…Your Voice for Safe Food

By Edgar S. Hasse

Andrea Heinze was a 29-year-old in perfectly good health — until she ate those sprouts.
Like hundreds of others in Germany, she had consumed produce contaminated with the E. coli bacteria.
Now Heinze knows this summer won't include trips to the swimming pool: not only would people stare at the blue marks on her legs and hips, she's got a catheter in her arm — and there's also the high risk of infection. She won't be going jogging or playing other sports either — she'll be happy if she manages to climb the stairs on her own. Heinze, in fact, is still very, very sick.

She has to undergo four hours of dialysis three times a week. Once a week, she needs antibody therapy. Heinze suffers from the hemolytic-uremic syndrome (HUS), caused by the E. coli bacteria. Some 850 others in Germany present the same condition. At least 47 of them have died.

While Heinze's situation is no longer life-threatening, her world has been turned upside down. Her body is always at risk due to swellings caused by toxins and her kidney function is severely limited.
Although she is back in her own apartment, going back to work as a sales agent is out of the question for now. Her mother has moved in with her part-time.

The Asklepios Clinic in Hamburg-Barmbek has become a second home for Heinze. She's there this particular morning, making her way to the third floor in her wheelchair. There she's greeted by Dr. Tobias N. Meyer who takes her to the treatment room where she lies down with a folded towel supporting her head. Meyer, the hospital's lead kidney specialist, attaches the catheter in Heinze's shoulder, and for 30 minutes the liquid from the bag suspended overhead drips into her bloodstream.

It contains Soliris. One dose of the drug costs 5,800 euros, making it one of the most expensive medications on the planet. For many HUS patients it's their only hope of one day leading a normal life again. Kidney specialists know the drug well, but it has never been tested or approved for treating an E. coli infection. However, because of the astonishing results in some cases, it is being used on 100 seriously ill HUS and E. coli patients in Germany.

"Five outpatients and four patients here in the hospital are presently being treated with Soliris," says Meyer. He adds that the drug, produced by American biotech company Alexion, may prevent or at least alleviate the swellings in the brain and kidneys that HUS causes.

Alexion's German subsidiary currently provides the vials free of charge, and began researching other possible uses of the drug. Andrea Heinze is part of that study. She knows that there may be risks, but she just wants her life back; a life that doesn't involve dialysis or the risk of inflammation. She says, to her, the risk is worth it.

Heinze first went to the emergency room at the Barmbek Asklepios Clinic on May 20th. She was complaining of serious stomach pains and doctors told her she was infected with E. coli. Not long after, she developed the hemolytic-uremic syndrome, which can lead to severe neurological damage and renal failure.

Later, doctors determined her illness had been caused by contaminated sprouts that she had eaten at her favorite restaurant on May 1st. Since, Heinze has avoided raw foods. "Everything I eat is cooked," she says.

As the anti-inflammatory antibodies slowly drip into her veins — a process that in itself is not painful — Heinze talks about her illness, and the terrible headaches she suffered. "But it's a lot better now than those first four weeks in intensive care."
Back then, she even suffered hallucinations. She only partially remembers what happened. Her parents came to see her twice a day. She was in a lot of pain. And she was very afraid. "I also slept a lot, I was sedated."

As Heinze slowly began to feel better, she started watching news reports about the E. coli epidemic on TV. She then knew she was not the only case; there were others at the clinic who had also been infected. After three weeks of lying alone in her room, she was well enough to be wheeled outside. "I met other patients like me, who looked just like me. Green hospital gown, covered head, surgical mask," something she says helped her feel better.

Heinze doesn't ask herself why she had to be one of those who ate contaminated sprouts, and now has to receive antibodies and undergo dialysis three times a week. "It was just bad luck, it happened by pure chance," she says. "And I'm glad that I got through those terrible first few weeks." Psychologists call this inner strength resilience, the ability to bounce back when things go wrong.

Andrea Heinze hopes that Soliris will work and that one day she'll be able to come off dialysis. Until then, she can't return to work. She may have lost over 13 lb (6 kg) since falling ill, but she hasn't lost her sense of humor. "Talk about a summer diet!" she says with a laugh.

This article taken from: http://www.time.com/time/world/article/0,8599,2081766,00.html#ixzz1S10PvwpQ

By Robert Roos
Jul 12, 2011 (CIDRAP News) – The US Department of Agriculture (USDA) recently announced plans to expand a program that relaxes certain regulations for meat and poultry processors that want to try out new ways to reduce Salmonella in their products.

