Seafood HACCP Plan for Restaurants: Parasites, Histamine and Shellfish Tags

A seafood HACCP plan is something many restaurant owners assume they need because they have heard about the federal seafood HACCP rule. That rule applies to seafood processors, not restaurants. Restaurant seafood safety comes mainly from the FDA Food Code, as adopted by your state, with a few seafood-specific requirements that are easy to miss: parasite destruction for raw fish, histamine control, shellstock tags, and special rules for vacuum-packed fish.

This guide sorts out who needs what, explains each seafood hazard and its control, and shows how to write the seafood section of a restaurant or fish counter plan. It is written for US restaurants, sushi bars, oyster bars, seafood markets and caterers. The result is a draft for your health department to review.

Who the federal seafood HACCP rule covers

FDA's seafood HACCP regulation is 21 CFR Part 123. It requires processors of fish and fishery products to conduct a hazard analysis and, where hazards are reasonably likely, to have a written HACCP plan, along with sanitation monitoring. "Processing" is defined broadly, including handling, storing, preparing, freezing, packing, labeling and holding.

The same definitions section, 21 CFR 123.3, lists what the regulation does not apply to, and the operation of a retail establishment is on that list. Restaurants and retail fish counters that sell to consumers are therefore not covered by Part 123. Their seafood controls come from the state food code.

If you sell fish to other businesses (smoked salmon to cafés, portioned fish to other restaurants), you may become a processor. Talk to FDA or your state agency before you start wholesale sales.

Where the FDA hazards guide helps anyway

FDA publishes the Fish and Fishery Products Hazards and Controls Guidance. It is written for processors, but it is the most detailed public source on seafood hazards by species. Restaurant teams can use it to look up which hazards apply to a species they buy, such as which fish are associated with parasites, histamine, or natural toxins.

Seafood under the FDA Food Code

The FDA Food Code 2022 has several sections specific to seafood:

• Parasite destruction for fish served raw or undercooked (3-402.11) and records (3-402.12).
• Shellstock identification and tag retention (3-203.11, 3-203.12).
• Approved sources for fish and shellfish (3-201.14 to 3-201.16).
• Reduced oxygen packaging of fish (3-502.12), which has extra restrictions.
• Cooking of fish to 145°F for 15 seconds (3-401.11).
• Consumer advisory for raw and undercooked animal foods (3-603.11).

A written HACCP plan is required under 8-201.13 when you use a special process, such as smoking fish for preservation or reduced oxygen packaging, or ask for a variance. Most restaurants that simply cook and serve fish are not required to have one, but writing the seafood section into your overall plan is good practice. See when a HACCP plan is required.

Seafood hazards and their controls

Parasites in fish served raw

Some fish carry parasites such as roundworms and tapeworms. Cooking kills them. If you serve fish raw, undercooked, marinated or partly cooked (sushi, sashimi, ceviche, crudo, tartare, cold-smoked fish), the Food Code requires parasite destruction by freezing before service, unless the fish is exempt. The freezing options in 3-402.11 are:

• Frozen and stored at -4°F or below for a minimum of 168 hours (7 days) in a freezer.
• Frozen at -31°F or below until solid and stored at -31°F or below for a minimum of 15 hours.
• Frozen at -31°F or below until solid and stored at -4°F or below for a minimum of 24 hours.

Some species and products are exempt, including molluscan shellfish, some tuna species, and certain aquacultured fish raised under controlled conditions and fed formulated feed, with supplier documentation. Check the current exemptions in the code you follow and keep any supplier letters on file.

Most restaurant freezers do not reach -31°F, and many do not reliably hold -4°F. That is why many sushi restaurants buy fish already frozen by the supplier and keep the supplier's written statement. Section 3-402.12 requires records:

• If you freeze fish yourself, keep freezing temperature and time records.
• If the supplier freezes it, keep a written agreement or statement from the supplier that it was frozen to the required standard.
• For aquacultured fish relying on the exemption, keep the supplier's written statement.
• Keep these records for 90 calendar days beyond the time of service or sale.

This is the most commonly cited seafood issue in sushi inspections. If you serve raw fish, the records must be in the building.

Histamine (scombrotoxin)

Certain fish, including tuna, mahi-mahi, mackerel, bluefish, sardines and anchovies, can form histamine when they are kept too warm after catch. Histamine causes scombrotoxin poisoning, with symptoms such as flushing, headache, rash and nausea shortly after eating. Cooking, freezing and canning do not destroy histamine once it forms.

Controls in a restaurant:

• Approved suppliers who keep fish cold from boat to door.
• Receiving checks: fish at 41°F or below, or frozen solid. Reject anything warm, soft or with an off odor. Note that you cannot smell histamine reliably; temperature history is the real control.
• Cold holding at 41°F or below at all times.
• Short time out of refrigeration during cutting and prep.

21 CFR 123.3 defines scombroid toxin-forming species and the FDA hazards guide lists them by name, which helps when you add a new species.

