Speech by Laurie Girand of Safe Tables Our Priority
FDA Public Meeting: Produce Safety From Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated With Fresh Produce
June 29, 2025

I'd like to open with a quote from Mark Isaacs, of Sun Orchard.

"You know, we*, as always, have the most to lose and, you know, the newspapers and the press seem to forget that. But, you know, I would encourage everyone, each and every processor, to do their best to upgrade the safety of their product."

In the fall of 1998, the citrus juice industry had just convinced FDA that it should give them more time to explore the science of citrus juice safety. Their argument was that citrus fruit was uniquely different than apples and therefore their juice did not need to be pasteurized. At the time of this quote, Mr. Isaacs' company, which sold unpasteurized citrus juices, was conducting research into how to improve the safety of citrus juice without actually pasteurizing the juice.

Within seven months, Sun Orchard became responsible for the single, largest unpasteurized juice outbreak in the United States, which sent over 400 people to doctors and hospitals, caused at least one known miscarriage, and killed at least one person. In November of 1999, one whole year after this quote and three months after FDA allowed Sun Orchard to sell juice again, Sun Orchard was again in the news with a massive recall of contaminated juice.

Today, I want to remind you that industry does NOT have the most to lose from delays and outbreaks. I'd like to be sure that we are all clear about this. Consumers lose their LIVES from contaminated food. They can lose their livelihoods. They can also be left with lifelong injuries.

Haylee was 5 when she and her sister came down with bloody diarrhea. In three months of subsequent hospitalization, she also suffered from inhaling her own vomit, shock, pneumonia, diabetes, seizures and ultimately brain bleeding. She was subjected to extensive medical treatments: having multiple holes cut into her to perform dialysis and drain fluids from her chest, going on to a ventilator, and brain surgery. When she came home, she was blind and had to take 12 medications every day. Haylee was poisoned in 1996 by lettuce contaminated with E. coli O157:H7. Tragically, in the last year, seven years later, children, and the elderly, were again poisoned by pathogens in multiple outbreaks of lettuce and spinach. Like Haylee, Rustin was also 5. The latest lettuce outbreak is reported on CFSAN's What's New page, dated May 21, 2004. Outbreaks from sprouts have been ongoing since 1996. The latest sprout recall was publicized on June 3, 2004.

Everyone needs to understand that what we are talking about today is not just a little diarrhea. It is a very real poisoning of the body with foreign organisms, known in laboratories as biohazards, and to children, these organisms and their toxins can be lethal. Most children under 5 are unable to contain the bloody diarrhea that virtually explodes from their rectums. They scream in their agony. These organisms are also life-threatening to the elderly and people that are immune-comprised, including pregnant women. Not surprisingly, these three at-risk groups often seek the health benefits purported to come from raw fruits and vegetables.

It is critical that we all work from facts and the facts are these. The single largest source of contamination of produce is animal feces. The simple, direct proximity of animals-cattle, deer and other mammals and birds--and the application of feces, whether intentionally or unintentionally, to crops has been implicated in countless produce outbreaks. And when this contact has not been direct, it has been indirect by proximity. Flies and birds have been proven to carry fecal germs to fruit. Windblown dust can harbor organisms. In many outbreaks, fecally contaminated water has been sprayed onto, irrigated around, or runoff onto produce.

Science conducted in the study of sprouts has indicated that once pathogens are present in a sprout's water supply, pathogens are taken up by the root system and are then conducted internally to the top of the sprouts. Science has proven that pathogens exposed to lettuce are attracted to and absorbed at the broken edges of lettuce. Science has also proven that produce such as tomatoes and apples floating in contaminated water can uptake pathogens through the stem or flower end. So, once pathogens are present, the fruit or vegetable can become internally contaminated. Science has also proven that once E. coli O157:H7 forms a biofilm on the exterior of produce, it is protected to withstand rinsing and washing. In a study conducted by FDA researchers in Illinois, the only effective way to remove E. coli from the exterior of contaminated apples was with both heat and chlorine, not just one or the other. Science has demonstrated that E. coli can survive for months in soil, and up to a year in sheep manure, so the intentional application of manure results in long term contamination of the growing environment.

Science has also proven that the only effective consumer method for preventing illness against fecally contaminated fruit and vegetables is heating to high temperatures. Indeed, current advice coming from government about how consumers should rinse their produce under cold water reeks of superstition. Rinsing in hot water may reduce some organisms, but when the dosage of germs required to kill a child is less than 10 or as little as one organism, cold water will not prevent illness.

