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Cyclospora Outbreak Highlights Decline in FDA Foreign Inspections

A cyclospora outbreak linked to contaminated lettuce has raised concerns about the decline in FDA inspections of foreign food sources, which have decreased by nearly 35% since 2019. The FDA's ability to conduct inspections has been impacted by staffing shortages and reorganizations, leading to questions about food safety oversight. The agency is currently evaluating its inspection processes and the effectiveness of its methods in ensuring food safety.

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Taylor Farms Yum Brands
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Michael Rogers Susan Mayne Frank Yiannas Brian Ronholm

A nationwide outbreak of cyclospora linked to contaminated lettuce has raised safety concerns regarding imported food and highlighted a trend of decreasing international inspections by U.S. regulators. According to FDA records reviewed by The Associated Press, inspections of foreign food sites, including the Mexican farm associated with the outbreak, have decreased by nearly 35% since 2019, prior to the COVID-19 pandemic. The pandemic has led to a wave of retirements among FDA inspectors, affecting the agency's ability to conduct inspections.

Before the pandemic, the FDA had consistently failed to meet its congressionally mandated targets for international inspections. Staffing cuts and reorganizations under the Trump administration may result in even fewer inspections in the future, according to former FDA officials. Michael Rogers, a former FDA inspector, noted that the agency struggles to meet its responsibilities due to limited resources.

The Trump administration proposed new methods to optimize agency resources, including a pilot program for one-day inspections, but these abbreviated inspections do not provide the same level of scrutiny as traditional inspections, which typically take longer.

Susan Mayne, former food director at the FDA, emphasized that inspections are just one method of ensuring safety, as the agency also employs border inspections, importer inspections, and sampling.

The cyclospora outbreak has raised questions about the effectiveness of these methods. In July, the FDA had to retract a faulty test result that indicated cyclospora was present in a sample of lettuce from Taylor Farms. Despite this, FDA officials maintain that the farm is the source of the parasite, although Mexican authorities have not found any positive samples.

The FDA's investigation is ongoing, and officials are evaluating how many foreign inspections are necessary annually to ensure proper oversight. FDA inspectors visited the Taylor Farms site in Guanajuato, Mexico, in mid-August, marking their first visit since 2019. The number of foreign food inspections fell further last year, down 17% to 1,140 in fiscal year 2025.

Food experts criticized the delay in sending inspectors to Mexico, stating that a quicker response is necessary during outbreaks involving fresh produce. The Taylor Farms recall involved thousands of salad products shipped to major U.S. restaurant chains, including Yum Brands.

In the current fiscal year, there have been over 480 food recalls, surpassing four out of the five previous years. The Food Safety Modernization Act of 2011 aimed to improve the U.S. food safety system following several deadly outbreaks but has not led to the expected increase in inspections. The FDA is required to inspect over 19,000 international food sites annually but has never met this target, achieving only 1,700 inspections in 2019.

Challenges in increasing inspections include recruiting and retaining inspectors, with 10% to 15% of positions remaining unfilled. The demanding travel schedule for international inspectors contributes to high turnover rates. Experts suggest that new technologies, such as machine learning and remote monitoring, could help improve oversight of foreign producers.

The 2011 law also mandated that manufacturers place bar codes on produce batches for traceability in contamination events, but implementation has faced delays due to industry pushback. Brian Ronholm, a former Department of Agriculture official, criticized the lack of progress, stating that adequate preparation time should have allowed for successful implementation.

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Cyclospora outbreak followed years of declining FDA foreign inspections

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Cyclospora Outbreak Highlights Decline in FDA Foreign Inspections