U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Seafood
November 3, 2000
National Shellfish Sanitation Program
Model Ordinance
National Shellfish Sanitation Program (NSSP), Guide for the
Control of Molluscan Shellfish, Model Ordinance
This document is intended to provide guidance and shall supersede the 1997 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.
Office of Seafood
Document Released on: November 3, 2000
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Washington, DC 20204
1999 Revision
This Model Ordinance is in no way intended to discourage or limit States in establishing
more stringent requirements.
SHELLFISH SANITATION MODEL ORDINANCE
TABLE OF CONTENTS
Purpose
Definitions
I. Shellfish Sanitation Program
Requirements for the Authority
@.01 Administration
A. Scope
B. Records
C. Shared Responsibilities
D. Administrative Procedures
E. Epidemiologically Implicated Outbreaks of Shellfish Related Illnesses
F. Commingling
@.02 Dealer Certification
A. General
B. Initial Certification
C. Renewal of Certification
D. Revocation or Suspension of Certification
E. Interstate Certified Shellfish Shippers List (ICSSL)
F. Inspections
G. Performance Based Inspection Program
H. Enforcement
II. Risk Assessment and Risk Management
Requirements for the Authority
@.01 Outbreaks of Shellfish Related Illnesses
@.02 Presence of Human Pathogens in Shellfish Meats
A. Finding
B. Growing Area Investigation
C. Distribution and Processing Investigation
D. Risk Management and Tolerance Levels
@.03 Presence of Toxic Substance in Shellfish Meats
III. Laboratory
Requirements for the Authority
@.01 Quality Assurance
A. NSSP Conformance Required
B. State Program Requirements
C. FDA Certified State Shellfish Laboratory Officer
D. Laboratory Evaluation
E. Time Limit on Provisionally Conforming Status
F. Laboratory Services for Depuration Processors
@.02 Methods
A. Microbiological
B. Chemical and Physical
C. Biotoxin
IV. Shellstock Growing Areas
Requirements for the Authority
@.01 Sanitary Survey
A. General
B. Sanitary Survey Required
C. Sanitary Survey Performance
D. Shoreline Survey Requirements
@.02 Bacteriological Standards
A. General
B. Water Sample Stations
C. Exceptions
D. Standard for the Approved Classification of Growing Areas in the Remote Status
E. Standard for the Approved Classification of Growing Areas by Point Sources
F. Standard for the Approved Classification of Growing AreasAffected by Nonpoint Sources
G. Standard for the Restricted Classification of Growing Areas Affected by Point Sources and
Used as a Shellstock Source for Shellstock Depuration
H. 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
A. General
B. Approved Classification
C. Conditional Classifications
D. Restricted Classification
E. Prohibited Classification
@.04 Marine Biotoxin Control
A. Contingency Plan
B. Marine Biotoxin Monitoring
C. Closed Status of Growing Areas
D. Heat Processing
E. Records
@.05 Marinas
A. Marina Proper
B. Adjacent Waters
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
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
A. Operational Plan
B. Water Systems
C. Shellstock Quality
.06 Polyculture Systems
VII. Wet Storage in Approved and Conditionally Approved Growing Areas
Requirements for the Dealer
.01 Source of Shellstock
.02 General
.03 Wet Storage Sites
VIII. Control of Shellfish Harvesting
Requirements for the Authority
@.01 Control of Shellstock Growing Areas
A. General
B. Patrol of Growing Areas
C. Licensing of Harvesting
D. Penalties
E. Identification of Certain Growing Areas
F. Prohibited Classification
Requirements for Harvesters
.01 General
.02 Shellstock Harvesting and Handling
A. Harvesters
B. Vessels
C. Disposal of Human Sewage from Vessels
D. Shellstock Washing
E. Shellstock Identification
.03 Shellstock Temperature Control
Option 1
Option 2
Option 3
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
A. General
B. Shellfish Cargo Only
C. Mixed Cargos
D. Ice
.05 Shipping Times
A. Shipping Time is No More Than Four Hours
B. Shipping Time is Greater Than Four Hours
X. General Requirements for Dealers
.01 General HACCP Requirements
A. Hazard Analysis
B. HACCP Plan
C. Contents of the HACCP Plan
D. Signing and Dating the HACCP Plan
E. Sanitation
F. Corrective Actions
G. Verification
H. Records
I. Training
.02 General Sanitation Requirements
A. Sanitation Monitoring
B. Sanitation Monitoring Records
C. Relationship to HACCP Plan
.03 Other Model Ordinance Requirements
.04 Certification Requirements
A. General
B. Types of Certification
.05 Shellstock Identification
A. General
B. Tags
C. Tagging of a Lot of Shellstock During Intermediate Processing
D. Transaction Records
.06 Shucked Shellfish Labeling
A. Shellfish Labeling
B. Shucked Shellfish
.07 Shipping Documents and Records
A. Shipping Documents
B. Transaction and Shipping Records
.08 Wet Storage in Artificial Bodies of Water
A. General
B. Operational Specifications
C. Water Supply
D. Shellstock Handling
.09 Post-Harvest Processing
.10 Processed Products with Labeling Claims for Safety
