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National Shellfish Sanitation Program
Guide for the Control of Molluscan Shellfish
2005

This document also available in PDF (3.7 MB) for printing

This document is intended to provide guidance and shall supersede the 2003 NSSP Model Ordinance. It represents the Agency's current thinking on the safe and sanitary control of the growing, processing, and shipping of molluscan shellfish for human consumption. It does not create any rights for or on any persons and does not operate to bind FDA or the public under federal law. However, through their participation in the National Shellfish Sanitation Program and membership in the Interstate Shellfish Sanitation Conference, states have agreed to enforce the Model Ordinance as the requirements which are minimally necessary for the sanitary control of molluscan shellfish.

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U. S. Department of Health and Human Services
Public Health Service
Food and Drug Administration 		Interstate Shellfish Sanitation Conference
Interstate Shellfish Sanitation Conference

2005 Revision


GUIDE FOR THE CONTROL OF MOLLUSCAN SHELLFISH

TABLE OF CONTENTS

  1. PURPOSE
    Purpose of the National Shellfish Sanitation Program
  2. MODEL ORDINANCE
     (NOTE: This Model Ordinance is in no way intended to discourage or limit States in establishing more stringent requirements.)
    1. Purpose
    2. Definitions
    1. Shellfish Sanitation Program
      Requirements for the Authority
      @. 01 Administration
      1. Scope
      2. Records
      3. Shared Responsibilities
      4. Administrative Procedures
      5. Epidemiologically Implicated Outbreaks of Shellfish Related Illnesses
      6. Commingling
      @. 02 Dealer Certification
      1. General
      2. Initial Certification
      3. Renewal of Certification
      4. Revocation or Suspension of Certification
      5. Interstate Certified Shellfish Shippers List (ICSSL)
      6. Inspections
      7. Performance Based Inspection Program
      8. Enforcement
    2. Risk Assessment and Risk Management
      Requirements for the Authority
      @. 01 Outbreaks of Shellfish Related Illnesses
      @. 02 Presence of Human Pathogens in Shellfish Meats
      1. Finding
      2. Growing Area Investigation
      3. Distribution and Processing Investigation
      4. Risk Management and Tolerance Levels
      @. 03 Presence of Toxic Substance in Shellfish Meats
      @. 04 Vibrio vulnificus Risk Management for Oysters
    3. Laboratory
      Requirements for the Authority
      @. 01 Quality Assurance
      1. NSSP Conformance Required
      2. State Program Requirements
      3. FDA Certified State Shellfish Laboratory Officer
      4. Laboratory Evaluation
      5. Time Limit on Provisionally Conforming Status
      6. Laboratory Services for Depuration Processors
      @. 02 Methods
      1. Microbiological
      2. Chemical and Physical
      3. Biotoxin
    4. Shellstock Growing Areas
      Requirements for the Authority
      @. 01 Sanitary Survey
      1. General
      2. Sanitary Survey Required
      3. Sanitary Survey Performance
      4. Shoreline Survey Requirements
      @. 02 Bacteriological Standards
      1. General
      2. Water Sample Stations
      3. Exceptions
      4. Standard for the Approved Classification of Growing Areas in the Remote Status
      5. Standard for the Approved Classification of Growing Areas by Point Sources
      6. Standard for the Approved Classification of Growing AreasAffected by Nonpoint Sources
      7. Standard for the Restricted Classification of Growing Areas affected by Point Sources and Used as a Shellstock Source for Shellstock Depuration
      8. Standard for the Restricted Classification of Growing Areas Affected by Nonpoint Sources and Used as a Shellstock Source for Shellstock Depuration
      @. 03 Growing Area Classification
      1. General
      2. Approved Classification
      3. Conditional Classification
      4. Restricted Classification
      5. Prohibited Classification
      @. 04 Marine Biotoxin Control
      1. Contingency Plan
      2. Marine Biotoxin Monitoring
      3. Closed Status of Growing Areas
      4. Heat Processing
      5. Records
      @. 05 Marinas
      1. Marina Proper
      2. Adjacent Waters
    5. Shellstock Relaying
      Requirements for the Authority
      @. 01 General
      @. 02 Contaminant Reduction
      @. 03 Licenses to Relay Shellstock or Harvest Shellstock
      @. 04 Management of Relaying Activities
