According to press reports, an FDA requested panel says food safety in particular is in crisis. (Full Report) Questions about the FDA’s effectiveness have been underscored by alarming headlines in recent years — including E. coli in spinach, deadly chemicals in pet foods, toxic toothpaste and the heart-damaging side effects of drugs.  The report says Congress has given the FDA more responsibilities over the past two decades, but no funds to cover the extra work. Meanwhile, the agency hasn’t been able to recruit the sophisticated scientific expertise needed to oversee complex medicines and food.  The report says the FDA needs at least an extra 350 million dollars to address drug safety, and 450 million more dollars to improve food safety.  Actually, the same holds true for the USDA.  Just in the last two months we have seen the USDA move slowly on the Topps recall, putting people at risk, and then we see them announce one day that the USDA is getting tough on Canadian E. coli imports, only to turn around quietly and stop testing a week later.

In October Topps Meat Company, founded in 1940, went out of business. That was after Topps had recalled nearly 22 million pounds of frozen hamburger contaminated with E. coli and 40 people across the U.S. had become ill.

Tort deformers decried the “tragedy” that is this Topps’ collapse – that a business went under and employees had lost their jobs. Yes, a company bankrupt and unemployment are tragic. What makes it more so is that the catastrophic breakdown in the food-safety chain at Topps could have and should have been prevented by Topps management.

It’s been a century since Utpon Sinclair published the “Jungle," which exposed the contaminated underbelly of the American meat industry. Reform quickly followed. America got the Pure Food and Drug and Meat Inspection Acts. In the early 1990s, when these safeguards failed – e.g. Jack in the Box E. coli outbreak – again there was a public push for improving food safety.

The U.S.D.A. Food and Inspection Service responded with creating and aggressively enforcing the mandatory Risk Management System. Derived from research and operations in the American space program, this approach [HACCP] prevented new outbreaks by establishing check-points at every phase of meat processing. In addition, the agency classified the presence of E. coli O157:H7 as an adulterant under the Meat Inspection Act. Until recently, the meat contamination problem seemed fixed.

Had Topps complied with the letter and spirit of HACCP, it would not have processed contaminated meat in 2005 and again in 2007. So, why hadn’t Topps done what was the right thing to do for it and its now unemployed? We will be researching that question for years.

My theory is that Topps’ leadership might have chosen to take short-cuts on systemic food-safety procedures. Therefore, contamination which should have been detected early in meat processing wasn’t. The result wasn’t pretty: Food-poisoned consumers went through the agony that E. coli inflicts. They had incorrectly trusted that label “Inspected by the U.S.D.A.” as guaranteeing safety.

Over a century, two waves of reform in ensuring the safety of the American food supply chain have given business a total systems approach. That approach works if management follows the rules. Unfortunately, employees at Topps who lost their means of making a living were among those punished – severely.

Will other businesses be able to learn that century-old lesson: Inattention to proper food processing will be the kiss of death for their brandname, profitability and, yes, very existence.

Jeffrey Gold, AP’s "E. coli guy," in New Jersey filed the story that had been rumored about for weeks about Topps Meat Company’s Chapter 7 Bankruptcy.  Topps has up to 10,000 creditors (including several of my clients) and liabilities of up to $100 million, according to its Chapter 7 filing in U.S. Bankruptcy Court in Newark.  Interestingly, Topps put its assets in the same range.

As you recall, Topps closed its doors on October 5, six days after it issued the recall of 21.7 million pounds of frozen hamburger.  In September, the USDA said three people were confirmed as getting E. coli from Topps products, with 22 other cases under investigation. According to the CDC, cases were found in Connecticut, Florida, Indiana, Maine, New Jersey, New York, Ohio and Pennsylvania.  That number has grown to at least 40.  We have filed two lawsuits on behave of victims (two develpoded HUS) in New York and are investigating the claims of 24 others.  We filed a similar lawsuit against Topps in 2005 – bet they wished they would have listened then.  In early December we will be visiting the now empty plant.

Interestingly, also listed as creditors are Tyson Foods Inc., of Chicago, and the U.S. Department of Agriculture’s Food Safety and Inspection Service.  Another creditor appears to be Topps executive vice president Anthony L. D’Urso, a member of the family that ran Topps for about 60 years until a controlling interest was purchased in 2003 by Strategic Investments & Holdings, a private-equity firm based in Buffalo, N.Y.  That means that these and other creditors will compete with people injured by E. coli food poisoning – that is going to be an interesting fight over the corporate corpse.

