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Who decides what is safe to eat: The cyclosporiasis outbreak and the failure of American food safety

On August 25, 2026, the Centers for Disease Control and Prevention (CDC) recorded 17,180 laboratory-confirmed cases of cyclosporiasis acquired in the United States between May 1 and August 24, with these infections resulting in 922 hospitalizations and two deaths across 48 states and the District of Columbia. The parasite that causes it, Cyclospora cayetanensis, has no animal host. It passes from one person to another only through human feces, and it produces watery diarrhea that runs for weeks and returns after it seems to have gone.

A further 11,844 cases have not been laboratory-confirmed or remain under investigation, bringing the total to roughly 29,000 illnesses. Travel-associated infections, 1,805 of them, are counted separately. Among confirmed patients, the median age is 46, while the age range runs from 1 to 99, and the median date of symptom onset was July 7.

The CDC defines the seasonal monitoring window as running from May 1 to August 31, meaning these figures encompass almost the entire annual cycle and establish a staggering surge when measured against 2025, which produced only 1,180 cases over the identical four-month period. The confirmed caseload this season is 14.6 times last year’s total. 

Investigators have linked 11,458 of those cases, 495 of the hospitalizations and both Michigan deaths to iceberg lettuce grown in central Mexico and recalled by Taylor Farms in July, across 20 states. Three of those states appeared on federal distribution maps only in late August, well after the initial recall announcements and past the expiration of product best-by dates. The remaining 5,722 confirmed infections, a third of the national total, have no identified origin. Meanwhile, CDC and the Food and Drug Administration (FDA) continue to investigate at least six additional illness clusters whose agricultural sources remain unconfirmed.

Graph tracks the increases in cyclosporiasis

More egregious, these same institutions still cannot explain how a nation with a food-safety apparatus with more than a century of experience remains unable to determine what is carrying a parasite through 48 states. The explanation of this failure goes beyond the wrecking operation by the Trump administration on public health infrastructure. It is rooted in the historical compromises that shaped the American regulatory system.

Nobody is required to look

The United States Department of Agriculture (USDA) operated the Microbiological Data Program until December 2012, testing approximately 15,000 produce samples annually, including bagged lettuce, spinach, cilantro, hot peppers, tomatoes, sprouts and melons. This single program accounted for roughly 80 percent of all federal produce pathogen testing at an annual operational cost of $4.5 million. Following its termination, no federal agency has routinely sampled commercial produce for Cyclospora cayetanensis, leaving the nation’s retail food supply without any regular microbiological monitoring for parasitic contamination.

Federal rules do not test agricultural water for the organisms that make people sick. They test for only one bacterium, Escherichia coli, and treat its absence as evidence that the water is free of fecal contamination. The Produce Safety Rule requires that harvest, and post-harvest water carry no detectable E. coli, and the regulation states its own logic, that samples are tested “as an indicator of fecal contamination.” The test is cheap and it is fast, and for bacteria, perhaps, it is a defensible economy. But it is not one for parasites like cyclospora, and the government knows this.

The National Advisory Committee on Microbiological Criteria for Foods, a federal advisory body, reported in 2023 that Cyclospora oocysts are “resistant to harsh environmental conditions, as well as resistant to many common chemical treatments to reduce the presence of bacterial pathogens in the produce production environment and in agricultural inputs,” naming agricultural water specifically. The same committee noted that a positive Cyclospora finding “is indicative of the presence of human fecal contamination, as humans are the only known reservoir.” Water contaminated with the parasite will therefore pass the federal test, because the test measures a bacterium and nothing in the rule requires testing for parasites. 

Then, in May 2024, the FDA revised the rules again. It scrapped the numerical standard for pre-harvest water and left growers to assess their own systems once a year. The water that touches the crop in the field is now checked by the person who owns the field.

Commercial processing facilities wash chopped lettuce in recirculated water systems, an industrial step that the FDA identified in a 2013 environmental assessment as the precise point where a single contaminated head seeds an entire production run. The agency’s safety guidance also acknowledged that the standard chlorine-wash solutions applied during processing do not kill the oocysts these parasites shed. Processing machinery and conveyor belts must undergo required sanitation verifications, but the chemical and microbiological tests used to inspect those surfaces have the same limitations as water testing.

