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FDA Technical Scientific Workshop On How Citrus Juice Firms Can Achieve 5-Log Pathogen Reduction -- November 12, 1998

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NOVEMBER 12, 1998






Welcome, Ground Rules
Dr. Harold Browning

Ms. Elizabeth Campbel

Objectives of the Workshop
Dr. John Kvenberg

Overview of 5-log Reduction
Dr. Richard Whiting

Florida Regulations
Dr. Martha Roberts

Growing Harvesting and Packinghouse Controls
Dr. Mohamed Ismail
Mr. Richard Kinney
Dr. Steven Pao

Questions and Answers

Sanitary Controls and New Technologies Overview
Dr. John Kvenberg

Chemical Sanitizers
Mr. Steve Hunter

Legal Status 
Dr. Jur Strobos

Sanitizer Systems
Mr. Frank Martinelli

Questions and Answers  

Non-Chemical Treatments
Dr. Steven Pao
Mr. James Blood
Mr. Marc Isaacs

Extraction Techniques
Ms. Linda Beasley
Dr. Steven Pao Questions and Answers  

Validation Techniques
Mr. Frank Martinelli
Dr. Jur Strobos
Mr. Steve Hunter
Mr. Tony DeCastro
Dr. Jill Hollingsworth

Questions and Answers  


DR. BROWNING: Good morning. My name is Harold Browning. I'm the Director here at the Citrus Research and Education Center. I'm representing the University of Florida Institute of Food and Agricultural Sciences.

It's my pleasure to welcome you here this morning to the citrus juice workshop. And I think we have a very good session before us today with the principals in good attendance, so I think we'll have a very productive meeting this morning.

It's my pleasure to welcome you on behalf of the University of Florida Institute of Food and Agricultural Sciences and also the Florida Department of Citrus, which joins with us here at the research center to provide a fairly broad scientific base to the Florida citrus industry.

It's with pleasure that we host this meeting because we feel that as with most issues facing the industry, the scientific based information is very crucial to the decisions that are made and we continue to try to play a role in -- in providing opportunities for education to take place.

So I welcome, too, those of you from the Food and Drug Administration and from other agencies in Washington. We have representation from the State Department of Agriculture here today. Welcome to you. We have representation from many other agencies within the state, as well as a lot of the industry groups. So we look forward to hearing from you this morning.

Welcome to all of you who represent various aspects of the citrus industry and those of you who are citizens who are interested in these issues as they relate to Florida agriculture and consumer issues.

My role this morning is just to welcome you and -- and tell you a little bit about our facility in case you're not familiar with it so that as you work through the day you'll be able to -- to find those things that you need to find.

First of all, we request that all of you register for this meeting. So if you have not done so, I encourage you to step into the lobby and they can assist you with registration.

On the table near the coffee and juice is a copy of today's agenda as well as some additional information, so please take advantage of that.

There is a public phone in the lobby area, as well as a house phone if there is any need you have to contact someone here on the center, whether it be the DOC or IFAS people here. You're welcome to use that phone and it's out at the registration desk.

Restrooms, which may be an important thing as the morning moves on here, if you go into the lobby and move to your right along the wall of the hall of fame, there is a doorway and through that doorway are restrooms, as well as some snack machines, Coke machines and so on.

On the table at the beverage service area is also a list of local restaurants for the lunch period, so I would encourage you to take a look at those if you're not familiar with the area and want to get out for lunch.

So, with that, I'd like to introduce the first of the Food and Drug Administration team who will give you some more details about how the meeting is going to unfold and then we'll move on with the agenda. So it's my pleasure to introduce Ms. Elizabeth Campbell who is the acting director with the Office of Food Labeling with the FDA in Washington, D.C.


MS. CAMPBELL: Good morning. It's nice to be here. We are here today because FDA published a juice labeling regulation. The labeling regulation says that -- it requires a warning statement. This warning statement is on juice products that have not been adequately treated to remove pathogens.

I'm going through this kind of quickly because you all know about this regulation or you wouldn't be here. I don't need to explain this to you.

What we're here for today is to talk about how not -- how you can avoid using a warning statement without pasteurizing the juice. Because we said pasteurization is an adequate kill step to remove the pathogens, but there are other technologies and what we need to do is to achieve a 5-log reduction in the pertinent microorganism. And we're here today to talk about how to achieve that 5-log reduction and how to validate that that reduction has been achieved.

Just a little information on what we said was the pertinent microorganism, not just any bug, but relevant or pertinent microorganism is the significant one that may occur in the product. In this case we're talking about citrus juice.

After we published this regulation in July the fresh citrus juice industry came to the agency and said we can't, we're having trouble, we don't understand, we need more time. We think there's technology. We need to know how to achieve the 5-log reduction. We need to know how to validate. We need to know what the agency expects and we need more time.

