This document is intended to provide guidance and shall supersede the 2005 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.

U. S. Department of Health and Human Services Public Health Service Food and Drug Administration

Interstate Shellfish Sanitation Conference

2007 Revision

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GUIDE FOR THE CONTROL OF MOLLUSCAN SHELLFISH

TABLE OF CONTENTS

1. SECTION I. PURPOSE
   Purpose of the National Shellfish Sanitation Program
2. SECTION II. 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. Chapter I. Shellfish Sanitation Program
      1. Requirements for the Authority
      2. @. 01 Administration
         1. Scope
         2. Records
         3. Shared Responsibilities
         4. Administrative Procedures
         5. Epidemiologically Implicated Outbreaks of Shellfish Related Illnesses
         6. Commingling
      3. @. 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. Chapter II. Risk Assessment and Risk Management
      1. Requirements for the Authority
      2. @. 01 Outbreaks of Shellfish Related Illnesses
      3. @. 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
      4. @. 03 Presence of Toxic Substance in Shellfish Meats
      5. @. 04 Vibrio vulnificus Risk Management for Oysters
      6. @. 05 Vibrio parahaemolyticus Control Plan
   3. Chapter III. Laboratory
      1. Requirements for the Authority
      2. @. 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
      3. @. 02 Methods
         1. Microbiological
         2. Chemical and Physical
         3. Biotoxin
   4. Chapter IV. Shellstock Growing Areas
      1. Requirements for the Authority
      2. @. 01 Sanitary Survey
         1. General
         2. Sanitary Survey Required
         3. Sanitary Survey Performance
         4. Shoreline Survey Requirements
      3. @. 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
      4. @. 03 Growing Area Classification
         1. General
         2. Approved Classification
         3. Conditional Classification
         4. Restricted Classification
         5. Prohibited Classification
      5. @. 04 Marine Biotoxin Control
         1. Contingency Plan
         2. Marine Biotoxin Monitoring
         3. Closed Status of Growing Areas
         4. Heat Processing
         5. Records
      6. @. 05 Marinas
         1. Marina Proper
         2. Adjacent Waters
   5. Chapter V. Shellstock Relaying
      1. Requirements for the Authority
      2. @. 01 General
      3. @. 02 Contaminant Reduction
      4. @. 03 Licenses to Relay Shellstock or Harvest Shellstock
      5. @. 04 Management of Relaying Activities
      6. Requirement for Harvesters
      7. @ .01 Harvester License Required
   6. Chapter VI. Shellfish Aquaculture
      1. Requirements for the Authority
      2. @. 01 General
      3. @. 02 Seed Shellstock
      4. @. 03 Land Based Aquaculture
      5. Requirements for the Harvester/Dealer
      6. .01 Exceptions
      7. .02 General
      8. .03 Seed Shellstock
      9. .04 Open Water Aquaculture
      10. .05 Land Based Aquaculture
          1. Operational Plan
          2. Water Systems
          3. Shellstock Quality
      11. .06 Polyculture Systems
   7. Chapter VII. Wet Storage in Approved and Conditionally Approved Growing Areas
      1. Requirements for the Dealer
      2. .01 Source of Shellstock
      3. .02 General
      4. .03 Wet Storage Sites
   8. Chapter VIII. Control of Shellfish Harvesting
      1. Requirements for the Authority
      2. @. 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
      3. Requirements for Harvesters
      4. .01 General
      5. .02 Shellstock Harvesting and Handling
         1. Harvesters
         2. Vessels
         3. Disposal of Human Sewage from Vessels
         4. Shellstock Washing
         5. Shellstock Identification
      6. .03 Shellstock Temperature Control
         1. Option 1
         2. Option 2
         3. Option 3
   9. Chapter IX. Transportation
      1. Requirements for the Authority
      2. @. 01 General
      3. @. 02 Shipment Acceptability
      4. @. 03 Shipment Rejection
      5. @. 04 Bacteriological Examination of Shellfish Shipments
      6. Requirements for Harvester/Dealer
      7. .01 Trucks or Other Vehicles Used to Transport Shellstock to the Original Dealer
      8. .02 Receiving Shellfish
      9. .03 Transportation Containers
      10. .04 Cargo Protection from Cross Contamination
          1. General
          2. Shellfish Cargo Only
          3. Mixed Cargos
          4. Ice
      11. .05 Shipping Times
          1. Shipping Time is No More Than Four Hours
          2. Shipping Time is Greater Than Four Hours
   10. Chapter X. General Requirements for Dealers
       1. .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
