November 2012

Barry Estabrook has published a great story on the problems with FDA oversight – it is worth a full read, but I like these parts:

“It’s like doing 100 miles an hour on a lonely stretch of highway in Montana,” says William Marler, a Seattle-based attorney who has represented food-poisoning victims in court for 20 years. “Yeah, you might get caught, but in reality the chances of that happening are zero.”

Investigators for a congressional committee turned up something even more worrisome: internal e-mails indicating that Peanut Corporation’s owner, Stewart Parnell of Lynchburg, Virginia, not only knew about the salmonella at his plant, but ordered products that had tested positive for the bacterium to be shipped. “Turn them loose,” Parnell wrote in one message to a plant manager. Results showing contamination were “costing us huge $$$$$.” In a rare instance of prosecutorial vigor, the FDA, which lacks authority to file criminal charges on its own, teamed up with the Justice Department to pursue a case in early 2009. Yet three years have passed with no charges being filed. In the meantime, the lawsuit-besieged Peanut Corporation filed for bankruptcy. “I have never seen a clearer case that demanded criminal prosecution,” William Marler says.

In fact, during the past 20 years, the FDA has only once succeeded in pursuing a significant criminal case, according to Marler. In 1998, Odwalla, a fruit juice bottler based in California, pleaded guilty to 16 misdemeanor charges and agreed to pay fines totaling $1.5 million. Hardly an onerous penalty, given that the company’s E. coli–tainted apple juice killed a Colorado toddler. Three years later, Odwalla’s owners sold out to Coca-Cola for $181 million.

If there is an enforcement arm for food safety in the United States, it’s trial lawyers like Marler, an intense workaholic who estimates that his firm, Marler Clark, has won more than $600 million for clients since he filed his first lawsuits in the early 1990s. In one tongue-in-cheek blog post, Marler suggested that prosecuting executives of food companies that sicken their customers be privatized to him. “I would be willing to put people in jail for poisoning people, and I would do it on the cheap — perhaps for the fun of it,” he wrote. Then he listed several existing laws that any moderately competent government prosecutor could use to put executives of wayward food companies behind bars.

Marler wages his war against contaminated food from lavish offices on the 28th floor of a skyscraper in downtown Seattle. The walls are covered with framed newspaper and magazine clippings chronicling his victories. Given his reputation and plush surroundings, a first encounter with Marler can be disorienting. He favors faded cargo shorts, dress shirts with sleeves rolled up to the elbows, and running shoes that look as if they should have been replaced many, many miles ago. He spikes his conversation with salty language that you’d never hear in a courtroom. And his office is dominated by a stuffed boar’s head, its mouth open to reveal four sharp, curved, four-inch-long tusks — a gift from a satisfied client.

As Marler sees it, the FDA is being slowly starved of the resources and manpower required to fulfill its mandate. In the 1970s the agency conducted 35,000 inspections of food-processing plants each year. Today, it inspects fewer than 8,000, although the number of facilities under its jurisdiction has skyrocketed.

The Food Protection Plan became the basis for the Food Safety Modernization Act, which was passed in early 2011 but has not fully taken effect because it has been held up by the White House’s Office of Management and Budget — a puzzling delay, since the law is supported by both the food business and the administration. Although the act grants the FDA the power to revoke the registration of an offending company, preventing it from selling its products, sterner civil penalties and higher fines included in some early drafts of the bill were stripped out by legislators, Acheson says. While the law is estimated to cost $1.4 billion over five years for food safety, a proper system would cost $10 billion, Marler estimates, comparing the act to “a sparkling brand-new building that has no people working in it.”

The current policy of relying on third-party audits, such as those carried out at Jensen, the Peanut Corporation, and DeCoster, is a “complete and utter joke,” in Marler’s view. “It’s a cover-up. People think it means that inspections occur, but all that’s happening is that the skids are being greased to get product to market. Everyone knows it’s a scam.”

Acheson is more circumspect. He says that with a good auditor, third-party inspections can be effective, but concedes that the lack of oversight causes problems. Marler finds an inherent conflict of interest in the auditing system. Companies that are being inspected pay the inspectors. Those who are too strict will not get repeat business. Lenient ones will always be welcomed. “A better system would be to have public officials do the audits,” he says. But that would mean spending more money, which is unlikely in the current climate in Washington. “We just haven’t had the size of crisis to hit that critical mass where people are outraged enough to pressure politicians,” Marler says.

