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National Shellfish Sanitation Program
Guide for the Control of Molluscan Shellfish
2007
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
GUIDE FOR THE CONTROL OF MOLLUSCAN SHELLFISH
TABLE OF CONTENTS
- SECTION I. PURPOSE
Purpose of the National Shellfish Sanitation Program
- SECTION II. MODEL ORDINANCE
(NOTE: This Model Ordinance is in no way intended to discourage or
limit States in establishing more stringent requirements.)
- Purpose
- Definitions
- Chapter I.
Shellfish Sanitation Program
- Requirements for the Authority
- @. 01 Administration
- Scope
- Records
- Shared Responsibilities
- Administrative Procedures
- Epidemiologically Implicated Outbreaks of Shellfish Related
Illnesses
- Commingling
- @. 02 Dealer Certification
- General
- Initial Certification
- Renewal of Certification
- Revocation or Suspension of Certification
- Interstate Certified Shellfish Shippers List (ICSSL)
- Inspections
- Performance Based Inspection Program
- Enforcement
- Chapter II. Risk Assessment and Risk Management
- Requirements for the Authority
- @. 01 Outbreaks of Shellfish Related Illnesses
- @. 02 Presence of Human Pathogens in Shellfish Meats
- Finding
- Growing Area Investigation
- Distribution and Processing Investigation
- Risk Management and Tolerance Levels
- @. 03 Presence of Toxic Substance in Shellfish Meats
- @. 04 Vibrio vulnificus Risk Management for Oysters
- @. 05 Vibrio parahaemolyticus Control Plan
- Chapter III. Laboratory
- Requirements for the Authority
- @. 01 Quality Assurance
- NSSP Conformance Required
- State Program Requirements
- FDA Certified State Shellfish Laboratory Officer
- Laboratory Evaluation
- Time Limit on Provisionally Conforming Status
- Laboratory Services for Depuration Processors
- @. 02 Methods
- Microbiological
- Chemical and Physical
- Biotoxin
-
Chapter IV. Shellstock Growing Areas
- Requirements for the Authority
- @. 01 Sanitary Survey
- General
- Sanitary Survey Required
- Sanitary Survey Performance
- Shoreline Survey Requirements
- @. 02 Bacteriological Standards
- General
- Water Sample Stations
- Exceptions
- Standard for the Approved Classification of Growing Areas in the
Remote Status
- Standard for the Approved Classification of Growing Areas by
Point Sources
- Standard for the Approved Classification of Growing AreasAffected
by Nonpoint Sources
- Standard for the Restricted Classification of Growing Areas
affected by Point Sources and Used as a Shellstock Source for Shellstock
Depuration
- 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
- General
- Approved Classification
- Conditional Classification
- Restricted Classification
- Prohibited Classification
- @. 04 Marine Biotoxin Control
- Contingency Plan
- Marine Biotoxin Monitoring
- Closed Status of Growing Areas
- Heat Processing
- Records
- @. 05 Marinas
- Marina Proper
- Adjacent Waters
-
Chapter V. 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
-
Chapter VI. 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
- Operational Plan
- Water Systems
- Shellstock Quality
- .06 Polyculture Systems
-
Chapter VII. Wet Storage in Approved and Conditionally Approved
Growing Areas
- Requirements for the Dealer
- .01 Source of Shellstock
- .02 General
- .03 Wet Storage Sites
-
Chapter VIII. Control of Shellfish Harvesting
- Requirements for the Authority
- @. 01 Control of Shellstock Growing Areas
- General
- Patrol of Growing Areas
- Licensing of Harvesting
- Penalties
- Identification of Certain Growing Areas
- Prohibited Classification
- Requirements for Harvesters
- .01 General
- .02 Shellstock Harvesting and Handling
- Harvesters
- Vessels
- Disposal of Human Sewage from Vessels
- Shellstock Washing
- Shellstock Identification
- .03 Shellstock Temperature Control
- Option 1
- Option 2
- Option 3
-
Chapter IX. 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
- General
- Shellfish Cargo Only
- Mixed Cargos
- Ice
- .05 Shipping Times
- Shipping Time is No More Than Four Hours
- Shipping Time is Greater Than Four Hours
-
Chapter X. General Requirements for Dealers
-
.01 General HACCP Requirements
- Hazard Analysis
- HACCP Plan
- Contents of the HACCP Plan
- Signing and Dating the HACCP Plan
