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FDA ¡®Spokesperson¡¯ Justifies Reasoning Behind Pistachio Recall
Source of Article:
We wanted to get an update and clarification from the FDA itself on the state of the Setton Pistachio recall, so we asked Pundit Investigator and Special Projects Editor Mira Slott to find out more.
We run her conversation below, but the FDA now has a policy that all its people should be anonymous and go by the term ¡°spokesperson¡± so even though we know who we spoke to we are told not to identify the person by name.
This is almost precisely the opposite of the transparency and accountability President Obama promised in his campaign so we hope the new regime at FDA will change this ridiculous policy quickly. Spokespeople should always be identified by names so they can be evaluated for the honesty and accuracy and completeness of their communication:

FDA Spokesperson:

Q: FDA said it found salmonella in the Setton plant and problems in processing that could cause cross contamination of raw and roasted nuts. If FDA went to other plants and did comprehensive studies, could it find problems such as this? How unusual is this discovery? Do you have any baseline for comparison?

A: Hopefully, you wouldn¡¯t find salmonella in an area you wouldn¡¯t expect to ? in certain points in the production line. The key thing is that we sent a letter on April 3 to pistachio processors about current good manufacturing practices. FDA basically reminded processors of their legal responsibility to insure products are safe for consumption and walked through a number of pertinent things mentioned in the good manufacturing practices. FDA wants to work with the industry to help understand the risks, to examine current pistachio practices that could lead to contamination with bacteria and measures to prevent contamination.

Q: But that still doesn¡¯t answer the question. Setton has an excellent reputation for high food safety standards and has been regularly audited by respected third-party auditors and retailers. How does FDA reconcile the fact that these same problems it points to at Setton could be just as prevalent in other facilities? Without a baseline, how does FDA justify its sweeping recall action?

A: FDA is still doing its investigation. I can¡¯t directly address that. We need to finish the investigation to get an idea of the complete circumstances while these products were being processed. It is also possible the firm is very attentive to many things but may have missed something.

We hope to learn what went awry so it won¡¯t occur again. There is not necessarily a sense that anyone was intentionally doing something wrong. There are just times when something is going on that people miss. Our focus is on what exactly went wrong. This speaks to what I just mentioned. FDA wants to look at current practices that could lead to bacteria and provide additional guidance of measures that can be taken.

If we take a closer look, maybe there is additional information that could reduce the likelihood even further that pistachios could be the cause of a foodborne outbreak.

Q: But this recall was not related to an outbreak, was it?

A: You¡¯re right. This is not an outbreak because illnesses are not associated at this point. People reported illnesses that could be related, but we don¡¯t have a confirmed link to illness and product. There are two things that would trigger a recall. Why would we notify people not to eat a product? Certainly if people start getting sick from a product. Sometimes people take action due to a test showing a positive result for a pathogen. No one has gotten sick, but someone could.

In the case of the pistachio recall, Kraft did tests and got salmonella results that went back to Setton Farms. The fact there are no illnesses certainly doesn¡¯t mean there isn¡¯t a potential problem.

Q: Actually, there¡¯s quite a bit of confusion regarding the testing and the time line involved. Could you clarify who did testing, when, where, in what products, and what results were found at different time periods? For example, were all four salmonella serotypes discovered in Setton Pistachio product simultaneously in March at the Georgia Nut Company¡¯s facility? Was the determination that the problem was in pistachios from Setton Farms deduced as the common link from various tests done over an 18-month period? If testing was done over an extended period, I presume there were many negatives. Could this indicate sporadic infection?

A: There were four strains that came up, and I¡¯m quite sure all were from March. Some testing I understood to be in a Kraft trail mix product that turned out positive for several ingredients. I can¡¯t speak to the detailed time line of testing, but the bottom line is that somewhere along the line there¡¯s been some kind of processing breakdown at Setton, and we can all be certain of that. Salmonella in raw product is supposed to be eliminated in the roasting kill step.

Q: In Setton Pistachio¡¯s expanded recall release, it says, ¡®Setton¡¯s raw in-shell pistachio shipments are NOT affected by this recall expansion.¡¯ Why is that? Couldn¡¯t the raw product be a likely source of the salmonella?

A: Raw agriculture product may have some contamination. If this product is roasted, I don¡¯t know if it¡¯s a moot point.

For Setton Pistachio, it moved to expand its recall to all products harvested in 2008, let me reword that, to all roasted in-shell and shelled and raw shelled pistachios not subsequently roasted prior to retail sales. If I were selling you raw pistachios, but the expectation was that you were going to roast them, you would have that kill step in there, providing you roasted them at the right temperature, etc.

Even if you go with the presumption the raw pistachios are not salmonella-free, they¡¯re going to be roasted. If you were going to sell pistachios to consumers raw, it wouldn¡¯t make sense to ship them. Setton did ship raw product to certain people, but if they weren¡¯t roasting it, the product has to come back.

Suppose you¡¯re Setton Farms or another pistachio processor and you have some product coming in from the field. A bird could have contaminated it. You move it through the facility and it goes down some processing line where it gets roasted. If the roasting process is adequate, you have a kill step and there should be no salmonella. It¡¯s possible, but our assumption is that if some is contaminated, you¡¯re decontaminating it as a kill step. Shipping that raw product someplace else, you¡¯re passing it through to the next company where someone else is roasting it and killing any contamination.

Q: Isn¡¯t there some risk that contamination or cross-contamination could occur from the time it¡¯s shipped until the time it¡¯s roasted at the other company?

A: Yes, that¡¯s a valid point. How is it shipped out from Setton? My understanding is that things got shipped in 1,000-pound and 2,000-pound containers. I imagine that raw in-shell product that is not part of the expanded recall is shipped like everything else.

