Food and Drug Administration (FDA), Food Safety Inspection Service (FSIS), National Advisory Committee on Microbiological Criteria for Foods (NACMCF)
Public Meeting on Bare-hand Contact of Ready-to-Eat Foods
Washington, DC
September 21, 2025

I am Heather Klinkhamer, advisory board member of S.T.O.P. -- Safe Tables Our Priority (ST.O.P.). Victims of foodborne illness formed S.T.O.P. in the summer of 1993. Most of its founders were parents of children maimed or killed by E. coli O157:H7 in meat. S.T.O.P. provides victim support, educates consumers about foodborne illnesses and food safety, and advocates improved food safety policies. S.T.O.P.’s purpose is to reduce illnesses and deaths caused by foodborne illness. I am delighted to be here today to present S.T.O.P.’s position on bare-hand contact with ready-to-eat (RTE) foods.

S.T.O.P. participated in the 1998 Conference for Food Protection, which made the recommendation that the NACMCF examine this issue. The other two consumer representatives at the Conference, Center for Science and the Public Interest and the National Consumers League, joined S.T.O.P. in opposing the resolution to alter the Food Code to allow bare hand contact with RTE foods.

Putting Risks and Hazards into Perspective

All segments of the food business -- farmers and ranchers, processors, retailers, and regulators -- communicate that food safety is their primary goal, and it is important that this goal remain fixed at the apex of our collective concern. Unfortunately, this goal is often diminished by lesser concerns, such as profit and convenience. Incidents in which bare hand contact with food has led to hundreds and thousands of foodborne illnesses are well documented. In at least two documented food worker contamination outbreaks, dozens of people could have avoided illnesses if food workers had used spoons rather than hands to mix foods. It is difficult to reconcile efforts to weaken the Food Code’s bare hand ban with efforts to improve food safety.

Every year, thousands of Americans are forever changed after pathogens such as Listeria or E. coli O157:H7 touch their lives. Foodborne illness victims always place consumer health and safety above all other food policy considerations. They work hard to keep other food safety stake-holders focused on health and safety goals by reminding everyone that the pathogens we address elicit a real and profound toll. Today, I will relay the experiences of some of S.T.O.P.’s members in an effort to re-acquaint all present with the consequences of foodborne illnesses.

· In 1993, Nancy and Tom Donley lost their vibrant six-year-old son, Alex. He died four days after onset of E. coli O157:H7 illness symptoms. The pathogen was so destructive that they were not able to donate his organs to help other children live. For example, the bacteria’s toxins liquefied portions of Alex’s brain.
· The Bernstein’s thought they were eating a healthy meal when they served organically grown lettuce to their family in 1996. Unfortunately, the lettuce was contaminated with E. coli O157:H7 and both three-year-old Haylee and seven-year-old Chelsea contracted illnesses that required hospitalization. Haylee’s illness developed into the deadly Hemolytic Uremic Syndrome (HUS). Her treatment included several surgeries, including brain surgery. She was hospitalized for four weeks and is now partially blind.
· Mary and Marnix Heersink’s son, Damion, contracted E. coli O157:H7 at a Boy Scout camping trip. He developed HUS, which kept him hospitalized for seven weeks. He had seven surgical procedures in the five weeks that he was in pediatric intensive care. His kidneys failed, the lining of his heart was removed, and his intestines were punctured. He was on dialysis and a respirator for three weeks. After the illness, he suffered from severe malnutrition. He lost 20% of his body weight. He had to learn how to stand, sit and eat again. Seven years after his illness, his mother says, “this disease is never over.” Damion has been hospitalized three times this year with small bowel obstructions due to abdominal scarring.
· Brianne Kiner was one of many children hospitalized after eating contaminated Jack in the Box hamburger in 1993. She spent two months in intensive care and nearly six weeks in a coma. Her hospitalization lasted nearly six months. She suffered from thousands of seizures and three strokes. Every organ in her body failed. After she was released, she required acute care to learn how to walk and talk. Her health status has improved, but she will never return to her former state of health. She is now diabetic and will require additional surgery to repair her damaged intestines. Due to her illness, Brianne will not be able to bear children.
· The Doneth family has suffered twice from major foodborne illness. In March 1997, 10-year-old Lindsay contracted a severe case of Hepatitis A from contaminated school lunch strawberries. She was hospitalized for a week, lost 10% of her body weight and missed about a month of school. Repercussions of her illness include hair loss, skin rashes, low white blood cell count and chronic joint and back pain. In July 1998, 14-year-old Sara contracted E. coli O157:H7. She was hospitalized with HUS for more than two weeks. Her kidneys failed and she required both feeding tubes and blood transfusions. As a result of her illness, Sara’s kidneys are permanently damaged and she requires daily medication to control high blood pressure.
· Aimee Ermil was a healthy child before she contracted E. coli O157:H7 induced HUS. Two surgeries, multiple blood transfusions and kidney dialysis were needed to keep Aimee alive. In the two years following her illness, Aimee has regained her strength and learned how to walk again. She is almost back to normal, but her family anxiously awaits results of HIV tests - an anxiety shared by many victim families.

