Вы находитесь на странице: 1из 501

SGR 129

Fish and Fishery Products


Hazards and Controls Guidance
Fourth Edition – AUGUST 2019

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 – August 2019

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
www.ifasbooks.com

Copies of this guidance document may be downloaded from:


www.FDA.gov/Seafood

U.S. Department of Health and Human Services


Food and Drug Administration
Center for Food Safety and Applied Nutrition
(240) 402-2300

August 2019
TABLE OF CONTENTS: FISH AND FISHERY PRODUCTS HAZARDS
AND CONTROLS GUIDANCE - FOURTH EDITION - AUGUST 2019

Guidance for Industry: Fish and Fishery Products Hazards and Control Guidance ………………………………… G-1
CHAPTER 1: General Information …………………………………………………………………………………....………………….. 1–1
CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan ……………………………………………. 2–1
CHAPTER 3: Potential Species-Related and Process-Related Hazards …………………………………………………… 3–1
CHAPTER 4: Pathogens from the Harvest Area ……………………………………………………………………..……………… 75
CHAPTER 5: Parasites …………………………………………………………………………………………………………….…………….. 91
CHAPTER 6: Natural Toxins ……………………………………………………………………………………………………………………. 6–1
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 Intolerances Causing Substances ….. 19 – 1
CHAPTER 20: Metal Inclusion ……………………………………………………………………………………………….………………. 385
CHAPTER 21: Glass Inclusion ………………………………………………………………………………………………………………… 395
APPENDIX 1: Forms …………………………………………………………………………………………………………….………………… A1 – 1
APPENDIX 2: Product Flow Diagram – Example …………………………………………………………………….……………. A2 – 1
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 …………………………………………………. A5 – 1
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 A8 – 1
APPENDIX 9: Allergen Cleaning and Sanitation …………………………………………………………………………………… A9 – 1
APPENDIX 10: Allergen Cross-Contact Prevention ………………………………………………………………………………… A10 – 1

Table of Contents
(August 2019)
GUIDANCE FOR THE INDUSTRY: FISH AND FISHERY PRODUCTS HAZARDS
AND CONTROLS GUIDANCE FOURTH EDITION - AUGUST 2019

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

I. INTRODUCTION II. DISCUSSION


This guidance is intended to assist processors of A. Scope and Limitations
fish and fishery products in the development of
their Hazard Analysis Critical Control Point (HACCP) The control strategies and practices provided in
plans. Processors of fish and fishery products will this guidance are recommendations to the fish and
find information in this guidance that will help fishery products industry unless they are required
them identify hazards that are associated with by regulation or statute. This guidance provides
their products and help them formulate control information that would likely result in a HACCP plan
strategies. The guidance will help consumers and that is acceptable to FDA. Processors may choose
the public generally to understand commercial to use other control strategies, as long as they
seafood safety in terms of hazards and their comply with the requirements of the applicable food
controls. The guidance does not specifically address safety laws and regulations. However, processors
safe handling practices by consumers or by retail that chose to use other control strategies (e.g.,
establishments, although many of the concepts critical limits) should scientifically establish their
contained in this guidance are applicable to both. adequacy.
This guidance is also intended to serve as a tool to
be used by federal and state regulatory officials in The information contained in the tables in Chapter 3
the evaluation of HACCP plans for fish and fishery and in Chapters 4 through 21 provide guidance for
products. determining which hazards are “reasonably likely
to occur” in particular fish and fishery products
FDA’s guidance documents, including this guidance, under ordinary circumstances. However, the tables
do not establish legally enforceable responsibilities. should not be used separately for this purpose. The
Instead, guidance describes the Agency’s current tables list potential hazards for specific species and
thinking on a topic and should be viewed only finished product types. This information should be
as recommendations, unless specific regulatory combined with the information in the subsequent
or statutory requirements are cited. The use of chapters to determine the likelihood of occurrence.
the word should in Agency guidance means that
something is suggested or recommended, but not The guidance is not a substitute for the performance
required. of a hazard analysis by a processor of fish and
fishery products, as required by FDA’s regulations.
This guidance has been prepared by the Division Hazards not covered by this guidance may be
of Seafood Safety in the Center for Food Safety relevant to certain products under certain cir-
and Applied Nutrition at the U.S. Food and Drug cumstances. In particular, processors should be
Administration. 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
G - 1 (August 2019)
FDA announced its adoption of final regulations However, this guidance document does contain
to ensure the safe and sanitary processing of fish recommendations only for allergen cleaning and
and fishery products in the Federal Register of sanitation, and allergen cross-contact through
December 18, 1995 (60 FR 65096) (hereinafter two new appendixes since normal cleaning and
referred to as the Seafood HACCP Regulation). This sanitation does not necessarily address allergen
guidance, the Seafood HACCP Regulation (21 CFR residues.
123), and the Control of Communicable Diseases
regulation (21 CFR 1240) apply to all aquatic animal This guidance does not describe corrective action
life, other than birds and mammals, used as food or verification records, because these records
for human consumption. For example, in addition are not required to be listed in the HACCP plan.
to fresh and saltwater finfish and crustaceans, Nonetheless, such records must be maintained,
this guidance applies to echinoderms such as where applicable, as required in § 123.7 and §
sea cucumbers and sea urchins; reptiles such as 123.8. Additionally, this guidance does not restate
alligators and turtles; amphibians such as frogs; the general requirements for records that are set
and to all mollusks, including land snails (escargot). out in § 123.9(a).
It also applies to extracts and derivatives of fish,
such as eggs (roe), oil, cartilage, and fish protein This guidance does not cover reassessment of the
concentrate. In addition, this guidance applies to HACCP plan and/or the hazard analysis or review
products that are mixtures of fish and non-fish of consumer complaints, as mandated by § 123.8.
ingredients, such as tuna sandwiches and soups.
This guidance also does not provide specific
Appendix 8, § 123.3, lists the definitions for “fish”
guidance to importers of fish and fishery products
and “fishery product” used in the Seafood HACCP
for the development of required importer verification
Regulation.
procedures. However, the information contained in
This guidance covers safety hazards associated the text, and, in particular, in Appendix 5 (“FDA and
with fish and fishery products only. It does not EPA Safety Levels in Regulations and Guidance”),
cover most hazards associated with non-fishery should prove useful for this purpose.
ingredients (e.g., Salmonella enteritidis in raw
eggs). However, where such hazards are presented B. Chapter Modifications
by a fishery product that contains non-fishery
The following is a summary of the most significant
ingredients, control must be included in the
changes made to this guidance. Moving forward,
HACCP plan (§ 123.6). Processors may use the
FDA will publish this guidance as a living document
principles included in this guidance for assistance in
on the FDA Seafood website (www.fda.gov/seafood).
developing appropriate controls for these hazards.
Until all the chapters and/or appendixes have been
This guidance does not cover the hazard associated updated this guidance will continue to be identified
with the formation of Clostridium botulinum (C. as the fourth edition with the date being modified
botulinum) toxin in low-acid canned foods (LACFs) to reflect the most recent changes. Each chapter
or shelf-stable acidified foods. Mandatory controls or appendix will also reference the date (month
for this hazard are contained in the Thermally and year) the most recent changes were made and
Processed Low-Acid Foods Packaged in Hermetically published. Chapters and appendixes that have not
Sealed Containers regulation (hereinafter referred been modified will reflect the original publication
to as the LACF Regulation, 21 CFR 113) and the date of April 2011. Additionally, the “Guidance for
Acidified Foods regulation (21 CFR 114). Such Industry” section will identify the specific changes
controls may be, but are not required to be, in the header with the date of publication. You
included in HACCP plans for these products. should carefully review the chapters applicable to
your product and process in addition to using this
This guidance does not cover all sanitation controls summarized list of significant changes.
required by the Seafood HACCP Regulation. The
maintenance of a sanitation monitoring program The following changes have been made throughout
is an essential prerequisite to the development of this guidance document:
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).

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition
G - 2 (August 2019)
Chapter 1 for general information has been modified • Footnote 13 has been added to the header of
with the following recommendations as of April Natural Toxins.
2011: • Amberjack – S. rivoliana has been added
with the hazards of CFP and Scombrotoxin
• No modifications made at this time.
(Histamine).
Chapter 2 for conducting a hazard analysis and • Amberjack or Yellowtail, aquacultured – Parasite
developing a HACCP plan has been modified with hazard has been added.
the following recommendations as of April 2011:
• Amberjack or Buri, aquacultureed – Seriola
• No modifications made at this time. quinqueradiata has been added.

Chapter 3 for identifying potential species-related • Anchovy – The following changes have been
made:
and process-related hazards has been modified
with the following recommendations as of o Footnote 12 has been added to the market
August 2019: name;

• Table 3-1: Potential Species- Related Hazards o The hazard of Parasites has been added;
Associated with the Actual Market Name of
Product (from Table 3-2): • Mackerel, Atka - is listed under “Atka Mackerel.”

o Escolar - “Gempylotoxin” and “Histamine” • Barracuda (Sphyraena spp.) – The hazard of


has been changed to “Gempylid Fish CFP has been removed.
Poisoning” and “Scombrotoxin (Histamine).”
• Basa or Bocourti – Footnote 8 has been
• Table 3-1: Potential Species- Related Hazards removed.
Associated with the Actual Market Name of
Product (from Table 3-2): • Basa or Bocourti, aquacultured – Footnote 8
has been removed.
o Puffer fish - “Pufferfish Poisoning” has been
included in parenthesis after “Tetrodotoxin;” • Bream (Acanthopagrus spp.) – Footnote 7 has
been removed.
• Table 3-1 Under Potential Species- Related
Hazards Associated with the Actual Market • Butterfish – Footnote 8 has been removed.
Name of Product (from Table 3-2):
• Caparari – Footnote 8 has been removed.
o Spanish Mackerel - “Scombrotoxin” has
• Cascarudo – Footnote 8 has been removed.
been added with “Histamine” being placed
in parenthesis. • Cisco or Tullibee (Coregonus artedi) – Footnote
7 has been removed.
• Potential Species- Related Hazards Associated
with the Actual Market Name of Product • Clarias Fish or Walking Clarias Fish – Footnote
(from Table 3-2): 8 has been removed.
o Basa - “Environmental Chemical Con- • Clarias fish or Walking Clarias Fish, or Claresse,
taminants” and “Pesticides” has been aquacultured – The following changes have
changed to “Environmental Chemicals” and been made:
“Aquaculture Drugs.”
o Footnote 8 has been removed;
Chapter 3, Table 3-2 (“Potential Vertebrate Species-
Related Hazards”) has been modified with the o Claresse has been added as a market name;
following recommendations as of August 2019: o Clarias gariepinus has been replaced with
Clarias spp.
• Footnote 3 has been added to the header of
Parasites.

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition
G - 3 (August 2019)
• Cod, Morid, (Psendophycis barbata) – Footnote • Flounder, aquacultured – Footnote 15 has been
7 has been removed. added.

• Coroata – Footnote 8 has been removed. • Flounder, aquacultured - Taxonomy change


from Pleuronectes glacialis to Liopsetta glacialis.
• Corvina (Cilus gilberti) – Footnote 7 has been
removed. • Flounder or Dab – Footnote 7 has been removed.

• Croaker or Yellowfish (Larimichthys polyactis) • Flounder or Fluke (Paralichthys flesus) –


– Footnote 7 has been removed. Footnote 7 has been removed.

• Drum or Cubbyu (Pareques umbrosus) – • Flounder, Arrowtooth (Atheresthes stomias) –


Footnote 7 has been removed. Footnote 7 has been removed.

• Drum or Lion Fish (Collichthys spp) - The market • Flounder or California Flounder (Paralichthys
name “lion Fish” has been removed. californicus) – The name has been moved to
Flounder.
• Drum or Meagre (Argyrosomus regius) –
Footnote 7 has been removed. • Frog, aquacultured (Rana spp.) – New listing
has been added.
• Eel – The following changes have been made:
• Gemfish (Lepidocybium flavobrunneum) – Has
o Anguilla anguilla has been added with the been removed from this market name.
hazard of Ichthyohemotoxin.
• Gillbacker or Gilleybaka or Whiskerfish (Sciades
• Eel, aquacultured – The following changes have parkeri) – The following changes have been
been made: made:

o Anguilla anguilla – The hazard of o The alternate market name of “Whiskerfish”


Ichthyohemotoxin has been added. has been added;

o Anguilla japonica – Footnote 7 has been o Footnote 8 has been added;


removed.
o Taxonomy change from Aspistor parkeri
• Eel, Conger – The following changes have been to Sciades parkeri with Footnote 7 being
made: added.

o Conger conger has been added with the • Greenbone (Odax pullus) – Footnote 7 has been
hazard of Ichthyohemotoxin: removed from species name.

o Conger spp. – The hazard of Parasite has • Greenland Turbot (Reinhardtius hippoglossoides)
been added. – The following changes have been made:

• Eel, Moray o Has been moved to turbot;

o Muraena helena has been added with the o The hazard of Parasites has been added.
hazard of Ichthyohemotoxin:
• Grenadier – Footnote 7 has been removed from
o Muraena retifera – The hazard of CFP has the following: Nezumia bairdii, Macruronus spp.
been added. Nezumia bairdii, and Trachyrhynchus spp.

• Emperor (Lethrinus spp.) – The hazard of CFP • Grouper - Dermatolepis inermis has been added
has been added. with the hazards of CFP and Parasite.

• Flatwhiskered Fish – Footnote 8 has been • Grouper or Scamp - Mycteroperca phenax


removed. has been added with the hazards of CFP and
parasite.
• Flounder – Footnote 15 has been added.

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition
G - 4 (August 2019)
• Halibut or California Halibut – Paralichthys • Mullet (Mugil cephalus) – The following changes
californicus been moved to “Flounder.” have been made:

• Hamlet, Mutton (Alphestes afer) – Footnote 7 o Footnote 7 has been removed;


has been removed.
o Mugil curena with the hazards of Parasites
• Herring – Footnote 12 has been added. and ASP has been added.

• Herring or Sea Herring or Sild – Footnote 12 • Nile Perch – Row added to accommodate this
has been added. market name.

• Herring or Sea Herring or Sild roe – Footnote • Nile Perch, aquacultured – Row added to
12 has been added. accommodate this market name.

• Herring, Thread – Footnote 12 has been added. • Oreo Dory – Footnote 12 has been added to
market name.
• Jack (Seriola rivoliana) - Has been moved to
Amberjack. • Pangasius, Giant – The following changes have
been made:
• Jack or Crevalle (Alectis indicus) – Footnote 7
has been removed. o Footnote 8 has been removed;

• Jacksmelt or Silverside (Antherinopsis o P. sanitwongsei with the hazard of


californiensis) – New line entry with the hazard Environmental Chemicals has been added.
of ASP has been added.
• Pangasius Shortbarbel – Footnote 8 has been
• Jobfish or Snapper – Footnote 8 has been added. removed.

• Kingfish (Menticirrhus littoralis) – The hazard • Parrotfish – The following changes have been
of ASP has been added. made:

• Ling, Mediterranean (Molva macrophthalma) o Scarus spp. has been removed;


– Footnote 7 has been removed.
o The following with the hazard of CFP were
• Lionfish – New line entry with the hazard of added: Chlorurus gibbus, Scarus coeruleus,
CFP has been added. S. taeniopterus, Sparisoma chrysopterum,
S. viride.
• Mackerel (Scomber scombrus) – The hazard of
PSP has been added. • Patagonian Toothfish or Chilean Sea Bass
(Dissostichus eleginoides) – Footnote 7 has
• Mackerel, Spanish or Narrow-Barred – The been removed.
market name has been modified.
• Perch, Ocean or Rockfish – The following
• Mackerel, Spanish or Cero – Cero has been changes have been made:
added.
o Rockfish has been added;
• Menhaden (Brevoortia partonus) The hazard
has of ASP has been added. o Footnote 8 has been added.

• Milkfish – The hazard of Scombrotoxin • Piramutaba or Laulao Fish – Footnote 8 has


(Histamine) has been added. been removed.

• Milkfish, aquacultured – The hazard of • Pollock or Alaska Pollock – the following changes
Scombrotoxin (Histamine) has been added. have been made:

• Morwong (Aplodactylus arctidens) – Footnote o Alaska Pollock has been replaced with
7 has been removed. “Walleye Pollock;”

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition
G - 5 (August 2019)
o Footnote 8 has been added; o Sander canadensis has been added.

o Taxonomy changed from Theragra • Scad (Atule mate) – Footnote 7 has been
chalcogrammus to Gadus chalcogrammus removed.
with Footnote 7 added.
• Sea Bream – Footnote 7 has been removed
• Pompano, aquacultured – New listing has been from species name Chrysophrys auratus.
added.
• Shad – The following changes have been made:
• Porgy spp. (Calamus spp.) The hazard of CFP
has been added. o The hazard of ASP has been added;

• Puffer Fish – The following changes have been o Footnote 5 has been added to the hazard
made: of ASP.

o Puffer has been replaced with Puffer Fish; • Silverside - Atherinopsis californiensis and
Membras marinica with the hazard of ASP have
o Footnotes 8, 11, and 16 have been added; been added.

o Toxin acronym has changed to PFP; • Skate - Amblyraja spp., Leucoraja spp., and
Malacoraja spp. with hazard of Environmental
o The following species are no longer Chemicals have been added.
listed Arothron spp. Legocephalus spp.
Sphoeroides annulatus, Sphoeroides • Snakehead (Parachanna obscura) - Footnote
spengleri, Sphoeroides testudineus, and 7 has been removed.
Tetraodon spp.
• Snapper – The following changes have been
• Puffer Fish, aquacultured – The following made:
changes have been made:
o The hazard of CFP14 has been added to
o Puffer has been replaced with Puffer Fish; Ocyurus chrysurus and Pristipomoides spp.;

o Footnote 8, 11, and 16 have been added; o The hazard of Parasites has been added to
Symphorus nematophorus;
o Toxin acronym has changed to PFP;
o Lutjanus spp. has been replaced with the
o Takifugu spp. has been replaced with specific Lutjanus species names.
Takifugu rubripes.
• Snapper or Schoolmaster – Lutjennus apodus
• Roughy, Orange – Footnote 12 has been added. has been added with the hazard of CFP.

• Roughy, Silver – Footnote 7 has been added. • Sole or Flounder – Footnote 7 has been
removed.
• Sardine – The following changes have been
made: • Sole or Flounder, aquacultured – Footnote 7
has been removed.
o Footnote 12 has been added;
• Sorubim or Surubi – Footnote 8 has been
o The following species with the hazards of removed.
ASP have been added Harengula clupeola,
H. jaguana, and Sardinops sagax. • Spot – The hazard of ASP has been added.

• Sauger – The following changes have been • Sturgeon and roe (Caviar) – Caviar with
made: Footnote 8 has been added.

o Atule mate has been removed; • Sturgeon and roe, (Caviar) aquacultured –
Caviar with Footnote 8 has been added.

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition
G - 6 (August 2019)
• Sunfish – “Not Mola mola” has now been o Balistes vetula has been added with the
removed. hazard of CFP.

• Sutchi or Swai – The following changes have • Trout, aquacultured – Taxonomy change from
been made: from Oncorhynchus mykiss aguabonita to
Oncorhynchus aguabonita with Footnote 7
o Footnote 8 has been removed; being added.

o Taxonomy change from Pangasius • Tuna - The descriptions of “Small” and “Large”
hypophthalmus to Pangasianodon have been removed.
hypophthalmus with Footnote 7 being
added. • Tuna, (Thunnus alalonga) – The hazard of ASP
has been added.
• Sutchi or Swai – The following changes have
been made: • Turbot – Footnote 7 has been removed.

o Footnote 8 has been removed; • Turbot, aquacultured – The hazard of Parasites


with Footnote 4 has been added.
o Taxonomy change Pangasius hypophthalmus
to Pangasianodon hypophthalmus; with • Unicornfish – The hazard of CFP has been
Footnote 7 being added. added.

• Swordfish – The hazard of Scombrotoxin • Walleye - Sander spp. has been replaced with
(Histamine) has been added. Sander vitreus.

• Tang – The following changes have been made: • Whiskered Fish – Footnote 8 has been removed.

o Ctenochaetus spp. has been replaced with • Whiskered Fish or Gafftopsail Fish – Footnote
Ctenochaetus striatus; 8 has been removed.

o Footnote 2 has been added to the hazard • Whiskered Fish or Hardhead Whiskered Fish –
of CFP. Footnote 8 has been removed.

• Threadfin – Gnathanodon spp. has been • Whiting – The hazard of Parasites has been
removed. added.

• Tilapia – The hazard of Parasites has been • Whiting, Blue – The hazard of Parasites has
added. been added.

• Tilapia, aquacultured – The hazard of Parasites • Yellowtail Amberjack, aquacultured – The


with Footnote 4 has been added. following changes have been made:

• Trevally – The following changes have been o Footnote 7 has been removed;
made:
o The hazard of Parasites with Footnote 4 has
o Caranx ignobilis, and C. melampygus been added.
with the hazards of CFP, Parasites, and
Scombrotoxin (Histamine) have been added; • Zander – Footnote 7 has been removed.

o The hazards associated with Gnathanodon • Zander, aquacultured – Footnote 7 has been
speciosus have been removed. removed.

• Triggerfish – The following changes have been • Acronym Changes – The following changes have
made: been made:

o Balistes spp. has been removed; o G = Gemplytoxin has been changed to GFP
= Gempylid Fish Poisoning;

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition
G - 7 (August 2019)
o IHT = Ichthyohemotoxin has been added; • Scallop (Euvola spp.) – Footnote 4 has been
removed.
o T = Tetrodotoxin has been changed to PFP
= Puffer Fish Poisoning. • Sea Cucumber, aquacultured – New listing has
been added.
• Footnotes – Footnotes 11, 12, 13, and 14 have
been added. • Shrimp – Footnote 4 has been removed from
Farfantepenaeus spp. Fenneropenaeus spp.,
Chapter 3, Table 3-3 (“Potential Invertebrate Species- Litopenaeus spp. Marsupenaeus spp., and
Related Hazards”) has been modified with the Melicertus spp.
following recommendations as of August 2019: • Shrimp or Prawn – Taxonomy change from
Hymenopenaeus sibogae to Haliporoides
• Clam, Surf or Surfclam – The spelling of
sibogae.
Mactrotoma spp. has been corrected.
• Squid or Calamari – Market name has been
• Crab, Beni-zuwai – New listing has been added.
updated to add “Calamari.”
• Crab, Golden King – The following changes
• Squid (Dosidicus gigas) – The hazard of Natural
have been made:
Toxin with Footnote 2 has been added.
o Market name has changed from Crab, Brown
• Squid (Loligo media) – Footnote 4 has been
King;
removed.
o Footnote 4 has been removed.
• Whelk or Sea Snail (Zidona dufresnei) – New
• Crab, Chinese Mitten – New listing has been listing has been added.
added.
Chapter 3, Table 3-4 (“Potential Process-Related
• Crab, Chinese Mitten, aquacultured – New listing Hazards”) has been modified with the following
has been added. recommendations as of August 2019:
• Crab, Dungeness – The following changes have • Footnote 2 has been removed.
been made:
• Footnotes 3, 4, 5, 6, and 7 have been
o Taxonomy change from Cancer magister to renumbered as a result of footnote 2 being
Metacarcinus magister; removed.
o Footnote 4 has been added. • Header – Allergens and Food Intolerance
Substances – Chapter 19 – The following
• Crab, Red – Footnote 4 has been removed.
changes have been made:
• Crab, Santolla, Nova, or Southern Red – New
o Chapter title updated to remove “Prohibited
listing has been added.
Food and Color Additives;”
• Crab, Swimming, (Ovalipes punctatus) – New
o Footnote 5 has been added to the header.
listing has been added.
• Smoked Fish (Other than ROP) – New listing
• Cuttlefish – The hazard of Natural Toxin with
for Chap 16 with Footnote 6 has been added.
Footnote 2 has been added.
• Dried Fish (All) - Footnote 7 for Chapter 13
• Lobster – The hazard of Natural Toxin with
has been added.
Footnote 2 has been added.
• Battered or Breaded Finished Product Food –
• Octopus – The hazard of Natural Toxin with
The following changes have been made:
Footnote 2 has been added.
o “Package Type” has been divided into two
• Octopus, Blue-Ringed (Hapalochlaena spp.) -
types;
New listing has been added

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition
G - 8 (August 2019)
o New listing for Chapter 13 for the ROP at least to some extent, the nature of the
Package Type has been added. controls for this pathogen in HACCP plans;

• Raw oysters, clams, and mussels (ROP) – The • The control strategy examples are restructured
following changes have been made: for improved clarity: one for source controls
(e.g., tagging, labeling, source waters, harvester
o “Hot Fill” and “Steam Flush” has been licensure, and raw consumption advisory) and
removed from the Package Type description; a second for time from harvest to refrigeration
controls.
o The hazard of undeclared allergen has been
removed. Chapter 5 for the control of parasites has been
• Raw oysters, clams, and mussels (other than modified with the following recommendations
ROP) – The following changes have been made: as of April 2011:
o “Hot Fill” and “Steam Flush” has been • It is now recognized that the parasite hazard
removed from the Package Type description; may be reasonably likely to occur in fish raised
in freshwater containing larvae of pathogenic
o The hazard of undeclared allergen has been liver, lung and intestinal flukes because these
removed. parasites enter the fish through the skin rather
than in the food.
• Footnotes – Footnotes 5, 6, and 7 have been
added. Chapter 6 for the control of natural toxins has been
modified with the following recommendations
Chapter 4 for the control of pathogens from the
as of August 2019:
harvest area has been modified with the
following recommendations as of April 2011: • The information in the Chapter has been
reorganized into two categories in each section.
• Hydrostatic pressure, individual quick freezing
(IQF) with extended storage, and irradiation are o “Fish other than molluscan shellfish” and
now identified as processes that are designed
to retain raw product characteristics and that o “Molluscan Shellfish.”
can be used to reduce Vibrio vulnificus (V.
vulnificus) and Vibrio parahaemolyticus (V. • Natural Toxin Detection Section was removed.
parahaemolyticus) to non-detectable levels; This information is utilized to confirm illnesses/
outbreaks, inform advisories for at risk harvest
• It is now recognized that a tag on a container of areas, and/or make a determination for harvest
shellstock (in-shell molluscan shellfish) received area closures. This information was never
from another dealer need not identify the intended for a processor to include in the HACCP
harvester; plan as a control measure. The information has
been relocated to Appendix 5.
• Critical limits relating to control of pathogen
growth prior to receipt of raw molluscan shellfish • Ciguatera Fish Poisoning (CFP) – The following
by the primary processor are now linked to changes have been made:
monitoring the time that the shellfish are
o Additional locations were included based on
exposed to air (i.e., by harvest or receding
scientific discovery of the toxin;
tide) rather than to the time that the shellfish
are harvested; o Areas included are Florida, Hawaii, and
Puerto Rico;
• Reference is now made to the role of the Federal,
state, tribal, territorial and foreign government o Addition of finfish to contain CFP) – lionfish,
shellfish control authorities in determining mackerel and tang;
whether the hazard of V. parahaemolyticus
is reasonably likely to occur in raw molluscan o Finfish previously listed in Chapter 3 are
shellfish and in the development of a V. now included in Chapter 6.
parahaemolyticus control plan that will dictate,

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition
G - 9 (August 2019)
• Tetrodotoxin – Symptomology development has the adductor muscle from the scallop to
been updated to align with the Bad Bug Book. eliminate the toxin;

• Natural Toxins addition – The following changes o Molluscan Shellfish – The statement: “States
have been made: must have a Biotoxin Contingency Plan”
was added.
o Clupeotoxin has been added as a natural
toxin with associated information; • Control Strategy Example 1 – Source control
for fish other than molluscan shellfish – The
o Ichthyohemotoxin has been added as a following changes have been made:
natural toxin with associated information;
o Critical Limit – “ASP for consumption
o Seafood-associated rhabdomyolysis advisory” was added;
(sometimes referred to as Haff disease)
has been added as a natural toxin with o Establish Verification procedures – “Periodic
associated information. verification of harvest locations” was added.

