HACCP Industry-Specific Program Development - Seafood HACCP Plans (21 CFR 123)

Fully Compliant, Audit-Ready HACCP Systems for Seafood Processors & Importers

Requirement Overview

Seafood processors and importers are required by law to develop and implement HACCP plans that comply with 21 CFR Part 123 (Seafood HACCP Regulation). Unlike voluntary HACCP systems, seafood HACCP is mandatory and closely monitored through FDA inspections, import examinations, and foreign facility audits.

Our Seafood HACCP Program Development Services provide complete, compliant HACCP systems tailored specifically to the biological, chemical, and physical hazards associated with seafood and aquatic products.

Why Seafood HACCP Requires Specialized Expertise

Seafood presents unique food safety risks, and FDA expects companies to demonstrate full understanding and control of critical hazards, including:

  • ✓ Histamine Formation in Scombroid Species
    Controls to prevent time–temperature abuse that can lead to histamine development.
  • ✓ Parasites in Finfish
    Freezing and sourcing controls to address parasitic hazards in raw or undercooked fish.
  • ✓ Pathogenic Bacteria in RTE Seafood
    Controls for Listeria, Salmonella, and other pathogens in ready-to-eat products.
  • ✓ Aquaculture Drug Residues
    Supplier verification and import controls to prevent illegal or unsafe drug residues.
  • ✓ Environmental Contaminants
    Evaluation of mercury and naturally occurring toxins based on species and harvest area.
  • ✓ Shellfish Toxins
    Source approval and tagging controls for molluscan shellfish.
  • ✓ Foreign Supplier Risks for Imported Seafood
    Verification of supplier controls and compliance with FDA Seafood HACCP requirements.

Seafood HACCP requires specialized hazard analysis, validated controls, and rigorous monitoring to meet FDA regulatory expectations and protect consumer safety.

Our Seafood HACCP Development Services

Seafood-Specific Hazard Analysis (21 CFR 123.6)

We develop a hazard analysis tailored to your seafood products and processes, addressing FDA-identified risks across your operation:

  • ✓ Histamine-Producing Fish Species
    Evaluation of time–temperature abuse risks with preventive controls for scombroid and related species.
  • ✓ Parasites Requiring Freezing Controls
    Identification of species requiring freezing treatments and verification of compliant freezing parameters.
  • ✓ Pathogens in Raw and RTE Products
    Assessment of biological hazards such as Listeria, Salmonella, and Vibrio with appropriate control strategies.
  • ✓ Environmental Chemicals & Heavy Metals
    Species- and source-based evaluation of contaminants including mercury and naturally occurring toxins.
  • ✓ Aquaculture Drug Residue Risks
    Supplier approval and verification controls to prevent illegal or unsafe veterinary drug residues.
  • ✓ Foreign Processing Risks for Imported Seafood
    Hazard evaluation aligned with FDA Seafood HACCP and importer verification expectations.

Each hazard evaluation includes FDA-compliant justification and preventive controls, ensuring your Seafood HACCP plan meets regulatory requirements and inspection expectations.

Development of Seafood-Specific CCPs & Critical Limits

We create validated controls and monitoring procedures to address critical seafood hazards and meet FDA Seafood HACCP requirements:

  • ✓ Time–Temperature Controls for Histamine Prevention
    Controls to prevent histamine formation in scombroid and related species, including harvest, receiving, storage, and processing limits.
  • ✓ Freezing Treatments for Parasite Destruction
    FDA-compliant freezing parameters with verification records to control parasites in finfish intended for raw or undercooked consumption.
  • ✓ Cooking & Pasteurization CCPs for RTE Seafood
    Validated lethality steps designed to control pathogens such as Listeria, Salmonella, and Vibrio.
  • ✓ Refrigeration & Chilled Storage Monitoring
    Continuous or manual temperature monitoring systems with documented corrective actions for deviations.
  • ✓ Receiving Controls for Histamine-Forming Species
    Sensory evaluation, temperature checks, and supplier documentation verification at receipt.
  • ✓ Shellfish Tagging & Certification Verification
    Procedures to verify shellfish harvest tags, dealer certifications, and required record retention.
  • ✓ Metal Detection & Foreign Material Controls
    Preventive measures and verification activities to control physical hazards during processing and packaging.

Each CCP includes detailed monitoring, verification, corrective action procedures, and scientific support to ensure full compliance with FDA Seafood HACCP regulations and inspection expectations.