Like anything, if the raw product is contaminated, anything it touches along the way could be cross-contaminated. One thing that gets confusing is that people might have in mind that things coming from the field are sterile but they aren¡¯t.

Q: Dr. Acheson says salmonella was found in ¡°critical areas¡± of the Setton facility. Can you define those areas specifically? Where was the salmonella found exactly? And how many samples came back positive? Have you connected the serotypes to the positive results found at the Georgia Nut Company?

A: We are still working on some of the environmental samples. I can¡¯t tell you where exactly or how many environmental samples came back positive. The results indicate the presence of salmonella in critical areas of the processing plant and where there is potential for cross-contamination. I can¡¯t say the positives were from a belt or a drain. We also don¡¯t have the type of serotypes yet. But that becomes a moot point because you don¡¯t want any type of salmonella at the plant.

Having seen what happened with peanuts, we certainly don¡¯t want someone to get sick and die. First we must isolate product and give consumers advice, then we look to see if we can isolate where the problem occurred specifically and take corrective action.

Q: When FDA got positive results for salmonella at the Setton facility, why didn¡¯t it hold a press briefing to inform the media as it regularly did during the Salmonella Saintpaul outbreak? Why is Dr. Acheson selectively releasing information the FDA considers important to only certain reporters?

A: I don¡¯t know the reason for the change in policy. All I can say is that I didn¡¯t get much of a break during the Salmonella Saintpaul investigation because of the frequently held press briefings.

Q: This slow trickle of piecemeal information is leading to confusing, inaccurate and often sensationalized reporting. The Associated Press quoted Acheson on the positive findings, but also reported inaccurate information on the extent of the expanded recall.

A: You are correct in pointing out that the AP and other newspapers were not right when they reported that Setton was recalling its entire 2008 crop. I kept seeing the word ¡°entire¡±, which was never the case. .

Q: That confusion actually began early on during the original joint FDA/California Department of Public Health press briefing and got picked up from there in The New York Times, among other media outlets.

Is there any real change in the advice you¡¯re giving consumers in terms of consuming pistachios? An article in the Sacramento Bee (April 8) gives that impression: It leads off: ¡°Federal food safety officials have lifted last week¡¯s blanket salmonella warning on all pistachios focusing on nuts now being recalled by a single San Joaquin Valley processor.¡± Isn¡¯t there still a blanket warning to consumers to avoid eating pistachio products until they can verify none of the ingredients originate from Setton Pistachio?

A: There is no difference. Our advice to consumers remains the same because pistachios are used as an ingredient in a variety of foods. Consumers shouldn¡¯t eat pistachios or food products containing them until they can determine if those products contain recalled pistachio products. Nothing has changed. The problem originally pointed to Setton and still does.

There is a problem or potential problem and consumers need to be worried if they got pistachios processed by Setton Farms. How do you know? Well you don¡¯t. We¡¯re telling consumers, don¡¯t throw product out, just put it aside and as we get information, we¡¯ll post the list of recalled products. Go in and check and see if your product comes out on the list, and if it does, don¡¯t eat it and throw it out.

Q: When will they know it¡¯s OK to eat it? This isn¡¯t like fresh produce, where at a certain point, all product is out of circulation due to its perishable nature.

A: Over a certain amount of time, hopefully we¡¯ll get most products out there that contain these things, and the consumer can say, ¡®look it¡¯s been a few weeks, and I am reasonably confident my products aren¡¯t on that list and I¡¯m going to eat pistachios.¡¯

Advice has been the same all along. The only difference is that at the beginning of this week, Setton expanded its recall. Now it isn¡¯t just product after September 1, 2008. We expect additional recalls, maybe different products, earlier code dates, and consumers should be aware of that.

Q: What actions can FDA take to alleviate these kinds of sweeping recalls and to improve its handling of these investigations in the future?

A: At FDA¡¯s request, it has a contract with the University of California Davis to research chemical propylene oxide as a means of killing salmonella in pistachios and other tree nuts. The method has been validated to kill salmonella in almonds.

Q: But you¡¯ve pointed out that roasting pistachios already provides a kill step. FDA says the Setton recall centered on the recontamination by raw pistachios, so in that case, a pasteurization process wouldn¡¯t have changed the outcome.

A: Pasteurization could be an alternative food safety step. There¡¯s more than one way to skin a cat. It¡¯s about looking at what else could work. Roasting only works as a kill step at the right temperature, for the right amount of time, and deep enough to make sure it penetrates. You have to validate the process and make sure it¡¯s implemented properly. Of course it¡¯s all for naught if roasted product is then re-contaminated with raw product.

The point is that companies can do things to minimize risk. Designing the plant properly is important, but obviously more difficult and costly when retrofitting. There are a lot of things involved in food safety. Over time, we try and learn. It might be that now we think we¡¯ve addressed 90 percent of the problem, five years later 95 percent, and five years later 98 percent. The goal is to minimize the likelihood the best you can.

The key issue the FDA desperately wishes to avoid any consideration of is whether its efforts actually help public health in these types of recalls. In a situation such as this ? where, as the FDA spokesperson says, there is no indication of maliciousness, the vendor has a good reputation and has multiple audits ? it is highly likely that by excluding this one shipper¡¯s product from the market, the FDA is leaving the market to product no safer than the Setton Farms product. Indeed, because there are sub-standard operators in the world, the remaining product may, on average, be less safe.

What clearly has to change is that the FDA cannot be prosecutor, judge, jury and executioner. Simply screaming ¡°public health¡± does not justify destroying Setton Farms because the FDA wants to ¡°work with the industry to help understand the risks, to examine current pistachio practices that could lead to contamination with bacteria and measures to prevent contamination.¡±

This may all be some project to the FDA, but this company is the property of real people, it provides a livelihood for real people and it is not the FDA¡¯s right to destroy it.

