Publisher’s Platform: The President Has Nominated Dr. Heidi Overton to Run FDA. She Would Inherit the Largest Cyclospora Outbreak Ever Recorded, and Here Is the To-Do List I Would Put on Her Desk.

President Trump announced on Wednesday that he will nominate Dr. Heidi Overton, deputy director of the White House Domestic Policy Council, as the next Commissioner of Food and Drugs. If the Senate confirms her, she inherits an agency that as of Monday was counting 15,716 laboratory-confirmed Cyclospora infections, 828 hospitalizations and two deaths, with 11,841 more reports still being worked through, plus open investigations into jalapeños and shell eggs. I wish her well. Now here is the desk.

A word about what this is not. Her confirmation will be fought over the abortion pill and the childhood vaccine schedule. Senator Cassidy, who chairs the committee that has to move her, has already said he has strong concerns. That argument belongs to people who know those subjects better than I do, and I am not going to pretend otherwise. My interest is the other half of the agency, the half that regulates roughly eighty percent of what Americans eat. My prediction is that her hearing runs three hours without one question about lettuce.

She arrives without a food background. Food Safety Magazine said so the day the news broke, and it is not an insult. Almost nobody arrives with one. Marty Makary did not have one. Scott Gottlieb did not have one. What is different is the timing. She would take the job in the middle of the largest outbreak of this parasite this country has ever recorded, in an agency that has been losing senior people all year, with no permanent head named for the human foods program, and with the acting commissioner reported to have been offered the permanent job more than once and to have said no each time. That is the building.

On August 7 I published fifteen things FDA and CDC could do about this outbreak, sorted by how long each one takes. Five of them belong to the Commissioner of Food and Drugs and to nobody else. These are the five, and they do not require an act of Congress, an appropriation, or a single change of heart at the White House.

1. Say who runs food and say it in the first week. The human foods program has been led by an acting commissioner who was simultaneously running the whole agency. Food is not a portfolio that survives being somebody’s second job. Name a deputy commissioner for human foods, give the position a public calendar, and let the country see who answers when a parasite turns up in a salad.

2. Grant the Stop Foodborne Illness citizen petition on naming companies. It has been pending since February, and it comes from a nonprofit that parents of children killed by contaminated food built in 1993, the same year I started this work. When a food makes people sick, the public should learn which company grew it, which company processed it and which company sold it, not a letter of the alphabet. Produce very often carries no brand at all, which is why the disclosure has to reach the processor and the grower, not just the retailer with its name on the bag.

3. Say what is in the clusters the agency cannot explain. CDC now says on its own public page that it and FDA are looking at least six other clusters of this parasite whose sources have not been confirmed. Those files sit in a table with hundreds of sick people in them and no food named beside any of them. Somebody should be able to say out loud what has been ruled out, what is still being chased, and why none of it has produced an answer.

4. Put the traceability rule back on the calendar. FSMA section 204 was written to let investigators follow a head of lettuce back to a field in days instead of weeks, and its compliance date now sits in 2028. Every argument for the delay assumed there would not be a summer like this one. There was a summer like this one.

5. Name this parasite in the pre-harvest agricultural water rule and go look at the water. The only numeric microbial criterion growers must meet is generic E. coli, and the agency’s own action plan and testing methodsacknowledge that indicator testing will not find Cyclospora. We are requiring the wrong test and treating the result as a safeguard. In 2013, after the last big outbreak traced to the same region of Mexico, FDA said it would sample the water. Somebody should find out whether that ever happened.

The contamination happened in a field in central Mexico in the spring, and no memorandum signed in College Park in September reaches backward. What they would have done is make this summer shorter, smaller and legible. And not one of the five is partisan. The traceability rule was written under one administration and delayed under two.

There is a sixth thing, and it is not on the list because it is not a policy. It is a practice, and I have been asking for it since 1993. Spend an hour with somebody this happened to. Not a briefing, not a listening session, not a roundtable with the trade associations in the other chairs. An hour with one of the 828 people hospitalized this summer, or with the family of one of the two who died. I asked the Secretary for that hour in June about a different outbreak and different families, and as far as I can tell it has not happened. I am asking the next Commissioner before she is sworn in, when her calendar is the emptiest it will ever be.

I have watched commissioners arrive since 1993, each with an agenda, and I have outlasted every one of them. That is not a boast. It is the problem, and it is the reason I am writing this the day the name came out rather than the day something goes wrong. The last acting commissioner spent August telling Americans to feel confident about lettuce while the count went up. Confidence is not a thing you can hand out. It is a thing you earn back.

The five items cost a memorandum apiece. The hour costs an hour. Take the hour first, and the other five will write themselves.