So we're here today to -- to talk about how to get the validation. And the agency has also decided, under limited circumstances, to allow more time.

On a firm by firm basis, for those firms that sign an agreement with their local district office and agree to these three conditions, that firm can have until January -- excuse me. July 8th of 1999, to develop the 5-log reduction and validate that it's there, that the 5-log reduction is being achieved before that firm has to -- if it fails to achieve the 5-log reduction, it would then have to label. That's an additional eight months of time on a firm by firm basis. That is, if you don't register for this with the district, then you do not get the extension.

We have a couple of documents out on the desk that include mailing addresses for the three major districts involved with citrus juice, Florida district, Texas and our district office out of Los Angeles in Irvine.

The Federal Register notice that's out there has the wrong address in it. This is the correct address.

The other notice that's out there, though, that announces this program and this meeting today is from our web page. That has been corrected and it has the correct address, or at least what's on the web page now does.

I haven't looked at your copies to see, but Maitland, Florida, is the correct address for the Florida district office.

If any of you are doing business in a different FDA district from the one that is served by Orlando, by the Maitland, Florida office, then you need to deal with your local FDA district office. And while we didn't put all of their addresses in these documents, the addresses are in the telephone books. They can be reached through the telephone books.

One additional item that is important to the folks in this room and has come up, it is not directly a part of this regulation, but it's an additional policy that comes into play. The regulation the FDA has on use of the term "fresh".

Our regulation, for those of you who are familiar with regulations, its number in the CFR is 101.95. Most of you don't care about that. But the regulation says that fresh food is one that is in its raw state and has not been frozen or subjected to any form of thermal processing or any other form of preservation.

There are some exceptions. These exceptions are listed in the regulation. Post harvest use of pesticides, waxes and coatings, mild washes, approved uses of ionizing radiation. Now, that UV radiation is ionizing radiation and may need a regulation, may need an approval regulation, but once it's approved it may be exempted, it may not. It depends on the technology involved. And refrigeration. Taking a fresh product and putting it in a refrigerator does not make the product not fresh. We just stated that in the regulation just for clarity.

In general, what we think we're going to be talking about today are treatments to the fruit before extraction. And in general, unless you wind up cooking that fruit so hard that you have actually cooked the juice while it's still in the fruit, in general treatment of the fruit, washing and sanitizing, brushing, cleaning, of course it's still fresh. It will not deprive the product of the use of the term fresh.

However, after extraction treatments to the juice, then the juice becomes processed. According to the way the regulation is written right now, that processing would make the juice not fresh. We are looking at whether we need to put some additional flexibility into that regulation for processing of juice. But to the extent that we're talking that our control measures are addressing the intact fruit prior to extraction, we're talking about extracting juice that is fresh.

Okay, that's all I have right now. We can talk about these issues. We'll be talking about the technology as we go through the day. We can talk about any of these other issues as -- as they come up. We need to move a little faster as we start out this morning. There will be time later on.

Your next speaker from the Food and Drug Administration is John Kvenberg, who is the director of the HACCP division, Hazard Analysis and Critical Control Points. I think everybody is using that word nowadays. John Kvenberg.

DR. KVENBERG: Thank you, Betty, and good morning. My job today is, No. 1, to start off with the objectives of what we hope to accomplish at today's workshop. And, secondly, I'm going to be acting as a facilitator for the workshop as we proceed through today.

The first thing I guess that I would like to say relative to how we move through the agenda today is that we have a list of speakers that have stepped forward and have something to say on the outline of where we're going, but this is truly your workshop.

The idea of having a performance standard that the agency put forth discussing on how a 5-log reduction can be accomplished didn't provide any specific guidelines intentionally. The whole idea of a performance standard as we crafted it is to leave it in the hands of the industry who knows best, frankly, how to control their products to work with the issue of safe production of food, in this case citrus juice, discuss the technologies that can be applied and come up with a strategy for achieving this performance standard 5-d.

These recordings today are going to be transcribed and so one thing that I do ask is we hope to have audience participation and comments from people who are here. Please state your name and your affiliation for the benefit of the transcriber so that we can capture the comments that are made.

And I hope that this open dialogue will result in an ongoing activity. I hope today is the beginning of a new interaction for the industry and the Food and Drug Administration on how to operate under a system where you've got a general performance standard that's laid out for the industry, an industry meeting the challenge to achieve that standard.

Now, the way I see it, the audience that is sitting out here today represents various segments of the industry and it's my hope that as we move through the day we will be hearing from segments of the industry from the field, from groves where oranges are grown through packing operations on through processing and on through retail sale.

