Annex 1 Seafood Reference

Natural Toxins¹

Natural Toxins	Type of fish (species)	Control
Paralytic Shellfish Poisoning (PSP)	Molluscan Shellfish N.E. and N.W. coastal regions of N. America	NSSP approved waters (tags(1)) (FDA ICSSL listing)
Neurotoxic Shellfish Poisoning (NSP)	Molluscan Shellfish harvested along coast of Gulf of Mexico	NSSP approved waters (tags) (FDA ICSSL listing)
Diarrhetic Shellfish Poisoning (DSP)	Molluscan Shellfish	NSSP approved waters (tags)2 (FDA ICSSL listing)
Amnesic Shellfish Poisoning (ASP)	Molluscan Shellfish N.E. & N.W. coasts of N. America	NSSP approved waters (tags)2 (FDA ICSSL listing)
Ciguatera Fish Poisoning (CFP)	fin fish from extreme S.E. U.S., Hawaii, Subtropical and Tropical areas: barracuda amberjack horse-eye jack black jack other larger species of jack king mackerel large groupers large snappers	Purchase from approved sources: get fish from areas that are not subject of a CFP advisory, or get fish from an area known by you or your supplier to be free of CFP problems
Gempylotoxin, a strong purgative oil (can cause severe diarrhea)	Escolar	FDA recommendation: Escolar should not be marketed in interstate commerce
Tetrodotoxin	Puffer Fish or Fugu, usually from Indo-Pacific ocean, however some noted from Atlantic Ocean, Gulf of Mexico and Gulf of California	Illegal to import or receive (exemption: an agreement with one N.Y. importer)

Fish Considered to be Scombrotoxin-Forming Species³

Toxin Formation	Species - Market Names	Control
Scombrotoxin formation as a result of time/temperature abuse	Most scombroid poisonings from tuna, mahi-mahi and bluefish. Other species are: Amberjack or yellowtail Anchovy Bluefish Bonito Escolar or Snake Mackerel Gemfish Herring (not River herring) Jack Jobfish Kahawai Mackerel (not Atka) Mahi-Mahi Marlin Pilchard or Sardine Sardine Saury Shad & roe Shad, Gizzard Snapper (Pristipomoides ssp) Sprat or Bristling Trevally Tuna Wahoo	Buy from approved federally inspected suppliers. They are required to receive, hold, and process using a HACCP system. Check for an adequate quantity of ice or other cooling media. If not, a federally inspected supplier or directly from a fishing boat, check for the following at receipt: an adequate quantity of ice or other cooling media the time the fish were caught (from the vessel or supplier) internal temperatures of the fish expected for safety: * 50°F (10°C) or below if delivered 12 or more hours after death. * 40°F (4.4°C) or below if the fish are delivered 24 hours or more after death. Control temperature after receipt Note following table for safe shelf-life time and temperature guidelines.

Approximate Safe Shelf Life for Scombrotoxin-Forming
Species at Various Storage Temperatures³

Product Temperature	Shelf Life (Days) with Rapid Cooling	Shelf Life (Days) with Delayed Cooling
0°F (-17.8°C)	No limit	No limit
32°F (0°C)	14	8
38°F (3.3°C)	10	7
40°F (4.4°C)	7	5
50°F (10°C)	3	0
70°F (21.1°C)	0	0
90°F (32.2°C)	0	0

Parasites⁴

Parasites(2)	Type of fish/species likely to be used in menu items that will not be cooked	Control
nematodes or roundworm cestodes or tapeworms trematodes or flukes	Sea bass Capelin & roe Cod Flounder   - Dab   - Fluke Grouper Halibut Herring Jack Jobfish Kahawai Mackerel Monkfish Mullet Chilean Sea Bass Ocean Perch Plaice Pollock Rockfish Sablefish Salmon & roe (aquacultured and wild) Seatrout Sole Sprat/Bristling Trout/steelhead/rainbow Tuna, small Turbot Wolfish	Purchase from a processor, require the raw fish to have been frozen: -4°F (-20°C) or below for 7 days or -31°F (-35°C) or below for 15 hours Freezing can be done in your operation if it is done in accordance with the Food Code, Chapter 3.

Some products that have been implicated in human infection are:

ceviche lomi lomi poisson cru

salmon roe sashimi sushi

green herring drunken crabs cold smoke fish

undercooked grilled fish

²The tags must contain a unique state issued "certification number" specific for each certified dealer. If the firm is engaged in interstate commerce, this number appears in FDA's Interstate Certified Shellfish Shippers List (ICSSL).

³Fish & Fisheries Products Hazards & Controls Guide: Second Edition, January, 1998, Chapter 7.

⁴Fish & Fisheries Products Hazards & Controls Guide: Second Edition, January, 1998, Chapter 5.

NOTICE: This is a Draft document to guide operators in voluntarily applying HACCP principles in food establishments in the retail segment. It will be trial tested in a structured FDA pilot. The pilot, Notice of which will appear in the Federal Register, is an open process and as experience is gained from the various phases of that pilot, this Guide will be modified. The Agency recognizes that this document has areas that need to be further clarified and developed with broader input and based on industry's experiences with the practicalities of integrating the HACCP approach in their operations. The Guide will continue to evolve and improve. It is anticipated that the field application of this guidance document will identify additional processes, special food considerations, or other facets of a HACCP program that need to be addressed. It is also expected, as reflected in the Annex, that the listing of commodity-specific haza developing their HACCP systems. The Agency fully recognizes the diversity of "retail food establishments" and their varying in-house resources to implement HACCP. That recognition is combined with an understanding that the success of such implementation is dependent upon identifying realistic and useful ways of making it happen that are customized to the operation. FDA is open to record keeping applications that minimize the burden of instituting a HACCP system while providing the added consumer protection. FDA is most interested in receiving comments from parties who may review or use this Guide either within the pilot program or outside of that process. Of particular interest to the Agency are alternative ways of controlling hazards, input regarding special food considerations as described in Annex 2, and specific comments with respect to providing additional practical HACCP guidance for the retail industry. To submit comments, please photocopy the pages of concern, mark them up with your suggested changes, and forward them to: Dr. John E. Kvenberg HACCP Policy Strategic Manager (HFS-10) Office of Policy, Planning and Strategic Initiatives Food and Drug Administration 200 C Street, S. W. Washington, DC 20204