Showing posts with label nestle cookie dough. Show all posts
Showing posts with label nestle cookie dough. Show all posts

Tuesday, August 18, 2009

Nestlé Refrigerated Cookie Dough Is Back

August 18, 2009

With full fanfare, Nestlé announced today that the first five of the company's Toll House® raw cookie dough products returned to store shelves this week.

Toll House® raw cookie dough was behind a recent outbreak of E. coli O157:H7 that sickened 80 individuals – two thirds of them children and teenagers – in 31 states during May and June of this year. Thirty-five of the victims were hospitalized as a result of their illness. Ten developed hemolytic uremic syndrome, a life-threatening complication that typically affects 5-10% of those infected with E. coli O157:H7.

Nestlé's Danville, VA cookie dough production facility was shut down in mid-June to facilitate FDA's investigation. While two different samples of Toll House® raw cookie dough yielded E. coli when tested during the outbreak investigation, neither of the E. coli strains matched the genetic fingerprint of the outbreak strain. The source of the contaminants was never traced. Following the investigation, the cookie dough plant was thoroughly cleaned and sanitized before production was restarted with fresh ingredients from new suppliers.

The newly released Toll House® cookie dough products will sport new packaging, including a blue "New Batch" label. While Nestlé tests all ingredients as they arrive, and also carries out "in process" tests of the cookie dough during production, the Company reminds consumers that no testing program can guarantee safety of a raw product. Each package of raw cookie dough will carry the following statement, which all consumers should take to heart:

Do not consume raw cookie dough.



Tuesday, July 14, 2009

Wrapping Up The Nestlé Toll House Outbreak Investigation

July 14, 2009

FDA made it official yesterday evening. The agency has wrapped up its investigation into Nestlé's Toll House cookie dough manufacturing facility in Danville, Virginia. Raw cookie dough produced in the Danville plant is believed to be responsible for an outbreak of E. coli O157:H7 infections that has sickened 76 people in 31 states. Thirty-five of the victims were hospitalized, 11 with life-threatening hemolytic uremic syndrome.

After an investigation that lasted from June 18th through July 9th, no one is any the wiser as to how at least three different strains of E. coli were able to contaminate the raw cookie dough.

"Three different strains," you ask?

Yes. Three different strains of E. coli have been recovered during the course of this outbreak investigation.

  • Strain #1: A common strain of E. coli O157:H7 was isolated from all 76 outbreak victims.
  • Strain #2: A different E. coli O157:H7 was isolated by FDA from a retained sample of Toll House raw cookie dough that was analyzed as part of the federal outbreak investigation. The E. coli O157:H7-positive sample was produced on February 10, 2009 (based on package date code #9041)
  • Strain #3: E. coli O124 – a completely different strain of toxin-producing E. coli was found in a sample of cookie dough recovered from the home of two Minnesota children who were infected with the outbreak strain.

As Roy Costa pointed out in his guest article on Marler Blog two days ago, "...the finding of more than one E coli O157:H7 strain is clearly indicative of a highly contaminated environment reservoir, and this reservoir is likely in the plant or was during the outbreak."

Or, as I suggested on Saturday, "...a long-standing build-up of contaminants over time."

In an attempt to figure out how this build-up could occur, I've been combing the old inspection reports for the Danville plant that the FDA has posted on its website. The clue may be buried in this excerpt from a 2005 inspection report, which summarizes the cookie dough production process.

"Dry ingredients are weighed out in prep rooms according to recipe specifications. Ingredients are then transported in stainless steel tubs and added to one of several mixers located near the beginning of each production line. Dough is then transferred to a hopper and extruded into either a sheet or a tube (chubs). Dough then passes through a series of cooling tunnels and is either scored or stamped into different shapes depending on the production line. Rework from the cookie dough lines is collected in stainless steel drums and added back into the mixer for a subsequent batch."


"Rework" refers to dough that is left over at the end of a production run - perhaps in the extrusion equipment, in the hoppers, or after trimming away ragged edges. This dough is saved and mixed back in with a subsequent batch – along with any contamination that the reworked dough might have picked up along the way. The Nestlé employee who accompanied the FDA inspector on this particular plant visit dodged the inspector's question as to how long "rework" might be held before being folded into to a new batch of dough.