S.T.O.P.’s perspective is that of people who have suffered profoundly from gaps in the nation’s food safety net. Many here today have heard the Centers for Disease Control and Prevention’s (CDC) recently released estimates of 76 million illnesses and 5,000 deaths attributed to foodborne illness each year in the U.S. When one ponders the faces and the lives behind each number, the gravity of our responsibility to forge responsible food safety policies is more apparent.

America’s most vulnerable population is suffering the brunt of foodborne illness. 1997 FoodNet data revealed that rates of illness for infants and children are double, triple and quadruple the rates of cases for all other age groups combined. As you can see in the CDC FoodNet 97 table, infants and children are suffering from Salmonella and Shigella twice as often as all other age groups combined. Their rate of Yersinia infection is thirteen times the rate for all other age groups combined.

The fact that our nation’s children are suffering from a disproportionately high foodborne illness rate is terrible. We know this is a susceptible population, and therefore the risk of severe illness and death is higher. What compounds the tragedy of this situation is the fact that many of the infants and children who survive these illnesses will inherit a lifetime of severe health complications that will forever hamper their lives.

The loss of potential in those at the start of life is a terrible shame. It is also very costly. Providing health care to a population acquiring acute need of care at an early age is expensive because health care expenditures will be made for a greater length of time. ERS estimates that the top seven foodborne pathogens cost the U.S. between $5.6 and $9.4 billion annually in lost productivity and medical expenses.

Foodborne illnesses are more than bellyaches. S.T.O.P.’s victim members have suffered brain damage, strokes, heart attacks, kidney failure, liver failure, and blindness due to foodborne illness. Our members have spent between $300,000 and $500,000 to treat single cases of HUS induced by E. coli O157:H7 infection. These actual expenditures far exceed the ERS estimates of HUS treatment costs.

One in five Americans lacks health insurance. This is a significant proportion of our population - approximately 43.4 million people. The public tends to hear about foodborne illness incidents in which victims are compensated for medical expenses and pain and suffering. Yet, it is more often the case that no entity can be held responsible for covering exorbitant medical expenses. S.T.O.P.’s membership includes those who not only suffer from life long medical complications, but those who also suffer extreme economic hardship resulting from foodborne illness and its repercussions.

Even those with health insurance have cause to worry. If they ever lose coverage for their child -- through a loss of employment or a missed insurance payment -- that child may never get insurance coverage again. This fact reduces the options of those who survive these illnesses.

The ramifications of these illnesses go on and on. The costs often are not quantifiable. It is impossible to estimate the toll of the many restraints imposed on lives, of the subsequent marital strains and ruptures or of the grief and suffering born by children, parents and communities. Each time those present hear a foodborne illness statistic, I encourage you to think about the people behind the numbers and the impact of the illnesses on their lives and on their futures.

Risks and Hazards of Bare Hand Contact with RTE Foods

The bare-hand contact ban (Section 3-301.11) was added to the Food Code in response to outbreaks linked to food contaminated by food preparers. Food worker transmission of foodborne illnesses is a significant problem. According to FDA, approximately one third of foodborne illness outbreaks are linked to food preparer contact with food.

