S.T.O.P.-Safe Tables Our Priority
The Four Cornerstones of Safe Food

Comments by Barbara Kowalcyk
September 23, 2025
Washington, DC

Introduction
Foodborne disease is a serious public health threat that often leads to serious illness and death. According to the Centers for Disease Control and Prevention (CDC), each year over 76 million - that's one in four - Americans are struck by foodborne illnesses.
The suffering that results from this pathogenic contamination takes a terrible human toll. Victims have suffered heart attacks, blindness, seizures, paralysis, liver failure, kidney failure, brain damage and death due to foodborne illness. I would like to tell you about one child - my child - and the impact foodborne illness has had on my family and my community.

Kevin's Story

Our nightmare began on July 31, 2001, when Kevin awoke with diarrhea and a mild fever. On the evening of August 1st, we took him to the emergency room for bloody diarrhea but were sent home. By the next morning, Kevin was much sicker and was hospitalized for dehydration and bloody stools. Later, that afternoon, we were given the diagnosis: E.coli O157:H7. On August 3rd, Kevin's kidneys started failing. He had developed the dreaded Hemolytic Uremic Syndrome (HUS). Late that night he was transferred to the Pediatric ICU at the University of Wisconsin's Children's Hospital. Mike and I spent the next eight days living in that hospital - watching our beautiful son slip away from us.

On that first Saturday in the PICU, Kevin received his first dialysis - a three-hour procedure during which he needed to keep still. That's a tall order for any toddler, so my husband, the nurse and two of our friends held his arms and legs while they talked and sang songs to reassure him for the entire treatment. Kevin spent the rest of that day and the next two crawling around a crib in agony. He threw up black bile. He became drawn and his eyes were sunken. He looked like a malnourished third world child. And he smelled - a horrible and overwhelming smell - a smell you could never forget. During those three long days, Kevin begged us to give him water or juice, but the doctors said it would only make him worse. He repeatedly asked to swim in his turtle - a pool we used at home. Kevin finally convinced us to give him a sponge bath and, as soon as the washcloth came near his mouth, he grabbed it, bit down on it and sucked the water out of it. It broke our hearts.

On Tuesday, August 7th, Kevin was placed on a ventilator and continuous dialysis. In hopes of preventing Kevin from remembering this horrible ordeal, doctors heavily sedated him. As the medication would wear off, Kevin would try to pull the tubes out so braces were put on his arms. His body began to swell. Doctors inserted tubes to drain fluid off both of his lungs. By the end of the week, he was receiving more medications than we could count to stabilize his blood pressure and heart rate. He had received eight units of blood. A special bed was ordered to help alleviate some of his pain, but throughout it all the hospital staff remained optimistic. They said that this was typically the way HUS/E.coli kids got through the illness. But for Kevin, all of this was not enough and finally on August 11th at 8:20 pm after being resuscitated twice - as doctors were attempting to put him on a heart-lung machine - our beloved Kevin died. He was only 2 years, 8 months and 1 day old. The autopsy later showed that both Kevin's large and small intestines had died - a condition that is 100% fatal.
I find it difficult to come before you to tell you about the death of my son. Kevin was a wonderful little boy who died a horrific death. But as tragic as Kevin's story is, he is not alone - 325,000 Americans are hospitalized and 5,000 die each year from foodborne illness. If our nation is to make meaningful progress in reducing death and disease from foodborne illness, stronger food safety policies need to be put in place. These food safety policies should include these four cornerstones:

1. A unified, independent food safety agency whose primary mission is to protect public health.
2. Mandatory recall authority over contaminated food products.
3. A uniform, mandatory and enforceable traceability system designed to protect public health.
4. Pathogen testing with enforceable performance standards.

"Who's on First?" A Single Food Safety Agency

Abbott and Costello's "Who's on First?" is a classic comedy sketch. Unfortunately, it can also be a reflection of America's food safety network. Just think about the recent finding of the first BSE-positive cow in the United States. It was unclear who was ultimately responsible: FDA or USDA; in other words, "Who's on First?"