We are quite aware that there is a variation in systems in how fresh juice, fresh citrus juice, is supplied to the public. And one of the discussions we hope to go through today is a discussion and a strategy on how to achieve a cumulative 5-log strategy. I think there is a difference between the strategy to be employed by processors of fresh juice where everything is under their control directly within the plant operations from the time they receive the fruit to the time the cap goes on the bottle.

Part of today's discussion is going to be about the role of packers and incoming fruit and how it is processed in secondary facilities to include retail establishments.

But as I said, we have a very full agenda today. The next speaker that's coming up is Dr. Dick Whiting from the Food and Drug Administration. He was formerly with the Agricultural Research Service at U.S.D.A. and brings a great deal of expertise to the subject area of food microbiology. He's had a long and very illustrious career at FDA.

The only other thing I would say relative to an overview of the objectives is that how you count the 5-d and how it's put together and how it's validated, I think, is an important discussion that's going to be on the minds of many people over the next several months as we move ahead with the issue of how you produce a five decimal log reduction of a pathogen potentially being on the outside of a fruit, not getting into the citrus itself.

And the work that we are aware of that's been done so far has taken two forms. One is the measurement by replicating in a laboratory setting what happens in an actual process with a pathogen that's on the citrus.

And the second approach has been used -- has been using organisms which are not pathogenic in measuring what is going on in the actual processing environment through an organism that's termed as a surrogate organism, so you can tell along the various points of the chain what kind of reduction is being achieved by the processing itself.

Part of the work that needs to be done and summed up is do the parts add up to the whole in this kind of testing? And do the pieces of information that have been gained from studies that have been done by the industry in a pilot based operation match up with actual plant observation with organisms in a realtime situation as the juice is being processed?

That's all I really have to say on the overview except I would like to have you note that in the agenda there is going to be time this afternoon for informal discussions at approximately 3:40 on the agenda. That section of today's program will not be transcribed. Obviously, you need to have time and have informal discussions. And it's my hope that in the waning hours of the afternoon we will have a discussion on the issues that were raised during the day and discussions and input from you folks to determine what our next steps are going to be past today.

So with that I'd like to turn the microphone over to Dr. Whiting. Thank you.

Very briefly. I'm sorry, I didn't know this. Sorry, Dick.

What I didn't say is that we didn't open the HACCP regulation for comment following today's meeting. So today's discussion is not really about the issue of is 5-log attainable or is it the appropriate number or whether HACCP should or should not be a regulatory issue. But I just wanted to mention in passing this morning that we plan to open the record for comments on this shortly, perhaps at the end of the month, I don't have an exact date, and hold that comment period open. This will occur after this meeting and the meeting we're going to be holding in Irvine, California next week.

Sorry about that.

DR. WHITING: Thank you, John. I'm just going to give sort of a brief overview of what we mean by this 5-log reduction just so we have everybody talking and thinking about the same thing.

Now, we're dealing with pathogens, of course, that get on to the fruit from the environment, they're in the soil, the water, airborne, dust, any animals, either domestic or wild, that might be near the fruit.

We do know that once these pathogens get into the fruit they're probably not going to grow, but they can survive very well. The pH of orange juice is not enough that they will rapidly die off within the shelf life period that this product typically has.

So the National Advisory Committee for the Microbial Criteria for Food is a group that advises the Food and Drug Agency and the U.S.D.A. on microbial issues and this is a group composed of academic and industry microbiologists and the produce working group came up with this reduction scheme. And we talked about 5 logs of reduction and this is some of the logic that they used in coming up with that.

They're looking at one pathogen initially being present in a mil of the juice and then with a 5-log reduction, that means we're down to 10 to the minus 5th pathogens per mil at the time of consumption. And 10 to the minus 5th -- if you're a little rusty on logarithms, I will go over that again in just another slide or so.

But basically 10 to the minus 5th means that there would be one pathogen in every 1,000 servings, if the serving was of 100 mil volume. And this is the kind of logic that they went through when they came up with this kind of a number. And when they talk about pathogens, we're thinking about primarily E. coli virus 7, H-7 and Salmonella.

Now, when you look at one pathogen per mil, the committee did not really think that all of the juice that you put out is going to have one pathogen per mil. What we're looking at here is sort of the -- the extreme here. We're looking, if this is zero or 10 to the zero one pathogen at this line, we're looking at this minority of juice up here on the shoulder that is on the bad side, if you will. Most of time our juice is down here. And this is just a very suggestive or illustrative slide here. I really don't know what the typical numbers of pathogens in the juice are or the distribution should be. But it's this small group here up at the end that we feel we have to set the criteria for.