FDA’s literature review identified 81 outbreaks linked to food worker contamination. Review of CDC reported outbreaks for which contributing factors were reported reveals that between 28% and 36% of outbreaks from 1983 to 1992 were linked to poor personal hygiene of workers. Of outbreaks in New York between 1980 and 1993 for which contributing factors were reported, infected food workers caused nearly 18%.

Ill foodworkers and cross contamination are primary contributing factors to food worker implicated outbreaks. According to FDA’s White Paper, most food worker implicated outbreaks involved transfer of the pathogen from hands to food. Of the 81 outbreaks attributed to food worker contamination, 93% were linked to workers who were ill either prior to or at the time of the outbreak.

Hepatitis A and Norwalk-like viruses caused 60% of the 81 outbreaks resulting from food workers contaminating food. These are human source rather than zoonotic pathogens. This is an important fact because it implies that food contaminated by food worker contact rather than food contaminated by contact with animal feces is responsible for a significant proportion of foodborne illness. FDA notes that the most common method of Hepatitis A transmission in foodborne disease outbreaks is contamination of food by a food worker.

The repercussions of foodborne illness outbreaks increase as the number of people exposed to the tainted food increases. Outbreaks attributed to retail establishments tend to cause more illnesses than those linked to foods produced, processed or prepared at home because retailers tend to serve a large volume of food to a large number of people at one time. Of the 81 food worker contamination outbreaks identified by FDA, 89% were linked to retail establishments.

Single food workers who taint food are significant public health threats. The 81 food worker contamination outbreaks identified in the White Paper caused nearly 15,000 illnesses, approximately 440 hospitalizations, and 2 deaths. Some of these outbreaks affected large populations. For example, a single1991 Shigella outbreak produced 3,175 illnesses and a single1984 Norwalk-like virus outbreak resulted in 3,000 cases.

Americans are consuming larger quantities of foods partially or fully prepared outside of the home. According to ERS, the percentage of food dollars spent for “food away from home” increased from 34% in 1970 to 41% in 1993. Between 1984 and 1994 sales of “food away from home” increased 5.6% annually. During this time period, fast food outlet sales more than doubled and non-commercial food service sales, such as school and hospital cafeterias, doubled. As Americans consume more “food away from home,” the retail food workers’ role in containing illnesses gains more prominence.

Food Safety Roles, Attitudes and Enforcement

There is wide agreement that frequent hand washing and prohibition of bare hand contact is beneficial for food safety. Consumers frequently call the S.T.O.P. hotline to complain about poor hand washing facilities at restaurants and food workers touching food with bare hands. In a 1998 consumer survey, 77% of participants agreed that an unsanitary restroom would strongly influence their opinion of an eating establishment’s food handling practices. Forty percent of respondents agreed that a well-stocked food worker handwashing station would positively influence their opinion of an eating establishment.

The government, consumer groups and food industry trade associations highlight the importance of hand washing and contact avoidance in consumer education materials. The National Food Processor’s Association website includes consumer food safety tips such as “be sure to wash hands often” and “use clean utensils.” The National Restaurant Association’s foodborne illness fact sheets list hand washing and minimal “manual contact with food and food contact surfaces” as control measures.

It is widely recognized through industry policies and government regulations that retail establishments have a responsibility to prevent foodborne illnesses by getting food workers to wash hands and to avoid bare hand contact with food. But violations of these policies occur too often. A New York newspaper’s review of three county grocery store inspection records found that inadequate employee hand washing facilities accounted for 20% of store violations. Because the 139 stores in this catchment area only passed inspection on average 58% of the time, 20% is a significant number of hand washing violations. A Philadelphia news article about hot dog safety noted that food workers staffing a major sports stadium relied upon the same dirty, soap-less bathrooms used by fans. Many of us here today have probably visited restaurant bathrooms that posted signs informing food preparers that they must wash hands, but the facilities lacked soap, hand dryers, towels or warm water.