Subsequent inspection reports do not mention rework; those reports don't describe the production process in any detail. Nor does rework, alone, answer the mystery of where the contamination originated. But it could help explain how the problem may have been perpetuated.

Nestlé has completely dismantled, cleaned and disinfected its raw cookie dough production lines. The company also has changed to new suppliers for its main ingredients, and is phasing production back in on a limited basis.

FDA has remained close-mouthed on any investigations it may have carried out of Nestlé's ingredient suppliers, or whether any of these investigations are still in progress. But from the tone of the most recent FDA update, the agency will be adding this particular outbreak to its "Unsolved Mysteries" file.

Saturday, July 11, 2009

Transparency 101: A Primer for FDA

July 11, 2009

The new kids on the block in Washington, DC have made much of their intention to promote "transparency and openness in government". It seems, though, that FDA needs some help to figure out what "transparency" and "openness" mean.

transparency: characterized by visibility or accessibility of information especially concerning business practices (from Merriam-Webster Online Dictionary)

openness (derivative of open): completely free from concealment, exposed to general view or knowledge (from Merriam-Webster Online Dictionary)

For example, openness and transparency mean:
  • Releasing the entire inspection report for Nestlé's Toll House cookie dough production facility, not just a one-page summary for an investigation that took two weeks to carry out
  • Releasing the results of lab tests, including the genetic fingerprints of the strains of E. coli that were found in the cookie dough
  • Explaining what additional steps FDA and Nestlé have taken – or plan to take – to find the source of the contamination (such as investigating all of suppliers of ingredients for Toll House cookie dough)
  • Describing how Nestlé plans to change its procedures or processes in order to prevent a repeat of their contamination problem
  • Releasing a full list of retail consignees of the recalled Toll House cookie dough (as USDA does for meat recalls) rather than relying solely on individual retailers to inform their customers of the recall

According to the one-page summary report released by FDA, inspectors found only two relatively minor deficiencies in the Toll House production plant during their two-week investigation. Yet raw cookie dough that was manufactured in that facility contained enough E. coli O157:H7 contamination to sicken 74 people in 32 states, and send 34 of the victims to hospital. Furthermore, the strain of E. coli o157:H7 that FDA recovered from a sample of cookie dough as part of its investigation did not match the outbreak strain found in all 74 outbreak victims, and a third E. coli strain (not O157:H7) was recovered from a sample of raw cookie dough obtained from an outbreak victim.

This doesn't add up. Multiple strains suggest either a recurring source of contamination – perhaps from a particular ingredient supplier – or a long-standing build-up of contaminants over time. What have Nestlé and FDA missed? What leads are they still following up? Or has the plug been pulled on this investigation? We won't know unless and until more information is released.

Consumers have the right to know what is being done to protect the safety of their food supply. But until FDA figures out how to follow through on this Administration's promise to provide the public with complete and timely information, "transparency" and "openness" will remain nothing more than words in the Merriam-Webster dictionary.

Monday, June 29, 2009

FDA Finds E. coli O157:H7 In Toll House Cookie Dough

June 29, 2009

Nestlé USA's Baking Division announced this afternoon that FDA has found E. coli O157:H7 in a "... retained production sample of 16 oz. Nestle Toll House refrigerated chocolate chip cookie dough bar." The unopened package of cookie dough carries a production code of 9041 (corresponding to a production date of February 10, 2009) and a "Best Before" indication of 10 JUN 2009.

The Company's news release went on to say,
"Nestle continues to work closely and in full cooperation with the FDA on the ongoing investigation. We are very concerned about those who have become ill from E. coli 0157:H7, and deeply regret that this has occurred."

Nestlé recalled all of its refrigerated Toll House cookie dough from the retail market on June 19th, after CDC established a link between the Company's products and an outbreak of E. coli O157:H7 illnesses. As of last report, CDC has confirmed that at least 46 people in 29 states were infected as a result of eating Nestlé Toll House raw cookie dough. The agency expects to update its outbreak report on Wednesday, July 1st.

According to CDC Press Officer Lola Scott Russell, the particular E. coli O157:H7 that is responsible for this outbreak is a very common strain. It has been circulating at a "background level" in the United States since early in 2005. CDC became suspicious when the number of reported cases due to this strain spiked above the usual background level in May and continued above that baseline early in June.

