I have spent more than 30 years representing people sickened by contaminated food. I do not often read a speech by an FDA official and find myself agreeing with nearly every line. This week I did.
Dr. Donna Garren, director of the Food and Drug Administration’s Office of Produce Safety, spoke on Sept. 15 at the annual meeting of the National Association of State Departments of Agriculture in Portland, Maine. I could find only two outlets that covered it, Agri-Pulse and Lancaster Farming, and both are worth reading in full. Her message, in short: the 2026 Cyclospora outbreak exposed weaknesses in how we oversee fresh produce, and FDA needs a system that finds hazards before people get sick rather than after.
She has been on the job less than three months. She joined FDA effective June 29, after nearly 15 years at the American Frozen Food Institute and earlier leadership roles at Boskovich Farms, the United Fresh Fruit and Vegetable Association, the National Restaurant Association, the Consumer Goods Forum and NSF International. Her office writes FDA’s regulations, policy and guidance for fresh fruits and vegetables, including the minimum standards under the FSMA Produce Safety Rule. That background matters. When someone who has spent a career working alongside industry says the system has to change, growers and processors will hear it in a way they may not hear it from me.
Never let a good crisis go to waste
The numbers are hard to overstate. According to FDA, CDC reported 19,595 laboratory-confirmed cases of cyclosporiasis in the United States as of Sept. 8, including more than 12,000 from one multistate outbreak linked to iceberg lettuce from Taylor Farms de Mexico. CDC declared that outbreak over on Sept. 11. Two people died.
Garren told the state agriculture officials that the outbreak should be a moment of reckoning for FDA, because it showed a food safety system that does not always reflect the complexity of today’s global supply chain. Then, according to Lancaster Farming, she reached for the old saying: never let a good crisis go to waste. She is exactly right, and that saying is the history of food safety in this country.
Crises are how this system changes. After the 1993 Jack in the Box E. coli outbreak, USDA declared E. coliO157:H7 an adulterant in ground beef in 1994. Hamburger cases were the core of my practice for a decade, and today they are close to zero for my firm. That is the best thing to happen in food safety in my lifetime, and it came out of a crisis. After the 2006 spinach outbreak and the 2008 to 2009 peanut outbreak, Congress passed the Food Safety Modernization Act, signed in January 2011.
Crises also get wasted. Less than two years after FSMA was signed, USDA shut down its produce testing program. Fifteen years after FSMA, the food traceability rule Congress required, the tool that would let investigators trace lettuce faster, has been delayed again after pushback from industry. Attention fades when the case counts stop climbing. Garren is telling her own agency not to let that happen this time.
If we don’t act, shame on us
The sharpest line of the day did not come from Garren. It came from California Secretary of Food and Agriculture Karen Ross, who chairs NASDA’s Food Systems and Nutrition Committee, the committee Garren addressed. Speaking about how communication breaks down in every outbreak, Ross said: “If we don’t act on this, shame on us.”
She is right, and the “us” is broad. It includes FDA and USDA, the growers, processors and retailers, the Congress that writes the budget, the state agriculture departments in that room, and people like me who have been making these arguments for more than thirty years. More than 19,000 people were sickened in one season, more than 12,000 of them in a single outbreak, and two people died. If a year from now all we have is another round of statements, with no testing program, no rule on naming firms and no published root cause, then shame on all of us.
She wants produce testing back
This is the part of her speech I most want to highlight. Lancaster Farming reports that she wants FDA to reinstate a national approach to microbiological data on produce, similar to USDA’s Microbiological Data Program.
I know that program well. USDA ran it from 2001 to 2012, working with state agriculture departments to sample and test fresh fruits and vegetables for foodborne pathogens, and it ended in December 2012 when its funding was eliminated. In its final year it was a $4.5 million program that accounted for more than 80 percent of government produce testing. The Associated Press reported in 2012 that it had found more than two dozen contaminated samples that led to recalls of lettuce, tomatoes and other foods. I argued at the time that ending it was a mistake, and I have said so many times since. Hearing a senior FDA official say publicly that something like it should come back is welcome news.
She wants the data used before people get sick
Garren described a system that brings together surveillance data, inspection records, outbreak histories and even satellite imaging to flag hazards before illnesses occur. That is the right goal. FDA already holds much of this information. All summer I have been tracking FDA’s own outbreak investigations table, where many files list no food, no on-site inspection, or both. The information exists. What has been missing is putting it to work, and putting it in front of the public. A director who wants to do both has my support.
Same rules for everyone
She said domestic growers, foreign farms and importers must be held to the same standard, and that fairness and public health point in the same direction. That principle matters. The Associated Press found that FDA inspections of foreign food sites are down nearly 35 percent since 2019. When I went through FDA’s investigations table in August, eleven of seventeen open investigations showed no on-site inspection, and the six that did all involved firms on American soil. Parity is fair to American farmers and safer for American consumers.
Name them
Here is the line from her speech I would put on the wall. Garren called transparency both a value and a mechanism, and she said: “When bad actors know they will be named … behavior changes.” She added that this means publishing outcomes, sharing data, and showing that oversight is real and applied without exception.
I have been making that argument in outbreak after outbreak. Earlier this month FDA closed a summer E. coliO157:H7 file by saying romaine lettuce caused it, naming no grower and no processor. Stop Foodborne Illness has a citizen petition pending at FDA, Docket FDA-2026-P-1448, on naming the firms tied to outbreaks. Garren’s principle, applied, answers the question that petition asks.
States as partners
She also wants FDA to work more closely with state agriculture departments and to share information better, describing state staff as the boots on the ground who talk to producers every day. The old Microbiological Data Program ran through state agriculture departments, so a closer federal-state partnership is exactly how a revived testing program would work.
How to make it stick
A speech is a start. Three steps would turn what she said into policy: funding for a national produce testing program in the next federal budget, a rule requiring FDA to name the firms linked to outbreaks, and publication of the root cause findings in the iceberg lettuce outbreak, which FDA says it is committed to sharing. Each of those follows directly from her own words, and together they are what not wasting this crisis looks like. If she wants allies in getting them done, she has one here.
Garren told Lancaster Farming that friends say she picked the worst time to join FDA. She disagrees, and said she likes figuring out what happened and building plans that keep it from happening again. After this summer, that is exactly the attitude the job needs. Welcome, Dr. Garren. Keep saying it.
