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FDA Weighing Use of Pooled Sprout Water
Samples for Testing FDA
is examining industry information and some of its own data in an effort to
decide if it will change its guidance to allow industry to pool spent irrigation
water samples used for the testing of pathogens in sprouts, an agency source
told Food Chemical News. LeeAnne
Jackson, a senior policy analyst at FDA’s Center for Food Safety and Applied
Nutrition, said additional work still needs to be done to answer the question of
whether pooling spent irrigation water dilutes samples and makes pathogen
contamination harder to detect. "We
need to be sure that by pooling samples you’re not going to be decreasing the
sensitivity of the assay," Jackson said. FDA has yet to change its
position, but if the agency is satisfied that pathogens can be adequately
detected, it plans to revise the guidance. Under
the sprout field assignment, some FDA field districts have issued warning
letters for growers who pooled samples, while others have not. Sprout growers
have been pushing for the option of using pooled samples because it would allow
them to cut down on their analytical costs. Half
of growers not testing sprout water FDA met with members of the sprout industry
in Washington, D.C., last week to discuss pooling samples, as well as the
results of the sprout field assignment, which showed that about half of the
sprout growers visited are not testing spent irrigation water at all. The
agency suspects that in many cases growers are not aware of the guidance FDA
published last October outlining procedures for sampling. In fact, FDA learned
at the meeting last week with industry that there are likely 250–280 sprout
growers 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 one
state or in one or two counties. The
cost of testing has been brought up as a concern in the past and a possible
reason for why some growers were not testing the spent irrigation water.
However, Jackson said that was not something brought up at last week’s meeting
and that most growers recognize that testing is necessary in order to produce a
safe product. FDA
visited 140 firms over the course of the sprout field assignment, which began in
May, FDA has inspected about 140 firms. While those initial visits have been
completed, not all of the information from those visits has reached CFSAN, such
as the results of questionnaires given to growers. The next step will be to
complete a detailed analysis of the results and to conduct follow-up inspections
of firms that received warning letters to ensure that corrective action has been
taken. The
field assignment looked at seed storage, sprout production, seed treatment,
pathogen testing methods, and traceback capability. It was also a way to gather
information about pooling samples. Another
product of the meeting is that FDA has acknowledged the need to make additional
changes to the guidance to cover bean sprouts. Currently, the guidance deals
specifically with alfalfa and other green sprouts, but it does not make
adjustments for the different way that bean sprouts are grown. |