Hello, this is Julia Stewart, and welcome back to Produce Marketing Association’s new briefing series, “Ask Dr. Bob Whitaker”. PMA is excited to have this opportunity to use high-technology tools to bring you these personal postings from our new chief of technology, Food Science Officer Bob Whitaker.

Bob, the tomato industry is understandably upset about the ongoing foodborne illness outbreak that has been linked to certain types of fresh tomatoes. The Food and Drug Administration has been working for more than 10 days to identify the source of the contaminated tomatoes – but in the meantime many retailers and foodservice operators have pulled all tomatoes from their shelves and menus. Everyone in the produce industry puts public health and the health of our consumer customers, first and foremost. But now even safe production areas and products are being shunned by the market. Some production areas are at risk of losing their entire season, and tens of millions of dollars. Meanwhile, consumers are missing out on one of the true joys of summer eating, fresh tomatoes.

Can you explain why a traceback can take so long?

Dr. Bob Whitaker:

First let me say that at its very core, traceback is an investigation. It relies on data gathering and analysis. That process is performed under the simultaneous pressures of having to communicate sufficiently to protect public health and perhaps removing potentially contaminated products, while at the same time being mindful to minimize disruption to food supplies – and it has to be 100 percent accurate.

As state health agencies and/or CDC determine that an unusual illness pattern is emerging and they identify a causative microorganism, it triggers epidemiological studies to determine how people are becoming infected. Often this is called “identifying the vehicle”. One of the key questions epidemiologists ask patients is where they contacted the food product in question – be it restaurant, retail store, family picnic, school, church social, friend’s house, et cetera. They use a questionnaire to guide their questioning, but you can imagine how difficult this can be. Just think about it, can you remember what you had for dinner three weeks ago Wednesday? The epidemiologist is looking for the patient who can – and they need to be able to tell them where they purchased or ate the food. This can take several days or even weeks to find a handful of credible patients who can. When the epidemiologist can credibly link the patient with the food vehicle and a point of service location, it becomes an investigative leg for traceback.

FDA and state investigators begin traceback by visiting the points of service looking to establish a link between the food product and its source. As we all know, stores and restaurants often have multiple sources of any one item, so the investigators need to determine what suppliers potentially provided the item under examination. They also need to assess the time periods and quantities of product involved, along with the various types or varieties of the product — in the case of tomatoes, you might have, round red, cherries, Romas or plums, grape, on-the-vine, heirlooms, yellows, et cetera.

The efficiency of this process is largely based on whether the investigators can get access to complete purchase and receipt records from the point of service – in other words, this is where the quality of the supply chain’s record keeping becomes important. As the investigators visit multiple sites identified by credible patients, they can look for common threads, for example suppliers that are common to the most of the points of service. At this point, the investigators can contact those common suppliers and begin tracing the product back to the production site. FDA inspectors generally visit the distribution, production or supply facilities to interview the operators, and review records to be sure they tie in with the point of service documents. Again, the efficiency and the time needed to complete this task are often dependent on the completeness of the supplier’s receiving and shipping records. This process becomes further complicated when we have multiple states involved like we do currently, and while new cases are still being reported. The matter is made even more difficult because the produce industry is so complex. We can have many links in the distribution chain, from growers to packers, distributors, wholesalers, re-packers, processors, cooler, distribution centers and end users – so trackback can be challenging.

Early on in this most recent tomato outbreak, FDA contacted industry trade and commodity groups to help them understand how tomatoes move through commerce from grower to consumer. That tomato production is in a seasonal transition during the traceback of this outbreak likely complicated the situation. To date this tomato traceback has involved numerous site visits and thousands of pages of shipping and receiving records that must be reviewed and analyzed by FDA. This unfortunately, and frustratingly, takes time. It can be thought of as like solving a puzzle or moving through one of those kid’s mazes – except that before you can turn right or left, you must use the data you have in hand to guide your decision. It is important for the traceback investigators to thoroughly review the documentation because if they fail to do so, they can take a wrong turn in the investigative maze and waste time and valuable resources. I think that this tomato outbreak has been unusual in that, while this investigative traceback has been going on, the FDA has also been identifying locations the tomatoes could not have come from. They have done this by looking at the dates when illness started to appear and when certain areas of the country were producing tomatoes. Generally, if an area started production after the bulk of the illnesses occurred and they can document it, then it is not likely to be a source of the outbreak, and has been removed from the alert. So at least we’ve been able to exclude products and production areas along the way.