Collaborative investigation efforts of state, local, and federal public health and regulatory agencies indicated that Trader Joe’s Valencia Peanut Butter, manufactured by Sunland, Inc. of Portales, New Mexico, was a likely source of this outbreak.

On November 14, 2012, FDA issued a document that lists observations made by FDA investigators during inspections of Sunland, Inc.

On November 26, 2012, FDA suspended Sunland, Inc.’s food facility registration, prohibiting Sunland, Inc. from introducing food into interstate or intrastate commerce.

A total of 42 individuals infected with the outbreak strain of Salmonella Bredeney were reported from 20 states. The number of ill persons identified in each state was as follows: Arizona (1), California (7), Connecticut (3), Illinois (1), Louisiana (1), Massachusetts (3), Maryland (1), Michigan (1), Minnesota (1), Missouri (2), New Jersey (2), New Mexico (1), New York (2), Nevada (1), North Carolina (3), Pennsylvania (2), Rhode Island (1), Texas (5), Virginia (2), West Virginia (2).

28% of ill persons were hospitalized, and no deaths were reported.

61% percent of ill persons were children under the age of 10 years.

The McLean County Health Department and the Illinois Department of Public Health are currently investigating a cluster of salmonella cases who reported eating at a variety of restaurants in Central Illinois from October 18 through November 11.

The McDonalds on South Main Street in Bloomington was found to have a suspected connection to the salmonella cases. The health department discussed the situation with the franchise ownership, at which time they chose to voluntarily close in an abundance of caution. No substantial information was discovered to connect the establishment with the cluster of illnesses until over the holiday weekend. It is still early in the investigation; however, the suspected link does not seem to be a certain food, but rather human transmission.

The employees of the establishment are being tested and will be allowed to return to work as lab results confirm they are safe to serve food to the public.

The FDA suspends Sunland Inc.’s Food Facility Registration; Facility Prohibited from Distributing Food

In the interest of protecting public health, the U.S. Food and Drug Administration suspended the food facility registration of Sunland Inc., a producer of nuts, and nut and seed spreads. Registration with the FDA is required for any facility that manufactures, processes, packs, or holds food for consumption in the United States. If a facility’s registration is suspended, that facility is prohibited from introducing food into interstate or intrastate commerce.

The fact that peanut butter made by the company has been linked to an outbreak of Salmonella Bredeney that has sickened 41 people in 20 states, coupled with Sunland’s history of violations led FDA to make the decision to suspend the company’s registration.

This was the FDA’s first use of its registration suspension authority, under the Food Safety Modernization Act. This new authority enables the agency to take this action when food manufactured, processed, packed, received, or held by a facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, and other conditions are met.

A review of Sunland Inc.’s product testing records showed that 11 product lots of nut butter showed the presence of Salmonella between June 2009 and September 2012. Between March 2010 and September 2012, at least a portion of 8 product lots of nut butter that Sunland Inc.’s own testing program identified as containing Salmonella was distributed by the company to consumers.

Additionally, during its inspection of the plant in September and October 2012, the FDA found the presence of Salmonella in 28 environmental samples (from surfaces in production or manufacturing areas) and in 13 nut butter product samples and one product sample of raw peanuts. Four of the peanut butter product samples showed the presence of the outbreak strain of Salmonella Bredeney.

The suspension order offers Sunland, Inc. the opportunity to request an informal hearing on certain issues related to the order. If, after providing this opportunity, the FDA determines that the suspension remains necessary, the FDA will require Sunland, Inc. to submit a corrective action plan to address the immediate problems and to implement a sustainable solution to those problems in a sound scientific manner. The FDA will reinstate Sunland, Inc.’s registration only when FDA determines that the company has implemented procedures to produce safe products.

 

For a company that has poisoned its customers, recalled years of product and been closed for months, China’s decision likely does not come as a surprise.

According to China Daily, the General Administration of Quality Supervision, Inspection and Quarantine will suspend import of nuts produced by Sunland Inc.

