Seafood Hazard Analysis Critical Control Points (HACCP) is a systematic approach to identify and control biological, physical and chemical hazards related to the receiving, storage, handling, production and distribution of fish and fishery products that can cause these products to be unsafe. An effective HACCP system will eliminate or reduce the risks to an acceptable level. A HACCP system is required to be implemented for all wholesale processors and distributors of seafood.

Processing is defined as: handling, storing, preparing, heading, eviscerating, shucking, freezing, changing into different market forms, manufacturing, preserving, packing, labeling, dockside unloading or holding (Title 21, Section 123.3, Code of Federal Regulations (CFR)). If your food establishment conducts any of these operations, you are considered a seafood processor. Processors of fish and fishery products are subject to the requirements in 21 CFR 123 and 21 CFR 117 subparts A, B and F. 

Are There Exemptions From the Seafood HACCP Regulations?

Retail establishments, fishing vessels, transporters that do not process seafood, and practices on the harvest vessel to prepare seafood solely for storage on board are not required to operate under a HACCP system. Hazards associated with the harvest and transportation of seafood are required to be evaluated by the receiver.

What Type of Training Is Needed?

At a minimum, standardized training or equivalent job experience is required to perform HACCP plan development, reassessment and modification. Additionally, record review of critical control point monitoring, corrective actions and process control instrument calibration must be conducted by a trained or otherwise qualified individual (21 CFR 123.10). Additionally, 21 CFR 117.4 requires training appropriate to individuals' assigned duties and training in the principles of food hygiene and food safety.

To meet the standardized training requirement, the Seafood HAACP Alliance Basic HACCP training course or both Segment 1 (online course) and Segment 2 (live course) must be successfully completed; other courses may be acceptable.

More information on the standardized training can be obtained from the Seafood HACCP Alliance.

Steps to Complete Before Starting a Business Processing Fish or Fishery Products

1. Receive a training certificate in HACCP principles for fish and fishery products or be able to demonstrate an equivalent knowledge.
2. Find a commercial processing facility that meets the Food Establishment Minimum Construction Standards [ 273.9 kB ] .
3. Register as a food facility with the U.S. Food and Drug Administration (FDA).
4. Conduct a hazard analysis on each fish and fishery product that you process.
5. Prepare a written HACCP plan for each fish and fishery product in which you identified a hazard.
6. Prepare to document monitoring of the eight key areas of sanitation that apply to your operation.
7. Submit a Wholesale/Manufactured Food Establishment Permit to the Florida Department of Agriculture and Consumer Services (FDACS).

What Regulations Apply to Seafood Processors?

In addition to Chapter 500, Florida Statutes, and Rule 5K-4, Florida Administrative Code, fish and fishery processors are subject to the requirements in 21 CFR 123 and 21 CFR 117 subparts A, B and F (training records).

Fish and fishery processors are exempt from the requirements of 21 CFR 117 Subpart C (Preventive Controls) and Subpart G (Supply-Chain Program). 

See Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act.

Overview of HACCP

Hazard Analysis

Every processor must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product processed by that processor and to identify the preventive measures that the processor can apply to control those hazards.

The Fish and Fishery Products Hazards and Controls Guidance can assist a processor in identifying hazards.

HACCP Plan

Every processor shall have a written HACCP plan whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur. A HACCP plan must be specific to:

• Each location where fish and fishery products are processed; and
• Each kind of fish and fishery product processed by the processor. The plan may group kinds of fish and fishery products together, or kinds of production methods together, if the food safety hazards, critical control points, critical limits and procedures are identical for all fish and fishery products within the group.

HACCP Plan Contents

The HACCP plan must at a minimum:

• List the food safety hazards that are reasonable likely to occur;
• List the critical control points for each identified food safety hazard;
• List the critical limits that must be met at each of the critical control points;
• List the procedures and frequency that will be used to monitor each critical control point (What, How, Frequency and Who);
• List the corrective actions to be followed in response to deviations from critical limits;
• List the verification procedures and frequency that the processor will use;
• Provide for a recordkeeping system that documents the monitoring of the critical control points;
• Include business name and address; and
• Be signed and dated.

Required Records

All records must meet the general requirements listed under 21 CFR 123.9.

In addition to the written HACCP plan, the following records are required:

• Monitoring records for each identified critical control point;
• Corrective action records in response to a deviation from a critical limit;
• Sanitation control records; and 
• Verification records:
  • Calibration of process monitoring instruments and
  • Performance of any periodic end-product or in-process testing.

Sanitation Control Procedures

Sanitation control procedures are necessary for the effective implementation of HACCP. The regulation does not require written sanitation control procedures. However, each processor shall monitor in records the conditions and practices during processing with sufficient frequency to ensure conformance with the regulation.

Monitoring must be conducted for the following eight key areas of sanitation that apply to your operation:

• Safety of water;
• Condition and cleanliness of food contact surfaces;
• Prevention of cross-contamination from unsanitary objects to food, food packaging material and other food contact surfaces;
• Maintenance of hand washing and sanitizing facilities and toilet facilities;
• Protection of food, food packaging material and other food contact surfaces from adulteration;
• Proper labeling, storage and use of toxic compounds;
• Control of employee health conditions; and
• Exclusion of pests.

What Should You Expect During a Seafood HACCP Inspection?

The inspector will observe processing activities to identify any potential hazards and evaluate the controls that you have implemented. The Fish and Fishery Products Hazards and Controls Guidance is a resource the inspector uses to assess these hazards and controls. Your facility and equipment will also be thoroughly inspected to assess Sanitation Control Procedures and Current Good Manufacturing Practices. A comprehensive review of the required records is also necessary to determine compliance with the regulations and verify the effectiveness of your HACCP system. At the conclusion, an inspection report will be issued and an opportunity for questions and clarification provided.

Presentations

• Listeria — All You Wanted to Ever Know [ Windows Media Video ]: Presented by Jamie Dement, MNS Food and Waterborne Disease Program Coordinator DOH
• Cold and Hot Smoked Fish Process and Controls [ Windows Media Video ]: Presented by Michael Lombardi, USFDA; Carolina Schaffer, FDACS
• Listeria — Environmental Controls [ Windows Media Video ]: Presented by Michael Lombardi, USFDA; Carolina Schaffer, FDACS
• Smoked Seafood Environmental Monitoring — Listeria monocytogenes [ Windows Media Video ]: Presented by Rita J. Johnson, FDACS
• Recalls and Reportable Food Registry [ Windows Media Video ]: Meredith M. Cobb, FDA; Nelson E. Venerio, FDA; and Richard Stephens, FDACS
• Regulatory Strategies and Compliance [ Windows Media Video ]: Commander Travis Chapman, FDA; Brian Schuettler, FDACS
• Controlling Listeria monocytogenes in Smoked Fish Processing Facilities [ Windows Media Video ]: Jennifer Cripe, FDA