Clinical diagnostic protocols present an equally steep obstacle for infected patients seeking treatment. Routine ova-and-parasite stool examinations performed in hospital laboratories do not reliably detect Cyclospora oocysts, requiring attending physicians to order specialized acid-fast staining or molecular assays by name. CDC acknowledges this institutional barrier in its public outbreak notices, explicitly warning consumers that they may need to request specific laboratory screening because standard medical stool tests routinely omit this parasite.

Map shows which states tracked the cyclosporiasis outbreak.

Epidemiological investigators face a parallel void because federal laboratories possess no genomic matching system for Cyclospora comparable to PulseNet, which links bacterial strains of Salmonella and E. coli through standardized molecular sequencing. Public health teams cannot connect patient stool samples to farm fields or processing lines through a shared laboratory fingerprint, relying instead on grocery receipts and patient recall. The CDC then hollowed out population-level monitoring on July 1, 2025, when it reduced the mandatory surveillance targets of the Foodborne Diseases Active Surveillance Network from eight pathogens to two, ending active laboratory surveillance across its 10 participating states, where epidemiologists had regularly contacted more than 700 clinical laboratories to identify cases.

Federal statutes mandate that health departments report every confirmed diagnosis of cyclosporiasis, designating it a nationally notifiable condition. However, no federal law requires any farm, processing plant, distribution facility, or clinical laboratory to look for the parasite at any stage of production or treatment. The national case tally therefore measures only the small subset of patients who were specifically screened rather than the full population of infected individuals, which is why official agency bulletins repeatedly acknowledge that the true number of sick people is higher than the number reported.

The 1906 Food and Drugs Act

The regulatory underpinnings of this institutional blindness were established during the infancy of federal food oversight, and the standard account of how that happened is James Harvey Young’s 1989 study Pure Food: Securing the Federal Food and Drugs Act of 1906. For 25 years before the Act passed, members of Congress introduced more than a hundred separate bills, and every one of them died in committee or was blocked from a floor vote by corporate lobbies and conservative legislative leaders. 

Popular histories celebrate the eventual enactment of the 1906 Food and Drug law as a triumph of aroused consumer conscience. Young, however, weighing the archival research of the historian Ilyse Barkan, describes something else. Between 1902 and 1907, American manufacturers of processed foods and patent medicines deliberately dumped their lowest-grade products onto foreign markets, on a schedule so systematic that Barkan suspected commercial coordination. By 1905 the dominant domestic processors were prepared for national regulation and signaled Congress to act, whereupon the resistance of two decades dissolved and the statute passed with negligible opposition through a legislature dominated by corporate interests.

Why big business wanted the law is a question the business historian Donna Wood answered succinctly. Processors needed federal certification to reopen the European export markets that had closed against adulterated American shipments. Large firms wanted uniform federal standards to supersede a patchwork of contradictory state statutes and to protect their market share against rivals who undercut them by diluting ingredients. Most consequentially, dominant processors used federal administrative authority to restrict market entry against smaller competitors manufacturing cheaper substitutes: dairy syndicates against oleomargarine, cream-of-tartar baking powder trusts against alum producers, cane sugar refiners against glucose manufacturers, and straight-whiskey distillers against blenders of rectified spirits.

The 1906 legislation, Wood concluded, was a victory for established commercial participants against adulterators, unlicensed imitators, and the newer producers whose low-cost goods threatened entrenched market positions. 

However, the passage of the 1906 Pure Food and Drugs Act did not resolve the concerns of the dominant factions of the food industry. The statute had done something more consequential than list prohibitions. It had created an office to decide what those prohibitions meant, and at the head of that office stood Harvey Washington Wiley, chief of the federal Bureau of Chemistry since 1883, whose rulings would determine which substances rendered a food adulterated and therefore not shippable across a state line. Wiley moved against sodium benzoate in ketchup and canned goods, against saccharin as a cheap replacement for sugar, and against the caffeine in Coca-Cola, so that whole product lines now depended on the judgment of one chemist.

