U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
July 28, 2000

INDUSTRY
Donna Garren, United Fresh Fruit and Vegetable Association
Al Yamada, Masaoka & Associates (for Fresh Produce Association of the Americas)
Gabriele Ludwig, Shramm, Williams & Associates (for Western Growers)
*Lee Frankel, Fresh Produce Association of the Americas
*John McClung, Texas Produce Association
*Daniel Funk, Del Monte Fresh Produce
*Dan Botts, Florida Fruit and Vegetable Association
*James Gurney, International Fresh Cut Produce

STATE
*James Waddell, Jeffrey Farrar, (California Department of Health and Human Services/Food and Drug Branch)
*Steven Steinhoff (Association of Food and Drug Officials)

FDA
Joseph Baca, John Kvenberg, Dennis Dignan, Jack Guzewich (Office of Field Programs)
Nega Beru (Office of Plant and Dairy Foods and Beverages)
Karen Deasey, (Centers for Disease Control and Prevention)
Louis Carson, Mary Ayling, Angel Gil, Camille Brewer (Food Safety Initiative)

CFSAN held a briefing with industry and other interested constituents to discuss the enforcement component of the domestic produce sampling survey. (Refer to the May 19, 2000 Constituent Briefing - Domestic Produce Sampling Survey, on this website).

An update was provided as follows:

• Sampling began in May, 2000. The rate of sampling in the southern U.S. is lower than expected due to the recent drought.

• 175 samples have been collected to date.

• 118 samples have been analyzed and 5 are positive for pathogens (4.2%).

• 95% of firms are not holding the lot following sample collection.

The following issues were discussed:

• For how long is the firm required to hold the sampled lot?

  The agency does not require that the product be held. The associations were asked to communicate this to dealers (packers and shippers) and ask them retrieve the lot if sample analysis reveals pathogen contamination.

• Is FDA going to identify the contaminated products/firms to the press or issue a recall?

  FDA will discuss the results with the firm and ask them to identify distribution and recall the product. If they will not recall, then FDA may take action through the courts. In the interim, FDA will work with the states and ask them to embargo lots that have not been recalled.

• How long does it take to receive the lab results?

  The laboratories are usually beginning analysis as soon as samples are received; preliminary findings are normally available in 3 days.

• What kind of data evaluation is being planned? Will it describe results on a regional basis?

  We haven't decided; there is insufficient data at this time.

• How quickly will FDA send a team to a farm when a violative sample has been found and how long after that will there be results of the investigation?

  Ideally, we should have a team ready to investigate within a week of confirmatory analytical results. The confirmatory results may not be completed for up to a month after sample collection.

• What have FDA investigations revealed so far?

  We have not completed investigations of domestic firms. Investigation of farms implicated in the imported produce survey revealed contaminated water and employee practices which may have contributed to contamination of produce. FDA's report of findings of the imported produce survey will discuss the results of investigations conducted by the agency as well as other parties.

• If the sample is clear, do you notify the firm?

  We don't routinely notify the firm of analytical results. We only notify the firm if the firm has requested notification at the time of sample collection.

• Will the state agencies be routinely notified of violative samples?

  We will revise the assignment to include instructions to our field offices to contact state counterparts when violative samples are found.

• Is there a way to inform the packers/dealers of this policy at the time of collection?

  We will request that a copy of the Constituent Briefing of May 19, 2000 be provided to the packer/dealer at the time of collection. The assignment will be revised to include this instruction.

• What have the evaluations shown to date?

  It is too early to evaluate the domestic produce assignment. We will periodically provide updates during the course of the survey with an evaluation to follow after the survey is completed.

• Is the imported produce sampling survey completed? When will an evaluation of that survey be completed?

  The imported produce survey is not completed but we expect completion in the next few months. We are preparing a report of the results of the survey to date and an evaluation will be prepared after the completion of the survey. We acknowledge the suggestion that the evaluation of the imported produce assignment be structured by product and region.

• When will the domestic produce survey be completed?

  The survey is targeted for completion in May 2001. The drought has slowed some sample collections but we expect to collect those samples during the next season and before May 2001.

• Are samples being collected as they are packed or as they arrive at the packing shed? Often, the product receives a wash prior to packing.

  We will revise the assignment to suggest that samples be collected after packing. If samples are collected at a different stage in the process, we will ask that information be noted on the collection report. It is still important that we are able to identify the grower at the time of collection. If product is co-mingled product prior to the washing stage in the process, it may be impossible to identify the grower.

• On what findings will the agency take action?

  To be consistent with the imported survey, the agency will initiate action (request recall or embargo, initiate seizure, etc) when salmonella or e coli 0157:H7 are found in two composites or samples and when shigella is found in one sample.

• When will all samples be tested for shigella?

  We are in the process of adapting the shigella method for all the food commodities included in the survey. We will update the assignment (and constituents) when shigella testing for all products is initiated.

• Are there any speedier methods being used to get quicker results?

  The agency, and others, are researching faster methodology but none are being used for this survey.

• To trade associations: If a grower informs you that his samples revealed pathogen contamination, what would be your response?

  We would tell them to start preparing for an investigation by FDA or the states. We would tell them to take their own samples as the first step. The problem is that if industry does its own testing, the results are often not trusted. We would also assist them in conducting an investigation; we have a joint interest with FDA in determining the source of the contamination and the cause as quickly as possible.

Hypertext updated by bap 2000-SEP-28