       2. .02 General Sanitation Requirements
          1. Sanitation Monitoring
          2. Sanitation Monitoring Records
          3. Relationship to HACCP Plan
       3. .03 Other Model Ordinance Requirements
       4. .04 Certification Requirements
          1. General
          2. Types of Certification
       5. .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
       6. .06 Shucked Shellfish Labeling
          1. Shellfish Labeling
          2. Shucked Shellfish
       7. .07 Post Harvest Process Labeling
       8. .08 Shipping Documents and Records
          1. Shipping Documents
          2. Transaction and Shipping Records
   11. Chapter XI. Shucking and Packing
       1. Requirements for the Authority
       2. @. 01 Heat Shock
       3. Requirements for Dealers
       4. .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
       5. .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
       6. .03 Other Model Ordinance Requirements
          1. Plants and Grounds
          2. Plumbing and Related Facilities
          3. Utilities
          4. Disposal of Other Wastes
          5. Equipment Conditions, Cleaning, Maintenance, and Construction of Non-Food Contact Surfaces
          6. Shellfish Storage and Handling
          7. Heat Shock
          8. Supervision
   12. Chapter XII. Repacking of Shucked Shellfish
       1. .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
       2. .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
       3. .03 Other Model Ordinance Requirements
          1. Plants and Grounds
          2. Plumbing and Related Facilities
          3. Utilities
          4. Disposal of Other Wastes
          5. Equipment Conditions, Cleaning, Maintenance, and Construction of Non-food Contact Surfaces
          6. Shellfish Storage and Handling
          7. Heat Shock
          8. Supervision
   13. Chapter XIII. Shellstock Shipping
       1. .01 Critical Control Points
          1. Receiving Critical Control Point - Critical Limits
          2. Shellstock Storage Critical Control Point - Critical Limits
       2. .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
       3. .03 Other Model Ordinance Requirements
          1. Plants and Grounds
          2. Plumbing and Related Facilities
          3. Utilities
          4. Disposal of Other Waste
          5. Equipment Condition, Cleaning, Maintenance, and Construction of Non-food Contact Surfaces
          6. Shellstock Storage and Handling
          7. Heat Shock
          8. Supervision
   14. Chapter XIV. Reshipping
       1. .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
       2. .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
       3. .03 Other Model Ordinance Requirements
          1. Plants and Grounds
          2. Plumbing and Related Facilities
          3. Utilities
          4. Disposal of Other Wastes
          5. Equipment Condition, Cleaning, Maintenance, and Construction of Non-food Contact Surfaces
          6. Shellfish Storage and Handling
          7. Heat Shock
          8. Supervision
   15. Chapter XV. Depuration
       1. Requirements for the Authority
       2. Requirements for the Dealer
       3. .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
       4. .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
       5. .03 Other Model Ordinance Requirements
          1. Plant and Grounds
          2. Plumbing and Related Facilities
          3. Utilities
          4. Disposal of Wastes
          5. Equipment Condition, Cleaning, Maintenance, and Construction of Non-food Contact Surfaces
          6. Shellstock Storage and Handling
          7. Heat Stock
          8. Supervision
          9. Plant Operating Manual
          10. Process Verification
   16. Chapter XVI. Post-Harvest Processing
       1. Post-Harvest Processing
3. SECTION III. PUBLIC HEALTH REASONS AND EXPLANATIONS
   1. Introduction
   2. Chapter I. Shellfish Sanitation Program
      1. Requirements for the Authority.
      2. @. 01 Administration
      3. @. 02 Dealer Certification
   3. Chapter II. Risk Assessment and Risk Management
      1. Requirements for the Authority
      2. @ .01 Outbreaks of Shellfish Related Illness
      3. @ .02 Presence of Human Pathogen in Shellfish Meats
      4. @ .03 Presence of Toxic Substances in Shellfish Meats
   4. Chapter III. Laboratory
      1. Requirements for the Authority
      2. @ .01 Quality Assurance
      3. @ .02 Methods
   5. Chapter IV. Shellstock Growing Areas
      1. Requirements for the Authority
      2. @ .01 Sanitary Survey
      3. @ .02 Bacteriological Standards
      4. @ .03 Growing Area Classification
      5. @ .04 Marine Biotoxin Control
      6. @ .05 Marinas
