Rewind: WPPC-FDA meeting Sept. 11 - Marjorie Davidson on communications

More from the WPPC-FDA meeting of Sept. 11 - Part 8, if you are counting at home. These comments wrap up the FDA panel's address to the WPPC. These remarks are given by Marjorie Davidson, communications specialist at FDA, concerning communications with industry and consumers during the Salmonella Saintpaul outbreak of 2008.


Marjorie Davidson: I have been asked to go over a few points on communications during this recent outbreak, I’d like to preface this by saying we communicate with other federal agencies, state and local governments and within FDA. My focus is concerning the agency’s communication with industry during the outbreak, as well as communications with consumers.
First communications with industry; we learned from our lessons learned” from the spinach as well as when the FDA participated in USDA sponsored stakeholder conference earlier this year, and the message coming from the industry was loud and clear, they wanted to be alerted right away when an incident occurred and an issue was arising and wanted to be kept advised of the progress of the investigation as it progressed through an outbreak.
So during our Saintpaul outbreak, we called trade associations and industry and met with them regularly on conference calls. We called them first very much earlier than we did in the spinach outbreak as soon as we had an implicated vehicle. Then subsequently we held regular conference calls with the associations to keep them apprised of what was going in the investigation as it went forward. At times, were asked to meet more frequently than we had scheduled and we arranged them as much as humanly possible to make sure we continually kept our communications open. Industry industry(associations) was invited to participate in a listen only mode to media press briefings so they could be kept aware of what kind of issues the media was interested in as soon as we heard about them as well.
To be effective, communication needs to be two ways, and not only did we pass information on (to the industry) we needed to hear back from the industry as well. We asked throughout this outbreak industry to provide information about distribution patterns, harvesting, and seasonality. We got information back rapidly and concisely and it at was very, very helpful to help us target the investigations and focus our resources.
Right now the agency is developing a comprehensive plan from the “lessons learned” from this outbreak to address communications with industry and you will be hearing about this in the near future. We are interested in getting feedback from you on how the communication worked and what we can do to prepare best for next time.
Communications and consumers; our first consumers is to get accurate information out to the general public as quickly as we can in order to protect public health. At the same time, we don’t’ want to unnecessarily limit consumer access to nutritious produce, in this case. So as a result, we attempted to narrow the warnings early by putting an exclusionary list up. We wanted to indicate geographic areas where produce was being grown that wasn’t implicated in this outbreak. This was a very resource intensive activity but we wanted the market to stay open – the ones that weren’t implicated. This was our rationale in developing the list and we are reviewing our thinking about this and will be interested in talking with you all as we go forward with our plans. Another thing we learned from spinach (and communications with consumers during that outbreak) is that our internal daily deliberation process often caused to get information out too late and we missed the nightly news deadlines.
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As a result of this, we held press briefings earlier in the day. Another issue that developed during spinach was that CDC and FDA were issuing separate press releases so it made it quite challenging to make sure our messages were the same and there wasn’t confusion with the public. So we held press briefings in cooperation with CDC. This was particularly helpful in keeping our messages similar between federal agencies but also to further explain what was really a complicated message in this particular outbreak. It gave us a dialogue with the media and were able to clarify things quickly.
The Web was also a critical part of communications during the outbreak and it was complicated by the fact we were doing massive renovation of our Web site ad it hit right in the middle of that occurring. We were able through use of the Web to get much more detailed information different (audiences) for difference concerns. We were able to get much more specific information out that way. We also realize we need to have available to us more graphics and other visual aids to help visually represent was what is going on to consumers and other stakeholders looking at the Web.
Another lesson learned from spinach was consumers didn’t know when the outbreak was over;. Many of them still thought (during the spinach outbreak) it was ongoing when it was for all practically purposes stopped. So during this particular outbreak, on two separate occasions, first after tomatoes and after for peppers, we had press briefing and announced with great finality that consumers could return to enjoying produce and that FDA believed that there was no implicated product still out in the market place.
I’d like to add a final note on communications. FDA – as well as they are doing with communications with industry - FDA is doing an extensive analysis of is communications with consumers over these next few months. We are going to particularly focusing on our ability to use new technology to get information to the public as well as to other stakeholders. We are also going to be conducting research to explore how messaging, to try to understand better how it is received by consumers in the market place and how we can work better frame and identify our messages.
Jack Guzewich: We can think the panel for their overviews, now we can open the floor for discussion and for questions and answers...



