Latest salmonella contamination outbreak underscores urgent need for restructuring of the nations food safety regulations, enforcement, and oversight authority.
Published: January 30, 2009. In what may be the largest food scare in US history, The Food and Drug Administration, in conjunction with the Center For Disease Control, Georgia Department of Agriculture, and other State Health Agencies across the country, are investigating the most recent Salmonella outbreak that has sickened 501 people in 43 states (one person in Canada), and has resulted in 8 deaths; 22% of those stricken required hospitalization.
According to the CDC, the type of salmonella strain associated with this outbreak, Salmonella Typhimurium, causes diarrhea, fever, and abdominal cramps between 12–72 hours after infection, and on average lasts between 4-7 days. Those who are at greater risk of hospitalization include infants, the elderly, and people whose immune systems are already in a weakened state.
The first reported illnesses began on September 1, 2008, and are still continuing, as the product recall expands to a growing list of over 400 food products suspected of containing the King Nut brand peanut butter (not sold directly to consumers), and peanut paste ingredients from the Peanut Corporation of America’s Blakely, Georgia, manufacturing plant. At the moment, this plant is considered the sole source for the contaminated ingredients, though it’s proving exceedingly difficult for the FDA, and its State counterparts, to trace the full path of these ingredients after they left the Blakely plant.
In a (January 21) teleconference between FDA investigators, Center for Disease Control scientists, and reporters, the following exchange took place between Dr. Sundlof from the CDC, and reporter Lisa Stark from ABC News:
Lisa Stark: And why is so difficult to identify these products? I mean doesn’t the company know who it ships to and isn’t it – wouldn’t it be fairly easy to figure that out?
Stephen Sundlof: Well we are – we’ve asked for the company records, they have given us the records. We – the way that it works though is that companies are required to keep records of who they purchase their source ingredients from and who they sold them to. And so we go down the line so we know who the primary purchasers were. We’ve been to them, we’ve – you know we’ve visited many of the first line purchasers and we’re going downstream from there.
But it gets to be a fairly complex web and again we’re targeting our efforts towards the primary purchasers and following those out.
In fact, in another published report, Andrew Schneider, senior correspondent investigations for the Seattle Post Intelligencer in his Secret Ingredients article, describes how his friend who works in this investigation for the FDA, claims that trying to plot the trajectory of the spread of Salmonella was indeed more difficult than tracking the spread of Ebola virus, or Avian Flu:
But, according to my friend, the white boards on which they were plotting the product’s travels became a mass of squiggly lines as they tried to pinpoint the hundreds of manufacturing and food processing plants to which the
possibly tainted material was further distributed for use in other retail products.
During the same teleconference referenced above, LA Times reporter, Mary McVane, picks up on Lisa Stark’s earlier question:
Mary McVane: Hi. I wanted to sort of follow up on something that was previously discussed. One company with one or two products seems to have such a pervasive reach and I’m wondering if that in some way points out the vulnerability of our food supply.
Stephen Sundlof: This is Steve Sundlof. Well it certainly points to complexity of our food supply and you know there – you know we have seen this before with the – in fact last year with the pet foods, melamine contamination in which two very small companies ended up having a tremendously large impact on that – on pet food. It is – I only can say that it is what it is and that a relatively small company may have great scope of distribution if that ingredient is used in a lot of different products.
Robert Tauxe: This is Dr. Tauxe. Exactly as Dr. Sundlof said, this is the complexity we are seeing in what we are calling an ingredient driven outbreak. In this outbreak the output of this small company is basically in two forms.
One is as a peanut butter that has a brand and goes to institutions, the King Nut brand, that was the initial signal. But it also puts out an ingredient, a peanut butter ingredient that is used in a huge variety of different foods, and tracking them down both epidemiologically in our investigation, tracking them down by reviewing the sales and invoices as FDA is doing and finding samples that can be cultured is a very large and ongoing undertaking involving many people.
Mary McVane: Okay. Is that – does that then suggest that our – we are not really prepared as a – you know that the government is not really prepared to do everything to prevent this, that it’s up to consumers to play a role?
Stephen Sundlof: Well I wouldn’t say consumers as much as the food industry is really the responsible party for ensuring that the products that they produce are safe.
It is their responsibility to do that, so whatever moves are necessary but they are required to follow certain things like good manufacturing practices. And so when this happens you know it represents a failure of the industry to – and I don’t mean to paint the whole industry, but an individual within the industry of living up to what is expected of them both legally and from a moral standpoint. And that is to make sure that the products that they produce are not harmful to the public. You know we don’t want to – you know consumers do have some responsibility in making sure that once they receive a product that they handle it in a manner that doesn’t render it unsafe.
And that’s you know cross contamination and washing hands and all of that other stuff. But it is not the responsibility of the consumer to make sure that the product that they receive is a safe product. That is the responsibility of the food industry and with the oversight of the Food and Drug Administration.