Although, Topps has listed $12,000,000 in insurance to cover the claims of the victims of the E. coli outbreak, with at least 40 ill, and punitive damage claims, retail outlets (stores that sold the product) and the suppliers of the meat, are clearly going to be brought into the case once the bankruptcy stay has been lifted.  I also really want to subpoena USDA/FSIS officials.  The bottom line for us is that we intend to make sure our clients are fairly compensated AND we find out when both Topps and the USDA knew about the extent of the E. coli contamination and why the recall took weeks to occur.

I have also had a few email chats over the last 24 hours with Law Firm Blogger (who has a significant background following bankruptcy cases).  I appreciate her insight and her post today, and her article today.

Robert Roos, CIDRAP News Editor caught the USDA ones again saying that it is interested in public safety, but when no one is looking changes the rules.  Mr. Roos’ article entitled, “USDA modifies E. coli testing rules for Canadian beef,” is frankly shocking. According to the story, the “USDA has modified its program of increased testing and inspection of Canadian meat, after finding no problems in the first week or so, a USDA official said today.” Wow, after nearly killing 40 people in the US in the Topps E. coli outbreak (and, no one is counting the 44 sick and 1 dead Canadian), and after one whole week of testing, our government decreases testing AND allows meat to be shipped to consumers BEFORE test results even come back.

Mr. Roos also reported that, despite hundreds of people sickened in the US in 2007 and over 30 million pounds of meat recalled, the “USDA is not considering requiring American meat companies to hold meat until pathogen testing is completed, contrary to a recent news report…. the USDA has long had guidelines recommending that companies hold meat until test results come back, "but it’s not something we require."

Does anyone wonder why people think government is useless?

Late last night Christopher Doering of Reuters quoted USDA/FSIS head guy, U.S. Agriculture Undersecretary Richard Raymond, in an article entitled – USDA says has enough legal authority to do recalls – Dr. Raymond testified that the U.S. Agriculture Department does not need additional authority to conduct meat recalls and would oppose any move to make the removal of such items from the market mandatory, the USDA’s top meat safety official told lawmakers on Wednesday.

"I think we do a very good job with recalls at this point at time," U.S. Agriculture Undersecretary Richard Raymond told a House Agriculture subcommittee on livestock, dairy, and poultry. "I believe we have all the legal authority we need to do our job," he said.

REALLY? So, what about this from the Associated Press this morning:

Recalled Topps meat found in N.J. stores

State inspectors said Wednesday that they have found more boxes of potentially tainted meat on store shelves more than a month after a nationwide recall of Topps frozen hamburgers. New Jersey authorities have also subpoenaed additional distributors and wholesalers to determine what other stores have the frozen patties and whether they were delivered after the Sept. 29 recall by the now-defunct Topps Meat Co. of Elizabeth. Over the past few weeks, 141 boxes of Topps burgers have been found at 12 stores, all in northern New Jersey except for one in Gloucester City in Camden County.

More from Dr. Raymond:

According to Dr. Raymond, currently, the industry initiates recalls voluntarily. Raymond said the current process works and any move by lawmakers to make recalls mandatory was unnecessary and risks causing the system to work less efficiently.

My definition of a "good job" differs a bit from Dr. Raymond.  Perhaps that is why under his leadership, 2007 has had close to 20 beef recalls, amounting to nearly 30,000,000 million pounds of meat and hundreds ill.  When was the last time anyone recalls a governmental official being fired?  Also, don’t forget the USDA’s complete failure to protect the public in the Topps Recall of a month ago.  Reread by post –  USDA/FSIS Timeline of Topps Recall.   Frankly, I am not sure giving USDA/FSIS recall authority, given its record, would make anyone safer.  But hey, as Dr. Raymond says:

“Our meat supply is the safest in the world.”

Or, perhaps not – See my Op-ed from a month ago – even before the Cargill recalls and illnesses  – Is the US beef supply safe?

I leave in the morning (a few hours away actually) to NYC in part to meet several new clients from the Topps E. coli outbreak, but also to meet with representatives of YUM Brands to try and resolve several E. coli cases stemming from the Taco Bell E. coli outbreak of 2006. Interestingly, today, YUM Brands outlined its third-quarter financials:

The domestic division of YUM Brands has been struggling. In the company’s third quarter, U.S. profit grew only 1 percent. Even worse, same-store sales, or sales at stores open at least a year, dropped 6 percent at Taco Bell. Much of the problem rests with the Mexican fast food chain, which is still reeling from an E. coli outbreak last year and publicity related to a rat infestation in a KFC/Taco Bell New York City restaurant in February.

The company says its U.S. business is starting to turn around and sees signs of a recovery at Taco Bell. "With each month that passes, those memories tend to fade from the consumers’ minds," says Morningstar analyst John Owens.

