAKE SALMON, COHO HAKKAKU SCULPIN HAMACHI YELLOWTAIL HAMAGURI CLAM HANASAKI KANI CRAB, HANASAKI HATA GROUPER HAYA DACE HAZE GOBY HIGEDARA LINGCOD HIRAAJI JACK HIRAME FLUKE, FLOUNDER HIUCHIDAI ORANGE ROUGHY HOSHI-GAREI FLOUNDER HOTARUIKA SQUID HOTATE-GAI SCALLOP, GIANT HOUBOU SEA ROBIN HOYA SEA SQUIRT IBODAI BUTTERFISH IIDAKO OCTOPUS

APPENDIX 6: Japanese and Hawaiian Vernacular Names for Fish Eaten Raw 444 TABLE A-1 COMMONLY USED JAPANESE VERNACULAR NAMES FOR FISH EATEN RAW WITH CORRESPONDING U.S. MARKET NAMES

WHEN THE JAPANESE VERNACULAR NAME IS … THE U.S. MARKET NAME IS … IKA SQUID IKANAGO SAND EEL IKURA SALMON, ROE INADA YELLOWTAIL ISAKI GRUNT ISAKI GRUNT OR SWEETLIPS ISEEBI LOBSTER ISEEBI LOBSTER, NORWAY ISEEBI LOBSTER, SLIPPER ISHIDAI, ISHIGAKIDAI KNIFEJAW ISHIMOCHI GUCHI CROAKER ITOYORIDAI THREADFIN BREAM IWANA CHAR IWASHI SARDINE JNADA YELLOWTAIL KAJ I KA SCULPIN KAMASU BARRACUDA KAMASUSAWARA WAHOO KANI CRAB, BROWN KANI CRAB, DEEP SEA KANI CRAB, KING KANI CRAB, SNOW KAREI FLOUNDER KASAGO ROCKFISH KATSUO BONITO KATSUO SMALL TUNA KAWAHAGI TRIGGERFISH KAWAHGI FILEFISH KEGANI (KANI) CRAB, KEGANI KIJIHATA GROUPER KINK THORNEYHEAD KINME ALFONSINO KINMEDAI ALFONSINO KINTOKIDAI BIGEYE KISU JAPANESE WHITING KOBUDAI, BUDAI PARROTFISH KOCHI FLATFISH KOHADA GIZZARD SHAD KOHADA SHAD KOI CARP KOIKA CUTTLEFISH KONOSHIRO GIZZARD SHAD KOSHODAI GRUNT OR SWEETLIPS KURAGE JELLYFISH KURODAI PORGY KURUMA-EBI SHRIMP, TIGER PRAWN KYABIA CAVIAR KYURINO SMELT MA-DAKO TAKO OCTOPUS MA-IKA CUTTLEFISH

APPENDIX 6: Japanese and Hawaiian Vernacular Names for Fish Eaten Raw 445 TABLE A-1 COMMONLY USED JAPANESE VERNACULAR NAMES FOR FISH EATEN RAW WITH CORRESPONDING U.S. MARKET NAMES

WHEN THE JAPANESE VERNACULAR NAME IS … THE U.S. MARKET NAME IS … MADAI SEA BREAM MAGURO TUNA MAIWASHI SARDINE MAKOGAREI FLOUNDER MANAGA TSUO, ECHIOPIA POMFRET MANBOH SUNFISH, OCEAN MANDAI OPAH MEBARU ROCKFISH MEDAL BLUENOSE MEKAJIKI SWORDFISH MIRU-GAI CLAM, GEODUCK MIZUDAKO OCTOPUS MIZUIK SQUID MONGOIKA CUTTLEFISH MONGORAKAWAHAGI TRIGGERFISH NAMAKO SEA CUCUMBER NIBE CROAKER NIJI-MASU TROUT, RAINBOW NISHIN HERRING O’HYOU HALIBUT ODORI SHRIMP, TIGER PRAWN OKAMASU BARRACUDA OKAMSU BARRACUDA ONAGADAI SNAPPER SABA MACKEREL SAIRA SAURY SAKANA FISH SAKE SALMON, CHUM SAME SHARK SAMMA SAURY SANMA SAURY SAWAGANI RIVER CRAB SAYORI, SAVORI HALFBEAK SAZAE TOP SHELL SAZAE TURBOT, SHELL SHINKO SHAD SHIIRA MAHI-MAHI SHIMAAJI JACK SHISHAMO CAPELIN AND ROE SHITA-BIRAME SOLE SHIZU BUTTERFISH SUJI-KO SALMON, ROE SUKESODORA POLLOCK AND ROE SUMIIKA CUTTLEFISH SURUMEIKA SQUID SUZUKI SEA BASS SWARA MACKEREL, SPANISH TACHIUO CUTTLEFISH TAI SEA BREAM, RED SNAPPER TAKO OCTOPUS

APPENDIX 6: Japanese and Hawaiian Vernacular Names for Fish Eaten Raw 446 TABLE A-1 COMMONLY USED JAPANESE VERNACULAR NAMES FOR FISH EATEN RAW WITH CORRESPONDING U.S. MARKET NAMES

WHEN THE JAPANESE VERNACULAR NAME IS … THE U.S. MARKET NAME IS … TARA COD AND ROE/MILT TARUMI FEUDA SNAPPER TARUMI FEUDAI SNAPPER TENEGADAKO OCTOPUS TOBIUO FLYING FISH TORIGAI COCKLE TORO TUNA TSUBUGAI WHELK UMAZURAHAGI TRIGGERFISH UNAGI EEL UNI SEA URCHIN ROE WAKASAGI SMELT WARASA YELLOWTAIL YAMAME SALMON, CHERRY YARIIKA SQUID Y ANAGI-GAREI FLOUNDER ZUWAI-GANI CRAB, SNOW

