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 

Additional copies may be purchased from: 

Florida Sea Grant 

IFAS - Extension Bookstore 

University of Florida 

P.O. Box 110011 

Gainesville, FL 32611-0011 

(800) 226-1764 

Or 

www.ifasbooks.com 

Or you may download a copy from: 

http://www.fda.gov/FoodGuidances 

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 

Note: This document was corrected on August 3, 2011. The Agency corrected a typographical error appearing in the April

 2011 version of this document. The Agency corrected "15%" to "1.5%" so that the sentence in "Chapter 11: Aquaculture Drugs

" now reads "Sodium sulfite Used in a 1.5% solution for 5 to 8 minutes to treat eggs in order to improve their hatchability."

 

 

 

 

 

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

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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 

This guidance is intended to assist processors 

of fish and fishery products in the development 

of their Hazard Analysis Critical Control Point 

(HACCP) plans. Processors of fish and fishery 

products will find information in this guidance 

that will help them identify hazards that are 

associated with their products, and help them 

formulate control strategies. The guidance will 

help consumers and the public generally to 

understand commercial seafood safety in terms 

of hazards and their controls. The guidance does 

not specifically address safe handling practices by 

consumers or by retail establishments, although 

many of the concepts contained in this guidance 

are applicable to both. This guidance is also 

intended to serve as a tool to be used by federal 

and state regulatory officials in the evaluation of 

HACCP plans for fish and fishery products. 

FDA’s guidance documents, including this 

guidance, do not establish legally enforceable 

responsibilities. Instead, guidance describe the 

Agency’s current thinking on a topic and should 

be viewed only as recommendations, unless 

specific regulatory or statutory requirements are 

cited. The use of the word should in Agency 

guidance means that something is suggested or 

recommended, but not required. 

II. DISCUSSION 

A. Scope and Limitations 

The control strategies and practices provided in 

this guidance are recommendations to the fish 

and fishery products industry unless they are 

required by regulation or statute. This guidance 

provides information that would likely result in a 

HACCP plan that is acceptable to FDA. Processors 

may choose to use other control strategies, as 

long as they comply with the requirements of 

the applicable food safety laws and regulations. 

However, processors that chose to use other 

control strategies (e.g., critical limits) should 

scientifically establish their adequacy. 

The information contained in the tables in 

Chapter 3 and in Chapters 4 through 21 provide 

guidance for determining which hazards are 

“reasonably likely to occur” in particular fish and 

fishery products under ordinary circumstances. 

However, the tables should not be used separately 

for this purpose. The tables list potential hazards 

for specific species and finished product types. 

This information should be combined with 

the information in the subsequent chapters to 

determine the likelihood of occurrence. 

The guidance is not a substitute for the 

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 

to ensure the safe and sanitary processing of fish 

and fishery products in the Federal Register of 

December 18, 1995 (60 FR 65096) (hereinafter 

referred to as the Seafood HACCP Regulation). 

This guidance, the Seafood HACCP Regulation 

(21 CFR 123),and the Control of Communicable 

Diseases regulation (21 CFR 1240) apply to 

all aquatic animal life, other than birds and 

mammals, used as food for human consumption. 

For example, in addition to fresh and saltwater 

finfish and crustaceans, this guidance applies 

to echinoderms such as sea cucumbers and sea 

urchins; reptiles such as alligators and turtles; 

amphibians such as frogs; and to all mollusks, 

including land snails (escargot). It also applies 

to extracts and derivatives of fish, such as eggs 

(roe), oil, cartilage, and fish protein concentrate. 

In addition, this guidance applies to products 

that are mixtures of fish and non-fish ingredients, 

such as tuna sandwiches and soups. Appendix 8, 

§ 123.3, lists the definitions for “fish” and “fishery 

product” used in the Seafood HACCP Regulation. 

This guidance covers safety hazards associated 

with fish and fishery products only. It does 

not cover most hazards associated with nonfishery ingredients (e.g., Salmonella enteritidis 

in raw eggs). However, where such hazards are 

presented by a fishery product that contains nonfishery 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 LowAcid 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. 

This guidance does not cover the sanitation 

controls required by the Seafood HACCP 

Regulation. However, the maintenance of a 

sanitation monitoring program is an essential 

prerequisite to the development of a HACCP 

program. When sanitation controls are necessary 

for food safety, but are not included in a 

sanitation monitoring program, they must be 

included in the HACCP plan (21 CFR 123.6). 

This guidance does not describe corrective action 

or verification records, because these records 

are not required to be listed in the HACCP plan. 

Nonetheless, such records must be maintained, 

where applicable, as required in § 123.7 and § 

123.8. Additionally, this guidance does not restate 

the general requirements for records that are set 

out in § 123.9(a). 

This guidance does not cover reassessment of the 

HACCP plan and/or the hazard analysis or review 

of consumer complaints, as mandated by § 123.8. 

This guidance also does not provide specific 

guidance to importers of fish and fishery 

products for the development of required 

importer verification procedures. However, 

the information contained in the text, and, in 

particular, in Appendix 5 (“FDA and EPA Safety 

Levels in Regulations and Guidance”), should 

prove useful for this purpose. 

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

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B. Changes in This Edition 

Following is a summary of the most significant 

changes in this edition of the guidance 

document. In addition to using this summary list, 

you should carefully review the chapters that are 

applicable to your product and process. 

The information contained throughout this 

guidance document is changed as follows: 

The elements of a control strategy (i.e., critical 

limits, monitoring procedures, corrective action 

procedures, recordkeeping system, and verification 

procedures) are now consolidated for each control 

strategy. In most cases, an example of a HACCP 

plan follows the discussion of each control strategy; 

•	 A bibliography is now located at the end of 

most chapters. References have been added 

and deleted for many of the chapters; 

•	 Information on the mechanics of completing 

a HACCP plan, previously repeated in 

Chapters 4 through 21, is now contained in 

Chapter 2; 

•	 Information on the potential public health 

consequences (i.e., illness or injury) of 

seafood safety hazards is now provided; 

•	 Recommendations for specific job positions 

are no longer listed for “Who should perform 

the monitoring?” in Chapters 4 through 21; 

•	 Additional information is now provided on 

the performance of accuracy checks and 

calibration of temperature-indicating devices 

(e.g., thermometers) and temperaturerecording devices (e.g., recording 

thermometers); and 

•	 Reference is no longer made to the 

intended issuance by FDA of guidance on 

the development of Sanitation Standard 

Operating Procedures (SSOPs) and sanitation 

monitoring or guidance on the development 

of importer verification procedures. 

The recommendations in Chapter 2 for 

conducting a hazard analysis and developing a 

HACCP plan are changed as follows: 

•	 Additional information that is broadly 

applicable to these tasks, also contained in 

the companion document to this guidance, 

“HACCP: Hazard Analysis Critical Control 

Point Training Curriculum,” developed by the 

Seafood HACCP Alliance for Training and 

Education, is now included. 

The information in Chapter 3 for identifying 

potential species-related and process-related 

hazards is changed as follows: 

•	 Information is now provided on how illicit 

species substitution can impact on the 

identification of potential species-related 

hazards. 

The information contained in Table 3-2 

(“Potential Vertebrate Species-Related 

Hazards”) is changed as follows: 

•	 There are several scientific name changes to 

reflect changes in taxonomic conventions; 

•	 Aholehole (Kuhlia spp.) is no longer listed as 

having a potential ciguatera fish poisoning 

(CFP) hazard; 

•	 Amberjack or Yellowtail, Aquacultured 

(Seriola lalandi), is no longer listed as having 

a potential CFP hazard; 

•	 Barramundi (Lates calcarifer) is now listed as 

a species that is aquacultured; 

•	 Basa or Bocourti (Pangasius bocourti) is now 

listed as a species in U.S. commerce; 

•	 Bass, Sea (Dicentrarchus labrax) is now 

listed as a species that is aquacultured; 

•	 Bata (Labeo bata) is now listed as a species 

in U.S. commerce; 

•	 Bream (Abramis brama) is now listed as a 

species that is aquacultured; 

•	 Caparari (Pseudoplatystoma tigrinum) is 

now listed as a market name for a species 

previously referred to as catfish; 

•	 Carp (Barbonymus spp., Hypophthalmichthys 

nobilis, and Carassius carassius) is now 

listed as a species in U.S. commerce; 

•	 Carp (Hypophthalmichthys nobilis and 

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

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Carassius carassius) is now listed as a 

species that is aquacultured; 

•	 Cascarudo (Callichthys callichthys) is now 

listed as a market name for a species 

previously referred to as catfish; 

•	 Characin (Leporinus obtusidens) is now listed 

as a species in U.S. commerce; 

•	 Charal (Chirostoma jordani) is now listed as 

a species in U.S. commerce; 

•	 Chiring (Apocryptes bato) is now listed as a 

species in U.S. commerce; 

•	 Clarias Fish, or Walking Clarias Fish (Clarias 

anguillaris and Clarias gariepinus), is 

now listed as a market name for a species 

previously referred to as catfish, and is now 

listed as a species that is aquacultured; 

•	 Cobia (Rachycentron canadum) is now listed 

as a species that is aquacultured; 

•	 Coroata (Platynematichthys notatus) is 

now listed as a market name for a species 

previously referred to as catfish; 

•	 Curimbata or Guramata (Prochilodus lineatus) 

is now listed as a species in U.S. commerce; 

•	 Cusk-eel (Brotula clarkae) is now listed as a 

species in U.S. commerce; 

•	 Dace (Rhinichthys spp.) is now listed as a 

species that is aquacultured; 

•	 Eel, Moray (Muraena retifera), is no longer 

listed as having a potential CFP hazard; 

•	 Featherback (Notopterus notopterus) is now 

listed as a species in U.S. commerce; 

•	 Flathead (Platycephalus conatus) is now 

listed as a species in U.S. commerce; 

•	 Flatwhiskered Fish (Pinirampus pirinampu) 

is now listed as a market name for a species 

previously referred to as catfish; 

•	 Frog (Rana spp.) is now listed as having a 

parasite hazard; 

•	 Gillbacker, or Gilleybaka (Aspistor parkeri), 

is now listed as a market name for a species 

previously referred to as catfish; 

•	 Goatfish (Mulloidichthys vanicolenis) is now 

listed as a species in U.S. commerce; 

•	 Goatfish (Mulloidichthys spp., Pseudupeneus 

spp., and Upeneichthys lineatus) is no longer 

listed as having a potential CFP hazard; 

•	 Goby (Neogobius melanostomus) is now 

listed as a species in U.S. commerce; 

•	 Grouper (Anyperodon spp., Caprodon 

schlegelii, and Diplectrum formosum) is 

no longer listed as having a potential CFP 

hazard; 

•	 Grouper, or Coral Grouper (Plectropomus 

spp.), is now listed as a species in U.S. 

commerce; 

•	 Grouper, or Jewfish (Epinephelus itajara), is 

no longer listed as a having a potential CFP 

hazard; 

•	 Herring, or Sea Herring, or Sild (Clupea 

spp.), is no longer listed as having a potential 

scombrotoxin (histamine) hazard associated 

with its roe; 

•	 Hind (Epinephelus drummondhayi) is no 

longer listed as having a potential CFP 

hazard; 

•	 Jack (Carangoides bartholomaei) is now 

listed as having a potential CFP hazard; 

•	 Jack (Selene spp., Urapsis secunda, and 

Oligoplites saurus) is no longer listed as 

having a potential CFP hazard; 

•	 Jack or Crevalle (Alectis indicus) is no longer 

listed as having a potential CFP hazard; 

•	 Jack or Roosterfish (Nematistius pectoralis) 

is no longer listed as having a potential CFP 

hazard; 

•	 Jobfish (Aprion spp.) is now listed, and 

Aprion virescens is deleted because it is 

included in Aprion spp.; 

•	 Jobfish (Aphareus spp., Aprion spp., and 

Pristipomoides spp.) is no longer listed as 

having a potential scombrotoxin (histamine) 

hazard; 

•	 Kahawai (Arripis spp.) is no longer listed as 

having a potential CFP hazard; 

•	 Loach (Somileptus gongota) is now listed as a 

species in U.S. commerce; 

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

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•	 Mackerel, narrow-barred Spanish 

(Scomberomorus commerson), is now listed 

as having a potential CFP hazard; 

•	 Menhaden (Brevoortia spp. and Ethmidium 

maculatum) is now listed as having 

a potential scombrotoxin (histamine) 

hazard for products intended for direct 

human consumption of the muscle and 

for aqueous components, such as fish 

protein concentrates, that are to be used 

as food additives. It is also listed as 

having a potential environmental chemical 

contaminant and pesticide hazard when 

the food products are intended for human 

consumption, such as oil extracts used as 

dietary ingredients; 

•	 Oreo Dory (Neocyttus spp.)is now listed as a 

species in U.S. commerce; 

•	 Oreo Dory (Pseudocyttus spp.) is now listed, 

and Pseudocyttus maculates is deleted 

because it is included in Pseudocyttus spp; 

•	 Pangasius or Shortbarbel (Pangasius 

micronemus) is now listed as a market name 

for a species previously referred to as catfish; 

•	 Parrotfish (Bolbometopon spp.) is now listed 

as a species in U.S. commerce; 

•	 Piramutaba or Laulao Fish (Brachyplatystoma 

vaillanti) is now listed as a market name for 

a species previously referred to as catfish; 

•	 Puffer (Fugu spp., now Takifugu spp.) is now 

listed as an aquacultured species; 

•	 Puffer (Sphoeroides annulatus, Sphoeroides 

nephelus, Sphoeroides spengleri, and 

Sphoeroides testudineus, Tetraodon spp.) is 

now listed as a species in U.S. commerce; 

•	 Puffer (Fugu spp., now Takifugu spp.) is now 

listed as having a potential Paralytic Shellfish 

Poisoning (PSP) hazard; 

•	 Rita (Rita rita) is now listed as a species in 

U.S. commerce; 

•	 Rohu (Labeo rohita) is now listed as a 

species in U.S. commerce; 

•	 Sailfish (Istiophorus platypterus) is now listed 

as a species in U.S. commerce; 

•	 Salmon and roe (wild) (freshwater) 

(Oncorhynchus spp. and Salmo salar) is now 

listed as having a potential parasite hazard; 

•	 Scad (Trachurus spp.) is now listed as having 

a potential scombrotoxin (histamine) hazard; 

•	 Scad or Horse Mackerel (Trachurus trachurus) 

is now listed as a market name for a species 

previously referred to as only scad; 

•	 Shad (Alosa spp.) is no longer listed as having 

a potential scombrotoxin (histamine) hazard 

associated with its roe; 

•	 Shad, Hilsa (Tenualosa ilisha), is now listed 

as a species in U.S. commerce; 

•	 Snapper (Etelis spp. and Pristipomoides spp.) 

is no longer listed as having a potential CFP 

hazard; 

•	 Snapper (Pristipomoides spp.) is no longer 

listed as having a potential scombrotoxin 

(histamine) hazard; 

•	 Snapper (Symphorus nematophorus) is now 

listed as having a potential CFP hazard; 

•	 Sorubim, or Surubi (Pseudoplatystoma 

corruscans), is now listed as a market name 

for a species previously referred to as catfish; 

•	 Spearfish (Tetrapturus spp.) is now listed as 

having a potential scombrotoxin (histamine) 

hazard; 

•	 Squirrelfish (Holocentrus spp.) is no longer 

listed as having a potential CFP hazard; 

•	 Sutchi or Swai (Pangasius hypophthalmus) 

are now listed as market names for a species 

previously referred to as catfish and are now 

listed as species that are aquacultured; 

•	 Tang (Naso spp.) is now listed as a species in 

U.S. commerce; 

•	 Tang (Tenthis spp.) is no longer listed. 

•	 Tang (Zebrasoma spp.) is no longer listed as 

a having a potential CFP hazard; 

•	 Tigerfish (Datnioides microlepis and 

Datnioides polota) is now listed as a species 

in U.S. commerce; 

•	 Tinfoil (Barbonymus altus) is now listed as a 

species in U.S. commerce; 

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

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•	 Trahira (Hoplias malabaricus) is now listed 

as a species in U.S. commerce; 

•	 Triggerfish (Canthidermis sufflamen and 

Melichthys niger) is no longer listed as having 

a potential CFP hazard; 

•	 Tuna (Thunnus spp.) is now listed as a genus 

that is aquacultured; 

•	 Turbot (Scophthalmus maximus, now Psetta 

maxima) is now listed as a species that is 

aquacultured; 

•	 Turtle (Malaclemys spp., Chelydra spp., 

Apalone spp., and Trachemys spp.) is now 

listed as a species in U.S. commerce; 

•	 Turtle, Aquacultured (Malaclemys spp., 

Chelydra spp., Apalone spp., and Trachemys 

spp.), is now listed as a species in U.S. 

commerce; 

•	 Unicornfish (Naso unicornis) is now listed as 

a species in U.S. commerce; 

•	 Weakfish (Cynoscion spp.) is now listed as 

having a potential environmental chemical 

contaminant and pesticide hazard; 

•	 Weakfish, or Bangamary (Macrodon ancylodon), 

is now listed as a market name for a species 

previously referred to as only weakfish; 

•	 Whiskered Fish (Arius spp.) is now listed 

as a market name for a species previously 

referred to as sea catfish; 

•	 Whiskered Fish, or Gafftopsail Fish (Bagre 

marinus), is now listed as a market name for 

a species previously referred to as sea catfish; 

•	 Whiskered Fish, or Hardhead Whiskered 

Fish (Ariopsis felis), is now listed as a market 

name for a species previously referred to as 

sea catfish; 

•	 Wrasse (Cheilinus undulatus) is now listed as 

a species in U.S. commerce; 

•	 Yellowtail Amberjack (Seriola lalandi) is now 

listed as a species that is aquacultured and 

is no longer listed as having a potential CFP 

hazard; 

•	 Zander (Sander lucioperca) is now listed as a 

species that is aquacultured. 

The information contained in Table 3-3 

(“Potential Invertebrate Species-Related 

Hazards”) is changed as follows: 

•	 There are several scientific name changes to 

reflect changes in taxonomic conventions; 

•	 Abalone (Haliotis spp.) is now listed as 

having a natural toxin hazard; 

•	 Conch (Lambis lambis) is now listed as a 

species in U.S. commerce; 

•	 Crab, all species are now listed as having 

a potential environmental chemical 

contaminant and pesticide hazard; 

•	 Crab, Blue (Callinectes sapidus), is now listed 

as a species that is aquacultured; 

•	 Crab, Japanese Freshwater (Geothelphusa 

dehaani), is now listed as a species in U.S. 

commerce; 

•	 Crab, Sheep (Loxorhynchus grandis), is now 

listed as a species in U.S. commerce; 

•	 Crab, Swamp (Scylla serrata), is now listed as 

a species in U.S. commerce; 

•	 Murex, or Merex (Murex brandaris), is now 

listed as a species in U.S. commerce; 

•	 Oyster (Spondylus spp.) is now listed as a 

species in U.S. commerce; 

•	 Sea Squirt (Styela spp.) is now listed as a 

species in U.S. commerce; 

•	 Shrimp (Pleoticus muelleri) is now listed as a 

species in U.S. commerce; 

•	 Snail, Moon (Polinices spp.), is now listed as 

a species in U.S. commerce; 

•	 Whelk (Busycon spp.) is now listed as having 

a potential natural toxin hazard. 

The information contained in Table 3-4 

(“Potential Process-Related Hazards”) is 

changed as follows: 

•	 Fish oil is now listed as a food category; 

•	 Changes have been made to be consistent 

with changes in Chapters 13, 16, and 17. 

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

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The recommendations in Chapter 4 for the 

control of pathogens from the harvest area are 

changed as follows: 

Hydrostatic pressure, individual quick 

freezing (IQF) with extended storage, 

and irradiation are now identified as 

processes that are designed to retain 

raw product characteristics and that can 

be used to reduce Vibrio vulnificus (V. 

vulnificus) and Vibrio parahaemolyticus (V. 

parahaemolyticus) to non-detectable levels; 

It is now recognized that a tag on a container 

of shellstock (in-shell molluscan shellfish) 

received from another dealer need not 

identify the harvester; 

Critical limits relating to control of pathogen 

growth prior to receipt of raw molluscan 

shellfish by the primary processor are now 

linked to monitoring the time that the 

shellfish are exposed to air (i.e., by harvest 

or receding tide) rather than to the time that 

the shellfish are harvested; 

Reference is now made to the role of the 

Federal, state, tribal, territorial and foreign 

government shellfish control authorities 

in determining whether the hazard of V. 

parahaemolyticus is reasonably likely to occur in 

raw molluscan shellfish and in the development 

of a V. parahaemolyticus control plan that will 

dictate, at least to some extent, the nature of the 

controls for this pathogen in HACCP plans; 

The control strategy examples are 

restructured for improved clarity: one for 

source controls (e.g., tagging, labeling, 

source waters, harvester licensure, and raw 

consumption advisory) and a second for time 

from harvest to refrigeration controls. 

The recommendations in Chapter 5 for the 

control of parasites are changed as follows: 

It is now recognized that the parasite hazard 

may be reasonably likely to occur in fish 

raised in freshwater containing larvae of 

pathogenic liver, lung and intestinal flukes 

because these parasites enter the fish 

through the skin rather than in the food. 

The recommendations in Chapter 6 for the 

control of natural toxins are changed as follows: 

•	

•	

•	

•	

•	

•	

•	 Azaspiracid Poisoning (AZP) is now 

described, and an action level of 0.16 mg/kg 

is now provided; 

•	 Information regarding potential molluscan 

shellfish toxins, pectenotoxins (PTXs) 

and yessotoxins (YTXs), is now provided, 

although FDA has no specific expectations 

for control of YTXs; 

•	 An example of a HACCP plan is now 

provided for control of natural toxins in 

molluscan shellfish; 

•	 The action level for Diarrhetic Shellfish 

Poisoning (DSP) is now listed as 0.16 ppm 

total okadaic acid equivalents; 

•	 Action levels for CFP are now listed as 0.01 

ppb for Pacific ciguatoxin and 0.1 ppb for 

Caribbean ciguatoxin; 

•	 It is now noted that in 2008, FDA advised 

against the consumption of lobster tomalley 

because unusually high levels of PSP toxins 

were detected in that organ in lobsters 

caught in the waters of New England during 

a red tide event; 

•	 CFP is now described as being associated 

with consumption of toxin-contaminated fish 

found in tropical or subtropical areas around 

the world between 35° north latitude and 35° 

south latitude, particularly the Caribbean Sea, 

Pacific Ocean, and Indian Ocean and in the 

Flower Garden Banks area in the northern 

Gulf of Mexico; 

•	 Gempylotoxin is now described as being 

associated with orange roughy (Hoplostethus 

atlanticus) and oreo dory (Allocyttus spp., 

Pseudocyttus spp. and Neocyttus spp.) 

although in lesser amounts than escolar. 

The recommendations in Chapter 7 for the 

control of scombrotoxin (histamine) formation 

are changed as follows: 

•	 Information is now provided about the 

potential for scombrotoxin (histamine) 

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

7 
formation in products like tuna salad 

that have been allowed to become 

recontaminated and then subjected to time 

and temperature abuse; 

•	 The recommendations regarding on-board 

chilling of scombrotoxin-forming species of 

fish are now listed as follows: 

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 during 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 

during 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 during 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, 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; 

° 

•	 Cautions are now provided that handling 

practices and processing controls that are 

recommended as suitable for preventing 

the formation of scombrotoxin may not 

be sufficient to prevent fish from suffering 

quality or shelf-life degradation (i.e., 

decomposition) in a way that may otherwise 

render it adulterated under the Federal Food, 

Drug, and Cosmetic Act; 

•	 The lower anterior portion of the loin is 

now identified as the best place to collect a 

sample from large fish for histamine analysis; 

•	 Fermenting, pickling, smoking, and drying 

are now identified as likely critical control 

points (CCPs) for this hazard; 

•	 When fish are checked for internal 

temperature at off-loading, it is now 

recommended that: 

° For fish held iced or refrigerated (not 

frozen) onboard the vessel and offloaded from the vessel by the processor 

24 or more hours after death, the internal 

temperature should be 40°F (4.4°C) or 

below, 

OR 

For fish held iced or refrigerated (not 

frozen) onboard the vessel and offloaded from the vessel by the processor 

from 15 to less than 24 hours after death, 

the internal temperature should be 50°F 

(10°C) or below, 

° 

OR 

For fish held iced or refrigerated (not 

frozen) onboard the vessel and offloaded from the vessel by the processor 

from 12 to less than 15 hours after death, 

the internal temperature should be 60°F 

(15.6°C) or below; 

° 

•	 The recommended level at which a lot 

should be rejected based on sensory 

examination when 118 fish are examined 

is now corrected to be no more than 2 fish 

to coincide with the goal of less than 2.5% 

decomposition in the lot; 

•	 It is now recommended that the number of 

fish subjected to sensory examination be 

increased if there is likely to be greater than 

normal variability in the lot, and that only 

one species constitute a lot for sampling 

purposes; 

•	 When histamine analysis is performed as a 

corrective action, it is now recommended 

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 

included in the sample; 

•	 When the sensory critical limit has not 

been met, it is now recommended that 

the processor perform histamine analysis 

of a minimum of 60 fish, collected 

representatively from throughout the lot, 

including all fish in the lot that show 

evidence of decomposition, and reject the lot 

if any fish are found with a histamine level 

greater than or equal to 50 ppm; 

•	 Subdividing and retesting for histamine is no 

longer recommended after an initial failed 

histamine test; 

•	 It is now recommended that employees who 

conduct sensory screening receive adequate 

training; 

•	 It is now recommended that for shipments 

of scombrotoxin-forming species received 

under ice on open-bed trucks be checked for 

both sufficiency of ice and internal product 

temperature; 

•	 It is now recommended that shipments of 

scombrotoxin-forming species received under 

gel packs be checked for both adequacy of 

gel packs and internal product temperature; 

•	 It is now recommended that if only the 

internal temperature of fish is checked at 

receipt by a secondary processor because 

the transit time is no more than 4 hours, 

calculation of transit time should include 

all time outside a controlled temperature 

environment; 

•	 It is now recommended that if only the 

internal temperature of fish is checked at 

receipt by a secondary processor because 

the transit time is no more than 4 hours, 

a temperature-indicating device (e.g., a 

thermometer) should be used to determine 

internal product temperatures in a minimum 

of 12 fish, unless there are fewer than 12 fish 

in a lot, in which case all of the fish should 

be measured; 

•	 When checks of the sufficiency of ice or 

chemical cooling media, such as gel packs, 

or internal product temperatures are used 

at receipt of fish from another processor, it 

is now recommended that the number of 

containers examined and the number of 

containers in the lot be recorded; 

•	 Control of scombrotoxin (histamine) 

formation during processing and storage are 

now provided as separate control strategy 

examples, and examples of HACCP plans are 

now provided for both strategies; 

•	 The extended exposure times during 

processing (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)) previously recommended for 

fish that have been previously frozen are 

now also recommended for fish that have 

been previously heat treated sufficiently 

to destroy scombrotoxin-forming bacteria 

and are subsequently handled in a 

manner where there is an opportunity for 

recontamination with scombrotoxin-forming 

bacteria; 

•	 It is now acknowledged that it may be 

possible to control scombrotoxin formation 

during unrefrigerated processing using a 

critical limit that is time of exposure only 

(i.e., no temperature component), if it is 

developed with an assumption that worstcase temperatures (e.g., in excess of 70°F 

(21.1°C)) may occur; 

•	 Chemical coolants (e.g., gel packs) are 

no longer recommended for control of 

temperature during in-plant storage; 

•	 For control of time and temperature during 

refrigerated storage, it is now noted that 

critical limits that specify a cumulative time 

and temperature of exposure to temperatures 

above 40°F (4.4°C) are not ordinarily suitable 

because of the difficulty in determining 

when specific products have entered and 

left the cooler and the time and temperature 

exposures to which they were subjected. 

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 

that minor variations in cooler temperature 

measurements can be avoided by 

submerging the sensor for the temperaturerecording device in a liquid that mimics the 

characteristics of the product; 

•	 High-temperature alarms are no longer 

recommended for monitoring temperatures 

in coolers or processing areas; 

•	 When the adequacy of ice is established as 

the critical limit for refrigerated storage, it 

is now recommended that monitoring be 

performed with sufficient frequency to ensure 

control rather than at least twice per day. 

The recommendations in Chapter 8 related 

to other decomposition-related hazards are 

changed as follows: 

•	 It is now noted that FDA has received 

consumer complaints concerning illnesses 

associated with the consumption of 

decomposed salmon, attributable to the 

production in the fish of toxins other than 

histamine (e.g., biogenic amines, such as 

putrescine and cadaverine); 

•	 It is now noted that there are also some 

indications that chemicals formed when fats 

and oils in foods oxidize may contribute to 

long-term detrimental health effects. 

The recommendations in Chapter 9 for the 

control of environmental chemical contaminants 

and pesticides are changed as follows: 

•	 Toxic element guidance levels for arsenic, 

cadmium, lead, and nickel are no longer listed; 

•	 Tolerance levels for endothall and its 

monomethyl ester in fish and carbaryl in 

oysters are now listed; 

•	 The collection of soil samples from 

aquaculture production sites is no longer 

listed as a preventive measure; 

•	 An example of a HACCP plan is now 

provided for control of environmental 

chemical contaminants in molluscan 

shellfish; 

•	 When testing for environmental chemical 

contaminants and pesticides is used as the 

control measure, it is now recommended 

that the adequacy of the testing methods 

and equipment be verified periodically (e.g., 

by comparing results with those obtained 

using an Association of Official Analytical 

Chemists (AOAC) or equivalent method, or 

by analyzing proficiency samples). 

Chapter 10, which covers the control of 

methylmercury, has been rewritten to 

acknowledge that FDA is receiving comments 

on a draft quantitative risk assessment 

for methylmercury, which may result in a 

reassessment of its risk management strategies. 

The recommendations in Chapter 11 for the 

control of aquaculture drugs are changed as 

follows: 

•	 The potential for this hazard to occur during 

transportation of live fish is now recognized, 

and recommended controls are provided; 

•	 An explanation of extra-label use of drugs is 

now provided, and a list of drugs prohibited 

for extra-label use is now listed; 

•	 FDA high enforcement priority aquaculture 

drugs are now listed; 

•	 Aquaflor® Type A Medicated Article 

(florfenicol) is now listed as an approved 

drug for catfish and salmonids; 

•	 Aquaflor® CA1 is now listed as an approved 

drug for catfish or in fingerling to food fish 

as the sole ration for 10 consecutive days. 

•	 35% PEROX-AID® (hydrogen peroxide) 

is now listed as an approved drug for 

freshwater-reared salmonids and freshwaterreared cool water finfish and channel catfish; 

•	 Terramycin® 200 for Fish (oxytetracycline 

dihydrate) Type C, is now listed as an approved 

drug for catfish, salmonids; and lobster; 

•	 OxyMarineTM, Oxytetracycline HCl Soluble 

Powder-343, Terramycin-343, TETROXY Aquatic 

is now listed as an approved drug for all finfish 

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, 

or finished product testing is now 

recommended as a verification step for 

control strategies involving review of 

suppliers’ certificates at receipt of raw 

materials, review of records of drug use at 

receipt of raw materials, and on-farm visits; 

•	 When testing for aquaculture drugs is 

used as the control measure, it is now 

recommended that the adequacy of the 

testing methods and equipment be verified 

periodically (e.g., by comparing results with 

those obtained using an AOAC or equivalent 

method, or by analyzing proficiency 

samples). 

The recommendations in Chapter 12 for the 

control of pathogenic bacteria growth and 

toxin formation (other than C. botulinum) as 

a result of time and temperature abuse are 

changed as follows: 

•	 It is now recognized that V. vulnificus, V. 

parahaemolyticus, and Vibrio cholarae 

non-O1 and non-0139 are generally 

associated with marine and estuarine species 

of fish and may not be reasonably likely to 

occur in freshwater species or non-fishery 

ingredients, unless they have been crosscontaminated; 

•	 It is now clarified that products that are 

partially cooked to set the batter or breading 

or stabilize the product shape (e.g., fish balls, 

shrimp egg rolls, and breaded fish portions) 

are not considered to be ready to eat; 

•	 Information is now provided on the 

determination of CCPs for products that are a 

combination of raw, ready-to-eat and cooked, 

ready-to-eat fishery ingredients; 

•	 Control of time and temperature abuse 

at receipt, during cooling after cooking, 

during unrefrigerated processing, and during 

refrigerated storage and processing are now 

provided as four separate control strategy 

examples. Examples of HACCP plans are 

now provided for all four strategies; 

•	 For control of transit conditions at receipt 

of ready-to-eat fish or fishery products 

delivered refrigerated (not frozen), it is now 

recommended that all lots be accompanied 

by transportation records that show that 

the fish were held at or below an ambient 

or internal temperature of 40°F (4.4°C) 

throughout transit or, for transit times of 4 

hours or less, that the internal temperature 

of the fish at time of receipt was at or below 

40°F (4.4°C); 

•	 For control of time and temperature 

during refrigerated storage and refrigerated 

processing, it is now noted that critical 

limits that specify a cumulative time and 

temperature of exposure to temperatures 

above 40°F (4.4°C) are not ordinarily suitable 

because of the difficulty in determining 

when specific products have entered and 

left the cooler and the time and temperature 

exposures to which they were subjected. 

However, there may be circumstances where 

this approach is suitable. It is also noted 

that minor variations in cooler temperature 

measurements can be avoided by 

submerging the sensor for the temperaturerecording device in a liquid that mimics the 

characteristics of the product; 

•	 It is now recommended that if only the 

internal temperature of the fishery product 

is checked at receipt, because the transit 

time is no more than 4 hours, calculation of 

transit time should include all time outside a 

controlled temperature environment; 

•	 It is now recommended that if only the 

internal temperature of product is checked 

at receipt by a secondary processor because 

the transit time is no more than 4 hours, 

a temperature-indicating device (e.g., a 

thermometer) should be used to determine 

internal product temperatures in a minimum 

of 12 containers (e.g., cartons and totes), 

unless there are fewer than 12 containers 

in a lot, in which case all of the containers 

should be measured; 

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

11 
Alternatively, exposure time (i.e., time at 

internal temperatures above 50°F (10°C) 

but below 135oF (57.2oC)) should be 

limited to 4 hours, as long as no more 

than 2 of those hours are between 70°F 

(21.1°C) and 135oF (57.2oC), 

•	 When checks of the sufficiency of ice or 

chemical cooling media, such as gel packs, 

or internal product temperatures are used 

at receipt of fish from another processor, it 

is now recommended that the number of 

containers examined and the number of 

containers in the lot be recorded; 

•	 Chemical coolants (e.g., gel packs) are 

no longer recommended for control of 

temperature during in-plant storage; 

•	 Recommended cumulative exposure times 

and temperatures (i.e., critical limits) are now 

listed as follows: 

For raw, ready-to-eat products: 

If at any time the product is held at 

internal temperatures above 70°F 

(21.1°C), exposure time (i.e., time 

at internal temperatures above 50°F 

(10°C) but below 135oF (57.2oC)) 

should be limited to 2 hours (3 hours if 

Staphylococcus aureus (S. aureus) is the 

only pathogen of concern), 

° 

OR 

OR
 

If the product is held at internal
 

temperatures above 50°F (10°C), but never 

above 70°F (21.1°C), exposure time at 

internal temperatures above 50°F (10°C) 

should be limited to 5 hours (12 hours if S. 

aureus is the only pathogen of concern), 

° 

OR
 

The product is held at internal 


temperatures below 50°F (10°C), 

° 

OR 

Alternatively, the product is held at 

ambient air temperatures below 50°F 

(10°C) throughout processing; 

For cooked, ready-to-eat products: 

If at any time the product is held at 

internal temperatures above 80°F 

(27.2°C), exposure time (i.e., time at 

internal temperatures above 50°F (10°C) 

but below 135oF (57.2oC)) should be 

limited to 1 hour (3 hours if S. aureus is 

the only pathogen of concern), 

° 

OR 

Alternatively, if at any time the product 

is held at internal temperatures above 

80°F (26.7°C), exposure time (i.e., time at 

internal temperatures above 50°F (10°C) 

but below 135oF (57.2oC)) should be 

limited to 4 hours, as long as no more 

than 1 of those hours is above 70°F 

(21.1°C), 

OR 

If at any time the product is held at 

internal temperatures above 70°F 

(21.1°C), but never above 80°F (26.7°C), 

exposure time at internal temperatures 

above 50°F (10°C) should be limited to 

2 hours (3 hours if S. aureus is the only 

pathogen of concern), 

° 

OR 

Alternatively, if the product is never held at 

internal temperatures above 80°F (26.7°C), 

exposure times at internal temperatures 

above 50°F (10°C) should be limited to 4 

hours, as long as no more than 2 of those 

hours are above 70°F (21.1°C), 

OR 

If the product is held at internal 

temperatures above 50°F (10°C), but never 

above 70°F (21.1°C), exposure time at 

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
 

The product is held at internal 


temperatures below 50°F (10°C), 

° 

OR 

Alternatively, the product is held at 

ambient air temperatures below 50°F 

(10°C) throughout processing; 

•	 High-temperature alarms are no longer 

recommended for monitoring temperatures 

in coolers or processing areas; 

•	 When the adequacy of ice is established as 

the critical limit for refrigerated storage, it 

is now recommended that monitoring be 

performed with sufficient frequency to ensure 

control rather than at least twice per day; 

•	 It is now recommended that monitoring 

shipments received under gel packs include 

both adequacy of gel packs and internal 

product temperature. 

The recommendations in Chapter 13 for the 

control of C. botulinum toxin formation are 

changed as follows: 

•	 Information is now provided on TimeTemperature Indicator (TTI) performance 

and suitability; 

•	 A control strategy is now provided for 

application of TTIs on each of the smallest 

package units (i.e., the unit of packaging that 

will not be distributed any further, usually 

consumer or end-user package), where 

refrigeration is the sole barrier to prevent 

toxin formation; 

•	 It is no longer recommended that 

consideration be given to whether the 

finished product will be stored and 

distributed frozen when determining whether 

the hazard is significant. A control strategy is 

now provided to ensure that frozen products 

are properly labeled when freezing is the 

sole barrier to prevent toxin formation; 

•	 Processors are now advised to take particular 

care in determining the safety of a packaging 

material for a product in which (1) the 

spoilage organisms have been eliminated or 

significantly reduced by such processes as 

high pressure processing and (2) refrigeration 

is the sole barrier to toxin formation. The 

generally recommended 10,000 cc/m2

/24 

hours at 24oC oxygen transmission rates may 

not be suitable in this case; 

•	 High-temperature alarms are no longer 

recommended for monitoring temperatures 

in coolers or processing areas; 

•	 Chemical coolants (e.g., gel packs) are 

no longer recommended for control of 

temperature during in-plant storage; 

•	 When the adequacy of ice is established 

as the critical limit for refrigerated storage, 

it is now recommended that monitoring 

be performed with sufficient frequency to 

ensure control rather than at least twice per 

day; 

•	 It is now recommended that a water phase 

salt level of 20% be achieved in shelf-stable, 

reduced oxygen packaged products in which 

salt is the only barrier to pathogenic bacteria 

growth and toxin formation; 

•	 It is now recommended that monitoring 

shipments received under gel packs include 

both adequacy of gel packs and internal 

product temperature; 

•	 It is now recommended that if only the 

internal temperature of the fishery product 

is checked at receipt, because the transit 

time is no more than 4 hours, calculation of 

transit time should include all time outside a 

controlled temperature environment; 

•	 It is now recommended that if only the 

internal temperature of product is checked 

at receipt by a secondary processor because 

the transit time is no more than 4 hours, 

a temperature-indicating device (e.g., a 

thermometer) should be used to determine 

internal product temperatures in a minimum 

of 12 containers (e.g., cartons and totes), 

unless there are fewer than 12 containers 

in a lot, in which case all of the containers 

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 

for receipt by a secondary processor of 

refrigerated reduced oxygen packaged 

products that may be stored and further 

distributed or used as an ingredient for 

further processing; 

•	 It is now clarified that brining time should be 

monitored during the processing of smoked 

fish; 

•	 It is now recommended that brine be 

treated to minimize microbial contamination 

or be periodically replaced as a good 

manufacturing practice control. 

The recommendations in Chapter 14 for the 

control of pathogenic bacteria growth and 

toxin formation as a result of inadequate 

drying are changed as follows: 

•	 It is no longer recommended that consideration 

be given to whether the finished product 

will be stored and distributed frozen (in the 

case of reduced oxygen packaged products) 

or refrigerated (in the case of aerobically 

packaged products) when determining whether 

the hazard is significant. A control strategy 

to ensure that refrigerated dried products are 

properly labeled when refrigeration is the sole 

barrier to toxin formation is now provided. A 

control strategy to ensure that frozen products 

are properly labeled when freezing is the sole 

barrier to toxin formation is now provided in 

Chapter 13. 

The recommendations in Chapter 15 for the 

control of S. aureus toxin formation in hydrated 

batter mixes are changed as follows: 

•	 The number of S. aureus organisms normally 

needed to produce toxin is now listed as 

500,000 to 1,000,000 per gram; 

•	 High-temperature alarms are no longer 

recommended for monitoring temperatures 

in processing areas. 

The recommendations in Chapter 16 for the 

control of pathogenic bacteria survival through 

cooking are changed as follows: 

•	 The separate chapters that previously 

covered pathogen survival through cooking 

and pathogen survival through pasteurization 

are now combined; 

•	 Pasteurization is now defined as a heat 

treatment applied to eliminate the most 

resistant pathogen of public health concern 

that is reasonably likely to be present in 

food; 

•	 Information is now provided for an option 

to monitor End-Point Internal Product 

Temperature, instead of continuous time 

and temperature monitoring during cooking 

or pasteurization, when a scientific study 

has been conducted to validate that it will 

provide a 6D process for the target pathogen; 

•	 For surimi-based products, soups, or sauces, 

the following pasteurization process is now 

recommended: a minimum cumulative, 

total lethality of F194°F (F90°C) = 10 minutes, 

where z = 12.6°F (7°C) for temperatures less 

than 194°F (90°C), and z = 18°F (10°C) for 

temperatures above 194°F (90°C); 

•	 For dungeness crabmeat, the following 

pasteurization process is now recommended: 

a minimum cumulative total lethality of F194°F 

(F90°C) = 57 minutes, where z = 15.5°F (8.6°C); 

•	 Information concerning levels of Listeria 

monocytogenes (L. monocytogenes) in foods 

is now updated based on the final FDA/U.S. 

Department of Agriculture L. monocytogenes 

risk assessment. 

Chapter 17 is a new chapter that contains 

guidance for the control of pathogen survival 

through processes designed to retain raw 

product characteristics, including high 

hydrostatic pressure processing, mild heat 

processing, IQF with extended frozen storage, 

and irradiation. At present, the chapter applies 

exclusively to the processing of molluscan 

shellfish products for which there is a desire 

to retain raw product characteristics. However, 

these technologies may have other applications 

as well. 

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

14 
The recommendations in Chapter 18 for the 

control of the introduction of pathogenic 

bacteria after pasteurization and specialized 

cooking processes are changed as follows: 

•	 It is no longer recommended that consideration 

be given to whether the finished product 

will be stored and distributed frozen when 

determining whether the hazard is significant. 

A control strategy to ensure that frozen 

products are properly labeled when freezing is 

the sole barrier to prevent C. botulinum toxin 

formation is now provided in Chapter 13. 

•	

The recommendations in Chapter 19 for the 

control of undeclared food allergens and 

intolerance substances and prohibited food 

and color additives are changed as follows: 

Additional explanatory material on food 

allergens is now included, with information 

on the Food Allergen Labeling and 

Consumer Protection Act of 2004 and its 

impact on preventive controls for allergens; 

Additional information is now provided on 

the factors to be considered in judging when 

the presence of certain food intolerance 

substances and prohibited food and color 

additives is or is not reasonably likely to 

occur, such as the historical use of the 

substance and the expected level of sulfiting 

agent in the formulated finished food; 

Additional information is now provided on 

regulatory requirements for food additives. 

Corrective actions are now expanded to 

include steps that should be taken to regain 

control over the operation after a critical limit 

deviation, for consistency with guidance in 

the other chapters; 

It is now recommended that finished product 

labels be checked at time of labeling rather 

than at time of label receiving; 

It is now recommended that finished product 

testing be included as a verification step 

when review of suppliers’ labeling is used as 

a monitoring procedure for the presence of 

sulfiting agents; 

The use of sulfiting agents in conch meat is 

now identified as a reasonably likely hazard. 

The recommendations in Chapter 20 for the 

control of metal inclusion are changed as 

follows: 

•	

•	

•	

•	

•	

•	

•	 Foreign objects less than 0.3 inch (7 mm) 

are now identified as having a potential for 

causing trauma or serious injury to persons 

in special risk groups, such as infants, 

surgery patients, and the elderly; 

•	 Additional information on calibration and 

validation of electronic metal detectors is 

now provided; 

•	 Wire mesh baskets are no longer used as 

an example of an unlikely source of metal 

fragments; 

•	 The recommended critical limit for the metal 

detection or separation control strategy has 

been expanded to read, “All product passes 

through an operating metal detection or 

separation device,” and “No detectable metal 

fragments in a product passing through 

the metal detection or separation device.” 

As a result, the recommended monitoring 

procedures are also expanded so that they 

now are designed to also ensure that the 

processes are in place and operating; 

•	 It is now recommended that when metal 

fragments are found in a product by a metal 

detector or separated from the product stream 

by magnets, screens, or other devices, the 

source of the fragment is located and corrected. 

The recommendations in Chapter 21 for the 

control of glass inclusion are changed as follows: 

•	 This chapter is no longer identified as a draft; 

•	 The use of x-ray detection devices is no 

longer recommended as a reliable method for 

controlling glass inclusion; 

•	 The recommended critical limit for the glass 

container cleaning and visual inspection 

control strategy has been expanded to read, 

“All container pass through an operating 

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 

in glass containers passing the CCP.” As 

a result, the recommended monitoring 

procedures are also expanded so that they 

now are designed to also ensure that the 

processes are in place and operating; 

•	 The monitoring procedures for the 

glass container cleaning and visual 

inspection control strategy now include a 

recommendation that a representative sample 

of the cleaned or inspected containers be 

examined at the start of processing, every 

4 hours during processing, at the end of 

processing, and after any breakdowns; 

•	 It is now recommended that monitoring for 

the presence of glass be performed at the 

start of each production day and after each 

shift change. 

•	 It is now recommended that a 

representative sample of cleaned or 

inspected glass containers be examined 

daily, at the start of processing, every 4 

hours during processing, at the end of 

processing, and after any breakdowns. 

The Hazard Analysis Worksheet in Appendix 

1 has been changed for consistency with the 

worksheet in the “HACCP: Hazard Analysis 

Critical Control Point Training Curriculum,” 

developed by the Seafood HACCP Alliance for 

Training and Education. 

The recommendations in Appendix 4 for 

bacterial pathogen growth and inactivation are 

changed as follows: 

•	 Recommended summary cumulative 

exposure times and temperatures are now 

listed as described above for Chapter 12; 

•	 The maximum water phase salt level for 

growth of Campylobacter jejuni is now listed 

as 1.7%; 

•	 The maximum level of acidity (pH) for 

growth of pathogenic strains of Escherichia 

coli (E. coli) is now listed as 10; 

•	 The maximum recommended cumulative 

exposure times for Bacillus cereus are now 

listed as follows: 5 days at temperatures of 

39.2 to 43°F (4 to 6°C); 1 day at temperatures 

of 44 to 59°F (7 to 15°C); 6 hours at 

temperatures of 60 to 70°F (16 to 21°C); and 

3 hours at temperatures above 70°F (21°C); 

•	 The maximum cumulative exposure times for 

E. coli, Salmonella, and Shigella spp. are now 

listed as follows: 2 days for temperatures 

from their minimum growth temperature 

41.4 to 50°F (10°C); 5 hours for temperatures 

of 51 to 70°F (11 to 21°C); and 2 hours for 

temperatures above 70°F (21°C); 

•	 The maximum cumulative exposure times 

for Listeria monocytogenes are now listed 

as follows: 7 days for temperatures of 31.3 

to 41oF (-0.4 to 5oC); 1 day for temperatures 

of 42 to 50°F (6 to 10°C); 7 hours for 

temperatures of 51 to 70°F (11 to 21°C); 3 

hours for temperatures of 71 to 86°F (22 to 

30°C); and 1 hour for temperatures above 

86°F (30°C); 

•	 The maximum cumulative exposure times 

for Vibrio cholerae, V. vulnificus, and V. 

parahaemolyticus are now listed as follows: 

21 days for temperatures from their minimum 

growth temperature to 50°F (10°C); 6 hours 

for temperatures of 51 to 70°F (11 to 21°C); 

2 hours at temperatures of 71 to 80°F (22 to 

26.7°C); and 1 hour at temperatures above 

80°F (26.7°C), with the last temperature range 

applying only to cooked, ready-to-eat products. 

The safety levels listed in Appendix 5, Table 

A-5, “FDA and EPA Safety Levels in Regulations 

and Guidance,” are changed as follows: 

•	 Toxic element guidance levels for arsenic, 

cadmium, lead, and nickel are no longer 

listed; 

•	 Tolerance levels for endothall and its 

monomethyl ester in fish and carbaryl in 

oysters are now listed; 

•	 A tolerance level for Florfenicol in channel 

catfish and freshwater-reared salmonids is 

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 

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. 

THE GUIDANCE 

This is the fourth edition of the Food and Drug 

Administration’s (FDA’s) “Fish and Fishery Products 

Hazards and Controls Guidance.” This guidance 

relates to FDA’s Fish and Fishery Products 

regulation (called the Seafood HACCP Regulation, 

21 CFR 123, in this guidance document) and the 

Control of Communicable Diseases regulation, 

21 CFR 1240, that require processors of fish 

and fishery products to develop and implement 

HACCP systems for their operations. Those final 

regulations were published in the Federal Register 

on December 18, 1995, and became effective on 

December 18, 1997. The codified portion of the 

regulations is included in Appendix 8. 

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. 

Copies of the training document may be 

purchased from: 

Florida Sea Grant 

IFAS - Extension Bookstore 

University of Florida 

P.O. Box 110011 

Gainesville, FL 32611-0011 

(800) 226-1764 

Or 

www.ifasbooks.com 

Or you may download a copy from: 

http://www.fda.gov/FoodGuidances 

CHAPTER 1: General Information 

19 
NOTES:
 

CHAPTER 1: General Information 

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

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. 

THE HACCP PLAN FORM 

This guidance document is designed to walk 

you through a series of 18 steps that will yield a 

completed Hazard Analysis Critical Control Point 

(HACCP) plan. A blank HACCP Plan Form is 

contained in Appendix 1. Note that this is a twopage form, with the second page to be used if 

your process has more critical control points than 

can be listed on one page. The Procedures for 

the Safe and Sanitary Processing and Importing 

of Fish and Fishery Products regulation, 21 CFR 

123 (hereinafter, the Seafood HACCP Regulation), 

requires that you prepare a HACCP plan for fish 

and fishery products that you process if there are 

significant food safety hazards associated with the 

products. The regulation does not require that you 

use the form included in Appendix 1. However, 

using this standardized form may help you develop 

an acceptable plan and will expedite regulatory 

review. A separate HACCP plan should be 

developed for each location where fish and fishery 

products are processed and for each kind of fish 

and fishery product processed at that location. You 

may group products together in a single HACCP 

plan if the food safety hazards and controls are the 

same for all products in the group. 

THE HAZARD ANALYSIS WORKSHEET 

In order to complete the HACCP Plan Form, 

you will need to perform a process called 

hazard analysis. The Seafood HACCP Regulation 

requires that all seafood processors conduct, 

or have conducted for them, a hazard analysis 

to determine whether there are food safety 

hazards that are reasonably likely to occur in 

their product and to the preventive measures that 

a processor can apply to control those hazards 

(21 CFR 123.6(a)). FDA has found that the use 

of a standardized Hazard Analysis Worksheet 

assists with this process. A blank Hazard Analysis 

Worksheet is contained in Appendix 1. Note that 

this is also a two-page form, with the second page 

to be used if your process has more processing 

steps than can be listed on one page. The Seafood 

HACCP Regulation does not require that the 

hazard analysis be kept in writing. However, 

FDA expects that a written hazard analysis will 

be useful when you perform mandatory HACCP 

plan reassessments and when you are asked by 

regulators to justify why certain hazards were or 

were not included in your HACCP plan. 

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan 

21 
THE STEPS	 

Following is a list of the steps that this guidance 

uses in HACCP plan development: 

Preliminary Steps 

Provide general information; 

Describe the food; 

Describe the method of distribution and

storage; 


Identify the intended use and consumer;


Develop a flow diagram. 

Hazard Analysis Worksheet 

Set up the Hazard Analysis Worksheet; 

Identify potential species-related hazards;

Identify potential process-related hazards;

Understand the potential hazard;

Determine whether the potential hazard 

is significant; 


Identify critical control points.


HACCP Plan Form 

Set up the HACCP Plan Form; 

Set critical limits;

Establish monitoring procedures:

What,
 

How,
 

Frequency,
 

Who;
 

Establish corrective action procedures; 


Establish a recordkeeping system; 

Establish verification procedures. 

PRELIMINARY STEPS 

STEP 1: Provide general information. 

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Record the name and address of your processing 

facility in the spaces provided on the first page 

of both the Hazard Analysis Worksheet and the 

HACCP Plan Form (Appendix 1). 

STEP 2: Describe the food. 

Identify the market name or Latin name (species) 

of the fishery component(s) of the product. 

Examples: 

•	 Tuna (Thunnus albacares); 

•	 Shrimp (Pandals spp.); 

•	 Jack mackerel (Trachurus spp.). 

Fully describe the finished product food. 

Examples: 

•	 Individually quick frozen, cooked, peeled 

shrimp; 

•	 Fresh tuna steaks; 

•	 Frozen, surimi-based, imitation king crab 

legs; 

•	 Fresh, raw drum, in-the-round; 

•	 Raw shrimp, in-shell; 

•	 Raw, shucked clams; 

•	 Fresh seafood salad, with shrimp and blue 

crabmeat; 

•	 Frozen, breaded pollock sticks; 

•	 Frozen crab cakes. 

Describe the packaging type. 

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 

and storage. 

Identify how the product is distributed and stored 

after distribution. 

Examples: 

•	 Stored and distributed frozen; 

•	 Distributed on ice and then stored under 

refrigeration or on ice. 

Record this information in the space provided 

on the first page of both the Hazard Analysis 

Worksheet and the HACCP Plan Form. 

STEP 4: Identify the intended use and 

consumer. 

Identify how the product will be used by the end 

user or consumer. 

Examples: 

•	 To be heated (but not fully cooked) and 

served; 

•	 To be eaten with or without further cooking; 

•	 To be eaten raw or lightly cooked; 

•	 To be fully cooked before consumption; 

•	 To be further processed into a heat and serve 

product. 

Identify the intended consumer or user of the 

product. The intended consumer may be the 

general public or a particular segment of the 

population, such as infants or the elderly. The 

intended user may also be another processor that 

will further process the product. 

Examples: 

•	 By the general public; 

•	 By the general public, including some 

distribution to hospitals and nursing homes; 

•	 By another processing facility. 

Record this information in the space provided 

on the first page of both the Hazard Analysis 

Worksheet and the HACCP Plan Form. 

STEP 5: Develop a flow diagram. 

The purpose of the diagram is to provide a 

clear, simple description of the steps involved in 

the processing of your fishery product and its 

associated ingredients as they “flow” from receipt 

to distribution. The flow diagram should cover 

all steps in the process that your firm performs. 

Receiving and storage steps for each of the 

ingredients, including non-fishery ingredients, 

should be included. The flow diagram should be 

verified on-site for accuracy. 

Figure A-1 (Appendix 2) is an example of a flow 

diagram. 

HAZARD ANALYSIS WORKSHEET 

STEP 6: Set up the Hazard Analysis 

Worksheet. 

Record each of the processing steps (from 

the flow diagram) in Column 1 of the Hazard 

Analysis Worksheet. 

STEP 7: Identify the potential species-related 

hazards. 

Biological, chemical, and physical hazards can 

affect the safety of fishery products. Some food 

safety hazards are associated with the product 

(e.g., the species of fish, the way in which the 

fish is raised or caught, and the region of the 

world from which the fish originates). These 

hazards are introduced outside the processing 

plant environment before, during, or after 

harvest. This guidance refers to these as “speciesrelated hazards.” Other food safety hazards are 

associated with the way in which the product 

is processed (e.g., the type of packaging, the 

manufacturing steps, and the kind of storage). 

These hazards are introduced within the 

processing plant environment. This guidance 

refers to these as “process-related hazards.” They 

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 

identified in Step 2. Use Table 3-2 for vertebrates 

(animals with backbones) such as finfish. Use 

Table 3-3 for invertebrates (animals without 

backbones) such as shrimp, oysters, crabs, and 

lobsters. Determine whether the species has a 

potential species-related hazard by looking for 

a “√” mark (or one- or three-letter codes for a 

natural toxin) in the right-hand columns of the 

table. If it does, record the potential speciesrelated hazard(s) in Column 2 of the Hazard 

Analysis Worksheet, at every processing step. 

Tables 3-2 and 3-3 include the best information 

currently available to FDA concerning hazards that 

are specific to each species of fish. You should use 

your own expertise, or that of outside experts, as 

necessary, to identify any hazards that may not 

be included in the table (e.g., those that may be 

new or unique to your region). You may already 

have effective controls in place for a number of 

these hazards as part of your routine or traditional 

handling practices. The presence of such controls 

does not mean that the hazard is not significant. 

The likelihood of a hazard occurring should be 

judged in the absence of controls. For example, the 

fact that scombrotoxin (histamine) development 

in a particular species of fish has not been noted 

may be the result of (1) the inability of the fish to 

produce histamine or (2) the existence of controls 

that are already in place to prevent its development 

(e.g., harvest vessel time and temperature controls). 

In the first case, the hazard is not reasonably 

likely to occur. In the second case, the hazard is 

reasonably likely to occur, and the controls should 

be included in the HACCP plan. 

STEP 8: Identify potential process-related 

hazards. 

Find in Table 3-4 (Chapter 3) the finished product 

food (Column 1) and package type (Column 2) 

that most closely match the information that you 

developed in Steps 2 and 3. Record the potential 

hazard(s) listed in the table for that product in 

Column 2 of the Hazard Analysis Worksheet, at 

every processing step. 

You may need to include potential hazards for 

more than one finished product food category 

from Table 3-4, which will happen when your 

product fits more than one description. For 

example, if you cook shrimp and use it to prepare 

a finished product salad, you should look at both 

the “cooked shrimp” and the “salads ... prepared 

from ready-to-eat fishery products” categories in 

Table 3-4, Column 1. Potential hazards from both 

finished product food categories apply to your 

product and should be listed in Column 2 of the 

Hazard Analysis Worksheet. 

Table 3-4 includes the best information currently 

available to FDA concerning hazards that are 

related to specific processing techniques. You 

should use your own expertise, or that of outside 

experts as necessary, to identify any hazards 

that may not be included in the table (e.g., those 

that are new or unique to your physical plant, 

equipment, or process). 

STEP 9: Understand the potential hazard. 

Consult the hazards and controls chapters of 

this guidance document (Chapters 4 through 7, 

9, and 11 through 21) for each of the potential 

hazards that you entered in Column 2 of the 

Hazard Analysis Worksheet. These chapters offer 

guidance for completing your hazard analysis 

and developing your HACCP plan. Each chapter 

contains a section, “Understand the Potential 

Hazard,” that provides information about the 

significance of the hazard, the conditions under 

which it may develop in a fishery product, and 

methods available to control the hazard. 

STEP 10: Determine whether the potential 

hazard is significant. 

Narrow the list of potential hazards that you 

entered in Column 2 of the Hazard Analysis 

Worksheet to those that are significant or, in 

other words, “reasonably likely to occur.” The 

Seafood HACCP Regulation defines a food safety 

hazard that is reasonably likely to occur as “one 

for which a prudent processor would establish 

controls because experience, illness data, 

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan 

24 
 

scientific reports, or other information provide 

a basis to conclude that there is a reasonable 

possibility that it will occur in the particular type 

of fish or fishery product being processed in the 

absence of those controls.” 

The hazards and controls chapters of this 

guidance (Chapters 4 through 7, 9, and 11 

through 21) each contain a section, “Determine 

Whether this Potential Hazard Is Significant,” 

that provides information about how to assess 

the significance of potential hazards. You should 

evaluate the significance of a potential hazard 

independently at each processing step. It may 

be significant at one step but not at another. A 

potential hazard is significant at the processing 

or handling step if (1) it is reasonably likely that 

the hazard can be introduced at an unsafe level 

at that processing step; or (2) it is reasonably 

likely that the hazard can increase to an unsafe 

level at that processing step; or (3) it is significant 

at another processing or handling step and it 

can be prevented, eliminated, or reduced to 

an acceptable level at the current processing or 

handling step. When evaluating the significance 

of a hazard at a processing step, you should 

consider the method of distribution and storage 

and the intended use and consumer of the 

product, which you developed in Steps 3 and 4. 

If you determine that a potential hazard is 

significant at a processing step, you should 

answer “Yes” in Column 3 of the Hazard Analysis 

Worksheet. If you determine that a potential 

hazard is not significant at a processing step, you 

should answer “No” in that column. You should 

record the reason for your “Yes” or “No” answer 

in Column 4. You need not complete Steps 11 

through 18 for a hazard for those processing 

steps where you have recorded a “No.” 

It is important to note that identifying a hazard 

as significant at a processing step does not mean 

that it must be controlled at that processing step. 

Step 11 will help you determine where in the 

process the critical control point is located. 

STEP 11: Identify critical control points. 

For each processing step where a significant 

hazard is identified in Column 3 of the Hazard 

Analysis Worksheet, determine whether it 

is necessary to exercise control at that step 

in order to control the hazard. Figure A-2 

(Appendix 3) is a critical control point (CCP) 

decision tree that can be used to aid you in 

your determination. 

The hazards and controls chapters of this 

guidance (Chapters 4 through 7, 9, and 11 

through 21) each contain a section, “Identify 

Critical Control Points (CCPs),” which provides 

information about where control should be 

exercised. Each chapter discusses one or more 

“control strategy example(s)” for how the hazard 

can be controlled, because there are often more 

ways than one to control a hazard. CCP(s) for 

one control strategy example often differ from 

those of another example for the same hazard. 

The control strategies contain preventive measure 

information. Record the preventive measure(s) in 

Column 5 of the Hazard Analysis Worksheet for 

each “Yes” answer in Column 3. 

For every significant hazard, there must be at 

least one CCP where the hazard is controlled 

(21 CFR 123.6(c)(2)). In some cases, control may 

be necessary at more than one CCP for a single 

hazard. In other cases, a processing step may 

be a CCP for more than one hazard. CCPs are 

points in the process (i.e., processing steps) 

where the HACCP control activities will occur. 

Control activities at a CCP can effectively prevent, 

eliminate, or reduce the hazard to an acceptable 

level (21 CFR 123.3(b)). 

If you determine that a processing step is a CCP 

for a significant hazard, you should enter “Yes” in 

Column 6 of the Hazard Analysis Worksheet. If 

you determine that a processing step is not a CCP 

for a significant hazard, you should enter “No” 

in that column. You need not complete Steps 12 

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 

STEP 12: Set up the HACCP Plan Form. 

Find the processing steps that you have identified 

as CCPs in Column 6 of the Hazard Analysis 

Worksheet. Record the names of these processing 

steps in Column 1 of the HACCP Plan Form. 

Enter the hazard(s) for which these processing 

steps were identified as CCPs in Column 2 of 

the HACCP Plan Form. This information can 

be found in Column 2 of the Hazard Analysis 

Worksheet. 

Complete Steps 13 through 18 for each of the 

significant hazards. These steps involve setting 

critical limits, establishing monitoring procedures, 

establishing corrective action procedures, 

establishing a recordkeeping system, and 

establishing verification procedures. 

STEP 13: Set critical limits. 

For each processing step where a significant 

hazard is identified on the HACCP Plan Form, 

identify the maximum or minimum value to 

which a parameter of the process must be 

controlled in order to control the hazard. Each 

control strategy example provided in the hazards 

and controls chapters of this guidance (Chapters 

4 through 7, 9, and 11 through 21) each contain 

a section, “Set Critical Limits,” that provides 

information about appropriate critical limits for 

each of the control strategy example(s) discussed. 

You should set a critical limit at such a value that 

if it is not met, the safety of the product may be 

questionable. If you set a more restrictive critical 

limit, you could, as a result, be required to take 

corrective action when no safety concern actually 

exists. On the other hand, if you set a critical 

limit that is too loose, you could, as a result, 

allow an unsafe product to reach the consumer. 

As a practical matter, it may also be advisable 

to set an operating limit that is more restrictive 

than the critical limit. In this way, you can adjust 

the process when the operating limit is not 

met, but before a critical limit deviation would 

require you to take corrective action. You should 

set operating limits based on your experience 

with the variability of your operation and with 

the closeness of typical operating values to the 

critical limit. 

Consider that the critical limit should directly 

relate to the parameter that you will be 

monitoring. For example, if you intend to 

monitor the temperature of the water in the 

cooker and the speed of the belt that carries the 

product through the cooker (because you have 

determined that these factors result in the desired 

internal product temperature for the desired 

time), you should specify water temperature 

and belt speed as critical limits, not the internal 

temperature of the product. 

Enter the critical limit(s) in Column 3 of the 

HACCP Plan Form. 

STEP 14: Establish monitoring procedures. 

For each processing step where a significant 

hazard is identified on the HACCP Plan Form, 

describe monitoring procedures that will ensure 

that critical limits are consistently met (21 CFR 

123.6(c)(4)). The hazards and controls chapters 

of this guidance document (Chapters 4 through 

7, 9, and 11 through 21) each contain a section, 

“Establish Monitoring Procedures,” that provides 

information about appropriate monitoring 

procedures for each of the control strategy 

example(s) discussed. 

To fully describe your monitoring program, you 

should answer four questions: (1) What will be 

monitored? (2) How will monitoring be done? (3) 

How often will monitoring be done (frequency)? 

and (4) Who will do the monitoring? 

It is important for you to keep in mind that the 

monitoring process should directly measure 

the parameter for which you have established 

a critical limit. The necessary frequency of 

monitoring is dependent upon the circumstances. 

Continuous monitoring is always desirable, and 

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 

values you are measuring will be detected. This 

is especially true if these values are typically 

close to the critical limit. Additionally, the greater 

the time span between measurements, the 

more products you are putting at risk should a 

measurement show a deviation from a critical 

limit has occurred, because you should assume 

that the critical limit had not been met since 

the last “good” value. Even with continuous 

monitoring, the paper or electronic record of the 

continuous monitoring should be periodically 

checked in order to determine whether 

deviations from the critical limit have occurred. 

The frequency of that check should be at least 

daily, and more frequent if required in order to 

implement an appropriate corrective action. 

Enter the “What,” “How,” “Frequency,” and “Who” 

monitoring information in Columns 4, 5, 6, and 7, 

respectively, of the HACCP Plan Form. 

STEP 15: Establish corrective action 

procedures. 

A corrective action must be taken whenever there 

is a deviation from a critical limit at a CCP (21 

CFR 123.7((a)). For each processing step where 

a significant hazard is identified on the HACCP 

Plan Form, describe the procedures that you 

will use when your monitoring indicates that 

the critical limit has not been met. Note that the 

Seafood HACCP Regulation does not require 

that you predetermine your corrective actions. 

You may instead elect to follow the prescribed 

corrective action procedures listed at 21 CFR 

123.7(c). However, a predetermined corrective 

action has the following advantages: (1) It 

provides detailed instructions to the processing 

employee that can be followed in the event of a 

critical limit deviation; (2) it can be prepared at a 

time when an emergency situation is not calling 

for an immediate decision; and (3) it removes 

the obligation to reassess the HACCP plan in 

response to a critical limit deviation. 

The hazards and controls chapters of this 

guidance (Chapters 4 through 7, 9, and 11 

through 21) each contain a section, “Establish 

Corrective Action Procedures,” that provides 

information about appropriate corrective action 

procedures for each of the control strategy 

example(s) discussed. An appropriate corrective 

action procedure must accomplish two goals: (1) 

ensure that an unsafe product does not reach 

the consumer and (2) correct the problem that 

caused the critical limit deviation (21 CFR 123.7). 

If the corrective action involves testing the 

finished product, the limitations of the sampling 

plan should be understood. Because of these 

limitations, microbiological testing is often not a 

suitable corrective action. The Seafood HACCP 

Regulation requires that corrective actions be fully 

documented in records (21 CFR 123.7(d)). Note 

that if a critical limit deviation occurs repeatedly, 

the adequacy of that CCP for controlling the 

hazard should be reassessed. Remember that 

deviations from operating limits do not need to 

result in formal corrective actions. 

Enter the corrective action procedures in Column 

8 of the HACCP Plan Form. 

STEP 16: Establish a recordkeeping system. 

For each processing step where a significant 

hazard is identified on the HACCP Plan Form, list 

the records that will be used to document the 

accomplishment of the monitoring procedures 

discussed in Step 14 (21 CFR 123.9(a)(2)). 

The hazards and controls chapters of this 

guidance (Chapters 4 through 7, 9, and 11 

through 21) each contain a section, “Establish 

a Recordkeeping System,” that provides 

information about appropriate records for each 

of the control strategy example(s) discussed. 

Records must document monitoring of the 

CCP and shall contain the actual values and 

observations obtained during monitoring (21 

CFR 123.6(b)(7)) The Seafood HACCP Regulation 

lists specific requirements about the content of 

the records (21 CFR 123.9(a)). 

Enter the names of the HACCP monitoring 

records in Column 9 of the HACCP Plan Form. 

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan 

27 
STEP 17: Establish verification procedures. 

For each processing step where a significant 

hazard is identified on the HACCP Plan Form, 

describe the verification procedures that will 

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 

that of the most responsible individual on-site at 

your processing facility or a higher level official 

(21 CFR 123.6(d)(1)). It signifies that the HACCP 

plan has been accepted for implementation by 

your firm. 

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan 

28 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

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. 

INTRODUCTION 

•	 Purpose 

The purpose of this chapter is to identify 

potential food safety hazards that are species 

related and process related. It also provides 

information on how the illicit substitution of 

one species for another can impact on the 

identification of species-related hazards. 

To assist in identifying species-related and 

process-related hazards, this chapter contains 

three tables: 

•	 Table 3-2, “Potential Vertebrate 

Species-Related Hazards,” contains a 

list of potential hazards that are associated 

with specific species of vertebrates 

(species with backbones). These hazards 

are referred to as species-related hazards; 

•	 Table 3-3, “Potential Invertebrate 

Species-Related Hazards,” contains a 

list of potential hazards that are associated 

with specific species of invertebrates 

(species without backbones). These 

hazards are also referred to as speciesrelated 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. 

It is important to note that the tables provide 

lists of potential hazards. You should use 

the tables, together with the information 

provided in Chapters 4 through 21, and your 

own expertise or that of outside experts, to 

determine whether the hazard is significant 

for your particular product and, if so, how it 

should be controlled. 

•	 Species substitution 

Illicit substitution of one species for another 

may constitute economic fraud and/or 

misbranding violations of the Federal Food, 

Drug, and Cosmetic Act. Furthermore, species 

substitution may cause potential food safety 

hazards to be overlooked or misidentified by 

processors or end users, as shown in Table 

3-1, “The Effect of Misbranding Through 

Species Substitution on the Identification of 

Potential Species-Related Hazards.” These 

examples are based on actual incidents of 

species substitution or misbranding. 

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

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

30 

TABLE 3-1 

THE EFFECT OF MISBRANDING THROUGH SPECIES SUBSTITUTION ON THE 

IDENTIFICATION OF POTENTIAL SPECIES-RELATED HAZARDS 

ACTUAL MARKET NAME 

OF PRODUCT 

POTENTIAL 

SPECIES- RELATED HAZARDS 

ASSOCIATED WITH 

THE ACTUAL PRODUCT 

(FROM TABLE 3-2) 

PRODUCT 

INAPPROPRIATELY LABELED AS 

POTENTIAL SPECIES-RELATED HAZARDS 

THAT WOULD BE IDENTIFIED BASED ON 

INAPPROPRIATE SPECIES LABELING 

(FROM TABLE 3-2) 

Escolar Gempylotoxin 

Histamine Sea bass Parasites 

Puffer fish Tetrodotoxin 

Paralytic Shellfish Poisoning Monkfish Parasites 

Spanish mackerel 

Parasites 

Histamine 

Ciguatera Fish Poisoning 

Kingfish None 

Basa Environmental

 chemical contaminants

 and pesticides 

Grouper Parasites 

Ciguatera Fish Poisoning 

Grouper Parasites 

Ciguatera Fish Poisoning Cod Parasites 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

31 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES 

CHP 5 

NATURAL 

TOXINS 

CHP 6 

SCOMBROTOXIN 

(HISTAMINE) 

CHP 7 

ENVIRONMENTAL 

CHEMICALS 

CHP 9 

AQUACULTURE 

DRUGS 

CHP 11 

AHOLEHOLE Kuhlia spp. 

ALEWIFE OR RIVER 

HERRING 

Alosa pseudoharengus √ √ 

ALFONSINO Beryx spp. 

Centroberyx spp. 

ALLIGATOR 

Alligator 

mississipiensis 

√ 

Alligator sinensis √ 

ALLIGATOR, 

AQUACULTURED 

Alligator 

mississipiensis 

√ √ 

Alligator sinensis √ √ 

AMBERJACK Seriola spp. CFP √ 

AMBERJACK 

OR YELLOWTAIL 

Seriola lalandi √ 

AMBERJACK 

OR YELLOWTAIL, 

AQUACULTURED 

Seriola lalandi √ √ √ 

ANCHOVY 

Anchoa spp. ASP5 √ 

Anchoviella spp. ASP5 √ 

Cetengraulis 

mysticetus 

ASP5 √ 

Engraulis spp. ASP5 √ 

Stolephorus spp. ASP5 √ 

ANGELFISH Holacanthus spp. 

Pomacanthus spp. 

ARGENTINE 

QUEENFISH 

Argentina elongata 

BARRACUDA 

Sphyraena spp. CFP √ 

S. barracuda CFP √ 

S. jello CFP √ 

BARRAMUNDI Lates calcarifer √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

32 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

BARRAMUNDI 

AQUACULTURED 

Lates calcarifer √ √ 

BASA OR 

BOCOURTI8 

Pangasius bocourti √ 

BASA OR 

BOCOURTI8, 

AQUACULTURED 

Pangasius bocourti √ √ 

BASS 

Ambloplites spp. √ 

Micropterus spp. √ 

Morone spp. √ 

Stereolepis gigas √ 

Synagrops bellus √ 

BASS, 

AQUACULTURED 

Morone spp. √ √ 

Centropristis spp. √ √ 

BASS, SEA 

Acanthistius 

brasilianus 

√3 

Centropristis spp. √3 

Dicentrarchus labrax √3 

Lateolabrax japonicus √3 

Paralabrax spp. √3 

Paranthias furcifer √3 

Polyprion americanus √3 

Polyprion oxygeneios √3 

Polyprion yanezi √3 

BASS, SEA, 

AQUACULTURED 

Dicentrarchus labrax √3 √ √ 

BATA Labeo bata √ 

BIGEYE 

Priacanthus arenatus 

Pristigenys alta 

BLUEFISH Pomatomus saltatrix √ √ 

BLUEGILL Lepomis macrochirus √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

33 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

BLUENOSE Hyperoglyphe 

antarctica 

BOMBAY DUCK Harpadon nehereus √ 

BONITO 

Cybiosarda elegans √ 

Gymnosarda unicolor √ 

Orcynopsis unicolor √ 

Sarda spp. √ 

BOWFIN AND ROE Amia calva √ 

BREAM 

Abramis brama 

Acanthopagrus spp.7 

Argyrops spp. 

Gymnocranius 

grandoculis7 

Monotaxis spp. 

Sparus aurata 

Wattsia spp. 

BREAM, 

AQUACULTURED 

Abramis brama √ √ 

BREAM OR BOGUE Boops boops 

BREAM, THREADFIN Nemipterus japonicus 

BUFFALOFISH Ictiobus spp. √ 

BULLHEAD Ameiurus spp. √ 

BURBOT Lota lota √ 

BUTTERFISH8 

Odax pullus √ 

Peprilus spp. √ 

Pampus cinereus √ 

CAPARARI8 Pseudoplatystoma 

tigrinum 

√ 

CAPELIN AND ROE Mallotus villosus √3 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

34 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

CARP 

Barbonymus spp. √ 

Cyprinus carpio √ 

Hypophthalmichthys 

molitrix 

√ 

Hypophthalmichthys 

nobilis 

√ 

Carassius carassius √ 

CARP, 

AQUACULTURED 

Cyprinus carpio √ √ 

Hypophthalmichthys 

molitrix 

√ √ 

Hypophthalmichthys 

nobilis. 

√ √ 

Carassius carassius √ √ 

CASCARUDO8 Callichthys callichthys √ √ 

CATFISH 

Ameiurus catus √ 

Ictalurus spp. √ 

Pylodictis oliveris √ 

CATFISH, 

AQUACULTURED 

Ictalurus spp. √ √ 

CHAR Salvelinus alpinus √ 

CHAR, 

AQUACULTURED 

Salvelinus alpinus √ √ 

CHARACIN Leporinus obtusidens √ 

CHARAL Chirostoma jordani 

CHIMAERA Harriota raleighana 

Hydrolagus spp. 

CHIRING Apocryptes bato 

CHUB 

Coregonus kiyi √ 

Kyphosus spp. √ 

Semotilus 

atromaculatus 

√ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

35 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

CISCO OR CHUB 

Coregonus alpenae √ 

Coregonus reighardi √ 

Coregonus zenithicus √ 

CISCO OR TULLIBEE Coregonus artedi7 √ 

CLARIAS FISH 

OR WALKING 

CLARIAS FISH8 

Clarias spp. √ 

CLARIAS FISH 

OR WALKING 

CLARIAS FISH, 

AQUACULTURED8 

Clarias anguillaris √ √

 Clarias gariepinus √ √ 

COBIA Rachycentron 

canadum 

√3 

COBIA, 

AQUACULTURED 

Rachycentron 

canadum 

√3 √ √ 

COD 

Arctogadus spp. √3 

Boreogadus saida √3 

Eleginus gracilis √3 

Gadus spp. √3 

COD OR ALASKA 

COD 

Gadus macrocephalus √3 

COD, MORID 

Lotella rhacina √3 

Mora moro √3 

Psendophycis barbata7 √3 

Pseudophycis spp. √3 

COROATA8 Platynematichthys 

notatus 

√3 √ 

CORVINA 

Cilus gilberti7 √3 

Micropogonias 

undulates7 

√3 

CRAPPIE Pomoxis spp. √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

36 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

CROAKER 

Argyrosomus spp. √ 

Bairdiella spp. √ 

Cheilotrema saturnum √ 

Genyonemus lineatus √ 

Micropogonias spp. √ 

Nebris microps √ 

Nibea spp. √ 

Pachypops spp. √ 

Pachyurus spp. √ 

Paralonchurus spp. √ 

Plagioscion spp. √ 

Pseudotolithus spp. √ 

Pterotolithus spp. √ 

Roncador stearnsii7 √ 

Umbrina roncador √ 

Odontoscion dentex √ 

CROAKER OR 

CORVINA 

Cynoscion spp. √ 

CROAKER OR 

SHADEFISH 

Argyrosomus regius √ 

CROAKER OR 

YELLOWFISH 

Larimichthys polyactis7 √ 

CURIMBATA OR 

GURAMATA 

Prochilodus lineatus 

CUSK Brosme brosme 

CUSK-EEL 

Lepophidium spp. 

Brotula clarkae 

CUTLASSFISH 

Aphanopus carbo 

Lepidopus caudatus 

Trichiurus spp. 

DACE Rhinichthys ssp. √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

37 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

DACE, 

AQUACULTURED 

Rhinichthys ssp. √ √ 

DORY 

Cyttus 

novaezealandiae 

Zenopsis spp. 

Zeus spp. 

DRIFTFISH Hyperoglyphe spp. 

DRUM 

Equetus punctatus √ 

Larimus spp. √ 

Pogonias cromis √ 

Stellifer spp. √ 

Totoaba macdonaldi √ 

Umbrina coroides √ 

DRUM OR CUBBYU Pareques umbrosus7 √ 

DRUM, FRESHWATER Aplodinotus grunniens √ 

DRUM OR LION FISH Collichthys spp. √ 

DRUM OR MEAGRE Argyrosomus regius7 √ 

DRUM OR 

QUEENFISH 

Seriphus politus √ 

DRUM OR REDFISH Sciaenops ocellatus √ 

DRUM OR REDFISH, 

AQUACULTURED 

Sciaenops ocellatus √ √ 

EEL Anguilla spp. 

EEL, 

AQUACULTURED 

Anguilla Anguilla √ √ 

Anguilla australis √ √ 

Anguilla dieffenbachii √ √ 

Anguilla japonica7 √ √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

38 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

EEL, CONGER 

Ariosoma balearicum √ 

Conger spp. √ 

Gnathophis cinctus √ 

Rhynchoconger spp. √ 

Paraconger 

caudilimbatus 

√ 

EEL, FRESHWATER Anguilla rostrata √ 

EEL, FRESHWATER, 

AQUACULTURED 

Anguilla rostrata √ √ 

EEL, MORAY 

Gymnothorax funebris CFP 

Lycodontis javanicus CFP 

Muraena retifera 

EEL, SPINY Notacanthus 

chemnitzii 

EELPOUT 

Zoarces americanus √3 

Zoarces viviparus √3 

ELEPHANT FISH Callorhynchus millii 

EMPEROR Lethrinus spp. 

ESCOLAR OR 

OILFISH 

Lepidocybium 

flavobrunneum 

G √ 

Ruvettus pretiosus G √ 

FEATHERBACK Notopterus notopterus 

FLATHEAD Platycephalus conatus 

FLATWHISKERED 

FISH8 

Pinirampus 

pirinampu 

√ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

39 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

FLOUNDER 

Ancylopsetta dilecta √3 √1 

Arnoglossus scapha √3 √1 

Reinhardtius 

evermanni 

√3 √1 

Bothus spp. √3 √1 

Chascanopsetta 

crumenalis 

√3 √1 

Cleisthenes pinetorum √3 √1 

Colistium spp. √3 √1 

Cyclopsetta chittendeni √3 √1 

Hippoglossoides 

robustus 

√3 √1 

Limanda ferruginea √3 √1 

Liopsetta glacialis √3 √1 

Microstomus achne √3 √1 

Paralichthys albigutta √3 √1 

Hippoglossina oblonga √3 √1 

Paralichthys olivaceus √3 √1 

Paralichthys 

patagonicus 

√3 √1 

Paralichthys 

squamilentus 

√3 √1 

Pelotretis flavilatus √3 √1 

Peltorhampus 

novaezeelandiae 

√3 √1 

Platichthys spp. √3 √1 

Pseudorhombus spp. √3 √1 

Rhombosolea spp. √3 √1 

Samariscus 

triocellatus 

√3 √1 

Scophthalmus spp. √3 √1 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

40 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

FLOUNDER, 

AQUACULTURED 

Ancylopsetta dilecta √3,4 √ √ 

Arnoglossus scapha √3,4 √ √ 

Reinhardtius 

evermanni 

√3,4 √ √ 

Bothus spp. √3,4 √ √ 

Chascanopsetta 

crumenalis 

√3,4 √ √ 

Cleisthenes pinetorum √3,4 √ √ 

Colistium spp. √3,4 √ √ 

Cyclopsetta chittendeni √3,4 √ √ 

Hippoglossoides 

robustus 

√3,4 √ √ 

Limanda ferruginea √3,4 √ √ 

Liopsetta glacialis √3,4 √ √ 

Microstomus achne √3,4 √ √ 

Paralichthys spp. √3,4 √ √ 

Pelotretis flavilatus √3,4 √ √ 

Peltorhampus 

novaezeelandiae 

√3,4 √ √ 

Pseudorhombus spp. √3,4 √ √ 

Rhombosolea spp. √3,4 √ √ 

Samariscus 

triocellatus 

√3,4 √ √ 

Scophthalmus spp. √3,4 √ √ 

FLOUNDER OR DAB 

Limanda limanda7 √3 √1 

Limanda proboscidea7 √3 √1 

Limanda 

punctatissima7 

√3 √1 

FLOUNDER OR 

FLUKE 

Paralichthys dentatus √3 √1 

Paralichthys 

lethostigma 

√3 √1 

Paralichthys microps √3 √1 

Platichthys flesus7 √3 √1 

FLOUNDER, 

ARROWTOOTH 

Reinhardtius 

hippoglossoides 

√3 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

41 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

FLYINGFISH 

AND ROE 

Cypselurus spp. 

Exocoetus spp. 

Fodiator acutus 

Hirundichthys spp. 

Oxyporhamphus 

micropterus 

Parexocoetus 

brachypterus 

Prognichthys 

gibbifrons 

FROG Rana spp. √3 √ 

GAR Lepisosteus spp. √ 

GEMFISH 

Epinnula magistralis 

Nesiarchus nasutus 

Lepidocybium 

flavobrunneum 

G √ 

GEMFISH OR 

BARRACOUTA 

Rexea solandri 

Thyrsites atun 

GEMFISH OR 

CABALLA 

Thyrsites lepidopoides 

GILLBACKER OR 

GILLEYBAKA8 

Aspistor parkeri 

GOATFISH 

Mulloidichthys spp. 

Mulloidichthys 

vanicolenis 

Mullus auratus 

Parupeneus spp. 

Pseudupeneus spp. 

Upeneichthys lineatus 

Upeneus spp. 

GOBY Neogobius 

melanostomus 

√ 

GRAYLING Thymallus arcticus √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

42 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

GREENBONE Odax pullus7 

GREENLING Hexagrammos spp. 

GRENADIER 

Coryphaenoides spp. 

Lepidorhynchus 

denticulatus 

Macruronus spp7 

Nezumia bairdii7 

Trachyrhynchus spp.7 

GROUPER 

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 

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 

GROUPER OR 

CORAL GROUPER 

Plectropomus spp. 

√3 

CFP 

GROUPER OR GAG Mycteroperca 

microlepis 

√3 CFP 

GROUPER OR HIND Epinephelus guttatus √3 CFP 

GROUPER OR 

JEWFISH 

Epinephelus itajara √3 

GRUNION Leuresthes tenuis 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

43 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

GRUNT 

Anisotremus 

interruptus 

Conodon nobilis 

Haemulon spp. 

Orthopristis 

chrysoptera 

Pomadasys crocro 

GRUNT OR 

CATALINA 

Anisotremus taeniatus 

GRUNT OR 

MARGATE 

Haemulon album 

Anisotremus 

surinamensis7 

GRUNT OR 

SWEETLIPS 

Plectorhinchus spp. 

HADDOCK Melanogrammus 

aeglefinus 

HAKE Urophycis spp. 

HALIBUT Hippoglossus spp. √3 

HALIBUT, 

AQUACULTURED 

Hippoglossus spp. √3,4 √ √ 

HALIBUT OR 

CALIFORNIA 

HALIBUT 

Paralichthys 

californicus 

√3 

HAMLET, MUTTON Alphestes afer 7 

HERRING 

Etrumeus teres √3 √ √ 

Harengula thrissina √3 √ √ 

Ilisha spp. √3 √ √ 

Opisthopterus tardoore √3 √ √ 

Pellona ditchela √3 √ √ 

Alosa spp. √ √ 

HERRING OR SEA 

HERRING OR SILD 

Clupea spp. √3 √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

44 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

HERRING OR SEA 

HERRING OR SILD 

ROE 

Clupea spp. √3 

HERRING, THREAD Opisthonema spp. √ √ 

HIND 

Epinephelus guttatus √3 CFP 

Epinephelus 

adscensionis 

√3 CFP 

Epinephelus 

drummondhayi 

√3 

HOGFISH Lachnolaimus 

maximus 

√3 CFP 

HORSE MACKEREL 

OR SCAD 

Trachurus trachurus √3 √ 

JACK 

Caranx spp. √3 CFP √ 

C. ignobilis √3 CFP √ 

C.melampygus √3 CFP √ 

C.latus √3 CFP √ 

C. lugubris √3 CFP √ 

C. ruber √3 CFP √ 

Carangoides 

bartholomaei 

√3 CFP √ 

Oligoplites saurus √3 √ 

Selene spp. √3 √ 

Seriola rivoliana √3 CFP √ 

Urapsis secunda √3 √ 

JACK OR BLUE 

RUNNER 

Caranx crysos √3 CFP √ 

JACK OR CREVALLE Alectis indicus7 √3 √ 

JACK OR RAINBOW 

RUNNER 

Elagatis bipinnulata √3 CFP √ 

JACK OR 

ROOSTERFISH 

Nematistius pectoralis √3 √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

45 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

JOBFISH 

Aphareus spp. √3 CFP 

Aprion spp. √3 CFP 

Pristipomoides spp. √3 CFP 

KAHAWAI Arripis spp. √3 √ 

KINGFISH6 Menticirrhus spp. 

KINGKLIP Genypterus spp. 

LADYFISH Elops spp. 

LING Molva spp. 

LING, 

MEDITERRANEAN 

Molva 

macrophthalma7 

LINGCOD Ophiodon elongatus 

LIZARDFISH Synodus spp. 

LOACH Somileptus gongota 

LUMPFISH ROE Cyclopterus lumpus 

MACKEREL 

Gasterochisma 

melampus 

√3 √ 

Grammatorcynus spp. √3 √ 

Rastrelliger kanagurta √3 √ 

Scomber scombrus √3 √ 

MACKEREL, ATKA Pleurogrammus 

monopterygius 

√3 

MACKEREL, CHUB Scomber spp. √3 √ 

MACKEREL, JACK Trachurus spp. √3 √ 

MACKEREL, SPANISH 

Scomberomorus spp. √3 √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

46 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

MACKEREL, 

NARROW-BARRED 

SPANISH 

Scomberomorus 

commerson 

CFP √ 

MACKEREL, SPANISH 

OR KING 

Scomberomorus 

cavalla 

√3 CFP √ 

MAHI-MAHI Coryphaena spp. √ 

MAHI-MAHI, 

AQUACULTURED 

Coryphaena spp. √ √ √ 

MARLIN Makaira spp. √ 

Tetrapturus spp. √ 

MENHADEN 

Brevoortia spp. √9 √10 

Ethmidium 

maculatum 

√9 √10 

MILKFISH Chanos chanos √ 

MILKFISH, 

AQUACULTURED 

Chanos chanos √ √ 

MONKFISH Lophius spp. √3 

MORWONG 

Aplodactylus 

arctidens7 

Cheilodactylus spp. 

Goniistius spp. 

Nemadactylus spp. 

MULLET 

Agonostomus 

monticola 

√3 √ 

Aldrichetta forsteri √3 √ 

Crenimugil crenilabis √3 √ 

Mugil spp. √3 √ 

Mullus spp. √3 √ 

Mugil cephalus7 √3 √ 

Mugil thoburni √3 √ 

MUSKELLUNGE Esox masquinongy √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

47 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

OPAH Lampris guttatus 

OPALEYE Girella nigricans 

OREO DORY 

Allocyttus niger 

Neocyttus spp. 

Pseudocyttus spp. 

OSCAR Astronotus ocellatus √ 

OSCAR, 

AQUACULTURED 

Astronotus ocellatus √ √ 

PACU Myleus pacu 

PADDLEFISH AND 

ROE 

Polyodon spp. √ 

PADDLEFISH 

AND ROE, 

AQUACULTURED 

Polyodon spp. √ √ 

PANGASIUS, GIANT8 Pangasius gigas √ 

PANGASIUS 

SHORTBARBEL8 

Pangasius 

micronemus 

√ 

PARROTFISH Scarus spp. CFP2 

Bolbometopon spp. 

PATAGONIAN 

TOOTHFISH OR 

CHILEAN SEA BASS 

Dissostichus 

eleginoides7 

√3 

PERCH 

Hermosilla azurea √ 

Perca fluviatilis √ 

PERCH, LAKE OR 

YELLOW 

Perca flavescens √ 

PERCH, NILE Lates niloticus √ 

PERCH, NILE, 

AQUACULTURED 

Lates niloticus √ √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

48 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

PERCH, OCEAN Sebastes spp. √3 

PERCH, PILE Rhacochilus vacca √ 

PERCH, SILVER Bairdiella chrysoura √ 

PERCH, WHITE Morone americana √ 

PICAREL Spicara maena √ 

PICKEREL Esox spp. √ 

PIKE Esox lucius √ 

PILCHARD 

OR SARDINE 

Sardina pilchardus √ 

Sardinops spp. √ 

PIRAMUTABA OR 

LAULAO FISH8 

Brachyplatystoma 

vaillantii 

√ 

PLAICE 

Hippoglossoides 

platessoides 

√3 

Pleuronectes platessa √3 

Pleuronectes 

quadrituberculatus 

√3 

POLLOCK Pollachius pollachius √3 

Pollachius virens √3 

POLLOCK OR 

ALASKA POLLOCK 

Theragra 

chalcogramma 

√3 

POMFRET 

Brama spp. 

Parastromateus spp. 

Taractes rubescens 

POMPANO 

Alectis ciliaris CFP 

Parastromateus niger 

Trachinotus spp. 

POMPANO 

OR PERMIT 

Trachinotus kennedyi 

Trachinotus falcatus 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

49 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

POMPANO 

OR POMPANITO 

Trachinotus rhodopus 

PORGY 

Calamus spp. 

Chrysophrys auratus 

Dentex spp. 

Diplodus spp. 

Lagodon rhomboides 

Pagrus spp. 

Pterogymnus laniarus 

Stenotomus caprinus 

PORGY OR SCUP Stenotomus chrysops 

PUFFER 

Arothron spp. T, PSP 

Lagocephalus spp. T, PSP 

Sphoeroides annulatus T, PSP 

Sphoeroides nephelus T, PSP 

Sphoeroides maculatus T, PSP 

Sphoeroides spengleri T, PSP 

Sphoeroides 

testudineus 

T, PSP 

Takifugu spp.7 T, PSP 

Tetraodon spp. T, PSP 

PUFFER, 

AQUACULTURED 

Takifugu spp.7 T, PSP √ √ 

RACEHORSE Congiopodus 

leucopaecilus 

RITA Rita rita 

ROCKFISH 

Scorpaena papillosus √3 

Scorpaena cardinalis √3 

Sebastes spp. √3 

ROCKLING Ciliata spp. 

Enchelyopus cimbrius 

ROHU Labeo rohita √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

50 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

ROSEFISH Helicolenus 

dactylopterus 

ROUGHY Paratrachichthys trailli 

ROUGHY, ORANGE Hoplostethus 

atlanticus 

ROUGHY, SILVER 

Hoplostethus 

mediterraneus 

mediterraneus7 

SABLEFISH Anoplopoma fimbria √3 

SAILFISH Istiophorus platypterus √ 

SALMON AND ROE, 

AQUACULTURED 

Oncorhynchus spp. √3,4 √ √ 

Salmo salar √3,4 √ √ 

SALMON AND ROE 

(WILD)(FRESHWATER) 

Oncorhynchus spp. √3 √ 

Salmo salar √3 √ 

SALMON AND ROE, 

(WILD) (OCEAN) 

Oncorhynchus spp. √3 

Salmo salar √3 

SANDDAB Citharichthys sordidus √ 

SANDPERCH Mugiloides chilensis 

Parapercis spp. 

SARDINE Harengula spp. √ 

Sardinella spp. √ 

SAUGER Atule mate7 

SAURY 

Cololabis saira √ 

Scomberesox saurus √ 

SCAD 

Atule mate7 √3 

Decapterus spp. √3 

Selar 

crumenophthalmus 

√3 

Trachurus spp. √3 √ 

SCAD OR HORSE 

MACKEREL 

Trachurus trachurus √3 √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

51 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

SCULPIN 

Hemitripterus 

americanus 

Myoxocephalus 

polyacanthocephalus 

Scorpaenichthys 

marmoratus 

SEA BREAM 

Archosargus 

rhomboidalis 

Chrysophrys auratus7 

Pagellus spp. 

SEAROBIN 

Chelidonichthys spp. 

Peristedion miniatum 

Prionotus carolinus 

Pterygotrigla picta 

SEATROUT Cynoscion spp. √3 

SHAD Alosa spp. √ √ 

SHAD ROE Alosa spp. √ 

SHAD, GIZZARD Dorosoma spp. √ √ 

Nematalosa vlaminghi √ √ 

SHAD, HILSA Tenualosa ilisha √ 

SHARK 

Carcharhinus spp. 

Cetorhinus maximus 

Galeocerdo cuvier 

Galeorhinus spp. 

Hexanchus griseus 

Lamna ditropis 

Negaprion brevirostris 

Notorynchus 

cepedianus 

Prionace glauca 

Sphyrna spp. 

Triaenodon obesus 

Triakis semifasciata 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

52 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

SHARK OR 

PORBEAGLE 

Lamna nasus 

SHARK OR 

SMOOTHHOUND 

Mustelus spp. 

SHARK, ANGEL Squatina spp. 

SHARK, DOGFISH 

OR CAPE SHARK 

Centrophorus spp. 

Mustelus spp. 

Scyliorhinus spp. 

Squalus spp. 

SHARK, MAKO Isurus spp. 

SHARK, THRESHER Alopias spp. 

SHEEPHEAD 

Semicossyphus pulcher √ 

Archosargus 

probatocephalus 

√ 

SHINER Notropis spp. √ 

SILVERSIDE 

Atherinops spp. √ 

Basilichthys australis √ 

Menidia menidia √ 

SKATE Bathyraja spp. √ 

Raja spp. √ 

SKILLFISH Erilepis zonifer 

SMELT 

Allosmerus elongatus √ 

Argentina spp. √ 

Hypomesus spp. √ 

Osmerus spp. √ 

Plecoglossus altivelis 

altivelis7 

√ 

Retropinna retropinna √ 

Spirinchus spp. √ 

Thaleichthys pacificus √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

53 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

SNAKEHEAD 

Channa striata 

Parachanna obscura7 

SNAPPER 

Apsilus dentatus 

Etelis spp. 

Lutjanus spp. CFP 

L. bohar CFP 

L. gibbus CFP 

L. sebae CFP 

L. buccanella CFP 

L. cyanopterus CFP 

L. jocu CFP 

Symphorus 

nematophorus 

CFP 

Macolor spp. 

Ocyurus chrysurus 

Pristipomoides spp. √3 

Rhomboplites 

aurorubens 

Symphorichthys 

spilurus 

SNOOK Centropomus spp. √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

54 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

SOLE OR FLOUNDER 

Aseraggodes spp. √3 

Austroglossus spp. √3 

Buglossidium luteum √3 

Clidoderma 

asperrimum 

√3 

Embassichthys 

bathybius 

√3 

Lyopsetta exilis7 √3 

Eopsetta jordani √3 

Glyptocephalus 

zachirus7 

√3 

Glyptocephalus spp. √3 

Gymnachirus melas √3 

Hippoglossina spp. √3 

Lepidopsetta bilineata √3 

Microchirus spp. √3 

Microstomus kitt √3 

Microstomus pacificus √3 

Pseudopleuronectes 

americanus7 

√3 

Parophrys vetulus7 √3 

Psettichthys 

melanostictus 

√3 

Solea solea7 √3 

Brachirus orientalis7 √3 

Trinectes spp. √3 

Xystreurys liolepis √3 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

55 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

SOLE OR FLOUNDER, 

AQUACULTURED 

Aseraggodes spp. √3,4 √ √ 

Austroglossus spp. √3,4 √ √ 

Buglossidium luteum √3,4 √ √ 

Clidoderma 

asperrimum 

√3,4 √ √ 

Embassichthys 

bathybius 

√3,4 √ √ 

Lyopsetta exilis 7 √3,4 √ √ 

Eopsetta jordani √3,4 √ √ 

Glyptocephalus 

zachirus 7 

√3,4 √ √ 

Glyptocephalus spp. √3,4 √ √ 

Gymnachirus melas √3,4 √ √ 

Hippoglossina spp. √3,4 √ √ 

Lepidopsetta bilineata √3,4 √ √ 

Microchirus spp. √3,4 √ √ 

Pseudopleuronectes 

americanus 7 

√3,4 √ √ 

Parophrys vetulus 7 √3,4 √ √ 

Psettichthys 

melanostictus 

√3,4 √ √ 

Solea solea 7 √3,4 √ √ 

Brachirus orientalis7 √3,4 √ √ 

Trinectes spp. √3,4 √ √ 

Xystreurys liolepis √3,4 √ √ 

SORUBIM 

OR SURUBI8 

Pseudoplatystoma 

corruscans 

√ 

SPADEFISH Chaetodipterus spp. 

SPEARFISH Tetrapturus spp. √ 

SPOT Leiostomus xanthurus √ 

SPRAT OR BRISTLING Sprattus spp. √3 √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

56 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

SQUIRRELFISH 

Holocentrus spp. 

Myripristis spp. 

Sargocentron spp. 

STURGEON 

AND ROE 

Acipenser spp. √ 

Huso huso √ 

Pseudoscaphirhynchus 

spp. 

√ 

Scaphirhynchus spp. √ 

STURGEON 

AND ROE, 

AQUACULTURED 

Acipenser spp. √ √ 

Huso huso √ √ 

Pseudoscaphirhynchus 

spp. 

√ √ 

Scaphirhynchus spp. √ √ 

SUCKER 

Carpiodes spp. √ 

Catostomus 

commersonii 

√ 

Cycleptus elongatus √ 

SUCKER OR 

REDHORSE 

Moxostoma 

macrolepidotum 

√ 

SUNFISH 

(NOT MOLA MOLA) 

Archoplites interruptus √ 

Lepomis spp. √ 

SURFPERCH 

Amphistichus spp. √ 

Cymatogaster 

aggregata 

√ 

Embiotoca spp. √ 

Hyperprosopon 

argenteum 

√ 

Rhacochilus toxotes √ 

SUTCHI OR SWAI8 Pangasius 

hypophthalmus 

√ 

SUTCHI OR SWAI8, 

AQUACULTURED 

Pangasius 

hypophthalmus 

√ √ 

SWORDFISH Xiphias gladius 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

57 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

TANG 

Acanthurus spp. CFP2 

Ctenochaetus spp CFP2 

Naso spp. CFP2 

Zebrasoma spp. 

TARPON Megalops atlanticus √ 

TAUTOG Tautoga onitis √ 

THORNYHEAD Sebastolobus spp. √3 √ 

THREADFIN 

Eleutheronema 

tetradactylum 

Galeoides 

decadactylus 

Gnathanodon spp. 

Polydactylus spp. 

Polynemus spp. 

TIGERFISH Datnioides microlepis √ 

Datnioides polota √ 

TILAPIA 

Tilapia spp. √ 

Oreochromis spp. √ 

Sarotherodon spp √ 

TILAPIA, 

AQUACULTURED 

Oreochromis spp. √ √ 

Sarotherodon spp. √ √ 

Tilapia spp. √ √ 

TILEFISH 

Caulolatilus spp. 

Lopholatilus 

chamaeleonticeps 

Malacanthus plumieri 

Prolatilus jugularis 

TINFOIL Barbonymus altus 

TOMCOD Microgadus spp. √3 

TONGUESOLE Cynoglossus spp. √3 

TRAHIRA Hoplias malabaricus 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

58 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

TREVALLY Caranx spp. √3 CFP √ 

TRIGGERFISH 

Balistes spp. CFP 

Canthidermis 

sufflamen 

Melichthys niger 

Navodon spp. 

TRIPLETAIL 

Datnioides 

quadrifasciatus 

Lobotes spp 

TROUT, 

AQUACULTURED 

Oncorhynchus mykiss 

aguabonita 

√ √ 

Oncorhynchus clarkii √ √ 

Oncorhynchus gilae √ √ 

Oncorhynchus mykiss √ √ 

Salmo trutta √ √ 

Salvelinus fontinalis √ √ 

Salvelinus malma √ √ 

Salvelinus namaycush √ √ 

Stenodus leucichthys √ √ 

TROUT, RAINBOW 

OR STEELHEAD 

Oncorhynchus mykiss √3 

TRUMPETER Latridopis spp. √ 

Latris lineata √ 

TUNA (SMALL) 

Allothunnus fallai √3 √ 

Auxis spp. √3 √ 

Euthynnus spp. √3 √ 

Katsuwonus pelamis √3 √ 

Thunnus tonggol √3 √ 

TUNA (LARGE) 

Thunnus alalunga √ 

Thunnus albacares √ 

Thunnus atlanticus √ 

Thunnus maccoyii √ 

Thunnus obesus √ 

Thunnus thynnus √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

59 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

TUNA, 

AQUACULTURED 

Thunnus spp. √3,4 √ √ √ 

TURBOT 

Pleuronichthys 

guttulatus7 

√3 

Pleuronichthys spp. √3 

Psettodes spp. √3 

Reinhardtius 

hippoglossoides 

√3 

Psetta maxima7 √3 

TURBOT, 

AQUACULTURED 

Psetta maxima √ √ 

TURTLE 

Malaclemys spp. 