• A “Note” was added to the chapter regarding • Control Strategy Example 2 – Harvest Area for
venomous fish. This was to correspond to the Molluscan Shellfish – The following changes
Bad Bud Book new chapter to address the have been made:
potential concern and FDA’s thoughts.
o Critical Limit –
• Amnesic shellfish poisoning (ASP) – Additional
species of lobster, sardine, white mullet,  Update made to align with the NSSP and
menhaden, and predatory species, such as regulations for shellfish and HACCP, and
Florida pompano, Gulf Kingfish and spot, were
 A note was added regarding dockside
included.
screening to align with NSSP;
• Diarrhetic shellfish poisoning (DSP) – Addition
o Monitoring Procedures –
locations for the toxin were included such as
Puget Sound and the west coast of Canada,  Update made to include information
Texas, Washington State, Alabama, Maryland, that would be required for monitoring
Massachusetts, and New York. as identified though the regulation and
NSSP;
• Paralytic shellfish poisoning (PSP) – The
following additions were made: • Bibliography was updated to reflect the additions
throughout the chapter.
o Molluscan shellfish examples of clams,
cockles, mussels, oysters, and scallops;
Chapter 7 for the control of scombrotoxin
o Information regarding retention of the toxin (histamine) formation has been modified with
and depuration; the following recommendations as of April 2011:
o Expanded the information regarding • Information is now provided about the potential
gastropod accumulation of the toxin; for scombrotoxin (histamine) formation in
products like tuna salad that have been allowed
o Addition of finfish species where the toxin
to become recontaminated and then subjected
has been found in the viscera such as
to time and temperature abuse;
mackerel, Dungeness crab, tanner crab
and red rock crab. • The recommendations regarding on-board
chilling of scombrotoxin-forming species of
• Natural Toxin Control Section – The following
fish are now listed as follows:
changes have been made: in the Natural Toxin
Control Section: o Fish exposed to air or water temperatures
above 83°F (28.3°C) should be placed in
o ASP and PSP in fish other than molluscan
ice, or in refrigerated seawater, ice slurry,
shellfish – An example was added of
or brine of 40°F (4.4°C) or less, as soon as

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition
G - 10 (August 2019)
possible during harvest, but not more than o For fish held iced or refrigerated (not frozen)
6 hours from the time of death, or onboard the vessel and off-loaded from the
vessel by the processor from 15 to less
o Fish exposed to air and water temperatures than 24 hours after death, the internal
of 83°F (28.3°C) or less should be placed in temperature should be 50°F (10°C) or
ice, or in refrigerated seawater, ice slurry, below,
or brine of 40°F (4.4°C) or less, as soon as
possible during harvest, but not more than OR
9 hours from the time of death, or
o For fish held iced or refrigerated (not frozen)
o Fish that are gilled and gutted before chilling onboard the vessel and off-loaded from the
should be placed in ice, or in refrigerated vessel by the processor from 12 to less
seawater, ice slurry, or brine of 40°F (4.4°C) than 15 hours after death, the internal
or less, as soon as possible during harvest, temperature should be 60°F (15.6°C) or
but not more than 12 hours from the time below;
of death, or
• The recommended level at which a lot should
o Fish that are harvested under conditions be rejected based on sensory examination when
that expose dead fish to harvest waters 118 fish are examined is now corrected to be
of 65°F (18.3°C) or less for 24 hours or no more than 2 fish to coincide with the goal
less should be placed in ice, refrigerated of less than 2.5% decomposition in the lot;
seawater, ice slurry, or brine of 40°F (4.4°C)
or less, as soon as possible after harvest, • It is now recommended that the number of fish
but not more than the time limits listed subjected to sensory examination be increased
above, with the time period starting when if there is likely to be greater than normal
the fish leave the 65°F (18.3°C) or less variability in the lot, and that only one species
environment; constitute a lot for sampling purposes;

• Cautions are now provided that handling • When histamine analysis is performed as a
practices and processing controls that are corrective action, it is now recommended
recommended as suitable for preventing the that any fish found to exceed the internal
formation of scombrotoxin may not be sufficient temperature at receiving critical limit be
to prevent fish from suffering quality or shelf-life included in the sample;
degradation (i.e., decomposition) in a way that
may otherwise render it adulterated under the • When the sensory critical limit has not been
Federal Food, Drug, and Cosmetic Act; met, it is now recommended that the processor
perform histamine analysis of a minimum of 60
• The lower anterior portion of the loin is now fish, collected representatively from throughout
identified as the best place to collect a sample the lot, including all fish in the lot that show
from large fish for histamine analysis; evidence of decomposition, and reject the lot
if any fish are found with a histamine level
• Fermenting, pickling, smoking, and drying are greater than or equal to 50 ppm;
now identified as likely critical control points
(CCPs) for this hazard; • Subdividing and retesting for histamine is no
longer recommended after an initial failed
• When fish are checked for internal temperature histamine test;
at off-loading, it is now recommended that:
• It is now recommended that employees who
o For fish held iced or refrigerated (not frozen) conduct sensory screening receive adequate
onboard the vessel and off-loaded from the training;
vessel by the processor 24 or more hours
after death, the internal temperature should • It is now recommended that for shipments
be 40°F (4.4°C) or below, of scombrotoxin-forming species received
under ice on open-bed trucks be checked for
OR both sufficiency of ice and internal product
temperature;

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition
G - 11 (August 2019)
• It is now recommended that shipments of an assumption that worst-case temperatures
scombrotoxin-forming species received under (e.g., in excess of 70°F (21.1°C)) may occur;
gel packs be checked for both adequacy of gel
packs and internal product temperature; • Chemical coolants (e.g., gel packs) are no
longer recommended for control of temperature
• It is now recommended that if only the internal during in-plant storage;
temperature of fish is checked at receipt by a
secondary processor because the transit time • For control of time and temperature during
is no more than 4 hours, calculation of transit refrigerated storage, it is now noted that
time should include all time outside a controlled critical limits that specify a cumulative time
temperature environment; and temperature of exposure to temperatures
above 40°F (4.4°C) are not ordinarily suitable
• It is now recommended that if only the internal because of the difficulty in determining when
temperature of fish is checked at receipt by a specific products have entered and left the
secondary processor because the transit time is cooler and the time and temperature exposures
no more than 4 hours, a temperature-indicating to which they were subjected. However, there
device (e.g., a thermometer) should be used may be circumstances where this approach is
to determine internal product temperatures in suitable. It is also noted that minor variations
a minimum of 12 fish, unless there are fewer in cooler temperature measurements can be
than 12 fish in a lot, in which case all of the avoided by submerging the sensor for the
fish should be measured; temperature-recording device in a liquid that
mimics the characteristics of the product;
• When checks of the sufficiency of ice or chemical
cooling media, such as gel packs, or internal • High-temperature alarms are no longer
product temperatures are used at receipt of fish recommended for monitoring temperatures in
from another processor, it is now recommended coolers or processing areas;
that the number of containers examined and
the number of containers in the lot be recorded; • When the adequacy of ice is established as the
critical limit for refrigerated storage, it is now
• Control of scombrotoxin (histamine) formation recommended that monitoring be performed
during processing and storage are now provided with sufficient frequency to ensure control
as separate control strategy examples, and rather than at least twice per day.
examples of HACCP plans are now provided
for both strategies; Chapter 8 related to other decomposition-related
hazards has been modified with the following
• The extended exposure times during processing
(more than 12 hours, cumulatively, if any recommendations as of April 2011:
portion of that time is at temperatures above
• It is now noted that FDA has received consumer
70°F (21.1°C); or more than 24 hours,
complaints concerning illnesses associated
cumulatively, as long as no portion of that
with the consumption of decomposed salmon,
time is at temperatures above 70°F (21.1°C))
attributable to the production in the fish of
previously recommended for fish that have been
toxins other than histamine (e.g., biogenic
previously frozen are now also recommended
amines, such as putrescine and cadaverine);
for fish that have been previously heat treated
sufficiently to destroy scombrotoxin-forming • It is now noted that there are also some
bacteria and are subsequently handled in a indications that chemicals formed when fats
manner where there is an opportunity for and oils in foods oxidize may contribute to
recontamination with scombrotoxin-forming long-term detrimental health effects.
bacteria;
Chapter 9 for the control of environmental chemical
• It is now acknowledged that it may be possible
to control scombrotoxin formation during contaminants and pesticides has been modified
unrefrigerated processing using a critical with the following recommendations as of April
limit that is time of exposure only (i.e., no 2011:
temperature component), if it is developed with

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition
G - 12 (August 2019)
• Toxic element guidance levels for arsenic, • Aquaflor® CA1 is now listed as an approved
cadmium, lead, and nickel are no longer listed; drug for catfish or in fingerling to food fish as
the sole ration for 10 consecutive days.
• Tolerance levels for endothall and its
monomethyl ester in fish and carbaryl in oysters • 35% PEROX-AID® (hydrogen peroxide) is now
are now listed; listed as an approved drug for freshwater-reared
salmonids and freshwater-reared cool water
• The collection of soil samples from aquaculture finfish and channel catfish;
production sites is no longer listed as a
preventive measure; • Terramycin® 200 for Fish (oxytetracycline
dihydrate) Type C, is now listed as an approved
• An example of a HACCP plan is now provided for drug for catfish, salmonids; and lobster;
control of environmental chemical contaminants
in molluscan shellfish; • OxyMarine, Oxytetracycline HCl Soluble
Powder-343, Terramycin-343, TETROXY Aquatic
• When testing for environmental chemical is now listed as an approved drug for all finfish
contaminants and pesticides is used as the fry and fingerlings as an aid in identification;
control measure, it is now recommended that
the adequacy of the testing methods and • Quarterly raw material, in-process, or finished
equipment be verified periodically (e.g., by product testing is now recommended as a
comparing results with those obtained using verification step for control strategies involving
an Association of Official Analytical Chemists review of suppliers’ certificates at receipt of
(AOAC) or equivalent method, or by analyzing raw materials, review of records of drug use
proficiency samples). at receipt of raw materials, and on-farm visits;

Chapter 10, which covers the control of methy- • When testing for aquaculture drugs is used as
lmercury, has been rewritten to acknowledge the control measure, it is now recommended
that the adequacy of the testing methods and
that FDA is receiving comments on a draft equipment be verified periodically (e.g., by
quantitative risk assessment for methylmercury, comparing results with those obtained using an
which may result in a reassessment of its risk AOAC or equivalent method, or by analyzing
management strategies has been modified with proficiency samples).
the following recommendations as of April 2011:
Chapter 12 for the control of pathogenic bacteria
• No modifications made at this time. growth and toxin formation (other than C.
botulinum) as a result of time and temperature
Chapter 11 for the control of aquaculture abuse has been modified with the following
drugs has been modified with the following recommendations as of April 2011:
recommendations as of April 2011:
• It is now recognized that V. vulnificus, V.
• The potential for this hazard to occur during parahaemolyticus, and Vibrio cholarae non-O1
transportation of live fish is now recognized, and non-0139 are generally associated with
and recommended controls are provided; marine and estuarine species of fish and may
not be reasonably likely to occur in freshwater
• An explanation of extra-label use of drugs is species or non-fishery ingredients, unless they
now provided, and a list of drugs prohibited for have been cross-contaminated;
extra-label use is now listed;
• It is now clarified that products that are partially
• FDA high enforcement priority aquaculture cooked to set the batter or breading or stabilize
drugs are now listed; the product shape (e.g., fish balls, shrimp
egg rolls, and breaded fish portions) are not
• Aquaflor® Type A Medicated Article (florfenicol) considered to be ready to eat;
is now listed as an approved drug for catfish
and salmonids; • Information is now provided on the deter-
mination of CCPs for products that are a

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition
G - 13 (August 2019)
combination of raw, ready-to-eat and cooked, • When checks of the sufficiency of ice or chemical
ready-to-eat fishery ingredients; cooling media, such as gel packs, or internal
product temperatures are used at receipt of fish
• Control of time and temperature abuse at from another processor, it is now recommended
receipt, during cooling after cooking, during that the number of containers examined and
unrefrigerated processing, and during refrig- the number of containers in the lot be recorded;
erated storage and processing are now provided
as four separate control strategy examples. • Chemical coolants (e.g., gel packs) are no
Examples of HACCP plans are now provided longer recommended for control of temperature
for all four strategies; during in-plant storage;

• For control of transit conditions at receipt of • Recommended cumulative exposure times and
ready-to-eat fish or fishery products delivered temperatures (i.e., critical limits) are now listed
refrigerated (not frozen), it is now recommended as follows:
that all lots be accompanied by transportation
records that show that the fish were held at or For raw, ready-to-eat products:
below an ambient or internal temperature of
40°F (4.4°C) throughout transit or, for transit o If at any time the product is held at
times of 4 hours or less, that the internal internal temperatures above 70°F (21.1°C),
temperature of the fish at time of receipt was exposure time (i.e., time at internal tem-
at or below 40°F (4.4°C); peratures above 50°F (10°C) but below
135ºF (57.2ºC)) should be limited to 2
• For control of time and temperature during hours (3 hours if Staphylococcus aureus (S.
refrigerated storage and refrigerated processing, aureus) is the only pathogen of concern),
it is now noted that critical limits that specify a
cumulative time and temperature of exposure OR
to temperatures above 40°F (4.4°C) are not
o Alternatively, exposure time (i.e., time at
ordinarily suitable because of the difficulty
internal temperatures above 50°F (10°C)
in determining when specific products have
but below 135ºF (57.2ºC)) should be limited
entered and left the cooler and the time
to 4 hours, as long as no more than 2 of
and temperature exposures to which they
those hours are between 70°F (21.1°C) and
were subjected. However, there may be
135ºF (57.2ºC),
circumstances where this approach is suitable.
It is also noted that minor variations in cooler OR
temperature measurements can be avoided by
submerging the sensor for the temperature- o If the product is held at internal tem-
recording device in a liquid that mimics the peratures above 50°F (10°C), but never
characteristics of the product; above 70°F (21.1°C), exposure time at
internal temperatures above 50°F (10°C)
• It is now recommended that if only the internal should be limited to 5 hours (12 hours if S.
temperature of the fishery product is checked aureus is the only pathogen of concern),
at receipt, because the transit time is no more
than 4 hours, calculation of transit time should OR
include all time outside a controlled temperature
environment; o The product is held at internal temperatures
below 50°F (10°C),
• It is now recommended that if only the internal
temperature of product is checked at receipt OR
by a secondary processor because the transit
time is no more than 4 hours, a temperature- o Alternatively, the product is held at ambient
indicating device (e.g., a thermometer) air temperatures below 50°F (10°C)
should be used to determine internal product throughout processing;
temperatures in a minimum of 12 containers
(e.g., cartons and totes), unless there are fewer For cooked, ready-to-eat products:
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
G - 14 (August 2019)
o If at any time the product is held at • High-temperature alarms are no longer recom-
internal temperatures above 80°F (27.2°C), mended for monitoring temperatures in coolers
exposure time (i.e., time at internal tem- or processing areas;
peratures above 50°F (10°C) but below
135ºF (57.2ºC)) should be limited to 1 hour • When the adequacy of ice is established as the
(3 hours if S. aureus is the only pathogen critical limit for refrigerated storage, it is now
of concern), recommended that monitoring be performed
with sufficient frequency to ensure control
OR rather than at least twice per day;

o Alternatively, if at any time the product is • It is now recommended that monitoring ship-
held at internal temperatures above 80°F ments received under gel packs include both
(26.7°C), exposure time (i.e., time at adequacy of gel packs and internal product
internal temperatures above 50°F (10°C) temperature.
but below 135ºF (57.2ºC)) should be limited
to 4 hours, as long as no more than 1 of Chapter 13 for the control of C. botulinum toxin
those hours is above 70°F (21.1°C), formation has been modified with the following
OR recommendations as of April 2011:

o If at any time the product is held at internal • Information is now provided on Time-Tem-
temperatures above 70°F (21.1°C), but perature Indicator (TTI) performance and
never above 80°F (26.7°C), exposure time suitability;
at internal temperatures above 50°F (10°C)
• A control strategy is now provided for application
should be limited to 2 hours (3 hours if S.
of TTIs on each of the smallest package units
aureus is the only pathogen of concern),
(i.e., the unit of packaging that will not be
OR distributed any further, usually consumer or
end-user package), where refrigeration is the
o Alternatively, if the product is never held at sole barrier to prevent toxin formation;
internal temperatures above 80°F (26.7°C),
exposure times at internal temperatures • It is no longer recommended that consideration
above 50°F (10°C) should be limited to 4 be given to whether the finished product will be
hours, as long as no more than 2 of those stored and distributed frozen when determining
hours are above 70°F (21.1°C), whether the hazard is significant. A control
strategy is now provided to ensure that frozen
OR products are properly labeled when freezing
is the sole barrier to prevent toxin formation;
o If the product is held at internal tem-
peratures above 50°F (10°C), but never • Processors are now advised to take particular
above 70°F (21.1°C), exposure time at care in determining the safety of a packaging
internal temperatures above 50°F (10°C) material for a product in which (1) the spoilage
should be limited to 5 hours (12 hours if S. organisms have been eliminated or significantly
aureus is the only pathogen of concern), reduced by such processes as high-pressure
processing and (2) refrigeration is the sole
OR barrier to toxin formation. The generally recom-
mended 10,000 cc/m2/24 hours at 24ºC oxygen
o The product is held at internal temperatures transmission rates may not be suitable in this
below 50°F (10°C), case;

OR • High-temperature alarms are no longer recom-


mended for monitoring temperatures in coolers
o Alternatively, the product is held at ambient or processing areas;
air temperatures below 50°F (10°C)
throughout processing; • Chemical coolants (e.g., gel packs) are no
longer recommended for control of temperature
during in-plant storage;

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition
G - 15 (August 2019)
• When the adequacy of ice is established as the be stored and distributed frozen (in the case
critical limit for refrigerated storage, it is now of reduced oxygen packaged products) or
recommended that monitoring be performed refrigerated (in the case of aerobically packaged
with sufficient frequency to ensure control products) when determining whether the hazard
rather than at least twice per day; is significant. A control strategy to ensure that
refrigerated dried products are properly labeled
• It is now recommended that a water phase when refrigeration is the sole barrier to toxin
salt level of 20% be achieved in shelf-stable, formation is now provided. A control strategy
reduced oxygen packaged products in which to ensure that frozen products are properly
salt is the only barrier to pathogenic bacteria labeled when freezing is the sole barrier to
growth and toxin formation; toxin formation is now provided in Chapter 13.

• It is now recommended that monitoring ship- Chapter 15 for the control of S. aureus toxin
ments received under gel packs include both
adequacy of gel packs and internal product
formation in hydrated batter mixes has been
temperature; modified with the following recommendations
as of April 2011:
• It is now recommended that if only the internal
temperature of the fishery product is checked • The number of S. aureus organisms normally
at receipt, because the transit time is no more needed to produce toxin is now listed as
than 4 hours, calculation of transit time should 500,000 to 1,000,000 per gram;
include all time outside a controlled temperature
environment; • High-temperature alarms are no longer
recom-mended for monitoring temperatures
• It is now recommended that if only the internal in processing areas.
temperature of product is checked at receipt
by a secondary processor because the transit Chapter 16 for the control of pathogenic bacteria
time is no more than 4 hours, a temperature- survival through cooking has been modified with
indicating device (e.g., a thermometer) the following recommendations as of April 2011:
should be used to determine internal product
temperatures in a minimum of 12 containers • The separate chapters that previously covered
(e.g., cartons and totes), unless there are fewer pathogen survival through cooking and path-
than 12 containers in a lot, in which case all of ogen survival through pasteurization are now
the containers should be measured; combined;
• A control strategy example is now provided for • Pasteurization is now defined as a heat treat-
receipt by a secondary processor of refrigerated ment applied to eliminate the most resistant
reduced oxygen packaged products that may pathogen of public health concern that is
be stored and further distributed or used as an reasonably likely to be present in food;
ingredient for further processing;
• Information is now provided for an option to
• It is now clarified that brining time should be monitor End-Point Internal Product Temperature,
monitored during the processing of smoked fish; instead of continuous time and temperature
monitoring during cooking or pasteurization,
• It is now recommended that brine be treated when a scientific study has been conducted to
to minimize microbial contamination or be validate that it will provide a 6D process for
periodically replaced as a good manufacturing the target pathogen;
practice control.
• For surimi-based products, soups, or sauces,
Chapter 14 for the control of pathogenic bacteria the following pasteurization process is now
growth and toxin formation as a result of recommended: a minimum cumulative, total
inadequate drying has been modified with the lethality of F194°F (F90°C) = 10 minutes, where z =
following recommendations as of April 2011: 12.6°F (7°C) for temperatures less than 194°F
(90°C), and z = 18°F (10°C) for temperatures
• It is no longer recommended that consideration above 194°F (90°C);
be given to whether the finished product will

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition
G - 16 (August 2019)
• For Dungeness crabmeat, the following pas- • The language regarding allergen sanitation
teurization process is now recommended: a and cleaning has been enhanced.
minimum cumulative total lethality of F194°F
(F90°C) = 57 minutes, where z = 15.5°F (8.6°C); • The examples have been consolidated for
relevance.
• Information concerning levels of Listeria
monocytogenes (L. monocytogenes) in foods
• Unnecessary examples have been removed.
is now updated based on the final FDA/U.S.
Department of Agriculture L. monocytogenes
risk assessment. • “Prohibited additives” has been removed
from the title and chapter since they are
Chapter 17 is a new chapter that contains guidance prohibited.
for the control of pathogen survival through
• Label review for the appropriate identification
processes designed to retain raw product char- of the allergen and being applied to the
acteristics, including high hydrostatic pres-sure appropriate product has been added.
processing, mild heat processing, IQF with
extended frozen storage, and irradiation. At • CFR and other regulatory references have
present, the chapter applies exclusively to the been removed.
processing of molluscan shellfish products for
which there is a desire to retain raw product Chapter 20 for the control of metal inclusion has been
characteristics. However, these technologies modified with the following recommendations
may have other applications as well has been as of April 2011:
modified with the following recommendations • Foreign objects less than 0.3 inch (7 mm) are
as of April 2011: now identified as having a potential for causing
trauma or serious injury to persons in special
• No modifications made at this time. risk groups, such as infants, surgery patients,
and the elderly;
Chapter 18 for the control of the introduction of
pathogenic bacteria after pasteurization and • Additional information on calibration and vali-
specialized cooking processes has been modified dation of electronic metal detectors is now
provided;
with the following recommendations as of April
2011: • Wire mesh baskets are no longer used as
an example of an unlikely source of metal
• It is no longer recommended that consideration fragments;
be given to whether the finished product will be
stored and distributed frozen when determining • The recommended critical limit for the metal
whether the hazard is significant. A control detection or separation control strategy has
strategy to ensure that frozen products are been expanded to read, “All product passes
properly labeled when freezing is the sole through an operating metal detection or
barrier to prevent C. botulinum toxin formation separation device,” and “No detectable metal
is now provided in Chapter 13. fragments in a product passing through the
metal detection or separation device.” As a
Chapter 19 for the control of undeclared food result, the recommended monitoring procedures
allergens and intolerance substances has been are also expanded so that they now are designed
modified with the following recommendations to also ensure that the processes are in place
and operating;
as of August 2019:
• It is now recommended that when metal
• The language regarding allergen cross-
contact has been enhanced. 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.

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition
G - 17 (August 2019)
Chapter 21 for the control of glass inclusion has been Appendix 3: “Critical Control Point Decision
modified with the following recommendations Tree” has been modified with the following
as of April 2011: recommendations as of April 2011:
• This chapter is no longer identified as a draft; • No modifications made at this time.

• The use of x-ray detection devices is no Appendix 4: “Bacterial Pathogen Growth and
longer recommended as a reliable method for Inactivation,” has been modified with the
controlling glass inclusion;
following recommendations as of April 2011:
• The recommended critical limit for the glass
container cleaning and visual inspection • Recommended summary cumulative exposure
control strategy has been expanded to read, times and temperatures are now listed as
“All container pass through an operating glass described above for Chapter 12;
container inspection or cleaning process,”
• The maximum water phase salt level for growth
and “No detectable glass fragments in glass
of Campylobacter jejuni is now listed as 1.7%;
containers passing the CCP.” As a result, the
recommended monitoring procedures are also • The maximum level of acidity (pH) for growth
expanded so that they now are designed to of pathogenic strains of Escherichia coli (E. coli)
also ensure that the processes are in place is now listed as 10;
and operating;
• The maximum recommended cumulative
• The monitoring procedures for the glass exposure times for Bacillus cereus are now listed
container cleaning and visual inspection control as follows: 5 days at temperatures of 39.2 to
strategy now include a recommendation that 43°F (4 to 6°C); 1 day at temperatures of 44
a representative sample of the cleaned or to 59°F (7 to 15°C); 6 hours at temperatures
inspected containers be examined at the start of 60 to 70°F (16 to 21°C); and 3 hours at
of processing, every 4 hours during processing, temperatures above 70°F (21°C);
at the end of processing, and after any
breakdowns; • The maximum cumulative exposure times for
E. coli, Salmonella, and Shigella spp. are now
• It is now recommended that monitoring for listed as follows: 2 days for temperatures from
the presence of glass be performed at the their minimum growth temperature 41.4 to 50°F
start of each production day and after each (10°C); 5 hours for temperatures of 51 to 70°F
shift change. (11 to 21°C); and 2 hours for temperatures
above 70°F (21°C);
• It is now recommended that a representative
sample of cleaned or inspected glass containers • The maximum cumulative exposure times
be examined daily, at the start of processing, for Listeria monocytogenes are now listed as
every 4 hours during processing, at the end of follows: 7 days for temperatures of 31.3 to
processing, and after any breakdowns. 41ºF (-0.4 to 5ºC); 1 day for temperatures of 42
to 50°F (6 to 10°C); 7 hours for temperatures
Appendix 1: “Forms” has been modified with the of 51 to 70°F (11 to 21°C); 3 hours for
following recommendations as of April 2011: temperatures of 71 to 86°F (22 to 30°C); and
1 hour for temperatures above 86°F (30°C);
• No modifications made at this time.
• The maximum cumulative exposure times
Appendix 2: “Sample Product Flow Diagram” for Vibrio cholerae, V. vulnificus, and V.
has been modified with the following parahaemolyticus are now listed as follows:
recommendations as of April 2011: 21 days for temperatures from their minimum
growth temperature to 50°F (10°C); 6 hours
• No modifications made at this time. 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

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition
G - 18 (August 2019)
80°F (26.7°C), with the last temperature range o Vibrio cholerae for all fish other than raw
applying only to cooked, ready-to-eat products. molluscan shellfish – toxigenic has been
added in front of organism;
Appendix 5: Table A-5, “FDA and EPA Safety Levels in
Regulations and Guidance,” has been modified o Vibrio cholerae for raw molluscan shellfish
– the sample size and serotype has been
with the following recommendations as of removed;
August 2019:
o Vibrio parahaemolyticus for raw molluscan
• Refer to Appendix 5 for the specific changes shellfish – Kanagawa positive or negative
to the values and applicable fish and fishery has been removed;
products.
o Vibrio vulnificus for raw molluscan shellfish
• The introduction has been modified to include has been removed.
information regarding US FDA reserving the
right to take action with or without levels being • Chemical Safety Levels – The following were
listed in this guidance document. added/modified/removed:

• References have been added back into the table. o 2,4-D has been modified;

• Appendix has been reorganized into food o Bispyribac-sodium has been added;
hazards categories (Animal Drugs, Biological,
Chemical, Natural Toxins, and Physical). o Carbaryl has been modified;

• The applicable sign for “greater than” or o Carfentrazone-ethyl has been added;
“greater than and equal to” has been added
to the individual levels. o Diquat has been modified;

• Animal drugs - The following changes have o Ethoxyquin has been added;
been made:
o Flumioxazin has been added;
o Azamethiphos has been added;
o Fluzapyroxad has been added;
o Benzocaine has been added;
o Florpyrauxifen-benzyl has been added;
o Chloramine-T (para-toluenesulfonamide-
o Imazapyr has been added;
marker residue) has been added;
o Penoxsulam has been added;
o Florfenicol (florfenicol amine-the marker
residue) has been added; o Saflufenacil has been added;
o Lufenuron has been added; o Simazine and its metabolites has been
removed;
o Oxytetracycline has been modified and
expanded to include sum of tetracycline o Spinosad has been added;
residues;
o Triclopyrand (its metabolites and deg-
o Telfubenzuron has been added. radates) has been added;
• Biologicals – The following changes have been o Topramexone has been added.
made:
• Natural Toxins – The values and labels have been
o Staphylococcus aureus: levels indicative added/updated/modified for appropriateness:
to insanitary conditions has been added;
o Azaspiracid (Azaspiracid shellfish poisoning)
o Vibrio spp. has been added; has been added to the appendix;

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition
G - 19 (August 2019)
o Brevetoxin (Neurotoxic shellfish poisoning) Appendix 8: “Procedures for Safe and Sanitary
label has been changed from ppm to mg/kg; Processing and Importing of Fish and Fishery
o Ciguatoxin (Ciguatera fish poisoning) label Products” has been modified with the following
has been changed from ppb to µg/kg; recommendations as of August 2019:
o Domoic acid (Amnesic shellfish poisoning) • Part 123 has been updated to include 21 CFR
label has been changed from ppm to mg/kg; Part 117.

o Okadaic acid (Diarrhetic shellfish poisoning) • Part 1240 has been updated to include “d.”
label has been changed from ppm to mg/kg;
Appendix 9 – “Allergen Cleaning and Sanitation”
o Saxitoxin (Paralytic shellfish poisoning) label
has been modified with the following recom-
has been changed from ppm to mg/kg.
mendations as of August 2019:
• Footnotes – The following changes have been
made: • New appendix with recommendations for est-
ablishing an allergen cleaning and sanitation
o Footnotes 3 – 9 have been added; program has been added.

o Footnote 10: Appendix 10 – “Allergen Cross-Contact Prevention”


has been modified with the following recom-
• The “Note” has been changed to footnote
10; mendations as of August 2019:

• The text has been modified to become • New appendix with recommendations for est-
more inclusive of fish and fishery pro- ablishing controls to prevent cross-contact in
ducts, and a facility has been added.

• The footnote has been applied to the


table as deemed appropriate.

o Footnote 11 – 13 have been added.

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 has been modified with the
following recommendations as of April 2011:
• No modifications made at this time.

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 has been
modified with the following recommendations
as of April 2011:
• No modifications made at this time.

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition
G - 20 (August 2019)
NOTES:

Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition
G - 21 (August 2019)
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 Copies of the training document may be
Administration’s (FDA’s) “Fish and Fishery Products purchased from:
Hazards and Controls Guidance.” This guidance
Florida Sea Grant
relates to FDA’s Fish and Fishery Products
IFAS - Extension Bookstore
regulation (called the Seafood HACCP Regulation,
University of Florida
21 CFR 123, in this guidance document) and the
P.O. Box 110011
Control of Communicable Diseases regulation,
Gainesville, FL 32611-0011
21 CFR 1240, that require processors of fish
(800) 226-1764
and fishery products to develop and implement
HACCP systems for their operations. Those final Or
regulations were published in the Federal Register www.ifasbooks.com
on December 18, 1995, and became effective on
December 18, 1997. The codified portion of the Or you may download a copy from:
regulations is included in Appendix 8. http://www.fda.gov/FoodGuidances
This guidance is being issued as a companion
document to “HACCP: Hazard Analysis Critical
Control Point Training Curriculum,” which was
developed by the Seafood HACCP Alliance
for Training and Education. The Alliance is an
organization of federal and state regulators,
including FDA, academia, and the seafood
industry. FDA recommends that processors of
fish and fishery products use the two documents
together in the development of a HACCP system.
This guidance document will be maintained on
the FDA.GOV website, which should be consulted
for subsequent updates.

CHAPTER 1: General Information

19
NOTES:

CHAPTER 1: General Information

20

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

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 THE HAZARD ANALYSIS WORKSHEET

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

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

21
THE STEPS PRELIMINARY STEPS

Following is a list of the steps that this guidance STEP 1: Provide general information.
uses in HACCP plan development:
Record the name and address of your processing
• Preliminary Steps facility in the spaces provided on the first page
° Provide general information; of both the Hazard Analysis Worksheet and the
° Describe the food; HACCP Plan Form (Appendix 1).
° Describe the method of distribution and
STEP 2: Describe the food.
storage;

° Identify the intended use and consumer;


Identify the market name or Latin name (species)
° Develop a flow diagram. of the fishery component(s) of the product.

• Hazard Analysis Worksheet Examples:


° Set up the Hazard Analysis Worksheet; • Tuna (Thunnus albacares);
• Shrimp (Pandals spp.);
° Identify potential species-related hazards;
• Jack mackerel (Trachurus spp.).
° Identify potential process-related hazards;
° Understand the potential hazard; Fully describe the finished product food.

° Determine whether the potential hazard Examples:


is significant;
• Individually quick frozen, cooked, peeled
° Identify critical control points.
shrimp;

• HACCP Plan Form • Fresh tuna steaks;


• Frozen, surimi-based, imitation king crab
° Set up the HACCP Plan Form; legs;
° Set critical limits;
• Fresh, raw drum, in-the-round;
° Establish monitoring procedures:
• Raw shrimp, in-shell;
• What,
• Raw, shucked clams;
• How,
• Fresh seafood salad, with shrimp and blue
• Frequency,
crabmeat;
• Frozen, breaded pollock sticks;
• Who;

• Frozen crab cakes.


° Establish corrective action procedures;

Describe the packaging type.


° Establish a recordkeeping system;
Examples:
° Establish verification procedures.
• Vacuum-packaged plastic bag;
• Aluminum can;
• Bulk, in wax-coated paperboard box;
• Plastic container with snap lid.
Record this information in the space provided
on the first page of both the Hazard Analysis
Worksheet and the HACCP Plan Form.

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

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

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

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

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

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

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

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

STEP 13: Set critical limits. STEP 14: Establish monitoring procedures.
For each processing step where a significant For each processing step where a significant
hazard is identified on the HACCP Plan Form, hazard is identified on the HACCP Plan Form,
identify the maximum or minimum value to describe monitoring procedures that will ensure
which a parameter of the process must be that critical limits are consistently met (21 CFR
controlled in order to control the hazard. Each 123.6(c)(4)). The hazards and controls chapters
control strategy example provided in the hazards of this guidance document (Chapters 4 through
and controls chapters of this guidance (Chapters 7, 9, and 11 through 21) each contain a section,
4 through 7, 9, and 11 through 21) each contain “Establish Monitoring Procedures,” that provides
a section, “Set Critical Limits,” that provides information about appropriate monitoring
information about appropriate critical limits for procedures for each of the control strategy
each of the control strategy example(s) discussed. example(s) discussed.