Our friendly FDA spokesperson speaks with certitude but is not convincing when saying:¡±... the bottom line is that somewhere along the line there¡¯s been some kind of processing breakdown at Setton and we can all be certain of that.¡±

Actually we don¡¯t think this consensus is justified. As of today, without a serotype match between the allegedly contaminated pistachios in Illinois and the plant, we don¡¯t even know if the plant had anything to do with the contamination. After all, product sat at Georgia Nut Company for months ? maybe it got contaminated there.

The FDA also just assumes it needs to do things although the legislative justification for doing so is dubious. For example, our spokesperson explains FDA¡¯s position well: ¡°First we must isolate product and give consumers advice.¡±

But one wonders if the FDA has considered that in a situation such as this, the ¡°advice¡± can only be a reflection of the risk-tolerance level of the individual giving the advice. Unlike peanut butter, pistachios are not generally eaten by children; they are a relatively expensive item and are not generally eaten in great quantity. So what , exactly, does the FDA think the risk is?

Why doesn¡¯t the FDA publish this assessment and allow citizens to make their own decisions rather than give its advice to consumers?

We suspect it is because the ludicrous nature of the ¡°risks¡± FDA is acting against would soon cause people to ignore it, if not laugh at it. By the CDC¡¯s reckoning, there are 76 million cases of foodborne illness and 5,000 deaths in the US each year from foodborne illness. So, if we have 305 million Americans and all Americans are equally vulnerable, there is a 24.918% chance of an American getting a foodborne illness and .0016% chance of an American dying from a foodborne illness during the course of a year.

Of course, these numbers are after the FDA¡¯s vigilant market withdrawals, so the question is how much greater would the numbers be if they let the pistachios be sold freely? Would there be any difference? If the replacement product is less safe, wouldn¡¯t the numbers actually be worse? Who would pay attention to such uncertain and inconsequential risks?

We let people ski without helmets, ski dive, hang glide, etc. ? on what basis do we deny them some ¡°risky¡± pistachios? It is preposterous.

Does FDA Put Its Reputation Above Enhanced Food Safety?
Source of Article:

Why has the FDA chosen to act in the manner it has regarding the pistachio industry? Gardiner Harris and Andrew Martin of The New York Times explain the matter this way:

¡°The food industry needs to be on notice that F.D.A. is going to be much more proactive and move things far faster,¡± said Dr. David Acheson, associate commissioner for foods at the Food and Drug Administration. ¡°We¡¯re going to try to stop people from getting sick in the first place, as opposed to waiting until we have illness and death before we take action.¡±

They also point to new management:

Agency officials said in interviews that Dr. Joshua Sharfstein ? the administration¡¯s choice to lead the agency while Dr. Margaret Hamburg goes through the confirmation process to become commissioner ? sought to avoid the agency¡¯s cautious, step-by-step actions in the recent peanut recall. More than a month passed between the initial recall of a few lots of peanut butter and a decision to recall years of production from the Georgia and Texas plants of the Peanut Corporation of America.
Agency officials have long been reluctant to seek broad food recalls unless contamination has been proved, and such gradually expanding recalls have been a common feature of F.D.A. food actions for decades. Last week, Dr. Sharfstein told agency officials to act boldly far earlier, officials said.
Dr. Sharfstein speeded the agency¡¯s decision making by getting as many as 40 agency officials to talk to one another in weekend conference calls. Dr. Sharfstein ¡°wanted to drive it hard and drive it fast,¡± Dr. Acheson said.
So the question that should be fairly asked is a simple one: Has the FDA¡¯s aggressive action increased food safety? The answer is that this is unlikely. The powers that be at FDA are either well intentioned but incorrect in their analysis, or they are more concerned with burnishing FDA¡¯s reputation for enhancing food safety than with actually enhancing food safety.
Here is the problem. The particular firm implicated in this food safety investigation has a good reputation. We quickly get calls when things like this break, from ex-employees, competitors, etc., telling us if the management of a company is sleazy. That is why if you check out past editions of the Pundit you will find no pieces defending the management of Peanut Corporation of America ? we heard from too many people of too many problematic decisions.

We are not getting that feedback on this firm.
Now what about the FDA¡¯s alleged finding of salmonella in the plant in California¡¦ doesn¡¯t that, you may ask, prove that the FDA acted prudently and, in fact, enhanced food safety by getting this product out of the system? Especially since the FDA simultaneously identified some imperfect production practices?
No it does not. In order to enhance food safety, the FDA would have to know that the product from this one plant is more likely to have pathogens on it than the average product being turned out by alternative sources.
Yet the methodology the FDA is using is simply not designed to prove anything like that.
In this case, the FDA dove in to the implicated plant, did hundreds of tests, a super thorough evaluation and found some things that were problematic.
We have absolutely no issue with its efforts and, indeed, think the plant should correct them and produce safer food. We have no indication ? from the FDA or anyone else ? that the company is unwilling to do so.
But if we did hundreds of tests and super-thorough inspections of all other pistachio facilities, how do we know all of them would be flawless in design and execution and without a pathogen to be found? And if we don¡¯t know that, then how can we possibly know whether we are helping or hurting food safety?
If the implicated plant is imperfect but less imperfect than its competitors, then restricting its sales but not those of its competitors simply makes the food supply more dangerous ? not safer.
It is the failure of FDA to present rational arguments for its actions or to even indicate its awareness of these dilemmas that make us feel its executives are more concerned with enhancing the institutional reputation of FDA than they are with enhancing food safety.