Harvey Washington Wiley

He was also, by the standards of his own discipline, unreliable. Wiley recognized no threshold below which a preservative might be tolerable, treating every additive as though it were an absolute menace, such as formaldehyde, and pronounced on substances he had never tested. In the account Jonathan Rees gives in his 2021 book, The Chemistry of Fear, Wiley came to hold that anything unnatural was unhealthy, and his Poison Squad trials succeeded in frightening the public into demanding a law rather than in establishing what any specific chemical did. His alarmism was the source of his popularity and of his errors alike, and the results were expensive. Manufacturers whose products he ruled against lost markets, and they had nowhere to appeal.

In 1908 President Theodore Roosevelt appointed a Referee Board of Consulting Scientific Experts to review the Bureau’s findings and placed at its head Ira Remsen, the chemist who had discovered saccharin. The board overruled Wiley on saccharin and on sodium benzoate, and he resigned in 1912. Nobody moved to repeal the Pure Food and Drugs Act, and nobody needed to. What changed was the personnel who interpreted it.

Upton Sinclair, author of the famous muckraking work on the meat industry, had intended something else entirely. He serialized The Jungle in the socialist weekly Appeal to Reason to expose the exploitation of packinghouse labor and observed afterward that he had aimed at the public’s heart and hit it in the stomach. Barkan’s account explains why the packers gave way: their public relations counterattack against Sinclair’s disclosures failed to restore confidence, and federal inspection stamps offered the most effective means of rebuilding it at public expense.

Upton Sinclair

Congress granted in 1906 precisely what industrial capital could absorb and ignored what it could not. The statute contained no provision regarding wages, hours, workplace safety or the sanitary conditions of labor. From that omission descends a regulatory tradition that polices the chemical purity of the finished commodity in complete separation from the material conditions of the workers who harvest, process, pack and transport the nation’s food.

A century of laws—and lack of enforcement

The agency’s enforcement problem predates the statute it enforces. Nathan Meijer, Nikolaas Tilkin-Franssens and Bernd van der Meulen, in a 2015 legal-historical survey of federal food law, trace it to an administrative arrangement under which the government documented the adulteration of the food supply but had no power to stop any of it. The USDA’s Bureau of Chemistry received no administrative authority under the 1906 Act either. Enforcement remained litigation-based, confined to judicial seizure and court fines backed by criminal prosecutions, reducing the bureau’s practical function to handing chemical analyses to district attorneys.

In 1938 Congress shifted the agency from a reactive to a proactive posture by enacting the Federal Food, Drug, and Cosmetic Act, granting powers to establish formal standards of identity, tolerances for unavoidable poisonous substances, court injunctions and factory inspections. But Congress appropriated neither the funds nor the personnel to use them. Only after Commissioner Charles Crawford convened an advisory committee in 1954, which found agency resources seriously deficient, did the budget rise from $5 million in 1955 to over $320 million by 1980, and staff expand from under 1,000 to over 7,000. 

Notably, American food changed faster after the war than anyone had counted. Preservatives, dyes, emulsifiers and stabilizers were entering the supply in quantity, and nobody in government knew what they were or how many there were. James Delaney, a congressman from Queens, New York, spent two years from 1950 asking who checked them. The answer was nobody. His committee found manufacturers introducing new substances without testing them or telling anyone, and a government with no power to make them do either. Thousands of chemicals were already in the food with nothing behind them.

The Food Additives Amendment of 1958 required that a company wanting to use a new chemical had to prove it safe before selling it, submitting its own testing to the Food and Drug Administration for review. But Congress exempted everything already in food. Substances the government had approved before 1958 were untouched, and so were substances that experts “generally recognized as safe.” The Delaney investigation established the danger. The statute confined the remedy to the future.

In 1995, Congress reinforced that commercial priority by enacting the Unfunded Mandates Reform Act, requiring federal agencies to conduct cost-benefit analyses before adopting any regulation with substantial economic impact, creating the administrative machinery that priced prevention against profit. 