      Requirement for Harvesters
      .01 Harvester License Required
    6. Shellfish Aquaculture
      Requirements for the Authority
      @. 01 General
      @. 02 Seed Shellstock
      @. 03 Land Based Aquaculture
      Requirements for the Harvester/Dealer
      .01 Exceptions
      .02 General
      .03 Seed Shellstock
      .04 Open Water Aquaculture
      .05 Land Based Aquaculture
      1. Operational Plan
      2. Water Systems
      3. Shellstock Quality
      .06 Polyculture Systems
    7. Wet Storage in Approved and Conditionally Approved Growing Areas
      Requirements for the Dealer
      .01 Source of Shellstock
      .02 General
      .03 Wet Storage Sites
    8. Control of Shellfish Harvesting
      Requirements for the Authority
      @. 01 Control of Shellstock Growing Areas
      1. General
      2. Patrol of Growing Areas
      3. Licensing of Harvesting
      4. Penalties
      5. Identification of Certain Growing Areas
      6. Prohibited Classification
      Requirements for Harvesters
      .01 General
      .02 Shellstock Harvesting and Handling
      1. Harvesters
      2. Vessels
      3. Disposal of Human Sewage from Vessels
      4. Shellstock Washing
      5. Shellstock Identification
      .03 Shellstock Temperature Control
      Option 1
      Option 2
      Option 3
    9. Transportation
      Requirements for the Authority
      @. 01 General
      @. 02 Shipment Acceptability
      @. 03 Shipment Rejection
      @. 04 Bacteriological Examination of Shellfish Shipments
      Requirements for Harvester/Dealer
      .01 Trucks or Other Vehicles Used to Transport Shellstock to the Original Dealer
      .02 Receiving Shellfish
      .03 Transportation Containers
      .04 Cargo Protection from Cross Contamination
      1. General
      2. Shellfish Cargo Only
      3. Mixed Cargos
      4. Ice
      .05 Shipping Times
      1. Shipping Time is No More Than Four Hours
      2. Shipping Time is Greater Than Four Hours
    10. General Requirements for Dealers
      .01 General HACCP Requirements
      1. Hazard Analysis
      2. HACCP Plan
      3. Contents of the HACCP Plan
      4. Signing and Dating the HACCP Plan
      5. Sanitation
      6. Corrective Actions
      7. Verification
      8. Records
      9. Training
      .02 General Sanitation Requirements
      1. Sanitation Monitoring
      2. Sanitation Monitoring Records
      3. Relationship to HACCP Plan
      .03 Other Model Ordinance Requirements
      .04 Certification Requirements
      1. General
      2. Types of Certification
      .05 Shellstock Identification
      1. General
      2. Tags
      3. Bulk Tagging Lots of Shellstock for Sales Between Dealers
      4. Tagging of a Lot of Shellstock During Intermediate Processing
      5. Transaction Record
      .06 Shucked Shellfish Labeling
      1. Shellfish Labeling
      2. Shucked Shellfish
      .07 Post Harvest Process Labeling
      .08 Shipping Documents and Records
      1. Shipping Documents
      2. Transaction and Shipping Records
      .09 Wet Storage in Artificial Bodies of Water
      1. General
      2. Operational Specifications
      3. Water Supply
      4. Shellstock Handling
    11. Shucking and Packing
      Requirements for the Authority
      @. 01 Heat Shock
      Requirements for Dealers
      .01 Critical Control Points
      1. Receiving Critical Control Point - Critical Limits
      2. Shellstock Storage Critical Control Point - Critical Limit
      3. Processing Critical Control Point - Critical Limits
      4. Shucked Meat Storage Critical Control Point - Critical Limit
      .02 Sanitation
      1. Safety of Water for Processing and Ice Production
      2. Condition and Cleanliness of Food Contact Surfaces
      3. Prevention of Cross Contamination
      4. Maintenance of Hand Washing, Hand Sanitizing, and Toilet Facilities
      5. Protection from Adulterants
      6. Proper Labeling, Storage and Use of Toxic Compounds
      7. Control of Employees with Adverse Health Conditions
      8. Exclusion of Pests
      .03 Other Model Ordinance Requirements
      1. Plants and Grounds
      2. Plumbing and Related Facilities
      3. Utilities
      4. Insect and Vermin Control
      5. Disposal of Wastes
      6. Equipment Construction for Non-food Contact Surfaces 
      7. Cleaning and Sanitizing and Non-food Contact Surfaces
      8. Shellfish Storage and Handling
      9. Heat Shock
      10. Personnel
      11. Supervision
    12. Repacking of Shucked Shellfish
      .01 Critical Control Points
