Testimony Regarding Juice HACCP Issues

Laurie Girand, Advisory Board Member; S.T.O.P.
Meeting to Discuss Implications of Penetration of Pathogens into Citrus Fruit
and Juice HACCP Issues
Washington, DC
December 8, 2025

Thank you very much.

Three years ago, in December of 1996, many of those here were invited to Washington, DC to discuss the state of unpasteurized juice. I remember that time vividly because when I learned that no juice victims had been notified or invited, I cried. Shortly thereafter, I joined a nonprofit organization called S.T.O.P. -- Safe Tables Our Priority, which consists of victims of foodborne illness, their family and friends who are committed to ensuring that the foodborne tragedies they have experienced are not needlessly repeated.

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My own intimate association with juice safety began in the fall of 1996. When my husband and I returned from our parents-only vacation, our only daughter, a 3 year old had had diarrhea with stomach cramps for four days. My mother had told us that she had bought a couple of quarts of Odwalla apple juice while we were gone and that Anna had really liked it. In the night, the cramps would cause Anna to awaken in agony, screaming. During the day, she would lie listless in my lap, moaning, "My tummy hurts. My tummy hurts." Because she was refusing to drink, her doctor asked us to push fluids. So we bought Anna more Odwalla apple juice--after all, the company slogan was "Drink it and thrive." It wasn't until the eighth day of her illness, when Anna was finally hospitalized, that the doctors first told of E. coli O157:H7.

On the 10th day of Anna's illness, they discontinued fluids of all kinds because her kidneys were failing, and she was beginning to swell. They had to cut off her hospital bracelets which became constricting. She would beg us for water but we could only give her one swallow per hour. Her lips became cracked and bloody; her speech slurred. Her urine turned, what they call "tea" colored. Then, because of an allergic reaction, doctors stopped her first transfusion, and we waited another 15 hours before they started a second.

And then the face of death came to visit my only child, my baby girl. From the anemia, her lips and gums turned gray. Her puffy face was ashen. Her bloodwork indicated she should be dialyzed.

Ultimately, our daughter was discharged, but we will never have the good fortune to be able to describe her as recovered. People who appear to recover from the initial HUS illness are at risk of developing chronic conditions such as complete kidney failure even a decade later. At least four of the surviving Odwalla children presently suffer from gastrointestinal ailments that suggest their colons have not recovered. Over half of the 70 Odwalla victims were under the age of 6. Another toddler named Anna died in that outbreak.

U.S. Outbreaks/Recalls Unpasteurized Apple Juice/Cider

When I learned that these children had been poisoned by unpasteurized juice and that government and industry had known it was possible that this would happen again, I was outraged. Parents should not be misled into believing that unpasteurized beverages are healthier for their children. Here on the cusp of the millennium, with technology readily available, no one should have to die from drinking juice. No one should be unwillingly sacrificed on the altar of freshness. Yet, less than two months ago, three children's lives hung in the balance again from HUS caused by contaminated unpasteurized apple juice.

But today we're not here to rehash apple juice. We're here because the citrus juice industry has wanted to convince the FDA that orange juice is somehow different than apple juice. In fact, the two are different. In 1999 alone, unpasteurized orange juice has caused the two largest, identified unpasteurized juice outbreaks in the world.

U.S. Outbreaks/Recalls Unpasteurized Orange Juice

This is a list of known, unpasteurized citrus juice outbreaks caused by U.S. producers in the United States. This data does not include additional outbreaks from insufficiently pasteurized citrus juices and concentrates.

S.T.O.P. is here today to describe the qualitative side of the numbers and charts you will be shown, the human cost of outbreaks that is not typically measured. To epidemiologists and doctors at the CDC and to investigators at FDA, we are numbers and percentages for the purposes of reporting. Yet, officials can't begin to count the people whose doctors simply don't culture a diarrheal. They won't follow up on miscarriages and stillbirths. They don't ask about the children turned away from Emergency Rooms. And importantly for you, as you weigh risk factors, they do not begin to measure the long term cost to people with kidney failure, chronic bowel problems, diabetes or reactive arthritis that can result from foodborne illnesses. Juice victims are not just statistics; we have faces. Here, are two.