The USDA's Food Safety and Inspection Service (FSIS) announced Jul 8 that it will waive certain food safety regulations for processing plants proposing to try new procedures, equipment, or techniques to control Salmonella. In return, the plants will be required to collect samples from each production line on every shift, test them for Salmonella and other common pathogens, and share the results with the FSIS.

"This program will encourage innovation by the industry to make food safer while providing us with data and information we can use to protect public health," said Under Secretary for Food Safety Dr. Elizabeth Hagen in a press release.

The Salmonella Initiative Program (SIP), as it is called, was first announced in January 2008, and it has operated as a small pilot project until now, with just a few plants participating, according to FSIS officials. The expansion plan incorporates responses to comments the FSIS received after the initial announcement 3 years ago.

A draft Federal Register notice published by the FSIS explains that the agency's existing regulations permit it to waive regulatory requirements for limited periods "so that new procedures, equipment, or processing techniques may be tested to facilitate definite improvements." The program is open to all processing facilities.

The notice gives little information about what kinds of regulations the FSIS will waive for SIP participants, but an FSIS spokesman provided a statement saying that examples of waivers "include those made for time/temperature requirements, on-line reprocessing (OLR), the HACCP-Based Inspection Models Project (HIMP), or other waivers that impact slaughter processes."

The Federal Register notice also says that the FSIS will relax restrictions on production line speeds for no more than five plants that applied for that waiver in 2008. The evaluation of the effects of increased line speed should include an examination of the effects on worker health and safety, it says, and therefore the agency has asked the National Institute for Occupational Safety and Health (NIOSH) to conduct such monitoring.

The notice suggests that increased microbial testing will be an important result of the program. "SIP benefits public health because it encourages establishments to test for microbial pathogens, which is a key feature of effective process control," it states.

It says the program includes safeguards against increases in contamination: "If the establishment's results show it is not meeting the agency's current performance standards for turkey or young chickens, it is to increase testing, determine whether its waiver is affecting its public health protection performance, and take steps to regain process control in order to minimize the presence of pathogens of public health concern."

However, the notice also says a SIP participant will not lose its waiver solely because of its Salmonella testing results.

Other program provisions, according to the notice, include the following:

SIP facilities are not routinely required to provide pathogen isolates to the FSIS, "but, if requested, establishments must work with FSIS on a mutually agreeable means for doing so."
The FSIS is considering reducing the required frequency of product testing for SIP participants that meet the agency's Salmonella standard for at least 6 months and can maintain that performance with reduced testing. (The new performance standard for Salmonella, which took effect this month, is that the pathogen should not be found in more than of 7.5% of young chicken samples and 1.7% of turkey samples. The standard is not a requirement.)
The FSIS also may reduce the required frequency of product testing for small and very small facilities that participate in the program.
The agency will conduct its own unannounced product sampling and testing to check the performance of all facilities, including SIP participants.
Information about the SIP pilot project appears to be scarce. The FSIS spokesman said six young-chicken facilities are operating with waivers under the SIP project, and another 140 such plants have waivers under other programs. But he couldn't offer any details on how the SIP pilot program has worked out.

Tony Corbo, a lobbyist with the nonprofit consumer group Food and Water Watch, also said details about the program have been hard to come by. "We're not aware of exactly which plants [are involved], what waivers were granted, or how the evaluation is being done on the plants in order to take the next step," he told CIDRAP News.

"How the pilot has been operating up to now has been a mystery to a lot of us and I guess even to industry," he said.

Corbo commented that the increased testing required for SIP participants should be helpful to the FSIS.

The program "does increase the amount of testing industry has to do, and they have to share some of their own data with FSIS, which has always been a big problem with FSIS," he said. The agency does much more testing than the Food and Drug Administration does, and it may help it verify companies' control efforts, he said, "but statistically it may not be as robust as you'd want."

"FSIS has always been in search of additional data so they could see what's going on from a statistical standpoint, so this program would be a benefit to the agency," he added.

Corbo also commented that the FSIS announced back in 2006 that it was considering allowing facilities to increase their production line speeds—a proposal that concerned Food and Water Watch—but the agency never followed through at the time.

