Guilty Verdict Puts Food Safety Responsibility Where It Belongs

Richard Williams — Thu, 24 Sep 2015 05:02:27 +0000

Guilty! The perpetrator of the 2008-09 Salmonella outbreak, Stewart Parnell of the Peanut Corporation of America, just received a 28-year sentence for knowingly distributing Salmonella-containing peanuts. The familiar refrain will be that this is evidence that our food safety system is broken. But those who believe that the response in 2010, the Food Safety Modernization Act (FSMA), is the answer have it completely wrong. In fact, the results of this court case provide a strong incentive for everyone involved in food safety, from farms to restaurants, to exercise due diligence. This case proves that innovation like traceback technology (being able to find where a particular food was produced that made people sick) makes it possible for our legal system to punish those who knowingly cause food safety outbreaks. But avoiding prosecution is an added incentive on top of those that already exist. When a food is found to be contaminated and traced back to the source, the costs rapidly begin to pile up. First, the food will have to be recalled, a costly exercise. Next, people who have been sickened can be expected to sue, and there are both the legal expenses as well as the costs of remedying the harm imposed by the courts. And, in the information age, all of the data go public very quickly and the value of the brand name plummets, as do sales and profits. If that’s not enough, now you also may go to prison, perhaps for a very long time. Two decades ago, it would have been exceedingly difficult to incur any of these costs by negligent producers. Everyone in the food industry knew how difficult it was to trace a problem back from sickened people to the source. There is always a delay in when you consume a tainted food to when you get sick, from several hours to several months, the latter of which is the case for listeriosis in pregnant women. In order to trace illness back to the source, you needed a lot of people to get sick from the same food and, even then, you couldn’t necessarily prove that a specific food they ate was what made people sick. The federal government and private firms now have better tools that make traceback and positive identification much more likely. The Centers for Disease Control’s Foodborne Disease Active Surveillance Network (FoodNet) was established in 1995 and conducts surveillance for certain pathogen infections that have laboratory-tested samples from patients. There are other systems as well, including PulseNet, that can match DNA in food pathogens consumed by ill patients to DNA in food plants or farms. All of this means that there is a much higher probability of being caught today. What’s more, once a problem has been traced back to the origin, it is possible to figure out the root cause of the problem. This is really important. Posting that root cause of the problem allows everyone in the food industry chain to be aware and will cause the industry to reexamine the millions and millions of food safety contracts to see if they need updating. When that happens, private inspections will incorporate those changes. There are at least 10 times more private than public inspections, which will bring about changes more rapidly than if the responsibility is left to public entities. What won’t bring about change rapidly is telling everyone to use a 50-year-old technology, known as Hazard Analysis Critical Control Points (HACCP), and then trying to inspect everyone into compliance. That is what FSMA does and, because it is universal, it doesn’t matter whether that technology is useful in a particular situation or not. We’ve tried the regulation-and-inspection route for years, and every year we get the same statistics: 48 million people become sick with foodborne disease. The trends over the past 15 years from CDC show mixed results by individual pathogens but not much in the way of progress. So “guilt” is exactly what is needed and points the way toward a much more effective system of reducing foodborne disease. Put the responsibility back on those in the food chain by giving them the incentives to do the right thing and avoid the disastrous consequences.

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FSMA: No Safety, No Modernization

Richard Williams — Mon, 31 Aug 2015 05:02:30 +0000

In the midst of food prices that are already on the rise, the U.S. Food and Drug Administration’s Food Safety Modernization Act (FSMA) will vastly increase costs, but it’s not likely to change food safety nor will it modernize our approach to food safety. In a new research paper, I examine four of the biggest of the new regulations (ultimately, there may be as many as 50) and find no evidence that they will have much effect on the safety of manufactured food, produce, imported food or animal food. And, despite the name of the law, the approach taken with all of these rules is not modern. Instead, it is trying to tell manufacturers how to produce food and inspect producers for compliance — an approach that dates back to the 1870s in the United States. In the modern information age, there is a much better way. There are two essential items that should be present for a regulation to have an impact: First, there must be a problem to solve, and second, there must be some measure of effectiveness at solving that problem. Ideally, there is not an excessive cost attached to the solution. By FDA’s own analysis, each of the four regulations examined in my recent study fail in one of the two categories. An example of the first issue — failure to identify a large, ongoing problem to be solved — is best illustrated by a proposed rule on “intentional adulteration.” Put simply, this is a rule to prevent terrorists from poisoning food. FDA admits there has been no intentional adulteration and that it has no idea what food companies have been doing since 9/11 to protect their plants. In other words, they have absolutely no idea whether there is a problem to fix with this large and expensive solution. There is also scant evidence to suggest a large, systemic problem with packaged food; nevertheless, FDA does have a large and expensive rule. Using elements of a regulatory cost calculator, the solution to this nonexistent problem will cost $18 billion, according to industry estimates. While there have been a few highly publicized outbreaks traced back to packaged food, FDA notes that most food safety problems occur in restaurants, other retail establishments or homes.¹ These problems are not covered by the current rule. Then there is the second problem, when there is no effective solution presented. This is surely the case with FDA’s rule for fresh produce. Fresh produce from farms certainly can cause foodborne disease, but FDA has focused on forcing Hazard Analysis Critical Control Points (HACCP), created for manufactured food, to fit produce. Unfortunately, this method has been tried by FDA before for products that do not have a control step between harvest and mouth, e.g., raw shellfish, without success. If there is no control point, HACCP is useless. In some cases, Congress allowed discretion to reduce the scope of these rules, but FDA has chosen not to exercise discretion, proposing the biggest possible rules. For animal foods, FDA has evidence that contact with pet foods cause illness in humans, but no evidence that the same is true for farm animal food. Nevertheless, they proposed regulating both pet and farm animal feed with the same controls. For fresh produce, they have evidence associated with outbreaks for some fruits and vegetables, but note that others have no such associated outbreaks. Incredibly, they have adopted a philosophy that, because something could happen with the produce that has never been associated with an outbreak, they should be covered. It doesn’t take much of an imagination to expand that philosophy to justifying the regulation of everything on the planet. The biggest problem, however, comes with the entire approach, command-and-control regulation and inspection. It’s old, it’s outdated, and it’s not likely to work. FDA will never have the knowledge to tell every type of domestic and foreign producer, warehouse, transporter and retailer what the best way is to keep their products safe. Nor will they ever have enough inspectors to cover them all in a timely fashion, even though they will continue to press American taxpayers for more resources. What they do have is a new information age where — if/when producers make mistakes — those mistakes can often be traced back to the producers, and that information is immediately spread to millions of consumers. That creates an incentive for producers to mitigate lawsuits, recalls and diminished sales. FDA can help to determine what caused the problem, allowing everyone who might experience a similar problem to change their own practices or contracts with suppliers. In other words, we now have better trace-back, problem identification and communication abilities to create incentives. With those incentives will come both more due diligence and creation of more technologies, such as pasteurization, which historically have made the biggest difference in food safety. Those incentives are much more powerful than the old regulatory approaches and, if embraced, we may finally start to make a dent in the millions of food safety cases that plague Americans annually.

¹FSMA Supplemental Notice of Proposed Rulemaking for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food, Docket No. FD-2011-N-0920, Preliminary Regulatory Impact Analysis, p. 6 (To sign up for a free subscription to Food Safety News, click here.)

Richard Williams | Food Safety News

Guilty Verdict Puts Food Safety Responsibility Where It Belongs

FSMA: No Safety, No Modernization