APPENDIX 6: Japanese and Hawaiian Vernacular Names for Fish Eaten Raw 447 TABLE A-2 COMMONLY USED HAWAIIAN VERNACULAR NAMES FOR FISH EATEN RAW WITH CORRESPONDING U.S. MARKET NAME WHEN THE HAWAIIAN VERNACULAR NAME IS … THE U.S. MARKET NAME IS … A'AWA HOGFISH A'U BLUE MARLIN A'U BLACK MARLIN, SILVER MARLIN A'U LEPE SAILFISH A'UKU SWORDFISH AHA NEEDLEFISH AHI YELLOWFIN TUNA AHI PALAHA ALBACORE AHOLEHOLE AHOLHOLE AKU SKIPJACK TUNA AKULE BIGEYE SCAD ALA'IHI SQUIRRELFISH AMA'AMA MULLET API SAILFIN TANG AUWEKE, MOANA KALI GOLDSADDLE GOATFISH AWA MILKFISH AWEOWEO BIGEYE TUNA DEEPSEA MOI BEARDFISH EHU SQUIRRELFISH SNAPPER HAHALALU BIGEYE SCAD HAPU'UPU'U SEALE’S GROUPER HE'E MAULI OCTOPUS HEBE SHORTNOSE SPEARFISH HILU BLACK STRIPED WRASSE IHEIHE HALFBEAK KAHALA AMBERJACK KAKU BARRACUDA KALA UNICORNFISH KALEKALE VON SIEBOLD’S SNAPPER KAMANU RAINBOW RUNNER KAWAKAWA KAWAKAWA KAWELE'A JAPANESE BARRACUDA KOLE YELLOW-EYED SURGEON KUMU WHITE SADDLE GOATFISH KUPIPI GRAY DAMSELFISH LAI LEATHERBACK LAINIHI RAZOR WRASSE MAHIMAHI DOLPHIN FISH MAHIMAHI SMALL DOLPHIN FISH MAI'I'I BLACK AND BROWN SURGEON MAILKO BLUELINED SURGEON MAKIAWA SARDINE MAKUA OCEAN SUNFISH MALOLO FLYING FISH MAMO SERGEANT MAJOR DAMSEL MANINI CONVICT TANG MOANA MANYBAR GOATFISH MOI THREADFIN MU PORGY NA'ENA'A ORANGE SPOT WRASSE

APPENDIX 6: Japanese and Hawaiian Vernacular Names for Fish Eaten Raw 448 TABLE A-2 COMMONLY USED HAWAIIAN VERNACULAR NAMES FOR FISH EATEN RAW WITH CORRESPONDING U.S. MARKET NAME WHEN THE HAWAIIAN VERNACULAR NAME IS … THE U.S. MARKET NAME IS … NENUE RUDDERFISH NUNU TRUMPETFISH O'OPU KAI NOHU LARGE-HEADED SCORPION OILIPA BLUELINED LEATHER JACKET OIO BONEFISH ONO WAHOO OPAH MOONFISH OPAKAPAKA PINK SNAPPER OPELU MACKEREL SCAD PAKI'I FLOUNDER PAKU'IKU'I ACHILLES TANG PALANI DUSSUMIER’S SURGEON PANUUNUHU GAIMARD’S PARROTFISH PAPAIKUALOA KONA CRAB PO'ONUI BIGEYE TUNA PO'OPA'A HAWKFISH PO'OU ROSE-COLORED WRASSE POMFRET POMFRET PUALU ELONGATE SURGEONFISH PUHIUHA WHITE EEL ROI ARGUS GROUPER SAMOAN CRAB MANGROVE SQUID PURPLEBACK FLYING SQUID STRIPED MARLIN STRIPED MARLIN TA'APE BLUE-STRIPED SNAPPER TO'AU BLACK TAIL SNAPPER U'U SQUIRRELFISH UHU PARROTFISH UKIUKI BRIGHAM’S SNAPPER UKU GRAY JOBFISH, SNAPPER ULA SPINY LOBSTER ULAPAPA SLIPPER LOBSTER ULUA THICK-LIPPED TREVALLY ULUA KIHIKIHI THREADFIN JACK UOAUOA MULLET UPAPALU CARDINAL FISH WALU OILFISH WHITE WEKE WHITE/SAMOAN GOATFISH

APPENDIX 6: Japanese and Hawaiian Vernacular Names for Fish Eaten Raw 449 BIBLIOGRAPHY.

• Organization for Economic Co-operation and Development. 1995. Multilingual dictionary of ﬁsh and ﬁsh products. Fishing News Book. University Press, Cambridge. • U.S. Food and Drug Administration. 2009. The seafood list. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park, MD. http://www.fda.gov/Food/ GuidanceComplianceRegulatoryInformation/ GuidanceDocuments/Seafood/ucm113260. • Tinker, S. W. 1991. Fishes of Hawaii. Hawaiian Service, Inc., Honolulu HI.

APPENDIX 6: Japanese and Hawaiian Vernacular Names for Fish Eaten Raw 450 APPENDIX 7: Bacterial and Viral Pathogens of Greatest Concern in Seafood Processing - Public Health Impacts