Hopefully, we will be able to resolve all the cases without the necessity of further litigation.  There is nothing like a little litigation to help folks remember things – perhaps we can re-run the famous YouTube video shot in NYC:

Beef recalls raise concerns about food safety

Jeffrey Gold, AP Business Writer (a.k.a. “E. coli Guy”) interviewed the husband and father of two of my clients in the Topps E. coli case:

‘Food is being pushed out at such a rapid pace to keep up with demand, the product is not as safe as it could be. And we’re risking human life.’
—Keith Goodwin

Topps eventually issued a recall Sept. 25, and then expanded it Sept. 29 to include all frozen patties it had made in the past year—21.7 million pounds—the second-largest beef recall in U.S. history. Much of the meat had already been eaten, however, and illness in at least 40 people in eight states has been linked to the Topps hamburgers.  Keith Goodwin said the victims include his wife and a son, and wondered if the timing of the recall was at fault. He said they ate Topps hamburgers at a family picnic Sept. 15 in upstate New York, more than a week after authorities had evidence that Topps patties were contaminated.

“If the public had been made aware of that, a lot of these illnesses would have been avoided,” said Mr. Goodwin, of Groton, N.Y., who teaches at the town’s elementary school. He said his wife, Kristin, 34, was hospitalized for two days, while his son Lucas, 8, suffered kidney failure and was hospitalized for eight days. “The whole ordeal has been very scary,” Goodwin said.

Jeff Gold, AP Business Writer in New Jersey, has continued to dig into the complete failure of the “voluntary recall” system to get this E. coli – contaminated Topps hamburger off store shelves. I posted nearly a week ago when reports first surfaced that the product was still being sold a month after Topps issued a recall (and went out of business). So, who is responsible for removing E. coli – contaminated meat off store shelves?  Mr. Gold’s story:

State inspectors find more recalled meat at New Jersey stores

Meat recalled a month ago that could be contaminated with a potentially fatal bacteria was found in seven northern New Jersey stores, state consumer safety officials said Tuesday. Inspectors in the past week have seized 138 boxes of frozen hamburgers made by Topps Meat Co., which issued a nationwide recall on Sept. 29 for 21.7 million pounds of frozen patties.

Greater New York Frozen Food Distribution Co. Inc., of New York, was subpoenaed last week. A spokesman for the company said Tuesday that no meat was delivered after the recall. "The meat was delivered before the recall, on Sept. 10," spokesman Frank Conner said. "We are one of many companies that delivered the meat before the recall. We stopped delivering the meat as soon as we heard about the recall. We have no control over what a grocery store owner does with his stock."

"Recall," that it has been reported that there are at least three "genetic fingerprints" of E. coli O157:H7 (potentially meaning that the contamination at Topps came from multiple sources – at least three) that has been found in ill people and in left over product.  One of those fingerprints was found in a Canadian Meat Plant (now also in bankruptcy) that was the source of both meat to Topps and to the death of one Canadian and the sickening of 44 others this past summer.  It will be interesting if the paperwork and grinding records at Topps allows for the "traceback" of all genetic fingerprints to the source.

I had a nice chat with Neil Waugh of the Edmonton Sun yesterday about the twisted trail of E. coli from Canada. I am hurt (not really) that he called me a “legal vulture.”

Fallout from ‘dirty’ Alberta beef plant felt on both sides of the border

According to Mr. Waugh:

Ranchers Beef Ltd. of Balzac collapsed on Aug.15 after company president Tony Martinez reported in a court affidavit that his outfit was "in the midst of a severe liquidity crisis". In other words it was broke. And likely would have stayed that way if the United States Department of Agriculture hadn’t blown the whistle on what Ranchers and the feds’ controversial Canadian Food Inspection Agency were doing – or apparently NOT doing -last summer. Which might or might not have resulted in the death of "one elderly individual" from E. coli poisoning, another 44 cases in Canada, plus 40 cases with 26 "known hospitalizations" as of last Friday in the U.S.

The above is shocking, however, here is the most ominous part, Ranchers was funded in large part by the Canadian Government:

The company business plan was "developed in the wake of the 2003 BSE crisis," Martinez told the court, as a result of the "near decimation" of the Canadian cattle industry when the U.S. border was closed. And it wasn’t just a brainwave of 45 unidentified ranchers plus Sunterra Foods and Picture Butte feedlot kingpin Cor Van Raay. In an attempt to "ameliorate the reliance" on U.S. markets, the Alberta and federal governments "developed policies to encourage construction of Canadian-based meat processing facilities." The feasibility study costs were split between the partners and the Alberta Tories. Then the taxpayers’ grease really started to roll. There was a $46.5-million loan from Alberta Treasury Branches, the feds’ Business Development Bank and the National Bank of Canada. A $20-million "credit enhancement" from the federal ag department added to the taxpayers’ exposure. The Alberta Agricultural Financial Services also kicked in $9.35 million in "credit facilities" so investors could "purchase" company preferred shares.

