Let’s Let the FDA Do Its Job

It’s gotta be tough to be head of FDA these days. You exert efforts to develop a reorganization plan — only to have Congress reintroduce a single food agency bill that would make all your work moot. You enact new regulations to make food safer — only to have the Supreme Court reverse a standing doctrine enabling them to now question the validity of every regulation you pass. You answer one consumer call for focus on chemicals in food — only to have another question the lack of focus on microorganisms. Each of these has made headlines, but what might be the real impact?

Let’s begin with the push for a single food agency. In July, Senator Dick Durbin (D-IL) introduced the Federal Food Administration Act. But with it being the ninth time he has sponsored or cosponsored a bill to establish a single food safety agency, it could be seen as “(yawn) Again?” There is a bit of a difference this time, however. Past bills strove to consolidate USDA into FDA (or FDA into USDA), while this bill focuses specifically, and only, on FDA, with the primary focus being the separation of the food side from the drug side.

The proposed plan would also consolidate the existing food programs into one — which is not all that different than the track that FDA is on in its own reorganization. Perhaps the best bet is to allow FDA to continue with its plans (which it seems to be doing anyway, if the recent call for qualified individuals to apply to “Join the Human Foods Program Team” is any indication), then determine if further reorganization is needed for further unification. Once that is solidified, the question of USDA integration could be addressed.

Meanwhile, questions around the Supreme Court’s decision to overturn the 1984 Chevron Decision need to be considered. Through the reversal, the Court took away the ability of the federal agency (which is given its authorities due to its considered expertise) to interpret ambiguous statutes without having to apply to the Court (with questionable subject matter expertise) for interpretation of every aspect of a law for which they are seeking to set or enforce regulation.

To provide an example of the impact it could have, consider FSMA. It has taken more than a decade for FDA to develop all the required regulations, for which it had to interpret the Congressional statutes to befit, and enable compliance by, the varied segments of the food industry. If the experts of FDA had to apply to the Supreme Court every time they needed an interpretation, would we even have any FSMA regulations today? While I doubt that anything already in place for FSMA is vulnerable, I would not be surprised if the new traceability regulations are challenged as part of the Supreme Court decision.

The decision was set out in a 114-page document (which included both assenting and dissenting opinions), but it still has to be wondered exactly why the Court chose to reverse this 40-year precedent, which now gives it ultimate power over every federal agency. There’s also the question of how far the Court will take this power. Will it allow the agencies to continue moving forward? Or will new (and old) regulations be revisited, redefined or even revoked?

That takes us to our final topic: chemicals versus microorganisms, which, I acknowledge, is one I’ve posed myself. A recent FoodNet report found that food transmission of Campylobacter, Cyclospora, STEC, Vibrio and Yersinia infections has increased since 2016, resulting in nearly 30,000 cases of pathogenic infections in 2023 in the FoodNet 10-state surveillance area. Also, the rates of Campylobacter, Listeria, Salmonella and STEC infections remain above the Healthy People 2030 targets with little sign of decline.

While chemicals in food are of concern, should we really be so focused on chasing the near-zero levels advocated by consumer groups that we lose sight of pathogenic contamination? Take for example the EPA’s interim health advisory of 0.004 ppt PFAS in drinking water. Not only did that jump from the previous advisory of 70 ppt, but it is equivalent to 1 second/32,000 years — a fraction so astronomically low as to essentially be a nonissue. Chemicals can be an issue under certain circumstances, but we don’t want to pay so much attention to those that we take our eyes off the ball on microbes. And the FoodNet results indicate that we are.

What impact will these have on the FDA, the industry or food safety itself? I’m not sure I can predict that, but we need to allow our food safety experts to focus on what they have been selected to do due to their expertise. Stakeholder input is critical, but final decisions and direction should be made by the experts, not a court, politician or activist.