Bacillus cereus (B. cereus) is the bacterium poisoning. An estimated 249,000 foodborne cases responsible for B. cereus food poisoning. An of perfringens food poisoning occur annually in estimated 27,400 foodborne cases of B. cereus the United States. Symptoms include: abdominal food poisoning occur annually in the United cramps and diarrhea. Symptoms start from 8 States. There are two forms of the intoxication: hours to 1 day after consumption and last for one causes diarrhea, starting from 6 to 15 hours about a day. after consumption, and the other causes vomiting Everyone is susceptible to perfringens food and nausea, starting from 30 minutes to 6 hours poisoning, but it is more common in the young after consumption. Symptoms in both forms last and elderly. about 24 hours. Everyone is susceptible to B. cereus food poisoning While most Escherichia coli (E. coli) are non- pathogenic, certain strains of the bacterium are Campylobacter jejuni (C. jejuni) is the bacterium responsible for four types of illness: gastroenteritis responsible for campylobacteriosis. An estimated or infantile diarrhea, caused by enteropathogenic 1,960,000 foodborne cases of campylobacteriosis E. coli (EPEC); travelers’ diarrhea, caused by occur annually in the United States. Symptoms enterotoxigenic E. coli (ETEC); bacillary dysentery, include: diarrhea, fever, abdominal pain, nausea, caused by enteroinvasive E. coli (EIEC); and headache, and muscle pain. Symptoms start from hemorrhagic colitis, caused by enterohemorrhagic 2 to 5 days after consumption and last from 7 to E. coli (EHEC). EHEC is the most severe, with 10 days. Everyone is susceptible to infection by potential for serious consequences, such as C. jejuni. hemolytic uremic syndrome, particularly in young Clostridium botulinum (C. botulinum) toxin is the children. An estimated 173,000 foodborne cases toxin responsible for botulism. An estimated 58 from all four types of E. coli occur annually in the foodborne cases of botulism occur annually in United States. Symptoms vary for the different the United States. Symptoms include: weakness; forms of illness, but include: abdominal pain, vertigo; double vision; difficulty in speaking, diarrhea, vomiting, fever, chills, dehydration, swallowing, and breathing; abdominal swelling; electrolyte imbalance, high body fluid acidity, and constipation; paralysis; and death. Symptoms start general discomfort. Symptoms start from 8 hours from 18 to 36 hours after consumption. Everyone to 9 days after consumption and last from 6 hours is susceptible to intoxication by C. botulinum to 19 days, with both periods varying significantly toxin; only a few micrograms of the toxin can between the illness types. Everyone is susceptible cause illness. Mortality is high; without the to all forms of infection from E. coli, but EPEC is antitoxin and respiratory support, death is likely. most commonly associated with infants, and all types tend to result in more severe symptoms in Clostridium perfringens (C. perfringens) is the the very young and elderly. bacterium responsible for perfringens food

APPENDIX 7: Bacterial and Viral Pathogens of Greatest Concern in Seafood Processing - Public Health Impacts 451 Hepatitis A virus is responsible for foodborne and other closely related bacterial pathogens, such hepatitis. An estimated 4,200 foodborne cases as Shigella spp., E. coli, and Yersinia enterocolitica of hepatitis A occur annually in the United infections can lead to chronic reactive arthritic States. Symptoms include: fever, malaise, symptoms in pre-disposed individuals. nausea, anorexia, abdominal discomfort, and Shigella spp. is the bacterium responsible for jaundice. Symptoms start from 10 to 50 days shigellosis. An estimated 89,600 foodborne cases after consumption and last 1 to 2 weeks. Unless of shigellosis occur annually in the United States. previously infected or immunized, everyone is Symptoms include: abdominal pain; cramps; susceptible to infection by hepatitis A virus. diarrhea; fever; vomiting; blood, pus, or mucus Listeria monocytogenes (L. monocytogenes) in stools; continuous or frequent urges for bowel is the bacterium responsible for listeriosis. movement; and death. Symptoms start from An estimated 2,500 foodborne cases of 12 hours to 2 days after consumption and last listeriosis occur annually in the United from 1 to 2 weeks. Everyone is susceptible to States. L. monocytogenes can produce infection by Shigella spp. mild ﬂu-like symptoms in all individuals. However, in susceptible individuals, including Staphylococcus aureus (S. aureus) is the pregnant women, newborns, and the bacterium responsible for staphylococcal food immunocompromised, it can result in more poisoning. An estimated 185,000 foodborne severe symptoms, which include: septicemia, cases of staphylococcal food poisoning occur meningitis, encephalitis, spontaneous abortion, annually in the United States. Symptoms and stillbirth. Symptoms start from include: vomiting, diarrhea, abdominal pain, nausea, and weakness. Symptoms usually 3 days to 3 weeks after consumption. Mortality start within 4 hours of consumption. Everyone is high in those that display the more severe is susceptible to intoxication by S. aureus symptoms. toxin, with more severe symptoms, including Norovirus (also known as Norwalk-like virus) occasional death, occurring in infants, the is a major cause of viral gastroenteritis. An elderly, and debilitated persons. estimated 9,200,000 foodborne cases of norovirus Vibrio cholerae (V. cholerae) O1 and O139 are occur annually in the United States. Symptoms the bacteria responsible for Asiatic or epidemic include: diarrhea, nausea, vomiting, abdominal cholera. No major outbreaks of this disease cramps, headache, body ache, and low-grade have occurred in the United States since 1911, fever. Symptoms start from 2 to 4 days after but an estimated 49 sporadic foodborne cases consumption and generally last 2½ days. occur annually (including V. cholerae non-O1 and Everyone is susceptible to infection by norovirus. non-O139). Symptoms include: mild-to-severe Salmonella spp. is the bacterium responsible for diarrhea, abdominal cramps, nausea, vomiting, salmonellosis. An estimated 1,340,000 cases dehydration, shock, and death. Symptoms of foodborne salmonellosis occur annually in start from 6 hours to 5 days after consumption. the United States. Symptoms include: nausea, Everyone is susceptible to infection by V. cholerae vomiting, abdominal cramps, diarrhea, fever, O1 and O139, but those with weakened immunity, and headache. Symptoms start from 6 hours reduced stomach acidity, or malnutrition may to 2 days after consumption and generally last suffer more severe forms of the illness. from 1 to 2 days. The most severe form, typhoid V. cholerae non-O1 and non-O139 are bacteria fever, is caused by Salmonella typhi. Everyone that are also responsible for vibriosis. V. is susceptible to infection by Salmonella spp., but cholerae non-O1 and non-O139 may also cause symptoms are most severe in the elderly, infants, gastroenteritis and, rarely, septicemia. The and the inﬁrmed. Infections by Salmonella spp.