The food that ends up on our dining tables travels a long journey. From the farm or ranch, food moves through many stages of processing before entering the wholesale distribution system. Consumers buy food at the retail level (either in restaurants or stores) and finally the food is prepared and eaten. Governmental responsibility for ensuring the safety of your food shifts depending on where in the supply chain the food currently resides.

Today, the oversight of the safety of the American food system is severely fragmented, with jurisdiction scattered across numerous federal agencies, including USDA, FDA, HHS, EPA, CDC, ARS and DOC. In addition, there are over fifty state and thousands of local public health departments that monitor foodborne illnesses under diverse regulatory programs. The National Academies of Science in its recent 2003 report, entitled Scientific Criteria to Ensure Safe Food, found that the lack of integration among agencies and between federal and state governments is inhibiting the implementation and enforcement of good food safety policies. We agree.

An effective food safety system must extend from farm to table. Coupled with the ambiguity of "who is responsible" - or "Who's on First?" certain segments of the food production system have been virtually ignored. In fact, the current food safety system ignores some of the most obvious contamination entry points along the food chain. For example, while responsibility for the safety of produce lies primarily with the FDA, it has little role in supervising the growing and processing of produce. FDA conducts no inspections on farms, except in response to a foodborne illness outbreak. In a similar fashion, animal manure, which is frequently a vehicle of produce pathogen contamination, has no federal regulations that prevent its use in direct application on human food crops.

Transportation of Food Products

With today's global economy, your food travels great distances before it winds up on your dinner plate and the conditions in which it is transported can easily affect food safety. FDA and the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) are still debating which agency is responsible for inspecting food in transit.

This disjointed state of food safety regulations and enforcement prevents the development of consistent strategies and policies with regard to food safety measures. Gaps in our food production system will continue until there is a single, federal food safety agency whose mission is to protect public health, with enforceable jurisdiction that extends from the farm to the table.

"Will You PLEASE Recall Your Meat?" Mandatory Recall Authority

Most Americans are shocked to learn that all food recalls are voluntary and that the agency charged with that food product's oversight does not have authority to force a recall, even when scientific testing conclusively establishes the presence of deadly bacteria in food that is on its way to our kitchens. Our government can only "request" a recall, while food producers retain the right "to refuse to comply."
Even when it is agreed by both government and industry that a food is contaminated, there is a period of negotiations between the food producer and the agency charged with the food's oversight. Weeks may lapse before a recall is announced. As a result, bacterial contamination in our food supply is typically not brought to the public's attention until after the food has continued down the distribution pipeline towards our supermarkets and dinner tables. On the other hand, recall of contaminated food is often of critical importance, representing the last opportunity to protect public health by removing contaminated products from the food pipeline.
Congress and the President MUST give agencies, like USDA and FDA, the authority to order mandatory recalls of contaminated food products.
Accountability Fosters Responsibility: Traceability

Americans want clean, wholesome food that is traceable to its source and accountable for its safety. Americans do not want deadly pathogens in their food. The food inspection program is financed by the public's taxes for their protection. Taxpayers expect swift and sure action on the part of governmental agencies to remove defective products from commerce whenever it is identified.

When the prevention system fails and people are sickened by food that carries deadly pathogens, it is critical to quickly trace that defective product back to the original source. Information and accountability are essential to a successful system of food safety. If a product cannot be linked to its source, the entity responsible for the product cannot be held accountable for its quality.

Many food products, particularly fresh seafood, meat, poultry and produce, are not labeled to identify the producers or processors of the product. "Anonymous" food interferes with effective trace back in cases of foodborne illnesses and outbreaks. It is well known among food processors that foodborne illnesses are rarely traced to their source. The likelihood of finding and correcting contamination, therefore, is very slim. Allowing "anonymous" food into commerce contradicts a major food safety principle: food purveyors should be responsible for the safety of their products.

