FDA Weighing Use of Pooled Sprout Water Samples for Testing Mary EllenButler Food Chemical News

FDA Weighing Use of Pooled Sprout WaterSamples for Testing
Mary EllenButler
Food Chemical News, October 23, 2000, Volume 42, Number 36,

FDAis examining industry information and some of its own data in an effort todecide if it will change its guidance to allow industry to pool spent irrigationwater samples used for the testing of pathogens in sprouts, an agency sourcetold Food Chemical News.

LeeAnneJackson, a senior policy analyst at FDA’s Center for Food Safety and AppliedNutrition, said additional work still needs to be done to answer the question ofwhether pooling spent irrigation water dilutes samples and makes pathogencontamination harder to detect.

“Weneed to be sure that by pooling samples you’re not going to be decreasing thesensitivity of the assay,” Jackson said. FDA has yet to change itsposition, but if the agency is satisfied that pathogens can be adequatelydetected, it plans to revise the guidance.

Underthe sprout field assignment, some FDA field districts have issued warningletters for growers who pooled samples, while others have not. Sprout growershave been pushing for the option of using pooled samples because it would allowthem to cut down on their analytical costs.

Halfof growers not testing sprout water FDA met with members of the sprout industryin Washington, D.C., last week to discuss pooling samples, as well as theresults of the sprout field assignment, which showed that about half of thesprout growers visited are not testing spent irrigation water at all.

Theagency suspects that in many cases growers are not aware of the guidance FDApublished last October outlining procedures for sampling. In fact, FDA learnedat the meeting last week with industry that there are likely 250-280 sproutgrowers in the U.S., instead of the 150 estimated by the agency. In some cases,those growers have very small operations and only sell their products in onestate or in one or two counties.

Thecost of testing has been brought up as a concern in the past and a possiblereason for why some growers were not testing the spent irrigation water.However, Jackson said that was not something brought up at last week’s meetingand that most growers recognize that testing is necessary in order to produce asafe product.

FDAvisited 140 firms over the course of the sprout field assignment, which began inMay, FDA has inspected about 140 firms. While those initial visits have beencompleted, not all of the information from those visits has reached CFSAN, suchas the results of questionnaires given to growers. The next step will be tocomplete a detailed analysis of the results and to conduct follow-up inspectionsof firms that received warning letters to ensure that corrective action has beentaken.

Thefield assignment looked at seed storage, sprout production, seed treatment,pathogen testing methods, and traceback capability. It was also a way to gatherinformation about pooling samples.

Anotherproduct of the meeting is that FDA has acknowledged the need to make additionalchanges to the guidance to cover bean sprouts. Currently, the guidance dealsspecifically with alfalfa and other green sprouts, but it does not makeadjustments for the different way that bean sprouts are grown.