   6. Chapter V. Shellstock Relaying
      1. Requirements for the Authority
      2. @ .01 General
      3. @ .02 Contaminant Reduction
      4. @ .03 Licenses to Relay Shellstock
      5. @ .04 Management of Relaying Activities
      6. Requirements for Harvesters
   7. Chapter VI. Shellfish Aquaculture
   8. Chapter VII. Wet Storage in Approved and Conditionally Approved Growing Area
   9. Chapter VIII. Control of Shellfish Harvesting
      1. Requirements for the Authority
      2. Requirements for Harvesters
   10. Chapter IX. Transportation
       1. Requirements for the Authority
   11. Chapter X. General Requirements for Dealers
       1. .01 General HACCP Requirements
       2. .02 General Sanitation Requirements
       3. .03 Other Model Order Requirements
       4. .04 Certification Requirements
       5. .05 - .07 Shellstock Identification, Shucked Shellfish Labeling, Shipping Documents, Records
       6. .08 Wet Storage in Artificial Bodies of Water
   12. Chapter XI., Chapter XII., Chapter XIII., and Chapter XIV. Shellfish Processing and Handling
       1. Requirements for Dealers
       2. .01 Critical Control Points
       3. .02 Sanitation Requirements
       4. .03 Other Model Ordinance Requirements
   13. Chapter XV. Depuration
       1. Requirements for the Authority
       2. @ .01 Administration
       3. Requirements for the Depuration Processor
       4. @ .01 Critical Control Points
       5. @ .02 Sanitation
       6. @ .03 Other Model Ordinance Requirements
   14. Chapter XVI - Post Harvest Processing
4. SECTION IV. GUIDANCE DOCUMENTS
   1. Chapter I - General
      1. .01 Evaluation Standards
      2. .02 Procedures for Initiating a New State Program
   2. Chapter II - Growing Areas
      1. .01 Total Coliform Standards
      2. .02 Guidance for Developing Marine Biotoxin Contingency Plans
      3. .03 Sanitary Survey and the Classification of Growing Waters
      4. .04 Action Levels, Tolerances and Guidance Levels for Poisonous or Deleterious Substances in Seafood
      5. .05 Management Plans for Growing Areas in the Conditional Classification
      6. .06 Shellstock Relay
      7. .07 Systematic Random Sampling Monitoring Strategy
      8. .08 Growing Area Patrol and Enforcement
      9. .09 Control of Shellfish Harvesting
      10. .10 Approved NSSP Laboratory Test
      11. .11 Evaluation of Laboratories by State Laboratory Evaluation Officers Including Laboratory Evaluation Checklists
      12. .12 Bacteriological Examination of Shellfish Shipments Decision Tree
      13. .13 Protocol For Reviewing Classification Of Areas Implicated By Pathogens In Shellfish Meat Samples
      14. .14 Calculating the 90th Percentile for End-Product Depurated Shellfish
      15. .15 Decision Tree for Shellfish from Non-MOU Countries
   3. Chapter III - Harvesting, Handling, Processing, and Distribution
      1. .01 Shellfish Industry Equipment Construction Guide
      2. .02 Shellfish Plant Inspection Standardization Procedures/NSSP Standardized Shellfish Processing Plant Inspection Form
      3. .03 Dealer Certification and the Interstate Certified Shellfish Shippers List
      4. .04 Shellstock Tagging
      5. .05 Guidance for a Time-Temperature Evaluation of a Shellfish Implicated Outbreak
      6. .06 Protocol for Addressing Positive Coliform Sample in an Artificial Wet Storage Water Body
      7. .07 Guidance for Reinstating a Previously Infected Employee
   4. Chapter IV - Naturally Occurring Pathogens
      1. .01 Vibrio Risk Management for Oysters
      2. .02 Vibrio vulnificus Management Plan
      3. .03 Vibrio parahaemolyticus Control Plan
      4. .04 Post Harvest Processing (PHP) Validation/Verification Guidance for Vibrio vulnificus and Vibrio parahaemolyticus
5. SECTION V. SUGGESTED FORMS
   1. Shellfish Harvest Record
   2. Shellfish Harvest / Purchase Record
   3. Shellfish Sales Record
   4. Export Health Certificate
6. SECTION VI. NSSP POLICY SETTING DOCUMENTS
   1. Department of Health and Human Services FDA Policy Statement Consumption of Raw Molluscan Shellfish
   2. ISSC Policy Statement Consumption of Raw Molluscan Shellfish
   3. Interstate Shellfish Sanitation Conference Resolution 97 - 01
7. SECTION VII. FEDERAL REGULATIONS - SHELLFISH
8. SECTION VIII. FDA MANUAL OF INTERPRETATIONS
   1. Manual of Interpretations Codification System
   2. 07-I-@.02-100
   3. 07-I-@.02-101
   4. 07-III-@.02-100
   5. 07-IV-@.02-100
   6. 07-IV-@.02-101
   7. 07-IV-@.02-102
   8. 07-VIII-.03-100
   9. 07-XI-.01-100
   10. 07-XI-.02-100
   11. 07-XI-.02-101
   12. 07-XV-.03-100
9. SECTION IX. HISTORY OF THE NSSP
   1. Introduction
   2. A Declaration of Principles
   3. National Shellfish Sanitation Program
   4. Interstate Shellfish Sanitation Program