There are certain odd things about what the FDA is saying happened that really don’t make sense.
How is it possible for so many brands to be implicated? Even if they come from the same packing plant, it doesn’t make sense. These items are batch processed. If Natural Selection Foods is packing for Dole, it packs for Dole for many hours. It doesn’t pack in bits and pieces for each brand.
Since so many brands are implicated, it would have had to have been packed over many different packing days. But an E. coli problem is typically in a small batch. It doesn’t make sense.
Nobody has discussed the possibility of the packaging material being implicated. But this may be a hole in the food safety and food security defense. Packers don’t sanitize the bags they receive. Could that be the source of a problem?
Why wasn’t the E. coli washed off in processing? The FDA has made vague statements that in laboratory conditions, they have found that a plant can absorb E. coli internally through the roots. But I can’t find any peer-reviewed research attesting to this even in a laboratory, certainly not in field activity.
Below I link to an article regarding a lawsuit, and I’ll link to it again here. This lawsuit is against Fresh Express and Chiquita and claims that a person got sick with the same E. coli strain as is implicated in this outbreak. If this lawsuit is based on fact, then why hasn’t Fresh Express been implicated? What is the criteria FDA uses to decide when to implicate a company and when not to?
FDA has not called for a mandatory recall. So everything is voluntary. Natural Selection Foods deserves kudos for stepping up to the plate early and voluntarily recalling its product from the market, even though there is no bacteriological evidence to tie it to the outbreak. Should other companies have done the same? If they had taken the voluntary recall step right away, would that have moved the FDA to not recommend against consumption thus, effectively, closing the market?
This is not the first time an outbreak has been identified — but why it is being treated very differently than is typical? Typically, a manufacturer gets a call from some agency, and the agency says there is an outbreak. The processor then asks what the agency would like them to do. The agency typically asks for the data related to trace-back and, since the expiration date is past, there is nothing to be done. Once in a while, you have a voluntary recall and that is the end of it.
Is it possible that the FDA has gotten itself in a position it can’t get out of easily? Having announced this crisis, it now needs to reassure Americans that everything is 100% safe, but it can never be sure of that. So it can never act. Bryan Silbermann, President of PMA, reported from Salinas that in a meeting he attended with industry, government and academic experts, the governmental agencies…
“…suggested that industry propose a plan for assuring public safety and, until that is ready, the current health advisory would remain in place. FDA encouraged industry to review the actions taken by other food sectors in responding to similar situations. These included meat, eggs, and other produce items impacted by previous outbreaks.
I read that as saying that the industry needs to announce a new food safety plan. I wonder if the real purpose here isn’t just to give the FDA cover.
Why didn’t the FDA order a mandatory recall if the risk is so great? A mandatory recall would have triggered a wide variety of insurance policies. But the fact that the FDA just closed down the spinach market by recommending people not eat spinach is unheard of. And left many companies unable to collect from their insurance companies.
Reports from Salinas are that the FDA inspectors are concentrating on the biggest, corporate-owned farms. Don’t they know this is a classic mistake? Who are the outside growers that the big processors bought from? Is their data complete? The firms give representations and warranties to keep all their data, but they sometimes don’t. Why isn’t the FDA looking there?
Is it really 100% certain that no outside influence was involved? Many people still doubt the government’s assertions that the anthrax attacks were not terrorism. The distribution patterns and the multiple brands are very unlike a normal food safety outbreak.
Long after all the contaminated spinach is off the shelves, the spinach crisis goes on. We have already discussed the impact of this crisis on fresh-cuts here, on organics here, given an initial take on ten points raised by this outbreak here and pointed out that the FDA is now acting beyond any reasonable concern about public health here. Today brings additional issues to the fore:
- RLB Food Distributors, in West Caldwell, New Jersey, became the third company to announce a voluntary recall as it recalled salad mixes that may contain spinach purchased from Natural Selection Foods. These salad mixes were sold under the Balducci’s and FreshPro brands. Though the recall is pointless at this point, the fact it comes so late into the crisis is bad news.
One of the things we’ve learned is that the industry’s trace-back mechanisms are imperfect and the industry’s trace-forward mechanisms are horrible.
As late as yesterday, the FDA said that 20% of those patients who have reported eating spinach have claimed they ate a brand not on the recalled list from Natural Selection Foods and River Ranch.
Some of this may be mistaken memory; some of it may be true, but not the source of contamination. In other words, someone might have eaten a bag of spinach with a specific label but gotten sick because the sandwich they bought in a restaurant had tainted spinach on it.
But a problem that has dogged this investigation from the start is that there is no easy way to identify all the brands that may contain product from one source.
Initially this caused confusion at FDA as they were getting reports of many different brands and didn’t realize that many of them were packed by Natural Selection Foods.