APPENDIX 7: Bacterial and Viral Pathogens of Greatest Concern in Seafood Processing - Public Health Impacts 452 symptoms of gastroenteritis include: diarrhea, include: fever, abdominal pain, diarrhea, abdominal cramps, fever, vomiting, and vomiting, arthritis, and, rarely, septicemia. nausea. Symptoms start from 6 hours to 3 days Symptoms start from 3 to 7 days after after consumption and last from 6 to 7 days. consumption and last from 1 to 3 days. Everyone Everyone is susceptible to gastroenteritis from V. is susceptible to infection by Y. enterocolitica, but cholerae non-O1 and non-O139, but septicemia symptoms are more severe in the very young, usually develops only in those with underlying debilitated, elderly, and immunocompromised. chronic disease. Vibrio parahaemolyticus (V. parahaemolyticus) is another bacterium that is responsible for vibriosis. An estimated 3,600 foodborne cases of vibriosis from V. parahaemolyticus occur annually in the United States. Vibriosis from V. parahaemolyticus, as with Vibrio vulnificus, may cause gastroenteritis and primary septicemia, although primary septicemia is uncommon with V. parahaemolyticus. The symptoms of gastroenteritis include: diarrhea; abdominal cramps, nausea, vomiting, headache, fever, and chills. Symptoms start from 4 hours to 4 days after consumption and last for about 2½ days. Everyone is susceptible to gastroenteritis from V. parahaemolyticus, but septicemia usually develops only in those with underlying chronic disease. Vibrio vulnificus (V. vulnificus) is another bacterium that is responsible for vibriosis. An estimated 47 foodborne cases of vibriosis caused by V. vulnificus (mostly septicemia) occur annually in the United States, about half of those resulting in death. Vibriosis caused by V. vulnificus can take one of two forms, gastroenteritis and primary septicemia. The symptoms of gastroenteritis include: nausea, chills, and fever. The symptoms of primary septicemia include: septic shock and death. Symptoms of gastroenteritis start from 16 hours to 2 days after consumption, and death from septicemia may occur within 36 hours. Everyone is susceptible to gastroenteritis from V. vulnificus, but septicemia usually develops only in those with underlying chronic disease, particularly liver disease. Yersinia enterocolitica (Y. enterocolitica) is the bacterium responsible for yersiniosis. An estimated 86,700 foodborne cases of yersiniosis occur annually in the United States. Symptoms

APPENDIX 7: Bacterial and Viral Pathogens of Greatest Concern in Seafood Processing - Public Health Impacts 453 BIBLIOGRAPHY.

We have placed the following references on display in the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may see them at that location between 9 a.m. and 4 p.m., Monday through Friday. As of March 29, 2011, FDA had veriﬁed the Web site address for the references it makes available as hyperlinks from the Internet copy of this guidance, but FDA is not responsible for any subsequent changes to Non- FDA Web site references after March 29, 2011. • Mead, P. S., L. Slutsker, V. Dietz, L. F. McCaig, J. S. Bresee, C. Shapiro, P. M. Grifﬁn, and R. V. Tauxe. 1999. Food-related illness and death in the United States. Emerg. Infect. Dis. 5:607-625. • Painter, J. 2004. Estimated cases of Vibrio parahaemolyticus in the United States. Personal communication. • U.S. Food and Drug Administration. 2000. The bad bug book: foodborne pathogenic microorganisms and natural toxins handbook. http://www.cfsan.fda.gov/~mow/ intro.html.

APPENDIX 7: Bacterial and Viral Pathogens of Greatest Concern in Seafood Processing - Public Health Impacts 454 APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products

TITLE 21 OF THE CODE OF FEDERAL • SUBPART A - GENERAL PROVISIONS REGULATIONS PART 123 - FISH AND • Sec. 123.3 Definitions FISHERY PRODUCTS The definitions and interpretations of terms in section 201 of the Federal Food, • SUBPART A - GENERAL PROVISIONS Drug, and Cosmetic Act (the act) and in • Sec. part 110 of this chapter are applicable to 123.3 Definitions such terms when used in this part, except 123.5 Current good manufacturing practice where they are herein redefined. The 123.6 Hazard analysis and Hazard Analysis following definitions shall also apply: Critical Control Point (HACCP) plan a. Certification number means a unique 123.7 Corrective actions combination of letters and numbers 123.8 Verification assigned by a shellfish control authority to 123.9 Records a molluscan shellfish processor. 123.10 Training 123.11 Sanitation control procedures b. Critical control point means a point, step, 123.12 Special requirements for imported or procedure in a food process at which products control can be applied, and a food safety hazard can as a result be prevented, • SUBPART B - SMOKED AND SMOKE-FLAVORED eliminated, or reduced to acceptable FISHERY PRODUCTS levels. • Sec. 123.15 General c. Critical limit means the maximum or 123.16 Process controls minimum value to which a physical, biological, or chemical parameter must • SUBPART C - RAW MOLLUSCAN SHELLFISH be controlled at a critical control point • Sec. to prevent, eliminate, or reduce to an 123.20 General acceptable level the occurrence of the 123.28 Source controls identified food safety hazard. Authority: Secs. 201, 402, 403, 406, 409, 701, d. Fish means fresh or saltwater finfish, 704, 721, 801, 903 of the Federal Food, Drug, crustaceans, other forms of aquatic animal and Cosmetic Act (21 U.S.C. 321, 342, 343, 346, life (including, but not limited to, alligator, 348, 371, 374, 379e, 381, 393); secs. 301, 307, frog, aquatic turtle, jellyfish, sea cucumber, 361 of the Public Health Service Act (42 U.S.C. and sea urchin and the roe of such 241, 2411, 264). animals) other than birds or mammals,

APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products 455 and all mollusks, where such animal life changing into different market forms, is intended for human consumption. manufacturing, preserving, packing, labeling, dockside unloading, or e. Fishery product means any human food holding. product in which fish is a characterizing ingredient. (2) The regulations in this part do not apply to: f. Food safety hazard means any biological, chemical, or physical property that may (i) Harvesting or transporting cause a food to be unsafe for human fish or fishery products, consumption. without otherwise engaging in processing. g. Importer means either the U.S. owner or consignee at the time of entry into (ii) Practices such as heading, the United States, or the U.S. agent or eviscerating, or freezing representative of the foreign owner intended solely to prepare a fish or consignee at the time of entry into for holding on board a harvest the United States, who is responsible vessel. for ensuring that goods being offered (iii) The operation of a retail for entry into the United States are in establishment. compliance with all laws affecting the importation. For the purposes of this l. Processor means any person engaged definition, ordinarily the importer is not in commercial, custom, or institutional the custom house broker, the freight processing of fish or fishery products, forwarder, the carrier, or the steamship either in the United States or in a foreign representative. country. A processor includes any person engaged in the production of means any edible h. Molluscan shellfish foods that are to be used in market or species of fresh or frozen oysters, clams, consumer tests. mussels, or scallops, or edible portions of such species, except when the product m. Scombroid toxin-forming species means consists entirely of the shucked adductor tuna, bluefish, mahi mahi, and other muscle. species, whether or not in the family Scombridae, in which significant levels means physical, i. Preventive measure of histamine may be produced in the fish chemical, or other factors that can be flesh by decarboxylation of free histidine used to control an identified food safety as a result of exposure of the fish after hazard. capture to temperatures that permit the j. Process-monitoring instrument means an growth of mesophilic bacteria. instrument or device used to indicate n. Shall is used to state mandatory conditions during processing at a critical requirements. control point. o. Shellfish control authority means a Federal, (1) means, with respect to k. Processing State, or foreign agency, or sovereign fish or fishery products: Handling, tribal government, legally responsible storing, preparing, heading, for the administration of a program that eviscerating, shucking, freezing, includes activities such as classification

APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products 456 of molluscan shellfish growing areas, • Sec. 123.6 Hazard Analysis and Hazard enforcement of molluscan shellfish Analysis Critical Control Point (HACCP) harvesting controls, and certification of plan molluscan shellfish processors. a. Hazard analysis. Every processor p. Shellstock means raw, in-shell molluscan shall conduct, or have conducted shellfish. for it, a hazard analysis to determine whether there are food safety hazards q. Should is used to state recommended that are reasonably likely to occur for or advisory procedures or to identify each kind of fish and fishery product recommended equipment. processed by that processor and to identify the preventive measures that r. Shucked shellfish means molluscan the processor can apply to control shellfish that have one or both shells those hazards. Such food safety removed. hazards can be introduced both s. Smoked or smoke-flavored fishery products within and outside the processing means the finished food prepared by: plant environment, including food safety hazards that can occur before, (1) Treating fish with salt (sodium during, and after harvest. A food chloride), and safety hazard that is reasonably likely to occur is one for which a prudent (2) Subjecting it to the direct action processor would establish controls of smoke from burning wood, because experience, illness data, sawdust, or similar material and/ scientific reports, or other information or imparting to it the flavor provide a basis to conclude that there of smoke by a means such as is a reasonable possibility that it will immersing it in a solution of occur in the particular type of fish or wood smoke. fishery product being processed in the absence of those controls. t. Tag means a record of harvesting information attached to a container of b. The HACCP plan. Every processor shellstock by the harvester or processor. shall have and implement a written • Sec. 123.5 Current good manufacturing HACCP plan whenever a hazard practice analysis reveals one or more food safety hazards that are reasonably a. Part 110 of this chapter applies in likely to occur, as described in determining whether the facilities, paragraph (a) of this section. A methods, practices, and controls used HACCP plan shall be specific to: to process fish and fishery products are safe, and whether these products (1) Each location where fish and have been processed under sanitary fishery products are processed by conditions. that processor; and

b. The purpose of this part is to set (2) Each kind of fish and fishery forth requirements specific to the product processed by the processing of fish and fishery processor. The plan may group products. kinds of fish and fishery products

APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products 457 together, or group kinds of process sufficient to kill production methods together, if the parasites, or where the the food safety hazards, critical processor represents, labels, control points, critical limits, or intends for the product and procedures required to be to be so consumed; identified and performed in paragraph (c) of this section are (viii) Unapproved use of direct identical for all fish and fishery or indirect food or color products so grouped or for all additives; and production methods so grouped. (ix) Physical hazards; The c. The contents of the HACCP plan. (2) List the critical control points for HACCP plan shall, at a minimum: each of the identified food safety (1) List the food safety hazards that hazards, including as appropriate: are reasonably likely to occur, (x) Critical control points as identified in accordance with designed to control paragraph (a) of this section, and food safety hazards that that thus must be controlled for could be introduced each fish and fishery product. in the processing plant Consideration should be given to environment; and whether any food safety hazards are reasonably likely to occur as (xi) Critical control points a result of the following: designed to control food safety hazards introduced (i) Natural toxins; outside the processing plant (ii) Microbiological environment, including food contamination; safety hazards that occur before, during, and after (iii) Chemical contamination; harvest;

(iv) Pesticides; (3) List the critical limits that must be met at each of the critical control (v) Drug residues; points;

(vi) Decomposition in (4) List the procedures, and scombroid toxin-forming frequency thereof, that will be species or in any other used to monitor each of the species where a food safety critical control points to ensure hazard has been associated compliance with the critical with decomposition; limits;

(vii) Parasites, where the (5) Include any corrective action processor has knowledge plans that have been developed or has reason to know that in accordance with Sec. 123.7(b), the parasite-containing to be followed in response to ﬁsh or ﬁshery product will deviations from critical limits at be consumed without a critical control points;

APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products 458 (6) List the verification procedures, safety hazards that are reasonably and frequency thereof, that the likely to occur. processor will use in accordance with Sec. 123.8(a); f. Sanitation. Sanitation controls may be included in the HACCP plan. (7) Provide for a recordkeeping However, to the extent that they are system that documents the monitored in accordance with Sec. monitoring of the critical control 123.11(b) they need not be included points. The records shall in the HACCP plan, and vice versa. contain the actual values and observations obtained during g. Legal basis. Failure of a processor monitoring. to have and implement a HACCP plan that complies with this d. Signing and dating the HACCP plan. section whenever a HACCP plan is necessary, [or] otherwise operate in (1) The HACCP plan shall be signed accordance with the requirements and dated, either by the most of this part, shall render the fish or responsible individual on- fishery products of that processor site at the processing facility adulterated under section 402(a) or by a higher level official of (4) of the act. Whether a processor’s the processor. This signature actions are consistent with ensuring shall signify that the HACCP the safety of food will be determined plan has been accepted for through an evaluation of the implementation by the firm. processor overall implementation of its HACCP plan, if one is required. (2) The HACCP plan shall be dated and signed: • Sec. 123.7 Corrective actions