XI. Shucking and Packing
Requirements for the Authority
@.01 Heat Shock
Requirements for Dealers
.01 Critical Control Points
A. Receiving Critical Control Point -Critical Limits
B. Shellstock Storage Critical Control Point -Critical Limit
C. Processing Critical Control Point -Critical Limits
D. Shucked Meat Storage Critical Control Point -Critical Limit
.02 Sanitation
A. Safety of Water for Processing and Ice Production
B. Condition and Cleanliness of Food Contact Surfaces
C. Prevention of Cross Contamination
D. Maintenance of Hand Washing, Hand Sanitizing, and Toilet Facilities
E. Protection from Adulterants
F. Proper Labeling, Storage and Use of Toxic Compounds
G. Control of Employees with Adverse Health Conditions
H. Exclusion of Pests
.03 Other Model Ordinance Requirements
A. Plants and Grounds
B. Plumbing and Related Facilities
C. Utilities
D. Insect and Vermin Control
E. Disposal of Wastes
F. Equipment Construction for Non-food Contact Surfaces
G. Cleaning and Sanitizing and Non-food Contact Surfaces
H. Shellfish Storage and Handling
I. Heat Shock
J. Personnel
K. Supervision
XII. Repacking of Shucked Shellfish
.01 Critical Control Points
A. Receiving Critical Control Point -Critical Limits
B. Processing Critical Control Point -Critical Limits
C. Shucked Meat Storage Critical Control Point -Critical Limit
.02 Sanitation
A. Safety of Water for Processing and Ice Production
B. Condition and Cleanliness of Food Contact Surfaces
C. Prevention of Cross Contamination . 97
D. Maintenance of Hand Washing, Hand Sanitizing, and Toilet Facilities
E. Protection from Adulterants
F. Proper Labeling, Storage and Use of Toxic Compounds
G. Control of Employees with Adverse Health Conditions
H. Exclusion of Pests
.03 Other Model Ordinance Requirements
A. Plants and Grounds
B. Plumbing and Related Facilities
C. Utilities
D. Insect and Vermin Control
E. Disposal of Other Wastes
F. Equipment Construction for Non-food Contact Surfaces
G. Cleaning Non-food Contact Surfaces
H. Shellfish Storage and Handling
I. Heat Shock
J. Personnel
K. Supervision
XIII. Shellstock Shipping
.01 Critical Control Points
A. Receiving Critical Control Point -Critical Limits
B. Shellstock Storage Critical Control Point -Critical Limits
.02 Sanitation
A. Safety of Water for Processing and Ice Production
B. Condition and Cleanliness of Food Contact Surfaces
C. Prevention of Cross Contamination
D. Maintenance of Hand Washing, Hand Sanitizing, and Toilet Facilities
E. Protection from Adulterants
F. Proper Labeling, Storage and Use of Toxic Compounds
G. Control of Employees with Adverse Health Conditions
H. Exclusion of Pests
.03 Other Model Ordinance Requirements
A. Plants and Grounds
B. Plumbing and Related Facilities
C. Utilities
D. Insect and Vermin Control
E. Disposal of Other Waste
F. Equipment Construction for Non-food Contact Surfaces
G. Cleaning of Non-food Contact Surfaces
H. Shellstock Storage and Handling
I. Heat Shock
J. Personnel
K. Supervision
XIV. Reshipping
.01 Critical Control Points
A. Receiving Critical Control Point -Critical Limits
B. Shellstock Storage Critical Control Point -Critical Limits
C. Shucked Meat Storage Critical Control Point -Critical Limit
.02 Sanitation
A. Safety of Water for Processing and Ice Production
B. Condition and Cleanliness of Food Contact Surfaces
C. Prevention of Cross Contamination
D. Maintenance of Hand Washing, Hand Sanitizing, and Toilet Facilities
E. Protection from Adulterants
F. Proper Labeling, Storage and Use of Toxic Compounds
G. Control of Employees with Adverse Health Conditions
H. Exclusion of Pests
.03 Other Model Ordinance Requirements
A. Plants and Grounds
B. Plumbing and Related Facilities
C. Utilities
D. Insect and Vermin Control
E.. Disposal of Other Wastes
F. Equipment Construction for Non-food Contact Surfaces
G. Cleaning Non-food Contact Surfaces
H. Shellfish Storage and Handling
I. Heat Shock
J. Personnel
K. Supervision
XV. Depuration
Requirements for the Authority
Requirements for the Dealer
.01 Critical Control Points
A. Receiving Critical Control Point -Critical Limits
B. Processing Critical Control Point -Critical Limits
C. Finished Shellstock Storage Critical Control Point -Critical Limits
.02 Sanitation
A. Safety of Water for Processing and Ice Production
B. Condition and Cleanliness of Food Contact Surfaces
C. Prevention of Cross Contamination
D. Maintenance of Hand Washing, Hand Sanitizing and Toilet Facilities
E. Protection from Adulterants
F. Proper Labeling, Storage and Use of Toxic Compounds
G. Control of Employees with Adverse Health Conditions
H. Exclusion of Pest
.03 Other Model Ordinance Requirements
A. Plant and Grounds
B. Plumbing and Related Facilities
C. Utilities
D. Insect and Vermin Control
E. Disposal of Wastes
F. Equipment Construction for Non-food Contact Surfaces
G. Cleaning of Non-food Contact Surfaces
H. Shellstock Storage and Handling
I. Personnel
J. Supvervision
K. Plant Operating Manual
L. Process Verification
Seafood
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