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This is Brandi and Tanner Ulrey. Brandi was eight weeks pregnant with her second child when she and her 2-year old son went out to breakfast with her father. It was to be a joyful occasion; Brandi planned to tell her father for the first time about the pregnancy, and they would talk about her college commencement just 9 days away. She had been attending night classes for three years to finish her degree. They were expecting 15 friends and relatives to come for the celebration. At the restaurant, Brandi ordered orange juice for Tanner. As the meal unfolded, and she told her father the good news, she took sips from Tanner's juice.

The next night, Tanner had diarrhea and abdominal cramping. His parents were awakened at 3:00 a.m. to the sound of Tanner screaming. He had thrown up all over his bed and pooped in his pants, and was trying to make it to the bathroom. By the next day, Brandi was also sick with diarrhea, abdominal cramping, nausea and a headache. For the next four days, she held Tanner as he screamed and cried, in between trips to the bathroom. When an attack was coming on, he would clutch his tummy and fall to the floor, while crying out, "Mommy owie, owie, owie." During that time, she called the triage line four times in two hours, but they kept telling her that he hadn't been sick long enough.

On the fourth day of Tanner's illness, the doctor said it was likely just a "tummy bug." Though the doctor noted blood in his stool, she told Brandi that if Tanner still felt ill in three days the doctor would request a culture then. While they were at the office, Tanner suffered a bout of cramping, and the doctor commented, "Little kids don't understand what a tummy ache is, so it's scary for them. That's why he's screaming." A teenager suffering from this same outbreak was put on morphine for the pain. Brandi told the doctor that she was pregnant, and asked her if the illness could harm the baby. She was assured that the flu would not harm the fetus.

Over the next several days, Tanner began to get better, but Brandi's condition deteriorated. On the eighth day, she vomited until she was dry-heaving, and then collapsed on the floor of the bathroom. Her head ached so badly that she could barely move. Her stomach churned and gurgled. Her husband managed to get her into bed. She slept for four hours, and when she woke up, she had begun to bleed vaginally.

On the tenth day, her graduation day, she woke up with contractions and diarrhea. She was bleeding heavily by this time, and was in a lot of pain. Brandi's mother-in-law mentioned that she had seen news about the Sun Orchard outbreak, and that the symptoms described matched what Tanner and Brandi had been going through. Brandi called the restaurant. A manager there assured her that they had never carried the tainted juice; all of their juice had been pasteurized ­ but he did say that just "out of courtesy" they had pulled all of their juice from the shelves. Several weeks later, the family would have genetic fingerprinting from Tanner's positive culture that pointed right back to that restaurant. That same restaurant is, even today, serving unpasteurized juice that is noted as "fresh squeezed" on the menu.

Brandi never made it to commencement. Instead, she was rushed to the ER. Diagnosis: complete miscarriage.

In addition to Brandi and Tanner, almost 500 other identified victims, and countless others that went unidentified, were affected by the Sun Orchard fiasco, victims who ranged in age from 2 to 88. One was an Alzheimer's patient in an institution. And Sun Orchard orange juice was implicated in the death of a senior citizen. You won't hear his name today because Sun Orchard has settled with his family. This man, a father, was taken out to a Father's Day meal and served unpasteurized orange juice. I think he deserves a moment of silence. Because three years have gone by since the 1996 juice meetings. Three years of delay. Three years of illnesses and death. Three years of acting as if we haven't had enough science when a solution was available three years ago.

Let's talk about science and risk assessment, for a moment. S.T.O.P. has been skeptical about the strength of analysis behind the recommendation of a 5-log reduction as sufficient to render juice safe. We have repeatedly asked for data supporting it. A number of assumptions were made by this committee; assumptions that in the last three years seem to have been proven less and less valid. Here are seven key points that we believe refute the validity of 5-logs.

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Flaw in Development of 5-Log Standard
* Consumption of juice underestimated
* Levels of contaminant in feces underestimated
* Fruit for juice is usually considered "juice grade"-ignored
* Growth of pathogens on fruit ­ ignored
* Quantity of contaminated fruit underestimated
* Final contamination rates in juice underestimated
* Pseudo-validation with insufficient standards

We have data for these, and in the interest of time, we will distribute it later today:

If you have any doubt in your minds after three years as to whether 5 is the right number or not, then you owe it to consumers to adopt more conservative recommendations.