Now in the case of River Ranch and RLB, the product wasn’t packed by Natural Selection Foods; each company bought bulk product and repacked it.
Clearly, we need a trace-forward registry for every shipper in which, instantaneously, we can see both what labels they pack under and what labels any customer of theirs packs under.
Even this is a very incomplete registry because so many products get purchased through second-hand sources.
Natural Selection Foods has announced that it exported product to Mexico, Canada and Taiwan. But I’ll bet it is in many other countries. Many customers don’t buy straight trailerloads of spinach. They buy mixed loads from an exporter or wholesale grocer who puts in cases of spring mix, cases of bagged spinach, along with hundreds of other items. Natural Selection Foods has no way of knowing where this product is.
And who says that if a processor is short, they don’t run to a local wholesaler and buy some product? Once again, Natural Selection Foods would have no idea.
A good registry would help. We can’t let the industry be in a position again where the FDA is hearing all these brands and not making a connection. But the real long-term 100% solution is to get the whole industry working on RFID and GTIN solutions.
It is clear we need a solution where every item is tracked at every step along the way. So if Natural Selection Foods sells a box to a wholesaler on a terminal market in New York City, who then sells it to a wholesaler in Buffalo, who then sells it to a processor, we can enter the original source and find that carton’s current location.
- The FDA has about a dozen inspectors on the ground in Salinas. There are over 10,000 acres in spinach in Monterey County alone. They may find some violations of Good Agricultural Practices — once before they found a well without a cover, which was supposed to be covered to prevent animals from falling in or other contamination — but they could find those types of violations if they went anywhere in the country.
The odds of the inspectors finding evidence in the fields that they can identify as the cause of this particular outbreak are not very good. It is the nature of agriculture. You are going back to a place where the crop in question was long ago harvested. A well can be infected one day and not infected a week later. It just is not the kind of thing that can usually be established with any certainty weeks and months after the fact.
And if they did find that an animal violated a field and contaminated the water supply? One wonders what, precisely, they would do with this information.
It is obvious that the solution will not be in the fields. Sure, Good Agricultural Practices can be refined, and the FDA has applied its letter, originally sent to lettuce farmers, to spinach as well. This may all help.
We can and should take more dramatic steps such as banning the use of animal manure in agriculture. But it is the processing plant that is the only hope. Product can be tested there, new procedures developed to wash and clean product.
It is clear we are moving toward universal testing at every plant. Ground beef is much less serious as an E. coli problem because, if properly cooked, the E. coli dies. But as we all remember from the Jack in the Box food safety incident, ground beef is not always properly cooked. So, today, the Food Safety and Inspection Service (FSIS) of the USDA inspects a random sample of ground beef-producing facilities:
About the Testing Program
On October 17, 1994, FSIS began a microbiological testing program to detect Escherichia coli O157:H7 in raw ground beef. The objective of the testing program is to detect E. coli O157:H7, and to stimulate industry action to reduce the presence of the pathogen in raw ground beef. Since the initiation of the FSIS testing program, some grinders have instituted their own programs and routinely test their ground beef products or raw materials used in ground beef products for E. coli O157:H7. Others have begun requiring suppliers of raw boneless beef to test for and certify that the organism is not detectable in the product. Over time, FSIS has taken steps to improve the public health effectiveness of this testing program by detection of lower numbers of this pathogen through increased sample size and adoption of new more sensitive methods (see footnote following Table 2 ).
There are approximately 1,700 establishments producing ground beef under FSIS inspection, and approximately 100,000 retail outlets grind beef on a regular basis. Each month, inspected plants and retail outlets are selected randomly for sample collection. Also, imported ground beef products collected by FSIS Import Inspection personnel and ground beef products produced at state inspected establishments and collected by comparable state program personnel are analyzed. FSIS based its sampling plan on information from Centers for Disease Control and Prevention (CDC) sentinel sites that collect data on foodborne disease, historic data on outbreaks of foodborne illness, and information developed by the Office of Public Health Science (OPHS). On February 29, 2000, FSIS held a public meeting to discuss the Agency’s policy regarding E. coli O157:H7 and new information concerning the pathogen and its relation to human health. Based on new data concerning E. coli O157:H7, the FSIS E. coli O157:H7 Risk Assessment, and information from the February 29, 2000, public meeting, FSIS is continuing to evaluate its E. coli O157:H7 policy and testing program.
Here is the data so far for 2006.
Fresh-cut processors are not operators of produce packingsheds; they are operators of food processing facilities, and, as that realization dawns, they will be held to significantly tougher standards than they have been.
- If you listen to all the consumer-press reporters talk to the FDA, you realize how ignorant most are about agriculture in general and produce in particular. I’ve been speaking with my counterparts in the consumer media all week, and it is a full time job to talk them off the cliff. Since 73% of the people who have gotten sick are female, more than one reporter has wanted my opinion on this “new pathogen” that is especially dangerous to women.
