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Nestle E. Coli Cookie Dough Plant Legally Kept Records from FDA During Past Inspections.

Jun 26, 2009 | Parker Waichman LLP Officials at a Nestle USA facility in Virginia legally refused on several occasions to give Food & Drug Administration (FDA) officials access to certain records during inspections, The Wall Street Journal reported today.  The Nestle facility in Danville, Virginia produced Toll House cookie dough that has been implicated in a multistate outbreak of E. coli O157:H7.

Last Friday, the FDA warned consumers not to eat any varieties of Prepackaged Nestle Toll House refrigerated cookie dough following reports of people infected with E. coli O157:HY in dozens of states. At the time, the agency said that dozens of E. coli illnesses might be related to consumption of raw cookie dough.  That same day, Nestle recalled 300,000 cases of those cookie dough products.

According to the latest Centers for Disease Control (CDC) update, at least  69 people  in 29 states had been sickened by  the same strain of E. coli. Thirty-four people have been hospitalized, 9 developed hemolytic uremic syndrome (HUS).   There have been no deaths reported.  

Earlier this week, Nestle announced the temporary closing of its Danville, Virginia plant because of the E. coli outbreak.  Inspectors from the FDA have been at the plant trying to determine how the cookie dough might have come in contact with E. coli.  According to the CDC, E. coli O157:H7 has not been previously associated with eating raw cookie dough.

According to The Wall Street Journal, during some  inspections over the past five years, officials at the Nestle plant in Danville refused to allow the FDA to  look at records relating to issues like pest control. For instance, in 2006 an FDA inspector was not permitted access to consumer complaints, and was not able to inspect the facilities food contamination prevention program.  During that inspection, dirty equipment and "three live ant-like insects" were noted, but these weren't enough to give the facility a failing grade, the Journal said.

According to the Journal, in most instances, companies  are not required to show those types of records to the FDA, and such refusals are not uncommon. The FDA can only compel food firms to turn them over if it invokes a bioterrorism law, and can show that foods made at a facility pose a serious health threat.  The only exception to this are facilities that produce infant formula, seafood, juices and low-acid canned food, the Journal said.

Recently, a House of Representatives committee approved food safety legislation that would give the FDA access to all records at a food manufacturing facility, but it is not known when it will come up for  a final vote, the Journal  said.  A similar law was recently introduced in Senate.

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