Chelydra spp. 

Apalone spp. 

Trachemys spp. 

√ 

TURTLE, 

AQUACULTURED 

Malaclemys spp. 

Chelydra spp. 

Apalone spp. 

Trachemys spp. 

√ √ 

UNICORNFISH Naso unicornis 

WAHOO Acanthocybium 

solandri 

√ 

WALLEYE Sander spp.7 √ 

WAREHOU Seriolella spp. 

WEAKFISH Cynoscion spp. √ 

WEAKFISH OR 

BANGAMARY 

Macrodon ancylodon 

WHISKERED FISH8 Arius spp. √ 

WHISKERED FISH OR 

GAFFTOPSAIL FISH8 

Bagre marinus √ 

WHISKERED FISH OR 

HARDHEAD 

WHISKERED FISH8 

Ariopsis felis √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

60 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11 

WHITEFISH 

Coregonus spp. √ 

Prosopium 

cylindraceum 

√ 

WHITING 

Merluccius gayi 

Merluccius hubbsi 

Merluccius merluccius 

WHITING, BLUE Micromesistius spp. 

WHITING OR 

PACIFIC WHITING 

Merluccius productus 

WHITING, 

NEW ZEALAND 

Macruronus 

novaezelandiae 

WRASSE Cheilinus 

undulatus 

CFP 

WOLFFISH Anarhichas spp. √3 

YELLOW TAIL OR 

AMBERJACK 

Seriola lalandi √ 

YELLOWTAIL 

AMBERJACK, 

AQUACULTURED 

Seriola lalandi7 √ √ √ 

ZANDER Sander lucioperca7 √ 

ZANDER, 

AQUACULTURED 

Sander lucioperca7 √ √ 
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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PARASITES NATURAL 

TOXINS 

SCOMBROTOXIN 

(HISTAMINE) 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

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

62 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PATHOGENS 

CHP 4 

PARASITES 

CHP 5 

NATURAL 

TOXINS 

CHP 6 

ENVIRONMENTAL 

CHEMICALS 

CHP 9 

AQUACULTURE 

DRUGS 

CHP 11 

ABALONE 

Haliotis spp √ √ 

Marinauris roei √ 

Haliotis ruber √ 

Haliotis laevigata √ 

ARKSHELL 

Anadara subcrenata √ √ √ 

Arca spp. √ √ √ 

CLAM, BENTNOSE Macoma nasuta √ √ √ 

CLAM BUTTER Saxidomus spp. √ √ √ 

CLAM, CALICO Macrocallista maculata √ √ √ 

CLAM, GEODUCK Panopea abrupta √ √ √ 

Panopea bitruncata √ √ √ 

CLAM, HARD 

Arctica islandica √ √ √ 

Meretrix spp. √ √ √ 

Venus mortoni √ √ √ 

CLAM, HARDSHELL 

OR QUAHOG 

Protothaca thaca √ √ √ 

Mercenaria spp. √ √ √ 

CLAM, LITTLENECK 

Protothaca staminea √ √ √ 

Protothaca tenerrima √ √ √ 

Tapes variegata √ √ √ 

Tapes virginea √ √ √ 

Venerupis aurea4 √ √ √ 

Venerupis decussata4 √ √ √ 

Venerupis philippinarum √ √ √ 

CLAM, MARSH Corbicula japonica √ √ √ 

CLAM, PISMO Tivela stultorum √ √ √ 

CLAM, RAZOR 

Ensis spp. √ √ √ 

Siliqua spp. √ √ √ 

Solen spp. √ √ √ 

Tagelus spp. √ √ √ 

CLAM, SANGUIN Sanguinolaria spp. √ √ √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

63 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PATHOGENS PARASITES NATURAL 

TOXINS 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11 

CLAM, SOFTSHELL Mya arenaria √ √ √ 

CLAM, SURF OR 

SURFCLAM 

Mactrellona alata √ √ √ 

Mactromeris spp. √ √ √ 

Mactra spp. √ √ √ 

Mactrotomas spp. √ √ √ 

Simomactra spp. √ √ √ 

Spisula spp. √ √ √ 

Tresus spp. √ √ √ 

CLAM, SURF 

AQUACULTURED 

Mactra schalinensis √ √ √ 

CLAM, VENUS 

Chione spp. √ √ √ 

Chionista spp.4 √ √ √ 

Macrocallista nimbosa √ √ √ 

CLAM, WEDGE Paphies spp. √ √ √ 

COCKLE 

Cardium spp. √ √ √ 

Clinocardium spp. √ √ √ 

Dinocardium robustum √ √ √ 

Serripes groenlandicus √ √ √ 

CONCH Strombus spp. √ √ 

Lambis lambis √ √ 

COQUINA Donax spp. √ √ √ 

COQUINA, FALSE Iphigenia brasiliana √ √ √ 

CRAB, BLUE, 

AQUACULTURED 

Callinectes sapidus 

√ 

√ 

CRAB, BLUE Callinectes sapidus √ 

CRAB, BROWN Chaceon fenneri4 √ 

CRAB, BROWN 

KING 

Lithodes aequispinus4 √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

64 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PATHOGENS PARASITES NATURAL 

TOXINS 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11 

CRAB, CENTOLLA 

Lithodes antarcticus √ 

Lithodes murrayi √ 

CRAB, DEEPSEA Paralomis granulosa √ 

CRAB, DUNGENESS Cancer magister √2 √ 

CRAB, JAPANESE 

FRESHWATER 

Geothelphusa dehaani √1 √ 

CRAB, JONAH Cancer borealis √2 √ 

CRAB, KING 

Paralithodes camtschaticus √ 

Paralithodes platypus √ 

CRAB, KING OR 

HANASAKI 

Paralithodes brevipes √ 

CRAB, KOREAN OR 

KEGANI 

Erimacrus isenbeckii √ 

CRAB, LITHODES Neolithodes brodiei √ 

CRAB, RED Chaceon quinquedens4 √ 

CRAB, RED ROCK Cancer productus √2 √ 

CRAB, ROCK 

Cancer irroratus √ 

Cancer pagurus √ 

CRAB, SHEEP Loxorhynchus grandis √ 

CRAB, SNOW 

Chionoecetes angulatus √ 

Chionoecetes bairdi √ 

Chionoecetes opilio √ 

Chionoecetes tanneri √ 

CRAB, SPIDER Jacquinotia edwardsii √ 

Maja squinado √ 

CRAB, STONE Menippe spp.4 √ 

CRAB, SWAMP Scylla serrata √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

65 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PATHOGENS PARASITES NATURAL 

TOXINS 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11 

CRAB, SWAMP, 

AQUACULTURED 

Scylla serrata √ √ 

CRAB, SWIMMING 

Callinectes arcuatus √ 

Callinectes toxotes √ 

Portunus spp. √ 

CRAWFISH OR 

CRAYFISH 

Cambarus spp. √ 

Cherax spp. √ 

Euastacus armatus √ 

Pacifastacus spp. √ 

Paranephrops spp. √ 

Procambarus spp. √ 

Astacus spp. √ 

CRAWFISH OR 

CRAYFISH, 

AQUACULTURED 

Cambarus spp. √ √ 

Cherax spp. √ √ 

Euastacus armatus √ √ 

Pacifastacus spp. √ √ 

Paranephrops spp. √ √ 

Procambarus spp. √ √ 

Astacus spp. √ √ 

CUTTLEFISH Sepia spp. 

JELLYFISH Rhopilema spp. 

KRILL 

Euphausia spp. 

Meganyctiphanes 

norvegica 

Thysandoessa inermis 

LANGOSTINO 

Cervimunida johni 

Munida gregaria 

Pleuroncodes spp. 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

66 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PATHOGENS PARASITES NATURAL 

TOXINS 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11 

LIMPET 

Tectura testudinalis4 

Cellana denticulata 

Diodora aspera 

Fissurella maxima 

Lottia gigantea 

Patella caerulea 

LOBSTER Homarus spp. √3 

LOBSTER, NORWAY Nephrops norvegicus 

LOBSTER, ROCK Jasus spp. 

LOBSTER, 

ROCK OR SPINY 

Palinurus spp. 

Panulirus spp. 

LOBSTER, SLIPPER 

Ibacus ciliatus 

Scyllarides spp. 

Thenus orientalis 

LOBSTERETTE Metanephrops spp. 

Nephropsis aculeata 

MUREX OR MEREX Murex brandaris 

MUSSEL 

Modiolus spp. √ √ √ 

Mytilus spp. √ √ √ 

Perna canaliculus √ √ √ 

OCTOPUS Eledone spp. √1 

Octopus spp. √1 

OYSTER 

Crassostrea spp. √ √ √ 

Ostrea spp. √ √ √ 

Spondylus spp. √ √ √ 

Tiostrea spp. √ √ √ 

PEN SHELL Atrina pectinata √ √ √ 

PERIWINKLE Littorina littorea 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

67 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PATHOGENS PARASITES NATURAL 

TOXINS 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11 

SCALLOP 

Aequipecten spp. √2 √2 √ 

Amusium spp. √2 √2 √ 

Argopecten nucleus √2 √2 √ 

Chlamys spp. √2 √2 √ 

Euvola spp.4 √2 √2 √ 

Patinopecten yessoensis √2 √2 √ 

Pecten spp. √2 √2 √ 

Placopectin magellanicus √2 √2 √ 

SCALLOP 

AQUACULTURED 

Aequipecten spp. √2 √2 √ 

Amusium spp. √2 √2 √ 

Argopecten nucleus √2 √2 √ 

Chlamys spp. √2 √2 √ 

Euvola spp.4 √2 √2 √ 

Patinopecten yessoensis √2 √2 √ 

Pecten spp. √2 √2 √ 

Placopectin magellanicus √2 √2 √ 

SCALLOP OR BAY 

SCALLOP 

Argopecten irradians √2 √2 √ 

SCALLOP, CALICO Argopecten gibbus √2 √2 √ 

SCALLOP OR 

WEATHERVANE 

Patinopecten caurinus √2 √2 √ 

SEA CUCUMBER 

Cucumaria spp. √ 

Holothuria spp. √ 

Parastichopus spp. √ 

Stichopus spp. √ 

SEA URCHIN ROE 

Echinus esculentus √ 

Evechinus chloroticus √ 

Heliocidaris spp. √ 

Loxechimus spp. √ 

Paracentrotus spp. √ 

Pseudocentrotus spp. √ 

Strongylocentrotus spp. √ 

SEABOB Xiphopenaeuskroyeri 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

68 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PATHOGENS PARASITES NATURAL 

TOXINS 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11 

SEA SQUIRT Styela spp. √ 

SHRIMP 

Crangon spp. 

Farfantepenaeus spp.4 

Fenneropenaeus spp.4 

Litopenaeus spp.4 

Marsupenaeus spp.4 

Melicertus spp.4 

Metapenaeus affinis 

Palaemon serratus 

Palaemonetes vulgaris 

Pandalopsis dispar 

Pandalus spp. 

Penaeus spp. 

Pleoticus muelleri 

Plesionika martia 

SHRIMP, 

AQUACULTURED 

Crangon spp. √ √ 

Exopalaemon styliferus √ √ 

Farfantepenaeus spp.4 √ √ 

Fenneropenaeus spp.4 √ √ 

Litopenaeus spp.4 √ √ 

Marsupenaeus spp.4 √ √ 

Macrobrachium spp. √ √ 

Melicertus spp.4 √ √ 

Metapenaeus spp. √ √ 

Palaemon serratus √ √ 

Palaemonetes vulgaris √ √ 

Pandalopsis dispar √ √ 

Pandalus spp. √ √ 

Penaeus spp. √ √ 

Plesionika martia √ √ 

Crangon spp. √ √ 

SHRIMP, 

FRESHWATER 

Macrobrachium spp. 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

69 

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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PATHOGENS PARASITES NATURAL 

TOXINS 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

DRUGS 

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11 

SHRIMP, 

FRESHWATER, 

AQUACULTURED 

Macrobrachium spp. √ √ 

SHRIMP, ROCK Sicyonia brevirostris 

SHRIMP, ROYAL Pleoticus robustus 

SHRIMP 

OR PINK SHRIMP 

Pandalus borealis 

Pandalus jordani 

SHRIMP OR PRAWN Hymenopenaeus sibogae 

SNAIL 

OR ESCARGOT 

Otala spp. √ 

Helix pomatia √ 

Achatina fulica √1 

SNAIL, MOON Polinices spp. √ 

SQUID 

Berryteuthis magister √1 

Dosidicus gigas √1 

Illex spp. √1 

Loligo spp. √1 

Loligo media4 √1 

Lolliguncula spp. √1 

Nototodarus spp. √1 

Ommastrephes spp. √1 

Rossia macrosoma √1 

Sepiola rondeleti √1 

Sepioteuthis spp. √1 

Todarodes sagittatus √1 

TOP SHELL 

Turbo cornutus 

Monodonta turbinata4 

WHELK 

OR SEA SNAIL 

Buccinum spp. 

Busycon spp. √ 

Neptunea spp. √2 
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.) 

MARKET NAMES LATIN NAMES 

HAZARDS 

PATHOGENS PARASITES NATURAL 

TOXINS 

ENVIRONMENTAL 

CHEMICALS 

AQUACULTURE 

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

71 

TABLE 3-4 

POTENTIAL PROCESS-RELATED HAZARDS 

FINISHED 

PRODUCT FOOD1 

PACKAGE 

TYPE 

HAZARDS 

PATHOGENIC BACTERIA GROWTH - 

TEMPERATURE ABUSE

CHP 

12 

C. BOTULINUM TOXIN

CHP 

13 

S. AUREUS TOXIN - DRYING

CHP 

14 

S. AUREUS TOXIN - BATTER

CHP 

15 

PATHOGENIC BACTERIA 

SURVIVAL THROUGH COOKING OR 

PASTEURIZATION

CHP 

16 

PATHOGENIC BACTERIA SURVIVAL THROUGH 

PROCESSES DESIGNED TO

RETAIN RAW PRODUCT CHARACTERISTICS

CHP 

17 

PATHOGENIC BACTERIA CONTAMINATION 

AFTER PASTEURIZATION AND SPECIALIZED 

COOKING PROCESSES

CHP 

18 

ALLERGENS/

ADDITIVES

CHP 

19 

METAL INCLUSION

CHP 

20 

GLASS INCLUSION 

CHP 

21 

Cooked shrimp, 

crab, lobster, 

and other fish, 

including cooked 

meat, sections, 

and whole fish, 

and surimi-based 

analog products 

Reduced oxygen 

packaged (e.g., 

mechanical vacuum, 

steam flush, hot 

fill, MAP, CAP, 

hermetically sealed, 

or packed in oil) 

√ √ √ √ √ 

Cooked shrimp, 

crab, lobster, 

and other fish, 

including cooked 

meat, sections, 

and whole fish, 

and surimi-based 

analog products 

Other than reduced 

oxygen packaged 

√ √ √ √ 

Pasteurized crab, 

lobster, and other 

fish, including 

pasteurized 

surimi-based 

analog products 

Reduced oxygen 

packaged (e.g., 

mechanical vacuum, 

steam flush, hot 

fill, MAP, CAP 

hermetically sealed, 

or packed in oil) 

√ √ √ √ √ √ 

Pasteurized crab, 

lobster, and other 

fish, including 

pasteurized 

surimi-based 

analog products 

Other than reduced 

oxygen packaged 

√ √ √ √ √ 

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 

72 

TABLE 3-4 

POTENTIAL PROCESS-RELATED HAZARDS 

FINISHED 

PRODUCT FOOD1 

PACKAGE 

TYPE 

HAZARDS 

PATHOGENIC BACTERIA GROWTH - 

TEMPERATURE ABUSE

C. BOTULINUM TOXIN

S. AUREUS TOXIN - DRYING

S. AUREUS TOXIN - BATTER

PATHOGENIC BACTERIA 

SURVIVAL THROUGH COOKING OR 

PASTEURIZATION

PATHOGENIC BACTERIA SURVIVAL THROUGH 

PROCESSES DESIGNED TO

RETAIN RAW PRODUCT CHARACTERISTICS

PATHOGENIC BACTERIA CONTAMINATION 

AFTER PASTEURIZATION AND SPECIALIZED 

COOKING PROCESSES

ALLERGENS/

ADDITIVES

METAL INCLUSION

GLASS INCLUSION 

CHP 

12 

CHP 

13 

CHP 

14 

CHP 

15 

CHP 

16 

CHP 

17 

CHP 

18 

CHP 

19 

CHP 

20 

CHP 

21 

Smoked fish Other than reduced 

oxygen packaged 

√ √ √ 

Salads, 

sandwiches, 

dips, cocktails, 

and similar 

seafood products 

prepared from 

ready-to-eat 

fishery products 

Reduced oxygen 

packaged (e.g., 

mechanical vacuum, 

steam flush, hot 

fill, MAP, CAP, 

hermetically sealed, 

or packed in oil) 

√ √ √ √ √ 

Salads, 

sandwiches, 

dips, cocktails, 

and similar 

seafood products 

prepared from 

ready-to-eat 

fishery products 

Other than reduced 

oxygen packaged 

√ √ √ √ 

Battered or 

breaded 

(including 

surface-browned) 

raw shrimp, 

finfish, oysters, 

clams, squid, and 

other fish 

All √ √ √ 

Stuffed crab, 

shrimp, finfish, 

and other fish 

All √ √ √ 

Dried fish All √ √ √ √ √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

73 

TABLE 3-4 

POTENTIAL PROCESS-RELATED HAZARDS 

FINISHED 

PRODUCT FOOD1 

PACKAGE 

TYPE 

HAZARDS 

PATHOGENIC BACTERIA GROWTH - 

TEMPERATURE ABUSE

C. BOTULINUM TOXIN

S. AUREUS TOXIN - DRYING

S. AUREUS TOXIN - BATTER

PATHOGENIC BACTERIA 

SURVIVAL THROUGH COOKING OR 

PASTEURIZATION

PATHOGENIC BACTERIA SURVIVAL THROUGH 

PROCESSES DESIGNED TO

RETAIN RAW PRODUCT CHARACTERISTICS

PATHOGENIC BACTERIA CONTAMINATION 

AFTER PASTEURIZATION AND SPECIALIZED 

COOKING PROCESSES

ALLERGENS/

ADDITIVES

METAL INCLUSION

GLASS INCLUSION 

CHP 

12 

CHP 

13 

CHP 

14 

CHP 

15 

CHP 

16 

CHP 

17 

CHP 

18 

CHP 

19 

CHP 

20 

CHP 

21 

Raw oysters, 

clams, and 

mussels 

Reduced oxygen 

packaged (e.g., 

mechanical vacuum, 

steam flush, hot 

fill, MAP, CAP, 

hermetically sealed, 

or packed in oil) 

√ √ √ √ √ √ 

Raw oysters, 

clams, and 

mussels 

Other than reduced 

oxygen packaged 

√ √ √ √ √ 

Raw fish other 

than oysters, 

clams, and 

mussels (finfish 

and non-finfish) 

Reduced oxygen 

packaged (e.g. 

mechanical vacuum, 

steam flush, hot 

fill, MAP, CAP, 

hermetically sealed, 

or packed in oil) 

√2 √ √ √ 

Raw fish other 

than oysters, 

clams, and 

mussels (finfish 

and non-finfish) 

Other than reduced 

oxygen packaged 

√2 √ √ 

Partially cooked 

or uncooked 

prepared foods 

Reduced oxygen 

packaged (e.g., 

mechanical vacuum, 

steam flush, hot 

fill, MAP, CAP, 

hermetically sealed, 

or packed in oil) 

√ √ √ √ √ 

Partially cooked 

or uncooked 

prepared foods 

Other than reduced 

oxygen packaged 

√ √ √ √ 
CHAPTER 3: Potential Species-Related and Process-Related Hazards 

74 

TABLE 3-4 

POTENTIAL PROCESS-RELATED HAZARDS 

FINISHED 

PRODUCT FOOD1 

PACKAGE 

TYPE 

HAZARDS 

PATHOGENIC BACTERIA GROWTH - 

TEMPERATURE ABUSE

C. BOTULINUM TOXIN

S. AUREUS TOXIN - DRYING

S. AUREUS TOXIN - BATTER

PATHOGENIC BACTERIA 

SURVIVAL THROUGH COOKING OR 

PASTEURIZATION

PATHOGENIC BACTERIA SURVIVAL THROUGH 

PROCESSES DESIGNED TO

RETAIN RAW PRODUCT CHARACTERISTICS

PATHOGENIC BACTERIA CONTAMINATION 

AFTER PASTEURIZATION AND SPECIALIZED 

COOKING PROCESSES

ALLERGENS/

ADDITIVES

METAL INCLUSION

GLASS INCLUSION 

CHP 

12 

CHP 

13 

CHP 

14 

CHP 

15 

CHP 

16 

CHP 

17 

CHP 

18 

CHP 

19 

CHP 

20 

CHP 

21 

Fully cooked 

prepared foods 

Reduced oxygen 

packaged (e.g., 

mechanical vacuum, 

steam flush, hot 

fill, MAP, CAP, 

hermetically sealed, 

or packed in oil) 

√ √ √ √ √ √ 

Fully cooked 

prepared foods 

Other than reduced 

oxygen 

√ √ √ √ √ 

Fermented, 

acidified, 

pickled, salted, 

and LACFs 

All √ √3 √ √ √ 

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 4: Pathogens From the Harvest Area 

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 

This chapter covers the control of pathogens from 

the harvest area for both molluscan shellfish and 

fish other than molluscan shellfish. 

•	 Strategies for control of pathogens 

There are a number of strategies for the control 

of pathogens in fish and fishery products. They 

include: 

•	 Controlling the source (i.e., harvest waters) 

of molluscan shellfish and the time from 

exposure to air (i.e., by harvest or receding 

tide) to refrigeration to control pathogens from 

the harvest area (covered in this chapter); 

•	 Controlling the amount of moisture that is 

available for pathogenic bacteria growth 

(water activity) in the product by drying 

(covered in Chapter 14); 

•	 Controlling the amount of moisture that is 

available for pathogenic bacterial growth 

(water activity) in the product by formulation 

(covered in Chapter 13); 

•	 Controlling the amount of salt or 

preservatives, such as sodium nitrite, in the 

product (covered in Chapter 13); 

•	 Controlling the level of acidity (pH) in the 

product (covered by the Acidified Foods 

regulation, 21 CFR 114, for shelf-stable 

acidified products, and by Chapter 13, for 

refrigerated acidified products); 

•	 Controlling the introduction of pathogenic 

bacteria after the pasteurization process 

(covered in Chapter 18); 

•	 Managing the amount of time that food is 

exposed to temperatures that are favorable 

for pathogenic bacteria growth and toxin 

production (covered generally in Chapter 12; 

for Clostridium botulinum, in Chapter 13; and 

for Staphylococcus aureus in hydrated batter 

mixes, in Chapter 15); 

•	 Killing pathogenic bacteria by cooking or 

pasteurization (covered in Chapter 16) or 

retorting (covered by the Thermally Processed 

Low-Acid Foods Packaged in Hermetically 

Sealed Containers regulation (hereinafter, the 

Low-Acid Canned Foods (LACF) Regulation), 

21 CFR 113); 

•	 Killing pathogenic bacteria by processes that 

retain raw product characteristics (covered in 

Chapter 17). 

•	 Molluscan shellfish 

Pathogens found in waters from which molluscan 

shellfish are harvested can cause disease in 

consumers. For the purposes of this guidance, 

molluscan shellfish include: 

(1) oysters; (2) clams; (3) mussels; and (4) scallops, 

except where the final product is the shucked 

adductor muscle only. The pathogens of concern 

include both bacteria (e.g., Vibrio spp., Salmonella 

spp., Shigella spp., and Campylobacter jejuni (C. 

jejuni)) and viruses (e.g., hepatitis A virus and 

norovirus). See Appendix 7 for a description of the 

public health impacts of these pathogens. 

Pathogens from the harvest area are of particular 

concern in molluscan shellfish because (1) 

environments in which molluscan shellfish grow 

are commonly subject to contamination from 

CHAPTER 4: Pathogens From the Harvest Area 

75 
sewage, which may contain pathogens, and 

contamination from naturally occurring bacteria, 

which may also be pathogens; (2) molluscan 

shellfish filter and concentrate pathogens that 

may be present in surrounding waters; and (3) 

molluscan shellfish are often consumed whole, 

either raw or partially cooked. 

Certain pathogens generally originate 

from human or animal fecal sources (e.g., 

Vibrio cholerae (V. cholerae) O1 and O139, 

Salmonella spp., Shigella spp., C. jejuni, Yersinia 

enterocolitica (Y. enterocolitica), hepatitis A virus, 

and norovirus). Other pathogens are naturally 

occurring in certain waters (e.g., Vibrio vulnificus 

(V. vulnificus), Vibrio parahaemolyticus (V. 

parahaemolyticus), and V. cholerae non-O1 and 

non-O139), and their presence is not associated 

with human or animal fecal sources. 

See Appendix 7 for a description of the public 

health impacts of these pathogens. 

Control of pathogens of human or animal origin 

To minimize the risk of molluscan shellfish 

containing pathogens of human or animal fecal 

origin (e.g., V. cholerae O1 and O139, Salmonella 

spp., Shigella spp., C. jejuni, hepatitis A virus, 

and norovirus), Federal, state, tribal, territorial 

and foreign government agencies, called shellfish 

control authorities, classify waters in which 

molluscan shellfish are found, based, in part, 

on an assessment of water quality. As a result 

of these classifications, molluscan shellfish 

harvesting is allowed from some waters, not 

from others, and only at certain times or under 

certain conditions from others. Shellfish control 

authorities exercise control over the molluscan 

shellfish harvesters to ensure that harvesting 

takes place only when and where it has been 

determined to be safe. 

Other significant elements of shellfish control 

authorities’ efforts to control the safety 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, the 

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. 

The controls listed above serve to minimize the 

risk of molluscan shellfish containing pathogens 

of human or animal origin, but do not fully 

eliminate the risk. As a result, consumption 

of raw or undercooked molluscan shellfish 

may not be safe for individuals with certain 

health conditions, such as liver disease; chronic 

alcohol abuse; diabetes; and stomach, blood, 

and immune disorders. For this reason, shellfish 

control authorities require that shellstock 

intended for raw consumption bear a tag that 

instructs retailers to inform their customers that 

consuming raw or undercooked shellfish may 

increase the risk of foodborne illness, especially 

for individuals with certain medical conditions. 

You can also eliminate the hazard of pathogens 

from the harvest area by properly cooking, 

pasteurizing, or retorting the product. Guidance 

on cooking and pasteurizing to control 

pathogenic bacteria is provided in Chapter 16. 

Mandatory retorting controls are described in 

the LACF Regulation (21 CFR 113). It should be 

noted that neither cooking, nor pasteurizing, nor 

retorting will eliminate the hazards of natural 

toxins or environmental chemical contaminants 

and pesticides that also may be associated with 

molluscan shellfish. Appropriate control strategies 

for these hazards are provided in Chapters 6 and 

9. Additionally, the laws and regulations of states 

that participate in the National Shellfish Sanitation 

Program administered by FDA require that all 

molluscan shellfish be harvested from waters 

authorized for harvesting by the shellfish control 

authority, regardless of how it will be processed. 

Control of naturally occurring pathogens 

To minimize the risk of illness from the 

consumption of molluscan shellfish containing 

CHAPTER 4: Pathogens From the Harvest Area 

76 
naturally occurring pathogens such as V. 

vulnificus, V. parahaemolyticus, and V. cholerae 

non-O1 and non-O139, shellfish control 

authorities place certain controls on the harvest 

of molluscan shellfish. 

Naturally occurring pathogens may be present in 

relatively low numbers at the time that molluscan 

shellfish are harvested but may increase to more 

hazardous levels if they are exposed to time 

and temperature abuse. To minimize the risk of 

growth of Vibrio spp., shellfish control authorities 

place limits on the time from exposure to air (i.e., 

by harvest or receding tide) to refrigeration. The 

length of time is dependent upon the Average 

Monthly Maximum Air Temperature (AMMAT) or 

the Average Monthly Maximum Water Temperature 

(AMMWT) at the time of harvest, which is 

determined by the shellfish control authority. 

In addition to the above, control for V. 

parahaemolyticus in oysters involves (1) a risk 

evaluation by the shellfish control authority to 

determine whether the risk of V. parahaemolyticus 

illness from the consumption of oysters harvested 

from a growing area(s) in a state is reasonably 

likely to occur; and (2) a determination by 

shellfish control authorities about whether a 

growing area(s) in a state has average monthly 

daytime water temperatures that exceed 60°F 

for waters bordering the Pacific Ocean or 81°F 

for waters bordering the Gulf of Mexico and the 

Atlantic Ocean (New Jersey and south) at times 

during which harvesting occurs. If either of these 

conditions is met, the shellfish control authority 

develops and implements a V. parahaemolyticus 

control plan intended to reduce the incidence of 

V. parahaemolyticus illnesses. As part of the plan, 

shellfish control authorities may (1) temporarily 

close some waters to the harvesting of oysters; (2) 

limit the time from exposure to air (i.e., by harvest 

or receding tide) to refrigeration; (3) temporarily 

permit harvesting of oysters for products that will 

be labeled “For Shucking Only” from some waters; 

or (4) temporarily permit harvesting of oysters for 

processes that retain raw product characteristics 

(covered in Chapter 17) only from some waters. 

As with pathogens of sewage origin, the above 

controls for naturally occurring pathogens help 

minimize the risk from these pathogens in 

molluscan shellfish but do not fully eliminate 

the risk. For this same reason, shellfish control 

authorities require that shellstock intended 

for raw consumption bear a tag containing 

an advisory relative to raw and undercooked 

consumption (described above). 

The controls for Vibrio spp. discussed in this 

chapter apply only to molluscan shellfish if they 

are intended for raw consumption. For example, 

they would not be applied to oyster shellstock 

if tags on the containers of shellstock indicate 

that they must be shucked before consumption. 

Vibrio spp. can be eliminated or reduced to nondetectable levels by cooking, pasteurizing, and 

retorting. These control mechanisms are widely 

used in the processing of fishery products for the 

control of pathogens. Guidance for these control 

mechanisms can be found in Chapter 16 (cooking 

and pasteurization to control pathogenic bacteria) 

and the LACF Regulation, 21 CFR 113 (retorting). 

Other mechanisms for control of Vibrio spp. include 

processes that are designed to retain the raw 

characteristics of the food, including individual quick 

freezing (IQF) with extended storage, mild heat, 

high hydrostatic pressure, and irradiation. These 

control mechanisms are covered in Chapter 17. 

Appropriate controls to prevent further growth 

of these pathogenic bacteria during processing, 

storage, and transportation between processors 

are discussed in Chapter 12. 

•	 Fish other than molluscan shellfish 

Pathogens from the harvest area may also be a 

potential hazard for fish other than molluscan 

shellfish. Pathogens may be found on raw 

fish as a result of near-shore harvest water 

contamination, poor sanitary practices on the 

harvest vessel, and poor aquacultural practices. 

The pathogens of concern include those 

described above for molluscan shellfish, but also 

include Listeria monocytogenes and Escherichia 

coli. See Appendix 7 for a description of the 

public health impacts of these pathogens. 

CHAPTER 4: Pathogens From the Harvest Area 

77 
Control of pathogens 

The processor can control pathogens by proper 

cooking, pasteurizing, or retorting. Guidance 

for these control mechanisms can be found in 

Chapter 16 (cooking and pasteurizing to kill 

pathogenic bacteria) and the LACF Regulation, 21 

CFR 113 (retorting). 

For many products (e.g., raw fish fillets), there 

is no cooking, pasteurizing, or retorting step 

performed by the processor. For most of these 

products, cooking is performed by the consumer 

or end user before consumption. FDA is not 

aware of any Hazard Analysis Critical Control 

Point (HACCP) controls that exist internationally 

for the control of pathogens in fish and fishery 

products that are customarily fully cooked by 

the consumer or end user before consumption 

other than a rigorous sanitation regime as part 

of a prerequisite program or as part of HACCP 

itself. The Fish and Fishery Products regulation 

(21 CFR 123.11, “Sanitation control procedures”) 

requires such a regime. The proper application 

of sanitation controls is essential because of the 

likelihood that pathogens in seafood products 

can be introduced through poor handling 

practices by the aquaculture producer, the 

harvester, or the processor. 

For some products (e.g., raw fish intended for 

sushi), there is no cooking performed by either the 

processor, or the consumer, or the end user. When 

the processor has knowledge or has reason to 

know that the product will be consumed without 

a process sufficient to kill pathogens of public 

health concern or where the processor represents, 

labels, or intends for the product to be so 

consumed, the processor should control time and 

temperature exposure of the product to prevent 

growth of bacterial pathogens and formation of 

toxins by any bacterial pathogens that may be 

present in the product. Guidance for these controls 

can be found in Chapter 12 and in Chapter 13 (for 

those products where the packaging technique 

creates a reduced oxygen environment). 

Note: The guidance contained in the remainder of this chapter 

applies to receiving controls for molluscan shellfish only. 

DETERMINE WHETHER THIS POTENTIAL 

HAZARD IS SIGNIFICANT. 

The following guidance will assist you in 

determining whether pathogens from the harvest 

area are a significant hazard at a processing step: 

1.	 Is it reasonably likely that an unsafe level 

of pathogens from the harvest area will be 

introduced at this processing step (e.g., are 

pathogens present in the raw material at an 

unsafe level)? 

Under ordinary circumstances, it would be 

reasonably likely that pathogens of human 

or animal origin from the harvest area could 

enter the process at an unsafe level at the 

receiving step for the following types of fish: 

•	 Raw oysters; 

•	 Raw clams; 

•	 Raw mussels; 

•	 Raw scallops (see information 


provided under “Intended use”).
 

In addition: 

•	 Under ordinary circumstances, it would 

be reasonably likely that an unsafe level 

of V. vulnificus (a naturally occurring 

pathogen) could enter the process 

from oysters harvested from areas that 

have been confirmed as the original 

source of oysters associated with two 

or more V. vulnificus illnesses (e.g., 

states bordering the Gulf of Mexico); 

•	 Under ordinary circumstances, it 

would be reasonably likely that an 

unsafe level of V. parahaemolyticus 

could enter the process from oysters 

harvested from an area that meets any 

one of the following conditions: 

The shellfish control authority

has conducted a risk evaluation 

and determined that the risk of V. 

parahaemolyticus illness from the 

consumption of oysters harvested 

° 

CHAPTER 4: Pathogens From the Harvest Area 

78 
from that growing area is reasonably 

likely to occur. Specific guidance for 

determining risk can be found in the 

“National Shellfish Sanitation Program 

Guide for the Control of Molluscan 

Shellfish 2007 Revision”; 

The shellfish control authority has

determined that harvesting occurs 

in the growing area at a time when 

average monthly daytime water 

temperatures exceed 60°F for waters 

bordering the Pacific Ocean and 

81°F for waters bordering the Gulf of 

Mexico and the Atlantic Ocean (New 

Jersey and south), except where a 

more rigorous risk evaluation has 

led the shellfish control authority 

to conclude that the risk of V. 

parahaemolyticus illness from the 

consumption of oysters harvested 

from that growing area is not 

reasonably likely to occur; 

° 

The growing area has been confirmed 

as the original source of oysters 

associated with two or more V. 

parahaemolyticus illnesses in the past 

3 years. 

° 

2.	 Can an unsafe level of pathogens from the 

harvest area that was introduced at the receiving 

step be eliminated or reduced to an acceptable 

level at this processing step? 

Pathogens from the harvest area should 

also be considered a significant hazard at 

any processing step where a measure is 

or can be used to eliminate the pathogens 

that had been introduced at a previous step 

or is adequate to reduce the likelihood of 

occurrence of the hazard to an acceptable 

level. Measures to eliminate pathogens or to 

reduce the likelihood of occurrence of the 

hazard from the harvest area include: 

•	 Checking incoming molluscan 


shellfish to ensure that they are 


properly tagged or labeled; 


•	 Making sure that incoming molluscan 

shellfish are supplied by a licensed 

harvester (where licensing is required 

by law) or by a certified dealer; 

•	 Killing pathogenic bacteria by 

cooking or pasteurizing (covered in 

Chapter 16) or retorting (covered by 

the LACF Regulation, 21 CFR 113). It 

should be noted that neither cooking 

nor retorting will eliminate the 

hazards of natural toxins or chemical 

contamination that also may be 

associated with molluscan shellfish; 

•	 Killing Vibrio spp. by IQF with 

extended storage, mild heat, 

irradiation, or high hydrostatic 

pressure (covered in Chapter 17); 

•	 Minimizing the growth of V. 

cholerae, V. parahaemolyticus, and V. 

vulnificus by limiting the time from 

exposure to air (i.e., by harvesting 

or receding tide) to refrigeration; 

•	 Including an advisory on tags on 

containers of molluscan shellstock 

intended for raw consumption or 

on containers of shucked molluscan 

shellfish that instructs retailers to 

inform their customers that consuming 

raw or undercooked shellfish may 

increase the risk of foodborne 

illness, especially for individuals 

with certain medical conditions. 

•	 Intended use 

For most raw molluscan shellfish products, 

you should assume that the product will be 

consumed raw. You should, therefore, identify 

the hazard as significant if it meets the criteria in 

the previous section. 

Where the product consists of scallop adductor 

muscle only, it may be reasonable to assume that 

the product will be cooked before consumption. 

In this case, you would not need to identify 

pathogens from the harvest area as a significant 

hazard. However, if you have knowledge, or have 

CHAPTER 4: Pathogens From the Harvest Area 

79 
reason to know, that the scallop adductor muscle 

will be consumed without a process sufficient to 

kill pathogens of public health concern or where 

the processor represents, labels, or intends for the 

product to be so consumed, you should control 

time and temperature exposure of the product 

to prevent growth of bacterial pathogens and 

formation of toxins by any bacterial pathogens that 

may be present in the product. Guidance for these 

controls can be found in Chapter 12 and in Chapter 

13 (for those products where the packaging 

technique creates a reduced oxygen environment). 

The controls for V. vulnificus and V. 

parahaemolyticus that are discussed in this chapter 

do not need to be applied to molluscan shellfish 

that are not marketed for raw consumption. For 

example, they need not be applied to oyster 

shellstock from the Gulf of Mexico if tags on the 

containers of shellstock indicate that they must be 

shucked before consumption. 

IDENTIFY CRITICAL CONTROL POINTS. 

The following guidance will assist you in 

determining whether a processing step is a 

critical control point (CCP) for pathogens from 

the harvest area: 

1.	 Will the product be cooked, pasteurized, or 

retorted sufficiently to kill all bacterial pathogens 

of public health concern during processing in your 

facility? 

a.	 If it will be, you should identify the cook 

step, pasteurization step, or retorting step 

as the CCP. In this case, you would not 

need to identify the receiving step as a 

CCP for the hazard of pathogens from 

the harvest area. However, note that 

neither cooking, nor pasteurizing, nor 

retorting will eliminate the hazards of 

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. 

Additionally, the laws and regulations 

of states that participate in the National 

Shellfish Sanitation Program require that 

all molluscan shellfish be harvested from 

waters authorized for harvesting by the 

shellfish control authority, regardless of 

how it will be processed. 

Example: 

A canned clam chowder processor 

should set the CCP for pathogens from 

the harvest area at the retorting step, 

and would not identify the receiving 

step as a CCP for this hazard. 

b.	 If the product will not be cooked, 

pasteurized, or retorted sufficiently to kill 

bacterial pathogens during processing 

in your facility, you should identify the 

receiving step as a CCP where you can 

exercise control over the source of the 

molluscan shellfish and the time from 

exposure to air (i.e., by harvest or receding 

tide) to refrigeration in order to control 

pathogens from the harvest area. If the 

finished product is shellstock intended for 

raw consumption, you should also identify 

the labeling step or the label (tag) receiving 

step as a CCP, because you can ensure that 

the raw consumption advisory is on the tag. 

Example: 

A processor that shucks raw oysters 

and ships a raw product should 

check the tags of incoming shellstock 

(in-shell oysters), the license of the 

harvesters that supply the shellstock, 

and the length of time between 

exposure to air (i.e., by harvest or 

receding tide) and refrigeration. The 

processor should identify the receiving 

step as the CCP for this hazard. 

CHAPTER 4: Pathogens From the Harvest Area 

80 
Example: 

A processor that ships oyster shellstock 

should check the tags of incoming 

shellstock, the license of the harvesters 

that supply the shellstock, the 

harvest location, and the length of 

time between exposure to air (i.e., 

by harvest or receding tide) and 

refrigeration. The processor should 

identify the receiving step as a CCP 

for this hazard. The processor should 

also identify the labeling step as a CCP 

for this hazard and would check for 

the presence of the raw consumption 

advisory on the label or tag. 

This control approach includes two 

control strategies referred to in this 

chapter as “Control Strategy Example 1 

- Source Control” and “Control Strategy 

Example 2 - Shellstock Temperature 

Control.” Refer to Control Strategy 

Example 2 - Shellstock Temperature 

Control” when controls for V. vulnificus 

or V. parahaemolyticus are needed.” 

Conditions that warrant control for these 

pathogens are described below. 

2.	 If the finished product is raw oyster shellstock 

intended for raw consumption and is harvested 

from a state that has been confirmed as the original 

source of oysters associated with two or more V. 

vulnificus illnesses (e.g., the Gulf of Mexico), will it be 

subjected in your plant to a process that is designed 

to retain raw product characteristics (e.g., mild 

heat processing, IQF with extended storage, high 

hydrostatic pressure processing, or irradiation) and is 

sufficient to kill V. vulnificus during processing in your 

facility (i.e., reduced to a non-detectable level of less 

than 30 Most Probable Number per gram (herein 

referred to as 30 MPN/gram), as defined in the 

“National Shellfish Sanitation Program Guide for the 

Control of Molluscan Shellfish 2007 Revision”)? 

a.	 If the finished product will be subjected 

to such a process in your facility, you 

should identify the processing step 

that is designed to retain raw product 

characteristics as the CCP for control of 

V. vulnificus. In this case, you would not 

need to identify the receiving step as a 

CCP for the control of V. vulnificus. 

Example: 

A Gulf of Mexico oyster processor 

should set the CCP for V. vulnificus 

at the mild heat processing step and 

would not identify the receiving step 

as a CCP for that pathogen. 

If you choose to follow this approach, 

you should refer to Chapter 17 for further 

guidance. 

b.	 If the finished product will not be 

subjected to a process that is designed 

to retain raw product characteristics and 

is sufficient to kill V. vulnificus during 

processing in your facility, you should 

identify the receiving step as a CCP, 

because you can exercise control over 

the time from exposure to air (i.e., by 

harvest or receding tide) to refrigeration 

in order to control V. vulnificus. 

Example: 

A Gulf of Mexico oyster processor 

should set the CCP for V. vulnificus at 

the receiving step. 

This control strategy is referred to as 

“Control Strategy Example 2 - Shellstock 

Temperature Control” Refer to “Control 

Strategy Example 2 - Shellstock 

Temperature Control” when controls for 

V. vulnificus are needed.” These controls 

should be considered in addition to the 

controls contained in “Control Strategy 

Example 1 - Source Control.” If your 

shellfish control authority has developed 

a V. vulnificus control plan, you should 

develop a HACCP plan that is based on 

the requirements of that plan. Elements 

of the control strategy example provided 

in this chapter and in Chapter 17 may be 

useful for development of such a plan. 

CHAPTER 4: Pathogens From the Harvest Area 

81 
3.	 If the finished product is raw oyster shellstock 

intended for raw consumption and is harvested 

from an area where: (1) The shellfish control 

authority has conducted a risk evaluation and 

determined that the risk of V. parahaemolyticus 

illness from the consumption of oysters harvested 

from that growing area is reasonably likely 

to occur; (2) the shellfish control authority 

has determined that harvesting occurs in the 

growing area at a time when average monthly 

daytime water temperatures exceed 60°F for 

waters bordering the Pacific Ocean and 81°F 

for waters bordering the Gulf of Mexico and the 

Atlantic Ocean (New Jersey and south); or (3) 

the waters of the state have been confirmed as 

the original source of oysters associated with two 

or more V. parahaemolyticus illnesses in the past 

3 years, will it be subjected in your facility to a 

process that is designed to retain raw product 

characteristics (e.g., mild heat processing, IQF 

with extended storage, high hydrostatic pressure 

processing, or irradiation) and is sufficient to 

kill V. parahaemolyticus (i.e., reduced to a nondetectable level of less than 30 MPN/gram, 

as defined in the “National Shellfish Sanitation 

Program Guide for the Control of Molluscan 

Shellfish 2007 Revision”)? 

a.	 If the finished product will be subjected to 

such a process in your facility, you should 

identify the processing step designed to 

retain raw product characteristics as the 

CCP for the control of V. parahaemolyticus. 

In this case, you would not need to 

identify the receiving step as a CCP for the 

control of V. parahaemolyticus. 

Example: 

An oyster processor should set the CCP 

for V. parahaemolyticus at the mild 

heat processing step and would not 

identify the receiving step as a CCP 

for that pathogen. 

If you choose to follow this approach, 

you should refer to Chapter 17 for further 

guidance. 

b.	 If the finished product will not be 

subjected in your facility to a process 

that is designed to retain raw product 

characteristics and is sufficient to kill V. 

parahaemolyticus during processing, 

you should identify the receiving step 

as a CCP, because you can exercise 

control over the time from exposure 

to air (i.e., by harvest or receding tide) 

to refrigeration in order to control V. 

parahaemolyticus or exercise other 

controls as determined by your state’s V. 

parahaemolyticus control plan. 

Example: 

An oyster processor should set the 

CCP for V. parahaemolyticus at the 

receiving step. 

This control strategy is referred to as 

“Control Strategy Example 2 - Shellstock 

Temperature Control.” Refer to “Control 

Strategy Example 2 - Shellstock 

Temperature Control” when controls for 

V. parahaemolyticus are needed.” These 

controls should be considered in addition 

to the controls contained in “Control 

Strategy Example 1 - Source Control.” 

If your shellfish control authority has 

developed a V. parahaemolyticus control 

plan, you should develop a HACCP plan 

that is based on the requirements of that 

plan. Elements of the control strategy 

examples provided in this chapter 

and in Chapter 17 may be useful for 

development of such a plan. 

Only the primary processor (the processor who 

takes possession of the molluscan shellfish 

from the harvester) should apply the time-torefrigeration controls for Vibrio spp. that are 

discussed in this chapter, because this processor 

is in the best position to control the time from 

exposure to air (i.e., by harvest or receding tide) 

to refrigeration. 

CHAPTER 4: Pathogens From the Harvest Area 

82 
DEVELOP A CONTROL STRATEGY. 

The following guidance provides three examples 

of control strategies for pathogens from the 

harvest area. You may select a control strategy 

that is different from those which are suggested, 

provided it complies with the requirements of the 

applicable food safety laws and regulations, except 

that some parts of “Control Strategy Example 1 - 

Source Control” are specifically required by the 

Procedures for the Safe and Sanitary Processing 

and Importing of Fish and Fishery Products 

regulation, 21 CFR 123 (called the Seafood HACCP 

Regulation in this guidance document). 

The following are examples of control strategies 

included in this chapter: 

MAY APPLY TO 

PRIMARY 

PROCESSOR 

MAY APPLY TO 

SECONDARY 

PROCESSOR 

CONTROL STRATEGY 

Source control  

Shellstock temperature 

control 

•	 CONTROL STRATEGY EXAMPLE 1- 

SOURCE CONTROL 

Note: The following controls should be considered in addition to 

those in “Control Strategy Example 2 - Shellstock Temperature 

Control.” 

Set Critical Limits. 

•	 All containers of shellstock (in-shell 

molluscan shellfish) received from a 

harvester must bear a tag that discloses the 

date and place they were harvested (by 

state and site), type and quantity of shellfish, 

and information on the harvester or the 

harvester’s vessel (i.e., the identification 

number assigned to the harvester by the 

shellfish control authority, where applicable, 

or if such identification numbers are not 

assigned, the name of the harvester or 

the name or registration number of the 

harvester’s vessel). For bulk shipments 

of shellstock where the shellstock is not 

containerized, the shellstock must be 

accompanied by a bill of lading or similar 

shipping document that contains the same 

information; 

Note: The source controls listed in this critical limit are required under 

21 CFR 123.28(c). 

OR 

•	 All containers of shellstock received from 

a processor must bear a tag that discloses 

the date and place they were harvested 

(by state and site), the type and quantity of 

shellfish, and the certification number of the 

processor; 

OR 

•	 All containers of shucked molluscan shellfish 

must bear a label that identifies the name, 

address, and certification number of the 

packer or repacker of the product; 

AND 

•	 All molluscan shellfish must have been 

harvested from waters authorized for 

harvesting by a shellfish control authority. 

For U.S. federal waters, no molluscan 

shellfish may be harvested from waters that 

are closed to harvesting by an agency of the 

federal government; 

AND 

•	 All molluscan shellfish must be from a 

harvester that is licensed as required (note 

that licensing may not be required in all 

jurisdictions) or from a processor that is 

certified by a shellfish control authority; 

AND 

•	 All finished product shellstock intended 

for raw consumption must bear a tag that 

instructs retailers to inform their customers 

that consuming raw or undercooked shellfish 

may increase the risk of foodborne illness, 

especially for individuals with certain 

medical conditions. 

Note: Only the primary processor, the processor that takes possession 

of the molluscan shellfish from the harvester, needs to apply controls 

relative to the identification of the harvester, the harvester’s license, or 

the approval status of the harvest waters. 

CHAPTER 4: Pathogens From the Harvest Area 

83 
Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 Information contained on tags on containers 

of incoming shellstock or on the bill 

of lading or similar shipping document 

accompanying bulk shipments of shellstock; 

AND 

•	 Information on whether the harvest area is 

authorized for harvest by a shellfish control 

authority or information on whether federal 

harvest waters are closed to harvesting by an 

agency of the federal government; 

OR 

•	 Information contained on labels on 

containers of incoming shucked molluscan 

shellfish; 

AND 

•	 The harvester’s license, where applicable; 

AND 

•	 The raw consumption advisory on tags on 

containers of finished product shellstock 

intended for raw consumption or the 

raw consumption advisory on labels on 

containers of shucked molluscan shellfish. 

»	 How Will Monitoring Be Done? 

•	 Perform visual checks; 

AND 

•	 Ask the shellfish control authority of the 

state in which your shellstock are harvested 

whether the harvest area is authorized for 

harvest. 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 For checking incoming tags: 

Every container; ° 

OR 

•	 For checking the bill of lading or similar 

shipping document:
 

Every delivery;
 ° 

OR 

•	 For checking incoming labels: 

At least three containers randomly 

selected from every lot;
 

° 

AND
 

•	 For checking licenses: 

Every delivery; ° 

AND 

•	 For checking the raw consumption advisory 

on finished product tags or labels: 

Each container of finished product 

shellstock intended for raw consumption 

or at least three containers randomly 

selected from every lot of shucked 

molluscan shellfish. 

° 

»	 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 

•	 Relabel finished product shellstock intended 

for raw consumption that does not bear a tag 

that contains the raw consumption advisory 

or relabel shucked molluscan shellfish that 

does not bear a label that contains the raw 

consumption advisory; 

OR 

•	 Reject any incoming tags to be used on 

finished product shellstock intended for 

raw consumption that do not contain the 

raw consumption advisory or reject any 

incoming labels to be used on shucked 

molluscan shellfish that do not contain the 

raw consumption advisory. 

AND 

CHAPTER 4: Pathogens From the Harvest Area 

84 
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, tagging, 

and/or label manufacturing practices have 

changed; 

OR 

•	 Modify labeling practices. 

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 

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 

° Quantity and type of shellfish; 

AND 

Name and certification number of the 

packer or repacker; 

° 

AND 

Presence of the raw consumption 

advisory. 

° 

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 

85 
CHAPTER 4: Pathogens From the Harvest Area 

86 

TABLE 4-1

CONTROL STRATEGY EXAMPLE 1 - SOURCE CONTROL

This table is an example of a portion of a HACCP plan using “Control Strategy Example 1 - Source Control.” This example illustrates how a primary processor (processor that takes possession of the oysters from the harvester) of shellstock oysters, that is, the shellstock shipper, can control pathogens from the harvest area. It is provided forillustrative purposes only. This control strategy should be considered in addition to “Control Strategy Example 2 - Shellstock Temperature Control.”Pathogens from the harvest area may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., natural toxins, environmental chemical contaminants and pesticides, and pathogens during processing).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS FOR

EACH PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE ACTION(S) RECORDS VERIFICATION

WHAT HOW FREQUENCY WHO 

Receiving 

shellstock 

Pathogens 

from the

harvest area 

All incoming

shellstock must be

tagged with the date

and place of harvest,

type and quantity of

shellfish, and name or 

registration number of 

the harvester’s vessel 

Information on 

incoming shellstock

tags 

Visual

checks 

Every sack Receiving 

employee 

Reject the lot

Discontinue use of the

supplier until evidence 

is obtained that tagging

practices have changed 

Receiving 

record 

Review 

monitoring and

corrective action 

records within

1 week of 

preparation 

All shellstock must be

from waters approved 

by the state shellfish 

control authority 

Harvest site on tags

Ask the shellfish

control authority of

the state in which the

shellstock are harvested 

whether the area is

authorized for harvest 

Visual

checks 

Every lot Receiving 

employee 

Reject lots from 

unapproved waters

Discontinue use of the

supplier until evidence is 

obtained that harvesting 

practices have changed 

Receiving 

record 

All shellstock must

be from a licensed

harvester 

Harvester’s license Visual

checks 

Every 

delivery 

Receiving 

employee 

Reject lots from unlicensed 

harvesters

Discontinue use of the

supplier until evidence is 

obtained that the harvester 

has secured a license 

Receiving 

record 
 

•	 CONTROL STRATEGY EXAMPLE 2 - SHELLSTOCK 

TEMPERATURE CONTROL 

Note: The following controls should be considered in addition to 

those in “Control Strategy Example 1 - Source Control.” 

Set Critical Limits. 

•	 When controls for neither V. vulnificus nor V. 

parahaemolyticus are needed: 

For AMMAT of less than 66°F (less than 

19°C): 36 hours;
 

° 

OR
 

For AMMAT of 66 to 80°F (19 to 27°C): 


24 hours; 

° 

OR 

For AMMAT of greater than 80°F (greater 

than 27°C): 20 hours; 

° 

Note: AMMAT is determined by the shellfish control authority. 

OR 

•	 When controls for V. vulnificus are needed: 

For AMMWT of less than 65°F (less than 

18°C): 36 hours; 


OR
 

For AMMWT of 65 to 74°F (18 to 23°C): 


14 hours; 

° 

° 

OR 

For AMMWT of greater than 74 to 84°F 

(greater than 23 to 29°C): 12 hours; 

° 

OR 

For AMMWT of greater than 84°F (greater 

than 29°C): 10 hours; 

° 

Note: AMMWT is determined by the shellfish control authority. The 

shellfish control authority may implement time to temperature controls 

that are more stringent than those described here. Processors should 

consult with their shellfish control authority for current requirements. 

OR 

When controls for V. parahaemolyticus are 

needed: 

•	

For AMMAT of less than 66°F (less than 

19°C): 36 hours;
 

° 

OR
 

For AMMAT of 66 to 80°F (19 to 27°C): 
 ° 

12 hours; 

OR 

For AMMAT of greater than 80°F (greater 

than 27°C): 10 hours. 

° 

Note: AMMAT is determined by the shellfish control authority. The 

shellfish control authority may implement time to temperature controls 

that are more stringent than those described here. Processors should 

consult with their shellfish control authority for current requirements. 

Note: Only the primary processor, the processor that takes possession 

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 

refrigeration. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 The time shellfish was exposed to air (i.e., by 

harvest or receding tide); 

AND 

•	 The time shellstock was placed under 

refrigeration; 

»	 How Will Monitoring Be Done? 

•	 For the time from exposure to air (i.e., by 

harvest or receding tide) to refrigeration: 

Obtain information from the shellfish 

control authority; 


° 

OR
 

Check the harvester’s log or tags; 
 ° 

OR 

Note the time of departure from and 

return to dock; 


° 

OR
 

Ask the harvester.
 ° 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 Every delivery. 

»	 Who Will Do the Monitoring? 

•	 Any person who has an understanding of 

the nature of the controls may perform the 

monitoring. 

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 
CHAPTER 4: Pathogens From the Harvest Area 

89 

TABLE 4-2

CONTROL STRATEGY EXAMPLE 2 - SHELLSTOCK TEMPERATURE CONTROL

(V. VULNIFICUS MODEL)

This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Shellstock Temperature Control.” This example illustrates how a primary processor (one that takes possession of the oysters from the harvester) of shellstock oysters, that is, the shellstock shipper, can control the pathogen from the harvest area, V. vulnificus. It is provided for illustrative purposes only. This control strategy should be considered in addition to “Control Strategy Example 1 - Source Control.”Pathogens from the harvest area may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., natural toxins, environmental chemical contaminants and pesticides, and pathogens during processing).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Receiving 

shellstock 

Pathogens from 

the harvest area 

Maximum time

from harvest to 

refrigeration: 

AMMWT < 65°F: 

36 hours

AMMWT 65 to 

74°F: 14 hours

AMMWT >74 to 

84°F: 12 hours;

AMMWT >84oF: 

10 hours 

Time of 

harvest 

Harvester’s log Every 

delivery 

Receiving 

employee 

Reject lot

Discontinue use

of the supplier

until

evidence is 

obtained that

harvesting 

practices 

have changed 

Receiving 

record 

Review 

monitoring and

corrective 

action 

records within

1 week of 

preparation 

Time 

placed in

refrigeration 

Visual checks Every 

delivery 

Receiving 

employee

AMMWT = Average Monthly Maximum Water Temperature 
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 NonFDA Web site references after March 29, 2011. 

•	 Cook, D. W., J. C. Bowers, and A. DePaola. 

2002. Density of total and pathogenic (tdh+) 

Vibrio parahaemolyticus in Atlantic and Gulf 

Coast molluscan shellfish at harvest. J. Food 

Prot. 65:1873-1880. 

•	 DePaola, A., L. H. Hopkins, J. T. Peeler, 

B. Wentz, and R. M. McPhearson. 1990. 

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. 

•	 U.S. Centers for Disease Control and 

Prevention. 2001. “Norwalk-like viruses: 

Public health consequences and outbreak 

management. Morb. Mortal. Wkly. Rep. 50:1-18. 

•	 U.S. Centers for Disease Control and 

Prevention. February 2010 Norovirus: 

Technical Fact Sheet. Atlanta, GA. http://www. 

cdc.gov/ncidod/dvrd/revb/gastro/norovirusfactsheet.htm. 

•	 U.S. Food and Drug Administration. 2007. 

National Shellfish Sanitation Program Guide 

for the control of molluscan shellfish 2007 

revision. Department of Health and Human 

Services, Public Health Service, Food and 

Drug Administration, Division of Seafood 

Safety, College Park, MD. http://www.fda.gov/ 

Food/FoodSafety/Product-SpecificInformation/ 

Seafood/FederalStatePrograms/ 

NationalShellfishSanitationProgram/ 

ucm046353.htm. 

CHAPTER 4: Pathogens From the Harvest Area 

90 
CHAPTER 5: Parasites 

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 

Parasites (in the larval stage) consumed in 

uncooked or undercooked seafood can present 

a human health hazard. Among parasites, the 

nematodes or roundworms (Anisakis spp., 

Pseudoterranova spp., Eustrongylides spp., and 

Gnathostoma spp.), cestodes or tapeworms 

(Diphyllobothrium spp.), and trematodes or flukes 

(Chlonorchis sinensis (C. sinensis), Opisthorchis 

spp., Heterophyes spp., Metagonimus spp., 

Nanophyetes salmincola, and Paragonimus spp.) 

are of most concern in seafood. Most of these 

parasites cause mild-to-moderate illness, but 

severe symptoms can occur. Roundworms may 

embed in the intestinal wall and cause nausea, 

vomiting, diarrhea, and severe abdominal pain 

and sometimes may penetrate the intestine. 

Tapeworms can cause abdominal swelling and 

abdominal cramps and may lead to weight loss 

and anemia. Intestinal flukes (Heterophyes spp., 

Metagonimus spp., and Nanophyetes salmincola) 

may cause abdominal discomfort and diarrhea. 

Some intestinal flukes may also migrate to and 

damage the heart and central nervous system. 

Liver flukes (C. sinensis and Opisthorchis spp.) and 

lung flukes (Paragonimus spp.) may migrate to 

the liver and lung and sometimes cause serious 

problems in other vital organs. 

Some products that have been implicated in human 

parasite infection are the following: ceviche (fish and 

spices marinated in lime juice); lomi lomi (salmon 

marinated in lemon juice, onion, and tomato); 

poisson cru (fish marinated in citrus juice, onion, 

tomato, and coconut milk); herring roe; sashimi 

(slices of raw fish); sushi (pieces of raw fish with rice 

and other ingredients); green herring (lightly brined 

herring); drunken crabs (crabs marinated in wine 

and pepper); cold-smoked fish; and, undercooked 

grilled fish. A survey of U.S. gastroenterologists 

confirmed that seafood-borne parasitic infections 

occur in the United States with sufficient frequency 

to recommend preventive controls during the 

processing of parasite-containing species of fish that 

are intended for raw consumption. 

•	 Controlling parasites 

The process of heating raw fish sufficiently 

to kill bacterial pathogens is also sufficient to 

kill parasites. Guidance concerning cooking 

and pasteurizing to kill bacterial pathogens is 

provided in Chapters 13 (hot smoking) and 

16 (cooking and pasteurization). Regulatory 

requirements for retorting (i.e., thermal processing 

of low acid canned foods) are contained in the 

Thermally Processed Low-Acid Foods Packaged 

in Hermetically Sealed Containers regulation, 

21 CFR 113 (hereinafter, the Low-Acid Canned 

Foods (LACF) Regulation). This guidance does not 

provide further information on retorting. 

The effectiveness of freezing to kill parasites 

depends on several factors, including the 

temperature of the freezing process, the length of 

time needed to freeze the fish tissue, the length of 

time the fish is held frozen, the species and source 

of the fish, and the type of parasite present. The 

temperature of the freezing process, the length 

of time the fish is held frozen, and the type of 

parasite appear to be the most important factors. 

For example, tapeworms are more susceptible to 

freezing than are roundworms. Flukes appear to 

be more resistant to freezing than roundworms. 

CHAPTER 5: Parasites 

91 
Freezing and storing at an ambient temperature 

of -4°F (-20°C) or below for 7 days (total time), 

or freezing at an ambient temperature of -31°F 

(-35°C) or below until solid and storing at an 

ambient temperature of -31°F (-35°C) or below for 

15 hours, or freezing at an ambient temperature of 

-31°F (-35°C) or below until solid and storing at an 

ambient temperature of -4°F (-20°C) or below for 

24 hours are sufficient to kill parasites. Note that 

these conditions may not be suitable for freezing 

particularly large fish (e.g., thicker than 6 inches). 

Brining and pickling may reduce the parasite 

hazard in a fish, but they do not eliminate it, 

nor do they minimize it to an acceptable level. 

Nematode larvae have been shown to survive 

28 days in an 80° salinometer brine (21% salt 

by weight). 

Fish that contain parasites in their flesh may also 

contain parasites within their egg sacs (skeins), but 

generally not within the eggs themselves. For this 

reason, eggs that have been removed from the sac 

and rinsed are not likely to contain parasites. 

Trimming away the belly flaps of fish or 

candling and physically removing parasites are 

effective methods for reducing the numbers 

of parasites. However, they do not completely 

eliminate the hazard, nor do they minimize it to 

an acceptable level. 

DETERMINE WHETHER THE POTENTIAL 

HAZARD IS SIGNIFICANT. 

The following guidance will assist you in 

determining whether parasites are a significant 

hazard at a processing step: 

1.	 Is it reasonably likely that parasites will be 

introduced at the receiving step (e.g., do they 

come in with the raw material)? 

Tables 3-2 and 3-3 (Chapter 3) list those 

species for which FDA has information that 

a potential parasite hazard exists. Ordinarily, 

you should identify the receiving step for 

these species as having a significant parasite 

hazard if you know or have reason to know 

that the fish will be consumed without 

thorough cooking by the end user or if you 

represent, label, or intend for the product to 

be consumed in that manner. 

Species of fish not listed with a parasite 

hazard in Tables 3-2 and 3-3 may have a 

parasite hazard that has not been identified 

if these fish are not customarily consumed 

raw or undercooked, or if the hazard occurs 

in certain localized harvest areas that are not 

known commercial sources of fresh fish for 

the U.S. You should consider this possibility 

in your hazard analysis. 

Species that normally have a parasite hazard as 

a result of consuming infected prey apparently 

do not have the same parasite hazard when 

raised only on pelleted feed in an aquaculture 

operation. You need not consider such 

aquacultured fish as having a parasite hazard. 

On the other hand, aquacultured fish that are 

fed processing waste, fresh fish, or plankton 

may have a parasite hazard, even when wildcaught fish of that species do not normally 

have a parasite hazard. Pellet fed fish that 

sometimes depend on wild-caught prey to 

supplement their diet may have a parasite 

hazard. In addition, fish raised in freshwater 

may have a parasite hazard from trematodes 

because these parasites enter the fish through 

the skin rather than in the food. You should 

verify the culture methods used by your 

aquaculture producers before eliminating 

parasites as a significant hazard. 

If the finished product is fish eggs that have 

been removed from the sac (skein) and rinsed, 

the fish eggs are not reasonably likely to 

contain parasites and you need not consider 

such product as having a parasite hazard. 

However, unrinsed fish eggs or fish eggs 

that remain in the sac ordinarily will have a 

parasite hazard if the species is identified in 

Table 3-2 or 3-3 as having a parasite hazard. 

If you receive the fish frozen and have 

documented assurance from your supplier 

that the fish are frozen in a way that will 

CHAPTER 5: Parasites 

92 
kill the parasites (e.g., consistent with the 

guidance in this chapter), you do not need to 

identify the hazard of parasites as reasonably 

likely to occur in your product. 

It is not reasonably likely that parasites will 

enter the process at other processing steps. 

2.	 Can the parasite hazard that was introduced at 

an earlier step be eliminated or reduced to an 

acceptable level at this processing step? 

Parasites should be considered a significant 

hazard at any processing step where a 

preventive measure is, or can be, used to 

eliminate the hazard that was introduced at an 

earlier step or to reduce to an acceptable level 

the likelihood of occurrence of the hazard. 

Preventive measures for parasites can include: 

•	 Retorting (covered in 21 CFR 


113, the LACF Regulation);
 

•	 Hot smoking (covered in Chapter 13); 

•	 Cooking and pasteurization 


(covered in Chapter 16); 


•	 Freezing (covered in this chapter). 

•	 Intended use 

If the consumer intends to cook the fish 

thoroughly before consumption, then you do 

not need to consider the hazard significant, even 

if Table 3-2 or 3-3 lists the species as having a 

potential parasite hazard. In order to eliminate 

parasites as a significant hazard when you are 

unsure of the product’s intended use, you should 

obtain documented assurance from the subsequent 

processor, restaurateur, or institutional user (e.g., 

prison or nursing home) that the fish will be 

processed in a way that will kill the parasites. 

Example: 

A primary processor receives whole salmon 

from the harvest vessel and re-ices the fish 

for shipment to a second processor. The 

second processor butchers the fish for sale 

to the sushi market. The primary processor 

has documented assurance that the second 

processor freezes the fish before sale. The 

primary processor would not need to identify 

parasites as a significant hazard. 

IDENTIFY CRITICAL CONTROL POINTS. 

The following guidance will assist you in 

determining whether a processing step is a 

critical control point (CCP) for parasites: 

1.	 Does the process contain a heating step, such 

as retorting, cooking, or pasteurizing that is 

designed to kill bacterial pathogens? 

a.	 If the process contains a heating step, 

you should identify the heating step as 

the CCP and would not need to identify 

receiving as a CCP for this hazard. 

See Chapters 13 (Clostridium botulinum 

toxin formation) and 16 (Pathogen 

bacteria survival through cooking or 

pasteurization), and the LACF Regulation 

(21 CFR 113) for further information on 

this control strategy. 

Example: 

A hot-smoked salmon processor 

should set the CCP for parasites at the 

hot-smoking step and would not need 

to identify the receiving step as a CCP 

for this hazard. 

b.	 If the process does not contain a heating 

step, you should identify a freezing 

step as the CCP, and would not need to 

identify receiving as a CCP for this hazard. 

Example: 

A salmon processor that sells the 

finished product for raw consumption 

should identify a freezing step as the 

CCP for parasites. The processor would 

not need to identify the receiving step 

as a CCP for this hazard. 

This control approach is a control 

strategy referred to in this chapter as 

“Control Strategy Example 1 - Freezing.” 

CHAPTER 5: Parasites 

93 
DEVELOP A CONTROL STRATEGY. 

The following guidance provides an example of 

a control strategy for parasites. It is important 

to note that you may select a control strategy 

that is different from that which is suggested, 

provided it complies with the requirements of the 

applicable food safety laws and regulations. 

The following is an example of the control 

strategy included in this chapter: 

MAY APPLY TO 

PRIMARY 

PROCESSOR 

MAY APPLY TO 

SECONDARY 

PROCESSOR 

CONTROL STRATEGY 

Freezing  

•	 CONTROL STRATEGY EXAMPLE - FREEZING 

Set the Critical Limits. 

•	 Freezing and storing at an ambient temperature 

of -4°F (-20°C) or below for 7 days (total time); 

OR 

•	 Freezing at an ambient temperature of -31°F 

(-35°C) or below until solid and storing at 

an ambient temperature of -31°F (-35°C) or 

below for 15 hours; 

OR 

•	 Freezing at an ambient temperature of -31°F 

(-35°C) or below until solid and storing at an 

ambient temperature of -4°F (-20°C) or below 

for 24 hours. 

Note: These conditions may not be suitable for freezing particularly 

large fish (e.g., thicker than 6 inches). It may be necessary for you 

to conduct a study to determine effective control parameters specific 

to your freezing method, fish thickness, fish species, method of 

preparation, and target parasites. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 Freezer temperature; 

AND 

•	 Length of time fish is held at freezer temperature 

or held solid frozen, as appropriate: 

For 7-day freezing critical limit: ° 

•	 Starting time of freezing and ending 

time of the frozen storage period; 

OR 

For 15-hour and 24-hour freezing critical 

limits: 

° 

•	 Time when all fish are solid 

frozen and ending time of 

the frozen storage period. 

»	 How Will Monitoring Be Done? 

•	 Use a continuous temperature-recording 

device (e.g., a recording thermometer); 

AND 

•	 Perform a visual check of time and physical 

check of solid frozen condition, as appropriate. 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 For temperature: 

Continuous monitoring, with a visual 

check of the recorded data at least once 

during each freezing or storage period, 

but no less than once per day; 

° 

AND 

•	 For time: 

Each batch, at the beginning and end 

of the freezing or storage period, as 

appropriate. 

° 

»	 Who Will Do the Monitoring? 

•	 The device itself performs the monitoring. Any 

person who has an understanding of the nature 

of the controls may perform the visual check of 

the data generated by this device to ensure that 

the critical limits have been met consistently. 

Establish Corrective Action Procedures. 

Take the following corrective action to a product 

involved in a critical limit deviation: 

•	 Refreeze and store the product at an ambient 

temperature of -4°F (-20°C) or below for 7 

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 

(-35°C) or below for 15 hours, or refreeze it at an 

ambient temperature of -31°F (-35°C) or below 

until solid and store at an ambient temperature 

of -4°F (-20°C) or below for 24 hours. Note that 

these conditions may not be suitable for freezing 

particularly large fish (e.g., thicker than 6 inches); 

OR 

•	 Destroy or divert the product to a non-raw or 

non-food use. 

AND 

Take the following corrective action to regain control 

over the operation after a critical limit deviation: 

•	 Make repairs or adjustments to the freezer; 

OR 

•	 Move some or all of the product in the 

freezer to another freezer. 

Establish a Recordkeeping System. 

•	 Record of continuous temperature monitoring; 

AND 

•	 Record of visual checks of recorded data. 

AND 

•	 Record of notation of the start time and end 

time of the freezing periods; 

AND 

•	 Record of notation of the time the fish is 

solid frozen (if appropriate). 

Establish Verification Procedures. 

•	 Before a temperature-recording device (e.g., 

a recording thermometer) is put into service, 

check the accuracy of the device to verify 

that the factory calibration has not been 

affected. This check can be accomplished by: 

Immersing the sensor in an ice slurry 

(32°F (0°C)) if the device will be used at 

or near refrigeration temperature; 

° 

OR 

Comparing the temperature reading 

on the device with the reading on a 

° 

known accurate reference device (e.g., 

a thermometer traceable to the 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 temperaturerecording 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. 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 

•	 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 5: Parasites 

95 
­

CHAPTER 5: Parasites 

96 

TABLE 5-1

CONTROL STRATEGY EXAMPLE - FREEZING

This table is an example of a portion of a Hazard Analysis Critical Control Point plan using “Control Strategy Example 1 - Freezing.” This example illustrates how a processor can control parasites in frozen salmon fillets with pin bones removed, where the finished product will be distributed to other processors for the production of refrigeratedlox. It is provided for illustrative purposes only.Parasites may be only one of several significant hazards for this product. Refer to Tables 3-2, and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides, aquaculture drugs, food and color additives, and metal fragments).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Freezing Parasites Blast freeze at

-31°F or below 

until solid, and 

hold at -4°F or

below for 24 

hours 

Temperature of 

blast

freezer and

storage freezer 

Recorder 

thermometers 

Continuous,

with visual

check of

recorded data

at end of each

freezing

process 

Freezer

operator 

Adjust or

repair freezer

Refreeze 

product 

Recorder chart 

with notations

for visual 

temperature 

check, time 

solid frozen,

and time at

end of storage 

period 

Check the

recorder

thermometer 

for accuracy 

and damage

and to ensure

that it is

operational 

before putting 

into service; 

check it daily,

at the

beginning of

operations; and 

calibrate it once 

per year

Review 

monitoring,

corrective 

action, and 

verification 

records within

1 week of 

preparation 

Time when all 

fish are visually

solid frozen 

and time at

end of storage 

period 

Visual and

physical checks 

Each batch, at 

beginning and

end of storage 

period 
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. 

•	 Adams, A. M., K. D. Murrell, and J. H. 

Cross. 1997. Parasites of fish and risks to 

public health. Rev. Sci. Tech. Off. Int. Epiz. 

16(2):652-660. 

•	 Adams, A. M., M. N. Ton, M. M. Wekell, 

A. P. MacKenzie, and F. M. Dong. 2005. 

Survival of Anisakis simplex in arrowtooth 

flounder (Atheresthes stomia) during frozen 

storage. J. Food Prot. 68(7):1441-1446. 

•	 American Gastroenterological Association. 

2000. Determination of the incidence of 

gastrointestinal parasitic infections from the 

consumption of raw seafood in the U.S. 

[Report under FDA Contract 223-97-2328 

with Life Sciences Research Office, American 

Society for Nutritional Sciences]. AGA, 

Bethesda, MD. 

•	 Berland, B. 1961. Nematodes from some 

Norwegian marine fishes. Sarsia 2:1-50. 

•	 Bier, J. W. 1988. Anisakiasis. In A. Balows, W. 

J. Hausler, Jr., M. Ohashi, and A. Turano (ed.), 

Laboratory diagnosis of infectious diseases, 

vol. I. Springler-Verlag, New York, NY. 

•	 Bouree, P., A. Paugam, and J. C. Petithory. 

1995. Review - Anisakidosis: report of 25 

cases and review of the literature. Comp. 

Immunol. Microbiol. Infect. Dis. 18(2):75-84. 

•	 Daniel, R. J. 1950. A guide to marketable fish. 

Proc. Lpool. Biol. Soc. 57:App1, 68 pp. 

•	 Deardorff, T. L., and M. L. Kent. 1989. 

Prevalence of larval Anisakis simplex in penreared and wild-caught salmon (Salmonidae) 

from Puget Sound, Washington. J. Wildl. Dis. 

25:416-419. 

•	 Deardorff, T. L., and R. M. Overstreet. 1990. 

Seafood-transmitted zoonoses in the United 

States: the fish, the dishes and the worms, p. 

211-265. In D. Ward and C. R. Hackney (ed.). 

Microbiology of marine food products, Van 

Nostrand Reinhold, New York, NY. 

•	 Deardorff, T. L., and R. Throm. 1988. 

Commercial blast-freezing of third-stage 

Anisakis simplex larvae encapsulated in 

salmon and rockfish. J. Parasitol. 74(4):600

603. 

­

•	 Deardorff, T. L., M. J. Klicks, M. E. Rosenfeld, 

R. A. Rychlinski, and R. S. Desowitz. 1982. 

Larval ascaroid nematodes from fishes near 

the Hawaiian Islands, with comments on 

pathogenicity experiments. Pac. Sci. 36:187

201. 

­

•	 Deardorff, T. L., R. B. Raybourne, and R. S. 

Desowitz. 1984. Behavior and viability of 

third-stage larvae of Terranova sp. (Type 

HA) and Anisakis simplex (type I) under 

coolant conditions. J. Food Prot. 47(1):49-52. 

•	 Edgerton, B. F., L. H. Evans, F. J. Stephens, 

and R. M. Overstreet. 2002. Synopsis of 

freshwater crayfish diseases and commensal 

organisms. Aquaculture 206:57-135. 

•	 Eslami, A., and B. Mokhayer. 1997. Nematode 

larvae of medical importance found in 

market fish in Iran. Pahlavi Med. J. 8:345-348. 

•	 Freeman, R. S., P. F. Stuart, S. J. Cullen, 

A. C. Ritchie, A. Mildon, B. J. Fernandes, 

and R. Bonin. 1976. Fatal human infection 

with mesocercariae of the trematode Alaria 

americana, Am. J. Trop. Med. Hyg. 25(6):803

807. 

­

•	 Gardner, M. A. 1990. Survival of Anisakis in 

cold-smoked salmon. Can. Inst. Food Sci. 

Technol. J. 23:143-144. 

•	 Hauck, A. K. 1977. Occurrence and survival 

of the larval nematode Anisakis sp. in the 

CHAPTER 5: Parasites 

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flesh of fresh, frozen, brined, and smoked 

Pacific herring, Clupea harengus pallasi, J. 

Parasitol. 63:515-519. 

•	 Jensen, T., K. Andersen, and S. des Clers. 

1994. Sealworm (Pseudoterranova decipiens) 

infections in demersal fish from two areas in 

Norway. Can. J. Zool. 72:598-608. 

•	 Karl, H., and M. Leinemann. 1989. Viability 

of nematode larvae (Anisakis sp.) in frozen 

herrings. Archiv fur Lebensmittelhygiene. 

40(1):14-16 (in German). 

•	 Lile, N. K., O. Halvorsen, and W. 

Hemmingsen. 1994. Zoogeographical 

classification of the macroparasite faunas of 

four flatfish species from the northeastern 

Atlantic. Polar Biol. 14(2):137-141. 

•	 Margolis, L., and J. R. Arthur. 1979. Synopsis 

of the parasites of fishes of Canada. Fish. 

Res. Board Can. Bull. Canadian Department 

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. 

•	 Templeman, W., H. J. Squires, and A. M. 

Fleming. 1957. Nematodes in the fillets of 

cod and other fishes in Newfoundland and 

neighbouring areas. J. Fish. Res. Bd. Can. 

14:831-897. 

•	 Verhamme, M. A. M., and C. H. R. Ramboer. 

1988. Anisakiasis caused by herring in 

vinegar: a little known medical problem. Gut. 

29:843-847. 

•	 Williamson, H. C. 1910. Nematodes in the 

muscle of the cod (Gadus callarias). Rep. 

Fish. Bd. Scot. 28:61-62. 

•	 Williamson, H. C. 1919. The distribution of 

parasite-infected fish. Ann. App. Biol. 6:48

52. 

­

•	 World Health Organization. 1995. Control of 

foodborne trematode infections: report of 

a WHO study group. WHO, Geneva. WHO 

Technical Report Series No. 849. 

CHAPTER 5: Parasites 

98 
 

CHAPTER 6: Natural Toxins 

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. 

Contamination of fish with natural toxins from the 

harvest area can cause consumer illness. Most of 

these toxins are produced by species of naturally 

occurring marine algae (phytoplankton). They 

accumulate in fish when they feed on the algae 

or on other fish that have fed on the algae. There 

are also a few natural toxins that are normal 

constituents of certain species of fish. 

For fish products in the United States (U.S.) 

commerce there are six recognized fish poisoning 

syndromes that can occur from the consumption 

of fish or fishery products contaminated with 

natural toxins: Paralytic shellfish poisoning 

(PSP), neurotoxic shellfish poisoning (NSP), 

diarrhetic shellfish poisoning (DSP), amnesic 

shellfish poisoning (ASP), ciguatera fish poisoning 

(CFP) and azaspiracid shellfish poisoning (AZP). 

Scombrotoxin (histamine) poisoning, that can 

occur as a result of scombrotoxin formation 

in time and temperature abused fish, is not 

considered a natural toxin, and is covered in 

Chapter 7. 

•	 Species and geographic areas involved 

This section provides information about species of 

fish and geographic areas that have been linked 

to one of the five fish poisoning syndromes by 

historical occurrence of the syndrome. However, 

it is important to note that historical occurrence 

may be an inadequate guide to future occurrence 

in the case of natural toxins, because the 

distribution of the source algae may vary over 

time. You should be alert to the potential for 

emerging problems. 

Paralytic Shellfish Poisoning (saxitoxin) in the 

U.S. is generally associated with the consumption 

of molluscan shellfish from its northeast and 

northwest coastal regions. PSP in other parts of 

the world has been associated with molluscan 

shellfish from environments ranging from tropical 

to temperate waters. Certain gastropods (e.g., 

conch, snails and whelk) are also known to 

accumulate PSP toxins. They may accumulate 

toxins by feeding on molluscs that are toxic. In 

particular, moon snails and whelk are commonly 

found to contain PSP toxins off the northeast 

coast of the U.S. Abalone from South Africa and 

Spain have been reported to contain PSP toxins, 

although there have been no reports of PSP toxins 

in abalone off the coast of the U.S. Similarly, 

PSP toxins have been reported in sea cucumbers, 

octopi and a variety of echinoderms, targeted 

for human consumption in sub-tropical regions 

of Australia, but to date no reports have been 

shown in these species in U.S. waters. In the U.S., 

PSP toxin has been reported from the viscera of 

lobster and crabs are often eaten whole, therefore 

it is important to include toxin loads contained 

in the viscera and flesh for these animals. The 

levels of PSP toxins found in lobster tomalley and 

crab viscera may pose a health hazard if eaten 

from a heavily contaminated area. In 2008, FDA 

advised against the consumption of American 

lobster tomalley because unusually high levels 

of PSP toxins were detected in that organ in 

lobsters caught in the waters of New England. In 

2002, PSP from the consumption of the flesh of 

puffer fish was first reported in the U.S. All cases 

to date have been due to fish harvested from 

central east coast Florida. PSP toxins have been 

CHAPTER 6: Natural Toxins 

99 
 

 

 

 

 

confirmed in southern (Sphoeroides nephelus), 

checkered (Sphoeroides testudineus), and bandtail 

(Sphoeroides spengleri) puffer fish. There is 

currently a ban on the harvesting of all puffer 

fish in the Florida counties of Volusia, Brevard, 

Indian River, St. Lucie, and Martin. 

The effects of PSP are primarily neurological 

and can include: tingling, burning, numbness, 

drowsiness, incoherent speech, and respiratory 

paralysis. Respiratory paralysis can result in 

death if respiratory support is not provided in a 

timely manner. PSP toxin is an extremely potent 

toxin with a high mortality rate. The symptoms 

develop from 1⁄2 to 2 hours after consumption. 

Neurotoxic shellfish poisoning (from brevetoxin) 

in the U.S. is generally associated with the 

consumption of molluscan shellfish from the 

coast of the Gulf of Mexico, and, sporadically, 

along the southern Atlantic coast. NSP has also 

been linked to gastropods (whelk) harvested off 

the Florida Gulf Coast. In addition, there has 

been a significant occurrence of toxins similar 

to NSP in New Zealand and some suggestions of 

occurrence elsewhere. 

NSP is characterized by gastrointestinal and 

neurological symptoms, including: tingling 

and numbness of the lips, tongue, and 

throat; muscular aches; dizziness; reversal 

of sensations of hot and cold; diarrhea; and 

vomiting. Symptoms develop from a few 

minutes to a few hours after consumption. 

There are few, if any, after effects and there 

have been no reported fatalities. 

Diarrhetic shellfish poisoning (from okadaic acid 

and dinophysistoxins) is generally associated 

with the consumption of molluscan shellfish. 

There have been no documented occurrences 

of illness to date in the U.S. however reports of 

this illness can be misidentified as a bacterial or 

viral source and is expected to be highly underreported. Outbreaks have been documented 

in Japan, Southeast Asia, Scandinavia, Western 

Europe, Chile, New Zealand, and eastern Canada. 

However, in 2008, okadaic acid levels in excess 

of the 0.16 ppm guidance level were recorded for 

the first time in several locations along the Texas 

Gulf Coast during a large marine algae bloom. 

DSP is characterized by gastrointestinal 

symptoms, including: nausea, vomiting, diarrhea, 

abdominal pain, headache, and fever. Symptoms 

develop from 30 minutes to 3 hours after 

consumption and last for up to 4 days. DSP is 

generally not considered life threatening but 

complications could occur as a result of severe 

dehydration in some patients. 

Amnesic shellfish poisoning (from domoic acid) 

is generally associated with the consumption 

of molluscan shellfish from the northeast and 

northwest coasts of North America. In these 

regions, domoic acid has been identified in 

the viscera of Dungeness (Cancer magister), 

tanner, and red rock crab. Domoic acid has also 

been identified in several fish species including 

anchovies (Engraulis mordax), Pacific sanddab 

(Citharichthys sordidus), chub mackerel (Scomber 

japonicas), albacore tuna (Thunnas alalunga), 

jack smelt (Atherinopsis californiensis), and 

market squid (Loligo opalescens) along the west 

coast of the U.S. It has not yet been a problem 

in the Gulf of Mexico, although the planktonic 

algae that produce the toxin have been reported 

in coastal waters, and more recently detected in 

menhaden (Brevoortia partonus) collected from 

Louisiana. Although this planktivorous species is 

not currently commercially harvested for human 

food in the Gulf of Mexico, it is used in dietary 

supplements, feed products, and occasionally 

caught recreationally and eaten by locals. 

ASP is characterized by gastrointestinal 

symptoms, including: nausea, vomiting, 

abdominal cramps, and diarrhea. These 

symptoms develop within 24 hours of 

consumption. In severe cases, neurological 

symptoms also appear, including: dizziness, 

headache, seizures, disorientation, short-term 

memory loss, respiratory difficulty, and coma. 

These symptoms usually develop within 48 

hours of consumption. These marine toxins 

described above are not ordinarily a problem in 

scallops if only the adductor muscle is consumed. 

CHAPTER 6: Natural Toxins 

100 
 

 

 

 

 

However, products such as roe-on scallops and 

whole scallops do present a potential hazard for 

natural toxins. 

Ciguatera fish poisoning (from ciguatoxin 

(CTX)) is associated with consumption of toxincontaminated subtropical and tropical reef fish. 

The toxin is introduced to the marine food chain 

by microscopic algae and moves up the food 

chain as small plant-eating reef fish eat the toxic 

algae and are then eaten by larger reef fish. 

The toxin accumulates in the flesh of certain 

predatory reef fish species. Although ciguatera 

hotspots are well recognized, there is not an 

even distribution of toxic fish within a given 

reef; fish caught side by side may have widely 

differing contamination levels. Ciguatoxic fish 

may be found in tropical or subtropical areas 

around the world between 35° north latitude and 

35° south latitude and are common in several 

areas in the Caribbean Sea, Pacific Ocean, Indian 

Ocean, and in the Flower Garden Banks area in 

the northern Gulf of Mexico. Reef fish associated 

with CFP include: barracuda (Sphyraenidae), 

amberjack (Seriola), grouper (Family: Serranidae), 

snapper (Family: Lutjanidae), po’ou (Chelinus 

spp.), jack (Family: Carangidae), travelly (Caranx 

spp.), wrasse (Family: Labridae), surgeon fish 

(Family: Acanthuridae), moray eel (Family: 

Muraenidae), roi (Cephalopholis spp.), and parrot 

fish (Family: Scaridae). 

CFP is characterized by numbness and tingling 

of the lips and tongue, which may spread to the 

extremities; nausea; vomiting; diarrhea; joint pain; 

muscle pain; headache; reversal of sensation of 

hot and cold; acute sensitivity to temperature 

extremes; vertigo; muscular weakness; irregular 

heartbeat, and reduced blood pressure. 

Gastrointestinal symptoms may develop within 2 

hours following consumption of toxic fish while 

neurological and cardiovascular symptoms will 

usually emerge within 6 hours post-ingestion. 

Azaspiracid shellfish poisoning (AZP) is caused 

by the consumption of molluscan shellfish 

contaminated with azaspiracids (AZA). AZP was 

first recognized following a 1995 outbreak in the 

Netherlands, linked to consumption of mussels 

harvested in Ireland. Since then, several outbreaks 

of AZP have been reported in various regions in 

Europe. In 2008, two cases of AZP were reported 

in the US, and linked to consumption of an 

imported mussel product from Ireland confirmed 

to contain AZP toxins in excess of guidance levels. 

To date, AZP toxins have not been confirmed in 

any product harvested in the US. 

AZP is characterized by severe gastrointestinal 

disorders including abdominal pain, nausea, 

vomiting, and diarrhea. Symptoms develop 

within minutes to hours after consumption of the 

contaminated shellfish and last for several days. 

There have been no reported fatalities. 

A number of additional toxins that have been 

identified in molluscan shellfish have shown 

toxicity in mouse studies but have not been 

linked to human illness. Pectenotoxins (PTX) 

have been detected in phytoplankton and/ 

or molluscan shellfish in Australia, Italy, Japan, 

New Zealand, Norway, Portugal, and Spain. 

Yessotoxins (YTX) have been detected in 

phytoplankton and/or molluscan shellfish in 

Australia, Canada, Italy, Japan, New Zealand, 

Norway, the United Kingdom, and the U.S. Cyclic 

imines have been found in phytoplankton and/ 

or molluscan shellfish in Canada, Denmark, New 

Zealand, Norway, Scotland, Tunisia, and the 

U.S. PTX and YTX have been found to occur in 

shellfish along with the DSP toxins okadaic acid 

and dinophysistoxins. At this time, FDA makes 

no recommendations in this guidance and has no 

specific expectations with regard to controls for 

PTX, YTX and cyclic imines in processors’ Hazard 

Analysis Critical Control Point (HACCP) plans. 

•	 Natural toxin detection 

The FDA has established action levels for natural 

toxins as follows: 

•	 PSP - 0.8 ppm (80 ug/100 g) saxitoxin 

equivalents; 

•	 NSP - 0.8 ppm (20 mouse units/100 g) 

brevetoxin-2 equivalents; 

•	 DSP - 0.16 ppm total okadaic acid 

CHAPTER 6: Natural Toxins 

101 
 

 

equivalents (i.e., combined free okadaic acid, 

dinophysistoxins, acyl-esters of okadaic acid 

and dinophysistoxins); 

•	 ASP - 20 ppm domoic acid, except in the 

viscera of dungeness crab, where the action 

level is 30 ppm; 

•	 CFP - 0.01 ppb P-CTX-1 equivalents for 

Pacific ciguatoxin and 0.1 ppb C-CTX-1 

equivalent for Caribbean ciguatoxin; 

•	 AZP - 0.16 ppm azaspiracid equivalents. 

There are currently no NSSP-accepted rapid test 

methods for NSP, ASP, DSP, CFP or AZP, and only 

one rapid test method has been validated (for PSP). 

•	 Natural toxin control 

Natural toxins cannot be reliably eliminated by 

heat. However, severe heating processes, such as 

retorting, may be effective at reducing the levels 

of some natural toxins. 

To minimize the risk of molluscan shellfish 

containing natural toxins from the harvest area, 

state and foreign government agencies, called 

shellfish control authorities, classify waters in 

which molluscan shellfish are found, based, 

in part, on the presence of natural toxins in 

shellfish meats. Shellfish control authorities 

may also use cell counts of the toxin-forming 

algae in the harvest waters to classify shellfish 

harvest areas. As a result of these classifications, 

molluscan shellfish harvesting is allowed from 

some waters, not from others, and only at certain 

times, or under certain conditions, from others. 

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, except where the scallop product 

contains the shucked adductor muscle only. 

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. 

An established water classification system similar 

to that in use for the molluscan shellfish system 

is not in place for controlling CFP in finfish. 

However, some states issue advisories regarding 

reefs that are known to be toxic. In areas where 

there is no such advisory system, fishermen and 

processors must depend on their own knowledge 

of local reporting of illnesses associated with 

reefs from which they obtain fish. 

Where PSP or ASP has become a problem in 

finfish or crustaceans, states generally have 

closed or restricted the appropriate fisheries or 

have issued consumption advisories. In addition, 

removal and destruction of the viscera will 

eliminate the hazard, and this is at times required 

by state public health authorities. In 2008, FDA 

advised against the consumption of American 

lobster tomalley, but not the lobster meat itself, 

because unusually high levels of PSP toxins were 

detected in the lobster tomalley of lobsters caught 

in the waters of New England. 

•	 Escolar, puffer fish, and whelk 

There are naturally occurring toxins in some 

species that do not involve marine algae. Escolar 

or oilfish (i.e., Lepidocybium flavobrunneum or 

Ruvettus pretiosus) contains a strong purgative oil 

(wax ester), called gempylotoxin, that may cause 

diarrhea, abdominal cramps, nausea, headache, 

and vomiting when consumed. FDA advises 

against importation and interstate marketing 

of these fish. Additional deep sea fish species, 

such as orange roughy (Hoplostethus atlanticus), 

and, oreo dory (Allocyttus spp., Pseudocyttus 

spp., Oreosoma spp., and Neocyttus spp.) are 

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 

of these fish. Improperly handled escolar 

and oilfish also have been associated with 

scombrotoxin (histamine) poisoning (Covered in 

Chapter 7). 

Puffer fish (also known as fugu, swellfish, bok, 

blowfish, globefish, balloonfish, or sea squab) 

may contain tetrodotoxin. Poisonings from 

tetrodotoxin have usually been associated with 

the consumption of puffer fish from waters of the 

Indo-Pacific Ocean regions. However, several 

reported cases of poisonings, including fatalities, 

involved puffer fish from the Atlantic Ocean, Gulf 

of Mexico, and Gulf of California. There have 

been no confirmed cases of poisonings from 

northern puffer fish (Sphoeroides maculatus), 

which was once harvested and marketed as “sea 

squab” on the U.S. east coast, but there is still 

reason for concern. There is a restriction on 

importation of all species of puffer fish and fishery 

products containing puffer fish. See Import 

Alert #16-20 at the internet location http://www. 

accessdata.fda.gov/cms_ia/importalert_37.html. 

Some puffer fish are also subject to contamination 

with PSP toxins, covered earlier in this chapter. 

Tetrodotoxin has been implicated in illnesses 

from the consumption of additional species 

besides puffer fish, for example, certain species 

of xanthid crabs, marine gastropods, and goby 

fish. Reports of these illnesses have been mainly 

limited to Asia, and involve species unlikely to be 

imported into the U.S. 

Tetrodotoxin poisoning is characterized by 

slight numbness of the lips and tongue, tingling 

sensation in the face and extremities, headache, 

abdominal pain, nausea, diarrhea, vomiting, 

difficulty in walking, paralysis, respiratory 

distress, difficulty in speech, shortness of breath, 

blue or purplish discoloration of the lips and 

skin, lowering of blood pressure, convulsions, 

mental impairment, irregular heartbeat, and death. 

Symptoms usually develop between 30 minutes 

and 3 hours after consumption and may last for 

20 minutes to 8 hours. If respiratory aid is not 

provided, death may occur within 4 to 6 hours. 

Tetramine is a toxin that is found in the salivary 

glands of Neptunia spp., a type of whelk. The 

hazard can be controlled by removing the glands. 

Symptoms of tetramine poisoning include: 

double vision, temporary blindness, difficulty 

in focusing, tingling of the fingers, prostration, 

nausea, vomiting, diarrhea, and loss of muscle 

control. Symptoms usually develop within 1 

hour of consumption. 

FDA makes no recommendations in this guidance 

document and has no specific expectations with 

regard to controls for gempylotoxin in processors’ 

HACCP plans. Additionally, FDA makes no 

specific recommendation in this guidance for 

control of tetrodotoxin and tetramine. 

DETERMINE WHETHER THE POTENTIAL 

HAZARD IS SIGNIFICANT. 

The following guidance will assist you in 

determining whether natural toxins are a 

significant hazard at a processing step: 

1.	 Is it reasonably likely that unsafe levels of natural 

toxins will be introduced at this processing step 

(e.g., does the toxin come in on the raw material 

at an unsafe level)? 

Tables 3-2 and 3-3 (Chapter 3) identify the 

species of fish for which natural toxins are 

known to be a potential hazard. Under 

ordinary circumstances, it would be 

reasonably likely to expect that, without 

proper controls, natural toxins from the 

harvest area could enter the process at 

unsafe levels at the receiving step for those 

species. There may be circumstances in 

your geographic area that would allow you 

to conclude that it is not reasonably likely for 

a particular natural toxin to occur at unsafe 

levels in fish from your area. You should be 

guided by the information provided above 

and the historical occurrence of the toxin 

in the fish, at levels above the established 

guidance levels, in your geographic area. 

However, you should remain alert to the 

potential for emerging problems. Examples 

CHAPTER 6: Natural Toxins 

103 
of natural toxin hazards that had not until 

recently been known to exist are PSP in 

puffer fish and domoic acid in anchovies. 

If you are receiving fish, other than 

molluscan shellfish, from another processor, 

you would not need to identify natural toxins 

as a significant hazard. This hazard should 

have been fully controlled by the primary 

(first) processor. 

2.	 Can natural toxins that were introduced at unsafe 

levels at an earlier step be eliminated or reduced 

to an acceptable level here? 

Natural toxins should also be considered 

a significant hazard at any processing step 

where a preventive measure is, or can be, 

used to eliminate the natural toxin hazard, 

which had been introduced at a previous 

step, or is adequate to reduce the likelihood 

of occurrence of the hazard to an acceptable 

level. Preventive measures for natural toxins 

can include: 

For molluscan shellfish: 

•	 Checking incoming molluscan
 

shellfish to ensure that they are
 

properly tagged or labeled;
 

•	 Making sure that incoming molluscan 

shellfish are supplied by a licensed 

harvester (where licensing is required 

by law) or by a certified dealer. 

For finfish other than molluscan shellfish: 

•	 Making sure that incoming fish have 

not been caught in an area from which 

harvesting is prohibited or restricted 

because of a natural toxin problem; 

•	 Making sure that incoming finfish have 

not been caught in an area for which 

there is a CFP advisory or for which you 

have knowledge there is a CFP problem. 

These preventive measures are ordinarily 

employed at the receiving step. 

•	 Intended use 

In most cases, it is unlikely that the intended 

use of the product would determine whether 

the hazard is significant. One exception is with 

certain products for which only the muscle tissue 

will be consumed. For example, where the 

finished product is only the shucked adductor 

muscle of the scallop, it is reasonable to assume 

that the product as consumed will not contain 

natural toxins. In this case, you may not need to 

identify natural toxins as a significant hazard. 

IDENTIFY CRITICAL CONTROL POINTS. 

The following guidance will assist you in 

determining whether a processing step is a 

critical control point (CCP) for natural toxins. 

Where preventive measures, such as those 

described above, are available to you the hazard 

of natural toxins can best be controlled at the 

receiving step. This control approach consists of 

two control strategies referred to in this chapter as 

“Control Strategy Example 1 - Source Control for 

Molluscan Shellfish” and “Control Strategy Example 

2 - Source Control for Fish Other Than Molluscan 

Shellfish” (for primary (first) processors only). 

DEVELOP A CONTROL STRATEGY. 

The following guidance provides two control 

strategies for natural toxins. You may select a 

control strategy that is different from those which 

are suggested, provided it complies with the 

requirements of the applicable food safety laws 

and regulations. 

The following are examples of control strategies 

included in this chapter: 

MAY APPLY TO 

PRIMARY 

PROCESSOR 

MAY APPLY TO 

SECONDARY 

PROCESSOR 

CONTROL STRATEGY 

Source control for 

molluscan shellfish 

 

Source control for 

fish other than 

molluscan shellfish 



CHAPTER 6: Natural Toxins 

104 
•	 CONTROL STRATEGY EXAMPLE 1 - SOURCE 

CONTROL FOR MOLLUSCAN SHELLFISH 

Set Critical Limits. 

•	 All containers of shellstock (in-shell molluscan 

shellfish) received from a harvester must 

bear a tag that discloses the date and place 

they were harvested (by state and site), type 

and quantity of shellfish, and information on 

the harvester or the harvester’s vessel (i.e., 

the identification number assigned to the 

harvester by the shellfish control authority, 

where applicable, or if such identification 

numbers are not assigned, the name of 

the harvester or the name or registration 

number of the harvester’s vessel). For bulk 

shipments of shellstock where the shellstock 

is not containerized, the shellstock must be 

accompanied by a bill of lading or similar 

shipping document that contains the same 

information; 

Note: The source controls listed in this critical limit are required 

under 21 CFR 123.28(c). 

OR 

•	 All containers of shellstock received from a 

processor must bear a tag that discloses the 

date and place they were harvested (by state 

and site), type and quantity of shellfish, and 

the certification number of the processor; 

OR 

•	 All containers of shucked molluscan shellfish 

must bear a label that identifies the name, 

address, and certification number of the 

packer or repacker of the product; 

AND 

•	 All molluscan shellfish must have been 

harvested from waters authorized for 

harvesting by a shellfish control authority. 

For U.S. federal waters, no molluscan 

shellfish may be harvested from waters that 

are closed to harvesting by an agency of the 

federal government; 

AND 

•	 All molluscan shellfish must be from a 

harvester that is licensed as required (note 

that licensing may not be required in all 

jurisdictions) or from a processor that is 

certified by a shellfish control authority. 

Note: Only the primary processor, the processor that takes 

possession of the molluscan shellfish from the harvester, should apply 

controls relative to the identification of the harvester, the harvester’s 

license, or the approval status of the harvest waters. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 Information contained on tags on containers 

of incoming shellstock or on the bill 

of lading or similar shipping document 

accompanying bulk shipments of shellstock; 

AND 

•	 Information on whether the harvest area is 

authorized for harvest by a shellfish control 

authority or information on whether federal 

harvest waters are closed by an agency of 

the federal government. 

OR 

•	 Information contained on labels on 

containers of incoming shucked molluscan 

shellfish; 

AND 

•	 The harvester’s license. 

»	 How Will Monitoring Be Done? 

•	 Perform visual checks; 

AND 

•	 Ask the shellfish control authorities of the 

state or country in which your shellstock 

are harvested whether the harvest area is 

authorized for harvest. 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 For checking incoming tags: 

Every container; ° 

OR 

•	 For checking the bill of lading or similar 

shipping document:
 

Every delivery;
 ° 

CHAPTER 6: Natural Toxins 

105 
OR 

•	 For checking incoming labels: 

At least three containers randomly 

selected from every lot;
 

° 

AND
 

•	 For checking licenses: 

Every delivery. ° 

»	 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. 

AND 

Take the following corrective action to regain control of 

the operation after a critical limit deviation: 

•	 Discontinue use of the supplier until 

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 

° Number and date of expiration of the 

harvester’s license, where applicable; 

AND 

° Certification number of the shipper, 

where applicable. 

For shucked molluscan shellfish: 

•	 Receiving record that documents: 

Date of receipt; ° 

AND
 

Quantity and type of shellfish;
 ° 

AND 

Name and certification number of the 

packer or repacker. 