You should set a critical limit at such a value that To fully describe your monitoring program, you
if it is not met, the safety of the product may be should answer four questions: (1) What will be
questionable. If you set a more restrictive critical monitored? (2) How will monitoring be done? (3)
limit, you could, as a result, be required to take How often will monitoring be done (frequency)?
corrective action when no safety concern actually and (4) Who will do the monitoring?
exists. On the other hand, if you set a critical It is important for you to keep in mind that the
limit that is too loose, you could, as a result, monitoring process should directly measure
allow an unsafe product to reach the consumer. the parameter for which you have established
As a practical matter, it may also be advisable a critical limit. The necessary frequency of
to set an operating limit that is more restrictive monitoring is dependent upon the circumstances.
than the critical limit. In this way, you can adjust Continuous monitoring is always desirable, and
the process when the operating limit is not in some cases necessary. In other cases, it may
not be necessary or practical. You should monitor

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

26
often enough that the normal variability in the through 21) each contain a section, “Establish
values you are measuring will be detected. This Corrective Action Procedures,” that provides
is especially true if these values are typically information about appropriate corrective action
close to the critical limit. Additionally, the greater procedures for each of the control strategy
the time span between measurements, the example(s) discussed. An appropriate corrective
more products you are putting at risk should a action procedure must accomplish two goals: (1)
measurement show a deviation from a critical ensure that an unsafe product does not reach
limit has occurred, because you should assume the consumer and (2) correct the problem that
that the critical limit had not been met since caused the critical limit deviation (21 CFR 123.7).
the last “good” value. Even with continuous If the corrective action involves testing the
monitoring, the paper or electronic record of the finished product, the limitations of the sampling
continuous monitoring should be periodically plan should be understood. Because of these
checked in order to determine whether limitations, microbiological testing is often not a
deviations from the critical limit have occurred. suitable corrective action. The Seafood HACCP
The frequency of that check should be at least Regulation requires that corrective actions be fully
daily, and more frequent if required in order to documented in records (21 CFR 123.7(d)). Note
implement an appropriate corrective action. that if a critical limit deviation occurs repeatedly,
the adequacy of that CCP for controlling the
Enter the “What,” “How,” “Frequency,” and “Who”
hazard should be reassessed. Remember that
monitoring information in Columns 4, 5, 6, and 7,
deviations from operating limits do not need to
respectively, of the HACCP Plan Form.
result in formal corrective actions.
STEP 15: Establish corrective action Enter the corrective action procedures in Column
procedures. 8 of the HACCP Plan Form.

A corrective action must be taken whenever there STEP 16: Establish a recordkeeping system.
is a deviation from a critical limit at a CCP (21
CFR 123.7((a)). For each processing step where For each processing step where a significant
a significant hazard is identified on the HACCP hazard is identified on the HACCP Plan Form, list
Plan Form, describe the procedures that you the records that will be used to document the
will use when your monitoring indicates that accomplishment of the monitoring procedures
the critical limit has not been met. Note that the discussed in Step 14 (21 CFR 123.9(a)(2)).
Seafood HACCP Regulation does not require The hazards and controls chapters of this
that you predetermine your corrective actions. guidance (Chapters 4 through 7, 9, and 11
You may instead elect to follow the prescribed through 21) each contain a section, “Establish
corrective action procedures listed at 21 CFR a Recordkeeping System,” that provides
123.7(c). However, a predetermined corrective information about appropriate records for each
action has the following advantages: (1) It of the control strategy example(s) discussed.
provides detailed instructions to the processing Records must document monitoring of the
employee that can be followed in the event of a CCP and shall contain the actual values and
critical limit deviation; (2) it can be prepared at a observations obtained during monitoring (21
time when an emergency situation is not calling CFR 123.6(b)(7)) The Seafood HACCP Regulation
for an immediate decision; and (3) it removes lists specific requirements about the content of
the obligation to reassess the HACCP plan in the records (21 CFR 123.9(a)).
response to a critical limit deviation. Enter the names of the HACCP monitoring
The hazards and controls chapters of this records in Column 9 of the HACCP Plan Form.
guidance (Chapters 4 through 7, 9, and 11

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

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

STEP 18: Complete the HACCP Plan Form.


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

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

28
CHAPTER 3: POTENTIAL SPECIES-RELATED
AND PROCESS-RELATED HAZARDS

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

• 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

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


3 - 1 (August 2019)
TABLE 3-1
THE EFFECT OF MISBRANDING THROUGH SPECIES SUBSTITUTION ON THE
IDENTIFICATION OF POTENTIAL SPECIES-RELATED HAZARDS
Actual Market Name Potential Species-Related Product Potential Species-Related
of Product. Hazards Associated with Inappropriately Hazards that would
the Actual Product. Labeled as: be Identified Based on
Inappropriate Species
(Table 3-2). Labeling.
(Table 3-2).
Gempylid Fish Poisoning:
Escolar Sea Bass Parasites
Scombrotoxin (Histamine)

Tetrodotoxin (Pufferfish
Poisoning);
Puffer Fish. Monkfish. Parasites.
Paralytic Shellfish Poisoning.

Parasites;

Spanish Mackerel Scombrotoxin (Histamine); Kingfish None

Ciguatera Fish Poisoning

Environmental Chemicals; Parasites;


Basa. Grouper.
Aquaculture Drugs. Ciguatera Fish Poisoning.

Parasites;
Grouper Cod Parasites
Ciguatera Fish Poisoning

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


3 - 2 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


AHOLEHOLE Kuhlia spp.
ALEWIFE or RIVER
Alosa pseudoharengus
HERRING
ALFONSINO Beryx spp.
ALFONSINO Centroberyx spp.

ALLIGATOR Alligator mississipiensis

ALLIGATOR Alligator sinensis

ALLIGATOR, aquacultured Alligator mississipiensis

ALLIGATOR, aquacultured Alligator sinensis

AMBERJACK Seriola dumerili CFP

AMBERJACK S. rivoliana CFP

AMBERJACK S. spp.

AMBERJACK or
Seriola lalandi
YELLOWTAIL
AMBERJACK or 4
Seriola lalandi
YELLOWTAIL, aquacultured
AMBERJACK or BURI,
Seriola quinqueradiata
aquacultured

ANCHOVY 12 . Anchoa spp. ASP 5

ANCHOVY. 12
Anchoviella spp. ASP 5

Cetengraulis
ANCHOVY. 12
ASP 5
mysticetus

ANCHOVY. 12
Engraulis spp. ASP 5

ANCHOVY. 12
Stolephorus spp. ASP 5

ANGELFISH Holacanthus spp.


ANGELFISH Pomacanthus spp.

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


3 - 3 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


ARGENTINE QUEENFISH Argentina elongata
Pleurogrammus
ATKA MACKEREL
monopterygius

BARRACUDA Sphyraena barracuda CFP

BARRACUDA S. jello CFP

BARRACUDA S. spp.

BARRAMUNDI Lates calcarifer

BARRAMUNDI,
Lates calcarifer
aquacultured

BASA or BOCOURTI Pangasius bocourti

BASA or BOCOURTI,
Pangasius bocourti
aquacultured

BASS Ambloplites spp.

BASS Micropterus spp.

BASS Morone spp.

BASS Stereolepis gigas

BASS Synagrops bellus

BASS, aquacultured Centropristis spp.

BASS, aquacultured Morone spp.

BASS, SEA Acanthistius brasilianus

BASS, SEA Centropristis spp.

BASS, SEA Dicentrarchus labrax

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


3 - 4 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11

BASS, SEA (cont.) Lateolabrax japonicus

BASS, SEA Paralabrax spp.

BASS, SEA Paranthias furcifer

BASS, SEA Polyprion americanus

BASS, SEA P. oxygeneios

BASS, SEA P. yanezi

BASS, SEA, aquacultured Dicentrarchus labrax

BATA Labeo bata

BIGEYE Priacanthus arenatus


BIGEYE Pristigenys alta

BLUEFISH Pomatomus saltatrix

BLUEGILL Lepomis macrochirus

Hyperoglyphe
BLUENOSE
antarctica

BOMBAY DUCK Harpadon nehereus

BONITO Cybiosarda elegans

BONITO Gymnosarda unicolor

BONITO Orcynopsis unicolor

BONITO Sarda spp.

BOWFIN and roe Amia calva

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


3 - 5 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


BREAM Abramis brama
BREAM Acanthopagrus spp.
BREAM Argyrops spp.
Gymnocranius
BREAM
grandoculis
BREAM Monotaxis spp.
BREAM Sparus aurata
BREAM Wattsia spp.

BREAM, aquacultured Abramis brama

BREAM or BOGUE Boops boops


BREAM, THREADFIN Nemipterus japonicus

BUFFALOFISH Ictiobus spp.

BULLHEAD Ameiurus spp.

BURBOT Lota lota

BUTTERFISH Odax pullus

BUTTERFISH Peprilus spp.

BUTTERFISH Pampus cinereus

Pseudoplatystoma
CAPARARI
tigrinum

CAPELIN and roe Mallotus villosus

CARP Barbonymus spp.

CARP Carassius carassius

CARP Cyprinus carpio

Hypophthalmichthys
CARP
molitrix

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


3 - 6 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11

CARP (cont.) H. nobilis

CARP, aquacultured Carassius carassius

CARP, aquacultured Cyprinus carpio

Hypophthalmichthys
CARP, aquacultured
molitrix

CARP, aquacultured H. nobilis.

CASCARUDO Callichthys callichthys

CATFISH Ameiurus catus

CATFISH Ictalurus spp.

CATFISH Pylodictis oliveris

CATFISH, aquacultured Ictalurus spp.

CHAR Salvelinus alpinus

CHAR, aquacultured Salvelinus alpinus

CHARACIN Leporinus obtusidens

CHARAL Chirostoma jordani


CHIMAERA Harriota raleighana
CHIMAERA Hydrolagus spp.
CHIRING Apocryptes bato

CHUB Coregonus kiyi

CHUB Kyphosus spp.

Semotilus
CHUB
atromaculatus

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


3 - 7 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11

CISCO or CHUB Coregonus alpenae

CISCO or CHUB C. reighardi

CISCO or CHUB C. zenithicus

CISCO or TULLIBEE Coregonus artedi

CLARIAS FISH or
Clarias spp.
WALKING CLARIAS FISH
CLARIAS FISH or
WALKING CLARIAS Clarias gariepinus x
FISH, or CLARESSE, Clarias macrocephalus
aquacultured
CLARIAS FISH or WALKING CLARIAS FISH, or
CLARESSE, aquacultured C. spp.

Heterobranchus
CLARIAS FISH or WALKING CLARIAS FISH, or
CLARESSE, aquacultured longifilis x Clarias
gariepinus

COBIA Rachycentron canadum

COBIA, aquacultured Rachycentron canadum

COD Arctogadus spp.

COD Boreogadus saida

COD Eleginus gracilis

COD Gadus spp.

COD or ALASKA COD Gadus macrocephalus

COD, MORID Lotella rhacina

COD, MORID Mora moro

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


3 - 8 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11

COD, MORID (cont.) Pseudophycis barbata

COD, MORID P. spp.

Platynematichthys
COROATA
notatus

CORVINA Cilus gilberti

Micropogonias
CORVINA
undulates

CRAPPIE Pomoxis spp.

CROAKER Argyrosomus spp.

CROAKER Bairdiella spp.

CROAKER Cheilotrema saturnum

CROAKER Genyonemus lineatus

CROAKER Micropogonias spp.

CROAKER Nebris microps

CROAKER Nibea spp.

CROAKER Odontoscion dentex

CROAKER Pachypops spp.

CROAKER Pachyurus spp.

CROAKER Paralonchurus spp.

CROAKER Plagioscion spp.

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


3 - 9 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11

CROAKER (cont.) Pseudotolithus spp.

CROAKER Pterotolithus spp.

CROAKER Roncador stearnsii

CROAKER Umbrina roncador

CROAKER or CORVINA Cynoscion spp.

CROAKER or SHADEFISH Argyrosomus regius

CROAKER or YELLOWFISH Larimichthys polyactis

CURIMBATA or GURAMATA Prochilodus lineatus


CUSK Brosme brosme
CUSK-EEL Brotula clarkae
CUSK-EEL Lepophidium spp.
CUTLASSFISH Aphanopus carbo
CUTLASSFISH Lepidopus caudatus
CUTLASSFISH Trichiurus spp.

DACE Rhinichthys spp.

DACE, aquacultured Rhinichthys spp.

DORAB Chirocentrus dorab


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

DRUM Collichthys spp.

DRUM Equetus punctatus

DRUM Larimus spp.

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


3 - 10 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11

DRUM (cont.) Pogonias cromis

DRUM Stellifer spp.

DRUM Totoaba macdonaldi

DRUM Umbrina coroides

DRUM or CUBBYU Pareques umbrosus

DRUM, FRESHWATER Aplodinotus grunniens

DRUM or MEAGRE Argyrosomus regius

DRUM or QUEENFISH Seriphus politus

DRUM or REDFISH Sciaenops ocellatus

DRUM or REDFISH,
Sciaenops ocellatus
aquacultured

EEL Anguilla anguilla IHT


EEL A. spp.

EEL, aquacultured Anguilla anguilla IHT

EEL, aquacultured A. australis

EEL, aquacultured A. dieffenbachii

EEL, aquacultured A. japonica

EEL, CONGER Ariosoma balearicum

EEL, CONGER Conger conger IHT

EEL, CONGER Conger spp.

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


3 - 11 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11

EEL, CONGER (cont.) Gnathophis cinctus

Paraconger
EEL, CONGER
caudilimbatus

EEL, CONGER Rhynchoconger spp.

EEL, FRESHWATER Anguilla rostrata

EEL, FRESHWATER,
Anguilla rostrata
aquacultured
EEL, MORAY Gymnothorax funebris CFP
EEL, MORAY Lycodontis javanicus CFP
EEL, MORAY Muraena helena IHT
EEL, MORAY Muraena retifera CFP
EEL, SPINY Notacanthus chemnitzii
EELPOUT Zoarces americanus

EELPOUT Z. viviparus

ELEPHANT FISH Callorhynchus millii


EMPEROR Lethrinus spp. CFP
Lepidocybium
ESCOLAR or OILFISH GFP
flavobrunneum

ESCOLAR or OILFISH Ruvettus pretiosus GFP

FEATHERBACK Notopterus notopterus


FLATHEAD Platycephalus conatus
FLATWHISKERED FISH Pinirampus pirinampu

FLOUNDER 15 . Ancylopsetta dilecta 1

FLOUNDER. 15
Arnoglossus scapha 1

FLOUNDER. 15
Bothus spp. 1

FLOUNDER. 15
Chascanopsetta 1
crumenalis

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


3 - 12 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


FLOUNDER .
15
(cont.) Cleisthenes pinetorum 1

FLOUNDER 15 . Colistium spp. 1

FLOUNDER 15 . Cyclopsetta chittendeni 1

FLOUNDER. 15
Hippoglossina oblonga 1

FLOUNDER. 15
Hippoglossoides 1
robustus
FLOUNDER. 15
Limanda ferruginea 1

FLOUNDER. 15
Liopsetta glacialis 1

FLOUNDER. 15
Microstomus achne 1

FLOUNDER. 15
Paralichthys albigutta 1

FLOUNDER. 15
P. olivaceus 1

FLOUNDER. 15
P. patagonicus 1

FLOUNDER. 15
P. squamilentus 1

FLOUNDER. 15
Pelotretis flavilatus 1

FLOUNDER. 15
Peltorhampus 1
novaezeelandiae
FLOUNDER. 15
Platichthys spp. 1

FLOUNDER. 15
Pseudorhombus spp. 1

FLOUNDER. 15
Reinhardtius 1
evermanni
FLOUNDER. 15
Rhombosolea spp. 1

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


3 - 13 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


FLOUNDER .
15
(cont.) Samariscus triocellatus 1

FLOUNDER 15 . Scophthalmus spp. 1

FLOUNDER 15, aquacultured


. Ancylopsetta dilecta 4

FLOUNDER. , aquacultured
15
Arnoglossus scapha 4

FLOUNDER. , aquacultured
15
Bothus spp. 4

FLOUNDER. , aquacultured
15
Chascanopsetta 4
crumenalis
FLOUNDER. , aquacultured
15
Cleisthenes pinetorum 4

FLOUNDER. , aquacultured
15
Colistium spp. 4

FLOUNDER. , aquacultured
15
Cyclopsetta chittendeni 4

FLOUNDER. , aquacultured
15
Hippoglossoides 4
robustus
FLOUNDER. , aquacultured
15
Limanda ferruginea 4

FLOUNDER. , aquacultured
15
Liopsetta glacialis 4

FLOUNDER. , aquacultured
15
Microstomus achne 4

FLOUNDER. , aquacultured
15
Paralichthys spp. 4

FLOUNDER. , aquacultured
15
Pelotretis flavilatus 4

FLOUNDER. , aquacultured
15
Peltorhampus 4
novaezeelandiae
FLOUNDER. , aquacultured
15
Pseudorhombus spp. 4

FLOUNDER. , aquacultured
15
Reinhardtius 4
evermanni

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


3 - 14 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


FLOUNDER. , 15
Rhombosolea spp. 4
aquacultured (cont.)
FLOUNDER 15, aquacultured Samariscus triocellatus
.
4

FLOUNDER 15, aquacultured


. Scophthalmus spp. 4

FLOUNDER or DAB Limanda limanda 1

FLOUNDER or DAB L. proboscidea 1

FLOUNDER or DAB L. punctatissima 7 1

FLOUNDER or FLUKE Paralichthys dentatus 1

FLOUNDER or FLUKE P. flesus 1

FLOUNDER or FLUKE P. lethostigma 1

FLOUNDER or FLUKE P. microps 1

FLOUNDER, ARROWTOOTH Atheresthes stomias 7 .

FLOUNDER OR Paralichthys
CALIFORNIA FLOUNDER californicus
FLYINGFISH and roe Cypselurus spp.
FLYINGFISH and roe Exocoetus spp.
FLYINGFISH and roe Fodiator acutus
FLYINGFISH and roe Hirundichthys spp.
FLYINGFISH and roe Oxyporhamphus
micropterus
FLYINGFISH and roe Parexocoetus
brachypterus
FLYINGFISH and roe Prognichthys gibbifrons
FROG Rana spp.

FROG, aquacultured Rana spp.

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


3 - 15 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


GAR Lepisosteus spp.

GEMFISH Epinnula magistralis


GEMFISH Nesiarchus nasutus
GEMFISH or BARRACOUTA Rexea solandri
GEMFISH or BARRACOUTA Thyrsites atun
GEMFISH or CABALLA Thyrsites lepidopoides
GILLIBACKER or Sciades parkeri 7
GILLEYBAKA or
WHISKERFISH 8 .

GOATFISH Mulloidichthys spp.


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

GREENBONE Odax pullus


GREENLAND TURBOT Reinhardtius
hippoglossoides
GREENLING Hexagrammos spp.
GRENADIER Coryphaenoides spp.
GRENADIER Lepidorhynchus
denticulatus
GRENADIER Macruronus spp.
GRENADIER Nezumia bairdii
GRENADIER Trachyrhynchus spp.
GROUPER Anyperodon spp.

GROUPER Caprodon schlegelii

GROUPER Cephalopholis argus CFP

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


3 - 16 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


GROUPER (cont.) C. miniata CFP

GROUPER C. spp. CFP

GROUPER Dermatolepis inermis CFP

GROUPER Diplectrum formosum

GROUPER Epinephelus CFP


fuscoguttatus
GROUPER E. lanceolatus CFP

GROUPER E. morio CFP

GROUPER E. spp. CFP

GROUPER Mycteroperca bonaci CFP

GROUPER M. spp. CFP

GROUPER M. venenosa CFP

GROUPER Variola louti CFP

GROUPER V. spp. CFP

GROUPER or CORAL Plectropomus spp. CFP


GROUPER
GROUPER or GAG Mycteroperca CFP
microlepis
GROUPER or HIND Epinephelus guttatus CFP

GROUPER or JEWFISH Epinephelus itajara CFP

GROUPER or SCAMP Mycteroperca phenax CFP

GRUNION Leuresthes tenuis

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


3 - 17 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


GRUNT Anisotremus
interruptus
GRUNT Conodon nobilis
GRUNT Haemulon spp.
GRUNT Orthopristis
chrysoptera
GRUNT Pomadasys crocro
GRUNT or CATALINA Anisotremus taeniatus
GRUNT or MARGATE Anisotremus
surinamensis
GRUNT or MARGATE Haemulon album
GRUNT or SWEETLIPS Plectorhinchus spp.
HADDOCK Melanogrammus
aeglefinus
HAKE Urophycis spp.
HALIBUT Hippoglossus spp.

HALIBUT, aquacultured Hippoglossus spp. 4

HAMLET, MUTTON Alphestes afer


HERRING .
12
Alosa spp.

HERRING. 12
Etrumeus teres

HERRING. 12
Harengula thrissina

HERRING. 12
Ilisha spp.

HERRING. 12
Opisthopterus tardoore

HERRING. 12
Pellona ditchela

HERRING or SEA HERRING Clupea spp.


or SILD 12 .

HERRING or SEA HERRING Clupea spp.


or SILD 12 roe .

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


3 - 18 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


HERRING, THREAD .
12
Opisthonema spp.

HIND Epinephelus CFP


adscensionis
HIND E. drummondhayi

HIND E. guttatus CFP

HOGFISH Lachnolaimus maximus CFP

HORSE MACKEREL or Trachurus trachurus


SCAD
JACK Carangoides CFP
bartholomaei
JACK Caranx ignobilis CFP

JACK C. latus CFP

JACK C. lugubris CFP

JACK C. melampygus CFP

JACK C. ruber CFP

JACK C. spp. CFP

JACK Oligoplites saurus CFP

JACK Selene spp.

JACK Urapsis secunda

JACK or BLUE RUNNER Caranx crysos CFP

JACK or CREVALLE Alectis indicus

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


3 - 19 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


JACK or RAINBOW Elagatis bipinnulata CFP
RUNNER
JACK or ROOSTERFISH Nematistius pectoralis

JACKSMELT or SILVERSIDE Antherinopsis ASP


californiensis
JOBFISH or SNAPPER Aphareus spp. CFP

JOBFISH or SNAPPER Aprion spp. CFP

JOBFISH or SNAPPER Pristipomoides spp. CFP

KAHAWAI Arripis spp.

KINGFISH 6 . Menticirrhus littoralis ASP


KINGFISH. 6
M. spp.
KINGKLIP Genypterus spp.
LADYFISH Elops spp.
LING Molva spp.
LING, MEDITERRANEAN Molva macrophthalma
LINGCOD Ophiodon elongatus
LIZARDFISH Synodus spp.
LOACH Somileptus gongota
LIONFISH Pterois miles CFP 14
LIONFISH P. volitans CFP 14
LUMPFISH roe Cyclopterus lumpus
MACKEREL Gasterochisma
melampus
MACKEREL Grammatorcynus spp.

MACKEREL Rastrelliger kanagurta

MACKEREL Scomber scombrus PSP

MACKEREL, ATKA Pleurogrammus


monopterygius

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


3 - 20 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


MACKEREL, CHUB Scomber spp.

MACKEREL, JACK Trachurus spp.

MACKEREL, SPANISH Scomberomorus spp.

MACKEREL, SPANISH or Scomberomorus regalis CFP


CERO
MACKEREL, SPANISH or Scomberomorus CFP
KING cavalla
MACKEREL, SPANISH or Scomberomorus CFP
NARROW-BARRED commerson
MAHI-MAHI Coryphaena spp.

MAHI-MAHI, aquacultured Coryphaena spp.

MARLIN Makaira spp.

MARLIN Tetrapturus spp.

MENHADEN Brevoortia partonus ASP

MENHADEN B. spp. 9 10

MENHADEN Ethmidium maculatum 9 10

MILKFISH Chanos chanos

MILKFISH, aquacultured Chanos chanos

MONKFISH Lophius spp.

MORWONG Aplodactylus arctidens


MORWONG Cheilodactylus spp.
MORWONG Goniistius spp.
MORWONG Nemadactylus spp.

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


3 - 21 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


MULLET Agonostomus
monticola
MULLET Aldrichetta forsteri

MULLET Crenimugil crenilabis

MULLET Mugil cephalus

MULLET M. curerna ASP

MULLET M. spp.

MULLET M. thoburni

MULLET Mullus spp.

MUSKELLUNGE Esox masquinongy

NILE PERCH Lates niloticus

NILE PERCH, aquacultured Lates niloticus

OPAH Lampris guttatus


OPALEYE Girella nigricans
OREO DORY .
12
Allocyttus niger
OREO DORY. 12
Neocyttus spp.
OREO DORY. 12
Pseudocyttus spp.
OSCAR Astronotus ocellatus

OSCAR, aquacultured Astronotus ocellatus

PACU Myleus pacu


PADDLEFISH and roe Polyodon spp.

PADDLEFISH and roe, Polyodon spp.


aquacultured

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


3 - 22 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


PANGASIUS, GIANT Pangasius gigas

PANGASIUS, GIANT P. sanitwongsei

PANGASIUS Pangasius micronemus


SHORTBARBEL
PARROTFISH Bolbometopon spp.
PARROTFISH Chlorurus gibbus CFP 2
PARROTFISH Scarus coeruleus CFP
PARROTFISH S. taeniopterus CFP
PARROTFISH Sparisoma CFP
chrysopterum
PARROTFISH S. viride CFP
PATAGONIAN TOOTHFISH Dissostichus
or CHILEAN SEABASS eleginoides
PERCH Hermosilla azurea

PERCH Perca fluviatilis

PERCH, LAKE or YELLOW Perca flavescens

PERCH, NILE Lates niloticus

PERCH, NILE, aquacultured Lates niloticus

PERCH, OCEAN or Sebastes spp.


ROCKFISH
PERCH, PILE Rhacochilus vacca

PERCH, SILVER Bairdiella chrysoura

PERCH, WHITE Morone americana

PICAREL Spicara maena

PICKEREL Esox spp.

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


3 - 23 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


PIKE Esox lucius

PILCHARD or SARDINE Sardina pilchardus

PILCHARD or SARDINE Sardinops spp. ASP 5

PIRAMUTABA or LAULAO Brachyplatystoma


FISH 8 . vaillantii
PLAICE Hippoglossoides
platessoides
PLAICE Pleuronectes platessa

PLAICE P. quadrituberculatus

POLLOCK Pollachius pollachius

POLLOCK P. virens

POLLOCK or WALLEYE Gadus


POLLOCK chalcogrammus 7
POMFRET Brama spp.
POMFRET Parastromateus spp.
POMFRET Taractes rubescens
POMPANO Alectis ciliaris CFP
POMPANO Parastromateus niger
POMPANO Trachinotus spp.
POMPANO, aquacultured Trachinotus carolinus

POMPANO or PERMIT Trachinotus kennedyi


POMPANO or PERMIT T. falcatus
POMPANO or POMPANITO Trachinotus rhodopus
PORGY Calamus spp. CFP
PORGY Chrysophrys auratus
PORGY Dentex spp.
PORGY Diplodus spp.
PORGY Lagodon rhomboides

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


3 - 24 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


PORGY (cont.) Pagrus spp.
PORGY Pterogymnus laniarus
PORGY Stenotomus caprinus
PORGY or SCUP Stenotomus chrysops
PUFFER FISH 8, 16 . Sphoeroides
maculatus 11**
PUFFER FISH 8,16 . S. nephelus 11* PFP
PUFFER FISH. 8,16
Takifugu rubripes 11*** PFP
PUFFER FISH 8, 16, . Takifugu rubripes 11*** PFP
aquacultured
RACEHORSE Congiopodus
leucopaecilus
RITA Rita rita
ROCKFISH Scorpaena cardinalis

ROCKFISH S. papillosus

ROCKFISH Sebastes spp.

ROCKLING Ciliata spp.


ROHU Labeo rohita

ROSEFISH Helicolenus
dactylopterus
ROUGHY Paratrachichthys trailli
ROUGHY, ORANGE .
12
Hoplostethus atlanticus
ROUGHY, SILVER Hoplostethus
mediterraneus
SABLEFISH Anoplopoma fimbria

SAILFISH Istiophorus platypterus

SALMON and roe, Oncorhynchus spp. 4


aquacultured
SALMON and roe, Salmo salar 4
aquacultured

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


3 - 25 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


SALMON and roe (WILD, Oncorhynchus spp.
FRESHWATER)
SALMON and roe (WILD, Salmo salar
FRESHWATER)
SALMON and roe, (WILD, Oncorhynchus spp.
OCEAN)
SALMON and roe, (WILD, Salmo salar
OCEAN)
SANDDAB Citharichthys sordidus

SANDPERCH Mugiloides chilensis


SANDPERCH Parapercis spp.
SARDINE .
12
Harengula clupeola ASP

SARDINE. 12
H. jaguana ASP

SARDINE. 12
H. spp.

SARDINE. 12
Sardinella spp.

SARDINE. 12
Sardinops sagax ASP

SAUGER Sander canadensis


SAURY Cololabis saira

SAURY Scomberesox saurus

SCAD Atule mate

SCAD Decapterus spp.

SCAD Selar
crumenophthalmus
SCAD Trachurus spp.

SCAD or HORSE Trachurus trachurus


MACKEREL

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


3 - 26 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


SCULPIN Hemitripterus
americanus
SCULPIN Myoxocephalus
polyacanthocephalus
SCULPIN Scorpaenichthys
marmoratus
SEA BREAM Archosargus
rhomboidalis
SEA BREAM Chrysophrys auratus
SEA BREAM Pagellus spp.
SEAROBIN Chelidonichthys spp.
SEAROBIN Peristedion miniatum
SEAROBIN Prionotus carolinus
SEAROBIN Pterygotrigla picta
SEATROUT Cynoscion spp.

SHAD Alosa spp. ASP 5

SHAD roe Alosa spp.

SHAD, GIZZARD Dorosoma spp.

SHAD, GIZZARD Nematoalosa vlaminghi

SHAD, HILSA Tenualosa ilisha

SHARK Carcharhinus spp.


SHARK Cetorhinus maximus
SHARK Galeocerdo cuvier
SHARK Galeorhinus spp.
SHARK Hexanchus griseus
SHARK Lamna ditropis
SHARK Negaprion brevirostris
SHARK Notorynchus
cepedianus
SHARK Prionace glauca
SHARK Sphyrna spp.

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


3 - 27 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


SHARK (cont.) Triaenodon obesus
SHARK Triakis semifasciata
SHARK, ANGEL Squatina spp.
SHARK, DOGFISH or CAPE Centrophorus spp.
SHARK
SHARK, DOGFISH or CAPE Mustelus spp.
SHARK
SHARK, DOGFISH or CAPE Scyliorhinus spp.
SHARK
SHARK, DOGFISH or CAPE Squalus spp.
SHARK
SHARK, MAKO Isurus spp.
SHARK or PORBEAGLE Lamna nasus
SHARK or SMOOTHHOUND Mustelus spp.
SHARK, THRESHER Alopias spp.
SHEEPHEAD Archosargus
probatocephalus
SHEEPHEAD Semicossyphus pulcher

SHINER Notropis spp.

SILVERSIDE Atherinopsis ASP


californiensis
SILVERSIDE A. spp.
SILVERSIDE Basilichthys australis

SILVERSIDE Membras marinica ASP


SILVERSIDE Menidia menidia

SKATE Amblyraja spp.

