DE ANN DAVIS, Vice President Food Safety & Quality, Church Brothers Farms, True Leaf Farms

Gone are the days of the potluck supper being representative of a big outbreak. Not only did an outbreak in those pre-PulseNet days need to “big” for it to be identified, but pulsed field gel electrophoresis (PFGE), which was commonly used for detection, had distinct limitations. Today, whole genome sequencing (WGS) is revolutionizing investigations into foodborne illness in a way that goes beyond anything PFGE could do. But with this new technology, is it time to update our definition of an outbreak? For example:

1. Merriam-Webster defines an outbreak as: “a sudden rise in the incidence of a disease — an  outbreak  of measles.”
2. CDC’s definition takes a different twist. Its website states that an outbreak is  “the occurrence of more cases of disease, injury, or other health condition than expected in a given area or among a specific group of persons during a specific period. Usually, the cases are presumed to have a common cause or to be related to one another in some way. Sometimes distinguished from an epidemic as more localized, or the term less likely to evoke public panic.”
3. The Public Health Agency of Canada (PHAC) defines an outbreak as “an incident in which two or more persons experience similar illness after a common source exposure. An outbreak is identified through laboratory surveillance or an increase in illness that is unusual in terms of time or geography. An outbreak is confirmed through laboratory and/or epidemiological evidence.”

There are some nuanced differences between the CDC and PHAC definitions. Nevertheless, historically, the defining elements of an outbreak included having a common food, linked multiple illness, and a distinct period of time. Now, WGS is pushing back on how we describe the source of an outbreak (e.g., food vs. shared equipment, land, water, etc.) as well as the element of time. Even linked multiple illnesses span a timeframe — and potentially a geography — much wider than we’ve seen in the past. At what point do we stray so far from our conventional thinking of an “outbreak” that we call it something else?

What makes WGS extremely powerful, and what challenges the definition of an outbreak, is the ability of the technology to identify illnesses over the long haul. No longer do we need a “sudden rise” in the incidence of disease. And indeed, there are several examples of long-standing issues that have been uncovered using WGS. Additionally, WGS may untangle epidemiological investigations if the actual source is not a specific food product.

This can be illustrated through two types of “outbreak” scenarios:

• Environmental contamination of a facility. Environmental pathogens such as Listeria monocytogenes and Salmonella can lurk in manufacturing environments and contaminate food products, causing illness. They can be difficult to eradicate, meaning that food can be contaminated over a long period of time. Additionally, because it’s a facility issue, more than one food type can be contaminated. Has WGS moved us from linking an outbreak to a specific food toward a common source that could be a conveyor, water, field, harvest bin, tote, etc.? If WGS is able to show that illnesses are genetically linked, what would the role of epidemiology be if different people reported consuming different products? It’s quite possible that there would be no suspect food that could be traced. As the PHAC outbreak definition suggests, laboratory surveillance alone could be sufficient to call something an outbreak.
• “Natural” recurring contamination. Say you’re a farmer whose field happens to be below the path followed by migratory birds. Each year the same birds fly over, making sporadic deposits on your harvest. If you are growing fresh produce that lacks a kill step, someone (or maybe two, three, or more people) may become ill from this situation. For the sake of illustration, let’s say one person became ill in 2015. The next year, someone else becomes ill. But since it’s the same birds or flock, WGS shows a close genetic relatedness between the two illnesses. Does this now meet the definition of an outbreak? While this is an extreme example, it’s entirely possible — and plausible — that WGS would be able to detect this kind of occurrence.

Are we saying that illnesses related to these types of events shouldn’t be investigated? Absolutely not! It’s imperative that these issues be discovered so additional illness can be avoided. Further, public health agencies should get credit for recognizing these issues. But words matter, and in the past, calling something an outbreak elicited a focused consumer response aimed at avoiding illness. Given the potential of WGS to uncover long-standing issues that only occasionally cause illness, will consumers experience “outbreak fatigue” the way they have experienced recall fatigue? Calling linked cases outbreaks may dilute the urgency of a consumer’s response to take action.

Outbreaks that last for years even though the number of cases remain in the single digits (e.g., Blue Bell with 10 cases reported over five years, CRF Frozen Foods with nine cases over two-and-a-half years, etc.) represent situations so far from our classical definition of an outbreak that maybe we need a new term. It’s time to rethink what we mean by outbreak.

What do basil, black pepper, coriander, cumin, curry powder, oregano, white pepper, red pepper, paprika and sesame seeds have in common?

The most general answer, of course, is that all are spices or herbs. Running a close second is that imports are the major source of the U.S. spice supply. But what you may not know is that these spices and herbs have become a key focus on FDA’s radar because of the high risk of contamination, particularly in those that are imported. These can be highly susceptible to pathogens because of the way they are harvested and dried, primarily in developing countries.