° 

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 6: Natural Toxins 

106 
CHAPTER 6: Natural Toxins 

107 

TABLE 6-1

CONTROL STRATEGY EXAMPLE 1 - SOURCE CONTROL FOR MOLLUSCAN SHELLFISH

This table is an example of a portion of a HACCP plan using “Control Strategy Example 1 - Source Control for Molluscan Shellfish.” This example illustrates how a primary processor (processor that takes possession of the oysters from the harvester) of shellstock oysters, that is, the shellstock shipper, can control natural toxins from the harvest area in shellstock oysters received directly from a harvester. It is provided for illustrative purposes only. 

Natural toxins may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., natural toxins,

environmental chemical contaminants and pesticides, and pathogens during processing). Example Only See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Receiving 

shellstock 

Natural toxins All incoming

shellstock must

be tagged

with the date

and place of

harvest, type 

and quantity

of shellfish,

and name or

registration 

number of

the harvester’s 

vessel 

Information 

on

incoming

shellstock

tags 

Visual

checks 

Every 

sack 

Receiving 

employee 

Reject 

untagged sacks

Discontinue use of the

supplier until evidence 

is obtained that tagging

practices have changed 

Receiving 

record 

Review 

monitoring

and corrective 

action records 

within

1 week of 

preparation 

All shellstock

must be

from waters 

approved 

by the state 

shellfish control

authority 

Harvest site 

on tags 

Visual checks

Ask the shellfish control

authority of the state

in which the shellstock

are harvested whether 

the area is authorized

for harvest 

Every 

lot 

Receiving 

employee 

Reject lots from 

unapproved waters

Discontinue use of the

supplier until evidence is 

obtained that harvesting 

practices have changed 

All shellstock

must be from a

licensed

harvester 

Harvester’s 

license 

Visual

checks 

Every 

delivery 

Receiving 

employee 

Reject lots from 

unlicensed harvesters

Discontinue use of the

supplier until evidence is 

obtained that the harvester 

has secured a license 
•	 CONTROL STRATEGY EXAMPLE 2 - SOURCE 

CONTROL FOR FISH OTHER THAN MOLLUSCAN 

SHELLFISH 

This guidance applies to primary (first) 

processors only. 

Set Critical Limits. 

•	 No fish may be received that has been 

harvested from: 

An area that is closed to fishing by 

foreign, federal, state, tribal, territorial or 

local authorities (e.g., certain counties in 

Florida for puffer fish); 

° 

OR 

An area that is the subject of a CFP or 

ASP consumption advisory; 

° 

OR 

An area for which you have knowledge 

that there is a CFP problem. 

° 

Establish Monitoring Procedures. 

»	 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. 

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 of 

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 the location 

and status (e.g., prohibited, restricted, or 

unrestricted) of the harvest area. 

Establish Verification Procedures. 

•	 Review monitoring and corrective action 

records within 1 week of preparation to 

ensure they are complete and any deviations 

that occurred were addressed appropriately. 

CHAPTER 6: Natural Toxins 

108 
CHAPTER 6: Natural Toxins 

109 

TABLE 6-2

CONTROL STRATEGY EXAMPLE 2 - SOURCE CONTROL FOR FISH OTHER THAN MOLLUSCAN SHELLFISH 

This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Source Control for Fish Other Than Molluscan Shellfish.” This example illustrateshow a fish processor in Hawaii that receives locally harvested barracuda can control natural toxins. It is provided for illustrative purposes only. Natural toxins may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides). 

Example Only

See Text for Full Recommendations 

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL

LIMITS FOR

EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Receiving fresh 

fish 

Natural 

toxins - CFP 

No fish may 

be harvested 

from an area

that is covered 

by a state CFP 

advisory or for 

which there

is information 

from a valid 

scientific source

that there is

a current CFP 

problem 

Location

and status of

the harvest area 

Ask the

fisherman for 

the harvest 

location 

Every lot Receiving 

employee 

Reject lot 

Discontinue use

of the supplier

until evidence 

is obtained

that harvesting 

practices have 

changed 

Receiving 

record 

Review 

monitoring and

corrective 

action records 

within 1 week 

of preparation 
 

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 NonFDA Web site references after March 29, 2011. 

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1995. Paralytic shellfish toxin profiles of 

xanthid crabs Zosimus aeneus and Atergatis 

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Fish. Sci. 61(4):659-662. 

•	 Bakes, M. J., N. G. Elliott, G. J. Green, 

and P. D. Nichols. 1995. Variation in lipid 

composition of some deep-sea fish (Teleostei: 

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Biochem. Physiol B. 111(4):633-642. 

•	 Bravo, I., J. M. Franco, A. Alonzo, R. Dietrich, 

and P. Molist. 2001. Cytological study and 

immunohistochemical location of PSP 

toxins in foot skin of the ormer, Haliotis 

tuberculata, from the Galacian coast (NW 

Spain). Mar. Biol. 138:709-715. 

•	 Bravo, I., M. I. Reyero, E. Cacho, and J. M. 

Franco. 1999. Paralytic shellfish poisoning in 

Haliotis tuberculata from the Galician coast: 

geographical distribution, toxicity by lengths and 

parts of the mollusc. Aquat. Toxicol. 46:79-85. 

•	 Clifford, M. N., R. Walker, P. Ijomah, 

J. Wright, C. K. Murray, R. Hardy, E. P. 

Martlbauer, E. Usleber, and G. Terplan. 1993. 

Do saxitoxin-like substances have a role in 

scombrotoxicosis? Food Addit. Contamin. 

9(6):657-667. 

•	 Dickey, R. W. 2008. Ciguatera toxins: chemistry, 

toxicology and detection, p. 479-500. In L. M. 

Botana (ed.), Seafood and freshwater toxins: 

pharmacology, physiology, and detection, 2nd 

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Toxic phytoplankton blooms in the sea. 

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­

•	 James, K. A. C., and B. P. Treloar. 1984. 

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Isolation of tetrodotoxin from a goby Gobius 

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(research report). Mar. Pollut. Bull. 52:1735-1745. 

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paralytic shellfish poison in the Taiwanese 

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poisoning: a review on the chemistry, 

ecology, and toxicology with an emphasis on 

human health impacts. 6:39-72. 

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diarrhoeic shellfish poisons: occurrence in 

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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. 

Scombrotoxin (histamine) formation as a result 

of time and temperature abuse of certain species 

of fish can cause consumer illness. The illness 

is closely linked to the development of histamine 

in these fish. In most cases, histamine levels in 

illness-causing fish have been above 200 ppm, 

often above 500 ppm. However, there is some 

evidence that other chemicals (e.g., biogenic 

amines such as putrescine and cadaverine) may 

also play a role in the illness. The possible role of 

these chemicals in consumer illness is the subject 

of Chapter 8. 

Seafood-related scombrotoxin poisoning is 

primarily associated with the consumption of 

tuna, mahi-mahi, marlin, and bluefish. Table 3-2 

(Chapter 3) identifies other species that are also 

capable of developing elevated levels of histamine 

when temperature abuse occurs. 

The illness caused by the consumption of fish 

in which scombrotoxin has formed is most 

appropriately referred to as “scombrotoxin 

poisoning.” The illness has historically been 

known by other names. Originally, the illness 

was termed “scombroid poisoning” because of its 

association with fish in the families Scombridae 

and Scomberesocidae. However, other species 

of fish are now known to cause the illness. The 

terms “histamine poisoning” and “histamine fish 

poisoning” have also been applied to the illness. 

However, because biogenic amines other than 

histamine have been associated with the illness, 

these terms also present difficulties. Nonetheless, 

this chapter refers to control measures to prevent 

the formation of histamine. It is expected 

that the methods of control used to inhibit the 

bacteria that result in histamine formation will 

also inhibit the bacteria that produce other 

biogenic amines. 

Symptoms of scombrotoxin poisoning include 

tingling or burning in or around the mouth or 

throat; rash or hives on the upper body; drop in 

blood pressure; headache; dizziness; itching of the 

skin; nausea; vomiting; diarrhea; asthmatic-like 

constriction of the air passage; heart palpitation; 

and respiratory distress. Symptoms usually 

occur within a few minutes to a few hours of 

consumption and last from 12 hours to a few days. 

•	 Scombrotoxin (histamine) formation 

Certain bacteria produce the enzyme histidine 

decarboxylase during growth. This enzyme reacts 

with histidine, a naturally occurring amino acid 

that is present in larger quantities in some fish 

than in others. The result is the formation of 

scombrotoxin (histamine). 

Histamine-forming bacteria are capable of growing 

and producing histamine over a wide temperature 

range. Growth of histamine is more rapid, however, 

at high-abuse temperatures (e.g., 70°F (21.1°C) 

or higher) than at moderate-abuse temperatures 

(e.g., 45°F (7.2°C)). Growth is particularly rapid 

at temperatures near 90°F (32.2°C). Histamine is 

more commonly the result of high temperature 

spoilage than of long-term, relatively lowtemperature spoilage, which is commonly associated 

with organoleptically detectable decomposition. 

Nonetheless, there are a number of opportunities 

for histamine to form under more moderate-abuse 

temperature conditions. 

CHAPTER 7: Scombrotoxin (Histamine) Formation 

113 
 

 

 

 

 

 

 

 

Once the enzyme histidine decarboxylase is 

present in the fish, it can continue to produce 

histamine in the fish even if the bacteria are not 

active. The enzyme can be active at or near 

refrigeration temperatures. The enzyme remains 

stable while in the frozen state and may be 

reactivated very rapidly after thawing. 

Freezing may inactivate some of the enzymeforming bacteria. Both the enzyme and 

the bacteria can be inactivated by cooking. 

However, once histamine is produced, it cannot 

be eliminated by heat (including retorting) or 

freezing. After cooking, recontamination of 

the fish with the enzyme-producing bacteria 

is necessary for additional histamine to form. 

For these reasons, histamine development is 

more likely in raw, unfrozen fish but should 

not be discounted in other product forms of 

scombrotoxin-forming fish species. 

The kinds of bacteria that are associated with 

histamine development are commonly present in 

the saltwater environment. They naturally exist 

on the gills, on external surfaces, and in the gut 

of live, saltwater fish, with no harm to the fish. 

Upon death, the defense mechanisms of the fish 

no longer inhibit bacterial growth in the muscle 

tissue, and histamine-forming bacteria may start 

to grow, resulting in the production of histamine. 

Evisceration and removal of the gills may reduce, 

but not eliminate, the number of histamineforming bacteria. Packing of the visceral cavity 

with ice may aid in chilling large fish in which 

internal muscle temperatures are not easily 

reduced. However, when done improperly, these 

steps may accelerate the process of histamine 

development in the edible portions of the fish by 

spreading the bacteria from the visceral cavity to 

the flesh of the fish. 

With some harvesting practices, such as 

longlining and gillnetting, death may occur many 

hours before the fish is removed from the water. 

Under the worst conditions, histamine formation 

can already be underway before the fish is 

brought onboard the vessel. This condition 

can be further aggravated with certain tuna 

species that generate heat, resulting in internal 

temperatures that may exceed environmental 

temperatures and increasing the likelihood 

of conditions favorable to growth of enzymeforming bacteria. 

The potential for histamine formation is increased 

when the scombrotoxin-forming fish muscle is in 

direct contact with the enzyme-forming bacteria. 

This direct contact occurs when the fish are 

processed (e.g., butchering or filleting) and can 

be particularly problematic when the surface-tovolume ratio of the exposed fish muscle is large, 

such as minced tuna for salads. Even when such 

products are prepared from canned or pouch 

retorted fish, recontamination can occur during 

salad preparation, especially with the addition of 

raw ingredients. The mixing in of the bacteria 

throughout the product and the high surface-tovolume ratio can result in substantial histamine 

formation if time and temperature abuse occurs. 

At least some of the histamine-forming bacteria 

are halotolerant (salt tolerant) or halophilic (salt 

loving). Some are more capable of producing 

histamine at elevated acidity (low pH). As a 

result, histamine formation is possible during 

processes such as brining, salting, smoking, 

drying, fermenting, and pickling until the product 

is fully shelf-stable. Refrigeration can be used 

to inhibit histamine formation during these 

processes. 

A number of the histamine-forming bacteria are 

facultative anaerobes that can grow in reduced 

oxygen environments. As a result, reduced 

oxygen packaging (e.g., vacuum packaging, 

modified atmosphere packaging, and controlled 

atmosphere packaging) should not be viewed as 

inhibitory to histamine formation. 

Histamine is water soluble (dissolves in water) 

and would not be expected in significant 

quantity in products such as fish oil that do not 

have a water component. However, histamine 

could be present in products such as fish protein 

concentrate that are prepared from the muscle or 

aqueous (water-based) components of fish tissue. 

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 
CHAPTER 7: Scombrotoxin (Histamine) Formation 

116

 TABLE 7-1

RECOMMENDED MAXIMUM TIME TO GET SCOMBROTOXIN-FORMING FISH INTO CHILLING MEDIUM ONBOARD HARVEST VESSELS TO PREVENT 

SCOMBROTOXIN FORMATION1 

WHEN... THEN, THE MAXIMUM TIME IN HOURS TO GET THE FISH INTO CHILLING MEDIUM (≤ 40°F) FROM THE TIME OF... 

THE WATER 

TEMPERATURE (°F) IS... 

AND THE AIR TEMPERATURE (°F) IS... DEATH OF THE FISH OR EARLIEST ESTIMATED 

TIME OF DEATH IS... 

ONBOARD LANDING IS... 

FOR UNEVISCERATED FISH:

> 65 > 83 6 -­

> 83 Any 6 -­

> 65, but ≤ 83 ≤ 83 9 -­

≤ 652 > 83 -­ 6 

≤ 652 ≤ 83 -­ 9 

FOR FISH EVISCERATED ONBOARD BEFORE CHILLING:

> 65 Any 12 -­

≤ 652 Any -­ 12 

1. This table is a summary of the preceding recommendations. For complete understanding of the recommendations, refer to the text above.2. Provided exposure of the fish in the water at 65°F or less is ≤ 24 hours. 
 

 

 

The controls listed above for onboard chilling 

will prevent the rapid formation of the enzyme 

histidine decarboxylase. Once this enzyme is 

formed, control of the hazard is unlikely. It is 

important to recognize that the parameters listed 

above are intended to control scombrotoxin 

formation; these criteria may not effectively control 

the activity of other spoilage organisms, raising 

the possibility that fish may become adulterated 

because of decomposition (not a food safety 

hazard covered by the Procedures for the Safe and 

Sanitary Processing and Importing of Fish and 

Fishery Products regulation, 21 CFR 123, called 

the Seafood Hazard Analysis Critical Control Point 

(HACCP) Regulation in this guidance document) 

before scombrotoxin (histamine) is formed. 

•	 The size of the fish; 

•	 The chilling method: 

Further chilling toward the freezing point is also 

desirable to safeguard against the less common, 

longer term, lower temperature development of 

histamine. Additionally, the shelf life and quality 

of the fish are significantly compromised when 

product temperature is not rapidly dropped to 

near freezing. 

Although it may be possible for a harvest vessel 

to completely avoid onboard chilling and still 

deliver fish to the processor within the time and 

temperature limitations recommended above 

for chilling the fish, this practice is discouraged. 

Failure to chill onboard may permit bacteria and 

enzymes, including those that form scombrotoxin 

(histamine), to increase unnecessarily. 

The time required to lower the internal 

temperature of fish after capture will be 

dependent upon a number of factors, including: 

•	 The harvest method: 

Delays in removing fish from the water 

after capture, such as those captured by 

a longline, may significantly limit the 

amount of time left for chilling and may 

allow some fish to heat up; 

 ̊ 

Large quantities of fish captured in a 

single fishing set, such as those captured 

on a purse seiner, may exceed a vessel’s 

ability to rapidly chill the product; 

 ̊ 

Ice alone takes longer to chill fish 

than does an ice slurry or recirculated 

refrigerated seawater or brine, a 

consequence of reduced contact area 

and heat transfer; 

 ̊ 

The quantity of ice or ice slurry and 

the capacity of refrigerated seawater or 

brine systems, as well as the physical 

arrangement of the fish in the chilling 

media, should be suitable for the 

quantity of catch. 

 ̊ 

Once chilled, the scombrotoxin-forming fish 

should be maintained as close as possible to the 

freezing point (or held frozen) until it is consumed. 

Exposure to temperatures above 40°F (4.4°C) 

should be minimized. The amount of post-harvest 

time at elevated temperatures (after proper chilling 

onboard the harvest vessel) to which a fish can 

be exposed (e.g., during processing, storage, and 

distribution) without adverse effects is dependent 

primarily upon whether the fish was previously 

frozen (e.g., onboard the harvest vessel) or heat 

processed sufficiently to destroy scombrotoxinforming bacteria. 

Extended frozen storage (e.g., 24 weeks) or 

cooking minimizes the risk of additional 

histamine development by inactivating the 

enzyme-forming bacteria and, in the case 

of cooking, the enzyme itself. As previously 

mentioned, recontamination with enzymeforming bacteria and significant temperature 

abuse is necessary for histamine formation 

following cooking. Such recontamination may 

not be likely if the fish is processed under a 

conscientious sanitation program. However, 

addition of raw ingredients, employee contact, 

or poor sanitary conditions could reintroduce 

contamination. Further guidance is provided 

below: 

•	 Scombrotoxin-forming fish that have not 

been previously frozen or heat processed 

sufficiently to destroy scombrotoxinforming 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 scombrotoxinforming 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 
CHAPTER 7: Scombrotoxin (Histamine) Formation 

119 

TABLE 7-2

RECOMMENDED MAXIMUM HOURS OF EXPOSURE OF SCOMBROTOXIN-FORMING FISH TO AMBIENT TEMPERATURES GREATER THAN 

40°F TO PREVENT SCOMBROTOXIN FORMATION AFTER PROPER ONBOARD HARVEST VESSEL CHILLING, FOR DIFFERING TEMPERATURE 

EXPOSURE AND PREVIOUS PROCESSING CONDITIONS1 

1. This table is a summary of the preceding recommendations. For complete understanding of the recommendations, refer to the text above. 

WHEN THE AMBIENT TEMPERATURE (°F) OF EXPOSURE IS... THEN, THE MAXIMUM HOURS OF EXPOSURE TIME FOR...

Fresh fish (not heat processed

or previously frozen) is ... 

Previously frozen fish, or heat processed fish (that has been

exposed to possible recontamination), is...

> 70 AT ANY TIME ≤ 4 ≤ 12 

≤ 70 DURING ENTIRE EXPOSURE ≤ 8 ≤ 24 
 

 

 

 

 

 

 

•	 Detection 

Sensory evaluation 

Sensory evaluation is generally used to screen 

fish for indicators of spoilage that develop when 

the fish is exposed to time and temperature 

abuse. Odor in particular is an effective means 

of detecting fish that have been subjected to a 

variety of abusive conditions. However, odors of 

decomposition that are typical of relatively low 

temperature spoilage may not be present if the 

fish has undergone high temperature spoilage. 

This condition makes sensory examination 

alone an ineffective control for preventing 

scombrotoxin (histamine) formation. 

It is important to recognize that the Federal 

Food, Drug, and Cosmetic Act (the FFD&C Act) 

prohibits interstate commerce of adulterated 

foods (21 U.S.C. 331). Under the FFD&C 

Act, a food that is decomposed is considered 

adulterated (21 U.S.C 342). Accordingly, a fish 

or fishery product that is decomposed in whole 

or in part is prohibited from entering interstate 

commerce even if the type of decomposition 

may not lead to scombrotoxin (histamine) 

formation. You should distinguish between 

recommendations in this chapter for sensory 

screening, as a component of a HACCP control 

strategy for scombrotoxin formation, and your 

obligation to avoid otherwise violating the 

FFD&C Act with regard to the distribution of 

decomposed food. 

Chemical testing 

Chemical testing is an effective means of 

detecting the presence of histamine in fish flesh. 

However, the variability in histamine levels 

between fish and within an individual fish can be 

large, even in fish from the same harvest vessel. 

For this reason, a guidance level has been set of 

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 

histamine testing is dependent upon the design 

of the sampling plan. The amount of sampling 

required to accommodate such variability of 

distribution is necessarily quite large. The 

method of collection of the fish sample is also 

critical. In large scombrotoxin-forming fish, the 

lower, anterior (forward) portion of the fish loin 

(not the belly flap) is likely to provide the best 

information about the histamine content of the 

fish. The number of samples (i.e., scombrotoxinforming fish) necessary to make a judgment 

about a lot depends on the anticipated variability, 

but should not be fewer than 18 samples per lot, 

unless the lot contains less than 18 fish, in which 

case a sample should be collected from each fish. 

Where samples are composited to reduce the 

number of analyses needed on a lot, it should 

be done in a manner that ensures meaningful 

results. No more than three samples should be 

composited, in order to minimize masking of 

problematic fish. Furthermore, the analytical 

method and instrument used should be capable 

of reliably detecting histamine at the lower levels 

that are necessary for composited samples (e.g., 

17 ppm histamine in a three-sample composite, 

rather than 50 ppm in an uncomposited sample ). 

Combining additional indicators of conditions 

that can lead to histamine formation, such as 

sensory examination and internal temperature 

measurement, with histamine testing can provide 

better assurance of product safety. Observation 

for the presence of honeycombing (voids in 

the fish flesh) in cooked tuna loins intended 

for canning is a valuable means of screening 

for fish that have been exposed to the kinds of 

temperature abuse that can lead to histamine 

development. Any scombrotoxin-forming fish 

that demonstrate the trait should be destroyed or 

diverted to a non-food use. 

CHAPTER 7: Scombrotoxin (Histamine) Formation 

120 
 

 

 

 

 

DETERMINE WHETHER THE POTENTIAL 

HAZARD IS SIGNIFICANT. 

The following guidance will assist you in 

determining whether scombrotoxin (histamine) 

formation is a significant hazard at a processing 

step: 

1.	 Is it reasonably likely that unsafe levels of 

histamine will be introduced at this processing step 

(do unsafe levels come in with the raw material)? 

Table 3-2 (Chapter 3) lists those species of 

fish that are generally known to be capable 

of producing elevated levels of histamine if 

temperature abused. Such species of fish 

have this capability because they contain 

naturally high levels of histidine. They also 

have this capability because they are marine 

fish that are likely to harbor the kinds of 

bacteria that produce histidine decarboxylase. 

It is, therefore, reasonable to assume that 

without proper onboard vessel controls, these 

species of fish will contain unsafe levels of 

histamine upon receipt by the primary (first) 

processor. 

However, if the worst case environmental 

conditions (i.e., air and water temperatures) 

during the harvest season in a particular 

region would not permit the formation of 

histamine during the time necessary to 

harvest and transport the fish to the primary 

processor, onboard controls may not be 

necessary. For example, such conditions 

might exist if the fish are harvested when air 

and water temperatures do not exceed 40°F 

(4.4°C), as evidenced by supporting data. 

It is also reasonable to assume that without 

proper controls during refrigerated (not 

frozen) transportation between processors, 

scombrotoxin-forming species of fish will 

contain unsafe levels of histamine upon 

receipt by the secondary processor (including 

warehouses). In addition, you may need 

to exercise control to prevent pathogen 

growth or toxin formation when receiving 

a refrigerated (not frozen) raw or cooked 

product from another processor (see Chapter 

12). The in-transit controls for secondary 

processors recommended in Chapter 12 are 

similar to those recommended in this chapter. 

2.	 Is it reasonably likely that unsafe levels of 

histamine will form at this processing step? 

To answer this question, you should consider 

the potential for time and temperature abuse 

in the absence of controls. You may already 

have controls in your process that minimize 

the potential for time and temperature abuse 

that could result in unsafe levels of histamine. 

This guidance will help you determine 

whether those or other controls should be 

included in your HACCP plan. 

Time and temperature abuse that occurs 

at successive processing and storage steps 

may be sufficient to result in unsafe levels 

of histamine, even when abuse at one 

step alone would not result in such levels. 

For this reason, you should consider the 

cumulative effect of time and temperature 

abuse during the entire process. Information 

is provided above to help you assess the 

significance of time and temperature abuse 

that may occur in your process. 

3.	 Can unsafe levels of histamine formation that are 

reasonably likely to occur be eliminated or reduced 

to an acceptable level at this processing step? 

Scombrotoxin (histamine) formation should 

also be considered a significant hazard at any 

processing or storage step where a preventive 

measure is or can be used to eliminate the 

hazard if it is reasonably likely to occur. 

Preventive measures for scombrotoxin 

(histamine) formation can include: 

•	 Examining harvest vessel records 


to ensure that incoming fish were 


properly handled onboard the 


harvest vessel, including:
 

Rapidly chilling the fish immediately 

after death; 

° 

CHAPTER 7: Scombrotoxin (Histamine) Formation 

121 
Controlling onboard refrigeration 

(other than frozen storage) 


temperatures;
 

° 

Performing proper onboard icing; 
 ° 

•	 Testing incoming fish for 


histamine levels; 


•	 Ensuring that incoming fish 

were handled properly during 

refrigerated transportation from the 

previous processor, including: 

Controlling refrigeration temperatures 

during transit;
 

° 

Performing proper icing during 


transit; 

° 

•	 Checking incoming fish to ensure 


that they are not at an elevated 


temperature at time of receipt; 


•	 Checking incoming fish to ensure 


that they are properly iced or 


refrigerated at time of receipt;
 

•	 Performing sensory examination on 

incoming fish to ensure that they do 

not show signs of decomposition; 

•	 Controlling refrigeration 


temperatures in your plant; 


•	 Performing proper icing in your plant; 

•	 Controlling the amount of time that the 

product is exposed to temperatures 

that would permit histamine 

formation during processing. 

These preventive measures are ordinarily employed 

at receiving, processing, and storage steps. 

•	 Intended use 

Because of the heat stable nature of histamine, 

the intended use of the product is not likely to 

affect the significance of this hazard. 

IDENTIFY CRITICAL CONTROL POINTS. 

The following guidance will assist you in 

determining whether a processing step is a 

critical control point (CCP) for scombrotoxin 

(histamine) formation: 

1.	 If scombrotoxin (histamine) formation is a 

significant hazard at the receiving step, you 

should identify receiving as a CCP for this 

hazard. 

a.	 If you are the primary processor of the 

scombrotoxin-forming fish (i.e., if you 

receive the fish directly from the harvest 

vessel) and have a relationship with the 

operator of the harvest vessel(s) from 

which you purchase fish that enables 

you to obtain documentation of onboard 

practices, you should identify the 

following preventive measures for control 

of this hazard: 

•	 Examining harvest vessel records 

to ensure that incoming fish 

were properly handled onboard 

the harvest vessel, including: 

Rapidly chilling the fish 

immediately after death; 

 ̊ 

Controlling onboard refrigeration 

(other than frozen storage) 


temperatures;
 

 ̊ 

Performing proper onboard icing; 
  ̊ 

•	 Checking incoming fish to ensure 

that they are not at an elevated 

temperature at time of receipt; and, 

•	 Performing sensory examination of 

incoming fish to ensure that they do 

not show signs of decomposition. 

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 

the internal temperatures of 

incoming fish and perform sensory 

examination of these fish. The 

processor should then set a CCP for 

histamine formation at receiving. 

This control approach is a control strategy 

referred to in this chapter as “Control 

Strategy Example 1 - Harvest Vessel 

Control.” 

b.	 If you are the primary processor of the 

scombrotoxin-forming fish (i.e., if you 

receive the fish directly from the harvest 

vessel) and do not have a relationship 

with the operator of the harvest vessel(s) 

that enables you to obtain documentation 

of onboard practices, you should identify 

the following preventive measures for 

control of this hazard: 

•	 Testing incoming fish for 


histamine levels; 


•	 Checking incoming fish to ensure 

that they are not at an elevated 

temperature at time of receipt and, 

•	 Performing sensory examination of 

incoming fish to ensure that they do 

not show signs of decomposition. 

Example: 

A canned tuna processor that 

purchases from a variety of harvest 

vessels should subject incoming fish 

from each harvest vessel to histamine 

testing, internal temperature checks, 

and sensory examination. The 

processor should then set a CCP for 

histamine formation at receiving. 

This control approach is a control strategy 

referred to in this chapter as “Control 

Strategy Example 2 - Histamine Testing.” 

c.	 If you are a secondary processor of the 

scombrotoxin-forming fish (i.e., if you 

receive the fish from another processor), 

you should identify the following 

preventive measures for control of this 

hazard: 

•	 Ensuring that incoming fish were 

properly refrigerated during 

transportation from the previous 

processor, by controlling refrigeration 

temperatures during transit or, 

•	 Checking incoming fish to 

ensure that they are properly 

iced at time of receipt. 

Example: 

A tuna processor that receives fish 

from another processor should require 

evidence of temperature control 

throughout transit as a condition of 

receipt. The processor should then 

set a CCP for histamine formation at 

receiving. 

This control approach is a control strategy 

referred to in this chapter as “Control 

Strategy Example 3 - Transit Control.” 

This control strategy, in addition to 

“Control Strategy Example 1 - Harvest 

Vessel Control” or “Control Strategy 

Example 2 - Histamine Testing,” may 

also be applicable if you are a primary 

processor and transport the fish by truck 

from your harvest vessel unloading site to 

your processing facility. 

2.	 If scombrotoxin (histamine) formation is a 

significant hazard at one or more processing 

steps, you should identify the processing step(s) 

as a CCP for this hazard. 

a.	 The preventive measure for this type of 

control is: 

•	 Controlling the amount of time 

that the scombrotoxin-forming 

product is exposed to temperatures 

that would permit histamine 

formation during processing. 

CHAPTER 7: Scombrotoxin (Histamine) Formation 

123 
 

 

 

 

Example: 

A mahi-mahi processor should 

control histamine formation 

by limiting exposure time and 

temperature of the product during 

processing. The processor should 

then set CCPs for histamine 

formation at the processing steps. 

This control approach is a control strategy 

referred to in this chapter as “Control 

Strategy Example 4 - Processing Control.” 

This control strategy is intended for 

processing at ambient and air-conditioned 

temperatures. “Control Strategy 

Example 5 - Storage Control” may be 

more appropriate for processing under 

refrigerated conditions. 

3.	 If scombrotoxin (histamine) formation is a 

significant hazard at a storage step for raw 

material, in-process product, or finished product, 

you should identify the storage step(s) as a CCP 

for this hazard. 

a.	 The preventive measures for this type of 

control are: 

•	 Controlling refrigeration 

temperatures in your plant or, 

•	 Performing proper icing 

in your plant. 

Example: 

A mahi-mahi processor should control 

histamine formation by icing the 

product during raw material, in-process 

product, and finished product storage. 

The processor should then set CCPs for 

histamine formation at the storage steps. 

This control approach is a control strategy 

referred to in this chapter as “Control 

Strategy Example 5 - Storage Control.” 

•	 Likely CCPs 

Following is further guidance on processing 

steps that are likely to be identified as CCPs 

for this hazard: 

•	 Receiving; 

•	 Processing, such as: 

Thawing; ° 

Brining and salting; ° 

Smoking; ° 

Heading and gutting; ° 

Manual filleting and steaking; ° 

Fermenting; ° 

Pickling; ° 

Drying; ° 

Stuffing; ° 

Mixing (e.g., salad preparation); ° 

Portioning; ° 

•	 Packaging; 

•	 Final chilling after processing 


and packaging; 


•	 Storing raw material, in-process product, 

and finished product under refrigeration. 

Note: Rather than identify each processing step as an individual 

CCP when the controls are the same at those steps, it may be more 

convenient to combine into one CCP those processing steps that 

together contribute to a cumulative time and temperature exposure. 

•	 Unlikely CCPs 

Time and temperature controls will usually 

not be needed at processing steps that meet 

the following conditions: 

•	 Continuous, mechanical processing 

steps that are brief, such as: 

Mechanical filleting; ° 

•	 Processing steps that are brief and 

unlikely to contribute significantly 

to the cumulative time and 

temperature exposure, such as: 

Date code stamping; ° 

Case packing; ° 

•	 Processing steps where the product 

is held in a frozen state, such as: 

Assembly of orders for distribution; ° 

Frozen product storage; ° 

CHAPTER 7: Scombrotoxin (Histamine) Formation 

124 
 

•	 Retorting and post-retorting steps (if the 

product is covered by the Thermally 

Processed Low-Acid Foods Packaged 

in Hermetically Sealed Containers 

regulation, 21 CFR 113 (called the 

Low-Acid Canned Foods Regulation 

in this guidance document)); 

DEVELOP A CONTROL STRATEGY. 

The following guidance provides examples of five 

control strategies for scombrotoxin (histamine) 

formation. It may be necessary to select more 

than one control strategy in order to fully control 

the hazard, depending upon the nature of your 

operation. You may select a control strategy 

that is different from those which are suggested, 

provided it complies with the requirements of the 

applicable food safety laws and regulations. 

The following are examples of control strategies 

included in this chapter: 

CONTROL STRATEGY 

MAY APPLY TO 

PRIMARY 

PROCESSOR 

MAY APPLY TO 

SECONDARY 

PROCESSOR 

Harvest vessel control 

Histamine testing 

Transit control  

Processing control  

Storage Control  

•	 CONTROL STRATEGY EXAMPLE 1 - HARVEST 

VESSEL CONTROL 

It may be necessary to select more than one 

control strategy in order to fully control the 

hazard, depending upon the nature of your 

operation. 

Set Critical Limits. 

The critical limits for this control strategy should 

include three components: 

•	 Harvest vessel records; 

•	 Sensory examination; 

•	 Internal temperature measurements. 

Harvest vessel records: 

•	 All scombrotoxin-forming fish lots received 

are accompanied by harvest vessel records 

that show: 

Fish exposed to air or water temperatures 

above 83°F (28.3°C) were 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 longer 

than 6 hours from the time of death; 

 ̊ 

OR 

Fish exposed to air and water temperatures 

of 83°F (28.3°C) or less were 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 longer than 9 

hours from the time of death; 

 ̊ 

OR 

Fish that were gilled and gutted 

before chilling were 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 longer 

than 12 hours from the time of death; 

 ̊ 

OR 

Fish that were harvested under 

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 

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 left the 

65°F (18.3°) or less environment; 

 ̊ 

OR 

Other critical limits for onboard handling 

(e.g., maximum refrigerated brine or 

seawater temperature, maximum fish 

size, maximum fish to brine/seawater/ 

ice ratio, maximum initial temperature of 

 ̊ 

CHAPTER 7: Scombrotoxin (Histamine) Formation 

125 
 

 

the fish) necessary to achieve a cooling 

rate that will prevent development of 

an unsafe level of histamine in the 

specific species, as established through a 

scientific study. 

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). Table 7-1 provides a summary of 

the preceding recommended critical limits. 

AND
 

For fish held refrigerated (not frozen) 


onboard the vessel: 

 ̊ 

•	 The fish were stored at or below 

40°F (4.4°C) after cooling; 

OR 

•	 The fish were stored completely 

and continuously surrounded 

by ice after cooling; 

AND 

Sensory examination: 

•	 Sensory examination of a representative 

sample of scombrotoxin-forming fish shows 

decomposition (persistent and readily 

perceptible) in less than 2.5% of the fish in 

the sample. For example, no more than 2 

fish in a sample of 118 fish may show signs 

of decomposition. Note that the FFD&C 

Act prohibits interstate commerce of any 

decomposed fish whether or not the HACCP 

critical limit has been exceeded; 

AND 

Internal temperature measurements: 

•	 For fish held iced or refrigerated (not frozen) 

onboard the vessel 24 or more hours after 

death: 

The internal temperature should be 40°F 

(4.4°C) or below; 


 ̊ 

OR
 

•	 For fish held iced or refrigerated (not frozen) 

onboard the vessel from 15 to less than 24 

hours after death: 

The internal temperature should be 50°F  ̊ 

(10°C) or below; 


OR
 

•	 For fish held iced or refrigerated (not frozen) 

onboard the vessel from 12 to less than 15 

hours after death: 

The internal temperature should be 60°F 

(15.6°C) or below; 


 ̊ 

OR
 

•	 For fish held iced or refrigerated (not frozen) 

onboard the vessel less than 12 hours after 

death: 

The internal temperature should 

be sufficiently below water and air 

temperatures to indicate that appropriate 

chilling methods were implemented 

onboard the harvest vessel. Chilling 

of the fish should begin on the harvest 

vessel regardless of the time from death 

until off-loading from the vessel by the 

processor unless the environmental 

conditions (e.g., air and water 

temperatures) are below 40°F (4.4°C) 

from the time of death until off-loading 

from the vessel by the processor; 

 ̊ 

OR 

•	 For fish held iced or refrigerated (not frozen) 

onboard the vessel: 

Elapsed time from death and internal 

temperatures at the time of off-loading 

from the vessel by the processor should 

be consistent with cooling curves that 

will prevent development of an unsafe 

level of histamine in the specific species, 

as established through a scientific study. 

 ̊ 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

Harvest vessel records containing the following 

information: 

•	 Method of capture*; 

AND 

•	 Where applicable to the critical limit, the 

CHAPTER 7: Scombrotoxin (Histamine) Formation 

126 
date and time of landing the fish onboard 

the harvest vessel; 

AND 

•	 Where applicable to the critical limit, the 

estimated earliest date and time of death for 

fish brought onboard in the fishing set (e.g., 

trawl, gillnet, longline, or purse seine); 

AND 

•	 Where applicable to the critical limit, the 

air and water temperatures at the time of 

landing the fish onboard the harvest vessel*; 

AND 

•	 Where applicable to the critical limit, the 

water temperature at the depth where dead 

fish may remain until harvest; 

AND 

•	 Where applicable to the critical limit, the 

method of cooling* and temperature of the 

cooling medium; 

AND 

•	 Where applicable to the critical limit, the 

date and time cooling began and/or the date 

and time when the last fish in a fishing set 

(e.g., trawl, gillnet, longline, or purse seine) 

was placed in the cooling medium; 

AND 

•	 Where applicable to the critical limit, those 

factors of the cooling process that have been 

established through a scientific study as critical 

to achieving the cooling rate critical limits (e.g., 

refrigerated brine or seawater temperature, fish 

size, fish to brine/seawater/ice ratio, maximum 

initial temperature of the fish); 

AND 

•	 For fish held iced or refrigerated (not frozen) 

onboard the vessel: 

The storage temperature, as evidenced by:  ̊ 

•	 The temperature of refrigerated 

seawater or brine in which 

the fish are stored; 

OR 

•	 The presence of ice that completely 

and continuously surrounds the fish. 

(*These items may be documented by the primary (first) processor, 

on the receiving records, rather than by the harvest vessel operator, 

on the harvest vessel records, provided the primary processor has 

direct knowledge about those aspects of the harvesting practices and 

has made first-hand observations for each lot received. The vessel 

operator should document other onboard handling information. The 

primary processor should maintain all relevant information.) 

AND 

Sensory examination: 

•	 Amount of decomposition in the lot; 

AND 

Internal temperature measurement: 

•	 For fish held iced or refrigerated (not frozen) 

onboard the vessel: 


The internal temperature of a 


representative number of the largest 


fish in the lot at the time of off-loading 


from the harvest vessel, concentrating on 


any fish that show signs of having been 


mishandled (e.g., inadequately iced);
 

 ̊ 

AND
 

Date and time of off-loading.
  ̊ 

Example: 

A primary processor receives 

bluefish from several day-boats 

that catch the fish when the air 

and water temperatures are below 

83°F (28.3°C). The day-boats take 

on ice at the processor’s facility 

immediately before setting out for the 

day and return within 9 hours to the 

processor’s facility with the iced catch. 

The processor monitors and records 

the date and time of departure of 

the vessels after they take on ice; the 

date and time of the return of the 

vessels; the ambient water and air 

temperatures of the fishing grounds; 

and the adequacy of icing of the 

catch at the time of off-loading. The 

processor also conducts sensory 

evaluations and checks the internal 

CHAPTER 7: Scombrotoxin (Histamine) Formation 

127 
 

 

temperature of the catch upon arrival. 

The harvest vessel operators perform 

no monitoring or record keeping. 

»	 How Will Monitoring Be Done? 

•	 For harvest vessel records: 

Review controls documented in the 

records; 


 ̊ 

AND
 

•	 For sensory examination: 

Examine at least 118 fish, collected 

representatively throughout each lot (or the 

entire lot, for lots smaller than 118 fish). 

Additional fish should be examined if 

variability in fish-to-fish histamine content 

is expected to be high. Lots should 

consist of only one species of fish; for 

vessels delivering multiple species, testing 

should generally be done separately on 

each species. All fish within a lot should 

have a similar history of harvest. If the 

fish are received frozen, this monitoring 

procedure may be performed by a 

sensory examination on the warmed flesh 

produced by drilling the frozen fish (drill 

method). It may also be performed after 

thawing, rather than at receipt; 

 ̊ 

AND 

•	 For fish held iced or refrigerated (not frozen) 

onboard the vessel: 

Use a temperature-indicating device 

(e.g., a thermometer) to measure the 

internal temperature of a representative 

number of the largest fish in each 

lot, concentrating on any that show 

signs of having been mishandled (e.g., 

inadequately iced). For example, 

when receiving 10 tons or more of fish, 

measure a minimum of one fish per ton, 

and when receiving less than 10 tons of 

fish, measure a minimum of one fish per 

1,000 pounds. Measure a minimum of 

12 fish, unless there are fewer than 12 

fish in the lot, in which case measure all 

 ̊ 

of the fish. Randomly select fish from 

throughout the lot. Lots that show a high 

level of temperature variability or lots 

of very small fish may require a larger 

sample size; 

AND 

Visually determine the date and time of 

off-loading. 

 ̊ 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 Every lot of scombrotoxin-forming fish 

received. 

»	 Who Will Do the Monitoring? 

•	 For sensory examination: 

Any person who is qualified by 

experience or training to perform the 

examination; 

 ̊ 

AND 

•	 For other checks: 

Any person who has an understanding of

the nature of the controls. 

 ̊ 

Establish Corrective Action Procedures. 

Take the following corrective actions to a product 

involved in a critical limit deviation: 

•	 In the absence of harvest vessel records or 

when one of the harvester-related critical 

limits has not been met, or when the internal 

temperature critical limit at receiving has not 

been met: 

Chill and hold the affected lot (i.e., 

fish of common origin) until histamine 

analysis is performed on a minimum 

of 60 fish representatively collected 

from throughout the lot, including any 

fish measured to have temperatures 

that exceeded the critical limit (or the 

entire lot for lots smaller than 60 fish). 

Reject the lot if any fish are found with 

histamine greater than or equal to 50 

ppm. The fish collected for analysis 

may be composited for analysis if the 

action point is reduced accordingly. For 

 ̊ 

CHAPTER 7: Scombrotoxin (Histamine) Formation 

128 
example, a sample of 60 fish may be 

composited into 20 units of 3 fish each, 

provided the action point is reduced 

from 50 ppm to 17 ppm for each unit; 

OR
 

Reject the lot; 
  ̊ 

AND 

•	 When the sensory examination critical limit 

has not been met: 

Chill and hold the affected lot (i.e., 

fish of common origin) until histamine 

analysis is performed on a minimum 

of 60 fish representatively collected 

from throughout the lot, including all 

fish in the lot that show evidence of 

decomposition (persistent and readily 

perceptible odors) (or the entire lot for 

lots smaller than 60 fish), and reject the 

lot if any fish is found with histamine 

greater than or equal to 50 ppm; 

 ̊ 

AND 

If any fish in the lot are to proceed

into commerce for food use, perform 

a sensory examination of all fish in the 

lot to ensure that no decomposed fish 

proceed; 

 ̊ 

AND 

Any individual fish found to be 

decomposed (persistent and readily 

perceptible) should be destroyed or 

diverted to a non-food use; 

 ̊ 

OR
 

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 identified 

harvesting and onboard practices and 

controls have been improved. 

Establish a Recordkeeping System. 

•	 Harvest vessel records containing the 

information described above; 

AND 

•	 Receiving records showing the date and time 

of off-loading; 

AND 

•	 Results of sensory examination; 

AND 

•	 For fish held iced or refrigerated (not frozen) 

onboard the vessel: 


Internal temperatures of the fish.
  ̊ 

Establish Verification Procedures. 

•	 Collect a representative sample of the raw 

material, in-process product, or finished 

product, and analyze it for histamine at least 

quarterly; 

AND 

•	 Ensure that new sensory examiners receive 

training to calibrate their ability to identify 

decomposed fish and that all sensory 

examiners receive periodic refresher training; 

AND 

•	 Where histamine testing is part of a 

corrective action plan, periodically verify 

the findings (e.g., by comparing results with 

those obtained using an Association of 

Official Analytical Chemists (AOAC) method); 

AND 

•	 Before a temperature-indicating device (e.g., 

a thermometer) is put into service, check 

the accuracy of the device to verify that the 

factory calibration has not been affected. 

This check can be accomplished by: 

Immersing the sensor in an ice slurry 

(32°F (0°C)), if the device will be used at 

or near refrigeration temperature; 

 ̊ 

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., 

a thermometer traceable to the 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; 

•	 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. 

OR 

Following the manufacturer’s instructions;  ̊ 

AND 

•	 Once in service, check the temperatureindicating 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 
CHAPTER 7: Scombrotoxin (Histamine) Formation 

131 

TABLE 7-3 

CONTROL STRATEGY EXAMPLE 1 - HARVEST VESSEL CONTROL

This table is an example of a portion of a HACCP plan using “Control Strategy Example 1 - Harvest Vessel Control.” This example illustrates how a fresh mahi-mahi processor thatreceives the fish on ice directly from harvest vessels that use a hook and line technique (fish brought onboard alive) can control scombrotoxin formation. It is provided for illustrativepurposes only. It may be necessary to select more than one control strategy in order to fully control the hazard, depending upon the nature of your operation. Histamine formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., metal fragments).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Receiving 

fresh

mahimahi on

ice from

harvest 

vessels 

Scombrotoxin 

formation 

All lots received are accompanied 

by harvest vessel records that show 

(1) placement of fish on ice

within 9 hours of death if the

maximum exposure temperature 

does not exceed 83°F or within 6 

hours if the maximum exposure 

temperature exceeds 83°F;

(2) The fish were stored 

completely and continuously

surrounded by ice after capture 

Harvest vessel 

records 

Review of 

controls

documented

in the records 

Every 

lot

received 

Receiving 

supervisor 

Reject 

the lot

Discontinue

use of the

supplier

until

evidence 

is obtained

that

harvesting 

and

onboard

practices 

and

controls

have been 

improved 

Harvester 

vessel 

records 

Perform histamine analysis on 

1 incoming lot every 3 months 

(18 fish per sample)

Review monitoring, corrective 

action, and verification records 

within 1 week of preparation 

Less than 2.5% decomposition

(persistent and readily perceptible)

in the incoming lot 

Amount

of

decomposition

in the incoming

lot 

Sensory

examination

(118 fish per

lot; or all fish

in the lot if

less than 118

fish) 

Every 

lot

received 

Quality

control

staff 

Receiving 

record 

Provide sensory training 

for new fish examiners and 

annual training for all fish 

examiners

Review monitoring, corrective 

action, and verification records 

within 1 week of preparation

Internal temperatures of all fish 

are to meet the following criteria 

based on the time since the death

of the fish:

>24 hours 

g ≤ 40° 

15 to < 24 hours 

g ≤ 50° 

12 to < 15 hours

g ≤ 60° 

< 12 hours 

g below ambient 

air and water temperatures 

commensurate with size of fish and 

time since death 

Internal 

temperature 

of the fish at

time of

off-loading 

from vessel; 

Date and time

of off-loading 

Digital

thermometer 

(1 fish/1,000

pounds;

minimum of

12 fish per

lot) 

Every 

lot

received 

Receiving 

supervisor 

Receiving 

record 

Check the digital thermometer

for accuracy and damage and

to ensure that it is operational

before putting it into operation;

perform these same checks

daily, at the beginning of

operations; and calibrate it once

per year

Review monitoring, corrective 

action, and verification records 

within 1 week of preparation 
 

 

 

•	 CONTROL STRATEGY EXAMPLE 2 - HISTAMINE 

TESTING 

It may be necessary to select more than one 

control strategy in order to fully control the 

hazard, depending upon the nature of your 

operation. 

Set Critical Limits. 

The critical limits for this control strategy should 

include three components: 

•	 Histamine testing; 

•	 Sensory examination; 

•	 Internal temperature measurements. 

Histamine testing: 

•	 Analysis of a representative sample of 

scombrotoxin-forming fish shows less than 

50 ppm histamine in all fish in the sample; 

AND 

Sensory examination: 

•	 Sensory examination of a representative 

sample of scombrotoxin-forming fish shows 

decomposition (persistent and readily 

perceptible) in less than 2.5% of the fish in 

the sample. For example, no more than 2 

fish in a sample of 118 fish may show signs 

of decomposition. Note that the FFD&C 

Act prohibits interstate commerce of any 

decomposed fish whether or not the HACCP 

critical limit has been exceeded; 

AND 

Internal temperature measurements: 

•	 For fish held iced or refrigerated (not frozen) 

onboard the vessel 24 or more hours after 

death: 

The internal temperature should be 40°F 

(4.4°C) or below; 


 ̊ 

OR
 

•	 For fish held iced or refrigerated (not frozen) 

onboard the vessel from 15 to less than 24 

hours after death: 

The internal temperature should be 50°F 

(10°C) or below; 


 ̊ 

OR
 

•	 For fish held iced or refrigerated (not frozen) 

onboard the vessel from 12 to less than 15 

hours after death: 

The internal temperature should be 60°F 

(15.6°C) or below; 


 ̊ 

OR
 

•	 For fish held iced or refrigerated (not frozen) 

onboard the vessel less than 12 hours after 

death: 

The internal temperature should 

be sufficiently below water and air 

temperatures to indicate that appropriate 

chilling methods were implemented 

onboard the harvest vessel. Chilling 

of the fish should begin on the harvest 

vessel regardless of the time from death 

until off-loading from the vessel by the 

processor, unless the environmental 

conditions (e.g. air and water 

temperatures) are below 40°F (4.4°C) 

from the time of death until off-loading 

from the vessel by the processor; 

 ̊ 

OR 

•	 For fish held iced or refrigerated (not frozen) 

onboard the vessel: 

Elapsed time from death and internal 

temperatures at the time of off-loading 

from the vessel by the processor should 

be consistent with cooling curves that 

will prevent development of an unsafe 

level of histamine in the specific species, 

as established through a scientific study. 

 ̊ 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

Histamine testing: 

•	 Histamine content in the scombrotoxinforming fish flesh; 

AND 

CHAPTER 7: Scombrotoxin (Histamine) Formation 

132 
 

Sensory examination: 

•	 Amount of decomposition in the 

scombrotoxin-forming fish lot; 

AND 

Internal temperature measurement: 

•	 For scombrotoxin-forming fish held iced or 

refrigerated (not frozen) onboard the vessel: 

The internal temperature of a 

representative number of the largest 


fish in the lot at the time of off-loading 


from the harvest vessel by the processor,
 

concentrating on any fish that show 


signs of having been mishandled (e.g.,
 

inadequately iced);
 

 ̊ 

AND
 

Date and time of off-loading.
  ̊ 

»	 How Will Monitoring Be Done? 

•	 For histamine analysis: 

Test a minimum of 18 fish, collected 

representatively throughout each lot (or 

the entire lot when there are fewer than 

18 fish in the lot). Additional fish should 

be examined if variability in fish-to-fish 

histamine content is expected to be high. 

Lots should consist of only one species 

of fish; for vessels delivering multiple 

species, testing should generally be done 

separately on each species. Reject the 

lot if any fish are found with histamine 

greater than or equal to 50 ppm. The 

fish collected for analysis may be 

composited if the critical limit is reduced 

accordingly. For example, a sample of 

18 fish may be composited into 6 units 

of 3 fish each, provided the critical limit 

is reduced from 50 ppm to 17 ppm for 

each unit; 

 ̊ 

AND 

•	 For sensory examination: 

Examine at least 118 fish, collected 

representatively throughout each lot 

(or the entire lot, for lots smaller than 

118 fish). Additional fish should be 

examined if variability in fish-to-fish 

histamine content is expected to be high. 

Lots should consist of only one species 

of fish; for vessels delivering multiple 

species, testing should generally be 

done separately on each species. If the 

fish are received frozen, this monitoring 

procedure may be performed by a 

sensory examination on the warmed 

flesh produced by drilling the frozen fish 

(drill method). It may also be performed 

after thawing, rather than at receipt; 

 ̊ 

AND 

•	 For fish held iced or refrigerated (not frozen) 

onboard the vessel: 

Use a temperature-indicating device 

(e.g., a thermometer) to measure the 

internal temperature of a representative 

number of the largest fish in each 

lot, concentrating on any that show 

signs of having been mishandled (e.g., 

inadequately iced). For example, 

when receiving 10 tons or more of fish, 

measure a minimum of one fish per ton, 

and when receiving less than 10 tons of 

fish, measure a minimum of one fish per 

1,000 pounds. Measure a minimum of 

12 fish, unless there are fewer than 12 

fish in the lot, in which case measure all 

of the fish. Randomly select fish from 

throughout the lot. Lots that show a high 

level of temperature variability or lots 

of very small fish may require a larger 

sample size; 

 ̊ 

AND 

Visually determine the date and time of 

off-loading. 

 ̊ 

CHAPTER 7: Scombrotoxin (Histamine) Formation 

133 
 

 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 Every lot of scombrotoxin-forming fish received. 

»	 Who Will Do the Monitoring? 

•	 For sensory examination and histamine 

testing:
 

Any person who is qualified by 


experience or training to perform the 

work; 

 ̊ 

AND 

•	 For other checks: 

Any person who has an understanding of

the nature of the controls. 

 ̊ 

Establish Corrective Action Procedures. 

Take the following corrective actions to a product 

involved in a critical limit deviation: 

•	 When the histamine-level critical limit at the 

receiving step has not been met, reject the lot; 

AND 

•	 When the internal temperature critical limit 

has not been met: 

If histamine did not exceed 50 ppm in 

the initial testing: 

 ̊ 

•	 Chill and hold the affected lot 

(i.e., fish of common origin) until 

histamine analysis is performed on a 

minimum of 60 fish representatively 

collected from throughout the lot, 

including any fish measured to 

have temperatures that exceeded 

the critical limit (or the entire lot 

for lots smaller than 60 fish). Reject 

the lot if any fish are found with 

histamine greater than or equal 

to 50 ppm. The fish collected for 

analysis may be composited for 

analysis if the action point is reduced 

accordingly. For example, a sample 

of 60 fish may be composited into 

20 units of 3 fish each, provided 

the action point is reduced from 

50 ppm to 17 ppm for each unit; 

OR 

•	 Reject the lot;
 

AND 


•	 When the sensory examination critical limit 

has not been met: 

If histamine did not exceed 50 ppm in 

the initial testing: 

 ̊ 

•	 Chill and hold the affected lot 

(i.e., fish of common origin) until 

histamine analysis is performed on a 

minimum of 60 fish representatively 

collected from throughout the lot, 

including all fish in the lot that 

show evidence of decomposition 

(persistent and readily perceptible 

odors) (or the entire lot for lots 

smaller than 60 fish). Reject the 

lot if any fish are found with 

histamine greater than or equal 

to 50 ppm. The fish collected for 

analysis may be composited for 

analysis if the action point is reduced 

accordingly. For example, a sample 

of 60 fish may be composited into 

20 units of 3 fish each, provided 

the action point is reduced from 

50 ppm to 17 ppm for each unit; 

AND 

If any fish in the lot are to proceed

into commerce for food use, perform 

a sensory examination of all fish in the 

lot to ensure that no decomposed fish 

proceed; 

 ̊ 

AND 

Any individual fish found to be 

decomposed (persistent and readily 

perceptible) should be destroyed or 

diverted to a non-food use; 

 ̊ 

OR
 

Reject the lot.
  ̊ 

AND 

CHAPTER 7: Scombrotoxin (Histamine) Formation 

134 
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 identified harvesting and 

onboard practices have been improved. 

Establish a Recordkeeping System. 

•	 Receiving records showing: 

Date and time of off-loading;  ̊ 

AND 

•	 Results of histamine analysis; 

AND 

•	 Results of sensory examination; 

AND 

For fish held iced or refrigerated (not frozen) 

onboard the vessel: 


Internal temperatures of the fish.
 

•	

 ̊ 

Establish Verification Procedures. 

•	 Periodically verify histamine findings (e.g., by 

comparing results with those obtained using 

an AOAC method or by analyzing proficiency 

samples); 

AND 

•	 Ensure that new sensory examiners receive 

training to calibrate their ability to identify 

decomposed fish and that all sensory 

examiners receive periodic refresher training; 

AND 

•	 Before a temperature-indicating device (e.g., 

a thermometer) is put into service, check 

the accuracy of the device to verify that the 

factory calibration has not been affected. 

This check can be accomplished by: 

Immersing the sensor in an ice slurry 

(32°F (0°C)), if the device will be used at 

or near refrigeration temperature; 

 ̊ 

OR 

Comparing the temperature reading on 

the device with the reading on a known 

accurate reference device (e.g., a NIST-

 ̊ 

traceable thermometer) 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;
 

OR 


Following the manufacturer’s instructions;
  ̊ 

AND 

•	 Once in service, check the temperatureindicating 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 

•	 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 

135 
CHAPTER 7: Scombrotoxin (Histamine) Formation 

136 

TABLE 7-4 

CONTROL STRATEGY EXAMPLE 2 - HISTAMINE TESTING

This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Histamine Testing.” This example illustrates how a canned tuna processor thatreceives frozen tuna directly from the harvest vessel can control scombrotoxin formation. It is provided for illustrative purposes only. It may be necessary to select more than one control strategy in order to fully control the hazard, depending upon the nature of your operation.Histamine formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., Clostridium botulinum growth and toxin formation). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE ACTION(S) RECORDS VERIFICATION

WHAT HOW FREQUENCY WHO 

Receiving 

frozen 

tuna from

harvest 

vessels 

Scombrotoxin 

formation 

Less than

50 ppm

histamine in

all fish in the

sample 

Fish fl esh for 

histamine

content 

Histamine testing

using the AOAC 

977.13 method

on a minimum

of 18 fish per

lot (36 fish from

vessels with 

high variability 

of histamine

detected 

between fish 

or when 1 of

the first 18 fish

exceeds 30 ppm 

histamine) 

Every lot 

received 

Quality

assurance 

staff 

Reject the lot;

Discontinue use of the supplier

until evidence is obtained 

that harvesting and onboard 

practices have been improved

If the initial histamine sample

was <50 ppm, perform

histamine analysis on a

min, of 60 fish, collected

representatively from the lot

and reject the lot if any fish

contains ≥50 ppm histamine;

and if all fish <50 ppm 

Reports of 

histamine

analysis 

Do a quarterly 

comparison of histamine

test results with AOAC 

method

Review 

monitoring,

corrective action, and 

verification records 

within 1 week of 

preparation 

Less than 3

decomposed

fish

(persistent

and readily

perceptible)

in a 118-fish

sample 

Amount of

decomposition

in the

incoming lot 

Sensory 

examination (118 

fish per lot, or all 

fish if lot is less

than 118 fish) 

Every lot 

received 

Quality

assurance 

staff 

Conduct sensory evaluation of 

all fish in the lot, removing and 

destroying all decomposed fish 

Discontinue use of the supplier

until evidence is obtained 

that harvesting and onboard 

practices have been improved 

Sensory 

examination 

record 

Provide sensory training 

for new fish examiners 

and annual training for 

all fish examiners

Review monitoring,

corrective action, and 

verification records 

within 1 week of 

preparation 
 

•	 CONTROL STRATEGY EXAMPLE 3 - TRANSIT 

CONTROL 

It may be necessary to select more than one 

control strategy in order to fully control the hazard, 

depending upon the nature of your operation. 

Set Critical Limits. 

•	 For fish delivered refrigerated (not frozen): 

All lots received are accompanied by 

transportation records that show that the 

fish were held at or below an ambient 

or internal temperature of 40°F (4.4°C) 

throughout transit. Note that allowance 

for routine refrigeration defrost cycles may 

be necessary; 

 ̊ 

OR 

•	 For fish delivered under ice: 

Fish are completely surrounded by ice at 

the time of delivery; 


 ̊ 

OR
 

•	 For fish delivered under ice on an open-bed 

truck: 

Fish are stored completely surrounded by 

ice; 

 ̊ 

AND 

The internal temperature of the fish at the 

time of delivery is 40°F (4.4°C) or below; 

 ̊ 

OR 

•	 For fish delivered under chemical cooling 

media such as gel packs: 


There is an adequate quantity of


cooling media that remain frozen to 

have maintained product at an internal 

temperature of 40°F (4.4°C) or below 

throughout transit; 

 ̊ 

AND 

The internal temperature of the fish at the 

time of delivery is 40°F (4.4°C) or below; 

 ̊ 

OR 

•	 For fish delivered refrigerated (not frozen) 

with a transit time (including all time outside 

a controlled temperature environment) of 4 

hours or less (optional control strategy): 

Time of transit does not exceed 4 hours;  ̊ 

AND 

 Internal temperature of the fish at the 

time of delivery does not exceed 40°F 

(4.4°C). 

 ̊

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. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 For scombrotoxin-forming fish delivered 

refrigerated (not frozen): 

The internal temperature of the fish 

throughout transportation; 

 ̊ 

OR 

The ambient temperature within the truck 

or other carrier throughout transportation; 

 ̊ 

OR 

•	 For scombrotoxin-forming fish delivered under 

ice: 

The adequacy of ice surrounding the 

product at the time of delivery;
 

 ̊ 

OR
 

•	 For scombrotoxin-forming fish delivered under 

ice on an open-bed truck: 

The adequacy of ice surrounding the 

product at the time of delivery; 

 ̊ 

AND 

The internal temperature of the fish at 

time of delivery;
 

 ̊ 

OR
 

•	 For scombrotoxin-forming fish held under 

chemical cooling media such as gel packs: 

The quantity and frozen status of cooling 

media at the time of delivery; 

 ̊ 

AND 

The internal temperature of the fish at the 

time of delivery; 

 ̊ 

CHAPTER 7: Scombrotoxin (Histamine) Formation 

137 
OR 

•	 For scombrotoxin-forming fish delivered 

refrigerated (not frozen) with a transit time of 

4 hours or less: 

The date and time fish were removed 

from a controlled temperature 

environment before shipment and the 

date and time delivered; 

 ̊ 

AND 

The internal temperature of a representative 

number of fish at the time of delivery. 

 ̊ 

»	 How Will Monitoring Be Done? 

•	 For fish delivered refrigerated (not frozen): 

Use a continuous temperature-recording 

device (e.g., a recording thermometer) 

for internal product temperature or 

ambient air temperature monitoring 

during transit; 

 ̊ 

OR 

•	 For fish delivered under ice: 

Make visual observations of the adequacy 

of ice in a representative number of 

containers (e.g., cartons and totes) from 

throughout the shipment, at delivery; 

 ̊ 

OR 

•	 For fish delivered under ice on an open-bed 

truck:
 

Make visual observations of the 


adequacy of ice surrounding the product 


in a representative number of containers 


(e.g., cartons and totes) from throughout 


the shipment, at delivery;
 

 ̊ 

AND
 

Use a temperature-indicating device (e.g.,
 

a thermometer) to determine internal 

product temperatures in a representative 

number of fish from throughout the 

shipment, at delivery; 

 ̊ 

OR 

•	 For fish delivered under chemical cooling 

media such as gel packs: 

Make visual observations of the 

adequacy and frozen state of the cooling 


media in a representative number of 


containers (e.g., cartons and totes) from 


throughout the shipment;
 

 ̊ 

AND
 

Use a temperature-indicating device (e.g.,
 

a thermometer) to determine internal 

product temperatures in a representative 

number of fish from throughout the 

shipment, at delivery; 

 ̊ 

OR 

•	 For fish delivered refrigerated (not frozen) 

with a transit time of 4 hours or less: 

Review carrier records to determine the 

date and time fish were removed from 


a controlled temperature environment 


before shipment and the date and time 


delivered;
 

 ̊ 

AND
 

Use a temperature-indicating device (e.g.,
 

a thermometer) to determine internal 

product temperatures in a representative 

number of fish randomly selected from 

throughout the shipment, at delivery. 

Measure a minimum of 12 fish, unless 

there are fewer than 12 fish in a lot, in 

which case measure all of the fish. Lots 

that show a high level of temperature 

variability or lots of very small fish may 

require a larger sample size. 

 ̊ 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 Every scombrotoxin-forming fish lot received. 

»	 Who Will Do the Monitoring? 

•	 For continuous temperature-recording 

devices: 

Monitoring is performed by the device itself. 

The visual check of the data generated 

by the device, to ensure that the critical 

limits have consistently been met, may 

be performed by any person who has an 

understanding of the nature of the controls; 

 ̊ 

CHAPTER 7: Scombrotoxin (Histamine) Formation 

138 
OR 

•	 For other checks: 

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: 

•	 Chill and hold the affected lot until histamine 

analysis is performed on a minimum of 

60 fish representatively collected from 

throughout the lot, including any with 

temperatures that exceeded a critical limit 

and any fish observed to have been exposed 

to inadequate cooling media (or the entire lot 

for lots smaller than 60 fish). Reject the lot if 

any fish is found with histamine greater than 

or equal to 50 ppm. 

The fish collected for analysis may be 

composited if the action point is reduced 

accordingly. For example, a sample of 60 fish 

may be composited into 20 units of 3 fish 

each, provided the action point is reduced 

from 50 ppm to 17 ppm for each unit; 

OR 

•	 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 or carrier 

until evidence is obtained that the identified 

transportation-handling practices have been 

improved. 

Establish a Recordkeeping System. 

•	 Receiving records showing: 

For continuous temperature monitoring:  ̊ 

•	 Printouts, charts, or readings from 

temperature-recording devices (e.g., 

temperature recorder); 

OR
 

For ice checks:
  ̊ 

•	 The number of containers examined 

and the sufficiency of ice for each; 

AND 

•	 The number of containers in the lot; 


OR
 

For chemical cooling media checks:
  ̊ 

•	 The number of containers 

examined and the frozen status 

of the cooling media for each; 

AND 

•	 The number of containers in the lot; 

AND 

Results of internal product temperature 

monitoring, where applicable, including: 

 ̊ 

•	 The number of containers 

examined and the internal 

temperatures observed for each; 

AND 

•	 The number of containers in the lot; 

AND 

Date and time fish were initially 

removed from a controlled temperature 

environment and the date and time fish 

were delivered, when applicable. 

 ̊ 

Establish Verification Procedures. 

•	 Before a temperature-indicating device (e.g., 

a thermometer) is put into service, check 

the accuracy of the device to verify that the 

factory calibration has not been affected. 

This check can be accomplished by: 

Immersing the sensor in an ice slurry 

(32°F (0°C)), if the device will be used at 

or near refrigeration temperature; 

 ̊ 

OR 

Comparing the temperature reading on 

the device with the reading on a known 

accurate reference device (e.g., a NISTtraceable thermometer) under conditions 

that are similar to how it will be used 

 ̊ 

CHAPTER 7: Scombrotoxin (Histamine) Formation 

139 
(e.g., 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 temperatureindicating 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 

•	 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 

the device with the reading on a known 

accurate reference device (e.g., a NISTtraceable thermometer) under conditions that 

are similar to how it will be used (e.g., air 

temperature) within the temperature range at 

which it will be used; 

AND 

•	 When visual checks of ice are used, 

periodically measure internal temperatures 

of fish to ensure that the ice are 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 are complete and any 

critical limit deviations that occurred were 

appropriately addressed. 

CHAPTER 7: Scombrotoxin (Histamine) Formation 

140 
CHAPTER 7: Scombrotoxin (Histamine) Formation 

141 

TABLE 7-5 

CONTROL STRATEGY EXAMPLE 3 - TRANSIT CONTROL

This table is an example of a portion of a HACCP plan using “Control Strategy Example 3 - Transit Control.” This example illustrates how a fresh mahi-mahi secondary processor that receives the product by air under chemical coolant (gel packs) can control scombrotoxin formation. It is provided for illustrative purposes only. It may be necessary to select more than one control strategy in order to fully control the hazard, depending upon the nature of your operation.Histamine formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., metal fragments). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE ACTION(S) RECORDS VERIFICATION

WHAT HOW FREQUENCY WHO 

Receiving Scombrotoxin 

formation 

Adequate 

quantity of

frozen gel 

packs to

maintain the

product at 

40°F or less

throughout

transit; and 

Quantity

and frozen 

condition of

gel packs 

Visual observation 

of a minimum of

25% of shipping

containers in the

lot but not fewer 

than 12 containers

(or all containers if

lot has less than 12

containers) 

Every lot 

received 

Receiving 

clerk 

Reject the lot

Discontinue use of the

supplier or carrier until 

evidence is obtained that 

transportation-handling 

practices have been 

improved 

Receiving 

record 

Check the

thermometer for 

accuracy and 

damage, and to 

ensure that it

is operational 

before putting 

into operation; 

perform these 

same checks daily

at the beginning

of operations, and 

calibrate it once per 

year

Review 

monitoring,

corrective action,

and verification 

records within 1

week of preparation 

Internal 

temperatures 

of all fish at

delivery are 

40°F or below 

Internal core 

temperature 

and a

near-surface 

temperature 

of each fish 

Digital thermometer 

for internal 

temperature of 

one fish in 25% of

shipping containers

but not fewer than 

12 containers (or

all containers if lot

has less than 12

containers) 

Every lot 

received 

Receiving 

clerk 

Reject the lot

Discontinue use of the

supplier or carrier until 

evidence is obtained that 

transportation-handling 

practices have been 

improved 

Receiving 

record 
 

•	 CONTROL STRATEGY EXAMPLE 4 - PROCESSING 

CONTROL 

It may be necessary to select more than one 

control strategy in order to fully control the 

hazard, depending upon the nature of your 

operation. 

Set Critical Limits. 

•	 During processing (e.g., butchering, 

cleaning, brining, salting, smoking, drying, 

fermenting, pickling, mixing, fermenting, 

stuffing, packing, labeling, and staging) of 

scombrotoxin-forming fish that have not 

been previously frozen or heat processed 

sufficiently to destroy scombrotoxin-forming 

bacteria: 

The fish are not exposed to ambient 

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 

The fish are not exposed to ambient 

temperatures above 40°F (4.4°C) for 

more than 8 hours, cumulatively, as 

long as no portion of that time is at 

temperatures above 70°F (21.1°C). 

 ̊ 

Note: Only one of the two limits above should be selected. They 

should not be added for a total exposure of 12 hours. 

OR 

•	 During processing (e.g., thawing, butchering, 

cleaning, brining, mixing, fermenting, 

stuffing, packing, labeling, and staging) 

of scombrotoxin-forming fish or fishery 

products that have been (1) previously 

frozen or (2) heat processed sufficiently to 

destroy scombrotoxin-forming bacteria and 

are processed in a manner where there is 

an opportunity for recontamination with 

scombrotoxin-forming bacteria (e.g., contact 

with fresh fish, employees, or introduction 

of raw ingredients), such as in a tuna salad 

made from canned tuna with added raw 

ingredients: 

The fish are not exposed to ambient 

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 

The fish are not exposed to ambient 

temperatures above 40°F (4.4°C) for 

more than 24 hours, cumulatively, as 

long as no portion of that time is at 

temperatures above 70°F (21.1°C). 

 ̊ 

Note: Only one of the two limits above should be selected. They 

should not be added for a total exposure of 36 hours. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 The length of time the scombrotoxin-forming 

fish are exposed to unrefrigerated conditions 

(i.e., above 40°F (4.4°C)); 

AND 

•	 The ambient temperatures during the 

exposure periods. 

Note: If the critical limit is based on an assumption that temperatures 

may exceed 70°F (21.1°C), then only the length of exposure may 

need to be monitored. 

»	 How Will Monitoring Be Done? 

•	 Make visual observations of the length of 

time of product exposure to unrefrigerated 

conditions (i.e., above 40°F (4.4°C)); 

AND 

•	 Measure ambient air temperature, using: 

A continuous temperature-recording 

device (e.g., a recording thermometer) 


located in the processing area; 


 ̊ 

OR 


A temperature-indicating device (e.g., a 


thermometer) located in the processing 

area. 

 ̊ 

Note: Where multiple processing locations are combined in a 

cumulative exposure control strategy, temperature monitoring may be 

needed in each of the processing locations. 

CHAPTER 7: Scombrotoxin (Histamine) Formation 

142 
 

Example: 

A fresh tuna processor using raw 

material that was not previously 

frozen has identified a series of 

processing steps (i.e., from raw 

material cooler to finished product 

cooler) as CCPs for scombrotoxin 

formation. The processor establishes 

a critical limit of no more than 4 

cumulative hours of exposure to 

unrefrigerated temperatures in 

excess of 40°F (4.4°C) during these 

processing steps. The processor uses 

a marked product to monitor the 

progress of the product through the 

processing steps. The time that the 

marked product is removed from 

refrigeration to the time the last of 

the marked product is placed in the 

finished product cooler is monitored 

visually and recorded. It is not 

necessary for the processor to measure 

temperature because the critical limit 

is based on an assumption that the 

product temperature may exceed 70°F 

(21.1°C). 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 For exposure time: 

At least every 2 hours;  ̊ 

AND 

•	 For temperature measurements: 

For a continuous temperature-recording 

device: 

 ̊ 

•	 Continuous monitoring during 

processing operations is 

accomplished by the device itself, 

with a visual check of the device 

at least once per lot or batch, but 

no less often than once per day; 

OR
 

For a temperature-indicating device: 
  ̊ 

•	 At least every 2 hours. 

»	 Who Will Do the Monitoring? 

•	 For a continuous temperature-recording device: 

Monitoring is performed by the device 

itself. The visual check of the data 

generated by the device, to ensure that 

the critical limits have consistently been 

met, may be performed by any person 

who has an understanding of the nature 

of the controls; 

 ̊ 

OR 

•	 For other checks: 

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: 

•	 Chill and hold the affected product until 

histamine analysis is performed on a 

minimum of 60 fish representatively collected 

from throughout the affected lot. Destroy 

the lot or divert it to a non-food use if any 

fish is found with histamine greater than 

or equal to 50 ppm. The fish collected for 

analysis may be composited if the action 

plan is reduced accordingly. For example, 

a sample of 60 fish may be composited into 

20 units of 3 fish each, provided the action 

point is reduced from 50 ppm to 17 ppm for 

each unit; 

OR 

•	 Destroy the product; 

OR 

•	 Divert the product to a non-food use. 

AND 

Take the following corrective actions to regain control 

over the operation after a critical limit deviation: 

•	 Add ice to the product; 

OR 

•	 Return the affected product to the cooler; 

AND 

CHAPTER 7: Scombrotoxin (Histamine) Formation 

143 
•	 Modify the process as needed to reduce the 

time and temperature exposure. 

Establish a Recordkeeping System. 

•	 Processing records showing the results 

of time and temperature exposure 

measurements. 

Establish Verification Procedures. 

•	 Before a temperature-indicating device (e.g., 

a thermometer) or a temperature-recording 

device (e.g., a recording thermometer) is 

put into service, check the accuracy of the 

device to verify that the factory calibration 

has not been affected. This check can be 

accomplished by: 

Immersing the sensor in an ice slurry 

(32°F (0°C)), if the device will be used at 

or near refrigeration temperature; 

 ̊ 

OR 

Immersing the sensor in boiling water 

(212°F (100°C)) if the device will be used 

at or near the boiling point. Note that 

the temperature should be adjusted to 

compensate for altitude, when necessary; 

 ̊ 

OR 

Doing a combination of the above if 

the device will be used at or near room 

temperature; 

 ̊ 

OR 

Comparing the temperature reading on 

the device with the reading on a known 

accurate reference device (e.g., a NISTtraceable thermometer) under conditions 

that are similar to how it will be used (e.g., 

air temperature) within the temperature 

range at which it will be used; 

 ̊ 

AND 

•	 Once in service, check the temperatureindicating device or 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 has sufficient ink and paper, 

where applicable; 

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 

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 

•	 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 

144 
CHAPTER 7: Scombrotoxin (Histamine) Formation 

145 

TABLE 7-6 

CONTROL STRATEGY EXAMPLE 4 - PROCESSING CONTROL

This table is an example of a portion of a HACCP plan using “Control Strategy Example 4 - Processing Control.” This example illustrates how a fresh bluefish processorthat butchers, cleans, packs, labels, and boxes the fish at ambient temperature can control scombrotoxin formation. It is provided for illustrative purposes only. It may be necessary to select more than one control strategy in order to fully control the hazard, depending upon the nature of your operation. Histamine formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., metal fragments). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Processing

(butchering,

cleaning,

packaging,

labeling, and 

boxing) 

Scombrotoxin 

formation 

The product 

is not out of

refrigeration 

for more 

than 4 hours

cumulatively 

Time of product 

exposure to 

unrefrigerated 

conditions

during

processing

operations 

Visual tracking 

of time for a 

marked batch 

of product to 

move from raw 

material cold

storage to final 

product cold 

storage 

Every batch of 

fish

removed from 

raw material 

cold storage for 

processing 

Quality control

supervisor 

Ice and hold

the

affected batch 

in raw material 

cooler

Perform 

histamine

analysis on a

minimum of

60 fish in the

affected batch

Destroy the 

entire batch

if any fish

exceeds 

50 ppm

histamine

Modify the

process, if 

necessary, to 

reduce delays 

Processing

record 

Review 

monitoring,

corrective 

action, and 

verification 

records within

1 week of 

preparation 
 

 

 

 

•	 CONTROL STRATEGY EXAMPLE 5 - STORAGE 

CONTROL 

Establish Monitoring Procedures. 

It may be necessary to select more than one 

control strategy in order to fully control the 

hazard, depending upon the nature of your 

operation. 

Set Critical Limits. 

•	 For refrigerated (not frozen) storage or 

processing of raw material, in-process 

product, or finished product: 

The product is held at a cooler 

temperature of 40°F (4.4°C) or 

below. Note that allowance for 

routine refrigeration defrost cycles 

may be necessary. On the other 

hand, minor variations in cooler 

temperature measurements can be 

avoided by submerging the sensor 

for the temperature-recording device 

(e.g., temperature-recorder) in a liquid 

that mimics the characteristics of the 

product. Also note that critical limits 

during refrigerated storage that specify 

a cumulative time and temperature 

of exposure to temperatures above 

40°F (4.4°C) are not ordinarily suitable 

because of the difficulty in tracking 

the specific products and the specific 

cumulative temperature exposures 

that those products experience. The 

cumulative exposure for each product 

would then need to be determined prior 

to shipping. If you chose this approach, 

the critical limit for cumulative exposure 

to temperatures above 40°F (4.4°C) 

should include time during transit, 

refrigerated storage, and refrigerated and 

unrefrigerated processing; 

 ̊ 

OR 

•	 For raw material, in-process product, or 

finished product stored under ice: 


The product is completely and 


continuously surrounded by ice 

throughout the storage time. 

 ̊ 

»	 What Will Be Monitored? 

•	 For refrigerated storage of scombrotoxin

forming fish: 


­

The temperature of the cooler; 
  ̊ 

OR 

•	 For storage under ice of scombrotoxinforming fish: 

The adequacy of ice surrounding the  ̊ 

product. 

»	 How Will Monitoring Be Done? 

•	 For refrigerated storage: 

Measure cooler temperature using a 

continuous temperature-recording device 

(e.g., a recording thermometer); 

 ̊ 

OR 

•	 For storage under ice: 

Make visual observations of the 

adequacy of ice in a representative 

number of containers (e.g., cartons and 

totes) from throughout the cooler. 

 ̊ 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 For continuous temperature-recording devices: 

Continuous monitoring during storage is 

accomplished by the device itself, with a 

visual check of the recorded data at least 

once per day; 

 ̊ 

OR 

•	 For storage under ice: 

Monitoring with sufficient frequency to 

ensure control. 

 ̊ 

»	 Who Will Do the Monitoring? 

•	 For continuous temperature-recording devices: 

Monitoring is performed by the device 

itself. The visual check of the data 

generated by the device, to ensure that 

the critical limits have consistently been 

met, may be performed by any person 

who has an understanding of the nature 

of the controls; 

 ̊ 

CHAPTER 7: Scombrotoxin (Histamine) Formation 

146 
 

OR 

•	 For other checks: 

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: 

•	 Chill and hold the product until it can 

be evaluated based on its total time and 

temperature exposure, including exposures 

during prior processing operations. 

OR 

•	 Chill and hold the affected product until 

histamine analysis is performed on a 

minimum of 60 fish collected from throughout 

each affected lot. Destroy the lot or divert 

it to a non-food use if any fish is found 

with histamine greater than or equal to 50 

ppm. The fish collected for analysis may 

be composited if the action point is reduced 

accordingly. For example, a sample of 60 fish 

may be composited into 20 units of 3 fish 

each, provided the action point is reduced 

from 50 ppm to 17 ppm for each unit; 

OR 

•	 Destroy the product; 

OR 

•	 Divert the product to a non-food use. 

AND 

Take the following corrective actions to regain control 

over the operation after a critical limit deviation: 

•	 Prevent further deviation: 

Add ice to the product;  ̊ 

OR 

Move some or all of the product in the 

malfunctioning cooler to another cooler; 

 ̊ 

AND 

•	 Address the root cause: 

Make repairs or adjustments to the 

malfunctioning cooler; 

 ̊ 

OR 

Make adjustments to the ice application 

operations.  ̊ 

Establish a Recordkeeping System. 

•	 For refrigerated storage: 

Printouts, charts, or readings from 

continuous temperature-recording
 

devices;
 

 ̊ 

AND
 

Record of visual checks of recorded data;
  ̊ 

OR 

•	 For storage under ice: 

The number of containers examined and 

the sufficiency of ice for each; 

 ̊ 

AND 

The approximate number of containers 

in the cooler. 

 ̊ 

Establish Verification Procedures. 

•	 Before a temperature-recording device (e.g., 

a recording thermometer) is put into service, 

check the accuracy of the device to verify that 

the factory calibration has not been affected. 

This check can be accomplished by: 

Immersing the sensor in an ice slurry 

(32°F (0°C)), if the device will be used at 

or near refrigeration temperature; 

 ̊ 

OR 

Comparing the temperature reading on 

the device with the reading on a known 

accurate reference device (e.g., a NISTtraceable thermometer) under conditions 

that are similar to how it will be used (e.g., 

air temperature) within the temperature 

range at which it will be used; 

 ̊ 

AND 

•	 Once in service, check the temperaturerecording device daily before the beginning 

of operations. Less frequent accuracy checks 

may be appropriate if they are recommended 

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 
CHAPTER 7: Scombrotoxin (Histamine) Formation 

149 

TABLE 7-7 

CONTROL STRATEGY EXAMPLE 5 - STORAGE CONTROL

This table is an example of a portion of a HACCP plan using “Control Strategy Example 5 - Storage Control.” This example illustrates how a fresh fish processor cancontrol scombrotoxin formation. It is provided for illustrative purposes only. It may be necessary to select more than one control strategy in order to fully control the hazard, depending upon the nature of your operation.Histamine formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., metal fragments). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Raw material 

and finished

product cold 

storage (shared 

cooler) 

Scombrotoxin 

formation 

Maximum

cooler

temperature of 

40°F 

Cooler

temperature 

Time and 

temperature 

data logger 

Continuous,

with a visual

check of

recorded data

once per day 

Production 

supervisor 

Ice and hold the

affected product 

inside the cooler

Check

sufficiency of ice 

on the product 

two times per 

day until cooler 

is functioning 

reliably

Perform 

histamine analysis

on a minimum

of 60 fish

representative 

of the affected 

product

Destroy all 

affected 

product if any fish 

exceeds 50 ppm 

histamine

Adjust and repair 

cooler as needed 

Data

logger

printout 

Check the

data logger for 

accuracy and 

damage and to

ensure that it

is operational 

before putting 

into operation; 

perform these 

checks daily, at 

the beginning

of operations; 

and calibrate it 

once per year 

Review 

monitoring,

corrective 

action, and 

verification 

records within

1 week of 

preparation 
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 

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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 

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. 

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. 

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. 

•	 Arnold, S. H., and D. W. Brown. 1978. 

Histamine toxicity from fish products. Adv. 

Food Res. 24:113-154. 

•	 Bjeldanes, L. F., D. E. Schultz, and M. M. 

Morris. 1978. On the aetiology of scombroid 

poisoning: cadaverine potentiation of 

histamine toxicity in the guinea pig. Food 

Cosmet. Toxicol. 16:157-159. 

•	 Concon, J. 1988. Food toxicology. Part A. 

Principles and concepts, p. 626-627. Marcel 

Dekker, Inc., New York, NY. 

•	 Eitenmiller, R., and S. DeSouza. 1984. 

Enzymatic mechanisms for amine formation 

in fish, p. 431-442. In Ragelis, E. (ed.), 

Seafood toxins. 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. 

Food Microbiol. 58:1-37. 

•	 Parrot, J., and G. Nicot. 1986. Absorption 

de l’histamine par l’appareil digestif, p. 

148-161. In Handbuch der Experimentellen 

Pharmakologie, Vol. 18. Springer-Verlag, New 

York, NY. 

•	 Quakenbush, F. W. 1945. Toxicity of rancid 

fats. Oil & Soap. 22:336-338. 

•	 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. 

Determination of histamine, putrescine, and 

cadaverine, p. 235-246. In D. Kramer and J. 

Liston (ed.), Seafood quality determination 

(Book 15 of Developments in food 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. 

CHAPTER 8: Other Decomposition-Related Hazards 

154 
CHAPTER 9: Environmental Chemical Contaminants and Pesticides 

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. 

Environmental chemical contaminants and 

pesticides in fish pose a potential human health 

hazard. Fish can be harvested from waters that 

are contaminated by varying amounts of industrial 

chemicals, including heavy metals and pesticides. 

These contaminants may accumulate in fish at 

levels that can cause human health problems 

(e.g., carcinogenic and mutagenic effects). The 

hazard is most commonly associated with 

exposure over a prolonged period of time (chronic 

exposure). Illnesses related to a single exposure 

(one meal) are very rare. Concern for these 

contaminants primarily focuses on fish harvested 

from aquaculture ponds, freshwater bodies, 

estuaries, and near-shore coastal waters (e.g., areas 

subject to shoreside contaminant discharges), 

rather than from the open ocean. Environmental 

chemicals and pesticides may also accumulate 

in aquacultured fish through contaminated feed 

ingredients (e.g., pesticides in oil-containing feed 

ingredients derived from near-shore bait fish). 

Although some pesticides have not been produced 

or used in the United States for many years (e.g., 

dichloro-diphenyl-trichloroethane (DDT) and 

polychlorinated biphenyls (PCBs)), many are very 

persistent and tend to accumulate in soil and 

sediments. Once pesticides are introduced into the 

environment, they may travel beyond their point 

of application or discharge. 

Certain pesticides are applied directly to the water in 

aquaculture ponds to control weeds and algae and 

to eliminate fish and invertebrates. These products 

can be used legally only if they are registered with 

the U.S. Environmental Protection Agency (US EPA) 

and used according to conditions described on the 

label (40 CFR 180 and the “Guide to Drug, Vaccine, 

and Pesticide Use in Aquaculture,” the Federal Joint 

Subcommittee on Aquaculture (http://aquanic.org/ 

jsa/wgqaap/drugguide/drugguide.htm)). 

Many contaminants accumulate in the edible fatty 

tissues of fish. Concentrations of these contaminants 

can vary considerably in individual fish of the same 

species from the same location, depending on factors 

such as their fat content, size, age, and gender. 

In the case of components or extracts of whole 

fish (e.g., dietary supplements, dietary ingredients, 

and flavors), the component or extract may contain 

higher or lower concentrations of environmental 

chemical contaminants and pesticides than 

the whole fish from which it was derived. For 

example, organochlorine contaminants, such as 

PCBs, are oil soluble. When producing fish oil 

and fish meal, any PCBs present will become 

more concentrated in the oil fraction and less 

concentrated in the water fraction, as compared 

with the levels in the whole fish. 

•	 Control of chemical contaminants 

Federal tolerances and action levels are 

established for some of the most toxic and 

persistent contaminants that can be found in 

fish. These levels are listed in Table 9-1. State, 

tribal, local, or foreign authorities may use the 

federal tolerances or action levels to decide 

whether to issue local advisories to consumers 

recommending limits on consumption of all or 

certain species of locally harvested fish (some of 

which may be commercially important) or to close 

waters for commercial harvesting of all or certain 

species of fish. 

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 

155 
In the case of molluscan shellfish, state, tribal, 

territorial and foreign government agencies, 

called shellfish control authorities, consider the 

degree of chemical contamination as part of their 

classification of harvesting waters. As a result of 

these classifications, molluscan shellfish harvesting 

is allowed from some waters and not from others. 

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. 

•	 Tolerance and action levels 

Table 9-1, “Environmental Chemical Contaminants 

and Pesticides Tolerance and Action Levels,” 

lists the tolerance and action levels that have 

been established for environmental chemical 

contaminants and pesticides in the edible portion 

of fish (wet weight). 

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 

156 
CHAPTER 9: Environmental Chemical Contaminants and Pesticides 

157 

TABLE 9-1 

ENVIRONMENTAL CHEMICAL CONTAMINANTS AND PESTICIDES TOLERANCE AND ACTION LEVELS 

Tolerance Levels 

DELETERIOUS 

SUBSTANCE 

LEVEL IN 

EDIBLE TISSUE FOOD COMMODITY REFERENCE 

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 

metabolites 

2 ppm Farm-raised, 

freshwater finfish 

40 CFR 180.106 

Endothall and 

its monomethyl ester 

0.1 ppm All fish 40 CFR 180.293 

Fluridone 0.5 ppm Finfish and 

crayfish 

40 CFR 180.420 

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 

SUBSTANCE 

LEVEL IN 

EDIBLE TISSUE FOOD COMMODITY REFERENCE 

Aldrin and 

dieldrin1 

0.3 ppm All fish “Compliance Policy Guide,” Sec. 575.100 

Benzene 

hexachloride 

0.3 ppm Frog legs “Compliance Policy Guide,” Sec. 575.100 

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, 

and DDE3 

5 ppm All fish “Compliance Policy Guide,” Sec. 575.100 

Methylmercury4 1 ppm All fish “Compliance Policy Guide,” Sec. 540.600 

Heptachlor and 

Heptachlorepoxide5 

0.3 ppm All fish “Compliance Policy Guide,” Sec. 575.100 

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. 
DETERMINE WHETHER THE POTENTIAL 

HAZARD IS SIGNIFICANT. 

The following guidance will assist you in 

determining whether environmental chemical 

contaminants and pesticides are a significant 

hazard at a processing step: 

1.	 Is it reasonably likely that unsafe levels of 

environmental chemical contaminants or 

pesticides will be introduced at this processing 

step (e.g., do such contaminants and pesticides 

come in on the raw material)? 

Tables 3-2 and 3-3 (Chapter 3) identify the 

species of fish for which environmental 

chemical contaminants and pesticides 

are a potential hazard. Under ordinary 

circumstances, it would be reasonably likely 

to expect that, without proper controls, 

unsafe levels of environmental chemical 

contaminants and pesticides could enter 

the process at the receiving step from 

those species. However, there may be 

circumstances that would allow you to 

conclude that it is not reasonably likely for 

unsafe levels of environmental chemical 

contaminants and pesticides to occur in 

fish harvested from your area. You should 

be guided by the historical occurrence of 

environmental contaminants and pesticides, 

at levels above established tolerance and 

action levels, in fish from the area in which 

your fish are caught. This information may be 

available from federal, state, tribal, territorial, 

local, or foreign health or environmental 

authorities in the area where your fish are 

caught. 

If you are receiving fish, other than molluscan 

shellfish, from another processor, you would 

not need to identify environmental chemical 

contaminants and pesticides as a significant 

hazard. This hazard should have been fully 

controlled by the primary (first) processor. 

2.	 Can unsafe levels of environmental chemical 

contaminants and pesticides that were introduced 

earlier be eliminated or reduced to an acceptable 

level at this processing step? 

Environmental chemical contaminants and 

pesticides should be considered a significant 

hazard at any processing step where a 

preventive measure is or can be used 

to eliminate the hazard or to reduce the 

likelihood of its occurrence to an acceptable 

level. Preventive measures for environmental 

chemical contaminants and pesticides can 

include: 

For wild-caught fish other than molluscan 

shellfish: 

•	 Making sure that incoming fish have 

not been harvested from waters that are 

closed to commercial harvest because of 

concentrations of environmental chemical 

contaminants or pesticides exceeding 

the federal tolerance or action levels; 

•	 Making sure that incoming fish have 

not been harvested (for commercial 

purposes) from the same waters that 

are under a consumption advisory 

by a state, tribal, territorial, local, or 

foreign regulatory authority based 

on a determination by the authority 

that fish harvested from these waters 

are reasonably likely to contain 

contaminants above the federal 

tolerance or action levels. Note that 

many consumption advisories are not 

based on such a determination. 

For aquacultured fish other than molluscan 

shellfish: 

•	 Reviewing, at time of receipt, the 

producer’s lot-by-lot certification that 

harvest is from uncontaminated waters, 

coupled with appropriate verification; 

•	 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 

obtaining information on present land 

use practices in the area immediately 

surrounding the production area (tests 

and monitoring may be performed by 

the aquacultural producer, a state, tribal, 

territorial, local, or foreign authority, 

or a third-party organization); 

•	 Conducting on-farm visits to the 

aquacultural producer to collect and 

analyze water or fish samples for those 

environmental chemical contaminants 

and pesticides that are reasonably likely 

to be present, and to review present land 

use practices in the area immediately 

surrounding the production area; 

•	 Reviewing, at time of receipt, evidence 

(e.g., a third-party certificate) that 

the producer operates under a thirdparty-audited Quality Assurance (QA) 

program for environmental chemical 

contaminants and pesticides (e.g., the 

National Aquaculture Association’s Fish 

Producers Quality Assurance Program); 

•	 Conducting, at time of receipt, 

environmental chemical contaminant 

and pesticide testing of fish tissue 

for those contaminants that are 

reasonably likely to be present. 

For molluscan shellfish, both aquacultured 

and wild caught: 

•	 Checking incoming molluscan 

shellfish to ensure that containers 

are properly tagged or labeled; 

•	 Screening incoming molluscan shellfish 

to ensure that they are supplied by a 

licensed harvester (where licensing is 

required by law) or by a certified dealer. 

These preventive measures are ordinarily 

employed either at the receiving step or 

at the pre-harvest step. In the case of an 

integrated operation, where fish cultivation 

and processing are performed by the same 

firm, it may be possible and desirable to 

exercise preventive measures early in the 

process (ideally when the cultivation site is 

selected), rather than at receipt of the fish 

at the processing plant. Such preventive 

measures will not be covered in this 

guidance document. 

•	 Intended use 

For environmental chemical contaminants and 

pesticides, it is unlikely that the intended use of the 

product will affect the significance of the hazard. 

IDENTIFY CRITICAL CONTROL POINTS. 

The following guidance will assist you in 

determining whether a processing step is a 

critical control point (CCP) for the hazard of 

environmental chemical contaminants and 

pesticides: 

Is the raw material an aquacultured product other than 

molluscan shellfish? 

1.	 If the raw material is an aquacultured product 

other than molluscan shellfish, do you have a 

relationship with the producer that enables you to 

visit the farm before receipt of the fish? 

a.	 If you have such a relationship with 

the producer, then you should identify 

the pre-harvest step as the CCP for 

environmental chemical contaminants 

and pesticides. The preventive measure 

for this type of control is: 

•	 Conducting on-farm visits to the 

aquacultural producer to collect 

and analyze water or fish samples 

for those environmental chemical 

contaminants and pesticides that 

are reasonably likely to be present, 

and to review present land use 

practices in the area immediately 

surrounding the production area. 

Example: 

An aquacultured catfish processor 

that regularly purchases from the same 

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 

159 
producers should visit the producers 

before the fish are harvested. The 

processor should collect and analyze 

water or fish samples for those 

environmental chemical contaminants 

and pesticides that are reasonably likely 

to be present and should review present 

land use at the pond site and in the 

adjacent areas. The processor should 

then set the CCP for environmental 

chemical contaminants and pesticides 

at the pre-harvest step. 

This control approach is a control 

strategy referred to in this chapter as 

“Control Strategy Example 1 - OnFarm Visits.” 

b.	 If no such relationship exists with the 

producer, then you should identify 

the receiving step as the CCP for 

environmental chemical contaminants 

and pesticides. At the receiving step, you 

should exercise one of the following 

preventive measures: 

•	 Reviewing, at time of receipt, 

the supplier’s lot-by-lot 

certification of harvesting from 

uncontaminated waters, coupled 

with appropriate verification. 

Example: 

An aquacultured shrimp processor 

that purchases raw material through 

various brokers should receive lotby-lot certificates from the suppliers. 

The certificates would state that 

shrimp were not harvested from 

contaminated waters that would 

cause the levels in shrimp to exceed 

the established tolerance or action 

levels. The processor should combine 

this monitoring procedure with 

quarterly raw material testing 

for those environmental chemical 

contaminants and pesticides that are 

reasonably likely to be present for 

verification and should set the CCP 

at receiving. 

This control approach is a control 

strategy referred to in this chapter 

as “Control Strategy Example 2 - 

Supplier’s Certification.” 

•	 Reviewing, at time of receipt, 

test results of water or fish tissue 

samples for those contaminants that 

are reasonably likely to be present 

and obtaining information on the 

present land use practices in the 

area immediately surrounding the 

production area (the aquaculture 

producer, a state, tribal, territorial, 

local or foreign authority, or a 

third-party organization may 

perform tests and monitoring). 

Example: 

A farm-raised catfish processor 

purchases catfish from producers 

with which the processor has no 

long-term relationship. The processor 

requires all new suppliers to provide 

the test results of water samples or 

fish tissue for those contaminants 

that are reasonably likely to be 

present and reports on present 

agricultural and industrial land use 

at and near the pond site. The land 

use reports are updated annually 

and whenever information on the 

land use change warrants a more 

frequent update (the aquaculture 

producer, a state, tribal, territorial, 

local or foreign authority, or a thirdparty organization may perform 

tests and monitoring). The processor 

should set the CCP at receiving. 

This control approach is a control 

strategy referred to in this chapter 

as “Control Strategy Example 3 - 

Records of Testing and Monitoring.” 

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 

160 
•	 Conducting, at time of receipt, 

analysis of fish tissue for 

those environmental chemical 

contaminants and pesticides that are 

reasonably likely to be present. 

Example: 

An aquacultured shrimp processor 

that purchases raw material 

through various brokers should 

screen all incoming lots of shrimp 

for those environmental chemical 

contaminants and pesticides that 

are reasonably likely to be used in 

the production area. The processor 

should set the CCP at receiving. 

This control approach is a control 

strategy referred to in this chapter 

as “Control Strategy Example 4 - 

Chemical Contaminant Testing.” 

•	 Reviewing, at time of receipt, 

evidence (e.g., a continuing or 

lot-by-lot third- party certificate) 

that the producer operates under 

a third-party-audited QA program 

that covers environmental chemical 

contaminants and pesticides. 

The certificate should outline the 

audit steps and summarize the 

water and/or fish test results. 

Example: 

An aquacultured trout processor that 

regularly purchases raw trout from the 

same producer should obtain a thirdparty certificate, valid for 1 year (i.e., 

a continuing certificate), that attests 

that the producer operates under a QA 

program that controls environmental 

chemical contaminants and pesticides 

or should receive a lot-by-lot certificate 

issued by the third party. The processor 

should set the CCP at receiving. 

This control approach is a control 

strategy referred to in this chapter 

as “Control Strategy Example 5 - QA 

Program.” 

Is the raw material molluscan shellfish (aquacultured or 

wild caught) or wild caught fish other than molluscan 

shellfish? 

1.	 If the raw material is molluscan shellfish or wildcaught fish other than molluscan shellfish, you 

should identify the receiving step as the CCP 

for environmental chemical contaminants and 

pesticides. At the receiving step, you should 

exercise the following preventive measures: 

a.	 For wild-caught fish other than 


molluscan shellfish:
 

•	 Making sure that incoming fish have 

not been harvested from waters 

that are closed to commercial 

harvest because of concentrations of 

environmental chemical contaminants 

or pesticides exceeding the federal 

tolerance or action levels; 

•	 Making sure that incoming fish have 

not been harvested from waters that 

are under a consumption advisory 

by a state, tribal, territorial, local, 

or foreign regulatory authority 

based on a determination by the 

authority that fish harvested from 

the waters are reasonably likely to 

contain contaminants above the 

federal tolerance or action levels. 

Example: 

A processor purchases bluefish directly 

from the harvester. The processor 

asks the harvester where the fish were 

caught. The processor then compares 

the harvest area location with the areas 

that are closed to commercial fishing by 

state or local regulatory authorities or 

that are under consumption advisories 

that include bluefish and that are 

based on the reasonable likelihood that 

a contaminant level in fish tissue will 

exceed a federal tolerance or action 

level. The processor should set the CCP 

at receiving. 

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 

161 
This control approach is a control 

strategy referred to in this chapter as 

“Control Strategy Example 6 - Source 

Control for wild caught Fish Other 

Than Molluscan Shellfish.” 

b.	 For molluscan shellfish: 

•	 Checking incoming molluscan 

shellfish to ensure that they are 

properly tagged or labeled; 

•	 Checking incoming molluscan 

shellfish to ensure that they are 

supplied by a licensed harvester 

(where licensing is required by 

law) or by a certified dealer. 

Example: 

A processor purchases oysters directly 

from the harvesters. The processor 

should check the harvest location 

on the tags attached to the sacks of 

oysters. The processor should then 

compare the harvest area location 

with information on closed waters 

and check the harvesters’ state 

licenses. The processor should set the 

CCP at receiving. 

This control approach is a control 

strategy referred to in this chapter as 

“Control Strategy Example 7 - Source 

Control for Molluscan Shellfish.” 

DEVELOP A CONTROL STRATEGY. 

The following guidance provides seven 

control strategies for environmental chemical 

contaminants and pesticides. It is important to 

note that you may select a control strategy that 

is different from those which are suggested, 

provided it complies with the requirements of the 

applicable food safety laws and regulations. 

The following are examples of control strategies 

included in this chapter: 

CONTROL STRATEGY 

MAY APPLY TO 

PRIMARY 

PROCESSOR 

MAY APPLY TO 

SECONDARY 

PROCESSOR 

On-farm visit 

Supplier’s certification 

Records of testing and 

monitoring 

Chemical contaminant 

testing 

QA program 

Source control for wild 

caught fish other than 

molluscan shellfish 



Source control for 

molluscan shellfish  

•	 CONTROL STRATEGY EXAMPLE 1 - ON-FARM 

VISIT 

Set Critical Limits. 

•	 Environmental chemical contaminants 

and pesticides that are reasonably likely 

to be present in farm water may not be 

at levels so high that they are reasonably 

likely to result in concentrations in fish 

tissue above the established tolerance or 

action levels (refer to Table 9-1). Elevated 

concentrations of chemical contaminants 

in water can be an indication that they are 

reasonably likely to be present in the fish 

tissue. Note that US EPA has developed water 

quality guidance documents that may be 

suitable for evaluating water quality in local 

situations (U.S. EPA Water Quality Standards 

Handbook, Appendix I); 

OR 

•	 The levels of environmental contaminants 

and pesticides in fish tissue samples that 

are reasonably likely to be present may not 

exceed the established tolerance or action 

levels (refer to Table 9-1); 

AND 

•	 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 

tolerance or action levels (refer to Table 9-1). 

» Who Will Do the Monitoring? 

•	 Any person who has an understanding of the 

nature of the controls. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 The levels of environmental chemical 

contaminant and pesticide residues found in 

water or in fish tissue for those contaminants 

that are reasonably likely to occur; 

AND 

•	 Agricultural and industrial practices in the 

area near the production site. 

»	 How Will Monitoring Be Done? 

•	 Collect and analyze water samples or fish 

tissue samples from each production site; 

AND 

•	 Ask questions about and observe agricultural 

and industrial practices in the area near the 

production site, such as: 

Which types of crops, if any, are grown 

in the area near the production site? 

° 

What pesticides, if any, are used on these 

crops, how are they applied, and at what 

time of year? 

° 

What industrial and urban discharges, if 

any, enter the watershed surrounding the 

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. 

° 

Establish Corrective Action Procedures. 

Take the following corrective action to a product 

involved in a critical limit deviation: 

•	 Do not have the product shipped from the 

production site for processing. 

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 the 

chemical contamination has been eliminated. 

Establish a Recordkeeping System. 

•	 Test results; 

AND 

•	 On-site audit report. 