Some members of the retail food industry blame high worker turn over for hand washing inspection violations. In a series of Michigan grocery store inspection articles, a store manager and a trade association representative said difficulties attracting and maintaining employees diminished food safety education efforts and sanitation performance.

However, there is evidence that many retailers simply do not appreciate the significant role hand washing plays in preventing transmission of pathogens from food workers to customers. Food service industry consultant, Archer Taylor, told 1998 Public Voice annual conference participants that hand washing is the food safety procedure most often overlooked. She said food workers are educated and know they should wash their hands, but hand washing doesn’t take place because workers are busy and management doesn’t insist that hand washing procedures are followed. A posting on USDA’s Foodsafe list serve corroborates this assertion. A Serve Safe instructor complained that restaurants are more interested in acquiring food safety training credential-ed staff than implementing the food safety practices the staff learned.

Clearly, food safety training and food safety policy implementation are important components of industry efforts to comply with regulations and reduce public health risks. An article in an Australian food industry journal noted:

“A successful (hygiene) program requires a committed manager. If management is not concerned about hand washing, employees will not be concerned. Recognition should be given to employees who adhere to personal hygiene principles.”

A food safety supervisor recently posted a message on USDA’s Foodsafe list serve that emphasized the role of positive incentives in encouraging application of food safety training. The New York newspaper article regarding violations of food safety retail regulations cited experts who correlate adherence with food safety practices to management leadership: “stores that regularly pass inspections make it clear to employees that food safety is important.”

Unfortunately, some retailers are enforcing dangerous so-called safety policies. A consumer recently wrote to S.T.O.P. to complain that a worker at a top-grossing, national fast food chain used bare hands to put burgers on a grill and to place lettuce, onions, pickles and cheese on hamburgers. A supervisor told the customer that the handling method observed was the standard. The supervisor explained that the handling didn’t affect the safety of the product because the burger was treated prior to cooking to remove all E. coli. A customer service representative from this prominent fast food chain later told the consumer that bare hand contact was condoned because the burgers were cooked and cooking kills pathogens.

Considerations and Recommendations

S.T.O.P. supports establishment of food safety standards that protect public health. Protection of the most vulnerable consumers should be the goal of the minimum standard. A lack of scientific data on fine details of regulation should not become an excuse to remove a public health protection established in response to actual incidences of foodborne illness.

Development of regulations and recommendations should include review of typical business and consumer practices, but the regulations and recommendations should not merely codify present business practices. Likewise, scientific limits should inform regulatory development, but not dictate it. The effectiveness of food safety enforcement programs and laws and the rate of compliance with food safety regulations and laws, should guide the degrees of stringency incorporated into food safety standards.

A. Epidemiology

Epidemiological evidence clearly proves that bare hand contact with food has repeatedly resulted in foodborne illnesses. Even incidents in which there was only incidental bare hand contact with food, such as placing garnishes and mixing drinks, have resulted in documented illnesses. With hand washing and bare hand contact violations holding steady, it is very likely that outbreaks will continue. This month, a single, ill food worker has been implicated in a new Norwalk-like virus outbreak that sickened 39 people at an Ohio country club.

Epidemiological data is not comprehensive because the surveillance system is passive, many illnesses are not diagnosed, the source of illnesses often cannot be identified and factors contributing to the transmission of illness often cannot be determined. The surveillance system should be improved to strengthen the epidemiological base upon which regulatory decisions are made. Better information would help identify specific causes of illness, numbers of people affected, severity of illnesses and effects of interventions.

The surveillance system would be strengthened if:

· all states reported CDC notifiable illnesses,
· there were greater continuity between local, state and federal investigation and surveillance practices,
· all foodborne illnesses were investigated,
· incentives and disincentives for reporting were adopted and
· origin labeling were required for all foods.

B. Current practices and compliance levels

An understanding of current practices is needed to evaluate the effectiveness of existing programs and to assess the need for additional safeguards. Review of current business practices should include rates of deviation from hand washing and contact regulations and levels of industry compliance with voluntary programs and HACCP plans. It would be helpful if state regulators with hand washing and contact prohibitions would compile this data. Inspection records should contain compliance data. A survey of industry practices and voluntary guidelines would also be useful.

