11:00 a.m. Tom Karst: What are you working on this week?
11:00 a.m. David Gombas: I was pilot testing the harmonized standard to see if it works in a greenhouse as well as in the field, and it does.
11:01 a.m. Karst: So the Produce GAPS Harmonized Standard is in place?
11:02 a.m. Gombas: Some companies are already using it. It just recently got finalized, and now we have to have auditors trained to calibrate so they all do it the same way. That’s the next step. The field standard was finalized at the of July.
11:02 a.m. Karst: So the next step would be to train the auditors?
11:02 .am. Gombas: We want to bring all the audit organizations together so they are using the tool the same way, whether that is USDA, GFSI, or anybody. Any audit organization that wants to come to the table and use this standard. Information can be found here.
11:03 a.m. Karst: What has been the highlight of the process of GAP harmonization since you first began working on it in 2007?
11:04 a.m. Gombas: “The real highlight of the process has been the openness of the whole process. Harmonization has been tried many, many times by really good people, but yet it has never succeeded. Why not? We sat down on the technology council to figure out what has gone wrong in the past, what to not repeat. It was about the openness of the process. You have a group of six or seven really smart people sitting in a room figuring out what standards their suppliers are required to follow, and the suppliers aren’t part of the meeting. Or you have suppliers getting together figuring what the standards should be and trying to push it up to the buyers. That doesn’t work, either. This one, we just said everyone come to the table, and we didn’t care what commodity it was, whether you were a buyer, supplier, distributor, academic or government interest. We had 150 people sign on, large and small, members and non-members. And they all had a say in how it was developed When they had a say in it, we found an answer that everybody could live with. And we said, okay, they are buying in to it. I think that is what the big improvement is.
11:06 a.m. Karst: How many years ago did this effort start?
11:06 a.m. Gombas: It started in 2007 when we asked the technology council what were the big issues facing the industry and overwhelmingly the response came back: audit fatigue. Multiple standards, mutually exclusive standards, having to track auditors through the same operation time and time again through the year. It was getting to be expensive and just painful. They said, ‘Stop the madness.” That was 2007. It took us two more years to figure out how to do it and not fail. That’s when we brought together the buyers and said, ‘If we build this, will you come?’ That was 2009. We got all the major produce buyers in the U.S. together at the same table and said, ‘This is our vision; what do you think?’ They said, yes, if you can do this, we will accept it. With that promise, that’s when we got started, started calling the entire supply chain together and said we are going to do this. The other big learning we had was that everyone wanted to create the standards from scratch. But we said, let’s not do that; there are plenty of standards out there that people are already following. Let’s go use those and bring all those standards together and pick and choose words that everyone thinks best represents a harmonized standard instead of creating all new words. That was the second learning from the past; we didn’t create anything from scratch, we started with what already was developed.
11:08 a.m. Karst: So now the process is complete, then?
11:09 a.m. Gombas: The development of the standard is complete. It is out there, ready to be used, we pilot tested it, We didn’t just toss it out there and walk away. We went out and over a course of a year and pilot tested this standard at over a dozen different types of operations, large, small, all different commodities, East, West, all different customers, all different audit organizations to see if this meets everybody’s needs. And the overwhelming response was yes, it works. The next step is getting these actual audit organizations trained as to how use the standard so we don’t have the problem of the same words but everyone interpreting differently.
11:10 a.m. Karst: How will that process occur?
11:11 a.m. Gombas: We are creating a calibration committee. We had an operations committee about how the standards will be used and updated. That was led by Dave Corsi of Wegman’s. That group decided that what we need a committee that will train the auditors and will also be responsible for real time interpretations of the standards as disputes occur. This group would become the go-to group for any interpretation issues. What does the standard mean? What is expected here? We have those questions already from auditors, suppliers and customers. So that’s what this group will be responsible for.
11:12 a.m. Karst: So this calibration committee is in place? Those people are identified?
11:13 a.m. Gombas: Yes it has been identified. We had a first teleconference, but we haven’t’ had an actual meeting to develop the training materials. We’re hoping to get some of the training materials from groups who are already started training their auditors. USDA is using this audit for the benefit of one of the major foodservice companies, and they have already been training the auditors how to use it even though they recognize that this may change. NSF has said they plan to use the standard starting this month and anyone who wants to use the harmonized standard, they will do audits according to that standard. USDA and NSF are not working together in training their auditors, so that is what this calibrating committee has to do; bring all the entities together and training them at the same time, and develop a training course so that those auditors can use those same training materials to train their auditors.
11:15 a.m. Karst: How many auditing firms will use the harmonized standard?
11:16 a.m. Gombas: We don’t know at this stage. USDA and NSF have committed to it. GlobalGAP is going to use the standard when we get it passed through their governing structure. SQF has said they will replace their module 7 - production agriculture - with a harmonized standard. And so their certification bodies would be using the harmonized standard. All the folks that do audits for GlobalGAP, all the folks that do agriculture audits for SQF in the U.S I would want to have at the table.
11:17 a.m. Karst: So a lot of work has done into this process. When do you think it can start paying dividends as far as reducing the number of audits? How soon do you think it will have that effect in the market place?
11:18 a.m. Gombas: My guess is that it will take at least a year. The reason I’m saying that is that the prototype was the tomato industry. When we worked with the tomato industry to create the tomato metrics, it was the same thing, to create a single audit for the tomato industry, to see if it would work. And it has. If it works for the tomato industry it should work for the rest of the produce industry.
11:19 a.m. Karst: As you look at the work on the harmonized standard, how does it relate to the work that the FDA is doing on its produce safety regulations?