Pathogens in raw molluscan shellfish

Raw oysters, clams and mussels can carry Vibrio bacteria and norovirus from their growing waters. Cooking reduces the risk; raw service relies on sourcing and cold control.

• Buy only from certified shippers listed on the Interstate Certified Shellfish Shippers List or approved by your state.
• Receive shellstock at an air temperature of 45°F or below, with an internal temperature of 50°F or below, as the Food Code allows, then cool to 41°F.
• Keep each container's tag attached until the container is empty, then keep the tag for 90 calendar days, in order by date.
• Do not mix shellstock from different tags in one container.
• Post a consumer advisory for raw oysters.

Pathogens in cooked seafood

Cooked fish and shellfish are TCS foods. Cook to 145°F for 15 seconds (3-401.11), then hold hot at 135°F or above or cool following the 135 to 70 to 41 rule. Crab cakes, seafood salads and chowders are typical items that are cooked, cooled and held.

Clostridium botulinum in vacuum-packed fish

Vacuum-packed fish is a known risk for C. botulinum type E, which can grow at refrigeration temperatures in low-oxygen conditions. The Food Code puts specific limits on reduced oxygen packaging of fish: generally, fish must be frozen before, during and after packaging unless it meets narrow conditions. This is not a process to start without a HACCP plan and a talk with your health department. See our reduced oxygen packaging HACCP plan page.

Allergens

Fish and crustacean shellfish are both major food allergens. Fish sauce, anchovy paste, Worcestershire sauce and some dressings contain fish. Train staff to know where they appear. See food allergen control plan.

Flow diagram: raw fish for sushi or crudo

For fish the restaurant freezes itself, add a freezing step with time and temperature monitoring as the CCP.

Hazard analysis table for a seafood restaurant

| Step | Hazard | Significant? | Control | |---|---|---|---| | Receive tuna | Histamine from prior temperature abuse | Yes | Approved supplier, receive at 41°F or below or frozen | | Receive salmon for raw service | Parasites | Yes | CCP 1: parasite destruction records | | Receive oysters | Vibrio, norovirus | Yes | Certified shipper, tags, 45°F air receiving | | Cold hold | Pathogen growth, histamine | Yes | CCP 2: 41°F or below | | Cook fish | Survival of pathogens | Yes | CCP: 145°F for 15 s | | Cool chowder | Spore-former growth | Yes | CCP: two-stage cooling | | Serve raw items | Increased risk to consumers | Yes | Consumer advisory |

Write a reason for each line. See hazard analysis examples for the format.

Critical control points for restaurant seafood

| CCP | Critical limit | Monitoring | Corrective action | Record | |---|---|---|---|---| | Parasite destruction (raw fish) | Food Code 3-402.11 freezing time and temperature, or valid exemption | Check supplier statement for each lot, or freezer log if freezing in house | Do not serve raw; cook or discard | Supplier letters, freezer log, kept 90 days | | Cold holding | 41°F or below | Probe fish every 2 to 4 hours | Assess time; discard histamine-forming fish if temperature abuse is unknown | Holding log | | Cooking | 145°F for 15 s | Probe each batch | Continue cooking | Cook log | | Cooling (cooked seafood) | 135 to 70°F in 2 h; to 41°F in 6 h | Probe start, 2 h, end | Reheat and restart, or discard | Cooling log | | Shellstock receiving | 45°F air, 50°F internal, then cool to 41°F | Check at receiving | Reject | Receiving log, tags |

Records seafood operations must keep

• Shellstock tags: 90 calendar days from the date the container is emptied, filed in date order.
• Parasite destruction records: 90 calendar days beyond service or sale.
• Receiving logs with temperatures. See receiving temperature log.
• Cold holding logs. See restaurant temperature log.
• Cooling logs for cooked seafood. See cooling log.
• Thermometer calibration. See thermometer calibration log.
• Corrective actions.

Print the logs from free logs.

Corrective actions for seafood

• No parasite destruction records for fish meant for raw service: do not serve it raw. Cook it or discard it. Contact the supplier for documentation.
• Fish received above 41°F (or not frozen solid if delivered frozen): reject.
• Histamine-forming fish found above 41°F for an unknown time: discard. Cooking will not help.
• Shellstock without a tag: do not accept it. If a tag is lost after receiving, follow your health department's direction.
• Cooling failure on cooked seafood: reheat and restart if stage 1 failed, discard if stage 2 failed.

See HACCP corrective actions examples.

Thawing frozen fish safely

Frozen fish has to be thawed in a way that keeps it out of the danger zone. The Food Code allows thawing under refrigeration at 41°F or below, under cool running water at 70°F or below, in a microwave if cooked immediately, or as part of cooking. For reduced oxygen packaged fish labeled to be kept frozen until use, the Food Code adds a specific rule (3-501.13): take the fish out of the package before thawing it under refrigeration, or before or right after thawing it under running water. Many vacuum-packed fish boxes print this instruction on the label, and inspectors look for it. That rule exists because of the C. botulinum type E risk. Write the thawing method you use into the plan and teach it to the prep team.

