Guidance Documents

Chapter II. Growing Areas

.13 Protocol for Reviewing Classification of Areas Implicated
by Pathogens in Shellfish Meat Samples

Table of Contents

 

PROTOCOL FOR REVIEWING CLASSIFICATION OF AREAS IMPLICATED BY PATHOGENS IN SHELLFISH MEAT SAMPLES

 ¹ FDA has established action levels or levels of concern for certain microbial pathogens in molluscan shellfish. The Agency will consider enforcement action against the shipment of molluscan shellfish if the following levels of pathogens are detected:

 

<Salmonella - positive for the presence of the organism;

 

<Enterotoxigenic Escherichia coli (ETEC) - 1,000 per gram, heat-labile toxin (LT) or heat-stable enterotoxin (ST) positive (may be determined by MPN method);

 

<Vibrio cholerae - presence of toxin-producing 01 or non-01 organisms;

 

<Vibrio parahaemolyticus - levels equal to or greater than a MPN count of 10,000 per gram and Kanagawa positive or negative; and

 

<Staphylococcus aureus - positive for staphylococcal enterotoxin or when the viable MPN count is 10,000 per gram.

 

²Other pathogens under review include: Listeria monocytogenes, non-toxin producing non-01 Vibrio cholerae, and Vibrio vulnificus. In the absence of an established action level or level of concern for these pathogens, enforcement action is considered on a case-by-case basis taking into account all the factors associated with the specific situation.