ISSC: Interstate Shellfish Sanitation Conference

NSSP Guide

Guide for the Control of Molluscan Shellfish 2009 Revision

Full File (6MB) PDF

Interstate Shellfish Sanitation Conference

2009 NSSP Guide

Table of Contents

 

 

 

 

 

Title

Page

 

 

 

SECTION I.

 

PURPOSE

 

1

 

Purpose of the National Shellfish Sanitation Program

 

 

SECTION II.

MODEL ORDINANCE

2

 

(NOTE:  This Model Ordinance is in no way intended to discourage or limit States in establishing more stringent requirements.)

 

 


Purpose

 

2

 

 

Definitions

 

2

 

Chapter I.

 

Shellfish Sanitation Program

 

9

 

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

 

 

Chapter II.

 

Risk Assessment and Risk Management

 

13

 

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

                @. 04 Vibrio vulnificus Risk Management for 
                     Oysters

                @. 05 Vibrio parahaemolyticus Control Plan

 

 

Chapter III.

 

Laboratory

 

22

 

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

 

 

Chapter IV.

 

Shellstock Growing Areas

 

26

 

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 Areas Affected by Non Point 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 Non Point Sources
                     and Used as a Shellstock Source
for Shellstock
                     Depuration

                @. 03 Growing Area Classification

                A. General

                B. Approved Classification

                C. Conditional Classification

                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

 

 

Chapter V.

 

Shellstock Relaying

 

40

 

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

 

43

 

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

 

 

Chapter VII.

 

Wet Storage in Approved and Conditionally Approved Growing Areas

 

47

 

Requirements for the Dealer

.01 Source of Shellstock

.02 General

.03 Wet Storage Sites

 

 

Chapter VIII.

 

Control of Shellfish Harvesting

 

52

 

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

 

 

Chapter IX.

 

Transportation

 

63

 

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

 

 

Chapter X.

 

General Requirements for Dealers

 

67

 

.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. Bulk Tagging Lots of Shellstock for Sales
                     Between Dealers

                D. Tagging of a Lot of Shellstock During
                     Intermediate Processing

                E.  Transaction Record

                .06 Shucked Shellfish Labeling

                A. Shellfish Labeling

                B. Shucked Shellfish

                .07 Post Harvest Process Labeling

                .08 Shipping Documents and Records

                A. Shipping Documents

                B. Transaction and Shipping Records

 

 

Chapter XI.

 

Shucking and Packing 

78

 

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. Disposal of Other Wastes

                E. Equipment Condition, Cleaning, Maintenance,
                    and Construction 
for Non-Food Contact
                    Surfaces

                F. Shellfish Storage and Handling

                G. Heat Shock

                H. Supervision

 

 

Chapter XII.

 

Repacking of Shucked Shellfish

 

89

 

.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

                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. Disposal of Other Wastes

                E. Equipment Condition, Cleaning, Maintenance,
                    and Construction 
for Non-Food Contact
                    Surfaces

                F. Shellfish Storage and Handling

                G. Heat Shock

                H. Supervision

 

 

Chapter XIII.

 

Shellstock Shipping

 

97

 

.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. Disposal of Other Wastes

                E. Equipment Condition, Cleaning, Maintenance,
                    and Construction 
for Non-Food Contact
                    Surfaces

                F. Shellfish Storage and Handling

                G. Heat Shock

                H. Supervision

 

 

Chapter XIV.

 

Reshipping

 

106

 

.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. Disposal of Other Wastes

                E. Equipment Condition, Cleaning, Maintenance,
                    and Construction 
for Non-Food Contact
                    Surfaces

                F. Shellfish Storage and Handling

                G. Heat Shock

                H. Supervision

 

 

Chapter XV.

 

Depuration

 

113

 

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 Pests

                .03 Other Model Ordinance Requirements

                A.  Plant and Grounds

                B.  Plumbing and Related Facilities

                C. Utilities

                D. Disposal of Other Wastes

                E. Equipment Condition, Cleaning, Maintenance,
                    and Construction
for Non-Food Contact
                    Surfaces

                F. Shellfish Storage and Handling

                G. Heat Shock

                H. Supervision

                I. Plant Operating Manual

                J. Process Verification

 

 

Chapter XVI.

