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FDA ‘High-Risk’ Designation Would be a Recipe for Disaster

Opinion

(This May 23, 2014, opinion column by Tom Karst, national editor of The Packer, is republished here with permission.)

Is there any way to overcome the distinction of being tabbed by the Food and Drug Administration (FDA) as a “high-risk” food?

Perhaps one fanciful marketing tack to consumers would go something like this:

“Sure, our much-loved commodity X is called ‘high risk’ by FDA. But, it should be pointed out, it is also ‘high reward’ as well. Big-time phytonutrients and vitamins are on board, along with the risk of Salmonella and E. coli bacteria.”

I kid, of course.

Having your star-performing fruit or veggie tabbed a “high risk” food is absolutely the worst designation possible for a commodity group or shipper.

In that context, I was visiting with one industry leader this week, and he mentioned that the comment period closed May 22 on FDA’s request for industry input on the agency’s methodology for its designation of high-risk foods.

In its request for comments, FDA pointed out that the Food Safety Modernization Act (FSMA) requires the designation of high-risk foods.

“Specifically, … FSMA requires FDA to designate high-risk foods for which additional record-keeping requirements are appropriate and necessary to protect the public health,” according to the request for comments.

The law also requires FDA to publish the list of such foods on the agency’s website at the time when FDA issues final rules to establish the additional record-keeping requirements for high-risk foods.

So it is a double whammy. Yes, you are a high-risk food! And, yes, you have extra record-keeping requirements!

Former FDA official David Acheson, president and chief executive officer of Frankfort, IL-based The Acheson Group LLC, said in February that the biggest challenge FDA may face is the question of whether a high-risk food can ever be classified as a low-risk food.

“Can you get fresh produce, or certain aspects of fresh produce, from a high-risk (list) to a lower risk?” he asked. “That’s part of the challenge.”

No one in the food industry, including fresh produce, wants their commodity to be on the list of high-risk foods.

FDA plans to publish the list either before or at the same time it issues a proposed rule establishing record-keeping requirements for designated high-risk foods.

FDA’s draft approach to identifying high-risk foods uses several criteria to determine a total risk score, according to the notice. However, no commodities were identified as high-risk in FDA’s initial document.

Some of the factors that FDA will weigh as it determines which foods are high-risk include outbreak frequency, illness occurrence, severity of illness, the likelihood of microbial or chemical contamination, potential for the food to support pathogen growth, food consumption patterns and the probability of contamination and steps taken during manufacturing to reduce contamination.

FDA also will look at health and economic factors, cost of illness and disabilities expected, according to the notice.

One of Acheson’s colleagues, Jennifer McEntire, vice president and chief science officer, told me this week that FDA is under no hard deadline to produce this rule, unlike the 2015 deadline for the produce safety rule and other major FSMA regulations.

Even so, she said that FDA’s designation of “high-risk” foods is drawing a lot of food industry attention.

McEntire thinks that, with the way FDA has proposed its matrix of scoring risk, nearly all commodities could be labeled “high risk.”

“How will they draw the line between high-risk and what is not?” she asked.

The question of risk methodology on which FDA is currently seeking advice is just a prelude to the main show.

Once FDA actually identifies the specific food items that are high-risk, watch out. Fortunes will be spent, I would think, in either keeping commodities off the “high-risk” list or trying to extract them if they are shamed and named.

FDA can only solve this by making every food high-risk — or dumping the idea entirely. Since the latter isn’t likely, prepare for the former. High-risk, yes, but consider the rewards!

© Food Safety News
  • Michael Bulger

    Imagine if those fortunes were spent on actually making the food safer!

  • J T

    There could be a legal benefit to the affected companies. “Our food is labeled high risk, but you ate it anyway. So, you can’t sue us.”

    • Linda Adsit

      That was an ingenious observation. I hadn’t thought of it. Food Safety Immunity, from your FDA.

  • Linda Adsit

    I’ve read a number of FDA abstracts, and rules, on their website. Generally speaking, I have found them to be jabberwocky. They are way too slanted to be valuable. They tend to be silly, repetitive and maddeningly confusing. They flip-flop way too often, and for dubious reasons. Personally, I wouldn’t trust them to evaluate a flea and tick spray.

  • Linn Steward

    As a knowledge produce buyer and a dietitian, it is possible Mr. Karst that you are underestimating the consumer? On the assumption that you sell what you have, how about this as a marketing tool. Tell the folks that yes the product is high risk. Then detail how the company or supplier is managing those risks. Granted many consumers are unaware that eating can be dangerous for your health, but I for one would appreciate a more realistic acknowledgement that yes most food are high risk. And I really like your idea of linking high risk / high reward.