"We felt it could impact food safety with the USDA inspectors not being able to perform their tasks effectively," he said. "It was also an issue of employee health and safety."

He added that NIOSH has never taken a systematic look at the health and safety aspects of increasing line speeds, despite plenty of anecdotal reports of problems.

"Industry has been reluctant to allow NIOSH in," he said. "What's interesting about this notice is that a plant that wants to increase line speed has to allow NIOSH to study the health and safety aspects."

This article taken from: http://www.cidrap.umn.edu/cidrap/content/fs/food-disease/news/jul1211usda.html

Moscow - Russia on Wednesday banned a wide range of Egyptian seeds and beans following a European Union report that some of the products might contain E coli bacteria, a senior government official said.
The ban would go into effect immediately and was based on a Tuesday announcement by EU officials that Egyptian fenugreek seeds used to grow bean sprouts in Germany were the probable cause of a deadly E coli outbreak, said Gennady Onishchenko, Russia's chief food safety officer.
'We are doing this because we were informed by the EU, it is in response to their announcement,' Onishchenko said. 'We congratulate them on finding a possible source of the infections.'
At least 47 people have died and more than 4,000 sickened in Europe's E coli outbreak, which has hit Germany hardest.
Cairo officials have said EU allegations Egyptian fenugreek seeds are the culprit are unfair, as the strain of E coli killing people in Europe does not exist in Egypt.
Fenugreek seeds were only one of a long list of Egyptian produce now illegal to import into Russia. Other banned vegetable products included arugula, radish and beet sprouts, most beans and vegetable oils and other foods produced from them, Onishchenko said.
Russia in early June banned the import of all EU vegetables because, Kremlin officials said, it was unclear how the E coli bacteria found its way into the bean sprouts that made people sick.
Russia and the EU came into conflict over the blanket ban, which EU officials said was too wide-reaching, and unfair to European vegetable producers.
The Russian ban remains mostly in effect, however, since the beginning of July the Kremlin has agreed to allow vegetable imports from Belgium, Spain, the Netherlands and Denmark as exceptions.
Shippers must obtain a safety certification from an independent laboratory, and a written guarantee from the EU that the each individual shipment is E coli-free, before the vegetables are allowed into Russia.

This article taken form: http://www.monstersandcritics.com/news/health/news/article_1649556.php/R...

By Monica Eng, Tribune reporter

At a time of rising concern over pathogens in produce, Congress is moving to eliminate the only national program that regularly screens U.S. fruits and vegetables for the type of E. coli that recently caused a deadly outbreak in Germany.

The House last month approved a bill that would end funding for the 10-year-old Microbiological Data Program, which tests about 15,000 annual samples of vulnerable produce such as sprouts, lettuce, spinach, tomatoes, cantaloupe and cilantro for pathogens including salmonella and E. coli.

Over the last two years, its findings have triggered at least 19 produce recalls, according to the Food and Drug Administration.

The commercial produce industry, which has long expressed concerns about the program, this spring suggested ending its $4.5 million funding. In a memo to Agriculture Secretary Tom Vilsack, the USDA's Fruit and Vegetable Industry Advisory Committee complained about "unnecessary recalls" and asked if the funds would be "better utilized elsewhere."

Industry representatives call the program duplicative, suggesting that similar screening is already done by other agencies.

"We're in a budget climate right now that is looking for a lot of cuts," said Kathy Means, of the Produce Marketing Association. "I think there are other programs out there. So we would not be left in a lurch if the MDP is not out there."

But defenders of the program note that no other agency tests the same breadth of produce for pathogens. For example, the FDA typically spot-checks about 1,000 samples a year, compared with 15,000 for the Microbiological Data Program. In addition, the only E. coli the FDA tests for is the O157 H7 strain, but the MDP also tests for non-O157 strains that include the increasingly mercurial and virulent Shiga toxin-carrying strains of E. coli that contaminated sprouts in Europe, killing more than 40 and sickening 4,100.

Eliminating the program "may serve the interests of agribusiness, but it's a serious disservice to consumers and public health," said Ken Cook, president of Environmental Working Group, a consumer advocacy organization. "Since when does it make sense not to check food for potentially deadly pathogens?"

The question now moves to the Senate, which will be crafting its version of the discretionary spending bill for the FDA and USDA programs over the next few months.