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 9: Environmental Chemical Contaminants and Pesticides 

163 
CHAPTER 9: Environmental Chemical Contaminants and Pesticides 

164 

TABLE 9-2

CONTROL STRATEGY EXAMPLE 1 - ON-FARM VISITS

This table is an example of a portion of a HACCP plan using “Control Strategy Example 1 - On-Farm Visits.” This example illustrates how an aquacultured catfish 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 Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., aquaculture drugs, food and color additives, and metal fragments).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Pre-harvest Environmental

chemical

contaminants

and pesticides 

Levels of 

environmental

chemical

contaminants and

pesticides in fish

tissue may not 

exceed established 

tolerance and action 

levels for those 

contaminants that

are reasonably likely 

to be present* 

Environmental

chemical

contaminant

and pesticide

levels in fish 

tissue for those 

contaminants

that are

reasonably

likely to be 

present* 

Collect samples 

and analyze for 

environmental

chemical

contaminants

and pesticides* 

Before each 

harvest 

Field agent willsubmit samples

to the contract 

laboratory 

Do not have the 

product shipped 

for processing 

Discontinue use

of the supplier

until evidence 

is obtained that

the cause of

the chemical

contamination has

been eliminated 

Test 

results 

Review 

monitoring

and correction 

action records 

within 1 week 

of preparation 

Agricultural and 

industrial practices 

in the area near the

pond must not be

reasonably likely to 

cause contamination

of the fish

tissue above 

the established

tolerances and 

action levels 

Agricultural 

and industrial

practices near 

the pond 

Ask questions

and observe 

agricultural 

and industrial

practices 

Once per year Field agent Do not have the 

product shipped 

for processing 

Discontinue use

of the supplier

until evidence 

is obtained that

the cause of

the chemical

contamination has

been eliminated 

Field

agent

report 

Review 

monitoring

and correction 

action records 

within 1 week 

of preparation 

* Note: This plan is for illustrative purposes only. An actual plan should specify (1) in the Critical Limits column: the environmental chemical contaminants and pesticides that are reasonably likely to 

be present and the critical limits to be applied to each contaminant; and (2) in the Monitoring columns: the contaminants for which analysis will be conducted, the protocol for sample collection, and the analytical method to be used for each contaminant. 
•	 CONTROL STRATEGY EXAMPLE 2 - SUPPLIER’S 

CERTIFICATION 

Set Critical Limits. 

•	 A certificate accompanying all lots received 

(lot by lot) that indicates that fish were not 

harvested from contaminated waters that 

could cause the levels in fish tissue to exceed 

the established federal tolerance and action 

levels (refer to Table 9-1). 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 Presence of a certificate indicating harvesting 

from uncontaminated waters. 

»	 How Will Monitoring Be Done? 

•	 Visual check for the presence of a certificate. 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 Each lot received. 

»	 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. 

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. 

Establish a Recordkeeping System. 

•	 Copy of the certificate; 

AND 

•	 Receiving record showing lots received and 

the presence or absence of a certificate. 

Establish Verification Procedures. 

•	 Visit all new aquacultured fish producers 

within the year and all existing fish suppliers 

at a predetermined frequency (e.g., 25% per 

year) to collect and analyze water or fish 

tissue samples, as appropriate, for those 

environmental chemical contaminants 

and pesticides that are reasonably likely 

to be present, and review agricultural and 

industrial practices in the production area; 

OR 

•	 Collect a representative sample of the raw 

material, in-process product, or finished 

product at least quarterly, and analyze it for 

those environmental chemical contaminants 

and pesticides that are reasonably likely to 

be present; 

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 9: Environmental Chemical Contaminants and Pesticides 

165 
CHAPTER 9: Environmental Chemical Contaminants and Pesticides 

166 

TABLE 9-3

CONTROL STRATEGY EXAMPLE 2 - SUPPLIER’S CERTIFICATION

This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Supplier’s Certification.” This example illustrates how an aquacultured shrimp 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 Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., aquaculture drugs, food and color additives, and metal fragments).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Receiving Environmental

chemical

contaminants

and pesticides 

Certificate 

accompanying

all lots received 

indicates that

fish were not 

harvested from 

contaminated

waters that 

could cause the

levels in fish 

tissue to exceed 

the established

federal 

tolerance and 

action levels 

Presence

of a

certificate 

Visual

check 

Each lot

received 

Receiving dock 

employee 

Reject lot

Discontinue use

of the supplier

until evidence 

is obtained that

the supplier

will comply

with the

certification 

controls 

Copy of the 

certificate

Receiving 

record 

Review 

monitoring,

corrective 

action, and 

verification 

records within

1 week of 

preparation 

Visit all new 

aquacultured

fish producers

within the year 

and 25% of

existing 

suppliers each

year to collect 

and analyze

water samples,

and review 

agricultural 

and industrial

practices in 

the area 
•	 CONTROL STRATEGY EXAMPLE 3 - RECORDS OF 

TESTING AND MONITORING 

pesticides that are reasonably likely to be 

present; 

Set Critical Limits. AND 

•	 Reports of analyses of the water from all 

new suppliers that show that levels of those 

environmental chemical contaminants 

and pesticides that are reasonably likely 

to be present are not so high that they are 

reasonably likely to result in levels in the 

fish tissue that exceed the established federal 

tolerance and action levels (refer to Table 9-1). 

(The aquaculture producer, a state, tribal, 

territorial, local, or foreign authority, or a 

third-party organization may perform tests.) 

Note that US EPA has developed water quality 

documents that may be suitable for evaluating 

water quality in local situations (U.S. EPA Water 

Quality Standards Handbook, Appendix I); 

OR 

•	 Reports of analyses of fish tissue for each 

delivery that show that levels of those 

environmental chemical contaminants 

and pesticides that are reasonably likely 

to be present are below the established 

federal tolerance and action levels (the 

aquaculture grower, a state, tribal, territorial, 

local, or foreign authority, or a third-party 

organization may perform tests); 

AND 

•	 Reports from all suppliers that show that 

agricultural and industrial practices in the 

area near the aquaculture production site are 

not reasonably likely to cause contamination 

of fish tissue above the established federal 

tolerance or action levels (the aquaculture 

producer, a state, tribal, territorial, local, 

or foreign authority, or a third-party 

organization may perform monitoring). 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 Test results of water or fish tissue for those 

environmental chemical contaminants and 

•	 Monitoring results for agricultural and 

industrial practices. 

»	 How Will Monitoring Be Done? 

•	 Visual check of test results and monitoring 

reports. 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 For results of water testing: 

All new suppliers; ° 

OR 

•	 For results of fish tissue testing: 

Each delivery; ° 

AND 

•	 For reports of evaluation of agricultural and 

industrial practices: 


At least once every year.
 ° 

»	 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. 

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 testing and evaluation 

controls. 

Establish a Recordkeeping System. 

•	 Test results; 

AND 

•	 Reports of evaluation of agricultural and 

industrial practices. 

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 

167 
CHAPTER 9: Environmental Chemical Contaminants and Pesticides 

168 

TABLE 9-4

CONTROL STRATEGY EXAMPLE 3 - RECORDS OF TESTING AND MONITORING

This table is an example of a portion of a HACCP plan using “Control Strategy Example 3 - Records of Testing and Monitoring.” This example illustrates how a farm-raised catfish 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 Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., aquaculture drugs, food and color additives, and metal fragments).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Receiving Environmental

chemical

contaminants

and pesticides 

Reports of analyses of 

the water from all new 

suppliers that show that 

levels of environmental 

chemical contaminants

and pesticides that are

reasonably likely to be 

present are not so high

that they are likely to 

result in levels in fish 

tissue that exceed the 

established federal 

tolerance or action levels* 

Reports of 

analyses

showing levels 

of environmental

chemical

contaminants

and pesticides in

water samples 

for those 

contaminants that

are reasonably

likely to be 

present* 

Visual

check 

At first

delivery 

Quality

control staff 

Reject the lot 

Discontinue use

of the supplier

until evidence 

is obtained that

the supplier will

comply with the

testing and

evaluation 

controls. 

Test 

results 

Review 

monitoring

and

corrective 

action 

records

within 1

week of 

preparation 

Reports from all suppliers 

that show that agricultural 

and industrial practices 

in the area near the

production site are not 

reasonably likely to 

cause contamination

of fish tissue above the 

established tolerance or 

action levels 

Reports of 

agricultural 

and industrial

practices in the 

area near the

production site 

Visual

check 

Once per year Quality

control staff 

Reject the lot 

Discontinue use

of the supplier

until evidence 

is obtained that

the supplier will

comply with the

testing and

evaluation 

controls 

Reports of 

agricultural 

and

industrial

practices 

Review 

monitoring

and

corrective 

action 

records

within

1 week of 

preparation 

* Note: This plan is for illustrative purposes only. An actual plan should specify (1) in the Critical Limits column: the environmental chemical contaminants and pesticides that are reasonably likely to 

be present and the critical limits to be applied to each contaminant; and (2) in the Monitoring columns: the contaminants for which analysis will be conducted, the protocol for sample collection, and the analytical method to be used for each contaminant. 
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. 

•	 CONTROL STRATEGY EXAMPLE 4 - CHEMICAL 

CONTAMINANT TESTING 

Set Critical Limits. 

•	 No lot may exceed the federal tolerance 

or action levels for those environmental 

chemical contaminants and pesticides that 

are reasonably likely to be present (refer to 

Table 9-1). 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 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 

° 

the chemical contamination has been 

eliminated. 

Establish a Recordkeeping System. 

•	 Test results. 

Establish Verification Procedures. 

•	 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, or equivalent method, or by 

analyzing proficiency samples); 

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 9: Environmental Chemical Contaminants and Pesticides 

169 
CHAPTER 9: Environmental Chemical Contaminants and Pesticides 

170 

TABLE 9-5

CONTROL STRATEGY EXAMPLE 4 - CHEMICAL CONTAMINANT TESTING

This table is an example of a portion of a HACCP plan using “Control Strategy Example 4 - Chemical Contaminant Testing.” This example illustrates how an aquacultured shrimp 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 Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., aquaculture drugs, food and color additives, and metal fragments).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL CONTROL POINT SIGNIFICANT HAZARD(S) 

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Receiving Environmental

chemical

contaminants

and pesticides 

No lot of

shrimp may 

exceed the 

established

tolerance or 

action 

levels for 

environmental

chemical

contaminants

and pesticides

that are

reasonably

likely to be 

present* 

Chemical

residue levels 

in shrimp

tissue that are

reasonably

likely to be 

present* 

Obtain samples

and

analyze for 

environmental

chemical

contaminants

and pesticides* 

Each lot

received 

Receiving 

employee will 

submit sample

to quality

control staff 

Reject the lot 

Discontinue use

of the supplier

until evidence 

is obtained that

the cause of

the chemical

contamination

has been

eliminated 

Test 

results 

Annual

methods

comparison to

AOAC methods

Review 

monitoring

and corrective 

action records 

within 1 week 

of

preparation 

* Note: This plan is for illustrative purposes only. An actual plan should specify (1) in the Critical Limits column: the environmental chemical contaminants and pesticides that are reasonably likely to 

be present and the critical limits to be applied to each contaminant; and (2) in the Monitoring columns: the contaminants for which analysis will be conducted, the protocol for sample collection, and the analytical method to be used for each contaminant. 
•	 CONTROL STRATEGY EXAMPLE 5 - QA 

PROGRAM 

Set Critical Limits. 

•	 A certificate indicating that the producer 

operates under a third-party-audited QA 

program that covers environmental chemical 

contaminants and pesticides. The certificate 

may accompany each lot of incoming 

aquacultured fish or may be issued for each 

producer of incoming aquacultured fish as a 

continuing certification. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 Certificate indicating operation under a thirdparty-audited QA program. 

»	 How Will Monitoring Be Done? 

•	 Visual check for the presence of a certificate. 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 Each lot received is checked for the presence 

of a certificate. Certificates may be issued on 

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. 

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. 

Establish a Recordkeeping System. 

•	 Third-party certificates; 

AND 

•	 Records showing lots received and the 

presence or absence of a certificate. 

Establish Verification Procedures. 

•	 Review the third-party-audited QA program 

and results of audits annually; 

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 9: Environmental Chemical Contaminants and Pesticides 

171 
CHAPTER 9: Environmental Chemical Contaminants and Pesticides 

172 

TABLE 9-6

CONTROL STRATEGY EXAMPLE 5 - QA PROGRAM

This table is an example of a portion of a HACCP plan using “Control Strategy Example 5 - QA Program.” This example illustrates how an aquacultured trout processor can 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 Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., aquaculture drugs, food and color additives, and metal fragments).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Receiving Environmental

chemical

contaminants

and pesticides 

Certificate 

indicating that

the producer

operates under 

a third-partyaudited QA 

program that 

covers 

environmental

chemical

contaminants

and pesticides 

Presence of a

third-party 

certificate 

Visual check for 

the presence of

a certificate 

Each lot Receiving dock 

employee 

Reject the lot 

Discontinue use

of the supplier

until evidence 

is obtained that

the supplier

will comply

with the

certification 

controls 

Certificate 

Receiving 

record 

Review the 

third-partyaudited QA 

program and 

results of audits

annually

Review 

monitoring,

corrective 

action, and 

verification

records within

1 week of 

preparation 
•	 CONTROL STRATEGY EXAMPLE 6 - SOURCE 

CONTROL FOR WILD CAUGHT FISH OTHER THAN 

MOLLUSCAN SHELLFISH 

Set Critical Limits. 

•	 No fish may be harvested from an area that is 

closed to commercial harvesting by state, tribal, 

territorial, local, or foreign authorities because 

of concentrations of environmental chemical 

contaminants or pesticides exceeding the 

federal tolerance or action levels; 

AND 

•	 No fish may be harvested from an area that 

is under a consumption advisory by a, state, 

tribal, territorial, local, or foreign regulatory 

authority based on a determination by the 

authority that fish harvested from the waters 

are reasonably likely to contain contaminants 

above the federal tolerance or action levels. 

Note that many consumption advisories are 

not based on such a determination. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 Location of harvest and whether the 

harvest area is subject to closure or 

consumption advisory. 

»	 How Will Monitoring Be Done? 

•	 Ask the harvester for the harvest site at time 

of receipt, or obtain the information from the 

harvester’s catch record, where applicable; 

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. 

Establish Corrective Action Procedures. 

Take the following corrective action to a product 

involved in a critical limit deviation: 

•	 Reject the lot; 

OR 

•	 For fish harvested from an area under a 

consumption advisory based on federal 

tolerance or action levels: 

Sample the lot and analyze it for the 

appropriate environmental chemical 

contaminant or pesticide. Reject the lot if 

the results exceed the federal tolerance 

or action level. 

° 

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 records that document the location 

and whether the harvest area is subject to 

closure or consumption advisory. 

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 9: Environmental Chemical Contaminants and Pesticides 

173 
CHAPTER 9: Environmental Chemical Contaminants and Pesticides 

174 

TABLE 9-7

CONTROL STRATEGY EXAMPLE 6 - SOURCE CONTROL 

FOR WILD CAUGHT FISH OTHER THAN MOLLUSCAN SHELLFISH

This table is an example of a portion of a HACCP plan using “Control Strategy Example 6 - Source Control for Wild Caught Fish Other Than Molluscan Shellfish.” This example illustrates how a wild caught bluefish processor can control environmental chemical contaminants and pesticides. It is provided for illustrative purposes only. Environmental contaminants and pesticides from the harvest area may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., scombrotoxin (histamine), metal fragments). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Receiving Environmental

chemical

contaminants

and pesticides 

No fish may be harvested 

from an area that is closed to

commercial harvesting by state,

or local authorities because of

concentrations of environmental 

chemical contaminants or

pesticides exceeding the federal 

tolerance or action levels

No fish may be commercially 

harvested from an area that is 

under a consumption advisory 

by a state, local, or local 

regulatory authority based on a 

determination by the authority 

that fish harvested from the 

waters are reasonably likely to 

contain contaminants above the 

federal tolerance or action levels 

Location of

harvest and 

whether the

harvest area 

is subject to 

closure or

consumption

advisory 

Ask the

harvester for 

the harvest 

location, and 

ask state

and local

authorities the

status of the

area 

Each lot

received 

Receiving 

dock

employee 

Reject the lot 

Discontinue

use of the

supplier

until

evidence 

is obtained

that

harvesting 

practices 

have

changed 

Receiving 

record 

Review 

monitoring

and

corrective 

action 

records

within

1 week of 

preparation 
•	 CONTROL STRATEGY EXAMPLE 7 - SOURCE 

CONTROL FOR MOLLUSCAN SHELLFISH 

Set Critical Limits. 

•	 All containers of shellstock (in-shell 

molluscan shellfish) received from a 

harvester must bear a tag that discloses the 

date and place they were harvested (by state 

and site), the type and quantity of shellfish, 

and the harvester’s or harvester’s vessel 

information (i.e., the identification number 

assigned to the harvester by the shellfish 

control authority, where applicable, or if 

such identification numbers are not assigned, 

the name of the harvester or the name or 

registration number of the harvester’s vessel). 

For bulk shipments of shellstock, where the 

shellstock is not containerized, the shellstock 

must be accompanied by a bill of lading 

or other similar shipping document that 

contains the same information; 

Note: The source controls listed in this critical limit are required under 

21 CFR 123.28(c). 

OR 

•	 All containers of shellstock received from 

a processor must bear a tag that discloses 

the date and place they were harvested 

(by state and site), the type and quantity of 

shellfish, and the certification number of the 

processor; 

OR 

•	 All containers of shucked molluscan shellfish 

must bear a label that identifies the name, 

address, and certification number of the 

packer or repacker of the product; 

AND 

•	 All molluscan shellfish must have been 

harvested from waters authorized for 

harvesting by a shellfish control authority. 

For U.S. federal waters, no molluscan 

shellfish may be harvested from waters that 

are closed to harvesting by an agency of the 

federal government; 

AND 

•	 All molluscan shellfish must be from a 

harvester that is licensed as required (note 

that licensing may not be required in all 

jurisdictions) or from a processor that is 

certified by a shellfish control authority. 

Note: Only the primary processor (the processor that receives 

molluscan shellfish directly from the harvester) needs to apply controls 

relative to the identification of the harvester, the harvester’s license, or 

the approval status of the harvest waters. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 The information contained on tags on 

containers of incoming shellstock or on 

the bill of lading or other similar shipping 

document accompanying bulk shipments of 

shellstock and whether the harvest area is 

authorized for harvest by a shellfish control 

authority; 

AND 

•	 The license of the harvester; 

OR 

•	 The information contained on labels on 

containers of incoming shucked molluscan 

shellfish. 

»	 How Will Monitoring Be Done? 

•	 Perform visual checks; 

AND 

•	 Ask the relevant shellfish control authority 

whether the harvest area is authorized for 

harvest. 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 For checking tags: 

Every container; ° 

AND 

•	 For checking harvester licenses: 

Every delivery; ° 

OR 

CHAPTER 9: Environmental Chemical Contaminants and Pesticides 

175 
•	 For checking labels: 

At least three containers randomly 

selected from throughout every 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. 

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 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 

Number and date of expiration of the 

harvester’s license, where applicable; 


° 

AND
 

Certification number of the shipper,
 

where applicable. 

° 

For shucked molluscan shellfish: 

•	 Receiving record that documents: 

° Date of receipt; 

AND 

° Quantity and type of shellfish; 

AND 

° Name and certification number of the 

packer or repacker. 

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 9: Environmental Chemical Contaminants and Pesticides 

176 
CHAPTER 9: Environmental Chemical Contaminants and Pesticides 

177 

TABLE 9-8

CONTROL STRATEGY EXAMPLE 7 - SOURCE CONTROL FOR MOLLUSCAN SHELLFISH

This table is an example of a portion of a HACCP plan using “Control Strategy Example 7 - Source Control for Molluscan Shellfish.” The example illustrates how a processor of shellstock oysters received directly from a harvester can control environmental chemical contaminants and pesticides. It is provided for illustrative purposes only. Environmental contaminants and pesticides from the harvest area may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., natural toxins and pathogens from the harvest area). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Receiving Environmental

chemical

contaminants

and pesticides 

All shellstock must be

tagged with the date

and place of harvest,

type and quantity of

shellfish, and name or 

registration number of 

the harvester’s vessel 

Information 

on incoming

shellstock tags 

Visual checks Every sack Receiving 

employee 

Reject 

untagged sacks

Discontinue use

of the supplier

until evidence 

is obtained that

tagging practices 

have changed 

Receiving 

record 

Review 

monitoring

and

corrective 

action 

records

within

1 week of 

preparation 

All shellstock must be

from waters 

approved by the state 

shellfish control

authority 

Harvest site on 

tags 

Perform 

visual checks

and ask the

shellfish control

authority

whether

the area is

authorized for 

harvest 

Every lot Reject lots from 

unapproved waters 

Discontinue use

of the supplier

until evidence 

is obtained that

harvesting practices 

have changed 

All shellstock must be

from licensed

harvesters 

License of

harvester 

Perform visual 

checks 

Every 

delivery 

Reject lots from 

unlicensed

harvesters

Discontinue use

of the supplier

until evidence 

is obtained that

the harvester is 

properly licensed 
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 NonFDA Web site references after March 29, 2011. 

•	 Catfish Farmers of America. 1993. Catfish 

quality assurance. Cooperative Extension 

Service Publication 1873. Mississippi State 

University, Mississippi State, MS. 

•	 Federal Joint Subcommittee on Aquaculture. 

2007. Guide to drug, vaccine, and pesticide 

use in aquaculture. http://aquanic.org/jsa/ 

wgqaap/drugguide/drugguide.htm. 

•	 Gutenmann, W. H., J. G. Ebel, Jr., H. T. 

Kuntz, K. S. Yourstone, and D. J. Lisk. 1992. 

Residues of p,p’-DDE and mercury in lake 

trout as a function of age. Arch. Environ. 

Contam. Toxicol. 22(4):452-455. 

•	 Karl, H., I. Lehmann, and K. Oetjen. 1998. 

Levels of chlordane compounds in fish 

muscle, -meal, -oil and -feed. Chemosphere. 

36(13):2819-2832. 

•	 Ruus, A., K. I. Ugland, and J. U. Skaare. 

2002. Influence of trophic position on 

organochlorine concentrations and 

compositional patterns in a marine food web. 

Environ. Toxicol. Chem. 21(11):2356-2364. 

•	 Smith, A. G., and S. D. Grangolli. 2002. 

Organochlorine chemicals in seafood: 

occurrence and health concerns. Food Chem. 

Toxicol. 40:767-779. 

•	 Striped Bass Growers Association. 1996. 

The hybrid striped bass industry from fish 

farmer to consumer. Striped Bass Growers 

Association, P.O. Box 11280, Columbia, SC. 

•	 U.S. Environmental Protection Agency. 1992. 

Water quality standards – Establishment of 

numeric criteria for priority toxic pollutants; 

states’ compliance, p. 60848-60923. In Federal 

Register, vol. 57, no. 246. U.S. Government 

Printing Office, Washington, DC. 

•	 U.S. Environmental Protection Agency. 1994. 

Appendix I: list of EPA water quality criteria 

documents. In Water quality standards 

handbook: second edition. http://www.epa. 

gov/waterscience/standards/handbook/. 

•	 U.S. Environmental Protection Agency. 1995. 

Final water quality guidance for the Great 

Lakes System. In Federal Register, vol. 60, 

no. 56. U.S. Government Printing Office, 

Washington, DC. 

•	 U.S. Environmental Protection Agency. 

Updated February 2011. Residue Analytical 

Methods (RAM). http://www.epa.gov/ 

pesticides/methods/ramindex.htm. 

•	 U.S. Environmental Protection Agency. 

Revised July 2006. Tolerances and exemptions 

from tolerances for pesticide chemicals in 

or on raw agricultural products. In Code 

of Federal Regulations, 40 CFR 180. U.S. 

Government Printing Office, Washington, 

DC. http://www.access.gpo.gov/nara/cfr/ 

waisidx_05/40cfr180_05.html. 

•	 U.S. Food and Drug Administration. 

Updated July 2009. Pesticide Analytical 

Manual (PAM). http://www.fda.gov/Food/ 

ScienceResearch/LaboratoryMethods/ 

PesticideAnalysisManualPAM/default.htm. 

•	 U.S. Food and Drug Administration. Updated 

January 2008. Pesticide chemical residues in 

food - enforcement criteria. In Compliance 

policy guides, sect. 575.100. Department of 

Health and Human Services, Public Health 

Service, Food and Drug Administration, 

Center for Food Safety and Applied 

Nutrition, Washington, DC. http://www.fda. 

gov/downloads/ICECI/ComplianceManuals/ 

CompliancePolicyGuidanceManual/ 

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 

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. 

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 

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. 

Note: This document was corrected on August 3, 2011. The Agency corrected a typographical error appearing in the

 April 2011 version of this document. The Agency corrected "15%" to "1.5%" so that the sentence in "Chapter 11: 

Aquaculture Drugs" now reads "Sodium sulfite Used in a 1.5% solution for 5 to 8 minutes to treat eggs in order to 

improve their hatchability."

UNDERSTAND THE POTENTIAL HAZARD. 

Use of unapproved drugs or misuse of approved 

drugs in aquacultured fish poses a potential 

human health hazard. These substances may 

be toxic, allergenic, or carcinogenic, and/or may 

cause antibiotic resistance in pathogens that 

affect humans. 

To control this hazard, drugs for use in food 

animals, whether they are for direct medication or 

for addition to feed, generally must be approved, 

conditionally approved or index listed by FDA 

(Federal Food, Drug, and Cosmetic Act Section 

512). Under certain conditions authorized by FDA, 

unapproved new animal drugs may be used in 

conformance with the terms of an Investigational 

New Animal Drug (INAD) application (21 CFR 511 

and FDA’s Center for Veterinary Medicine (CVM) 

Guide 1240.3025). Off label use in animals of 

approved human or animal drugs is permissible 

in certain circumstances. Drugs on the Index 

of Legally Marketed Unapproved New Animal 

Drugs for Minor Species (the Index) may not be 

used in food animals except in early nonfood life 

stages of food producing minor species in certain 

circumstances. 

Reasons for the use of drugs in aquaculture 

include the need to (1) treat and prevent disease, 

(2) control parasites, (3) affect reproduction and 

growth, and (4) provide tranquilization (e.g., 

for weighing). Relatively few drugs have been 

approved for aquaculture. This factor may lead to 

the inappropriate use of unapproved drugs, 

general-purpose chemicals, or approved drugs in a 

manner that deviates from the labeled instructions. 

When a drug is approved by CVM, the conditions 

of the approval are listed on its label or in the 

labeling (21 CFR 514.1). These conditions specify 

the species for which the drug is approved for use; 

indications (disease or other circumstances) for 

use; dosage regimen; and other limitations, such 

as route of administration and withdrawal time. 

Labeled withdrawal times must be followed to 

ensure that no harmful drug residues are present 

in the edible tissue of the animal when harvested 

for human consumption and offered for sale. 

Tolerances for some drug residues in the edible 

tissue have been established (21 CFR 556). 

Only a licensed veterinarian may legally prescribe 

a drug under conditions that are not listed on 

the label (extra-label use). This includes: use in 

species not listed on the label; use for indications 

(disease or other conditions) not listed on the 

label; use at dosage levels, frequencies, or routes 

of administration other than those stated on the 

label; and deviation from the labeled withdrawal 

time. A veterinarian is a person licensed by a 

state, territory, or foreign government to practice 

veterinary medicine. 

The extra-label use restrictions are fully 

explained in 21 CFR 530. Information on the 

new animal drug approval process and for 

other information on the laws, regulations 

and policies pertaining to drugs can be found 

on FDA’s internet website, http://www.fda.gov/ 

AnimalVeterinary/DevelopmentApprovalProcess/ 

Aquaculture/default.htm. 

CHAPTER 11: Aquaculture Drugs 

183 
 

 

 

•	 Approved aquaculture drugs 

FDA-approved aquaculture drugs, with their 

approved sponsor, species for which they have 

been approved and required withdrawal times 

are listed below. Additional details on conditions 

of use (e.g., dosage levels) can be obtained from 

the Code of Federal Regulations (CFR) as cited 

below; the labeling for the drug; the FDA CVM 

Website, (http://www.fda.gov/AnimalVeterinary/ 

DevelopmentApprovalProcess/Aquaculture/ 

ucm132954.htm). 

FDA’s determination that these substances are 

approved aquaculture drugs does not exempt 

facilities from complying with other federal, 

state, tribal, territorial and local environmental 

requirements. For example, in the United States, 

facilities using these substances would still be 

required to comply with the National Pollutant 

Discharge Elimination System requirements. 

Chorionic gonadotropin 

Chorulon® 

Chorulon®, supplied by Intervet, Inc., 

Roseland, NJ, is approved for use as an aid 

in improving spawning function in male 

and female brood finfish. The drug may be 

administered for up to three doses. The total 

dose should not exceed 25,000 I.U. chorionic 

gonadotropin in fish intended for human 

consumption. Federal law restricts this 

drug to use by or on the order of a licensed 

veterinarian (21 CFR 522.1081). Because 

residues are expected to be well below the 

safe concentration in the edible portion of 

fish, there is no tolerance level set for residues 

of gonadotropin in fish tissue 21 CFR 556.304). 

Formalin solution 

Paracide-F® 

Paracide-F®, supplied by Argent Laboratories, 

Redmond, WA, is approved for use as 

follows: in salmon, trout, catfish, largemouth 

bass, and bluegill for the control of external 

protozoa (Ichthyophthirius spp., Chilodonella 

spp., Costia spp., Scyphidia spp., Epistylis 

spp., and Trichodina spp.) and monogenetic 

trematodes (Cleidodiscus spp., Gyrodactylus 

spp., and Dactylogyrus spp.); and on the eggs 

of salmon, trout, and esocids for the control 

of fungi of the family Saprolegniaceae (21 

CFR 529.1030). There is no mandatory 

withdrawal time prior to harvest and 

no residue tolerance (formalin does not 

bioaccumulate in animals). This drug is 

approved as an over-the-counter (OTC) 

product, and a prescription is not required. 

Parasite-S® , Formacide-B® and Formalin-F® 

Parasite-S® is supplied by Western Chemical, 

Inc., Ferndale, WA. Formacide-B® is 

supplied by B.L. Mitchell, Inc., Leland, 

MS. Formalin-F® is supplied by Natchez 

Animal Supply Company, Natchez, MS. 

Each is approved for use to control external 

protozoan parasites (Chilodonella spp., Costia 

spp., Epistylis spp., Ichthyophthirius spp., 

Scyphidia spp., and Trichodina spp.) and 

monogenetic trematodes (Cleidodiscus spp., 

Dactylogyrus spp., and Gyrodactylus spp.) 

on all finfish species; external protozoan 

parasites (Bodo spp., Epistylis spp., and 

Zoothamnium spp.) on Penaeid shrimp; and 

fungi of the family Saprolegniaceae on the 

eggs of all finfish species (21 CFR 529.1030). 

There is no mandatory withdrawal time 

prior to food animal harvest and no residue 

tolerance (formalin does not bioaccumulate in 

animals). These drugs are approved as OTC 

products, and a prescription is not required. 

Florfenicol 

Aquaflor® Type A Medicated Article 

Aquaflor® Type A is supplied by Intervet, 

Inc., Millsboro DE/ Schering-Plough Animal 

Health Corporation, Roseland, NJ, and is 

approved for use in medicated feed for the 

control of mortality due to enteric septicemia 

of channel catfish (Ictalurus punctatus) 

associated with Edwardsiella ictaluri, control 

CHAPTER 11: Aquaculture Drugs 

184 
 

 

 

 

of mortality in freshwater-reared salmonids 

due to coldwater disease associated with 

Flavobacterium psychrophilum, and control of 

mortality in freshwater-reared salmonids due 

to furunculosis associated with Aeromonas 

salmonicida. The minimum withdrawal time 

before harvest is 12 days for catfish and 15 

days for salmonids (21 CFR 558.261). The 

tolerance level for florfenicol amine (the 

marker residue) in muscle is 1 ppm (21 CFR 

556.283). The product is restricted to use by 

or on the order of a licensed veterinarian (21 

CFR 558.261). Extra-label use of medicated 

feed containing florfenicol is prohibited (21 

CFR 558.6(a)(4) and (6)). 

Aquaflor® CA1 

Aquaflor® CA1 is supplied by Intervet, Inc./ 

Schering-Plough Animal Health Corporation, 

Roseland, NJ, and is approved for use in 

medicated feed for the control of mortality in 

catfish due to columnaris disease associated 

with Flavobacterium columnare. The drug 

can be used at any stage of production, from 

fingerling to food fish, as the sole ration 

for 10 consecutive days. The minimum 

withdrawal time before harvest is 12 days. 

The product is restricted to use by or on 

the order of a licensed veterinarian (21 CFR 

516.1215) . Extra-label use of medicated feed 

containing florfenicol is prohibited (21 CFR 

558.6(a)(4) and (6)). Because Aquaflor® CAI 

is a conditionally approved new animal drug, 

it extra-label use is also prohibited by 21 

U.S.C. 360ccc(a)(1). 

Tricaine methanesulfonate (MS-222) 

Finquel® and Tricaine-S 

Finquel® is supplied by Argent Laboratories, 

Redmond, WA, and Tricaine-S is supplied 

by Western Chemical, Inc., Ferndale, WA, 

Tricaine-S. This drug is approved for 

use to temporary immobilization of fish, 

amphibians, and other aquatic cold-blooded 

animals. Tricaine methanesulfonate has 

been recognized as a valuable tool for the 

proper handling of these animals during 

manual spawning (fish stripping), weighing, 

measuring, marking, surgical operations, and 

transport. Use in fish intended for human 

consumption is restricted to the following 

families: Ictaluridae (catfish), Salmonidae 

(salmon and trout), Esocidae (pike), and 

Percidae (perch). There is a mandatory 21­

day withdrawal time before harvest. In other 

non-food, aquatic, cold-blooded animals, 

the drug should be limited to hatchery or 

laboratory use (21 CFR 529.2503). These 

drugs are approved as OTC products, and 

a prescription is not required. There is no 

tolerance level set for residues in fish tissue. 

Oxytetracycline 

Terramycin® 200 for Fish (oxytetracycline 

dihydrate) Type A Medicated Article 

Terramycin® 200 for Fish (oxytetracycline 

dihydrate) Type A Medicated Article 

is supplied by Phibro Animal Health, 

Ridgefield Park, NJ. Terramycin® 200 for 

Fish is approved for use to treat bacterial 

hemorrhagic septicemia caused by 

Aeromonas liquefaciens and pseudomonas 

disease in catfish. For salmonids, 

Terramycin® 200 for Fish is approved 

for use to control ulcer disease caused 

by Hemophilius piscium, furunculosis 

caused by Aeromonas salmonicida, 

bacterial hemorrhagic septicemia caused 

by Aeromonas liquefaciens, pseudomonas 

disease and for control of mortality due 

to coldwater disease associated with 

Flavobacterium psychrophilium. This drug is 

also approved for use to mark skeletal tissue. 

For lobster, Terramycin® 200 for Fish is 

approved for use to control gaffkemia caused 

by Aerococcus viridians. Withdrawal times 

vary with indication as follows: for marking 

skeletal tissue in Pacific salmon, 7 days; for 

disease control in salmonids, 21 days; catfish, 

21 days; lobster, 30 days (21 CFR 558.450). 

CHAPTER 11: Aquaculture Drugs 

185 
 

 

 

OxyMarineTM, Oxytetracycline
 

HCl Soluble Powder-343, 


Terramycin-343, TETROXY Aquatic
 

OxyMarineTM is supplied by Alpharma, 

Inc., Fort Lee, NJ. Oxytetracycline HCl 

Soluble Powder-343 is supplied by Teva 

Animal Health, Inc., St. Joseph, MO. 

Terramycin-343 is supplied by Aquatic 

Health Resources. TETROXY Aquatic is 

supplied by Cross Vetpharm Group Ltd., 

Dublin, Ireland. Each of these drugs is 

administered by immersion, approved for 

use to mark skeletal tissue of all finfish fry 

and fingerlings as an aid in identification. 

These drugs are approved as OTC products, 

and a prescription is not required. A 

tolerance level of 2 ppm in muscle tissue (as 

the sum of tetracycline residues, including 

oxytetracycline, chlortetracycline, and 

tetracycline) has been established for all 

finfish and lobster (21 CFR 556.500). 

Hydrogen peroxide 

35% PEROX-AID® 

35% PEROX-AID®, supplied by Eka 

Chemicals, Inc., Marietta, GA, is approved 

for the control mortality in freshwater-reared 

finfish eggs due to saprolegniasis; freshwaterreared salmonids due to bacterial gill disease; 

and freshwater-reared coolwater finfish and 

channel catfish due to external columnaris 

disease. This drug is approved as an OTC 

product, and a prescription is not required. 

There are no limitations on acceptable daily 

intake; there is no required withdrawal time; 

and no tolerance has been set for residues in 

fish tissue. However, as with all new animal 

drugs, a licensed veterinarian is required to 

prescribe an extra-label use of 35% PEROXAID® to treat diseases or species not listed on 

the product label (21 CFR 529.1150). 

Sulfamerazine 

Sulfamerazine, supplied by Alpharma, Inc., 

Bridgewater, NJ, is approved for use only in 

trout (rainbow, brook, and brown) to control 

furunculosis. It may be used for treatment 

not more than 14 days. The withdrawal time 

is 21 days before harvest for marketing or 

stocking in stream open to fishing (21 CFR 

558.582). A tolerance of zero is established 

for residues of sulfamerazine in the edible 

flesh (21 CFR 556.660). 

Sulfadimethoxine/ormetoprim combination 

Romet-30® 

Romet-30®, supplied by Pharmaq AS, 

Overhalla, Norway, is approved for use only 

in medicated feed only for control of enteric 

septicemia of catfish caused by Edwardsiella 

ictaluri and furunculosis in salmonids 

(trout and salmon) caused by Aeromonas 

salmonicida. Required withdrawal times 

are as follows: salmonids, 42 days; catfish, 

3 days (21 CFR 558.575). The withdrawal 

time for catfish is shorter because any 

residues that might be present in the skin are 

removed during processing. The tolerance 

for Sulfadimethoxine and ormetoprim in 

the flesh is 0.1 ppm for each drug (21 CFR 

556.490 and 556.640). 

•	 FDA low regulatory priority aquaculture 

drugs 

CVM has identified a number of unapproved 

aquaculture drugs that are of low regulatory 

priority when used in food fish. The 

following list identifies these compounds 

and provides their indicated use and usage 

levels (CVM’s Policy and Procedures Manual 

Attachment: “Enforcement Priorities for Drug 

use in Aquaculture” (Guide 1240.4200) (http:// 

www.fda.gov/downloads/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

PoliciesProceduresManual/UCM046931.pdf). 

CHAPTER 11: Aquaculture Drugs 

186 
The agency does not intend to take enforcement 

action against low regulatory priority substances 

if the following conditions are met: (1) the 

substances are used for the stated indications; 

(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 

appropriate grade for use in food animals; and 

(5) use of these products is not likely to result in 

an adverse effect on the environment. 

The agency’s enforcement position on the use 

of these substances should not be considered an 

approval, or an affirmation of their safety and 

effectiveness. The agency reserves the right to 

take a different position on the use of any or all 

of these substances at some time in the future. 

FDA’s determination that these substances are 

new animal drugs of low regulatory priority 

does not exempt facilities from complying with 

other federal, state, tribal, territorial and local 

environmental requirements. For example, in 

the United States, facilities using these substances 

would still be required to comply with the 

National Pollutant Discharge Elimination System 

requirements. 

Acetic acid 

Used in a 1,000 to 2,000 ppm dip for 1 to 10 

minutes as a parasitide for fish. 

Calcium chloride 

Used to increase water calcium concentration 

to ensure proper egg hardening. Dosages used 

would be those necessary to raise calcium 

concentration to 10 to 20 ppm CaCO3

. Used up 

to 150 ppm indefinitely to increase the hardness 

of water for holding and transporting fish in 

order to enable fish to maintain osmotic balance. 

Calcium oxide 

Used as an external protozoacide for fingerlings 

to adult fish at a concentration of 2,000 mg/L for 

5 seconds. 

Carbon dioxide gas 

Used for anesthetic purposes in fish. 

Fuller’s earth 

Used to reduce the adhesiveness of fish eggs to 

improve hatchability. 

Garlic (whole form) 

Used for control of helminth and sea lice 

infestations in marine salmonids at all life stages. 

Ice 

Used to reduce metabolic rate of fish during 

transport. 

Magnesium sulfate 

Used to treat external monogenic trematode 

infestations and external crustacean infestations 

in freshwater fish species at all life stages. Fish 

are immersed in a 30,000 mg MgSO4

/L and 7,000 

mg NaCl/L solution for 5 to 10 minutes. 

Onion (whole form) 

Used to treat external crustacean parasites and to 

deter sea lice from infesting the external surface 

of salmonids at all life stages. 

Papain 

Used in a 0.2% solution to remove the gelatinous 

matrix of fish egg masses in order to improve 

hatchability and decrease the incidence of 

disease. 

CHAPTER 11: Aquaculture Drugs 

187 
Potassium chloride 

Used as an aid in osmoregulation; relieves 

stress and prevents shock. Dosages used would 

be those necessary to increase chloride ion 

concentration to 10 to 2,000 mg/L. 

Povidone iodine 

Used in a 100 ppm solution for 10 minutes as an 

egg surface disinfectant during and after water 

hardening. 

Sodium bicarbonate 

Used at 142 to 642 ppm for 5 minutes as a means 

of introducing carbon dioxide into the water to 

anesthetize fish. 

Sodium chloride 

Used in a 0.5% to 1% solution for an indefinite 

period as an osmoregulatory aid for the relief 

of stress and prevention of shock; and in a 3% 

solution for 10 to 30 minutes as a parasitide. 

Sodium sulfite 

Used in a 1.5% solution for 5 to 8 minutes to treat 

eggs in order to improve their hatchability. 

Thiamine hydrochloride 

Used to prevent or treat thiamine deficiency in 

salmonids. Eggs are immersed in an aqueous 

solution of up to 100 ppm for up to 4 hours 

during water hardening. Sac fry are immersed in 

an aqueous solution of up to 1,000 ppm for up to 

1 hour. 

Urea and tannic acid 

Used to denature the adhesive component of 

fish eggs at concentrations of 15g urea and 

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. 

•	 FDA high enforcement priority aquaculture 

drugs 

CVM has identified a number of drugs and 

families of drugs historically used in fish without 

FDA approval that are of high enforcement 

priority. They should not be used in fish that 

is to be consumed, unless a sponsor obtains 

an approval or index listing for them. The 

following list identifies these compounds 

(CVM Program Policy and Procedures Manual 

Attachment: “Enforcement Priorities for Drug 

Use in Aquaculture” (Guide 1240.4200) (http:// 

www.fda.gov/downloads/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

PoliciesProceduresManual/UCM046931.pdf ): 

•	 Chloramphenicol; 

•	 Nitrofurans; 

•	 Fluoroquinolones and Quinolones; 

•	 Malachite Green; 

•	 Steroid Hormones. 

•	 Drugs prohibited for extra-label use 

The following drugs and families of drugs are 

prohibited for extra-label use in food-producing 

animals (21 CFR 530.41(a)): 

•	 Chloramphenicol; 

•	 Clenbuterol; 

•	 Diethylstilbestrol (DES); 

•	 Dimetridazole, Ipronidazole, and other 

Nitroimidazoles; 

•	 Furazolidone, and Nitrofurazone; 

•	 Fluoroquinolones; 

•	 Glycopeptides. 

None of these drugs and families of drugs 

has been approved use in fish. Additional 

information on aquaculture-related topics can be 

obtained from FDA/CVM at: http://www.fda.gov/ 

cvm/aqualibtoc.htm. 

CHAPTER 11: Aquaculture Drugs 

188 
 

DETERMINE WHETHER THE POTENTIAL 

HAZARD IS SIGNIFICANT. 

The following guidance will assist you in 

determining whether aquaculture drugs are a 

significant hazard at a processing step: 

1.	 Is it reasonably likely that unsafe levels of 

aquaculture drugs will be introduced at this 

processing step? 

Under ordinary circumstances, if you 

are a primary (first) processor, it would 

be reasonably likely that unsafe levels 

of aquaculture drugs could enter the 

process at the receiving step of any type of 

aquacultured fish, including: 

•	 Finfish; 

•	 Crustaceans; 

•	 Other aquatic food animals,
 

such as alligator.
 

Under ordinary circumstances it would also 

be reasonably likely that unsafe levels of 

aquaculture drugs could enter the process 

during aquatic holding (e.g., live lobster in 

pounds) or transport of live fish. 

Under ordinary circumstances, it would 

not be reasonably likely to expect that 

aquaculture drugs could enter the process 

during the receiving of wild-caught fish. 

Currently, FDA is not aware of drug use in 

the grow-out of molluscan shellfish. 

If you are receiving fish (other than live fish) 

from another processor, you would not need 

to identify aquaculture drugs as a significant 

hazard. The primary (first) processor should 

have fully controlled this hazard. 

2.	 Can unsafe levels of aquaculture drugs that are 

reasonably likely to occur be eliminated or reduced 

to an acceptable level at this processing step? 

Aquaculture drugs should be considered 

a significant hazard at any processing step 

at a primary processor where a preventive 

measure is or can be used to eliminate the 

hazard or to reduce the likelihood of its 

occurrence to an acceptable level. Preventive 

measures for the hazard of aquaculture drugs 

used in aquaculture operations and during 

live transportation can include: 

•	 Conducting on-farm visits to review 

drug usage (other than INADs) before 

receipt of the product, coupled with 

a supplier’s certificate that any INADs 

used were used in conformance 

with the application requirements 

and appropriate verification; 

•	 Reviewing, at time of receipt, drug usage 

records (other than INADs), coupled 

with a supplier’s certificate that any 

INADs used were used in conformance 

with the application requirements 

and appropriate verification; 

•	 Reviewing, at time of receipt, the 


producer’s lot-by-lot certification 


of proper drug usage, including 


INAD usage, coupled with 


appropriate verification;
 

•	 Conducting, at time of receipt,
 

drug residue testing; 


•	 Reviewing, at time of receipt, evidence 

(e.g., a third-party certificate) that 

the producer operates under a thirdparty-audited Quality Assurance (QA) 

program for aquaculture drug use. 

Note: INAD records are confidential unless an exception is made by 

the sponsor of the drug research. Thus, review of INAD drug usage 

records by the processor may not be practical in certain situations. 

Written certification, on a lot-by-lot basis, from the producer 

to the processor stating that INAD usage is in accordance with 

authorizations from FDA/CVM is a suitable alternative. 

These preventive measures are ordinarily 

employed at either the receiving step or the 

pre-harvest step. 

Preventive measures for the control of 

aquaculture drugs used during aquatic 

holding (e.g. lobster pounds) can include 

CHAPTER 11: Aquaculture Drugs 

189 
controlled application of animal drugs in a 

manner consistent with: 

•	 Established withdrawal times; 

•	 Labeled instructions for use; 

•	 Conditions for extra-label use of FDAapproved drugs, under a veterinarian’s 

supervision and in accordance with 

FDA regulations and guidelines; 

•	 Conditions specified in the FDA list of 

low regulatory priority aquaculture drugs; 

•	 Conditions of an INAD application. 

These preventive measures are ordinarily 

applied at the holding step. 

In the case of an integrated operation, where 

fish processing and farming, and perhaps 

feed manufacture, are performed by the 

same firm, it may be possible and desirable 

to exercise preventive measures early in the 

process (ideally, at feed manufacture), rather 

than at receipt of the fish at the processing 

plant. Such preventive measures will not be 

covered in this guidance document. 

•	 Intended use 

For aquaculture drugs, it is unlikely that the 

intended use of the product will affect the 

significance of the hazard. 

IDENTIFY CRITICAL CONTROL POINTS. 

The following guidance will assist you in 

determining whether a processing step is a 

critical control point (CCP) for the hazard of 

aquaculture drugs. 

Is the hazard the result of the use of aquaculture drugs 

during the raising of fish (i.e., aquaculture) or during 

aquatic holding (e.g., lobster pounds) or transport of live 

fish? 

1.	 If the hazard is the result of aquaculture, do you 

have a relationship with the grower that enables 

you to visit the farm before receipt of the fish? 

a.	 If you have such a relationship with the 

grower, then you should identify a preharvest step as the CCP for aquaculture 

drugs. The preventive measure for this 

type of control is: 

•	 Conducting on-farm visits to 

review drug usage, coupled with 

a supplier’s certificate that any 

INAD used is used in accordance 

with food use authorization 

and appropriate verification. 

Example: 

A primary processor of aquacultured 

catfish that regularly purchases from 

the same grower should visit the 

grower before the fish are harvested 

and review drug usage practices and 

records. The processor should also 

receive a guarantee that any INAD 

used is used in conformance with the 

food use authorization requirements. 

The processor should combine this 

monitoring procedure with quarterly 

raw material testing for verification 

and should set the CCP at the preharvest step. 

This control approach is a control 

strategy referred to in this document 

as “Control Strategy Example 1 - OnFarm Visits.” 

b.	 If you have no such relationship with 

the grower, then you should identify the 

receiving step as the CCP for aquaculture 

drugs. At the receiving step, you should 

exercise one of the following preventive 

measures: 

•	 Reviewing, at time of receipt, the 

producer’s lot-by-lot certification 

of proper drug usage, coupled 

with appropriate verification. 

Example: 

A primary processor of aquacultured 

shrimp that purchases raw material 

CHAPTER 11: Aquaculture Drugs 

190 
 

 

shrimp through various brokers 

should receive lot-by-lot certificates 

from the producers. The certificates 

should state that all drugs were used 

in conformance with applicable FDA 

regulations and labeled instructions. 

The processor should combine this 

monitoring procedure with quarterly 

raw material testing for verification 

and should set the CCP at receiving. 

This control approach is a control 

strategy referred to in this document 

as “Control Strategy Example 2 - 

Supplier’s Certification.” 

•	 Reviewing, at time of receipt, drug 

usage records (other than INADs), 

coupled with a supplier’s lot-bylot certificate that any INAD used 

was used in conformance with the 

use authorization requirements 

and appropriate verification. 

Example: 

A primary processor of aquacultured 

shrimp that purchases raw material 

shrimp through various brokers 

should receive records of drug 

usage (other than INADs) from 

the producers when the product is 

delivered. Additionally, the processor 

should receive a lot-by-lot certificate 

stating that any INAD used was 

used in conformance with the food 

use authorization requirements. 

The processor should combine this 

monitoring procedure with quarterly 

raw material testing for verification 

and should set the CCP at receiving. 

This control approach is a control 

strategy referred to in this document 

as “Control Strategy Example 3 - 

Records of Drug Use.” 

•	 Conducting, at time of receipt, drug 

screening on all lots for the presence 

of approved or unapproved drugs. 

This screening can be performed by 

rapid analytical methods that may 

indicate the presence of a family of 

drugs, rather than any specific drug. 

If the rapid screening test indicates 

that a family of drugs is present, 

further testing and/or follow-up with 

the supplier could be necessary. 

Note: A limited number of drug screening tests for 

aquaculture drugs are available. Tests are not available to 

assay for all drugs that might be used in all aquacultured 

species. Processors should be cautioned that tests that 

have not been validated may be unreliable. These tests 

may fail to detect a residue or may give a false positive. 

Processors should ensure that the tests that they intend 

to use have been validated and are appropriate for the 

species and tissue to be tested. 

Example: 

A primary processor of aquacultured 

shrimp that purchases raw material 

shrimp through various brokers 

should screen all incoming lots of 

shrimp with a series of validated 

rapid tests that target the families 

of drugs that are reasonably likely 

to be used during grow-out (e.g., 

chloramphenicol, nitrofurans, and 

fluoroquinolones). The processor 

should set the CCP at receiving. 

This control approach is a control 

strategy referred to in this document 

as “Control Strategy Example 4 - 

Drug Residue Testing.” 

•	 Reviewing, at time of receipt, 

evidence (e.g., continuing or lotby-lot third- party certificate) that 

the producer operates under a 

third-party-audited QA program 

that covers aquaculture drug use. 

Example: 

A primary processor of aquacultured 

trout that regularly purchases 

raw material trout from the same 

grower should obtain a third-party 

certificate, valid for 1 year (i.e., 

continuing certification), that attests 

CHAPTER 11: Aquaculture Drugs 

191 
that the grower operates under a QA 

program that covers aquaculture 

drug use. The processor should set the 

CCP at receiving. 

This control approach is a control 

strategy referred to in this document 

as “Control Strategy Example 5 - 

Quality Assurance Program.” 

2.	 If the hazard is the result of aquatic holding (e.g., 

lobster pounds), then you should identify the 

holding step as the CCP for aquaculture drugs. 

The preventive measure for this type of control is: 

•	 Applying animal drugs in a 

manner consistent with: 

Established withdrawal times; ° 

Labeled instructions for use; ° 

Conditions for extra-label use 

of FDA-approved drugs under a 

veterinarian’s supervision and in 

accordance with FDA regulations and 

guidances; 

° 

Conditions specified in the FDA “low 

regulatory priority aquaculture drug”
 

list; 


° 

Conditions of an INAD food use 


authorization. 

° 

Example: 

A primary processor that uses 

oxytetracycline in the holding of live 

lobster in a lobster pound should 

use the drug as a medicated feed in 

accordance with labeled instructions 

and should document the withdrawal 

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.” 

3.	 If the hazard is the result of transportation of live 

fish, then you should identify the receiving step 

as the CCP for aquaculture drugs. In this case, 

you should refer to described in Control Strategy 

Examples 2 through 5 for guidance. However, 

if live transportation is on your own truck, you 

should identify the transportation step as the 

CCP, and refer to Control Strategy Example 6 for 

guidance. 

Example: 

A primary processor that receives 

live basa from a broker on the 

broker’s truck should receive lotby-lot certificates from the broker. 

The certificates should state that all 

drugs were used in conformance 

with applicable regulations and 

labeled instructions. The processor 

should combine this monitoring 

procedure with quarterly raw 

material testing for verification 

and should set the CCP at 

receiving. 

Example: 

A primary processor that receives 

live catfish from the growers on 

the processor’s own truck and uses 

drugs to control animal health 

during transportation (e.g., carbon 

dioxide as an anesthetizing agent 

at levels appropriate for the purpose) 

should control drug use during 

transportation and should set the CCP 

at transportation. 

CHAPTER 11: Aquaculture Drugs 

192 
DEVELOP A CONTROL STRATEGY. 

The following guidance provides six control 

strategies for aquaculture drugs. You may select 

a control strategy that is different from those 

which are suggested provided it complies with 

the requirements of the applicable food safety 

laws and regulations. 

The following are examples of control strategies 

included in this chapter: 

CONTROL STRATEGY 

MAY APPLY TO 

PRIMARY 

PROCESSOR 

MAY APPLY TO 

SECONDARY 

PROCESSOR 

On-farm visit 

Supplier’s certification 

Records of drug use 

Drug residue testing 

Quality assurance program 

Control during holding  

•	 CONTROL STRATEGY EXAMPLE 1 - ON-FARM VISITS 

Set Critical Limits. 

Aquaculture drugs are used on food-producing 

fish only if they have been: 

•	 Approved by FDA or granted a conditional 

approval by FDA and used in accordance 

with all labeled conditions; 

OR 

•	 Approved by FDA and used in an extra-label 

manner under a veterinarian’s supervision in 

accordance with FDA regulations; 

OR 

•	 Put on the FDA list of low regulatory priority 

aquaculture drugs and used according to the 

provisions in the list; 

OR 

•	 Used in food fish as an INAD subjected 

to an investigational new animal drug 

exemption under 21 CFR Part 511 and used 

according to the requirements of the food 

use authorization; 

AND 

•	 Verified by a certificate from the producer 

indicating that any investigational new 

drug used is subject to an investigational 

new animal drug exemption under 21 

CFR Part 511, that fish intended for human 

consumption is subject to a food use 

authorization, and that the INAD is used 

in the fish according to the food use 

authorization requirements. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 On-farm drug usage procedures; 

AND 

•	 Certificate indicating proper INAD usage. 

»	 How Will Monitoring Be Done? 

•	 Survey farm husbandry procedures, ask 

questions, and review drug usage records; 

AND 

•	 Visual check for presence of INAD certificate 

of proper use. 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 At least once per year for each aquaculture 

site. 

»	 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: 

•	 Do not have the product shipped from the 

production site for processing. 

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 

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 
CHAPTER 11: Aquaculture Drugs 

195 

TABLE 11-1

CONTROL STRATEGY EXAMPLE 1 - ON-FARM VISITS

This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using “Control Strategy Example 1 - On-Farm Visits.” This example illustrates howa primary processor of farm-raised catfish can control aquaculture drugs. It is provided for illustrative purposes only. Aquaculture drugs may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Preharvest Aquaculture drugs Aquaculture drugs are used on fish only if the drugs have been 

approved by FDA or granted conditional 

approval by FDA and used in accordance 

with all labeled conditions;

approved by FDA and used in an extra-label 

manner under a veterinarian’s supervision in 

accordance with FDA regulations; 

put on the list of low regulatory priority 

aquaculture drugs and used in accordance 

with the provisions in the list; or use in food 

fish as an INAD subject to an investigational 

new animal drug exemption under 21 CFR 

Part 511 and used in accordance with the 

requirements of the food use authorization 

On-farm 

drug usage 

procedures 

Survey 

farm 

husbandry 

procedures,

ask

questions,

and review 

drug 

records 

Once

per year 

for each 

aquaculture

site 

Field

agent 

Reject the 

product

Do not

have the 

product 

shipped

from the

production 

site for 

processing.

Discontinue

use of the

supplier

until

evidence 

is obtained

that drug 

treatment

practices 

have

changed 

On-site

audit

report 

Collect a 

representative sample of 

the raw material 

quarterly, and 

analyze for those 

drug residues that are 

reasonably likely to be 

present*

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)

Review 

monitoring, verification,

and corrective action 

records within 1 week of 

preparation 

Certificate from the producer indicating 

that any investigational new drug used in 

fish intended for human consumption is 

subject to an investigational new animal 

drug exemption under 21 CFR Part 511 

and that the INAD is used according to the

requirements of the food use authorization 

Certificate 

indicating

proper

INAD

usage 

Visual 

check 

Once

per year 

for each 

aquaculture

site 

Field

agent 

Certificate 

of INAD

usage 

* Note: This plan is for illustrative purposes only. An actual plan should specify in the Verification column: the aquaculture drugs for which analysis will be conducted, the protocol for sample

collection, and the analytical method to be used for each drug 
•	 CONTROL STRATEGY EXAMPLE 2 - SUPPLIER’S 

CERTIFICATION 

Set Critical Limits. 

•	 Certificate proper drug usage accompanying 

each lot of incoming aquacultured fish. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 Presence of a certificate indicating proper 

drug usage. 

»	 How Will Monitoring Be Done? 

•	 Visual check for presence of certificate of 

proper use. 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 Each lot received. 

»	 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 

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. 

Establish a Recordkeeping System. 

•	 Copy of certificates; 

AND 

•	 Receiving record showing lots received and 

presence or absence of a 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, 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 11: Aquaculture Drugs 

196 
CHAPTER 11: Aquaculture Drugs 

197 

TABLE 11-2

CONTROL STRATEGY EXAMPLE 2 - SUPPLIER’S CERTIFICATION

This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Supplier’s Certification.” This example illustrates how a primary processor of pondraised shrimp can control aquaculture drugs. It is provided for illustrative purposes only. Aquaculture drugs may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Receiving Aquaculture 

drugs 

Certificate 

indicating

proper

drug usage 

accompanying

all lots of

incoming pondraised shrimp 

Presence of

a certificate 

indicating

proper drug 

usage 

Visual

check 

Each lot

received 

Receiving 

dock

employee 

Reject the lot

Discontinue use

of the supplier

until evidence 

is obtained that

the supplier

will comply

with the

certification 

controls 

Producer’s drug 

usage certificate

Receiving 

record 

Collect a 

representative 

sample of the raw 

material quarterly,

and analyze for 

those drug residues 

that are reasonably

likely to be present* 

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)

Review monitoring,

corrective action,

and verification 

records within 1

week of 

preparation 

* Note: This plan is for illustrative purposes only. An actual plan should specify in the Verification column: the aquaculture drugs for which analysis will be conducted, the protocol for sample

collection, and the analytical method to be used for each drug 
•	 CONTROL STRATEGY EXAMPLE 3 - RECORDS OF 

DRUG USE 

Set Critical Limits. 

Drug usage records for each delivery that show 

aquaculture drugs were used on food–producing 

fish only if the drugs have been: 

•	 Approved by FDA or granted conditional 

approval by FDA and used in accordance 

with all labeled conditions; 

OR 

•	 Approved by FDA and used in an extra-label 

manner under a veterinarian’s supervision in 

accordance with FDA regulations; 

OR 

•	 Put on the list of low regulatory priority 

aquaculture drugs and used according to the 

provisions in the list; 

AND 

Lot-by-lot certificate from the producer indicating 

that any investigational new drug used in fish 

intended for human consumption is subjected to 

an investigational new animal drug exemption 

under 21 CFR Part 511 and that the INAD is used 

according to the requirements of the food use 

authorization. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 Records of on-farm drug use; 

AND 

•	 Certificate indicating proper INAD usage. 

»	 How Will Monitoring Be Done? 

•	 Visual check of drug use records and INAD 

certificate of proper use. 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 Each lot received. 

»	 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. 

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 and/or the producer 

will comply with the certification controls. 

Establish a Recordkeeping System. 

•	 Producer’s drug records; 

AND 

•	 INAD certificate of proper use; 

AND 

•	 Receiving record showing lots received and 

presence or absence of a certificate. 

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 

198 
CHAPTER 11: Aquaculture Drugs 

199 

TABLE 11-3

CONTROL STRATEGY EXAMPLE 3 - RECORDS OF DRUG USE

This table is an example of a portion of a HACCP plan using “Control Strategy Example 3 - Records of Drug Use.” This example illustrates how a pond-raised shrimp processorcan control aquaculture drugs. It is provided for illustrative purposes only. Aquaculture drugs may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., chemical contaminants). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Receiving Aquaculture 

drugs 

Drug usage records for each delivery 

that show that drugs were used on 

fish only if the drugs have been 

approved by FDA or granted a 

conditional approval by FDA and 

used in accordance with all labeled

conditions; approved by FDA and 

used in an extra-label manner under 

a veterinarian’s supervision in 

accordance with FDA regulations; or

put on the list of low regulatory 

priority aquaculture drugs and used 

according to the provisions on the list 

Records 

of onfarm drug 

usage 

Visual

check 

Each lot

received 

Production 

supervisor 

Reject the lot 

Discontinue use

of the supplier

until evidence is 

obtained that drug 

treatment practices 

have changed 

Grower’s 

drug 

usage

records

Receiving 

record 

Collect a 

representative sample of 

the raw material quarterly,

and analyze for those drug 

residues that are reasonably

likely to be present*

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)

Review monitoring,

verification, and corrective 

action records within 1 

week of preparation 

Lot-by-lot certificate from the 

producer indicating that any

investigational new drug used in fish 

intended for human consumption 

is subject to an investigational new 

animal drug exemption under 21 CFR 

Part 511 and that the INAD is used 

according to the requirements of the

food use authorization 

Certificate 

indicating

proper

INAD

usage 

Visual

check 

Each lot

received 

Production 

supervisor 

Reject the lot 

Discontinue use

of the supplier

until evidence 

is obtained that

the supplier will

comply with

the certification 

requirements 

Certificate 

of INAD

usage

Receiving 

record 

* Note: This plan is for illustrative purposes only. An actual plan should specify in the Verification column: the aquaculture drugs for which analysis will be conducted, the protocol for sample

collection, and the analytical method to be used for each drug 
•	 CONTROL STRATEGY EXAMPLE 4 - DRUG 

RESIDUE TESTING 

Set Critical Limits. 

•	 No fish may contain a residue of an 

unapproved drug (other than for those 

drugs used as an INAD and according to the 

requirements of the food use authorization 

or used in accordance with the criteria 

specified in the list of low regulatory priority 

aquaculture drugs); 

AND 

•	 No fish may contain a residue level of an 

approved drug that is above FDA tolerance 

for that drug. 

Establish Monitoring Procedures. 

»	 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. 

Establish a Recordkeeping System. 

•	 Test results. 

Establish Verification Procedures. 

•	 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, 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 11: Aquaculture Drugs 

200 
CHAPTER 11: Aquaculture Drugs 

201 

TABLE 11-4

CONTROL STRATEGY EXAMPLE 4 - DRUG RESIDUE TESTING

This table is an example of a portion of a HACCP plan using “Control Strategy Example 4 - Drug Residue Testing.” This example illustrates how a primary processor of farmraised catfish can control aquaculture drugs. It is provided for illustrative purposes only. Aquaculture drugs may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Receiving Aquaculture 

drugs 

No fish may 

contain residues

of unapproved 

drugs (other than 

those used as an

INAD subject to 

an investigational 

new animal drug 

exemption under 

21 CFR Part511 

and according

to requirements

of the food use 

authorization or

included on the list

of low regulatory 

priority aquaculture

drugs)*

No fish may 

contain a residue

level of an 

approved drug 

that is above FDA 

tolerance for that 

drug* 

Fish edible

fl esh for drug 

residues* 

Obtain samples

and analyze

for drugs using 

rapid screening 

methods or

other analytical 

methods* 

Each lot

received 

Quality

assurance 

personnel 

Reject the lot

Discontinue use

of the supplier

until evidence 

is obtained

that drug 

treatment

practices 

have changed 

Analytical 

results 

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

Review 

monitoring,

verification,

and corrective 

action records 

within 1 week 

of preparation 

* Note: This plan is for illustrative purposes only. An actual plan should specify: (1) in the Critical Limits column: the aquaculture drugs that are reasonably likely to be present and the critical 

limits to be applied to each drug; and (2) in the Verification column: the aquaculture drugs for which analysis will be conducted, the protocol for sample collection, and the analytical method to be used for each drug. 
•	 CONTROL STRATEGY EXAMPLE 5 - QUALITY 

ASSURANCE PROGRAM 

Set Critical Limits. 

Certificate indicating that the producer operates 

under a third-party-audited quality assurance 

(QA) program that controls aquaculture drug 

use. The certificate may accompany each lot of 

incoming aquacultured fish or may be issued for 

each producer of incoming aquacultured fish as a 

continuing certification. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 Certificate indicating operation under thirdparty-audited QA program. 

»	 How Will Monitoring Be Done? 

•	 Visual check for presence of a certificate. 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 Each lot received must be checked for the 

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 

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. 

Establish a Recordkeeping System. 

•	 Third-party certificates; 

AND 

•	 Receiving record showing lots received and 

presence or absence of a certificate. 

Establish Verification Procedures. 

•	 Review the third-party QA program and 

results of audits annually; 

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 11: Aquaculture Drugs 

202 
CHAPTER 11: Aquaculture Drugs 

203 

TABLE 11-5

CONTROL STRATEGY EXAMPLE 5 - QUALITY ASSURANCE PROGRAM

This table is an example of a portion of a HACCP plan using “Control Strategy Example 5 - Quality Assurance Program.” This example illustrates how an aquacultured troutprocessor can control aquaculture drugs. It is provided for illustrative purposes only.Aquaculture drugs may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Receiving Aquaculture 

drugs 

Certificate 

indicating that

the producer

operates 

under a thirdparty-audited 

QA program 

that covers 

aquaculture

drug usage 

Presence of a

third-party 

certificate 

Visual check Each lot Receiving dock 

employee 

Reject the lot 

Discontinue use

until evidence 

is obtained that

the supplier

will comply

with the

certificate 

requirements 

Third- party 

certificate 

Receiving 

record 

Review 

third-party QA 

program and 

results of audits

annually

Review 

monitoring,

verification,

and corrective 

action records 

within 1 week 

of preparation 
•	 CONTROL STRATEGY EXAMPLE 6 - CONTROL 

DURING HOLDING 

Set Critical Limits. 

Aquaculture drugs are used on fish only if the 

drugs have been: 

•	 Approved by FDA or granted a conditional 

approval by FDA and used in accordance 

with all labeled conditions; 

OR 

•	 Approved by FDA and used in an extra-label 

manner under a veterinarian’s supervision in 

accordance with FDA regulations; 

OR 

•	 Put on the FDA list of low regulatory priority 

aquaculture drugs and used according to the 

provisions on the list; 

OR 

•	 Used for use in food fish as an INAD subject 

to an investigational new animal drug 

exemption under 21 CFR Part 511 and used 

according to the requirements in the food 

use authorization. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 Type of aquaculture drug used; 

AND 

•	 Date and quantity of drug use; 

AND 

•	 Any other conditions of drug usage that are 

relevant to:
 

Established withdrawal times; 
 ° 

Labeled instructions; ° 

Extra-label use of an FDA-approved drug 

used under a veterinarian’s supervision 

in accordance with FDA regulations and 

guidances; 

° 

Conditions specified in the FDA list 

of low regulatory priority aquaculture 

drugs; 

° 

OR 

Requirements of the INAD food use 

authorization;
 

° 

AND
 

•	 Date of distribution of the finished product. 

»	 How Will Monitoring Be Done? 

•	 Visually observe drug use and finished 

product distribution. 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 Every time aquaculture drugs are used 

during holding or transportation; 

AND 

•	 Every time the finished product is 

distributed. 

»	 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: 

•	 Destroy the product; 

OR 

•	 Divert the product to non-food use; 

OR 

•	 If the drug is approved for the species in 

which it was used, hold the product until the 

mandatory withdrawal period (if applicable) 

has been met and until the drug residue 

level is below the established tolerance. 

These corrective actions may be verified by 

collecting and analyzing a representative 

sample of the product, using an appropriate 

analytical method. 

AND 

Take the following corrective action to regain control 

over the operation after a critical limit deviation: 

•	 Modify drug use practices. 

CHAPTER 11: Aquaculture Drugs 

204 
CHAPTER 11: Aquaculture Drugs 

205 

TABLE 11-6

CONTROL STRATEGY EXAMPLE 6 - CONTROL DURING HOLDING

This table is an example of a portion of a HACCP plan using “Control Strategy Example 6 - Control During Holding.” This example illustrates how a processor that holds livelobster in a lobster pound can control aquaculture drugs. It is provided for illustrative purposes only. Aquaculture drugs may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants, pesticides and natural toxins). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Holding Aquaculture 

drug 

oxytetracycline 

Lobster will be

withheld from

distribution for 

30 days after 

treatment with

oxytetracycline 

in accordance

with the labeled

directions for 

use

No other

aquaculture

drugs will be 

used 

Type of

aquaculture

drug used 

Visual 

observation of 

drug use 

Every time 

aquaculture

drugs are used 

Production 

employee 

Hold the product

Collect a sample of 

the finished product 

and analyze for drug 

residues

(oxytetracycline)

Release the product 

if the drug residue 

level is below the 

tolerance (2 ppm)

Hold the product if 

the drug residue level 

exceeds the tolerance 

and retest

Destroy the lot when 

unapproved drugs 

are used

Modify drug use 

practices 

Drug use 

record 

Review 

monitoring

and corrective 

action records 

within 1 week 

of preparation 

Date and

quantity of drug 

use 

Visual 

observation of 

drug use 

Every time 

aquaculture

drugs are used 

Production 

employee 

Drug use 

record 

Date of finished

product 

distribution 

Visual check 

of product 

distribution 

Every time 

finished

product is 

shipped 

Shipping

supervisor 

Shipping

record 
Establish a Recordkeeping System. 

•	 Drug use records; 

AND 

•	 Records indicating date of distribution of the 

finished product. 

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 11: Aquaculture Drugs 

206 
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 NonFDA Web site references after March 29, 2011. 

•	 Federal Joint Subcommittee on Aquaculture. 

April 2007. Guide to drug, vaccine, and 

pesticide use in aquaculture. http://aquanic. 

org/jsa/wgqaap/drugguide/drugguide.htm. 

•	 Federal Register. November 21, 2005. 

Rules and regulations: new animal drugs: 

florfenicol, vol. 70, no 233. U.S. Government 

Printing Office, Washington, DC. 

•	 Federal Register. February 6, 2007. Rules and 

regulations: new animal drugs: hydrogen 

peroxide, vol. 72, no. 24. U.S. Government 

Printing Office, Washington, DC. 

•	 Federal Register. November 26, 2007. 

Rules and regulations: new animal drugs: 

florfenicol, vol. 72, no. 226. U.S. Government 

Printing Office, Washington, DC. 

•	 U.S. Food and Drug Administration. February 

19, 2008. Extralabel use of approved 

drugs in aquaculture. In Program policy 

and procedures manual guide 1240.4210. 

Department of Health and Human Services, 

Food and Drug Administration, Center 

for Veterinary Medicine. http://www. 

fda.gov/downloads/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

PoliciesProceduresManual/ucm046932.pdf. 

•	 U.S. Food and Drug Administration. 

October 23, 2003. Evaluating the safety 

of antimicrobial new animal drugs with 

regard to their microbiological effects 

on bacteria of human health concern. In 

Guidance for industry, no. 152. Department 

of Health and Human Services, Food 


and Drug Administration, Center for 


Veterinary Medicine. http://www.fda.
 

gov/downloads/AnimalVeterinary/
 

GuidanceComplianceEnforcement/
 

GuidanceforIndustry/ucm052519.pdf.
 

•	 U.S. Food and Administration. April 2010. 

Certain other dosage form new animal 

drugs. In Code of Federal Regulations, 21 

CFR 529. U.S. Government Printing Office, 

Washington, DC. 

•	 U.S. Food and Administration. April 2010. 

Extra label drug use in animals. In Code 

of Federal Regulations, 21 CFR 530. U.S. 

Government Printing Office, Washington, DC. 

•	 U.S. Food and Administration. April 2010. 

Implantation or injectable dosage form 

new animal drugs. In Code of Federal 

Regulations, 21 CFR 522. U.S. Government 

Printing Office, Washington, DC. 

•	 U.S. Food and Administration. April 2010. 

New animal drug applications. In Code 

of Federal Regulations, 21 CFR 514. U.S. 

Government Printing Office, Washington, DC. 

•	 U.S. Food and Drug Administration. April 

2010. New animal drugs for investigational 

use. In Code of Federal Regulations, 21 

CFR 511. U.S. Government Printing Office, 

Washington, DC. 

•	 U.S. Food and Administration. April 2010. 

Tolerances for residues of new animal drugs 

in food. In Code of Federal Regulations, 21 

CFR 556. U.S. Government Printing Office, 

Washington, DC. 

•	 U.S. Food and Drug Administration. April 

26, 2007. Enforcement priorities for drug 

use in aquaculture; part B and part C. 

In CVM’s policy and procedures manual 

1240.4200. Department of Health and Human 

Services, Food and Drug Administration, 

Center for Veterinary Medicine. http://www. 

fda.gov/downloads/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

PoliciesProceduresManual/ucm046931.pdf. 

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
 

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. 

Pathogenic bacteria growth and toxin formation 

as a result of time and temperature abuse of fish 

and fishery products can cause consumer illness. 

This hazard is limited to bacterial pathogens since 

viral pathogens (viruses) are not able to grow in 

food. Of particular concern in seafood are the 

pathogenic forms of Listeria monocytogenes (L. 

monocytogenes), Vibrio vulnificus (V. vulnificus), 

Vibrio parahaemolyticus (V. parahaemolyticus), 

Vibrio cholera (V. cholera), Escherichia coli (E. 

coli), Salmonella spp., Shigella spp., Staphylococcus 

aureus (S. aureus), Clostridium perfringens 

(C. perfringens), Bacillus cereus (B. cereus), 

Campylobacter jejuni (C. jejuni), and Yersinia 

enterocolitica (Y. enterocolitica). See Appendix 7 

for a description of the public health impacts of 

these pathogens. 

Pathogenic bacteria can enter the process on raw 

materials. They can also be introduced into foods 

during processing from the air, unclean hands, 

insanitary utensils and equipment, contaminated 

water, or sewage and through cross-contamination 

between raw and cooked product. The primary 

method for control is to reduce levels through 

cooking or other treatments, when feasible, 

minimize the potential for recontamination and 

to maintain products at temperatures that do not 

support growth of pathogenic bacteria. 

Time and temperature abuse occurs when a 

product is allowed to remain at temperatures 

favorable to pathogenic bacteria growth for 

sufficient time to result in unsafe levels of 

pathogenic bacteria or their toxins in the product. 

Therefore, management of time and temperature 

of product exposure is important to producing 

a safe product. Table A-1 (Appendix 4) provides 

guidance concerning the conditions under which 

certain pathogenic bacteria can grow. The bacteria 

listed are those of greatest concern in fish and 

fishery products. 

Managing time and temperature of exposure 

Time and temperature management relies 

on identification of time and temperature 

combinations that ensure the safety of your 

product. The following factors should be 

considered: 

•	 The types of pathogenic bacteria that are 

reasonably likely to be present; 

•	 Whether those pathogens can grow in the 

food; 

•	 The infective dose of the pathogenic bacteria; 

•	 The expected initial level of the pathogenic 

bacteria in the food. 

Presence of pathogenic bacteria 

It is reasonable to assume that 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. 

They might be present only at low levels or only 

sporadically, but even such occurrences warrant 

consideration because of the potential for growth 

and toxin production under temperature abuse 

conditions. However, certain pathogenic bacteria 

are associated with specific food sources, and it 

may not be necessary to assume that they will be 

present in other foods unless introduced from a 

contaminated source. For example, V. vulnificus, 

V. parahaemolyticus, and V. cholerae non-O1 

and non-O139 are generally associated with 

marine and estuarine species of fish and not with 

freshwater species or non-fishery ingredients. 

Pathogenic bacteria can also be introduced 

during processing, even after cooking. Welldesigned sanitation programs will minimize 

their introduction. However, in most cases, 

it is not reasonable to assume that sanitation 

programs will fully prevent the introduction of 

pathogenic bacteria. For this reason, controls 

should be in place to minimize the risk of 

pathogenic bacteria growth. 

Pathogenic bacteria growth 

Fish and fishery products generally provide 

sufficient nutrients for pathogenic bacteria 

growth. However, chemical and physical 

characteristics of the product and its packaging 

could limit or enhance pathogenic bacteria 

growth and toxin formation. Furthermore, 

these characteristics could restrict competing 

microorganism growth and provide conditions 

favorable to pathogenic bacteria growth. 

Consider: 

•	 The moisture available to support pathogenic 

bacteria growth in the product (i.e., water 

activity); 

•	 The amount of salt and preservatives in the 

product (e.g., water phase salt and nitrates); 

•	 The acidity of the product (i.e., pH); 

•	 The availability of oxygen in the product 

(i.e., aerobic or anaerobic conditions); 

•	 The presence of competing spoilage 

organisms in the food. 

Table A-1 (Appendix 4) provides guidance 

on some conditions that limit the growth 

of those pathogenic bacteria that are most 

relevant to fish and fishery products. Table A-1 

provides minimum and maximum values of 

pathogenic bacteria growth. This table can help 

you to decide whether particular pathogenic 

bacteria will grow in your food if it is time and 

temperature-abused. 

Certain pathogenic bacteria grow well in time 

and temperature-abused raw fish and fishery 

products (e.g., raw molluscan shellfish), and 

others do not. Those that grow well in time 

and temperature-abused raw fish include: V. 

vulnificus, V. parahaemolyticus, V. cholerae, and 

L. monocytogenes. Others may grow if the natural 

condition of the raw fish is changed, such as 

through salting or reduced oxygen packaging. 

Those that ordinarily do not grow well, because 

they compete poorly with the normal spoilage 

bacteria, include: C. jejuni, pathogenic strains of 

E. coli, Salmonella spp., Shigella spp., S. aureus, 

C. perfringens, B. cereus, and Y. enterocolitica. 

Most pathogenic bacteria will grow well in 

temperature-abused cooked fish if their growth is 

not controlled by means such as drying, salting, 

or acidification, because competing bacteria are 

destroyed by the cooking process. 

Infective dose 

The infective dose or toxic dose is the total 

number of a pathogen, or the total amount of a 

toxin, that is necessary to produce human illness. 

The dose often varies considerably for a single 

pathogen based on the health of the consumer 

and the virulence (infective capacity) of the 

particular strain of the pathogen. 

The typical infectious dose is known or 

suspected to be very low (i.e., one to several 

hundred organisms can cause illness) for 

many of the pathogenic bacteria listed in Table 

A-1 (Appendix 4). These include C. jejuni, 

E. coli, Salmonella spp., Shigella spp., and Y. 

enterocolitica. The typical infectious dose for 

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 

than 100,000). These include V. vulnificus and 

V. parahaemolyticus. In the case of both of 

these categories of pathogens, it is advisable to 

prevent any significant growth so that the typical 

infective dose is not exceeded. In other words, 

product temperatures should be maintained 

below the minimum growth temperature for the 

pathogen or should not be allowed to exceed 

that temperature for longer than the lag growth 

phase (i.e., the slow growth phase during 

which a pathogenic bacteria acclimates to its 

environment before proceeding to rapid growth) 

of the pathogenic bacteria at the exposure 

temperature. 

Still other pathogenic bacteria require large 

numbers in order to cause disease. The typical 

infectious dose of V. cholerae is suspected to be 

1,000,000 cells. S. aureus and B. cereus toxin do 

not normally produce sufficient toxin to cause 

illness until numbers of the pathogen reach 

100,000 to 1,000,000/gram. 

C. perfringens typically does not produce toxin 

in the human gut unless at least 100,000,000 

bacteria are consumed. Limited growth of these 

pathogens might not compromise the safety of 

the product. However, time and temperature 

controls must be adequate to prevent growth 

before the infectious or toxic dose is reached. 

Levels of pathogenic bacteria 

The levels of a pathogen that are likely to be 

present in a fish or fishery product is dependent 

on factors such as the quality of the harvest 

water, how the raw material was handled 

before it was delivered to your plant, and the 

effectiveness of your sanitation control program. 

As a practical matter, the initial number of lowto-moderate infectious dose pathogenic bacteria 

in a food is usually of limited importance when 

you develop a time and temperature management 

strategy because these pathogens should be 

controlled by a time and temperature strategy 

that does not permit their growth to pass the 

lag phase. On the other hand, when controlling 

pathogenic bacteria that have a relatively high 

infective dose, the initial number of pathogenic 

bacteria may be a significant consideration. 

Practical considerations for unrefrigerated 

processing 

Consider the above described factors to identify 

the pathogen(s) that presents the greatest 

challenge with respect to managing time and 

temperature exposure in your product. This then 

becomes the target pathogen(s) for time and 

temperature control. Table A-2 (Appendix 4) can 

then be used to establish safe exposure times 

for the target pathogen(s) at the temperatures at 

which you expect your product to be exposed. 

As an alternative, you can use predictive 

microbiology models, such as the U.S. 

Department of Agriculture Pathogen Modeling 

Program (http://ars.usda.gov/Services/docs. 

htm?docid=6786) or ComBase (http://www. 

combase.cc/default.html) for product-specific 

time and temperature exposure calculations. 

However, you should validate the reliability of 

predictions from such models for your food. 

Growth rates of pathogens are highly 

temperature dependent. Ordinarily, pathogenic 

bacteria growth is relatively slow at temperatures 

below 70°F (21.1°C). In most cases, growth is 

very slow below 50°F (10°C), and 40°F (4.4°C) 

is below the minimum growth temperature of 

most pathogenic bacteria, although there are 

some exceptions. On the other hand, pathogenic 

bacteria grow relatively fast at temperatures 

above 70°F (21.1°C). Product temperatures should 

be maintained below the minimum growth 

temperature for the pathogen or should not be 

allowed to exceed that temperature for longer 

than the lag growth phase of the pathogen 

growth cycle. 

Consider the following recommendations when 

developing a product monitoring program. Product 

surface temperature or ambient temperature 

generally should be monitored when the ambient 

temperature (e.g., air) is warmer than the product 

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 

be monitored when the ambient temperature 

(e.g., air, ice, and brine) is cooler than the product 

internal temperature. Similarly, when selecting a 

product for temperature measurement, consider 

the location of the product selected in relation to 

the environment and select the likely worse case 

product. For example, a product in the center of 

a pile of products will take longer to cool than a 

product at the surface. 

•	 Strategies for control of pathogenic bacteria 

There are a number of strategies for the control 

of pathogenic bacteria in fish and fishery 

products. They include: 

•	 Managing the amount of time that food is 

exposed to temperatures that are favorable 

for pathogen growth and toxin production 

(covered generally in this chapter; for 

Clostridium botulinum (C. botulinum), in 

Chapter 13; and for S. aureus in hydrated 

batter mixes, in Chapter 15); 

•	 Killing pathogenic bacteria by cooking 

or pasteurization (covered in Chapter 16) 

or by retorting (covered by the Thermally 

Processed Low-Acid Foods Packaged in 

Hermetically Sealed Containers regulation, 21 

CFR 113 (hereinafter, the Low-Acid Canned 

Foods (LACF) Regulation); 

•	 Killing pathogenic bacteria by processes 

that retain the raw product characteristics 

(covered in Chapter 17); 

•	 Controlling the amount of moisture that is 

available for pathogen growth (water activity) in 

the product by drying (covered in Chapter 14); 

•	 Controlling the amount of moisture that is 

available for pathogen growth (water activity) 

in the product by formulation (covered in 

Chapter 13); 

•	 Controlling the amount of salt or 

preservatives, such as sodium nitrite, in the 

product (covered in Chapter 13); 

•	 Controlling the level of acidity (pH) in the 

product (covered by the Acidified Foods 

regulation, 21 CFR 114, for shelf-stable 

acidified products, and by Chapter 13 for 

refrigerated acidified products); 

•	 Controlling the introduction of pathogenic 

bacteria after the pasteurization process 

(covered in Chapter 18); 

•	 Controlling the source of molluscan shellfish 

and the time from exposure to air (e.g., by 

harvest or receding tide) to refrigeration to 

control pathogens from the harvest area 

(covered in Chapter 4). 

DETERMINE WHETHER THE POTENTIAL 

HAZARD IS SIGNIFICANT. 

The following guidance will assist you in 

determining whether pathogenic bacteria growth 

and toxin formation as a result of time and 

temperature abuse is a significant hazard at a 

processing step: 

1.	 Is it reasonably likely that unsafe levels of 

pathogenic bacteria will be introduced at this 

processing step (do unsafe levels come in with the 

raw material or will the process introduce them)? 

It is reasonable to assume that 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 and fishery 

products and non-fishery ingredients. 

However, certain pathogenic bacteria are 

associated with specific food sources, and it 

may not be necessary to assume that they 

will be present in other foods unless they 

have been cross-contaminated. For example, 

V. vulnificus, V. parahaemolyticus, and V. 

cholerae non-O1 and non-O139 are generally 

associated with marine and estuarine species 

of fish and not with freshwater species or 

non-fishery ingredients. 

Pathogenic bacteria also could be introduced 

during processing, even after cooking. Welldesigned sanitation programs (prerequisite 

programs) will minimize the introduction of 

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 

fully prevent the introduction of pathogenic 

bacteria. Additional information on this 

topic is presented in the previous section, 

“Understand the Potential Hazard.” 

2.	 Is it reasonably likely that pathogenic bacteria 

will grow to unsafe levels and/or produce toxin 

at this processing step? 

In order to answer this question, you must 

first determine which of those pathogenic 

bacteria that are reasonably likely to be 

present in your product would be able 

to grow under time and temperature 

abuse conditions. Information on this 

topic is presented in the previous section, 

“Understand the Potential Hazard.” 

Time and temperature abuse at one step 

alone might not result in an unsafe product. 

However, time and temperature abuse 

that occurs at successive processing steps 

(including storage steps) might be sufficient 

to result in unsafe levels of pathogenic 

bacteria or toxins. For this reason, you should 

consider the cumulative effect of time and 

temperature abuse during the entire process. 

Table A-2 (Appendix 4) provides guidance 

about the kinds of time and temperature 

abuse that might cause a product to be 

unsafe. A study may need to be conducted to 

determine time and temperature exposure of 

your seafood to temperature abuse for each 

process step. 

Remember that you should consider the 

potential for time and temperature abuse in 

the absence of controls. You might already 

have controls in your process that minimize 

the potential for time and temperature 

abuse that could result in unsafe levels of 

pathogenic bacteria or toxins. This section 

and subsequent sections will help you 

determine whether those or other controls 

should be included in your Hazard Analysis 

Critical Control Point (HACCP) plan. 

In summary, under ordinary circumstances 

(e.g., without data to the contrary), you 

should consider that it is reasonably likely 

that a pathogenic bacteria in Table A-1 

(Appendix 4) will grow to an unsafe level or 

produce toxin in your product at a particular 

processing step if all of the following 

conditions are met: 

•	 It is reasonably likely to be present; 

•	 Its growth is not prevented by 


a condition of the food; 


•	 It is reasonably likely that, in the 

absence of controls, cumulative time 

and temperature abuse conditions 

such as those described in Table A-2 

(Appendix 4) could occur during 

processing of the product, and the 

processing step could contribute 

significantly to that cumulative abuse. 

3.	 Can unsafe levels of pathogenic bacteria and/ 

or toxin production that are reasonably likely to 

occur be eliminated or reduced to an acceptable 

level at this processing step? 

Pathogenic bacteria growth and toxin 

formation due to time and temperature abuse 

should be considered a significant hazard 

at any processing step 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. The preventive 

measures that can be applied for pathogenic 

bacteria growth and toxin formation due to 

time and temperature abuse include: 

•	 Refrigeration of the product and 

controlling refrigeration temperatures; 

•	 Proper icing of the product; 

•	 Controlling the amount of time that the 

product is exposed to temperatures 

that would permit pathogenic bacteria 

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 

were handled properly during 

refrigerated transportation from the 

previous processor, including: 

Controlling refrigeration temperatures 

during transit; 

° 

Proper icing during transit. ° 

•	 Intended use 

Except as noted, it is unlikely that the 

intended use will affect the significance of 

the hazard. 

FDA is not aware of any HACCP controls 

that exist internationally for the control 

of pathogenic bacteria in fish and fishery 

products that are customarily fully cooked 

by the consumer or end user before 

consumption, other than a rigorous sanitation 

regime as part of a prerequisite program 

or as part of HACCP itself. The Fish and 

Fishery Products regulation, 21 CFR 123 

(called the Seafood HACCP Regulation in 

this guidance document) requires such a 

regime. The proper application of sanitation 

controls is essential because of the likelihood 

that pathogenic bacteria can be introduced 

into fish and fishery products through 

poor handling practices by the aquaculture 

producer, the fisherman, or the processor. 

FDA is interested in information regarding any 

HACCP controls beyond sanitation that could 

be necessary and practical for the control 

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 

the processor for culinary purposes (e.g., 

setting the batter or breading, or stabilizing 

the product shape), and are customarily 

fully cooked by the consumer or end user. 

Examples include: fish balls, shrimp egg rolls, 

shrimp and cheese stuffed ravioli, crab cakes, 

and breaded fish portions. Although the 

exterior of these products may appear cooked, 

the interior fish protein is not coagulated, and 

the products are not ready-to-eat. 

Other products contain a combination of 

raw or partially cooked, and fully cooked 

ingredients (e.g., seafood mixture of raw 

oysters, cooked shrimp, and raw or cooked 

octopus). Although the protein of some of 

the fishery ingredients is coagulated, some is 

not. As a result, many of these products are 

not ready-to-eat. However, these combination 

products should be considered ready-to-eat 

if the raw or partially cooked ingredients are 

customarily eaten without cooking by the 

consumer or end user. 

Note that the toxin produced by S. aureus 

is not destroyed by cooking or retorting. Its 

formation should, therefore, be prevented 

in all fish and fishery products. However, as 

previously mentioned, S. aureus does not 

grow well in raw fish, unless the growth of 

competing spoilage organisms is inhibited (e.g., 

by salting or vacuum packaging). B. cereus also 

produces a heat-stable toxin and forms heatresistant spores that can survive cooking. 

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. 

The following guidance will assist you in 

determining whether a processing step is a 

critical control point (CCP) for pathogenic 

bacteria growth and toxin formation as a result of 

time and temperature abuse: 

1.	 If there is a cook step, pasteurization step, or 

retorting step later in your manufacturing process, 

you should, in most cases, identify that step as 

the CCP. You would not usually need to identify 

processing steps prior to cooking, pasteurization, 

or retorting as CCPs for this hazard. 

Example: 

A cooked shrimp processor should set 

the critical control point for pathogenic 

bacteria growth and toxin formation as 

a result of time and temperature abuse 

at the cook step. The processor would not 

need to identify each of the processing 

steps prior to cooking as CCPs. 

Guidance for this pathogen control strategy 

is contained in Chapter 16 (for cooking and 

pasteurization) and the LACF Regulation, 21 

CFR 113 (for retorting). 

However, there are two important limitations 

to this strategy: 

•	 The cooking, pasteurizing, or retorting 

process must be sufficient to eliminate 

the most resistant pathogenic bacteria 

of public health concern that are 

reasonably likely to be present; 

•	 Certain toxins (e.g., S. aureus and B. 

cereus toxins) are heat stable. Heat 

treatment, including retorting, might not 

eliminate the toxin once it is formed. 

In either case, time and temperature control 

would be necessary at the processing steps 

at which growth and toxin formation could 

occur. 

2.	 If there is no cook step, pasteurization step, or 

retorting step later in the process, you should 

identify as a CCP each processing step at which 

you have identified this hazard as significant. You 

should control cumulative exposure of the product 

to time and temperatures that will permit growth 

or toxin formation at these steps. 

Example: 

A crabmeat processor identifies a series 

of post-cook processing and storage 

steps (e.g., backing, picking, packing, 

and refrigerated storage) as presenting 

a reasonable likelihood of pathogenic 

bacteria growth and toxin formation. 

The processor does not subject the product 

to a final pasteurization process and 

recognizes that it might be consumed 

without further cooking. The processor 

controls the temperature during 

refrigerated storage and the time of 

exposure to unrefrigerated conditions 

during the processing steps. The processor 

should identify each of the post-cook 

processing and storage steps as CCPs for 

this hazard. 

This chapter provides the following four 

control approaches, or control strategies, each 

relating to a separate potential CCP or a set 

of CCPs: 

•	 “Control Strategy Example 1 - Transit 

Control.” This control strategy should 

be applied to the control of transit at 

receipt of chilled (i.e., refrigerated, 

iced, or held under chemical cooling 

media, such as gel packs, and not 

frozen) ready-to-eat fishery products; 

•	 “Control Strategy Example 2 - 

Refrigerated Storage and Refrigerated 

Processing Control.” This control 

strategy should be applied to chilled 

(i.e., refrigerated, iced, and not 

frozen) storage and refrigerated 

(i.e., <40oF (4.4oC)) processing; 

•	 “Control Strategy Example 3 - Cooling 

After Cooking Control.” This control 

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 

handling during the cooling and 

there is a need to control sporeforming pathogenic bacteria; 

•	 “Control Strategy Example 4 - 

Unrefrigerated Processing Control.” 

This control strategy should be 

applied to unrefrigerated (i.e., 

≥40oF (4.4oC)) processing. 

Following is further guidance that may help 

you determine whether these processing 

steps should be identified as CCPs for this 

hazard. The guidance is divided into two 

types of finished products: cooked ready-toeat and raw ready-to-eat. 

•	 Cooked, ready-to-eat products 

These products may be cooked by the 

processor, received by the processor already 

cooked, or assembled by the processor from 

ready-to-eat components. They may appear 

to the consumer or end user to be ready-toeat products and may, therefore, be eaten 

without further cooking. Examples include: 

cooked crabmeat, lobster meat, and crayfish 

meat; surimi-based analog products; seafood 

salads; and hot-smoked fish. Note that 

smoked fish is also covered in Chapter 13, 

and cooking and pasteurization are covered 

in Chapter 16. 

Cooked, ready-to-eat products, especially 

assembled products, might develop pathogen 

hazards as a result of cross-contamination 

and growth. Contributing factors to this 

risk are manual handling steps, multiple 

ingredients, unrefrigerated processing, and 

multiple cooling steps. Cumulative exposure 

to time and temperature abuse after the 

cook step should be taken into consideration 

when establishing CCPs based on time and 

temperature. 

In some cases, refrigerated cooked, readyto-eat foods (e.g., lobster meat, pasteurized 

crabmeat, smoked fish, and surimi-based 

analog products) are received by a secondary 

processor and held for sale without further 

handling. In other cases, these products 

are received by a secondary processor and 

used as ingredients in a ready-to-eat product 

that will not be cooked or pasteurized by 

that processor (e.g., seafood salad). In these 

cases, the receiving and storage steps by the 

secondary processor should be designated 

as CCPs to control the hazard of pathogenic 

bacteria growth. On the other hand, if 

these ready-to-eat foods are received by the 

secondary processor to be used in a product 

that will be cooked or pasteurized by that 

processor, the receiving and storage steps 

before the cooking or pasteurization step 

might not need to be designated as CCPs, 

unless S. aureus or B. cereus toxin formation 

is a significant hazard. Remember that these 

toxins are not likely to be inactivated by heat. 

In still other cases, ready-to-eat foods are 

received by a secondary processor and 

used as ingredients in a non-ready-to-eat 

product (e.g., cooked octopus used by the 

processor as an ingredient in a seafood mix 

that is customarily eaten after cooking by the 

consumer or end user). Again, the receiving 

and storage steps might not need to be 

designated as CCPs, unless S. aureus or B. 

cereus toxin formation is a significant hazard. 

The need to establish a CCP at cooling after 

cooking or pasteurization depends on: 

•	 The severity of the cooking (including 

hot smoking) or pasteurization step; 

•	 The extent to which the product 

is handled between the end of the 

cooking or pasteurization step and 

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 

rice, spores of C. perfringens and B. cereus 

could be present, could survive the cooking 

process, and could grow and produce toxin 

in the product during cooling and subsequent 

handling. In fact, the heat from the cooking 

process might initiate growth of the surviving 

spores. In this case, a CCP may be needed 

at product cooling. However, some cooking 

processes might be adequate to kill even the 

spores of C. perfringens and B. cereus. In this 

case, a CCP at product cooling may not be 

necessary. 

When significant handling occurs after 

cooking or pasteurization, there is a risk 

that the product might be recontaminated 

with pathogenic bacteria. Because many of 

the normally occurring spoilage organisms 

may have been eliminated by the cooking 

or pasteurization process and are no longer 

present to compete with the pathogenic 

bacteria, rapid growth and toxin formation 

by the pathogenic bacteria are possible. It 

is advisable to fully cool a product before 

it is further handled, in order to minimize 

pathogenic bacteria growth and toxin 

formation. When significant handling occurs 

after the heating process but before the 

completion of the cooling process or when 

the cooked product comes into contact with 

equipment that was not heated along with 

the product, time and temperature exposure 

controls may need to start at that point. In 

some processes, cooling is performed (1) 

before any significant handling of the cooked 

product; and (2) in the same container 

in which the product was cooked. Under 

these conditions, cooling after cooking may 

not need to be identified as a CCP for this 

hazard. However, such a determination is 

dependent upon strict adherence to good 

sanitation practices to further minimize the 

risk of recontamination with pathogenic 

bacteria. 

Time and temperature controls may be 

needed at the following steps (CCPs): 

•	 Receiving; 

•	 Thawing; 

•	 Cooling after cooking; 

•	 Processing after cooking: 

Slicing hot-smoked salmon; ° 

Mixing seafood salad; ° 

Picking crabmeat; ° 

•	 Packaging; 

•	 In-process and finished product 

refrigerated (not frozen) storage. 

Time and temperature controls will usually 

not be needed at processing steps that meet 

the following conditions: 

•	 Continuous, mechanical 

processing steps that are brief: 

Mechanical size grading of cooked ° 

shrimp; 


Mechanical forming of surimi-based 
 ° 

analog products; 

Individual quick freezing; ° 

•	 Processing steps that are brief and 

unlikely to contribute significantly to 

the cumulative time and temperature 

exposure to unrefrigerated conditions: 

Date code stamping; ° 

Case packing; ° 

•	 Processing steps where the product 

is held in a frozen state:
 

Glazing;
 ° 

Assembly of orders for distribution; ° 

Frozen product storage; ° 

•	 Processing steps where the 

product is held at temperatures 

above 135°F (57.2°C): 

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 

These products are not heated during 

processing to a temperature that destroys 

pathogenic bacteria. They are often 

consumed without cooking. Examples 

include: cold-smoked fish, raw oysters, 

clams and mussels, and raw finfish (when 

the processor has knowledge or has reason 

to know that the product will be consumed 

without a process sufficient to kill pathogens 

of public health concern or where the 

processor represents, labels, or intends for 

the product to be so consumed). 

Like cooked, ready-to-eat products, raw 

ready-to-eat products may contain pathogenic 

bacteria as a result of near-shore harvest 

water contamination, poor aquaculture 

practices, or poor sanitary practices during 

harvesting, transportation, or processing. 

For example, oysters, especially those 

harvested during the warm weather 

months, might contain V. vulnificus or 

V. parahaemolyticus. Raw finfish might 

contain V. parahaemolyticus, Salmonella 

spp., or L. monocytogenes. Some of these 

pathogenic bacteria (e.g., V. vulnificus, V. 

parahaemolyticus, and L. monocytogenes) are 

capable of growth in raw fish. 

Time and temperature controls may be needed 

at the following processing steps (CCPs): 

•	 Receiving; 

•	 Processing: 


Thawing;
 ° 

Shucking; ° 

Portioning; ° 

•	 Packaging; 

•	 Raw material, in-process product,
 

and finished product refrigerated 


(not frozen) storage.
 

Time and temperature controls will usually 

not be needed at processing steps that meet 

the following conditions: 

•	 Continuous, mechanical 

processing steps that are brief: 

Mechanical filleting; ° 

•	 Processing steps that are brief and 

unlikely to contribute significantly to 

the cumulative time and temperature 

exposure to unrefrigerated conditions: 

Date code stamping; ° 

Case packing; ° 

•	 Processing steps where the product 

is held in a frozen state: 

Assembly of orders for distribution; ° 

Frozen storage. ° 

•	 Time and temperature profile 

Preparing a diagram that depicts the 

maximum times and temperatures at which 

your product will be exposed at each 

processing step may help you determine 

cumulative product exposure, especially if 

your product is cooked, ready-to-eat. This 

diagram can help you identify CCPs, as 

well as critical limits, as will be discussed 

later. Figures 12-1 and 12-2 are examples 

of time and temperature profiles for two 

different crabmeat processes. Although the 

figures show similar time and temperature 

profiles, they demonstrate how differences in 

processing operations, especially with respect 

to when significant handling occurs, can have 

an impact on the location of CCPs and on the 

critical limits at those CCPs. 

Figure 12-1 shows a time and temperature 

profile for a cooked crabmeat processor that 

significantly handles product before it is 

cooled to 50°F (10°C). As a result, a CCP is 

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 

profile for a cooked crabmeat processor that 

does not significantly handle product before 

it is cooled to 50°F (10°C). As a result, a CCP 

is not needed until the picking operation, 

which is the first point at which significant 

handling occurs. A more restrictive set of 

critical limits is also likely for the product 

depicted by Figure 12-1 than for that depicted 

by Figure 12-2, because the former product is 

handled while still warm. 

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. 

The following guidance provides examples of four 

control strategies for pathogenic bacteria growth 

and toxin formation. It may be necessary to select 

more than one control strategy in order to fully 

control the hazard, depending upon the nature of 

your operation. You may select a control strategy 

that is different from those which are suggested, 

provided it complies with the requirements of the 

applicable food safety laws and regulations. 

The following are examples of control strategies 

included in this chapter: 

CONTROL STRATEGY 

MAY APPLY TO 

PRIMARY 

PROCESSOR 

MAY APPLY TO 

SECONDARY 

PROCESSOR 

Transit control 

Refrigerated storage and 

refrigerated 

processing control 

 

Cooling after cooking 

control 

 

Unrefrigerated processing 

control 

 

•	 CONTROL STRATEGY EXAMPLE 1 - TRANSIT 

CONTROL (FOR REFRIGERATED (NOT FROZEN) 

COOKED, READY-TO-EAT OR RAW, READY-TOEAT FISHERY PRODUCTS TO BE STORED OR 

PROCESSED WITHOUT FURTHER COOKING) 

It may be necessary to select more than one 

control strategy in order to fully control the 

hazard, depending upon the nature of your 

operation. 

Set Critical Limits. 