President Barack Obama signed the Food Safety Modernization Act in 2011, the largest expansion of authority since 1938. Before its passage the agency could only request a recall and had no power to compel one. The statute authorized fees for reinspections and recall orders, but the agency has never once collected them in 15 years. The traceability rule written under that authority, finalized in 2022 with a compliance date of January 2026, was deferred to July 2028 before it took effect, at the direction of Robert F. Kennedy Jr. as Secretary of Health and Human Services.

All this boils down to a century of statutes, and not one enforced as written. Congress granted powers in 1906 and withheld the money until 1954. It put the burden of proof on manufacturers in 1958 and exempted them from it by the same law. It let the FDA charge for its own inspections in 2011, and the agency has never sent a bill. The same operation is under way now, at greater speed and with less pretense. What remains of enforcement is being dismantled so that no one can enforce anything, and what is being done to food safety is what has already been done to public health.

Jack in the Box 1994: From E. coli to cyclospora

Twenty-nine thousand Americans have been sickened with cyclosporiasis this summer and two are dead, and Health Secretary Kennedy has cut the surveillance, deferred the traceability rule and announced that the outbreak is under control. When the food industry faced a similar crisis in 1993—more than 700 sickened across four states and four children dead of E. coli after eating hamburgers sold by Jack in the Box—the federal government made the pathogen an adulterant, mandated new process controls, built the surveillance systems the country still uses, and was sued by the meat industry for doing it.

The outbreak began with patties produced on two days in November 1992 and was recognized on January 12, 1993, when a Seattle pediatric gastroenterologist reported a cluster of children with bloody diarrhea and kidney failure to the Washington State Department of Health. Within six days the state had identified the source, and the chain had stopped selling hamburgers. By late February, 732 people had been confirmed infected across four states, 178 of them severely, and four children were dead with a median victim age of 7. Only 12 states then required that E. coli O157:H7 infections be reported at all.

The difference to today is not in the casualties. Nor was the earlier period one of foresight or careful policy. What the state did in 1994 it did in reaction, after the fact, and it did the minimum. But it did something, because the cost of doing nothing was still higher than the cost of acting, and public confidence in the meat supply was an asset the industry could not afford to lose. Those calculations no longer hold today.

In response to the crisis, on October 17, 1994, the Department of Agriculture announced by administrative action, without new legislation from Congress, that ground beef testing positive for E. coli O157:H7 would be treated as adulterated. Two weeks later, supermarket and meat industry organizations sued the agency arguing that the department had exceeded its statutory authority. In Texas Food Industry Association v. Espy, the federal district court denied an injunction and upheld the designation, accepting the agency’s interpretation under administrative deference rather than finding any enforceable right on the public’s side.

The American Meat Institute resisted testing by contending that mandatory screening would give consumers “false assurance that they no longer have to thoroughly cook ground beef.” The industry’s purported fear was that a government stamp would make people careless at the stove. 

While the public was assured the problem had been handled, nearly all pathogen contamination across the nation’s food supply remained legal to sell. The agency added six strains of non-O157 Shiga toxin-producing Escherichia coli in 2011, but salmonella, which sickens far more Americans than E.coli, has never been designated an adulterant across the general meat supply.

Supreme Beef Processors demonstrated seven years later what that omission was worth. Between 1999 and 2000, the company failed the federal salmonella performance standard during three consecutive testing rounds, with 47 percent of samples contaminated in the first round and 20.8 percent contaminated in the second, against a regulatory standard of 7.5 percent. When the Department of Agriculture moved to withdraw its inspectors, which would have closed the plant, the processor sued.

In Supreme Beef Processors, Inc. v. United States Department of Agriculture, the Fifth Circuit Court of Appeals struck down the standard. The court ruled that unsanitary plant conditions must actively cause the product to become injurious while prepared or packed inside the facility, meaning a characteristic the meat already possessed on arrival lies beyond federal reach.