SKATE Bathyraja spp.

SKATE Leucoraja spp.

SKATE Malacoraja spp.

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


3 - 28 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


SKATE (cont.) Raja spp.

SKILLFISH Erilepis zonifer


SMELT Allosmerus elongatus

SMELT Argentina spp.

SMELT Hypomesus spp.

SMELT Osmerus spp.

SMELT Plecoglossus altivelis


altivelis
SMELT Retropinna retropinna

SMELT Spirinchus spp.

SMELT Thaleichthys pacificus

SNAKEHEAD Channa striata


SNAKEHEAD Parachanna obscura
SNAPPER Apsilus dentatus
SNAPPER Etelis spp.
SNAPPER Lutjanus bohar CFP
SNAPPER L. buccanella CFP
SNAPPER L. cyanopterus CFP
SNAPPER L. gibbus CFP
SNAPPER L. griseus CFP
SNAPPER L. jocu CFP
SNAPPER L. sebae CFP
SNAPPER Macolor spp.
SNAPPER Ocyurus chrysurus CFP 14
SNAPPER Pristipomoides spp. CFP

SNAPPER Rhomboplites
aurorubens

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


3 - 29 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


SNAPPER (cont.) Symphorichthys
spilurus
SNAPPER Symphorus CFP
nematophorus
SNAPPER or Letjenus apodus CFP
SCHOOLMASTER
SNOOK Centropomus spp.

SOLE or FLOUNDER Aseraggodes spp.

SOLE or FLOUNDER Austroglossus spp.

SOLE or FLOUNDER Brachirus orientalis

SOLE or FLOUNDER Buglossidium luteum

SOLE or FLOUNDER Clidoderma


asperrimum
SOLE or FLOUNDER Embassichthys
bathybius
SOLE or FLOUNDER Eopsetta jordani

SOLE or FLOUNDER Glyptocephalus spp.

SOLE or FLOUNDER G. zachirus

SOLE or FLOUNDER Gymnachirus melas

SOLE or FLOUNDER Hippoglossina spp.

SOLE or FLOUNDER Lepidopsetta bilineata

SOLE or FLOUNDER Lyopsetta exilis

SOLE or FLOUNDER Microchirus spp.

SOLE or FLOUNDER Microstomus kitt

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


3 - 30 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


SOLE or FLOUNDER (cont.) M. pacificus

SOLE or FLOUNDER Parophrys vetulus

SOLE or FLOUNDER Psettichthys


melanostictus
SOLE or FLOUNDER Pseudopleuronectes
americanus
SOLE or FLOUNDER Solea solea

SOLE or FLOUNDER Trinectes spp.

SOLE or FLOUNDER Xystreurys liolepis

SOLE or FLOUNDER, Aseraggodes spp. 4


aquacultured
SOLE or FLOUNDER, Austroglossus spp. 4
aquacultured
SOLE or FLOUNDER, Brachirus orientalis 4
aquacultured
SOLE or FLOUNDER, Buglossidium luteum 4
aquacultured
SOLE or FLOUNDER, Clidoderma 4
aquacultured asperrimum
SOLE or FLOUNDER, Embassichthys 4
aquacultured bathybius
SOLE or FLOUNDER, Eopsetta jordani 4
aquacultured
SOLE or FLOUNDER, Glyptocephalus spp. 4
aquacultured
SOLE or FLOUNDER, G. zachirus 4
aquacultured
SOLE or FLOUNDER, Gymnachirus melas 4
aquacultured
SOLE or FLOUNDER, Hippoglossina spp. 4
aquacultured

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


3 - 31 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


SOLE or FLOUNDER, Lepidopsetta bilineata 4
aquacultured (cont.)
SOLE or FLOUNDER, Lyopsetta exilis 4
aquacultured
SOLE or FLOUNDER, Microchirus spp. 4
aquacultured
SOLE or FLOUNDER, Parophrys vetulus 4
aquacultured
SOLE or FLOUNDER, Psettichthys 4
aquacultured melanostictus
SOLE or FLOUNDER, Pseudopleuronectes 4
aquacultured americanus
SOLE or FLOUNDER, Solea solea 4
aquacultured
SOLE or FLOUNDER, Trinectes spp. 4
aquacultured
SOLE or FLOUNDER, Xystreurys liolepis 4
aquacultured
SORUBIM or SURUBI Pseudoplatystoma
corruscans
SPADEFISH Chaetodipterus spp.
SPEARFISH Tetrapturus spp.

SPOT Leiostomus xanthurus ASP

SPRAT or BRISTLING Sprattus spp.

SQUIRRELFISH Holocentrus spp.


SQUIRRELFISH Myripristis spp.
SQUIRRELFISH Sargocentron spp.
STURGEON and roe Acipenser spp.
(CAVIAR) 8 .

STURGEON and roe Huso huso


(CAVIAR). 8
STURGEON and roe Pseudoscaphirhynchus
(CAVIAR). 8 spp.

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


3 - 32 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


STURGEON and roe Scaphirhynchus spp.
(CAVIAR) 8 (cont.)
.

STURGEON and roe Acipenser spp.


(CAVIAR) 8, aquacultured
.

STURGEON and roe Huso huso


(CAVIAR). 8, aquacultured
STURGEON and roe Pseudoscaphirhynchus
(CAVIAR). 8, aquacultured spp.
STURGEON and roe Scaphirhynchus spp.
(CAVIAR). 8, aquacultured
SUCKER Carpiodes spp.

SUCKER Catostomus
commersonii
SUCKER Cycleptus elongatus

SUCKER or REDHORSE Moxostoma


macrolepidotum
SUNFISH Archoplites interruptus

SUNFISH Lepomis spp.

SURFPERCH Amphistichus spp.

SURFPERCH Cymatogaster
aggregata
SURFPERCH Embiotoca spp.

SURFPERCH Hyperprosopon
argenteum
SURFPERCH Rhacochilus toxotes

SUTCHI or SWAI Pangasianodon


hypophthalmus
SUTCHI or SWAI, Pangasianodon
aquacultured hypophthalmus

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


3 - 33 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


SWORDFISH Xiphias gladius

TANG Acanthurus spp. CFP 2


TANG Ctenochaetus striatus CFP 2
TANG C. strigosus CFP 2
TANG Naso spp. CFP 2
TANG Zebrasoma spp.
TARPON Megalops atlanticus

TAUTOG Tautoga onitis

THORNYHEAD Sebastolobus spp.

THREADFIN Eleutheronema
tetradactylum
THREADFIN Galeoides decadactylus
THREADFIN Polydactylus spp.
THREADFIN Polynemus spp.
TIGERFISH Datnioides microlepis

TIGERFISH D. polota

TILAPIA Oreochromis spp.

TILAPIA Sarotherodon spp.

TILAPIA Tilapia spp.

TILAPIA, aquacultured Oreochromis spp. 4

TILAPIA, aquacultured Sarotherodon spp. 4

TILAPIA, aquacultured Tilapia spp. 4

TILEFISH Caulolatilus spp.


TILEFISH Lopholatilus
chamaeleonticeps

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


3 - 34 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


TILEFISH (cont.) Malacanthus plumieri
TILEFISH Prolatilus jugularis
TINFOIL Barbonymus altus
TOMCOD Microgadus spp.

TONGUESOLE Cynoglossus spp.

TRAHIRA Hoplias malabaricus


TREVALLY Caranx ignobilis CFP

TREVALLY C. melampygus CFP

TREVALLY C. spp.

TREVALLY Gnathanodon
speciosus
TRIGGERFISH Balistes vetula CFP
TRIGGERFISH Canthidermis
sufflamen
TRIGGERFISH Melichthys niger
TRIGGERFISH Navodon spp.
TRIPLETAIL Datnioides
quadrifasciatus
TRIPLETAIL Lobotes spp.
TROUT, aquacultured Oncorhynchus
aguabonita
TROUT, aquacultured O. clarkii

TROUT, aquacultured O. gilae

TROUT, aquacultured O. mykiss

TROUT, aquacultured Salmo trutta

TROUT, aquacultured Salvelinus fontinalis

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


3 - 35 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


TROUT, aquacultured S. malma
(cont.)
TROUT, aquacultured S. namaycush

TROUT, aquacultured Stenodus leucichthys

TROUT, RAINBOW or Oncorhynchus mykiss


STEELHEAD
TRUMPETER Latridopis spp.

TRUMPETER Latris lineata

TUNA Allothunnus fallai

TUNA Auxis spp.

TUNA Euthynnus spp.

TUNA Katsuwonus pelamis

TUNA Thunnus alalunga ASP

TUNA T. albacares

TUNA T. atlanticus

TUNA T. maccoyii

TUNA T. obesus

TUNA T. thynnus

TUNA T. tonggol

TUNA, aquacultured Thunnus spp. 4

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


3 - 36 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


TURBOT Pleuronichthys
guttulatus
TURBOT P. spp.

TURBOT Psetta maxima

TURBOT Psettodes spp.

TURBOT Reinhardtius
hippoglossoides
TURBOT, aquacultured Psetta maxima 4

TURTLE Apalone spp.

TURTLE Chelydra spp.

TURTLE Malaclemys spp.

TURTLE Trachemys spp.

TURTLE, aquacultured Apalone spp.

TURTLE, aquacultured Chelydra spp.

TURTLE, aquacultured Malaclemys spp.

TURTLE, aquacultured Trachemys spp.

UNICORNFISH Naso unicornis CFP


WAHOO Acanthocybium
solandri
WALLEYE Sander vitreus

WAREHOU Seriolella spp.


WEAKFISH Cynoscion spp.

WEAKFISH or BANGAMARY Macrodon ancylodon

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


3 - 37 (August 2019)
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 3 Natural Scombrotoxin Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins13 (Histamine) Chemicals Drugs

CHP 5 CHP 6 CHP 7 CHP 9 CHP 11


WHISKERED FISH Arius spp.

WHISKERED FISH or Bagre marinus


GAFFTOPSAIL FISH
WHISKERED FISH or Ariopsis felis
HARDHEAD WHISKERED
FISH
WHITEFISH Coregonus spp.

WHITEFISH Prosopium
cylindraceum
WHITING Merluccius gayi

WHITING M. hubbsi

WHITING M. merluccius

WHITING, BLUE Micromesistius spp.

WHITING, NEW ZEALAND Macruronus


novaezelandiae
WHITING or PACIFIC Merluccius productus
WHITING
WRASSE Cheilinus undulatus CFP
WOLFFISH Anarhichas spp.

YELLOWTAIL or Seriola lalandi


AMBERJACK
YELLOWTAIL or Seriola lalandi 4
AMBERJACK, aquacultured
ZANDER Sander lucioperca

ZANDER, aquacultured Sander lucioperca

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


3 - 38 (August 2019)
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.)

Acronyms: ASP = Amnesic Shellfish Poisoning; CFP = Ciguatera Fish Poisoning; GFP = Gempylid Fish Poisoning; IHT = Ichthyohemotoxin;
PSP = Paralytic Shellfish Poisoning; and PFP = Pufferfish Poisoning

Footnotes:
1. This hazard does not apply to offshore catch (e.g., areas not subject to shoreside 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. 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. See Chapter 5 for further information.
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.
11. Puffer Fish:
* PFP has been associated with fish from the east coast of Florida specifically in the following counties: Volusia, Brevard, Indian
River, St. Lucie, and Martin.
** There have been no reported tetrodotoxin or PFP illnesses associated with this species as of May 2018.
*** Takifugu rubripies is the only species to be offered for importation from Japan based on the agreement between US FDA and the
government of Japan.
12. Other Natural Marine Toxins may be applicable to this species. Refer to Chapter 6 for clarification.
13. Many of the fish and families of fish listed in this table have been identified with specific natural marine toxins as a result of illnesses/
outbreaks which have occurred or have been identified through research. For further information regarding each toxin refer to
Chapter 6 and its references.

14. The toxin has been identified through an FDA research project; however, the toxin levels found do not exceed the established guidance
levels and/or have not been associated with illnesses.
15. Some flounder are also known as sole and can be found under “Sole or Flounder.”
16. FDA recommends consuming these species of fish only as appropriate.

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


3 - 39 (August 2019)
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 Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins Chemicals Drugs

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11

ABALONE Haliotis laevigata

ABALONE H. ruber

ABALONE H. spp.

ABALONE Marinauris roei

ARKSHELL Anadara spp.

ARKSHELL Arca spp.

CLAM, BENTNOSE Macoma nasuta

CLAM BUTTER Saxidomus spp.

CLAM, CALICO Macrocallista maculata

CLAM, GEODUCK Panopea bitruncata

CLAM, GEODUCK P. spp.

CLAM, HARD Arctica islandica

CLAM, HARD Meretrix spp.

CLAM, HARD Venus mortoni

CLAM, HARDSHELL or
Mercenaria spp.
QUAHOG
CLAM, HARDSHELL or
Protothaca thaca
QUAHOG

CLAM, LITTLENECK Protothaca staminea

CLAM, LITTLENECK P. tenerrima

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


3 - 40 (August 2019)
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 Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins Chemicals Drugs

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11

CLAM, LITTLENECK (cont.) Tapes variegata

CLAM, LITTLENECK T. virginea

CLAM, LITTLENECK Venerupis aurea

CLAM, LITTLENECK V. decussata 4

CLAM, LITTLENECK V. philippinarum

CLAM, MARSH Corbicula japonica

CLAM, PISMO Tivela stultorum

CLAM, RAZOR Ensis spp.

CLAM, RAZOR Siliqua spp.

CLAM, RAZOR Solen spp.

CLAM, RAZOR Tagelus spp.

CLAM, SANGUIN Sanguinolaria spp.

CLAM, SOFTSHELL Mya arenaria

CLAM, SURF or SURFCLAM Mactra spp.

CLAM, SURF or SURFCLAM Mactrellona alata

CLAM, SURF or SURFCLAM Mactromeris spp.

CLAM, SURF or SURFCLAM Mactrotoma spp.

CLAM, SURF or SURFCLAM Simomactra spp.

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


3 - 41 (August 2019)
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 Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins Chemicals Drugs

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11


CLAM, SURF or SURFCLAM
Spisula spp.
(cont.)

CLAM, SURF or SURFCLAM Tresus spp.

CLAM, SURF or SURFCLAM,


Mactra schalinensis
aquacultured

CLAM, VENUS Chione spp.

CLAM, VENUS Chionista spp.

CLAM, VENUS Macrocallista nimbosa

CLAM, WEDGE Paphies spp.

COCKLE Cardium spp.

COCKLE Clinocardium spp.

COCKLE Dinocardium robustum

COCKLE Serripes groenlandicus

CONCH Lambis lambis

CONCH Strombus spp.

COQUINA Donax spp.

COQUINA, FALSE Iphigenia brasiliana

CRAB, BENI-ZUWAI Chionocetes japonicus

CRAB, BLUE Callinectes sapidus

CRAB, BLUE, aquacultured Callinectes sapidus

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


3 - 42 (August 2019)
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 Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins Chemicals Drugs

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11

CRAB, BROWN Chaceon fenneri

CRAB, GOLDEN KING Lithodes aequispinus

CRAB, CENTOLLA Lithodes antarcticus

CRAB, CENTOLLA L. murrayi

CRAB, CHINESE MITTEN Eriocheir sinensis

CRAB, CHINESE MITTEN,


Eriocheir sinensis
aquacultured

CRAB, DEEPSEA Paralomis granulosa

2
CRAB, DUNGENESS Metacarcinus magister 4

CRAB, JAPANESE 1
Geothelphusa dehaani
FRESHWATER

2
CRAB, JONAH Cancer borealis

Paralithodes
CRAB, KING
camtschaticus

CRAB, KING P. platypus

CRAB, KING or HANASAKI Paralithodes brevipes

CRAB, KOREAN or KEGANI Erimacrus isenbeckii

CRAB, LITHODES Neolithodes brodiei

CRAB, RED Chaceon quinquedens

2
CRAB, RED ROCK Cancer productus

CRAB, ROCK Cancer irroratus

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


3 - 43 (August 2019)
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 Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins Chemicals Drugs

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11

CRAB, ROCK (cont.) C. pagurus

CRAB, SANTOLLA, NOVA,


Lithodes santolla
or SOUTHERN RED

CRAB, SHEEP Loxorhynchus grandis

CRAB, SNOW Chionoecetes angulatus

CRAB, SNOW C. bairdi

CRAB, SNOW C. opilio

CRAB, SNOW C. tanneri

CRAB, SPIDER Jacquinotia edwardsii

CRAB, SPIDER Maja squinado

CRAB, STONE Menippe spp.

CRAB, SWAMP Scylla serrata

CRAB, SWAMP,
Scylla serrata
aquacultured

CRAB, SWIMMING Callinectes arcuatus

CRAB, SWIMMING C. toxotes

CRAB, SWIMMING Ovalipes punctatus

CRAB, SWIMMING Portunus spp.

CRAB, SWIMMING,
Portunus pelagicus
aquacultured

CRAWFISH or CRAYFISH Astacus spp.

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


3 - 44 (August 2019)
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 Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins Chemicals Drugs

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11


CRAWFISH or CRAYFISH
Cambarus spp.
(cont.)

CRAWFISH or CRAYFISH Cherax spp.

CRAWFISH or CRAYFISH Euastacus armatus

CRAWFISH or CRAYFISH Pacifastacus spp.

CRAWFISH or CRAYFISH Paranephrops spp.

CRAWFISH or CRAYFISH Procambarus spp.

CRAWFISH or CRAYFISH,
Astacus spp.
aquacultured
CRAWFISH or CRAYFISH,
Cambarus spp.
aquacultured
CRAWFISH or CRAYFISH,
Cherax spp.
aquacultured
CRAWFISH or CRAYFISH,
Euastacus armatus
aquacultured
CRAWFISH or CRAYFISH,
Pacifastacus spp.
aquacultured
CRAWFISH or CRAYFISH,
Paranephrops spp.
aquacultured
CRAWFISH or CRAYFISH,
Procambarus spp.
aquacultured

2
CUTTLEFISH Sepia spp.

JELLYFISH Rhopilema spp.


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

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


3 - 45 (August 2019)
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 Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins Chemicals Drugs

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11


LIMPET Cellana denticulata
LIMPET Diodora aspera
LIMPET Fissurella maxima
LIMPET Lottia gigantea
LIMPET Patella caerulea
LIMPET Tectura testudinalis
2 3
LOBSTER Homarus spp.

LOBSTER, NORWAY Nephrops norvegicus


LOBSTER, ROCK Jasus spp.
LOBSTER, ROCK or SPINY Palinurus spp.
LOBSTER, ROCK or SPINY Panulirus spp.
LOBSTER, SLIPPER Ibacus ciliatus
LOBSTER, SLIPPER Scyllarides spp.
LOBSTER, SLIPPER Thenus orientalis
LOBSTERETTE Metanephrops spp.
LOBSTERETTE Nephropsis aculeata
MUREX or MEREX Murex brandaris

MUSSEL Modiolus spp.

MUSSEL Mytilus spp.

MUSSEL Perna canaliculus

1 2
OCTOPUS Eledone spp.

1 2
OCTOPUS Octopus spp.

OCTOPUS, BLUE-RINGED Hapalochlaena spp.

OYSTER Crassostrea spp.

OYSTER Ostrea spp.

OYSTER Spondylus spp.

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


3 - 46 (August 2019)
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 Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins Chemicals Drugs

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11

OYSTER (cont.) Tiostrea spp.

PEN SHELL Atrina pectinata

2 2
PERIWINKLE Littorina littorea

2 2
SCALLOP Aequipecten spp.

2 2
SCALLOP Amusium spp.

2 2
SCALLOP Argopecten nucleus

2 2
SCALLOP Chlamys spp.

2 2
SCALLOP Euvola spp.

2 2
SCALLOP Patinopecten yessoensis

2 2
SCALLOP Pecten spp.

2 2
SCALLOP Placopectin magellanicus

2 2
SCALLOP, aquacultured Aequipecten spp.

2 2
SCALLOP, aquacultured Amusium spp.

2 2
SCALLOP, aquacultured Argopecten nucleus

2 2
SCALLOP, aquacultured Chlamys spp.

2 2
SCALLOP, aquacultured Euvola spp.

2 2
SCALLOP, aquacultured Patinopecten yessoensis

2 2
SCALLOP, aquacultured Pecten spp.

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


3 - 47 (August 2019)
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 Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins Chemicals Drugs

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11

SCALLOP, aquacultured 2 2
Placopectin magellanicus
(cont.)

2 2
SCALLOP or BAY SCALLOP Argopecten irradians

2 2
SCALLOP, CALICO Argopecten gibbus

SCALLOP or 2 2
Patinopecten caurinus
WEATHERVANE

SEA CUCUMBER Cucumaria spp.

SEA CUCUMBER Holothuria spp.

SEA CUCUMBER Parastichopus spp.

SEA CUCUMBER Stichopus spp.

SEA CUCUMBER,
Apostichopus spp.
aquacultured
SEA CUCUMBER,
Cucumaria spp.
aquacultured
SEA CUCUMBER,
Holothuria spp.
aquacultured
SEA CUCUMBER,
Parastichopus spp.
aquacultured
SEA CUCUMBER,
Stichopus spp.
aquacultured (cont.)

SEA URCHIN roe Echinus esculentus

SEA URCHIN roe Evechinus chloroticus

SEA URCHIN roe Heliocidaris spp.

SEA URCHIN roe Loxechimus spp.

SEA URCHIN roe Paracentrotus spp.

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


3 - 48 (August 2019)
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 Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins Chemicals Drugs

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11

SEA URCHIN roe (cont.) Pseudocentrotus spp.

SEA URCHIN roe Strongylocentrotus spp.

SEABOB Xiphopenaeus kroyeri

SEA SQUIRT Styela spp.

SHRIMP Crangon spp.


SHRIMP Farfantepenaeus spp.
SHRIMP Fenneropenaeus spp.
SHRIMP Litopenaeus spp.
SHRIMP Marsupenaeus spp.
SHRIMP Melicertus spp.
SHRIMP Metapenaeus affinis
SHRIMP Palaemon serratus
SHRIMP Palaemonetes vulgaris
SHRIMP Pandalopsis dispar
SHRIMP Pandalus spp.
SHRIMP Penaeus spp.
SHRIMP Pleoticus muelleri
SHRIMP Plesionika martia

SHRIMP, aquacultured Crangon spp.

SHRIMP, aquacultured Exopalaemon styliferus

SHRIMP, aquacultured Farfantepenaeus spp.

SHRIMP, aquacultured Fenneropenaeus spp.

SHRIMP, aquacultured Litopenaeus spp.

SHRIMP, aquacultured Marsupenaeus spp.

SHRIMP, aquacultured Macrobrachium spp.

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


3 - 49 (August 2019)
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 Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins Chemicals Drugs

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11

SHRIMP, aquacultured
Melicertus spp.
(cont.)

SHRIMP, aquacultured Metapenaeus spp.

SHRIMP, aquacultured Palaemon serratus

SHRIMP, aquacultured Palaemonetes vulgaris

SHRIMP, aquacultured Pandalopsis dispar

SHRIMP, aquacultured Pandalus spp.

SHRIMP, aquacultured Penaeus spp.

SHRIMP, aquacultured Plesionika martia

SHRIMP, FRESHWATER Macrobrachium spp.


SHRIMP, FRESHWATER,
Macrobrachium spp.
aquacultured
SHRIMP, ROCK Sicyonia brevirostris
SHRIMP, ROYAL Pleoticus robustus
SHRIMP or PINK SHRIMP Pandalus borealis
SHRIMP or PINK SHRIMP P. jordani
SHRIMP or PRAWN Haliporoides sibogae 4

SNAIL or ESCARGOT Achatina fulica

SNAIL or ESCARGOT Helix pomatia

1
SNAIL or ESCARGOT Otala spp.

SNAIL, MOON Polinices spp.

1
SQUID or CALAMARI Berryteuthis magister

1 2
SQUID or CALAMARI Dosidicus gigas

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


3 - 50 (August 2019)
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 Environmental Aquaculture
MARKET NAMES LATIN NAMES Toxins Chemicals Drugs

CHP 4 CHP 5 CHP 6 CHP 9 CHP 11


SQUID or CALAMARI 1
Illex spp.
(cont.)

1
SQUID or CALAMARI Loligo media

SQUID or CALAMARI L. opalescens

1
SQUID or CALAMARI L. spp.

1
SQUID or CALAMARI Lolliguncula spp.

1
SQUID or CALAMARI Nototodarus spp.

1
SQUID or CALAMARI Ommastrephes spp.

1
SQUID or CALAMARI Rossia macrosoma

1
SQUID or CALAMARI Sepiola rondeleti

1
SQUID or CALAMARI Sepioteuthis spp.

1
SQUID or CALAMARI Todarodes sagittatus

TOP SHELL Monodonta turbinate 4

TOP SHELL Turbo cornutus


WHELK or SEA SNAIL Buccinum spp.

WHELK or SEA SNAIL Busycon spp.

2
WHELK or SEA SNAIL Neptunea spp.

WHELK or SEA SNAIL Zidona dufresnei

Footnotes:
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


3 - 51 (August 2019)
TABLE 3-4
POTENTIAL PROCESS-RELATED HAZARDS
Finished Product Food 1 Package Type
Hazards

Intolerance Substances4
- Drying
C. botulinum Toxin (CHp 13)

- Batter
Growth - Temperature

Processes Designed to

Contamination After
Pathogenic Bacteria

Pathogenic Bacteria

Pathogenic Bacteria

Metal Inclusion (CHP 20)


Retain Raw Product
Through Cooking or

Specialized Cooking

Glass Inclusion (CHP 21)


Allergens and Food
Characteristics (CHP 17)
Pasteurization (CHP 16)

Pasteurization and
Survival Through
Bacteria Survival

Processes (CHP 18)


Pathogenic
Abuse (CHP 12)

Toxin
S. aureus Toxin
(CHP 14)

15)

(CHP 19)
Finished Product Food 1 Package Type

S. aureus (CHP
Finished Product Food 1 Package Type
CHP 12 CHP 13 CHP 14 CHP 15 CHP 16 CHP 17 CHP 18 CHP 19 CHP 20 CHP 21
Battered or breaded Reduced oxygen packaged
(including surface- (e.g., mechanical vacuum,
browned) raw shrimp, MAP, CAP, hermetically
finfish, oysters, clams, sealed)
squid, and other fish
Battered or breaded Other than reduced
(including surface- oxygen packaged
browned) raw shrimp,
finfish, oysters, clams,
squid, and other fish
Cooked shrimp, crab, Reduced oxygen packaged
lobster, and other fish, (e.g., mechanical vacuum,
including cooked meat, steam flush, hot fill, MAP,
sections, and whole fish, CAP, hermetically sealed,
and surimi-based analog or packed in oil).
products.
Cooked shrimp, crab, Other than reduced
lobster, and other fish, oxygen packaged.
including cooked meat,
sections, and whole fish,
and surimi-based analog
products.
Dried fish All 6

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


3 - 52 (August 2019)
TABLE 3-4
POTENTIAL PROCESS-RELATED HAZARDS
Finished Product Food 1 Package Type
Hazards

Intolerance Substances4
- Drying
C. botulinum Toxin (CHp 13)

- Batter
Growth - Temperature

Processes Designed to

Contamination After
Pathogenic Bacteria

Pathogenic Bacteria

Pathogenic Bacteria

Metal Inclusion (CHP 20)


Retain Raw Product
Through Cooking or

Specialized Cooking

Glass Inclusion (CHP 21)


Allergens and Food
Characteristics (CHP 17)
Pasteurization (CHP 16)

Pasteurization and
Survival Through
Bacteria Survival

Processes (CHP 18)


Pathogenic
Abuse (CHP 12)

Toxin
S. aureus Toxin
(CHP 14)

15)

(CHP 19)
Finished Product Food 1 Package Type

S. aureus (CHP
Finished Product Food 1 Package Type
CHP 12 CHP 13 CHP 14 CHP 15 CHP 16 CHP 17 CHP 18 CHP 19 CHP 20 CHP 21
Fermented, acidified, All. 2
pickled, salted, and LACFs.

Fish oil All 3

Fully cooked prepared Reduced oxygen packaged


foods. (e.g., mechanical vacuum,
steam flush, hot fill, MAP,
CAP, hermetically sealed,
or packed in oil).
Fully cooked prepared Other than reduced
foods. oxygen packaged.

Pasteurized crab, lobster, Reduced oxygen packaged


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

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


3 - 53 (August 2019)
TABLE 3-4
POTENTIAL PROCESS-RELATED HAZARDS
Finished Product Food 1 Package Type
Hazards

Intolerance Substances 4
- Drying
C. botulinum Toxin (CHp 13)

- Batter

.
Growth - Temperature

Processes Designed to

Contamination After
Pathogenic Bacteria

Pathogenic Bacteria

Pathogenic Bacteria

Metal Inclusion (CHP 20)


Retain Raw Product
Through Cooking or

Specialized Cooking

Glass Inclusion (CHP 21)


Allergens and Food
Characteristics (CHP 17)
Pasteurization (CHP 16)

Pasteurization and
Survival Through
Bacteria Survival

Processes (CHP 18)


Pathogenic
Abuse (CHP 12)

Toxin
S. aureus Toxin
(CHP 14)

15)

(CHP 19)
Finished Product Food 1 Package Type

S. aureus (CHP
Finished Product Food 1 Package Type
CHP 12 CHP 13 CHP 14 CHP 15 CHP 16 CHP 17 CHP 18 CHP 19 CHP 20 CHP 21
Raw fish other than Reduced oxygen packaged
oysters, clams, and (e.g. mechanical vacuum,
mussels (finfish and non- MAP, CAP, hermetically
finfish). sealed, or packed in oil).
Raw fish other than Other than reduced
oysters, clams, and oxygen packaged.
mussels (finfish and non-
finfish).
Raw oysters, clams, and Reduced oxygen packaged
mussels (e.g., mechanical vacuum,
MAP, CAP, hermetically
sealed, or packed in oil)
Raw oysters, clams, and Other than reduced
mussels oxygen packaged

Salads, sandwiches, dips, Reduced oxygen packaged


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

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


3 - 54 (August 2019)
TABLE 3-4
POTENTIAL PROCESS-RELATED HAZARDS
Finished Product Food 1 Package Type
Hazards

Intolerance Substances4
- Drying
C. botulinum Toxin (CHp 13)

- Batter
Growth - Temperature

Processes Designed to

Contamination After
Pathogenic Bacteria

Pathogenic Bacteria

Pathogenic Bacteria

Metal Inclusion (CHP 20)


Retain Raw Product
Through Cooking or

Specialized Cooking

Glass Inclusion (CHP 21)


Allergens and Food
Characteristics (CHP 17)
Pasteurization (CHP 16)

Pasteurization and
Survival Through
Bacteria Survival

Processes (CHP 18)


Pathogenic
Abuse (CHP 12)

Toxin
S. aureus Toxin
(CHP 14)

15)

(CHP 19)
Finished Product Food 1 Package Type

S. aureus (CHP
Finished Product Food 1 Package Type
CHP 12 CHP 13 CHP 14 CHP 15 CHP 16 CHP 17 CHP 18 CHP 19 CHP 20 CHP 21
Smoked fish Reduced oxygen packaged
(e.g., mechanical vacuum, 5
steam flush, hot fill, MAP,
CAP, hermetically sealed,
or packed in oil)
Smoked fish Other than reduced 5
oxygen packaged

Stuffed crab, shrimp, Reduced oxygen packaged


finfish, and other fish. (e.g., mechanical vacuum,
MAP, CAP, or hermetically
sealed).
Stuffed crab, shrimp, Other than reduced
finfish, and other fish. oxygen packaged.