TK: From Marjorie's comments, it seems to me the agency was fairly accommodating with the industry during the salmonella outbreak investigation. As you will see in the Q and A, a good portion of the industry's frustrations lie with the CDC and federal laws that prohibit sharing of specific information about an outbreak with industry. Next up (all in good time, my friends) a transcript of the question and answer session from the WPPC-FDA meeting of Sept. 11.

Rewind - WPPC-FDA meeting - More from John

Okay, my (nearly) word for word transcription of the meeting is painfully slow. But here is another selection from John Guzewich, senior environmental health scientist in the Center for Food Safety and Applied Nutrition of the Food and Drug Administration, addressing WPPC attendees in the FDA auditorium on Sept. 11. More coming..


Part 7

And we have the problem of repacking that you have all heard about in this traceback. We had more than one instance of where there was repacking going on – that really compounded the problem. Along with repacking, we also had co mingling of tomatoes, and that compounded the problem.
We also had a lot of product with no address information, invoices and bills of lading with no address information, making it very difficult to trace back the step before that.
As is always the case with traceback, the locations where the tomatoes and peppers were exposed (to consumers), they (the restaurant or retailer) may have got that product in some kind of case or container, but that case or container has long since been thrown away by the time we get there, days or weeks after the fact. Any labeling on those tomatoes or peppers is gone, all we have to work with invoices or bills of lading. The range of record keeping was very broad, with some keeping records in a shoebox; at other times we were handed a box of computer printouts and (told) the information was "in there somewhere."

We had producing states of products importing (and repacking ) product from other places, confounding the traceback. We weren’t sure if was shipped out of that area or not. Some of the produce (repacked) was shipped with their own labels on the product.

Later, contrasting the traceback of tomatoes and peppers with that of the salmonella-tainted peanut butter…

I would contrast the traceback with what happened in February 2007, when we had had a traceback on salmonella that was tied to peanut butter. Once we had a jar with a label, by the next morning we had completed the traceback. That’s what we call traceback.

Part 6 - WPPC-FDA Meeting Problems with traceback

More from John Guzewich, senior environmental health scientist in the Center for Food Safety and Applied Nutrition of the Food and Drug Administration, addressing WPPC attendees in the FDA auditorium on Sept. 11. He speaking about the salmonella Saintpaul traceback investigation.



Some of the problems that we had with traceback were the lack of adequate identifiers. All that we had in some cases was a pull date or an invoice and it may say case of tomatoes, it may say red rounds, it may say romas, it may say just tomatoes. But the terminology was quite variable. That was one our problems. The products go through the market place and the names referred to on the records often are changed. The same product can have multiple names through the system, and it makes it difficult to know if we are tracing the right product or not.

And we have the problem of repacking as well….

Part 5 - Rewind WPPC-FDA Meeting Sept. 11

John (Jack) Guzewich of the FDA continues his presentation to the WPPC attendees on Sept. 11. (much more to come)

As far as traceback is concerned, like I said, the role that FDA picks up on is when the food we regulate has been implicated by the epidemiologists, when the CDC or the states say to us, “Well it is the tomatoes.” Our job is to conduct a traceback. We try to respond as quickly as possible for public health reasons, and also to limit the scope of economic harm to companies and also to limit the scope to consumers so they don’t get sick but they are able to have access to saleable food in the market place.

This was a very difficult traceback for us.

Our tracebacks are conducted by going into places where the people were exposed. In other words, supermarkets where they bought the products or restaurants where they ate. Where the point of exposure is, our tracebacks begin there. First using bills of lading and invoices, which some people keep good records on and some people do not, we have to work our way back through the distribution system, step by step by step, and there are multiple suppliers all through the system at each node in the system. We have to sort which of the multiple sources was the one that was likely involved on the contaminated product we are tracing.

And so this was a very tedious process and time consuming process, it takes took days and weeks to complete, and that was with people working nights and weekends, people that didn’t take a break from early June to early August, including weekends and holidays.

Our traces were complicated. There are two kinds of cases; one is called sporadic case, sporadic cases are where one individual who is positive for the disease organism, this Salmonella Saintpaul, Not only that, they feel like they know where they got exposed, they know which meal they could have eaten. That could be problematic, though; if they are a tomato eater they could have multiple exposures.

In the tomato investigation, we had primarily sporadic cases.

We go from the point of where the person said he ate at a restaurant or purchased product at a supermarket. We collect records, working our way back through the system from node to node to node, back to where it came from as best we can.