Here’s a different exchange between Scott Bronstein (CNN news) and Dr. Sundlof (CDC) during another teleconference with FDA, CDC, and the media on January 28, 2009:
Scott Bronstein: Yes thank you. Some food safety experts blame FDA and CDC for not properly regulating this plant and other plants that have had problems.
I’d like to hear both from Dr. Sundlof and Dr. Tauxe, do you take any responsibility for allowing this outbreak to happen? Do you think that the regulatory procedures have not protected the public?
Stephen Sundlof: This is Steve Sundlof. And again I want to reiterate some of the remarks I’ve made in the previous media calls. And that is that it is the responsibility of the industry to produce safe product.
The FDA is not in plants on a continuous basis. We do rely on inspections to find problems when they exist. There, again, there is – when it’s just as if it we’re, you know, an individual citizen.
We expect individual citizens to obey the law. And occasionally people don’t obey the law. And when they don’t obey the law then the responsibility of the regulatory authorities to take the appropriate enforcement action.
And that is what we were doing, we are doing now. I will let Dr. Tauxe speak for CDC. But I would just say that, you know, we without the CDC out there continuously monitoring, using some very sophisticated surveillance techniques and DNA fingerprinting.
And with the states helping us in that regard, it’s – we are able to identify outbreaks much quicker then we could in the past. Dr. Tauxe would you like to respond?
The FDA typically contracts with State agencies to inspect manufacturing plants to insure compliance with their standards. According to the Center For Science in the Public Interest, a non-profit consumer advocacy organization, the response by the FDA to the recent Salmonella outbreak was described in part, as follows: “Without mandates for recall and few inspectors, the agency’s ability to protect the public is minimal. This latest outbreak proves again that FDA is woefully inadequate to the task of protecting American consumers from unsafe food.”
It’s not clear that the Georgia Department of Agriculture inspectors that inspected the PCA plant in 2007 and 2008, had the specialized knowledge to properly identify potential problems specific to peanut manufacturing when they inspected the PCA plant in Blakely. Gardiner Harris, New York Times reporter in his January 28 post, Peanut Product Recall Grows in Salmonella Scare noted in his article that the FDA recent report: “…”concluded that the plant should never have been allowed to make peanut butter at all because it did not adequately separate raw and finished products, among other problems.” The article went on to say that this lack of specialization was common among FDA inspectors.
Of course, the FDA did not conduct any of the inspections to the plant, since 2001, before it began manufacturing peanut butter, and peanut butter ingredients.
Since the initial January 9th inspection of the plant by the FDA, it was reported that on 12 different occasions the company deliberately shipped products that had previously tested positive for Salmonella contamination, after having the products successfully retested a second time. Federal law does not require a manufacturer to report to the FDA when a product (from their own internal testing) tests positive for bacteria contamination.
As a result, the time frame for the FDA recall of suspected products has now been extended to January 1, 2007 to the present. One would think that the FDA “good practices” requirements would dictate immediate destruction of contaminated products upon receiving a positive test; apparently, the guidelines do not specifically address this issue.
The FDA does not have authority from Congress (though they have requested it in the past) to be able to issue a mandatory recall of products, instead, they rely upon a voluntary recall system, and cooperation with manufacturers. Even more cogent, given the complexity of how an ingredients based outbreak can travel so extensively through the food chain, and the extended amount of time needed to identify and contain suspected contamination problem, there’s a clear lack of “trace back” documentation that would provide thorough enough records for identifying the paths and products that ultimately originated from each point source.
Also of concern, have we unintentionally created the food processing and distribution equivalent of a weapon of mass destruction aimed directly upon ourselves? In the same vein as financial institutions being too big to be allowed to fail, have we created a food ingredient based processing monster that offers the ultimate target, a single point of vulnerability that poses an amplified risk to public health? Would the trade-offs of a more decentralized approach to food manufacturing, processing, and distribution reduce such risks?
Washington has also taken notice. A two year ongoing congressional subcommittee on food safety, that began during the first salmonella outbreak associated with peanut butter in 2007 (at another peanut manufacturing plant owned by a different company, just 70 miles away), is now looking into this outbreak. Likely questions that it will have to address, include:
Should food manufacturers be required to do more of their own testing?
Should they be required to report any positive results to the appropriate State and Federal Agencies? Should any products that test positive, never be allowed to go into the food system for animal or human consumption?
Should more extensive “trace back” documentation be required of all food manufacturers, processors, and distributors to faciliate faster product recalls, and more effective response during contamination outbreaks?
Should more funding be provided to Agencies with direct responsible to insure the safety of our food system?
Should more inspectors be hired and trained? And, more emphasis placed on specialized training necessary to insure adequate “industry” or “manufacturing” knowledge to insure proper inspections.
Should all inspections be required by law to be unannounced?
What specific ideas do you have to help insure the safety of our food supply?