U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
August 09, 2000

INDUSTRY
Dan Botts, Florida Fresh Fruit and Vegetable Association
Wally Ewart, Northwest Horticultural Council

FDA
John Kvenberg, CFSAN/Office of Field Programs
Dennis Dignan, CFSAN/Office of Field Programs
Bill Correll, CFSAN/Office of Field Programs
John Sanders, CFSAN/Office of Field Programs
Sherri McGarry, CFSAN/Office of Field Programs
Michelle Smith, CFSAN/Office of Plant and Dairy Foods and Beverages
Quynh-Anh Nguyen, CFSAN/Office of Plant and Dairy Foods and Beverages
D.B. Shah, CFSAN/Office of Special Research Skills
Wallace H. Andrews, CFSAN/Office of Special Research Skills
Mary Ayling, CFSAN/Food Safety Initiative Staff
Lou Carson, CFSAN/Food Safety Initiative Staff
Irving Weitzman, Office of Regulatory Affairs, Division of Emergency and Investigational Operations
Jody Robinson, Office of Regulatory Affairs, Division of Emergency and Investigational Operations
Marsha Hayden, Office of Regulatory Affairs, Division of Field Science (by phone)

Date: August 9, 2000

Location: FB8, 200 "C" St, SW, Washington, DC 20204

Mr. Botts and Dr. Ewart requested the meeting to further discuss the agency's Domestic Produce Sampling Survey assignment. Two previous meetings were held to discuss the assignment; May 19^th (Dr. Ewart participated by phone) and July 28th (Mr. Botts participated by phone).

Mr. Botts provided four areas for discussion:

1. What information is shared with the firm at the time of sample collection?

   The memorandum of the meeting of May 19th and the assignment document, both located at the foodsafety.gov website were referenced. FDA said that samples were being collected at packers and that communications would normally be with and through the packers. The trade associations were encouraged to advise grower members to talk with packers and assure they are kept in the communication. Trade associations could also advise members to request that packers provide the growers' addresses, phone numbers, and contact names to FDA at the time of sample collection to further assure communication of analytical findings.

2. Is the definition of a lot dependent on the point in process where the sample is collected?

   FDA said that the assignment instructions would be revised to direct sampling to a point in the process after the product was rinsed but prior to loss of grower identification. If the sample is collected prior to a packer rinse, the collection report would be annotated. This method will provide for a more similar point of collection with the Imported Produce Sampling Survey assignment.

3. Where can industry get information on sample preparation and analytical methodology?

   Some specific methodology instructions were contained in an attachment to the assignment and the attachment was not posted on the internet nor provided in hardcopy to industry. The method for sample preparation was described and the methods are located in the most recent edition of B.A.M. (Bacteriological Analytical Methods). At the close of the meeting copies of all 4 attachments to the assignment were provided to Mr. Botts and Dr. Ewart.

4. How can industry use the results of the survey and use the results to learn of ways to improve industry practices?

   All agreed that timely sharing of the results of the survey would aid both government and industry in efforts to improve practices. We discussed the best methods of alerting trade associations to findings of pathogens in sampled products and suggested that the trade associations provide the agency with regional or local contacts for the commodities being sampled; the agency would then alert the field offices to communicate findings with the associations.

   All agreed that, in addition to a visit to the farm associated with a violative sample, visits should also be made to growers of the same product, also sampled but found free of pathogens. Information should be shared and compared to determine any specific practices that may be effecting the pathogen level in the sampled products.

   In order to do these investigations with the least amount of duplication of efforts and to share the information, several things need to be agreed to and accomplished:
   
   

   • We should be using the same method of farm audit/investigation. To accomplish this, FDA should post the Farm Investigation Checklist on the internet and/or share the list with trade associations. (CFSAN/OFP)
     
   • The state agencies that may be responsible for follow-up investigations should be involved in this process as soon as possible. (ORA/DEIO/DFSR)
     
   • Representatives from FDA, states, and trade associations need to further discuss how to collect information, share that information, and evaluate that information to determine if there are practices identified by the audits which significantly impact the pathogen level in the sampled products. (CFSAN/OPDFB)
     
   • FDA should determine if there are restrictions on the sharing of this information based upon 21 U.S.C. 331(j) (trade secret provision) (CFSAN/OFP)
     

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