Uncooked prepared food Reduced oxygen packaged


(e.g., mechanical vacuum,
steam flush, hot fill, MAP,
CAP, hermetically sealed,
or packed in oil)
Uncooked prepared food Other than reduced
oxygen packaged

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


3 - 55 (August 2019)
TABLE 3-4
POTENTIAL PROCESS-RELATED HAZARDS.

Acronyms: C. botulinum = Clostridium botulinum; S. aureus = Staphylococcus aureus; MAP = modified atmosphere packaging; CAP = controlled atmosphere
packaging; and LACF = low-acid canned food.
Footnotes:
1. You should include potential hazards from more than one finished product food category if your product fits more than one description.
2. 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.
3. This hazard does not apply to highly refined fish oil.
4. Applies to finfish and crustacean only in accordance with the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004. Molluscan shellfish are not
subject to FALCPA.
5. This hazard applies to hot smoked fish.
6. This hazard applies to dried uneviscerated fish in any type of packaging and to other dried fish and fishery products in reduced oxygen packaging used to
prevent rehydration. Fish and fishery products are defined in 21 CFR 123.3.

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


3 - 56 (August 2019)
NOTES:

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


3 - 57 (August 2019)
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 • Managing the amount of time that food is
exposed to temperatures that are favorable
This chapter covers the control of pathogens from for pathogenic bacteria growth and toxin
the harvest area for both molluscan shellfish and production (covered generally in Chapter 12;
fish other than molluscan shellfish. for Clostridium botulinum, in Chapter 13; and
for Staphylococcus aureus in hydrated batter
• Strategies for control of pathogens mixes, in Chapter 15);
There are a number of strategies for the control • Killing pathogenic bacteria by cooking or
of pathogens in fish and fishery products. They pasteurization (covered in Chapter 16) or
include: retorting (covered by the Thermally Processed
• Controlling the source (i.e., harvest waters) Low-Acid Foods Packaged in Hermetically
of molluscan shellfish and the time from Sealed Containers regulation (hereinafter, the
exposure to air (i.e., by harvest or receding Low-Acid Canned Foods (LACF) Regulation),
tide) to refrigeration to control pathogens from 21 CFR 113);
the harvest area (covered in this chapter); • Killing pathogenic bacteria by processes that
• Controlling the amount of moisture that is retain raw product characteristics (covered in
available for pathogenic bacteria growth Chapter 17).
(water activity) in the product by drying
• Molluscan shellfish
(covered in Chapter 14);
Pathogens found in waters from which molluscan
• Controlling the amount of moisture that is
shellfish are harvested can cause disease in
available for pathogenic bacterial growth
consumers. For the purposes of this guidance,
(water activity) in the product by formulation
molluscan shellfish include:
(covered in Chapter 13);
• Controlling the amount of salt or (1) oysters; (2) clams; (3) mussels; and (4) scallops,
preservatives, such as sodium nitrite, in the except where the final product is the shucked
product (covered in Chapter 13); adductor muscle only. The pathogens of concern
include both bacteria (e.g., Vibrio spp., Salmonella
• Controlling the level of acidity (pH) in the
spp., Shigella spp., and Campylobacter jejuni (C.
product (covered by the Acidified Foods
jejuni)) and viruses (e.g., hepatitis A virus and
regulation, 21 CFR 114, for shelf-stable
norovirus). See Appendix 7 for a description of the
acidified products, and by Chapter 13, for
public health impacts of these pathogens.
refrigerated acidified products);
Pathogens from the harvest area are of particular
• Controlling the introduction of pathogenic
concern in molluscan shellfish because (1)
bacteria after the pasteurization process
environments in which molluscan shellfish grow
(covered in Chapter 18);
are commonly subject to contamination from

CHAPTER 4: Pathogens From the Harvest Area

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

CHAPTER 4: Pathogens From the Harvest Area

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

CHAPTER 4: Pathogens From the Harvest Area

77
Control of pathogens DETERMINE WHETHER THIS POTENTIAL
The processor can control pathogens by proper HAZARD IS SIGNIFICANT.
cooking, pasteurizing, or retorting. Guidance
for these control mechanisms can be found in The following guidance will assist you in
Chapter 16 (cooking and pasteurizing to kill determining whether pathogens from the harvest
pathogenic bacteria) and the LACF Regulation, 21 area are a significant hazard at a processing step:
CFR 113 (retorting). 1. Is it reasonably likely that an unsafe level
For many products (e.g., raw fish fillets), there of pathogens from the harvest area will be
is no cooking, pasteurizing, or retorting step introduced at this processing step (e.g., are
performed by the processor. For most of these pathogens present in the raw material at an
products, cooking is performed by the consumer unsafe level)?
or end user before consumption. FDA is not
Under ordinary circumstances, it would be
aware of any Hazard Analysis Critical Control
reasonably likely that pathogens of human
Point (HACCP) controls that exist internationally
or animal origin from the harvest area could
for the control of pathogens in fish and fishery
enter the process at an unsafe level at the
products that are customarily fully cooked by
receiving step for the following types of fish:
the consumer or end user before consumption
other than a rigorous sanitation regime as part • Raw oysters;
of a prerequisite program or as part of HACCP • Raw clams;
itself. The Fish and Fishery Products regulation
(21 CFR 123.11, “Sanitation control procedures”) • Raw mussels;
requires such a regime. The proper application • Raw scallops (see information

of sanitation controls is essential because of the provided under “Intended use”).

likelihood that pathogens in seafood products


can be introduced through poor handling In addition:
practices by the aquaculture producer, the • Under ordinary circumstances, it would
harvester, or the processor. be reasonably likely that an unsafe level
of V. vulnificus (a naturally occurring
For some products (e.g., raw fish intended for
pathogen) could enter the process
sushi), there is no cooking performed by either the
from oysters harvested from areas that
processor, or the consumer, or the end user. When
have been confirmed as the original
the processor has knowledge or has reason to
source of oysters associated with two
know that the product will be consumed without
or more V. vulnificus illnesses (e.g.,
a process sufficient to kill pathogens of public
states bordering the Gulf of Mexico);
health concern or where the processor represents,
labels, or intends for the product to be so • Under ordinary circumstances, it
consumed, the processor should control time and would be reasonably likely that an
temperature exposure of the product to prevent unsafe level of V. parahaemolyticus
growth of bacterial pathogens and formation of could enter the process from oysters
toxins by any bacterial pathogens that may be harvested from an area that meets any
present in the product. Guidance for these controls one of the following conditions:
can be found in Chapter 12 and in Chapter 13 (for ° The shellfish control authority
those products where the packaging technique has conducted a risk evaluation
creates a reduced oxygen environment). and determined that the risk of V.
Note: The guidance contained in the remainder of this chapter
parahaemolyticus illness from the
applies to receiving controls for molluscan shellfish only. consumption of oysters harvested

CHAPTER 4: Pathogens From the Harvest Area

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

CHAPTER 4: Pathogens From the Harvest Area

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

CHAPTER 4: Pathogens From the Harvest Area

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

CHAPTER 4: Pathogens From the Harvest Area

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

CHAPTER 4: Pathogens From the Harvest Area

82
DEVELOP A CONTROL STRATEGY. accompanied by a bill of lading or similar
shipping document that contains the same
The following guidance provides three examples information;
of control strategies for pathogens from the Note: The source controls listed in this critical limit are required under
harvest area. You may select a control strategy 21 CFR 123.28(c).

that is different from those which are suggested, OR


provided it complies with the requirements of the • All containers of shellstock received from
applicable food safety laws and regulations, except a processor must bear a tag that discloses
that some parts of “Control Strategy Example 1 - the date and place they were harvested
Source Control” are specifically required by the (by state and site), the type and quantity of
Procedures for the Safe and Sanitary Processing shellfish, and the certification number of the
and Importing of Fish and Fishery Products processor;
regulation, 21 CFR 123 (called the Seafood HACCP
Regulation in this guidance document). OR
• All containers of shucked molluscan shellfish
The following are examples of control strategies
must bear a label that identifies the name,
included in this chapter:
address, and certification number of the
packer or repacker of the product;
MAY APPLY TO MAY APPLY TO
CONTROL STRATEGY PRIMARY SECONDARY AND
PROCESSOR PROCESSOR
• All molluscan shellfish must have been
Source control   harvested from waters authorized for
Shellstock temperature harvesting by a shellfish control authority.
control

For U.S. federal waters, no molluscan
shellfish may be harvested from waters that
• CONTROL STRATEGY EXAMPLE 1- are closed to harvesting by an agency of the
SOURCE CONTROL federal government;
Note: The following controls should be considered in addition to
AND
those in “Control Strategy Example 2 - Shellstock Temperature
Control.” • All molluscan shellfish must be from a
harvester that is licensed as required (note
Set Critical Limits. that licensing may not be required in all
• All containers of shellstock (in-shell jurisdictions) or from a processor that is
molluscan shellfish) received from a certified by a shellfish control authority;
harvester must bear a tag that discloses the AND
date and place they were harvested (by
• All finished product shellstock intended
state and site), type and quantity of shellfish,
for raw consumption must bear a tag that
and information on the harvester or the
instructs retailers to inform their customers
harvester’s vessel (i.e., the identification
that consuming raw or undercooked shellfish
number assigned to the harvester by the
may increase the risk of foodborne illness,
shellfish control authority, where applicable,
especially for individuals with certain
or if such identification numbers are not
medical conditions.
assigned, the name of the harvester or
the name or registration number of the Note: Only the primary processor, the processor that takes possession
of the molluscan shellfish from the harvester, needs to apply controls
harvester’s vessel). For bulk shipments relative to the identification of the harvester, the harvester’s license, or
of shellstock where the shellstock is not the approval status of the harvest waters.
containerized, the shellstock must be

CHAPTER 4: Pathogens From the Harvest Area

83
Establish Monitoring Procedures. • For checking incoming labels:

» What Will Be Monitored? ° At least three containers randomly


selected from every lot;

• Information contained on tags on containers


of incoming shellstock or on the bill AND

of lading or similar shipping document • For checking licenses:


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

° Every delivery;

OR

CHAPTER 4: Pathogens From the Harvest Area

84
Take the following corrective action to regain control ° Quantity and type of shellfish;
over the operation after a critical limit deviation:
AND
• Discontinue use of the supplier until
evidence is obtained that harvesting, tagging, ° Name and certification number of the
packer or repacker;
and/or label manufacturing practices have
changed; AND

OR ° Presence of the raw consumption


advisory.
• Modify labeling practices.
Establish Verification Procedures.
Establish a Recordkeeping System.
• Review monitoring and corrective action records
For shellstock: within 1 week of preparation to ensure they are
• Receiving record that documents: complete and any critical limit deviations that
occurred were appropriately addressed.
° 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

CHAPTER 4: Pathogens From the Harvest Area

85
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 for
illustrative 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)

MONITORING
CRITICAL CRITICAL LIMITS FOR
SIGNIFICANT
CONTROL EACH PREVENTIVE CORRECTIVE ACTION(S) RECORDS VERIFICATION
HAZARD(S) WHAT HOW FREQUENCY WHO
POINT MEASURE

Receiving Pathogens All incoming Information on Visual Every sack Receiving Reject the lot Receiving Review
shellstock from the shellstock must be incoming shellstock checks employee Discontinue use of the record monitoring and
harvest area tagged with the date tags supplier until evidence corrective action
and place of harvest, is obtained that tagging records within
type and quantity of practices have changed 1 week of

86
shellfish, and name or preparation
registration number of
the harvester’s vessel

All shellstock must be Harvest site on tags Visual Every lot Receiving Reject lots from Receiving
from waters approved Ask the shellfish checks employee unapproved waters record
by the state shellfish control authority of Discontinue use of the

CHAPTER 4: Pathogens From the Harvest Area


control authority the state in which the supplier until evidence is
shellstock are harvested obtained that harvesting
whether the area is practices have changed
authorized for harvest
All shellstock must Harvester’s license Visual Every Receiving Reject lots from unlicensed Receiving
be from a licensed checks delivery employee harvesters record
harvester Discontinue use of the
supplier until evidence is
obtained that the harvester
has secured a license
• CONTROL STRATEGY EXAMPLE 2 - SHELLSTOCK 12 hours;
TEMPERATURE CONTROL
OR
Note: The following controls should be considered in addition to
those in “Control Strategy Example 1 - Source Control.” ° For AMMAT of greater than 80°F (greater
than 27°C): 10 hours.
Set Critical Limits. Note: AMMAT is determined by the shellfish control authority. The
• When controls for neither V. vulnificus nor V. shellfish control authority may implement time to temperature controls
that are more stringent than those described here. Processors should
parahaemolyticus are needed: consult with their shellfish control authority for current requirements.

° For AMMAT of less than 66°F (less than Note: Only the primary processor, the processor that takes possession
19°C): 36 hours;
of the molluscan shellfish from the harvester, should apply controls
for the time from exposure to air (i.e., by harvest or receding tide) to
OR
refrigeration.

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

24 hours; Establish Monitoring Procedures.


OR » What Will Be Monitored?
° For AMMAT of greater than 80°F (greater • The time shellfish was exposed to air (i.e., by
than 27°C): 20 hours; harvest or receding tide);
Note: AMMAT is determined by the shellfish control authority.
AND
OR • The time shellstock was placed under
• When controls for V. vulnificus are needed: refrigeration;
° For AMMWT of less than 65°F (less than
» How Will Monitoring Be Done?
18°C): 36 hours;

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


OR
harvest or receding tide) to refrigeration:
° For AMMWT of 65 to 74°F (18 to 23°C):

° Obtain information from the shellfish


14 hours; control authority;

OR OR

° For AMMWT of greater than 74 to 84°F


° Check the harvester’s log or tags;

(greater than 23 to 29°C): 12 hours;


OR
OR
° Note the time of departure from and
° For AMMWT of greater than 84°F (greater return to dock;

than 29°C): 10 hours;


OR

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


shellfish control authority may implement time to temperature controls
that are more stringent than those described here. Processors should
° Ask the harvester.

consult with their shellfish control authority for current requirements. » How Often Will Monitoring Be Done (Frequency)?
OR • Every delivery.
• When controls for V. parahaemolyticus are » Who Will Do the Monitoring?
needed:
• Any person who has an understanding of
° For AMMAT of less than 66°F (less than the nature of the controls may perform the
19°C): 36 hours;
monitoring.
OR

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

CHAPTER 4: Pathogens From the Harvest Area

87
Establish Corrective Action Procedures.
Take the following corrective action to a product
involved in a critical limit deviation:
• Reject lots that do not meet the critical limit;
OR
• Subject the shellstock to a cooking,
pasteurization, retorting, or other process
that reduces pathogens of public health
concern to acceptable levels. See Chapters 16
and 17 and LACF Regulation (21 CFR 113) for
further guidance;
OR
• Destroy the product;
OR
• Divert the product to a non-food use.
AND
Take the following corrective action to regain control
over the operation after a critical limit deviation:
• Discontinue use of the supplier until
evidence is obtained that harvesting practices
have changed.

Establish a Recordkeeping System.


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

AND

° AMMWT.

Establish Verification Procedures.


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

CHAPTER 4: Pathogens From the Harvest Area

88
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 MONITORING
CRITICAL LIMITS
SIGNIFICANT CORRECTIVE
CONTROL FOR EACH RECORDS VERIFICATION
HAZARD(S) WHAT HOW FREQUENCY WHO ACTION(S)
POINT PREVENTIVE
MEASURE

Receiving Pathogens from Maximum time Time of Harvester’s log Every Receiving Reject lot Receiving Review
shellstock the harvest area from harvest to harvest delivery employee Discontinue use record monitoring and
refrigeration: of the supplier corrective

89
AMMWT < 65°F: until action
36 hours evidence is records within
obtained that 1 week of
AMMWT 65 to
harvesting preparation
74°F: 14 hours
practices
AMMWT >74 to have changed
84°F: 12 hours;

CHAPTER 4: Pathogens From the Harvest Area


AMMWT >84ºF:
10 hours
Time Visual checks Every Receiving
placed in delivery employee
refrigeration

AMMWT = Average Monthly Maximum Water Temperature


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

CHAPTER 4: Pathogens From the Harvest Area

90
CHAPTER 5: Parasites

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

CHAPTER 5: Parasites

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

CHAPTER 5: Parasites

92
kill the parasites (e.g., consistent with the primary processor would not need to identify
guidance in this chapter), you do not need to parasites as a significant hazard.
identify the hazard of parasites as reasonably
likely to occur in your product. IDENTIFY CRITICAL CONTROL POINTS.
It is not reasonably likely that parasites will
enter the process at other processing steps. The following guidance will assist you in
determining whether a processing step is a
2. Can the parasite hazard that was introduced at critical control point (CCP) for parasites:
an earlier step be eliminated or reduced to an
acceptable level at this processing step? 1. Does the process contain a heating step, such
as retorting, cooking, or pasteurizing that is
Parasites should be considered a significant designed to kill bacterial pathogens?
hazard at any processing step where a
preventive measure is, or can be, used to a. If the process contains a heating step,
eliminate the hazard that was introduced at an you should identify the heating step as
earlier step or to reduce to an acceptable level the CCP and would not need to identify
the likelihood of occurrence of the hazard. receiving as a CCP for this hazard.
Preventive measures for parasites can include:
See Chapters 13 (Clostridium botulinum
• Retorting (covered in 21 CFR
toxin formation) and 16 (Pathogen
113, the LACF Regulation);
bacteria survival through cooking or
pasteurization), and the LACF Regulation
• Hot smoking (covered in Chapter 13);
(21 CFR 113) for further information on
• Cooking and pasteurization
this control strategy.
(covered in Chapter 16);

Example:
• Freezing (covered in this chapter). A hot-smoked salmon processor
should set the CCP for parasites at the
• Intended use
hot-smoking step and would not need
If the consumer intends to cook the fish to identify the receiving step as a CCP
thoroughly before consumption, then you do for this hazard.
not need to consider the hazard significant, even
if Table 3-2 or 3-3 lists the species as having a b. If the process does not contain a heating
potential parasite hazard. In order to eliminate step, you should identify a freezing
parasites as a significant hazard when you are step as the CCP, and would not need to
unsure of the product’s intended use, you should identify receiving as a CCP for this hazard.
obtain documented assurance from the subsequent
Example:
processor, restaurateur, or institutional user (e.g.,
A salmon processor that sells the
prison or nursing home) that the fish will be
finished product for raw consumption
processed in a way that will kill the parasites.
should identify a freezing step as the
Example: CCP for parasites. The processor would
A primary processor receives whole salmon not need to identify the receiving step
from the harvest vessel and re-ices the fish as a CCP for this hazard.
for shipment to a second processor. The
This control approach is a control
second processor butchers the fish for sale
strategy referred to in this chapter as
to the sushi market. The primary processor
“Control Strategy Example 1 - Freezing.”
has documented assurance that the second
processor freezes the fish before sale. The

CHAPTER 5: Parasites

93
DEVELOP A CONTROL STRATEGY. ° For 7-day freezing critical limit:
• Starting time of freezing and ending
The following guidance provides an example of time of the frozen storage period;
a control strategy for parasites. It is important
OR
to note that you may select a control strategy
that is different from that which is suggested, ° For 15-hour and 24-hour freezing critical
provided it complies with the requirements of the limits:
applicable food safety laws and regulations. • Time when all fish are solid
The following is an example of the control frozen and ending time of
strategy included in this chapter: the frozen storage period.

» How Will Monitoring Be Done?


MAY APPLY TO MAY APPLY TO
CONTROL STRATEGY PRIMARY SECONDARY • Use a continuous temperature-recording
PROCESSOR PROCESSOR
device (e.g., a recording thermometer);
Freezing  
AND
• Perform a visual check of time and physical
• CONTROL STRATEGY EXAMPLE - FREEZING check of solid frozen condition, as appropriate.
Set the Critical Limits.
» How Often Will Monitoring Be Done (Frequency)?
• Freezing and storing at an ambient temperature • For temperature:
of -4°F (-20°C) or below for 7 days (total time);
OR
° Continuous monitoring, with a visual
check of the recorded data at least once
• Freezing at an ambient temperature of -31°F during each freezing or storage period,
(-35°C) or below until solid and storing at but no less than once per day;
an ambient temperature of -31°F (-35°C) or AND
below for 15 hours;
• For time:
OR
• Freezing at an ambient temperature of -31°F
° Each batch, at the beginning and end
of the freezing or storage period, as
(-35°C) or below until solid and storing at an appropriate.
ambient temperature of -4°F (-20°C) or below
for 24 hours. » Who Will Do the Monitoring?
Note: These conditions may not be suitable for freezing particularly • The device itself performs the monitoring. Any
large fish (e.g., thicker than 6 inches). It may be necessary for you person who has an understanding of the nature
to conduct a study to determine effective control parameters specific of the controls may perform the visual check of
to your freezing method, fish thickness, fish species, method of
preparation, and target parasites.
the data generated by this device to ensure that
the critical limits have been met consistently.
Establish Monitoring Procedures.
Establish Corrective Action Procedures.
» What Will Be Monitored?
Take the following corrective action to a product
• Freezer temperature; involved in a critical limit deviation:
AND • Refreeze and store the product at an ambient
• Length of time fish is held at freezer temperature temperature of -4°F (-20°C) or below for 7
or held solid frozen, as appropriate: days (total time), or refreeze it at an ambient
temperature of -31°F (-35°C) or below until solid

CHAPTER 5: Parasites

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

CHAPTER 5: Parasites

95
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 proces­
sor 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 refrigerated
lox. 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)

MONITORING
CRITICAL LIMITS
CRITICAL
SIGNIFICANT FOR EACH CORRECTIVE
CONTROL RECORDS VERIFICATION
HAZARD(S) PREVENTIVE WHAT HOW FREQUENCY WHO ACTION(S)
POINT
MEASURE

Freezing Parasites Blast freeze at Temperature of Recorder Continuous, Freezer Adjust or Recorder chart Check the
-31°F or below blast thermometers with visual operator repair freezer with notations recorder

96
until solid, and freezer and check of Refreeze for visual thermometer
hold at -4°F or storage freezer recorded data product temperature for accuracy
below for 24 at end of each check, time and damage

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

CHAPTER 5: Parasites

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

CHAPTER 5: Parasites

98
CHAPTER 6: NATURAL TOXINS

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


Fish and molluscan shellfish contaminated with CFP), inform advisories for at risk harvest areas
natural toxins from the water in which they lived (i.e., CFP) and/or make a determination for harvest
can cause consumer illness. Most of these toxins area closures (i.e., ASP, AZP, DSP, NSP, and PSP.)
are produced by naturally occurring marine algae
(phytoplankton). Fish or molluscan shellfish Scombrotoxin fish poisoning, resulting from
consume the algae, or animals that have consumed consumption of certain species of fish that have
the algae, which causes the toxins to accumulate been time/temperature abused, is caused by
in the fish’s or molluscan shellfish’s flesh. The toxin spoilage bacteria that form biogenic amines, such
continues to accumulate in the feeding animal’s as histamine, that are not considered natural
body at each point of consumption and results in toxins. Refer to Chapter 7 for information related
higher levels further up the food chain. Typically, to scombrotoxin formation and associated controls.
contamination occurs following blooms of the
This chapter has been organized to identify specific
toxic algal species; however, toxin contamination
information regarding the natural toxins and
is possible even when algal concentrations are
controls that are specifically associated to “fish
low in certain instances. In addition, there are a
other than molluscan shellfish” and “molluscan
few natural toxins and harmful compounds, not
shellfish.” Refer to specific sections appropriately.
produced by algae, that are specific to certain
fish species.
• Specific Information Associated with Recognized
There are numerous natural toxins identified Natural Toxins in Fish Other Than Molluscan
worldwide; however, there are currently six Shellfish
recognized natural toxin poisoning syndromes
that can occur from consuming contaminated fish This section provides information regarding the
and fishery products which are: implicated finfish, geographic regions, and illness
characteristics associated with natural toxins in fish
• amnesic shellfish poisoning (ASP),
other than molluscan shellfish. It is important to
• azaspiracid shellfish poisoning (AZP), note that additional geographic locations may occur
• ciguatera fish poisoning (CFP), because the distribution of the source algae can
vary over time. Processors should always be alert
• diarrhetic shellfish poisoning (DSP),
to the potential for emerging hazards in harvest
• neurotoxic shellfish poisoning (NSP), and waters and fish sources.
• paralytic shellfish poisoning (PSP).
While CFP is the prominent syndrome associated
All safety levels identified through guidance with fish as presented in this section, there are
and regulations for natural toxins may be found other natural toxins that may occur in fish such
in “Appendix 5: FDA and EPA Safety Levels in as ASP and PSP toxins. Refer to specific toxins
Regulations and Guidance” of this Guide; however, in the molluscan shellfish section for information
these levels should not be identified in the HACCP regarding other natural toxins that may occur in
plan as they are utilized for confirming illnesses (i.e. fish other than molluscan shellfish.

Chapter 6: Natural Toxins


6 - 1 (August 2019)
Ciguatera fish poisoning (from ciguatoxin) is • Additional Toxins Found in Fish Other Than
commonly related to the consumption of subtropical Molluscan Shellfish
and tropical reef fish which have accumulated
naturally occurring ciguatoxins through their diet. There are naturally occurring toxins in some fish
The highest incidences of ciguatoxins occur between species that are either not a result or have not yet
latitudes 35° north and 35° south, and include areas been proven conclusively to be a result, of marine
of the Caribbean Sea, Gulf of Mexico, and Atlantic, algae such as: clupeotoxin, gempylotoxin, tetramine,
Pacific, and Indian Oceans. Unsafe ciguatoxin levels tetrodotoxin, and a possible unidentified toxin
have also been detected from fish populations in that causes seafood-associated rhabdomyolysis
areas such as the Flower Garden Banks of the Gulf (sometimes referred to as Haff disease).
of Mexico, and specific areas of Florida, Hawaii,
Puerto Rico, and the U.S. Virgin Islands. Clupeotoxin poisoning is a rare but severe
type of seafood poisoning resulting from the
Ciguatoxins originate from marine algae, are consumption of certain filter-feeding fish such as
transferred through the food web, and accumulate sardines, herring, and anchovies. The exact cause
in the flesh of reef dwelling fish with the highest of clupeotoxin poisoning is unknown but it has been
levels of the toxin being observed in long-lived suggested that the marine toxin palytoxin, produced
fish-eating predators. These fish may then be by certain marine algae, contributes to this illness.
harvested by commercial or recreational fishermen All illnesses as of August 2019 have been linked to
for human consumption. Due to differences in life fish harvested from African, Caribbean, and Indo-
history and diet, not all fish within a given region Pacific waters. No suspected cases of clupeotoxin
are equally contaminated. Thus, fish caught side poisoning have been linked to fish harvested from
by side may contain widely differing toxin levels. U.S. waters and no cases of clupeotoxin poisoning
Because ciguatoxic endemic areas are localized, the have occurred in the U.S. Clupeotoxin poisoning is
primary seafood processors should recognize and associated with a high mortality rate.
avoid purchasing fish from known and/or emerging
areas of concern. Gempylotoxin(s) are wax esters naturally found
in high concentrations in the meat of escolar
Many fish species have been associated with CFP (Lepidocybium flavobrunneum) and oilfish
including but not limited to: barracuda (Family: (Ruvettus pretiosus). These particular wax esters
Sphyraenidae), grouper (Family: Serranidae), are indigestible and may cause diarrhea, abdominal
snapper (Family: Lutjanidae), jacks and trevally cramps, nausea, headache, and vomiting when
(Family: Carangidae), wrasse (Family: Labridae), consumed in sufficient quantities or consumed
mackerel (Family: Scombridae), tang (Family: in lower quantities by sensitive individuals. The
Acanthuridae), moray eels (Family: Muraenidae), exact quantity required to cause these purgative
and parrotfish (Scarus spp.). Ciguatoxins have effects is not known and appears to vary based
also been found in lionfish (Pterois volitans and on individual sensitivities. FDA advises against the
Pterois miles) collected in waters surrounding the importation and interstate marketing of these fish.
U.S. Virgin Islands. Additionally, deep sea fish species, such as orange
roughy (Hoplostethus atlanticus), and oreo dory
CFP is characterized by gastrointestinal symptoms (Allocyttus spp., Pseudocyttus spp., Oreosoma
including: nausea, vomiting, and diarrhea. spp., and Neocyttus spp.) are known to contain
Neurological symptoms include: numbness and lesser amounts of the same indigestible wax esters
tingling of the lips and extremities; itching of as escolar and oilfish. Sensitive individuals may
hands and feet; joint pain; muscle pain; muscle also experience symptoms from the consumption
weakness; reversal and sensitivity to temperature; of these fish. Improperly handled escolar and
dizziness; and vertigo. Cardiovascular symptoms oilfish also have been associated with scombrotoxin
may occur and include irregular heartbeat and low (histamine) poisoning (Refer to Chapter 7).
blood pressure. The onset of symptoms typically
occurs within 6 hours after consuming toxic fish Ichthyohemotoxin is found in the blood of a
and may persist from several days to weeks. In variety of different species of eels and considered
severe cases, some neurological symptoms may a rare form of food poisoning. Known implicated
persist for months and can recur for years. Fatalities species of eels include Anguilla anguilla, Conger
do not usually occur from CFP; however, isolated conger, and Muraena helena. Very little is known
fatalities have been reported. about the nature of the toxin. Ichthyohemotoxin

