2009 NSSP Guide

Guide for the Control of Molluscan Shellfish 2009 Revision (full file - 6MB)

	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 Outbreak 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

Table of Contents

Title

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INTERSTATE SHELLFISH

SANITATION CONFERENCE