FDA Safety Rules for Juice, Seafood Industries Don¡¯t Affect Peanuts
Source of Article:

Monday, April 13, 2009 ::
By Emily Stephenson - Juice, seafood, meat and poultry producers must take steps to identify and eliminate spots where salmonella and other bacteria could contaminate products.
Washington, D.C. - infoZine - No such regulations govern most foods under the Food and Drug Administration's jurisdiction, including peanuts.
Some experts say a mandatory, industry-wide Hazard Analysis and Critical Control Points safety program - known as HACCP - could help prevent salmonella outbreaks like the one that has sickened more than 690 people and killed nine since September.
"FDA is going to have to implement HACCPs for high-risk products," said Martin Cole, director of the National Center for Food Safety and Technology. He said peanuts, also blamed for a 2007 salmonella outbreak, are high-risk.
"You've had a couple of outbreaks in the last two years for that product, so that should be governed by HACCP."
The seven-point system, first used by Pillsbury in the 1960s to produce safe foods for astronauts, requires identifying steps in the production process in which contamination could occur and pre-empting problems.
HACCP also requires testing to guarantee contamination points are eliminated and extensive record-keeping.
The FDA has been criticized for failing to enact preventive measures and avert outbreaks. The agency requires only that seafood and juice manufacturers follow HACCPs.
FDA spokeswoman Stephanie Kwisnek said in an e-mail the agency could expand its HACCP requirements to other industries, as the Department of Agriculture has done for meat and poultry - the only foods under its jurisdiction.
"HACCP-style planning is already a requirement for all meat and poultry plants, and it should be a prerequisite for all food processors that want to sell food in the U.S.," said Caroline Smith DeWaal, director of food safety at the Center for Science in the Public Interest, in March 11 testimony before a House subcommittee.
The process is now standard for large manufacturers in most industries, Cole said.
Peanut Corp. of America, identified as the cause of the peanut-related salmonella outbreak, does not appear to have followed an effective plan.
A 2002 Nestle audit of the Peanut Corp.'s Blakely, Ga., plant said it had no HACCP plan. Auditors in 2006 determined that the company's Plainview, Texas, plant's plan didn't address all hazards. The audits were released at a March hearing held by a House subcommittee.
In the 2006 audit, Nestle recommended that a plant manager take a HACCP training course to better understand hazards that could affect peanuts during treatment.
A later audit by a private organization said the Peanut Corp. did follow a safety plan. But when FDA inspectors entered the company's plants, they found obvious safety violations, including dead rodents and insects, animal droppings and a leaking roof.
Juice is one of only two industries under FDA with mandatory HACCPs.
A 1996 E. coli outbreak traced to unpasteurized apple juice and two later salmonella outbreaks caused by citrus juices resulted in more than 570 illnesses and two deaths.

The FDA required HACCP plans and told producers beginning in 2002 to reduce pathogens by a set amount.
Kristen Gunter, executive director of the Florida Citrus Producers Association, said the citrus industry had little difficulty conforming to the FDA's standards.
"We'd never been considered high-risk. We weren't, you know, the seafood industry; we weren't the poultry industry," she explained. "Once everybody got their heads around what HACCP principles were being applied, the juice industry embraced the program.
"The application of HACCP principles is a system to produce safe and sanitary product, and you can't argue with those principles."
In the years after the FDA issued its juice rule, the Centers for Disease Control and Prevention have not listed juice as a major source of illness in annual reports. A 2003 report cites decreases in E. coli and salmonella following reforms, including reassessing HACCP plans, in the meat and poultry industries.
But some of those improvements have not been sustained, according to a 2007 report, and there are other problems with mandatory HACCPs. The FDA partners with inspectors in some states to regulate the 44,000 producers under its jurisdiction, but the agency is overworked and understaffed.
The FDA has said that the Plainview, Texas, plant linked to the current salmonella outbreak operated for years without being inspected.
And Steve Cockram, technical director for the Growers' Cooperative Grape Juice Co., said he thinks FDA rules leave too much room for interpretation. His company has argued with New York inspectors about how best to address hazards.
Cole said the cost of establishing a HACCP varies depending on plants' size and safety practices. For small plants with no safety plan, conforming could be time-consuming.
Juice plants must typically train an employee in HACCP procedures, and some also hire outside auditors or inspectors, Cockram said.
Tomato growers in Florida imposed their own food-safety program, which does not include a HACCP and is overseen by the U.S. Department of Agriculture instead of FDA. The program went into place last summer.

Some see lack of progress in reducing food safety risks
Source of Article:

By GEORGINA GUSTIN, St. Louis Post-Dispatch Monday, April 13, 2009
Rates of food-borne illnesses have remained roughly level since 2004, the Centers for Disease Control and Prevention reported Thursday, revealing what health officials and regulators say is an alarming lack of progress in reducing food safety risks.
The rate of illnesses from salmonella ? the bug that struck hundreds of Americans in recent outbreaks involving peanut butter and hot peppers ? is twice the level federal agencies had hoped to reach, according to the CDC. Meanwhile, produce-related food poisonings are on the rise.
¡°We need greater efforts along the food chain ? from farm to table,¡± said Dr. Robert Tauxe of the CDC.
Faced with bigger, more complex food-poisoning outbreaks in recent years, government agencies have been forced to devote the bulk of their resources to reacting only after people became sick. Outbreaks also are becoming more difficult to investigate as more imported food pours into the U.S. and food distribution networks become more complex.
¡°As supply chains get longer and longer, there¡¯s more opportunity for contaminants,¡± said Dr. Stephen F. Sundlof, director of the Food and Drug Administration¡¯s Center for Food Safety. ¡°One single ingredient can have a very wide distribution.¡±
Investigators also have to cope with the emergence of new forms of illness. ¡°Our pathogens have complicated ecologies that may be changing, and we have very little information about that,¡± Tauxe said.
The CDC report focused on data collected from 10 states through a government surveillance network dubbed FoodNet. The network tracked food-borne pathogens dating back to 1996. The data showed declines in cases of several food-borne illnesses from 1996 to 2004, but those numbers have leveled off since.
In recent years, however, several prominent outbreaks have heightened awareness of food poisoning and triggered several bills in Congress that would overhaul the food safety system. The Obama administration has declared food safety a priority, and last month established a Food Safety Working Group to address what the president called an ¡°unacceptable¡± status quo.
¡°Our system of inspection and enforcement is spread out so widely among so many people that it¡¯s difficult for different parts of the government to share information, work together and solve problems,¡± the president said in March.
The agencies responsible for food safety and responding to outbreaks are vast, unwieldy and often fail to communicate effectively, many critics and regulators say. Last year, when a cluster of salmonellosis cases appeared in Jefferson County, inspectors and scientists from three federal agencies came to the area to oversee different parts of the investigation.
¡°We¡¯ve dealt directly with the CDC, the FDA and the Department of Agriculture on some of these issues as most health departments have,¡± said Dennis Diehl, the county¡¯s health director. ¡°But because of the way the responsibilities are delegated to those different agencies, the FDA doesn¡¯t always know what Agriculture or what CDC is doing, and sometimes it¡¯s hard to get information.¡±
Critics say the Food and Drug Administration, which oversees 80 percent of the food in the U.S., is overwhelmed and devotes more resources to drug oversight than food. Last year, however, the agency hired 150 more inspectors, and plans to hire roughly 30 more scientists and consumer safety officers. The agency also has opened several international offices, in China, Latin America and India. ¡°It¡¯s become very clear that preventative controls are critical,¡± said David Acheson, associate commissioner for foods at the Food and Drug Administration. ¡°FDA certainly needs to do more inspections.¡±
Food safety experts generally agree that more inspections and more emphasis on prevention rather than reaction will be key to addresses food poisoning challenges.
One bill introduced in Congress would call for a single food safety agency to streamline the food safety system. Another calls for preventative controls in high-risk facilities and points along the food chain.
Michael Taylor, a professor at the George Washington School of Public Health and former deputy commissioner for policy at the Food and Drug Administration, agrees the country¡¯s food safety system needs to undergo a ¡°paradigm shift.¡±
¡°It has to shift from people getting sick to a framework of prevention where you clarify the industry¡¯s duty to implement modern preventative controls,¡± Taylor said. ¡°Also defining through government standards what¡¯s good enough, and following up with inspection and enforcement.¡±
Taylor, as well as other food safety experts, say the time is ripe for substantial change, noting the reform theme of the Obama administration.
¡°You¡¯ve got a visible presence for reform,¡± Taylor said, ¡°and that¡¯s an important part of this.¡±

Wildlife found to be unlikely E. coli culprits
Source of Article:
Two years of testing show that wild animals are not 'Typhoid Marys,' California biologist says.
By Bettina Boxall April 11, 2009
After wild pigs were linked to the deadly E. coli outbreak in California spinach nearly three years ago, Central Coast growers started shooting and poisoning wildlife.
Workers on one large farm killed 33 deer in a single year. Farmers poisoned ponds to get rid of frogs, ripped out trees and bushes and erected miles of expensive fencing.
But two years of testing wild animals and birds in the region suggests that only a small fraction actually carry the strain of Escherichia coli responsible for the contamination.
The results, released by the state Department of Fish and Game this week, "show that wildlife are not the Typhoid Marys some people think they are and some of the extreme measures are not necessary," said state wildlife biologist Terry Palmisano.
As part of an ongoing study of the pathogen, researchers collected samples from 866 animals, including 311 black-tailed deer, 184 feral pigs, 73 birds, 61 rabbits, 58 tule elk, squirrels, mice, skunks and coyotes.
Only four -- from a pig, a coyote and two elk -- tested positive for the lethal bacterium, E. coli 0157:H7. That is slightly less than half of 1%.
Three people, including a toddler, died in the spinach outbreak in the late summer of 2006. Federal authorities estimated that several thousand people were sickened across the country.
The contamination was traced to spinach grown on a cattle ranch east of Salinas. Although the precise source was never determined, the virulent E. coli was found in river water as well as in feces from cattle and wild pigs on the ranch.
The produce industry later adopted a voluntary set of standards for growing and handling leafy greens that amounted to a big "Keep Out" sign for any wildlife considered potential carriers of E. coli 0157:H7.
Big produce buyers also struck their own safety agreements with farmers, calling for even more precautions.
Requests jumped for state depredation permits allowing farmers to shoot wildlife damaging their crops. Growers who might otherwise have tolerated a deer browsing some lettuce shot the animals, fearing they couldn't sell a crop if safety auditors found droppings or tracks in a field.
"The buyers don't want even mice getting close," Palmisano said.
Baited PVC pipes with traps are a common sight along the edge of fields. Much of the Salinas River has been fenced. Grass along irrigation and runoff ditches has been dug up, leaving wide strips of bare ground.
"Folks are having to do stuff they don't want to do in order to sell their crop," said Paul Robins, executive director of the Monterey County Resource Conservation District.
In a 2007 survey by the district, one grower reported he had lost $17,500 worth of a crop because there were deer tracks in a field. A harvest was stopped when frogs and tadpoles were found in a creek.
The district's program director, Melanie Beretti, said farmers are resisting anti-erosion and water quality projects that involve vegetation that could attract wildlife.
She cited a strawberry grower who wanted to plant a hedgerow next to a long ditch. He dropped the idea because another farmer sometimes grew leafy greens in the field and couldn't plant within 50 feet of the shrubs.
Hank Giclas, vice president of the Western Growers Assn., said farmers are caught in a bind between satisfying wholesalers' demands and conservation practices.
"We're very supportive" of the E. coli study, he added. "We want to fundamentally understand where the risks are -- and are not -- and have designs that minimize the risk with the least negative impact on the environment in which people farm."
But he said his group, which helped draw up the voluntary standards, would wait until the research was finished before taking any action on the guidelines. In the meantime, an effort is underway to expand the safety program nationally.
The E. coli testing is part of a broader investigation by government and university scientists that will sample livestock, water and soil. More wildlife will also be tested.
"You can't make the interpretation yet that there is not a problem with wildlife," said Robert Mandrell, the lead researcher and a microbiologist with the U.S. Department of Agriculture. "But so far the data don't indicate there is a major red flag here."