The Quarantine branches will step up checks on nuts or nut products from the United States, as well as postal goods and luggage carried by passengers.

Parts of nuts and nut products from Sunland Inc. have been linked with a Salmonella Bredeney outbreak. Forty-one people have fallen ill in 20 US states with ten of them being hospitalized, according to the CDC.

Sunland Inc. has recalled products in 200-plus production batches, including those sold through the Internet. The shelf life of the products vary with the longest being October 2013, according to the administration.

The FDA found that between June of 2009 and August of 2012, Sunland Inc. had distributed, or cleared for distribution, portions of 11 lots, or daily production runs, of peanut or almond butter after its own testing program identified the presence of at least one of nine different Salmonella types (Arapahoe, Bredeney, Cerro, Dallgow, Kubacha, Mbandaka, Meleagridis, Newport, and Teddington) in those lots. Two of these lots showed the presence of the outbreak strain of Salmonella Bredeney.

I am beginning to sound a bit like a broken record.  How many of these outbreaks have to happen until WE rethink what WE are exposing our kids to?

For those interested, see my post on Food Safety News“Publisher’s Platform: Time to Ban Petting Zoos, Yet?”

Now, here is the reality of this E. coli O157:H7 outbreak – there are at least 106 who were sickened.  There was 1 death and a dozen who developed hemolytic uremic syndrome (HUS), and many more who were hospitalized.  Medical bills are likely to be in excess of $1 Million in total, and future needs for some of these kids will be very, very expensive.  My educated guess in that the petting zoo owner and the Cleveland County Fair have not much more than$1 Million each in insurance, and even less in assets.

So, what to do?

My friend and great lawyer from North Carolina, Mark Kurdys, and I will file a Lawsuit next week.  We will do the case pro bono (for free) and seek to get all lawyers to do the same.  Hopefully, we can get the medical insurance companies to waive any rights for reimbursement and get the petting zoo and Fair to do the right thing.

We shall see.

• A total of 22 persons infected with the outbreak-associated strain of Listeria monocytogenes were reported from 13 states and the District of Columbia.

• 20 ill persons were hospitalized. Four deaths were reported. Public health officials determined that two of these deaths were related to listeriosis. One fetal loss was reported.

• Collaborative investigation efforts of local, state, and federal public health and regulatory agencies indicated that Frescolina Marte brand ricotta salata cheese imported from Italy and distributed by Forever Cheese, Inc. was the likely source of this outbreak.

• On September 10, 2012, Forever Cheese, Inc. initiated a voluntary recall of this cheese with a single lot number and/or production code.

• On September 13, 2012, the U.S. Food and Drug Administration placed the exporter of the recalled cheese, Fattorie Chiarappa S.R.L.of Conversano, Italy, on Import Alert . This means that Fattorie Chiarappa cheese will be denied admission into the United States unless the importer shows that the cheese product is not contaminated with Listeria.

• On September 14, 2012, Forever Cheese, Inc. issued an expanded recall of all lots and production codes of Frescolina Marte brand ricotta salata cheese and issued a market withdrawal of all cheeses they received that were produced by the Italian cheese exporter.

Rio Queen Citrus, Inc. of Mission, TX is recalling 840 cartons of 12/1 Dry Pints of Mexican cherry tomatoes in “Karol” brand boxes, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The “Karol” cherry tomatoes were distributed through retail stores in the states of Texas & South Carolina.

The product was originally distributed in a bulk container of 12/1 Dry Pints in boxes labeled “Karol” with the Lot No. “01W45” stamped in the upper, right-hand corner on the face of the box. The box states “Distributed by Interstate Fruit & Vegetable”, which is an affiliated business of Rio Queen Citrus, Inc. These packages were distributed at the retail level between November 10th & November 19th, 2012. At the retail level, the tomatoes may have been packaged in an alternative container depending on the area and retailer.

No illnesses have been reported to date in connection with this problem.

The potential for contamination was noted after routine testing by FDA revealed the presence of Salmonella in a sample taken from the product, identified by Lot No. “01W45.”

Further distribution of the product has been suspended while FDA and the company continue their investigation as to the source of the problem.