What Is a “Reasonable Belief?”

As the new Food Safety Act (FSMA) is being implemented, the food manufacturing industry is confronting an expanded array of compliance regulations, most notably in record-keeping requirements.

As food manufacturers would undoubtedly agree, federal record-keeping regulations are plentiful and costly. But under the Food & Drug Administration’s intent to prevent as much as possible food illness outbreaks, companies are required to put in place written food safety plans that include food products that are “reasonably likely” to be adulterated. That’s not all. The FDA can also request records of products for which there is a “reasonable probability” that the items could cause serious adverse health consequences or death to humans or animals.

Once either of these circumstances is met (in the opinion of the agency), the FDA may request “all existing records” needed to help the agency in determining whether (quoting from the FDA’s website): “the circumstances, which gave rise to the records request, exist.”

If your head hurts after reading that, you are probably not alone. And, regrettably, the FDA hasn’t been able so far to clarify just what this means. It does offer up this explanation: “reasonable belief” is a determination that will be made on a case-by-case basis. That leaves manufacturers with the disagreeable duty of maintaining lots of new records on production just in case the FDA comes calling.

In FDA’s defense, expanded record keeping is in large part a response to what has long been a significant challenge: tracing a recalled product – one that threatens public health – back along its production and distribution path. Congress directed that traceability be baked into the new food safety act, and one manifestation of that inclusion is the requirement for manufacturers and suppliers to maintain more comprehensive records.

Not unexpectedly, the record keeping requirements have generated criticism as being either too vague, on the one hand, and too detailed, on the other. The records can be kept electronically or in print, but they must be instantly available within 24 hours notice, for example. Also, the records need to be updated every two years. One law firm that represents manufacturers posed this dystopian possibility: “FSMA expands the conditions under which the FDA has access to company records containing sensitive product-related information, (and it also has the ability) to publicize agency findings, suggesting that particular products and companies may be linked to foodborne disease outbreaks or other public health risks.”

Others are more sanguine. Former FDA and USDA Medical Officer David Acheson summarized the record-keeping requirements as a precautionary duty for the industry: “My main message on recordkeeping is that it is really important to do it right. I say this because the FDA view is that if you can’t produce the records you didn’t do it. I think this could be an Achilles heel for many facilities in that they do the right thing but don’t keep the records, and that will not be acceptable to the regulators. As noted above, keep in mind that your records will demonstrate to FDA that you know what you are doing, that you are taking a risk-based approach, and that you are compliant with the new rules.”

As Acheson suggests, the FDA expects that companies will take seriously their obligation to minimize risks inherent in food manufacturing and do all in their power to prevent contaminated product from reaching the market.

That’s a reasonable belief, certainly, and a welcomed one for consumers.

Share