For the survey, fish and game workers collected fecal samples from freshly killed deer and live animals and birds that were trapped and released. One technique is to place birds in a brown paper bag to collect droppings. But for the most part, fish and game spokesman Harry Morse said, "gloves and little bitty jars" are used.

WOW! Peanut Corporation of America Texas Plant Fined $14.6 Million Due to Salmonella Contamination
Source of Article:
According to press reports, the Texas Department of State Health Services has levied a $14.6 million fine against the Texas plant owned by a peanut company at the heart of a national salmonella outbreak. The Texas Department of State Health Services said Thursday it was fining Plainview Peanut Co. LLC over alleged violations that include unsanitary conditions, product contamination, illnesses linked to peanuts from the plant and operating without a food manufacturers' license. The Plainview plant has been closed since Feb. 9. The plant's owner, Peanut Corp. of America, is blamed for an outbreak that has sickened nearly 700 people and is said to be the cause of at least nine deaths.
I look forward to seeing the insides of both the Texas and Georgia plants in the coming weeks.

CDC report shows ¡®plateau¡¯ in foodborne disease prevention
Source of Article:
By Ann Bagel Storck on 4/10/2009
The incidence of the most common foodborne illnesses has changed very little over the past three years, according to a 10-state report released Thursday by the Centers for Disease Control and Prevention.
The findings are from 2008 data reported by the Foodborne Diseases Active Surveillance Network (FoodNet), a collaborative project of CDC, USDA's Food Safety and Inspection Service (FSIS), the U.S. Food and Drug Administration and 10 state sites.
Campylobacter, Cryptosporidium, Listeria, Shiga toxin-producing Escherichia coli (STEC) O157, Salmonella, Shigella, Vibrio and Yersinia did not change significantly when compared to the previous three years (2005-2007), the latest data showed. Although there have been significant declines in the incidence of some foodborne infections since surveillance began in 1996, these declines all occurred before 2004.
"We have reached a plateau in the prevention of foodborne disease, and there must be new efforts to develop and evaluate food safety practices from the farm to the table," said Robert Tauxe, deputy director of CDC's Division of Foodborne, Bacterial and Mycotic Diseases
"We have worked hard to reduce contamination in FSIS-regulated products and have seen marked success in Salmonella and Listeria monocytogenes," said David Goldman, assistant administrator of FSIS. "We are concerned about the lack of progress in reducing the incidence of foodborne illness and believe this report points to the need for better information about sources of infection."

No salmonella found in New York pistachio plant
Source of Article:
1 hour ago
FRESNO, Calif. (AP) ? New York officials say they found no traces of salmonella in a Long Island pistachio processing plant whose sister company sparked a nationwide recall of the nut last week.
New York State Agriculture Commissioner Patrick Hooker said Friday that inspectors received negative results on nine environmental swabs of Commack, N.Y.-based Setton International Foods, Inc. and eight sample tests of company food products.
The probe was conducted in tandem with an investigation into Setton's sister firm in California, where federal food safety officials found traces of the bacteria inside the plant earlier this week.
Setton Pistachio of Terra Bella, Inc. has temporarily closed after recalling more than 2 million pounds of potentially tainted nuts.

OK officials don¡¯t know source of rare E. coli strain
Source of Article:
Tuesday, April 14, 2009
OKLAHOMA CITY, OK ? An April 9 Oklahoma Health Department report leaves open the possibility that the E. coli outbreak that killed one man and sickened hundreds of others last August in Locust Grove, OK, may have come from a water well, according to an April 9 Associated Press (AP) report.
The report said analysis suggests there was ongoing foodborne transmission of the bacteria at the Country Cottage restaurant in Locust Grove from August 15 to August 24; however, because no specimen of the bacteria was found in the restaurant, investigators could not determine how it was introduced or spread, AP reported.
State Epidemiologist Dr. Kristy Bradley acknowledged that she wished the source of the rare E. coli strain O111 had been found, adding ¡°it will have to remain a mystery.¡± Other strains of the bacteria were found in the Country Cottage¡¯s private well water.
Oklahoma Attorney General Drew Edmondson previously said that the tainted well water may have been to blame for the outbreak, and has alleged that chicken waste polluted water supplies in the region, as WaterTech Online¢ç reported.
According to the AP report, Edmondson has said the Health Department ¡°botched¡± the probe and he is pursuing a lawsuit against Arkansas poultry companies.

