Where the subject may be perishable
but the insight isn’t.

The FDA Needs To Reexamine
Its Methodology

Jim Prevor's Perishable Pundit — October 2, 2006

As the FDA has so far explained it, this whole outbreak has never made much sense. As we asked in a previous article, how was it possible for so many brands to be implicated?

These things typically come in the form of a “bad batch,” so the notion that all these wildly divergent brands packed on different days -- some organic, some conventional -- were contaminated strains credulity.

Now the laboratory tests are coming in, and we have 10 confirmed product samples that contain E. coli 0157:H7 outbreak strain. I list them below.

Of the 10 product samples, eight are identified as Dole brand bagged baby spinach; two are unidentified.

The most reasonable explanation for the whole outbreak is that we had a bad batch of spinach that Natural Selection Foods bagged under the Dole brand.

So the whole worldwide recall and shutdown of the industry was not needed. All they had to do was recall Dole product.

This is consistent with the kinds of outbreaks that have occurred for the last decade.

There is something wrong with the way FDA is questioning people that is producing too many “false positives”.

While the industry is redoubling its efforts to produce safe food, we need a little humility from FDA acknowledging its systems seriously malfunctioned, and we need an “Action Plan” from FDA on how they will make sure that future food recalls are narrowly tailored to solve the problem.

The FDA is not supposed to bankrupt industries, throw people out of work or destroy family farms because of bad survey methodology.


LABORATORY FINDINGS
There are now a total of 10 confirmed product samples that contain the E. coli O157:H7 outbreak strain.

• The Colorado Department of Public Health and Environment has confirmed the presence of the outbreak strain of E. coli O157:H7 in a sample of Dole spinach with a lot code of P227A02 and a “best if used by” date of August 30, 2006.

• The Ohio Department of Health confirmed the isolation of E. coli O157:H7, matching the outbreak strain from a package of bagged spinach.

• The Wisconsin Department of Health and Family Services has confirmed that E. coli O157:H7, the same strain as that associated with the outbreak, has been found in two bags of Dole baby spinach with lot codes of P227A.

• The Nevada Department of Health and Human Services has reported a confirmed finding of E. coli O157:H7 in bagged spinach, matching the outbreak strain. The Nevada sample was analyzed by FDA Pacific Regional Lab NW.

• The Pennsylvania Department of Health has confirmed that E. coli O157:H7, the same strain as that associated with the outbreak, has been found in two individual bags of Dole spinach purchased in Pennsylvania with a “best if used by” date of August 30, 2006, and a lot code of P227A01.

• The Utah Department of Health (UDOH) and the Salt Lake Valley Health Department (SLVHD) have confirmed that E. coli O157:H7, the same strain as that associated with the outbreak, has been found in a bag of Dole baby spinach purchased in Utah, with a lot code of P227A01. Laboratory tests were conducted by the Utah Public Health Laboratory (UPHL).

• The New Mexico Department of Health announced on September 20, 2006, that it had linked a sample from a package of spinach with the outbreak strain of E. coli O157:H7. DNA fingerprinting tests determined that the strain from the spinach matches the strain from patients in the outbreak. The package of spinach that tested positive was Dole baby spinach, with a lot code of P227A03.

• The Illinois Department of Public Health has confirmed that E. coli O157:H7, matching the outbreak strain, has been found in a package of Dole fresh spinach with a lot code of P227A02, and a “best if used by” date of August 30.