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:
The following issues were discussed:
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.
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.
The laboratories are usually beginning analysis as soon as samples are received; preliminary findings are normally available in 3 days.
We haven't decided; there is insufficient data at this time.
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.
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.
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.
We will revise the assignment to include instructions to our field offices to contact state counterparts when violative samples are found.
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.
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.
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.
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.
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.
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.
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.
The agency, and others, are researching faster methodology but none are being used for this survey.
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