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Trade secret clause gags FDA on distribution of recalled flour

“CCI” may look and sound like a primetime crime series, but it’s actually the abbreviation for a legal phrase blocking FDA from revealing what food companies received flour that General Mills later recalled after it was linked to an ongoing E. coli outbreak.

CDC-map-E. coli-General-Mills-FlourOfficials with the U.S. Food and Drug Administration declined to comment on whether the recall of American Original Beer Bread mix by Molly & Drew is a secondary recall to the General Mills recall associated with the E. coli O121 outbreak.

“FDA can neither confirm nor deny that the two are related. FDA is prohibited by law from releasing publicly certain information about supply chains, which may constitute confidential commercial information ‘CCI’,” an agency spokeswoman told Food Safety News on Tuesday.

“As consignees are notified of the General Mills recall, they are following the recall instructions, reviewing their manufacturing processes, contacting their FDA district offices, and conducting new recalls if it’s determined a recall is needed. FDA also conducts audit checks to evaluate the effectiveness of the initial recall and any secondary recalls as needed. … Discussions with the firm (General Mills) are ongoing.”

General Mills has not publicly released the names of food producers and wholesalers who received bulk shipments of the recalled flour, which was produced in late 2015 at a Kansas City, MO, facility.

However, a company spokesman told Food Safety News the Molly & Drew company is not a direct customer of General Mills.

recalled Molly and Drew brear bread mix“All of our customers have been notified about the recall. This company is not one of our customers, but it is possible that they purchased our flour from one of our wholesale customers,” Mike Siemienas of General Mills said Wednesday.

On June 2 the General Mills spokesman said company officials “are not aware of it (the recalled flour) being used in any dry mixes.”

Officials with Molly & Drew did not respond to requests for comment on the recall, which involved beer bread mixes distributed to Cracker Barrel Old Country Store locations nationwide. However, the recall notice from the Sac City, IA, company said the action was necessary because “we were notified by one of our suppliers that they were conducting a recall of an ingredient used in our mix for the potential presence of E. coli O121.”

E. coli O121 is the same variety of the pathogen found in the General Mills flour and in lab samples from outbreak victims.

What are the odds?
Of the varieties of E. coli that are dangerous to humans, E. coli O121 is a relatively rare cause of foodborne outbreaks, according to statistics from the Centers for Disease Control and Prevention.

Out of the 26 multi-state, foodborne E. coli outbreaks investigated by the CDC from 2006 to date in 2016, only three — including the current outbreak linked to General Mills flour — involved E. coli O121. By contrast, E. coli O157:H7 was the pathogen in 17 of those 26 outbreaks.

The ongoing E. coli O121 outbreak linked to General Mills flour has sickened at least 38 people in 20 states. The illnesses began Dec. 21, 2015, with the most recent confirmed May 3, according to the CDC, which has not posted an outbreak update since June 1.

These are three of several varieties and brands of flour recalled by General Mills in relation to a multi-state outbreak of E. coli.

These are three of several varieties and brands of flour recalled by General Mills in relation to a multi-state outbreak of E. coli.

Using whole genome sequencing, FDA investigators on June 10 confirmed the outbreak strain of E. coli O121 in a bag of General Mills flour recovered from an outbreak victim’s home. That same day FDA posted an outbreak investigation update. It included information about bulk customers that was not revealed in the General Mills May 31 recall.

“General Mills also sells bulk flour to customers who use it to make other products. General Mills has contacted these customers directly to inform them of the recall,” the added paragraph states. “FDA is working with General Mills to ensure that the customers have been notified, and to evaluate the recall for effectiveness. Because of legal restrictions on commercial confidential information, FDA is not at this time authorized to release the names of these customers or the products they make with the flour.”

FDA’s revised outbreak investigation notice came out after Food Safety News requested information from FDA and General Mills about the potential for secondary recalls of consumer food products such as baking mixes. Earlier in June, FDA officials said there was no need for the general public to know about the bulk shipments because unlike the General Mills flour sent to retail stores, there was no way for the public to identify the bulk product.

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