The U.S. Food and Drug Administration (FDA) is completing its investigation of Nestlé USA’s cookie-dough plant, but is unable to determine the source of the E. coli outbreak linked to a package of cookie dough. The Wall Street Journal reported that the agency was unable to match the strain’s DNA fingerprint that resulted in over 70 illnesses in 30 states; over 30 people were hospitalized and at least nine developed hemolytic uremic syndrome (HUS).
Extensive testing on samples, production lines, and ingredients were conducted and the Danville, Virginia plant has reopened and resumed production, said the Journal. FDA’s associate commissioner for foods, Dr. David Acheson, said the agency probably will not determine how the tainted dough became contaminated, saying, “This will be one of those situations where we won’t definitely know what went wrong,” quoted the Journal.
The FDA recently warned consumers not to eat any varieties of Prepackaged Nestlé Toll House refrigerated cookie dough following reports of people infected with E. coli. At the time, the agency said dozens of E. coli illnesses might be related to raw cookie dough consumption. Nestlé then recalled 300,000 cases of those products and, soon after, announced the temporary closing of its Danville, Virginia plant.
The federal Centers for Disease Control and Prevention (CDC) determined that many victims were young girls who ate raw Toll House cookie dough before falling ill, said the Journal. Soon after, the FDA discovered E. coli O157 in a 16-ounce refrigerated chocolate-chip cookie dough bar during its inspection of the plant, said the Journal; however, tests could not connect the genetic fingerprint. “Obviously, there is more than one E. coli O157 [strain] in the cookie dough,” the Journal quoted Dr. Acheson.
Of note, officials at the Nestlé facility in Danville legally refused on several occasions to give FDA officials access to certain records during inspections, according to an earlier Journal report, which explained that during some inspections over the past five years, Nestlé officials 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 facility’s food contamination prevention program. During that inspection, dirty equipment and “three live ant-like insects” were noted, insufficient to give the facility a failing grade, the Journal said, previously.
According to the Journal, generally, 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 foods made at a facility pose a serious health threat. The only exception is facilities that produce infant formula, seafood, juices, and low-acid canned food, the Journal said.
Nestlé will now indicate “New Batch” on the products produced following the outbreak with shipping cartons marked, as well. “The packaging will also include a reminder to consumers to not consume raw cookie dough, and to use safe food handling procedures,” a Nestlé spokeswoman said, quoted the Journal.
Although the investigation turned up a design flaw in a gate valve as well as a refrigeration pipe dripping condensation, Nestlé claimed these issues were not linked to the contamination, said The Journal. Also, investigators suspected that wheat flour could have been a contamination source, but E. coli was not found at the flour mill Nestlé used, said the Journal. And, although dough could have come in contact with raw meat, Dr. Acheson said such lines are separated at the Danville plant, reported the Journal, which added that dough could have been deliberately contaminated, but there is no evidence to support such tampering.
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