Chapter 6: Natural Toxins


6 - 2 (August 2019)
manifests in two different forms: 1. Systemic A restriction exists on the importation of all species
(caused by the consumption of fresh, uncooked of puffer fish and fishery products containing
blood); and 2. Topical. Symptoms of the systemic puffer fish. See “The Exchange of Letters between
form include: diarrhea, bloody stools, nausea, Japan and the U.S. Food and Drug Administration
vomiting, hypersalivation, skin eruptions, cyanosis, Regarding Puffer Fish” (at website: https://www.
apathy, irregular pulse, weakness, paresthesia, fda.gov/InternationalPrograms/Agreements/
paralysis, respiratory distress, and possibly MemorandaofUnderstanding/ucm107601.htm),
death. Symptoms from the topical form includes Import Alert #16-20 (at website: https://www.
a severe inflammatory response when raw eel accessdata.fda.gov/cms_ia/importalert_37.html),
serum comes in contact with eyes or the mouth. and the Regulatory Food Code for Retail Foods
Oral symptoms consist of burning, redness of (at website: https://www.fda.gov/food/retail-
mucosa and hypersalivation. Ocular contact invokes food-protection/fda-food-code) for further details
a severe burning sensation and redness of the regarding importation and control of tetrodotoxin.
conjunctivae, lacrimination, and swelling of the In addition to tetrodotoxin, some puffer fish have
eyelids. Eye irritation may persist for a several also been found to be contaminated with PSP toxins,
days. Recovery is usually spontaneous. Care should which are covered elsewhere in this chapter.
be taken when handling eels. Cooking has been
known to denature the toxic properties. Tetrodotoxin poisoning is characterized by
symptoms including: numbness of the lips
Tetramine is a toxin that is found in the salivary and tongue; tingling sensation in the face and
glands of whelks (Neptunia spp.). This hazard extremities; headache; abdominal pain; nausea;
can be controlled through the removal of the diarrhea; vomiting; difficulty in walking; paralysis;
glands. Symptoms of tetramine poisoning include: respiratory distress; difficulty in speech; shortness
double vision, temporary blindness, difficulty of breath; blue or purplish discoloration of the lips
in focusing, tingling of the fingers, prostration, and skin; lowering of blood pressure; convulsions;
nausea, vomiting, diarrhea, and loss of muscle mental impairment; irregular heartbeat; and death
control. Symptoms usually develop within 1 hour in extreme cases. Symptoms usually develop within
of consumption. 3 hours after consumption of contaminated fish
and may last from 24 to 48 hours. Death from this
Tetrodotoxin poisoning is usually associated toxin commonly occurs due to muscle paralysis
with the consumption of puffer fish from waters of resulting in respiratory failure when ventilatory
the Indo-Pacific Ocean regions. However, several support is not accessible.
reported cases of poisonings, including fatalities,
involved puffer fish from the Atlantic Ocean, Gulf Seafood-associated rhabdomyolysis (some-
of Mexico, and Gulf of California. There have been times referred to as Haff disease) was first
no confirmed cases of poisonings from northern documented in Russia in 1924 with 1,000 cases
puffer fish (Sphoeroides maculatus) as of August being reported over a 15-year period at that time
2019, which was once harvested and marketed as from consuming burbot, eel, and pike. Several cases
“sea squab” on the U.S. east coast. have been reported in the U.S. from the consumption
of commercially available domestic buffalo fish.
Puffer fish are also known as fugu, swellfish, bok, Other isolated cases have been documented from
blowfish, globefish, toadfish, blaasop, or balloonfish, the consumption of crayfish, salmon and imported
depending on the country of origin. Other fish canned mackerel. Internationally, similar cases
species such as xanthid crabs, marine gastropods, have been reported after the consumption of
and goby fish may contain this toxin and have been crayfish in China and recently from amberjack and
implicated in tetrodotoxin illnesses outside of the yellow jack from Brazil. The cause(s) of seafood-
U.S. Reports of these illnesses have mainly been associated rhabdomyolysis is unknown. Seafood-
limited to Asia, and involve species unlikely to be associated rhabdomyolysis results in the breakdown
imported into the U.S. Although strictly regulated, of skeletal muscle (rhabdomyolysis), with a risk
it should be noted that there have been several of acute kidney failure that develops within 24
cases of tetrodotoxin illness in the U.S. from the hours after consuming certain fish. FDA is currently
consumption of illegally imported and commercially collecting meal remnants from patients diagnosed
sold puffer fish products in multiple forms (i.e., with seafood-associated rhabdomyolysis to confirm
frozen and dried). the causative species and research the causative

Chapter 6: Natural Toxins


6 - 3 (August 2019)
agent(s). years, levels of domoic acid in Dungeness crab
on the west coast have exceeded guidance levels
FDA makes no recommendations in this guidance for this toxin and required harvesting closures.
document and has no specific expectations Along the west coast of the U.S., domoic acid
with regard to specific controls for clupeotoxin, has also been detected in other fish species
gempylotoxin, tetramine, and seafood-associated including the sardine (Sardinops sagax), anchovy
rhabdomyolysis for use in a processor’s HACCP (Engraulis mordax), Pacific sanddab (Citharichthys
plan(s). sordidus), chub mackerel (Scomber japonicas),
albacore tuna (Thunnus alalunga), jack smelt
Note: Venomous Fish: Care should be taken when (Atherinopsis californiensis), and market squid
handling venomous fish such as lionfish, (Loligo opalescens). Domoic acid has also been
scorpion fish and certain species of catfish. detected in several finfish species from the U.S.
The potential for harm from consuming the Gulf of Mexico, including plankton-eating fish
venom of any venom-producing fish has not [e.g., white mullet (Mugil curema), menhaden
been adequately investigated. Currently, (Brevoortia partonus), and predatory species, such
FDA makes no recommendations in this as the Florida pompano (Trachinotus carolinus),
guidance and has no specific guidance for Gulf kingfish (Menticirrhus littoralis), and spot
food processors with regard to controlling (Leiostomus xanthurus).]
the hazard associated with fish venom. Ad-
ditional information regarding venomous fish ASP is characterized by gastrointestinal symptoms
may be found in the “Venomous fish” chap- including: nausea, vomiting, abdominal cramps,
ter of the FDA’s Bad Bug Book, which can and diarrhea. These symptoms develop within 24
be found at the following website: https:// hours of consumption. In severe cases, neurological
www.fda.gov/food/foodborne-pathogens/ symptoms may also occur within 48 hours of
bad-bug-book-second-edition. consumption including: dizziness, headache,
seizures, disorientation, short-term memory
• Specific Information Associated with Recognized loss, respiratory difficulty, and coma. In severe
Natural Toxins in Molluscan Shellfish cases, ASP should be considered a potentially life-
threatening illness. There have been no confirmed
This section provides information regarding the cases of ASP in the U.S. since 1987, following
implicated molluscan shellfish, geographic regions, the implementation of effective seafood toxin-
and illness characteristics that have been historically monitoring programs.
associated with natural toxin poisoning syndromes.
However, it is important to note that historical Azaspiracid shellfish poisoning (from aza-
precedent may not be an adequate guide for future spiracids) is associated with consumption of bivalve
occurrences regarding geographic locations because molluscan shellfish. AZP was first recognized
the distribution of the source algae may vary over following a 1995 outbreak of severe gastroenteritis
time. Processors should always be alert to the in the Netherlands which was linked to the
potential for emerging hazards in harvest waters. consumption of mussels harvested in Ireland.
Since then, several outbreaks of AZP have been
ASP, AZP, DSP, NSP, and PSP are not considered reported in Europe. In 2008, two cases of AZP
a likely food safety hazard for scallops if only the were reported in the U.S., and traced to azaspiracid
adductor muscle is consumed. However, products contaminated mussels imported from Ireland. AZP
such as roe-on scallops and whole scallops do toxins have recently been reported for the first
present a potential hazard for natural toxins. time in Washington State but toxins in excess of
guidance levels have not been reported in any
Amnesic shellfish poisoning (from domoic acid) commercially harvested shellfish in the U.S. as of
has been associated with molluscan shellfish, crabs, August 2019.
and finfish species. It is most often associated with
the consumption of bivalve molluscan shellfish AZP is characterized by severe gastrointestinal
(e.g., mussels, scallops, and razor clams) from the disorders including: abdominal pain, nausea,
northeast and northwest coasts of North America. vomiting, and diarrhea. Symptoms develop
Domoic acid has also been identified in the viscera within a few hours following the consumption of
of lobster, Dungeness crab (Cancer magister), contaminated shellfish and can persist for several
Tanner crab (Chionoecetes bairdi), and Red Rock days. AZP illness is self-limiting and non-fatal.
crab (Cancer productus) in these regions. In recent

Chapter 6: Natural Toxins


6 - 4 (August 2019)
Diarrhetic shellfish poisoning (from okadaic Paralytic shellfish poisoning (from saxitoxins)
acid and dinophysistoxins) is generally associated in the U.S. is most often associated with the
with the consumption of bivalve molluscan shellfish consumption of bivalve molluscan shellfish (e.g.,
with outbreaks being reported worldwide. In 2008, clams, cockles, mussels, oysters, and scallops)
DSP toxin levels were documented in excess of the from the northeast and northwest coastal regions.
guidance level for the first time in several locations PSP in other parts of the world has been associated
along the Texas Gulf Coast during a large algal with molluscan shellfish from tropical to temperate
bloom which led to the first closure of shellfish waters.
harvest areas in the U.S.
Bivalve molluscan shellfish can retain the toxin
DSP and DSP-like illnesses have also been for different lengths of time. Some species
associated with shellfish harvested in the Pacific depurate toxins rapidly, whereas others are much
northwest of North America, including Puget Sound slower to depurate the toxins. This lengthens the
and the west coast of Canada. In addition to Texas period of time they pose a human health risk
and Washington State, harvesting closures due to from consumption. For example, most species
DSP toxins have recently occurred in Maine and of bivalves can eliminate the toxin within weeks;
Massachusetts. DSP toxins have now been found however, others such as Washington butter clams,
in shellfish from Alabama, California, Delaware, sea scallops, and Atlantic surfclams have been
Maryland, and New York; however, not above known to retain high levels of toxins for months
guidance levels in commercial growing areas as to more than five years.
of August 2019.
Certain predatory gastropods (e.g., conch, snails,
DSP is characterized by gastrointestinal symptoms and whelk) are also known to accumulate PSP
including: nausea, abdominal pain, vomiting, toxins by feeding on toxic bivalve molluscs. In
and diarrhea. In addition, headaches and fever particular, moon snails and whelk from the northeast
may also occur and are usually associated with U.S. are commonly found to contain PSP toxins.
dehydration. Symptoms typically develop within Gastropods can accumulate high concentrations of
3 hours after consuming contaminated shellfish toxin through their predation on toxic bivalves and
and may persist for several days. DSP is normally those concentrations can exceed the levels found
considered self-limiting and non-life threatening. in the bivalves. Since gastropods accumulate high
However, complications could occur as a result of concentrations of the toxins, they are a significant
severe dehydration in compromised individuals. risk to humans if consumed when harvested from
Due to the similarity of symptoms, DSP can be closed waters or waters where PSP has been found.
misidentified as a bacterial or viral illness. Gastropods may also retain the toxin for longer
periods of time than bivalve molluscan shellfish
Neurotoxic shellfish poisoning (from brev- since they are slow to depurate the toxin.
etoxins) in the U.S. is generally associated with
the consumption of bivalve molluscs (clams and Abalone from South Africa and Spain have been
oysters) from coastal waters of the Gulf of Mexico, reported to contain PSP toxins, although there
and, sporadically, along the southern Atlantic coast. have been no reports of the toxin in abalone
Gastropods (whelk) harvested from the Florida Gulf from U.S. waters. Similarly, PSP toxins have been
Coast have also caused NSP. In addition, there have reported in echinoderms (e.g., sea cucumbers) and
been occurrences of the toxins in New Zealand cephalopods (e.g., octopi and squid) harvested for
shellfish and reports of brevetoxin-producing algae human consumption from Australia and Portugal;
in other regions of the world. The largest recorded however, there have been no reports of PSP toxins
NSP outbreak occurred in New Zealand from 1992 in echinoderms or cephalopods from U.S. waters.
– 1993; cockles, green shell mussels, and oysters In the U.S., moon snails and whelks from the
were implicated in the outbreak. northeast U.S. are commonly found to contain PSP
toxins. PSP toxins have also been reported in the
NSP is characterized by gastrointestinal symptoms viscera of mackerel (Scomber scombrus), lobster
including diarrhea and vomiting. Neurological (Homarus spp.), Dungeness crab (Metacarcinus
symptoms include: tingling and numbness of the magister), Tanner crab (Chionoecetes bairdi), and
lips, tongue, and throat; muscular aches; and Red Rock crab (Cancer productus). While the viscera
dizziness. Symptoms develop within a few hours of mackerel are not usually consumed, the viscera
of consuming contaminated seafood. Treatment of lobsters and crabs may pose a health hazard
consists mainly of supportive care.

Chapter 6: Natural Toxins


6 - 5 (August 2019)
if harvested from contaminated waters. In 2008, and cyclic imines for processors’ Hazard Analysis
FDA advised against the consumption of American Critical Control Point (HACCP) plans.
lobster tomalley from New England waters due to
unusually high levels of PSP toxins. • Natural Toxin Controls
In 2002, the first reported case of PSP in the U.S. Natural toxins are odorless, tasteless, colorless,
from the consumption of puffer fish harvested from and temperature stable; therefore, they cannot
the central east coast of Florida was identified. be reliably eliminated through cooking or freezing.
PSP toxins were detected in southern (Sphoeroides
nephelus), checkered (Sphoeroides testudineus), Amnesic shellfish poisoning and paralytic
and bandtail (Sphoeroides spengleri) puffer fish. As shellfish poisoning in fish other than molluscan
a result, Florida Department of State has prohibited shellfish: Where ASP or PSP is a potential hazard
the taking of puffer fish (genus Sphoeroides) from in finfish or crustaceans, states have generally
the central east coast of Florida per rule 68B-3.007. closed or restricted fishing areas. Harvesters and
processors must rely on public announcements,
PSP symptoms can include: vomiting; abdominal postings, and advisories by state authorities to
pain; numbness, burning, or tingling of the face avoid harvesting or receiving finfish or crustacean
and extremities; incoherent speech; loss of from potential unsafe waters. In addition, removal
coordination and muscle paralysis; shortness of and destruction of the viscera may eliminate the
breath; and in severe cases respiratory paralysis. hazard, and at times is required by state public
Respiratory paralysis can result in death if ventilator health authorities. For example, eviscerating fish
support is not provided in a timely manner. The or harvesting the adductor muscle from the scallop
onset of symptoms can develop within 2 hours can eliminate the food safety hazards of ASP and/
post consumption of the PSP toxin contaminated or PSP.
seafood. PSP is an extremely potent toxin with a
high mortality rate in cases where medical support Ciguatera Fish Poisoning: Due to the nature of
is not available. CFP, a harvest water management system similar to
the molluscan shellfish system is not an appropriate
• Additional Toxins Found in Molluscan Shellfish control measure. Some states issue advisories
identifying endemic areas. For areas without an
A number of toxins identified in molluscan shellfish advisory system, fishermen and processors must
have shown toxicity in mouse studies but have not rely on their knowledge to avoid harvesting and
been linked to human illnesses. These toxins are receiving fish from areas where illnesses have been
as follows: associated. The state or local department of health
and/or associated departments of fisheries would
• Cyclic imines have been found in phyto-
be able to further assist in determining whether
plankton and/or molluscan shellfish in
harvest areas are free of ciguatoxins.
Canada, Denmark, New Zealand, Norway,
Scotland, Tunisia, and the U.S. Guidance levels have been established for Caribbean
• Pectenotoxins (PTX) have been detected in and Pacific CFP toxins (see Appendix 5) but at this
phytoplankton and/or molluscan shellfish time, these guidance levels are only used to confirm
in Australia, Italy, Japan, New Zealand, CFP as the cause of illnesses/outbreaks, to establish
Norway, Portugal, Spain, and the U.S. CFP endemic regions, and to determine potential
CFP-causing species based on the analysis of meal
• Yessotoxins (YTX) have been detected in
remnants involved in cases of CFP.
phytoplankton and/or molluscan shellfish
in Australia, Canada, Italy, Japan, New Molluscan Shellfish: To minimize the risk of
Zealand, Norway, the United Kingdom, and molluscan shellfish containing natural toxins from
the U.S. the harvest area, state and foreign government
Note: PTX and YTX have been found to co- agencies, called shellfish control authorities,
occur with DSP toxins (okadaic acid and manage harvesting activities, based in part on the
dinophysistoxins) in shellfish. presence of natural toxins in water and shellfish
meats. Shellfish control authorities may also use
At this time, FDA makes no recommendations cell counts of the toxin-forming algae in the harvest
in this guidance document and has no specific waters to manage shellfish harvest areas, and
expectations with regard to controls for PTX, YTX, in areas with no previous history of illnesses.

Chapter 6: Natural Toxins


6 - 6 (August 2019)
States must have a Biotoxin Contingency Plan molluscan shellfish. The information provided
that will provide information regarding actions to in this Guide and the historical occurrence
be taken if toxin-forming algae or natural toxins of a toxin in the fish or molluscan shellfish,
are likely or have been detected. Shellfish control where toxin levels exceed established guidance,
authorities exercise control over the molluscan should be utilized to make a determination
shellfish harvesters to ensure that harvesting takes whether these fish and molluscan shellfish
place only when and where shellfish are determined are harvested and received at the processor.
to be safe. In this context, molluscan shellfish Awareness of emerging geographic areas and
include oysters, clams, mussels, and scallops, additional species of fish should be monitored
except where the scallop product contains only and acted upon appropriately. Examples of
the shucked adductor muscle. fish species recently identified with the hazard
of natural toxins are lobster, specifically the
Other significant elements of shellfish control tomalley, containing PSP, anchovies containing
authorities’ efforts to manage the harvesting of ASP, and lionfish have been found with levels
molluscan shellfish include requirements that: of CFP that can cause illness.
• Molluscan shellfish harvesters be licensed
The following preventive measures for natural
(note that licensing may not be required in
toxins can be applied as appropriate:
all jurisdictions);
• Processors that ship, reship, shuck, or • Fish other than molluscan shellfish:
repack molluscan shellfish be certified; o Ensuring that incoming fish have not
• Containers of molluscan shellfish (shellstock) been caught in an area from which
bear a tag with the harvester’s identification harvesting is prohibited, restricted
number, type and quantity of shellfish, date due to the presence of a natural
of harvest, and harvest location; toxin, or where an advisory exists
such as for the presence of CFP.
AND
• Molluscan shellfish:
• Containers of shucked molluscan shellfish
bear a label with the processor’s name, o Ensuring that incoming molluscan
address, and certification number. shellfish (shellstock) are from an
Approved or Conditionally Approved
DETERMINE WHETHER THE POTENTIAL area in the open status;
HAZARD IS SIGNIFICANT o Ensuring that incoming molluscan
shellfish are properly tagged or
The following guidance will assist you in determining labeled; and
whether natural toxins are considered a significant o Ensuring that incoming molluscan
hazard at a processing step: shellfish are supplied by a licensed
harvester (where licensing is
1. Is it reasonably likely that unsafe levels of natural required by law) or by a certified
toxins will be introduced at this processing step dealer.
(e.g., is the natural toxin present in the raw
FDA requires both primary and secondary
material at an unsafe level)?
processors of raw molluscan shellfish to
Tables 3-2 and 3-3 in Chapter 3 identify the implement steps at receiving to assure that
species of vertebrate and non-vertebrate species their shellfish originate from safe sources.
of fish and molluscan shellfish for which natural
toxins are known to be a potential hazard. Under 2. Can natural toxins that were introduced at un-
ordinary circumstances, it would be reasonably safe levels at an earlier step be eliminated or
likely to expect that, without proper controls, reduced to an acceptable level here?
natural toxins from the harvest area could enter
the process at unsafe levels at the receiving Even though natural toxins should be considered
step for those species. There may be other a significant hazard at any processing step,
circumstances in a geographic area to conclude they are usually controlled at receiving by
that a particular natural toxin is reasonably the primary processor who has the ability
likely to occur at unsafe levels in those fish or to directly communicate with the harvester

Chapter 6: Natural Toxins


6 - 7 (August 2019)
to identify the harvest locations. FDA also identified as controls and are referred to in this
requires subsequent processors who receive raw chapter as:
molluscan shellfish to consider natural toxins
as a significant hazard. Similarly, the hazard • “Control Strategy Example 1 – Source
usually may be controlled at receiving where Control for Fish Other Than Molluscan
the processor has the ability to assure that the Shellfish” and
shellfish has originated from certified facilities.
• “Control Strategy Example 2 – Harvest Area
Since, natural toxins are not eliminated through Control for Molluscan Shellfish.”
cooking or freezing, subsequent processing steps
after receiving the potentially contaminated fish DEVELOP A CONTROL STRATEGY.
are unlikely to eliminate the hazard. Therefore,
if the fish or molluscan shellfish has been The following guidance provides two control strategy
identified as potentially containing the hazard examples for natural toxins. A control strategy
of natural toxins, and no measures were taken different from those suggested is acceptable,
to prevent its harvest from endemic areas, provided it complies with requirements of all
the processor should not accept the fish or applicable food safety laws and regulations.
molluscan shellfish.
The following are examples of control strategies
If a processor chooses to implement controls included in this chapter:
other than at the receiving step, those controls
must provide an equivalent assurance of safety
and should be supported by sound scientific
evidence. There are limited instances where
processing may in fact be able to remove
the toxin from the consumed part of the fish
or molluscan shellfish. These exceptions are
dependent on the type of fish or molluscan
shellfish, toxin, and process. Examples include
but are not limited to eviscerating the fish,
such as lobsters, crabs, and anchovies, or only
receiving the adductor muscle of scallops. Control Strategy May apply May apply
to primary to secondary
• Intended Use processor processor
Source control
In most cases, it is unlikely that the intended use
of the product would determine whether the hazard for fish other
of natural toxin is significant. An exception is with than molluscan
certain products where only the muscle tissue will shellfish
be consumed. For example, where the finished Harvest area
product is only the shucked adductor muscle of control for
the scallop, it is reasonable to assume that the molluscan
product will not contain natural toxins. In this case,
shellfish
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 during processing,


such as those described above, are not feasible,
the hazard of natural toxins should be controlled
at the receiving step. Two strategies have been

Chapter 6: Natural Toxins


6 - 8 (August 2019)
• CONTROL STRATEGY EXAMPLE 1 – SOURCE  Who Will Do the Monitoring?
COUNTROL FOR FISH OTHER THAN MOLLUSCAN
• Any person with an understanding of the
SHELLFISH nature of the controls and areas of restricted
This strategy only applies to primary processors fishing due to natural toxin hazard.
(processors that receive or off-load the fish from
the harvest vessel). Establish Corrective Action Procedures.
Take the following corrective action for a
Set Critical Limits. product involved in a critical limit deviation:
Suspect fish may not be received by the primary
• Reject the lot.
processor when harvest locations are:
AND
• Closed to fishing by foreign, federal, state,
tribal, territorial, or local authorities (e.g., Take the following corrective action to regain
certain counties in Florida for puffer fish); control of the operation after a critical limit
deviation:
OR
• Discontinue use of the supplier until evidence
• The subject of a consumption advisory
is obtained that harvesting practices have
for ASP, AZP, CFP, DSP, NSP, PSP, or other
changed through record review of harvest
naturally occurring toxins;
locations.
OR
Establish a Recordkeeping System.
• Known to be contaminated with ciguatoxin.
• Receiving record(s) that documents the
Establish Monitoring Procedures. location and status (e.g., prohibited,
restricted, or unrestricted) of the harvest
area.
 What Will Be Monitored?
• The status of the harvest location iden- Establish Verification Procedures.
tified on the harvest vessel records are
not restricted, subject of an advisory, • Review monitoring and corrective action
or prohibited from harvest based on records within 1 week of preparation to
governmental or other known resources, ensure they are complete and any deviations
or through declaration stating that the that occurred were addressed appropriately.
harvest area are free from natural toxins.
• Periodically monitor governmental and other
resources for the most current information
 How Will Monitoring Be Done? regarding harvest restrictions, advisories,
and fishing prohibitions due to natural
• Obtain assurances through visual exam-
toxins.
ination of the harvest records for the harvest
area location, or declaration identifying
the harvest area location is not under a
restriction, advisory or prohibition from
fishing.

 How Often Will Monitoring Be Done (Frequency)?


• Every lot of raw fish received from the
harvest vessel.

Chapter 6: Natural Toxins


6 - 9 (August 2019)
TABLE 6-1
Control Strategy Example 1 – SOURCE CONTROL FOR FISH OTHER THAN MOLLUSCAN SHELLFISH
This example table illustrates a hypothetical application of the control strategy just presented in “Control Strategy Example 1 – Source Control for Fish Other Than Molluscan
Shellfish.” The example illustrates the basic control for natural toxins by a primary processor receiving locally harvested grouper. 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 species or process related hazards.

Example Only: See Text for Full Recommendations

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

Monitoring
Critical
Significant What
Monitoring

How
Monitoring

Frequency
Monitoring

Who
Monitoring
Corrective
Control Critical Limits Records Verification
Hazard(s) Action(s)
Point
Receiving Natural Grouper may Harvest Visual Records for Receiving Reject lot Receiving Review
fresh fish - toxins - not be received vessel records examination of every lot employee record monitoring
Grouper ciguatoxin when a harvest to ensure harvest vessel of grouper with Discontinue use and
location is under harvest records for received knowledge of the supplier corrective
a regulatory or locations are harvest locations of harvest until evidence action
other ciguatoxin not identified and compared locations is obtained records
advisory, or for in a regulatory with known and hazard that harvesting within 1
which there is or other ciguatoxin practices week of
information from advisory, locations have changed preparation
a valid scientific or locations through
source that where examination of
ciguatoxin exists ciguatoxin harvest records
exist. compared to
location intel

Chapter 6: Natural Toxins


6 - 10 (August 2019)
• CONTROL STRATEGY EXAMPLE 2 – HARVEST • All molluscan shellfish must have been
AREA CONTROL FOR MOLLUSCAN SHELLFISH harvested from waters authorized for
harvesting by a shellfish control authority.
Set Critical Limits. For U.S. federal waters, no molluscan
shellfish may be harvested from waters
• All containers of shellstock received from a that are closed to harvesting by an agency
harvester must bear a tag identifying the: of the federal government;
o Date and place of harvest (by state Note: The National Shellfish Sanitation Program
and site), (NSSP) allows for harvest of surf clams
o Type and quality of shellfish, and quahogs in federal waters closed
due to the risk of PSP utilizing the
AND
onboard screening dockside testing
o By whom they were harvested (i.e., protocol. Refer to the NSSP for specific
the identification number assigned to requirements.
the harvester by the shellfish control
authority, where applicable or, if such AND
identification numbers are not assigned, • All molluscan shellfish must be from a
the name of the harvester or the name harvester that is licensed as required (note
or registration number of the harvester’s that licensing may not be required in all
vessel); jurisdictions) or from a processor that is
certified by a shellfish control authority.
OR
• For bulk shipments of shellstock where Note: Both primary and secondary processors
the shellstock is not containerized, the of molluscan shellfish are required to
shellstock must be accompanied by a bill implement source controls in their
of lading or similar shipping document that HACCP plans. Only the primary processor
contains the same information; needs to apply controls relative to the
identification of the harvester, the
OR
harvester’s license, or the approval
• All containers of shellstock received from a status of the harvest waters. The source
processor must bear a tag identifying the controls listed in this critical limit are
processor who supplied the shellstock and required under 21 CFR 123.28(c).
that discloses the:
o Date and place of harvest (by state Establish Monitoring Procedures.
and site),
 What Will Be Monitored?
o Type and quantity of shellfish,
AND • Information listed on tags, or on the bill
of lading, or similar shipping document
o The certification number of the
accompanying bulk shipments of shellstock
processor;
which includes at a minimum;
OR o Date of harvest;
• All containers of shucked molluscan shellfish o Location of harvest by state and site;
must bear a label identifying the packer or
o Quantity and type of shellfish;
repacker that identifies the:
o Name of the harvester, name or
o Name,
registration number of the harvester’s
o Address, vessel, or an identification number
AND issued to the harvester by the shellfish
control authority (for shellstock received
o Certification number of the packer or directly from the harvester only);
re-packer of the product;
o Number and date of expiration of the
AND harvester’s license, where applicable;

Chapter 6: Natural Toxins


6 - 11 (August 2019)
AND o At least three containers randomly
selected from every lot received;
o Certification number of the shipper,
where applicable. AND
AND • Checking licenses:
• Receiving information on whether the o Every delivery received.
harvest area is authorized for harvest by
a shellfish control authority or information  Who Will Do the Monitoring?
regarding closures of federal harvest waters • Any person with an understanding of the
by an agency of the federal government. nature of the controls and closures.
AND
Establish Corrective Action Procedures.
• The harvester’s license.
Take the following corrective action for a
OR product involved in a critical limit deviation:
• Information declared on labels on containers • Reject the lot.
of incoming shucked molluscan shellfish
such as: AND
o Name of the packer or repacker of the
Take the following corrective action to regain
product;
control of the operation after a critical limit
o Address of the packer or repacker of deviation:
the product;
• Discontinue use of the supplier until
AND evidence is obtained that harvesting and/
o The certification number of the packer or tagging practices have changed.
or re-packer of the product.
Establish a Recordkeeping System.
 How Will Monitoring Be Done?
For shellstock:
• Visual examination of the harvest area • Receiving record(s) that documents:
location through harvest records to ensure
o Date of harvest;
they are not from areas under a restriction,
advisory or prohibition from harvesting; o Location of harvest by state and site;
o Quantity and type of shellfish;
AND
o Name of the harvester, name of
• Obtain assurance from shellfish control
registration number of the harvester’s
authorities from the state or country in
vessel, or an identification number
which your shellstock are harvested that
issued to the harvester by the shellfish
the harvest area is open for harvest.
control authority (for shellstock received
directly for the harvester only);
 How Often Will Monitoring Be Done (Frequency)?
o Number and date of expiration of the
• Checking incoming tags:
harvester’s license, where applicable;
o Every container received;
AND
OR o Certification number of the shipper,
• Checking the bill of lading or similar shipping where applicable.
document: For shucked molluscan shellfish:
o Every delivery received:
• Receiving records that documents:
OR o Date of receipt;
• Checking incoming labels: o Quantity and type of shellfish;

Chapter 6: Natural Toxins


6 - 12 (August 2019)
AND
o Name and certification number of the
packer or re-packer.

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


6 - 13 (August 2019)
TABLE 6-2

Control Strategy Example 2 – HARVEST AREA CONTROL FOR MOLLUSCAN SHELLFISH


This example table illustrates a hypothetical application of the control strategy just presented in “Control Strategy Example 2 – Harvest Area Control for Molluscan Shellfish.” This
example illustrates how a primary processor of shellstock oysters, could control natural toxins 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 3-2 and 3-4 (Chapter 3) for other potential species or process related hazards.

Example Only: See Text for Full Recommendations

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

Monitoring
Critical
Significant Corrective
Control Critical Limits What How Frequency Who Records Verification
Monitoring Monitoring Monitoring Monitoring

Hazard(s) Action(s)
Point
Receiving Natural All incoming Information Visual checks Every sack Receiving Reject untagged Receiving Review
shellstock toxins shellstock must be on incoming employee sacks; record monitoring
tagged with the date shellstock and corrective
and place of harvest, tags AND action records
type and quantity within 1 week of
of shellfish, and preparation
name or registration Discontinue use
number of the of the supplier
harvester’s vessel until evidence
is obtained that
tagging practices
have changed

Chapter 6: Natural Toxins


6 - 14 (August 2019)
TABLE 6-2 (cont.)
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

Monitoring
Critical
Significant Corrective
Control Critical Limits What How Frequency Who Records Verification
Monitoring Monitoring Monitoring Monitoring

Hazard(s) Action(s)
Point
Receiving shellstock
All shellstock must Harvest site Visual checks; Every lot Receiving Reject lots from Review monitoring and corrective
action records within 1 week of

be harvested on tags employee unapproved


preparation

from an Approved Ask the shellfish waters;


or Conditionally control authority
Approved area from the state AND
or country
in which the Discontinue use
shellstock are of the supplier
harvested until evidence
whether is obtained
the area is that harvesting
authorized for practices have
harvest changed
Receiving shellstock
All shellstock must Harvester’s Visual check Every Receiving Reject delivery Review monitoring and corrective
action records within 1 week of

be from a licensed license for number and delivery employee from unlicensed
preparation

harvester expiration date from harvesters;


harvester
AND

Discontinue use
of the supplier
until evidence is
obtained that the
harvester has
secured a license

Chapter 6: Natural Toxins


6 - 15 (August 2019)
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 June 2018, 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 July 2018.

• Abraham, A., E. Jester, H. Granade, S. Plakas, and R. Dickey. 2012. Caribbean ciguatoxin profile in
raw and cooked fish implicated in ciguatera. Food Chemistry, 131(1);192-198.