What this means in practice is that a grinder may buy the cheapest and dirtiest meat available, and the government cannot touch him for it so long as his own floors are clean. Supreme’s defense was exactly that: it had failed the tests not because of anything inside its plant but because it bought trimmings arriving with more salmonella than other cuts. The Department did not dispute it. The law can adjudicate how a plant handles meat, but it has no say over what was in the meat when it arrives.

Taylor Farms is covered by this precedent. No adulterant designation exists for Cyclospora, so there is no standard the company can fail. No rule requires anyone to test the water in the field, and since May 2024 no rule requires a number at all. Taylor Farms recalled lettuce grown in central Mexico and the traceback stopped at a supplier, in something bought rather than something done. 

“Increasingly antiquated and fragmented regulatory framework”

Federal meat inspection was designed to catch visibly diseased livestock and filthy slaughterhouses, enacted long before laboratory methods could identify the microscopic pathogens that make a person ill. Under the Federal Meat Inspection Act, meat is deemed adulterated if prepared or packed under insanitary conditions whereby it may become contaminated with filth or rendered injurious to health. That vocabulary of filth and decomposition belongs to a 19th-century sanitary doctrine that equated disease with visible dirt and rot, generating an inspection regime based entirely on sensory observation: examining a carcass, inspecting a floor, and grading a facility on physical appearance. A microscopic pathogen on a pristine-looking food is invisible to such sensory methods, while such a pathogen that arrived in the raw material before reaching the plant gate lies outside statutory authority altogether.

The National Academies confirmed that structural obsolescence in 2003, answering an inquiry the regulatory agencies themselves had commissioned. At the formal request of the FDA and FSIS (Food Safety and Inspection Service), the Institute of Medicine and the National Research Council reviewed the scientific foundations of federal oversight, concluding that regulators were trapped within an “increasingly antiquated and fragmented regulatory framework.” Examining the meat statute specifically, the committee observed that its core adulteration standard “reflects the prevailing scientific theories from 100 years ago, which equated filth with disease,” and placed as its primary recommendation the urgent necessity for agencies to possess statutory authority to establish, enforce and update scientific food safety criteria. Congress funded the inquiry and ignored its central conclusions.

The record of congressional refusal extends throughout the entire postwar period. The Institute of Medicine and the National Research Council called for a unified framework under a single executive official in 1998; President Clinton’s science council endorsed that consolidation the following year. The Government Accountability Office characterized federal oversight as “a patchwork structure that cannot address existing and emerging food safety risks” in 2001, the same year the Fifth Circuit decided Supreme Beef, then returned to observe in 2004 that “the federal food safety system is not the product of strategic design,” placed food safety on its High-Risk List in 2007, counted 16 separate agencies administering it in 2017, and recommended structural consolidation again as recently as 2025.

What this record establishes is not a series of isolated oversights but a continuous, officially documented institutional failure. Every relevant instrument of federal authority—scientific advisory bodies, executive science councils, the government’s own investigative arm—produced findings that the system was broken. Congress acted on none of them. Across 77 years of unbroken official warnings, it never amended the statutory language upon which Supreme Beef turned.

The National Academies established the explicit standard that the current traceability deferral violates. The 2003 report affirmed that policymakers “need to ensure adequate government financial resources for the creation and enforcement of safety rules,” and that where expenditures to improve food safety exceed the commercial costs of the harm, “these expenditures should definitely be made.” The executive action of 2025 directly inverted that principle: the Department of Health and Human Services deferred the Food Safety Modernization Act traceability rule, making the simple economic calculation that $73 million in compliance savings for commercial enterprise outweighed $322 million in preventable public illness costs.

Congress preserves this administrative fragmentation as a deliberate political act. Calling the system chaotic implies that nobody benefits from its disorder, whereas 15 separate federal agencies administering more than 30 distinct statutes under 28 congressional committees produce an arrangement in which no single institution is answerable and any meaningful reform requires reorganizing everything simultaneously. That structural design explains why 77 years of official recommendations have failed, and it is precisely why the arrangement survives.