Many consumers ignore food-product recalls: study
Source of Article:
(, April 14, 2009) by Bryan Salvage
NEW BRUNSWICK, N.J. ? Many Americans do not check their homes for recalled food products, according to a Rutgers¡¯ Food Policy Institute study released on April 14. Approximately 60% of the studied sample reported ever having looked for recalled food in their homes, and only 10% said they had ever found a recalled food product.
The study was based on a survey of 1,101 Americans interviewed by telephone from Aug. 4 to Sept. 24, 2008.
Although most respondents said they pay a lot of attention to food recalls and when they learn about them tell many other people, 40% of these consumers think the foods they purchase are less likely to be recalled than those purchased by others ? appearing to believe that food recalls just don¡¯t apply to them.
Approximately half of Americans say that food recalls have had no impact on their lives, despite widespread awareness of recent foodborne-illness outbreaks and a sense that the number of food recalls is increasing, said William K. Hallman, psychologist and professor of human ecology at Rutgers, The State University of New Jersey, School of Environmental and Biological Sciences, and lead author of the study report.
"Getting consumers to pay attention to news about recalls isn¡¯t the hard part. It¡¯s getting them to take the step of actually looking for recalled food products in their homes," said Mr. Hallman, who is also the director of F.P.I.
Rutgers¡¯ researchers offered suggestions on how to improve food recall communications. Approximately 75% of those surveyed said they would like to receive personalized information about recalls on their receipt at the grocery store, and more than 60% said they also would also like to receive such information through a letter or an e-mail.
Personalizing communications about food recalls may be the way to overcome the sense that the messages are meant for someone else, Mr. Hallman said. Providing consumers with recall information about specific products they have purchased makes it harder for them to ignore the advice to look for the recalled items.
However, even when people find recalled food, not all do what they are told. Approximately 12% reported eating a food they thought had been recalled. On the other hand, more than 25% reported that they had discarded food products after hearing about a recall, potentially wasting safe, nutritious food. Many consumers also avoid purchasing products not included in the recall but which are similar or are from the same manufacturer.
"Our research also points out that instructions to consumers must be clear and comprehensible if you want them to act appropriately after a food recall," Mr. Hallman said.
Authors of the study also include Cara L. Cuite, a researcher at F.P.I., and Neal H. Hooker, a researcher at the Ohio State University. The U.S. Department of Agriculture and the Grocery Manufacturers Association funded the study.

'Maple Leaf was responsible for the loss of 21 lives'
Source of Article:
CEO Michael McCain says company not rigorous enough analyzing listeria test results
Apr 14, 2009 04:30 AM
If Michael McCain had known last year what he knows today about the deadly listeria bacteria, 21 lives could have been saved, the president and CEO of Maple Leaf Foods said yesterday.
"It's blindingly clear that Maple Leaf was responsible for the loss of 21 lives," McCain told a meeting of the Star's editorial board. "I felt that personally."
While Maple Leaf conducted its own internal listeria tests prior to the outbreak, McCain said the company wasn't rigorous enough about analyzing the results.
"We didn't have a sense of what was high," he said. "We weren't asking the government for more rigorous standards. We should have been."
The Maple Leaf outbreak, traced to cold cuts produced in the company's Bartor Rd. plant last August, triggered a national scare and a public-relations nightmare for one of Canada's oldest and most identifiable food companies.
With two separate federal investigations into the outbreak underway, McCain is calling for tougher food regulations in Canada and coming clean about an industry-wide lack of scrutiny around the deadly pathogen.
The listeria outbreak was caused, in part, by a "failure of expectations" in Canadian food safety regulations that historically had no requirement for listeria testing, he said.
Data collected at Maple Leaf's Bartor Rd. plant in 2008 prior to the outbreak indicated 4.1 per cent of samples were positive, a figure not previously released to the public. Those findings were within company protocols in place at the time, he said.
"However, we were not as good as we thought we were then, and we now know that this positive sample rate would be higher than compared to our current practices and the rigour we now have in place ... We wish we knew then what we know today."
By the time McCain was warned about the test results, people were already dying. "I wish we had known earlier. But we didn't."
Since the outbreak, the company has doubled its testing and increased analysis of the results, he said. It also now quarantines any food that produces positive tests until further testing can be done.
The company's new quarantining protocol ? in which suspect meat is blocked from shipment until it is proven to be safe ? already had an embarrassing failure in February when 26,000 packages of quarantined hot dogs were accidentally sent to distributors and stores.
The federal government has also imposed new listeria testing rules on the industry since the Maple Leaf outbreak.
As of April 1, companies and Canadian Food Inspection inspectors must conduct occasional tests on meat before it is shipped to market and all positive tests must be reported. McCain calls the new measure a meaningful step forward.
But he is calling for further government reforms including greater transparency around food-borne illness trends and enforcement activities.
As it stands, detailed inspection results from Canadian meat plants cannot be obtained under the federal access to information act. Such records, along with an array of other food-borne illness information, are widely available in the U.S.
While the outbreak has been damaging for Maple Leaf, including a $27 million lawsuit it settled with victims in December, sales have largely rebounded, McCain said.
Next Monday, McCain is scheduled to appear before the parliamentary agriculture committee that recently launched a public investigation into the outbreak and, more broadly, the country's food safety system.
A separate probe, ordered by the Prime Minister's Office, is being led by Sheila Weatherill, former president and CEO of Edmonton's Capital Health Region. Weatherill, who will not hold public hearings and has no authority to call witnesses, is expected to issue her report July 20.