• Arakawa, O., T. Noguchi, and Y. Onoue. 1995. Paralytic shellfish toxin profiles of xanthid crabs
Zosimus aeneus and Atergatis floridus collected on reefs of Ishigaki Island. Fish. Sci. 61(4):659−662.

• Azziz-Baumgartner, E., Luber, G., Conklin, L., Tosteson, T., Granade, H., Dickey, R., & Backer, L.
2012. Assessing the Incidence of Ciguatera Fish Poisoning with Two Surveys Conducted in Culebra,
Puerto Rico, during 2005 and 2006. Environmental Health Perspectives.

• Bakes, M. J., N. G. Elliott, G. J. Green, and P. D. Nichols. 1995. Variation in lipid composition of
some deep-sea fish (Teleostei: Oreosomatidae and Trachichthyidae). Comp. Biochem. Physiol B.
111(4):633−642.

• Braid, H., J. Deeds, S. DeGrasse, J. Wilson, J. Osborne, and R. Hanner. 2011. Preying on commercial
fisheries and accumulating paralytic shellfish toxins: a dietary analysis of invasive Dosidicus gigas
(Cephalopoda Ommastrephidae) stranded in Pacific Canada. Marine Biology. DOI 10.1007/s00227-
011-1786-4.

• Braidotti, G. June 2014. Seafood and the food-safety Golden Rules. Fisheries Research & Development
Corporation News. Vol 22 Number 2.

• 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.

• Deeds, J., J. Landsberg, S. Etheridge, G. Pitcher, and S. Longan. 2008. Non-Traditional Vectors for
Paralytic Shellfish Poisoning. Marine Drugs, ISSN: 1660-3397.

• Deshpande, S. S. 2002. Handbook of Food Toxicology, p 699-700.

• 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 ed.
CRC Press/Taylor & Francis.

• Dickey, R.W. and S.M. Plakas. 2010. Ciguatera: A public health perspective. Toxicon 56(2): 123-136.

• Dickey, R.W., S.M. Plakas, E. L. E. Jester, K.R. El Said, J.N. Johannessen, L.J. Flewelling, P. Scott,
D.G. Hammond, F.M.V. Dolah, T.A. Leighfield, M-YB Dachraoui, J.S. Ramsdell, R.H. Pierce, M.S.
Henry, M.A. Poli, C. Walker, J. Kurtz, J. Naar, D.G. Baden, S.M. Musser, K.D. White, P. Truman, A.
Miller, T.P. Hawryluk, M.M. Wekkell, D. Stirling M.A. Quilliam, J.K. Lee. 2004. Multi-laboratory study

Chapter 6: Natural Toxins


6 - 16 (August 2019)
of five methods for determination of brevetoxins in shellfish tissue extracts. Harmful Algae 2002.
St. Petersburg, FL USA: Florida Fish and Wildlife Conservation Commission, Florida Institute of
Oceanography, and Intergovernmental Oceanographic Commission of UNESCO. pp. 300-302.

• European Communities. 2002. Commission Decision of 15 March 2002. Laying down rules for the
implementation of Council Directive 91/492/EEC as regards the maximum levels and the methods
of analysis of certain marine biotoxins in bivalve molluscs, echinoderms, tunicates and marine
gastropods. Off. J. Eur. Communities. (2002/225/EC) L 75:62−63.

• Florida Department of State. 2004. Prohibition on Take of Puffer Fish in Volusia, Brevard, Indian
River, St. Lucie, and Martin Counties. Rule 68B-3.007.

• Food and Agriculture Organization.  2004.  In, FAO (ed), FAO Food and Nutrition Paper 80.  Risk
Assessment of Toxins Associated with PSP, DSP, and ASP in Seafood, pp 56-95.  3. Diarrhoeic Shellfish
Poisoning (DSP).  Food and Agriculture Organization of the United Nations, Rome.

• Food and Drug Administration: Guidance for Industry: “Purchasing Reef Fish Species Associated
with the Hazard of Ciguatera Fish Poisoning”, March 2013.

• Food and Drug Administration: Bad Bug Book, Foodborne Pathogenic Microorganisms and Natural
Toxins. Second Edition. 2012.

• Food Safety Authority of Ireland. August 2006. Risk assessment of azaspiracids (AZAs) in shellfish.
Food Safety Authority of Ireland, Dublin, Ireland.

• Friedman, M. A., L. E. Fleming, M. Fernandez, P. Bienfang, K. Schrank, R. Dickey, M. Y. Bottein, L.


Backer, R. Ayyar, R. Weisman, S. Watkins, R. Granade, and A. Reich. 2008. Ciguatera fish poisoning:
treatment, prevention, and management. Mar. Drugs 6:456−479.

• Friedman, M.A., M. Fernandez, L. Backer, R. Dickey, J. Bernstein, K. Schrank, S. Kibler, W. Stephan,


M.O. Gribble, P. Bienfang, R. Bowen, S. Degrasse, H. Flores-Quintana, C. Loeffler, R. Weisman,
D. Blythe, E. Berdalet, D. Ayyare, D. Clarkson-Towsend, K. Swajian, R. Benner, T. Brewer, and
L.E. Flemming. 2017. An Updated Review of Ciguatera Fish Poisoning: Clinical, Epidemiological,
Environmental, and Public Health Management. Mar. Drugs 15:1-41.

• Hall, S. and G. Strichartz (ed.). 1990. Marine toxins: origin, structure, and molecular pharmacology.
ACS Symposium Series 418. American Chemical Society, Washington, DC.

• Halstead, B. W. 1967. Poisonous and venomous marine animals of the world, vol. 2 - invertebrates.
U.S. Government Printing Office, Washington, DC.

• Halstead, B. W. 1988. Poisonous and venomous marine animals of the world, 2nd rev. ed. The
Darwin Press, Inc., Princeton, NJ.

• Hess, P., L. Nguyen, J. Aasen, M. Keogh, N. Keogh, J. Kilcoyne, P. McCarron, and T. Aune. 2005.
Tissue distribution, effects on cooking, and parameters affecting the extraction of azaspiracids from
mussels, Mytilus edulis, prior to analysis by liquid chromatography coupled to mass spectrometry.
Toxicon. 46:62−71.

• Hwang, D-F., and Y-H. Tsai. 1999. Toxins in toxic Taiwanese crabs. Food. Rev. 15(2):145−162.

• Hwang, D-F., Y-H. Tsai, T-J. Chai, and S-S Jeng. 1996. Occurrence of tetrodotoxin and paralytic
shellfish poison in Taiwan crab Zosimus aeneus. Fish. Sci. 62(3):500−501.

• James, K. A. C. and B. P. Treloar. 1984. Comparative effects of orange roughy (Hoplostethus atlanticus)
and snapper (Chrysophrys auratus) in the diets of growing rats. New Zealand J. Sci. 27:295−305.

Chapter 6: Natural Toxins


6 - 17 (August 2019)
• James, K. A. C., D. R. Body, and W. C. Smith. 1986. A nutritional evaluation of orange roughy
(Hoplostethus atlanticus) using growing pigs. New Zealand J. Tech. 2:219−223.

• James, K. J., A. Furey, M. Lehane, H. Ramstad, T. Aune, P. Hovgaard, S. Morris, W. Higman, M.


Satake, and T. Yasumoto. 2002. First evidence of an extensive northern European distribution of
azaspiracid poisoning (AZP) toxins in shellfish. Toxicon. 40:909−915.

• Kawai, N., Y. Nakayama, S. Matsuoka, and T. Mori. 1985. Lipid composition of various tissues of
Lepidocybium flavobrunneum. Yukagaku 34:25−31.

• Kim, J., U. Tillmann, N. Adams, B. Krock, W. Stutts, J. Deeds, M. Han, and V. Trainer. 2017. Identification
of Azadinuim species and a new azaspiracid from Azadinium poporum in Puget Sound, Washington
State, USA. Harmful Algae. 68: 152-167.

• Krishna, N, and J Wood. 2001. It looked like a myocardial infarction after eating crawfish.... Ever
heard of Haff disease? Louisiana Morbidity Report. May-June2001 Volume 12 Number 3.

• Lawrence, J. F., M. Maher, and W. Watson-Wright. 1994. Effect of cooking on the concentration of
toxins associated with paralytic shellfish poison in lobster hepatopancreas. Toxicon. 33(12):1669−1673.

• Lehane, L. 2000. Paralytic shellfish poisoning: a review. National Office of Animal and Plant Health
Agriculture, Fisheries and Forestry, Canberra, Australia.

• Lehane, L. and R. J. Lewis. 2000. Ciguatera: recent advances but the risk remains. Int. J. Food
Microbiol. 61:91–125.

• Ling, K. H., C. W. Cheung, S. W. Cheng, L. Cheng, S-L. Li, P. D. Nichols, R. D. Ward, A. Graham, and
P. P-H. But. 2008. Rapid detection of oilfish and escolar in fish steaks: a tool to prevent keriorrhea
episodes. Food Chem. 110:538−546.

• Lopes, V., A. Lopes, P. Costa, and R. Rosa. 2013. Cephalopods as Vectors of Harmful Algal Bloom
Toxins in Marine Food Webs. Marine Drugs.

• Martinez, A., J. M. Franco, I. Bravo, M. Mazoy, and E. Cacho. 1993. PSP toxicity in Haliotis tuberculata
from NW Spain, p. 419−423. In T. J. Smayda and Y. Shimizu (ed.), Toxic phytoplankton blooms in
the sea. Elsevier, Amsterdam, Netherlands.

• National Shellfish Sanitation Program (NSSP): Guide for the Control of Molluscan Shellfish 2013
Revision.

• Nichols, P. D., B. D. Mooney, and N. G. Elliott. 2001. Unusually high levels of non-saponifiable
lipids in the fishes escolar and rudderfish. Identification by gas chromatography and thin-layer
chromatography. J. Chromatogr A 936:183−191.

• Noguchi, T. and Y. Hashimoto. 1973. Isolation of tetrodotoxin from a goby Gobius criniger. Toxicon.
11:305−307.

• Ochiai, Y., S. Watabe, K. Hashimoto, H. Narita, Y. Ukishima, and M. Nara. 1984. Biochemical
identification of two gempylid fish causative of a food poisoning. Bull. Japan. Soc. Sci. Fish. 50:721−725.

• Olsen, D., D. Nellis, and R. Wood. 1984. Ciguatera in the Eastern Caribbean. Marine Fisheries Review.

• Perez-Zarza, M. C., V. Ruiz-Gutierrez, and L. Bravo. 1993. Lipid composition of two purgative fish:
Ruvettus pretiosus and Lepidocybium flavobrunneum. Grasas y Aceites 44:47−52.

• Pitcher, G. C., M. Franco, G. J. Doucette, C. L. Powell, and A. Mouton. 2001. Paralytic shellfish poisoning
in abalone Haliotis midae on the west coast of South Africa. J. Shellfish Res. 20(2):895−904.

Chapter 6: Natural Toxins


6 - 18 (August 2019)
• Poli, M., S. Musser, R. Dickey, P. Eilers, and S. Hall. 2000. Neurotoxic shellfish poisoning and brevetoxin
metabolites: a case study from Florida. Toxicon. 38:981−993.

• Robertson, A., D. Stirling, C. Robillot, L. Llewellyn and A. Negri. 2004. First report of saxitoxin in
octopi. Toxicon 44 (2004) 765-771.

• Saito, T., T. Kohama, K. Ui, and S. Watabe. 2006. Distribution of tetrodotoxin in the xanthid crab
(Atergatis floridus) collected in the coastal waters of Kanagawa and Wakayama prefectures. Comp.
Biochem. Physiol. D: Genomics and Proteomics 1(1):158−162.

• Satake, M., K. Ofuji, H. Naoki, K. James, A. Furey, T. McMahon, J. Silke, and T. Yasumoto. 1998. Azaspiracid,
a new toxin having unique spiro ring assemblies, isolated from Irish mussels, Mytilus edulis. J. Am.
Chem. Soc. 120: 9967−9968.

• Shui, L. M., K. Chen, K., J. Y. Wang, H. Z. Mei, A. Z. Wang, Y.-H. Lu, and D.-F. Hwang. 2003.
Tetrodotoxin-associated snail poisoning in Zhoushan: a 25-year retrospective analysis. J. of Food
Prot. 66(1):110−114.

• Sobel, J. and J. Painter. November 1, 2005. Illnesses caused by marine toxins. Food Safety Invited
Article. Clin. Infect. Dis. 41:1290−1296.

• Spark, A. A. and A. A. deWit. 1980. Wax esters in edible fish. Identification of wax esters, p. 45−47.
In Annual Report of the Fishing Industry Research Institute of South Africa, no. 34.

• Torgersen, T., J. Aasen, and T. Aune. 2005. Diarrhetic Shellfish Poisoning by okadaic acid esters from
Brown crabs (Cancer pagurus) in Norway. Toxicon 46 572-578.

• Toyofuku, H. 2006. FAO/WHO/IOC activities to provide scientific advice on marine biotoxins (research
report). Mar. Pollut. Bull. 52:1735−1745.

• Tsai, Y-H., D-F. Hwang, T-J. Chai, and S. S. Jeng. 1995. Occurrence of tetrodotoxin and paralytic
shellfish poison in the Taiwanese crab Lophozozymus pictor. Toxicon. 33(12):1669−1673.

• Tsai, Y-H., D-F. Hwang, T-J. Chai, and S. S. Jeng. 1996. Occurrence of paralytic shellfish toxin in
Taiwanese crab Atergatopsis germaini. Toxicon. 34(4):467−474.

• Twiner, M. J., N. Rehmann, P. Hess, G. J. Doucette. 2008. Azaspiracid shellfish poisoning: a review
on the chemistry, ecology, and toxicology with an emphasis on human health impacts. 6:39−72.

• Van Egmond, H. P., T. Aune, P. Lassus, G. Speijers, and M. Waldock. 1993. Paralytic and diarrhoeic
shellfish poisons: occurrence in Europe, toxicity, analysis and regulation. J. Nat. Toxins 2:41−83.

• Witers, N. 1988. Marine toxins and venoms. In A. T. Tu (ed.), Handbook of natural toxins, vol. 3.
Marcel Dekker, New York, NY.

• Yasumoto, T., and M. Murata. 1993. Marine toxins. Chem. Rev. 93:1897−1909.

Chapter 6: Natural Toxins


6 - 19 (August 2019)
NOTES:

Chapter 6: Natural Toxins


6 - 20 (August 2019)
CHAPTER 7: Scombrotoxin (Histamine) Formation
This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create
or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative
approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss
an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the
appropriate FDA staff, call the telephone number listed on the title page of this guidance.

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

CHAPTER 7: Scombrotoxin (Histamine) Formation

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

CHAPTER 7: Scombrotoxin (Histamine) Formation

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

CHAPTER 7: Scombrotoxin (Histamine) Formation

115
TABLE 7-1
RECOMMENDED MAXIMUM TIME TO GET SCOMBROTOXIN-FORMING FISH INTO CHILLING MEDIUM ONBOARD HARVEST VESSELS TO PREVENT
SCOMBROTOXIN FORMATION1

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

THE WATER AND THE AIR TEMPERATURE (°F) IS… DEATH OF THE FISH OR EARLIEST ESTIMATED ONBOARD LANDING IS…
TEMPERATURE (°F) IS… TIME OF DEATH IS…

FOR UNEVISCERATED FISH:

> 65 > 83 6 -­
> 83 Any 6 -­
> 65, but ≤ 83 ≤ 83 9 -­
2
≤ 65 > 83 -­ 6
≤ 652 ≤ 83 -­ 9

FOR FISH EVISCERATED ONBOARD BEFORE CHILLING:

> 65 Any 12 -­

116
≤ 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.

CHAPTER 7: Scombrotoxin (Histamine) Formation


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

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

CHAPTER 7: Scombrotoxin (Histamine) Formation

118
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

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

Fresh fish (not heat processed Previously frozen fish, or heat processed fish (that has been
or previously frozen) is … exposed to possible recontamination), is…
> 70 AT ANY TIME ≤4 ≤ 12
≤ 70 DURING ENTIRE EXPOSURE ≤8 ≤ 24

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

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

CHAPTER 7: Scombrotoxin (Histamine) Formation

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

contain unsafe levels of histamine upon to ensure that incoming fish were

receipt by the secondary processor (including properly handled onboard the

warehouses). In addition, you may need harvest vessel, including:

to exercise control to prevent pathogen ° Rapidly chilling the fish immediately


growth or toxin formation when receiving after death;

CHAPTER 7: Scombrotoxin (Histamine) Formation

121
° Controlling onboard refrigeration IDENTIFY CRITICAL CONTROL POINTS.
(other than frozen storage)

temperatures;
The following guidance will assist you in
° Performing proper onboard icing;
determining whether a processing step is a
• Testing incoming fish for
critical control point (CCP) for scombrotoxin
histamine levels;
(histamine) formation:

• Ensuring that incoming fish 1. If scombrotoxin (histamine) formation is a


were handled properly during significant hazard at the receiving step, you
refrigerated transportation from the should identify receiving as a CCP for this
previous processor, including: hazard.

° Controlling refrigeration temperatures a. If you are the primary processor of the


during transit;
scombrotoxin-forming fish (i.e., if you
° Performing proper icing during
receive the fish directly from the harvest
transit; vessel) and have a relationship with the
• Checking incoming fish to ensure
operator of the harvest vessel(s) from
that they are not at an elevated
which you purchase fish that enables
temperature at time of receipt;
you to obtain documentation of onboard
practices, you should identify the
• Checking incoming fish to ensure
following preventive measures for control
that they are properly iced or
of this hazard:
refrigerated at time of receipt;

• Examining harvest vessel records


• Performing sensory examination on
to ensure that incoming fish
incoming fish to ensure that they do
were properly handled onboard
not show signs of decomposition;
the harvest vessel, including:
• Controlling refrigeration

temperatures in your plant;

˚ Rapidly chilling the fish


immediately after death;
• Performing proper icing in your plant; ˚ Controlling onboard refrigeration
(other than frozen storage)

• Controlling the amount of time that the


temperatures;

product is exposed to temperatures


that would permit histamine ˚ Performing proper onboard icing;

formation during processing. • Checking incoming fish to ensure


These preventive measures are ordinarily employed that they are not at an elevated
at receiving, processing, and storage steps. temperature at time of receipt; and,
• Performing sensory examination of
• Intended use
incoming fish to ensure that they do
Because of the heat stable nature of histamine, not show signs of decomposition.
the intended use of the product is not likely to
affect the significance of this hazard. Example:
A mahi-mahi processor that regularly
purchases from the same harvest
vessels should require harvest vessel
records as a condition of purchase.

CHAPTER 7: Scombrotoxin (Histamine) Formation

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

CHAPTER 7: Scombrotoxin (Histamine) Formation

123
Example: • Receiving;
A mahi-mahi processor should • Processing, such as:
control histamine formation
by limiting exposure time and ° Thawing;

temperature of the product during ° Brining and salting;


processing. The processor should ° Smoking;
then set CCPs for histamine ° Heading and gutting;
formation at the processing steps.
° Manual filleting and steaking;
This control approach is a control strategy ° Fermenting;
referred to in this chapter as “Control
Strategy Example 4 - Processing Control.”
° Pickling;

This control strategy is intended for ° Drying;


processing at ambient and air-conditioned ° Stuffing;
temperatures. “Control Strategy ° Mixing (e.g., salad preparation);
Example 5 - Storage Control” may be
° Portioning;
more appropriate for processing under
• Packaging;
refrigerated conditions.
• Final chilling after processing

3. If scombrotoxin (histamine) formation is a


and packaging;

significant hazard at a storage step for raw


material, in-process product, or finished product, • Storing raw material, in-process product,
you should identify the storage step(s) as a CCP and finished product under refrigeration.
for this hazard. Note: Rather than identify each processing step as an individual
CCP when the controls are the same at those steps, it may be more
a. The preventive measures for this type of convenient to combine into one CCP those processing steps that
together contribute to a cumulative time and temperature exposure.
control are:

• Controlling refrigeration • Unlikely CCPs


temperatures in your plant or, Time and temperature controls will usually
not be needed at processing steps that meet
• Performing proper icing
the following conditions:
in your plant.
• Continuous, mechanical processing
Example:
steps that are brief, such as:
A mahi-mahi processor should control
histamine formation by icing the ° Mechanical filleting;
product during raw material, in-process • Processing steps that are brief and
product, and finished product storage. unlikely to contribute significantly
The processor should then set CCPs for to the cumulative time and
histamine formation at the storage steps. temperature exposure, such as:
This control approach is a control strategy ° Date code stamping;
referred to in this chapter as “Control
Strategy Example 5 - Storage Control.”
° Case packing;
• Processing steps where the product
• Likely CCPs is held in a frozen state, such as:
Following is further guidance on processing ° Assembly of orders for distribution;
steps that are likely to be identified as CCPs
for this hazard:
° Frozen product storage;

CHAPTER 7: Scombrotoxin (Histamine) Formation

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

CHAPTER 7: Scombrotoxin (Histamine) Formation

125
the fish) necessary to achieve a cooling (10°C) or below;

rate that will prevent development of


OR

an unsafe level of histamine in the


specific species, as established through a • For fish held iced or refrigerated (not frozen)
scientific study. onboard the vessel from 12 to less than 15
hours after death:
Note: If the actual time of death is not known, an estimated time
of the first fish death in the set may be used (e.g., the time the ˚ The internal temperature should be 60°F
deployment of a longline begins). Table 7-1 provides a summary of (15.6°C) or below;

the preceding recommended critical limits.


OR

AND

• For fish held iced or refrigerated (not frozen)


˚ For fish held refrigerated (not frozen)
onboard the vessel less than 12 hours after
onboard the vessel: death:
• The fish were stored at or below ˚ The internal temperature should
40°F (4.4°C) after cooling; be sufficiently below water and air
OR temperatures to indicate that appropriate
chilling methods were implemented
• The fish were stored completely onboard the harvest vessel. Chilling
and continuously surrounded of the fish should begin on the harvest
by ice after cooling; vessel regardless of the time from death
AND until off-loading from the vessel by the
processor unless the environmental
Sensory examination:
conditions (e.g., air and water
• Sensory examination of a representative temperatures) are below 40°F (4.4°C)
sample of scombrotoxin-forming fish shows from the time of death until off-loading
decomposition (persistent and readily from the vessel by the processor;
perceptible) in less than 2.5% of the fish in
OR
the sample. For example, no more than 2
fish in a sample of 118 fish may show signs • For fish held iced or refrigerated (not frozen)
of decomposition. Note that the FFD&C onboard the vessel:
Act prohibits interstate commerce of any ˚ Elapsed time from death and internal
decomposed fish whether or not the HACCP temperatures at the time of off-loading
critical limit has been exceeded; from the vessel by the processor should
be consistent with cooling curves that
AND
will prevent development of an unsafe
Internal temperature measurements: level of histamine in the specific species,
• For fish held iced or refrigerated (not frozen) as established through a scientific study.
onboard the vessel 24 or more hours after
death: Establish Monitoring Procedures.
˚ The internal temperature should be 40°F
» What Will Be Monitored?
(4.4°C) or below;

Harvest vessel records containing the following


OR

information:
• For fish held iced or refrigerated (not frozen)
• Method of capture*;
onboard the vessel from 15 to less than 24
hours after death: AND
• Where applicable to the critical limit, the
˚ The internal temperature should be 50°F

CHAPTER 7: Scombrotoxin (Histamine) Formation

126
date and time of landing the fish onboard • The presence of ice that completely
the harvest vessel; and continuously surrounds the fish.
AND (*These items may be documented by the primary (first) processor,
on the receiving records, rather than by the harvest vessel operator,
• Where applicable to the critical limit, the on the harvest vessel records, provided the primary processor has
estimated earliest date and time of death for direct knowledge about those aspects of the harvesting practices and
has made first-hand observations for each lot received. The vessel
fish brought onboard in the fishing set (e.g.,
operator should document other onboard handling information. The
trawl, gillnet, longline, or purse seine); primary processor should maintain all relevant information.)

AND AND
• Where applicable to the critical limit, the
Sensory examination:
air and water temperatures at the time of
landing the fish onboard the harvest vessel*; • Amount of decomposition in the lot;

AND AND
• Where applicable to the critical limit, the Internal temperature measurement:
water temperature at the depth where dead • For fish held iced or refrigerated (not frozen)
fish may remain until harvest; onboard the vessel:

AND ˚ The internal temperature of a

• Where applicable to the critical limit, the representative number of the largest

method of cooling* and temperature of the fish in the lot at the time of off-loading

cooling medium; from the harvest vessel, concentrating on

any fish that show signs of having been

AND mishandled (e.g., inadequately iced);

• Where applicable to the critical limit, the


AND

date and time cooling began and/or the date


and time when the last fish in a fishing set ˚ Date and time of off-loading.

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


was placed in the cooling medium; A primary processor receives
AND bluefish from several day-boats
that catch the fish when the air
• Where applicable to the critical limit, those
and water temperatures are below
factors of the cooling process that have been
83°F (28.3°C). The day-boats take
established through a scientific study as critical
on ice at the processor’s facility
to achieving the cooling rate critical limits (e.g.,
immediately before setting out for the
refrigerated brine or seawater temperature, fish
day and return within 9 hours to the
size, fish to brine/seawater/ice ratio, maximum
processor’s facility with the iced catch.
initial temperature of the fish);
The processor monitors and records
AND the date and time of departure of
• For fish held iced or refrigerated (not frozen) the vessels after they take on ice; the
onboard the vessel: date and time of the return of the
vessels; the ambient water and air
˚ The storage temperature, as evidenced by:
temperatures of the fishing grounds;
• The temperature of refrigerated and the adequacy of icing of the
seawater or brine in which catch at the time of off-loading. The
the fish are stored; processor also conducts sensory
OR evaluations and checks the internal

CHAPTER 7: Scombrotoxin (Histamine) Formation

127
temperature of the catch upon arrival. of the fish. Randomly select fish from
The harvest vessel operators perform throughout the lot. Lots that show a high
no monitoring or record keeping. level of temperature variability or lots
of very small fish may require a larger
» How Will Monitoring Be Done? sample size;
• For harvest vessel records:
AND
˚ Review controls documented in the
records;
˚ Visually determine the date and time of
off-loading.
AND

• For sensory examination:


» How Often Will Monitoring Be Done (Frequency)?
• Every lot of scombrotoxin-forming fish
˚ Examine at least 118 fish, collected
received.
representatively throughout each lot (or the
entire lot, for lots smaller than 118 fish). » Who Will Do the Monitoring?
Additional fish should be examined if
• For sensory examination:
variability in fish-to-fish histamine content
is expected to be high. Lots should ˚ Any person who is qualified by
consist of only one species of fish; for experience or training to perform the
vessels delivering multiple species, testing examination;
should generally be done separately on AND
each species. All fish within a lot should • For other checks:
have a similar history of harvest. If the
fish are received frozen, this monitoring ˚ Any person who has an understanding of
the nature of the controls.
procedure may be performed by a
sensory examination on the warmed flesh
Establish Corrective Action Procedures.
produced by drilling the frozen fish (drill
method). It may also be performed after Take the following corrective actions to a product
thawing, rather than at receipt; involved in a critical limit deviation:

AND • In the absence of harvest vessel records or


when one of the harvester-related critical
• For fish held iced or refrigerated (not frozen)
limits has not been met, or when the internal
onboard the vessel:
temperature critical limit at receiving has not
˚ Use a temperature-indicating device been met:
(e.g., a thermometer) to measure the
internal temperature of a representative ˚ Chill and hold the affected lot (i.e.,
fish of common origin) until histamine
number of the largest fish in each
analysis is performed on a minimum
lot, concentrating on any that show
of 60 fish representatively collected
signs of having been mishandled (e.g.,
from throughout the lot, including any
inadequately iced). For example,
fish measured to have temperatures
when receiving 10 tons or more of fish,
that exceeded the critical limit (or the
measure a minimum of one fish per ton,
entire lot for lots smaller than 60 fish).
and when receiving less than 10 tons of
Reject the lot if any fish are found with
fish, measure a minimum of one fish per
histamine greater than or equal to 50
1,000 pounds. Measure a minimum of
ppm. The fish collected for analysis
12 fish, unless there are fewer than 12
may be composited for analysis if the
fish in the lot, in which case measure all
action point is reduced accordingly. For

CHAPTER 7: Scombrotoxin (Histamine) Formation

128
example, a sample of 60 fish may be Establish a Recordkeeping System.
composited into 20 units of 3 fish each, • Harvest vessel records containing the
provided the action point is reduced information described above;
from 50 ppm to 17 ppm for each unit;
AND
OR

• Receiving records showing the date and time


˚ Reject the lot;
of off-loading;
AND AND
• When the sensory examination critical limit • Results of sensory examination;
has not been met:
AND
˚ Chill and hold the affected lot (i.e.,
• For fish held iced or refrigerated (not frozen)
fish of common origin) until histamine
analysis is performed on a minimum onboard the vessel:

of 60 fish representatively collected ˚ Internal temperatures of the fish.

from throughout the lot, including all


fish in the lot that show evidence of Establish Verification Procedures.
decomposition (persistent and readily • Collect a representative sample of the raw
perceptible odors) (or the entire lot for material, in-process product, or finished
lots smaller than 60 fish), and reject the product, and analyze it for histamine at least
lot if any fish is found with histamine quarterly;
greater than or equal to 50 ppm;
AND
AND
• Ensure that new sensory examiners receive
˚ If any fish in the lot are to proceed training to calibrate their ability to identify
into commerce for food use, perform decomposed fish and that all sensory
a sensory examination of all fish in the examiners receive periodic refresher training;
lot to ensure that no decomposed fish
proceed; AND
• Where histamine testing is part of a
AND
corrective action plan, periodically verify
˚ Any individual fish found to be the findings (e.g., by comparing results with
decomposed (persistent and readily those obtained using an Association of
perceptible) should be destroyed or Official Analytical Chemists (AOAC) method);
diverted to a non-food use;
AND
OR

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


˚ Reject the lot.
a thermometer) is put into service, check
AND the accuracy of the device to verify that the
factory calibration has not been affected.
Take the following corrective action to regain control
This check can be accomplished by:
over the operation after a critical limit deviation:
• Discontinue use of the supplier until ˚ Immersing the sensor in an ice slurry
(32°F (0°C)), if the device will be used at
evidence is obtained that the identified
or near refrigeration temperature;
harvesting and onboard practices and
controls have been improved. OR
˚ Comparing the temperature reading
on the device with the reading on a

CHAPTER 7: Scombrotoxin (Histamine) Formation

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

CHAPTER 7: Scombrotoxin (Histamine) Formation

130
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 that
receives 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 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 MONITORING
CRITICAL LIMITS
SIGNIFICANT CORRECTIVE
CONTROL FOR EACH RECORDS VERIFICATION
HAZARD(S) WHAT HOW FREQUENCY WHO ACTION(S)
POINT PREVENTIVE
MEASURE
Receiving Scombrotoxin All lots received are accompanied Harvest vessel Review of Every Receiving Reject Harvester Perform histamine analysis on
fresh formation by harvest vessel records that show records controls lot supervisor the lot vessel 1 incoming lot every 3 months
mahi­ documented received records (18 fish per sample)
(1) placement of fish on ice
mahi on in the records Discontinue
within 9 hours of death if the
ice from use of the Review monitoring, corrective
maximum exposure temperature
harvest supplier action, and verification records
does not exceed 83°F or within 6
vessels until within 1 week of preparation
hours if the maximum exposure

131
evidence
temperature exceeds 83°F;
is obtained
(2) The fish were stored that
completely and continuously harvesting
surrounded by ice after capture and
Less than 2.5% decomposition Amount Sensory Every Quality onboard Receiving Provide sensory training
(persistent and readily perceptible) of examination lot control practices record for new fish examiners and

CHAPTER 7: Scombrotoxin (Histamine) Formation


in the incoming lot decomposition (118 fish per received staff and annual training for all fish
in the incoming lot; or all fish controls examiners
lot in the lot if have been
less than 118 improved Review monitoring, corrective
fish) action, and verification records
within 1 week of preparation
Internal temperatures of all fish Internal Digital Every Receiving Receiving Check the digital thermometer
are to meet the following criteria temperature thermometer lot supervisor record for accuracy and damage and
based on the time since the death of the fish at (1 fish/1,000 received to ensure that it is operational
of the fish: time of pounds; before putting it into operation;
>24 hours g ≤ 40° off-loading minimum of perform these same checks
15 to < 24 hours g ≤ 50° from vessel; 12 fish per daily, at the beginning of
12 to < 15 hoursg ≤ 60° lot) operations; and calibrate it once
< 12 hours g below ambient Date and time per year
air and water temperatures of off-loading
commensurate with size of fish and Review monitoring, corrective
time since death action, and verification records
within 1 week of preparation
• CONTROL STRATEGY EXAMPLE 2 - HISTAMINE ˚ The internal temperature should be 50°F
TESTING (10°C) or below;

It may be necessary to select more than one OR

control strategy in order to fully control the • For fish held iced or refrigerated (not frozen)
hazard, depending upon the nature of your onboard the vessel from 12 to less than 15
operation. hours after death:
Set Critical Limits. ˚ The internal temperature should be 60°F
(15.6°C) or below;

The critical limits for this control strategy should


include three components: OR

• Histamine testing; • For fish held iced or refrigerated (not frozen)


onboard the vessel less than 12 hours after
• Sensory examination;
death:
• Internal temperature measurements.
˚ The internal temperature should
Histamine testing: be sufficiently below water and air
• Analysis of a representative sample of temperatures to indicate that appropriate
scombrotoxin-forming fish shows less than chilling methods were implemented
50 ppm histamine in all fish in the sample; onboard the harvest vessel. Chilling
of the fish should begin on the harvest
AND
vessel regardless of the time from death
Sensory examination: until off-loading from the vessel by the
• Sensory examination of a representative processor, unless the environmental
sample of scombrotoxin-forming fish shows conditions (e.g. air and water
decomposition (persistent and readily temperatures) are below 40°F (4.4°C)
perceptible) in less than 2.5% of the fish in from the time of death until off-loading
the sample. For example, no more than 2 from the vessel by the processor;
fish in a sample of 118 fish may show signs OR
of decomposition. Note that the FFD&C
• For fish held iced or refrigerated (not frozen)
Act prohibits interstate commerce of any
onboard the vessel:
decomposed fish whether or not the HACCP
critical limit has been exceeded; ˚ Elapsed time from death and internal
temperatures at the time of off-loading
AND from the vessel by the processor should
Internal temperature measurements: be consistent with cooling curves that
will prevent development of an unsafe
• For fish held iced or refrigerated (not frozen)
level of histamine in the specific species,
onboard the vessel 24 or more hours after
as established through a scientific study.
death:
˚ The internal temperature should be 40°F
Establish Monitoring Procedures.
(4.4°C) or below;

OR
» What Will Be Monitored?
• For fish held iced or refrigerated (not frozen) Histamine testing:
onboard the vessel from 15 to less than 24 • Histamine content in the scombrotoxin­
hours after death: forming fish flesh;
AND

CHAPTER 7: Scombrotoxin (Histamine) Formation

132
Sensory examination: • For sensory examination:
• Amount of decomposition in the ˚ Examine at least 118 fish, collected
scombrotoxin-forming fish lot; representatively throughout each lot
(or the entire lot, for lots smaller than
AND
118 fish). Additional fish should be
Internal temperature measurement: examined if variability in fish-to-fish
• For scombrotoxin-forming fish held iced or histamine content is expected to be high.
refrigerated (not frozen) onboard the vessel: Lots should consist of only one species
of fish; for vessels delivering multiple
˚ The internal temperature of a
species, testing should generally be
representative number of the largest

fish in the lot at the time of off-loading


done separately on each species. If the
from the harvest vessel by the processor,
fish are received frozen, this monitoring
concentrating on any fish that show
procedure may be performed by a
signs of having been mishandled (e.g.,
sensory examination on the warmed
inadequately iced);
flesh produced by drilling the frozen fish
(drill method). It may also be performed
AND
after thawing, rather than at receipt;
˚ Date and time of off-loading.

