Some Worry FDA’s High-Risk Foods List May Have Unintended Consequences

The Produce Marketing Association (PMA) noted in its comments that it would be “patently unfair that [food companies] that have implemented robust preventive controls be burdened with additional tracing requirements due to the industry segment as a whole being designated a ‘high-risk’ food category.”

For example, FDA should evaluate facilities that manufacture, process, pack, or hold raw agricultural commodities in a manner different from low-acid canned food facilities, wrote James R. Gorny, PhD, vice president, PMA. “A one-size-fits-all approach to evaluating food risk will likely prove difficult, overestimating risk for some foods while underestimating risk for other food categories,” he said.

In its comments, United Fresh argued that “high risk” and the need for traceability are not connected.

“The need to trace implicated foods back to the source of contamination and forward to all other potentially contaminated foods can occur in any commodity, regardless of prior linkage to foodborne
outbreaks,” wrote David Gombas, PhD, senior vice president, United Fresh.

“Further, requiring enhanced recordkeeping will not make ‘high-risk’ foods safe, only potentially better assure their traceability in the event of a recall or outbreak, as would be necessary for any food regardless of calculated risk,” Dr. Gombas added. Accordingly, “it is unnecessary for FDA to designate a food as ‘high risk’ in order to require adequate and accurate recordkeeping to enable traceability.”

According to the consent decree, FDA can extend the court-imposed deadlines only if the plaintiffs (the Center for Food Safety and the Center for Environmental Health) agree. If agreement cannot be reached, FDA can petition the court for extension of time but it needs to demonstrate “good cause and/or exceptional circumstances,” with the burden resting on FDA.

“FDA has a large and complex job in front of it, which is most likely why it has taken so long” to compile a list of high-risk foods, Dr. Acheson says. “I also suspect that FDA has not seen this as a great public health tool and so has not given it priority. But I hope that FDA is able to leverage this for the minor gains it will give us and not create a two tier structure for food that will create potential complacency in the low-risk category.”