•	 For fish or fishery products delivered 

refrigerated (not frozen): 

All lots received are accompanied by 

transportation records that show that the 

product was held at or below an ambient 

or internal temperature of 40°F (4.4°C) 

throughout transit. Note that allowance 

for routine refrigeration defrost cycles 

may be necessary; 

° 

OR 

•	 For products delivered under ice: 

Product is completely surrounded by ice 

at the time of delivery; 


° 

OR
 

•	 For products delivered under chemical 

cooling media, such as gel packs: 

There is an adequate quantity of cooling

media that remain frozen to have 

maintained the product at an internal 

temperature of 40°F (4.4°C) or below 

throughout transit; 

° 

AND 

The internal temperature of the product 

at the time of delivery is 40°F (4.4°C) or 

below; 

° 

OR 

•	 For products delivered refrigerated (not 

frozen) with a transit time (including all 

time outside a controlled temperature 

environment) of 4 hours or less (optional 

control strategy): 

Time of transit does not exceed 4 hours; ° 

AND 

Internal temperature of the product at 

the time of delivery does not exceed 

40°F (4.4°C). 

° 

Note: Processors receiving product with transit times of 4 hours or 

less may elect to use one of the controls described for longer transit 

times instead. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 For products delivered refrigerated (not 

frozen): 

The internal temperature of the product 

throughout transportation; 

° 

OR 

The ambient temperature within the 

truck or other carrier throughout 

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: 

The adequacy of ice surrounding the 

product at the time of delivery;
 

° 

OR
 

•	 For products held under chemical cooling 

media, such as gel packs: 

The quantity and frozen status of cooling 

media at the time of delivery; 

° 

AND 

The internal temperature of a 

representative number of product units at 

time of delivery; 

° 

OR 

•	 For products delivered refrigerated (not 

frozen) with a transit time of 4 hours or less: 

The date and time product was 

removed from a controlled temperature 

environment before shipment and the 

date and time delivered; 

° 

AND 

The internal temperature of a 

representative number of product 

containers (e.g., cartons and totes) at the 

time of delivery. 

° 

»	 How Will Monitoring Be Done? 

•	 For products delivered refrigerated (not 

frozen): 

Use a continuous temperature-recording 

device (e.g., a recording thermometer) 

for internal product temperature or 

ambient air temperature monitoring 

during transit; 

° 

OR 

•	 For products delivered under ice: 

Make visual observations of the 

adequacy of ice in a representative 

number of containers (e.g., cartons and 

totes) from throughout the shipment at 

delivery; 

° 

•	 For products delivered under chemical 

cooling media, such as gel packs: 


Make visual observations of the 


adequacy and frozen state of the cooling 


media in a representative number of 


containers (e.g., cartons and totes) from 


throughout the shipment at delivery;
 

° 

AND
 

Use a temperature-indicating device (e.g.,
 

a thermometer) to determine internal 

product temperatures in a representative 

number of product containers from 

throughout the shipment at delivery; 

° 

OR 

•	 For products delivered refrigerated (not 

frozen) with a transit time of 4 hours or less: 

Review carrier records to determine the 

date and time product was removed from 


a controlled temperature environment 


before shipment and the date and time 


delivered;
 

° 

AND
 

Use a temperature-indicating device (e.g.,
 

a thermometer) to determine internal 

product temperatures in a representative 

number of product containers (e.g., 

cartons and totes) randomly selected 

from throughout the shipment, at 

delivery. Measure a minimum of 12 

product containers, unless there are 

fewer than 12 products in a lot, in which 

case measure all of the containers. Lots 

that show a high level of temperature 

variability may require a larger sample 

size. 

° 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 Every lot received. 

»	 Who Will Do the Monitoring? 

•	 For continuous temperature-recording 

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 

itself. The visual check of the data 

generated by the device, to ensure that 

the critical limits have consistently been 

met, may be performed by any person 

who has an understanding of the nature 

of the controls; 

° 

OR 

•	 For other checks: 

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: 

•	 Chill and hold the affected product until an 

evaluation of the total time and temperature 

exposure is performed (a product with 

cumulative exposures that exceed the critical 

limits recommended in “Control Strategy 

Example 4 - Processing Controls” should be 

cooked or diverted to a use in which the 

critical limit is not applicable (e.g., divert 

crabmeat to a stuffed flounder operation), 

after giving consideration to the fact that 

any S. aureus or B. cereus toxin that may be 

present may not be inactivated by heat, or 

destroyed or diverted to a non-food use); 

OR 

•	 Cook the product, after giving consideration 

to the fact that any S. aureus or B. cereus 

toxin that may be present may not be 

inactivated by heat; 

OR 

•	 Divert the product to a use in which the 

critical limit is not applicable (e.g., divert 

crabmeat to a stuffed flounder operation), 

after giving consideration to the fact that 

any S. aureus or B. cereus toxin that may be 

present may not be inactivated by heat; 

OR 

•	 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 or carrier 

until evidence is obtained that the identified 

transportation- handling practices have been 

improved. 

Establish a Recordkeeping System. 

•	 Receiving records showing: 

The results of continuous temperature 

monitoring, including: 

° 

•	 Printouts, charts, or readings from 

temperature-recording devices; 

AND 

•	 Visual check of recorded data;
 

OR
 

The results of ice checks, including:
 ° 

•	 The number of containers (e.g., 

cartons and totes) examined and 

the sufficiency of ice for each; 

AND 

•	 The number of containers (e.g., 

cartons and totes) in the lot; 

OR
 

The results of chemical media checks,


including: 

° 

•	 The number of containers (e.g., 

cartons and totes) examined and the 

frozen status of the media for each; 

AND 

•	 The number of units in the lot; 

AND/OR 

The results of internal product 

temperature monitoring, including: 

° 

•	 The number of containers (e.g., 

cartons and totes) examined 

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 

•	 The number of containers (e.g., 

cartons and totes) in the lot; 

AND 

•	 Date and time product was 

initially removed from a controlled 

temperature environment and 

date and time product was 

delivered, when applicable. 

Establish Verification Procedures. 

•	 Before a temperature-indicating device (e.g., 

a thermometer) is put into service, check 

the accuracy of the device to verify that the 

factory calibration has not been affected. 

This check can be accomplished by: 

Immersing the sensor in an ice slurry 

(32°F (0°C)) if the device will be used at 

or near refrigeration temperature; 

° 

OR 

Comparing the temperature reading on 

the device to the reading on a known 

accurate reference device (e.g., a 

thermometer traceable to standards of 

the National Institute of Standards and 

Technology (NIST)) 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 temperatureindicating device daily before the beginning of 

operations. Less frequent accuracy checks may 

be appropriate if they are recommended by 

the instrument manufacturer and if 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 

•	 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 

the device with the reading on a known 

accurate reference device (e.g., a NISTtraceable thermometer) under conditions that 

are similar to how it will be used (e.g., air 

temperature) within the temperature range at 

which it will be used; 

AND 

•	 When visual checks of ice or cooling media 

are used, periodically measure internal 

temperatures of fish to ensure that the ice 

or cooling media are 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 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 

223 
CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 

224 

TABLE 12-1

CONTROL STRATEGY EXAMPLE 1 - TRANSIT CONTROL

This table is an example of a portion of a HACCP plan using “Control Strategy Example 1 - Transit Control.” This example illustrates how a processor receiving pasteurized crabmeat can control pathogenic bacteria growth and toxin formation as a result of time and temperature abuse during transit. It is provided for illustrative purposes only. It may be necessary to select more than one control strategy in order to fully control the 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 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides, pathogen survival through cooking and pasteurization, and metal fragments).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Receiving 

pasteurized

crabmeat 

Pathogenic 

bacteria growth 

and toxin 

formation 

All lots received 

are

accompanied

by truck 

records that

show 

temperature 

was maintained 

at or below 

40°F 

Temperature 

of truck 

refrigerated 

compartment 

Digital time and

temperature 

data logger 

Continuous,

with visual

review and 

evaluation of 

temperature 

monitoring

records for each 

shipment 

Receiving 

employee 

Reject the 

shipment

Discontinue use

of the

supplier or

carrier until 

evidence is 

obtained that

the identifi ed 

transportationhandling

practices have 

been improved 

Data

logger printout 

Check

accuracy of the 

temperature 

data logger

upon

receipt of each

lot

Review 

monitoring,

corrective 

action, and 

verification 

records within

1 week of 

preparation 
•	 CONTROL STRATEGY EXAMPLE 2 - REFRIGERATED 

STORAGE AND REFRIGERATED PROCESSING 

CONTROL 

It may be necessary to select more than one 

control strategy in order to fully control the 

hazard, depending upon the nature of your 

operation. 

Set Critical Limits. 

•	 For refrigerated (not frozen) storage or 

processing of the raw material, in-process 

product, or finished product: 

The product is held at a cooler ambient 

air temperature of 40°F (4.4°C) or 

below. Note that allowance for routine 

refrigeration defrost cycles may be 

necessary. On the other hand, minor 

variations in cooler temperature 

measurements can be avoided 

by submerging the sensor for the 

temperature-recording device (e.g., a 

recording thermometer) in a liquid that 

mimics the characteristics of the product. 

Also note that critical limits during 

refrigerated storage and refrigerated 

processing that specify a cumulative 

time and temperature of exposure to 

temperatures above 40°F (4.4°C) are not 

ordinarily suitable to control the hazard 

because of the difficulty in tracking 

the specific products and the specific 

cumulative temperature exposures 

that those products experience. The 

cumulative exposure for each product 

would need to be determined prior to 

shipping. If you chose this approach, 

the critical limit for cumulative exposure 

to temperatures above 40°F (4.4°C) 

should include time during transit, 

refrigerated storage, and refrigerated and 

unrefrigerated processing; 

° 

OR 

•	 For raw material, in-process product, or 

finished product stored under ice: 


The product is completely and 


continuously surrounded by ice 

throughout the storage time. 

° 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 For refrigerated storage or processing: 

The ambient air temperature of the 

cooler or refrigerated processing room; 

° 

OR 

•	 For storage under ice: 

The adequacy of ice surrounding the 

product. 

° 

»	 How Will Monitoring Be Done? 

•	 For refrigerated storage or processing: 

Use a continuous temperature-recording 

device (e.g., a recording thermometer); 

° 

OR 

•	 For storage under ice: 

Make visual observations of the 

adequacy of ice in a representative 

number of containers (e.g., cartons and 

totes) from throughout the cooler. 

° 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 For continuous temperature recording 

devices: 

Continuous monitoring by the device 

itself, with a visual check of the recorded 

data at least once per day; 

° 

OR 

•	 For storage under ice: 

Sufficient frequency to ensure the critical 

limit is met. 

° 

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? 

•	 For continuous temperature-recording 

devices: 

Monitoring is performed by the device 

itself. The visual check of the data 

generated by the device, to ensure that 

the critical limits have consistently been 

met, may be performed by any person 

who has an understanding of the nature 

of the controls; 

° 

OR 

•	 For other checks: 

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: 

•	 Chill and hold the affected product 

until an evaluation of the total time and 

temperature exposure is performed. A 

product with cumulative exposures that 

exceed the critical limits recommended in 

“Control Strategy Example 4 - Unrefrigerated 

Processing Controls,” should be cooked or 

diverted to a use in which the critical limit 

is not applicable (e.g., divert crabmeat to 

a stuffed flounder operation), after giving 

consideration to the fact that any S. aureus 

or B. cereus toxin that may be present may 

not be inactivated by heat, or destroyed or 

diverted to a non-food use; 

OR 

•	 Cook the product, after giving consideration 

to the fact that any S. aureus or B. cereus 

toxin that may be present may not be 

inactivated by heat; 

OR 

•	 Divert the product to a use in which the 

critical limit is not applicable (e.g., divert 

crabmeat to a stuffed flounder operation), 

after giving consideration to the fact that 

any S. aureus or B. cereus toxin that may be 

present may not be inactivated by heat; 

OR 

•	 Destroy the product; 

OR 

•	 Divert the product to a non-food use. 

AND 

Take the following corrective actions to regain control 

over the operation after a critical limit deviation: 

•	 Prevent further deterioration of the product: 

Add ice to the product; ° 

OR 

Move some or all of the product in the 

malfunctioning cooler to another cooler;
 

° 

OR
 

Freeze the product;
 ° 

AND 

•	 Address the root cause: 

Make repairs or adjustments to the 

malfunctioning cooler; 

° 

OR 

Make adjustments to the ice application 

operations. 

° 

Establish a Recordkeeping System. 

•	 For refrigerated storage: 

Printouts, charts, or readings from 

continuous temperature-recording devices;
 

° 

AND
 

Record of visual checks of recorded data;
 ° 

OR 

•	 For storage under ice: 

The results of ice checks: ° 

•	 The number of containers (e.g., 

cartons and totes) examined and 

the sufficiency of ice for each; 

AND 

•	 The approximate number 

of containers (e.g., cartons 

and totes) in the cooler. 

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

226 
Establish Verification Procedures. 

•	 Before a temperature-recording device (e.g., 

a recording thermometer) is put into service, 

check the accuracy of the device to verify 

that the factory calibration has not been 

affected. This check can be accomplished by: 

Immersing the sensor in an ice slurry 

(32°F (0°C)) if the device will be used at 

or near refrigeration temperature; 

° 

OR 

Comparing the temperature reading 

on the device with the reading on a 

known accurate reference device (e.g., 

a NIST-traceable thermometer) under 

conditions that are similar to how it will 

be used (e.g., air temperature) within 

the temperature range at which it will be 

used; 

° 

AND 

•	 Once in service, check the temperaturerecording 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. 

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

227 
CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 

228 

TABLE 12-2

CONTROL STRATEGY EXAMPLE 2 - REFRIGERATED STORAGE 

AND REFRIGERATED PROCESSING CONTROL

(ICING MODEL)

This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Refrigerated Storage and Refrigerated Processing Control (Icing Model).” This example illustrates how a blue crabmeat processor can control pathogenic bacteria growth and toxin formation as a result of time and temperature abuse during icing. It is provided for illustrative purposes only. It may be necessary to select more than one control strategy in order to fully control the 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 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides, pathogen survival through cooking and pasteurization, and metal fragments). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Finished

product cooler 

Pathogenic 

bacteria growth 

and toxin 

formation 

Finished

product 

containers

completely

surrounded 

with ice 

Adequacy of ice Visual 

observation 

Each case

immediately

before 

shipping 

Production 

employee 

Re-ice the 

product

Hold and

evaluate 

based on

total time and

temperature 

exposure 

Ice storage 

record 

Check internal 

temperature of 

iced crabmeat 

weekly

Review 

monitoring,

corrective 

action, and 

verification 

records within

1 week of 

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

229 

TABLE 12-3

CONTROL STRATEGY EXAMPLE 2 - REFRIGERATED STORAGE 

AND REFRIGERATED PROCESSING CONTROL

(REFRIGERATION MODEL)

This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Refrigerated Storage and Refrigerated Processing Control (Refrigeration Model).” This example illustrates how a blue crabmeat processor can control pathogenic bacteria growth and toxin formation as a result of time and temperature abuse during 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 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides, pathogen survival through cooking and pasteurization, and metal fragments). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Finished

product cooler 

Pathogenic 

bacteria growth 

and toxin 

formation 

Cooler

maintained

at or below 

40°F 

Cooler

temperature 

Digital time and

temperature 

data logger 

Continuous,

with visual

check of

recorded data

once per day 

Production 

employee 

Move to 

alternate cooler 

and/or add ice

Hold and

evaluate based 

on total time

and

temperature 

exposure 

Data

logger printout

Record or visual 

checks 

Check the

data logger for 

accuracy and 

damage and to

ensure that it

is operational 

before putting 

into operation; 

check it

daily, at the 

beginning of

operations; and 

calibrate it once 

per year 

Review 

monitoring,

corrective 

action, and 

verification 

records within

1 week of 

preparation 
•	 CONTROL STRATEGY EXAMPLE 3 - COOLING 

AFTER COOKING CONTROL 

It may be necessary to select more than one 

control strategy in order to fully control the hazard, 

depending upon the nature of your operation. 

Set Critical Limits. 

•	 The product is cooled from 135°F (57.2°C) to 

70°F (21.1°C) within 2 hours; 

AND 

•	 The product is further cooled from 135°F 

(57.2°C) to 40°F (4.4°C) within an additional 

4 hours; 

OR 

•	 The minimum or maximum values for the 

critical factors of the process that affect the 

rate of cooling, as established by a cooling 

rate study (e.g., product internal temperature 

at the start of cooling, cooler temperature, 

quantity of ice, quantity or size of the 

product being cooled, product formulation, 

configuration of the product in the cooler). 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 The length of the cooling cycle and the 

internal temperature of the product; 

OR 

•	 The critical factors of the process that affect 

the rate of cooling, as established by a 

cooling rate study. 

»	 How Will Monitoring Be Done? 

•	 Clock; 

AND 

•	 Use a temperature-indicating device (e.g., a 

thermometer) and visual check on time of 

cooling; 

OR 

•	 Use a continuous temperature-recording device 

(e.g., time and temperature data logger); 

OR 

•	 Use appropriate instruments (e.g., a 

temperature-indicating device, such as a 

thermometer, a continuous temperaturerecording device, such as a time and 

temperature data logger, a scale) and/or 

visual observations as necessary to measure 

the critical factors of the process that affect 

the rate of cooling, as established by a 

cooling rate study. 

Example: 

A crayfish processor identifies cooling 

after the cook step as a CCP for 

pathogenic bacteria growth and toxin 

formation. The processor establishes a 

cooling critical limit of no more than 

2 hours from 135°F (57.2°C) to 70°F 

(21.1°C) and no more than 4 more 

hours from 70°F (21.1°C) to 40°F 

(4.4°C). The processor uses marked 

batches of cooked product to monitor 

the cooling process. The time that the 

marked batch is removed from the 

cooker is monitored visually, and the 

internal temperature of the product in 

that batch 2 hours after cooking and 4 

more hours after cooking is monitored 

with a dial thermometer. 

Example: 

Another crayfish processor has similarly 

identified cooling after cooking as 

a CCP and has established the same 

critical limit. The processor uses a 

digital time and temperature data logger 

to monitor the cooling rate of the cooked 

product. 

Example: 

Another crayfish processor has similarly 

identified cooling after cooking as a CCP. 

This processor has performed a cooling 

rate study that determined that a cooling 

rate of no more than 2 hours from 135°F 

(57.2°C) to 70°F (21.1°C) and no more 

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 

process. The study determined that the 

following critical limits must be met: 

a cooler temperature of no more than 

60°F (15.6°C) during the first 2 hours of 

cooling and no more than 40°F (4.4°C) 

during the remainder of cooling; and 

no more than 1,000 pounds of crayfish 

in the cooler. The processor monitors 

the cooler temperature with a recording 

thermometer and monitors the weight of 

the product at receiving with a scale. 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 For temperature-indicating devices: 

At least every 2 hours; ° 

OR 

•	 For temperature-recording devices: 

At least every 2 hours a device is placed 

in the product. It provides continuous 

monitoring, which is visually checked at 

the end of the cooling period; 

° 

OR 

•	 For critical aspects of the cooling process: 

As often as necessary to ensure control 

of the process. 

° 

»	 Who Will Do the Monitoring? 

•	 For temperature-recording devices: 

Monitoring is performed by the device 

itself. The visual check of the data 

generated by the device, to ensure that 

the critical limits have consistently been 

met, may be performed by any person 

who has an understanding of the nature 

of the controls; 

° 

OR 

•	 For other checks: 

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: 

•	 Recook the product, after giving 

consideration to the fact that any S. aureus 

toxin that may be present may not be 

inactivated by heat; 

OR 

•	 Divert the product to a use in which the 

critical limit is not applicable (e.g., divert 

crabmeat to a stuffed flounder operation), 

after giving consideration to the fact that any 

B. cereus toxin that may be present may not 

be inactivated by heat; 

OR 

•	 Destroy the product; 

OR 

•	 Divert the product to a non-food use. 

AND 

Take the following corrective actions to regain control 

over the operation after a critical limit deviation: 

•	 Prevent further deterioration of the product: 

Add ice to the product; ° 

AND 

•	 Address the root cause: 

Make repairs or adjustments to the 

malfunctioning cooler;
 

° 

OR
 

•	 Make adjustments to the ice application 

operation. 

Establish a Recordkeeping System. 

•	 For temperature-indicating devices: 

Cooling records showing the internal 

temperature of the product, and the 

length of time between the end of the 

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 

•	 For temperature-recording devices: 

° Record of continuous temperature 

monitoring; 

AND 

° Record of visual checks of recorded data; 

OR 

•	 For the critical factors of the process that 

affect the rate of cooling, as established by a 

cooling rate study: 

Appropriate records (e.g., processing 

record showing the results of the time 

and temperature checks and/or volume 

of product in cooler). 

° 

Establish Verification Procedures. 

•	 Before a temperature-indicating device (e.g., 

a thermometer) or temperature- recording 

device (e.g., a time and temperature data 

logger) is put into service, check the 

accuracy of the device to verify that the 

factory calibration has not been affected. 

This check can be accomplished by: 

Immersing the sensor in an ice slurry 

(32°F (0°C)) if the device will be used at 

or near refrigeration temperature; 

° 

OR 

Immersing the sensor in boiling water 

(212°F (100°C)) if the device will be used 

at or near the boiling point. Note that 

the temperature should be adjusted to 

compensate for altitude, when necessary; 

° 

OR 

Doing a combination of the above if 

the device will be used at or near room 

temperature; 

° 

OR 

Comparing the temperature reading on 

the device with the reading on a known 

accurate reference device (e.g., a NISTtraceable thermometer) 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 temperatureindicating device or 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 

•	 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 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 

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

232 
CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 

233 

TABLE 12-4

CONTROL STRATEGY EXAMPLE 3 - COOLING AFTER COOKING CONTROL

This table is an example of a portion of a HACCP plan using “Control Strategy Example 3 - Cooling After Cooking Control.” This example illustrates how a dungeness crabmeat processor can control pathogenic bacteria growth and toxin formation as a result of time and temperature abuse during cooling after cooking. In this case, the product is fully cooled, i.e., to 40°F (4.4°C), after cooking before significant handling. It is provided for illustrative purposes only. It may be necessary to select more than one control strategy in order to fully control the 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 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides, pathogen survival through cooking and pasteurization, and metal fragments). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Cooked crab 

cooler 

Pathogenic 

bacteria growth 

and toxin 

formation 

Crabs cooled 

from 135°F to

70°F in 2 hours

and 70°F to

40°F in 4 more

hours 

Length of 

cooling cycle 

Clock Start marked 

batch

Approximately 

every 2 hours 

during cooking 

Production 

supervisor 

Destroy product

Make 

adjustment

or repairs to

cooler 

Production 

record 

Check the dial

thermometer 

for accuracy 

and damage

and to ensure

that it is

operational 

before putting 

into operation; 

check it

daily, at the 

beginning of

operations; and 

calibrate it once 

per year

Review 

monitoring,

corrective 

action, and 

verification 

records within

1 week of 

preparation 

Cooked 

crab internal 

temperature 

Dial

thermometer in 

marked batches 

of cooked crabs

Note: Control during unrefrigerated processing is covered under “Control Strategy Example 4 - Unrefrigerated Processing Control.”Note: Control is necessary at this step because the processor has not established that the cook step is adequate to kill the spores of C. perfringens or B. cereus 
•	 CONTROL STRATEGY EXAMPLE 4 - 

UNREFRIGERATED PROCESSING CONTROL 

It may be necessary to select more than one 

control strategy in order to fully control the 

hazard, depending upon the nature of your 

operation. 

Set Critical Limits. 

The following recommended critical limits are 

intended to keep the pathogenic bacteria of 

greatest concern in fish and fishery products 

from reaching the rapid growth phase (i.e., 

keep them in the lag phase) as a result of time 

and temperature exposure during processing. 

You may also wish to reference Table A-2 

(Appendix 4), which provides cumulative time 

and temperature combinations for the pathogenic 

bacteria individually. 

For raw, ready-to-eat products: 

•	 CRITICAL LIMIT 1: 

If at any time the product is held at 

internal temperatures above 70°F 

(21.1°C), exposure time (i.e., time at 

internal temperatures above 50°F (10°C) 

but below 135oF (57.2oC)) should be 

limited to 2 hours (3 hours if S. aureus is 

the only pathogen of concern), 

° 

OR 

Alternatively, exposure time (i.e., time at 

internal temperatures above 50°F (10°C) 

but below 135oF (57.2oC)) should be 

limited to 4 hours, as long as no more 

than 2 of those hours are between 70°F 

(21.1°C) and 135oF (57.2oC); 

° 

OR 

•	 CRITICAL LIMIT 2: 

If at any time the product is held at 

internal temperatures above 50°F (10°C) 

but never above 70°F (21.1°C), exposure 

time at internal temperatures above 50°F 

(10°C) should be limited to 5 hours (12 

hours if S. aureus is the only pathogen of 

concern); 

° 

OR 

•	 CRITICAL LIMIT 3: 

The product is held at internal 

temperatures below 50°F (10°C) 


throughout processing,
 

° 

OR
 

Alternatively, the product is held at 


ambient air temperatures below 50°F 

(10°C) throughout processing. 

° 

For cooked, ready-to-eat products: 

Note: The critical limits for cooked, ready-to-eat products are 

intended to begin at the completion of cooling or at the time that the 

product is first significantly handled after cooking, whichever occurs 

first. 

•	 CRITICAL LIMIT 1: 

If at any time the product is held at 

internal temperatures above 80°F 

(26.7°C), exposure time (i.e., time at 

internal temperatures above 50°F (10°C) 

but below 135oF (57.2oC)) should be 

limited to 1 hour (3 hours if S. aureus is 

the only pathogen of concern), 

° 

OR 

Alternatively, if at any time the product 

is held at internal temperatures above 

80°F (26.7°C), exposure time (i.e., time at 

internal temperatures above 50°F (10°C) 

but below 135oF (57.2oC)) should be 

limited to 4 hours, as long as no more 

than 1 of those hours is above 70°F 

(21.1°C); 

° 

OR 

•	 CRITICAL LIMIT 2: 

If at any time the product is held at 

internal temperatures above 70°F 

(21.1°C) but never above 80°F (26.7°C), 

exposure time at internal temperatures 

above 50°F (10°C) should be limited to 

2 hours (3 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 

Alternatively, if the product is never 

held at internal temperatures above 

80°F (26.7°C), exposure times at internal 

temperatures above 50°F (10°C) should 

be limited to 4 hours, as long as no more 

than 2 of those hours are above 70°F 

(21.1°C); 

° 

OR 

•	 CRITICAL LIMIT 3: 

If at any time the product is held at 

internal temperatures above 50°F (10°C) 

but never above 70°F (21.1°C), exposure 

time at internal temperatures above 50°F 

(10°C) should be limited to 5 hours (12 

hours if S. aureus is the only pathogen of 

concern); 

° 

OR 

•	 CRITICAL LIMIT 4: 

The product is held at internal 

temperatures below 50°F (10°C) 


throughout processing,
 

° 

OR
 

Alternatively, the product is held at 


ambient air temperatures below 50°F 

(10°C) throughout processing. 

° 

Note: The preceding recommended critical limits do not address 

internal product temperatures between 40°F (4.4°C), the 

recommended maximum storage temperature for refrigerated 

fish and fishery products, and 50°F (10°C). The recommended 

critical limits do not address such temperatures because growth of 

foodborne pathogenic bacteria is very slow at these temperatures 

and the time necessary for significant growth is longer than would be 

reasonably likely to occur in most fish and fishery product processing 

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: 

Example: 

A crabmeat processor using a retort process 

identifies a series of post-cook processing 

steps (e.g., backing, picking, and packing) 

as CCPs for pathogenic bacteria growth 

and toxin formation. Initial cooling takes 

place in the cooking crates and then the 

product is first handled at temperatures of 

around 120°F (48.9°C). The processor sets a 

critical limit of maximum cumulative time 

of exposure of 4 hours at product internal 

temperatures above 50°F (10°C), no more 

than 1 of which is above 70°F (21.1°). This 

critical limit is selected because the crabs 

are handled while still warm (e.g., above 

80°F (26.7°C)). Cooling that takes place 

after the product is handled is included in 

the limit. 

Example: 

Another crabmeat processor using a retort 

process also identifies a series of post-cook 

processing steps (e.g., backing, picking, 

and packing) as CCPs. However, this 

product is cooled fully before handling, 

and ice is used on the product during 

processing to control time and temperature 

abuse. The processor sets a critical limit of 

a maximum product internal temperature 

of 50°F (10°C) at all times. Specifying a 

time of exposure is not necessary in this 

case, because it is not reasonably likely 

that the product would be held long 

enough that significant pathogen growth 

could occur at this temperature (e.g., 2 to 

21 days, depending upon the pathogen). 

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

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

236 

TABLE 12-5 

CUMULATIVE TIME AND TEMPERATURE CRITICAL LIMITS 

WHEN THE PRODUCT INTERNAL 

TEMPERATURE RANGE IN oF (oC) IS... 

THEN THE CUMULATIVE EXPOSURE TIME AT INTERNAL

 TEMPERATURES ABOVE 50°F (10°C) IN HOURS IS1... 

1 2 3 5 12 

RAW, READY TO EAT 

>503 

(>10) 

X X2 

Alternatively, 

>50 to ≤ 70 

(>10 to ≤ 21.1) 

X 

Plus 

>70 

(>21.1) 

X 

Alternatively, 

>50 to ≤ 70 

(>10 to ≤ 21.1) 

X 

Plus 

>70 

(>21.1) 

X 

>50 to ≤ 70 

(>10 to ≤21.1) 

X X2 

COOKED, READY TO EAT 

>504 

(>10) 

X X2 

Alternatively, 

>50 to ≤ 70 

(>10 to ≤ 21.1) 

X 

Plus 

>704 

(>21.1) 

X 

>50 to ≤ 80 

(>10 to ≤ 26.7) 

X X2 

Alternatively, 

>50 to ≤ 70 

(>10 to ≤ 21.1) 

X 

Plus 

>70 to <80 

(>21.1 to <26.7) 

X 

Alternatively, 

>50 to ≤ 70 

(>10 to ≤ 21.1) 

X 

Plus 

>70 to <80 

(>21.1 to <26.7) 

X 

>50 to ≤ 70 

(>10 to ≤ 21.1) 

X X2 

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). 
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 

unrefrigerated conditions (i.e., above 40°F 

(4.4°C)); 

The product internal temperature during 

the exposure period; 

° 

OR 

The ambient temperature of the 

processing area;
 

° 

OR
 

•	 The length of time only of product exposure 

to unrefrigerated conditions (i.e., >40°F 

(4.4°C)), for critical limit 1 (raw, ready-to-eat 

and cooked, ready-to-eat); 

OR 

•	 The internal temperature only of the 

product, when internal temperatures are held 

below 50°F (10°C) or above 135°F (57.2°C) 

throughout processing for critical limit 3 

for raw, ready-to-eat or critical limit 4 for 

cooked, ready-to-eat; 

OR 

•	 The ambient air temperature only, when 

ambient air temperature is held below 50°F 

(10°C) throughout processing for critical limit 

3 for raw, ready-to-eat or critical limit 4 for 

cooked, ready-to-eat. 

»	 How Will Monitoring Be Done? 

•	 For product internal temperature or ambient 

air temperature: 

Use a temperature-indicating device (e.g., 

a thermometer);
 

° 

OR
 

•	 For ambient air temperature: 

Use a continuous temperature-recording 

device (e.g., a recording thermometer); 

° 

AND/OR 

Example: 

A crabmeat processor identifies a 

series of processing steps (e.g., backing, 

picking, and packing) as CCPs for 

pathogenic bacteria growth. The processor 

establishes a critical limit of no more 

than 1 cumulative hour of exposure to 

unrefrigerated temperature during these 

processing steps (Critical Limit 1). The 

processor uses marked product containers 

to monitor the progress of the product 

through the three processing steps. The 

time that the marked container is removed 

from and returned to refrigeration is 

monitored using a clock. 

Example: 

Another crabmeat processor with identical 

CCPs establishes a more complex set of 

critical limits: no more than 4 cumulative 

hours with product internal temperatures 

above 50°F (10°C), with no more than 

1 of those hours above 70°F (21.1°C) 

(Critical Limit 1 Alternative). This 

processor also uses marked containers 

to monitor the progress of the product 

through the process. However, in addition 

to monitoring time using a clock, the 

processor also monitors product internal 

temperature for the marked containers 

using a thermometer. This monitoring 

technique provides the processor more 

flexibility in processing but requires more 

monitoring effort. 

Example: 

A lobster meat processor identifies the 

meat removal process as a CCP for 

pathogenic bacteria growth. The operation 

is performed under near-refrigeration 

conditions (<50°F (10°C)) (Critical Limit 

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)? 

•	 For continuous temperature-recording 

devices: 

Continuous monitoring during processing

is accomplished by the device itself, with 

a visual check of the recorded data at 

least once per day; 

° 

OR 

•	 For temperature-indicating devices and 

clocks:
 

At least every 2 hours;
 ° 

OR
 

Every batch.
 ° 

»	 Who Will Do the Monitoring? 

•	 For continuous temperature recording 

devices: 

Monitoring is performed by the device 

itself. The visual check of the data 

generated by the device, to ensure that 

the critical limits have consistently been 

met, may be performed by any person 

who has an understanding of the nature 

of the controls; 

° 

OR 

•	 For temperature-indicating devices and 

clocks: 

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: 

•	 Chill and hold the affected product until an 

evaluation of the total time and temperature 

exposure is performed; 

OR 

•	 Cook the product, after giving consideration 

to the fact that any S. aureus or B. cereus 

toxin that may be present may not be 

inactivated by heat; 

OR 

•	 Divert the product to a use in which the 

critical limit is not applicable (e.g., divert 

crabmeat to a stuffed flounder operation), 

after giving consideration to the fact that 

any S. aureus or B. cereus toxin that may be 

present may not be inactivated by heat; 

OR 

•	 Destroy the product; 

OR 

•	 Divert the product to a non-food use. 

AND 

Take the following corrective actions to regain control 

over the operation after a critical limit deviation: 

•	 Add ice to the product; 

OR 

•	 Return the affected product to the cooler; 

AND 

•	 Modify the process as needed to reduce the 

time and temperature exposure. 

Establish a Recordkeeping System. 

•	 Processing records showing the results of time 

and/or temperature exposure measurements. 

Establish Verification Procedures. 

•	 Before a temperature-indicating device (e.g., 

a thermometer) or temperature-recording 

device (e.g., a recording thermometer) is 

put into service, check the accuracy of the 

device to verify that the factory calibration 

has not been affected. This check can be 

accomplished by: 

Immersing the sensor in an ice slurry 

(32°F (0°C)) if the device will be used at 

or near refrigeration temperature; 

° 

OR 

Immersing the sensor in boiling water 

(212°F (100°C)) if the device will be used 

at or near the boiling point. Note that 

the temperature should be adjusted to 

compensate for altitude, when necessary; 

° 

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

238 
OR 

Doing a combination of the above if 

the device will be used at or near room 

temperature; 

° 

OR 

Comparing the temperature reading on 

the device with the reading on a known 

accurate reference device (e.g., a NISTtraceable thermometer) under conditions 

that are similar to how it will be used 

(e.g., air temperature and product internal 

temperature) within the temperature 

range at which it will be used; 

° 

AND 

•	 Once in service, check the temperatureindicating device or 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-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 

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 

•	 Where appropriate to the critical limit, by 

using a study that establishes the relationship 

between exposure time and product 

temperature; 

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

239 
CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse 

240 

TABLE 12-6

CONTROL STRATEGY EXAMPLE 4 - UNREFRIGERATED PROCESSING CONTROL

This table is an example of a portion of a HACCP plan using “Control Strategy Example 4 - Unrefrigerated Processing Control.” This example illustrates how a blue crabmeat processor that handles the crabs at the beginning of backing while still hot can control pathogenic bacteria growth and toxin formation as a result of time and temperature abuse during unrefrigerated processing. It is provided for illustrative purposes only. It may be necessary to select more than one control strategy in order to fully control the 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 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides, pathogen survival through cooking and pasteurization, and metal fragments). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Backing,

in-process

cooler, picking,

and packing 

Pathogenic

bacteria growth 

and toxin 

formation 

Exposure time

(i.e., time

 at internal 

temperatures 

above 50°F 

but below 

135oF) during

backing, inprocess cooler,

picking, and 

packing should

be limited to 4

hours, as long 

as no more

than 1 of those

hours is above 

70°F 

The length of 

time of product 

exposure to 

unrefrigerated 

conditions (i.e.,

above 40°F) 

Visual 

observation 

of marked 

containers

using a clock 

Start marked 

container

approximately 

every 2 hours 

during backing,

in-process

cooler, picking,

and packing 

Production 

supervisor 

Immediately

ice product or 

move to cooler

Hold and

evaluate 

based on

total time and

temperature 

exposure 

Production 

record 

Check the dial

thermometer for 

accuracy and 

damage and to

ensure that it

is operational 

before putting 

into operation; 

check it daily, at 

the beginning of

operations; and 

calibrate it once 

per year

Review 

monitoring,

verification, and 

corrective action 

records within

1 week of 

preparation 

The product 

internal 

temperature 

during the

exposure 

period 

Dial

thermometer

Note: Control during refrigerated storage is covered under “Control Strategy Example 2 - Refrigerated Storage and Refrigerated Processing Control.Note: This critical limit is necessary because the crabs are handled at internal temperatures above 80°F during backing 
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We have placed the following references on 

display in the Division of Dockets Management, 

Food and Drug Administration, 5630 Fishers Lane, 

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them at that location between 9 a.m. and 4 p.m., 

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FDA had verified the Web site address for the 

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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 

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. 

Clostridium botulinum (C. botulinum) toxin 

formation can result in consumer illness and 

death. It is the toxin responsible for botulism. 

About 10 outbreaks of foodborne botulism occur 

annually in the United States, from all sources. 

Symptoms include: weakness, vertigo, double 

vision, difficulty in speaking, swallowing and 

breathing, abdominal swelling, constipation, 

paralysis, and death. Symptoms start from 18 

hours to 36 hours after consumption. Everyone 

is susceptible to intoxication by C. botulinum 

toxin; only a few micrograms of the toxin can 

cause illness in a healthy adult. Mortality is high; 

without the antitoxin and respiratory support, 

death is likely. 

This chapter covers the hazard of C. botulinum 

growth and toxin formation as a result of time and 

temperature abuse during processing, storage, and 

distribution. 

•	 Strategies for controlling pathogen growth 

There are a number of strategies for the control 

of pathogens in fish and fishery products. They 

include: 

•	 Controlling the level of acidity (pH) in the 

product (covered by the Acidified Foods 

regulation, 21 CFR 114, for shelf-stable 

acidified products, and by this chapter for 

refrigerated acidified products); 

•	 Controlling the amount of salt or 

preservatives, such as sodium nitrite, in the 

product (covered in this chapter); 

•	 Controlling the amount of moisture that is 

available for pathogenic bacteria growth 

(water activity) in the product by formulation 

(covered in this chapter); 

•	 Controlling the amount of moisture that is 

available for pathogenic bacteria growth 

(water activity) in the product by drying 

(covered in Chapter 14); 

•	 Controlling the introduction of pathogenic 

bacteria after the pasteurization process 

and after the cooking process performed 

immediately before reduced oxygen packaging 

(covered in Chapter 18); 

•	 Controlling the source of molluscan shellfish 

and the time from exposure to air (e.g., by 

harvest or receding tide) to refrigeration 

to control pathogens from the harvest area 

(covered in Chapter 4); 

•	 Managing the amount of time that food is 

exposed to temperatures that are favorable 

for pathogenic bacteria growth and toxin 

production (covered generally in Chapter 

12; for C. botulinum, in this chapter; and for 

Staphylococcus aureus (S. aureus) in hydrated 

batter mixes, in Chapter 15); 

•	 Killing pathogenic bacteria by cooking or 

pasteurization (covered in Chapter 16), or 

retorting (covered by the Thermally Processed 

Low-Acid Foods Packaged in Hermetically 

Sealed Containers regulation, 21 CFR 113 

(hereinafter, the Low-Acid Canned Foods 

(LACF) Regulation)); 

•	 Killing pathogenic bacteria by processes that 

retain the raw product characteristics (covered 

in Chapter 17). 

CHAPTER 13: Clostridium botulinum Toxin Formation 

245 
 

 

 

•	 Formation of C. botulinum toxin 

When C. botulinum grows, it can produce a 

potent toxin, one of the most poisonous naturally 

occurring substances known. The toxin can be 

destroyed by heat (e.g., boiling for 10 minutes), 

but, because of its potency, you should not rely 

on this as a means of control. 

The strains of C. botulinum can be divided 

into two groups, the proteolytic group (i.e., 

those that break down proteins) and the nonproteolytic group (i.e., those that do not break 

down proteins). The proteolytic group includes 

C. botulinum type A and some of types B and F. 

The non-proteolytic group includes C. botulinum 

type E and some of types B and F. 

The vegetative cells of all types of C. botulinum 

are easily killed by heat. However, C. botulinum 

is able to produce spores. In this state, the 

pathogen is very resistant to heat. The spores 

of the proteolytic group are much more resistant 

to heat than are those of the non-proteolytic 

group (i.e., they require a canning process to be 

destroyed). Table A-4 (Appendix 4) provides 

guidance about the conditions under which 

the spores of the most heat-resistant form 

of non-proteolytic C. botulinum, type B, are 

killed. However, there are some indications 

that substances that may be naturally present 

in some products (e.g., dungeness crabmeat), 

such as lysozyme, may enable non-proteolytic 

C. botulinum to more easily recover after heat 

damage, resulting in the need for a considerably 

more stringent process to ensure destruction. 

C. botulinum is able to produce toxin when 

a product in which it is present is exposed to 

temperatures favorable for growth for sufficient 

time. Table A-1 (Appendix 4) provides guidance 

about the conditions under which C. botulinum 

and other pathogenic bacteria are able to grow. 

Table A-2 (Appendix 4) provides guidance about 

the time necessary at various temperatures for 

toxin formation to occur. 

Packaging conditions that reduce the amount 

of oxygen present in the package (e.g., vacuum 

packaging and modified atmosphere packaging) 

extend the shelf life of a product by inhibiting 

the growth of aerobic spoilage bacteria. There 

is a safety concern with these products because 

there is an increased potential for the formation 

of C. botulinum toxin before spoilage makes the 

product unacceptable to consumers. 

C. botulinum forms toxin more rapidly at higher 

temperatures than at lower temperatures. The 

minimum temperature for growth and toxin 

formation by C. botulinum type E and nonproteolytic types B and F is 38°F (3.3°C). For 

type A and proteolytic types B and F, the 

minimum temperature for growth is 50°F (10°C). 

As the shelf life of refrigerated foods is increased, 

more time is available for C. botulinum growth 

and toxin formation. As storage temperatures 

increase, the time required for toxin formation is 

significantly shortened. You should expect that at 

some point during storage, distribution, display, 

or consumer handling of refrigerated foods, safe 

refrigeration temperatures will not be maintained 

(especially for the non-proteolytic group). Surveys 

of retail display cases indicate that temperatures 

of 45 to 50°F (7 to 10°C) are not uncommon. 

Surveys of home refrigerators indicate that 

temperatures can exceed 50°F (10°C). 

In reduced oxygen packaged products in which 

the spores of non-proteolytic C. botulinum 

are inhibited or destroyed (e.g., smoked fish, 

pasteurized crabmeat, and pasteurized surimi), 

a normal refrigeration temperature of 40°F 

(4.4°C) is appropriate because it will limit 

the growth of proteolytic C. botulinum and 

other pathogens that may be present. Even 

in pasteurized products where non-proteolytic 

C. botulinum is the target organism for the 

pasteurization process, and vegetative pathogens, 

such as Listeria monocytogenes, are not likely 

to be present (e.g., pasteurized crabmeat and 

pasteurized surimi), a storage temperature of 

40°F (4.4°C) is still appropriate because of the 

potential for survival through the pasteurization 

process and recovery of spores of non-proteolytic 

C. botulinum, aided by naturally occurring 

CHAPTER 13: Clostridium botulinum Toxin Formation 

246 
 

 

 

 

 

substances, such as lysozyme. In this case, 

refrigeration serves as a prudent second barrier. 

However, in reduced oxygen packaged products 

in which refrigeration is the sole barrier to 

outgrowth of non-proteolytic C. botulinum and 

the spores have not been destroyed (e.g., vacuumpackaged refrigerated raw fish, vacuum-packaged 

refrigerated unpasteurized crayfish meat, and 

reduced oxygen packaged unpasteurized 

dungeness crabmeat), the temperature should be 

maintained below 38°F (3.3°C) from packing to 

consumption. Ordinarily you, as a processor, can 

ensure that temperatures are maintained below 

38°F (3.3°C) while the product is in your control. 

However, the current U.S. food distribution 

system does not ensure the maintenance of these 

temperatures after the product leaves your control. 

The use of a Time-Temperature Indicator (TTI) on 

each consumer package may be an appropriate 

means of overcoming these problems in the 

distribution system for reduced oxygen packaged 

products in which refrigeration is the sole barrier 

to outgrowth of non-proteolytic C. botulinum and 

in which the spores have not been destroyed. 

A TTI is a device that monitors the time and 

temperature of exposure of the package and 

alerts the consumer or end user if a safe exposure 

limit has been exceeded. If a TTI is used, it 

should be validated to ensure that it is fit for its 

intended purpose and verified that it is functional 

at the time of use. It should be designed to alert 

the consumer (e.g., a color change) that an unsafe 

time and temperature exposure has occurred 

that may result in C. botulinum toxin formation. 

Additionally, the alert should remain perpetually 

visible after it has been triggered, regardless of 

environmental conditions that could reasonably 

be expected to occur thereafter. Skinner, G. E., 

and J. W. Larkin in “Conservative prediction of 

time to Clostridium botulinum toxin formation for 

use with time-temperature indicators to ensure 

the safety of foods,” Journal of Food Protection, 

61:1154-1160 (1998), describe a safe time and 

temperature exposure curve (“Skinner-Larkin 

curve”) that may be useful in evaluating the 

suitability of a TTI for control of C. botulinum 

toxin formation in reduced oxygen packaged fish 

and fishery products. 

Alternatively, products of this type may be safely 

marketed frozen, with appropriate labeling 

to ensure that it is held frozen throughout 

distribution. For some reduced oxygen packaged 

products, control of C. botulinum can be 

achieved by breaking the vacuum seal before the 

product leaves the processor’s control. 

The guidance in this chapter emphasizes 

preventive measures for the control of nonproteolytic strains of C. botulinum in products 

that are contained in reduced oxygen packaging. 

As was previously described, this emphasis 

is because such an environment extends the 

shelf life of a refrigerated product in a way that, 

under moderate temperature abuse, favors C. 

botulinum growth and toxin formation over 

aerobic spoilage. It is also possible for both 

non-proteolytic and proteolytic C. botulinum 

to grow and produce toxin in a product that is 

not reduced oxygen packaged and is subjected 

to severe temperature abuse. This is the case 

because of the development within the product 

of microenvironments that support its growth. 

However, this type of severe temperature abuse 

of refrigerated products is not reasonably likely 

to occur in the processing environment of most 

fish or fishery products and the Current Good 

Manufacturing Practice in Manufacturing, Packing, 

or Holding Human Food regulation, 21 CFR 110, 

requires refrigeration of foods that support the 

growth of pathogenic microorganisms. 

•	 Sources of C. botulinum 

C. botulinum can enter the process on raw 

materials. The spores of C. botulinum are very 

common. They have been found in the gills 

and viscera of finfish, crabs, and shellfish. C. 

botulinum type E is the most common form found 

in freshwater and marine environments. Types 

A and B are generally found on land but may 

also be occasionally found in water. It should be 

assumed that C. botulinum will be present in any 

raw fishery product, particularly in the viscera. 

CHAPTER 13: Clostridium botulinum Toxin Formation 

247 
 

 

Because spores are known to be present in the 

viscera, any product that will be preserved by 

salting, drying, pickling, or fermentation should 

be eviscerated prior to processing (see the 

“Compliance Policy Guide,” Sec. 540.650). Without 

evisceration, toxin formation is possible during the 

process, even with strict control of temperature. 

Evisceration of fish is the careful and complete 

removal of all internal organs in the body cavity 

without puncturing or cutting them, including 

gonads. If even a portion of the viscera or its 

contents is left behind, the risk of toxin formation 

by C. botulinum remains. Uneviscerated small 

fish, less than 5 inches in length (e.g., anchovies 

and herring sprats), for which processing eliminates 

preformed toxin, prevents toxin formation during 

processing and that reach a water phase salt 

content of 10% in refrigerated finished products, 

or a water activity of below 0.85 in shelf-stable 

finished products, or a pH of 4.6 or less in shelfstable finished products, are not subject to the 

evisceration recommendation. 

Note: The water phase salt content of 10% is based on the control of 

C. botulinum type A and proteolytic types B and F. 

Note: The water activity value of below 0.85 is based on the 

minimum water activity for toxin production of S. aureus. 

•	 Reduced oxygen packaging 

A number of conditions can result in the creation 

of a reduced oxygen environment in packaged 

fish and fishery products. They include: 

•	 Vacuum, modified, or controlled atmosphere 

packaging. These packaging methods 

generally directly reduce the amount of 

oxygen in the package; 

•	 Packaging in hermetically sealed containers 

(e.g., double-seamed cans, glass jars 

with sealed lids, and heat-sealed plastic 

containers), or packing in deep containers 

from which the air is expressed (e.g., caviar 

in large containers), or packing in oil. These 

and similar processing and packaging 

techniques prevent the entry of oxygen into 

the container. Any oxygen present at the 

time of packaging (including oxygen that 

may be added during modified atmosphere 

packaging) may be rapidly depleted by the 

activity of spoilage bacteria, resulting in the 

formation of a reduced oxygen environment. 

Packaging that provides an oxygen transmission 

rate (in the final package) of at least 10,000 cc/ 

m2

/24 hours at 24oC can be regarded as an 

oxygen-permeable packaging material for fishery 

products. The oxygen transmission rate of 

packaging material is listed in the packaging 

specifications that can be obtained from the 

packaging manufacturer. 

An oxygen-permeable package should provide 

sufficient exchange of oxygen to allow aerobic 

spoilage organisms to grow and spoil the product 

before toxin is produced under moderate abuse 

temperatures. Particular care should be taken in 

determining the safety of a packaging material for a 

product in which the spoilage organisms have been 

eliminated or significantly reduced by processes 

such as high pressure processing. The generally 

recommended 10,000 cc/m2

/24 hours at 24oC 

transmission rate may not be suitable in this case. 

Use of an oxygen-permeable package may not 

compensate for the restriction to oxygen exchange 

created by practices such as packing in oil or in 

deep containers from which the air is expressed 

or the use of oxygen scavengers in the packaging. 

•	 Control of C. botulinum 

There are a number of strategies to prevent C. 

botulinum growth and toxin formation during 

processing, storage, and distribution of finished 

fish and fishery products. They include: 

For products that do not require refrigeration 

(i.e., shelf-stable products): 

•	 Heating the finished product in its final 

container sufficiently by retorting to destroy 

the spores of C. botulinum types A B, E, 

and F (e.g., canned fish). This strategy is 

covered by the LACF Regulation, 21 CFR 

113, and these controls are not required to 

be included in your Hazard Analysis Critical 

Control Point (HACCP) plan; 

CHAPTER 13: Clostridium botulinum Toxin Formation 

248 
•	 Controlling the level of acidity (pH) in the 

finished product to 4.6 or below, to prevent 

growth and toxin formation by C. botulinum 

types A, B, E, and F (e.g., shelf-stable 

acidified products). This strategy is covered 

by the Acidified Foods regulation, 21 CFR 

114, and these controls are not required to be 

included in your HACCP plan; 

•	 Controlling the amount of moisture that is 

available in the product (water activity) to 

0.85 or below by drying, to prevent growth 

and toxin formation by C. botulinum types 

A, B, E, and F and other pathogens that may 

be present in the product (e.g., shelf-stable 

dried products). This strategy is covered by 

Chapter 14; 

•	 Controlling the amount of salt in the product 

to 20% water phase salt (wps) or more, to 

prevent the growth of C. botulinum types A, 

B, E, and F and other pathogens that may 

be present in the product (e.g., shelf-stable 

salted products). This strategy is covered 

in this chapter. Water phase salt is the 

concentration of salt in the water-portion of 

the fish flesh and calculated as follows: (% 

NaCl X 100)/(% NaCl + % moisture) = % NaCl 

in water phase. The relationship between 

percent water phase salt and water activity in 

fish is described in the following graph. 

Relationship of Water Activity to Water Phase 

Salt in NaCl/Water Solutions1 

1.00 

0.98 

y it

0.96 

tivc

0.94 

r a

0.92 

tea

0.90 

W

0.88 

0.86 

0.84 

0 2 4 6 8 10 12 14 16 18 20 

Percent water phase salt 

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 

other pathogens that may be present in 

the finished product through refrigerated 

storage (e.g., refrigerated dried fish). Drying 

is covered in Chapter 14, controlling the 

growth of proteolytic C. botulinum through 

refrigeration is covered in this chapter, and 

controlling the growth of other pathogenic 

bacteria through refrigeration is covered in 

Chapter 12; 

• Controlling the amount of moisture that 

is available in the product (water activity) 

to 0.97 or below to inhibit the growth of 

C. botulinum type E and non-proteolytic 

types B and F by drying, and then 

controlling the growth of C. botulinum 

•	 Heating the finished product in its final 

container sufficiently by pasteurization to 

destroy the spores of C. botulinum type 

E and non-proteolytic types B and F, and 

then minimizing the risk of recontamination 

by controlling seam closures and cooling 

water, and next controlling the growth 

of the surviving C. botulinum type A and 

proteolytic types B and F in the finished 

product with refrigerated storage (e.g.. 

pasteurized crabmeat and some pasteurized 

surimi-based products). Pasteurization 

is covered in Chapter 16, controlling 

recontamination after pasteurization is 

covered in Chapter 18, and controlling the 

growth of proteolytic C. botulinum through 

•	 Controlling the level of pH to 5 or below, salt 

to 5% wps or more, moisture (water activity) 

to 0.97 or below, or some combination 

of these barriers, in the finished product 

sufficiently to prevent the growth of C. 

botulinum type E and non-proteolytic 

types B and F by formulation, and then 

controlling the growth of C. botulinum 

type A and proteolytic types B and F and 

other pathogens that may be present in 

the finished product with refrigerated 

storage (e.g., refrigerated acidified (pickled) 

products). Controlling the growth of nonproteolytic C. botulinum through formulation 

is covered in this chapter, controlling the 

growth of proteolytic C. botulinum through 

refrigeration is covered in this chapter, and 

controlling the growth of other pathogenic 

bacteria through refrigeration is covered in 

Chapter 12; 

refrigeration is covered in this chapter; 

•	 Heating the product sufficiently to destroy 

the spores of C. botulinum type E and 

non-proteolytic types B and F, and then 

minimizing the risk of recontamination 

by hot filling the product into the final 

container in a sanitary, continuous, closed 

filling system and controlling seam closures 

and cooling water, and next controlling 

the growth of the surviving C. botulinum 

type A and proteolytic types B and F and 

other pathogens that may be present in the 

finished product with refrigerated storage 

(e.g., vacuum packed soups, chowders, and 

sauces). Specialized cooking processes 

are covered in Chapter 16, prevention of 

recontamination after specialized cooking 

processes is covered in Chapter 18, 

controlling the growth of proteolytic C. 

botulinum through refrigeration is covered 

in this chapter, and controlling the growth 

of other pathogenic bacteria through 

refrigeration is covered in Chapter 12; 

•	 Controlling the amount of salt and 

preservatives, such as sodium nitrite, in 

the finished product, in combination with 

other barriers, such as smoke, heat damage, 

and competitive bacteria, sufficiently to 

prevent the growth of C. botulinum type 

E and non-proteolytic types B and F, and 

then controlling the growth of C. botulinum 

type A and proteolytic types B and F and 

other pathogens that may be present in the 

finished product with refrigerated storage 

(e.g., salted, smoked, or smoke-flavored fish). 

Controlling the growth of non-proteolytic 

C. botulinum through salting and smoking 

is covered in this chapter, controlling the 

growth of proteolytic C. botulinum through 

CHAPTER 13: Clostridium botulinum Toxin Formation 

250 
 

refrigeration is covered in this chapter, and 

controlling the growth of other pathogenic 

bacteria through refrigeration is covered in 

Chapter 12; 

•	 Controlling the amount of salt in the 

finished product, in combination with heat 

damage from pasteurization in the finished 

product container, sufficiently to prevent 

the growth of C. botulinum type E and 

nonproteolytic types B and F, and then 

controlling the growth of C. botulinum 

type A and proteolytic types B and F and 

other pathogens that may be present in 

the finished product with refrigerated 

storage (e.g., some pasteurized surimibased products). Controlling the growth 

of non-proteolytic C. botulinum through 

a combination of salt and heat damage 

is covered in this chapter, controlling the 

growth of proteolytic C. botulinum through 

refrigeration is covered in this chapter, and 

controlling the growth of other pathogenic 

bacteria through refrigeration is covered in 

Chapter 12. 

Examples of C. botulinum control in specific 

products: 

•	 Refrigerated (not frozen), reduced oxygen 

packaged smoked and smoke-flavored fish 

Achieving the proper concentration of 

salt and nitrite in the flesh of refrigerated, 

reduced oxygen packaged smoked and 

smoke-flavored fish is necessary to prevent 

the formation of toxin by C. botulinum type 

E and non-proteolytic types B and F during 

storage and distribution. Salt works along 

with smoke and any nitrites that are added 

to prevent growth and toxin formation by C. 

botulinum type E and non-proteolytic types 

B and F. Note that nitrites should be used 

only in salmon, sable, shad, chubs, and tuna, 

according to 21 CFR 172.175 and 21 CFR 

172.177 , and should not exceed a level of 

200 ppm in salmon, sable, shad, chubs and 

10 ppm in tuna. 

In hot-smoked products, heat damage to 

the spores of C. botulinum type E and nonproteolytic types B and F also helps prevent 

toxin formation. In these products, control of 

the heating process is critical to the safety of 

the finished product. It is important to note, 

however, that this same heating process also 

reduces the numbers of naturally occurring 

spoilage organisms. The spoilage organisms 

would otherwise have competed with, and 

inhibited the growth of, C. botulinum. 

In cold-smoked fish, it is important that 

the product does not receive so much heat 

that the numbers of spoilage organisms 

are significantly reduced. This is important 

because spoilage organisms must be present 

to inhibit the growth and toxin formation 

of C. botulinum type E and non-proteolytic 

types B and F. This inhibition is important 

in cold-smoked fish because the heat applied 

during this process is not adequate to 

weaken the C. botulinum spores. Control 

of the temperature during the cold-smoking 

process to ensure survival of the spoilage 

organisms is, therefore, critical to the safety 

of the finished product. 

The interplay of these inhibitory effects 

(i.e., salt, temperature, smoke, and nitrite) 

is complex. Control of the brining or dry 

salting process is clearly critical to ensure that 

there is sufficient salt in the finished product. 

However, preventing toxin formation by C. 

botulinum type E and non-proteolytic types 

B and F is made even more complex by the 

fact that adequate salt levels are not usually 

achieved during brining. Proper drying 

during smoking is also critical in order to 

achieve the finished product water phase 

salt level (i.e., the concentration of salt in 

the water portion of the fish flesh) needed 

to inhibit growth and toxin formation by C. 

botulinum. 

This chapter covers the control procedures 

described above. 

CHAPTER 13: Clostridium botulinum Toxin Formation 

251 
 

You should ordinarily restrict brining, dry 

salting, and smoking loads to single species 

and to fish portions of approximately 

uniform size. This restriction minimizes the 

complexity of controlling the operation. You 

should treat brine to minimize microbial 

contamination or periodically replace it as a 

good manufacturing practice control. 

The combination of inhibitory effects that are 

present in smoked and smoke-flavored fish 

are not adequate to prevent toxin formation 

by C. botulinum type A and proteolytic types 

B and F. Strict refrigeration control (i.e., at 

or below 40°F (4.4°C)) during storage and 

distribution should be maintained to prevent 

growth and toxin formation by C. botulinum 

type A and proteolytic types B and F and 

other pathogens that may be present in 

these products. Controlling the growth of 

proteolytic C. botulinum through refrigeration 

is covered in this chapter, and controlling the 

growth of other pathogenic bacteria through 

refrigeration is covered in Chapter 12. 

•	 Refrigerated (not frozen), reduced oxygen 

packaged, pasteurized fishery products 

Refrigerated, reduced oxygen packaged, 

pasteurized fishery products fall into two 

categories: (1) those which are pasteurized 

in the final container; and (2) those which 

are cooked in a kettle and then hot filled 

into the final container in a continuous, 

closed filling system (e.g., heat-and-fill 

soups, chowders, and sauces). In both 

cases, ordinarily the heating process should 

be sufficient to destroy the spores of C. 

botulinum type E and non-proteolytic types 

B and F. In neither case is it likely that 

the heating process will be sufficient to 

destroy the spores of C. botulinum type A 

and proteolytic types B and F. Therefore, 

strict refrigeration control (i.e., at or below 

40°F (4.4°C)) should be maintained during 

storage and distribution to prevent growth 

and toxin formation by C. botulinum type A 

and proteolytic types B and F. Refrigeration 

also serves as a prudent second barrier 

because of the potential survival through 

the pasteurization process and recovery of 

spores of non-proteolytic C. botulinum, aided 

by naturally occurring substances, such as 

lysozyme. Cooking and pasteurization are 

covered in Chapter 16, and controlling the 

growth of C. botulinum through refrigeration 

is covered in this chapter. 

In the second category of products, filling 

the product into the final container while it is 

still hot in a continuous, closed filling system 

(i.e., hot filling) is also critical to the safety of 

the finished product because it minimizes the 

risk of recontamination of the product with 

pathogens, including C. botulinum type E and 

non-proteolytic types B and F. This control 

strategy applies to products such as soups, 

chowders, and sauces that are filled directly 

from the cooking kettle, where the risk of 

recontamination is minimized. It may not 

apply to products such as crabmeat, lobster 

meat, or crayfish meat or to other products 

that are handled between cooking and filling. 

Control of hot filling is covered in Chapter 18. 

Chapter 18 also covers other controls that 

may be necessary to prevent recontamination, 

including controlling container sealing and 

controlling contamination of container 

cooling water. These controls may be critical 

to the safety of both categories of products. 

Examples of properly pasteurized products 

follow: fish and fishery products generally 

(e.g., surimi-based products, soups, 

or sauces) pasteurized to a minimum 

cumulative total lethality of F (F )

= 10 minutes, where z = 12.6°F (7°C) for 

temperatures less than 194°F (90°C), and 

z = 18°F (10°C) for temperatures above 

194°F (90°C); blue crabmeat pasteurized 

to a minimum cumulative total lethality of 

F

194°F 90°C

 (F ) = 31 minutes, where z = 16°F 

(9°C); and dungeness crabmeat pasteurized 

to a minimum cumulative total lethality of 

F

185°F 85°C

 (F ) = 57 minutes, where z = 15.5°F 194°F 90°C

CHAPTER 13: Clostridium botulinum Toxin Formation 

252 
 

(8.6°C). Equivalent processes at different 

temperatures can be calculated using the z 

values provided. 

EXAMPLES OF PROPERLY PASTEURIZED 

PRODUCTS 

PRODUCT MINIMUM CUMULATIVE 

TOTAL LETHALITY Z VALUE 

Fish and fishery 

products 

generally 

(e.g., surimibased products, 

soups, or 

sauces) 

F194°F (F90°C) = 10 minutes 12.6°F (7°C), for 

temperatures 

less than 194°F 

(90°C) 

18°F (10°C) for 

temperatures 

above 194°F 

(90°C) 

Blue crabmeat F185°F (F85°C) = 31 minutes 16°F (9°C) 

Dungeness 

crabmeat 

F194°F (F90°C) = 57 minutes 15.5°F (8.6°C) 

In some pasteurized surimi-based 

products, salt, in combination with a milder 

pasteurization process, in the finished product 

container works to prevent growth and toxin 

formation by C. botulinum type E and nonproteolytic types B and F. An example of a 

properly pasteurized surimi-based product 

in which 2.4% wps is present is one that has 

been pasteurized at an internal temperature 

of 185°F (85°C) for at least 15 minutes. This 

process may not be suitable for other types of 

products because of the unique formulation 

and processing involved in the manufacture of 

surimi-based products. 

•	 Refrigerated (not frozen), reduced oxygen 

packaged pickled fish, salted fish, caviar, 

and similar products 

In pickled fish, salted fish, caviar, and similar 

products that have not been preserved 

sufficiently for them to be shelf stable, 

growth and toxin formation by C. botulinum 

type E and non-proteolytic types B and F is 

controlled by one of the following: 

•	 Adding sufficient salt to produce 

a water phase salt level (i.e., the 

concentration of salt in the water 

portion of the fish flesh) of at least 5%; 

•	

•	

•	

Adding sufficient acid to reduce 

the acidity (pH) to 5.0 or below; 

Reducing the amount of moisture 

that is available for growth (water 

activity) to below 0.97 (e.g., by 

adding salt or other substances that 

“bind” the available water); or 

Making a combination of salt, pH, 

and/or water activity adjustments 

that, when combined, prevents the 

growth of C. botulinum type E and 

non-proteolytic types B and F (to be 

established by a scientific study). 

Much like smoked products, in some of these 

products the interplay of these inhibitory 

effects (i.e., salt, water activity, and pH) can 

be complex. Control of the brining, pickling, 

or formulation steps is, therefore, critical to 

ensure that there are sufficient barriers in the 

finished product to prevent the growth and 

toxin formation of C. botulinum type E and 

non-proteolytic types B and F during storage 

and distribution. These control procedures 

are covered in this chapter. 

You should ordinarily restrict brining and 

pickling loads to single species and to fish 

portions of approximately uniform size. 

This restriction minimizes the complexity of 

controlling the operation. You should treat 

brine to minimize microbial contamination 

or periodically replace it as a good 

manufacturing practice control. 

The controls discussed above are not 

sufficient to prevent toxin formation by C. 

botulinum type A and proteolytic types B 

and F. Strict refrigeration control (i.e., at 

or below 40°F (4.4°C)) during storage and 

distribution should, therefore, be maintained 

to prevent growth and toxin formation by C. 

botulinum type A and proteolytic types B and 

F and other pathogens that may be present 

in these products. Controlling the growth of 

proteolytic C. botulinum through refrigeration 

is covered in this chapter, and controlling the 

CHAPTER 13: Clostridium botulinum Toxin Formation 

253 
 

 

 

 

growth of other pathogenic bacteria through 

refrigeration is covered in Chapter 12. 

•	 Refrigerated (not frozen), reduced oxygen 

packaged raw, unpreserved fish and 

unpasteurized, cooked fishery products 

For refrigerated, reduced oxygen packaged 

raw, unpreserved fish (e.g., refrigerated, 

vacuum-packaged fish fillets) and refrigerated, 

reduced oxygen packaged, unpasteurized, 

cooked fishery products (e.g., refrigerated, 

vacuum-packaged, unpasteurized crabmeat, 

lobster meat, or crayfish meat), the sole 

barrier to toxin formation by C. botulinum 

type E and non-proteolytic types B and 

F during finished product storage and 

distribution is refrigeration. These types of C. 

botulinum will grow at temperatures as low 

as 38°F (3.3°C). As was previously noted, 

maintenance of temperatures below 38°F 

(3.3°C) after the product leaves your control 

and enters the distribution system cannot 

normally be ensured. The use of a TTI on 

the smallest unit of packaging (i.e., the unit 

of packaging that will not be distributed 

any further, usually consumer or end-user 

package) may be an appropriate means of 

overcoming these problems in the distribution 

system. This chapter provides controls for the 

application of TTIs for packaging. 

If you intend to package these products in 

a reduced oxygen package and you do not 

intend to apply a TTI on each consumer 

package, you should evaluate the effectiveness 

of other preventive measures, either singularly, 

or in combination, that may be effective in 

preventing growth and toxin formation by C. 

botulinum. Such evaluation is customarily 

accomplished by conducting an inoculated 

pack study under moderate abuse conditions. 

A suitable protocol for the performance of 

such studies is contained in a 1992 publication 

by the National Advisory Committee on 

Microbiological Criteria for Foods, “Vacuum 

or modified atmosphere packaging for 

refrigerated, raw fishery products.” 

•	 Frozen, reduced oxygen packaged raw, 

unpreserved fish and unpasteurized, cooked 

fishery products 

For frozen, reduced oxygen packaged raw, 

unpreserved fish (e.g., frozen, vacuumpackaged fish fillets) and frozen, reduced 

oxygen packaged, unpasteurized, cooked 

fishery products (e.g., frozen, vacuumpackaged, unpasteurized crabmeat, lobster 

meat, or crayfish meat), the sole barrier to 

toxin formation by C. botulinum type E 

and non-proteolytic types B and F during 

finished product storage and distribution 

is freezing. Because these products may 

appear to the retailer, consumer, or end user 

to be intended to be refrigerated, rather than 

frozen, labeling to ensure that they are held 

frozen throughout distribution is critical to 

their safety. 

Controls should be in place to ensure that 

such products are immediately frozen after 

processing, maintained frozen throughout 

storage in your facility, and labeled to 

be held frozen and to be thawed under 

refrigeration immediately before use (e.g., 

“Important, keep frozen until used, thaw 

under refrigeration immediately before use”). 

Frozen, reduced oxygen packaged products 

that are customarily cooked by the consumer 

or end user in the frozen state (e.g., boil-inbag products and frozen fish sticks) need not 

be labeled to be thawed under refrigeration. 

For purposes of hazard analysis, other frozen 

products that do not contain the “keep 

frozen” statement should be evaluated as if 

they will be stored refrigerated because the 

consumer or end user would not have been 

warned to keep them frozen. 

Control procedures to ensure that product 

is properly labeled with “keep frozen” 

instructions are covered in this chapter. 

CHAPTER 13: Clostridium botulinum Toxin Formation 

254 
 

 

 

•	 Control in unrefrigerated (shelf-stable), 

reduced oxygen packaged fishery products 

Examples of shelf-stable, reduced oxygen 

packaged fishery products are dried fish, 

acidified fish, canned fish, and salted fish. 

Because these products are marketed without 

refrigeration, either (1) the spores of C. 

botulinum types A, B, E, and F should be 

destroyed after the product is placed in the 

finished product container (covered by the 

LACF Regulation, 21 CFR 113) or (2) a barrier, 

or combination of barriers, should be in place 

that will prevent growth and toxin formation 

by C. botulinum types A, B, E, and F, and 

other pathogens that may be present in the 

product. Suitable barriers include: 

•	

•	

•	

•	

Adding sufficient salt to produce 

a water phase salt level (i.e., the 

concentration of salt in the water 

portion of the fish flesh) of at least 

20%. Note that this value is based on 

the maximum salt level for growth of 

S. aureus, covered in this chapter; 

Reducing the amount of moisture 

that is available for growth (water 

activity) to below 0.85 (e.g., by adding 

salt or other substances that bind the 

available water). Note that this value 

is based on the minimum water activity 

for growth and toxin formation of S. 

aureus, covered in this chapter; 

Adding sufficient acid to reduce the pH 

to 4.6 or below. This barrier is covered 

by the Acidified Foods regulation, 21 CFR 

114, and these controls are not required 

to be included in your HACCP plan; 

Drying the product sufficiently to 

reduce the water activity to 0.85 or 

below. Note that this value is based 

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. 

DETERMINE WHETHER THE POTENTIAL 

HAZARD IS SIGNIFICANT. 

The following guidance will assist you in 

determining whether C. botulinum toxin formation 

is a significant hazard at a processing step: 

1.	 Is it reasonably likely that C. botulinum will 

grow and produce toxin during finished product 

storage and distribution? 

The factors that make C. botulinum toxin 

formation during finished product storage 

and distribution reasonably likely to occur 

are those that may result in the formation of 

a reduced oxygen packaging environment. 

These are discussed in the section 

“Understand the potential hazard,” under the 

heading, “Reduced oxygen packaging.” 

2.	 Can growth and toxin formation by C. botulinum that 

is reasonably likely to occur be eliminated or reduced 

to an acceptable level at this processing step? 

C. botulinum toxin formation should also 

be considered a significant hazard at any 

processing step 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 C. botulinum toxin 

formation during finished product distribution 

and storage are discussed in the section, 

“Understand the potential hazard,” under the 

heading, “Control of C. botulinum.” 

•	 Intended use 

Because of the extremely toxic nature of 

C. botulinum toxin, it is unlikely that the 

significance of the hazard will be affected by the 

intended use of your product. 

CHAPTER 13: Clostridium botulinum Toxin Formation 

255 
IDENTIFY CRITICAL CONTROL POINTS. 

The following guidance will assist you in 

determining whether a processing step is a 

critical control point (CCP) for C. botulinum toxin 

formation: 

1.	 Is there an acidification step (equilibrium pH 

of 4.6 or below), a drying step, an in-package 

pasteurization step, a combination of cook and 

hot-fill steps, or a retorting step (commercial 

sterility) in the process? 

a.	 If there is, you should in most cases 

identify the acidification step, drying 

step, pasteurization step, cook and hotfill steps, or retorting step as the CCP(s) 

for this hazard. Other processing steps 

where you have identified C. botulinum 

toxin formation as a significant hazard 

will then not require control and will 

not need to be identified as CCPs for 

the hazard. However, control should 

be provided for time and temperature 

exposure during finished product 

storage and distribution of the following 

products: 

•	

•	

Products pasteurized in the final 

container to kill C. botulinum type 

E and non-proteolytic types B 

and F and refrigerated to control 

the growth of C. botulinum type 

A and proteolytic types B and F 

and other pathogens that may 

be present (e.g., pasteurized 

crabmeat and pasteurized surimi); 

Products cooked to kill C. botulinum 

type E and non-proteolytic types 

B and F, and then hot filled into 

the final container, and next 

refrigerated to control the growth 

of C. botulinum type A and 

proteolytic types B and F and other 

pathogens that may be present; 

•	 Products dried to control the 

growth of C. botulinum type E 

and non-proteolytic types B and 

F and refrigerated to control the 

growth of C. botulinum type A and 

proteolytic types B and F and other 

pathogens that may be present. 

In these cases, you should also identify 

the finished product storage step as 

a CCP for the hazard. Control of 

refrigeration is covered in this chapter for 

C. botulinum and in Chapter 12 for other 

pathogenic bacteria. 

Additionally, some pasteurized surimibased products rely on a combination of 

salt and a relatively mild pasteurization 

process in the finished product container 

for the control of C. botulinum type E 

and non-proteolytic types B and F. In 

these products, you should also identify 

the formulation step as a CCP for the 

hazard. Guidance provided in “Control 

Strategy Example 4 - Pickling and Salting” 

may be useful in developing controls at 

this step. 

Guidance for the C. botulinum control 

strategies listed above is contained in the 

following locations: 

•	

•	

•	

•	

•	

Control of cooking and hot-filling 

is covered in Chapters 16 and 18; 

Control of pasteurization is 

covered in Chapters 16 and 18; 

Control of drying is covered 

in Chapter 14; 

Control of acidification is 

covered in the Acidified Foods 

regulation, 21 CFR 114; 

Control of retorting is covered in 

the LACF Regulation, 21 CFR 113. 

Note: Acidification and retorting controls for C. botulinum 

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 

(equilibrium pH of 4.6 or below), drying 

step, pasteurization step, cooking and 

hot-filling, or retorting (commercial 

sterility) step in the process, then decide 

which of the following categories best 

describes your product and refer to the 

guidance below: 

•	 Smoked and smoke-flavored fish; 

•	 Fishery products in which 

refrigeration is the sole barrier 

to prevent toxin formation; 

•	 Fishery products in which freezing is 

the sole barrier to toxin formation; 

•	 Pickled fish and similar products. 

•	 Smoked and smoke-flavored fish 

1.	 Is the water phase salt level and, when permitted, 

the nitrite level, important to the safety of the 

product? 

For all products in this category, the water 

phase salt level is critical to the safety of the 

product, and the brining, dry salting and, 

where applicable, drying steps should be 

identified as CCPs. Nitrite, when permitted, 

allows a lower level of salt to be used. Salt 

and nitrite are the principal inhibitors to 

C. botulinum type E and non-proteolytic 

types B and F toxin formation in these 

products. The water phase salt level needed 

to inhibit toxin formation is partially achieved 

during brining or dry salting and is partially 

achieved during drying. Control should be 

exercised over both operations. 

This control approach is a control strategy 

referred to in this chapter as “Control Strategy 

Example 1 - Smoking (1a - Brining, Dry 

Salting, and Drying).” 

2.	 Is the temperature of the heating or smoking 

process important to the safety of the product? 

For both cold-smoked and hot-smoked fish 

products, the temperature of smoking is critical, 

and the smoking step should be identified as 

a CCP for this hazard. The smoking step for 

hot-smoked fish should be sufficient to damage 

the spores and make them more susceptible to 

inhibition by salt. The smoking step for coldsmoked fish should not be so severe that it kills 

the natural spoilage bacteria. These bacteria 

are necessary so that the product will spoil 

before toxin production occurs. It is likely 

that they will also produce acid, which will 

further inhibit C. botulinum growth and toxin 

formation. 

This control approach is a control strategy 

referred to in this chapter as “Control Strategy 

Example 1 - Smoking (1b - Cold Smoking and 

1c - Hot Smoking).” 

3.	 Is the storage temperature important to the safety 

of the product? 

Refrigerated (not frozen) finished product 

storage is critical to the safety of all products 

in this category and should be identified as 

a CCP. Toxin formation by C. botulinum 

type A and proteolytic types B and F is not 

inhibited by water phase salt levels below 

10%, nor by the combination of inhibitors 

present in most smoked or smoke-flavored 

fish. Bacillus cereus can grow and form 

toxin at water phase salt concentrations as 

high as 18%. 

This control approach is a control strategy 

referred to in this chapter as “Control Strategy 

Example 1 - Smoking (1d - Refrigerated 

Finished Product Storage).” 

In some cases, salted, smoked, or smokeflavored fish are received as ingredients 

for assembly into another product, such 

as a salmon paté. In other cases, they are 

received simply for storage and further 

distribution (e.g., by a warehouse). In either 

case, the refrigerated (not frozen) storage step 

is critical to the safety of the product and 

should be identified as a CCP. Control is the 

same as that provided under “Control Strategy 

Example 1 - Smoking (1d - Refrigerated 

CHAPTER 13: Clostridium botulinum Toxin Formation 

257 
 

 

 

 

Finished Product Storage).” Additionally, 

receiving of these products should be 

identified as a CCP, where control can be 

exercised over the time and temperature 

during transit. 

This control approach is a control strategy 

referred to in this chapter as “Control 

Strategy Example 1 - Smoking (1e - Receipt of 

Products by Secondary Processor).” 

•	 Fishery products in which refrigeration is 

the sole barrier to prevent toxin formation 

1.	 Is the storage temperature important to the safety 

of the product? 

Refrigerated finished product storage is 

critical to the safety of all products in this 

category and should be identified as a CCP. 

These products contain no barriers (other 

than refrigeration) to toxin formation by C. 

botulinum type E and non-proteolytic types 

B and F during finished product storage and 

distribution. These types of C. botulinum 

will grow at temperatures as low as 38°F 

(3.3°C), necessitating particularly stringent 

temperature control. 

This control approach is a control strategy 

referred to in this chapter as “Control Strategy 

Example 2 - Refrigeration With TTI (2d ­

Refrigerated Finished Product Storage).” 

In some cases, these products are received as 

ingredients for assembly into another product. 

In other cases, they are received simply for 

storage and further distribution (e.g., by a 

warehouse). In either case, the refrigerated 

storage step is critical to the safety of the 

product and should be identified as a CCP. 

Control is the same as that provided under 

“Control Strategy Example 2 - Refrigeration 

With a TTI (2d - Refrigerated Finished 

Product Storage).” Additionally, receiving of 

these products should be identified as a CCP, 

where control can be exercised over the time 

and temperature during transit. 

This control approach is a control strategy 

referred to in this chapter as “Control Strategy 

Example 2 - Refrigeration With a TTI (2e ­

Receipt of Product by Secondary Processor).” 

As previously noted, maintenance of 

temperatures below 38°F (3.3°C) after the 

product leaves your control and enters the 

distribution system cannot normally be 

ensured. The use of a TTI on the smallest 

unit of packaging (i.e., the unit of packaging 

that will not be distributed any further, 

usually consumer or end-user package) may 

be an appropriate means of overcoming these 

problems in the distribution system. When 

TTIs are used in this manner, their receipt, 

storage, and application and activation should 

be identified as CCPs. 

This control approach is a control strategy 

referred to as “Control Strategy Example 2 ­

Refrigeration With TTI (2a - Unactivated TTI 

Receipt, 2b - Unactivated TTI Storage, and 2c 

- Application and Activation of TTI).” 

•	 Fishery products in which freezing is the 

sole barrier to toxin formation 

1.	 Is the storage temperature important to the safety 

of the product? 

Frozen finished product storage is critical to 

the safety of all products in this category. 

These products contain no barriers (other 

than freezing) to toxin formation by C. 

botulinum type E and non-proteolytic types 

B and F during finished product storage and 

distribution. As previously noted, because 

these products may appear to the retailer, 

consumer, or end user to be intended to be 

refrigerated, rather than frozen, labeling to 

ensure that they are held frozen throughout 

distribution is critical to their safety and 

should be identified as a CCP. 

This control approach is a control strategy 

referred to in this chapter as “Control Strategy 

Example 3 - Frozen With Labeling.” 

CHAPTER 13: Clostridium botulinum Toxin Formation 

258 
 

 

•	 Pickled and salted fish and similar products 

1.	 Is the water phase salt level, water activity, and/ 

or pH level important to the safety of the product? 

For all products in this category, the water 

phase salt level, water activity, and/or pH 

level are critical to the safety of the product 

because they are the principal inhibitors to 

growth and toxin formation by C. botulinum 

type E and non-proteolytic type B and F. The 

levels of these inhibitors needed to inhibit 

toxin formation are achieved during the 

pickling, brining, or formulation step. Control 

should be exercised over the relevant step. 

This control approach is a control strategy 

referred to in this chapter as “Control Strategy 

Example 4 - Pickling and Salting (4a -

Brining, Pickling, Salting, and Formulation).” 

2.	 Is the storage temperature important to the safety 

of the product? 

Unless pickling, brining, or formulation results 

in a water phase salt level of at least 20% 

(note that this value is based on the maximum 

salt concentration for growth of S. aureus), a 

pH of 4.6 or below, or a water activity of 0.85 

or below (note that this value is based on 

the minimum water activity for growth of S. 

aureus), refrigerated finished product storage 

is critical to ensure the safety of the product 

and should be identified as a CCP. 

This control approach is a control strategy 

referred to in this chapter as “Control Strategy 

Example 4 - Pickling and Salting (4b ­

Refrigerated Finished Product Storage).” 

In some cases, pickled fish or similar 

products are received as ingredients 

for assembly into another product. In 

other cases, they are received simply for 

storage and further distribution (e.g., by a 

warehouse). In either case, the refrigerated 

storage step is critical to the safety of the 

product and should be identified as a CCP. 

Control is the same as that provided under 

“Control Strategy Example 4 - Pickling and 

Salting (4b - Refrigerated Finished Product 

Storage).” Additionally, receiving of these 

products should be identified as a CCP, 

where control can be exercised over time and 

temperature during transit. 

This control approach is a control strategy 

referred to in this chapter as “Control Strategy 

Example 4 - Pickling and Salting (4c - Receipt 

of Product by Secondary Processor).” 

DEVELOP A CONTROL STRATEGY. 

The following guidance provides four control 

strategies for C. botulinum toxin formation. You 

may select a control strategy that is different from 

those which are suggested, provided it complies 

with the requirements of the applicable food 

safety laws and regulations. Control strategies 

contain several elements that may need to be 

used in combination to result in an effective 

control program. 

The following are examples of control strategies 

included in this chapter: 

CONTROL STRATEGY 

MAY APPLY TO 

PRIMARY 

PROCESSOR 

MAY APPLY TO 

SECONDARY 

PROCESSOR 

Smoking  

Refrigeration with TTI  

Frozen with labeling  

Pickling and salting  

•	 CONTROL STRATEGY EXAMPLE 1 - SMOKING 

This control strategy should include the following 

elements, as appropriate: 

a.	 Brining, dry salting, and drying; 

b.	 Cold smoking; 

c.	 Hot smoking; 

d.	 Refrigerated finished product storage; 

e.	 Receipt of products by secondary 


processor.
 

CHAPTER 13: Clostridium botulinum Toxin Formation 

259 
1A. BRINING, DRY SALTING, AND DRYING 

Set Critical Limits. 

•	 The minimum or maximum values for the 

critical factors of the brining, dry salting, 

and/or drying processes established by a 

scientific study. The critical factors are those 

that are necessary to ensure that the finished 

product has not less than 3.5% wps or, where 

permitted, the combination of 3% wps and 

not less than 100 ppm nitrite. The critical 

factors may include: brine strength; brine to 

fish ratio; brining time; brining temperature; 

thickness, texture, fat content, quality, and 

species of fish; drying time; input/output air 

temperature, humidity, and velocity; smoke 

density; and drier loading. 

Establish Monitoring Procedures. 

»	 

»	 

»	 

What Will Be Monitored? 

•	 The critical factors of the established brining, 

dry salting, and/or drying processes. These 

may include: brine strength; brine to fish 

ratio; brining time; brining temperature; 

thickness, texture, fat content, quality, and 

species of fish; drying time; input/output air 

temperature, humidity, and velocity; smoke 

density; and drier loading; 

OR 

•	 The water phase salt and, where appropriate, 

nitrite level of the finished product. 

How Will Monitoring Be Done? 

•	 For monitoring critical factors: 

° Monitor brine strength with a 

salinometer;
 

AND
 

Monitor brine time with a clock;
 ° 

AND
 

Monitor brine temperature using:
 ° 

•	 A temperature-indicating device 

(e.g., a thermometer); 

OR 

•	 Monitor brine temperature at 

the start of the brining process 

with a temperature- indicating 

device (e.g., a thermometer), 

and then monitor ambient air 

temperature using a continuous 

temperature-recording device 

(e.g., a recording thermometer); 

AND
 

Monitor the drying time and the input/
 ° 

output air temperature (as specified 

by the study) using a continuous 

temperature-recording device (e.g., a 

recording thermometer); 

AND 

Monitor all other critical factors specified ° 

by the study with equipment appropriate 

for the measurement; 

OR 

•	 Collect a representative sample of the 

finished product and conduct water phase 

salt analysis and, when appropriate, nitrite 

analysis. 

How Often Will Monitoring Be Done (Frequency)? 

•	

° 

•	

° 

•	

° 

•	

° 

For brine strength: 

At least at the start of the brining 

process;
 

AND
 

For brine time: 

Once per batch;

AND 

For manual brine temperature monitoring: 

At the start of the brining process and at 

least every 2 hours thereafter;
 

AND
 

For continuous temperature-recording 

devices: 

Continuous monitoring by the device 

itself, with a visual check of the recorded 

data at least once per batch; 

CHAPTER 13: Clostridium botulinum Toxin Formation 

260 
AND 

•	 For brine to fish ratio: 

° At the start of the brining process; 

AND 

•	 For time requirements of the drying process: 

Each batch; ° 

AND 

•	 For all other critical factors specified by the 

study: 

° As often as necessary to maintain control; 

OR 

•	 For water phase salt and, when appropriate, 

nitrite: 

° Each lot or batch of finished product. 

Who Will Do the Monitoring? 

For continuous temperature-recording 

devices: 

Monitoring is performed by the device 

itself. The visual check of the data 

generated by the device, to ensure 

that the critical limits have been met 

consistently, may be performed by any 

person who has an understanding of the 

nature of the controls; 

OR 

For other checks: 

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: 

Chill and hold the product until its safety can 

be evaluated; 

OR 

Reprocess the product; 

that is not hermetically sealed, or an LACF, 

or a frozen product); 

OR 

Divert the product to a use in which the 

critical limit is not applicable (e.g., packaging 

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: 

•	 Adjust the salt and/or nitrite concentration in 

the brine; 

OR 

•	 Adjust the air velocity or input air 

temperature to the drying chamber; 

OR 

•	 Extend the drying process to compensate 

for a reduced air velocity or temperature or 

elevated humidity; 

OR 

•	 Adjust the brine strength or brine to fish ratio; 

OR 

•	 Cool the brine; 

OR 

Move some or all of the product to another 

drying chamber; 

•	

OR 

Make repairs or adjustments to the drying 

chamber as necessary. 

•	

Establish a Recordkeeping System. 

•	 Printouts, charts, or readings from continuous 

temperature-recording devices; 

AND 

•	 Record of visual checks of recorded data; 

AND 

Appropriate records (e.g., processing record 

showing the results of the brine strength 

and temperature, brine to fish ratio, size 

•	

CHAPTER 13: Clostridium botulinum Toxin Formation 

261 
 

and species of fish, and time of brining) as 

necessary to document the monitoring of 

the critical factors of the brining, dry salting, 

and/or drying process, as established by a 

study; 

OR 

Results of the finished product water phase 

salt determination and, when appropriate, 

nitrite determination. 

•	

Establish Verification Procedures. 

•	 Process validation study (except where water 

phase salt analysis and, where appropriate, 

nitrite analysis of the finished product are the 

monitoring procedure): 

° 

applicable, nitrite levels should be 

taken into consideration in the process 

establishment. A record of the process 

establishment should be maintained; 

The adequacy of the brining, dry 

salting, and drying processes should 

be established by a scientific study. It 

should be designed to consistently 

achieve a water phase salt level of 

3.5% or 3% with not less than 100 ppm 

nitrite. Expert knowledge of salting and/ 

or drying processes may be required 

to establish such a process. Such 

knowledge can be obtained by education 

or experience, or both. Process 

validation study for establishment of 

brining, dry salting, and drying processes 

may require access to adequate facilities 

and the application of recognized 

methods. The drying equipment should 

be designed, operated, and maintained to 

deliver the established drying process to 

every unit of product. In some instances, 

brining, dry salting, and/or drying studies 

may be required to establish minimum 

processes. In other instances, existing 

literature, which establishes minimum 

processes or adequacy of equipment, 

is available. Characteristics of the 

process, product, and/or equipment 

that affect the ability of the established 

minimum salting, dry salting, and drying 

process to deliver the desired finished 

product water phase salt and, where 

AND 

Before a temperature-indicating device (e.g., 

a thermometer) or temperature-recording 

device (e.g., a recording thermometer) is 

put into service, check the accuracy of the 

device to verify that the factory calibration 

has not been affected. This check can be 

accomplished by: 

•	

° 

° 

° 

° 

Immersing the sensor in an ice slurry 

(32°F (0°C)), if the device will be used at 

or near refrigeration temperature; 

OR 

Immersing the sensor in boiling water 

(212°F (100°C)) if the device will be used 

at or near the boiling point. Note that 

the temperature should be adjusted to 

compensate for altitude, when necessary; 

OR 

Doing a combination of the above if 

the device will be used at or near room 

temperature; 

OR 

Comparing the temperature reading 

on the device with the reading on a 

known accurate reference device (e.g., 

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., 

air temperature, brine temperature, 

product internal temperature) within the 

temperature range at which it will be 

used; 

AND 

Once in service, check the temperatureindicating device or temperature-recording 

device daily before the beginning of 

operations. Less frequent accuracy checks 

may be appropriate if they are recommended 

•	

CHAPTER 13: Clostridium botulinum Toxin Formation 

262 
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 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 

•	 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 and, where 

appropriate, nitrite analysis at least once 

every 3 months (except where such testing is 

performed as part of monitoring); 

and verification records within 1 week of 

preparation to ensure they are complete and 

any critical limit deviations that occurred 

were appropriately addressed. 

AND 

•	 Review monitoring, corrective action, 

1B. COLD SMOKING 

Set Critical Limits. 

•	 The smoker temperature must not exceed 

90°F (32.2°C). 

Establish Monitoring Procedures. 

»	 

»	 

»	 

»	 

What Will Be Monitored? 

•	 The smoker temperature. 

How Will Monitoring Be Done? 

•	 Measure ambient smoker chamber 

temperature using a continuous temperaturerecording device (e.g., a recording 

thermometer). 

How Often Will Monitoring Be Done (Frequency)? 

•	 Continuous monitoring by the device itself, 

with a visual check of the recorded data at 

least once per batch. 

Who Will Do the Monitoring? 

•	 Monitoring is performed by the device itself. 

The visual check of the data generated 

by the device, to ensure that the critical 

limits have been met consistently, may 

be performed by 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: 

•	 Chill and hold the product until its safety can 

be evaluated; 

OR 

•	 Divert the product to a use in which the 

critical limit is not applicable (e.g., packaging 

that is not hermetically sealed, or an LACF, 

or a frozen product); 

OR 

CHAPTER 13: Clostridium botulinum Toxin Formation 

263 
 

•	

•	

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: 

•	 Make repairs or adjustments to the smoking 

chamber; 

AND/OR 

•	 Move some or all of the product to another 

smoking chamber. 

Establish a Recordkeeping System. 

•	 Printouts, charts, or readings from continuous 

temperature-recording devices; 

AND 

•	 Record of visual checks of recorded data. 

Establish Verification Procedures. 

•	 Before a temperature-recording device (e.g., 

a recording thermometer) is put into service, 

check the accuracy of the device to verify that 

the factory calibration has not been affected. 

This check can be accomplished by: 

° 

° 

° 

° 

Immersing the sensor in an ice slurry 

(32°F (0°C)) if the device will be used at 

or near refrigeration temperature; 

OR 

Immersing the sensor in boiling water 

(212°F (100°C)) if the device will be used 

at or near the boiling point. Note that 

the temperature should be adjusted to 

compensate for altitude, when necessary; 

OR 

Doing a combination of the above if 

the device will be used at or near room 

temperature; 

OR 

Comparing the temperature reading on 

the device with the reading on a known 

accurate reference device (e.g., a NISTtraceable thermometer) under conditions 

that are similar to how it will be used (e.g., 

air temperature) within the temperature 

range at which it will be used; 

AND 

•	

•	

•	

Once in service, check the temperaturerecording 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. 

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 

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 13: Clostridium botulinum Toxin Formation 

264 
1C. HOT SMOKING 

Set Critical Limits. 

•	 The internal temperature of the fish must 

be maintained at or above 145°F (62.8°C) 

throughout the fish for at least 30 minutes. 

Establish Monitoring Procedures. 

What Will Be Monitored? 

•	 The internal temperature at the thickest 

portion of three of the largest fish in the 

smoking chamber. 

How Will Monitoring Be Done? 

•	 Use a continuous temperature-recording 

device (e.g., a recording thermometer) 

equipped with three temperature-sensing 

probes. 

How Often Will Monitoring Be Done (Frequency)? 

•	 Continuous monitoring by the device itself, 

with visual check of the recorded data at 

least once per batch. 

Who Will Do the Monitoring? 

•	 Monitoring is performed by the device itself. 

The visual check of the data generated 

by the device, to ensure that the critical 

limits have been met consistently, may 

be performed by 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: 

Chill and hold the product until its safety can 

be evaluated; 

OR 

Reprocess the product; 

OR 

Divert the product to a use in which the 

critical limit is not applicable (e.g., packaging 

that is not hermetically sealed, or a LACF, or 

a frozen product); 

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: 

Make repairs or adjustments to the heating 

chamber; 

OR 

Move some or all of the product to another 

heating chamber. 

Establish a Recordkeeping System. 

•	 Printouts, charts, or readings from continuous 

temperature-recording devices; 

AND 

•	 Record of visual checks of recorded data. 

Establish Verification Procedures. 

•	 Before a temperature-recording device (e.g., 

a recording thermometer) is put into service, 

check the accuracy of the device to verify 

that the factory calibration has not been 

affected. This check can be accomplished 

by: 

° 

° 

° 

Immersing the sensor in an ice slurry 

(32°F (0°C)) if the device will be used at 

or near refrigeration temperature; 

OR 

Immersing the sensor in boiling water 

(212°F (100°C)) if the device will be used 

at or near the boiling point. Note that 

the temperature should be adjusted to 

compensate for altitude, when necessary; 

OR 

Doing a combination of the above if 

the device will be used at or near room 

temperature; 

OR 

CHAPTER 13: Clostridium botulinum Toxin Formation 

265 
° 

•	

•	

•	

Comparing the temperature reading on 

the device with the reading on a known 

accurate reference device (e.g., a NISTtraceable thermometer) 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 temperaturerecording 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. 

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; 

preparation to ensure they are complete and 

any critical limit deviations that occurred 

were appropriately addressed. 

AND 

Review monitoring, corrective action, 

and verification records within 1 week of 

1D. REFRIGERATED FINISHED PRODUCT STORAGE 

Set Critical Limits. 

•	

° 

•	

° 

»	 

•	

° 

•	

° 

»	 

•	

° 

•	

° 

For refrigerated (not frozen) finished product 

storage:
 

The product is held at a cooler 


temperature of 40°F (4.4°C) or 

below. Note that allowance for routine 

refrigeration defrost cycles may be 

necessary. Also note that you may 

choose to set a critical limit that specifies 

a time and temperature of exposure to 

temperatures above 40°F (4.4°C); 

OR 

For finished product stored under ice: 

The product is completely and 

continuously surrounded by ice 

throughout the storage time. 

Establish Monitoring Procedures. 

What Will Be Monitored? 

For refrigerated finished product storage: 

The temperature of the cooler; 

OR 

For finished product storage under ice: 

The adequacy of ice surrounding the 

product. 

How Will Monitoring Be Done? 

For refrigerated finished product storage: 

Use a continuous temperature-recording 

device (e.g., a recording thermometer); 

OR 

For finished product storage under ice: 

Make visual observations of the 

adequacy of ice in a representative 

number of containers (e.g., cartons and 

totes) from throughout the cooler. 

CHAPTER 13: Clostridium botulinum Toxin Formation 

266 
»	 

•	 ° 

° 

° 

•	

•	

° ° 

»	 

•	 ° 

° 

•	

° 

•	 ° 

° 

•	

° 

•	

•	

•	

•	 •	

•	

° 

•	

° 

How Often Will Monitoring Be Done (Frequency)? 

For continuous temperature-recording 

devices: 

Continuous monitoring by the device 

itself, with a visual check of the recorded 

data at least once per day; 

OR 

For finished product storage under ice: 

Sufficient frequency to ensure control. 

Who Will Do the Monitoring? 

For continuous temperature-recording 

devices: 

Monitoring is performed by the device 

itself. The visual check of the data 

generated by the device, to ensure 

that the critical limits have been met 

consistently, may be performed by any 

person who has an understanding of the 

nature of the controls; 

OR 

For other checks: 

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: 

Chill and hold the affected product until an 

evaluation of the total time and temperature 

exposure is performed; 

OR 

Destroy the product; 

OR 

Divert the product to a non-food use. 

OR 

Move some or all of the product in the 

malfunctioning cooler to another cooler;
 

OR
 

Freeze the product;
 

AND 

Address the root cause: 

Make repairs or adjustments to the 

malfunctioning cooler; 

OR 

Make adjustments to the ice application 

operations. 

AND 

Take the following corrective actions to regain control 

over the operation after a critical limit deviation: 

Prevent further deterioration: 

Add ice to the product; 

Establish a Recordkeeping System. 

For refrigerated finished product storage: 

Printouts, charts, or readings from 

continuous temperature-recording 


devices;
 

AND
 

Record of visual checks of recorded data;
 

OR 

For finished product storage under ice: 

Results of ice checks: 

The number of containers examined 

and the sufficiency of ice for each; 

AND 

The approximate number of 

containers in the cooler. 

Establish Verification Procedures. 

Before a temperature-recording device (e.g., 

a recording thermometer) is put into service, 

check the accuracy of the device to verify that 

the factory calibration has not been affected. 

This check can be accomplished by: 

Immersing the sensor in an ice slurry 

(32°F (0°C)) if the device will be used at 

or near refrigeration temperature; 

OR 

CHAPTER 13: Clostridium botulinum Toxin Formation 

267 
° 

•	

•	

•	

° 

•	

° 

•	

•	

° 

° 

•	

•	

Comparing the temperature reading on 

the device with the reading on a known 

accurate reference device (e.g., a NISTtraceable thermometer) under conditions 

that are similar to how it will be used (e.g., 

air temperature) within the temperature 

range at which it will be used; 

AND 

Once in service, check the temperaturerecording 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. 

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. 

1E.	 RECEIPT OF PRODUCTS BY SECONDARY 

PROCESSOR 

Set Critical Limits. 

For fish or fishery products delivered 

refrigerated (not frozen): 

All lots received are accompanied by 

transportation records that show that 

the product was held at or below 40°F 

(4.4°C) throughout transit. Note that 

allowance for routine refrigeration 

defrost cycles may be necessary; 

OR 

For products delivered under ice: 

Product is completely surrounded by ice 

at the time of delivery; 


OR
 

For products delivered under chemical 

cooling media, such as gel packs: 

There is an adequate quantity of cooling

media that remain frozen to have 

maintained product at 40°F (4.4°C) or 

below throughout transit; 

AND 

The internal temperature of the product 

at the time of delivery is 40°F (4.4°C) or 

below; 

OR 

For products delivered refrigerated (not 

frozen) with a transit time (including all 

time outside a controlled temperature 

environment) of 4 hours or less (optional 

control strategy): 

CHAPTER 13: Clostridium botulinum Toxin Formation 

268 
° 

° » 

•	

° 

» 

•	

° •	

° 

° 

•	

•	

° 

° 

•	

° 

° 

° 

•	 •	

° ° 

° 

Time of transit does not exceed 4 hours; 

AND 

Temperature of the product at the time 

of delivery does not exceed 40°F (4.4°C). 

Note: Processors receiving product with transit times of 4 hours or less 

may elect to use one of the controls described for longer transit times. 

Establish Monitoring Procedures. 

What Will Be Monitored? 

For products delivered refrigerated (not 

frozen): 

The internal temperature of the product 

throughout transportation; 

OR 

The temperature within the truck or 

other carrier throughout transportation; 

OR 

For products delivered under ice: 

The adequacy of ice surrounding the 

product at the time of delivery;
 

OR
 

For products held under chemical cooling 

media, such as gel packs: 

The quantity and frozen status of cooling 

media at the time of delivery; 

AND 

The internal temperature of a 

representative number of product 

containers (e.g., cartons and totes) at 

time of delivery; 

OR 

For products delivered refrigerated (not 

frozen) with a transit time of 4 hours or less: 

The date and time fish were removed 

from a controlled temperature 

environment before shipment and the 

date and time delivered; 

AND 

The internal temperature of a 

representative number of product 

containers (e.g., cartons and totes) at the 

time of delivery. 

How Will Monitoring Be Done? 

For products delivered refrigerated (not 

frozen): 

Use a continuous temperature-recording 

device (e.g., a recording thermometer) 

for internal product temperature or 

ambient air temperature monitoring 

during transit; 

OR 

For products delivered under ice: 

Make visual observations of the 

adequacy of ice in a representative 

number of containers (e.g., cartons and 

totes) from throughout the shipment, at 

delivery; 

OR 

For products delivered under chemical 

cooling media, such as gel packs: 

Make visual observations of the 

adequacy and frozen state of the cooling 

media in a representative number of 

containers (e.g., cartons and totes) from 

throughout the shipment, at delivery; 

AND 

Use a temperature-indicating device (e.g., 

a thermometer) to determine internal 

product temperatures in a representative 

number of product containers from 

throughout the shipment, at delivery; 

OR 

For products delivered refrigerated (not 

frozen) with a transit time of 4 hours or less: 

Review carrier records to determine 

the date and time the product was 

removed from a controlled temperature 

environment before shipment and the 

date and time delivered; 

AND 

CHAPTER 13: Clostridium botulinum Toxin Formation 

269 
° Use a temperature-indicating device (e.g., 

a thermometer) to determine internal 

product temperatures in a representative 

number of product containers (e.g., 

cartons and totes) randomly selected 

from throughout the shipment, at 

delivery. Measure a minimum of 12 

product containers, unless there are 

fewer than 12 product containers in a 

lot, in which case measure all of the 

containers. Lots that show a high level 

of temperature variability may require a 

larger sample size. 

How Often Will Monitoring Be Done (Frequency)? 

•	 Each lot received. 

Who Will Do the Monitoring? 

For continuous temperature-recording 

devices: 

Monitoring is performed by the device 

itself. The visual check of the data 

generated by the device, to ensure 

that the critical limits have been met 

consistently, may be performed by any 

person who has an understanding of the 

nature of the controls; 

OR 

For other checks: 

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: 

Chill and hold the affected product until an 

evaluation of the total time and temperature 

exposure is performed; 

OR 

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 or carrier 

until evidence is obtained that the identified 

transportation-handling practices have been 

improved. 