Yet, of course, the most likely explanation is that more women eat spinach salads than men. It is a very hard job to educate consumer media because they are not interested in being educated until the crisis is upon us. Still, we need better resources to be ready to spring into action if needed.
- It is worth remembering that this entire outbreak is built on circumstantial evidence. As of yet, not one bag the FDA has been given has tested positive for E. coli 0157:H7, not one field or facility has tested positive. The entire case is built on reports by 50 people identifying that they had eaten bagged spinach.
- The basic problem with the FDA is that the standard they are utilizing to continue this recommendation not to eat spinach is sweeping with far too broad a brush. You can argue that the specific processing plant where this product was produced needs to be thoroughly investigated. You can even argue that the fields of growers who produced spinach that was used at that plant during this period need to be investigated. But there is no basis in the evidence we have that eating spinach grown elsewhere is any more dangerous than any other product vulnerable to E. coli contamination. And there is no reason to think when the FDA gives an “all clear” that we can’t get a contamination the next day.
- The core issue for the produce industry and society is this: David Acheson, MD, who is chief medical officer at FDA’s Center for Food Safety and Applied Nutrition, said at a press conference: “Clearly we are not where we need to be or this outbreak wouldn’t have happened.”
One wonders if he means it. There have been 19 foodborne illness outbreaks linked to lettuce or spinach in the past 11 years, eight traced to produce grown in Salinas. I am all in favor of toughening our standards. I think our food supply should be the safest in the world. I think we can make it safer. But in dealing with a live product, safety issues will arise.
I don’t know if the good doctor is wise to say that any outbreak is evidence of a failure. Would he really recommend banning growing outdoors and causing the population to incur the cost of all greenhouse-grown product to avoid, say, one outbreak every other year?
- Here is a suggestion for PMA since its convention is right around the corner. Have Janet Erickson, Chairman of PMA and Executive VP, Purchasing & Quality Assurance of Del Taco, call her peers at Jack in the Box and see if David Theno, Ph.D., will give a presentation at the convention.
He was brought in as a consultant right after Jack in the Box had its E. coli disaster. He stayed on and eventually became Sr. Vice President, Quality and Logistics. I’ve heard him speak and he gives an excellent presentation on what Jack in the Box did to recover from the horror.
Dr. Theno focuses on four myths, all relevant to the current controversy:
Myth #1: Meat quality doesn’t vary appreciably from one supplier to the next.
Myth #2: Testing for E. coli 0157:H7 is ineffective.
Myth #3: Testing for E. coli 0157:H7 is expensive.
Myth #4: Government will take care of the food-supply problem.
I know the PMA program has long been set, but some improvisation here would be valuable. You can read a short piece Dr. Theno wrote on these myths right here.
- Another similarity with the Jack in the Box situation is that the lawyer who handled the lawsuits against Jack in the Box and Odwalla has already filed a lawsuit as have several others. Interestingly, at least one of the lawsuits is against Fresh Express and its parent, Chiquita, neither of which the FDA has implicated in the current outbreak. One thing you can be certain of is that, in the end, the cost of litigation is going to be enormous.
- There are three basic marketing-related questions that people are asking:
- Will the market for spinach come back?
- Will the sales of other fresh-cuts be affected?
- Will over-all produce sales be affected?
The best guess:
- Yes, but it will take some time. Much, however, depends on how retail will deal with the return of spinach to the market. During the Alar crisis, sales of apples plummeted not solely because of consumer concern but because retailers stopped promotion of apples. If retailers get behind spinach, sales would bounce quickly, but retailers probably will be gun shy and will wait until memories fade before getting too close to spinach.
- Retailers are reporting a slight shift to bulk right now, but it won’t last. There are vast societal trends (working women, smaller households, etc.) that drive these trends, and they don’t get reversed because of a crisis. Indeed, even if fresh-cut were banned, it is not clear that bulk would be the primary beneficiary — it might be the deli department.
- It may not be nice but it is often true that one man’s problem is someone else’s opportunity. There is a certain amount of space in the produce department, a certain number of ad slots in the weekly newspaper ad. If they can’t go to one item, they have to go to another. In all probability, difficulties with one item lead to a rearrangement of space and promotional efforts so overall department sales are probably not going to be affected in the long term.
- One lesson of all this is that the food supply is very vulnerable to terrorist attack. Although none is suspected here, it is just a matter of time. National shippers provide an easy distribution network for poisons, and the complexity of our food distribution system means that we would be quite vulnerable if confronted with situations requiring the strict quarantine of different cities or regions.
When this crisis is over, we need to look hard at this problem.
The overwhelming response to our analysis of the spinach outbreak required a risky mid-day shift to greater server capacity.
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