According to USDA, more than 95% of coffee/cocoa/spice products consumed in the U.S. are imported, with the dollar value of imported spices nearly doubling between 2009 and 2014 (the most recent year for which USDA has data) from $647 million to more than $1.34 billion. But, in its 2013 spice risk profile, FDA found imported spices  to have an estimated 6.6% Salmonella prevalence rate at port of entry into the U.S., with some countries being significantly higher, such as Mexico’s which hit 14%. Additionally, there was a 12% prevalence of filth adulteration in the spice shipments.

On a positive note, the agency’s follow-up 2017 spice risk profile found that this risk is greatest at import, with no spices having a Salmonella prevalence rate greater than 0.65% at retail, and many at or nearly reaching zero. In the report, FDA stated that it sees this as consistent with the assumption that most (bulk) shipments of spices undergo a pathogen reduction treatment in U.S. processing. It also is consistent with the most recent data from CDC’s Foodborne Outbreak Online Database (spanning the years 1998-2016) which show only 18 foodborne illness outbreaks linked to herbs or spices resulting in 859 illnesses, 19 hospitalizations, and no deaths.

But because there is so much risk associated with spices, even these numbers are of concern, enough so that FDA is increasing its oversight to ensure that the risk is significantly reduced from import to consumer.

In a separate but somewhat related undertaking, FDA has begun a Microbiological Surveillance Sampling of fresh cilantro, basil, and parsley (along with avocado products) that are retailed without a kill step. Because of their susceptibility to contamination and the number of outbreaks that have occurred, the agency is testing for Salmonella and E. coli  (STEC) in these foods. Although the agency is sampling only fresh, raw herbs, it is focused on those of both imported and domestic origin, so is collecting samples virtually throughout the supply chain — prior to consumer handling.

So, if you sell spices, fresh herbs, or avocado products at retail or produce an RTE product in which these are used without a further kill step, FDA’s increased oversight is of critical significance to you. And that significance increases when one considers FDA’s current use of whole genome sequencing (WGS) which enables the linkage of pathogens from food or environmental samples to those of ill persons. Thus, when sampling data is logged into the National Antimicrobial Resistance Monitoring System (NARMS), it could link you as a source in an outbreak — past, present, or future.

There are very few foods that do not use spices or herbs, and you can be sure that whether FDA is showing up at your door to take samples for its microbiological surveillance or is simply conducting a regular inspection, your spices and herbs will be on their radar. The agency also has made it clear that it will be conducting the surveillance sampling in the same manner as a regular inspection; that is: no notice. And if a positive is found, action likely will be taken, which could include placing the firm on import alert, pushing for a recall, or issuing public warnings.

Spices and herbs are high-risk foods. And with Salmonella and E. coli being found in product, primarily at import but also at retail, FDA is concerned. Which means that you need to be concerned and conduct an intensive assessment of the steps you take for detection, prevention, and reduction of pathogenic contamination. Does your food safety plan include a focus on the herbs and spices you use? Do you have a stringent supply chain program? Are you in compliance with all relevant Preventive Controls of FSMA?

If not, you could be risking regulatory action.

Discussion of the need for supply chain transparency along with consumer communication and education is not a new topic for this column or QA overall. But until last month, I’d not known that consumers’ purchasing decisions based on product transparency, traceability, and authenticity could be wrapped into a neat, single-word package: buycott.

Although Googling the word pulls up more than two million results, it’s not one I’d come across until I read Michael Sansolo’s March 6 Morning News Beatarticle. The article discusses buycotting as an emerging trend in reaction to the new policies on gun sales of some retailers. In diligently searching backward through the web, I then found references to buycotting as far back as 1989, such as the LA Times article “ACLU Starts a ‘Buycott’ of TV Programs”. As described in that article, the union campaign included a buycott “in which members will be urged to go out of their way to buy the companies’ products.”

Buycott is defined by a number of online dictionaries as “the opposite of a boycott: deliberately purchasing a company’s or a country’s products in support of their policies, or to counter a boycott.”

So while it may be an emerging trend in the current political environment, any food business that has added label designations such as natural, organic, GMO-free, gluten-free, etc., can vouch that it is only the word buycotting (vs. the action it portrays) that is new to the food industry. Consumers have been buycotting — and boycotting — foods for years based on a vast array of social issues, such as ethical sourcing and humane treatment of animals.

Long aware of the negative impact of a boycott, businesses often seek to keep a low profile on controversial issues. However, because exactly the opposite is needed to encourage the benefits of a buycott, this trend of conscious buying is of importance to businesses of all industries and sizes.

Interestingly, even as I was writing this, I received a press release from a company that gets it — and broadcasts it right in the headline: “Consumers Have Spoken: Steaz Cactus Water now Steaz Prickly Pear Water.” The article goes on to cite Steaz CEO Linda Barron, who explained that the company’s consumer campaign showed that few understood what its product was. So, she said, “As a brand that is dedicated to consumer transparency and clean labels, we ultimately felt it was the right decision to relaunch the line with a name that better communicates what it is. Now we are shining a light on the prickly pear fruit, and consumers who are not yet familiar with the amazing functional ingredient will know exactly what they are getting.” 