Required FDA Seafood HACCP Documentation

We prepare all required documentation under 21 CFR Part 123 to ensure full FDA Seafood HACCP compliance and inspection readiness.

Our documentation package includes:

  • ✓ HACCP Plan
    A fully developed, product- and process-specific HACCP plan with identified CCPs and critical limits.
  • ✓ Hazard Analysis
    Detailed hazard identification and evaluation addressing biological, chemical, and physical hazards as required under Part 123.
  • ✓ Monitoring Records
    Standardized logs and forms to document routine monitoring of CCPs and preventive controls.
  • ✓ Verification & Validation Procedures
    Activities and records demonstrating that controls are effective and scientifically supported.
  • ✓ Corrective Action Plans
    Clearly defined procedures to address deviations and prevent recurrence, in compliance with FDA expectations.
  • ✓ Sanitation Monitoring Forms (8 Key Areas – 123.11)
    Daily sanitation control records covering safety of water, condition of food-contact surfaces, cross-contamination prevention, employee hygiene, pest control, and other required areas.
  • ✓ Receiving Logs & Supplier Documentation
    Records verifying approved suppliers, harvest controls, temperature checks, and compliance for incoming seafood.

All documents are formatted for FDA inspection readiness, supporting clear review, traceability, and regulatory confidence during inspections.

Sanitation Controls for Seafood Facilities (21 CFR 123.11)

FDA Seafood HACCP Sanitation Programs are a mandatory foundation under 21 CFR 123.11.

We establish comprehensive sanitation programs covering FDA’s eight key sanitation components:

  • ✓ Safety of Water
    Controls to ensure water used in processing, cleaning, ice, and handwashing is safe and potable.
  • ✓ Condition & Cleanliness of Food Contact Surfaces
    Sanitation procedures and inspection criteria for equipment, utensils, and contact surfaces.
  • ✓ Prevention of Cross-Contamination
    Measures to prevent contamination from insanitary objects, personnel, raw products, and the environment.
  • ✓ Maintenance of Handwashing & Restroom Facilities
    Requirements ensuring facilities are adequate, accessible, and properly maintained.
  • ✓ Protection from Adulterants
    Controls to protect food, packaging, and contact surfaces from chemicals, condensate, lubricants, and other contaminants.
  • ✓ Proper Labeling, Storage & Use of Toxic Compounds
    Procedures for segregation, identification, and controlled use of cleaning chemicals and pesticides.
  • ✓ Employee Health Conditions
    Policies to prevent food contamination from employees with communicable diseases or open lesions.
  • ✓ Exclusion of Pests
    Integrated pest management controls to prevent pest access and harborage.

Sanitation monitoring logs and corrective action procedures are included, ensuring deviations are documented, addressed promptly, and verified for effectiveness in line with FDA inspection expectations.

Foreign Supplier Verification for Imported Seafood

Seafood Importer Compliance requires alignment with both 21 CFR 123 (Seafood HACCP) and 21 CFR 1 Subpart L (FSVP).

We integrate seafood HACCP findings directly into your FSVP program by conducting a structured review of:

  • ✓ Foreign Processor HACCP Plans
    Verification that foreign suppliers maintain FDA-compliant seafood HACCP plans addressing all applicable hazards.
  • ✓ Monitoring & Verification Records
    Review of CCP monitoring, verification, and corrective action records to confirm effective hazard control.
  • ✓ COAs, Certificates & Sampling Programs
    Evaluation of laboratory results, certificates of analysis, and product testing programs supporting food safety.
  • ✓ Country-Specific Risk Profiles
    Assessment of known food safety risks, regulatory oversight, and compliance history associated with the country of origin.
  • ✓ Shipping, Time & Temperature Documentation
    Verification of transportation records to ensure cold chain control and prevention of histamine or pathogen risks.

These activities ensure your FSVP program is fully informed by seafood HACCP requirements, providing complete regulatory compliance for importers of seafood products and supporting FDA inspection readiness.

Process Flow Diagram & Operational Controls

Seafood-Specific Process Flow Diagrams are essential for accurate hazard identification and effective HACCP implementation.