FDA, which has been carrying out an in-depth investigation of Nestlé's Danville facility, has not yet determined how the E. coli O157:H7 found its way into the cookie dough. Nestlé is cooperating with the FDA investigation.

At least three personal injury lawsuits already have been filed against Nestlé by Marler Clark on behalf of outbreak victims; Pritzker Olsen also is representing one or more victims.

Nestlé urged its customers today not to consume the recalled products; consumers should return these to the store for refund. And the Company reminded consumers once again that cookie dough should never be eaten raw.

Consumers with questions about the cookie dough recall should contact Nestle Consumer Services at 1-800-559-5025.

Friday, June 26, 2009

Nestlé Toll House Cookie Dough: Rethinking A Pathogen

June 26, 2009

The outbreak strain of E. coli O157:H7 that has sickened as many as 69 people (46 confirmed, as of June 25th) in 29 states has been circulating in the United States for more than four years, according to CDC records.

Based on the chart displayed in CDC's outbreak investigation report, this strain has been reported in 363 E. coli O157:H7-infected individuals since February 2005. Significant clusters of reported cases occurred in February/March 2005, August 2005 through January 2006, April 2006 through December 2006, and April 2008 through December 2008. The present outbreak may have started as early as March 2009.

Without knowing the genetic fingerprint of the outbreak strain, we can only guess at the precise outbreaks associated with this particular E. coli O157:H7. Here are my best guesses.

  • February 2005: Florida farm animal petting zoo outbreak (22 cases in February/March 2005)
  • August 2005 - January 2006: Some of these illnesses may be linked to two ground beef recalls initiated in August 2005 and September 2005 by Flanders Provision Co. after CDC linked their meat epidemiologically to E. coli O157:H7 illnesses.
  • April 2006 - December 2006: The November/December 2006 outbreak that was traced to contaminated shredded lettuce served at Taco Bell fast food restaurants in the northeast may account for some of these cases.
  • April 2008 - December 2008: Iceberg lettuce outbreaks in the United States and Canada (September/October 2008) may have been due to this strain of E. coli O157:H7.
  • March 2009 - ?: Nestlé Toll House raw cookie dough.

If my suppositions prove to be correct – and we won't know unless CDC and USDA release the genetic fingerprints for these incidents – this strain of E. coli O157:H7 is now endemic. It has made itself at home right across the United States. As, most likely, one or more other strains of E. coli O157:H7 have done, too.


What does this mean for food safety?
Quite simply, the food industry and its regulators no longer have the luxury of treating E. coli O157:H7 as a niche pathogen – one that is found only in a limited range of food products. This pathogen has kept one step ahead of regulators and the industry for nearly three decades, jumping from dairy cows and petting zoo animals to recreational water, beef, apple cider, salad greens, and sprout seeds. Now it appears to have jumped into raw cookie dough.

E. coli O157:H7 is a hardy microbe – in many ways, hardier than Salmonella. It also is deadlier than Salmonella. Inevitably, E. coli O157:H7 will become as pervasive as Salmonella. Eventually, it might even challenge Salmonella at the top of the list of foodborne pathogens.

This scenario might sound far-fetched, but who would have predicted the contaminated cookie dough outbreak? Certainly not Nestlé's Corporate Quality Assurance group.

It's time to start paying closer attention to E. coli O157:H7 across the entire food spectrum – before this versatile pathogen outflanks us again.


Nestlé Cookie Dough Takes Its Toll

June 26, 2009

With 70 victims (41 confirmed as of June 22nd) in 30 states, FDA and Nestlé still don't know how E. coli O157:H7 was introduced into Toll House raw cookie dough products.

Yesterday, FDA posted a series of inspection reports for the Danville, Virginia facility where the Toll House cookie dough was manufactured. The most recent FDA inspection, performed over the course of 12 hours on March 12 2009 – only four hours of which were spent on the Toll House cookie dough area – did not uncover a single sanitary violation or "objectionable" condition.

The inspection reports reveal little else. Thanks to Nestlé's corporate policy,
  • FDA was not permitted to review the company's consumer complaint files;
  • FDA was not permitted to review the company's HACCP program;
  • FDA was refused permission to photograph any areas inside the facility; and
  • FDA was not permitted to review either the pest control records or the environmental testing program.