C. Hurdles

S.T.O.P. supports multiple hurdle approaches to food safety. Usually a combination of errors leads to illnesses. FDA’s literature review cited the following practices combined with food worker contamination of food to cause illness: tainted food-contact surfaces, cross contamination and temperature abuse.

Some members of the food industry appear to favor a single hurdle approach to food safety. The Food Marketing Institute has cited studies to assert that handwashing alone is sufficient to protect consumers. They note evidence that those who hourly sanitized hands had lower microbial values than those who wore gloves, that microbes grow in the moist and warm glove environment, that viruses can move through the gloves tested to contacted surfaces, and that the microbial values for the exterior of gloves exceeded those of regularly sanitized hands. It is clear from the incident mentioned earlier in this presentation, that at least one large fast food chain is relying upon a single hurdle, proper cooking, to compensate for poor handling practices.

These attitudes are disturbing. Reliance upon any single factor to control foodborne illness increases illness risk. If bare hand contact with raw food is allowed and a cooking error is made, the chance that food will be contaminated by bare hands and that illnesses will occur increases.

S.T.O.P. questions the assertion that hand washing alone will insure adequate consumer protection from contaminated hands. Hand washing combined with measures to prevent bare hand contact with food -- such as use of tissues, serving utensils or gloves -- improve chances that food handlers will not transfer pathogens to foods.

D. Research bias and financial disclosure

S.T.O.P. has encouraged the federal government to require Committee members to disclose financial ties to food related interests and to implement conflict of interest policies. Clearly those profiting from the marketing of food safety products have an interest in supporting policies that enhances the image and sale of those products. NACMCF members with financial ties to industries with an interest in the outcome of certain proceedings should recuse themselves from discussion and voting on those proceedings.

During its deliberations, S.T.O.P. also urges the NACMCF to consider the potential biases of those presenting information for its review. FDA’s White Paper acknowledged that most of the research conducted on the issue of hand washing was financed by food safety technology companies. Greater emphasis should be placed on studies that are published in peer-reviewed, scientific journals that have financial conflict of interest policies in place. Committee members and the public should be notified of potential biases when information is presented to the Committee. Research funding sources should be clearly identified in verbal presentations to the Committee and in written materials supplied to the Committee. The Committee should also note instances where particular research is needed or data from an independent source is desired.

E. Adequate data

S.T.O.P. suspects that the issue of bare hand contact has been reduced to a discussion of glove use because little information on other bare hand contact barriers exists. FDA’s White Paper noted “gloves were the only barriers that were included [in the report] due to lack of available data regarding other barrier methods.” S.T.O.P. is disappointed that the Committee would consider weakening this important public health precaution when so little data on the issue, particularly data that is not financed by food trade associations or technology companies, is available.

The Food Code’s bare hand contact ban is achieved through a variety of means. Weakening the standard recommendation based on data gathered on one barrier method is unjustified. Before the Committee considers changing the standard recommendation, it should assemble data on other barrier methods, such as tissues and tongs.

F. Priorities

Food safety is a large and complex issue. As foodborne illnesses continue to take their toll, the relative importance of food safety policy increases. Unfortunately, there isn’t sufficient information to address each policy challenge definitively, and it is very unlikely that resources will be available to fund research that will provide answers in the near future. In the mean-time, decisions must be made upon the best available data and our government’s commitment to protecting public health.

It has been definitively demonstrated that bare hand contact has caused a significant number of foodborne illnesses, that multiple barriers reduce the probability of contamination, and that hand contact barriers are effective in reducing illnesses. Currently, there is a foodborne illness epidemic in the U.S. There are fine points about barrier effectiveness that could be explored if there were ample research resources to do so, but it is unlikely that sound research will be available soon.

The Food Code is a model regulation that should reflect the best recommendations to protect public health. In the absence of sufficient data to discount the effectiveness of preventing bare hand contact with RTE foods, S.T.O.P. recommends retaining the Food Code ban. Prohibiting bare hand contact prevents food workers from infecting food and causing foodborne illness.