AND
» How Will Monitoring Be Done? • For fish held iced or refrigerated (not frozen)
• For histamine analysis: onboard the vessel:

˚ Test a minimum of 18 fish, collected ˚ Use a temperature-indicating device


representatively throughout each lot (or (e.g., a thermometer) to measure the
the entire lot when there are fewer than internal temperature of a representative
18 fish in the lot). Additional fish should number of the largest fish in each
be examined if variability in fish-to-fish lot, concentrating on any that show
histamine content is expected to be high. signs of having been mishandled (e.g.,
Lots should consist of only one species inadequately iced). For example,
of fish; for vessels delivering multiple when receiving 10 tons or more of fish,
species, testing should generally be done measure a minimum of one fish per ton,
separately on each species. Reject the and when receiving less than 10 tons of
lot if any fish are found with histamine fish, measure a minimum of one fish per
greater than or equal to 50 ppm. The 1,000 pounds. Measure a minimum of
fish collected for analysis may be 12 fish, unless there are fewer than 12
composited if the critical limit is reduced fish in the lot, in which case measure all
accordingly. For example, a sample of of the fish. Randomly select fish from
18 fish may be composited into 6 units throughout the lot. Lots that show a high
of 3 fish each, provided the critical limit level of temperature variability or lots
is reduced from 50 ppm to 17 ppm for of very small fish may require a larger
each unit; sample size;

AND AND
˚ Visually determine the date and time of
off-loading.

CHAPTER 7: Scombrotoxin (Histamine) Formation

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

» Who Will Do the Monitoring? AND

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

of 60 fish may be composited into


20 units of 3 fish each, provided ˚ Reject the lot.

the action point is reduced from AND


50 ppm to 17 ppm for each unit;

CHAPTER 7: Scombrotoxin (Histamine) Formation

134
Take the following corrective action to regain control traceable thermometer) under conditions

over the operation after a critical limit deviation: that are similar to how it will be used (e.g.,

• Discontinue use of the supplier until evidence product internal temperature) within the

is obtained that the identified harvesting and temperature range at which it will be used;

onboard practices have been improved. OR

Establish a Recordkeeping System. ˚ Following the manufacturer’s instructions;

AND
• Receiving records showing:
• Once in service, check the temperature-
˚ Date and time of off-loading;
indicating device daily before the beginning
AND of operations. Less frequent accuracy checks
• Results of histamine analysis; may be appropriate if they are recommended
by the instrument manufacturer and the history
AND
of use of the instrument in your facility has
• Results of sensory examination; shown that the instrument consistently remains
AND accurate for a longer period of time. In
• For fish held iced or refrigerated (not frozen) addition to checking that the device is accurate
onboard the vessel:
by one of the methods described above, this
process should include a visual examination of
˚ Internal temperatures of the fish.

the sensor and any attached wires for damage


or kinks. The device should be checked to
Establish Verification Procedures. ensure that it is operational;
• Periodically verify histamine findings (e.g., by
AND
comparing results with those obtained using
an AOAC method or by analyzing proficiency • Calibrate the temperature-indicating device
samples); against a known accurate reference device
(e.g., a NIST-traceable thermometer) at
AND least once a year or more frequently if
• Ensure that new sensory examiners receive recommended by the device manufacturer.
training to calibrate their ability to identify Optimal calibration frequency is dependent
decomposed fish and that all sensory upon the type, condition, past performance,
examiners receive periodic refresher training; and conditions of use of the device.
AND Consistent temperature variations away from
the actual value (drift) found during checks
• Before a temperature-indicating device (e.g.,
and/or calibration may show a need for more
a thermometer) is put into service, check
frequent calibration or the need to replace
the accuracy of the device to verify that the
the device (perhaps with a more durable
factory calibration has not been affected.
device). Calibration should be performed at
This check can be accomplished by:
a minimum of two temperatures that bracket
˚ Immersing the sensor in an ice slurry the temperature range at which it is used;
(32°F (0°C)), if the device will be used at
or near refrigeration temperature; AND
• Review monitoring, corrective action,
OR
and verification records within 1 week of
˚ Comparing the temperature reading on preparation to ensure they are complete and
the device with the reading on a known any critical limit deviations that occurred
accurate reference device (e.g., a NIST- were appropriately addressed.

CHAPTER 7: Scombrotoxin (Histamine) Formation

135
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 that
receives 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 MONITORING
CRITICAL LIMITS
SIGNIFICANT
CONTROL FOR EACH CORRECTIVE ACTION(S) RECORDS VERIFICATION
HAZARD(S) WHAT HOW FREQUENCY WHO
POINT PREVENTIVE
MEASURE

Receiving Scombrotoxin Less than Fish flesh for Histamine testing Every lot Quality Reject the lot; Reports of Do a quarterly
frozen formation 50 ppm histamine using the AOAC received assurance histamine comparison of histamine
tuna from histamine in content 977.13 method staff Discontinue use of the supplier analysis test results with AOAC
harvest all fish in the on a minimum until evidence is obtained method

136
vessels sample of 18 fish per that harvesting and onboard
lot (36 fish from practices have been improved Review
vessels with monitoring,
high variability If the initial histamine sample corrective action, and
of histamine was <50 ppm, perform verification records
detected histamine analysis on a within 1 week of
between fish min, of 60 fish, collected preparation

CHAPTER 7: Scombrotoxin (Histamine) Formation


or when 1 of representatively from the lot
the first 18 fish and reject the lot if any fish
exceeds 30 ppm contains ≥50 ppm histamine;
histamine) and if all fish <50 ppm
Less than 3 Amount of Sensory Every lot Quality Conduct sensory evaluation of Sensory Provide sensory training
decomposed decomposition examination (118 received assurance all fish in the lot, removing and examination for new fish examiners
fish in the fish per lot, or all staff destroying all decomposed fish record and annual training for
(persistent incoming lot fish if lot is less all fish examiners
and readily than 118 fish) Discontinue use of the supplier
perceptible) until evidence is obtained Review monitoring,
in a 118-fish that harvesting and onboard corrective action, and
sample practices have been improved verification records
within 1 week of
preparation
• CONTROL STRATEGY EXAMPLE 3 - TRANSIT a controlled temperature environment) of 4
CONTROL hours or less (optional control strategy):
It may be necessary to select more than one ˚ Time of transit does not exceed 4 hours;
control strategy in order to fully control the hazard, AND
depending upon the nature of your operation.
˚ Internal temperature of the fish at the
Set Critical Limits. time of delivery does not exceed 40°F
(4.4°C).
• For fish delivered refrigerated (not frozen):
Note: Processors receiving fish with transit times of 4 hours or less may
˚ All lots received are accompanied by elect to use one of the controls described for longer transit times instead.
transportation records that show that the
fish were held at or below an ambient Establish Monitoring Procedures.
or internal temperature of 40°F (4.4°C)
throughout transit. Note that allowance » What Will Be Monitored?
for routine refrigeration defrost cycles may • For scombrotoxin-forming fish delivered
be necessary; refrigerated (not frozen):
OR ˚ The internal temperature of the fish
• For fish delivered under ice: throughout transportation;

˚ Fish are completely surrounded by ice at OR


the time of delivery;

˚ The ambient temperature within the truck


OR
or other carrier throughout transportation;
• For fish delivered under ice on an open-bed OR
truck: • For scombrotoxin-forming fish delivered under
˚ Fish are stored completely surrounded by ice:
ice;
˚ The adequacy of ice surrounding the
AND product at the time of delivery;

˚ The internal temperature of the fish at the OR

time of delivery is 40°F (4.4°C) or below; • For scombrotoxin-forming fish delivered under
OR ice on an open-bed truck:
• For fish delivered under chemical cooling ˚ The adequacy of ice surrounding the
media such as gel packs:
product at the time of delivery;

˚ There is an adequate quantity of


AND
cooling media that remain frozen to
have maintained product at an internal
˚ The internal temperature of the fish at
time of delivery;

temperature of 40°F (4.4°C) or below


throughout transit; OR

• For scombrotoxin-forming fish held under


AND
chemical cooling media such as gel packs:
˚ The internal temperature of the fish at the
˚ The quantity and frozen status of cooling
time of delivery is 40°F (4.4°C) or below;
media at the time of delivery;
OR
AND
• For fish delivered refrigerated (not frozen)
with a transit time (including all time outside ˚ The internal temperature of the fish at the
time of delivery;

CHAPTER 7: Scombrotoxin (Histamine) Formation

137
OR ˚ Make visual observations of the
• For scombrotoxin-forming fish delivered adequacy and frozen state of the cooling

refrigerated (not frozen) with a transit time of media in a representative number of

4 hours or less: containers (e.g., cartons and totes) from

throughout the shipment;

˚ The date and time fish were removed


from a controlled temperature AND

environment before shipment and the


date and time delivered;
˚ Use a temperature-indicating device (e.g.,

a thermometer) to determine internal


AND product temperatures in a representative
number of fish from throughout the
˚ The internal temperature of a representative
shipment, at delivery;
number of fish at the time of delivery.
OR
» How Will Monitoring Be Done?
• For fish delivered refrigerated (not frozen)
• For fish delivered refrigerated (not frozen): with a transit time of 4 hours or less:
˚ Use a continuous temperature-recording
˚ Review carrier records to determine the
device (e.g., a recording thermometer) date and time fish were removed from

for internal product temperature or a controlled temperature environment

ambient air temperature monitoring before shipment and the date and time

during transit; delivered;

OR AND

• For fish delivered under ice:


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

˚ Make visual observations of the adequacy a thermometer) to determine internal


of ice in a representative number of product temperatures in a representative
containers (e.g., cartons and totes) from number of fish randomly selected from
throughout the shipment, at delivery; throughout the shipment, at delivery.
OR Measure a minimum of 12 fish, unless
there are fewer than 12 fish in a lot, in
• For fish delivered under ice on an open-bed
which case measure all of the fish. Lots
truck:

that show a high level of temperature


˚ Make visual observations of the
variability or lots of very small fish may
adequacy of ice surrounding the product
require a larger sample size.
in a representative number of containers

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


» How Often Will Monitoring Be Done (Frequency)?
the shipment, at delivery;
• Every scombrotoxin-forming fish lot received.
AND
» Who Will Do the Monitoring?
˚ Use a temperature-indicating device (e.g.,
• For continuous temperature-recording
a thermometer) to determine internal devices:
product temperatures in a representative
number of fish from throughout the ˚ Monitoring is performed by the device itself.
The visual check of the data generated
shipment, at delivery;
by the device, to ensure that the critical
OR limits have consistently been met, may
• For fish delivered under chemical cooling be performed by any person who has an
media such as gel packs: understanding of the nature of the controls;

CHAPTER 7: Scombrotoxin (Histamine) Formation

138
OR • The number of containers examined
• For other checks: and the sufficiency of ice for each;

˚ Any person who has an understanding of AND


the nature of the controls.
• The number of containers in the lot;

Establish Corrective Action Procedures. OR

Take the following corrective action to a product ˚ For chemical cooling media checks:

involved in a critical limit deviation: • The number of containers


• Chill and hold the affected lot until histamine examined and the frozen status
analysis is performed on a minimum of of the cooling media for each;
60 fish representatively collected from AND
throughout the lot, including any with
temperatures that exceeded a critical limit • The number of containers in the lot;
and any fish observed to have been exposed AND
to inadequate cooling media (or the entire lot
for lots smaller than 60 fish). Reject the lot if
˚ Results of internal product temperature
monitoring, where applicable, including:
any fish is found with histamine greater than
or equal to 50 ppm. • The number of containers
examined and the internal
The fish collected for analysis may be temperatures observed for each;
composited if the action point is reduced
accordingly. For example, a sample of 60 fish AND
may be composited into 20 units of 3 fish • The number of containers in the lot;
each, provided the action point is reduced
AND
from 50 ppm to 17 ppm for each unit;
OR ˚ Date and time fish were initially
removed from a controlled temperature
• Reject the lot. environment and the date and time fish
AND were delivered, when applicable.

Take the following corrective action to regain control Establish Verification Procedures.
over the operation after a critical limit deviation:
• Before a temperature-indicating device (e.g.,
• Discontinue use of the supplier or carrier a thermometer) is put into service, check
until evidence is obtained that the identified the accuracy of the device to verify that the
transportation-handling practices have been factory calibration has not been affected.
improved. This check can be accomplished by:

Establish a Recordkeeping System. ˚ Immersing the sensor in an ice slurry


(32°F (0°C)), if the device will be used at
• Receiving records showing: or near refrigeration temperature;
˚ For continuous temperature monitoring:
OR
• Printouts, charts, or readings from
temperature-recording devices (e.g., ˚ Comparing the temperature reading on
the device with the reading on a known
temperature recorder);
accurate reference device (e.g., a NIST-
OR
traceable thermometer) under conditions
that are similar to how it will be used
˚ For ice checks:

CHAPTER 7: Scombrotoxin (Histamine) Formation

139
(e.g., product internal temperature)
the device with the reading on a known
within the temperature range at which it
accurate reference device (e.g., a NIST-
will be used;
traceable thermometer) under conditions that
are similar to how it will be used (e.g., air
OR

temperature) within the temperature range at


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

CHAPTER 7: Scombrotoxin (Histamine) Formation

140
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)

MONITORING
CRITICAL
CRITICAL LIMITS
SIGNIFICANT
CONTROL FOR EACH CORRECTIVE ACTION(S) RECORDS VERIFICATION
HAZARD(S)
POINT PREVENTIVE WHAT HOW FREQUENCY WHO
MEASURE

Receiving Scombrotoxin Adequate Quantity Visual observation Every lot Receiving Reject the lot Receiving Check the
formation quantity of and frozen of a minimum of received clerk record thermometer for
frozen gel condition of 25% of shipping Discontinue use of the accuracy and

141
packs to gel packs containers in the supplier or carrier until damage, and to
maintain the lot but not fewer evidence is obtained that ensure that it
product at than 12 containers transportation-handling is operational
40°F or less (or all containers if practices have been before putting
throughout lot has less than 12 improved into operation;
transit; and containers) perform these
same checks daily

CHAPTER 7: Scombrotoxin (Histamine) Formation


at the beginning
of operations, and
Internal Internal core Digital thermometer Every lot Receiving Reject the lot Receiving calibrate it once per
temperatures temperature for internal received clerk record year
of all fish at and a temperature of Discontinue use of the
delivery are near-surface one fish in 25% of supplier or carrier until Review
40°F or below temperature shipping containers evidence is obtained that monitoring,
of each fish but not fewer than transportation-handling corrective action,
12 containers (or practices have been and verification
all containers if lot improved records within 1
has less than 12 week of preparation
containers)
• CONTROL STRATEGY EXAMPLE 4 - PROCESSING ˚ The fish are not exposed to ambient
CONTROL temperatures above 40°F (4.4°C) for
It may be necessary to select more than one more than 12 hours, cumulatively, if any
control strategy in order to fully control the portion of that time is at temperatures
hazard, depending upon the nature of your above 70°F (21.1°C);
operation. OR
Set Critical Limits. ˚ The fish are not exposed to ambient
temperatures above 40°F (4.4°C) for
• During processing (e.g., butchering, more than 24 hours, cumulatively, as
cleaning, brining, salting, smoking, drying, long as no portion of that time is at
fermenting, pickling, mixing, fermenting, temperatures above 70°F (21.1°C).
stuffing, packing, labeling, and staging) of
Note: Only one of the two limits above should be selected. They
scombrotoxin-forming fish that have not should not be added for a total exposure of 36 hours.
been previously frozen or heat processed
sufficiently to destroy scombrotoxin-forming Establish Monitoring Procedures.
bacteria:
» What Will Be Monitored?
˚ The fish are not exposed to ambient
• The length of time the scombrotoxin-forming
temperatures above 40°F (4.4°C) for
more than 4 hours, cumulatively, if any fish are exposed to unrefrigerated conditions
portion of that time is at temperatures (i.e., above 40°F (4.4°C));
above 70°F (21.1°C); AND
OR • The ambient temperatures during the
exposure periods.
˚ The fish are not exposed to ambient
temperatures above 40°F (4.4°C) for Note: If the critical limit is based on an assumption that temperatures
more than 8 hours, cumulatively, as may exceed 70°F (21.1°C), then only the length of exposure may
need to be monitored.
long as no portion of that time is at
temperatures above 70°F (21.1°C). » How Will Monitoring Be Done?
Note: Only one of the two limits above should be selected. They • Make visual observations of the length of
should not be added for a total exposure of 12 hours.
time of product exposure to unrefrigerated
OR conditions (i.e., above 40°F (4.4°C));
• During processing (e.g., thawing, butchering, AND
cleaning, brining, mixing, fermenting,
• Measure ambient air temperature, using:
stuffing, packing, labeling, and staging)
of scombrotoxin-forming fish or fishery ˚ A continuous temperature-recording
products that have been (1) previously device (e.g., a recording thermometer)

frozen or (2) heat processed sufficiently to located in the processing area;

destroy scombrotoxin-forming bacteria and OR

are processed in a manner where there is


an opportunity for recontamination with
˚ A temperature-indicating device (e.g., a

thermometer) located in the processing


scombrotoxin-forming bacteria (e.g., contact area.
with fresh fish, employees, or introduction
Note: Where multiple processing locations are combined in a
of raw ingredients), such as in a tuna salad cumulative exposure control strategy, temperature monitoring may be
made from canned tuna with added raw needed in each of the processing locations.
ingredients:

CHAPTER 7: Scombrotoxin (Histamine) Formation

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

OR
˚ For a temperature-indicating device:

• Return the affected product to the cooler;


• At least every 2 hours.
AND

CHAPTER 7: Scombrotoxin (Histamine) Formation

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

˚ Comparing the temperature reading on • Review monitoring, corrective action,


the device with the reading on a known and verification records within 1 week of
accurate reference device (e.g., a NIST- preparation to ensure they are complete and
traceable thermometer) under conditions any critical limit deviations that occurred
that are similar to how it will be used (e.g., were appropriately addressed.
air temperature) within the temperature
range at which it will be used;
AND
• Once in service, check the temperature-
indicating device or temperature-recording
device daily before the beginning of
operations. Less frequent accuracy checks
may be appropriate if they are recommended

CHAPTER 7: Scombrotoxin (Histamine) Formation

144
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 processor
that 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 MONITORING
CRITICAL LIMITS
SIGNIFICANT CORRECTIVE
CONTROL FOR EACH RECORDS VERIFICATION
HAZARD(S) WHAT HOW FREQUENCY WHO ACTION(S)
POINT PREVENTIVE
MEASURE

Processing Scombrotoxin The product Time of product Visual tracking Every batch of Quality control Ice and hold Processing Review
(butchering, formation is not out of exposure to of time for a fish supervisor the record monitoring,
cleaning, refrigeration unrefrigerated marked batch removed from affected batch corrective
packaging, for more conditions of product to raw material in raw material action, and

145
labeling, and than 4 hours during move from raw cold storage for cooler verification
boxing) cumulatively processing material cold processing records within
operations storage to final Perform 1 week of
product cold histamine preparation
storage analysis on a
minimum of
60 fish in the

CHAPTER 7: Scombrotoxin (Histamine) Formation


affected batch

Destroy the
entire batch
if any fish
exceeds
50 ppm
histamine

Modify the
process, if
necessary, to
reduce delays
• CONTROL STRATEGY EXAMPLE 5 - STORAGE Establish Monitoring Procedures.
CONTROL
» What Will Be Monitored?
It may be necessary to select more than one
control strategy in order to fully control the • For refrigerated storage of scombrotoxin­
hazard, depending upon the nature of your forming fish:

operation. ˚ The temperature of the cooler;

Set Critical Limits. OR


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

OR ˚ Monitoring is performed by the device


itself. The visual check of the data
• For raw material, in-process product, or generated by the device, to ensure that
finished product stored under ice:
the critical limits have consistently been
˚ The product is completely and
met, may be performed by any person
continuously surrounded by ice who has an understanding of the nature
throughout the storage time. of the controls;

CHAPTER 7: Scombrotoxin (Histamine) Formation

146
OR OR
• For other checks: ˚ Make adjustments to the ice application
operations.
˚ Any person who has an understanding of
the nature of the controls.
Establish a Recordkeeping System.
Establish Corrective Action Procedures. • For refrigerated storage:
Take the following corrective action to a product ˚ Printouts, charts, or readings from
involved in a critical limit deviation: continuous temperature-recording

devices;

• Chill and hold the product until it can


be evaluated based on its total time and AND

temperature exposure, including exposures


during prior processing operations.
˚ Record of visual checks of recorded data;

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

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
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 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 MONITORING
CRITICAL LIMITS
SIGNIFICANT CORRECTIVE
CONTROL FOR EACH RECORDS VERIFICATION
HAZARD(S) WHAT HOW FREQUENCY WHO ACTION(S)
POINT PREVENTIVE
MEASURE

Raw material Scombrotoxin Maximum Cooler Time and Continuous, Production Ice and hold the Data Check the
and finished formation cooler temperature temperature with a visual supervisor affected product logger data logger for
product cold temperature of data logger check of inside the cooler printout accuracy and
storage (shared 40°F recorded data damage and to

149
cooler) once per day Check ensure that it
sufficiency of ice is operational
on the product before putting
two times per into operation;
day until cooler perform these
is functioning checks daily, at
reliably the beginning

CHAPTER 7: Scombrotoxin (Histamine) Formation


of operations;
Perform and calibrate it
histamine analysis once per year
on a minimum
of 60 fish Review
representative monitoring,
of the affected corrective
product action, and
verification
Destroy all records within
affected 1 week of
product if any fish preparation
exceeds 50 ppm
histamine

Adjust and repair


cooler as needed
BIBLIOGRAPHY. seafood science). Elsevier, New York, NY.
• Fletcher, G. C., G. Summers, and P. W. C.
We have placed the following references on van Veghel. 1998. Levels of histamine and
display in the Division of Dockets Management, histamine-producing bacteria in smoked fish
Food and Drug Administration, 5630 Fishers from New Zealand markets. J. Food Prot.
Lane, rm. 1061, Rockville, MD 20852. You may 61(8):1064-1070.
see them at that location between 9 a.m. and 4 • Frank, H. A., and D. H. Yoshinaga. 1984.
p.m., Monday through Friday. As of March 29, Histamine formation in tuna, p. 443-451. In
2011, FDA had verified the Web site address for E. Ragelis (ed.), Seafood toxins. American
the references it makes available as hyperlinks Chemical Society, Washington, DC.
from the Internet copy of this guidance, but FDA • Frank, H. A., D. H. Yoshinaga, and W.
is not responsible for any subsequent changes Nip. 1981. Histamine formation and
to Non-FDA Web site references after March 29, honeycombing during decomposition of
2011. skipjack tuna. Katsuwonus pelamis, at
• Arnold, S., and D. Brown. 1978. Histamine elevated temperatures. Mar. Fisheries Rev.
toxicity from fish products. Adv. Food Res. 43(10):9-14.
24:113-154. • Hernández-Herrero, M. M., A. X. Roig-Sagués,
• Baranowski, J. D., H. A. Frank, P. A. Brust, J. J. Rodríguez-Jerez, and M. T. Mora-Ventura.
M. Chongsiriwatana, and R. J. Premaratne. 1999. Halotolerant and halophilic histamine-
1990. Decomposition and histamine content forming bacteria isolated during the ripening
in mahimahi (Coryphaena hippurus). J. Food of salted anchovies (Engraulis encrasicholus).
Prot. 53(3):217−222. J. Food Prot. 62(5):509-514.
• Behling, A. R., and S. L. Taylor. 1982. • Inestia, C. 1973. Significance and detection
Bacterial histamine production as a function of histamine in food, p. 327-347. In
of temperature and time of incubation. J. Microbiological safety of food. Academic
Food Sci. 47:1311-1317. Press, New York, NY.
• Bjeldanes, L. F., D. E. Schultz, and M. M. • Lehane, L., and J. Olley. 2000. Review:
Morris. 1978. On the aetiology of scombroid histamine fish poisoning revisited. Int. J.
poisoning: cadaverine potentiation of Food Microbiol. 58:1-37.
histamine toxicity in the guinea pig. Food • Predy, G., L. Honish, W. Hohn, and S. Jones.
Cosmet. Toxicol. 16:157-159. 2003. Was it something she ate? Case report
• Brillantes, S., S. Paknol, and A. Totakien. and discussion of scombroid poisoning. Can.
2002. Histamine formation in fish sauce Med. Assoc. J. 168(5):587-588.
production. J. Food Sci. 67:2090-2094. • Silva, C. C. G., J. B. Da Ponte, and M. L. N.
• Concon, J. (ed.), 1988. Food toxicology, p. Enes Dapkevicius. 1998. Storage temperature
511-605. Marcel Dekker, Inc., New York, NY. effect on histamine formation in big eye tuna
• Eitenmiller, R., and S. DeSouza. 1984. and skipjack. J. Food Sci. 63(4):644-647.
Enzymatic mechanisms for amine formation • Staruszkiewicz, W. F. April 2007. Report
in fish, p. 431-442. In E. Ragelis (ed.), on the 2005 Hawaii Bigeye Tuna Research
Seafood toxins. American Chemical Society, Project. Effects of onboard fish handling on
Washington, DC. the formation of histamine.
• Farn, G., and C. Sims. 1987. Chemical indices • Staruszkiewicz, W. F., J. D. Barnett, P. L.
of decomposition in tuna, p. 175-184. In D. Rogers, R. A. Benner, Jr., L. L. Wong, and
Kramer and J. Liston (ed.), Seafood quality J. Cook. 2004. Effects of on-board and
determination (Book 15 of Developments in
CHAPTER 7: Scombrotoxin (Histamine) Formation

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

CHAPTER 7: Scombrotoxin (Histamine) Formation

151
NOTES:

CHAPTER 7: Scombrotoxin (Histamine) Formation

152

CHAPTER 8: Other Decomposition-Related Hazards

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

• Farn, G., and C. Sims. 1987. Chemical indices


of decomposition in tuna, p. 175-184. In D.
Kramer and J. Liston (ed.), Seafood quality
determination (Book 15 of Developments in
food science). Elsevier, New York, NY.
• Guillén, M. D., and E. Goicoechea. 2008.
Toxic oxygenated alpha, beta-unsaturated
aldehydes and their study in foods: a review.
Crit. Rev. Food Sci. Nutr. 48:119-136.
• Kubow, S. 1992. Routes of formation and
toxic consequences of lipid oxidation
products in foods. Free Radic. Biol. Med.
12:63-81.
• Lehane, L., and J. Olley. 2000. Review:
histamine fish poisoning revisited. Int. J.
CHAPTER 8: Other Decomposition-Related Hazards

154
CHAPTER 9: Environmental Chemical Contaminants and Pesticides

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

CHAPTER 9: Environmental Chemical Contaminants and Pesticides

155
In the case of molluscan shellfis