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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
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![Interstate Shellfish Sanitation Conference](https://webarchive.library.unt.edu/web/20080916061449im_/http://www.cfsan.fda.gov/~ear/nsspissc.gif)
Interstate Shellfish Sanitation Conference |
2005 Revision
GUIDE FOR THE CONTROL OF MOLLUSCAN SHELLFISH
TABLE OF CONTENTS
- PURPOSE
Purpose of the National Shellfish Sanitation Program
- MODEL ORDINANCE
(NOTE: This Model Ordinance is in no way intended to discourage or
limit States in establishing more stringent requirements.)
- Purpose
- Definitions
-
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
- 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
-
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
-
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
-
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
-
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
-
Wet Storage in Approved and Conditionally Approved
Growing Areas
Requirements for the Dealer
.01 Source of Shellstock
.02 General
.03 Wet Storage Sites
-
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
-
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
-
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
.09 Wet Storage in Artificial Bodies of Water
- General
- Operational Specifications
- Water Supply
- Shellstock Handling
-
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
- Insect and Vermin Control
- Disposal of Wastes
- Equipment Construction for Non-food Contact Surfaces
- Cleaning and Sanitizing and Non-food Contact Surfaces
- Shellfish Storage and Handling
- Heat Shock
- Personnel
- Supervision
-
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
- Insect and Vermin Control
- Disposal of Other Wastes
- Equipment Construction for Non-food Contact Surfaces
- Cleaning Non-food Contact Surfaces
- Shellfish Storage and Handling
- Heat Shock
- Personnel
- Supervision
-
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
- Insect and Vermin Control
- Disposal of Other Waste
- Equipment Construction for Non-food Contact Surfaces
- Cleaning of Non-food Contact Surfaces
- Shellstock Storage and Handling
- Heat Shock
- Personnel
- Supervision
-
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
- Insect and Vermin Control
- Disposal of Other Wastes
- Equipment Construction for Non-food Contact Surfaces
- Cleaning Non-food Contact Surfaces
- Shellfish Storage and Handling
- Heat Shock
- Personnel
- Supervision
-
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
- Insect and Vermin Control
- Disposal of Wastes
- Equipment Construction for Non-food Contact Surfaces
- Cleaning of Non-food Contact Surfaces
- Shellstock Storage and Handling
- Heat Stock
- Personnel
- Supervision
- Plant Operating Manual
- Process Verification
-
Post-Harvest Processing
Post-Harvest Processing
-
PUBLIC HEALTH REASONS AND EXPLANATIONS
- Introduction
-
Shellfish Sanitation Program
Requirements for the Authority.
@. 01 Administration
@. 02 Dealer Certification
-
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
-
Laboratory
Requirements for the Authority
@ .01 Quality Assurance
@ .02 Methods
-
Shellstock Growing Areas
Requirements for the Authority
@ .01 Sanitary Survey
@ .02 Bacteriological Standards
@ .03 Growing Area Classification
@ .04 Marine Biotoxin Control
@ .05 Marinas
-
Shellstock Relaying
Requirements for the Authority
@ .01 General
@ .02 Contaminant Reduction
@ .03 Licenses to Relay Shellstock
@ .04 Management of Relaying Activities
Requirements for Harvesters
-
Shellfish Aquaculture
-
Wet Storage in Approved and Conditionally Approved Growing
Area
-
Control of Shellfish Harvesting
Requirements for the Authority
Requirements for Harvesters
-
Transportation
Requirements for the Authority
-
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
- , XII., XIII., and XIV.
Shellfish Processing and Handling
Requirements for Dealers
.01 Critical Control Points
.02 Sanitation Requirements
.03 Other Model Ordinance Requirements
-
Depuration
Requirements for the Authority
.01 Administration
Requirements for the Depuration Processor
.01 Critical Control Points
.02 Sanitation
.03 Other Model Ordinance Requirements
-
GUIDANCE DOCUMENTS
-
Chapter
I - General
.01 Evaluation Standards
.02 Procedures for Initiating a New State Program
-
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
-
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
-
SUGGESTED FORMS
Shellfish Harvest Record
Shellfish Harvest / Purchase Record
Shellfish Sales Record
Export Health Certificate
-
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
-
FEDERAL REGULATIONS - SHELLFISH
-
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
-
HISTORY OF THE NSSP
Introduction
A Declaration of Principles
National Shellfish Sanitation Program
Interstate Shellfish Sanitation Program