January 16, 2004 

Mr. Robert Wittman,

FDA concurs with Conference action on Proposal 01-224 with the exception of “no action” on Post Harvest Processing Committee recommendation number one. FDA requests that Post Processing Committee recommendation number one be referred back to the Conference for deliberation by an appropriate committee.  

Recommendation number one called for establishment of a Post Harvest Treatment (PHT) designation for use in the Interstate Certified Shellfish Shippers List (ICSSL). Such designation would identify dealers who utilize a validated process to reduce target pathogens in shellfish to safe levels. Recommendation number one also defined the PHT designation in a manner consistent with model Ordinance requirements for PHT processing. FDA considers the ability to identify shellfish dealers that have a validated process for reducing target pathogens to safe levels an important component of the comprehensive NSSP program for PHT. We remain committed to the premise that ICSSL identification of PHT processors provides incentive to processors provide incentive to processors who currently employ or who are considering installation of PHT processes, to improve shellfish safety.  

Proposal 03-200:  

FDA does not concur with action by the Conference to adopt Proposal 00-200. Proposal 00-200 provides for scheduled  inspections at shellfish firms that many operate intermittently or that may have infrequent Business hours. We recommend that this Proposal be referred back to the Conference for deliberation by an appropriate committee.  

FDA recognizes that there are instances when scheduling an inspection is necessary due to the unusual operating schedule of a firm. FDA believes that state shellfish authorities currently have the discretion to schedule inspections where unannounced visits have not been possible. Rather than establishing Model Ordinance language to address the infrequent occurrence of such situations. FDA supports handling them on a case-by-case basis where sound judgment can prevail. Of course, justification for conducting a scheduled inspection at a shellfish dealer must be documented in the central file.          

The following Proposals have FDA concurrence with the following comments: 

Proposal 01-114:  
FDA concurs with Conference action not to permit non-law enforcement personnel to conduct patrol activities. However, as part of the Conference’s action on Proposal 01-114. FDA was requested to evaluate the impact of using non-law enforcement  personnel during patrol activities. Prior to conducting this investigation, FDA asks that the Conference develop additional guidance regarding the type of evaluation that would provide useful information for future deliberation on the proposal.  

Proposal 01-127:  
The numbered reference to the Shellfish laboratory Evaluation Checklist cited in Proposal 01-127 is A.12. That reference must be changed to be consistent with new reference numbering in the 2002 National Shellfish Sanitation Program (NSSP) Guide.  

Proposal 02-115:   FDA concurs with adoption of Proposal 03-115 to establish membrane filtration as an acceptable alternative to the MPN test. However, the specific membrane filtration method that was deliberated and recommended for adoption by the Laboratory Review Committee was not identified in the Summary of Actions. The method officially adopted by the ISSC was the mTEC procedure and the primary refernce for performing this method is the Rippey, ct al, 1987 citation. The mTEC procedure must be identified in the Model Ordinance when changes resulting from the 2003 ISSC are incorporated.  

Proposal 03-116  
FDA concurs with adoption of proposal 03-116 to accept the Jellett Rapid PSP test as a tool for states to use in the control of PSP in shellfish.  However, several importantt caveats placed on use of the Jellett rapid PSP test were not clearly stated in the Summary of Actions. They are:                

  1.        Use of the Jellett PSP test must be based on the currently approved procedure for PSP toxin extraction. No other extraction procedures have been validated and approved for use under the NSSP, including those provided by Jellett Rapid Testing Ltd.

2.        When employing only the Jellett rapid PSP test to screen for saxitoxins, the Shellfish Authority shall make precautionary closures when positive results occur.                                                                                                          

The Interstate Shellfish Sanitation Conference is to be commended for its efforts at the 2003 annual meeting. Actions of the Conference continue to strengthen the National Shellfish Sanitation Program, provide improved shellfish safety, and promote future shellfish sanitation accomplishments by theISSC.                                                                                                          

Sincerely yours                                                                                              

Philip Spiller, Director
Office of Seafood
Center for Food  Safety 
and Applied Nutrition                                                                                                 

cc:
Ken Moore, Director
ISSC Executive Office
209-2 Dawson Road
Columbia, South Carolina 29223