As the Leafy Greens Marketing Association webinar on the cyclospora outbreak began, Jennifer McIntire, founder of Food Safety Strategy and former chief food safety and regulatory officer for the International Fresh Produce Association, said it’s natural to shift the focus to “What can we do to make sure this doesn’t happen again?”
She says it’s important to pause and look at what type of food safety measures are already in place and ask if those are sufficient.
“My assessment, based on the current LGMA metrics, is that they largely do address Cyclospora risks if they’re followed, if they’re implemented very well,” she says.
Biological Barriers That Make Cyclospora Hard to Treat
McIntire shares some of the unique biological challenges to cyclospora that make it more difficult to manage than E. coli or salmonella. First, McIntire says the parasite doesn’t grow in a laboratory setting or on a product, which limits research and effective testing methods.
“Because we can’t stick it in a test tube and create a culture of millions and billions of cyclospora we just don’t have that much cyclospora to do research on to answer a number of questions that we have,” she says.
She says the lack of organisms is a significant barrier to better understanding of treatment methods. It’s also resistant to standard antimicrobial water treatments such as chlorine and peracetic acid.
“A really weird thing is that it’s not immediately infectious,” she says. “It seems that this organism needs some time outside of the host in order to transition to move through its life cycle and become infectious. ... It’s not clear that there’s this direct fecal-oral route associated with illness.”
McIntire says researchers don’t really know why, but the illness strikes in the summertime, peaking in June and July. What researchers do know is that humans are the host and human fecal matter in sewage is the issue, she adds.
Why Prevention, Not Testing, Must Be the Focus
McIntire says there needs to be a focus needs to be on preventing the introduction of contaminated fecal matter, which could be through people directly (hands, shoes) or a contaminated water system through sewage.
“Preventing that introduction of fecal material is the top approach,” she says. “I think it’s kind of the only approach, one of the only really effective approaches that we have right now.”
Water testing and product testing are not a control, says McIntire, adding that that if the organism is detected, there are few opportunities to remove the parasite once the product has been contaminated.
“There are many reasons that testing has its limitations,” she says. “We know a lot of them in terms of just street statistics, but some of these challenges with testing are really exacerbated for cyclospora because it won’t grow.”
McIntire says if a company tests 25 grams of a product, it is essentially “looking for a needle in a haystack.” A larger sample size might provide a greater chance to detect the presence of organisms, if they are there. She says the type of testing for cyclospora isn’t something all laboratories can do, and there are significant issues with it.
“Even if you can crack open this kind of hard-shelled organism and get that genetic material out, there are several technical barriers to being able to effectively test,” she says. “There are questions around if you get a positive and what does a positive mean. Does it mean that you just happen to find some of this molecular material that triggered the test? Does it mean that there was an organism there? But we don’t know if it’s alive or dead. Even if it’s alive, is it infectious or not? What stage in its life cycle is it?”
McIntire says the announcement from the Food and Drug Administration on a false positive and traceback information underscores the challenges in testing for cyclospora.
“If FDA has trouble with the test method when they’re doing targeted testing and they are the ones who developed this method, well, how are the rest of us supposed to be able to use and trust the results of this type of test?” she says. “I will say, though, I don’t think that, as I suggested in my talk, testing is not the be-all end-all, and so a confirmed positive tells you a lot; a negative doesn’t mean that it’s all clear. And so, I think we need to be realistic about what testing — even under the best of circumstances, reliable circumstances — what testing tells us and what testing doesn’t tell us.”
McIntire says the unknowns in cyclospora are even more reason why additional research is needed. She says when there’s an outbreak, such as the one currently happening, it’s either an education or training issue, a system failure or, through root cause analysis, something new.
4 Actionable Steps for Fresh Produce Growers and Buyers Right Now
- First, McIntire says, adhere to metrics and the Produce Safety Rule with cyclospora in mind. “Really thinking about your growing environment, your conditions, what the metrics say, what you have to do — but [also] thinking about how they really apply to this issue of raw sewage and human fecal contamination,” she says.
- Second, for buyers, it’s important to verify products imported from other regions, McIntire says. Focus on the Foreign Supplier Verification Program. “If you’re a buyer subject to the Foreign Supplier Verification Program, in my experience, most buyers say, ‘Give me your third-party audit; OK, I’ve satisfied FSVP,’” she says. “Is there a better way to verify that controls are in place through the supply chain that are focused on prevention?”
- Thirdly, the Center for Produce Safety is currently seeking research proposals; McIntire says this is a chance for the industry to weigh in on some of the key questions surrounding cyclospora that need to be answered. “I feel it would be a really missed opportunity if the industry, buyers and growers, didn’t take advantage of this time to come together and to align on what are the key questions related to cyclospora that have to be answered that CPS could help fund. So, submit them to CPS,” she says. “CPS wants to hear from everyone on what those priorities are, not just for Cyclospora, but if you have other produce safety priorities, it’s all fair game. But I think given the crisis that we face right now, it would be prudent to align on cyclospora research priorities.
- And lastly, McIntire says it’s critical the fresh produce industry learns from the root cause analysis for future prevention and understanding. “My hope is that anything that’s uncovered from the outbreaks that have occurred historically, that are occurring this year, that may be occurring right now, that we do learn from these things and identify opportunities for more education, for better implementation and, perhaps, for research,” she says.


