FDA’s Conflicting Public Health and Enforcement Roles

Columns - Produce Production

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December 2, 2019

FDA Acting Commissioner Ned Sharpless and the FDA team.

FDA faces some of the perception challenges that I imagine police officers face. Are the police your friend or your foe? Are they there to help, or to get you in trouble?

FDA sits within the Department of Health and Human Services and is viewed as a public health agency. However, the agency is also responsible for inspection and enforcement. It is this dual, and perhaps conflicting, role that continues to challenge collaboration and cooperation between the food industry and FDA.

Sharing data. FDA (and other agencies, as well as some academics) wonder why industry is reluctant to share data. With a zero-tolerance policy for pathogens in ready-to-eat foods (and an ever-expanding list of what the public consumes without adequate cooking), any positive finding in a product renders the product adulterated. That is fairly straightforward, but it still serves as a disincentive to surveillance sampling for sporadic positives, especially in fresh produce items that grow outside.

The trickier circumstance is in the sharing of data from a facility, growing environment, or other location where the impact on product safety is unclear. As a scientist I love the power of whole genome sequencing. However, until we have a better sense of how organisms evolve, it will be hard to interpret the relevance of genetic drift and draw conclusions about relatedness.

Despite having tens of thousands of sequences in a public database, we know we’ve barely scratched the surface of understanding how these sequences are dispersed in the natural environment, but it’s tempting to connect dots that might not actually be connected.

If a farm tests for pathogens in soil and water and sequences those isolates, which are later matched to clinical isolates, it may be assumed that produce from that farm was responsible for that illness. However, it could be that the sequence is prevalent in a large production region consisting of dozens of farms. Without a more robust dataset, it’s hard to discern.

Currently, though, if a single company is the only one sharing data, any match will be to only them. This dissuades those who would otherwise be early adopters. Companies should not be penalized for taking proactive measures to better understand their environments. Rather, when it comes to sharing data, FDA’s mission as a public health agency should trump its role as an enforcer — at least until the line is crossed where public health is at risk.

Sharing outbreak information. In a recent outbreak in which I was involved, a firm agreed to conduct a recall based on the information shared during an initial phone call with FDA (essentially that the traceback investigation identified it as the common supplier of a product linked to the outbreak). FDA immediately wanted details on the root cause of the issue — but it had not provided the firm with so much as the traceback diagram.

Even once an initial diagram was provided, critical information, such as the supply chain pathways in which the firm was the sole source of product, as opposed to it being one of several suppliers, could not be readily discerned. This was only provided later in the investigation.

In other instances, when the traceback has not yet identified a source, the industry has offered to discuss “typical” supply chain pathways. Generalities can be made to rule in, rule out, and focus resources on certain supply chain possibilities if the locations where illness occurred are shared. However, “confidential information” is never shared, even though it could be the linchpin in cracking outbreak investigations.

Again, once an outbreak has occurred, the collaboration between the industry and the government that is needed to protect public health and determine the root cause of contamination should take priority over the collecting of “evidence” to use against the company.

Interacting with resisting firms. But when a company is not willing to collaborate and takes actions that hinder an investigation, such as slowly turning over records, providing inadequate information, or taking actions that are not aligned with public health, FDA should swiftly switch to enforcer mode.

Historically, FDA’s most effective tool has been the issuance of “warning letters” that provide a public shaming to firms. More recently, the FDA commissioner’s office has sent “letters to industry” and other briefs that similarly admonish an industry. Unlike agencies such as OSHA, FDA does not levy fines and rarely encourages the pursuit of criminal lawsuits.

FDA should take aggressive action to clearly signal to the industry that rules must be followed, and that public health is the priority. FDA should not tolerate companies that seek to bend the rules, putting the public at risk. Collaboration and cooperation is a two-way street, and both parties — industry and government — must act in good faith when it comes to the safety of our food supply.