Taking it a step further, the home page of the company’s website prominently displays its “best possible ingredients” sourcing with a link to “Go behind the label.” And it directly hits on consumers’ ethical sourcing hot button by discussing how “every sip makes a difference” in its fair-trade sourcing — i.e., purchasing the beverage will help save the developing world.

If you’ve ever had trouble convincing your E-suite that transparency, social responsibility, and ethical sourcing are more than a cost-center, they are good for business, you can now add consumer buycotting to your rationale.

The author is Editor of QA magazine. She can be reached at llupo@gie.net.

Have you ever asked yourself: How do I clean this equipment? How did this equipment get here? Does my boss know how much time it takes to clean and sanitize this equipment properly? Do engineers understand the food safety risk? Why are new food plants still installing equipment that is so difficult to clean? What are some practical solutions?

Cleaning time in food plants can be drastically reduced with good sanitary design of equipment. Substantial hours are spent cleaning poorly designed equipment such as warehouse storage rack legs, bins, silos, bucket-lift elevators, rotary airlocks, cyclone conveyance, underside belt conveyors, hollow framework, legs bolted to the floor, equipment spot welds, and recessed anchors, to name just a few.

Cleaning a storage-rack leg with a tethered, weighted, stiff-bristled nylon brush up and down the shaft, followed by vacuuming the droppings, is a somewhat effective approach for preventing an Indian meal moth infestation. But implementing this method on the leg of a warehouse storage-rack that is 30 feet high might take five minutes with three people: one on the lift, one on top, and one on the vacuum. How many storage rack legs are there in a warehouse? Assuming 1,000 legs per warehouse section times 50 sections, there are 50,000 legs, which equates to 12,500 hours to clean a warehouse storage rack system one time. But one time is never enough. Additionally, the design is made worse when the bottom shelf is positioned a few inches from the floor creating limited access to remove spillage.

This is just one example of the cost to clean poorly designed equipment that is commonly found in food plants. Equipment that is near or in the food-processing area typically has even higher food safety microbiological risks. Imagine the microbiological growth created from warm material flowing through an outdoor, 100-foot-high bucket-lift elevator and distributor in the cold weather. 

The optimal solution is to eliminate the need to clean. In the storage-rack example, you could eliminate the semi-open leg shafts, e.g. incorporating a solid or alternative design, to reduce the pest harborage areas. Eliminating the bottom shelf entirely would provide better access for cleaning. If the underside is partially accessible, a self-driven vacuum robot could be utilized but would still require vacuum cleaning of each leg anchored to the floor.

Other high-risk bacteria problems are the inability to properly clean equipment that has non-accessible void-space material (e.g., a double-lined coating drum) near post-kill material, as well as product coolers in that vicinity. Coolers are high risk for microbiological and insect contamination and must have the highest sanitary design.

There is a wide array of excellent reference material online for sanitary design of food equipment (e.g., http://bit.ly/2C6QbrE, http://bit.ly/2o1gIEq, http://edis.ifas.ufl.edu/fs119). Finding such references is not the problem; rather, an issue seems to be a lack of food safety and sanitation understanding within the architect, construction, engineering, and equipment-supply worlds. These industries probably did not have a food safety and sanitation curriculum in their studies.

PRACTICAL SOLUTIONS. One practical solution is to better educate these professionals. Food safety leaders must reach out in some manner to reduce the continuation of poorly designed equipment. Offer workshops, provide references, and review blueprints and images to brainstorm solutions before installation. Instead of reacting with laborious cleaning after installation, build in solutions that are more proactive to reduce cleaning costs. This activity will be a two-way learning curve as each will be learning from the other.

However, it is not enough. Equipment manufacturers should be held more accountable. As a condition of purchase, suppliers of food processing equipment should provide effective and efficient cleaning instructions. Providing this could move some suppliers into a more competitive advantage with better food safety and sanitation design.

Another practical solution is for top management to consider food safety and sanitation in their planning, budgeting, and acquisition. Low-cost equipment decisions can come with high-cost consequences. What does it cost to clean 50,000 warehouse storage rack legs four times per year? A million dollars? What is the cost to eliminate Salmonella in a food plant that was contaminated from an outside bucket-lift elevator? Some plants can’t do it and might eventually close.

FDA emphasizes that when evaluating hazards, food facilities must consider their effect on the safety of the finished food for consumers, as stated in 21 CFR 117.130(c)(2): “The condition, function, or design of a facility or its equipment could potentially result in the introduction of hazards into foods. For example, older equipment (e.g., older slicing, rolling, and conveying equipment) may be more difficult to clean (e.g., because of close-fitting components or hollow parts) and, thus, provide more opportunities for pathogens to become established in a niche environment than modern equipment designed to address the problem of pathogen harborage in niche environments; in such instances enhanced sanitation controls may be appropriate.”

Although older equipment is more expensive to maintain, new equipment should not be more expensive to clean. When one factors in cleaning costs, sanitary design of food equipment is not more expensive. Utilizing good sanitary design of food processing equipment will save money.