      1. Receiving Critical Control Point - Critical Limits
      2. Processing Critical Control Point - Critical Limits
      3. Shucked Meat Storage Critical Control Point - Critical Limit
      .02 Sanitation
      1. Safety of Water for Processing and Ice Production
      2. Condition and Cleanliness of Food Contact Surfaces
      3. Prevention of Cross Contamination
      4. Maintenance of Hand Washing, Hand Sanitizing, and Toilet Facilities
      5. Protection from Adulterants
      6. Proper Labeling, Storage and Use of Toxic Compounds
      7. Control of Employees with Adverse Health Conditions
      8. Exclusion of Pests
      .03 Other Model Ordinance Requirements
      1. Plants and Grounds
      2. Plumbing and Related Facilities
      3. Utilities
      4. Insect and Vermin Control
      5. Disposal of Other Wastes
      6. Equipment Construction for Non-food Contact Surfaces
      7. Cleaning Non-food Contact Surfaces
      8. Shellfish Storage and Handling
      9. Heat Shock
      10. Personnel
      11. Supervision
    13. Shellstock Shipping
      .01 Critical Control Points
      1. Receiving Critical Control Point - Critical Limits
      2. Shellstock Storage Critical Control Point - Critical Limits
      .02 Sanitation
      1. Safety of Water for Processing and Ice Production
      2. Condition and Cleanliness of Food Contact Surfaces
      3. Prevention of Cross Contamination
      4. Maintenance of Hand Washing, Hand Sanitizing, and Toilet Facilities
      5. Protection from Adulterants
      6. Proper Labeling, Storage and Use of Toxic Compounds
      7. Control of Employees with Adverse Health Conditions
      8. Exclusion of Pests
      .03 Other Model Ordinance Requirements
      1. Plants and Grounds
      2. Plumbing and Related Facilities
      3. Utilities
      4. Insect and Vermin Control
      5. Disposal of Other Waste
      6. Equipment Construction for Non-food Contact Surfaces
      7. Cleaning of Non-food Contact Surfaces
      8. Shellstock Storage and Handling
      9. Heat Shock
      10. Personnel
      11. Supervision
    14. Reshipping
      .01 Critical Control Points
      1. Receiving Critical Control Point - Critical Limits
      2. Shellstock Storage Critical Control Point - Critical Limits
      3. Shucked Meat Storage Critical Control Point - Critical Limit
      .02 Sanitation
      1. Safety of Water for Processing and Ice Production
      2. Condition and Cleanliness of Food Contact Surfaces
      3. Prevention of Cross Contamination
      4. Maintenance of Hand Washing, Hand Sanitizing, and Toilet Facilities
      5. Protection from Adulterants
      6. Proper Labeling, Storage and Use of Toxic Compounds
      7. Control of Employees with Adverse Health Conditions
      8. Exclusion of Pests
      .03 Other Model Ordinance Requirements
      1. Plants and Grounds
      2. Plumbing and Related Facilities
      3. Utilities
      4. Insect and Vermin Control
      5. Disposal of Other Wastes
      6. Equipment Construction for Non-food Contact Surfaces
      7. Cleaning Non-food Contact Surfaces
      8. Shellfish Storage and Handling
      9. Heat Shock
      10. Personnel
      11. Supervision
    15. Depuration
      Requirements for the Authority
      Requirements for the Dealer
      .01 Critical Control Points
      1. Receiving Critical Control Point - Critical Limits
      2. Processing Critical Control Point - Critical Limits
      3. Finished Shellstock Storage Critical Control Point - Critical Limits
      .02 Sanitation
      1. Safety of Water for Processing and Ice Production
      2. Condition and Cleanliness of Food Contact Surfaces
      3. Prevention of Cross Contamination
      4. Maintenance of Hand Washing, Hand Sanitizing and Toilet Facilities
      5. Protection from Adulterants
      6. Proper Labeling, Storage and Use of Toxic Compounds
      7. Control of Employees with Adverse Health Conditions
      8. Exclusion of Pests
      .03 Other Model Ordinance Requirements
      1. Plant and Grounds
      2. Plumbing and Related Facilities
      3. Utilities
      4. Insect and Vermin Control
      5. Disposal of Wastes
      6. Equipment Construction for Non-food Contact Surfaces
      7. Cleaning of Non-food Contact Surfaces
      8. Shellstock Storage and Handling
      9. Heat Stock
      10. Personnel
      11. Supervision
      12. Plant Operating Manual
      13. Process Verification
    16. Post-Harvest Processing
      Post-Harvest Processing
  3. PUBLIC HEALTH REASONS AND EXPLANATIONS
    1. Introduction