The other kind of outbreak is cluster phase; this is where there are a number of people that may all have a common exposure, they could have eaten at the same restaurant or all purchases the product at the same supermarket or grocery store. W e have number of people that have that in common, along with the same organism, we have more confidence we’re tracing the right product, then, because we have a number of people involved rather than a single exposure. The traceback works the same, in terms of bills of lading, working our way back from node to node to node.

In the early part of this investigation, we had only sporadic cases to trace and that was problematic.

That’s a little bit we had about traceback. Some of the problems we had with traceback….

Part 4 Rewind: WPPC-FDA Meeting Sept. 11

John (Jack) Guzewich of the FDA continues his presentation to the WPPC attendees on Sept. 11.

So it is often time starts out with a heads up that they(state and local officials) are suspicious something is going on, and then ultimately we get the word that a product we regulate is implicated and we are more heavily involved, and that’s the point a traceback investigation begins.

I hope that helps you understand…some of you are probably aware that the Centers for Disease Control, one of their publications is called Morbidity and Mortality Weekly report…….they issued a preliminary report on this investigation on August 29 and I’m sure some of you are aware of that, it is available on their Web page and so forth, and their conclusion, which is actually not the CDC’s conclusion (alone), but they vetted their investigation with a large number of epidemiologists across the country, at the state and local level, as to their analysis itself and their conclusions. They continue to maintain that in the early part of this investigation that tomatoes were an implicated vehicle but clearly later in the investigation jalapeno and Serrano peppers were also involved as vehicles in the outbreak. So this will go down in our records as a multi-vehicle or multi-food outbreak with tomatoes, either roma or round, as well as Serrano and jalapenos as possible vehicles.

That’s a little background. We’ll try to answer more of your questions in the QA time.
(of the session).

Part 3 - WPPC- FDA meeting Sept. 11 Jack Guzewich

John (Jack) Guzewich had a quick-paced delivery, and the remarks below are only the first portion of his comments at the WPPC FDA meeting on Sept. 11. In the later Q and A session, Jack often takes a lead role in explaining the FDA position, usually with refreshing frankness.

From his bio:

John (Jack) Guzewich is a senior environmental health scientist in the Center for Food Safety and Applied Nutrition of the Food and Drug Administration, where he has worked since 1977.

From his remarks:


Good afternoon everyone. I will speak a little bit on outbreak investigations and a little bit about traceback.
Outbreaks in the United States are investigated by state and local public health agencies. A lot of people have gotten the impression during the recent Salmonella Saintpual outbreak that FDA is in some way involved in the outbreak investigation, but that really isn’t the case.
In the United States, responsibility for epidemiology and surveillance in pending outbreaks lies primarily with state and local public health agencies.
And that was the case in this recent outbreak. It was first detected by New Mexico and Texas health departments, their health public health lab and epidemiologists at the state and local level. As the investigation expanded to ultimately 43 states, the District of Columbia and Canada, those investigations were conducted in all those states primarily by state and local health agencies sometimes working in partnership with their state departments of agriculture.
The Centers for Disease Control in Atlanta job was to provide consultations with those state and local agencies, in a coordinating role. Initially this investigation recently conducted was led by New Mexico, because they were the first ones who detected the outbreak
As it became apparent it involved more than New Mexico, that it was Texas, that it was more states, that baton was passed on to CDC and CDC performed in a coordinating role after that; they held over 50 conference calls involving all the organizations; they had epidemiologists in Atlanta that were heavily involved in compiling information and analyzing it, along with the states. They sent people from Atlanta out to work in several states on what are called epidemiology aids or assistants to these state and local investigations and perform what state or locals requested of CDC.
So the activities that made the link to tomatoes initially and later peppers were made by the epidemiologists and laboratory agencies at local, state, and CDC levels, respectively.
FDA gets involved when those agencies come to us and say “we’ve implicated an FDA regulated food.”

Part II - WPPC - FDA meeting on Sept. 11 - Amy Green

As promised, more from the WPPC-FDA meeting of Sept. 11. We are near the beginning of the 90 minute plus program, where a panel of about five or six FDA officials speak before answering questions. These are the remarks of Amy Green.

From her bio:


Amy Green has been with FDA’s Center for Food Safety and Applied Nutrition for eight years. She is policy analyst in the Office of Food Safety, and has been lead author for fresh-cut produce safety guidance.