(i) Upon initial acceptance; a. Whenever a deviation from a critical limit occurs, a processor shall take (ii) Upon any modiﬁcation; and corrective action either by:

(iii) Upon verification of the (1) Following a corrective action plan in accordance with plan that is appropriate for the Sec. 123.8(a)(1). particular deviation, or e. Products subject to other regulations. (2) Following the procedures in For fish and fishery products that paragraph (c) of this section. are subject to the requirements of part 113 or 114 of this chapter, the b. Processors may develop written HACCP plan need not list the food corrective action plans, which safety hazard associated with the become part of their HACCP plans formation of Clostridium botulinum in accordance with Sec. 123.6(c) toxin in the finished, hermetically (5), by which they predetermine the sealed container, nor list the controls corrective actions that they will take to prevent that food safety hazard. A whenever there is a deviation from a HACCP plan for such fish and fishery critical limit. A corrective action plan products shall address any other food that is appropriate for a particular deviation is one that describes

APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products 459 the steps to be taken and assigns trained in accordance with Sec. responsibility for taking those steps, 123.10, to determine whether the to ensure that: HACCP plan needs to be modified to reduce the risk of recurrence (1) No product enters commerce that of the deviation, and modify the is either injurious to health or is HACCP plan as necessary. otherwise adulterated as a result of the deviation; and d. All corrective actions taken in accordance with this section shall be fully (2) The cause of the deviation is documented in records that are subject corrected. to verification in accordance with Sec. 123.8(a)(3)(ii) and the recordkeeping c. When a deviation from a critical limit requirements of Sec. 123.9. occurs and the processor does not have a corrective action plan that is • Sec. 123.8 Verification appropriate for that deviation, the processor shall: a. Overall verification. Every processor shall verify that the HACCP plan (1) Segregate and hold the affected is adequate to control food safety product, at least until the hazards that are reasonably likely requirements of paragraphs (c)(2) to occur, and that the plan is being and (c)(3) of this section are met; effectively implemented. Verification shall include, at a minimum: (2) Perform or obtain a review to determine the acceptability of the (1) Reassessment of the HACCP plan. affected product for distribution. A reassessment of the adequacy The review shall be performed of the HACCP plan whenever any by an individual or individuals changes occur that could affect who have adequate training or the hazard analysis or alter the experience to perform such a HACCP plan in any way or at review. Adequate training may least annually. Such changes may or may not include training in include changes in the following: accordance with Sec. 123.10; Raw materials or source of raw materials, product formulation, (3) Take corrective action, when processing methods or systems, necessary, with respect to the finished product distribution affected product to ensure that systems, or the intended use no product enters commerce that or consumers of the finished is either injurious to health or is product. The reassessment shall otherwise adulterated as a result be performed by an individual of the deviation; or individuals who have been trained in accordance with Sec. (4) Take corrective action, when 123.10. The HACCP plan shall be necessary, to correct the cause of modified immediately whenever a the deviation; reassessment reveals that the plan (5) Perform or obtain timely is no longer adequate to fully reassessment by an individual meet the requirements of Sec. or individuals who have been 123.6(c).

APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products 460 (2) Ongoing verification activities. corrective actions were Ongoing verification activities taken in accordance with including: Sec. 123.7. This review shall occur within 1 week (i) A review of any consumer of the day that the records complaints that have been are made; and received by the processor to determine whether they (iii) The calibrating of any relate to the performance process control instruments of critical control points used at critical control or reveal the existence of points and the performing unidentified critical control of any periodic end- points; product or in-process testing that is part of the (ii) The calibration of process- processor’s verification monitoring instruments; activities. The purpose of and, these reviews shall be, at a minimum, to ensure that (iii) At the option of the the records are complete, processor, the performing and that these activities of periodic end-product or occurred in accordance in-process testing. with the processor’s (3) Records review. A review, written procedures. These including signing and dating, reviews shall occur within by an individual who has been a reasonable time after the trained in accordance with records are made. Sec. 123.10, of the records that Processors shall document: b. Corrective actions. immediately follow the procedures in (i) The monitoring of critical Sec. 123.7 whenever any verification control points. The procedure, including the review of purpose of this review a consumer complaint, reveals the shall be, at a minimum, to need to take a corrective action. ensure that the records are Reassessment of the hazard analysis. complete and to verify that c. Whenever a processor does not have they document values that a HACCP plan because a hazard are within the critical limits. analysis has revealed no food safety This review shall occur hazards that are reasonably likely to within 1 week of the day occur, the processor shall reassess that the records are made; the adequacy of that hazard analysis (ii) The taking of corrective whenever there are any changes that actions. The purpose of could reasonably affect whether a this review shall be, at a food safety hazard now exists. Such minimum, to ensure that the changes may include, but are not records are complete and limited to changes in: Raw materials to verify that appropriate or source of raw materials, product

APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products 461 formulation, processing methods or case of refrigerated products and systems, finished product distribution for at least 2 years after the date systems, or the intended use or they were prepared in the case of consumers of the finished product. frozen, preserved, or shelf-stable The reassessment shall be performed products. by an individual or individuals who have been trained in accordance with (2) Records that relate to the Sec. 123.10. general adequacy of equipment or processes being used by d. Recordkeeping. The calibration of a processor, including the process-monitoring instruments, results of scientific studies and and the performing of any periodic evaluations, shall be retained end-product and in-process testing, at the processing facility or the in accordance with paragraphs (a) importer’s place of business in (2)(ii) through (iii) of this section the United States for at least 2 shall be documented in records that years after their applicability to are subject to the recordkeeping the product being produced at requirements of Sec. 123.9. the facility.