Now Mr. Waugh tries to hurt my feelings (assuming I actually have any):

And now there are legal vultures hovering over the border planning on following the DNA fingerprints all the way back to the Alberta Tories and their BSE Bingo boondoggle. "We will clearly have to look at additional assets," said Seattle lawyer Bill Marler, who has already filed a class-action suit against Topps. "We’re going upstream looking at who supplied the meat," said Marler, who has already collected more than $250 million in food poisoning litigation. "Who owns them and what’s their backing."

Hey, do I get to wear a wig when I go to Canada?

I’m a bit confused. Yesterday it was reported that Ranchers Beef Ltd (now out of business) was both the source of an E. coli outbreak in the United States that had sickened at least 40 tied to the consumption of Topps Meat (also out of business) AND 44 ill persons and 1 death in Canada.  See, "Topps story continues to grow more ominous."  Now the Ottawa Government releases this press statement:

The Canadian Food Inspection Agency (CFIA) is warning the public not to consume the various beef products described below because these products may be contaminated with E. coli O157:H7 bacteria. The affected products are being recalled as a result of the CFIA’s investigation and traceback conducted on contaminated beef involving Ranchers Beef Ltd. (Establishment 630), Balzac, Alberta.  There have been no reported illnesses associated with the consumption of these products.

This does seem to contradict the press release from the same government entity just the day before:

The Canadian Food Inspection Agency (CFIA) and the Public Health Agency of Canada (PHAC) are currently investigating possible linkages between E. coli cases that occurred earlier this summer in Canada. The investigation is examining 45 cases of E. coli O157:H7 that were found in New Brunswick, Quebec, Saskatchewan, Ontario and British Columbia. These cases were previously reported from July to September, 2007. As a result of these cases, eleven people were hospitalized and one elderly individual died.

However, according to the USA FSIS, there seems to be a “genetic link” to both the 40 people ill from the Topps outbreak and the 44 people ill and 1 death in Canada:

On October 25, the CFIA provided FSIS with PFGE patterns, or DNA fingerprints, from tests of beef trim from a Canadian firm, Ranchers Beef, Ltd., Canadian establishment number 630. This firm provided trim to the Topps Meat Company. While the firm, which had been located in Balzac, Alberta, ceased operations on August 15, 2007, some product remained in storage and was collected and tested by CFIA as part of the joint investigation of the Topps recall and as part of CFIA’s own investigation into 45 illnesses in Canada from E. coli O157:H7.

It is hard to imagine that our USDA/FSIS might be more competent that its Canadian counterpart. 

Remember, according the New Jersey AP, Topps products revealed three different E. coli O157:H7 genetic "fingerprints," according to Kenneth Petersen, an assistant administrator at the USDA’s Food Safety and Inspection Service. This means that although one of these fingerprints has been traced to Ranchers Beef, Ltd., in Canada, it will be interesting to see if we can track the other fingerprints to the source – Tyson, IBP, Cargill, others?  It will also be interesting to get legal jurisdiction over out of country corporations.

Also, recall the report from the New York Times, revealed that Topps sourced a significant amount of beef trimmings from countries like Australia, New Zealand, Canada and Uruguay – countries that FSIS has required little E. coli O157:H7 testing.  Will FSIS change this rule too soon?

So, FSIS has limited requirements that out of country producers test for E. coli.  And, we have learned during the Topps recall that Topps had cut back on its testing for E. coli.  It will be interesting to see if other meat companies have been doing the same.  Perhaps more testing at the retail (grocer store) would be helpful in tracking this ugly bug?  According to the FSIS website, “the agency still collects some samples from retail stores, but normally only when the retail store actually produces raw ground beef using trimmings from a cutting/boning operation conducted at the store.”  Perhaps it or someone should do more retail testing?

I also think we need to look at several other reasons for the spike in E. coli illnesses and recalls (in addition to testing product), such as: 1)  has the make-up of workers in slaughter plants changed in 2007?  Do we have less experienced workers?  2)  has cattle feed in 2007 changed significantly to allow greater growth of E. coli O157:H7?  3)  has global warming impacted the ecology of E. coli O157:H7?  Other ideas?