Her remarks:

Welcome.. I see at least half of you have smiles on your faces, so I guess that's a good a sign. (laughter) Michelle told you that I would talk to you about the produce safety initiatives. I’ll start out with the produce safety initiatives.

There are two. The leafy greens safety began in September 2006 in the Salinas Valley in California. The tomato safety initiative began in June 2007 on the eastern shore of Virginia. Now these initiatives represent relatively new approaches for FDA. They are allowing us to visit a broader range of operations in non-outbreak situations.
At the same time, the initiatives are part of a risk-based strategy designed to reduce foodborne illness by focusing our food safety efforts on specific products, practices and growing regions.
The objectives of the initiatives are to assess current conditions and practices, the challenges that are (faced) by those conditions and practices and responses to those challenges, and also to enhance collaboration between the FDA, state/local governments and industry.
The information that we gained from the initiatives will be used to improve our understanding of current practices and provide data to inform policy decisions and future guidance that we write.

In 2006, the first year of the leafy greens initiative, assessments were conducted at farms, packing houses and fresh cut facilities in the Salinas Valley. In 2007, we narrowed the focus to environmental factors, particularly animals and water. San Benito County and Kern County were assessed, we spent a good deal of time before we went out to the field identifying the sites where we would visit. To identify specific locations were we would visit, we used Geographic Information Systems or GIS. We used GIS to map out where certain environmental factors appeared to converge the most often: with followed up (the use) of GIS with aerial photography to confirm what we had done with GIS and to further help our site selection so we could use our resources most efficiently.
The tomato safety initiative began on the eastern shore of Virginia in June 2007. The assessments done as part of the tomato initiative addressed growing, harvesting and packing practices. Thus far, two of the three parts of the tomato initiative have been completed and we just want to say that Florida growers have given us unprecedented cooperation throughout the initiative and we hope that will continue.

The success of these initiatives is due in large part to the collaborations with state partners, academia and industry.

Another produce activity that Michelle mentioned was FDA conduct of microbiological sampling survey that started in 1999. (The survey) is done on domestic and imported fresh produce commodities. In 2008 survey, we are sampling fresh whole cantaloupes, leaf lettuce, tomatoes, green onions, spinach, basil, cilantro and parsley. We are analyzing for salmonella, E. coli O157H7, shigella, Hepatitis A and cyclospora.
Throughout the years, we’ve made changes to these surveys; changes to commodities, pathogens and analytical methods. For example, in 2005 we added fresh spinach to the list of commodities and we added testing for Hepatitis A and cyclospora and changed the methods for detecting salmonella in potatoes and tomatoes because (the new method) improved accuracy of testing.

The surveys that we do are conducted for surveillance; we are basically trying to collect a body of data on incidence of contamination in select produce commodities.
In addition, if positive samples are found, regulatory follow up provides us the opportunity to observe practices and conditions that may be associated with contamination.

We start with same basic survey with domestic and imported product but some differences exist because it is unavoidable. One of the differences is that for domestic produce we can collect the sample close to the farm as possible, whereas for imported produce, we have to collect data at the port of entry. So that’s it for me. Jack will speak next.

Part 1 : Sept. 11 WPPC-FDA Meeting Michelle Smith

From the FDA-WPPC session of Sept. 11, we are joining the program barely in progress. Michelle Smith of the FDA speaks to WPPC attendees about rulemaking on GAPs and encouraging input....

From her bio:
Michelle is an interdisciplinary scientist with FDA's Office of Food Safety. She led the development of FDA's 1998 GAPs guidance, and had a leadership role with the 2004 Produce Safety Action Plan. Prior to coming to FDA, she was served on the faculty at the University of Maryland.

From Michelle Smith:

"On Sept. 2, the FDA published a Federal Register notice looking for information and data to help us update the 1998 good agricultural practices guidance. I think that the principles that were established in 1998 stood the test of time. Our experiences implementing that GAPs guidance, and certainly the experience of folks in industry trying to implement the GAPs guidance; have given us some ideas of the things we might improve. Working with the commodity specific work groups in a technical capacity has given me a chance to see how some of the thinking has changed.
The Federal Register notice has a list of questions to help focus comments; you are not bound to only comment on those questions, but they are intended to give you an idea of the kind of information and data we are looking for.
Again, what we ultimately do can only be as good as the information we have to work with; that’s my personal appeal to look at that and to the extent you can provide (input) to help make that better, please do.”