• Sec. 123.9 Records (3) If the processing facility is closed for a prolonged period between a. General requirements. All records seasonal packs, or if record required by this part shall include: storage capacity is limited on a (1) The name and location of the processing vessel or at a remote processor or importer; processing site, the records may be transferred to some other (2) The date and time of the activity reasonably accessible location at that the record reflects; the end of the seasonal pack but shall be immediately returned for (3) The signature or initials of the official review upon demand. person performing the operation; and c. Official review. All records required by this part and all plans and (4) Where appropriate, the identity of procedures required by this part shall the product and the production be available for official review and code, if any. Processing and copying at reasonable times. other information shall be entered on records at the time that it is d. Public disclosure. observed. (1) Subject to the limitations in b. Record retention. paragraph (d)(2) of this section, all plans and records required (1) All records required by this by this part are not available for part shall be retained at the public disclosure unless they have processing facility or importer’s been previously disclosed to the place of business in the United public as defined in Sec. 20.81 States for at least 1 year after the of this chapter or they relate to date they were prepared in the a product or ingredient that has

APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products 462 been abandoned and they no a. Developing a HACCP plan, which longer represent a trade secret could include adapting a model or or confidential commercial or generic-type HACCP plan, that is financial information as defined appropriate for a specific processor, in Sec. 20.61 of this chapter. in order to meet the requirements of Sec. 123.6(b); (2) However, these records and plans may be subject to disclosure b. Reassessing and modifying the to the extent that they are HACCP plan in accordance with otherwise publicly available, the corrective action procedures or that disclosure could not specified in Sec. 123.7(c)(5), the reasonably be expected to cause HACCP plan in accordance with the a competitive hardship, such as verification activities specified in Sec. generic-type HACCP plans that 123.8(a)(1), and the hazard analysis reflect standard industry practices. in accordance with the verification activities specified in Sec. 123.8(c); e. Tags. Tags as defined in Sec. 123.3(t) and are not subject to the requirements of this section unless they are used c. Performing the record review to fulfill the requirements of Sec. required by Sec. 123.8(a)(3). The 123.28(c). trained individual need not be an employee of the processor. f. Records maintained on computers. The maintenance of records on • Sec. 123.11 Sanitation control procedures computers is acceptable, provided a. Sanitation SOP. Each processor that appropriate controls are should have and implement a implemented to ensure the integrity written sanitation standard operating of the electronic data and signatures. procedure (herein referred to as • Sec. 123.10 Training SSOP) or similar document that is specific to each location where fish At a minimum, the following functions and fishery products are produced. shall be performed by an individual who The SSOP should specify how the has successfully completed training in processor will meet those sanitation the application of HACCP principles to conditions and practices that are to fish and fishery product processing at be monitored in accordance with least equivalent to that received under paragraph (b) of this section. a standardized curriculum recognized as adequate by the U.S. Food and Drug b. Sanitation monitoring. Each processor Administration or who is otherwise shall monitor the conditions and qualified through job experience to practices during processing with perform these functions. Job experience sufficient frequency to ensure, at a will qualify an individual to perform minimum, conformance with those these functions if it has provided conditions and practices specified in knowledge at least equivalent to that part 110 of this chapter that are both provided through the standardized appropriate to the plant and the food curriculum. being processed and relate to the following:

APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products 463 (1) Safety of the water that comes document the monitoring and into contact with food or food corrections prescribed by paragraph contact surfaces, or is used in the (b) of this section. These records are manufacture of ice; subject to the requirements of Sec. 123.9. (2) Condition and cleanliness of food contact surfaces, including utensils, d. Relationship to HACCP plan. Sanitation gloves, and outer garments; controls may be included in the HACCP plan, required by Sec. (3) Prevention of cross-contamination 123.6(b). However, to the extent that from insanitary objects to food, they are monitored in accordance food packaging material, and with paragraph (b) of this section other food contact surfaces, they need not be included in the including utensils, gloves, and HACCP plan, and vice versa. outer garments, and from raw product to cooked product; • Sec. 123.12 Special requirements for imported products (4) Maintenance of hand washing, This section sets forth specific hand sanitizing, and toilet requirements for imported fish and facilities; fishery products. (5) Protection of food, food a. Importer verification. Every importer of packaging material, and food fish or fishery products shall either: contact surfaces from adulteration with lubricants, fuel, pesticides, (1) Obtain the fish or fishery product cleaning compounds, sanitizing from a country that has an active agents, condensate, and other memorandum of understanding chemical, physical, and biological (MOU) or similar agreement with contaminants; the Food and Drug Administration, that covers the fish or fishery (6) Proper labeling, storage, and use product and documents the of toxic compounds; equivalency or compliance of the (7) Control of employee health inspection system of the foreign conditions that could result in the country with the U.S. system, microbiological contamination of accurately reflects the current food, food packaging materials, situation between the signing and food contact surfaces; and parties, and is functioning and enforceable in its entirety; or (8) Exclusion of pests from the food plant. (2) Have and implement written verification procedures for The processor shall correct in a timely ensuring that the fish and fishery manner, those conditions and practices products that they offer for that are not met. import into the United States were processed in accordance c. Sanitation control records. Each with the requirements of this processor shall maintain sanitation part. The procedures shall list at control records that, at a minimum, a minimum:

APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products 464 (i) Product specifications that D. Maintaining on file a are designed to ensure copy, in English, of that the product is not the foreign processor’s adulterated under section HACCP plan, and a 402 of the Federal Food, written guarantee from Drug, and Cosmetic Act the foreign processor because it may be injurious that the imported fish to health or have been or fishery product is processed under insanitary processed in accordance conditions, and, with the requirements of this part; (ii) Affirmative steps that may include any of the E. Periodically testing following: the imported fish or fishery product, and A. Obtaining from the maintaining on file a foreign processor the copy, in English, of a HACCP and sanitation written guarantee from monitoring records the foreign processor required by this part that the imported fish that relate to the specific or fishery product is lot of fish or fishery processed in accordance products being offered with the requirements for import; of this part or,