MSU researcher develops vaccine for E. coli diarrheal diseases that kill up to 3 million children annually
Source of Article:
Published: April 14, 2009
EAST LANSING, Mich. ? A Michigan State University researcher has developed a working vaccine for a strain of E. coli that kills 2 million to 3 million children each year in the developing world.
Enterotoxigenic E. Coli, which is responsible for 60 percent to 70 percent of all E. coli diarrheal disease, also causes health problems for U.S. troops serving overseas and is responsible for what is commonly called traveler¡¯s diarrhea.
A. Mahdi Saeed, professor of epidemiology and infectious disease in MSU¡¯s colleges of Veterinary Medicine and Human Medicine, has applied for a patent for his discovery and has made contact with pharmaceutical companies for commercial production. Negotiations with several firms are ongoing.
¡°This strain of E. coli is an international health challenge that has a huge impact on humanity,¡± said Saeed, who has devoted four years to develop a working vaccine at MSU¡¯s National Food Safety and Toxicology Center. ¡°By creating a vaccine, we can save untold lives. The implications are massive.¡±
ETEC affects millions of adults and children across the globe, mainly in southern hemisphere countries throughout Africa and South America. It also poses a risk to U.S. troops serving in southern Asia and the Middle East.
Saeed¡¯s breakthrough was discovering a way to overcome the miniscule molecular size of one of the illness-inducing toxins produced by the E. coli bug. Since the toxin was so small, it did not prompt the body¡¯s defense system to develop immunity, allowing the same individual to repeatedly get sick, often with more severe health implications.
Saeed created a biological carrier to attach to the toxin that once introduced into the body induces a strong immune response. This was done by mapping the toxin¡¯s biology and structure during the design of the vaccine. Saeed¡¯s work was funded in part by a $510,000 grant from the National Institutes of Health.
After creating the carrier in a lab at MSU, Saeed and his team tested it on mice and found the biological activity of the toxin was enhanced by more than 40 percent, leading to its recognition by the body¡¯s immune system. After immunizing a group of 10 rabbits, the vaccine led to the production of the highest neutralizing antibody ever reported for this type of the toxin.
Saeed hopes that human clinical trials could begin late in the year.
There also are several other human health implications for the vaccine, besides providing immunity against most E. coli disease, according to Saeed. Many patients who undergo anesthesia during a medical procedure surgery suffer from post-operative paralytic ileus, or an inability to have a bowel movement. A small oral dosage of the vaccine could act as a laxative, which often aren¡¯t prescribed after a surgery for fear of side effects, Saeed said. A small dose also could help with urinary retention.

The vaccine will be available for animals as well, Saeed added. He pointed out the E. coli bug also is a major cause of sickness and death for newborn animals such as calves and piglets, which in the United States alone causes $300 million in loss of agricultural products each year.

Rutgers Study Finds Many Consumers Ignore Food Product Recalls
Source of Article: April 14, 2009
NEW BRUNSWICK, N.J. ? Rutgers¡¯ Food Policy Institute (FPI) released a study today showing that many Americans fail to check their homes for recalled food products. Only about 60 percent of the studied sample reported ever having looked for recalled food in their homes, and only 10 percent said they had ever found a recalled food product.
The study was based on a survey of 1,101 Americans interviewed by telephone from Aug. 4 to Sept. 24, 2008. The study can be downloaded at

Most respondents said they pay a great deal of attention to food recalls and, when they learn about them, tell many other people. But 40 percent of these consumers think that the foods they purchase are less likely to be recalled than those purchased by others, appearing to believe that food recalls just don¡¯t apply to them.
Despite widespread awareness of recent foodborne illness outbreaks and a sense that the number of food recalls is increasing, about half of Americans say that food recalls have had no impact on their lives, said psychologist William K. Hallman, a professor of human ecology at Rutgers, The State University of New Jersey, School of Environmental and Biological Sciences. ¡°Getting consumers to pay attention to news about recalls isn¡¯t the hard part," he said. ¡°It¡¯s getting them to take the step of actually looking for recalled food products in their homes.¡± Hallman is also the director of FPI and lead author of the study report.

The Rutgers researchers also offered suggestions about how to improve communications about food recalls. Nearly 75 percent of those surveyed said they would like to receive personalized information about recalls on their receipt at the grocery store, and more than 60 percent said they also would also like to receive such information through a letter or an e-mail.

Hallman said that personalizing communications about food recalls may be the way to overcome the sense that the messages are meant for someone else. Providing consumers with recall information about specific products they have purchased makes it harder for them to ignore the advice to look for the recalled items.

But even when people find recalled food, not all do what they are told. Approximately 12 percent reported eating a food they thought had been recalled. At the other extreme, some consumers take a ¡°better safe than sorry¡± attitude. More than 25 percent reported that they had simply discarded food products after hearing about a recall, potentially wasting safe, nutritious food. Many consumers also avoid purchasing products not included in the recall but which are similar, or are from the same manufacturer.

¡°Our research also points out that instructions to consumers must be clear and comprehensible if you want them to act appropriately after a food recall,¡± Hallman said. He cites the Food and Drug Administration¡¯s recent advice to consumers not to eat pistachios, but to hold onto them and not throw them away as confusing to consumers.

¡°We found that clear, direct messages such as ¡®throw the food in the garbage¡¯ or ¡®return the food to the store for a refund,¡¯ should motivate action. Keeping people in a holding pattern is more likely to result in inaction, and it certainly increases the likelihood that someone might eat the food by accident.¡±

The authors of the study are William K. Hallman and Cara L. Cuite, researchers at FPI, and Neal H. Hooker, a researcher at the Ohio State University. The study was funded by the United States Department of Agriculture and the Grocery Manufacturers Association.

An earlier report based on data from the same survey provided insight into consumer awareness of the Salmonella Saintpaul advisory in the summer of 2008. The report is also available at

FPI is a research unit of Rutgers¡¯ New Jersey Agricultural Experiment Station. The institute addresses important emerging food policy issues and supports public and private decision makers who shape aspects of the food system within which government, agriculture, industry and the consumer interact.

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