11:20 a.m. Gombas: We have invited FDA to every single one of these meetings. They were present at every one of the tomato metrics meetings but once we started getting into GAP harmonization, that was when they started working on the produce rule so their day job started getting in the way. They have been copied on everything. The have asked for updates on the harmonized standard. When the final one came out, they asked immediately for a copy of the final harmonized standard so they can look at that in their deliberations. I’m sure when the produce rule finally comes out it will be consistent with the harmonized standard, but I expect it will look different.
11:23 a.m. Karst: So all that work will not be in vain, but a benefit to the industry?
11:23 a.m. Gombas: Oh yes, absolutely, FDA coming up with a regulation for commodity has never stopped third party audits. You look at juice, you look at seafood, you look at meat and poultry operations - they still go through audits for private sector purposes.
11:24 a.m. Karst: Looking ahead to the Washington Public Policy Conference, what are you looking forward to relating to your issues?
11:25 a.m. Gombas: On the food safety and regulatory side, we are going to be going up to FDA again and get a briefing on what they are working on. We are going to be talking about imports, the produce rule. People will be able ask questions. One of the things I’ve asked them to do is to (create) a top ten of issues that they are seeing on farms. They have investigators going to farms all the time. What the issues that they are perceiving as far as the farms? I’ve asked them to do that. The other thing that is really cool about this years is in the past, visitors had a choice. They could go to FDA or they could go to the Hill but they couldn’t do both because they were at the same time. Now, we have scheduled it so you can do both. Not only can you do both, but if you don’t want to go to FDA, you can also go to FDA or EPA and we’ve never been to those agencies before.
11:26 a.m. Karst; What do you think of the recent announcement of the Food and Drug Administration’s Coordinated Outbreak Response and Evaluation (CORE) Network?
11:27 a.m. Gombas: We are very hopeful. The plan sounds right, to have a dedicated team at FDA whose job it is to coordinate outbreak response rather than picking and choosing whoever is available and hoping somebody is going to be around. This promises to be a much more organized process for outbreak response. I’m hopeful that they will take on the role of being coordinator not just for FDA but also for all the state and local groups. Take for example the listeria outbreak linked to cantaloupe. I would like to see FDA be in coordination of what Colorado does, Nebraska and all the outbreak teams that are involved in investigating that, so there is a coordinated response not just guys trying to figure out who is in charge.
11:28 a.m. Karst: What role does industry have to play, if any, in something like this?
11:29 a.m. Gombas: Not much. This is definitely an internal role. We would like to be able to work with them in outbreak investigations, especially the early stages to test out hypothesis. Actually what I am doing this week is attending an outbreak meeting in Long Beach California speaking to the Centers for Disease Control and state epidemiologists about the role of industry in those early stages of outbreak investigations. They have all the epidemiology tools but they know nothing about the commodity. If the industry is involved in the early stages to test out the hypotheses, I think everybody would be better served so we wouldn’t have another 2008 incident. Epidemiology was very very clear that it was tomatoes and it was very wrong.
11:31 a.m. Karst: With this recent foodborne outbreak linked to cantaloupe, do you have any observation about that? Does it surprise you what has transpired wit the cantaloupe and listeria?
11:32 a.m. Gombas: Complete surprise. FDA pointed out there has only been three listeriosis outbreaks linked to commercially prepared produce in the U.S. ever, and that is going back 30 years. My first reaction to (the news) hat there was a listeriosis link to whole cantaloupes was that it was nonsense - they got it wrong. Well, apparently they got it right. Now the question is, how in the world could that have happened? So that’s another thing I’m hoping for out of this new CORE department - answers. In the past, whenever an outbreak occurred, as soon as FDA figured out who the responsible party was, it was pretty much mop up and move on. Now with CORE, I’m hoping they can do enough evaluation afterwards, as to what went wrong and what was the root cause. A dedicated team to evaluate the cause was so they can tell the industry that it is what went wrong, really, so we can avoid that from ever happening again. What I’m concerned with is that if you have a perfunctory evaluation- going back to the 2006 E. coli spinach investigation, they brought on a CDC hydrologist and the hydrologist concluded that the aquifer in that region was contaminated with E. coli O157 and that was the reason why produce got contaminated. We all know now that is nonsense, but it is out there in the history books.
11:34 a.m. Karst: Would the listeria be in the soils?
11:35 a.m. Gombas: One of the primary sources of listeria in the food supply is fresh produce. It grows out in the fields naturally, but it doesn’t grow to a level that causes illness. What in the world went wrong here that got it to grow at high levels, not just to high levels, but high enough levels on a cantaloupe that after it was prepared and eaten, it was still at enough of a dose to cause this number of illnesses. Unlike salmonella and E. Coli, you need a large dose of listeria to cause illness and that is not reasonable that would have occurred on cantaloupe.
11:36 a.m. Karst: So it is an organism that does grow in the field, but you wouldn’t expect it to be a problem?
11:37 a.m. Gombas: That’s right. The outbreaks associated with the fresh produce - three in 30 years - and they are looking or this stuff. Listeriosis is a deadly disease. If you get sick, one of four people die. It is a very serious disease and typically listeriosis has been linked to processing plants. It has been able to grow in the processing plant and contaminate some ready to eat food. It is not associated with field contamination.
11:38 a.m. Karst: As far as what happens to the farming operation that was linked to the outbreak, is it something they can do to plow over and the next crop will be fine?
11:39 a.m. Gombas: It depends on what actually went wrong. If it was a perfect storm of events that led to contamination, the chances of that happening again are pretty slim. But without knowing what it is, it could happen again. That is why for all of these outbreaks, we go to FDA and we say you’ve got to do a good enough investigation to figure out what went wrong so that we can prevent it from ever happening again.