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  • Archive for June 2008

    Will country of origin labeling speed traceback?

    Wednesday, June 18th, 2008

    Hello, this is Julia Stewart and welcome back to PMA’s new audio series, “Ask Dr. Bob Whitaker.” Today I am talking with Kathy Means, PMA’s vice president of government relations and public affairs. She and Bob Whitaker form the dynamic duo that heads PMA’s food safety team.

    Kathy, an Associated Press reporter recently asked you if the tomato traceback process would be going faster if mandatory country of origin labeling was already in place. Would you please share with our audience how you responded to that question?

    Kathy Means:

    While at first glance one might think that logic seems to make sense, in fact country of origin labeling would not speed the traceback – which makes sense when you think about your own produce consumption.

    Bob has talked a bit about how difficult epidemiological investigations can be a previous briefing. Let’s imagine you ate something that made you sick. It may take up to three days for you to get sick. Then you’re sick for a few days before you see the doctor, and then the tests they do take another week or so.

    So by the time the public health folks get to you, they are asking you what you ate over the course of three days two weeks ago — try it now, can you do it? Think about everything you ate June 2nd, 3rd and 4th – what you ate, where you ate it, et cetera. Write it all down. Now, can you also remember the sticker on every fresh produce item you bought – and remember, country of origin labeling only applies to the produce you bought at retail, not at foodservice. And also remember, you may have bought the produce earlier than June 2nd, 3rd and 4th. It’s tough, isn’t it?

    The goal of country of origin labeling is to inform consumers at point of sale – it’s not a food safety tracking system. What’s key in a traceback is the information the buyer has about where it sourced its products. As a consumer, you may remember that you bought your produce at Store A and/or Store B. And you may remember that you ate out at Restaurant X, a graduation party and a community pot luck. Then it’s up to the retailers and foodservice operators to work with public health officials to trace back all of those points of service. It’s not up to you as a consumer.

    What’s important for traceback is that everyone in the industry must know and be able to document where they got the product from and whom they sent it to – one up, one back – as required by the federal bioterrorism law. It’s also important that this process be quick and efficient – that’s why PMA is so strongly behind the ongoing industry-wide traceability initiative we are leading with United Fresh Produce Association and the Canadian PMA.

    But even when all of that is in place, traceability may hit a snag when products are commingled and repacked, as they often are in the case of tomatoes and other items. This is one example of a practice we’ll all have to take another look at in the future.

    So if country of origin labeling is not a food safety system, what is it? It is a way to let consumers know where their produce was grown – and for a lot of producers, it’s a marketing opportunity they can use proudly. Right now the top 20 fruits and top 20 vegetables make up more than 90 percent of the fresh produce sold to consumers at retail in the United States. And more than 60 percent of them have some sort of origin information – might be a country or a U.S. state or region. So we’re already well on our way to providing consumers with the information that the law will require us to do when country of origin labeling becomes mandatory starting this fall.


    Thank you, Kathy. To help our members get ready for the September 30 start date for mandatory country of origin labeling, PMA and Western Growers will be hosting a free Webinar June 24. The Webinar will introduce best practices developed by a task force made up of industry leaders from across the supply chain. For more information about the Webinar, or to access the best practices, please go to our Web site www.pma.com, and then to our country of origin labeling issues page. Remember, the June 24 Webinar is free, but you do have to register, so please register today.

    Thanks for listening. Please join us again next time!

    How are growing areas removed from the alert?

    Tuesday, June 17th, 2008

    Hello, this is Julia Stewart and welcome back to PMA’s new audio series, “Ask Dr. Bob Whitaker.” We’re going to jump right in today. Bob, we have received a number of calls from members with questions regarding the process FDA is using to exclude tomato growing areas from investigation as the source of the Salmonella saintpaul outbreak so they can be excluded from the consumer alert. Why is this being done, how are these areas identified and are there any more areas that might be removed from the alert?

    Dr. Bob Whitaker:

    As you know, PMA, United Fresh and our tomato industry members have been working with FDA to help expedite the traceback, so that the region and perhaps supplier that is the source of this outbreak can be identified as quickly as possible. As I’ve mentioned in previous recordings, this traceback has likely been complicated by the fact that the traceback has overlapped the normal seasonal transition of tomato production as the weather warms in the southern areas and production begins to move northward. While a hindrance on one hand, this transition also presented opportunities, because it allowed areas to be ruled out if they were not in production when the illnesses began. As the industry, FDA and state officials have been able to produce documentation that these production areas were not harvesting red round, plum or Roma tomatoes during the initial onset period – or that region’s distribution to the marketplace did not match up to the illness distribution – they have been removed or “excluded” from the FDA consumer alert. So, so far 27 states and 19 counties in Florida plus 7 off-shore suppliers have been cleared to harvest and ship tomatoes. This has all been done to maximize the ability of consumers to eat fresh, healthy tomatoes and to minimize, to the extent possible, losses of farms and packers who were not involved with the outbreak.

    The last part of your question asked if there were any more areas that might be excluded from the alert that were not producing tomatoes at the time of the outbreak. As of this recording on June 13th, to our knowledge only one major tomato production area is currently under review by FDA, although there may be others. Momentum has been building to exclude northern Baja California in Mexico. Similar to other regions excluded from the alert, Baja was not harvesting tomatoes at the onset of the illnesses in April. PMA sent a letter to the FDA commissioner Andrew von Eschenbach yesterday supporting a review of the Baja situation. Others have also been working diligently to ensure the Baja supply of fresh tomatoes can be released as soon as possible. From comments made at FDA’s press briefing June 12th by FDA Associate Commissioner of Foods Dr. David Acheson we know that the FDA is working with the Mexican government and Baja state to review their harvest and shipping data to see if it can meet the exclusion criteria.

    While we impatiently wait for the traceback to run its course, helping regulatory officials as we can, we should pause and take a note that this mechanism by the FDA to exclude those regions not supplying tomatoes during the onset of the illness in April has permitted tomatoes in the unaffected areas to be harvested and shipped. As we move forward, we remain concerned for those who have been made ill during this outbreak, and simultaneously we hope to learn from the traceback investigation about what we can do to improve the safety of tomatoes in the future and to begin the task of rebuilding consumer confidence in our products.


    Before we sign off, I want to make sure that our members know about PMA’s staff experts in food safety and crisis communications, who are available for your questions and to respond to your concerns should you be involved in this or any other food safety situations. If you have not yet taken advantage of the expertise of PMA staff, I encourage you to do so. On food safety and science issues, please contact Bob, or Kathy Means. For assistance in crisis communications, please contact me or Lorna Christie. Thanks for listening. We’ll see you next time!

    Why can traceback take so long?

    Wednesday, June 11th, 2008

    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.


    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!