Receiving seafood step by step

A receiving routine that covers the main seafood hazards:

1. Check the supplier is on your approved list.
2. Probe fresh fish between fillets or in the belly cavity. Accept at 41°F or below.
3. Check frozen fish is frozen solid with no signs of thawing and refreezing, such as large ice crystals or liquid in the box.
4. For shellstock, check the air temperature of the truck or the box and the tag on every container. Confirm the tag has the harvest date, area and certification number.
5. For fish you will serve raw, confirm the parasite destruction statement is on file for that supplier and species.
6. Record all of it on the receiving log.
7. Put fish away immediately on ice or in the coldest part of the cooler.

Training raw bar and sushi staff

The people who cut and serve raw fish need specific training beyond general food safety: which fish need parasite destruction and where the records are kept, why histamine fish must stay cold even for a few minutes, how to keep shellstock tags with their containers, and the exact consumer advisory wording. Norovirus spreads through ready-to-eat foods, so the employee health policy matters more than usual at a raw bar. Keep training sign-offs for each person. See HACCP training for restaurant staff.

Smoked fish and cured fish

Smoking fish for preservation, curing fish (gravlax, for example), and making ceviche each bring their own hazards. Hot smoking cooks the fish; cold smoking does not, so parasite destruction and Listeria control matter. Curing for preservation is a special process under 3-502.11 that requires a variance and a HACCP plan. Ceviche uses acid for flavor and texture, but acid does not reliably kill parasites, so fish for ceviche still needs parasite destruction. Our cured and smoked foods HACCP plan post goes into detail.

Seafood on buffets and in catering

Seafood displays on ice look great and are hard to keep cold. Shrimp cocktail, oysters and poke bowls on a buffet need ice that reaches up around the food, not just under it, and a probe check every 2 hours. Swap out trays rather than topping up. If you cannot hold 41°F, use time as a public health control with a 4-hour discard. See our HACCP plan for catering for transport and venue holding.

Consumer advisory for raw seafood

The Food Code requires a consumer advisory when raw or undercooked animal foods are served (3-603.11). It has two parts: a disclosure that identifies the items (with an asterisk on the menu, for example) and a reminder stating that eating raw or undercooked seafood may increase your risk of foodborne illness. Check whether your health department uses specific wording, and make sure the advisory appears on delivery app menus too.

Prerequisite programs for seafood

• Approved sources: keep supplier lists and certifications.
• Separate storage: raw seafood below ready-to-eat foods; shellstock in its original container.
• Ice management: ice used to hold fish is not used for drinks. Drain melt water so fish does not sit in it.
• Cleaning and sanitizing cutting boards and knives between raw fish and other foods. See sanitation SOP.
• Employee health and handwashing. Norovirus spreads easily through ready-to-eat foods like sushi.

Verification

• Monthly check that parasite destruction letters cover every species and supplier you use for raw service.
• Weekly manager review of holding and receiving logs.
• Spot-check tag files: are they complete, in date order, and older than 90 days only when they should be discarded?
• Review the plan when you add a species, supplier or raw menu item.

See HACCP verification and record keeping.

Writing your seafood HACCP plan

1. List every seafood item and whether it is served raw, undercooked, cooked, or cooked and cooled.
2. For each species, note the hazards from the FDA hazards guide (parasites, histamine, toxins).
3. Draw flow diagrams for raw service, cooked service and cooked-cooled items.
4. Set CCPs with Food Code limits and cite the sections.
5. Write the records, especially parasite letters and shellstock tags.
6. Add the consumer advisory wording.
7. If you vacuum pack, smoke or cure fish, add a special process section and talk to your health department.

For sushi rice, which often sits beside raw fish in the same plan, see our HACCP plan for sushi rice. For the overall structure, see how to write a HACCP plan.

Build your seafood plan

The HACCP builder covers cooking, cooling, cold holding and the special processes most often used with seafood, with Food Code limits and section numbers filled in and logs ready to print. The first process is free; the Plan Pack covers all of them for a one-time price. As always, the output is a draft for your health department to review and approve.

Frequently asked questions

Do restaurants need a seafood HACCP plan?

Not under the federal seafood rule. 21 CFR 123.3 says the seafood HACCP regulation does not apply to the operation of a retail establishment. Restaurants follow their state food code, which may require a HACCP plan for special processes like reduced oxygen packaging or smoking fish.

What freezing temperature kills parasites in fish?

Food Code 3-402.11 lists freezing and storing at -4°F or below for 7 days total, or freezing at -31°F or below until solid and storing at -31°F for 15 hours, or freezing at -31°F until solid and storing at -4°F for 24 hours. Some species are exempt.

How long do you keep shellfish tags?

The Food Code requires shellstock tags or labels to be kept for 90 calendar days from the date the container is emptied, in order by date.

Does cooking destroy histamine in fish?

No. Histamine that forms when certain fish are kept too warm is not destroyed by cooking, freezing or canning. Control depends on keeping the fish cold from harvest to service.