    1. Shellfish Sanitation Program
      Requirements for the Authority.
      @. 01 Administration
      @. 02 Dealer Certification
    2. Risk Assessment and Risk Management
      Requirements for the Authority
      @ .01 Outbreaks of Shellfish Related Illness
      @ .02 Presence of Human Pathogen in Shellfish Meats
      @ .03 Presence of Toxic Substances in Shellfish Meats
    3. Laboratory
      Requirements for the Authority
      @ .01 Quality Assurance
      @ .02 Methods
    4. Shellstock Growing Areas
      Requirements for the Authority
      @ .01 Sanitary Survey
      @ .02 Bacteriological Standards
      @ .03 Growing Area Classification
      @ .04 Marine Biotoxin Control
      @ .05 Marinas
    5. Shellstock Relaying
      Requirements for the Authority
      @ .01 General
      @ .02 Contaminant Reduction
      @ .03 Licenses to Relay Shellstock
      @ .04 Management of Relaying Activities
      Requirements for Harvesters
    6. Shellfish Aquaculture
    7. Wet Storage in Approved and Conditionally Approved Growing Area
    8. Control of Shellfish Harvesting
      Requirements for the Authority
      Requirements for Harvesters
    9. Transportation
      Requirements for the Authority
    10. General Requirements for Dealers
      .01 General HACCP Requirements
      .02 General Sanitation Requirements
      .03 Other Model Order Requirements
      .04 Certification Requirements
      .05 - .07 Shellstock Identification, Shucked Shellfish Labeling, Shipping Documents, Records
      .08 Wet Storage in Artificial Bodies of Water
    11. , XII., XIII., and XIV. Shellfish Processing and Handling
      Requirements for Dealers
      .01 Critical Control Points
      .02 Sanitation Requirements
      .03 Other Model Ordinance Requirements
    1. Depuration
      Requirements for the Authority
      .01 Administration
      Requirements for the Depuration Processor
      .01 Critical Control Points
      .02 Sanitation
      .03 Other Model Ordinance Requirements
  4. GUIDANCE DOCUMENTS
    1. Chapter I - General
      .01 Evaluation Standards
      .02 Procedures for Initiating a New State Program
    2. Chapter II - Growing Areas
      .01 Total Coliform Standards
      .02 Guidance for Developing Marine Biotoxin Contingency Plans
      .03 Sanitary Survey and the Classification of Growing Waters
      .04 Action Levels, Tolerances and Guidance Levels for Poisonous or Deleterious Substances in Seafood
      .05 Management Plans for Growing Areas in the Conditional Classification
      .06 Shellstock Relay
      .07 Systematic Random Sampling Monitoring Strategy
      .08 Growing Area Patrol and Enforcement
      .09 Control of Shellfish Harvesting
      .10 Approved NSSP Laboratory Test
      .11 Evaluation of Laboratories by State Laboratory Evaluation Officers Including Laboratory Evaluation Checklists
      .12 Bacteriological Examination of Shellfish Shipments Decision Tree
      .13 Protocol For Reviewing Classification Of Areas Implicated By Pathogens In Shellfish Meat Samples
      .14 Calculating the 90th Percentile for End-Product Depurated Shellfish
      .15 Decision Tree for Shellfish from Non-MOU Countries
    3. Chapter III - Harvesting, Handling, Processing, and Distribution
      .01 Shellfish Industry Equipment Construction Guide
      .02 Shellfish Plant Inspection Standardization Procedures/NSSP Standardized Shellfish Processing Plant Inspection Form
      .03 Dealer Certification and the Interstate Certified Shellfish Shippers List
      .04 Shellstock Tagging
      .05 Guidance for a Time-Temperature Evaluation of a Shellfish Implicated Outbreak
      .06 Protocol for Addressing Positive Coliform Sample in an Artificial Wet Storage Water Body
    4. Chapter IV - Naturally Occurring Pathogens
      .01 Vibrio Risk Management for Oysters
      .02 Vibrio vulnificus Management Plan
      .03 Vibrio parahaemolyticus Interim Control Plan
      .04 Validation/Verification Interim Guidance
  5. SUGGESTED FORMS
    Shellfish Harvest Record
    Shellfish Harvest / Purchase Record
    Shellfish Sales Record
    Export Health Certificate
  6. NSSP POLICY SETTING DOCUMENTS
    Department of Health and Human Services FDA Policy Statement Consumption of Raw Molluscan Shellfish
    ISSC Policy Statement Consumption of Raw Molluscan Shellfish
    Interstate Shellfish Sanitation Conference Resolution 97 - 01
  7. FEDERAL REGULATIONS - SHELLFISH
  8. FDA MANUAL OF INTERPRETATIONS
    Manual of Interpretations Codification System
    05-I-@.02-100
    05-I-@.02-101
    05-III-@.02-100
    05-IV-@.02-100
    05-IV-@.02-101
    05-IV-@.02-102
    05-VIII-.03-100
    05-XI-.01-100
    05-XI-.02-100
    05-XI-.02-101
    05-XV-.03-100
  9. HISTORY OF THE NSSP
    Introduction
    A Declaration of Principles
    National Shellfish Sanitation Program
    Interstate Shellfish Sanitation Program
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