Conclusion: science v. profit

The authoritative but now-forgotten figure of Alice Catherine Evans is worth examining in this context. Working in the dairy division of the Department of Agriculture’s Bureau of Animal Industry, she established in 1918 that the bacterium causing contagious abortion in cattle was closely related to the organism causing Malta fever (brucellosis) in people and drew the conclusion the profession had evaded: drinking raw cow’s milk was making Americans sick.

Alice Catherine Evans

Officials dismissed her for a decade, largely because she held no doctorate. The dairy lobby campaigned against her and accused her of promoting pasteurization for personal gain. She contracted chronic brucellosis in her own laboratory in 1922 and was misdiagnosed for years. Other researchers confirmed her work in the late 1920s, and the Society of American Bacteriologists elected her its first woman president in 1928. Throughout that decade of delay, unpasteurized milk went on entering American homes.

A federal eradication program began in 1934. Veterinarians tested herds and condemned infected cattle, and pasteurization became a condition of sale. American herds were largely clear by 1947. None of it required an inspector’s eye on whether a carcass looked wholesome. A specific organism was identified, its route through a specific food established, and a specific remedy compelled. Evans supplied the proof and the state supplied the compulsion, and neither would have worked alone. She held decisive evidence in 1918 and was powerless against commercial resistance, and no quantity of data would have cleared the milk supply while selling contaminated milk remained lawful. The principle is not complicated. Science establishes what is true and public authority compels the remedy against the profits of the food industry.

Nothing was built on it. The brucellosis campaign remained a single instance and the statute was never rewritten to make it repeatable. For cyclosporiasis the science is done: the transmission route through agricultural water was established in 2013 and the interventions detailed by federal advisers in 2023. There is no adulterant designation, so there is no standard a grower can fail. No federal program samples produce. The water rule looks for one bacterium and nothing else. No genomic system links cases across state lines. The CDC made Cyclospora surveillance optional in July 2025. Every instrument Evans’s case required is missing, and not one of the absences is a scientific problem.

The World Health Organization’s 2026 estimates, published in The Lancet Global Health, measured what these costs the world. Foodborne transmission of f42 hazards (a scientific term grouping certain bacteria, viruses and parasites) caused 866 million illnesses and 1.52 million deaths in 2021, a burden the authors place alongside tuberculosis and malaria and state plainly is preventable by systemic improvements along the supply chain. It does not fall evenly. Low- and middle-income countries absorbed $202 billion of productivity loss against $108 billion in wealthy economies, 1.16 percent of national output in the poorest countries against 0.52 percent globally. Children under 5 were infected at 2.7 times the rate of everyone older.

The same update counted Cyclospora cayetanensis for the first time, at 10.2 million illnesses and 14,600 deaths a year, with a margin of error wider than the estimate itself. The organism cannot be grown in a laboratory and is systematically counted in no country on Earth. The parasite American agencies decline to look for is one nobody anywhere can measure, and no government is trying.

Every researcher whose surveillance program was cut in 2025 stands where Evans stood in 1918. She was not refuted; she was outranked by credentials and opposed by an industry with money, and her findings were acted upon only when it suited others to act. Scientists are discovering that the worth of their work is settled by people who do none of it, and that they have more in common with the laborer cutting lettuce in Guanajuato than with anyone who signs their budget.

Agricultural and food processing workers, together with the scientists and inspectors whose work has been defunded, must build rank-and-file committees on every farm, in every plant and in every laboratory, independent of the union apparatus and of the professional bodies. Publicly funded inspection, laboratory testing and epidemiological surveillance must be restored and placed beyond the reach of corporate and state interference. The agribusiness and food processing monopolies must be expropriated and placed under the democratic control of the workers who grow, cut, pack and serve the food, and these struggles unified internationally through the International Workers Alliance of Rank-and-File Committees and the building of sections of the International Committee of the Fourth International.

The Jungle remains the indispensable book on this subject, and not because of what it exposed about the meat industry a century ago. Sinclair named the social order, capitalism, in which human beings are consumed and there is no law but predation, and his subject was the men and women in the packinghouses rather than what came out of them. A century and more of American food law has policed the commodity passing between the workers who produce it and the workers who eat it and shielded the firms that stand between them. The cyclosporiasis crisis only confirms what he saw.

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