 

Post-Harvest Processing

          Post-Harvest Processing 

127

 

SECTION III.

PUBLIC HEALTH REASONS AND EXPLANATIONS

 

129

 

 

 

 

Introduction

129

 

 

 

Chapter I.

Shellfish Sanitation Program

131

 

Requirements for the Authority.

@. 01 Administration

@. 02 Dealer Certification

 

 

Chapter II.

Risk Assessment and Risk Management

133

 

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

135

 

Requirements for the Authority

@  .01 Quality Assurance

@  .02 Methods

 

 

Chapter IV.

Shellstock Growing Areas

135

 

Requirements for the Authority

@  .01 Sanitary Survey

@  .02 Bacteriological Standards

@  .03 Growing Area Classification

@  .04 Marine Biotoxin Control

@  .05 Marinas

 

 

Chapter V.

Shellstock Relaying

150

 

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

151

 

 

 

Chapter VII.

Wet Storage in Approved and Conditionally Approved Growing Area

152

 

 

 

Chapter VIII.

Control of Shellfish Harvesting

153

 

Requirements for the Authority

Requirements for Harvesters

 

 

Chapter IX.

Transportation

156

 

Requirements for the Authority

 

 

Chapter X.

General Requirements for Dealers

157

 

.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., XII., XIII.,  and XIV.

 

Shellfish Processing and Handling

161

 

Requirements for Dealers

.01 Critical Control Points

.02 Sanitation Requirements

.03 Other Model Ordinance Requirements

 

 

Chapter XV.

Depuration

165

 

Requirements for the Authority

.01 Administration

 
Requirements for the Depuration Processor

.01 Critical Control Points

.02 Sanitation

.03 Other Model Ordinance Requirements

 

 

Chapter XVI.

Background & Performance of Post Harvest Processing
(PHP) Validation/Verification Protocols

 

172

SECTION IV. 

GUIDANCE DOCUMENTS

176

 

 

 

Chapter I.

General

 

176

 

.01 Evaluation Standards

.02 Procedures for Initiating a New State Program
.03 Patrol Evaluation Guidance

 

 

Chapter II.

Growing Areas

182

 

.01Total 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 Documents 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

.11Evaluation 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 – Shellfish From Non-MOU Countries

 

 

Chapter III.

Harvesting, Handling, Processing, and Distribution

285

 

.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 Protocol for Addressing Positive Coliform Sample in an

      Artificial Wet Storage Water Body

.06 Guidance for Reinstating a Previously Infected Employee

 

 

Chapter IV.

Naturally Occurring Pathogens

 

349

 

.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

.05 Guidance for Demonstrating the Effectiveness of Time to
      Temperature
Reduction Criteria for Vibrio vulnificus and

      Vibrio parahaemolyticus 

 

 

   Chapter V.

Illness Outbreaks and Recall Guidance

 

367

 .01 Guidance for Investigating and Illness Oubreak and
        Conducting Recall
.02 Guidance for a Time-Temperature Evaluation of a
       Shellfish Implicated Outbreak

  

SECTION V.

SUGGESTED FORMS

 

395

 

Shellfish Harvest Record

Shellfish Harvest / Purchase Record

Restricted Use Shellstock-Shellfish Harvest/Purchase Record

Shellfish Sales Record

Restricted Use Shellstock-Sales/Disposition Record

Export Health Certificate

 

 

SECTION VI.

NSSP POLICY SETTING DOCUMENTS

 

401

 

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

Interstate Shellfish Sanitation Conference Resolution 09-001

 

 

SECTION VII.

FEDERAL REGULATIONS – SHELLFISH

 

405

 

 

 

SECTION VIII.

FDA MANUAL OF INTERPRETATIONS

462

 

Manual of Interpretations Codification System

09-I@.02-100
09-I@02-101
09-III@.02-100
09-IV-@.02-100
09-IV-@.02.101
09-IV-@.02.102
09-VIII-.03-100
09-XI-.01-100
09-XI-.02-100

09-XI-.02.101
09-XV-.03-100 

 

 

SECTION IX.

HISTORY OF THE NSSP

 

496

 

                Introduction

                A Declaration of Principles

                National Shellfish Sanitation Program

                Interstate Shellfish Sanitation Program

 

 

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