B. Obtaining either a F. Other such verification continuing or lot- by- measures as appropriate lot certificate from an that provide an appropriate foreign equivalent level of government inspection assurance of compliance authority or competent with the requirements third party certifying of this part. that the imported fish b. Competent third party. An importer or fishery product is may hire a competent third party to or was processed in assist with or perform any or all of accordance with the the verification activities specified requirements of this in paragraph (a)(2) of this section, part; including writing the importer’s verification procedures on the C. Regularly inspecting importer’s behalf. the foreign processor’s facilities to ensure that c. Records. The importer shall maintain the imported fish or records, in English, that document fishery product is being the performance and results of processed in accordance the affirmative steps specified in with the requirements paragraph (a)(2)(ii) of this section. of this part;

APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products 465 These records shall be subject to the such processing does not include a applicable provisions of Sec. 123.9. treatment that ensures the destruction of vegetative cells of microorganisms d. Determination of compliance. There of public health concern. must be evidence that all fish and fishery products offered for entry • Sec. 123.28 Source controls into the United States have been In order to meet the requirements of processed under conditions that a. subpart A of this part as they apply to comply with this part. If assurances microbiological contamination, chemical do not exist that the imported fish or contamination, natural toxins, and fishery product has been processed related food safety hazards, processors under conditions that are equivalent shall include in their HACCP plans to those required of domestic how they are controlling the origin of processors under this part, the the molluscan shellfish they process to product will appear to be adulterated ensure that the conditions of paragraphs and will be denied entry. (b), (c), and (d) of this section are met. • SUBPART B - SMOKED AND SMOKE-FLAVORED b. Processors shall only process molluscan FISHERY PRODUCTS shellfish harvested from growing • Sec. 123.15 General waters approved for harvesting by a This subpart augments subpart A of this shellfish control authority. In the case part by setting forth specific requirements of molluscan shellfish harvested from for processing smoked and smoke- U.S. Federal waters, the requirements flavored fishery products. of this paragraph will be met so long as the shellfish have not been harvested • Sec. 123.16 Process controls from waters that have been closed to In order to meet the requirements of harvesting by an agency of the Federal subpart A of this part, processors of government. smoked and smoke-flavored fishery products, except those subject to the c. To meet the requirements of paragraph requirements of part 113 or 114 of this (b) of this section, processors who chapter, shall include in their HACCP receive shellstock shall accept only plans how they are controlling the shellstock from a harvester that is food safety hazard associated with in compliance with such licensure the formation of toxin by Clostridium requirements as may apply to the botulinum for at least as long as the shelf harvesting of molluscan shellfish or life of the product under normal and from a processor that is certified by moderate abuse conditions. a shellfish control authority, and that has a tag affixed to each container of • SUBPART C - RAW MOLLUSCAN SHELLFISH shellstock. The tag shall bear, at a minimum, the information required in • Sec. 123.20 General Sec. 1240.60(b) of this chapter. In place of the tag, bulk shellstock shipments This subpart augments subpart A may be accompanied by a bill of lading of this part by setting forth specific or similar shipping document that requirements for processing fresh or contains the information required in Sec. frozen molluscan shellfish, where

APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products 466 1240.60(b) of this chapter. Processors 2. Section 1240.3 is amended by revising shall maintain records that document paragraph (r), and by adding new paragraphs that all shellstock have met the (s), (t), and (u) to read as follows: requirements of this section. These • Sec. 1240.3 General Definitions records shall document: a. Molluscan shellfish. Any edible species of (1) The date of harvest; fresh or frozen oysters, clams, mussels, and scallops or edible portions thereof, (2) The location of harvest by State and except when the product consists entirely site; of the shucked adductor muscle. (3) The quantity and type of shellfish; b. Certification number means a unique (4) The date of receipt by the processor; combination of letters and numbers and assigned by a shellfish control authority to a molluscan shellfish processor. (5) The name of the harvester, the name or registration number of the c. Shellfish control authority means a Federal, harvester’s vessel, or an identification State, or foreign agency, or sovereign number issued to the harvester by tribal government, legally responsible the shellfish control authority. for the administration of a program that includes activities such as classification d. To meet the requirements of paragraph of molluscan shellfish growing areas, (b) of this section, processors who enforcement of molluscan shellfish receive shucked molluscan shellfish harvesting controls, and certification of shall accept only containers of shucked molluscan shellfish processors. molluscan shellfish that bear a label that complies with Sec. 1240.60(c) of d. Tag means a record of harvesting this chapter. Processors shall maintain information attached to a container of records that document that all shucked shellstock by the harvester or processor. molluscan shellfish have met the requirements of this section. These 3. Section 1240.60 is amended by revising the records shall document: section heading, by redesignating the existing text as paragraph (a) and adding the word (1) The date of receipt; “molluscan” before the word “shellfish” the two times that it appears, and by adding new (2) The quantity and type of shellfish; paragraphs (b), (c), and (d) to read as follows: and • Sec. 1240.60 Molluscan Shellfish (3) The name and certification number of

the packer or repacker of the product. a. All shellstock shall bear a tag that discloses the date and place they were harvested • PART 1240 - CONTROL OF COMMUNICABLE (by State and site), type and quantity DISEASES of shellfish, and by whom they were harvested (i.e., the identification number 1. The authority citation for 21 CFR part 1240 assigned to the harvester by the shellfish continues to read as follows: control authority, where applicable or, Authority: Secs. 215, 311, 361, 368 of the Public if such identification numbers are not Health Service Act (42 U.S.C. 216, 243, 264, 271). assigned, the name of the harvester

APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products 467 or the name or registration number of the harvester’s vessel). In place of the tag, bulk shellstock shipments may be accompanied by a bill of lading or similar shipping document that contains the same information. b. All containers of shucked molluscan shellfish shall bear a label that identifies the name, address, and certification number of the packer or repacker of the molluscan shellfish. c. Any molluscan shellfish without such a tag, shipping document, or label, or with a tag, shipping document, or label that does not bear all the information required by paragraphs (b) and (c) of this section, shall be subject to seizure or refusal of entry, and destruction.

APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products 468