National Shellfish Sanitation Program (NSSP) ... Chapter XVII Shellfish Gardening .....145 @ .01...

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Transcript of National Shellfish Sanitation Program (NSSP) ... Chapter XVII Shellfish Gardening .....145 @ .01...

National Shellfish Sanitation Program (NSSP)

Guide for the Control of Molluscan Shellfish 2017 Revision

From the U.S. Food and Drug Administration website http://www.fda.gov/Food/GuidanceRegulation/FederalStateFoodPrograms/ucm2006754.htm

http://www.fda.gov/Food/GuidanceRegulation/FederalStateFoodPrograms/ucm2006754.htm

National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish: 2017 Revision

This document is intended to provide guidance and shall supersede the 2015 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

2017 Revision

From the U.S. Food and Drug Administration website

http://www.fda.gov/Food/GuidanceRegulation/FederalStateFoodPrograms/ucm2006754.htm

http://www.fda.gov/Food/GuidanceRegulation/FederalStateFoodPrograms/ucm2006754.htm

National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish: 2017 Revision

i

Table of Contents Section I. Purpose & Definitions ........................................................................................................................ 1

Purpose ..................................................................................................................................................................... 2

Definitions ................................................................................................................................................................. 3

Purpose ................................................................................................................................................................. 3

Definitions ............................................................................................................................................................. 3

Section II. Model Ordinance ............................................................................................................................ 11

Chapter I. Shellfish Sanitation Program Requirements for the Authority .............................................................. 12

@.01 Administration ........................................................................................................................................... 12

@.02 Dealer Certification.................................................................................................................................... 13

@.03 Evaluation of Shellfish Sanitation Program Elements ............................................................................... 16

Chapter II. Risk Assessment and Risk Management ............................................................................................... 24

Requirements for the Authority ......................................................................................................................... 24

@.01 Outbreaks of Shellfish-Related Illness ....................................................................................................... 24

@.02 Shellfish Related Illnesses Associated with Vibrio parahaemolyticus (V.p.) ............................................. 26

@. 03 Annual Assessment of Vibrio vulnificus and Vibrio parahaemolyticus Illnesses and Shellfish Production27

@.04 Presence of Human Pathogens in Shellfish Meats .................................................................................... 28

@.05 Presence of Toxic Substances in Shellfish Meats ...................................................................................... 30

@.06 Vibrio vulnificus Control Plan ..................................................................................................................... 30

@.07 Vibrio parahaemolyticus Control Plan ....................................................................................................... 32

Chapter III. Laboratory ............................................................................................................................................ 35

Requirements for the Authority ......................................................................................................................... 35

@.01 Quality Assurance ...................................................................................................................................... 35

@.02 Methods .................................................................................................................................................... 36

Chapter IV. Shellstock Growing Areas ..................................................................................................................... 38

Requirements for the Authority ......................................................................................................................... 38

@.01 Sanitary Survey .......................................................................................................................................... 38

@.02 Microbiological Standards ......................................................................................................................... 40

@.03 Growing Area Classification ....................................................................................................................... 43

@.04 Marine Biotoxin Control ............................................................................................................................ 50

@.05 Marinas ...................................................................................................................................................... 53

Chapter V. Shellstock Relaying ................................................................................................................................ 55

National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish: 2017 Revision

ii

Requirements for the Authority ......................................................................................................................... 55

@.01 General ...................................................................................................................................................... 55

@.02 Contaminant Reduction ............................................................................................................................ 55

@.03 Licenses to Relay Shellstock or to Harvest Shellstock for Delivery to a Low Acid Canned Food Processing Facility ................................................................................................................................................................. 56

@.04 Management of Relaying Shellstock or the Harvesting for Delivery to a Low Acid Canned Food Processing Facility Activities.................................................................................................................................................. 57

Requirement for Harvesters ............................................................................................................................... 57

.01 Harvester License Required .......................................................................................................................... 57

Chapter VI. Shellfish Aquaculture ........................................................................................................................... 58

Requirements for the Authority ......................................................................................................................... 58

@ .01 General ..................................................................................................................................................... 58

@ .02 Seed Shellstock ......................................................................................................................................... 58

@.03 Aquaculture in Federal Waters.................................................................................................................. 58

Requirements for the Harvester/Dealer ............................................................................................................. 59

.01 Exceptions ..................................................................................................................................................... 59

.02 General .......................................................................................................................................................... 59

.03 Seed Production in Water Classified as Prohibited or Unclassified .............................................................. 59

.05 Land Based Aquaculture .....................