Establish a Recordkeeping System. 

Receiving records showing: 

Results of continuous temperature 

monitoring: 

Printouts, charts, or readings 

from continuous temperaturerecording devices; 

AND 

Visual check of recorded data;
 

OR
 

Results of ice checks, including:
 

The number of containers examined 

and the sufficiency of ice for each; 

AND 

The number of containers in the lot;
 

OR
 

Results of the chemical media checks,
 

including: 

The number of containers 

examined and the frozen status 

of the media for each; 

AND 

The number of containers in the lot; 

AND/OR 

Results of internal product temperature 

monitoring, including: 

The number of containers 

examined and the internal 

temperatures observed for each; 

AND 

The number of containers in the lot; 

AND 

Date and time fish were initially 

removed from a controlled 

CHAPTER 13: Clostridium botulinum Toxin Formation 

270 
temperature environment 

and date and time fish were 

delivered, when applicable. 

Establish Verification Procedures. 

•	 Before a temperature-indicating device (e.g., 

a thermometer) is put into service, check 

the accuracy of the device to verify that the 

factory calibration has not been affected. 

This check can be accomplished by: 

° Immersing the sensor in an ice slurry 

(32°F (0°C)), if the device will be used at 

or near refrigeration temperature; 

OR 

° Comparing the temperature reading on 

the device with the reading on a known 

accurate reference device (e.g., a NISTtraceable thermometer) 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 temperatureindicating 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 

•	 Check the accuracy of temperature-recording 

devices that are used for monitoring transit 

conditions, for all new suppliers and at 

least quarterly for each supplier thereafter. 

Additional checks may be warranted based 

on observations at receipt (e.g., refrigeration 

units appear to be in poor repair or readings 

appear to be erroneous). The accuracy of 

the device can be checked by comparing 

the temperature reading on the device with 

the reading on a known accurate reference 

device (e.g., a NIST-traceable thermometer) 

under conditions that are similar to how it 

will be used (e.g., air temperature) within the 

temperature range at which it will be used; 

AND 

•	 When visual checks of ice are used, 

periodically measure internal temperatures 

of fish to ensure that the ice or 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 13: Clostridium botulinum Toxin Formation 

271 
CHAPTER 13: Clostridium botulinum Toxin Formation 

272 

TABLE 13-1

CONTROL STRATEGY EXAMPLE 1 - SMOKING

This table is an example of a portion of a HACCP plan using “Control Strategy Example 1 - Smoking.” This example illustrates how a processor of vacuum-packaged hotsmoked salmon can control C. botulinum toxin formation. It is provided for illustrative purposes only. C. botulinum toxin formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., aquaculture drugs, environmental chemical contaminants and pesticides, parasites, growth of other pathogenic bacteria, survival of other pathogenic bacteria through the cook step, and metal fragments). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE* 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Brining C. botulinum 

toxin 

formation in 

the finished

product 

Minimum

brining time:

6 hours

Maximum brine

temperature: 40oF 

Start time 

and end time

of the brining

process

Brine

temperature 

Clock

Dial

thermometer 

Every batch

Every 2 hours 

Brine

room

employee 

Extend the 

brining

process

Hold and evaluate 

the product 

Cool the brine 

Production 

record 

Establish

a brining and

drying process 

Check the dial thermometer for 

accuracy and damage and to 

ensure that it is operational 

before putting into operation; 

check it daily, at the beginning of 

operations; and calibrate it once 

per year

Monthly calibration of the scale

Quarterly water phase salt analysis 

of the finished product

Review monitoring, corrective 

action, and verification records 

within 1 week of preparation 

Minimum salt

concentration of 

brine at the start 

of brining: 60°

salinometer 

Salt

concentration 

of brine 

Salinometer Start of each

brining

process 

Brine

room

employee 

Add salt Production 

record 

Minimum ratio of 

brine to fish:

2:1 

Weight of 

brine (as

determined 

by volume) 

Visual, to 

mark on the

tank 

Start of each

brining

process 

Brine

room

employee 

Add brine Production

record 

Weight of 

fish 

Scale Each batch Remove some fish 

and reweigh 

Maximum fish

thickness 11⁄2 in.

Note: To produce 

a minimum water 

phase salt level in 

the loin muscle of

3.5% 

Fish

thickness 

Caliper Each batch

(10 largest 

fish) 

Brine

room

employee 

Hold and evaluate 

based on finished

product water 

phase salt analysis 

Production 

record 
TABLE 13-1

CONTROL STRATEGY EXAMPLE 1 - SMOKING

This table is an example of a portion of a HACCP plan using “Control Strategy Example 1 - Smoking.” This example illustrates how a processor of vacuum-packaged hotsmoked salmon can control C. botulinum toxin formation. It is provided for illustrative purposes only. C. botulinum toxin formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., aquaculture drugs, environmental chemical contaminants and pesticides, parasites, growth of other pathogenic bacteria, survival of other pathogenic bacteria through the cook step, and metal fragments). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE* 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

CHAPTER 13: Clostridium botulinum Toxin Formation 

273 

Smoking

and

drying 

C. botulinum 

toxin 

formation 

in finished

product 

Minimum time

open vent: 2 hours 

Time of open 

vent 

Clock Each batch Smoker 

employee 

Extend the drying 

process

Hold and evaluate 

based on finished

product water 

phase salt analysis 

Production 

record 

Establish a brining and drying 

process Quarterly water phase salt 

analysis of the finished product

Review monitoring, corrective 

action, and verification records 

within 1 week of preparation 

Heating C. botulinum 

toxin 

formation in 

the finished

product 

Internal 

temperature of fish 

held at or above 

145°F for at least 30 

minutes 

Internal 

temperature 

of fish and

time at that

temperature 

Digital data

logger with

three probes

in thickest 

fish in cold

spot of

smoking

chamber 

Continuous,

with visual

check of

recorded data

at the end of

the batch 

Smoker 

employee 

Extend the 

heating

process

Make repairs or 

adjustments to the

smoking chamber 

Hold and evaluate 

the product 

Data

logger

printout 

Check the data logger for accuracy 

and damage and to ensure that

it is operational before putting 

into operation; check it daily, at 

the beginning of operations; and 

calibrate it once per year

Review monitoring, corrective 

action, and verification records 

within 1 week of preparation 

Finished

product 

storage 

C. botulinum 

toxin 

formation 

during

finished

product 

storage 

Maximum cooler

temperature: 40°F

(based on growth 

of vegetative 

pathogens) 

Cooler air

temperature 

Digital data

logger 

Continuous,

with visual

check of

recorded data

once per day 

Production 

employee 

Adjust or repair 

the cooler

Hold and evaluate 

the product based 

on time and

temperature of 

exposure 

Digital

data logger

printout 

Check the data logger for accuracy 

and damage and to ensure that

it is operational before putting 

into operation; check it daily, at 

the beginning of operations; and 

calibrate it once per year

Review monitoring, corrective 

action, and verification records 

within 1 week of preparation

*Note: The critical limits in this example are for illustrative purposes only and are not related to any recommended process. 
•	 CONTROL STRATEGY EXAMPLE 2 - 

REFRIGERATION WITH TTI 

This control strategy should include the following 

elements, as appropriate: 

a.	 Unactivated TTI receipt; 

b.	 Unactivated TTI storage; 

c.	 Application and activation of TTI; 

d.	 Refrigerated finished product storage; 

e.	 Receipt of product by secondary 


processor.
 

2A. UNACTIVATED TTI RECEIPT 

Set Critical Limits. 

•	 The TTI is suitable for use. It should be 

designed to perform properly under the 

conditions that it will be used. It should 

also be designed to produce an alert 

indicator (e.g., a color change of the device) 

at a combination of time and temperature 

exposures that will prevent the formation of 

non-proteolytic C. botulinum toxin formation 

(e.g., consistent with the “Skinner-Larkin 

curve”); 

AND 

•	 Where transportation conditions (e.g., 

temperature) could affect the functionality 

of the TTI, all lots of TTIs are accompanied 

by transportation records that show that they 

were held at conditions that do not result in 

loss of functionality throughout transit; 

AND 

•	 The TTI functions (i.e., produces an 

alert indicator, such as a color change of 

the device, when exposed to time and 

temperature abuse) at time of receipt. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 For suitability of use: 

° Performance data from the manufacturer; 

AND 

•	 For transportation conditions: 

° The temperature within the truck or 

other carrier throughout transportation; 

OR 

° Other conditions that affect the 

functionality of the TTI, where 

applicable; 

AND 

•	 For functionality at receipt: 

° The ability of the TTI to produce an 

alert indicator, such as a color change of 

the device, when exposed to time and 

temperature abuse at time of receipt. 

»	 How Will Monitoring Be Done? 

•	 For suitability of use: 

° Review performance data; 

AND 

•	 For transportation conditions: 

° Use a continuous temperature-recording 

device (e.g., a recording thermometer) 

for ambient air temperature monitoring 

during transit; 

AND 

•	 For functionality at receipt: 

° Activate and then expose a TTI from 

the lot to ambient air temperature for 

sufficient time to determine whether 

it is functional (i.e., produces an alert 

indicator, such as a color change of the 

device). 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 For suitability of use: 

° The first shipment of a TTI model; 

AND 

•	 For transportation conditions and 

functionality at receipt:
 

° Every shipment.
 

CHAPTER 13: Clostridium botulinum Toxin Formation 

274 
»	 Who Will Do the Monitoring? 

•	 For suitability of use: 

° Anyone with an understanding of TTI 

validation studies and of the intended 

conditions of use; 

AND 

•	 For transportation conditions and 

functionality at receipt: 

° Anyone with 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 or return the shipment. 

AND 

Take the following corrective actions to regain control 

over the operation after a critical limit deviation: 

•	 For suitability of use: 

° Discontinue use of the supplier until

documentation of validation has been 

provided; 

AND 

•	 For transportation conditions and 

functionality at receipt: 

° Discontinue use of the supplier or

carrier until evidence is obtained that the 

identified production or transportation 

practices have been improved. 

Establish a Recordkeeping System. 

•	 For suitability of use: 

° Manufacturer’s performance data; 

AND 

•	 For transportation conditions: 

° Printouts, charts, or readings from 

continuous temperature-recording 

devices; 

AND 

° Records of visual checks of recorded 

data;
 

AND
 

•	 For functionality at receipt: 

° Results of a TTI challenge test (i.e., 

whether the TTI produces an alert 

indicator, such as a color change of 

the device, when exposed to time and 

temperature abuse). 

Establish Verification Procedures. 

•	 Check the accuracy of temperature-recording 

devices that are used for monitoring transit 

conditions, for all new suppliers and at 

least quarterly for each supplier thereafter. 

Additional checks may be warranted based 

on observations at receipt (e.g., refrigeration 

units appear to be in poor repair or readings 

appear to be erroneous). The accuracy of 

the device can be checked by comparing 

the temperature reading on the device with 

the reading on a known accurate reference 

device (e.g., a NIST-traceable thermometer) 

under conditions that are similar to how it 

will be used (e.g., air temperature) within the 

temperature range at which it will be used; 

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. 

2B. UNACTIVATED TTI STORAGE 

Set Critical Limits. 

•	 The combination of storage conditions 

(e.g., temperature) that prevent loss of 

functionality throughout storage (based 

on manufacturer’s specifications). 

CHAPTER 13: Clostridium botulinum Toxin Formation 

275 
Establish Monitoring Procedures.	 Establish Corrective Action Procedures. 

»	 What Will Be Monitored? 

•	 Storage air temperature, where temperature 

affects functionality of the TTI; 

AND/OR 

•	 Other storage conditions that affect 

functionality of the TTI. 

»	 How Will Monitoring Be Done? 

•	 For temperature: 

° Use a continuous temperature-recording 

device (e.g., a recording thermometer); 

AND/OR 

•	 For other conditions: 

° Use instruments appropriate for the 

purpose. 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 For temperature: 

° Continuous monitoring by the device 

itself, with a visual check of the recorded 

data at least once per day; 

AND/OR 

•	 For other conditions: 

° With sufficient frequency to ensure 

control. 

»	 Who Will Do the Monitoring? 

•	 With continuous temperature-recording 

devices: 

° Monitoring is performed by the device 

itself. The visual check of the data 

generated by the device, to ensure 

that the critical limits have been met 

consistently, may be performed by any 

person who has an understanding of the 

nature of the controls; 

AND 

•	 For other checks: 

° Any person who has an understanding of

the nature of the controls. 

Take the following corrective action to a TTI involved in a 

critical limit deviation: 

•	 Destroy the lot of TTIs. 

AND 

Take the following corrective action to regain control 

over the operation after a critical limit deviation: 

•	 Make repairs or adjustments to the 

malfunctioning cooler; 

AND/OR 

•	 Make other repairs or adjustment appropriate 

for the condition. 

Establish a Recordkeeping System. 

•	 For refrigerated storage: 

° Printouts, charts, or readings from 

continuous temperature-recording 


devices;
 

AND
 

° Record of visual checks of recorded data;
 

AND/OR 

•	 Storage record showing the results of 

monitoring of other conditions. 

Establish Verification Procedures. 

•	 Before a temperature-recording device (e.g., 

a recording thermometer) is put into service, 

check the accuracy of the device to verify that 

the factory calibration has not been affected. 

This check can be accomplished by: 

° Immersing the sensor in an ice slurry 

(32°F (0°C)) if the device will be used at 

or near refrigeration temperature; 

OR 

° Comparing the temperature reading on 

the device with the reading on a known 

accurate reference device (e.g., a NISTtraceable thermometer) under conditions 

that are similar to how it will be used (e.g., 

air temperature) within the temperature 

range at which it will be used; 

CHAPTER 13: Clostridium botulinum Toxin Formation 

276 
AND 

•	 Once in service, check the temperaturerecording 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. 

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 other instrument calibration, as 

appropriate; 

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. 

2C. APPLICATION AND ACTIVATION OF TTI 

Set Critical Limits. 

•	 Each consumer package has an activated 

TTI. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 Packages for the presence of an activated 

TTI. 

»	 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: 

•	 Hold the lot below 38°F (3.3°C) until TTIs 

are applied and activated. 

AND 

Take the following corrective action to regain control 

over the operation after a critical limit deviation: 

•	 Identify and correct the cause of the TTI 

application or activation deficiency. 

Establish a Recordkeeping System. 

•	 Packaging control record that shows the 

results of the TTI checks. 

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 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 
CHAPTER 13: Clostridium botulinum Toxin Formation 

279 

TABLE 13-2

CONTROL STRATEGY EXAMPLE 2 - REFRIGERATION WITH TTI

This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Refrigeration With TTI.” This example illustrates how a processor of refrigerated,vacuum-packaged, raw fish fillets can control C. botulinum toxin formation. It is provided for illustrative purposes only. C. Botulinum toxin formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., aquaculture drugs, environmental chemical contaminants and pesticides, parasites, growth of other pathogenic bacteria, and metal fragments).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE ACTION(S) RECORDS VERIFICATION

WHAT HOW FREQUENCY WHO 

Receipt of 

TTI 

C. botulinum 

toxin 

formation in 

the finished

product 

TTI is 

suitable for use 

Performance 

data from the

manufacturer 

Review of 

performance 

data 

First

shipment of a

TTI model 

Quality

assurance 

supervisor 

Reject the 

shipment

Discontinue use of the

supplier until appropriate

validation 

documentation

is provided 

Manufacturer’s 

performance 

data 

Review 

monitoring,

corrective 

action records

within 1 week 

of preparation 

All lots received 

are

accompanied

by truck 

records

that show 

temperature 

was maintained 

at or below 

40°F 

Truck 

temperature 

Digital time and

temperature 

data logger 

Continuous,

with visual

review and 

evaluation of 

temperaturemonitoring

records for each 

shipment 

Receiving 

employee 

Discontinue use of the

supplier or carrier until 

evidence is obtained 

that the identifi ed 

transportation- handling 

practices have been 

improved

Reject the 

shipment 

Receiving 

record 

Check the data

logger for all 

new suppliers 

and for all 

suppliers at

least quarterly 

thereafter

Review 

monitoring,

corrective 

action records

within 1 week 

of preparation 

The TTI 

functions 

at receipt 

The ability

of the TTI to 

change color

when exposed 

to room air

temperature 

Expose a TTI 

from the lot

to room air

temperature for 

sufficient time 

to determine 

whether it

changes color 

Every 

shipment 

Quality

assurance 

staff 

Discontinue use of the

supplier or carrier until 

evidence is obtained that 

the identifi ed production 

or transportationhandling practices have 

been improved 

TTI 

challenge

record 

Review 

monitoring,

corrective 

action records

within 1 week 

of preparation 
TABLE 13-2

CONTROL STRATEGY EXAMPLE 2 - REFRIGERATION WITH TTI

This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Refrigeration With TTI.” This example illustrates how a processor of refrigerated,vacuum-packaged, raw fish fillets can control C. botulinum toxin formation. It is provided for illustrative purposes only. C. Botulinum toxin formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., aquaculture drugs, environmental chemical contaminants and pesticides, parasites, growth of other pathogenic bacteria, and metal fragments).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE ACTION(S) RECORDS VERIFICATION

WHAT HOW FREQUENCY WHO 

CHAPTER 13: Clostridium botulinum Toxin Formation 

280 

TTI 

storage 

C. botulinum 

toxin 

formation in 

the finished

product 

Cooler

maintained

below 38°F 

Cooler

temperature 

Digital time and

temperature 

data logger 

Continuous,

with visual

check of

recorded data

once per day 

Quality

assurance 

staff 

Repair or adjust cooler

Destroy the lot of TTIs 

Data

logger printout 

Check the

data logger for 

accuracy and 

damage and to

ensure that it

is operational 

before putting 

into operation; 

check it

daily, at the 

beginning of

operations; and 

calibrate it once 

per year

Review 

monitoring,

corrective 

action, and 

verification 

records within

1 week of 

preparation 

TTI 

attachment

and

activation 

C. botulinum 

toxin 

formation in 

the finished

product 

Each

package has an

activated TTI 

Packages for 

the presence

of an

activated TTI 

Visual 

examination 

Representative 

number of

packages from

each lot of

product 

Production 

employee 

Hold lot below 38°F, and 

apply and activate TTIs

Identify and correct the 

cause of TTI application 

deviation 

Packaging 

control record 

Review 

monitoring,

and corrective 

action and 

verification 

records within

1 week of 

preparation 
TABLE 13-2

CONTROL STRATEGY EXAMPLE 2 - REFRIGERATION WITH TTI

This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Refrigeration With TTI.” This example illustrates how a processor of refrigerated,vacuum-packaged, raw fish fillets can control C. botulinum toxin formation. It is provided for illustrative purposes only. C. Botulinum toxin formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., aquaculture drugs, environmental chemical contaminants and pesticides, parasites, growth of other pathogenic bacteria, and metal fragments).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE ACTION(S) RECORDS VERIFICATION

WHAT HOW FREQUENCY WHO 

CHAPTER 13: Clostridium botulinum Toxin Formation 

281 

Finished

product 

storage 

C. botulinum 

toxin 

formation 

during

finished

product 

storage 

Maximum

cooler

temperature 

38°F 

Cooler air

temperature 

Digital data

logger 

Continuous,

with visual

check of

recorded data

once per day 

Production 

employee 

Adjust or repair cooler 

Hold and

evaluate the product 

based on time and

temperature of exposure 

Digital logger

printout 

Check the

data logger for 

accuracy and 

damage and to

ensure that it

is operational 

before putting 

into operation; 

check it

daily, at the 

beginning of

operations; and 

calibrate it once 

per year

Review 

monitoring,

corrective 

action, and 

verification 

records within

1 week of 

preparation 

*Note: The critical limits in this example are for illustrative purposes only and are not related to any recommended process. 
•	 CONTROL STRATEGY EXAMPLE 3 - FROZEN WITH 

LABELING 

Set Critical Limits. 

•	 All finished product labels must contain a 

“keep frozen” statement (e.g., “Important, 

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. 

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 13: Clostridium botulinum Toxin Formation 

282 
CHAPTER 13: Clostridium botulinum Toxin Formation 

283 

TABLE 13-3

CONTROL STRATEGY EXAMPLE 3 - FROZEN WITH LABELING

This table is an example of a portion of a HACCP plan using “Control Strategy Example 3 - Frozen With Labeling.” This example illustrates how a processor of frozen,vacuum-packaged, raw fish fillets can control C. botulinum toxin formation. It is provided for illustrative purposes only. C. Botulinum toxin formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides, parasites, and metal fragments).

Example Only

See Text for Full Recommendations 

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Receipt of 

labeling 

C. botulinum 

toxin 

formation 

during

finished

product 

storage 

All finished

product labels 

must contain a

“keep 

frozen”

statement 

Finished

product 

labels for the 

presence of a

“keep frozen”

statement 

Visual 

examination 

Representative 

number of

packages from

each lot of

product 

Receiving 

employee 

Segregate and

relabel any

improperly

labeled product

Segregate and

destroy any 

label stock

that does not

contain the

proper

statement

Determine 

and correct 

the cause of

improper labels 

Label receiving

record 

Review 

monitoring and

correction 

action records 

within 1 week 

of preparation 
•	 CONTROL STRATEGY EXAMPLE 4 - PICKLING 

AND SALTING 

This control strategy should include the following 

elements, as appropriate: 

a.	 Brining, pickling, salting, and 


formulation;
 

b.	 Refrigerated finished product storage; 

c.	 Receipt of Product by secondary 


processor.
 

4A. BRINING, PICKLING, SALTING, AND 

FORMULATION 

Set Critical Limits. 

•	 The minimum or maximum values for 

the critical factors of the brining, pickling, 

or formulation process established by a 

scientific study. The critical factors are those 

that are necessary to ensure that the finished 

product has: 

For refrigerated, reduced oxygen-packaged 

fishery products: 

° A water phase salt level of at least 5%; 

OR
 

° A pH of 5.0 or below; 


OR
 

° A water activity of below 0.97; 


OR 

° A water phase salt level of at least 

2.4% in surimi-based products, when 


combined with a pasteurization process 


in the finished product container 


of 185°F (85°C) for 15 minutes 


(pasteurization controls are covered in 


Chapter 16); 


OR
 

° A combination of water phase salt,
 

pH, and/or water activity that, when 

combined, have been demonstrated to 

prevent the growth of C. botulinum type 

E and non-proteolytic types B and F. 

For unrefrigerated (shelf-stable), reduced oxygenpackaged products: 

° A water phase salt level of at least 20% 

(based on the maximum salt level for 


growth of S. aureus); 


OR
 

° A pH of 4.6 or below; 


OR 

° A water activity of 0.85 or below (based 

on the minimum water activity for 

growth and toxin formation of S. aureus). 

A heat treatment, addition of chemical additives, 

or other treatment may be necessary to inhibit or 

eliminate spoilage organisms (e.g., mold) in shelfstable products. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 The critical factors of the established 

pickling, brining, or formulation process. 

These may include: brine and acid strength; 

brine or acid to fish ratio; brining and 

pickling time; brine and acid temperature; 

thickness, texture, fat content, quality, and 

species of fish; 

OR 

•	 The water phase salt, pH, and/or water 

activity of the finished product. 

»	 How Will Monitoring Be Done? 

•	 For brine strength: 

° Use a salinometer;

AND 

•	 For acid strength: 

° Use a pH meter or titrate for acid 

concentration;
 

AND
 

•	 For brine/acid temperature: 

° Use a temperature-indicating device (e.g., 

a thermometer);
 

AND
 

CHAPTER 13: Clostridium botulinum Toxin Formation 

284 
•	 For all other critical factors specified by the 

study: 

°	 Use equipment appropriate for the 

measurement;
 

OR
 

•	 For water phase salt, pH, and/or water 

activity: 

° Collect a representative sample of the 

finished product, and conduct water 

phase salt, pH, and/or water activity 

analysis, as appropriate. 

Establish Corrective Action Procedures. 

Take the following corrective action to a product 

involved in a critical limit deviation: 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 For brine and acid strength: 

° At the start of each brining, pickling, and 

formulation process;
 

AND
 

•	 For brine and acid temperature: 

° At the start of each brining, pickling, and 

formulation process and at least every 2 

hours thereafter; 

AND 

•	 For brine or acid to fish ratio: 

° At the start of each brining, pickling, and 

formulation process;
 

AND
 

•	 For other critical factors specified by the study: 

° As often as necessary to maintain control; 

OR 

•	 Water phase salt, pH, and/or water activity 

analysis should be determined for each batch 

of finished product. 

»	 Who Will Do the Monitoring? 

•	 For water activity: 

° Any person with sufficient training to 

perform the analysis;
 

OR
 

•	 For other checks: 

° Any person with an understanding of the

nature of the controls. 

•	 Chill and hold the product until it can be 

evaluated based on its water phase salt, pH, 

and/or water activity level; 

OR 

•	 Reprocess the product (if reprocessing does 

not jeopardize the safety of the product); 

OR 

•	 Divert the product to a use in which the 

critical limit is not applicable (e.g., packaging 

that is not hermetically sealed, or a LACF, or 

a frozen product); 

OR 

•	 Divert the product to a non-food use; 

OR 

•	 Destroy the product. 

AND 

Take the following corrective action to regain control 

over the operation after a critical limit deviation: 

•	 Adjust the brine or acid strength or brine or 

acid to fish ratio; 

OR 

•	 Extend the brining or pickling time to 

compensate for an improper brine or acid 

temperature. 

Establish a Recordkeeping System. 

•	 Records, as necessary, to document the 

monitoring of the critical factors of the 

brining or pickling process, as established 

by a study (e.g., a processing record showing 

the results of the brine or acid strength 

and temperature, brine or acid to fish ratio, 

size and species of fish, time of brining or 

pickling); 

OR 

•	 Record of determinations of the finished 

product water phase salt, pH, or water activity. 

CHAPTER 13: Clostridium botulinum Toxin Formation 

285 
Establish Verification Procedures. 

•	 Process validation study (except where water 

phase salt, pH, or water activity analysis 

of the finished product is the monitoring 

procedure): 

° The adequacy of the pickling, brining, 

and formulation process steps should 

be established by a scientific study. For 

refrigerated, reduced oxygen-packaged 

products, it should be designed to 

consistently achieve: a water phase salt 

level of at least 5%; a pH of 5.0 or below; 

a water activity of below 0.97; a water 

phase salt level of at least 2.4% in surimibased products, when combined with 

a pasteurization process in the finished 

product container of 185°F (85°C) for 

at least 15 minutes; or a combination 

of salt, pH, and/or water activity that, 

when combined, prevent the growth of 

C. botulinum type E and non-proteolytic 

types B and F (established by a scientific 

study). For unrefrigerated (shelf-stable), 

reduced oxygen-packaged products, 

it should be designed to consistently 

achieve: a water phase salt level of 

at least 20% (based on the maximum 

water phase salt level for the growth of 

S. aureus); a pH of 4.6 or below; or a 

water activity of 0.85 or below (based 

on the minimum water activity for the 

growth of S. aureus). Expert knowledge 

of pickling, brining, and formulation 

processes may be required to establish 

such a process. Such knowledge can be 

obtained by education or experience, or 

both. Establishment of pickling, brining, 

and formulation processes may require 

access to adequate facilities and the 

application of recognized methods. In 

some instances, pickling, brining, and 

formulation studies may be required to 

establish minimum processes. In other 

instances, existing literature, which 

establishes minimum processes, is 

available. Characteristics of the process 

and/or product that affect the ability 

of the established minimum pickling, 

brining, and formulation process 

should be taken into consideration in 

the process establishment. A record of 

the process establishment should be 

maintained; 

AND 

•	 Before a temperature-indicating device (e.g., 

a thermometer) is put into service, check 

the accuracy of the device to verify that the 

factory calibration has not been affected. 

This check can be accomplished by: 

° Immersing the sensor in an ice slurry 

(32°F (0°C)) if the device will be used at 

or near refrigeration temperature; 

OR 

° Immersing the sensor in boiling water 

(212°F (100°C)) if the device will be 

used at or near the boiling point. Note 

that the temperature should be adjusted 

to compensate for altitude, when 

necessary); 

OR 

° Doing a combination of the above if 

the device will be used at or near room 

temperature; 

OR 

° Comparing the temperature reading on 

the device with the reading on a known 

accurate reference device (e.g., a NISTtraceable thermometer) under conditions 

that are similar to how it will be used 

(e.g., brine temperature) within the 

temperature range at which it will be 

used; 

AND 

•	 Once in service, check the temperatureindicating 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 

CHAPTER 13: Clostridium botulinum Toxin Formation 

286 
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 

•	 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 

any critical limit deviations that occurred 

were appropriately addressed. 

4B. REFRIGERATED FINISHED PRODUCT STORAGE 

Follow the guidance for “Control Strategy 

Example 1 - Smoking (1d - Refrigerated Finished 

Product Storage).” 

4C. RECEIPT OF PRODUCT BY SECONDARY 

PROCESSOR 

Follow the guidance for “Control Strategy 

Example 1 - Smoking (1e - Receipt of Product by 

Secondary Processor).” 

CHAPTER 13: Clostridium botulinum Toxin Formation 

287 
CHAPTER 13: Clostridium botulinum Toxin Formation 

288 

TABLE 13-4

CONTROL STRATEGY EXAMPLE 4 - PICKLING AND SALTING

This table is an example of a portion of a HACCP plan using “Control Strategy Example 4 - Pickling and Salting.” This example illustrates how a pickled herring processorcan control C. botulinum toxin formation. It is provided for illustrative purposes only. C. botulinum toxin formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., histamine, environmental and chemical contaminants and pesticides, parasites, and metal fragments).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Pickling C. botulinum 

toxin formation 

in the finished

product 

Maximum

finished

product pH in 

the loin muscle

of 5.0 

Finished

product pH in 

the loin muscle 

Collect a 

sample of the

product from 

each pickling

tank at the

end of each

pickling cycle 

and analyze for 

pH using a pH

meter 

Each

pickling

tank, each 

cycle 

Quality

control

personnel 

Continue the

pickling process

until pH meets

the critical limit 

Pickling control

record 

Daily calibration of 

the pH meter

Review 

monitoring,

corrective action,

and verification 

records within

1 week of 

preparation 

Finished

product storage 

C. botulinum 

toxin 

formation 

during

finished

product 

storage 

Maximum

cooler

temperature: 

40°F

(based on

growth of 

vegetative 

pathogens) 

Cooler air

temperature 

Time and 

temperature 

data logger 

Continuous,

with visual

check of

recorded

data once

per day 

Production 

employee 

Adjust or 

repair cooler

Hold and

evaluate the 

product based 

on time and

temperature of 

exposure 

Data logger

printout 

Check the data

logger for accuracy 

and damage and

to ensure that

it is operational 

before putting 

into operation; 

check it daily, at 

the beginning of

operations; and 

calibrate it once 

per year

Review 

monitoring,

corrective action,

and verification 

records within 1

week of 

preparation 
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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 NonFDA Web site references after March 29, 2011. 

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production of Clostridium botulinum type 

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and H. Sugiyama. 1968. Survival and 

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•	 Daniels, R. W. 1991. Applying HACCP to 

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2000. Effect of films of different oxygen 

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E. Peterson, and F. M. Teeny. 1982. Inhibition 

of Clostridium botulinum types A and E 

toxin production by liquid smoke and NaCl 

in hot-process smoke-flavored fish. J. Food 

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Africa: a study on processing marketing and 

consumption. FAO Fisheries technical paper no. 

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modified atmosphere packaging technology - 

a review. J. Food Prot. 54:58-70. 

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Huang. 1994. Clostridium botulinum type E 

outgrowth and toxin production in vacuumskin packaged shrimp. Food Microbiol. 

11:467-472. 

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Peck. 1996. Predictive model of the effect 

of temperature, pH and sodium chloride 

on growth from spores of non-proteolytic 

Clostridium botulinum. Int. J. Food Microbiol. 

31:69-85. 

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Effect of salt content and pH on toxigenesis 

by Clostridium botulinum in caviar. J. Food 

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•	 Hilderbrand, K. S. 1992. Fish smoking 

procedures for forced convection 

smokehouses, Special Report 887. Oregon 

State Extension Service, Newport, OR. 

•	 Kautter, D. A., P. K. Lynt, T. Lily, and H. M. 

Solomon. 1981. Evaluation of the botulism 

hazard from nitrogen-packed sandwiches. J. 

Food Prot. 44:59-61. 

•	 Kornacki, J. L., and D. A. Gabis. 1990. 

Microorganisms and Refrigeration 

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10:192-195. 

•	 Loha-unchit, K. 1998. How Fish Sauce 

is Made. Kasma’s Thai Food and Travel. 

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fishsauce1.html. 

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pasteurization of crab and shrimp from the 

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health aspects. J. Food Sci. 36:277-279. 

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Bacteria associated with processed 

crawfish and potential toxin production by 

Clostridium botulinum type E in vacuumpackaged and aerobically packaged crawfish 

tails. J. Food Prot. 63:1687-1696. 

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Smelt. 1994. Effects of water activity and pH 

on growth of Clostridium botulinum. J. Appl. 

Bact. Symp. Suppl. 76:105S-114S. 

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Correa. 2000. Smoked, cured, and dried fish. 

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Davis, (eds.), Marine & Freshwater Products 

Handbook, 2000. Technomic Publishing Co. 

Lancaster, PA 

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Microbiological Criteria for Foods. 1992. 

Vacuum or modified atmosphere packaging 

for refrigerated raw fishery products. 

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Department of Agriculture, Washington, DC. 

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map_ fishery.htm. 

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the safety of refrigerated processed foods 

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Technol. 8:186-192. 

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E. M. Suzuki, and M. E. Peterson. 1982. 

Inhibition of Clostridium botulinum types A 

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sodium chloride in hot process (smoked) 

salmon. J. Food Prot. 45:833-841. 

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F. T. Poysky, J. S. Almond, and M. W. Eklund. 

1993. Parameters for control of Listeria 

monocytogenes in smoked fishery products: 

sodium chloride and packaging method. J. 

Food Prot. 56:938-943. 

•	 Reddy, N. R., A. Paradis, M. G. Roman, H. M. 

Solomon, and E. J. Rhodehamel. 1996. Toxin 

development by Clostridium botulinum in 

modified atmosphere-packaged fresh tilapia 

fillets during storage. J. Food Sci. 61:632-635. 

•	 Reddy, N. R., D. J. Armstrong, E. J. 

Rhodehamel, and D. A. Kautter. 1992. Shelflife extension and safety concerns about 

fresh fishery products packaged under 

modified atmospheres: a review. J. Food Saf. 

12:87-118. 

•	 Reddy, N. R., H. M. Solomon, H. Yep, M. G. 

Roman, and E. J. Rhodehamel. 1997. Shelf 

life and toxin development by Clostridium 

botulinum during storage in modified 

atmosphere-packaged fresh aquacultured 

salmon fillets. J. Food Prot. 60:1055-1063. 

•	 Reddy, N. R., M. G. Roman, M. Villanueva, 

H. M. Solomon, D. A. Kautter, and E. J. 

Rhodehamel. 1996. Shelf life and Clostridium 

botulinum toxin development during storage 

of modified atmosphere-packaged fresh 

catfish fillets. J. Food Sci. 62:878-884. 

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sous vide processing. Food Technol. 46:73­

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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. 

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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. 

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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 

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. 

Pathogenic bacteria growth and toxin formation 

in the finished product as a result of inadequate 

drying of fishery products can cause consumer 

illness. The primary pathogens of concern are 

Staphylococcus aureus (S. aureus) and Clostridium 

botulinum (C. botulinum). See Appendix 7 for a 

description of the public health impacts of 

these pathogens. 

•	 Control by Drying 

Dried products are usually considered shelf stable 

and are, therefore, often stored and distributed 

unrefrigerated. Examples of shelf-stable dried 

fish products are salmon jerky, octopus chips, 

dried shrimp, stock fish, and shark cartilage. The 

characteristic of dried foods that makes them 

shelf stable is their low water activity (Aw). Water 

activity is the measure of the amount of water 

in a food that is available for the growth of 

microorganisms, including pathogenic bacteria. A 

water activity of 0.85 or below will prevent the 

growth and toxin production of all pathogenic 

bacteria, including S. aureus and C. botulinum, 

and is critical for the safety of a shelf-stable dried 

product. S. aureus grows at a lower water activity 

than other pathogenic bacteria, and should, 

therefore, be considered the target pathogen for 

drying for shelf-stable products. 

You should select a packaging material that will 

prevent rehydration of the product under the 

expected conditions of storage and distribution. 

Additionally, finished product package closures 

should be free of gross defects that could expose 

the product to moisture during storage and 

distribution. Chapter 18 provides guidance on 

control of container closures. 

Some dried products that are reduced oxygen 

packaged (e.g., vacuum packaged, modified 

atmosphere packaged) are dried only enough 

to control growth and toxin formation by C. 

botulinum type E and non-proteolytic types B 

and F (i.e., types that will not form toxin with 

a water activity of below 0.97). These dried 

products are then refrigerated to control growth 

and toxin formation by C. botulinum type A and 

proteolytic types B and F and by other pathogenic 

bacteria that may be present in the product, 

including S. aureus. The products might have the 

appearance of a fully dried product. Therefore, 

their packaging should include “keep refrigerated” 

labeling to ensure that temperature controls are 

applied throughout distribution. 

Distributing partially dried, reduced oxygen 

packaged products frozen also could be used 

to control these pathogens. However, labeling 

with “keep frozen” instructions would then be 

important to ensure food safety. More information 

on C. botulinum and reduced oxygen packaging is 

contained in Chapter 13. 

This chapter does not cover the growth of 

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 

during the drying process. That hazard is 

covered in Chapter 12. It also does not cover the 

control of C. botulinum type A and proteolytic 

types B and F and that of other pathogenic 

bacteria that may be present, including S. aureus, 

during refrigerated storage of reduced oxygen 

packaged, partially dried products. That hazard 

is covered in Chapters 12 and 13, respectively. 

Controlling pathogenic bacteria growth and toxin 

formation by drying is best accomplished by: 

•	 Scientifically establishing a drying process 

that reduces the water activity to 0.85 or 

below if the product will be stored and 

distributed unrefrigerated (shelf stable). Note 

that a heat treatment, addition of chemical 

additives, further drying, or other treatment 

may be necessary to inhibit or eliminate 

spoilage organisms, for example, mold; 

•	 Scientifically establishing a drying process 

that reduces the water activity to below 0.97 

if the product will be stored refrigerated (not 

frozen) in reduced oxygen packaging; 

•	 Designing and operating the drying 

equipment so that every unit of a product 

receives at least the established minimum 

process; 

•	 Packaging the finished product in a container 

that will prevent rehydration. 

The drying operation used in the production of 

smoked or smoke-flavored fish is not designed to 

result in a finished product water activity of 0.85 

or below. The controls for these products are 

described in Chapter 13. 

Because spores of C. botulinum are known to be 

present in the viscera of fish, any product that 

will be preserved by salting, drying, pickling, 

or fermentation should be eviscerated prior to 

processing (see the “Compliance Policy Guide,” 

Sec. 540.650). Without evisceration, toxin 

formation is possible during the process even 

with strict control of temperature. Evisceration 

should be thorough and performed to minimize 

contamination of the fish flesh. If even a portion 

of the viscera or its contents is left behind, the 

risk of toxin formation by C. botulinum remains. 

Small fish, less than 5 inches in length, that are 

processed in a manner that eliminates preformed 

toxin and prevents toxin formation and that 

reach (1) a water phase salt content of 10%, a 

value based on the control of C. botulinum type 

A and proteolytic types B and F, in refrigerated 

products; or (2) a water activity of 0.85 or below 

(note that this is a value based on the minimum 

water activity for toxin production by S. aureus, 

in shelf-stable products); or (3) a pH (acidity) 

level of 4.6 or less in shelf-stable products are not 

subject to the evisceration recommendation. 

•	 Strategies for controlling pathogenic 

bacteria growth 

Pathogens can enter the process on raw materials. 

They can also be introduced into foods during 

processing, from the air, unclean hands, insanitary 

utensils and equipment, contaminated water, and 

sewage. There are a number of strategies for the 

control of pathogenic bacteria in fish and fishery 

products. They include: 

•	 Controlling the amount of moisture that is 

available for pathogenic bacteria growth 

(water activity) in the product by drying 

(covered in this chapter); 

•	 Controlling the amount of moisture that is 

available for pathogenic bacteria growth 

(water activity) in the product by formulation 

(covered in Chapter 13); 

•	 Controlling the amount of salt or 

preservatives, such as sodium nitrite, in the 

product (covered in Chapter 13); 

•	 Controlling the pH in the product (covered 

by the Acidified Foods regulation, 21 CFR 

114, for shelf-stable acidified products, and 

by Chapter 13 for refrigerated acidified 

products); 

•	 Controlling the source of molluscan shellfish 

and the time from exposure to air (e.g., by 

harvest or receding tide) to refrigeration to 

control pathogens from the harvest area 

(covered in Chapter 12); 

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

294 
•	 Controlling the introduction of pathogenic 

bacteria after the pasteurization process 

(covered in Chapter 18); 

•	 Managing the amount of time that food is 

exposed to temperatures that are favorable 

for pathogenic bacteria growth and toxin 

production (covered generally in Chapter 12; 

for C. botulinum, in Chapter 13; and for S. 

aureus in hydrated batter mixes, in Chapter 

15); 

•	 Killing pathogenic bacteria by cooking 

or pasteurization (covered in Chapter 16) 

or by retorting (covered by the Thermally 

Processed Low-Acid Foods Packaged in 

Hermetically Sealed Containers regulation, 21 

CFR 113 (called the Low-Acid Canned Foods 

Regulation in this guidance document)); 

•	 Killing pathogenic bacteria by processes that 

retain raw product characteristics (covered in 

Chapter 17). 

DETERMINE WHETHER THE POTENTIAL 

HAZARD IS SIGNIFICANT. 

The following guidance will assist you in 

determining whether pathogenic bacteria growth 

and toxin formation as a result of inadequate 

drying is a significant hazard at a processing step: 

1.	 For shelf-stable, dried products, is it reasonably 

likely that S. aureus will grow and form toxin in 

the finished product if the product is inadequately 

dried? 

Table A-1 (Appendix 4) provides information 

on the conditions under which S. aureus will 

grow. If your food that is not distributed 

refrigerated or frozen and meets these 

conditions (i.e., in Table A-1) before drying, 

then drying will usually be important to the 

safety of the product, because it provides 

the barrier to S. aureus growth and toxin 

formation. Under ordinary circumstances, it 

would be reasonably likely that S. aureus will 

grow and form toxin in such products during 

finished product storage and distribution 

if drying is not properly performed. Note 

that drying to control toxin formation by S. 

aureus will also control toxin formation by C. 

botulinum in these products. 

2.	 For shelf-stable, dried products, can S. aureus 

toxin formation that is reasonably likely to occur 

be eliminated or reduced to an acceptable level 

at this processing step? 

Pathogenic bacteria growth and toxin 

formation as a result of inadequate drying 

should also be considered a significant 

hazard at any processing step where a 

preventive measure is, or can be, used to 

eliminate the hazard of S. aureus toxin 

formation (or reduce the likelihood of its 

occurrence to an acceptable level) if it is 

reasonably likely to occur. The preventive 

measure that can be applied for pathogenic 

bacteria growth and toxin formation as a 

result of inadequate drying are: 

•	 Proper design and control of the drying 

process (covered in this chapter); 

3.	 For refrigerated or frozen, partially dried (i.e., 

not shelf stable) products, is it reasonably likely 

that C. botulinum type E and nonproteolytic types 

B and F will grow and form toxin in the finished 

product if the product is inadequately dried? 

Table A-1 (Appendix 4) provides information 

on the conditions under which C. botulinum 

type E and non-proteolytic types B and F 

will grow. Because of the need to prevent 

rehydration of dried products, these products 

generally will be contained in a reduced 

oxygen package. If your refrigerated (not 

frozen), reduced oxygen packaged food meets 

these conditions (i.e., Table A-1) before drying, 

then drying will usually be important to the 

safety of the product, because it provides 

the barrier to growth and toxin formation 

by C. botulinum type E and non-proteolytic 

types B and F. Note that refrigeration will 

control toxin formation by S. aureus and C. 

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 

that C. botulinum type E and non-proteolytic 

types B and F will grow and form toxin 

in such products during finished product 

storage and distribution if drying is not 

properly performed. In addition, controlling 

labeling (e.g., “keep refrigerated” labeling) to 

ensure that the product is held refrigerated 

throughout distribution may be important to 

the safety of the product, because the product 

may appear to retailers, consumers, and end 

users to be shelf stable. 

However, if your dried, reduced oxygen 

packaged product is distributed frozen, then 

freezing may provide the barrier to growth 

and toxin formation by C. botulinum type 

E and non-proteolytic types B and F, rather 

than drying. In this case, labeling to ensure 

that the product is distributed frozen may 

be important to the safety of the product. 

Chapter 13 provides guidance on labeling 

controls to ensure that frozen product that 

supports the growth of non-proteolytic C. 

botulinum is distributed frozen. 

4.	 For refrigerated or frozen, partially dried, reduced 

oxygen packaged dried products, can growth 

and toxin formation by C. botulinum type E and 

non-proteolytic types B and F that are reasonably 

likely to occur be eliminated or reduced to an 

acceptable level at this processing step? 

Pathogenic bacteria growth and toxin 

formation as a result of inadequate drying 

should be considered a significant hazard 

at any processing step 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. The preventive 

measures that can be applied for pathogenic 

bacteria growth and toxin formation as a 

result of inadequate drying for refrigerated 

or frozen, partially dried, reduced oxygen 

packaged products are: 

•	 Proper design and control of the drying 

process (covered in this chapter); 

•	 Refrigeration (covered in Chapter 

12) and labeling to ensure that the 

product is held refrigerated throughout 

distribution (covered in this chapter); 

•	 Freezing (Chapter 13 provides guidance 

on labeling controls to ensure that a 

frozen product that otherwise supports 

the growth of non-proteolytic C. 

botulinum is distributed frozen). 

•	 Intended use 

Because of the highly stable nature of S. aureus 

toxin and the extremely toxic nature of C. 

botulinum toxin, it is unlikely that the intended 

use will affect the significance of the hazard. 

IDENTIFY CRITICAL CONTROL POINTS. 

The following guidance will assist you in 

determining whether a processing step is a critical 

control point (CCP) for pathogenic bacteria growth 

and toxin formation as a result of inadequate drying: 

1.	 If you identified the hazard of pathogenic 

bacteria growth and toxin formation as a result of 

inadequate drying as significant because drying 

(rather than, or in addition to, refrigeration) is 

important to the safety of the product, you should 

identify the drying step as a CCP for this hazard. 

Example: 

A salmon jerky processor that distributes 

the product unrefrigerated should set 

the CCP for controlling the hazard of 

pathogenic bacteria growth and toxin 

formation as a result of inadequate drying 

at the drying step. The processor would 

not need to identify the processing steps 

prior to drying as CCPs for that hazard. 

However, these steps may be CCPs for 

the control of other hazards, such as the 

growth of pathogenic bacteria as a result 

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 

referred to in this chapter as “Control Strategy 

Example 1 - Control by Drying.” 

2.	 If you identified the hazard of pathogenic 

bacteria growth and toxin formation as a result 

of inadequate drying as significant because 

refrigeration (in addition to drying) is important 

to the safety of the product, you should identify 

the finished product storage step and the 

labeling step, where you will ensure that the 

“keep refrigerated” labeling is included on every 

package, as a CCP, for this hazard. 

Example: 

A partially dried catfish processor that 

distributes the product refrigerated and 

reduced oxygen packaged should set 

the CCPs for controlling the hazard of 

pathogenic bacteria growth and toxin 

formation as a result of inadequate 

drying at the drying step, finished 

product labeling step, and finished 

product storage step. The processor would 

not need to identify the processing steps 

prior to drying as CCPs for that hazard. 

However, these steps may be CCPs for 

the control of other hazards, such as the 

growth of pathogenic bacteria as a result 

of time and temperature abuse during 

processing, covered by Chapter 12. 

The control by drying is covered in “Control 

Strategy Example 1 - Control by Drying.” 

Control of labeling is referred to in this 

chapter as “Control Strategy Example 2 ­

Control by Refrigeration With Labeling.” It 

should be used along with “Control Strategy 

Example 1 - Control by Drying.” Note that 

control of refrigerated finished product storage 

is covered in Chapter 12. Note also that 

Chapter 13 provides guidance on labeling 

controls to ensure that a frozen product 

that otherwise supports the growth of nonproteolytic C. botulinum is distributed frozen. 

DEVELOP A CONTROL STRATEGY. 

The following guidance provides examples of 

two control strategies for pathogenic bacteria 

growth and toxin formation that occurs as a 

result of inadequate drying. It may be necessary 

to select more than one control strategy in order 

to fully control the hazard, depending upon 

the nature of your operation. It is important 

to note that you may select a control strategy 

that is different from those that are suggested, 

provided it complies with the requirements of the 

applicable food safety laws and regulations. 

The following are examples of control strategies 

included in this chapter: 

MAY APPLY TO MAY APPLY TO 

CONTROL STRATEGY PRIMARY SECONDARY 

PROCESSOR PROCESSOR 

Control by drying  

Control by refrigeration 

with labeling 

 

•	 CONTROL STRATEGY EXAMPLE 1 - CONTROL BY 

DRYING 

It may be necessary to select more than one 

control strategy in order to fully control the 

hazard, depending upon the nature of your 

operation. 

Set Critical Limits. 

•	 The minimum or maximum values for the 

critical factors established by a scientific 

study (i.e., for shelf-stable products, those 

which must be met in order to ensure that 

the finished product has a water activity of 

0.85 or below; for refrigerated (not frozen), 

reduced oxygen packaged products, those 

which must be met in order to ensure that 

the finished product has a water activity of 

less than 0.97). These will likely include 

drying time, input/output air temperature, 

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 

•	 The minimum percent weight loss 

established by a scientific study (i.e., for 

shelf-stable products, that which must be met 

in order to ensure that the finished product 

has a water activity of 0.85 or below; for 

refrigerated (not frozen), reduced oxygen 

packaged products, that which must be met 

in order to ensure that the finished product 

has a water activity of less than 0.97); 

OR 

•	 For shelf-stable products: 

° Maximum finished product water activity 

of 0.85 or above;
 

OR
 

•	 For refrigerated (not frozen), reduced oxygen 

packaged products: 

° Maximum finished product water activity 

of less than 0.97. 

Note: A heat treatment, addition of chemical additives, further 

drying, or other treatment may be necessary to inhibit or eliminate 

spoilage organisms (e.g., mold) in shelf-stable products. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 Critical factors of the established drying process 

that affect the ability of the process to ensure 

the desired finished product water activity (i.e., 

0.85 or below for shelf-stable products, less 

than 0.97 for refrigerated (not frozen), reduced 

oxygen packaged products). These may 

include drying time, air temperature, humidity, 

and velocity, as well as flesh thickness; 

OR 

•	 Percent weight loss; 

OR 

•	 Water activity of the finished product. 

»	 How Will Monitoring Be Done? 

For batch drying equipment: 

•	 For drying time and input/output air 

temperature: 

° Use a continuous temperature-recording 

device (e.g., a recording thermometer); 

AND 

•	 For all other critical factors specified by the 

study: 

° Use equipment appropriate for the 

measurement;
 

OR
 

•	 For percent weight loss: 

° Weigh all, or a portion, of the batch 

before and after drying;
 

OR
 

•	 For water activity analysis: 

° Collect a representative sample of the 

finished product and conduct water 

activity analysis. 

For continuous drying equipment: 

•	 For input/output air temperature: 

° Use a continuous temperature-recording 

device (e.g., a recording thermometer); 

AND 

•	 For drying time: 

° Measure:

•	 The revolutions per minute (RPM) 

of the belt drive wheel, using 

a stopwatch or tachometer; 

OR 

•	 The time necessary for a test unit 

or belt marking to pass through the 

equipment, using a stopwatch; 

AND 

•	 For all other critical factors specified by the 

study: 

° Use equipment appropriate for the 

measurement;
 

OR
 

•	 For percent weight loss: 

° Weigh all, or a portion, of the batch 

before and after drying; 

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

298 
OR 

•	 For water activity: 

° Collect a representative sample of the 

finished product and conduct water 

activity analysis. 

»	 How Often Will Monitoring Be Done (Frequency)? 

For batch drying equipment: 

•	 For time and temperature: 

° Continuous monitoring, with a visual 

check of the recorded data at least once 

during each batch; 

AND 

•	 For all other critical factors specified by the 

study: 

° As often as necessary to maintain control; 

OR 

•	 For percent weight loss: 

° Each batch;

OR 

•	 For water activity: 

° Each batch.

For continuous drying equipment: 

•	 For temperature: 

° Continuous monitoring, with a visual 

check of the recorded data at least once 

per day; 

AND 

•	 For time: 

° At least once per day, and whenever any 

changes in belt speed are made;
 

AND
 

•	 For all other critical factors specified by the 

study: 

° As often as necessary to maintain control; 

OR 

•	 For percent weight loss: 

° Each lot of finished product; 

OR 

•	 For water activity: 

Each lot of finished product. ° 

»	 Who Will Do the Monitoring? 

•	 For continuous temperature-recording 

devices:
 

° Monitoring is performed by the
 

equipment itself. The visual check of 

the data generated by this equipment, 

to ensure that the critical limits have 

consistently been met, may be performed 

by any person who has an understanding 

of the nature of the controls; 

AND 

•	 For all other critical factors specified by the 

study: 

° Any person who has an understanding of

the nature of the controls;
 

OR
 

•	 For percent weight loss: 

° Any person who has an understanding of

the nature of the controls;
 

OR
 

•	 For water activity: 

° Any person with sufficient training to 

perform the analysis. 

Establish Corrective Action Procedures. 

Take the following corrective action to a product 

involved in a critical limit deviation: 

•	 Redry the product (provided that redrying 

does not present an unacceptable 

opportunity for pathogenic bacteria growth); 

OR 

•	 Chill and hold the product for an evaluation 

of the adequacy of the drying process. 

The evaluation may involve water activity 

determination on a representative sample 

of the finished product. If the evaluation 

shows that the product has not received an 

adequate drying process, the product should 

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 

product will be controlled by means other 

than drying, diverted to a non-food use, or 

redried; 

OR 

•	 Divert the product to a use in which the 

critical limit is not applicable because 

pathogenic bacteria growth in the finished 

product will be controlled by means other 

than drying (e.g., divert inadequately dried 

fish to a frozen fish operation); 

OR 

•	 Divert the product to a non-food use; 

OR 

•	 Destroy the product. 

AND 

Take the following corrective action to regain control 

over the operation after a critical limit deviation: 

•	 Adjust the air temperature or velocity; 

OR 

•	 Adjust the length of the drying cycle to 

compensate for a temperature or velocity 

drop, humidity increase, or inadequate 

percent weight loss; 

OR 

•	 Adjust the belt speed to increase the length 

of the drying cycle. 

Establish a Recordkeeping System. 

For batch drying equipment: 

•	 Record of continuous temperature 

monitoring; 

AND 

•	 Record of visual checks of recorded data; 

AND 

•	 Record of notation of the start time and end 

time of the drying periods; 

AND 

•	 Records that are appropriate for the other 

critical factors (e.g., a drying log that indicates 

input/output air humidity and/or velocity); 

OR 

•	 Record of weight before and after drying; 

OR 

•	 Record of water activity analysis. 

For continuous drying equipment: 

•	 Record of continuous temperature 

monitoring; 

AND 

•	 Record of visual checks of recorded data; 

AND 

•	 Drying log that indicates the RPM of the belt 

drive wheel or the time necessary for a test 

unit or belt marking to pass through the drier; 

AND 

•	 Records that are appropriate for the other 

critical factors (e.g., a drying log that indicates 

input/output air humidity and/or velocity); 

OR 

•	 Record of weight before and after drying; 

OR 

•	 Record of water activity analysis. 

Establish Verification Procedures. 

•	 Process validation study (except where a 

water activity analysis of the finished product 

is the monitoring procedure): 

° The adequacy of the drying process 

should be established by a scientific 

study. For shelf-stable products, the 

drying process should be designed to 

ensure the production of a shelf-stable 

product with a water activity of 0.85. 

For refrigerated (not frozen), reduced 

oxygen packaged products, it should be 

designed to ensure a finished product 

water activity of less than 0.97. Expert 

knowledge of drying process calculations 

and the dynamics of mass transfer in 

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 

knowledge can be obtained by education 

or experience or both. Establishment of 

drying processes may require access to 

adequate facilities and the application 

of recognized methods. The drying 

equipment should be designed, operated, 

and maintained to deliver the established 

drying process to every unit of a product. 

In some instances, drying studies may 

be required to establish the minimum 

process. In other instances, existing 

literature that establishes minimum 

processes or adequacy of equipment is 

available. Characteristics of the process, 

product, and/or equipment that affect 

the ability to achive the established 

minimum drying process should be 

taken into consideration in the process 

establishment. A record of the process 

establishment should be maintained; 

AND 

•	 Finished product sampling and analysis to 

determine water activity at least once every 

3 months (except where such testing is 

performed as part of monitoring); 

AND 

•	 Before a temperature-recording device (e.g., 

a recording thermometer) is put into service, 

check the accuracy of the device to verify 

that the factory calibration has not been 

affected. This check can be accomplished 

by: 

° Immersing the sensor in an ice slurry 

(32°F (0°C)) if the device will be used at 

or near refrigeration temperature; 

OR 

° Immersing the sensor in boiling water 

(212°F (100°C)) if the device will be used 

at or near the boiling point. Note that 

the temperature should be adjusted to 

compensate for altitude, when necessary; 

OR 

° Doing a combination of the above if 

the device will be used at or near room 

temperature; 

OR 

° Comparing the temperature reading 

on the device with the reading on a 

known accurate reference device (e.g., 

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., 

air temperature) within the temperature 

range at which it will be used; 

AND 

•	 Once in service, check the temperaturerecording 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. 

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 

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

303 

TABLE 14-1

CONTROL STRATEGY EXAMPLE 1 - CONTROL BY DRYING

This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using “Control Strategy Example 1 - Control by Drying.” This example illustrateshow a processor of shelf-stable salmon jerky can control pathogenic bacteria growth and toxin formation as a result of inadequate drying. It is provided for illustrative purposesonly. It may be necessary to select more than one control strategy in order to fully control the hazard, depending upon the nature of your operation.Pathogenic bacteria growth and toxin formation as a result of inadequate drying may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., aquaculture drugs, environmental chemical contaminants and pesticides, parasites, and metal fragments).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Drying 

(forced 

convection 

oven) 

Pathogenic 

bacteria growth 

and toxin 

formation 

Maximum

product 

thickness: 1⁄4 

inch 

Product 

thickness 

Preset slicer to

just less than 1⁄4

inch 

Once per

day before 

operations 

Slicer

operator 

Re-adjust 

slicer 

Processing log Documentation

of drying process 

establishment

Check the data

logger for accuracy 

and damage and

to ensure that

it is operational 

before putting 

into operation; 

check it daily, at 

the beginning of

operations; and 

calibrate it once 

per year 

Analyze the

finished product 

sample once every 

3 months for water 

activity 

Review of 

monitoring,

corrective action 

and verification,

records within

1 week of 

preparation 
TABLE 14-1

CONTROL STRATEGY EXAMPLE 1 - CONTROL BY DRYING

This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using “Control Strategy Example 1 - Control by Drying.” This example illustrateshow a processor of shelf-stable salmon jerky can control pathogenic bacteria growth and toxin formation as a result of inadequate drying. It is provided for illustrative purposesonly. It may be necessary to select more than one control strategy in order to fully control the hazard, depending upon the nature of your operation.Pathogenic bacteria growth and toxin formation as a result of inadequate drying may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., aquaculture drugs, environmental chemical contaminants and pesticides, parasites, and metal fragments).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

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

304 

Drying 

(forced 

convection 

oven) 

Pathogenic

bacteria growth 

and toxin 

formation 

Minimum

drying time: 5 

hours 

Drying time Digital time and

temperature 

data logger 

Continuous,

with visual

check of

recorded data

each batch 

Oven 

operator 

Continue

drying 

Data logger

printout 

Documentation

of drying process 

establishment

Check the data

logger for accuracy 

and damage and

to ensure that it is

operational before 

putting into

operation; check it 

daily, at the 

beginning of

operations; and 

calibrate it once 

per year 

Analyze the

finished product 

sample once every 

3 months for 

water activity 

Review of 

monitoring,

corrective action 

and verification,

records within 1

week of 

preparation 
TABLE 14-1

CONTROL STRATEGY EXAMPLE 1 - CONTROL BY DRYING

This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using “Control Strategy Example 1 - Control by Drying.” This example illustrateshow a processor of shelf-stable salmon jerky can control pathogenic bacteria growth and toxin formation as a result of inadequate drying. It is provided for illustrative purposesonly. It may be necessary to select more than one control strategy in order to fully control the hazard, depending upon the nature of your operation.Pathogenic bacteria growth and toxin formation as a result of inadequate drying may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., aquaculture drugs, environmental chemical contaminants and pesticides, parasites, and metal fragments).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

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

305 

Drying 

(forced 

convection 

oven) 

Pathogenic 

bacteria growth 

and toxin 

formation 

Minimum oven 

temperature: 

140°F

To achieve 

a final water 

activity of 0.85 

or less 

Oven air input 

temperature 

Digital time and

temperature 

data logger 

Continuous,

with visual

check of

recorded data

each batch 

Oven 

operator 

Extend 

drying 

process

Segregate the

product and 

hold under

refrigeration 

for 

evaluation

Evaluate by 

performing 

water 

activity 

analysis on

finished

product

Redry if less 

than 0.85 

Data logger

printout 

Documentation

of drying process 

establishment

Check the data

logger for accuracy 

and damage and

to ensure that

it is operational 

before putting 

into operation; 

check it daily, at 

the beginning of

operations; and 

calibrate it once 

per year 

Analyze the

finished product 

sample once every 

3 months for 

water activity 

Review of 

monitoring,

corrective action 

and verification,

records within 1

week of 

preparation 
•	 CONTROL STRATEGY EXAMPLE 2 - CONTROL BY 

REFRIGERATION WITH LABELING 

It may be necessary to select more than one 

control strategy in order to fully control the 

hazard, depending upon the nature of your 

operation. 

Set Critical Limits. 

•	 All finished product labels must contain 

a “keep refrigerated” statement (e.g., 

“Important, keep refrigerated until used”). 

Establish Monitoring Procedures. 

»	 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 

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. 

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 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying 

306 
TABLE 14-2

CONTROL STRATEGY EXAMPLE 2 - CONTROL BY REFRIGERATION WITH LABELING

This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Control by Refrigeration With Labeling.” This example illustrates how a processor ofrefrigerated, partially dried catfish can control pathogenic bacteria growth and toxin formation as a result of inadequate drying. It is provided for illustrative purposes only. It may be necessary to select more than one control strategy in order to fully control the hazard, depending upon the nature of your operation.Pathogenic bacteria growth and toxin formation as a result of inadequate drying may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides and metal fragments).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Receipt of 

labeling 

C. botulinum 

toxin 

formation 

during

finished

product 

storage 

All finished

product labels 

must contain a

“keep 

refrigerated”

statement 

Finished

product 

labels for the 

presence of

the “keep 

refrigerated”

statement 

Visual 

examination 

One label from

each case of

labels at

receipt 

Receiving 

employee 

Segregate and

re-label any

improperly

labeled product 

Segregate

and return or 

destroy any 

label stock

that does not

contain the

proper

statement

Determine 

and correct 

the cause of

improper labels 

Label receiving

record 

Review 

monitoring and

correction 

action records 

within 1 week 

of preparation 

*Note: Chapter 12 covers control of pathogenic bacteria growth at the CCP of finished product storage. 

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

307 
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 NonFDA Web site references after March 29, 2011. 

•	 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 

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. 

Staphylococcus aureus (S. aureus) toxin formation 

in hydrated batter mixes can cause consumer 

illness. S. aureus is the bacterium responsible 

for Staphylococcal Food Poisoning (SFP). Ten 

to thirty outbreaks of SFP occur annually in the 

United States, from all sources. Symptoms include: 

vomiting, diarrhea, abdominal pain, nausea, 

and weakness. Symptoms usually start within 4 

hours of consumption. Everyone is susceptible to 

intoxication by S. aureus toxin, with more severe 

symptoms, including occasionally death, occurring 

in infants, the elderly, and debilitated persons. 

Generally, it is a self-limiting illness. 

This chapter covers control of S. aureus toxin 

formation that occurs as a result of time and 

temperature abuse at the hydrated batter mix 

storage or recirculation step. This toxin in 

particular is a concern at this step because it is not 

likely to be destroyed by subsequent heating steps 

that the processor or the consumer may perform. 

Pathogenic bacteria other than S. aureus, such as 

those described in Chapter 12, are less likely to 

grow in hydrated batter mixes and/or are likely to 

be killed by subsequent heating. 

•	 Control of S. aureus in batter mixes 

S. aureus can enter the process on raw materials. 

It can also be introduced into foods during 

processing, from unclean hands and insanitary 

utensils and equipment. 

The hazard develops when a batter mix is 

exposed to temperatures favorable for S. aureus 

growth for sufficient time to permit toxin 

development. S. aureus toxin does not normally 

reach levels that will cause food poisoning until 

the numbers of the pathogen reach 500,000 

to 1,000,000 per gram. S. aureus will grow at 

temperatures as low as 44.6°F (7°C) and at a water 

activity as low as 0.83 (additional information 

on conditions favorable to S. aureus growth is 

provided in Table A-1 (Appendix 4)). However, 

toxin formation is not likely at temperatures lower 

than 50°F (10°C) or at water activities below 0.85. 

For this reason, toxin formation can be controlled 

by minimizing exposure of hydrated batter mixes 

to temperatures above 50°F (10°C). Exposure 

times greater than 12 hours at temperatures 

between 50°F (10°C) and 70°F (21.1°C) could result 

in toxin formation. Exposure times greater than 

3 hours at temperatures above 70°F (21.1°C) could 

also result in toxin formation. 

•	 Strategies for controlling pathogen growth 

There are a number of strategies for the control 

of pathogens in fish and fishery products. They 

include: 

•	 Managing the amount of time that food is 

exposed to temperatures that are favorable 

for pathogen growth and toxin production 

(covered in this chapter for S. aureus 

in hydrated batter mix; Chapter 13 for 

Clostridium botulinum; and Chapter 12 for 

other pathogenic bacteria and conditions); 

•	 Killing pathogenic bacteria by cooking or 

pasteurizing (covered in Chapter 16), or 

retorting (covered by the Thermally Processed 

Low-Acid Foods Packaged in Hermetically 

Sealed Containers regulation, 21 CFR 113 

(called the Low-Acid Canned Foods Regulation 

in this guidance document)); 

CHAPTER 15: Staphylococcus aureus Toxin Formation in Hydrated Batter Mixes 

309 
•	 Killing pathogenic bacteria by processes 

that retain the raw product characteristics 

(covered in Chapter 17); 

•	 Controlling the amount of moisture that is 

available for pathogenic bacteria growth 

(water activity) in the product by drying 

(covered in Chapter 14); 

•	 Controlling the amount of moisture that is 

available for pathogenic bacteria growth 

(water activity) in the product by formulation 

(covered in Chapter 13); 

•	 Controlling the amount of salt or 

preservatives, such as sodium nitrite, in the 

product (covered in Chapter 13); 

•	 Controlling the level of acidity (pH) in the 

product (covered by the Acidified Foods 

regulation, 21 CFR 114, for shelf-stable 

acidified products, and by Chapter 13 for 

refrigerated acidified products); 

•	 Controlling the source of molluscan shellfish 

and the time from exposure to air (e.g., by 

harvest or receding tide) to refrigeration to 

control pathogens from the harvest area 

(covered in Chapter 4); 

•	 Controlling the introduction of pathogenic 

bacteria after the pasteurization process 

(covered in Chapter 18). 

DETERMINE WHETHER THE POTENTIAL 

HAZARD IS SIGNIFICANT. 

The following guidance will assist you in 

determining whether S. aureus toxin formation in 

hydrated batter mixes is a significant hazard at a 

processing step: 

1.	 Is it reasonably likely that S. aureus will grow 

and form toxin in the hydrated batter mix at the 

hydrated batter mix storage or recirculation step? 

The previous section, “Understand the Potential 

Hazard,” provides information to help you 

decide whether the time and temperature 

conditions of your hydrated batter mix storage 

or recirculation step are favorable for S. aureus 

growth and toxin formation. 

2.	 Can the hazard of S. aureus growth and toxin 

formation that was introduced at an earlier step 

be eliminated or reduced to an acceptable level 

at this processing step? 

S. aureus toxin formation in hydrated batter 

mixes should be considered a significant 

hazard at any processing step 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. The preventive 

measure that can be applied for S. aureus 

toxin formation in hydrated batter mixes is 

controlling the amount of time that hydrated 

batter mixes are exposed to temperatures 

above 50°F (10°C). 

•	 Intended use 

Because of the highly heat-stable nature of S. 

aureus toxin, it is unlikely that the intended use 

will affect the significance of the hazard. 

IDENTIFY CRITICAL CONTROL POINTS. 

If the hazard of S. aureus toxin formation in 

hydrated batter mixes is significant, you should 

identify the hydrated batter mix storage or 

recirculation step as the critical control point 

(CCP) for this hazard. For hand-battering 

operations, where hydrated batter mix is stored 

at each hand-battering station, the hand-battering 

stations also should be identified as a CCP. 

This control approach is a control strategy 

referred to in this chapter as “Control Strategy 

Example - Hydrated Batter Mix Control.” 

Example: 

A mechanized breaded fish processor should 

set the CCP for controlling the hazard of 

S. aureus growth and toxin formation in 

hydrated batter mixes at the hydrated batter 

mix storage or recirculation step. The 

processor would not need to identify other 

processing steps as CCPs for that hazard. 

CHAPTER 15: Staphylococcus aureus Toxin Formation in Hydrated Batter Mixes 

310 
DEVELOP A CONTROL STRATEGY. 

The following guidance provides an example of 

a control strategy for S. aureus toxin formation 

in hydrated batter mixes. It is important to 

note that you may select a control strategy 

that is different from that which is suggested, 

provided it complies with the requirements of the 

applicable food safety laws and regulations. 

The following is an example of the control 

strategy included in this chapter: 

MAY APPLY TO MAY APPLY TO 

CONTROL STRATEGY PRIMARY SECONDARY 

PROCESSOR PROCESSOR 

Hydrated batter mix control  

•	 CONTROL STRATEGY EXAMPLE - HYDRATED 

BATTER MIX CONTROL 

Set Critical Limits. 

•	 Hydrated batter mix should not be held 

for more than 12 hours, cumulatively, at 

temperatures between 50°F (10°C) and 70oF 

(21.1oC); 

AND 

•	 Hydrated batter mix should not be held 

for more than 3 hours, cumulatively, at 

temperatures above 70oF (21.1oC). 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 The temperature of the hydrated batter mix 

and the time of exposure at temperatures 

above 50°F (10°C) and above 70oF (21.1oC). 

»	 How Will Monitoring Be Done? 

•	 Use a continuous temperature-recording 

device (e.g., a recording thermometer); 

OR 

•	 Use a temperature-indicating device (e.g., 

a thermometer) and observe the time of 

exposure. 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 For continuous temperature-recording 

devices: 

° Continuous monitoring, with a visual 

check of the recorded data at least once 

per day; 

OR 

•	 For temperature-indicating devices: 

At least every 2 hours. ° 

»	 Who Will Do the Monitoring? 

•	 For temperature-recording devices: 

° Monitoring is performed by the device 

itself. The visual check of the data 

generated by the device, to ensure that 

the critical limits have consistently been 

met, may be performed by any person 

who has an understanding of the nature 

of the controls; 

OR 

•	 For temperature-indicating devices: 

° 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: 

•	 Destroy the product and remaining hydrated 

batter mix; 

OR 

•	 Divert the product and remaining hydrated 

batter mix to a non-food use; 

OR 

•	 Hold the product and hydrated batter until it 

can be evaluated based on its total time and 

temperature exposure; 

OR 

•	 Hold the product and hydrated batter 

mix until the hydrated batter mix can be 

sampled and analyzed for the presence of 

staphylococcal enterotoxin. 

AND 

CHAPTER 15: Staphylococcus aureus Toxin Formation in Hydrated Batter Mixes 

311 
Take the following corrective action to regain control 

over the operation after a critical limit deviation: 

•	 Add ice to the hydrated batter mix storage 

and recirculation tank; 

AND/OR 

•	 Make repairs or adjustments to the hydrated 

batter mix refrigeration equipment. 

Establish a Recordkeeping System. 

•	 For continuous temperature-recording 

devices: 

° Recorder thermometer charts or digital time 

and temperature data logger printouts;
 

AND
 

° Record of visual checks of recorded data; 


OR 

•	 For temperature-indicating devices: 

° Record of visual checks of devices (time 

and temperature). 

Establish Verification Procedures. 

•	 Before a temperature-indicating device (e.g., 

a thermometer) or temperature-recording 

device (e.g., a recording thermometer) is 

put into service, check the accuracy of the 

device to verify that the factory calibration 

has not been affected. This check can be 

accomplished by: 

° Immersing the sensor in an ice slurry 

(32°F (0°C)) if the device will be used at 

or near refrigeration temperature; 

OR 

° Immersing the sensor in boiling water 

(212°F (100°C)) if the device will be used 

at or near the boiling point. Note that 

the temperature should be adjusted to 

compensate for altitude, when necessary; 

OR 

° Doing a combination of the above if 

the device will be used at or near room 

temperature; 

OR 

° Comparing the temperature reading 

on the device with the reading on a 

known accurate reference device (e.g., 

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., batter 

temperature) within the temperature range 

at which it will be used; 

AND 

•	 Once in service, check the temperatureindicating device or 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-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 

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 

•	 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 15: Staphylococcus aureus Toxin Formation in Hydrated Batter Mixes 

312 
CHAPTER 15: Staphylococcus aureus Toxin Formation in Hydrated Batter Mixes 

313 

TABLE 15-1

CONTROL STRATEGY EXAMPLE - HYDRATED BATTER MIX CONTROL

This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using “Control Strategy Example - Hydrated Batter Mix Control.” This example illustrates how a breaded fish processor can control S. aureus toxin formation in hydrated batter mixes. It is provided for illustrative purposes only. S. aureus toxin formation in hydrated batter mixes may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides and metal fragments).

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Batter mix

recirculation

tank 

S. aureus 

growth and 

toxin 

formation 

Hydrated 

batter mix

temperature not 

to exceed 50°F 

for more than 

12 hours,

cumulatively,

nor 70°F for 

more than

3 hours,

cumulatively 

The

temperature 

of the

hydrated 

batter mix and

the time of

exposure at 

temperatures 

above 50°F 

(10°C) and

above 70oF 

(21.1oC) 

Recorder 

thermometer 

Continuous,

with visual

check once per

day 

Production 

employee 

Destroy 

hydrated 

batter mix and

any product 

produced

during the

period of the

deviation 

Adjust hydrated 

batter mix

refrigeration 

equipment 

Recorder 

thermometer 

chart 

Check the

recorder

thermometer 

for accuracy 

and damage

and to ensure

that it is

operational 

before putting 

into operation; 

check it

daily, at the 

beginning of

operations; and 

calibrate it once 

per year 

Review 

monitoring,

corrective 

action, and 

verification 

records within

1 week of 

preparation 
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 NonFDA Web site references after March 29, 2011. 

•	 Baird-Parker, A. C. 1971. Factors affecting 

the production of bacterial food poisoning 

toxins. J. Appl. Bact. 34:181-197. 

•	 Beckers, H. J., F. M. van Leusden, and P. 

D. Tips. 1985. Growth and enterotoxin 

production of Staphylococcus aureus in 

shrimp. J. Hyg., Camb. 95:685-693. 

•	 Bryan, F. L. 1979. Staphylococcus aureus 

in food microbiology: public health and 

spoilage aspects. The Avi Publishing 

Company, Inc., Westport, CT. 

•	 Buchanan, R. L. 1991. Microbiological 

criteria for cooked, ready-to-eat shrimp and 

crabmeat. Food Technol. 45:157-160. 

•	 Dahl Sawyer, C. A., and J. J. Pestka. 1985. 

Foodservice systems: presence of injured 

bacteria in foods during food product flow. 

Ann. Rev. Microbiol. 39:51-67. 

•	 Deibel, K. E. 1995. Potential of 

Staphylococcus aureus to produce 

enterotoxin in fish batter at various 

temperatures, p. 33. In Medallion Lab (ed.), 

Proceedings of the IFT Annual Meeting. 

Medallion Lab, Minneapolis, MN. 

•	 Dengremont, E., and J. M. Membre. 1995. 

Statistical approach for comparison of the 

growth rates of five strains of Staphylococcus 

aureus. Appl. Environ. Microbiol. 61:4389­

4395. 

•	 Duran, A. P., B. A. Wentz, J. M. Lanier, F. D. 

McClure, A. H. Schwab, A. Swartzentruber, 

R. J. Barnard, and R. B. Read. 1983. 

Microbiological quality of breaded shrimp 

during processing. J. Food Prot. 46:974-977. 

•	 Godwin, G. J., R. M. Grodner, and A. F. 

Novak. 1977. Twenty-four hour methods 

for bacteriological analyses in frozen raw 

breaded shrimp. J. Food Sci. 42:750-754. 

•	 Greenwood, M. H., E. F. C. Coetzee, B. 

M. Ford, P. Gill, W. L. Hooper, S. C. W. 

Matthews, S. Patrick, J. V. S. Pether, and R. 

J. D. Scott. 1985. The bacteriological quality 

of selected retail, ready-to-eat food products. 

III. Cooked crustaceans and mollusks. 

Environ. Health 93:236-239. 

•	 Hughes, A., and A. Hurst. 1980. The effect 

of NaCl on the upper temperature limit for 

growth of and enterotoxin synthesis by 

Staphylococcus aureus. Can. J. Microbiol. 

26:507-510. 

•	 Lotter, L. P., and L. Leistner. 1978. Minimal 

water activity for enterotoxin A production 

and growth of Staphylococcus aureus. Appl. 

Environ. Microbiol. 36:377-380. 

•	 Ostovar, K., and M. J. Bremier. 1975. Effect of 

thawing on growth of Staphylococcus aureus 

in frozen convenience food items. J. Milk 

Food Technol. 38:337-339. 

•	 Potter, L., and L. Leistner. 1978. Minimal 

water activity for enterotoxin A production 

and growth of Staphylococcus aureus. Appl. 

Environ. Microbiol. 36:377-380. 

•	 Raj, H. D. 1970. Public health bacteriology of 

processed frozen foods. Lab. Pract. 19:374­

377, 394. 

•	 Sutherland, J. P., A. J. Bayliss, and T. A. 

Roberts. 1994. Predictive modeling of growth 

of Staphylococcus aureus: the effects of 

temperature, pH and sodium chloride. Int. J. 

Food Microbiol. 21:217-236. 

CHAPTER 15: Staphylococcus aureus Toxin Formation in Hydrated Batter Mixes 

314 
CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 

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. 

The survival of pathogenic bacteria through 

cooking or pasteurization can cause consumer 

illness. The primary pathogens of concern are 

Clostridium botulinum (C. botulinum), Listeria 

monocytogenes (L. monocytogenes), Campylobacter 

jejuni (C. jejuni), pathogenic strains of Escherichia 

coli (E. coli), Salmonella spp., Shigella spp., Yersinia 

enterocolitica (Y. enterocolitica), Staphylococcus 

aureus (S. aureus), Vibrio cholera (V. cholera), 

Vibrio vulnificus (V. vulnificus), and Vibrio 

parahaemolyticus (V. parahaemolyticus). See 

Appendix 7 for a description of the public health 

impacts of these pathogens. 

It is not practical to target viral pathogens in 

cooking or pasteurization processes because of 

their extreme heat resistance. Viral pathogens 

should be controlled through a rigorous sanitation 

regime as part of a prerequisite program or as 

part of Hazard Analysis Critical Control Point 

(HACCP) itself. The Procedures for the Safe and 

Sanitary Processing and Importing of Fish and 

Fishery Products regulation, 21 CFR 123 (called 

the Seafood HACCP Regulation in this guidance 

document) requires such a regime. 

•	 Types of heat processing 

Cooking is a heat treatment, usually performed 

before the product is placed in the finished product 

container. It is applied to fishery products that are 

distributed either refrigerated or frozen. Generally, 

after cooking, fishery products are referred to as 

cooked, ready to eat. Examples of cooked, readyto-eat fishery products are crabmeat, lobster meat, 

crayfish meat, cooked shrimp, surimi-based analog 

products, seafood salads, seafood soups and 

sauces, and hot-smoked fish. 

Pasteurization is a treatment (usually, but not 

always, the application of heat) applied to 

eliminate the most resistant pathogenic bacteria 

of public health concern that is reasonably likely 

to be present in the food for as long as the shelflife of the product, when stored under normal 

and moderate abuse conditions. With fishery 

products, pasteurization is usually performed after 

the product is placed in the hermetically sealed 

finished product container. It is applied to fishery 

products that are distributed either refrigerated or 

frozen. Examples of pasteurized fishery products 

are pasteurized crabmeat, pasteurized surimi-based 

analog products, and pasteurized lobster meat. 

In addition to eliminating bacterial pathogens, 

cooking and pasteurization also greatly reduce 

the number of spoilage bacteria present in the 

fishery product. These bacteria normally restrict 

the growth of pathogens through competition. 

Elimination of spoilage bacteria allows rapid 

growth of newly introduced pathogenic bacteria. 

Pathogenic bacteria that may be introduced after 

cooking or pasteurization are, therefore, a concern. 

This is especially true for pasteurization, because 

that process can significantly extend the shelf-life 

of the fishery product, providing more time for 

pathogenic bacteria growth and toxin formation. 

Retorting is a heat treatment that eliminates all 

food-borne pathogens and produces a product 

that is shelf stable. Mandatory controls for retorting 

are provided in the Thermally Processed Low-Acid 

Foods Packaged in Hermetically Sealed Containers 

regulation, 21 CFR 113 (hereinafter, the Low Acid 

Canned Foods (LACF) Regulation), but are not 

covered in this chapter. 

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 

315 
•	 Goal of pasteurization 

Selection of the target pathogen is critical to 

the effectiveness of pasteurization. You should 

consider the potential that C. botulinum type 

E or non-proteolytic types B and F will survive 

the pasteurization process and grow under 

normal storage conditions or moderate abuse 

conditions. This is of particular concern if the 

product is reduced oxygen packaged (e.g., 

vacuum packaged or modified atmosphere 

packaged), does not contain a barrier that is 

sufficient to prevent growth and toxin formation 

by this pathogen, is not equipped with a time 

and temperature integrator, and is stored or 

distributed refrigerated (not frozen). In such 

products, you should ordinarily select C. 

botulinum type E and non-proteolytic types 

B and F as the target pathogen. For example, 

vacuum-packaged lobster meat that is pasteurized 

to kill L. monocytogenes, but not C. botulinum 

type E or non-proteolytic types B and F, and 

is not equipped with a Time-Temperature 

Indicator should be frozen to prevent growth 

and toxin formation by C. botulinum type E 

and non-proteolytic types B and F, and should 

be labeled to be held frozen and to be thawed 

under refrigeration immediately before use (e.g., 

“Important, keep frozen until used, thaw under 

refrigeration immediately before use”). 

If the product is not reduced oxygen packaged, 

or contains a barrier that is sufficient to prevent 

the growth and toxin formation by C. botulinum 

type E or non-proteolytic types B and F, or 

is equipped with a time and temperature 

integrator, or is distributed frozen, then selection 

of another target pathogen may be appropriate. 

L. monocytogenes may be selected as the target 

pathogen for pasteurization of this type of 

product because it is the most resistant bacterial 

pathogen of public health concern that is 

reasonably likely to be present. 

Surveys of retail display cases and home 

refrigerators indicate that temperatures above the 

minimum growth temperature of C. botulinum 

type E and non-proteolytic types B and F 

(38°F (3.3°C)) are not uncommon. Therefore, 

refrigeration alone cannot be relied upon for 

control of the C. botulinum hazard. When 

freezing is relied upon to control the growth of 

C. botulinum type E and non-proteolytic types B 

and F, controls should be in place to ensure that 

the product is labeled with instructions that it be 

kept frozen throughout distribution. 

For pasteurization processes that target C. 

botulinum type E and non-proteolytic types B and 

F, generally a reduction of six orders of magnitude 

(six logarithms, e.g., from 103

 to 10-3) in the level 

of contamination is suitable. This is called a 6D 

process. However, lower degrees of destruction 

may be acceptable if supported by a scientific 

study of the normal levels in the food before 

pasteurization. It is also possible that higher levels 

of destruction may be necessary in some foods, if 

especially high initial levels of the target pathogen 

are anticipated. Table A-4 (Appendix 4) provides 

6D process times for a range of pasteurization 

temperatures, with C. botulinum type B (the 

most heat resistant form of non-proteolytic C. 

botulinum) as the target pathogen. The lethal rates 

and process times provided in the table may not 

be sufficient for the destruction of C. botulinum 

type E and non-proteolytic types B and F in 

dungeness crabmeat, because of the potential that 

naturally occurring substances, such as lysozyme, 

may enable the pathogen to more easily recover 

after heat damage. 

Examples of properly pasteurized products are 

fish and fishery products generally (e.g., surimibased products, soups, or sauces) pasteurized 

to a minimum cumulative total lethality of F194°F 

(F90°C) = 10 minutes, where z = 12.6°F (7°C) for 

temperatures less than 194°F (90°C) and z = 18°F 

(10°C) for temperatures above 194°F (90°C); blue 

crabmeat pasteurized to a minimum cumulative 

total lethality of F185°F (F85°C) = 31 minutes, where z 

= 16°F (9°C); and dungeness crabmeat pasteurized 

to a minimum cumulative total lethality of F194°F 

(F90°C) = 57 minutes, where z = 15.5°F (8.6°C). 

Equivalent processes at different temperatures can 

be calculated using the z values provided. 

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 

316 
EXAMPLES OF PROPERLY 

PASTEURIZED PRODUCTS 

PRODUCT MINIMUM CUMULATIVE 

TOTAL LETHALITY Z VALUE 

Fish and 

fishery 

products 

generally 

(e.g., surimibased 

products, 

soups, or 

sauces) 

F194°F (F90°C) = 10 minutes 12.6°F (7°C), for 

temperatures 

less than 194°F 

(90°C) 

18°F (10°C) for 

temperatures 

above 194°F (90°C) 

Blue 

crabmeat 

F185°F (F85°C) = 31 minutes 16°F (9°C) 

Dungeness 

crabmeat 

F194°F (F90°C) = 57 minutes 15.5°F (8.6°C) 

In some pasteurized surimi-based products, salt, 

in combination with a milder heat pasteurization 

process in the finished product container, works 

to prevent growth and toxin formation by C. 

botulinum type E and non-proteolytic types B 

and F. An example of a properly pasteurized 

surimi-based product in which 2.4% water phase 

salt is present is one that has been pasteurized 

at an internal temperature of 185°F (85°C) for 

at least 15 minutes. This process may not be 

suitable for other types of products because of 

the unique formulation and processing involved 

in the manufacture of surimi-based products. 

Reduced oxygen-packaged foods that are 

pasteurized to control C. botulinum type E 

and non-proteolytic types B and F, but not C. 

botulinum type A and proteolytic types B and 

F, and that do not contain barriers to its growth 

should be refrigerated or frozen to control C. 

botulinum type A and proteolytic types B and 

F. Control of refrigeration is critical to the safety 

of these products. Further information on C. 

botulinum and reduced oxygen packaging is 

contained in Chapter 13. 

In cases where L. monocytogenes is selected 

as the target pathogen, a 6D process is also 

generally suitable. FDA and U.S. Department of 

Agriculture’s L. monocytogenes risk assessment 

indicates that approximately 8% of raw seafood 

are contaminated with from 1 to 103 colony 

forming unit (CFU)/g and that approximately 91% 

are contaminated at less than 1 CFU/g. Less than 

1% of raw seafood are contaminated at levels 

greater than 103

 CFU/g and none at levels greater 

than 106 CFU/g. FDA’s limit for L. monocytogenes 

in ready-to-eat products, nondetectable, 

corresponds to a level of less than 1 CFU/25g. 

Table A-3 (Appendix 4) provides 6D process 

times for a range of pasteurization temperatures, 

with L. monocytogenes as the target pathogen. 

Lower degrees of destruction may be acceptable 

if supported by a scientific study of the normal 

levels in the food before pasteurization. It is also 

possible that higher degrees of destruction may 

be necessary in some foods if especially high 

initial levels are anticipated. 

Products that are pasteurized in the finished 

product container are at risk for recontamination 

after pasteurization. Controls, such as container 

seal integrity and protection from contaminated 

cooling water, are critical to the safety of these 

products and are covered in Chapter 18. 

•	 Goal of cooking for most products 

One reason for cooking products that will not 

be reduced oxygen packaged is to eliminate 

vegetative cells of pathogenic bacteria (or reduce 

them to an acceptable level) that may have been 

introduced to the process by raw materials or 

by processing that occurs before the cooking 

step. Selection of the target pathogen is critical 

to the effectiveness of cooking. Generally, L. 

monocytogenes is selected as the target pathogen 

because it is regarded as the most heat-tolerant, 

foodborne bacterial pathogen that does not form 

spores. Cooking processes are not usually designed 

to eliminate spores of bacterial pathogens. 

Determining the degree of destruction of the target 

pathogen is also critical. Generally, a reduction of 

six orders of magnitude (six logarithms, e.g., from 

103

 to 10-3) in the level of contamination is suitable. 

This is called a 6D process. 

Table A-3 provides 6D process times for a range of 

cooking temperatures, with L. monocytogenes as 

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 

study of the normal levels in the food before 

pasteurization. It is also possible that higher 

degrees of destruction may be necessary in some 

foods if especially high initial levels are anticipated. 

•	 Goal of cooking refrigerated, reduced 

oxygen-packaged products 

Cooking is sometimes performed on products 

immediately before placement in reduced oxygen 

packaging (e.g., vacuum packaging or modified 

atmosphere packaging). These products include 

cooked, hot-filled soups, chowders, or sauces 

that are filled directly from the cook kettle using 

sanitary, automated, continuous filling systems 

designed to minimize risk of recontamination. 

They are often marketed under refrigeration, 

which is important for the control of C. 

botulinum type A and proteolytic types B and F. 

The cooking process for these products should 

be sufficient to eliminate the spores of C. 

botulinum type E and non-proteolytic types B 

and F. This is the case when the product does 

not contain other barriers that are sufficient 

to prevent growth and toxin formation by 

this pathogen. Generally, a 6D process (six 

logarithms, e.g., from 103

 to 10-3) is suitable. 

However, lower degrees of destruction may 

be acceptable if supported by a scientific 

study of the normal levels in the food before 

pasteurization. It is also possible that higher 

degrees of destruction may be necessary in 

some foods if especially high initial levels are 

anticipated. 

Table A-4 provides 6D process times for a range 

of cooking temperatures, with C. botulinum type 

B (the most heat-resistant form of non-proteolytic 

C. botulinum) as the target pathogen. The lethal 

rates and process times provided in the table 

may not be sufficient for the destruction of C. 

botulinum type E and non-proteolytic types B 

and F in soups or sauces containing dungeness 

crabmeat because of the potential that naturally 

occurring substances, such as lysozyme, may 

enable the pathogen to more easily recover 

after damage. An example of a product that is 

properly cooked to eliminate C. botulinum type 

E and non-proteolytic types B and F is a soup or 

sauce that is cooked to a minimum cumulative 

total lethality of F194°F (F90°C) = 10 minutes, where 

z = 12.6°F (7°C) for temperatures less than 194°F 

(90°C) and z = 18°F (10°C) for temperatures 

above 194°F (90°C). 

Reduced oxygen-packaged soups or sauces that 

are cooked immediately before packaging to 

control C. botulinum type E and non-proteolytic 

types B and F, but not C. botulinum type A and 

proteolytic types B and F, and that do not contain 

barriers to its growth should be refrigerated 

or frozen to control C. botulinum type A and 

proteolytic types B and F. Control of refrigeration 

is critical to the safety of these products. Further 

information on C. botulinum and reduced oxygen 

packaging is contained in Chapter 13. 

Cooking processes that target C. botulinum 

type E and non-proteolytic types B and F have 

much in common with pasteurization processes. 

Like products that are pasteurized in the final 

container, products that are cooked and then 

placed in the final container also are at risk 

for recontamination after they are placed in 

the finished product container. Controls, such 

as container seal integrity and protection from 

contaminated cooling water, are critical to the 

safety of these products and are covered in 

Chapter 18. 

Additionally, because these products are cooked 

before they are packaged, they are at risk of 

recontamination between cooking and packaging. 

The risk of recontamination may be minimized 

by filling the container in a sanitary, automated, 

continuous filling system while the product is 

still hot (i.e., hot filling). This is another critical 

step for the safety of these products. This control 

strategy is suitable for products that are filled 

directly from the cooking kettle, where the risk of 

recontamination is minimized. It is not ordinarily 

suitable for products such as crabmeat, lobster 

meat, or crayfish meat that are handled between 

cooking and filling. Hot filling is also covered in 

Chapter 18. 

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 

318 
•	 Control by cooking or pasteurization 

Controlling pathogenic bacteria survival through 

cooking or pasteurization is accomplished by: 

•	 Scientifically establishing a cooking or 

pasteurization process that will eliminate 

pathogenic bacteria of public health concern 

or reduce their numbers to acceptable levels; 

•	 Designing and operating the cooking or 

pasteurization equipment so that every unit 

of product receives at least the established 

minimum process; 

•	 Continuously monitoring the critical process 

parameters to verify achievement of a 

scientifically established process (e.g., time 

and temperature). 

You may monitor End-Point Internal Product 

Temperature (EPIPT), a measurement of the 

temperature of the product as it exits the heat 

process, instead of performing continuous time 

and temperature monitoring. This approach is 

suitable if you have conducted a scientific study 

to validate that the EPIPT that you have selected 

will provide an appropriate reduction in the 

numbers of the target pathogen (e.g., 6D) in the 

slowest heating unit or portion of product under 

the worst set of heating conditions covered by 

the scientific study. You should (1) conduct a 

temperature distribution study within the heating 

system to identify any cold spots; (2) conduct 

a heat penetration study that accounts for the 

slowest heating product under the worst case 

heating conditions covered by the scientific study; 

and identify other critical factors of processing 

and/or packaging that affect the rate of product 

heating when scientifically establishing a cooking 

or pasteurization process (i.e., process validation). 

The EPIPT should be used as a monitoring 

technique only under those conditions that 

were evaluated by the scientific study. Those 

conditions may need to be identified as critical 

limits and monitored as part of the HACCP plan. 

EPIPT monitoring may not be an option when 

the objective is control of C. botulinum type E 

and non-proteolytic types B and F spores. These 

spores are far more heat resistant than vegetative 

cells of L. monocytogenes and destroying them 

requires an EPIPT that could be achieved only 

in a pressurized steam environment, making 

measurement impractical. Additional guidance 

on EPIPT monitoring can be found in Food 

Processors Association guidance document “FPA 

Guidance Document: Establishing or Verifying 

a Heat Process for Cooked, Ready-to-Eat 

Seafood Products, and Heat Process Monitoring 

Considerations under HACCP,” 2nd Edition, 

February 2005 and purchased at the Grocery 

Manufacturers Association, Washington DC 20005. 

•	 Strategies for controlling pathogenic 

bacteria growth 

There are a number of strategies for the control 

of pathogenic bacteria in fish and fishery 

products. They include: 

•	 Killing pathogenic bacteria by cooking or 

pasteurizing (covered in this chapter) or 

retorting (covered by the LACF Regulation, 21 

CFR 113); 

•	 Killing pathogenic bacteria by processes that 

retain the raw characteristics of the products 

(covered in Chapter 17); 

•	 Managing the amount of time that food is 

exposed to temperatures that are favorable 

for pathogenic bacteria growth and toxin 

production (covered generally in Chapter 

12; for C. botulinum, in Chapter 13; and 

for S. aureus in hydrated batter mixes, in 

Chapter 15); 

•	 Controlling the amount of moisture that is 

available for pathogenic bacteria growth 

(water activity) in the product by drying 

(covered in Chapter 14); 

•	 Controlling the amount of moisture that is 

available for pathogenic bacteria growth 

(water activity) in the product by formulation 

(covered in Chapter 13); 

•	 Controlling the amount of salt or 

preservatives, such as sodium nitrite, in the 

product (covered in Chapter 13); 

•	 Controlling the level of acidity (pH) in the 

product (covered by the Acidified Foods 

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 

319 
regulation, 21 CFR 114, for shelf-stable 

acidified products, and by Chapter 13 for 

refrigerated acidified products); 

•	 Controlling the source of molluscan shellfish 

and the time from exposure to air (e.g., by 

harvest or receding tide) to refrigeration to 

control pathogens from the harvest area 

(covered in Chapter 4); 

•	 Controlling the introduction of pathogenic 

bacteria after the pasteurization process 

(covered in Chapter 18). 

DETERMINE WHETHER THE POTENTIAL 

HAZARD IS SIGNIFICANT. 

The following guidance will assist you in 

determining whether pathogenic bacteria 

survival through cooking and pasteurization is a 

significant hazard at a processing step. 

1.	 Is it reasonably likely that unsafe levels of 

pathogenic bacteria will be introduced at this 

processing step (do unsafe levels of pathogenic 

bacteria come in with the raw material, or will 

the process introduce unsafe levels of pathogenic 

bacteria)? 

It is reasonable to assume that pathogens of 

various types, including those listed in Table 

A-1 (Appendix 4), will be present on raw fish 

and fishery products. They may be present 

only at low levels or only occasionally, but 

even such occurrences warrant consideration 

because of the potential for growth and toxin 

production. 

Pathogenic bacteria may also be introduced 

during processing, from the air, unclean 

hands, insanitary utensils and equipment, 

unsafe water, and sewage. Well-designed 

sanitation programs will minimize the 

introduction of pathogens. Such sanitation 

controls need not be part of your HACCP 

plan if they are monitored under your 

sanitation program (prerequisite program). 

In most cases, it is not reasonable to assume 

that they will fully prevent the introduction 

of bacterial pathogens. For this reason, you 

should consider it reasonably likely that 

low numbers of pathogenic bacteria will be 

present in the product. 

2.	 Can unsafe levels of pathogenic bacteria that 

were introduced at an earlier processing step be 

eliminated or reduced to an acceptable level at 

this processing step? 

Pathogenic bacteria survival through cooking 

or pasteurization should also be considered 

a significant hazard at any processing step 

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. The 

preventive measure that can be applied 

for pathogenic bacteria survival through 

cooking and pasteurization is proper design 

and control of the cooking or pasteurization 

process. 

•	 Intended use 

Because cooked or pasteurized products are 

ready to eat, it is unlikely that the intended use 

will affect the significance of the hazard. 

IDENTIFY CRITICAL CONTROL POINTS. 

The following guidance will assist you in 

determining whether a processing step is a 

critical control point (CCP) for the survival 

of pathogenic bacteria through cooking or 

pasteurization: 

Will the finished product be pasteurized in the final 

container? 

1.	 If the finished product will be pasteurized in 

the final container, you should identify the 

pasteurization step as the CCP. In this case, you 

would not need to identify the cooking step as 

a CCP for the hazard of pathogenic bacteria 

survival through cooking. 

Example: 

A crabmeat processor cooks, picks, 

packs, and pasteurizes the crabmeat. 

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 

320 
The processor sets the CCP for pathogenic 

bacteria survival through cooking and 

pasteurization at the pasteurization step 

and does not identify the cooking step as 

a CCP for this hazard. 

This control approach is a control strategy 

referred to in this chapter as “Control Strategy 

Example - Cooking and Pasteurization.” 

2.	 If the product will not be pasteurized, you should 

identify the cooking step as the CCP. 

This control approach is the same as the 

one above and is a control strategy also 

referred to in this chapter as “Control Strategy 

Example - Cooking and Pasteurization.” For 

products in reduced oxygen packaging for 

which the cooking process does not target 

C. botulinum type E and non-proteolytic 

types B and F, see Chapter 13 for additional 

guidance. 

DEVELOP A CONTROL STRATEGY. 

The following guidance provides a control 

strategy for survival of pathogenic bacteria 

through cooking or pasteurization. You may 

select a control strategy that is different from that 

which is suggested, provided it complies with the 

requirements of the applicable food safety laws 

and regulations. 

The following is an example of the control 

strategy included in this chapter: 

MAY APPLY TO MAY APPLY TO 

CONTROL STRATEGY PRIMARY SECONDARY 

PROCESSOR PROCESSOR 

Cooking and pasteurization  

•	 CONTROL STRATEGY EXAMPLE - COOKING AND 

PASTEURIZATION 

Set Critical Limits. 

•	 The minimum or maximum values for the 

critical factors established by a scientific 

study. These may include length of the 

cook or pasteurization cycle (speed of the 

belt for a continuous cooker or pasteurizer), 

temperature of the steam or water used 

for cooking or pasteurization (or visual 

observation of minutes at a boil for cooking), 

initial temperature of the product, container 

size (e.g., can dimensions, pouch thickness), 

and product formulation. Other critical 

factors that affect the rate of heating of the 

product may also be established by the 

study; 

OR 

•	 The EPIPT, established by a scientific 

study. Other critical factors that affect the 

rate of heating of the product may also be 

established by the study. 

Note: EPIPT monitoring may not be an option when the objective 

is control of C. botulinum type E and non-proteolytic types B and F 

spores. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 The critical factors established by a scientific 

study. These may include length of the cook 

or pasteurization cycle (speed of the belt 

for a continuous cooker or pasteurizer) and 

temperature of the steam or water used 

for cooking or pasteurization (or visual 

observation of minutes at a boil for cooking), 

initial temperature of the product, container 

size (e.g., can dimensions, pouch thickness), 

and product formulation; 

OR 

•	 The EPIPT. 

»	 How Will Monitoring Be Done? 

For batch cooking or pasteurization equipment: 

•	 For cooking or pasteurization temperature: 

° Use a continuous temperature-recording 

device (e.g., a recording thermometer). 

The device should be installed where 

it measures the coldest temperature of 

the cooking equipment (cold spot to be 

determined by a study). Where cooking 

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 

321 
is performed at the boiling point, visual 

observation of minutes at a boil may be 

an acceptable alternative; 

AND 

•	 For the start and end of each cooking or 

pasteurization cycle:
 

° Visual observation;
 

AND 

•	 For other critical factors: 

° Use equipment appropriate to the critical

factor (e.g., initial temperature with a 

temperature-indicating device, (e.g., a 

thermometer); 

OR 

•	 For the EPIPT: 

° Use a temperature-indicating device (e.g., 

a thermometer). 

For continuous cooking or pasteurization 

equipment: 

•	 For cooking or pasteurization temperature: 

° Use a continuous temperature-recording 

device (e.g., a recording thermometer). 

The device should be installed where 

it measures the coldest temperature of 

the cooking equipment (cold spot to 

be determined by a study). Because 

of the extended time of operation of 

such equipment, it is unlikely that 

visual observation of boiling will be an 

acceptable alternative, even if cooking is 

performed at the boiling point; 

AND 

•	 For cooking or pasteurization time, use: 

° A stopwatch or tachometer to monitor 

the speed of the belt drive wheel; 

OR 

° A stopwatch to monitor the time 

necessary for a test unit or belt marking 

to pass through the equipment; 

AND 

•	 For other critical factors: 

° Use equipment appropriate to the critical

factor (e.g., initial temperature with a 

temperature-indicating device, (e.g., a 

thermometer); 

OR 

•	 For the EPIPT: 

° Use a temperature-indicating device (e.g., 

a thermometer). 

» How Often Will Monitoring Be Done (Frequency)? 

For batch cooking or pasteurization equipment: 

•	 For cooking or pasteurization temperature: 

° Continuous monitoring, with a visual 

check of the recorded data at least once 

per batch; 

AND 

•	 For the start and end of each cooking or 

pasteurization cycle:
 

° Each batch;


AND 

•	 For other critical factors: 

° With sufficient frequency to achieve 

control; 


OR
 

•	 For the EPIPT: 

° Each batch.

For continuous cooking or pasteurization 

equipment: 

•	 For cooking or pasteurization temperature: 

° Continuous monitoring, with a visual 

check of the recorded data at least once 

per day; 

AND 

•	 For cooking or pasteurization time: 

° At least once per day, and whenever any 

changes in belt speed are made;
 

AND
 

•	 For other critical factors: 

° With sufficient frequency to achieve 

control; 

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 

322 
OR 

•	 For the EPIPT: 

° At least every 30 minutes, and whenever 

any changes in product-heating critical 

factors occur. 