Once the FDA and state investigators identify a region and/or a supplier, they then begin the task of searching for a cause of the contamination. They often inspect the site and facilities and evaluate production records to verify that a food safety program was in place and was being followed as required by the plan. They may also sample raw or finished products (especially if the same lots are still available), and may wish to take environmental samples from fields, equipment, agricultural inputs and water for microbial testing. They may also interview employees and take personal health histories to see whether anyone who may have contacted the product had a similar infection. Their goal is to try to find the cause for contamination, so it can be mitigated and the industry can learn from it – and so public health can be protected.

As of today, FDA continues to work to identify the specific region and supplier where the contamination originally occurred. FDA has a process they must follow and a legal responsibility to make decisions based on the data they collect. This traceback started on or about June 2nd and so it has been ongoing, round the clock for about 10 days. This is agonizingly slow for those still included in the FDA alert with millions of dollars tied up in aging tomatoes that cannot be sold - but the first and foremost role of FDA is public health, and they cannot release product until the traceback is complete. We remain hopeful that FDA will have the source location identified soon.

I hope this helps everybody understand the elements and time requirements of traceback and why traceback isn’t just a matter of going to a store or restaurant where a patient says he or she ate, and finding the supplier responsible.

Julia:

When this particular situation is over, PMA will meet with FDA to talk about how the agency can improve its produce traceback procedures, and how the industry can facilitate that process. We’ve been able to help a lot this time, but we think that there is even more than we can do on that end. And it is no secret that FDA is underfunded and understaffed, and PMA has long advocated for more funding for the agency. Here’s where our audience members can help. If you haven’t already signed up for our grassroots advocacy group called GROW, please email your contact information to grow@pma.com — and the next time that our government relations team asks you to call Congress about FDA funding, please pick up that phone promptly. Thank you, and we’ll see you next time!

Hello, this is PMA Public Relations Director Julia Stewart, and welcome back to PMA’s new briefing series, “Ask Dr. Robert Whitaker.” This is our second installment in a series about food safety, science and innovation.

Before we get to today’s topic, we would like to take this opportunity to briefly update our listeners on the latest developments regarding the tomato foodborne illness outbreak that is gripping the nation. The Food and Drug Administration has not yet been able to specifically identify the source of the affected tomatoes – although they have been able to exclude a number of products and producing regions. Meanwhile, retailers and foodservice operators are pulling all tomatoes from their shelves and menus – even tomatoes that have been deemed safe.

Please know that PMA and our tomato industry allies are doing everything we can to speed FDA’s traceback. While we are not apologists for FDA, they believe they are acting in the best interests of public health. We also must, and do, put public health first. But at the same time, PMA and other tomato industry leaders have made it abundantly clear to FDA that we expect a speedy resolution to their traceback process – and that the entire tomato industry’s livelihood is at stake.

Now to today’s briefing. Bob, one PMA member who is following the salmonella saintpaul illness outbreak that has been linked to certain types of tomatoes has asked us …

Can’t I just test the product I have in my warehouse, to prove that it is safe?

Dr. Whitaker:

Sure, Julia, but first I’d like to let our listeners know that I’m already working on our next briefing, which will address the question of why FDA’s traceback process takes so long, so stay tuned for that topic.

Now to testing: Any producer can certainly develop a testing program for either raw or finished products – but it is important to understand what the testing data means, and more importantly to know what it does not mean.

To set up a testing program, first it is important to find a certified laboratory that uses FDA and/or AOAC-approved methodologies for measuring pathogens. It is important to understand their test procedures, the handling practices their laboratory set up, and how the data will be reported and to whom. It is also important to remember that testing takes time. You will need to incorporate this time requirement into your logistical programs – for example, if you are testing raw product prior to harvest, you will need to schedule testing in advance of harvest so that you can get the results back before you start the harvest. If you are testing finished products, you will likely want to “hold” the finished products until you have the results from the testing in hand. This can take 24-48 hours or more depending on methods used and results. You will likely want to “hold” the products because if you ship them and then receive a positive test result, you will have to recover or recall those products – and incur the costs and potential publicity that would entail. Besides the time lost on your product’s “shelf life,” you will also need the storage space to hold finished products prior to receipt of the testing and clearing the products for shipment, and be willing to incur those related storage expenses.

Once you understand the issues related to testing programs, as if that wasn’t complex enough, then you move to the more difficult issue of sampling. This is where perception needs to come to grips with reality, folks.