But let's put the question of whether 5-logs is sufficient aside for the moment and talk about a series of issues that are being raised today. In developing the juice performance standard, the committee treated the issue of organism reduction as a black box .

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Fruit went in, never mind its condition, temperature or how much the pathogen load was on it. Juice came out at the other end.

By not recommending any specific, proven technology by which this standard could be achieved, you left FDA and industry the enormous task of defining what could and couldn't take place inside the black box. Because this committee's recommendation was so unspecific, the industry has been developing ways to wash the fruit in Florida and juice it at a grocery store seven states away and claim that it has been treated for safety purposes as if it were heat pasteurized. Small operations, juice bars and smoothie restaurants were declared exempt as if they had some unique way of keeping their juice safer, even though they played key roles in the Sun Orchard and Livesay Orchards outbreaks. The result has been that consumers have been used as guinea pigs.

As you review the latest data over the next few days, we urge you to consider the following. Your charge is not to defend average consumers against the average juice producer. Rather, you must produce recommendations that protect all consumers from producers that, through ignorance or negligence or economics, produce significantly contaminated juice.

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Risks Factors Not Quantified
* No standards for incoming fruit sanitation
* New technologies not validated for all cases
* Juices vary dramatically in acidity, particles
* Small companies do not have resources to define parameters specific to their juice
* Multiple reduction steps increases risk of error, growback

To assume that these factors are trivial matters of implementation is a luxury. Industry and consumers need a straightforward solution that even the smallest producer can implement. Today in this room, we need applied science, not just a gedanken experiment.

When this group addresses risk assessment over the next two days, S.T.O.P. urges that you add safety margin that takes into account the way some members of this industry have responded to the need for safety. Food safety is only as good as management's commitment to it.

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Some Juice Producers' Commitment to Safety
* Lobbying Congress to stop FDA funding
* Pressuring FDA to grant labeling extensions
* "WE have the most to lose,"- Mark Isaacs
* SSOPs support known hazardous processes

Mark Isaacs, President of Sun Orchard and former President of the American Fresh Juice Council, at the Florida meeting publicly stated that INDUSTRY had the most to lose from an outbreak, when consumers pay with their lives. Many members of the unpasteurized juice industry want to produce safer juice; you must ensure that those that are not committed to safe juice produce safe juice as well.

S.T.O.P. believes the answer for juice today is a single killstep prior to packaging, not a multiple step Rube Goldberg contraption. With heat pasteurization, government and industry have settled on a safety standard for milk that has served consumers well for decades. Based on the juice outbreaks visited on consumers in the pursuit of more science, S.T.O.P. has become convinced that in the United States today, all juice should be heat pasteurized. Rather than start with a minimal standard and keep increasing it as outbreaks occur, we would urge this committee to adopt a higher standard.

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S.T.O.P.'s Juice Safety Position
* Single killstep
* Heat pasteurization
* Mandatory for all processors
-->until alternatives are proven as safe and reliable.

The new juice performance standard must take into account that there is no minimum level of sanitation for fruit as an input to juice and that you and FDA are unable to guarantee it. The new performance standard must take into account a high level of pathogenic contamination, coming in on a large quantity of fruit, growing higher under unrefrigerated conditions, potentially spreading and uptaking pathogens through water, arriving in a juice that is less acid than expected. It should recognize that the juice will be produced at small orchards, large plants, restaurants, juice bars, and grocery stores. If you intend to continue supporting multiple reduction methods, then you must increase the standard as well to take into account the risk of failure inherent at and between each step. Ladies and gentlemen, you decide: either you are creating a safety net or it's just a collection of loopholes.

If there is only one proven technology that achieves this performance standard today, you should recommend it. S.T.O.P. believes that technologies other than heat pasteurization may ultimately be equivalent to heat pasteurization, but until then they should be withheld from commerce and should be required to petition FDA for equivalency once they've proven themselves on industry's time.

I'd like to close on this note. This year, my daughter is in the first grade, and she was asked to write about what she would like to do when she grew up. She doesn't really know what she wants to do, so she wrote this.

(slide) ("I like to sev piplle fram apple Jus and pet Reewood")

It reads: I like to save people from apple juice and get awards. You know, my prayer is that when my daughter grows up we will not still be trying to save people from unpasteurized juice. Three years is much too long when the technology to solve this problem has been around for 100 years. The time has come to use it.

Thank you very much.