»	 Who Will Perform the Monitoring? 

•	 For continuous temperature-recording 

devices: 

° Monitoring is performed by the device 

itself. The visual check of the data 

generated by the device, to ensure that 

the critical limits have consistently been 

met, may be performed by any person 

who has an understanding of the nature 

of the controls; 

AND 

•	 For other 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: 

•	 Recook or repasteurize the product; 

OR 

•	 Chill and hold the product for an evaluation 

of the adequacy of the cooking or 

pasteurization process. If the product has 

not received an adequate process, it should 

be destroyed, diverted to a non-food use, or 

recooked or repasteurized; 

OR 

•	 Divert the product to a use in which the 

critical limit is not applicable (e.g., divert 

improperly cooked or pasteurized shrimp to 

a shrimp canning operation); 

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: 

•	 Adjust the steam supply to increase the 

processing temperature; 

OR 

•	 Extend the length of the cooking or 

pasteurization cycle to compensate for a 

temperature drop, using a process developed 

by a process authority; 

OR 

•	 Process at a higher temperature to 

compensate for a low initial temperature, 

using a process developed by a process 

authority; 

OR 

•	 Adjust the belt speed. 

Establish a Recordkeeping System. 

For batch cooking or pasteurization equipment: 

•	 For temperature monitoring: 

° Record of continuous temperature 

monitoring;
 

AND
 

° Record of visual checks of recorded data;
 

OR 

•	 Cooking log that indicates visual observation 

of boiling, where cooking is performed at 

the boiling point; 

AND 

•	 Record of notation of the start time and end 

time of the cooking or pasteurization periods; 

AND 

•	 Records that are appropriate for the 

other critical factors (e.g., a cooking or 

pasteurization log that indicates the initial 

temperature); 

OR 

•	 Record of EPIPT results. 

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 

323 
For continuous cooking or pasteurization 

equipment: 

•	 Record of continuous temperature monitoring; 

AND 

•	 Record of visual checks of devices; 

AND 

•	 Cooking or pasteurization log that indicates 

the RPM of the belt drive wheel or the time 

necessary for a test unit or belt marking to 

pass through the tank; 

AND 

•	 Records that are appropriate for the other 

critical factors (e.g., a cooking or pasteurization 

log that indicates the initial temperature); 

OR 

•	 Record of EPIPT results. 

Establish Verification Procedures. 

For cooking, process validation study (process 

establishment): 

•	 The adequacy of the cooking process 

should be established by a scientific study. It 

should be designed to ensure an appropriate 

reduction in the number of pathogenic 

bacteria of public health concern. Selecting 

the target organism is critical. In most cases, 

it will be a relatively heat-tolerant vegetative 

pathogen, such as L. monocytogenes. 

However, in some cases where outgrowth 

of spore-forming pathogens, such as 

Clostridium perfringens and Bacillus cereus, 

during the post-cook cooling step must be 

prevented by eliminating these pathogens 

during the cook step (e.g., because cooling 

after cooking is not controlled (see 

Chapter 12)), then they will be the target 

organisms. Additionally, when cooking is 

performed immediately before reduced 

oxygen packaging (e.g., vacuum packaging 

or modified atmosphere packaging), for 

a product that will be marketed under 

refrigeration, it may be necessary for the 

cooking process to be sufficient to eliminate 

the spores of C. botulinum type E and non

proteolytic types B and F. This is the case 

when the product does not contain other 

barriers that are sufficient to prevent growth 

and toxin formation by this pathogen (e.g., 

refrigerated, vacuum packaged hot-filled 

soups and sauces). Generally, a 6D process 

is suitable, regardless of the target bacterial 

pathogen. However, lower degrees of 

destruction may be acceptable if supported 

by a scientific study of the normal levels in 

the food. Tables A-3 and A-4 provide 6D 

process times for a range of internal product 

temperatures, with L. monocytogenes and C. 

botulinum type B (the most heat-resistant 

form of non-proteolytic C. botulinum) as 

the target pathogens. The values provided 

in Table A-4 may not be sufficient for the 

destruction of C. botulinum type E and 

non-proteolytic types B and F in products 

containing dungeness crabmeat because of 

the potential protective effect of naturally 

occurring substances, such as lysozyme. 

Expert knowledge of thermal process 

calculations and the dynamics of heat transfer 

in processing equipment may be required 

to establish such a cooking process. Such 

knowledge can be obtained by education or 

experience, or both. Conducting a validation 

study for cooking processes may require 

access to suitable facilities and the application 

of recognized methods. The cooking 

equipment should be designed, operated, 

and maintained to deliver the established 

process to every unit of the product. In some 

cases, thermal death time, heat penetration, 

temperature distribution, and inoculated 

pack studies may be necessary to validate 

the minimum process. In many cases, 

establishing the minimum process may be 

simplified by repetitively determining the 

process needed to reach an internal product 

temperature that will ensure the inactivation 

of all vegetative bacterial pathogens of public 

health concern under the most difficult 

heating conditions likely to be encountered 

­

CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 

324 
during processing. In other instances, 

existing literature or federal, state, or local 

regulations that establish minimum processes 

or adequacy of equipment are available. 

Characteristics of the process, product, and/ 

or equipment that affect the ability of the 

established minimum cooking process should 

be taken into consideration in the validation 

of the process. A record of the process 

validation study should be maintained; 

OR 

For pasteurization, process validation study 

(process establishment): 

•	 The adequacy of the pasteurization process 

should be established by a scientific study. It 

should be designed to ensure an appropriate 

reduction in the number of target bacterial 

pathogens. Selecting the target organism 

is critical. In most cases, it will be the 

spores of C. botulinum type E and non

proteolytic types B and F. In some cases 

(e.g., products that are distributed frozen 

or contain other barriers to prevent growth 

and toxin formation by C. botulinum type 

E and non-proteolytic types B and F), the 

process will target another pathogen, such 

as L. monocytogenes. Generally, a 6D process 

is suitable, regardless of the target pathogen. 

However, lower degrees of destruction may 

be acceptable if supported by a scientific 

study of the normal levels in the food. Tables 

A-3 and A-4 provide 6D process times for 

a range of internal product temperatures, 

with L. monocytogenes and C. botulinum 

type B (the most heat-resistant form of 

non-proteolytic C. botulinum) as the target 

pathogens. The values provided in Table A-4 

may not be sufficient for the destruction of C. 

botulinum type E and non-proteolytic types 

B and F in products containing dungeness 

crabmeat because of the potential protective 

effect of naturally occurring substances, such 

as lysozyme. 

Expert knowledge of thermal process 

calculations and the dynamics of heat transfer 

­

in processing equipment may be required to 

determine the target bacterial pathogen and 

to establish a pasteurization process. Such 

knowledge can be obtained by education 

or experience, or both. Conducting a 

validation study for pasteurization processes 

may require access to suitable facilities and 

the application of recognized methods. 

The pasteurization equipment should be 

designed, operated, and maintained to 

deliver the established process to every 

unit of the product. In some cases, thermal 

death time, heat penetration, temperature 

distribution, and inoculated pack studies 

may be necessary to validate the minimum 

process. In other instances, existing literature 

or federal, state, or local regulations that 

establish minimum processes or adequacy 

of equipment are available. Characteristics 

of the process, product, and/or equipment 

that affect the adequacy of the established 

minimum pasteurization process should be 

taken into consideration in the validation of 

the process. A record of the validation study 

should be maintained; 

AND 

•	 Before a temperature-indicating device (e.g., 

a thermometer) or temperature-recording 

device (e.g., a recording thermometer) is 

put into service, check the accuracy of the 

device to verify that the factory calibration 

has not been affected. This check can be 

accomplished by: 

° Immersing the sensor in an ice slurry 

(32°F (0°C)) if the device will be used at 

or near refrigeration temperature; 

OR 

° Immersing the sensor in boiling water 

(212°F (100°C)) if the device will be used 

at or near the boiling point (note that 

the temperature should be adjusted to 

compensate for altitude, when necessary); 

OR 

° 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 

temperature; 

OR 

° Comparing the temperature reading 

on the device with the reading on a 

known accurate reference device (e.g., 

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., 

steam temperature, water temperature, 

product internal temperature) within the 

temperature range at which it will be 

used; 

AND 

•	 Once in service, check the temperatureindicating device or 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-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 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 

•	 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 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 

326 
CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 

327 

TABLE 16-1

CONTROL STRATEGY EXAMPLE - COOKING AND PASTEURIZATION

(COOKING MODEL)

This table is an example of a portion of a HACCP plan using “Control Strategy Example - Cooking and Pasteurization (Cooking Model).” This example illustrates how aprocessor of wild-caught cooked shrimp can control cooking using a continuous steam cooker. It is provided for illustrative purposes only. Pathogenic bacteria survival through cooking and pasteurization may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides, pathogenic bacteria growth and toxin formation during processing, food and color additives, and metal fragments). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE* 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Cooking Pathogenic 

bacteria 

survival 

Minimum

cook time: 2.5 

minutes 

Length of the 

cook cycle 

Belt speed

measurement

with stopwatch 

Once per day 

and after any 

adjustment 

Cooker 

operator 

Extend process 

or elevate 

temperature 

to compensate

for deviation 

from critical

limit, based 

on alternate 

processes

provided by 

the process

authority

Chill and hold

for evaluation 

Cooking

record 

Scientific study establishing

the thermal process 

(process

validation)

Check the

data logger for 

accuracy and 

damage and to ensure that

it is operational 

before putting 

into operation; check it 

daily, at the beginning of 

operations; and calibrate it 

once per year

Calibrate the scale monthly

Review 

monitoring,

corrective action and 

verification, records within

1 week of 

preparation 

Minimum cook

temperature: 

210°F

Note: To 

achieve a 6D 

reduction of L.

monocytogenes 

Temperature 

of steam in

the cooker 

Digital time and

temperature 

data logger 

Continuous,

with visual

check of

recorded data

once per day 

Cooker 

operator 

Data logger

printout 

Maximum

shrimp size: 40

count/pound 

Shrimp size Scale Hourly and

after every 

raw material 

lot change

or grader 

adjustment 

Grader operator Grading 

record 

*Note: The critical limits in this example are for illustrative purposes only and are not related to any recommended process. 
CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization 

328 

TABLE 16-2

CONTROL STRATEGY EXAMPLE - COOKING AND PASTEURIZATION

(PASTEURIZATION MODEL)

This table is an example of a portion of a HACCP plan using “Control Strategy Example - Cooking and Pasteurization (Pasteurization Model).” This example illustrates howa processor of pasteurized, refrigerated blue crabmeat can control pasteurization. It is provided for illustrative purposes only. Pathogenic bacteria survival through cooking and pasteurization may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides, pathogenic bacteria growth and toxin formation during processing, recontamination after pasteurization, and metal fragments). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE* 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Batch

pasteurization 

Pathogenic 

bacteria 

survival 

Minimum

initial

product 

temperature: 

37°F 

Initial

temperature 

Dial

thermometer 

Coldest

can entering

each batch 

Pasteurizer

operator 

Extend the

process or

elevate the 

temperature 

to compensate

for 

deviation 

from the

critical

limit

Segregate

and hold for 

evaluation 

Pasteurization 

log 

Process

establishment

Check the

temperaturerecording device and 

dial thermometer for 

accuracy and damage 

and to ensure that they 

are operational before 

putting into operation; 

check it daily, at the 

beginning of operations; 

and calibrate it once per 

year

Review 

monitoring,

verification, and 

corrective action records 

within 1 week of 

preparation 

Minimum

length of 

pasteurization

cycle: 

120 minutes 

Time up to 

189°F and

time cycle 

ends 

Temperaturerecording

device 

Each batch Pasteurizer

operator 

Pasteurization 

log 

Minimum

water bath 

temperature: 

189°F 

Temperature

of water bath 

Temperaturerecording

device 

Continuously,

with visual

check at end

of batch 

Recorder 

thermometer,

with visual

check by 

pasteurizer

operator 

Recorder 

thermometer 

chart 

*Note: The critical limits in this example are for illustrative purposes only and are not related to any recommended process. 
 

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 NonFDA Web site references after March 29, 2011. 

•	 Cockey, R. R., and M. C. Tatro. 1974. Survival 

studies with spores of Clostridium botulinum 

type E in pasteurized meat of the blue crab 

Callinectes sapidus. Appl. Microbiol. 27:629-633. 

•	 European Chilled Food Federation. 1997. 

Guidelines for good hygienic practice in the 

manufacture of chilled foods. 

•	 Frazier, J. 2005. Establishing or verifying a 

heat process for cooked, ready-to-eat seafood 

products, and heat process monitoring 

considerations under HACCP. 2nd ed. 

Grocery Manufacturers Association (Food 

Products Association), Washington, DC. 

•	 Hilderbrand, K. S., Jr. 1996. Personal 

communication. Oregon State University, 

Extension Service, Corvallis, OR. 

•	 Lum, K. C. 1996. Personal communication. 

National Food Processors Association, 

Seattle, WA. 

•	 Lynt, R. K., D. A. Kautter, and H. M. 

Solomon. 1982. Differences and similarities 

among proteolytic and nonproteolytic strains 

of Clostridium botulinum types A, B, E and 

F: a review. J. Food Prot. 45:466-474. 

•	 Lynt, R. K., H. M. Solomon, T. Lilly, and 

D. A. Kautter. 1977. Thermal death time of 

Clostridium botulinum type E in meat of the 

blue crab. J. Food Sci. 42:1022-1025. 

•	 Mackey, B. M., and N. Bratchell. 1989. The 

heat resistance of Listeria monocytogenes: a 

review. Lett. Appl. Microbiol. 9:89-94. 

•	 National Advisory Committee on 

Microbiological Criteria for Foods. 1990. 

Recommendations of the National Advisory 

Committee on Microbiological Criteria for 

Foods for Cooked Ready-to-Eat Shrimp and 

Cooked Ready-to-Eat Crabmeat. Executive 

Secretariat, Food Safety and Inspection 

Service, U.S. Department of Agriculture, 

Washington, DC. 

•	 National Advisory Committee on 

Microbiological Criteria for Foods. 1990. 

Recommendations of the National Advisory 

Committee on Microbiological Criteria for 

Foods for Refrigerated Foods Containing 

Cooked, Uncured Meat or Poultry Products 

that are Packaged for Extended Refrigerated 

Shelf Life and that are Ready-to-Eat or 

Prepared with Little or No Additional Heat 

Treatment. Executive Secretariat, Food Safety 

and Inspection Service, U.S. Department of 

Agriculture, Washington, DC. 

•	 National Advisory Committee on 

Microbiological Criteria for Foods. 1991. 

Listeria monocytogenes: recommendations 

of the National Advisory Committee on 

Microbiological Criteria for Foods for 

Refrigerated Foods. Intl. J. Food Microbiol. 

14:185-246. 

•	 Peterson, M. E., G. A. Pelroy, F. T. Poysky, R. 

N. Paranjpye, R. M. Dong, G. M. Pigott, and M. 

W. Eklund. 1997. Heat-pasteurization process 

for inactivation of nonproteolytic types of 

Clostridium botulinum in picked dungeness 

crabmeat. J. Food Prot. 60:928-934. 

•	 Peterson, M. E., R. N. Paranjpye, F. T. 

Poysky, G. A. Pelroy, and M. W. Eklund. 

2002. Control of nonproteolytic Clostridium 

botulinum types B and E in crab analogs 

by combinations of heat pasteurization and 

water phase salt. J. Food Prot. 65:130-139. 

•	 Rippen, T., C. Hackney, G. Flick, G. Knobl, 

and D. Ward. 1993. Seafood pasteurization 

and minimal processing manual. Virginia 

Cooperative Extension Publication 600­

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 

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. 

The survival of pathogenic bacteria through 

processes designed to retain raw product 

characteristics can cause consumer illness. 

The primary pathogens of concern are 

Vibrio vulnificus (V. vulnificus) and Vibrio 

parahaemolyticus (V. parahaemolyticus). See 

Appendix 7 for a description of the public health 

impacts of these pathogens. 

•	 Goal of processes designed to retain raw 

product characteristics 

Some processes are designed to reduce specific 

pathogens to acceptable levels while retaining 

the sensory qualities (appearance, taste, and 

texture) of the raw product. These processes 

are particularly useful in addressing the hazard 

associated with the target pathogen in raw 

products such as raw molluscan shellfish (i.e., 

oysters, clams, mussels, and whole and roe-on 

scallops) that are intended for the raw readyto-eat market. Because these processes do not 

eliminate all pathogens of public health concern, 

they are not considered cooking or pasteurization 

processes. Finished products in which the raw 

sensory qualities are not maintained are covered 

in Chapter 16, “Pathogenic Bacteria Survival 

Through Cooking and Pasteurization.” 

Examples of processes designed to retain raw 

product characteristics include: 

•	 High hydrostatic pressure processing (HPP); 

•	 Individual quick freezing (IQF) with extended 

frozen storage; 

•	 Mild heat processing; 

•	 Irradiation. 

HPP, IQF with extended frozen storage, mild heat 

processing, and irradiation are processes currently 

used for the treatment of raw molluscan shellfish 

to reduce the presence of V. vulnificus and V. 

parahaemolyticus to non-detectable levels. V. 

vulnificus and V. parahaemolyticus are naturally 

occurring pathogens (i.e., not associated with 

human or animal sources) that may be present in 

fish and fishery products, and in particular, raw 

molluscan shellfish. Non-detectable for these 

pathogens is defined under the National Shellfish 

Sanitation Program (NSSP) as less than 30 (MPN)/ 

gram. MPN means most probable number and it 

is an approximation of the bacterial population in 

analyzed product. Shellfish that are processed in 

a manner that achieves a non-detectable level for 

one or both of these pathogens may bear “added 

safety” labeling. Additionally, they need not meet 

the time from exposure to air (e.g., by harvest or 

receding tide) to refrigeration recommendations 

specific to V. vulnificus and V. parahaemolyticus 

described in Chapter 4. 

These processes also may have application to 

pathogens other than Vibrio spp. and to products 

other than raw molluscan shellfish, but such 

applications are not presently in commercial use 

in the U.S. fish and fishery products industry. 

Control of pathogenic bacteria growth and toxin 

formation during storage of these products may be 

important to their safety because: 

•	 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 

of spoilage bacteria in the food, reducing 

competition for any surviving pathogenic 

bacteria. 

Strategies for controlling pathogenic bacteria 

growth and toxin formation are included in 

Chapter 12 (for pathogens other than Clostridium 

botulinum (C. botulinum)) and Chapter 13 (for 

C. botulinum). 

•	 High Hydrostatic Pressure Processing (HPP) 

HPP is the application of hydrostatic compression 

in the range of 14,500 to 145,000 pound per 

square inch (100 to 1,000 megapascal (MPa)). 

These pressures are capable of inactivating 

pressure-sensitive pathogens, especially 

vegetative forms. Some pathogens are more 

sensitive to pressure than are others. For 

example, V. parahaemolyticus and V. vulnificus 

are particularly sensitive. However, HPP appears 

to have limited effect against bacterial spores 

like C. botulinum unless combined with other 

treatments, such as heat and acidity (pH). 

The effectiveness of the process is dependent 

upon the amount of pressure applied, the 

process temperature, and the duration of the 

process. However other organoleptic changes, 

such as texture, viscous liquor and a “plumper” 

appearance have been reported. Additionally, 

the pressure facilitates oyster adductor muscle 

changes; hence, HPP may result in a shucked 

oyster. 

•	 Individual quick freezing (IQF) with 

extended frozen storage 

IQF involves the use of cryogenic or blast 

freezing technology to rapidly lower the product 

temperature below freezing. This process results 

in a reduction in the number of freeze-sensitive 

pathogens. Some pathogens are more sensitive 

to freezing than are others. For example, V. 

parahaemolyticus and V. vulnificus are especially 

sensitive. To reduce V. parahaemolyticus and/ 

or V. vulnificus to non-detectable levels, the IQF 

process is followed by a period of frozen storage, 

which may vary depending on organism. 

•	 Mild heat processing 

Mild heat processing involves submerging the 

product first in a hot water bath for a prescribed 

time period followed by dipping it in an ice 

water bath. This process results in a reduction 

in the number of heat-sensitive pathogens. Some 

pathogens are more sensitive to heat than are 

others. V. parahaemolyticus and V. vulnificus are 

especially sensitive. 

•	 Irradiation 

Ionizing radiation (i.e., irradiation) is used to 

eliminate or reduce the numbers of bacterial 

pathogens, parasites, and insects in food. It 

can also be used to delay physiological 

processes (e.g., ripening) in fruit and vegetables. 

Acceptable sources of ionizing radiation in 

the United States include: gamma rays from 

sealed units of the radionuclides cobalt-60 and 

cesium-137; electrons generated by machine 

sources (at energies not exceeding 10 million 

electron volts); and, x-rays generated by machine 

sources (at energies not exceeding 5 or 7.5 

million electron volts, depending on the target 

material as set forth in 21 CFR 179.26 (a)). 

FDA has approved the use of ionizing radiation 

for the control of V. parahaemolyticus and V. 

vulnificus and other foodborne pathogens in 

fresh or frozen molluscan shellfish. Mandatory 

irradiation controls are described in the 

Irradiation in the Production, Processing and 

Handling of Food regulation (21 CFR 179). 

Irradiation of fresh and frozen molluscan 

shellfish may not exceed an absorbed dose of 5.5 

kilograys (kGy) (21 CFR 179.26(b)). 

Some pathogens are more sensitive to ionizing 

radiation than are others. V. parahaemolyticus 

and V. vulnificus are highly sensitive, whereas 

Salmonella spp. and Listeria monocytogenes (L. 

monocytogenes) are more resistant. Bacterial 

spores (e.g., C. botulinum) are more resistant to 

ionizing radiation than are bacterial vegetative 

cells (e.g., L. monocytogenes). 

The effectiveness of the process is determined 

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 

absorbed depends on factors associated with 

the irradiator itself, for example, activity (energy 

output) of the source (e.g., x-ray intensity and 

electron or photon energy spectrum), source 

geometry (configuration or relationship between 

the product and the source), source-to-product 

distance, process path through the irradiator, 

and beam characteristics. The amount of 

absorption also depends on factors associated 

with the specific process, for example, length of 

time irradiated, conveyor speed, environmental 

temperature, product temperature, product 

composition and density, packaging size, shape 

and composition, and configuration of the load 

of product in the irradiator. It is important 

that every part of the product receive the 

prescribed absorbed dose within a specified 

range. Dosimetry mapping is used to document 

the distribution of absorbed dose throughout 

a process load for a particular set of irradiator 

parameters. All factors listed above should be 

considered in the establishment of the process 

and its verification. The parameters that could 

affect the absorbed dose should be monitored. 

A suitable dosimetry system should be used to 

verify the range of absorbed dose delivered to 

each lot of product. 

•	 Control of processes intended to retain raw 

product characteristics 

Controlling pathogenic bacteria survival through 

processes intended to retain raw product 

characteristics is accomplished by: 

•	 Scientifically establishing and validating a 

process that will reduce the target pathogen(s) 

to an acceptable level (the scientific study may 

be conducted by the processor or obtained 

from scientific literature); 

•	 Designing and operating the processing 

equipment so that every unit of the product 

receives at least the established minimum 

process; 

•	 Continuously monitoring the critical process 

parameters to verify achievement of a 

scientifically established process. 

If “added safety” labeling is to be used on the 

product or if the process is used as a substitute for 

the time from exposure to air (e.g., by harvest or 

receding tide) to refrigeration recommendations 

specific to V. vulnificus and V. parahaemolyticus 

described in Chapter 4, the ability of a process to 

reliably achieve the appropriate reduction of the 

target pathogen should be validated by a scientific 

study approved by the shellfish control authority 

with concurrence from FDA. A scientific study is 

conducted to initially validate the efficacy of the 

process and to revalidate it when there has been a 

change in the process. Additional guidance on the 

conduct of a validation study can be found in the 

“National Shellfish Sanitation Program Guide for 

the Control of Molluscan Shellfish 2007 Revision.” 

•	 Strategies for control of pathogens 

There are a number of strategies for the control 

of pathogens in fish and fishery products. They 

include: 

•	 Killing pathogenic bacteria by processes 

that retain the raw product characteristics 

(covered in this chapter); 

•	 Killing pathogenic bacteria by cooking 

or pasteurizing (covered in Chapter 16) 

or by retorting (covered by the Thermally 

Processed Low-Acid Foods Packaged in 

Hermetically Sealed Containers regulation, 21 

CFR 113, called the Low-Acid Canned Foods 

Regulation in this guidance document); 

•	 Managing the amount of time that food is 

exposed to temperatures that are favorable 

for pathogenic bacteria growth and toxin 

production (covered generally in Chapter 

12; for C. botulinum, in Chapter 13; and for 

Staphylococcus aureus in hydrated batter 

mixes, in Chapter 15); 

•	 Controlling the amount of moisture that is 

available for pathogenic bacteria growth 

(water activity) in the product by drying 

(covered in Chapter 14); 

•	 Controlling the amount of moisture that is 

available for pathogenic bacteria growth 

(water activity) in the product by formulation 

(covered in Chapter 13); 

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

333 
•	 Controlling the amount of salt or 

preservatives, such as sodium nitrite, in the 

product (covered in Chapter 13); 

•	 Controlling the level of pH in the product 

(covered by the Acidified Foods regulation, 

21 CFR 114 for shelf-stable acidified products, 

and by Chapter 13 for refrigerated acidified 

products); 

•	 Controlling the source of molluscan shellfish 

and time from exposure to air (e.g., by 

harvest or receding tide) to refrigeration in 

order to control pathogens from the harvest 

area (covered in Chapter 4); 

•	 Controlling the introduction of pathogenic 

bacteria after the pasteurization process 

(covered in Chapter 18). 

DETERMINE WHETHER THE POTENTIAL 

HAZARD IS SIGNIFICANT. 

The following guidance will assist you in 

determining whether pathogenic bacteria survival 

through processes designed to retain raw 

product characteristics is a significant hazard at a 

processing step: 

1.	 Is it reasonably likely that unsafe levels of 

pathogenic bacteria will be introduced at this 

processing step (do unsafe levels of pathogenic 

bacteria come in with the raw material or will the 

process introduce unsafe levels of pathogens)? 

Under ordinary circumstances, it would be 

reasonably likely that an unsafe level of 

V. vulnificus could enter the process from 

oysters harvested from states that have been 

confirmed as the original source of oysters 

associated with two or more V. vulnificus 

illnesses (e.g., states bordering the Gulf of 

Mexico). 

Under ordinary circumstances, it would be 

reasonably likely that an unsafe level of V. 

parahaemolyticus could enter the process 

from oysters harvested from an area that 

meets any one of the following conditions: 

•	 The shellfish control authority 

has conducted a risk evaluation 

and determined that the risk of V. 

parahaemolyticus illness from the 

consumption of oysters harvested 

from that growing area is reasonably 

likely to occur. Specific guidance 

for determining risk can be found 

in the “National Shellfish Sanitation 

Program Guide for the Control of 

Molluscan Shellfish 2007 Revision”; 

•	 The shellfish control authority has 

determined that harvesting occurs in the 

growing area at a time when average 

monthly daytime water temperatures 

exceed 60°F for waters bordering the 

Pacific Ocean and 81°F for waters 

bordering the Gulf of Mexico and 

the Atlantic Ocean (New Jersey and 

south), except where a more rigorous 

risk evaluation has led the shellfish 

control authority to conclude that the 

risk of V. parahaemolyticus illness 

from the consumption of oysters 

harvested from that growing area 

is not reasonably likely to occur; 

•	 The waters of the state have been 

confirmed as the original source 

of oysters associated with two 

or more V. parahaemolyticus 

illnesses in the past 3 years. 

2.	 Can unsafe levels of pathogenic bacteria that 

were introduced at an earlier processing step be 

eliminated or reduced to an acceptable level at 

this processing step? 

Pathogenic bacteria survival through processes 

designed to retain raw product characteristics 

should also be considered a significant hazard 

at any processing step 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. 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 

to retain raw product characteristics is proper 

design and control of the process. 

•	 Intended use 

The controls for V. vulnificus and V. 

parahaemolyticus that are discussed in this 

chapter are only intended to be applied to 

oysters if they are intended for raw consumption. 

You should assume that most oysters will be 

consumed raw. However, controls need not 

be applied to oyster shellstock if tags on the 

containers of shellstock indicate that they must 

be shucked before consumption. 

IDENTIFY CRITICAL CONTROL POINTS. 

The following guidance will assist you in 

determining whether a processing step is a 

critical control point (CCP) for pathogenic 

bacteria survival through processes designed to 

retain raw product characteristics: 

1.	 If the finished product is raw oyster shellstock 

intended for raw consumption, will it be subjected 

to a process in your facility that is designed to 

retain raw product characteristics (e.g., mild 

heat processed, IQF with extended frozen 

storage, high hydrostatic pressure processed, or 

irradiated) and is sufficient to reduce V. vulnificus 

or V. parahaemolyticus to acceptable levels (i.e., 

reduced to a non-detectable level, less than 30 

MPN/gram)? 

a.	 If the finished product will be subjected 

to a process designed to retain raw 

product characteristics, you should 

identify that processing step as the CCP 

for the target pathogen. In this case, you 

would not need to identify the receiving 

step as a CCP for the control of the target 

pathogen. However, you may need to 

identify the receiving step as a CCP for 

control of other non-target pathogens 

(e.g., Salmonella spp. and norovirus), as 

described in Chapter 4. 

This control approach includes two 

control strategies referred to in this chapter 

as “Control Strategy Example 1 - High 

Hydrostatic Pressure Processing,” or 

“Control Strategy Example 2 - IQF With 

Extended Frozen Storage.” For guidance 

on controls for mild heat processing, see 

“Control Strategy Example 1 - Cooking and 

Pasteurization,” in Chapter 16; however, 

guidance on process validation for mild 

heat processing is more appropriately 

obtained from “Control Strategy Example 1 

- High Hydrostatic Pressure Processing,” in 

this chapter. No specific guidance is given 

on control of irradiation. 

b.	 If the product will not be subjected to a 

process in your facility that is designed 

to retain raw product characteristics 

and is sufficient to reduce V. vulnificus 

or V. parahaemolyticus to acceptable 

levels, you should identify the receiving 

step as the CCP for V. vulnificus and/ 

or V. parahaemolyticus, as appropriate. 

Guidance for development of this control 

strategy is provided in Chapter 4. 

DEVELOP A CONTROL STRATEGY. 

The following guidance provides two control 

strategies for pathogenic bacteria survival 

through processes designed to retain raw product 

characteristics. You may select a control strategy 

that is different from those which are suggested, 

provided it complies with the requirements of the 

applicable food safety laws and regulations. 

The following are examples of control strategies 

included in this chapter: 

MAY APPLY TO MAY APPLY TO 

CONTROL STRATEGY PRIMARY SECONDARY 

PROCESSOR PROCESSOR 

High hydrostatic pressure 

processing 

 

IQF with extended frozen 

storage 

 

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

335 
•	 CONTROL STRATEGY EXAMPLE 1 - HIGH 

HYDROSTATIC PRESSURE PROCESSING 

Set Critical Limits. 

•	 The minimum or maximum values for the 

critical factors established by conducting a 

scientific study to validate the process (e.g., 

minimum pressure, minimum hold time at 

pressure, and minimum initial temperature of 

the product). 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 Pressure; 

AND 

•	 Hold time at pressure; 

AND 

•	 Initial temperature of the product; 

AND 

•	 Other critical factors that affect the 

effectiveness of the process, as specified by 

the study (e.g., pressurization time (step-up 

time), decompression time (step-down time), 

and treatment temperature). 

»	 How Will Monitoring Be Done? 

•	 For time and pressure: 

° Use a continuous pressure-recording

device (e.g., a pressure recorder);
 

AND
 

•	 For initial temperature of the product: 

° Use a temperature-indicating device (e.g., 

a thermometer);
 

AND
 

•	 For other critical limits: 

° Use equipment appropriate to the critical

limit. 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 For time and pressure: 

° Continuous monitoring, with a visual 

check of the recorded data at least once 

per batch; 

AND 

•	 For initial temperature of the product: 

° Each batch;

AND 

•	 For other critical factors: 

° With sufficient frequency to achieve 

control. 

»	 Who Will Do the Monitoring? 

•	 For continuous-recording devices: 

° Monitoring is performed by the device 

itself. The visual check of the data 

generated by the device, to ensure that 

the critical limits have consistently been 

met, may be performed by any person 

who has an understanding of the nature 

of the controls; 

AND 

•	 For other checks: 

° 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: 

•	 Reprocess the product; 

OR 

•	 Chill and hold the product for an evaluation 

of the adequacy of the high hydrostatic 

pressure process. If the product has not 

received an adequate high hydrostatic 

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 

improperly processed product to a canning 

operation); 

OR 

•	 Destroy the product; 

OR 

•	 Divert the product to a non-food use or a 

use without the “added safety” labeling. 

AND 

Take the following corrective action to regain control 

over the operation after a critical limit deviation: 

•	 Adjust or repair the processing equipment; 

AND/OR 

•	 Extend the high hydrostatic pressure process 

to compensate for a pressure drop, using a 

process established by a scientific study. 

Establish a Recordkeeping System. 

•	 Record of continuous pressure monitoring; 

AND 

•	 Record of visual checks of recorded data; 

AND 

•	 Record of visual observations of initial 

temperature of product; 

AND 

•	 Records that are appropriate for other critical 

limit monitoring. 

Establish Verification Procedures. 

•	 Process validation study: 

° The adequacy of the high hydrostatic 

pressure treatment should be validated 

by conducting a scientific study. It 

should be designed to ensure an 

appropriate reduction in the number 

of the target pathogen(s). In the case 

of V. vulnificus or V. parahaemolyticus, 

it should be designed to reduce the 

presence of these pathogens to nondetectable levels. Non-detectable for 

these pathogens is defined under the 

NSSP as less than 30 MPN/gram. If 

“added safety” labeling is to be used 

on the product or if the process is 

used as a substitute for the time from 

exposure to air (e.g., by harvest or 

receding tide) to refrigeration limitations 

described in Chapter 4, the ability 

of a post-harvest process to reliably 

achieve the appropriate reduction of 

the target pathogen should be validated 

by a study approved by the shellfish 

control authority with concurrence 

from FDA. A study is used to initially 

validate the efficacy of the process and 

to revalidate it when there has been 

a change in the process. Additional 

guidance on conducting a validation 

study can be found in the “National 

Shellfish Sanitation Program Guide for 

the Control of Molluscan Shellfish 2007 

Revision” (http://www.fda.gov/Food/ 

FoodSafety/Product-SpecificInformation/ 

Seafood/FederalStatePrograms/ 

NationalShellfishSanitationProgram/ 

ucm046353.htm). 

Expert knowledge of high hydrostatic 

pressure process calculations may be 

required to validate a high hydrostatic 

pressure process. Such knowledge can 

be obtained by education or experience, 

or both. Validating high hydrostatic 

pressure processes may require access 

to suitable facilities and the application 

of recognized methods. The equipment 

should be designed, operated, and 

maintained to deliver the established 

process to every unit of the product. 

In some instances, inoculated pack 

studies may be necessary to validate the 

minimum process. In other instances, 

existing literature or federal, state, or 

local regulations that establish minimum 

processes or adequacy of equipment 

may be available. Characteristics of 

the process, product, and/or equipment 

that affect the adequacy of the 

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

337 
established minimum high hydrostatic 

pressure process should be taken into 

consideration in the validation of the 

process. A record of process validation 

studies should be maintained; 

AND 

•	 Before a temperature-indicating device (e.g., 

a thermometer) is put into service, check 

the accuracy of the device to verify that the 

factory calibration has not been affected. 

This check can be accomplished by: 

° Immersing the sensor in an ice slurry 

(32°F (0°C)) if the device will be used at 

or near refrigeration temperature; 

OR 

° Immersing the sensor in boiling water 

(212°F (100°C)) if the device will be 

used at or near the boiling point (note 

that the temperature should be adjusted 

to compensate for altitude, when 

necessary); 

OR 

° Doing a combination of the above if 

the device will be used at or near room 

temperature; 

OR 

° Comparing the temperature indicated 

by the device with the reading on a 

known accurate reference device (e.g., 

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 temperatureindicating 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 

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., 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 and calibrate other monitoring 

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

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

339 

TABLE 17-1

CONTROL STRATEGY EXAMPLE 1 - HIGH HYDROSTATIC PRESSURE PROCESSING

This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using “Control Strategy Example 1 - High Hydrostatic Pressure Processing.” This example illustrates how a raw oyster processor using a high hydrostatic pressure processor can control pathogen survival through processes designed to retain raw 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 hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., pathogens from the harvest area, environmental chemical contaminants, natural toxins, pathogenic bacteria growth and toxin formation during processing, food and color additives, and metal fragments). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE* 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

High

hydrostatic 

pressure

processing 

V. vulnificus 

survival 

Minimum hold

time: 250 seconds 

Hold time at

pressure 

Pressurerecording

device 

Continuous,

with visual

check of the

recorded data

once per batch 

Pressure

equipment

operator 

Chill and hold

for evaluation 

Adjust or repair 

equipment as

needed 

Pressurerecording

device 

printout 

Process validation

Check the dial thermometer 

for accuracy and damage 

and to ensure that it is

operational before putting 

into operation; check it 

daily, at the beginning of 

operations; and calibrate it 

once per year

Review monitoring,

 corrective action, and 

verification records within 

1 week of preparation 

Minimum pressure: 

350 MPa 

Pressure

during the

holding

period 

Pressurerecording

device 

Continuous,

with visual

check of the

recorded data

once per batch 

Pressure

equipment

operator 

Pressurerecording

device 

printout 

Minimum initial

temperature of 

product: 60°F 

Initial

temperature 

of product 

Dial

thermometer 

Each batch Pressure

equipment

operator 

Initial

temperature 

log 

*Note: The critical limits in this example are for illustrative purposes only and are not related to any recommended process. 
•	 CONTROL STRATEGY EXAMPLE 2 - IQF WITH 

EXTENDED FROZEN STORAGE 

Set Critical Limits. 

•	 There are minimum or maximum values for 

the critical factors established by conducting 

a scientific study to validate the process 

(e.g., amount of time to reach frozen state, 

maximum frozen storage temperature and 

minimum time) 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 IQF freezer and product parameters 

critical to ensure that the product internal 

temperature is achieved within the time 

established by the scientific study. These 

variables may include, but are not limited 

to: initial product temperature, tunnel air 

temperature, time in tunnel, air velocity, belt 

speed, product moisture, product size, and 

loading pattern; 

AND 

•	 Frozen storage temperature; 

AND 

•	 Length of frozen storage. 

»	 How Will Monitoring Be Done? 

•	 For the IQF freezer: 

° Use equipment appropriate to the critical

limit (e.g., initial temperature with a 

temperature-indicating device (e.g., a 

thermometer)); 

AND 

•	 For frozen storage temperature: 

° Use a continuous temperature-recording 

device (e.g., a recording thermometer); 

AND 

•	 For length of frozen storage: 

° Use a clock.

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 For the IQF freezer: 

° With sufficient frequency to achieve 

control;
 

AND
 

•	 For frozen storage temperature: 

° Continuous monitoring, with a visual 

check of the recorded data at least once 

per lot; 

AND 

•	 For length of frozen storage: 

° Each lot, at the beginning and end of a 

batch. 

»	 Who Will Do the Monitoring? 

•	 For temperature-recording devices: 

° Monitoring is performed by the device 

itself. The visual check of the data 

generated by the device, to ensure that 

the critical limits have consistently been 

met, may be performed by any person 

who has an understanding of the nature 

of the controls; 

AND 

•	 For other 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: 

•	 Refreeze the product; 

OR 

•	 Hold the product for an evaluation of the 

adequacy of the freezing process. If the 

product has not received an adequate 

process, it should be destroyed, diverted to 

a non-food use or other appropriate use, or 

refrozen; 

OR 

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

340 
•	 Divert the product to a use in which the 

critical limit is not applicable (e.g., divert an 

improperly frozen product to a cooking or 

canning operation); 

OR 

•	 Destroy the product; 

OR 

•	 Divert the product to a non-food use or a 

use without the “added safety” labeling. 

AND 

Take the following corrective action to regain control 

over the operation after a critical limit deviation: 

•	 Make repairs or adjustments to the IQF 

freezing equipment; 

OR 

•	 Make repairs or adjustments to the frozen 

storage freezer; 

OR 

•	 Move some or all of the product in the 

frozen storage freezer to a properly 

functioning freezer. 

AND/OR 

•	 Extend the freezing cycle or frozen storage 

time period to compensate for a rise in 

temperature, using a process developed by a 

process authority; 

Establish a Recordkeeping System. 

•	 For the IQF freezer: 

° Records that are appropriate to the 

monitoring;
 

AND
 

•	 For frozen storage temperature: 

° Record of continuous temperature 

monitoring;
 

AND
 

•	 For length of frozen storage: 

° Freezing log with notation of the start 

and end of frozen storage periods. 

Establish Verification Procedures. 

•	 Process validation study: 

° The adequacy of the IQF with extended 

frozen storage process should be validated 

by conducting a scientific study. It should 

be designed to ensure an appropriate 

reduction in the number of the target 

pathogen(s). In the case of V. vulnificus 

or V. parahaemolyticus, it should be 

designed to reduce the presence of 

these pathogens to non-detectable levels. 

Non-detectable for these pathogens is 

defined under the NSSP as less than 30 

MPN/gram. If “added safety” labeling 

is to be used on the product or if the 

process is used as a substitute for the time 

from harvest to refrigeration limitations 

described in Chapter 4, the ability of a 

post-harvest process to reliably achieve 

the appropriate reduction of the target 

pathogen should be validated by a study 

approved by the shellfish control authority 

with concurrence from FDA. A study is 

performed to initially validate the efficacy 

of the process and to revalidate it when 

there has been a change in the process. 

Process verification may also be required 

at predetermined intervals. Additional 

guidance on conducting a validation study 

can be found in the “National Shellfish 

Sanitation Program Guide for the Control 

of Molluscan Shellfish 2007 Revision.” 

Validating an IQF with extended frozen 

storage process may require access to 

suitable facilities and the application of 

recognized methods. The equipment 

should be designed, operated, and 

maintained to deliver the established 

process to every unit of the product. 

In some instances, inoculated pack 

studies may be necessary to establish the 

minimum process. In other instances, 

existing literature or federal, state, or 

local regulations that establish minimum 

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 

process, product, and/or equipment that 

affect the adequacy of the established 

minimum IQF with extended frozen 

storage process should be taken into 

consideration in the validation of 

the process. A record of the process 

validation studies should be maintained; 

AND 

•	 Before a temperature-indicating device (e.g., 

a thermometer) or temperature-recording 

device (e.g., a recording thermometer) is 

put into service, check the accuracy of the 

device to verify that the factory calibration 

has not been affected. This check can be 

accomplished by: 

° Immersing the sensor in an ice slurry 

(32°F (0°C)) if the device will be used at 

or near refrigeration temperature; 

OR 

° Immersing the sensor in boiling water 

(212°F (100°C)) if the device will be used 

at or near the boiling point (note that 

the temperature should be adjusted to 

compensate for altitude, when necessary); 

OR 

° Doing a combination of the above if 

the device will be used at or near room 

temperature; 

OR 

° Comparing the temperature indicated by 

the device with the reading on a known 

accurate reference device (e.g., a NISTtraceable 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 temperatureindicating device or temperature-recording 

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 

attached wires for damage or kinks. The 

device should be checked to ensure that it 

is operational and has, where applicable, 

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 

or the need to replace the device (perhaps 

with a more durable device). Devices 

used to determine the core temperature of 

frozen fish or fishery products 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 

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

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

343 

TABLE 17-2

CONTROL STRATEGY EXAMPLE 2 - IQF WITH EXTENDED STORAGE

This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using “Control Strategy Example 2 - IQF With Extended Storage.” Thisexample illustrates how a raw oyster processor using a continuous cryogenic freezer can control pathogen survival through processes designed to retain raw 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 hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., pathogens from the harvest area, environmental chemical contaminants and pesticides, natural toxins, pathogenic bacteria growth and toxin formation during processing, food and color additives, and metal fragments) 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE* 

MONITORING 

CORRECTIVE ACTION(S) RECORDS VERIFICATION

WHAT HOW FREQUENCY WHO 

IQF

freezer 

V. vulnificus 

survival 

The minimum or

maximum values for 

the critical factors

 established by a 

scientific validation 

study* 

Critical factors 

that affect the 

effectiveness 

of the

process, as 

specifi ed by 

the study* 

Use

equipment

appropriate

to the critical

limit* 

With 

sufficient 

frequency to

achieve control* 

IQF

equipment

operator 

Segregate and hold

the product for 

evaluation 

Adjust or repair 

equipment as needed 

IQF record Process validation

Check the data logger

for accuracy and 

damage and to ensure

that it

is operational before 

putting into operation; 

check it daily, at the 

beginning of

operations; and 

calibrate it once per 

year 

Review 

monitoring,

corrective action, and 

verification records 

within 1 week of 

preparation 

The minimum length 

of frozen storage 

established by a 

scientific validation 

study* 

Length of 

frozen 

storage 

Clock Beginning and

end of each lot 

Frozen storage 

operator 

Frozen 

storage 

record 

The

maximum temperature 

of frozen storage 

established by a 

scientific validation 

study* 

Temperature 

of

frozen 

storage 

Digital time/

temperature 

data logger 

Continuous,

with visual

check of

recorded data

once per lot 

Frozen storage 

operator 

Data

logger

printout 

* Note: This plan is for illustrative purposes only. An actual plan should specify the actual critical limits for the IQF freezer, actual minimum frozen storage temperature, and actual minimum length 

of frozen storage. Additionally, an actual plan should specify the actual critical factors that will be monitored, the way in which they will be monitored, and the frequency of monitoring. 
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 NonFDA Web site references after March 29, 2011. 

•	 Food Standards Program Codex Alimentarius 

Commission. 2003. Codex general standard for 

irradiated foods (CODEX STAN 106-1983, rev. 

1-2003). Food and Agriculture Organization and 

World Health Organization, Rome, Italy. 

•	 Food Standards Program Codex Alimentarius 

Commission. 2003. Recommended 

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 hardshelled 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. 

•	 U.S. Food and Drug Administration. 

Irradiation in the production, processing 

and handling of food. In Code of Federal 

Regulations, 21 CFR 179. U.S. Government 

Printing Office, Washington, DC. 

•	 U.S. Food and Drug Administration. Ionizing 

radiation for the treatment of food. In Code 

of Federal Regulations, 21 CFR 179.26. U.S. 

Government Printing Office, Washington, DC. 

•	 U.S. Food and Drug Administration. 2007. 

National Shellfish Sanitation Program, 

Guide for the Control of Molluscan Shellfish 

2007 Revision. 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/ 

FoodSafety/Product-SpecificInformation/ 

Seafood/FederalStatePrograms/ 

NationalShellfishSanitationProgram/ 

ucm046353.htm. 

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 

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. 

The introduction of pathogenic bacteria after 

pasteurization and certain specialized cooking 

processes can cause consumer illness. The 

primary pathogens of concern are Clostridium 

botulinum (C. botulinum), Listeria monocytogenes, 

Campylobacter jejuni, pathogenic strains of 

Escherichia coli, Salmonella spp., Shigella spp., 

Yersinia enterocolitica, Staphylococcus aureus (S. 

aureus), Vibrio cholerae, Vibrio vulnificus, and 

Vibrio parahaemolyticus. See Appendix 7 for a 

description of the public health impacts of 

these pathogens. 

•	 Goal of pasteurization and specialized 

cooking processes 

Pasteurization is a heat treatment applied to 

eliminate the most resistant pathogenic bacteria 

of public health concern that is reasonably likely 

to be present in the food. With fishery products, 

pasteurization is usually performed after the product 

is placed in the hermetically sealed finished product 

container. It is applied to fishery products that are 

distributed either refrigerated or frozen. Examples 

of pasteurized fishery products follow: pasteurized 

crabmeat, pasteurized surimi-based analog products, 

and pasteurized lobster meat. 

In addition to eliminating pathogenic bacteria, 

the pasteurization process also greatly reduces 

the number of spoilage bacteria present in the 

fishery product. Spoilage bacteria normally 

restrict the growth of pathogenic bacteria through 

competition. Rapid growth of pathogenic bacteria 

that may be introduced after pasteurization is, 

therefore, a concern. This chapter covers control 

of recontamination after pasteurization. 

For some products that are marketed refrigerated, 

cooking is performed immediately before reduced 

oxygen packaging (e.g., vacuum packaging, 

modified atmosphere packaging). For these 

products, the cooking process is targeted to 

eliminate the spores of C. botulinum type E 

and non-proteolytic types B and F, particularly 

when the product does not contain other 

barriers that are sufficient to prevent growth and 

toxin formation by this pathogen (e.g., many 

refrigerated, vacuum packaged hot-filled soups, 

chowders, and sauces). 

These specialized cooking processes, which are 

discussed in Chapter 16, have much in common 

with pasteurization processes, which are also 

discussed in Chapter 16. For example, control 

of recontamination after the product is placed in 

the finished product container is critical to the 

safety of these products. Additionally, because 

these products are cooked before they are 

packaged, they are at risk for recontamination 

between cooking and packaging. The risk of this 

recontamination may be minimized by filling 

directly from the cook kettle using a sanitary, 

automated, continuous-filling system (designed to 

minimize the risk of recontamination) while the 

product is still hot (i.e., hot filling). This control 

strategy may not be suitable for products such as 

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 

is covered in this chapter. 

•	 Control of pathogenic bacteria introduction 

after pasteurization and after specialized 

cooking processes 

There are three primary causes of 

recontamination after pasteurization and after 

cooking that is performed immediately before 

reduced oxygen packaging: 

•	 Defective container closures; 

•	 Contaminated container cooling water; 

•	 Recontamination between cooking and 

reduced oxygen packaging. 

Poorly formed or defective container closures 

can increase the risk of pathogens entering the 

container through container handling that occurs 

after pasteurization or after the cooked product is 

filled into the reduced oxygen package. This risk 

is a particular concern during container cooling 

performed in a water bath. Contaminated 

cooling water can enter through the container 

closure, especially when the closure is defective. 

Container closure can be controlled by adherence 

to seal guidelines that are provided by the 

container or sealing machine manufacturer. 

Control is accomplished through periodic seal 

inspection. 

Contamination of cooling water can be controlled 

either by ensuring that a measurable residual 

of chlorine, or other approved water treatment 

chemical, is present in the cooling water or by 

ensuring that ultraviolet (UV) treatment systems 

for the cooling water are operating properly, 

particularly for systems in which the water is 

reused or recirculated. 

Recontamination between cooking and reduced 

oxygen packaging in continuous filling systems, 

where the product is packaged directly from 

the kettle, can be controlled by hot filling at 

temperatures at or above 185°F (85°C). FDA 

is interested in information on the value of 

adding a time component (e.g., 3 minutes) to 

this hot filling temperature recommendation to 

provide limited lethality for any non-proteolytic 

C. botulinum spores present on the packaging 

material. 

It may also be prudent to use packaging that has 

been manufactured or treated to inactivate spores 

of C. botulinum type E and non-proteolytic 

types B and F (e.g., gamma irradiation and hot 

extrusion). FDA is also interested in comment on 

the utility of such measures. 

•	 Strategies for controlling pathogenic 

bacteria growth 

There are a number of strategies for the control 

of pathogenic bacteria in fish and fishery 

products. They include: 

•	 Controlling the introduction of pathogenic 

bacteria after the pasteurization process 

and after the cooking process performed 

immediately before reduced oxygen 

packaging (covered in this chapter); 

•	 Controlling the amount of moisture that is 

available for pathogenic bacteria growth 

(water activity) in the product by drying 

(covered in Chapter 14); 

•	 Controlling the amount of moisture that is 

available for pathogenic bacteria growth 

(water activity) in the product by formulation 

(covered in Chapter 13); 

•	 Controlling the amount of salt or 

preservatives, such as sodium nitrite, in the 

product (covered in Chapter 13); 

•	 Controlling the level of acidity (pH) in the 

product (covered by the Acidified Foods 

regulation, 21 CFR 114, for shelf-stable 

acidified products, and by Chapter 13 for 

refrigerated acidified products); 

•	 Controlling the source of molluscan shellfish 

and the time from exposure to air (e.g., by 

harvest or receding tide) to refrigeration 

to control pathogens from the harvest area 

(covered in Chapter 4); 

•	 Killing pathogenic bacteria by cooking 

or pasteurization (covered in Chapter 16) 

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 

Hermetically Sealed Containers regulation, 21 

CFR 113, called the Low Acid Canned Foods 

regulation in this guidance document); 

•	

•	

Killing pathogens by processes that retain 

the raw product characteristics (covered in 

Chapter 17); 

Managing the amount of time that food is 

exposed to temperatures that are favorable 

for pathogenic bacteria growth and toxin 

production (covered generally in Chapter 12; 

for C. botulinum, in Chapter 13; and for S. 

aureus in hydrated batter mixes, in Chapter 15). 

DETERMINE WHETHER THE POTENTIAL 

HAZARD IS SIGNIFICANT. 

The following guidance will assist you in 

determining whether introduction of pathogenic 

bacteria after pasteurization is a significant 

hazard at a processing step: 

1.	 Is it reasonably likely that pathogenic bacteria 

will be introduced at this processing step 

(consider post-pasteurization and post-cooking 

processing steps only)? 

It is reasonable to assume that in the absence 

of controls, pathogens of various types may 

enter the finished product container after 

pasteurization or after filling the cooked 

product into the reduced oxygen package. 

This is a particular concern for products that 

are cooled in a water bath. 

2.	 Can the introduction of pathogenic bacteria after 

pasteurization be eliminated or reduced to an 

acceptable level here? 

Introduction of pathogenic bacteria after 

pasteurization should also be considered 

a significant hazard at any processing step 

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 

pathogenic bacteria after pasteurization can 

include: 

•	 Controlling container sealing; 

•	 Controlling the residual of chlorine, 

or other approved water treatment 

chemical, in container cooling water; 

•	 Controlling UV light intensity of bulbs 

used for treating container cooling water 

and the flow rate of the cooling water 

moving through the UV treatment system; 

•	 Hot filling the product into the final 

container in a continuous filling system. 

•	 Intended use 

It is unlikely that the intended use will affect the 

significance of this hazard. 

IDENTIFY CRITICAL CONTROL POINTS. 

The following guidance will assist you in 

determining whether a processing step is a 

critical control point (CCP) for introduction of 

pathogenic bacteria after pasteurization. 

If you identified the hazard as significant, you 

should identify the container sealing step, the 

water bath container cooling step, and the hot 

filling step (where applicable) as the CCPs for this 

hazard. 

Example: 

A crabmeat processor that pasteurizes the 

finished product cans after filling and cools 

them in a water bath should set the CCPs for 

introduction of pathogenic bacteria after 

pasteurization at the can seaming and water 

bath can cooling steps. 

This control approach is a control strategy 

referred to in this chapter as “Control Strategy 

Example - Control of Recontamination.” 

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

347 
 

DEVELOP A CONTROL STRATEGY. 

The following guidance provides a strategy to 

control the introduction of pathogenic bacteria 

into the product after pasteurization. You may 

select a control strategy that is different from that 

which is suggested, provided it complies with the 

requirements of the applicable food safety laws 

and regulations. 

The following is an example of a control strategy 

included in this chapter: 

MAY APPLY TO 

PRIMARY 

PROCESSOR 

MAY APPLY TO 

SECONDARY 

PROCESSOR 

CONTROL STRATEGY 

Control of recontamination  

•	 CONTROL STRATEGY EXAMPLE - CONTROL OF 

RECONTAMINATION 

Set Critical Limits. 

For container sealing: 

•	 Container or sealing machine manufacturer’s 

seal guidelines. 

For container cooling: 

•	 Measurable residual of chlorine, or other 

approved water treatment chemical, at the 

discharge point of the container cooling 

tank; 

OR 

•	 Equipment manufacturer’s UV light intensity 

and flow rate guidelines. 

For hot filling: 

•	 Product temperature of 185°F (85°C) or 

higher as the product enters the final 

container. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

For container sealing: 

•	 Container integrity. 

For container cooling: 

•	 For chemical treatment: 

Residual chlorine, or other approved 

water treatment chemical, in the cooling 

water; 

° 

OR 

•	 For UV treatment: 

Intensity of UV light; ° 

AND
 

Cooling water flow rate.
 ° 

For hot filling: 

•	 Product temperature as the product enters 

the final container. 

»	 How Will Monitoring Be Done? 

For container sealing: 

Visual examination of containers (nondestructive): 

•	 Recommendations for visual examinations 

that ensure a reliable hermetic seal should 

be obtained from the container or sealing 

machine manufacturer. They should include: 

For double-seamed metal and plastic 

cans: 

° 

•	 The external features of the double 

seam should be examined for 

gross closure defects, including: 

cutovers, seam sharpness, false 

seams, deadheading, droop, damage 

to the countersink wall indicating 

a broken chuck, cable cuts, and 

product overlapping the flange. 

In addition, visual examination 

should include examination of 

the entire container for product 

leakage or other obvious defects; 

OR
 

For pouches: 
 ° 

•	 Visual examination should be 

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, 

puncture, abrasion, blister, 

contaminated seal, delamination, seal 

creep, wrinkle, flex cracks, crushed 

package, or other obvious defects; 

OR
 

For glass containers:
 ° 

•	 Visual examination should be 

sufficient to detect gross closure 

and glass defects, including: cap 

tilt, cocked cap, crushed lug, 

stripped cap, cut through, and 

chipped and cracked glass finish; 

AND 

Detailed examination of containers (destructive): 

•	 Recommendations for seal evaluation 

measurements that ensure a reliable hermetic 

seal should be obtained from the container 

or sealing machine manufacturer. They 

should include: 

For double-seamed metal and plastic 

cans: 

° 

•	 The examination should include a 

teardown examination of the can. 

If the micrometer method is used, 

three measurements, approximately 

120° apart around the double seam, 

should be made. Measurements 

should include: cover hook, 

body hook, width, tightness, and 

thickness. If the optical method 

(seamscope or projector) is used, 

cuts should be made at at least two 

different locations, excluding the 

side seam juncture. Measurements 

should include body hook, 

overlap, tightness, and thickness; 

OR
 

For pouches: 
 ° 

•	 The examination should include 

burst, vacuum or bubble testing. It 

may also include: drop testing, peel 

testing (tensile strength), residual 

gas testing, electroconductivity 

testing, and dye testing; 

OR
 

For glass containers: 
 ° 

•	 The examination should include cold 

water vacuum testing. Additional 

examinations may include: for 

lug-type caps, security values (lugtension) and for lug-type, twist 

caps, pull-up (lug position). 

For container cooling: 

•	 For chemical treatment: 

Measure residual of chlorine, or other 

approved water treatment chemical, 

at the discharge point of the container 

cooling tank; 

° 

OR 

•	 For UV treatment: 

Use a UV light meter; ° 

AND
 

Use a flow rate meter.
 ° 

For hot filling: 

•	 Use a continuous temperature-measuring 

instrument (e.g., a recorder thermometer). 

»	 How Often Will Monitoring Be Done (Frequency)? 

For container sealing:
 

Visual examination of containers:
 

•	 At least one container from each sealing 

head at least every 30 minutes of sealing 

machine operation. At a minimum, visual 

examinations should include those made 

at the beginning of the production day, 

and immediately after a jam in the sealing 

machine, or after machine adjustment, repair, 

or prolonged shutdown; 

AND 

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

349 
Detailed examination of containers: 

•	 At least one container from each sealing 

head at least every 4 hours of sealing 

machine operation. At a minimum, visual 

examinations should include those made 

at the beginning of the production day, 

and immediately after a jam in the sealing 

machine, or after machine adjustment, repair, 

or prolonged shutdown. 

For container cooling: 

•	 For chemical treatment: 

At least once every 4 hours of use; ° 

OR 

•	 For UV treatment: 

At least daily. ° 

For hot filling: 

•	 Continuous monitoring, with a visual check 

of the instrument at least once per batch of 

cooked product. 

»	 Who Will Do the Monitoring? 

For container sealing: 

•	 Monitoring may be performed by any person 

who is trained and qualified to conduct 

container examinations. 

For container cooling: 

•	 Monitoring may be performed by any person 

who has an understanding of the nature of 

the controls. 

For hot filling: 

•	 For continuous temperature-measuring 

instruments:
 

Monitoring is performed by the 


equipment itself. The visual check of 

the data generated by the equipment, 

to ensure that the critical limits have 

consistently been met, may be performed 

by 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: 

For container sealing: 

•	 Repack and recook or repasteurize the 

affected product; 

OR 

•	 Segregate and hold the product to evaluate 

the seriousness of the defects, which may 

include, but is not limited to, 100% visual 

inspection of all affected containers to 

remove the defective containers. Any 

containers that are found to be unsafe should 

be destroyed, diverted to a non-food use, or 

repacked and recooked; 

OR 

•	 Divert the product to a use in which the 

critical limit is not applicable (e.g., divert to a 

canning operation); 

OR 

•	 Destroy the product; 

OR 

•	 Divert the product to a non-food use. 

For hot filling: 

•	 Recook the product; 

OR 

•	 Segregate and hold the product for a safety 

evaluation. If the product is found to be 

unsafe, it should be destroyed, diverted to a 

non-food use, or recooked; 

OR 

•	 Divert the product to a use in which the 

critical limit is not applicable (e.g., divert to a 

canning operation); 

OR 

•	 Destroy the product; 

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 

regain control over the operation after a critical limit 

deviation: 

For container sealing: 

•	 Identify and correct the source of the defect. 

For container cooling: 

•	 If no measurable residual chlorine, or other 

approved water treatment chemical, is 

detected, add chlorine or adjust the chlorinemetering system and recheck for chlorine 

residual; 

OR 

•	 If UV intensity is inadequate, replace or 

clean the bulbs or shields; 

OR 

•	 If flow exceeds the critical limit, adjust or 

replace the pump. 

For hot filling: 

•	 Adjust the cooking equipment to increase the 

processing temperature; 

OR 

•	 Adjust the post-cook process to minimize 

time delays. 

Establish a Recordkeeping System. 

For container sealing: 

•	 Record of visual examination of containers; 

AND 

•	 Record of detailed examination of containers. 

For container cooling: 

•	 For chemical treatment: 

Record of residual chlorine, or other 

approved water treatment chemical; 

° 

OR 

•	 For UV treatment: 

Record of UV intensity testing; ° 

AND 

Record of flow rate testing. ° 

For hot filling: 

•	 Record of continuous temperature 

monitoring; 

AND 

•	 Record of visual checks of recorded data. 

Establish Verification Procedures. 

For container sealing: 

•	 Obtain container seal guidelines from 

container or sealing machine manufacturer; 

AND 

•	 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. 

For container cooling: 

•	 Obtain UV light intensity and flow rate 

guidelines from the UV light manufacturer; 

AND 

•	 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. 

For hot filling: 

•	 Before a temperature-recording device (e.g., 

a recording thermometer) is put into service, 

check the accuracy of the device to verify that 

the factory calibration has not been affected. 

This check can be accomplished by: 

Immersing the sensor in boiling water 

(212°F (100°C)) if the device will be used 

at or near the boiling point (note that 

the temperature should be adjusted to 

compensate for altitude, when necessary); 

° 

OR 

Comparing the temperature reading 

on the device with the reading on a 

known accurate reference device (e.g., 

a thermometer traceable to National 

° 

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

351 
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; 

•	 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. 

AND 

•	 Once in service, check the temperaturerecording 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 
CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes 

353 

TABLE 18-1

CONTROL STRATEGY EXAMPLE - CONTROL OF RECONTAMINATION 

This table is an example of a portion of a Hazard Analysis Critical Control Point plan using “Control Strategy Example - Control of Recontamination.” This example illustrateshow a processor of pasteurized blue crabmeat, packed in steel cans, can control introduction of pathogenic bacteria after pasteurization. It is provided for illustrativepurposes only. Pathogenic bacteria recontamination after pasteurization may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides, pathogenic bacteria growth and toxin formation during processing, pathogenic bacteria survival through cooking and pasteurization, and metal fragments). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE* 

MONITORING 

CORRECTIVE ACTION(S) RECORDS VERIFICATION

WHAT HOW FREQUENCY WHO 

Container

sealing 

Pathogenic 

bacteria 

introduction 

No visible cutovers, seam 

sharpness, false seams,

deadheading, droop,

damage to the countersink

wall indicating a broken 

chuck, cable cuts, product 

overlapping the flange,

product leakage, or other 

obvious defects 

Container

integrity 

Visual seam 

examination 

One can per

seaming head

every 30 

minutes; at startup; 

and after jams,

adjustments,

repairs, and 

prolonged

shutdowns 

Seamer

operator 

Identify and correct 

the source of the

defect 

Evaluate the 

seriousness of the

defect, and hold for 

further evaluation if 

necessary 

Visual seam 

examination 

record 

Obtain

can seam

guidelines

from the can

manufacturer

Review 

monitoring

and corrective 

action records 

within 1 week 

of preparation Cover hook: .070 inch minimum;

body hook: .072-.088 inch;

width: .125 inch maximum;

thickness .052-.058 inch;

tightness 80% 

Container

integrity 

Double seam

teardown 

examination,

using a

micrometer at

3 points on

the seam, 120° 

apart 

One can per

seaming head

every 4 hours; at 

startup; and 

after jams,

adjustments,

repairs, and 

prolonged

shutdowns 

Seamer

operator 

Identify and correct 

the source of the

defect 

Evaluate the 

seriousness of the

defect, and 

hold for further 

evaluation if 

necessary 

Double

seam

teardown 

record 

Water 

bath

container

cooling 

Pathogenic 

bacteria 

introduction 

Measurable 

residual chlorine 

Residual 

chlorine

in water 

bath 

Rapid test Every batch Pasteurizer 

operator 

Add chlorine and 

recheck for residual 

Residual 

chlorine

record 

* Note: The critical limits in this example are for illustrative purposes only and are not related to any recommended process 
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 NonFDA Web site references after March 29, 2011. 

•	 Gavin, A., and L. M. Weddig (ed.). 1995. 

Canned foods – principles of thermal 

process control, acidification, and container 

closure evaluation. National Food Processors 

Institute, Washington, DC. 

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 

355 

CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance 


Causing Substances and Prohibited Food and Color Additives 


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. 

•	 Food allergens 

A number of foods contain allergenic proteins, 

which are natural constituents of the food that can 

pose a health risk to certain sensitive individuals. 

The symptoms of food allergies can include a 

tingling sensation in the mouth, swelling of the 

tongue and throat, difficulty in breathing, hives, 

vomiting, abdominal cramps, diarrhea, drop in 

blood pressure, loss of consciousness, and, in 

severe cases, death. 

The Food Allergen Labeling and Consumer 

Protection Act of 2004 amended the Federal Food, 

Drug, and Cosmetic Act (FFD&C Act). The FFD&C 

Act now requires that all foods that are not raw 

agricultural commodities and that contain a major 

food allergen be labeled to clearly identify the 

name of the food source from which the allergen is 

derived (21 CFR U.S.C. 343(w)(1)). The Act defines 

the following eight foods and any ingredients that 

contain protein derived from these eight foods 

(with certain exemptions noted in section 201(qq) 

(2) of the Act) as major food allergens: 

•	 Milk; 

•	 Eggs; 

•	 Fish (e.g., bass, cod, or flounder); 

•	 Crustacean shellfish (e.g., crab, lobster, or 

shrimp); 

•	 Tree nuts (e.g., almonds, pecans, or walnuts); 

•	 Peanuts; 

•	 Wheat; and 

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 allergen itself for the following five foods: 

milk; egg; wheat; peanuts; and soybeans (e.g., 

milk must be listed as “milk”). The name of the 

food source that must be listed on the label for 

tree nuts must be the specific type of tree nut 

(e.g., almonds, pecans, or walnuts). Likewise, the 

name of the food source that must be listed on the 

label for fish or crustacean shellfish must be the 

specific type of fish (e.g., bass, cod, or flounder) or 

crustacean shellfish (e.g., crab, lobster, or shrimp) 

(21 CFR U.S.C. 343(w)(2)). The “market” names 

of species of fish and crustacean shellfish should 

be used to identify the food source of these two 

major food allergens. The market names are 

found in the document “Guidance for Industry: 

The Seafood List: FDA’s Guide to Acceptable 

Market Names for Seafood Sold in Interstate 

Commerce” revised 2009 ((http://www.fda.gov/ 

Food/GuidanceComplianceRegulatoryInformation/ 

GuidanceDocuments/Seafood/ucm113260.htm). 

You may add the term “fish” to the market name 

on the label if you believe that the market name 

may not otherwise be recognized to be fish by the 

consumer (e.g., “gar fish”). 

To meet the requirements of the FFD&C Act, the 

food labels of packaged fish and fishery products 

that are or contain a major food allergen must 

declare the name of the food source for the 

allergen, either: 

(1) Within the list of ingredients, in parentheses 

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 

356 

name of the ingredient that is a major food 

allergen, (e.g., “whey (milk)”) when its food 

source name: 

(a) is not already included as part of that 

ingredient’s common or usual name (e.g., the 

food source name “milk” is included in the 

name of the ingredient “non-fat dried milk”); 

or 

(b) does not appear elsewhere in the 

ingredient list (e.g., if the food contains both 

casein and whey and the label lists “whey 

(milk),” the term “(milk)” need not follow the 

term “casein”); or 

(2) In a separate “Contains” statement 

immediately after or adjacent to the list 

of ingredients in a print size no smaller 

than that used for the ingredient list (e.g., 

“Contains shrimp and eggs”). If a “Contains” 

statement is included on the label, it must 

identify the food source names of all 

major food allergens present as ingredients 

whether or not those food source names 

were previously mentioned within the list of 

ingredients (21 CFR U.S.C. 343(w)(1)). 

This chapter contains guidance on the kinds of 

preventive controls that may be suitable to ensure 

proper labeling if your fish or fishery product is 

made in whole or in part of a food that is a major 

food allergen. As a practical matter, this guidance 

covers all finfish and crustacean shellfish and all 

other fishery products (e.g., molluscan shellfish) 

that contain one or more of the other major food 

allergens. 

Labeling controls that are designed to ensure that 

any major food allergen that is present in a food 

is declared on the label are the most effective 

means of controlling this hazard. However, 

such controls are not suitable to prevent the 

unintentional introduction of allergenic proteins 

from foods that contain these allergens into foods 

that are not intended to contain them, through 

cross-contact (e.g., use of common equipment, 

improper production scheduling, or improper use 

of rework material). Unintentional introduction of 

allergenic proteins should be controlled through 

rigorous process controls, either as part of a 

prerequisite program or as part of the Hazard 

Analysis Critical Control Point (HACCP) program 

itself. The Fish and Fishery Products regulation, 

21 CFR 123 (called the Seafood HACCP 

Regulation in this guidance document), requires 

such a regime. 

•	 Food and color additives 

Certain food and color additives can cause 

hypersensitivity reactions, or food intolerances, 

in some consumers. Although in most cases 

there are no known allergic mechanisms, 

symptoms may be similar to those caused 

by food allergens and can include a tingling 

sensation in the mouth, swelling of the tongue 

and throat, difficulty in breathing (e.g. asthma), 

hives, vomiting, abdominal cramps, and diarrhea. 

Examples of such food and color additives that 

are used in fish and fishery products include 

sulfiting agents and FD&C Yellow No. 5 (Yellow 

No. 5) described below. 

•	 Sulfiting agents are mostly used during onboard handling of shrimp and lobster to 

prevent the formation of “black spot.” They 

are sometimes used by cooked octopus 

processors as an antioxidant, to retain the 

red color of the octopus skin. They are 

also sometimes used by conch processors 

to prevent discoloration or are used as 

stabilizers in some breading meals added to 

fish. People sensitive to sulfiting agents can 

experience symptoms that can range from 

mild severity to life-threatening reactions. 

•	 Yellow No. 5 is sometimes added to smoked 

fish to impart color. To help protect people 

who are sensitive to Yellow No. 5, FDA’s 

regulation for Yellow No. 5 states that any 

food for human use that contains Yellow 

No. 5 must specifically declare the presence 

of the color additive by listing it as an 

ingredient (21 CFR 74.705(d)(2)). If Yellow 

No. 5 is added to smoked fish but is not 

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 

357 

under section 403 of the FFD&C Act, but 

also is adulterated under section 402(c). (21 

U.S.C. 343(m) and 342(c)). People sensitive to 

Yellow No. 5 can experience symptoms that 

can range from mild to moderate severity. 

Under the FFD&C Act, a use or intended use 

of a food or additives is deemed unsafe unless 

the use or intended use either conforms with a 

regulation prescribing the conditions for safe use 

or the terms of an exemption for investigational 

use. A food additive that is a food contact 

substance also may be used in accordance 

with an effective notification (21 U.S.C. 348 

and 21 U.S.C. 379e). Any food that contains an 

unsafe food additive or color additive is deemed 

adulterated under sections 402(a)(2)(C)(i) and 

402(c) of the FFD&C Act, respectively (21 U.S.C 

342(a)(2)(C)(i) and 342(c)). 

The FFD&C Act excludes from the definition 

of “food additive” substances that are generally 

recognized among experts qualified by 

scientific training and experience to evaluate 

their safety as having been adequately shown 

through scientific procedures (or, in the case 

of a substance used in food prior to January 

1, 1958, through either scientific procedures or 

experience based on common use in food) to 

be safe under the conditions of their intended 

use (21 U.S.C. 321 (s)). A substance (other than a 

food contact substance) added to food for a use 

that is not generally recognized as safe (GRAS) 

under the conditions of its intended use and is 

not otherwise excluded from the food additive 

definition in section 201(s) of the FFD&C Act, 

must be used in accordance with a food additive 

regulation permitting that specific use (21 CFR 

348). Otherwise, the use of that substance in 

food makes the food adulterated under section 

402(a)(2)(C) of the FFD&C Act. Additionally, 

food may be deemed adulterated if it contains 

a poisonous or deleterious substance that may 

render the food injurious to health, but if the 

substance is not an added substance, the food is 

not considered adulterated if the quantity of the 

substance in the food does not ordinarily render 

the food injurious to health (21 U.S.C. 342(a) 

(1)). It is important to note that there is no GRAS 

status for color additives. 

In addition to the statutory requirements that 

ensure the safety of substances added to food, 

there are labeling requirements that apply to 

ingredients in food. Under the FFD&C Act, 

a food is deemed misbranded unless the 

label bears the common or usual name of 

each ingredient with the exception of spices, 

flavorings, and color additives not subject to 

certification by FDA (21 U.S.C. 343(i)). This list 

of ingredients on the food label is especially 

important for people who need to avoid certain 

ingredients for health reasons. 

If a substance is an incidental additive and has 

no functional or technical effect in the finished 

product, then it need not be declared on the 

label. Incidental additives are usually either 

processing aids present in the finished food 

or substances that have migrated to the food 

from packaging or equipment. Sulfiting agents, 

which are added to food as preservatives, are 

considered to be incidental only if they have 

no technical effect in the food and are present 

at less than 10 parts per million (ppm) (21 CFR 

101.100(a)(4)). 

Currently, there are six sulfiting agents allowed 

in processed food. The names by which they are 

listed on food labels are: 

•	 sulfur dioxide (21 CFR 182.3862); 

•	 sodium sulfite (21 CFR 182.3798); 

•	 sodium bisulfite (21 CFR 182.3739); 

•	 sodium metabisulfite (21 CFR 182.3766); 

•	 potassium bisulfite (21 CFR 182.3616); and 

•	 potassium metabisulfite (21 CFR 182.3637). 

The amount of any one or a combination of any 

of the six sulfiting agents that may be added to 

a processed food is restricted by Current Good 

Manufacturing Practices (CGMP) (See 21 CFR 

part 182, Subpart D). Under CGMP’s, the quantity 

of sulfiting agents added to food should not 

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 

358 

technical effect. If the total amount of sulfiting 

agent added to food results in a concentration 

of 10 ppm or greater, which is the current limit 

of analytical detection identified in the Code 

of Federal Regulation § 101.100(a)(4), then the 

sulfiting agents are not exempt from FFD&C 

Act food labeling requirements and must be 

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. 

Certain other food and color additives are 

specifically prohibited from use in food because 

of a determination by FDA that they present a 

potential risk to the public health (see 21 CFR 

part 189 and 21 CFR 81.10). Examples of such 

food and color additives are coumarin, safrole, 

and FD&C Red No. 4 (Red No. 4). 
CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 

359 

TABLE 19-1

RATIONALE FOR A FINISHED PRODUCT SULFITING AGENT DECLARATION

Is a Sulfiting Agent Declaration Required?

EXAMPLES OF SULFITING AGENT USE EXAMPLES OF FINISHED FOOD 

SULFITING AGENT LEVEL IN FINISHED FOOD

<10 PPM ≥10 PPM 

Raw, shell-on shrimp or lobster treated with 

sulfi ting agents to prevent black spot 

Sulfi ting agents added to cooked octopus as 

an antioxidant to retain the red skin color 

of the octopus

Sulfi ting agents added to conch meat to 

prevent discoloration 

Raw, shell-on shrimp or lobster

Cooked octopus

Conch meat 

YES1 YES1 

Raw, shell-on shrimp or lobster treated with 

sulfi ting agents to prevent black spot

Raw, shell-on shrimp or lobster treated with 

sulfi ting agents to prevent black spot 

Raw, peeled shrimp or lobster meat

Food containing raw, peeled shrimp or 

lobster meat as an ingredient (e.g., seafood 

casserole) 

NO2 YES2 

1. The sulfiting agents have an ongoing technical or functional effect on/in the finished food and must be declared regardless of the level in the finished food2. The sulfiting agents have no technical or functional effect in the finished food and do not have to be declared unless the level in the finished food is either ≥ 10 ppm or the sulfiting agents were

added to the finished food at any level. To further clarify, if a sulfiting agent or a combination of sulfiting agents is added to finished food such that their collective concentration in/on the finished food is ≥ 10 ppm , then you must declare each by its approved label name (listed above)(21CFR101.100). 
CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 

360 

 

DETERMINE WHETHER THE POTENTIAL 

HAZARD IS SIGNIFICANT. 

The following guidance will assist you in 

determining whether undeclared major food 

allergens, certain food intolerance causing 

substances, and prohibited food and color 

additives are a significant hazard at a processing 

step: 

1.	 Is it reasonably likely that an undeclared major 

food allergen, undeclared food intolerance 

causing substance (e.g., sulfiting agents or Yellow 

No. 5), or prohibited food or color additive 

(e.g., coumarin, safrole, or Red No. 4) will be 

introduced at each processing step (e.g., does it 

come in with the raw material or will the process 

introduce it)? 

Under ordinary circumstances, you should 

consider whether undeclared major food 

allergens, certain food intolerance causing 

substances, and prohibited food and color 

additives are a significant hazard at the: 

•	 Receiving step, if your finished product is 

or contains finfish or crustacean shellfish, 

because they are major food allergens; 

•	 Receiving step, if your finished product 

contains either shrimp or lobster, 

because there is a potential for sulfiting 

agents to be present. However, there 

may be circumstances that would allow 

you to conclude that the hazard is not 

reasonably likely to occur. For example, 

sulfiting agents may not be used in 

aquacultured shrimp from some regions. 

You should be guided by information 

about the historical use of sulfiting 

agents in your region. Also, in some 

formulated finished products that contain 

shrimp or lobster, the sulfiting agent may 

not have a functional effect and may 

not be present at 10 ppm or greater. 

You should conduct a study that tests 

the range of concentration of sulfiting 

agents in the raw material and possible 

variation in formulation to establish that 

sulfiting agents will not be present at 10 

ppm or greater in the finished product; 

•	 Product formulation step, if your 

finished product contains one or 

more of the major food allergens 

(including non-fishery allergens) 

listed in the previous section, 

“Understand the Potential Hazard.”; 

•	 Product formulation step, if you have 

an ingredient that is or contains one 

or more of the major food allergens 

(including non-fishery allergens) or food 

intolerance causing substances in your 

facility or use such an ingredient in the 

formulation of any of your products; 

•	 Product formulation step, if your finished 

product is cooked octopus or conch 

meat, because of the potential presence 

of sulfiting agents. However, you may not 

need to identify the hazard as significant 

if you do not have sulfiting agents in 

your facility and do not use it in the 

formulation of any of your products; 

•	 Product formulation step, if your finished 

product is a formulated fishery product 

(i.e., a product in which two or more 

ingredients are combined) because of 

the potential presence of Yellow No. 

5 or sulfiting agents. However, you 

may not need to identify the hazard as 

significant if you do not have Yellow No. 

5 in your facility and do not use it in the 

formulation of any of your products; and 

•	 Ingredient receiving step, if you receive 

ingredients in which you have reason 

to believe prohibited food or color 

additives (e.g., coumarin, safrole, or 

Red No. 4) may be present, based, for 

example, on an historic occurrence 

of the additive in that ingredient. 

2.	 Can the hazard of undeclared major food 

allergens, and certain food intolerance causing 

substances, and prohibited food and color 
CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 

361 

additives that were introduced at an earlier step 

be eliminated or reduced to an acceptable level 

at this processing step? 

Undeclared major food allergens, food 

intolerance causing substances and prohibited 

food and color additives should also be 

considered a significant hazard at a processing 

step if a preventive measure is or can be 

used to prevent or eliminate the hazard or 

to reduce the likelihood of its occurrence 

to an acceptable level. Preventive measures 

for undeclared major food allergens, food 

intolerance causing substances and prohibited 

food and color additives include: 

•	 Reviewing finished product labels 

to ensure that the presence of 

certain food intolerance causing 

substances (e.g., sulfiting agents 

or Yellow No. 5) is declared; 

•	 Testing incoming shrimp or lobster 

for residues of sulfiting agents; 

•	 Reviewing a supplier’s certification 

of the lack of sulfiting agent use on 

incoming lots of shrimp or lobster 

(with appropriate verification); 

•	 Reviewing the labeling (or 

accompanying documents, in the case 

of unlabeled product) on shipments 

of shrimp or lobster received from 

another processor for the presence 

of a sulfiting agent declaration; 

•	 Reviewing finished product labels 

to ensure that the presence of the 

major food allergens, listed in the 

previous section, “Understand the 

Potential Hazard” is declared; 

•	 Testing incoming lots of ingredients 

for the presence of prohibited food 

and color additives that you have 

reason to believe may be present; 

•	 Reviewing a supplier’s certification 

of the lack of prohibited food and 

color additive use in incoming lots of 

ingredients in which you have reason 

to believe the additive may be present 

(with appropriate verification). 

•	 Intended use 

In the case of undeclared major food allergens 

and certain food intolerance causing substances 

and prohibited food and color additives, it is not 

likely that the significance of the hazard will be 

affected by the intended use of the product. 

IDENTIFY CRITICAL CONTROL POINTS. 

The following guidance will assist you in 

determining whether a processing step is a 

critical control point (CCP) for undeclared major 

food allergens, certain food intolerance causing 

substances and prohibited food and color 

additives: 

1.	 In the case of shrimp or lobster for which you 

have identified sulfiting agents as a significant 

hazard, will the finished product label declare the 

presence of sulfiting agents? 

a.	 If the finished product label will declare 

the presence of sulfiting agents, you 

should identify the finished product 

labeling step as the CCP and review the 

labels at that step. You would not need 

to identify the shrimp or lobster receiving 

step as a CCP for this hazard. 

Example: 

A frozen shrimp processor labels all of 

the finished product with a sulfiting 

agent declaration. The processor 

should set the CCP for sulfiting agents 

at the finished product labeling step, 

where labels would be reviewed for 

the presence of the declaration. The 

processor would not need to have a 

CCP for this hazard at the shrimp 

receiving step. 

This control approach is a control 

strategy referred to in this chapter 

as “Control Strategy Example 1 
CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 

362 

- Finished Product Labeling for 

Control of Food Intolerance Causing 

Substances from Raw Materials.” 

b.	 If the finished product labeling will not 

declare the presence of sulfiting agents, 

you should identify the raw material 

receiving step as the CCP, where you 

could screen incoming lots for the 

presence of sulfiting agents. Preventive 

measures that can be applied here 

include: 

•	 Testing incoming shrimp or 

lobster for residues of sulfiting 

agents at or above 10 ppm. 

Example: 

A frozen shrimp processor receives 

shrimp directly from the harvest 

vessel and does not label the finished 

product with a sulfiting agent 

declaration. The processor should 

set the CCP for sulfiting agents at 

the raw material receiving step and 

test incoming lots of shrimp for the 

presence of sulfiting agents. The 

processor would not need to have 

a CCP for this hazard at finished 

product labeling. 

This control approach is a control 

strategy referred to in this chapter as 

“Control Strategy Example 2 - Raw 

Material Testing for Control of Food 

Intolerance Causing Substances and 

Prohibited Food and Color Additives 

From Raw Materials.” 

•	 Receiving a supplier’s certification 

of the lack of sulfiting agent use on 

incoming lots of shrimp or lobster 

(with appropriate verification). 

Example: 

A frozen shrimp processor receives 

shrimp directly from the harvest 

vessel and does not label the finished 

product with a sulfiting agent 

declaration. The processor should 

set the CCP for sulfiting agents at 

the raw material receiving step and 

obtain certificates from the harvest 

vessels that sulfiting agents were not 

used on the shrimp. The processor 

should verify the effectiveness of the 

monitoring procedures by collecting 

quarterly samples of all incoming 

shrimp and samples of incoming 

shrimp from all new suppliers and 

analyzing for the presence of sulfiting 

agents. The processor would not need 

to have a CCP for this hazard at 

finished product labeling. 

This control approach is a control 

strategy referred to in this chapter 

as “Control Strategy Example 3 - 

Review of Suppliers’ Certificates for 

Control of Food Intolerance Causing 

Substances and Prohibited Food and 

Color Additives from Raw Materials.” 

•	 Reviewing the labeling (or 

accompanying documents, in the 

case of an unlabeled product) 

on shipments of shrimp or 

lobster received from another 

processor for the presence of a 

sulfiting agent declaration (with 

appropriate verification). 

Example: 

A frozen shrimp processor receives 

shrimp from another processor and 

does not label the finished product 

with a sulfiting agent declaration. 

The processor should set the CCP for 

sulfiting agents at the raw material 

receiving step and reject incoming 

lots that are identified as having 

been treated with a sulfiting agent 

(e.g., identified on the label or, 

in the case of unlabeled product, 

on documents accompanying the 

shipment). The processor should verify 

the effectiveness of the monitoring 
CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 

363 

procedures by collecting quarterly 

samples of all incoming shrimp and 

samples of incoming shrimp from 

all new suppliers and analyzing for 

the presence of sulfiting agents. The 

processor would not need to have 

a CCP for this hazard at finished 

product labeling. 

This control approach is a control 

strategy referred to in this chapter as 

“Control Strategy Example 4 - Review 

of Suppliers’ Labeling for Control of 

Food Intolerance Causing Substances 

from Raw Materials.” 

c.	 If the finished product label will declare 

the presence of sulfiting agents only 

when it is present in the raw material, 

you should identify the finished product 

labeling step as the CCP, where you 

can ensure that the appropriate label 

is placed on the package based on 

the results of screening performed at 

the receiving step for the presence of 

sulfiting agents. You would not need to 

identify the shrimp or lobster receiving 

step as a CCP for this hazard, although 

you would be exercising controls by 

performing raw material tests. Preventive 

measures that can be applied here 

include: 

•	 Testing incoming shrimp or lobster 

for detectable residues of sulfiting 

agents at or above 10 ppm and 

review of finished product labels. 

Example: 

A frozen shrimp processor receives 

shrimp directly from the harvest vessel 

and labels the finished product with 

a sulfiting agent declaration only 

if testing at receiving step identifies 

a residue of a sulfiting agent. The 

processor should set the CCP for 

sulfiting agents at the finished 

product labeling step and check 

that the appropriate label is being 

applied based on the results of the 

raw material testing. The processor 

would not need to have a CCP for this 

hazard at the raw material receiving 

step, although controls would be 

exercised there by performing raw 

material testing at the receiving step. 

This control approach is a control 

strategy referred to in this chapter 

as “Control Strategy Example 5 - 

Finished Product Labeling Based on 

Raw Material Testing for Control of 

Food Intolerance Causing Substances 

from Raw Materials.” 

•	 Receiving a supplier’s certification 

of the lack of sulfiting agent use on 

incoming lots of shrimp or lobster 

(with appropriate verification) and 

review of finished product labels. 

Example: 

A frozen shrimp processor receives 

shrimp directly from the harvest vessel 

and labels the finished product with 

a sulfiting agent declaration only 

if a lot of raw material shrimp is 

received without a certificate attesting 

to the absence of sulfiting agent use. 

The processor should set the CCP 

for sulfiting agents at the finished 

product labeling step and check that 

the appropriate label is being applied 

based on the presence or absence of a 

certificate. The processor should verify 

the effectiveness of the monitoring 

procedures by collecting quarterly 

samples of incoming shrimp for the 

presence of sulfiting agents. The 

processor would not need to have 

a CCP for this hazard at the raw 

material receiving step, although 

controls for the receipt of a certificate 

attesting to the absence of sulfiting 

agent use would be applied there. 

This control approach is a control 
CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 

364 

strategy referred to in this chapter 

as “Control Strategy Example 6 - 

Finished Product Labeling Based on 

Review of Suppliers’ Certificates for 

Control of Food Intolerance Causing 

Substances from Raw Materials.” 

•	 Reviewing the labeling (or 

accompanying documents, in the 

case of an unlabeled product) on 

incoming shipments of shrimp 

or lobster received from another 

processor for the presence of a 

sulfiting agent declaration (with 

applicable verification), and review 

of finished product labels. 

Example: 

A frozen shrimp processor receives 

shrimp (as raw material) from 

another processor and labels the 

finished product with a sulfiting agent 

declaration only if the incoming lot 

was identified on the labeling (or, 

in the case of unlabeled product, 

on documents accompanying the 

shipment) as having been treated 

with a sulfiting agent. The processor 

should set the CCP for sulfiting agents 

at the finished product labeling step 

and check that the appropriate label 

is being applied based on the raw 

material label review. The processor 

should verify the effectiveness of the 

monitoring procedures by collecting 

quarterly samples of all incoming 

shrimp and collect at least one 

representative sample for each new 

supplier and analyzing for the 

presence of sulfiting agents. The 

processor would not need to have 

a CCP for this hazard at the raw 

material receiving step, although 

controls for reviewing the labeling 

(or, in the case of unlabeled product, 

on documents accompanying the 

shipment) would be applied there. 

This control approach is a control 

strategy referred to in this chapter 

as “Control Strategy Example 7 - 

Finished Product Labeling Based on 

Review of Suppliers’ Labeling for 

Control of Food Intolerance Causing 

Substances from Raw Materials.” 

2.	 In the case of (1) cooked octopus or conch 

meat for which you have identified sulfiting 

agents as a significant hazard; (2) products 

for which you have identified Yellow No. 5 as 

a significant hazard because you use one of 

this color additive in the product formulation; 

and (3) products for which you have identified 

undeclared major food allergens as a significant 

hazard, you should identify the finished product 

labeling step as the CCP, where you can ensure 

that the appropriate label is placed on the 

package based on the results of a review of the 

product formula for that product. You would not 

need to identify the product formulation step as 

a CCP for this hazard, although you may be 

exercising control at that point. 

Example: 

A smoked sablefish processor treats the 

fish with Yellow No. 5 before smoking. 

The processor should set the CCP for 

Yellow No. 5 at the finished product 

labeling step, where the labels would 

be examined to ensure that the color 

additive is declared. The processor 

would not need to have a CCP for 

this hazard at the treatment (product 

formulation) step. 

Example: 

A cooked octopus processor treats 

the fish with a sulfiting agent. 

The processor should set the CCP 

for sulfiting agents at the finished 

product labeling step, where the labels 

would be examined to ensure that 

the food additive is declared. The 

processor would not need to have a 

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 

365 

 

Example: 

A breaded fish processor uses pollock 

fillets and a batter mix containing 

egg and wheat for some formulations 

but not others listing egg, wheat, 

and pollock on the label only when 

those ingredients are included in the 

formulation. The processor should 

set the CCP for undeclared major 

food allergens at the finished product 

labeling step, where labels would 

be reviewed for the presence of an 

ingredient declaration that matches 

the current product formula. 

This control approach is a control 

strategy referred to in this chapter 

as “Control Strategy Example 8 - 

Finished Product Labeling Controls 

for Major Food Allergens and 

Added Food Intolerance Causing 

Substances.” 

3.	 In the case of products for which you have 

identified prohibited food and color additives 

(e.g., coumarin, safrole, or Red No. 4) as a 

significant hazard because you have reason to 

believe that it may be present in an ingredient 

used in the finished product, you should identify 

the raw material receiving step as the CCP, 

where you could screen incoming lots for the 

presence of the additive. Preventive measures that 

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 

Material Testing for Control of Food 

Intolerance Causing Substances and 

Prohibited Food and Color Additives 

from Raw Materials.” 

•	 Receiving a supplier’s certification 

of the lack of prohibited food and 

color additive use in the ingredient 

lot (with appropriate verification). 

Example: 

A shrimp salad processor uses 

an imported ingredient that has 

historically contained Red 4. The 

processor should set the CCP for 

prohibited food and color additives 

at the ingredient receiving step and 

obtain certificates from the supplier 

that Red No. 4 was not used in 

the formulation of the ingredient 

lot. The processor should verify 

the effectiveness of the monitoring 

procedures by collecting quarterly 

samples of the imported ingredient for 

the presence of Red No. 4. 

This control approach is the same 

control strategy previously identified 

as “Control Strategy Example 3 - 

Review of Suppliers’ Certificates for 

Control of Food Intolerance Causing 

Substances and Prohibited Food and 

Color Additives from Raw Materials.” 
CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 

366 

DEVELOP A CONTROL STRATEGY. 

The following guidance provides eight control 

strategies for undeclared major food allergens, 

certain food intolerance causing substances, and 

prohibited food and color additives. You may 

select a control strategy that is different from 

those that are suggested, provided it complies 

with the requirements of the applicable food 

safety laws and regulations. 

The following are examples of control strategies 

included in this chapter: 

CONTROL STRATEGY 

MAY APPLY TO 

PRIMARY 

PROCESSOR 

MAY APPLY TO 

SECONDARY 

PROCESSOR 

Finished product labeling for 

control of food intolerance 

causing substances from raw 

materials 

 

Raw material testing for control 

of food intolerance 

causing substances and 

prohibited food and color 

additives from raw materials 

 

Review of suppliers’ certificates 

for control of food 

intolerance causing substances 

and prohibited 

food and color additives from 

raw materials 

 

Review of suppliers’ labeling 

for control of food 

intolerance causing substances 

from raw materials 



Finished product labeling 

based on raw material testing 

for control of food intolerance 

causing substances from raw 

materials 

 

Finished product labeling 

based on review of suppliers’ 

certificates for control of food 

intolerance causing substances 

from raw materials 

 

Finished product labeling 

based on review of suppliers’ 

labeling for control of food 

intolerance causing substances 

from raw materials 



Finished product labeling 

controls for major food 

allergens and added food 

intolerance causing substances 

 

•	 CONTROL STRATEGY EXAMPLE 1 - FINISHED 

PRODUCT LABELING FOR CONTROL OF FOOD 

INTOLERANCE CAUSING SUBSTANCES FROM 

RAW MATERIALS 

Set Critical Limits. 

•	 All finished product packages must bear a 

label that declares the presence of a sulfiting 

agent. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 Labels on finished product packages for 

presence of sulfiting agent. 

»	 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 

Take the following corrective action to regain control 

over the operation after a critical limit deviation: 

•	 Modify labeling procedures, as appropriate; 

OR 

•	 Make corrections to the label generation 

program or equipment; 

OR 

•	 Discontinue use of the label supplier until 

evidence is obtained that the labeling will 

contain the appropriate declaration; 
CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 

367 

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. 

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

368 

TABLE 19-2

CONTROL STRATEGY EXAMPLE 1 - FINISHED PRODUCT LABELING FOR CONTROL OF 

FOOD INTOLERANCE CAUSING SUBSTANCES FROM RAW MATERIALS

This table is an example of a portion of a HACCP Plan using “Control Strategy Example 1 - Finished Product Labeling for Control of Food Intolerance Causing Substances from Raw Materials.” This example illustrates how a processor of shell-on shrimp can control sulfiting agents that are used on the harvest vessel. It is provided for illustrativepurposes only.Major food allergens, certain food intolerance causing substances and prohibited food and color additives may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides and metal fragments). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Finished

product 

labeling 

Undeclared

sulfi ting agents 

All finished

product 

packages must

bear labels that

contain

sulfi ting agent 

declaration 

Labels on

the finished

product 

for the 

presence of

sulfi ting agent 

declaration 

Visual One label

at the

beginning

of the

production of 

each lot and

one label every 

hour thereafter 

Quality

assurance 

employee 

Segregate

and relabel

improperly

labeled product

Discontinue

use of the label

supplier until

evidence is 

obtained that

labeling will

contain the

sulfi ting agent 

declaration 

Record of 

labeling checks

of finished

product 

packages 

Review 

monitoring

and corrective 

action records

within 1 week 

of preparation 
CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 

369 

•	 CONTROL STRATEGY EXAMPLE 2 - RAW 

MATERIAL TESTING FOR CONTROL OF FOOD 

INTOLERANCE CAUSING SUBSTANCES AND 

PROHIBITED FOOD AND COLOR ADDITIVES 

FROM RAW MATERIALS 

Set Critical Limits. 

•	 Incoming lots of shrimp or lobster must not 

contain a detectable level of sulfiting agents 

(Note that <10 ppm sulfiting agents may be 

present in finished product shell-off shrimp 

and lobster without a sulfiting agent declaration 

on the label if the sulfiting agents have no 

functional (ongoing technical) effect in the 

finished food. However, if the sulfiting agents 

have a functional (ongoing technical) effect in 

finished shell-on or shell-off shrimp or lobster 

product regardless of level, then they must be 

declared as ingredients on the product label). 

AND/OR 

•	 An incoming lot of raw materials must not 

contain a detectable level of prohibited food 

or color additive. 

Establish Monitoring Procedures. 

»	 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. 

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 of 

the operation after a critical limit deviation: 

•	 Discontinue use of the supplier until 

evidence is obtained that control of sulfiting 

agents and/or prohibited food and color 

additives, as appropriate, has improved. 

Establish a Recordkeeping System. 

•	 Test results for sulfiting agents and/or 

prohibited food and color additives, as 

appropriate. 

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 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives Major food allergens, certain food intolerance causing substances and prohibited food and color additives may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-3 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides and metal fragments). 

370 

TABLE 19-3

CONTROL STRATEGY EXAMPLE 2 - RAW MATERIAL TESTING FOR CONTROL OF FOOD INTOLERANCE CAUSING SUBSTANCES AND 

PROHIBITED FOOD AND COLOR ADDITIVES FROM RAW MATERIALS

This table is a an example of a portion of a HACCP plan using “Control Strategy Example 2 - Raw Material Testing for Control of Food Intolerance Causing Substances and Prohibited Food and Color Additives from Raw Materials.” This example illustrates how a processor of shell-on shrimp can control sulfiting agents that are used on theharvest vessel. It is provided for illustrative purposes only. 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Shrimp

receiving 

Undeclared

sulfi ting agents 

Incoming

lots of shrimp

must not

contain 10 ppm

or greater

sulfi ting agents 

Each lot of raw 

material shrimp

for 

sulfi ting agent 

residual 

Malachite green

test 

Three shrimp

selected 

randomly 

from each lot

of incoming

shrimp 

Receiving 

employee 

Reject any 

incoming lot

of shrimp

that contains

a detectable 

level of sulfi ting 

agent

Discontinue use

of the supplier

until evidence 

is obtained that

control of

sulfi ting agents 

has improved 

Test results for 

sulfi ting agents 

Review 

monitoring

and corrective 

action records 

within 1 week 

of preparation 
CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 

371 

•	 CONTROL STRATEGY EXAMPLE 3 - REVIEW OF 

SUPPLIERS’ CERTIFICATES FOR CONTROL OF 

FOOD INTOLERANCE CAUSING SUBSTANCES 

AND PROHIBITED FOOD AND COLOR ADDITIVES 

FROM RAW MATERIALS 

Set Critical Limits. 

•	 Incoming lots of shrimp or lobster must 

be accompanied by a supplier’s lot-bylot certificate that sulfiting agents and/ 

or prohibited food and color additives, as 

appropriate, were not used. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 The supplier’s lot-by-lot certificate that no 

sulfiting agents and/or prohibited food and 

color additives, as appropriate, were used on 

the lot. 

»	 How Will Monitoring Be Done? 

•	 Visual examination of certificates. 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 Each 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 

•	 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. 

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 certificates will 

accompany future shipments. 

Establish a Recordkeeping System. 

•	 Suppliers’ lot-by-lot certificates; 

AND 

•	 Receiving records showing lots received 

and the presence or absence of suppliers’ 

certificates. 

Establish Verification Procedures. 

•	 Collect at least one representative sample 

per quarter, randomly selected from each 

supplier, and analyze for sulfiting agents 

and/or prohibited food and color additives, 

as appropriate. Additionally, collect at least 

one representative sample from each new 

supplier, and analyze for sulfiting agents 

or prohibited food and color additives, as 

appropriate; 

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

372 

TABLE 19-4

CONTROL STRATEGY EXAMPLE 3 - REVIEW OF SUPPLIERS’ CERTIFICATES FOR CONTROL OF FOOD INTOLERANCE CAUSING SUBSTANCES 

AND PROHIBITED FOOD AND COLOR ADDITIVES FROM RAW MATERIALS

This table is an example of a portion of a HACCP plan using “Control Strategy Example 3 - Review of Suppliers’ Certificates for Control of Food Intolerance Causing Substances and Prohibited Food and Color Additives from Raw Materials.” This example illustrates how a processor of shell-on shrimp can control sulfiting agents that areused on the harvest vessel. It is provided for illustrative purposes only. Major food allergens and certain food intolerance causing substances and prohibited food and color additives may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-3 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides and metal fragments). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Shrimp

receiving 

Undeclared

sulfi ting agents 

All incoming

lots of shrimp

must be

accompanied

by a lot-bylot certificate 

stating that

sulfi ting agents 

were not used 

Suppliers’

lot-by-lot 

certificates 

stating that no

sulfi ting agents 

were used on 

the incoming

lot 

Visual 

examination 

Every lot 

received 

Receiving 

employee 

Test the lot 

for sulfi ting 

agents and

reject the lot 

if a detectable 

level of sulfi ting 

agents is found 

Discontinue use

of the supplier

until evidence 

is obtained that

certificates will 

accompany

future

shipments 

Suppliers’

lot-by-lot 

certificates 

Receiving 

records

showing lots 

received and 

the presence

or absence

of suppliers’

certificates 

Collect at 

least one

representative 

sample per

quarter and 

test for sulfi ting 

agents; in

addition, test 

at least one

lot from each

new supplier 

and analyze for 

sulfi ting agents

Review 

monitoring,

corrective 

action, and 

verification 

records within

1 week of 

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

373 

•	 CONTROL STRATEGY EXAMPLE 4 - REVIEW OF 

SUPPLIERS’ LABELING FOR CONTROL OF FOOD 

INTOLERANCE CAUSING SUBSTANCES FROM 

RAW MATERIALS 

Set Critical Limits. 

•	 The labeling or shipping documents for 

incoming lots of shrimp or lobster received 

from another processor must not contain a 

sulfiting agent declaration. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 Suppliers’ product labels or shipping 

documents for the presence of sulfiting agent 

declaration. 

»	 How Will Monitoring Be Done? 

•	 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. 

Establish a Recordkeeping System. 

•	 Record of review of labeling or shipping 

documents for raw materials. 

Establish Verification Procedures. 