If a producer had a large, wide-spread contamination – let’s say the water used for rinsing the harvest totes was contaminated – sampling of raw product post-harvest may indeed detect the contamination, and the unsafe product could be destroyed. But absent a large or catastrophic event, the general feeling in the scientific community is that the contaminations that lead to foodborne illness outbreaks are at low levels and not widely spread – for example, all it takes is a single ill worker that did not wash his or her hands properly after using a restroom, and Now lets say that worker handles perhaps a few hundred fruit out of millions processed by a given facility daily. Because it only takes a very low level of contamination to make people sick, we are then challenged to determine how many tomatoes or leafy greens samples or melons, et cetera that we would have to sample and test to be sure that we could find every fruit or leaf that was contaminated by our ill worker to keep them from reaching consumers. We can’t test every tomato, that is too expensive – and you end up with no fruit to sell because you had to destroy it all to test it.

Instead, you need to rely on statistical sampling to have confidence that you can eliminate any tomato that is contaminated. But because we believe that contamination events happen so infrequently and at low levels, there simply is not a satisfactory statistical solution to the problem. You can’t just take 20 or 30 tomatoes from a harvest of a thousand and sample them, get a negative result and expect that the remainder of the product is free of pathogens.

Here’s why: Let’s say there are a thousand tomato plants in a block for harvest. Let’s also say that we are going to harvest 20 fruits from each plant over the next 3 weeks; so 60,000 total tomato fruits will come out of that single block. Now let’s say that somehow during the harvest period, 200 fruits have become contaminated with a very low level of Salmonella. You have all your tomatoes in boxes; how do you sample to be sure you can eliminate those that are contaminated? Try it another way, imagine trying to pick 200 black marbles out of a huge box of 60,000 white marbles – and do it blindfolded to boot, because remember, you can’t see bacteria like salmonella. How many times would you have to “sample” the box to get all 200 black marbles? It is a daunting question and given the time, cost and the fact that the test is destructive, it is not practical.

So while the perception of product testing for pathogens on products sounds great, in reality it is currently too difficult to do with any acceptable sense of credibility. You are better off spending your resources to prevent contamination in the first place by having rigorous and frequently reviewed risk-based food safety programs in place.

Julia:

Please join us again next time, when Bob will talk about why traceback can be such a lengthy process. And if you would like to submit a question, email it to us at foodsafety@pma.com. Goodbye for now!

Hello, this is PMA Public Relations Director Julia Stewart. The association is pleased to introduce a new series of briefings on new series of briefings on food safety, science and innovation featuring PMA Chief Science Officer Dr. Robert Whitaker — welcome to our first installment.

Bob, many of our members are following the salmonella saintpaul illness outbreak that has been linked to certain types of tomatoes. One member has asked us …

What role can microbial testing play, and can it ensure our products are safer?

Dr. Bob Whitaker:

The simple answer to this question is that you can never test your way into food safety Testing is merely a tool, and an imperfect one at that. The best way to make sure your products are as safe as they can be is to have a documented food safety program in place to govern your operations – one that is driven by a comprehensive risk assessment that looks at all the potential contaminations that could take place. The absolute best way to avoid an illness associated with your products is to prevent the contamination from ever occurring.

Some in our industry mistakenly think a food safety program is the documentation you use to pass food safety audits. In fact, a food safety program is a risk assessment/risk management program — and the documentation is simply the verification that you are indeed managing the risks to the best of your ability. Then once you have a sound, risk-based food safety program in place, microbial testing may be used to help validate certain aspects of that program.

Water testing is one of these areas where microbial testing can be used as a validation tool. Incoming water should be tested on at least a monthly basis. But even before testing, first consider what risks does your water source pose? Obviously a municipal water source or a deep well poses much lower risks than an open water source like a canal, reservoir or river. In any event, you would want to put management procedures in place to manage the risk of contamination. Once that is done, microbial testing is a way to monitor the effectiveness of the risk management procedures. Often, testing for specific pathogens is not necessary, but perhaps a simple test for generic E. coli as an indicator for fecal contamination would suffice, and would be more cost effective. In the end, there is no perfect organism to test for and the operator or food safety professional will have to make their own decision on whether to test for specific pathogens or not. For example, if your risk assessment indicates that there is a potential for Salmonella or E. coli O157:H7 contamination because the water source is in proximity to a potential contamination source – for example, dairy, poultry, bird nesting areas, et cetera — then pathogen testing would be advisable.

Microbial testing can also be an excellent way to test for the efficacy of equipment and facility sanitation methods. Often a quick swab test for total plate count is sufficient for this purpose. There are also several “do it yourself”, ATP-based test kits available that have the advantage of lower cost and time savings that would fit this bill.

And finally, product testing has become a hot topic in our industry. It certainly seems like a logical thing to do until you look at it further. I’ll cover that question tomorrow. See you then!