Fresh Express Forms Blue-Ribbon Panel to Get Answers on Cyclospora

In late July, the FDA found that an unused package of romaine lettuce and carrot mix distributed to McDonald’s by a Fresh Express processor in Streamwood, Ill., tested positive for the presence of Cyclospora.

Romaine lettuce from the same lot was distributed in pre-made salads and wraps distributed by Caito Foods LLC, Indianapolis, Ind., though none were packaged for retail.

The FDA reported that as of August 23, there were 507 laboratory-confirmed cases of Cyclospora infection, spread throughout 15 different states, that came from eating those McDonald’s salads with the tainted produce.

An investigation by the FDA is ongoing and it’s now reviewing distribution and supplier information for romaine and carrots.

“We’re still not clear what caused that, the lettuce or carrots or some other source, but the bottom line is for the first time, we have a product produced solely inside the United States that is involved with Cyclospora,” says Michael T. Osterholm, PhD, MPH, a McKnight Presidential Endowed Chair in Public Health and the director of the Center for Infectious Disease Research and Policy.

To get answers, Fresh Express named Dr. Osterholm to head a new panel, which will be comprised of about eight experts in the field.

“Fresh Express has formed a Blue-Ribbon Panel of independent scientific experts to help better understand Cyclospora and to make recommendations for new or improved ways to prevent future outbreaks,” a Fresh Express spokesperson says. “At Fresh Express, food safety is our highest priority, and we are hopeful the panel’s work will shed light on this industry-wide problem in order to better protect public health and to ensure a continuing supply of healthy, safe fresh produce.”

Despite strong food safety standards and practices, unexplained Cyclospora outbreaks continue to occur in the fresh produce industry. These outbreaks have perplexed food safety experts and federal and state public health officials, as to how and why they originated.

“What Fresh Express has done, as they have in the past when issues hit the industry of some major public health importance, they’ve invested in finding answers,” Dr. Osterholm says.

For example, back in 2006 when E. coli became a real challenge with leafy vegetables, with nearly 200 laboratory-confirmed illnesses, 100 hospitalizations, and five deaths, even though Fresh Express’ products weren’t involved, the company put together a panel, which Dr. Osterholm also chaired.

“That helped define what the major challenges were, in terms of research questions and practices that needed to be adopted to address the problem,” says Dr. Osterholm, a world-renowned epidemiologist. “This new panel will take a similar path.”

The list of panel experts will be finalized before summer’s end, and will consist of a full breadth of those with knowledge on the subject, collaborating with officials from both the government and public health.

“We’re bringing together the brain trust of Cyclospora and looking at what we know and don’t know,” Dr. Osterholm says. “There are a lot of unanswered questions.”

In 1997, Dr. Osterholm wrote an editorial in the New England Journal of Medicine after the first Guatemalan raspberry outbreak was reported in 1996 in the U.S. In that he wrote, “there are many questions left unanswered and if we don’t answer them, we’re likely to see these seasonal outbreaks occur.”

“We unfortunately have had a spring/summer outbreak with a variety of produce items ever since 1996 and it just continues,” he says today. “We really need to continue to bring to bear a much greater understanding of the history of Cyclospora in the environment and how it might contaminate something like a leafy green. We’ve seen a number of outbreaks associated with cilantro and carrots. We’ve had outbreaks with berries. It’s very striking how it occurs almost routinely from mid-May through early July each year.”

The first goal of the panel will be to define what is known and unknown.

“At the end of this panel, our goal is to identify all the major unknowns we have to answer and we’ll explore these questions,” Dr. Osterholm says. “Plus, we will look at what we can do in the meantime to put another level of safety for good agricultural practices and good manufacturing processes for these products.”

Prevention, he adds, is the most important thing right now, and the panel of experts will review what can be done and what has worked in the past. Something as simple as safe water practices can help.

“We know in some areas of the world, particularly parts of South America and Central Asia, it’s likely contaminated water with feces from humans or animals may be involved,” Dr. Osterholm says. “We can surely put into place barriers relative to workers in a field in terms of sampling and we believe an extensive sampling program that could give us early warnings if there’s issues is important.”

The first meeting of the panel is expected to convene in October. A public report with findings and next steps is expected to released early 2019, well in time to be used for the next growing season.

“We will look at every possibility and this is information that will be shared across the industry,” Dr. Osterholm says. “We don’t view this as one company’s advantage over another to have more information or better information, this is an industry-wide issue that has to be dealt with as an industry as a whole.”