The Microbiological Data Program was started as a sister program to the equally controversial Pesticide Data Program, which monitors pesticide levels on produce. Both work with several states — including Wisconsin, Ohio and Michigan — to voluntarily test produce at distribution points. And both are run out of the USDA's Agricultural Marketing Service, which is partially funded by industry fees and designed to promote U.S. produce. Although both programs create data that largely affirm the safety of U.S. produce, they've drawn criticism from industry interests for their potential to share data that could harm growers.

Those critics say the pathogen testing program has overstepped its original mandate to monitor pathogens in produce, collect data and calculate a baseline of contamination levels from which to measure improvement.

"We thought that was fine and those were good things to do," said David Gombas, of United Fresh Produce, a major industry association. "But over time it got twisted and it turned into a regulatory program where they were finding contamination and turning it over to the FDA and causing recalls."

Although sharing data with other public health agencies was part of the Microbiological Data Program's original mandate, the spring memo from the produce growers urged the USDA to cease using the program's data "as an enforcement tool." It also alleged that past recalls have been triggered by "single samples" of contaminated produce.

"That was not the original design of the program," said Hank Giclas, senior vice president of science and technology at Western Growers, which ships much of the nation's produce. "It was not designed as a regulatory program. They need to focus on how we can identify the vulnerable areas and offer recommendations on how we can improve food safety."

Staffers with the testing program were not authorized to comment on the pending legislation, but USDA representatives stress that they don't make decisions about whether to request a recall. The FDA does.

Leaving the regulatory issues aside, many food safety experts agree that the testing program fills an important need by maintaining an unbiased database on produce contamination — an increasingly crucial but under-studied area of food safety. While much funding and attention have gone toward tracking pathogens in meat and dairy (the USDA's Food Safety and Inspection Service has a budget exceeding $900 million for those areas), relatively little is known about pathogens in produce, said Robert Tauxe, deputy director of the Division of Foodborne, Waterborne and Environmental Diseases at the Centers for Disease Control and Prevention.

"Over the last several decades it's become clear that fresh produce is an increasing part of the food (safety) problem," Tauxe said. "In contrast to the pathogen data available for meat and poultry … there is essentially nothing on produce, and MDP is an attempt to create that."

Supporters also say the Microbiological Data Program is the only national program that regularly screens for the kinds of deadly E. coli strains that took European scientists by surprise and are of increasing concern.

"If I were a producer of fresh produce I would want to have the program so I could know if there were problems in my product and I could correct the situation," said Michael Doyle, a former scientist with the program who is now director of the Center for Food Safety at the University of Georgia. "But as public health official and as a consumer I also believe it's very important to keep this program going."

Giclas counters that often "positive (pathogen) samples don't equate to any illness in the marketplace at all." The industry's memo expressed concern over "unnecessary product recalls that do not contribute to the protection of the public health, undermine consumer confidence in the safety of the produce supply chain, discourages the consumption of produce … and damages the reputation of the farmers growing it, along with (causing) financial injury."

Means, of the Produce Marketing Association, said she believed that other agencies may be able to perform the testing currently done by the Microbiological Data Program, and the House bill suggested that the USDA consider outsourcing the work. But supporters say the uniformity and efficiency of the program are among its greatest strengths, and that using various labs would disrupt the consistency necessary to make the data scientifically useful.

"If it's the exact same protocol year after year ... you start to be able to look at trends over time," said Michael Hansen, a senior staff scientist at Consumers Union, which publishes Consumer Reports. "So when this legislation comes in or this industry says they will do X, Y and Z then you can see the impact in the numbers. ... This is an independent look at the microbial status (of produce), and so I can't see how any company would not want this information unless they don't think much of their own capacity for food safety. I would think that any responsible company would want to improve that."

While there was little debate last month in the House over the provision to eliminate the program's funding, Rep. Hansen Clarke, D-Mich., did try to retain $1 million of it with an ultimately unsuccessful amendment. The total budget cuts in the bill amounted to $2.7 billion.

"Congressman Clarke is very concerned about food safety and food security," said policy adviser David Weinreich. "What's been going on in Europe really points out how important it is to be continually collecting data and making sure we know what's going on with our food and what microbiological contaminants might be in it. We need to let consumers know we are continually screening so people can have confidence at home and abroad about our agricultural products."

This article taken from: http://www.chicagotribune.com/health/ct-met-pathogen-program-20110704,0,7222819.story