All food products should be labeled with a brand name, farm of origin, and subsequent processing information. This type of labeling would facilitate more accurate and effective recalls and would improve product recovery. In addition, food producers would benefit in the long run. When recalled food cannot be identified, sometimes a whole class of foods is implicated. Clear product identification would limit the negative consequences of a recall to those establishments that are identified as responsible for allowing contaminated food to enter the marketplace.

Traceability in food products is eminently reasonable and doable. Indeed, it is being done already in other jurisdictions. For example, the UK has adopted a nation-wide bovine tracking system. Closer to home, a Colorado-based meat company has implemented a bar code system that tracks food products from the individual animal to the final product. FDA requires origin labels on mulluscan shellfish to identify the harvester, date of harvest, and location of harvest.

Stronger accountability increases the likelihood that establishments will take precautions to avoid recalls. The irresponsible advantage that food producers have enjoyed to skirt this accountability must be eliminated. There is nothing "proprietary" about safely slaughtering animals, harvesting crops or packaging and distributing raw and/or fresh food products. Accountability is a goal that Americans demand on many levels and in many areas. Food producers should not be excluded from this aspect of market scrutiny.

Putting Science in the Mix: Enforceable Performance Standards

In 1998, the U.S. Department of Agriculture switched from its traditional sight, smell and probe meat and poultry inspection system to a process oriented, science-based system called Hazard Analysis at Critical Control Points (HACCP). The emergence of deadly new pathogens in the preceding years had made adoption of this new inspection system a critical priority. Only the microbial testing promised by this new system would be able to detect these powerful bacteria. Enforceable pathogen testing can verify that food safety systems are working.

The first step in pathogen testing begins with the establishment of performance standards through scientific baseline studies designed to provide objective and meaningful information with which food safety systems can be evaluated. Ideally, each segment of the food safety chain and each oversight area would have a baseline. However, due to the extreme cost of conducting baseline studies, USDA opted to start with the seven meat and poultry products that carry the heaviest load of pathogens harmful to people. The Microbiological Baseline Surveys were conducted in the 1990's to estimate national prevalence for selected foodborne pathogens and were used to establish performance standards in these seven products. As noted by the National Academies of Science, these studies were flawed in their design and scope, especially in regard to ground meat products, and need be reviewed on a regular basis in order to assess if pathogen contamination has decreased. Unfortunately, USDA has not yet repeated these studies. Without statistically appropriate baseline studies that are reviewed on a timely schedule, it will be difficult to gauge which processes and interventions are effective and what segments of the food safety chain require greater attention
The second step is enforcing those performance standards so that contaminated products do not reach American consumers. The 1996 HACCP Final Rule gave USDA the authority to shut down plants that failed Salmonella's end-product performance standards three times. Shortly after HACCP's implementation, Supreme Beef, a large supplier for the national school lunch program, failed the Salmonella test three times. USDA attempted to shut down the plant. Supreme Beef responded with a court injunction and the shutdown lasted just one day. In December 2001, the 5th Circuit Court of Appeals ruled in favor of Supreme Beef, thereby challenging HACCP's end-product performance standards.

In addition, HACCP's Final Rule called for E.coli testing for sanitation purposes. According to the USDA's Office of Inspector General (OIG) Audit of the 2002 ConAgra Recall, within weeks of HACCP's implementation, a number of large establishments were granted exemptions from the E.coli testing. The enforceability of the E.coli testing was further compromised in January 2003 when USDA settled with Nebraska Beef after attempting to shut them down for not meeting these very same E.coli tests.
Without enforceable, microbial, critical control point testing and end-product microbial performance standards, it is unlikely that HACCP will achieve its goal of reducing pathogens on raw meat and poultry products.

Conclusion

A single food safety agency, mandatory recall authority, traceability and enforceable pathogen testing. These are the four cornerstones for safe food. We need to work together to improve food safety standards in this country - because not one more child should suffer the kind of death my son Kevin did. On behalf of Kevin, my family and all victims of foodborne illness, I urge all of our presidential candidates to protect consumers by supporting these four cornerstones.