With these facts in mind, Safe Tables believes that three key underlying principles should guide the 2004 Produce Safety Action Plan. These are:

1. Our inability to remove pathogens once they come into contact with produce demands that we focus on preventing contamination.
2. All fruit and vegetables are not alike. The action plan must treat ground grown crops, which come into direct contact with soil, differently than pole grown crops, differently than orchard grown crops, differently than sprouts and wheat grass. Regulations must be developed that are "food-specific" and address hazards, harvesting practices, and post-harvest processes specific to the type of fruit or vegetable grown. Crop safety standards must be consistently applied across the country regardless of the size or location of the business.
3. As ongoing outbreaks in lettuce and sprouts have proven, voluntary guidelines do nothing to improve the safety levels of outbreak-causing producers. Only regulations can ensure that the bottom feeder producers and fly-by-night operations are required to comply.

In order to achieve safer produce, FDA must:

Regulate manure and the application of human waste to crops:

1. a.) Owing to the extended survival of E. coli O157:H7 in soil, the practice of applying untreated manure to any soil or crops for human consumption should be ended.
   b.) All animal fecal products should be aged for a minimum of one year or composted to eliminate pathogens prior to application of unplanted soil or to crops. Time and temperatures for composting must be scientifically determined to eliminate pathogens.
   c.) The success of composting and aging should be verified by testing.
   d. No animal fecal products should be sold or distributed without proper treatment.
   e.) Any animal-fecal fertilization must be applied prior to planting of the crop.
   f.)The FDA must set soil quality standards by level of biological contamination.
   g.) If a crop farm is adjacent to an animal farm or wildlife refuge or downhill from either, soil testing should be mandated. A positive identification of E. coli or Salmonella in crop soil should result in crop tissue testing.
   h.) The application of human waste, and undertreated human waste water should be strictly prohibited.
2. Restrict the proximity of livestock and animal farms to crop farms. Crops should not be grown close to animal farms, and in particular, downhill from them, to reduce the risk of contamination by runoff, insect transmission, and dust. Dust management programs must be introduced to animal farms.
3. Mandate water quality. FDA must set water quality standards. Only potable water should be allowed to be sprayed on crops. Ground irrigation water must meet or exceed quality standards. Using potentially lower quality water earlier in the growing process is unacceptable.
4. On farm inspections must ensure that these basic water and feces hygiene and sanitation regulations are followed. As one farmer reminded me long ago, "You get what you inspect, not what you expect."
5. Require national registration of all participants in the food growing and distribution chain, not just processors. FDA cannot communicate with businesses for which it has no records. It cannot inspect farms if it doesn't know whether they exist. Registering all food producers and ensuring that they must have either a fax or email address would enhance communication and accountability.
6. Require certification that proves that growers have read and are aware of FDA crop safety regulations and guidelines and without which, no one in the United States can sell food commercially.
7. Mandate a traceback system in which the sellers, shippers, distributors and processors maintain records and can quickly identify the sources of batches of fruit, vegetables and other crops, and the vehicles in which they were transported.
8. Mandate farm of origin and country of origin labeling on produce at retail. U.S. food producers concerned about cheap imports should recognize that safer food is a feature for which consumers are willing to pay more.
9. Maintain a list of nationally identified outbreaks, the organisms involved in the outbreaks, the ages of victims, and the foods involved. To truly own the issue of food safety, FDA must document and maintain information about outbreaks. This is also the only way to measure relative harm caused by different types of produce.
10. Penalize industries with producers that cause repeated outbreaks. Not only should a producer be held accountable, all similar producers should share the burden. Should a crop have more than three nationally identified outbreaks in a year, those foods should be required to bear red labels that indicate to consumers that the industry is unable to deliver safe products to market. With repeated outbreaks beyond these, FDA should require that the strictest growing conditions available be employed until the food safety record is brought back to par.

Safe Tables will make additional recommendations addressing processing, transportation and imports in its comments to the dockets.

In conclusion, I would like to remind all of you of Mr. Isaacs. In 1998, nearly 6 years ago, Mr. Isaacs and his company faced a choice: embrace and act on the current science of food safety or delay and experiment to see if other options existed.

Every person in this room today faces the same choice. As we deliberate, people's lives, and particularly those of children, hang in the balance. We urge you to avoid repeating the mistakes of the past.

Choose wisely.