If these restrictions sound familiar, it's because FDA and the Georgia Department of Agriculture encountered similar roadblocks at Peanut Corporation of America. It was only during the Salmonella outbreak investigation that FDA gained access to all of the Company's files, including lab test results.

Nestlé released the following statement on June 24th:

"Nestlé USA’s Baking Division is continuing to work with the Food and Drug Administration (FDA), together with the Centers for Disease Control (CDC), on an investigation into reported E. coli 0157:H7 illnesses that may be related to consumption of raw cookie dough.

At this point, the E. coli strain implicated in the CDC investigation has not been detected in our products. FDA investigators have been working at our Danville, VA production facility, along with Nestlé experts, to obtain dough samples for testing. As well, the investigators are testing our equipment, water and air handling systems. They’re also analyzing our detailed production records and reviewing our procedures.

We have temporarily suspended production at our Danville facility and stopped shipping product to our retail customers. We estimate that about 300,000 cases of product have been removed from sale since the recall began.

Nestlé announced a voluntary recall of all of our Nestlé TOLL HOUSE refrigerated cookie dough on June 19, 2009. Because the health and safety of our consumers is so important, we began the recall while the investigation is still underway.

No other Nestlé TOLL HOUSE products are impacted, including already baked TOLL HOUSE cookies purchased outside the home, all varieties of Nestlé TOLL HOUSE morsels, chocolate baking bars, or cocoa, and Dreyer’s and Edy’s ice cream products with Nestlé TOLL HOUSE cookie dough ingredients. Also, the recall does not include any Nestlé Professional™ cookie dough products that are destined for foodservice use, including frozen Nestlé TOLL HOUSE cookie dough and cookie dough “mix-ins” purchased outside the home.

Consumers who have purchased the recalled products should not consume them. Instead, we are asking that consumers return these products to their local grocer for a full refund. We invite consumers with questions to contact Nestlé Consumer Services at 1-800-559-5025 and visit our web site at www.verybestbaking.com."


The Food Safety Enhancement Act of 2009, which is working its way through the House of Representatives, will increase FDA's access to quality assurance, environmental testing and other records during routine inspections – if the Act survives its trip through the House and Senate unaltered.

Meanwhile, it seems to take an outbreak investigation to bring about full cooperation between food corporations and regulators.

Saturday, June 20, 2009

Nestlé Toll House Cookie Dough: Is Cross-Contamination The Answer?

June 20, 2009

With 65 E. coli O157:H7 infections in 29 states appearing to be linked to the consumption of raw Toll House cookie dough, Nestlé's Quality Assurance staff must be scrambling to determine how the pathogen might have sneaked in.

E. coli O157:H7 usually is associated with raw meat, unpasteurized dairy products and raw produce. None of these items can be found on any Toll House cookie dough ingredient list. And none of the cookie dough ingredients ever have been associated until now with E. coli O157:H7 contamination, as far as we can tell.

Unless the pathogen was introduced into Nestlé's production facility by an asymptomatic carrier of the disease – a Typhoid Mary – we would suggest that the most probable source of the contamination is an ingredient.

While we have no inside information on Nestlé's processes or the FDA outbreak investigation, we have figured out one possible scenario. But, first, a little history lesson.

In 1994, nearly 600 people in 41 states suffered from gastroenteritis after consuming Salmonella-contaminated Schwan's ice cream. The contamination was blamed on a "sanitary" bulk tanker truck that had not been properly sanitized after hauling a load of raw liquid egg. The improperly cleaned tanker then was used to transport ice cream mix to Schwan's. The result: Salmonella-contaminated ice cream.

History might be repeating itself in this outbreak. Dairy herds are a major reservoir for E. coli O157:H7, and contamination of raw milk by this pathogen has been documented on several occasions. Bulk tanker trucks haul raw milk from the farm to dairy companies. They also deliver bulk pasteurized egg products to food processors, such as Nestlé.

Perhaps a particular tanker was not sanitized properly between carrying a load of raw milk and a load of bulk pasteurized egg. If so, E. coli O157:H7 may have survived the improper sanitizing treatment, and then contaminated the egg.