We design and document detailed flow diagrams tailored to your specific seafood operations, including:

  • ✓ Raw Fish Cutting & Packaging
    End-to-end mapping from receiving through cutting, trimming, packaging, and cold storage.
  • ✓ Ready-to-Eat (RTE) Seafood Processing
    Validated flows covering lethality steps, post-process handling, and contamination prevention.
  • ✓ Smoked Fish Operations
    Detailed process steps for curing, smoking, cooling, packaging, and refrigerated storage.
  • ✓ Shellfish Handling
    Mapping of receiving, tagging, storage, shucking (if applicable), and distribution controls.
  • ✓ Fresh, Frozen & Canned Seafood Processes
    Customized flows for chilling, freezing, thermal processing, and finished product handling.
  • ✓ Receiving, Storage, Thawing, Cooling & Distribution
    Supporting process steps critical for time–temperature control and product integrity.

Each flow diagram is reviewed and validated with your HACCP team to ensure process accuracy, regulatory alignment, and full audit readiness.

Deliverables You Receive

Comprehensive Seafood HACCP Documentation ensures full compliance with FDA Seafood HACCP regulations and inspection expectations.

We develop a complete, audit-ready Seafood HACCP package that includes:

  • ✓ Full Seafood HACCP Plan (21 CFR 123 Compliant)
    A fully customized HACCP plan aligned with FDA Seafood HACCP regulatory requirements.
  • ✓ Hazard Analysis & Preventive Controls
    Detailed evaluation of biological, chemical, and physical hazards specific to seafood products and processes.
  • ✓ Seafood-Specific CCPs With Scientific Justification
    Validated critical control points for histamine, parasites, cooking, cooling, and storage with supporting scientific references.
  • ✓ Sanitation Monitoring Program
    Sanitation controls addressing FDA’s eight key sanitation conditions with monitoring and corrective action procedures.
  • ✓ Supplier & Importer Verification Procedures
    Controls for approved suppliers, foreign processor verification, COA review, and FSVP alignment where applicable.
  • ✓ Monitoring, Verification & Corrective Action Forms
    User-friendly logs and records designed for daily implementation and inspection readiness.
  • ✓ Flow Diagrams & Process Descriptions
    Validated process flows and written descriptions to support accurate hazard identification.
  • ✓ Training Materials for Seafood HACCP Implementation
    Practical training resources to support employee understanding and consistent execution of the HACCP system.

All documentation is structured to support FDA inspections, customer audits, and long-term seafood safety compliance.

Who This Service Is Ideal For

Our Seafood HACCP solutions support a wide range of operations, including:

  • ✓ Domestic Seafood Processors
    Facilities handling raw, frozen, or ready-to-eat seafood products within the U.S.
  • ✓ Seafood Importers & Distributors
    Companies responsible for foreign supplier verification and FDA Seafood HACCP compliance.
  • ✓ Fresh & Frozen Seafood Packers
    Operations focused on handling, packing, and distributing temperature-controlled seafood.
  • ✓ RTE & Smoked Seafood Manufacturers
    High-risk operations requiring validated lethality, sanitation, and environmental controls.
  • ✓ Shellfish Handlers & Processors
    Facilities managing molluscan shellfish with tagging, certification, and traceability requirements.
  • ✓ Retail Processors Requiring HACCP Compliance
    Retail and foodservice operations processing seafood under FDA HACCP expectations.
  • ✓ Foreign Seafood Facilities Exporting to the U.S.
    International processors needing FDA-compliant Seafood HACCP programs to access U.S. markets.

Each program is customized to your specific products, processes, and regulatory obligations, ensuring reliable compliance and food safety assurance.

Build a Fully Compliant Seafood HACCP System Today

Seafood HACCP is highly specialized — and one of the most closely scrutinized food categories by FDA.

Let us build a fully compliant, inspection-ready HACCP system tailored to your seafood products and processes.

Start Your Seafood HACCP Program Today

Next Steps: Strengthen Your Seafood HACCP Program

  • ✓ Request a Seafood HACCP Proposal
    Receive a customized scope and roadmap based on your seafood products, processes, and regulatory obligations.
  • ✓ Schedule a Hazard Analysis & Process Review
    Conduct a detailed evaluation of hazards, CCPs, and controls aligned with FDA Seafood HACCP expectations.
  • ✓ Strengthen Compliance With 21 CFR 123 Requirements
    Build an inspection-ready HACCP system supported by validated controls, monitoring, and documentation.

Protect your products. Ensure consumer safety. Achieve full regulatory compliance.

GET STARTED NOW

This document is intended for internal training and compliance purposes only and is provided for informational use. It is not affiliated with or endorsed by any official HACCP certification body.

For guidance and compliance requirements included in our services, we follow recognized HACCP standards and applicable regulatory agencies.