•	 Collect at least one representative sample 

per quarter, randomly selected from among 

your suppliers, and analyze for sulfiting 

agents. Additionally, collect at least one 

representative sample for each new supplier, 

and analyze for sulfiting agents; 

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

374 

TABLE 19-5

CONTROL STRATEGY EXAMPLE 4 - REVIEW OF SUPPLIERS’ LABELING FOR CONTROL OF 

FOOD INTOLERANCE CAUSING SUBSTANCES FROM RAW MATERIALS

This table is an example of a portion of a HACCP plan using “Control Strategy Example 4 - Review of Suppliers’ Labeling for Control of Food Intolerance Causing Substances from Raw Materials.” This example illustrates how a processor of shell-on shrimp can control sulfiting agents that are used on the harvest vessel. It is provided for illustrativepurposes only. Major food allergens and certain food intolerance causing substances and prohibited food and color additives may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides and metal fragments). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Shrimp

receiving 

Undeclared

sulfi ting agents 

The labeling

of incoming

lots of shrimp

received 

from another

processor must

not contain a

sulfi ting agent 

declaration 

Suppliers’

product 

labels for the

presence of

sulfi ting agent

 declaration 

Visual 

examination of 

the labels 

Every lot 

received 

Receiving 

employee 

Reject 

the lot

Discontinue

use of supplier

until evidence 

is provided 

that they will 

not provide 

sulfi ting agent 

treated shrimp 

Record of 

labeling checks

of raw 

materials 

Collect at 

least one

representative 

sample per

quarter and 

test for 

sulfi ting agents; 

in addition, test 

at least one

lot from each

new supplier 

and analyze for 

sulfi ting agents

Review 

monitoring,

corrective 

action, and 

verification 

records within

1 week of 

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

375 

•	 CONTROL STRATEGY EXAMPLE 5 - FINISHED 

PRODUCT LABELING BASED ON RAW MATERIAL 

TESTING FOR CONTROL OF FOOD INTOLERANCE 

CAUSING SUBSTANCES FROM RAW MATERIALS 

Set Critical Limits. 

•	 All finished product packages processed from 

raw materials that contain a detectable level of 

sulfiting agents must bear a label that contains 

a sulfiting agent declaration. Note that 10 ppm 

sulfiting agent may be present in finished 

product shell-off shrimp and lobster without 

a sulfiting agent declaration on the label. 

However, any detectable level of sulfiting 

agent in finished product shell-on shrimp 

or lobster would require a sulfiting agent 

declaration on the label, because the sulfiting 

agents continue to have a functional effect. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 Labels on finished product packages for 

presence of sulfiting agent declaration; 

AND 

•	 A representative sample of each lot of raw 

material for the presence of sulfiting agents. 

»	 How Will Monitoring Be Done? 

•	 For labels on finished packages: 

Visual examination of labels; ° 

AND 

•	 For raw material testing: 

Screening test for sulfiting agents. ° 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 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. 

»	 Who Will Do the Monitoring? 

•	 For finished product labeling: 

Any person who has an ° 

understanding of the nature of the 

controls; 

AND 

•	 For raw material testing: 

Any person who is qualified by ° 

training or experience to perform the 

screening test. 

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 of 

the operation after a critical limit deviation: 

•	 Modify labeling procedures, as appropriate. 

Establish a Recordkeeping System. 

•	 Record of labeling checks of finished product 

packages; 

AND 

•	 Record of sulfiting agent test results. 

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

376 

TABLE 19-6

CONTROL STRATEGY EXAMPLE 5 - FINISHED PRODUCT LABELING BASED ON RAW MATERIAL TESTING FOR CONTROL OF FOOD 

INTOLERANCE CAUSING SUBSTANCES FROM RAW MATERIALS

This table is a an example of a portion of a HACCP plan using “Control Strategy Example 5 - Finished Product Labeling Based on Raw Material Testing for Control of Food Intolerance Causing Substances from Raw Materials.” This example illustrates how a processor of shell-on shrimp can control sulfiting agents that are used on the harvest vessel. It is provided for illustrative purposes only. Major food allergens and certain food intolerance causing substances and prohibited food and color additives may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-3 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides and metal fragments). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Finished

product 

labeling 

Undeclared

sulfi ting agents 

All finished

product 

packages

processed from

raw materials 

that contain 10

ppm or greater

sulfi ting agents 

must bear

a label that

contains a

sulfi ting agent 

declaration 

Labels on

finished

product 

packages

for the 

presence of a

sulfi ting agent 

declaration 

Visual

examination 

of labels

on finished

product 

packages 

One label at the

beginning of

the production 

of each lot and

one label every 

hour thereafter 

Quality

control

employee 

Segregate and

relabel any

improperly

labeled product

Modify

labeling

procedures, as 

appropriate 

Record of 

labeling checks

of finished

product 

packages 

Review 

monitoring and

corrective 

action records 

within 1 week 

of preparation 

Analysis of

raw

material shrimp

for sulfi ting 

agent

residual 

Malachite green

test 

Three shrimp

collected 

randomly from 

each lot of raw 

material shrimp 

Quality

control

employee 

Analytical 

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

377 

•	 CONTROL STRATEGY EXAMPLE 6 - FINISHED 

PRODUCT LABELING BASED ON REVIEW OF 

SUPPLIERS’ CERTIFICATES FOR CONTROL OF 

FOOD INTOLERANCE CAUSING SUBSTANCES 

FROM RAW MATERIALS 

Set Critical Limits. 

•	 All finished product packages must bear 

a label that contains a sulfiting agent 

declaration unless they are processed 

from raw material shrimp or lobster that 

are accompanied by a supplier’s lot-by-lot 

certificate that states that no sulfiting agents 

were used. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 Labels on finished product packages for the 

presence of a sulfiting agent declaration; 

AND 

•	 Suppliers’ lot-by-lot certificates for raw 

material shrimp or lobster that no sulfiting 

agent was used on the lot. 

»	 How Will Monitoring Be Done? 

•	 For finished product labeling: 

Visual examination of the labels; ° 

AND 

•	 For suppliers’ lot-by-lot certificates: 

Visual examination of the certificates. ° 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 For finished product labeling: 

A representative number of packages ° 

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. 

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 labeling procedures, as appropriate. 

Establish a Recordkeeping System. 

•	 Record of labeling checks; 

AND 

•	 Copy of certificates; 

AND 

•	 Receiving record showing lots received and 

the presence or absence of a certificate. 

Establish Verification Procedures. 

•	 Collect at least one representative sample per 

quarter from lots that are accompanied by 

a certificate, randomly selected from among 

your suppliers, and analyze for sulfiting 

agents. Additionally, collect at least one 

representative sample for each new supplier 

and analyze for sulfiting agents; 

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

378 

TABLE 19-7

CONTROL STRATEGY EXAMPLE 6 - FINISHED PRODUCT LABELING 

BASED ON REVIEW OF SUPPLIERS’ CERTIFICATES FOR 

CONTROL OF FOOD INTOLERANCE CAUSING SUBSTANCES FROM RAW MATERIALS

This table is an example of a portion of a HACCP plan using “Control Strategy Example 6 - Finished Product Labeling Based on Review of Suppliers’ Certificates for Control of Food Intolerance Causing Substances from Raw Materials.” This example illustrates how a processor of shell-on shrimp can control sulfiting agents that are used on theharvest vessel. It is provided for illustrative purposes only. Major food allergens and certain food intolerance causing substances and prohibited food and color additives may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides and metal fragments). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE ACTION(S) RECORDS VERIFICATION

WHAT HOW FREQUENCY WHO 

Finished

product

labeling 

Undeclared

sulfiting

agents 

All finished product

packages must bear a

label that contains a

sulfiting agent

declaration unless

they are processed

from raw material

shrimp that are

accompanied by a

supplier’s lot-by-lot 

certificate that states

that no sulfiting

agents were used 

Labels on

finished

product

packages

for the

presence of a

sulfiting agent

declaration 

Visual 

examination of

labels on

finished

product

packages 

One label at the

beginning of the

production of

each lot and one

label every hour

thereafter 

Labeling

supervisor 

Segregate and relabel

any improperly labeled

product

Modify labeling

procedure, as

appropriate 

Record of 

labeling

checks 

Collect at least one

representative sample

per quarter from lots

that are accompanied

by a certificate, selected

randomly from among

the suppliers and analyze

for sulfiting agents;

additionally, collect one 

representative sample from

each new supplier and

analyze for sulfiting agents

Review monitoring,

corrective action, and

verification records within

1 week of preparation 

Lot-by-lot

certificates

stating that no

sulfiting agent

was used on

the lot 

Visual 

examination

of lot-by-lot

certificates 

Each

incoming lot 

Receiving

employee 

Record

of raw

material

receiving

Lot-by-lot

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

379 

•	 CONTROL STRATEGY EXAMPLE 7 - FINISHED 

PRODUCT LABELING BASED ON REVIEW OF 

SUPPLIERS’ LABELING FOR CONTROL OF FOOD 

INTOLERANCE CAUSING SUBSTANCES FROM 

RAW MATERIALS 

Set Critical Limits. 

•	 All finished product packages must bear 

a label that contains a sulfiting agent 

declaration if they are processed from 

raw material shrimp or lobster that are 

labeled with a sulfiting agent declaration or 

accompanied by documents that contain a 

sulfiting agent declaration. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 Labels on finished product packages for the 

presence of a sulfiting agent declaration; 

AND 

•	 Labeling or shipping documents for each lot 

of raw material shrimp or lobster received 

from another processor for the presence of a 

sulfiting agent declaration. 

»	 How Will Monitoring Be Done? 

•	 Visual examination of labels and shipping 

documents. 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 For finished product labeling: 

A representative number of packages ° 

from each lot of a finished product; 

AND 

•	 For raw material labeling: 

Each 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: 

•	 Segregate and relabel any improperly labeled 

product. 

AND 

Take the following corrective action to regain control of 

the operation after a critical limit deviation: 

•	 Modify labeling procedures, as appropriate. 

Establish a Recordkeeping System. 

•	 Record of labeling checks of finished product 

packages; 

AND 

•	 Record of review of raw material labeling or 

shipping documents. 

Establish Verification Procedures. 

•	 Collect at least one representative sample 

per quarter from lots that are not labeled 

with a sulfiting agent declaration or not 

accompanied by documents with a sulfiting 

agent declaration, randomly selected from 

among your suppliers, and analyze for 

sulfiting agents. Additionally, collect at least 

one representative sample for each new 

supplier, and analyze for sulfiting agents; 

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

380 

TABLE 19-8

CONTROL STRATEGY EXAMPLE 7 - FINISHED PRODUCT LABELING 

BASED ON REVIEW OF SUPPLIERS’ LABELING FOR

CONTROL OF FOOD INTOLERANCE CAUSING SUBSTANCES FROM RAW MATERIALS

This table is an example of a portion of a HACCP plan using “Control Strategy Example 7 - Finished Product Labeling Based on Review of Suppliers’ Labeling for Control of Food Intolerance Causing Substances from Raw Materials.” This example illustrates how a processor of shell-on shrimp can control sulfiting agents that are used on theharvest vessel. It is provided for illustrative purposes only. Major food allergens and certain food intolerance causing substances and prohibited food and color additives may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides and metal fragments). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Finished

product

labeling 

Undeclared

sulfiting

agents 

All finished product

packages must bear a

label that contains a

sulfiting agent

declaration if they

are processed from

raw

material shrimp that

are labeled with a

sulfiting agent

declaration

or accompanied by

documents that

contain a sulfiting

agent

declaration 

Labels on

finished

product

packages for the

presence of a

sulfiting agent

declaration 

Visual 

examination of

labels on

finished

product

packages 

One label

at the

beginning

of the

production of

each lot and one

label every hour

thereafter 

Labeling

supervisor 

Segregate and

relabel any

improperly

labeled product

Modify labeling

procedure, as

appropriate 

Record of 

labeling

checks 

Collect at least one

representative sample per

quarter from lots that

are not labeled with a

sulfiting agent

declaration, randomly

selected from among your

suppliers, and analyze

for sulfiting agents;

additionally, collect at 

least one representative

sample for each new

supplier, and analyze for 

sulfiting agents

Review monitoring,

corrective action and

verification records within 

1 week of preparation 

Labeling for

each lot of raw

material shrimp

received from

another processor

for the presence of

a sulfiting agent

declaration 

Visual 

examination

of the raw

material

labeling 

Each

incoming lot 

Receiving

employee 

Records

of raw

material

labeling

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

381 

•	 CONTROL STRATEGY EXAMPLE 8 - FINISHED 

PRODUCT LABELING CONTROLS FOR MAJOR 

FOOD ALLERGENS AND ADDED FOOD 

INTOLERANCE CAUSING SUBSTANCES 

Set Critical Limits. 

•	 All finished product labeling must accurately 

list any major food allergens and added 

sulfiting agents that have an on-going 

functional effect or Yellow No. 5 that are 

included in the product formulation. 

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. 

Establish a Recordkeeping System. 

•	 Record of labeling checks of finished product 

packages. 

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

382 

TABLE 19-9

CONTROL STRATEGY EXAMPLE 8 - FINISHED PRODUCT LABELING CONTROLS FOR 

MAJOR FOOD ALLERGENS AND ADDED FOOD INTOLERANCE CAUSING SUBSTANCES

This table is an example of a portion of a HACCP plan using “Control Strategy Example 8 - Finished Product Labeling Controls for Major Food Allergens and Added Food Intolerance Causing Substances.” This example illustrates how a breaded fish processor can control undeclared major food allergens in the production of breaded fishportions containing egg, wheat, and pollock. It is provided for illustrative purposes only. Major food allergens and certain food intolerance causing substances and prohibited food and color additives may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides and metal fragments). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Finished

product 

labeling 

Undeclared

major food 

allergens 

Finished

product labels 

must declare

the presence of

egg, wheat, and 

pollock 

Finished

product labels 

for comparison 

with

product formula 

Visual 

examination 

of the

labels on

finished

product 

packages 

One label at the

beginning of

the production 

of each lot and

one label every 

hour thereafter 

Quality

assurance staff 

Segregate and

relabel any

incorrectly 

labeled product

Modify

labeling

procedure, as 

appropriate 

Record of 

review of 

finished

product labels 

Review 

monitoring and

corrective 

action records 

within 1 week 

of preparation 
CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 

383 

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 NonFDA Web site references after March 29, 2011. 

•	 U.S. Congress. Food Allergen Labeling and 

Consumer Protection Act of 2004. Title II of 

Public Law 108-282. http://www.fda.gov/Food/ 

LabelingNutrition/FoodAllergensLabeling/ 

GuidanceComplianceRegulatoryInformation/ 

ucm106187.htm. 

•	 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. 

•	 U.S. Food and Drug Administration. October 

2003. Import sample collection assignment 

for undeclared sulfites - DFP #04-08. 

Department of Health and Human Services, 

Public Health Service, Food and Drug 

Administration, Center for Food Safety and 

Applied Nutrition, College Park, MD. 

•	 U.S. Food and Drug Administration. 

Substances prohibited from use in human 

food. In Code of Federal Regulations, 

CFR 21 74.1304, 74.2303, 81.10, 81.30. U.S. 

Government Printing Office, Washington, DC. 

•	 Wade, A. D. October 2005. Final status report 

on import sample collection assignment 

for undeclared sulfites - DFP #04-08. 

(Memorandum). Department of Health and 

Human Services, Public Health Service, Food 

and Drug Administration, Center for Food 

Safety and Applied Nutrition, College Park, MD. 
CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives 

384
 

NOTES:
 
 

 

 

CHAPTER 20: Metal Inclusion 

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. 

Ingesting metal fragments can cause injury to 

the consumer. These injuries may include dental 

damage, laceration of the mouth or throat, or 

laceration or perforation of the intestine. FDA’s 

Health Hazard Evaluation Board has supported 

regulatory action against products with metal 

fragments 0.3 inch (7 mm) to 1 inch (25 mm) in 

length. The Federal Food, Drug, and Cosmetic 

Act (the FFD&C Act) prohibits interstate commerce 

of adulterated foods (21 U.S.C. 331). Under the 

FFD&C Act, a food containing foreign objects 

is considered adulterated (21 U.S.C 342). See 

FDA’s “Compliance Policy Guide,” Sec. 555.425. 

In addition, foreign objects that are less than 0.3 

inch (7 mm) may cause trauma or serious injury 

to persons in special risk groups, such as infants, 

surgery patients, and the elderly. 

Metal-to-metal contact (e.g., mechanical cutting 

or blending operations and can openers) and 

equipment with metal parts that can break loose 

(e.g., moving wire mesh belts, injection needles, 

screens and portion control equipment, and metal 

ties) are likely sources of metal that may enter 

food during processing. 

•	 Control of metal inclusion 

Once introduced into a product, metal fragments 

may be removed from the product by passing it 

through a screen, magnet, or flotation tank. The 

effectiveness of these measures depends on the 

nature of the product. These measures are more 

likely to be effective in liquids, powders, and 

similar products in which the metal fragment will 

not become imbedded. 

Alternatively, metal fragments may be detected 

in the finished food by an electronic metal 

detector. The use of electronic metal detectors 

is complex, especially with regard to stainless 

steel, which is difficult to detect. The orientation 

of the metal object in the food affects the ability 

of the equipment to detect it. For example, if a 

detector is not properly calibrated and is set to 

detect a sphere 0.08 inch (2 mm) in diameter, 

it may fail to detect a stainless steel wire that is 

smaller in diameter but up to 0.9 inch (24 mm) 

long, depending on the orientation of the wire as 

it travels through the detector. Processing factors, 

such as ambient humidity or product acidity, 

may affect the conductivity of the product and 

create an interference signal that may mask metal 

inclusion unless the detector is properly calibrated. 

You should consider these factors when calibrating 

and using this equipment. 

Finally, the hazard of metal inclusion may also 

be controlled by periodically examining the 

processing equipment for damage that can 

contribute metal fragments to the product. This 

measure will not necessarily prevent metal 

fragments from being incorporated into the 

product, but it will enable you to separate products 

that may have been exposed to metal fragments. 

Visually inspecting equipment for damaged or 

missing parts may only be feasible with relatively 

simple equipment, such as band saws, small orbital 

blenders, and wire mesh belts. More complex 

equipment that contains many parts, some of 

which may not be readily visible, may not be 

suitable for visual inspection and may require 

controls such as metal detection or separation. 

CHAPTER 20: Metal Inclusion 

385 
 

DETERMINE WHETHER THE POTENTIAL 

HAZARD IS SIGNIFICANT. 

The following guidance will assist you in 

determining whether metal inclusion is a 

significant hazard at a processing step: 

1.	 Is it reasonably likely that metal fragments will be 

introduced at this processing step (e.g., do they 

come in with the raw material or will the process 

introduce them)? 

For example, under ordinary circumstances, 

it would be reasonably likely to expect that 

metal fragments could enter the process from 

the following sources as a result of worn, 

damaged, or broken equipment parts: 

•	 Mechanical crabmeat pickers; 

•	 Wire-mesh belts used to 


convey products; 


•	 Saw blades used to cut 


portions or steaks; 


•	 Wire from mechanical mixer blades; 

•	 Blades on mechanical chopping,
 

filleting, or blending equipment; 


•	 Rings, washers, nuts, or bolts from 

breading, batter, sauce cooling, liquid 

dispensing, and portioning equipment; 

•	 Injection needles; 

•	 Metal ties used to attach 


tags or close bags;
 

•	 Can slivers from opening cans. 

Under ordinary circumstances, it would not 

be reasonably likely to expect that metal 

fragments could enter the food from the 

following sources: 

•	 Utensils used for manual blending, 

cutting, shucking, or gutting; 

•	 Metal processing tables or storage tanks. 

2.	 Can the hazard of metal inclusion that was 

introduced at an earlier step be eliminated or 

reduced to an acceptable level at this processing 

step? 

Metal inclusion should also be considered 

a significant hazard at any processing step 

where a preventive measure is or can be 

used to prevent or eliminate the hazard 

(or is adequate to reduce the likelihood of 

its occurrence to an acceptable level) if it 

is reasonably likely to occur. Preventive 

measures for metal inclusion can include: 

•	 Periodically checking equipment 


for damaged or missing parts; 


•	 Passing the product through metal 

detection or separation equipment. 

•	 Control of metal inclusion 

In most cases, you should assume that the 

product will be consumed in a way that would 

not eliminate any metal fragments that may 

be introduced during the process. However, 

in some cases, if you have assurance that the 

product will be run through a metal detector, for 

detection of metal fragments, or through screens 

or a magnet, for separation of metal fragments, 

by a subsequent processor, you would not need 

to identify metal inclusion as a significant hazard. 

Example: 

A primary processor produces frozen fish 

blocks by mechanically heading, eviscerating, 

and filleting fish in the round. The primary 

processor sells exclusively to breaded fish stick 

processors and has been given assurance by 

these processors that the finished breaded 

product will be subjected to a metal detector. 

The primary processor would not need to 

identify metal inclusion as a significant 

hazard. 

CHAPTER 20: Metal Inclusion 

386 
 

 

IDENTIFY CRITICAL CONTROL POINTS. 

The following guidance will also assist you 

in determining whether a processing step is a 

critical control point (CCP) for metal inclusion: 

1.	 Will the product be run through a metal detector 

or a separation device, such as a screen, 

magnet, or flotation tank, on or after the last step 

where metal inclusion is identified as a significant 

hazard? 

a.	 If it will be, you should identify final 

metal detection or separation as the 

CCP. Then processing steps prior to 

metal detection or separation would not 

require controls and would not need to 

be identified as CCPs for the hazard of 

metal fragments. 

Example: 

A breaded fish processor uses saws, 

breading and batter machines, and 

wire conveyor belts. The processor 

should choose to use a metal detector 

on the finished product containers and 

should set the CCP for metal inclusion 

at the metal detection step for packaged 

products. The processor would not need 

to have CCPs for this hazard at each of 

the previous processing steps at which 

there was a reasonable likelihood that 

metal fragments could be introduced. 

This control approach is a control strategy 

referred to in this chapter as “Control 

Strategy Example 1 - Metal Detection or 

Separation.” 

You should recognize that by setting the CCP 

at or near the end of the process, rather than 

at the point of potential metal fragment entry 

into the process, you are likely to have more 

labor and materials invested in the product 

before the problem is detected or prevented. 

b.	 If the product will not be run through 

such a device, you should have 

procedures to periodically check the 

processing equipment for damage or lost 

parts at each processing step where metal 

inclusion is identified as a significant 

hazard. In this case, you should identify 

those processing steps as CCPs. 

Example: 

A processor that cuts tuna steaks from 

frozen loins has identified the band 

saw cutting step as the only step that 

is reasonably likely to introduce metal 

fragments into the product. The processor 

should identify the band saw cutting step 

as the CCP for this hazard and should 

check the condition of the band saw blade 

every 4 hours to ensure that it has not 

been damaged. 

This control approach is a control strategy 

referred to in this chapter as “Control 

Strategy Example 2 - Equipment Checks.” 

Visually inspecting equipment for 

damaged or missing parts may only be 

feasible with relatively simple equipment, 

such as band saws, small orbital blenders, 

and wire mesh belts. More complex 

equipment that contains many parts, 

some of which may not be readily visible, 

may not be suitable for visual inspection 

and may require controls such as metal 

detection or separation. 

DEVELOP A CONTROL STRATEGY. 

The following guidance provides two examples 

of control strategies for metal inclusion. It is 

important to note that you may select a control 

strategy that is different from those which 

are suggested, provided it complies with the 

requirements of the applicable food safety laws 

and regulations. 

CHAPTER 20: Metal Inclusion 

387 
The following are examples of control strategies 

included in this chapter: 

MAY APPLY TO MAY APPLY TO 

CONTROL STRATEGY PRIMARY SECONDARY 

PROCESSOR PROCESSOR 

Metal detection or 

separation 

 

Equipment checks  

•	 CONTROL STRATEGY EXAMPLE 1 - METAL 

DETECTION OR SEPARATION 

Set Critical Limits. 

•	 All of the product passes through an 

operating metal detection or separation 

device; 

AND 

•	 No detectable metal fragments are in the 

product that passes through the metal 

detection or separation device. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 The presence of an operating metal detection 

or separation device; 

AND 

•	 The product for the presence of metal 

fragments. 

»	 How Will Monitoring Be Done? 

•	 Visual examination for the presence of an 

operating electronic metal detector, magnet, 

intact screen, or flotation tank; 

AND 

•	 Product monitoring is performed by the 

metal detection or separation device itself. 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 Check that the metal detection or separation 

device is in place and operating at the start 

of each production day; 

AND 

•	 Continuous monitoring by the metal 

detection or separation device itself. 

»	 Who Will Do the Monitoring? 

•	 Monitoring is performed by the metal 

detection or separation device itself. Visual 

checks to ensure that the device is in place 

and operating may be performed by 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: 

•	 When processing occurred without an 

operating metal detector or intact or 

operating separation device: 

Hold all of the product produced ° 

since controls were last confirmed as 

functioning properly until it can be run 

through a metal detection or separation 

device; 

OR 

Hold all of the product produced ° 

since controls were last confirmed as 

functioning properly until an inspection 

of the processing equipment that could 

contribute metal fragments can be 

completed to determine whether there 

are any broken or missing parts (may 

be suitable only for relatively simple 

equipment); 

OR 

Divert all of the product produced ° 

since controls were last confirmed as 

functioning properly to a use in which it 

will be run through a properly calibrated 

metal detector (e.g., divert fish fillets to a 

breading operation that is equipped with 

a metal detector); 

OR 

Destroy all of the product produced ° 

since controls were last confirmed as 

functioning properly; 

CHAPTER 20: Metal Inclusion 

388 
OR 

°	 Divert all of the product produced 

since controls were last confirmed as 

functioning properly to a non-food use. 

AND 

•	 When product is rejected by a metal detector: 

° Hold and evaluate the rejected product; 

OR 

° Rework the rejected product to eliminate 

metal fragments;
 

OR
 

° Destroy the rejected product;
 

OR 

° Divert the rejected product to a non-food 

use. 

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 metal separation or detection 

device; 

OR 

•	 Attempt to locate and correct the source of 

the fragments found in the product by the 

metal detector or separated from the product 

stream by the magnets, screens, or other 

devices; 

OR 

•	 Repair or replace the metal separation 

device. 

Establish a Recordkeeping System. 

•	 Record documenting that the metal detection 

or separation device is in place and 

operating. 

Establish Verification Procedures. 

For metal detectors: 

•	 Develop sensitivity standards that are based 

on whether the potential hazard is ferrous, 

non-ferrous, or stainless steel, or obtain such 

standards from the equipment manufacturer. 

The standards should be designed to ensure 

that metal fragments will be detected in 

the product. Conduct a validation study to 

identify the range of values for each of the 

processing factors over which the equipment 

will detect the standards that affect its 

operation in your product (e.g., ambient 

humidity and product acidity), or obtain such 

a study from the equipment manufacturer. 

The study should identify the appropriate 

equipment settings over the range of each of 

the processing factors. The study also should 

consider the range of orientations in which 

the metal fragments may be present; 

AND 

•	 Challenge the metal detector using validated 

sensitivity standards daily, at the start of 

production, every 4 hours during operation, 

when processing factors (e.g., ambient 

humidity and product acidity) change, and at 

the end of processing; 

AND 

For all metal detection and separation devices: 

•	 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 20: Metal Inclusion 

389 
CHAPTER 20: Metal Inclusion 

390 

TABLE 20-1

CONTROL STRATEGY EXAMPLE 1 - METAL DETECTION OR SEPARATION

This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using “Control Strategy Example 1 - Metal Detection or Separation.” This example illustrates how a frozen fish sticks processor can control metal fragment inclusion. It is provided for illustrative purposes only. Metal inclusion may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides and Staphylococcus aureus toxin formation in the hydrated batter mix). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Metal

detection 

Metal

inclusion 

All of the

product 

passes

through an

operating 

metal

detector 

Metal detector 

present and

operating 

Visual

examination 

Daily, at 

start of 

operations 

Production 

employee 

If the product is 

processed without

metal detection,

hold it for metal 

detection

Correct operating 

procedures to

ensure that the

product is not 

processed without

metal detection

Rework to remove 

metal fragments 

from any product 

rejected by the 

metal detector 

Identify the

source of the

metal found in the 

product and 

fix the

damaged

equipment 

Metal

detector 

operation 

log 

Conduct a 

validation study 

to determine

appropriate

settings for the metal 

detector

Develop metal detector 

sensitivity standardsChallenge the metal

detector with sensitivity 

standards daily,

before start-up, every 4 

hours

during production,

whenever 

processing factors 

change, and at the end of 

processing

Review 

monitoring,

corrective action and 

verification records within 

1 week of 

preparation 

No

detectable 

metal

fragments 

are in the

product 

passing the

through the

metal

detector 

The

product 

for the 

presence

of metal

fragments 

Electronic 

metal

detector 

Continuous Equipment

itself 
•	 CONTROL STRATEGY EXAMPLE 2 - EQUIPMENT 

CHECKS 

Set Critical Limits. 

•	 No broken or missing metal parts from 

equipment. 

Establish Monitoring Procedures. 

»	 What Will be Monitored? 

•	 The presence of broken or missing metal 

parts from equipment. 

»	 How Will Monitoring Be Done? 

•	 Visually check the equipment for broken or 

missing parts. 

Examples: 

Check saw blades for missing teeth or ° 

sections;
 

Check that all parts are present and 
 ° 

secure on blending equipment; 

Check for missing links or broken wires ° 

on metal belts. 

»	 How Often Will Monitoring Be Done? 

•	 Check before starting operations each day; 

AND 

•	 Check every 4 hours during operation; 

AND 

•	 Check at the end of operations each day; 

AND 

•	 Check whenever there is an equipment 

malfunction that could increase the 

likelihood that metal could be introduced 

into the food. 

»	 Who Will Do the Monitoring? 

•	 Any person who has a thorough 

understanding of the proper condition of the 

equipment. 

Establish Corrective Action Procedures. 

Take the following corrective action to a product 

involved in a critical limit deviation: 

•	 Hold all of the product produced since the 

previous satisfactory equipment check until it 

can be run through a metal detector; 

OR 

•	 Divert all of the product produced since 

the previous satisfactory equipment check 

to a use in which it will be run through a 

properly calibrated metal detector (e.g., divert 

fish fillets to a breading operation that is 

equipped with a metal detector); 

OR 

•	 Destroy all of the product produced since the 

previous satisfactory equipment check; 

OR 

•	 Divert all of the product produced since the 

previous satisfactory equipment check to a 

non-food use. 

AND 

Take the following corrective actions to regain control 

over the operation after a critical limit deviation: 

•	 Stop production; 

AND 

•	 If necessary, adjust or modify the equipment 

to reduce the risk of recurrence. 

Establish a Recordkeeping System. 

•	 Records of equipment inspections. 

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 20: Metal Inclusion 

391 
CHAPTER 20: Metal Inclusion 

392 

TABLE 20-2

CONTROL STRATEGY EXAMPLE 2 - EQUIPMENT CHECKS 

This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Equipment Checks.” This example illustrates how a frozen tuna steak processorcan control metal fragment inclusion. It is provided for illustrative purposes only. Metal inclusion may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., scombrotoxin (histamine) and parasites). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Fish

cutting 

Metal

inclusion 

No damage or

missing parts to 

the saw blade 

Check the saw 

blade 

Visual

check 

Before 

start-up,

every 4 

hours during

operation,

at the end of

day, and after 

an equipment

jam 

Saw 

operator 

Stop production

Adjust 

equipment

Hold all of the

product since 

the last visual

check until

it can be run 

through a metal

detector 

Destroy rejected 

product 

Equipment

maintenance

log 

Review 

monitoring

and corrective 

action records 

within 1

week of 

preparation 
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 NonFDA 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 

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. 

Ingesting glass fragments can cause injury to the 

consumer. These injuries may include damage 

to teeth, laceration of the mouth and throat, or 

perforation of the intestine. FDA’s Health Hazard 

Evaluation Board has supported regulatory action 

against products with glass 0.3 inch (7 mm) to 1 

inch (25 mm) in length. The Federal Food, Drug, 

and Cosmetic Act (the FFD&C Act) prohibits 

interstate commerce of adulterated foods (21 U.S.C. 

331). Under the FFD&C Act, a food containing 

foreign objects is considered adulterated (21 U.S.C 

342). See FDA’s “Compliance Policy Guide,” Sec. 

555.425. Foreign objects that are less than 0.3 inch 

(7 mm) may cause trauma or serious injury to 

persons in special risk groups, such as infants, 

surgery patients, and the elderly. 

Glass inclusion can occur whenever processing 

involves the use of glass containers. Normal 

handling and packaging methods, especially 

mechanized methods, can result in breakage. Most 

products packed in glass containers are eaten with 

minimal handling on the part of the consumer 

providing little opportunity to detect glass inclusion. 

The purpose of this chapter is to address only the 

hazard of glass fragments that results from the use 

of glass containers. Glass fragments originating 

from sources such as overhead light fixtures must 

be addressed where applicable in a prerequisite 

sanitation program. The Procedures for the Safe 

and Sanitary Processing and Importing of Fish and 

Fishery Products regulation, 21 CFR 123 (called 

the Seafood HACCP Regulation in this guidance 

document), requires such a program. 

•	 Control of glass inclusion 

Once introduced into a product container, the 

hazard of glass fragments may be controlled 

by (1) removing the fragments by cleaning the 

containers before filling or (2) detecting the 

fragments by visual inspection before or after 

filling. Glass containers may be cleaned using 

water or compressed air and inverted during or 

after cleaning to help with glass removal. This 

measure may be suited only to processes that do 

not use automated filling systems which include 

filled container conveyors or capping equipment, 

because this equipment can result in glass 

breakage after glass container cleaning. 

The effectiveness of visual inspection depends 

on the nature of the product and the process. For 

most fishery products, this measure also may be 

suited only to processes that do not use automated 

filled container conveyors or capping equipment, 

because visual inspection after the glass containers 

are filled is not practical. However, for clear liquids 

(e.g., some fish sauces), candling may be used to 

visually inspect all filled containers. Candling is a 

visual inspection process in which the container is 

illuminated from behind. 

Alternatively, the hazard of glass inclusion 

may be controlled by periodically checking 

the processing areas and equipment for glass 

breakage. This measure will not necessarily 

prevent glass fragments from being incorporated 

into the product, but it will enable you to separate 

products that may have been exposed to glass 

fragments. 

CHAPTER 21: Glass Inclusion 

395 
DETERMINE WHETHER THE POTENTIAL 

HAZARD IS SIGNIFICANT. 

The following guidance will assist you in 

determining whether glass inclusion is a 

significant hazard at a processing step: 

1.	 Is it reasonably likely that glass fragments will be 

introduced at this processing step (e.g., do they 

come in with the raw material or will the process 

introduce them)? 

For example, under ordinary circumstances, 

it would be reasonably likely to expect that 

glass fragments could enter the process 

during the processing of any product that is 

packed in a glass container. These are likely 

areas of concern for glass containers: 

•	 Glass container receiving; 

•	 Glass container storage, when 


cases are moved mechanically; 


•	 Mechanized glass container cleaning; 

•	 Glass container conveyor lines; 

•	 Glass container filling; 

•	 Mechanized capping of glass containers; 

•	 Pasteurizing product in glass containers. 

2.	 Can glass fragments that were introduced at 

an earlier step be eliminated or reduced to an 

acceptable level at this processing step? 

Glass inclusion should be considered a 

significant hazard at any processing step 

where a preventive measure is or can be 

used to prevent or eliminate the hazard 

(or is adequate to reduce the likelihood 

of its occurrence to an acceptable level) if 

it is reasonably likely to occur. Preventive 

measures for glass inclusion can include: 

•	 Visually examining the 


empty glass containers; 


•	 Cleaning (water or compressed air) and 

inverting the empty glass containers; 

•	 Periodically monitoring processing 

lines for evidence of glass breakage; 

•	 Visually examining glass 


containers containing transparent 


liquid fishery products.
 

•	 Intended use 

In most cases, you should assume that the 

product will be consumed in a way that would 

not eliminate any glass fragments that may be 

introduced during the process. 

IDENTIFY CRITICAL CONTROL POINTS. 

The following guidance will also assist you 

in determining whether a processing step is a 

critical control point (CCP) for glass inclusion: 

1.	 Will the containers be visually inspected for 

detection of glass fragments or be cleaned (water 

or compressed air) and inverted on or after the 

last step where glass inclusion is identified as a 

significant hazard? 

a.	 If they will be, you should identify the 

final visual inspection or cleaning as the 

CCP. For example, you should visually 

inspect the containers for broken glass 

or clean and invert the containers after 

the processing steps where breakage is 

reasonably likely to occur. 

For most fishery products, this method 

may be suited only to processes that do 

not use automated filling systems which 

include filled container conveyors or 

capping equipment. However, if your 

product is a clear liquid, you should 

visually inspect all filled containers by 

candling. In this case, the candling step 

would be designated as the CCP. 

Example: 

A processor that manually packs 

caviar into glass jars has identified 

the glass container receiving and 

storage steps as the only steps that 

are reasonably likely to introduce 

CHAPTER 21: Glass Inclusion 

396 
glass fragments into the process. The 

processor should visually inspect 

each jar prior to the filling process. 

The processor should also collect a 

representative sample of inspected 

glass jars at the start of processing, 

every 4 hours during processing, at 

the end of processing and after any 

jams. The processor should identify 

the container inspection step as the 

CCP for this hazard. 

Example: 

Another processor that manually 

packs caviar has identified the glass 

container receiving and storage steps 

as the only steps that are reasonably 

likely to introduce glass fragments 

into the process. Just before filling, 

the empty glass jars are inverted and 

cleaned using filtered, compressed 

air. The processor should also collect 

a representative sample of cleaned 

glass jars at the start of processing, 

every 4 hours during processing, at 

the end of processing and after any 

jams. The processor should identify 

the container cleaning and inverting 

step as the CCP for this hazard. 

Example: 

A processor that bottles a transparent 

fish sauce has identified glass 

container receiving and storage, 

mechanical conveyor lines, 

mechanical filling, and mechanical 

capping as processing steps that 

are reasonably likely to introduce 

glass fragments into the process. The 

processor should visually inspect 

each filled and capped bottle for 

visible glass fragments by candling. 

The processor should also collect a 

representative sample of inspected 

glass jars at the start of processing, 

every 4 hours during processing, at 

the end of processing and after any 

jams. The processor should identify 

the finished product candling step as 

the CCP for this hazard. 

This control approach is a control 

strategy referred to in this chapter 

as “Control Strategy Example 1 - 

Cleaning or Visual Inspection of 

Containers.” 

You should recognize that by setting 

the CCP at or near the end of the 

process, rather than at the point of 

potential glass fragment entry into 

the process, you are likely to have 

more labor and materials invested 

in the product before the problem is 

detected or prevented. 

b.	 If the containers will not be visually 

inspected or cleaned and inverted 

on or after the last step, you should 

periodically check the processing areas 

and equipment for glass breakage at each 

processing step where glass inclusion 

is identified as a significant hazard. In 

this case, those processing steps should 

be CCPs. It would not ordinarily be 

necessary to identify these steps as 

CCPs in addition to identifying a final 

inspection or cleaning step as a CCP. 

Example: 

A processor bottles clam juice and has 

identified glass container receiving 

and storage, mechanical conveyor 

lines, mechanical filling, and 

mechanical capping as processing 

steps reasonably likely to introduce 

glass fragments into the process. The 

processor should visually inspect 

all processing areas for broken 

glass at start-up and once every 4 

hours during processing. If broken 

glass is observed, the line should be 

stopped, the glass removed and the 

product that has moved through 

that area since the last inspection 

CHAPTER 21: Glass Inclusion 

397 
placed on hold to be filtered or 

destroyed. The processor should 

identify glass container receiving and 

storage, mechanical conveyor lines, 

mechanical filling, and mechanical 

capping as the CCPs for this hazard. 

This control approach is a control 

strategy referred to in this chapter 

as “Control Strategy Example 2 - 

Equipment Checks.” 

DEVELOP A CONTROL STRATEGY. 

The following guidance provides examples of 

two control strategies for glass inclusion. You 

may select a control strategy that is different from 

those which are suggested, provided it complies 

with the requirements of the applicable food 

safety laws and regulations. The following are 

examples of control strategies included in this 

chapter: 

CONTROL STRATEGY 

MAY APPLY TO 

PRIMARY 

PROCESSOR 

MAY APPLY TO 

SECONDARY 

PROCESSOR 

Cleaning or visual 

inspection of containers 

 

Equipment checks  

•	 CONTROL STRATEGY EXAMPLE 1 - CLEANING OR 

VISUAL INSPECTION OF CONTAINERS 

Set Critical Limits. 

•	 All containers pass through an operating 

glass container inspection or cleaning 

process; 

AND 

•	 No detectable glass fragments are in glass 

containers that pass through the glass 

container inspection or cleaning process. 

Establish Monitor Procedures. 

»	 What Will Be Monitored? 

•	 The presence of an operating glass container 

cleaning or inspection process; 

AND 

•	 Cleaned or inspected containers for the 

presence of glass fragments. 

»	 How Will Monitoring Be Done? 

•	 Visual examination for the presence of 

equipment and employees for cleaning or 

inspecting glass containers; 

AND 

•	 Visual examination of a representative 

sample of glass containers after cleaning or 

inspecting. 

»	 How Often Will Monitoring Be Done? 

•	 Check that the glass container cleaning or 

inspection process is in place and operating 

at the start of each production day and after 

each shift change; 

AND 

•	 Examine a representative sample of glass 

containers after cleaning or inspection daily, 

at the start of processing, every 4 hours 

during processing, at the end of processing, 

and after any breakdowns. 

»	 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: 

•	 Hold and evaluate all of the product 

processed since controls were last confirmed 

as functioning properly; 

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. 

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 21: Glass Inclusion 

399 
­

CHAPTER 21: Glass Inclusion 

400 

TABLE 21-1

CONTROL STRATEGY EXAMPLE 1 - CLEANING OR VISUAL INSPECTION OF CONTAINERS 

This table is an example of a portion of a HACCP plan using “Control Strategy Example 1 - Cleaning or Visual Inspection of Containers.” This example illustrates how a processor of pickled herring in glass jars can control glass inclusion. It is provided for illustrative purposes only. Glass inclusion may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., parasites, scombrotoxin (histamine), environmental chemical contaminants and pesticides, unapproved food and color additives, metal fragments, Clostridium botulinum toxin formation, and pathogen growth as a result of temperature abuse). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Jar

cleaning and

inversion 

Glass

inclusion 

All

containers

pass through

an operating 

glass cleaning

process

No glass

fragments 

are in glass

containers

passing through

the glass

container

cleaning

process 

The

presence of the

glass cleaning

process

The

presence of

glass fragments 

in cleaned

containers 

Visual check 

Visual 

examination 

of a

representative 

sample of glass

containers after 

cleaning 

At the start of 

the

production and 

shift changes

One dozen jars 

after cleaning 

daily, at the 

start of 

processing,

every 4 

hours during

processing,

at the end of

processing,

and after any 

breakdowns 

Quality

control staff 

Hold all of the

product for an 

evaluation

Correct 

operating 

procedures to

ensure that the

product is not 

processed

without jar

cleaning

Stop

operations 

and locate and

correct the 

source of the

glass fragments 

Glass

inspection 

record 

Review 

monitoring

and corrective 

action records 

within 1 week 

of preparation 
•	 CONTROL STRATEGY EXAMPLE 2 - EQUIPMENT 

CHECKS 

Set Critical Limits. 

•	 No broken glass on or near equipment. 

Establish Monitoring Procedures. 

»	 What Will Be Monitored? 

•	 The presence of broken glass on or near 

equipment. 

»	 How Will Monitoring Be Done? 

•	 Visually check the glass handling areas for 

broken glass. 

Examples: 


Check pallets and packing cases
 ° 

for damage, broken jars, and glass 

fragments; 

Check mechanical glass cleaning area for ° 

broken glass; 


Check floors around conveyors for broken 
 ° 

glass; 


Check filling and capping equipment and 
 ° 

surrounding floors for broken glass; 

Check glass containers for breakage ° 

after exposure to heat (e.g., after heated 

product is added or after pasteurization). 

»	 How Often Will Monitoring Be Done (Frequency)? 

•	 Check before starting operations each day; 

AND 

•	 Check at least every 4 hours during 

operation; 

AND 

•	 Check at the end of operations each day; 

AND 

•	 Check whenever there is an equipment 

malfunction that could increase the likelihood 

that glass containers could be damaged. 

»	 Who Will Do the Monitoring? 

•	 Any person who has a thorough 

understanding of the proper condition of the 

equipment and surrounding area. 

Establish Corrective Action Procedures. 

Take the following corrective action to a product 

involved in a critical limit deviation: 

•	 Hold and evaluate all of the product 

produced since the previous satisfactory 

equipment check; 

OR 

•	 Destroy all of the product produced since the 

previous satisfactory equipment check; 

OR 

•	 Divert all of the product produced since the 

previous satisfactory equipment check to a 

non-food use; 

OR 

•	 Rework the product packaged since the 

previous satisfactory equipment check by 

visually examining for the presence of glass 

or by running the product through a filter or 

screen. 

AND 

Take one of the following corrective actions to regain 

control over the operation after a critical limit deviation: 

•	 Stop production; 

AND 

•	 If necessary, adjust or modify the materials, 

equipment, and/or processes to reduce the 

risk of recurrence; 

AND 

•	 Remove all broken glass from the equipment 

and surrounding area. 

Establish a Recordkeeping System. 

•	 Records of equipment and processing area 

inspections. 

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 21: Glass Inclusion 

401 
CHAPTER 21: Glass Inclusion 

402 

TABLE 21-2

CONTROL STRATEGY EXAMPLE 2 - EQUIPMENT CHECKS 

This table is an example of a portion of a HACCP plan using “Control Strategy Example 2 - Equipment Checks.” This example illustrates how a processor of clam juice inglass jars can control glass inclusion. It is provided for illustrative purposes only. Glass inclusion may be only one of several significant hazards for this product. Refer to Tables 3-3 and3-4 (Chapter 3) for other potential hazards (e.g., pathogens from the harvest area, environmental chemical contaminants and pesticides, natural toxins, unapproved food and color additives, and metal fragments). 

Example Only

See Text for Full Recommendations

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

Glass bottle

receiving,

mechanical

bottle

conveyors,

mechanical

filling, and 

mechanical

capping 

Glass

inclusion 

No broken glass 

on or around

processing

equipment 

Broken glass 

on or around

equipment 

Visual check Before 

start-up, every 

4 hours during

operations,

after 

equipment

jams, and end 

of day 

Filler

Operator 

Stop

production 

Determine the 

source of the

broken glass 

Adjust 

equipment that

caused the

breakage, if 

necessary

Remove broken 

glass from the

area

Hold and

evaluate the 

product since 

the last

satisfactory 

check 

Glass

inspection 

record 

Review 

monitoring

and corrective 

action records 

within 1 week 

of preparation 
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 NonFDA 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 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 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. 

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 
APPENDIX 1: Forms 

406 

HACCP PLAN FORM

FIRM NAME: FIRM ADDRESS: 

PRODUCT DESCRIPTION: METHOD OF DISTRIBUTION AND STORAGE:INTENDED USE AND CONSUMER:

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

SIGNATURE OF COMPANY OFFICIAL: __________________________________________________________ DATE: _________________________

PAGE 1 OF ______________________________ 
APPENDIX 1: Forms 

407 

HACCP PLAN FORM

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) 

CRITICAL

CONTROL

POINT 

SIGNIFICANT

HAZARD(S) 

CRITICAL

LIMITS

FOR EACH

PREVENTIVE

MEASURE 

MONITORING 

CORRECTIVE

ACTION(S) RECORDS VERIFICATION WHAT HOW FREQUENCY WHO 

SIGNATURE OF COMPANY OFFICIAL: __________________________________________________________ DATE: _________________________

PAGE 1 OF _____________________________ 

APPENDIX 1: FORMS B 
APPENDIX 1: Forms 

408 

HAZARD ANALYSIS WORKSHEET

FIRM NAME: FIRM ADDRESS: 

PRODUCT DESCRIPTION: METHOD OF DISTRIBUTION AND STORAGE:INTENDED USE AND CONSUMER:

(1) (2) (3) (4) (5) (6) 

INGREDIENT/PROCESSING

STEP 

IDENTIFY POTENTIAL

BIOLOGICAL,

CHEMICAL, AND

PHYSICAL HAZARDS

ASSOCIATED WITH THIS 

PRODUCT AND

PROCESS 

ARE ANY POTENTIAL

FOOD SAFETY

HAZARDS SIGNIFICANT

AT THIS STEP? 

(YES/NO) 

JUSTIFY YOUR

DECISION FOR

COLUMN 3 

WHAT PREVENTIVE 

MEASURE(S) CAN BE

APPLIED FOR THE

SIGNIFICANT HAZARDS? 

IS THIS STEP A

CRITICAL CONTROL

POINT?

(YES/NO) 
APPENDIX 1: Forms 

409 

HAZARD ANALYSIS WORKSHEET

(1) (2) (3) (4) (5) (6) 

INGREDIENT/PROCESSING

STEP 

IDENTIFY POTENTIAL

BIOLOGICAL,

CHEMICAL, AND

PHYSICAL HAZARDS

ASSOCIATED WITH THIS 

PRODUCT AND

PROCESS 

ARE ANY POTENTIAL

FOOD SAFETY

HAZARDS SIGNIFICANT AT THIS STEP? 

(YES/NO) 

JUSTIFY YOUR

DECISION FOR

COLUMN 3 

WHAT PREVENTIVE 

MEASURE(S) CAN BE

APPLIED FOR THE

SIGNIFICANT HAZARDS? 

IS THIS STEP A

CRITICAL CONTROL

POINT?

(YES/NO) 

PAGE 1 OF _____________________________
 
NOTES:
 

APPENDIX 1: Forms 

410
 
APPENDIX 2: Sample Product Flow Diagram 

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. 

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 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. 

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 

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

YES NO NOT A CCP 

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

YES NO 

MODIFY 

THIS STEP, 

PROCESS OR 

PRODUCT 

IS CONTROL AT 

THIS STEP 

NECESSARY 

FOR 

SAFETY? 

YES 

NO NOT A CCP STOP* 

IS CONTROL AT THIS STEP NECESSARY TO PREVENT, ELIMINATE OR Q3. 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. 

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 NonFDA Web site references after March 29, 2011. 

•	 National Advisory Committee on 

Microbiological Criteria for Foods. 1992. 

Hazard Analysis and Critical Control Point 

System. Intl. J. Food Microbiol. 16:1-23. 

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 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. 

This appendix contains information on the growth 

and inactivation of bacterial pathogens. 

Table A-1 contains information on the minimum 

water activity (aw), acidity (pH), and temperature; 

the maximum, pH, water phase salt, and 

temperature; and oxygen requirements that will 

sustain growth for the bacterial pathogens that are 

of greatest concern in seafood processing. Data 

shown are the minimum or maximum values, 

the extreme limits reported among the references 

cited. These values may not apply to your 

processing conditions. 

Table A-2 contains information on maximum, 

cumulative time and internal temperature 

combinations for exposure of fish and fishery 

products that, under ordinary circumstances, will 

be safe for the bacterial pathogens that are of 

greatest concern in seafood processing. These 

maximum, cumulative exposure times are derived 

from published scientific information. 

Because the nature of bacterial growth is 

logarithmic, linear interpolation using the 

time and temperature guidance may not be 

appropriate. Furthermore, the food matrix effects 

bacterial growth (e.g., presence of competing 

microorganisms, available nutrients, growth 

restrictive agents). Consideration of such attributes 

is needed when using the information in Tables 

A-1 and A-2. 

In summary, Table A-2 indicates that: 

For raw, ready-to-eat products: 

•	 If at any time the product is held at internal 

temperatures above 70°F (21.1°C), exposure 

time (i.e., time at internal temperatures 

above 50°F (10°C) but below 135oF (57.2oC)) 

should be limited to 2 hours (3 hours if 

Staphylococcus aureus (S. aureus) is the only 

pathogen of concern), 

OR 

Alternatively, exposure time (i.e., time at 

internal temperatures above 50°F (10°C) but 

below 135oF (57.2oC)) should be limited to 

4 hours, as long as no more than 2 of those 

hours are between 70°F (21.1°C) and 135oF 

(57.2oC); 

OR 

•	 If at any time the product is held at internal 

temperatures above 50°F (10°C) but never 

above 70°F (21.1°C), exposure time at internal 

temperatures above 50°F (10°C) should be 

limited to 5 hours (12 hours if S. aureus is the 

only pathogen of concern); 

OR 

•	 The product is held at internal temperatures 

below 50°F (10°C) throughout processing, 

OR 

Alternatively, the product is held at ambient 

air temperatures below 50°F (10°C) throughout 

processing. 

For cooked, ready-to-eat products: 

•	 If at any time the product is held at internal 

temperatures above 80°F (26.7°C), exposure 

time (i.e., time at internal temperatures above 

50°F (10°C) but below 135oF (57.2oC)) should 

be limited to 1 hour (3 hours if S. aureus is 

the only pathogen of concern), 

OR 

APPENDIX 4: Bacterial Pathogen Growth and Inactivation 

417 
 

 

Alternatively, if at any time the product is 

held at internal temperatures above 80°F 

(26.7°C), exposure time (i.e., time at internal 

temperatures above 50°F (10°C) but below 

135oF (57.2oC)) should be limited to 4 hours, 

as long as no more than 1 of those hours is 

above 70°F (21.1°C); 

OR 

•	 If at any time the product is held at internal 

temperatures above 70°F (21.1°C) but never 

above 80°F (26.7°C), exposure time at 

internal temperatures above 50°F (10°C) 

should be limited to 2 hours (3 hours if S. 

aureus is the only pathogen of concern), 

OR 

Alternatively, if the product is never held at 

internal temperatures above 80°F (26.7°C), 

exposure times at internal temperatures 

above 50°F (10°C) should be limited to 4 

hours, as long as no more than 2 of those 

hours are above 70°F (21.1°C); 

OR 

•	 If at any time the product is held at internal 

temperatures above 50°F (10°C) but never 

above 70°F (21.1°C), exposure time at internal 

temperatures above 50°F (10°C) should be 

limited to 5 hours (12 hours if S. aureus is 

the only pathogen of concern); 

OR 

•	 The product is held at internal temperatures 

below 50°F (10°C) throughout processing, 

OR 

Alternatively, the product is held at ambient 

air temperatures below 50°F (10°C) 

throughout processing. 

Note that the preceding recommended 

critical limits do not address internal product 

temperatures between 40°F (4.4°C), the 

recommended maximum storage temperature 

for refrigerated fish and fishery products, 

and 50°F (10°C). That is because growth of 

foodborne pathogenic bacteria is very slow 

at these temperatures and the time necessary 

for significant growth is longer than would be 

reasonably likely to occur in most fish and fishery 

product processing steps. However, if you have 

processing steps that occur at these temperatures 

that approach the maximum cumulative exposure 

times listed in Table A-2 below for the pathogenic 

bacteria of concern in your product, you should 

consider development of a critical limit for 

control at these temperatures. 

It is not possible to furnish recommendations 

for each pathogenic bacteria, process, type of 

fish and fishery product, and temperature or 

combination of temperatures. Programmable 

models to predict growth rates for certain 

pathogens associated with various foods under 

differing conditions have been developed by 

the U.S. Department of Agriculture’s (Pathogen 

Modeling Program (PMP)) and the United 

Kingdom’s (Food MicroModel (FMM) program). 

These programs can provide growth curves 

for selected pathogens. You indicate the 

conditions, such as pH, temperature, and salt 

concentration that you are interested in and the 

models provide pathogen growth predictions 

(e.g., growth curve, time of doubling, time of 

lag phase, and generation time). FDA does not 

endorse or require the use of such modeling 

programs, but recognizes that the predictive 

growth information they provide may be of 

assistance to some processors. However, you 

are cautioned that significant deviations between 

actual microbiological data in specific products 

and the predictions do occur, including those for 

the lag phase of growth. Therefore, you should 

validate the time and temperature limits derived 

from such predictive models. 

Table A-3 contains information on the 

destruction of Listeria monocytogenes (L. 

monocytogenes). 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 internal product temperature of 158°F 

(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 nonproteolytic 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 
APPENDIX 4: Bacterial Pathogen Growth and Inactivation 

420 

TABLE A-1 

LIMITING CONDITIONS FOR PATHOGEN GROWTH

PATHOGEN MIN. AW (USING SALT) MIN. pH MAX. pH MAX. % WATER PHASE SALT MIN. TEMP. MAX. TEMP. OXYGEN REQUIREMENT

BACILLUS CEREUS 0.92 4.3 9.3 10 39.2°F

4°C 

131°F1 

55°C 

facultative 

anaerobe4 

CAMPYLOBACTER JEJUNI 0.987 4.9 9.5 1.7 86°F

30°C 

113°F

45°C 

microaerophile2 

CLOSTRIDIUM BOTULINUM,

TYPE A, AND PROTEOLYTIC 

TYPES B AND F 

0.935 4.6 9 10 50°F

10°C 

118.4°F

48°C 

anaerobe3 

CLOSTRIDIUM BOTULINUM,

TYPE E, AND NONPROTEOLYTIC 

TYPES B AND F 

0.97 5 9 5 37.9°F

3.3°C 

113°F

45°C 

anaerobe3 

CLOSTRIDIUM PERFRINGENS 0.93 5 9 7 50°F

10°C 

125.6°F

52°C 

anaerobe3 

PATHOGENIC STRAINS OF 

ESCHERICHIA COLI 

0.95 4 10 6.5 43.7°F

6.5°C 

120.9°F

49.4°C 

facultative 

anaerobe4 

LISTERIA

MONOCYTOGENES 

0.92 4.4 9.4 10 31.3°F

-0.4°C 

113°F

45°C 

facultative 

anaerobe4 

SALMONELLA SPP. 0.94 3.7 9.5 8 41.4°F

5.2°C 

115.2°F

46.2°C 

facultative 

anaerobe4 

SHIGELLA SPP. 0.96 4.8 9.3 5.2 43°F

6.1°C 

116.8°F

47.1°C 

facultative 

anaerobe4 

STAPHYLOCOCCUS AUREUS 

GROWTH 

0.83 4 10 20 44.6°F

7°C 

122°F

50°C 

facultative 

anaerobe4 

STAPHYLOCOCCUS AUREUS 

TOXIN FORMATION 

0.85 4 9.8 10 50°F

10°C 

118°F

48°C 

facultative 

anaerobe4 

VIBRIO CHOLERAE 0.97 5 10 6 50°F

10°C 

109.4°F

43°C 

facultative 

anaerobe4 

VIBRIO

PARAHAEMOLYTICUS 

0.94 4.8 11 10 41°F

5°C 

113.5°F

45.3°C 

facultative 

anaerobe4 

VIBRIO VULNIFICUS 0.96 5 10 5 46.4°F

8°C 

109.4°F

43°C 

facultative 

anaerobe4 

YERSINIA ENTEROCOLITICA 0.945 4.2 10 7 29.7°F

-1.3°C 

107.6°F

42°C 

facultative 

anaerobe4 

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 

421 

TABLE A-2 

TIME AND TEMPERATURE GUIDANCE FOR 

CONTROLLING PATHOGEN GROWTH AND TOXIN FORMATION IN FISH AND FISHERY PRODUCTS 

POTENTIALLY HAZARDOUS CONDITION PRODUCT TEMPERATURE MAXIMUM CUMULATIVE 

EXPOSURE TIME 

GROWTH AND TOXIN FORMATION 

BY BACILLUS CEREUS 

39.2-43°F (4-6°C) 

44-59°F (7-15°C) 

60-70°F (16-21°C) 

Above 70°F (21°C) 

5 days 

1 day 

6 hours 

3 hours 

GROWTH OF CAMPYLOBACTER JEJUNI 86-93°F (30-34°C) 

Above 93°F (34°C) 

48 hours 

12 hours 

GERMINATION, GROWTH, AND TOXIN 

FORMATION BY CLOSTRIDIUM BOTULINUM 

TYPE A, AND PROTEOLYTIC TYPES B AND F 

50-70°F (10-21°C) 

Above 70°F (21°C) 

11 hours 

2 hours 

GERMINATION, GROWTH, AND TOXIN 

FORMATION BY CLOSTRIDIUM BOTULINUM 

TYPE E, AND NON-PROTEOLYTIC 

TYPES B AND F 

37.9-41°F (3.3-5°C) 

42-50°F (6-10°C) 

51-70°F (11-21°C) 

Above 70°F (21°C) 

7 days 

2 days 

11 hours 

6 hours 

GROWTH OF CLOSTRIDIUM PERFRINGENS 50-54°F (10-12°C) 

55-57°F (13-14 °C) 

58-70°F (15-21°C) 

Above 70°F (21°C) 

21 days 

1 day 

6 hours1 

2 hours 

GROWTH OF PATHOGENIC STRAINS OF 

ESCHERICHIA COLI 

43.7-50°F (6.6-10°C) 

51-70°F (11-21°C) 

Above 70°F (21°C) 

2 days 

5 hours 

2 hours 

GROWTH OF LISTERIA MONOCYTOGENES 31.3-41°F (-0.4-5°C) 

42-50°F (6-10°C) 

51-70°F (11-21°C) 

71-86°F (22-30°C) 

Above 86°F (30°C) 

7 days 

1 day 

7 hours 

3 hours 

1 hour 

GROWTH OF SALMONELLA SPECIES 41.4-50°F (5.2-10°C) 

51-70°F (11-21°C) 

Above 70°F (21°C) 

2 days 

5 hours 

2 hours 

GROWTH OF SHIGELLA SPECIES 43-50°F (6.1-10°C) 

51-70°F (11-21°C) 

Above 70°F (21°C) 

2 days 

5 hours 

2 hours 

GROWTH AND TOXIN FORMATION BY 

STAPHYLOCOCCUS AUREUS 

50°F (7-10°C) 

51-70°F (11-21°C) 

Above 70°F (21°C) 

14 days 

12 hours1 

3 hours 

GROWTH OF VIBRIO CHOLERAE 50°F (10°C) 

51-70°F (11-21°C) 

71-80°F (22-27°C) 

Above 80oF (27oC) 

21 days 

6 hours 

2 hours 

1 hour2 

GROWTH OF VIBRIO PARAHAEMOLYTICUS 41-50°F (5-10°C) 

51-70°F (11-21°C) 

71-80°F (22-27°C) 

Above 80oF (27oC) 

21 days 

6 hours 

2 hours 

1 hour2 

GROWTH OF VIBRIO VULNIFICUS 46.4-50°F (8-10°C) 

51-70°F (11-21°C) 

71-80°F (22-27°C) 

Above 80oF (27oC) 

21 days 

6 hours 

2 hours 

1 hour2 

GROWTH OF YERSINIA ENTEROCOLITICA 29.7-50°F (-1.3-10°C) 

51-70°F (11-21°C) 

Above 70°F (21°C) 

1 day 

6 hours 

2.5 hours 

1. Additional data needed. 

2. Applies to cooked, ready-to-eat foods only. 
APPENDIX 4: Bacterial Pathogen Growth and Inactivation 

422 

TABLE A-3

INACTIVATION OF LISTERIA MONOCYTOGENES

INTERNAL PRODUCT

TEMPERATURE (°F) 

INTERNAL PRODUCT

TEMPERATURE (°C) LETHAL RATE TIME FOR 6D PROCESS (MINUTES)

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 

Note: z = 13.5°F (7.5°C). 
APPENDIX 4: Bacterial Pathogen Growth and Inactivation 

423 

TABLE A-4 

INACTIVATION OF NON-PROTEOLYTIC CLOSTRIDIUM BOTULINUM TYPE B

INTERNAL PRODUCT

TEMPERATURE (°F) 

INTERNAL PRODUCT

TEMPERATURE (°C) LETHAL RATE* TIME FOR 6D PROCESS (MINUTES)

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 

Note: 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).

*Note: These lethal rates and process times may not be sufficient for the destruction of non-proteolytic C. botulinum in dungeness crabmeat because of the potential that substances that may be naturally present, such as lysozyme, may enable the pathogen to more easily recover from heat damage. 
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display in the Division of Dockets Management, 

Food and Drug Administration, 5630 Fishers Lane, 

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references it makes available as hyperlinks from 

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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 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. 

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 
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 

READY-TO-EAT FISHERY PRODUCTS 

(MINIMAL COOKING BY CONSUMER) 

Listeria monocytogenes - presence of organism in 

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 

(MINIMAL COOKING BY CONSUMER) 

Vibrio cholerae - presence of toxigenic O1 or O139 or non-O1 

and 

non-O139 in 25 gram sample. 

READY-TO-EAT FISHERY PRODUCTS 

(MINIMAL COOKING BY CONSUMER) 

Vibrio parahaemolyticus - levels equal to or greater than 1 x 104

/g 

(Kanagawa positive or negative). 

POST-HARVEST PROCESSED CLAMS, MUSSELS, OYSTERS, 

AND WHOLE AND ROE-ON SCALLOPS, FRESH OR FROZEN, 

THAT MAKE A LABEL CLAIM OF “PROCESSED TO REDUCE 

VIBRIO PARAHAEMOLYTICUS TO NON-DETECTABLE LEVELS” 

Vibrio parahaemolyticus - levels less than 30/g (MPN). 

COOKED READY-TO-EAT FISHERY PRODUCTS 

(MINIMAL COOKING BY CONSUMER) 

Vibrio vulnificus - presence of organism. 

POST-HARVEST PROCESSED CLAMS, MUSSELS, OYSTERS, 

AND WHOLE AND ROE-ON SCALLOPS, FRESH OR FROZEN, 

THAT MAKE A LABEL CLAIM OF “PROCESSED TO REDUCE 

VIBRIO VULNIFICUS TO NON-DETECTABLE LEVELS” 

Vibrio vulnificus - levels less than 30/g (MPN). 

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 

SCALLOPS, FRESH OR FROZEN 

Microbiological ­

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 

441 

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 

SCALLOPS, FRESH, FROZEN, OR CANNED 

Neurotoxic Shellfish Poisoning - 0.8 ppm (20 mouse units/100 g) 

brevetoxin-2 equivalent. 

CLAMS, MUSSELS, OYSTERS, AND WHOLE AND ROE-ON 

SCALLOPS, FRESH, FROZEN, OR CANNED 

Diarrhetic Shellfish Poisoning - 0.2 ppm okadaic acid plus 

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). 
NOTES:
 

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

442
 
APPENDIX 6: Japanese and Hawaiian Vernacular Names for Fish Eaten Raw 

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. 

•	 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. 

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 NonFDA Web site references after March 29, 2011. 

•	 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 

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. 

Bacillus cereus (B. cereus) is the bacterium 

responsible for B. cereus food poisoning. An 

estimated 27,400 foodborne cases of B. cereus 

food poisoning occur annually in the United 

States. There are two forms of the intoxication: 

one causes diarrhea, starting from 6 to 15 hours 

after consumption, and the other causes vomiting 

and nausea, starting from 30 minutes to 6 hours 

after consumption. Symptoms in both forms last 

about 24 hours. Everyone is susceptible to B. 

cereus food poisoning 

Campylobacter jejuni (C. jejuni) is the bacterium 

responsible for campylobacteriosis. An estimated 

1,960,000 foodborne cases of campylobacteriosis 

occur annually in the United States. Symptoms 

include: diarrhea, fever, abdominal pain, nausea, 

headache, and muscle pain. Symptoms start from 

2 to 5 days after consumption and last from 7 to 

10 days. Everyone is susceptible to infection by 

C. jejuni. 

Clostridium botulinum (C. botulinum) toxin is the 

toxin responsible for botulism. An estimated 58 

foodborne cases of botulism occur annually in 

the United States. Symptoms include: weakness; 

vertigo; double vision; difficulty in speaking, 

swallowing, and breathing; abdominal swelling; 

constipation; paralysis; and death. Symptoms start 

from 18 to 36 hours after consumption. Everyone 

is susceptible to intoxication by C. botulinum 

toxin; only a few micrograms of the toxin can 

cause illness. Mortality is high; without the 

antitoxin and respiratory support, death is likely. 

Clostridium perfringens (C. perfringens) is the 

bacterium responsible for perfringens food 

poisoning. An estimated 249,000 foodborne cases 

of perfringens food poisoning occur annually in 

the United States. Symptoms include: abdominal 

cramps and diarrhea. Symptoms start from 8 

hours to 1 day after consumption and last for 

about a day. 

Everyone is susceptible to perfringens food 

poisoning, but it is more common in the young 

and elderly. 

While most Escherichia coli (E. coli) are nonpathogenic, certain strains of the bacterium are 

responsible for four types of illness: gastroenteritis 

or infantile diarrhea, caused by enteropathogenic 

E. coli (EPEC); travelers’ diarrhea, caused by 

enterotoxigenic E. coli (ETEC); bacillary dysentery, 

caused by enteroinvasive E. coli (EIEC); and 

hemorrhagic colitis, caused by enterohemorrhagic 

E. coli (EHEC). EHEC is the most severe, with 

potential for serious consequences, such as 

hemolytic uremic syndrome, particularly in young 

children. An estimated 173,000 foodborne cases 

from all four types of E. coli occur annually in the 

United States. Symptoms vary for the different 

forms of illness, but include: abdominal pain, 

diarrhea, vomiting, fever, chills, dehydration, 

electrolyte imbalance, high body fluid acidity, and 

general discomfort. Symptoms start from 8 hours 

to 9 days after consumption and last from 6 hours 

to 19 days, with both periods varying significantly 

between the illness types. Everyone is susceptible 

to all forms of infection from E. coli, but EPEC is 

most commonly associated with infants, and all 

types tend to result in more severe symptoms in 

the very young and elderly. 

APPENDIX 7: Bacterial and Viral Pathogens of Greatest Concern in Seafood Processing - Public Health Impacts 

451 
 

 

 

 

 

 

 

Hepatitis A virus is responsible for foodborne 

hepatitis. An estimated 4,200 foodborne cases 

of hepatitis A occur annually in the United 

States. Symptoms include: fever, malaise, 

nausea, anorexia, abdominal discomfort, and 

jaundice. Symptoms start from 10 to 50 days 

after consumption and last 1 to 2 weeks. Unless 

previously infected or immunized, everyone is 

susceptible to infection by hepatitis A virus. 

Listeria monocytogenes (L. monocytogenes) 

is the bacterium responsible for listeriosis. 

An estimated 2,500 foodborne cases of 

listeriosis occur annually in the United 

States. L. monocytogenes can produce 

mild flu-like symptoms in all individuals. 

However, in susceptible individuals, including 

pregnant women, newborns, and the 

immunocompromised, it can result in more 

severe symptoms, which include: septicemia, 

meningitis, encephalitis, spontaneous abortion, 

and stillbirth. Symptoms start from 

3 days to 3 weeks after consumption. Mortality 

is high in those that display the more severe 

symptoms. 

Norovirus (also known as Norwalk-like virus) 

is a major cause of viral gastroenteritis. An 

estimated 9,200,000 foodborne cases of norovirus 

occur annually in the United States. Symptoms 

include: diarrhea, nausea, vomiting, abdominal 

cramps, headache, body ache, and low-grade 

fever. Symptoms start from 2 to 4 days after 

consumption and generally last 21⁄2 days. 

Everyone is susceptible to infection by norovirus. 

Salmonella spp. is the bacterium responsible for 

salmonellosis. An estimated 1,340,000 cases 

of foodborne salmonellosis occur annually in 

the United States. Symptoms include: nausea, 

vomiting, abdominal cramps, diarrhea, fever, 

and headache. Symptoms start from 6 hours 

to 2 days after consumption and generally last 

from 1 to 2 days. The most severe form, typhoid 

fever, is caused by Salmonella typhi. Everyone 

is susceptible to infection by Salmonella spp., but 

symptoms are most severe in the elderly, infants, 

and the infirmed. Infections by Salmonella spp. 

and other closely related bacterial pathogens, such 

as Shigella spp., E. coli, and Yersinia enterocolitica 

infections can lead to chronic reactive arthritic 

symptoms in pre-disposed individuals. 

Shigella spp. is the bacterium responsible for 

shigellosis. An estimated 89,600 foodborne cases 

of shigellosis occur annually in the United States. 

Symptoms include: abdominal pain; cramps; 

diarrhea; fever; vomiting; blood, pus, or mucus 

in stools; continuous or frequent urges for bowel 

movement; and death. Symptoms start from 

12 hours to 2 days after consumption and last 

from 1 to 2 weeks. Everyone is susceptible to 

infection by Shigella spp. 

Staphylococcus aureus (S. aureus) is the 

bacterium responsible for staphylococcal food 

poisoning. An estimated 185,000 foodborne 

cases of staphylococcal food poisoning occur 

annually in the United States. Symptoms 

include: vomiting, diarrhea, abdominal pain, 

nausea, and weakness. Symptoms usually 

start within 4 hours of consumption. Everyone 

is susceptible to intoxication by S. aureus 

toxin, with more severe symptoms, including 

occasional death, occurring in infants, the 

elderly, and debilitated persons. 

Vibrio cholerae (V. cholerae) O1 and O139 are 

the bacteria responsible for Asiatic or epidemic 

cholera. No major outbreaks of this disease 

have occurred in the United States since 1911, 

but an estimated 49 sporadic foodborne cases 

occur annually (including V. cholerae non-O1 and 

non-O139). Symptoms include: mild-to-severe 

diarrhea, abdominal cramps, nausea, vomiting, 

dehydration, shock, and death. Symptoms 

start from 6 hours to 5 days after consumption. 

Everyone is susceptible to infection by V. cholerae 

O1 and O139, but those with weakened immunity, 

reduced stomach acidity, or malnutrition may 

suffer more severe forms of the illness. 

V. cholerae non-O1 and non-O139 are bacteria 

that are also responsible for vibriosis. V. 

cholerae non-O1 and non-O139 may also cause 

gastroenteritis and, rarely, septicemia. The 

APPENDIX 7: Bacterial and Viral Pathogens of Greatest Concern in Seafood Processing - Public Health Impacts 

452 
 

 

 

symptoms of gastroenteritis include: diarrhea, 


abdominal cramps, fever, vomiting, and 


nausea. Symptoms start from 6 hours to 3 days 


after consumption and last from 6 to 7 days. 


Everyone is susceptible to gastroenteritis from V.
 

cholerae non-O1 and non-O139, but septicemia 


usually develops only in those with underlying 


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 21⁄2 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 

include: fever, abdominal pain, diarrhea, 

vomiting, arthritis, and, rarely, septicemia. 

Symptoms start from 3 to 7 days after 

consumption and last from 1 to 3 days. Everyone 

is susceptible to infection by Y. enterocolitica, but 

symptoms are more severe in the very young, 

debilitated, elderly, and immunocompromised. 

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 NonFDA 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 

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. 

TITLE 21 OF THE CODE OF FEDERAL 

REGULATIONS PART 123 - FISH AND 

FISHERY PRODUCTS 

•	 SUBPART A - GENERAL PROVISIONS 

•	 Sec. 

123.3 Definitions 

123.5 Current good manufacturing practice 

123.6 Hazard analysis and Hazard Analysis 

Critical Control Point (HACCP) plan 

123.7 Corrective actions 

123.8 Verification 

123.9 Records 

123.10 Training 

123.11 Sanitation control procedures 

123.12 Special requirements for imported 

products 

•	 SUBPART B - SMOKED AND SMOKE-FLAVORED 

FISHERY PRODUCTS 

•	 Sec. 

123.15 General 

123.16 Process controls 

•	 SUBPART C - RAW MOLLUSCAN SHELLFISH 

•	 Sec. 

123.20 General 

123.28 Source controls 

Authority: Secs. 201, 402, 403, 406, 409, 701, 

704, 721, 801, 903 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 321, 342, 343, 346, 

348, 371, 374, 379e, 381, 393); secs. 301, 307, 

361 of the Public Health Service Act (42 U.S.C. 

241, 2411, 264). 

•	 SUBPART A - GENERAL PROVISIONS 

•	 Sec. 123.3 Definitions 

The definitions and interpretations of 

terms in section 201 of the Federal Food, 

Drug, and Cosmetic Act (the act) and in 

part 110 of this chapter are applicable to 

such terms when used in this part, except 

where they are herein redefined. The 

following definitions shall also apply: 

a.	 Certification number means a unique 

combination of letters and numbers 

assigned by a shellfish control authority to 

a molluscan shellfish processor. 

b.	 Critical control point means a point, step, 

or procedure in a food process at which 

control can be applied, and a food safety 

hazard can as a result be prevented, 

eliminated, or reduced to acceptable 

levels. 

c.	 Critical limit means the maximum or 

minimum value to which a physical, 

biological, or chemical parameter must 

be controlled at a critical control point 

to prevent, eliminate, or reduce to an 

acceptable level the occurrence of the 

identified food safety hazard. 

d.	 Fish means fresh or saltwater finfish, 

crustaceans, other forms of aquatic animal 

life (including, but not limited to, alligator, 

frog, aquatic turtle, jellyfish, sea cucumber, 

and sea urchin and the roe of such 

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 

is intended for human consumption. 

e. Fishery product means any human food 

product in which fish is a characterizing 

ingredient. 

f. Food safety hazard means any biological, 

chemical, or physical property that may 

cause a food to be unsafe for human 

consumption. 

g. Importer means either the U.S. owner 

or consignee at the time of entry into 

the United States, or the U.S. agent or 

representative of the foreign owner 

or consignee at the time of entry into 

the United States, who is responsible 

for ensuring that goods being offered 

for entry into the United States are in 

compliance with all laws affecting the 

importation. For the purposes of this 

definition, ordinarily the importer is not 

the custom house broker, the freight 

forwarder, the carrier, or the steamship 

representative. 

h. Molluscan shellfish means any edible 

species of fresh or frozen oysters, clams, 

mussels, or scallops, or edible portions of 

such species, except when the product 

consists entirely of the shucked adductor 

muscle. 

i.	 Preventive measure means physical, 

chemical, or other factors that can be 

used to control an identified food safety 

hazard. 

j.	 Process-monitoring instrument means an 

instrument or device used to indicate 

conditions during processing at a critical 

control point. 

k.	 (1) Processing means, with respect to 

fish or fishery products: Handling, 

storing, preparing, heading, 

eviscerating, shucking, freezing, 

changing into different market forms, 

manufacturing, preserving, packing, 

labeling, dockside unloading, or 

holding. 

(2) The regulations in this part do not 

apply to: 

(i)	 Harvesting or transporting 

fish or fishery products, 

without otherwise engaging in 

processing. 

(ii)	 Practices such as heading, 

eviscerating, or freezing 

intended solely to prepare a fish 

for holding on board a harvest 

vessel. 

(iii)	 The operation of a retail 

establishment. 

l.	 Processor means any person engaged 

in commercial, custom, or institutional 

processing of fish or fishery products, 

either in the United States or in a foreign 

country. A processor includes any 

person engaged in the production of 

foods that are to be used in market or 

consumer tests. 

m.	 Scombroid toxin-forming species means 

tuna, bluefish, mahi mahi, and other 

species, whether or not in the family 

Scombridae, in which significant levels 

of histamine may be produced in the fish 

flesh by decarboxylation of free histidine 

as a result of exposure of the fish after 

capture to temperatures that permit the 

growth of mesophilic bacteria. 

n.	 Shall is used to state mandatory 

requirements. 

o.	 Shellfish control authority means a Federal, 

State, or foreign agency, or sovereign 

tribal government, legally responsible 

for the administration of a program that 

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, 

enforcement of molluscan shellfish 

harvesting controls, and certification of 

molluscan shellfish processors. 

p.	 Shellstock means raw, in-shell molluscan 

shellfish. 

q. Should is used to state recommended 

or advisory procedures or to identify 

recommended equipment. 

r. Shucked shellfish means molluscan 

shellfish that have one or both shells 

removed. 

s.	 Smoked or smoke-flavored fishery products 

means the finished food prepared by: 

(1) Treating fish with salt (sodium 

chloride), and 

(2) Subjecting it to the direct action 

of smoke from burning wood, 

sawdust, or similar material and/ 

or imparting to it the flavor 

of smoke by a means such as 

immersing it in a solution of 

wood smoke. 

t.	 Tag means a record of harvesting 

information attached to a container of 

shellstock by the harvester or processor. 

•	 Sec. 123.5 Current good manufacturing 

practice 

a.	 Part 110 of this chapter applies in 

determining whether the facilities, 

methods, practices, and controls used 

to process fish and fishery products 

are safe, and whether these products 

have been processed under sanitary 

conditions. 

b.	 The purpose of this part is to set 

forth requirements specific to the 

processing of fish and fishery 

products. 

•	 Sec. 123.6 Hazard Analysis and Hazard 

Analysis Critical Control Point (HACCP) 

plan 

a.	 Hazard analysis. Every processor 

shall conduct, or have conducted 

for it, a hazard analysis to determine 

whether there are food safety hazards 

that are reasonably likely to occur for 

each kind of fish and fishery product 

processed by that processor and to 

identify the preventive measures that 

the processor can apply to control 

those hazards. Such food safety 

hazards can be introduced both 

within and outside the processing 

plant environment, including food 

safety hazards that can occur before, 

during, and after harvest. A food 

safety hazard that is reasonably likely 

to occur is one for which a prudent 

processor would establish controls 

because experience, illness data, 

scientific reports, or other information 

provide a basis to conclude that there 

is a reasonable possibility that it will 

occur in the particular type of fish or 

fishery product being processed in 

the absence of those controls. 

b.	 The HACCP plan. Every processor 

shall have and implement a written 

HACCP plan whenever a hazard 

analysis reveals one or more food 

safety hazards that are reasonably 

likely to occur, as described in 

paragraph (a) of this section. A 

HACCP plan shall be specific to: 

(1) Each location where fish and 

fishery products are processed by 

that processor; and 

(2) Each kind of fish and fishery 

product processed by the 

processor. The plan may group 

kinds of fish and fishery products 

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457 
 

together, or group kinds of 

production methods together, if 

the food safety hazards, critical 

control points, critical limits, 

and procedures required to be 

identified and performed in 

paragraph (c) of this section are 

identical for all fish and fishery 

products so grouped or for all 

production methods so grouped. 

c.	 The contents of the HACCP plan. The 

HACCP plan shall, at a minimum: 

(1) List the food safety hazards that 

are reasonably likely to occur, 

as identified in accordance with 

paragraph (a) of this section, and 

that thus must be controlled for 

each fish and fishery product. 

Consideration should be given to 

whether any food safety hazards 

are reasonably likely to occur as 

a result of the following: 

(i)	 Natural toxins; 

(ii)	 Microbiological 

contamination; 

(iii)	 Chemical contamination; 

(iv)	 Pesticides; 

(v)	 Drug residues; 

(vi)	 Decomposition in 

scombroid toxin-forming 

species or in any other 

species where a food safety 

hazard has been associated 

with decomposition; 

(vii)	 Parasites, 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; 

(viii) Unapproved use of direct 

or indirect food or color 

additives; and 

(ix)	 Physical hazards; 

(2) List the critical control points for 

each of the identified food safety 

hazards, including as appropriate: 

(x)	 Critical control points 

designed to control 

food safety hazards that 

could be introduced 

in the processing plant 

environment; and 

(xi)	 Critical control points 

designed to control food 

safety hazards introduced 

outside the processing plant 

environment, including food 

safety hazards that occur 

before, during, and after 

harvest; 

(3) List the critical limits that must be 

met at each of the critical control 

points; 

(4) List the procedures, and 

frequency thereof, that will be 

used to monitor each of the 

critical control points to ensure 

compliance with the critical 

limits; 

(5) Include any corrective action 

plans that have been developed 

in accordance with Sec. 123.7(b), 

to be followed in response to 

deviations from critical limits at 

critical control points; 

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(6) List the verification procedures, 

and frequency thereof, that the 

processor will use in accordance 

with Sec. 123.8(a); 

(7) Provide for a recordkeeping 

system that documents the 

monitoring of the critical control 

points. The records shall 

contain the actual values and 

observations obtained during 

monitoring. 

d.	 Signing and dating the HACCP plan. 

(1) The HACCP plan shall be signed 

and dated, either by the most 

responsible individual onsite at the processing facility 

or by a higher level official of 

the processor. This signature 

shall signify that the HACCP 

plan has been accepted for 

implementation by the firm. 

(2) The HACCP plan shall be dated 

and signed: 

(i)	 Upon initial acceptance; 

(ii)	 Upon any modification; and 

(iii)	 Upon verification of the 

plan in accordance with 

Sec. 123.8(a)(1). 

e.	 Products subject to other regulations. 

For fish and fishery products that 

are subject to the requirements of 

part 113 or 114 of this chapter, the 

HACCP plan need not list the food 

safety hazard associated with the 

formation of Clostridium botulinum 

toxin in the finished, hermetically 

sealed container, nor list the controls 

to prevent that food safety hazard. A 

HACCP plan for such fish and fishery 

products shall address any other food 

safety hazards that are reasonably 

likely to occur. 

f.	 Sanitation. Sanitation controls may 

be included in the HACCP plan. 

However, to the extent that they are 

monitored in accordance with Sec. 

123.11(b) they need not be included 

in the HACCP plan, and vice versa. 

g.	 Legal basis. Failure of a processor 

to have and implement a HACCP 

plan that complies with this 

section whenever a HACCP plan is 

necessary, [or] otherwise operate in 

accordance with the requirements 

of this part, shall render the fish or 

fishery products of that processor 

adulterated under section 402(a) 

(4) of the act. Whether a processor’s 

actions are consistent with ensuring 

the safety of food will be determined 

through an evaluation of the 

processor overall implementation of 

its HACCP plan, if one is required. 

•	 Sec. 123.7 Corrective actions 

a.	 Whenever a deviation from a critical 

limit occurs, a processor shall take 

corrective action either by: 

(1) Following a corrective action 

plan that is appropriate for the 

particular deviation, or 

(2) Following the procedures in 

paragraph (c) of this section. 

b.	 Processors may develop written 

corrective action plans, which 

become part of their HACCP plans 

in accordance with Sec. 123.6(c) 

(5), by which they predetermine the 

corrective actions that they will take 

whenever there is a deviation from a 

critical limit. A corrective action plan 

that is appropriate for a particular 

deviation is one that describes 

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459 
 

 

 

 

the steps to be taken and assigns 

responsibility for taking those steps, 

to ensure that: 

(1) No product enters commerce that 

is either injurious to health or is 

otherwise adulterated as a result 

of the deviation; and 

(2) The cause of the deviation is 

corrected. 

c.	 When a deviation from a critical limit 

occurs and the processor does not 

have a corrective action plan that is 

appropriate for that deviation, the 

processor shall: 

(1) Segregate and hold the affected 

product, at least until the 

requirements of paragraphs (c)(2) 

and (c)(3) of this section are met; 

(2) Perform or obtain a review to 

determine the acceptability of the 

affected product for distribution. 

The review shall be performed 

by an individual or individuals 

who have adequate training or 

experience to perform such a 

review. Adequate training may 

or may not include training in 

accordance with Sec. 123.10; 

(3) Take corrective action, when 

necessary, with respect to the 

affected product to ensure that 

no product enters commerce that 

is either injurious to health or is 

otherwise adulterated as a result 

of the deviation; 

(4) Take corrective action, when 

necessary, to correct the cause of 

the deviation; 

(5) Perform or obtain timely 

reassessment by an individual 

or individuals who have been 

trained in accordance with Sec. 

123.10, to determine whether the 

HACCP plan needs to be modified 

to reduce the risk of recurrence 

of the deviation, and modify the 

HACCP plan as necessary. 

d.	 All corrective actions taken in accordance 

with this section shall be fully 

documented in records that are subject 

to verification in accordance with Sec. 

123.8(a)(3)(ii) and the recordkeeping 

requirements of Sec. 123.9. 

•	 Sec. 123.8 Verification 

a.	 Overall verification. Every processor 

shall verify that the HACCP plan 

is adequate to control food safety 

hazards that are reasonably likely 

to occur, and that the plan is being 

effectively implemented. Verification 

shall include, at a minimum: 

(1) Reassessment of the HACCP plan. 

A reassessment of the adequacy 

of the HACCP plan whenever any 

changes occur that could affect 

the hazard analysis or alter the 

HACCP plan in any way or at 

least annually. Such changes may 

include changes in the following: 

Raw materials or source of raw 

materials, product formulation, 

processing methods or systems, 

finished product distribution 

systems, or the intended use 

or consumers of the finished 

product. The reassessment shall 

be performed by an individual 

or individuals who have been 

trained in accordance with Sec. 

123.10. The HACCP plan shall be 

modified immediately whenever a 

reassessment reveals that the plan 

is no longer adequate to fully 

meet the requirements of Sec. 

123.6(c). 

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460 
 

 

 

 

 

 

 

 

 

(2) Ongoing verification activities. 

Ongoing verification activities 

including: 

(i)	 A review of any consumer 

complaints that have been 

received by the processor 

to determine whether they 

relate to the performance 

of critical control points 

or reveal the existence of 

unidentified critical control 

points; 

(ii)	 The calibration of processmonitoring instruments; 

and, 

(iii)	 At the option of the 

processor, the performing 

of periodic end-product or 

in-process testing. 

(3) Records review. A review, 

including signing and dating, 

by an individual who has been 

trained in accordance with 

Sec. 123.10, of the records that 

document: 

(i)	 The monitoring of critical 

control points. The 

purpose of this review 

shall be, at a minimum, to 

ensure that the records are 

complete and to verify that 

they document values that 

are within the critical limits. 

This review shall occur 

within 1 week of the day 

that the records are made; 

(ii)	 The taking of corrective 

actions. The purpose of 

this review shall be, at a 

minimum, to ensure that the 

records are complete and 

to verify that appropriate 

corrective actions were 

taken in accordance with 

Sec. 123.7. This review 

shall occur within 1 week 

of the day that the records 

are made; and 

(iii)	 The calibrating of any 

process control instruments 

used at critical control 

points and the performing 

of any periodic endproduct or in-process 

testing that is part of the 

processor’s verification 

activities. The purpose of 

these reviews shall be, at 

a minimum, to ensure that 

the records are complete, 

and that these activities 

occurred in accordance 

with the processor’s 

written procedures. These 

reviews shall occur within 

a reasonable time after the 

records are made. 

b.	 Corrective actions. Processors shall 

immediately follow the procedures in 

Sec. 123.7 whenever any verification 

procedure, including the review of 

a consumer complaint, reveals the 

need to take a corrective action. 

c.	 Reassessment of the hazard analysis. 

Whenever a processor does not have 

a HACCP plan because a hazard 

analysis has revealed no food safety 

hazards that are reasonably likely to 

occur, the processor shall reassess 

the adequacy of that hazard analysis 

whenever there are any changes that 

could reasonably affect whether a 

food safety hazard now exists. Such 

changes may include, but are not 

limited to changes in: Raw materials 

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 

systems, finished product distribution 

systems, or the intended use or 

consumers of the finished product. 

The reassessment shall be performed 

by an individual or individuals who 

have been trained in accordance with 

Sec. 123.10. 

d.	 Recordkeeping. The calibration of 

process-monitoring instruments, 

and the performing of any periodic 

end-product and in-process testing, 

in accordance with paragraphs (a) 

(2)(ii) through (iii) of this section 

shall be documented in records that 

are subject to the recordkeeping 

requirements of Sec. 123.9. 

•	 Sec. 123.9 Records 

a.	 General requirements. All records 

required by this part shall include: 

(1) The name and location of the 

processor or importer; 

(2) The date and time of the activity 

that the record reflects; 

(3) The signature or initials of the 

person performing the operation; 

and 

(4) Where appropriate, the identity of 

the product and the production 

code, if any. Processing and 

other information shall be entered 

on records at the time that it is 

observed. 

b.	 Record retention. 

(1) All records required by this 

part shall be retained at the 

processing facility or importer’s 

place of business in the United 

States for at least 1 year after the 

date they were prepared in the 

case of refrigerated products and 

for at least 2 years after the date 

they were prepared in the case of 

frozen, preserved, or shelf-stable 

products. 

(2) Records that relate to the 

general adequacy of equipment 

or processes being used by 

a processor, including the 

results of scientific studies and 

evaluations, shall be retained 

at the processing facility or the 

importer’s place of business in 

the United States for at least 2 

years after their applicability to 

the product being produced at 

the facility. 

(3) If the processing facility is closed 

for a prolonged period between 

seasonal packs, or if record 

storage capacity is limited on a 

processing vessel or at a remote 

processing site, the records may 

be transferred to some other 

reasonably accessible location at 

the end of the seasonal pack but 

shall be immediately returned for 

official review upon demand. 

c.	 Official review. All records required 

by this part and all plans and 

procedures required by this part shall 

be available for official review and 

copying at reasonable times. 

d.	 Public disclosure. 

(1) Subject to the limitations in 

paragraph (d)(2) of this section, 

all plans and records required 

by this part are not available for 

public disclosure unless they have 

been previously disclosed to the 

public as defined in Sec. 20.81 

of this chapter or they relate to 

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 

longer represent a trade secret 

or confidential commercial or 

financial information as defined 

in Sec. 20.61 of this chapter. 

(2) However, these records and plans 

may be subject to disclosure 

to the extent that they are 

otherwise publicly available, 

or that disclosure could not 

reasonably be expected to cause 

a competitive hardship, such as 

generic-type HACCP plans that 

reflect standard industry practices. 

e.	 Tags. Tags as defined in Sec. 123.3(t) 

are not subject to the requirements 

of this section unless they are used 

to fulfill the requirements of Sec. 

123.28(c). 

f.	 Records maintained on computers. 

The maintenance of records on 

computers is acceptable, provided 

that appropriate controls are 

implemented to ensure the integrity 

of the electronic data and signatures. 

•	 Sec. 123.10 Training 

At a minimum, the following functions 

shall be performed by an individual who 

has successfully completed training in 

the application of HACCP principles to 

fish and fishery product processing at 

least equivalent to that received under 

a standardized curriculum recognized 

as adequate by the U.S. Food and Drug 

Administration or who is otherwise 

qualified through job experience to 

perform these functions. Job experience 

will qualify an individual to perform 

these functions if it has provided 

knowledge at least equivalent to that 

provided through the standardized 

curriculum. 

a.	 Developing a HACCP plan, which 

could include adapting a model or 

generic-type HACCP plan, that is 

appropriate for a specific processor, 

in order to meet the requirements of 

Sec. 123.6(b); 

b.	 Reassessing and modifying the 

HACCP plan in accordance with 

the corrective action procedures 

specified in Sec. 123.7(c)(5), the 

HACCP plan in accordance with the 

verification activities specified in Sec. 

123.8(a)(1), and the hazard analysis 

in accordance with the verification 

activities specified in Sec. 123.8(c); 

and 

c.	 Performing the record review 

required by Sec. 123.8(a)(3). The 

trained individual need not be an 

employee of the processor. 

•	 Sec. 123.11 Sanitation control procedures 

a.	 Sanitation SOP. Each processor 

should have and implement a 

written sanitation standard operating 

procedure (herein referred to as 

SSOP) or similar document that is 

specific to each location where fish 

and fishery products are produced. 

The SSOP should specify how the 

processor will meet those sanitation 

conditions and practices that are to 

be monitored in accordance with 

paragraph (b) of this section. 

b.	 Sanitation monitoring. Each processor 

shall monitor the conditions and 

practices during processing with 

sufficient frequency to ensure, at a 

minimum, conformance with those 

conditions and practices specified in 

part 110 of this chapter that are both 

appropriate to the plant and the food 

being processed and relate to the 

following: 

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(1) Safety of the water that comes 

into contact with food or food 

contact surfaces, or is used in the 

manufacture of ice; 

(2) Condition and cleanliness of food 

contact surfaces, including utensils, 

gloves, and outer garments; 

(3) Prevention of cross-contamination 

from insanitary objects to food, 

food packaging material, and 

other food contact surfaces, 

including utensils, gloves, and 

outer garments, and from raw 

product to cooked product; 

(4) Maintenance of hand washing, 

hand sanitizing, and toilet 

facilities; 

(5) Protection of food, food 

packaging material, and food 

contact surfaces from adulteration 

with lubricants, fuel, pesticides, 

cleaning compounds, sanitizing 

agents, condensate, and other 

chemical, physical, and biological 

contaminants; 

(6) Proper labeling, storage, and use 

of toxic compounds; 

(7) Control of employee health 

conditions that could result in the 

microbiological contamination of 

food, food packaging materials, 

and food contact surfaces; and 

(8) Exclusion of pests from the food 

plant. 

The processor shall correct in a timely 

manner, those conditions and practices 

that are not met. 

c.	 Sanitation control records. Each 

processor shall maintain sanitation 

control records that, at a minimum, 

document the monitoring and 

corrections prescribed by paragraph 

(b) of this section. These records are 

subject to the requirements of Sec. 

123.9. 

d.	 Relationship to HACCP plan. Sanitation 

controls may be included in the 

HACCP plan, required by Sec. 

123.6(b). However, to the extent that 

they are monitored in accordance 

with paragraph (b) of this section 

they need not be included in the 

HACCP plan, and vice versa. 

•	 Sec. 123.12 Special requirements for imported 

products 

This section sets forth specific 

requirements for imported fish and 

fishery products. 

a.	 Importer verification. Every importer of 

fish or fishery products shall either: 

(1) Obtain the fish or fishery product 

from a country that has an active 

memorandum of understanding 

(MOU) or similar agreement with 

the Food and Drug Administration, 

that covers the fish or fishery 

product and documents the 

equivalency or compliance of the 

inspection system of the foreign 

country with the U.S. system, 

accurately reflects the current 

situation between the signing 

parties, and is functioning and 

enforceable in its entirety; or 

(2) Have and implement written 

verification procedures for 

ensuring that the fish and fishery 

products that they offer for 

import into the United States 

were processed in accordance 

with the requirements of this 

part. The procedures shall list at 

a minimum: 

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464 
(i)	 Product specifications that 

are designed to ensure 

that the product is not 

adulterated under section 

402 of the Federal Food, 

Drug, and Cosmetic Act 

because it may be injurious 

to health or have been 

processed under insanitary 

conditions, and, 

(ii)	 Affirmative steps that 

may include any of the 

following: 

A.	 Obtaining from the 

foreign processor the 

HACCP and sanitation 

monitoring records 

required by this part 

that relate to the specific 

lot of fish or fishery 

products being offered 

for import; 

B.	 Obtaining either a 

continuing or lot- bylot certificate from an 

appropriate foreign 

government inspection 

authority or competent 

third party certifying 

that the imported fish 

or fishery product is 

or was processed in 

accordance with the 

requirements of this 

part; 

C.	 Regularly inspecting 

the foreign processor’s 

facilities to ensure that 

the imported fish or 

fishery product is being 

processed in accordance 

with the requirements 

of this part; 

D.	 Maintaining on file a 

copy, in English, of 

the foreign processor’s 

HACCP plan, and a 

written guarantee from 

the foreign processor 

that the imported fish 

or fishery product is 

processed in accordance 

with the requirements 

of this part; 

E.	 Periodically testing 

the imported fish or 

fishery product, and 

maintaining on file a 

copy, in English, of a 

written guarantee from 

the foreign processor 

that the imported fish 

or fishery product is 

processed in accordance 

with the requirements 

of this part or, 

F.	 Other such verification 

measures as appropriate 

that provide an 

equivalent level of 

assurance of compliance 

with the requirements 

of this part. 

b.	 Competent third party. An importer 

may hire a competent third party to 

assist with or perform any or all of 

the verification activities specified 

in paragraph (a)(2) of this section, 

including writing the importer’s 

verification procedures on the 

importer’s behalf. 

c.	 Records. The importer shall maintain 

records, in English, that document 

the performance and results of 

the affirmative steps specified in 

paragraph (a)(2)(ii) of this section. 

APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products 

465 
 

These records shall be subject to the 

applicable provisions of Sec. 123.9. 

d.	 Determination of compliance. There 

must be evidence that all fish and 

fishery products offered for entry 

into the United States have been 

processed under conditions that 

comply with this part. If assurances 

do not exist that the imported fish or 

fishery product has been processed 

under conditions that are equivalent 

to those required of domestic 

processors under this part, the 

product will appear to be adulterated 

and will be denied entry. 

•	 SUBPART B - SMOKED AND SMOKE-FLAVORED 

FISHERY PRODUCTS 

•	 Sec. 123.15 General 

This subpart augments subpart A of this 

part by setting forth specific requirements 

for processing smoked and smokeflavored fishery products. 

•	 Sec. 123.16 Process controls 

In order to meet the requirements of 

subpart A of this part, processors of 

smoked and smoke-flavored fishery 

products, except those subject to the 

requirements of part 113 or 114 of this 

chapter, shall include in their HACCP 

plans how they are controlling the 

food safety hazard associated with 

the formation of toxin by Clostridium 

botulinum for at least as long as the shelf 

life of the product under normal and 

moderate abuse conditions. 

•	 SUBPART C - RAW MOLLUSCAN SHELLFISH 

•	 Sec. 123.20 General 

This subpart augments subpart A 

of this part by setting forth specific 

requirements for processing fresh or 

frozen molluscan shellfish, where 

such processing does not include a 

treatment that ensures the destruction 

of vegetative cells of microorganisms 

of public health concern. 

•	 Sec. 123.28 Source controls 

a.	 In order to meet the requirements of 

subpart A of this part as they apply to 

microbiological contamination, chemical 

contamination, natural toxins, and 

related food safety hazards, processors 

shall include in their HACCP plans 

how they are controlling the origin of 

the molluscan shellfish they process to 

ensure that the conditions of paragraphs 

(b), (c), and (d) of this section are met. 

b.	 Processors shall only process molluscan 

shellfish harvested from growing 

waters approved for harvesting by a 

shellfish control authority. In the case 

of molluscan shellfish harvested from 

U.S. Federal waters, the requirements 

of this paragraph will be met so long as 

the shellfish have not been harvested 

from waters that have been closed to 

harvesting by an agency of the Federal 

government. 

c.	 To meet the requirements of paragraph 

(b) of this section, processors who 

receive shellstock shall accept only 

shellstock from a harvester that is 

in compliance with such licensure 

requirements as may apply to the 

harvesting of molluscan shellfish or 

from a processor that is certified by 

a shellfish control authority, and that 

has a tag affixed to each container of 

shellstock. The tag shall bear, at a 

minimum, the information required in 

Sec. 1240.60(b) of this chapter. In place 

of the tag, bulk shellstock shipments 

may be accompanied by a bill of lading 

or similar shipping document that 

contains the information required in Sec. 

APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products 

466 
 

 

1240.60(b) of this chapter. Processors 

shall maintain records that document 

that all shellstock have met the 

requirements of this section. These 

records shall document: 

(1) The date of harvest; 

(2) The location of harvest by State and 

site; 

(3) The quantity and type of shellfish; 

(4) The date of receipt by the processor; 

and 

(5) The name of the harvester, the 

name or registration number of the 

harvester’s vessel, or an identification 

number issued to the harvester by 

the shellfish control authority. 

d. To meet the requirements of paragraph 

(b) of this section, processors who 

receive shucked molluscan shellfish 

shall accept only containers of shucked 

molluscan shellfish that bear a label 

that complies with Sec. 1240.60(c) of 

this chapter. Processors shall maintain 

records that document that all shucked 

molluscan shellfish have met the 

requirements of this section. These 

records shall document: 

(1) The date of receipt; 

(2) The quantity and type of shellfish; 

and 

(3) The name and certification number of 

the packer or repacker of the product. 

•	 PART 1240 - CONTROL OF COMMUNICABLE 

DISEASES 

1.	 The authority citation for 21 CFR part 1240 

continues to read as follows: 

Authority: Secs. 215, 311, 361, 368 of the Public 

Health Service Act (42 U.S.C. 216, 243, 264, 271). 

2.	 Section 1240.3 is amended by revising 

paragraph (r), and by adding new paragraphs 

(s), (t), and (u) to read as follows: 

•	 Sec. 1240.3 General Definitions 

a.	 Molluscan shellfish. Any edible species of 

fresh or frozen oysters, clams, mussels, 

and scallops or edible portions thereof, 

except when the product consists entirely 

of the shucked adductor muscle. 

b.	 Certification number means a unique 

combination of letters and numbers 

assigned by a shellfish control authority 

to a molluscan shellfish processor. 

c.	 Shellfish control authority means a Federal, 

State, or foreign agency, or sovereign 

tribal government, legally responsible 

for the administration of a program that 

includes activities such as classification 

of molluscan shellfish growing areas, 

enforcement of molluscan shellfish 

harvesting controls, and certification of 

molluscan shellfish processors. 

d.	 Tag means a record of harvesting 

information attached to a container of 

shellstock by the harvester or processor. 

3.	 Section 1240.60 is amended by revising the 

section heading, by redesignating the existing 

text as paragraph (a) and adding the word 

“molluscan” before the word “shellfish” the 

two times that it appears, and by adding new 

paragraphs (b), (c), and (d) to read as follows: 

•	 Sec. 1240.60 Molluscan Shellfish 

a.	 All shellstock shall bear a tag that discloses 

the date and place they were harvested 

(by State and site), type and quantity 

of shellfish, and by whom they were 

harvested (i.e., the identification number 

assigned to the harvester by the shellfish 

control authority, where applicable or, 

if such identification numbers are not 

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. 

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468