This is pure speculation, of course. Nestlé might own a fleet of sanitary tankers that are dedicated to hauling pasteurized egg products. And as of this evening, neither FDA nor Nestlé have reported finding the outbreak strain in any sample of Toll House cookie dough, in the company's production environment, or in any of the ingredients.

But it might have happened that way.

Friday, June 19, 2009

Recall Roundup: June 19, 2009

Here is today's list of food safety recalls, product withdrawals and allergy alerts. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.



United States
  • Allergy Alert: Smith Dairy Products Company recalls SMITH’S Tea with Lemon in gallon size, lot no. 07/07/09, due to the presence of undeclared milk. The recalled product was distributed only in Ohio.
  • Stolen Insulin Warning: FDA warns that at least some of the stolen 129,000 vials of the injectable insulin product, Levemir – made by Novo Nordisk – have resurfaced and are being sold to US consumers. FDA has received one report of a patient who suffered a dangerous reaction due to poor control of blood glucose as a result of using a vial of the stolen insulin.
  • Food Safety Alert: The California Department of Public Health warns consumers not to eat canned Cioppino Sauce from Sea Harvest Fish Market & Restaurants, (Carmel, CA) because the product presents a botulism hazard. Sea Harvest does not have a cannery license, and did not process the Cioppino Sauce in accordance with the requirements for a low acid-canned food.
  • Food Safety Alert: The Utah Department of Health provides sport fishermen with a list of state fish advisories.
  • Food Safety Recall: Nestlé USA recalls all varieties of Nestlé Toll House refrigerated raw cookie dough products. Preliminary epidemiological evidence has linked consumption of raw Toll House cookie dough to a multistate outbreak of E. coli O157:H7.


Canada


Europe, Including the United Kingdom
  • Food Safety Alert (Norway & Denmark): The Norwegian Food Safety Authority has prohibited the sale of all sugar peas imported from Kenya after Shigella sonnei was detected in an unopened package. The imported sugar peas were linked to four cases of shigellosis in Norway and 10 cases in Denmark.


Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket's recall web site.


*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains, listed on the Kroger corporate home page.


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Nestlé USA Recalls Toll House Cooke Dough

June 19, 2009

Nestlé USA announced this morning that it was recalling all varieties of Nestlé TOLL HOUSE refrigerated Cookie Bar Dough, Cookie Dough Tub; Cookie Dough Tube; Limited Edition Cookie Dough items; Seasonal Cookie Dough and Ultimates Cookie Bar Dough.

The company acted out of an "abundance of caution" after being notified that FDA and CDC are investigating a multistate outbreak of E. coli O157:H7 illnesses that may be linked to consumption of raw Toll House cookie dough.

According to a news release issued yesterday evening by the Colorado Department of Public Health and Epidemiology, raw cookie dough may be behind as many as 66 confirmed illnesses in 28 states. Five of the illnesses were reported in Colorado.

Maine announced in late May that it had identified a group of 4 genetically related E. coli O157:H7 infections that were part of a national cluster. We are advised (by Bill Marler) that the Maine cluster is part of the national outbreak.

FDA reported this morning that 25 of the 66 victims of this outbreak have been hospitalized – seven with hemolytic uremic syndrome (HUS). There have been no deaths. The FDA news release did not identify the 28 states in which illnesses have been reported, but indicated that the outbreak began in March 2009.

The Colorado report makes it clear that its advisory is based on preliminary evidence, and that the investigation into the source of the E. coli O157:H7 outbreak is ongoing. Indeed, raw cookie dough seems to be an unlikely venue for this pathogen, which typically is associated with raw meat, raw produce and raw dairy products.

Nestlé, in announcing its recall this morning, reminded consumers that its Toll House cookie dough must be baked before being eaten. The following precaution is prominently displayed on the back of each package, just above the baking instructions:

"Cookie dough contains raw ingredients and should be baked before being consumed."

FDA advises that consumers should not use the recalled raw cookie dough in baking, because of the risk of cross-contamination from handling the dough. Any recalled packages should either be discarded or should be returned to the store for a refund.

For more information on the recall, consumers should visit the Nestlé web site or contact Nestlé Consumer Services at 1-800-559-5025.