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FSMA: No Safety, No Modernization

Opinion

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.

FDA inspectThere 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

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  • Gary

    Well, at least the way I understand it will be implemented on risk based factors. This is really the major improvement as the producers, facilities, and more high-risk products will receive more regulatory oversight.

  • Mike_Mychajlonka_PhD

    This analysis leaves out a great deal. For example, it leaves out the facts (as reported elsewhere in this forum) that the changes needed for FDA to implement FSMA have been continuously and seriously underfunded. You make no mention of FDA’s stated new direction of testing food for risk-assessment purposes at the same time that the link you provide to a ” . . . better way” would appear to shift FDA’s purpose from that of the regulatory agency it was established to be to a taxpayer-funded research facility whose results industry could adopt (or not) as they chose. I agree with your assertion that consumer buying habits are the ultimate mover of change. However, I must also agree with folks like David Robinson Simon (author of Meatonomics) that consumers are often systematically misled, sometimes by the same government agencies whose job it is to protect them.

  • Rob Bradley

    I take offense at this article and its tone. Saying “If there is no control point, HACCP is useless” is flat out wrong and purposefully inflammatory and frankly by saying such, leads me to believe you don’t understand HACCP. The foundation of HACCP is prerequisite programs. It is these programs that provide the biggest food safety benefit. In addition, FSMA doesn’t require HACCP, it requires risk based preventive controls, which are not the same as HACCP. It focuses on four components, Sanitation, allergen control, process controls and traceability. These four programs, when properly implemented, will and do improve food safety.

    “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.” Are you saying that because there haven’t been any outbreaks associated with say, eggplant, eggplant producers shouldn’t need a food safety plan? Should we wait for an outbreak before regulating? Besides, the FDA didn’t rubber stamp one size fits all with FSMA. Producers must perform a risk assessment, the risks with eggplant may be different than with mung bean sprouts and the controls they put in place will be different and individually tailored to that production.

    “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.” This statement is misleading. Have you read FSMA? Of course industry will have more and better knowledge of the hazards. FSMA acknowledges this and counts on it. It specifically states it is up to the producers to determine what their particular hazards are based on a risk assessment, and then to develop controls to prevent, eliminate, or reduce the hazard to an acceptable level. FDA is relying on industry to determine the best way to keep their products safe.

    “….to create incentives. With those incentives will come both more due diligence and creation of more technologies…” This is happening. FDA posts 483’s, and recalls, our customers and consumers read these. Social media has put these outbreaks right at everyone’s fingertips. It is not the FDA that is feared, if your product causes an outbreak, it is the backlash from social media that will kill your brand not the FDA. THAT is one heck of an incentive.

    FSMA is the right direction. The risk based preventive control guidance is based on science. It puts the work of determining the hazards and developing controls on the producers. This will spur innovation and it will make the food supply safer.

    • William_Sperber

      I’ve known Professor Williams for about ten years. He is on the same page as the other reasonable people in this discussion. His statement, “If there is no control point, HACCP is useless.” must have been a slip of the tongue. It should have been “If there is no Critical Control Point, you do not have a HACCP plan.” Nonetheless, we must still conduct the Hazard Analysis and determine which control points need to be identified and enforced as part of the multiple prerequisite programs. Much of the unnecessary confusion in the development of FDA and USDA “HACCP rules”the past twenty years stems from this fundamental lack of understanding exactly what a HACCP system is…

  • Tom Edlind

    Persuasive arguments, especially the idea that “What we do have is a new information age where…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…” But with the pathogen detection and typing technologies currently favored by FDA, USDA, and CDC, the “can often be traced back” step is more often a bottleneck, if not roadblock.

  • MrMcFritters

    There are several reasons the FSMA will fail. Lack of funding is one. The already quickly eroding relationship between the FDA and food manufacturers at the facility level is another. The increasing reliance on criminal enforcement is yet another.

    But the biggest is that it is based on an entirely outmoded way of thinking about how to improve the outcomes in a manufacturing process. The FSMA might look like an upgrade to the prior regulatory scheme to those in the food industry, but to those of us who are familiar with the history of the safety and quality movements in automotive manufacturing, and the quality movement in other industries, it rests on the same ISO process structure and thinking that is now held to be a failure.

    One business owner I know, an early adopter of this kind of system in furniture manufacturing, and a winner of the Shingo Prize, says that he thought ISO would be 80% real process and quality improvement and 20% waste in useless paperwork, auditing, and documentation. He now thinks it is the other way around.

    Another, an automotive parts manufacturer, routinely has to produce complex products with a 1 in a million maximum defect rate, and routinely performs at 1 in 10,000,000. He views his ISO activities as entirely beside the point in this effort. (Note that most food manufacturers couldn’t even begin to measure quality or safety deviations at that level of resolution.)

    In every industry that has succeeded in dramatic safety and quality improvements with reduced costs, it has been the ability to optimize activities at the key points across the supply chain that has made the difference. That is what is lacking in food, where everyone is concerned with passing the buck (legally and financially) to the next player in the chain, and where under the FSMA unnecessarily redundant analysis, testing, checking, auditing, auditing of the auditing, and regulatory enforcement of all of the foregoing is repeated at each step in the supply chain.

    The product I manufacture could be made effectively 100% safe if proper controls were applied one step up the supply chain. But the FDA does not have the courage to make that happen, and those at my place in the chain lack the economic power to do so. So we have to implement more costly and less effective controls at our level, and for those willing to sell their product as an ingredient, their customers have to repeat much of the work, but with less ability to be effective. The FSMA won’t fix this; it will just add a lot of cost to this with virtually no benefit.

    The FDA regulatory scheme did need an overhaul. Just not this one.