United Fresh VP ‘mystified’ by FDA process; federal investigators say they still need information
By Coral Beach | May 8, 2018
Eight weeks after the first person became sick, government inspectors still haven’t been able to pinpoint who grew and distributed pre-chopped romaine lettuce associated with a deadly and ongoing E. coli outbreak.
Some in the fresh produce industry are blaming the Food and Drug Administration for the delay, saying the government hasn’t taken advantage of assistance the industry has offered.
However, the FDA and state officials have consistently said — through this outbreak and many others — that hand-written records, a lack of uniformity in traceability labeling, and incomplete shipping and receiving records are slowing the investigation.
Jennifer McEntire, United Fresh Produce Association vice president of food safety, describes the FDA’s investigation as “mystifying.”
“… we — allied associations and our members — have provided information about processing and handling as well as product shipment data,” said Jennifer McEntire, United Fresh Produce Association vice president of food safety.
“We have offered to help FDA understand water sources, relative locations of fields, how to interpret and use some of the information on records they are receiving, and provide insight on how different supply chains work.
“Perhaps it is skepticism of industry or concerns about handling confidential business information, but during an outbreak, I’d hope FDA and CDC would accept help if it could protect public health.”
In a statement Monday, FDA investigators reinforced what they said this past week. They are digging through the distribution records for romaine from two dozen growers in the Yuma, AZ, area.
The only solid information FDA has gleaned is that eight inmates in an Alaskan prison were sickened by whole-head romaine from Harrison Farms in Yuma. Almost all of the other outbreak victims reported eating chopped romaine during the week before they became sick. Many of the victims said they ate the romaine in restaurant salads.
One person in California has died as a result of the outbreak. At least 120 others across 25 states are confirmed sick. The first confirmed illness began on March 13. The most recent confirmed case began April 21. However, people who became sick after that have probably not yet been added to the CDC’s cast count because of the two to three week lag time between when a person becomes sick and when the illness is confirmed and tallied by federal officials.
Of those for whom complete information is available, 52 have required hospitalization. Fourteen, including several children, have developed hemolytic uremic syndrome, a type of kidney failure according to the Centers for Disease Control and Prevention.
“We are working to identify multiple distribution channels to explain the entirety of the nationwide outbreak and are tracing back from multiple clusters of ill people located in diverse geographic areas to the most likely, individual sources in the Yuma region,” according to FDA’s statement Monday.
As it navigates a web of growers and cross-continental distribution channels, the FDA is continuing its warning to consumers, restaurants, and retailers about romaine lettuce from the Yuma area. As with the CDC’s warning, FDA is encouraging people to avoid romaine unless they can confirm it is not from the Yuma area.
Since the CDC and FDA first reported the link between romaine and the E. coli O157: H7 outbreak on April 13, officials at United Fresh, as well as the Produce Marketing Association and the Leafy Greens Marketing Agreement organizations for California and Arizona, have been saying the harvest season in Yuma was wrapping up.
From November through mid-to-late March every year the Yuma area produces and ships more than 80 percent of the romaine grown in the United States. As the weather warms, the harvest shifts into the fields of California.
“Since romaine lettuce is no longer being produced and distributed from the Yuma growing region, the potential for additional exposure to the contaminated product is diminished. But due to the 21-day shelf life, we can’t be certain that all of the product from this region is out of the supply chain,” FDA Commissioner Scott Gottlieb said in the agency’s statement Monday.
Preventive controls need more teeth
The problems investigators are encountering currently aren’t anything new. In fact, traceability during outbreaks and recalls was one of the issues that prompted Congress to approve the Food Safety Modernization Act (FSMA). President Obama signed the legislation into law on Jan. 4, 2011. The rulemaking process then started and has been subject to multiple public comment periods and multiple revisions, especially to the crucial Produce Rule.
Some provisions of the Produce Rule go into effect this year. However, in the process of developing it and other rules mandated by the FSMA, government agencies haven’t been able to meet the intent of the law, in no small part to industry pushback.
Those types of stumbling blocks to preventive controls have frustrated many public servants and food safety advocates. Seattle food safety attorney Bill Marler is among them. He has been pushing for the food industry to step up since the deadly 1993 Jack in the Box E. coli outbreak. Marler testified before Congress when FSMA was being developed. He was also a vocal advocate for transparency and traceability during the 2006 E. coli outbreak traced to fresh spinach.
“It’s 2018, and we’re basically a month into this outbreak, and they can’t link it to a farmer or a farm or a processor? I mean, candidly, that’s ridiculous,” Marler recently told the Washington Post. “They’re now 12 years post-spinach, and traceability was supposed to be one of the big things that came out of that disaster. And it just doesn’t seem to be getting there.”
Similar to FDA investigators, Marler said he doesn’t understand why FSMA hasn’t made a bigger difference. He told Boston’s National Public Radio the technology exists, but the industry hasn’t upgraded. He told WBUR-FM that the ability for the FDA and state health authorities hands are tied.
“I think one of the flaws in the law is that traceability was expected to roll out a little quicker, and that’s probably what the main problem is here, the ability for the FDA and state health authorities to be able to pinpoint where the outbreak happened is just not there,” Marler said.
“The technology exists, but we are really going to have to relook at the legal requirements — that producers have a much stronger ability to be able to know what product is being used when — so there’s no ambiguity, and we can get to the cause of the outbreak much faster.”