- Sanitation
- Corrective Actions
- Verification
- Records
- Training
- .02 General Sanitation Requirements
- Sanitation Monitoring
- Sanitation Monitoring Records
- Relationship to HACCP Plan
- .03 Other Model Ordinance Requirements
- .04 Certification Requirements
- General
- Types of Certification
- .05 Shellstock Identification
- General
- Tags
- Bulk Tagging Lots of Shellstock for Sales Between Dealers
- Tagging of a Lot of Shellstock During Intermediate Processing
- Transaction Record
- .06 Shucked Shellfish Labeling
- Shellfish Labeling
- Shucked Shellfish
- .07 Post Harvest Process Labeling
- .08 Shipping Documents and Records
- Shipping Documents
- Transaction and Shipping Records
-
Chapter XI. Shucking and Packing
- Requirements for the Authority
- @. 01 Heat Shock
- Requirements for Dealers
- .01 Critical Control Points
- Receiving Critical Control Point - Critical Limits
- Shellstock Storage Critical Control Point - Critical Limit
- Processing Critical Control Point - Critical Limits
- Shucked Meat Storage Critical Control Point - Critical Limit
- .02 Sanitation
- Safety of Water for Processing and Ice Production
- Condition and Cleanliness of Food Contact Surfaces
- Prevention of Cross Contamination
- Maintenance of Hand Washing, Hand Sanitizing, and Toilet
Facilities
- Protection from Adulterants
- Proper Labeling, Storage and Use of Toxic Compounds
- Control of Employees with Adverse Health Conditions
- Exclusion of Pests
- .03 Other Model Ordinance Requirements
- Plants and Grounds
- Plumbing and Related Facilities
- Utilities
- Disposal of Other Wastes
- Equipment Conditions, Cleaning, Maintenance, and Construction of Non-Food Contact Surfaces
- Shellfish Storage and Handling
- Heat Shock
- Supervision
-
Chapter XII. Repacking of Shucked Shellfish
- .01 Critical Control Points
- Receiving Critical Control Point - Critical Limits
- Processing Critical Control Point - Critical Limits
- Shucked Meat Storage Critical Control Point - Critical Limit
- .02 Sanitation
- Safety of Water for Processing and Ice Production
- Condition and Cleanliness of Food Contact Surfaces
- Prevention of Cross Contamination
- Maintenance of Hand Washing, Hand Sanitizing, and Toilet
Facilities
- Protection from Adulterants
- Proper Labeling, Storage and Use of Toxic Compounds
- Control of Employees with Adverse Health Conditions
- Exclusion of Pests
- .03 Other Model Ordinance Requirements
- Plants and Grounds
- Plumbing and Related Facilities
- Utilities
- Disposal of Other Wastes
- Equipment Conditions, Cleaning, Maintenance, and Construction of Non-food Contact Surfaces
- Shellfish Storage and Handling
- Heat Shock
- Supervision
-
Chapter XIII. Shellstock Shipping
- .01 Critical Control Points
- Receiving Critical Control Point - Critical Limits
- Shellstock Storage Critical Control Point - Critical Limits
- .02 Sanitation
- Safety of Water for Processing and Ice Production
- Condition and Cleanliness of Food Contact Surfaces
- Prevention of Cross Contamination
- Maintenance of Hand Washing, Hand Sanitizing, and Toilet
Facilities
- Protection from Adulterants
- Proper Labeling, Storage and Use of Toxic Compounds
- Control of Employees with Adverse Health Conditions
- Exclusion of Pests
- .03 Other Model Ordinance Requirements
- Plants and Grounds
- Plumbing and Related Facilities
- Utilities
- Disposal of Other Waste
- Equipment Condition, Cleaning, Maintenance, and Construction of Non-food Contact Surfaces
- Shellstock Storage and Handling
- Heat Shock
- Supervision
-
Chapter XIV. Reshipping
- .01 Critical Control Points
- Receiving Critical Control Point - Critical Limits
- Shellstock Storage Critical Control Point - Critical Limits
- Shucked Meat Storage Critical Control Point - Critical Limit
- .02 Sanitation
- Safety of Water for Processing and Ice Production
- Condition and Cleanliness of Food Contact Surfaces
- Prevention of Cross Contamination
- Maintenance of Hand Washing, Hand Sanitizing, and Toilet Facilities
- Protection from Adulterants
- Proper Labeling, Storage and Use of Toxic Compounds
- Control of Employees with Adverse Health Conditions
- Exclusion of Pests
- .03 Other Model Ordinance Requirements
- Plants and Grounds
- Plumbing and Related Facilities