Stop the tape

I earlier promised a more detailed excursion into the Q and A part of the WPPC - FDA session and I hope I get around to it - for your sake! The session represented a rare opportunity for WPPC attendees to ask FDA officials questions, and there were some probing questions and insightful exchanges, if no earthshaking revelations. We can only rue the fact that the biggest FDA critic of all was inexplicably absent and unavailable to deliver Lou Dobbs-esque zingers. Sigh.

In any case, you may have noted (but probably not) that I earlier posted an MP3 audio file of the meeting on the Fresh Produce Industry Discussion Group. United asked me to take the recording down last Friday, explaining in a later email “we (United) had an agreement with our guest speakers that the meeting would not be recorded for purposes of posting on the Internet and also that we (United) feel that such a posting would be unfair to those who paid to attend the meeting.”

I did take the audio down from the Discussion Group, though I wasn't happy about it. My position was that a panel of FDA officials (and United's David Gombas and Tom Stenzel) speaking in the FDA auditorium in College Park to about 140 trade members and multiple members of the press should have a presumption that the event was for public consumption, whether those words were transcribed from tape or available on the Web in MP3 format. No one at the FDA has responded to give their account or opinion. In any event, I've asked FDA and United to reconsider their policy on Web audio of future joint events that may garner wider industry interest.

I think the "new media" that the Web facilitates does present some challenges to both news organizations and the sources we cover. For example, associations want to maximize the value of each event, and news organizations seek to maximize the timely multimedia coverage offered. It is not an easy equation. But particularly in the case of events involving public officials, openness should be the default position.

John Block: think about the small farmer and blame it on the sand hill cranes

John Block was Agriculture Secretary during the Reagan Administration and now he is an agriculture advisor to the McCain campaign. He represented McCain during a presidential "debate" at the WPPC, and at one point during the exchange with Obama's surrogate cast a skeptical eye toward food safety regulation. Here is a blog post by Block forwarded by Doug Powell of the Food Safety Network relating to food safety regulation that captures his uncommon old school take on the issue:

For a long time, we have been hearing the screams of anguish from consumer organizations and politicians (especially the politicians) demanding that the government fix the food safety problem.I am here to say, yes, we can do a better job, and we should. However, to fix the problem will not be easy or cheap, and there will be some casualties.It is worth taking a look at a produce terminal market. I have visited these markets. Small growers and large growers deliver their produce in pick-up trucks. Tons of produce is sold every day. Move it fast while it’s fresh before it spoils. Some produce markets are huge – acres and acres in size with all levels of produce on display – peppers, mangoes, lettuce, spinach, watermelons, tomatoes, and more. Sometimes, product from different growers can be co-mingled. Produce from different countries is co-mingled. Distributors are selling. Buyers are buying. Some times on credit; sometimes with cash. Some buyers require records for traceability. Others don’t. They don’t have time. It costs too much money to handle all that paperwork. It is a madhouse.Improving traceability is going to cost the consumer. It won’t be free. I said there will be some casualties. Small producers may not be able to compete. Already, some distributors are buying direct from big produce farms, leaving the small pick-up truck suppliers out in the cold.Think about the small farmer markets that we’re familiar with. How much paperwork will they put up with? I was in my local supermarket last week. They featured tomatoes, melons, peaches, and other produce “locally grown.” Can all this be traced? Maybe.The fact is we have the safest food supply in the world. We need to do a better job of improving traceability. The salmonella tomato problem this summer cost tomato growers millions and they now believe the problem wasn’t even a tomato but a pepper.Our food safety system is not perfect. In fact, it never will be. Let me ask, do you get up in the morning worrying that you won’t be able to find any safe food to eat? I didn’t think so.Until next week, I am John Block from Washington

Blame it on the birds. Doug Powell of the Food Safety Network also passes on this link about sand hill cranes implicated in a foodborne outbreak in Alaska. From the story:


Apparently the migratory birds love the peas in Mat-Valley Peas' fields. And what geese can do to a sidewalk, cranes do to a field.
"The farmer thinks that's the likely scenario," McLaughlin said. "He has another field with cattle nearby, but it's highly plausible that the cranes' poop is the cause."
The 18 people were sickened by a campylobacter infection, according to a press release from the state and Municipality of Anchorage on Thursday. The illness' symptoms include diarrhea, abdominal pain, weakness, fever, nausea and vomiting. One person was hospitalized, the release said.