- Utilities
- Disposal of Other Wastes
- Equipment Condition, Cleaning, Maintenance, and Construction of Non-food Contact Surfaces
- Shellfish Storage and Handling
- Heat Shock
- Supervision
-
Chapter XV. Depuration
- Requirements for the Authority
- Requirements for the Dealer
- .01 Critical Control Points
- Receiving Critical Control Point - Critical Limits
- Processing Critical Control Point - Critical Limits
- Finished Shellstock Storage Critical Control Point - Critical
Limits
- .02 Sanitation
- Safety of Water for Processing and Ice Production
- Condition and Cleanliness of Food Contact Surfaces
- Prevention of Cross Contamination
- Maintenance of Hand Washing, Hand Sanitizing and Toilet Facilities
- Protection from Adulterants
- Proper Labeling, Storage and Use of Toxic Compounds
- Control of Employees with Adverse Health Conditions
- Exclusion of Pests
- .03 Other Model Ordinance Requirements
- Plant and Grounds
- Plumbing and Related Facilities
- Utilities
- Disposal of Wastes
- Equipment Condition, Cleaning, Maintenance, and Construction of Non-food Contact Surfaces
- Shellstock Storage and Handling
- Heat Stock
- Supervision
- Plant Operating Manual
- Process Verification
-
Chapter XVI. Post-Harvest Processing
- Post-Harvest Processing
-
SECTION III. PUBLIC HEALTH REASONS AND EXPLANATIONS
- Introduction
- Chapter I. Shellfish Sanitation Program
- Requirements for the Authority.
- @. 01 Administration
- @. 02 Dealer Certification
- Chapter II. 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
- Chapter III. Laboratory
- Requirements for the Authority
- @ .01 Quality Assurance
- @ .02 Methods
- Chapter IV. Shellstock Growing Areas
- Requirements for the Authority
- @ .01 Sanitary Survey
- @ .02 Bacteriological Standards
- @ .03 Growing Area Classification
- @ .04 Marine Biotoxin Control
- @ .05 Marinas
- Chapter V. Shellstock Relaying
- Requirements for the Authority
- @ .01 General
- @ .02 Contaminant Reduction
- @ .03 Licenses to Relay Shellstock
- @ .04 Management of Relaying Activities
- Requirements for Harvesters
- Chapter VI. Shellfish Aquaculture
- Chapter VII. Wet Storage in Approved and Conditionally Approved Growing
Area
- Chapter VIII. Control of Shellfish Harvesting
- Requirements for the Authority
- Requirements for Harvesters
- Chapter IX. Transportation
-
Requirements for the Authority
- Chapter X. 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
- Chapter XI., Chapter XII., Chapter XIII., and Chapter XIV. Shellfish Processing and Handling
- Requirements for Dealers
- .01 Critical Control Points
- .02 Sanitation Requirements
- .03 Other Model Ordinance Requirements
- Chapter XV. Depuration
- Requirements for the Authority
- @ .01 Administration
- Requirements for the Depuration Processor
- @ .01 Critical Control Points
- @ .02 Sanitation
- @ .03 Other Model Ordinance Requirements
- Chapter XVI - Post Harvest Processing
-
SECTION IV. GUIDANCE DOCUMENTS
-
Chapter I - General
- .01 Evaluation Standards
- .02 Procedures for Initiating a New State Program
- .03 Patrol Evaluation Criteria
-
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
-
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
- .07 Guidance for Reinstating a Previously Infected Employee
-
Chapter IV - Naturally Occurring Pathogens
- .01 Vibrio Risk Management for Oysters
- .02 Vibrio vulnificus Management Plan
- .03 Vibrio parahaemolyticus Control Plan
- .04 Post Harvest Processing (PHP) Validation/Verification Guidance for Vibrio vulnificus and Vibrio parahaemolyticus
-
SECTION V. SUGGESTED FORMS
- Shellfish Harvest Record
- Shellfish Harvest / Purchase Record
- Shellfish Sales Record
- Export Health Certificate
-
SECTION VI. 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
-
SECTION VII. FEDERAL REGULATIONS - SHELLFISH
-
SECTION VIII. FDA MANUAL OF INTERPRETATIONS
- Manual of Interpretations Codification System
- 07-I-@.02-100
- 07-I-@.02-101
- 07-III-@.02-100
- 07-IV-@.02-100
- 07-IV-@.02-101
- 07-IV-@.02-102
- 07-VIII-.03-100
- 07-XI-.01-100
- 07-XI-.02-100
- 07-XI-.02-101
- 07-XV-.03-100
- SECTION IX. HISTORY OF THE NSSP
- Introduction
- A Declaration of Principles
- National Shellfish Sanitation Program
- Interstate Shellfish Sanitation Program