Now, this slide just gives sort of a quick look at what we mean by a 5-log reduction. And on this scale here I've got -- it's a logarithmic scale of 3 means that it's 10 to the third, or 1,000; two is 10 to the 2, or 100; 10 to the one is 10; 10 to the zero is one. So this is a 10 fold scale here each time.

And there are classic thermal type processing. We see a straight line reduction for each additional time period. Now, this could be five minutes or whatever at 50 degrees or just maybe 10 seconds at 60 degrees, whatever.

The classic thermal depth is a straight line with time where each unit, if we call it a D value, we see a one log reduction. And that would be a 90 percent reduction. We have gone from, say, 200 organisms down to -- pardon me, 10 to the 2 is 100 organisms down to 10 to the 1, which would be 10, so 100 down to 10 organisms. And if we do the same treatment another unit of time, we have gone from 10 down to 1.

And if we keep going with this, then we see we get down to these, 10 to the minus 1. And what we mean with this now is we get down here to one organism and we give it another treatment period and we now have 1/10th of an organism which you can then interpret as one organism per 10 samples.

So if we give it another unit of treatment we're from one organism in 10 samples now down to one organism per hundred samples. So in theory here, then, we never actually get to zero. We keep going down by units of 10.

Now, of course, this slope and so on will depend on the particular temperatures, the times, it will depend on the media that the organism is in and it will vary with every particular pathogen.

Now, you take the same concept, this was for heating, but it also applies for many other microbial inactivation treatments, chemical treatment and so on.

And we can also break this down and not look at it as a single process. And what I'm trying to suggest with this slide here is instead of time here, now we've get got our individual processing steps. And if we start with our 100 organisms we can have one log reduction with the first step. The second step takes it down three logs, perhaps a step that doesn't have an effect. And, finally, another log reduction and then, perhaps, out to the consumer here.

And when we talk about a 5-log reduction in the case of orange juice, what we're interested in is basically from the beginning to the end. And we're not caring too much particularly at what the particular pattern of steps is along the way. And this is where the industry now can come up with different processes and a series of combination processes that will achieve this 5-log reduction.

Let me go back one step. One comment I would like to make and reemphasize that John did mention a little bit here, we look at trying to define what sort of reduction a particular step will have. This can be done by studying each individual step. And we can get a certain reduction for it. You can see that sort of the logic of this process is that these steps are additive. But this is something that does have to be checked rather carefully.

For example, if you devise two different washing treatments, for example, there may be a population of bacteria that is relatively easy to remove and then a population that is more difficult to remove. So if you study the step with the first treatment, you remove, you know, one log and then you remove a little bit more.

Then you take the second washing treatment, oh, that's good for a log and a half, too. But, in fact, if you then go from one and then go to the other, the first step already removes that easily removed group of bacteria and then the second step is no longer as effective. So when you put these different steps together they have to be considered both individually and the entire process, as well.

Okay. So just, then, reviewing back what we had here, I said the initial one pathogen per mil targeting what we believe at the moment to be the high risk side of the juice industry. Our 5-log reduction, that gets us down to a level of about here. And our experience with, you know, other particular -- other foods and pasteurizing whether we're looking at liquid eggs or milk, pasteurization is in the range of 10 to the 5th, 10 to the 7th is what our experience has shown has produced a food that produces a negligible risk of illness in the public.

And, of course, you know, one pathogen just by itself is not going to be always a dose that will cause illness. You will have a low probability there. So we might look at one pathogen and say there is only one in 100 probability for it times, then, one in 10,000 that is there. This is the kind of logic that is put together when they come up with these numbers.

I should mention in the HACCP plan, then, has to take this as the target. In other words, this is specifying what your HACCP plan should achieve. And I realized when I put this together that there is a need for data and I would say in this case our data is not real strong. We do have a need for more information on numbers in the raw juice. We need more information on numbers on these various steps. And we're going to get quite a bit of that today.

A couple quick comments on this topic of surrogate microorganisms. We're going to talk about this in more detail later on, but just to get it started it's obviously that we do not want pathogens deliberately introduced into the food plant or into most pilot plants. That organism is E. coli 0157, so, therefore, we need some surrogate microorganisms that can be used as substitutes.

The next slide, this just gives a couple of the criteria when we talk about surrogate organisms of what we need to have. The surrogate organism needs to have properties that are similar to the pathogen that we're trying to study. And by similar properties, I'm thinking of thermal resistance or acid adaptation, their ability to survive, their sensitivity to various antimicrobials. Whatever is relative to the food that's being studied, the surrogate organism needs to be similar to that pathogen.

And we have to be able to quantitatively detect these organisms. That's not always easy when you've got a large background flora of spoilage bacteria, we have to be able to identify these surrogates that we have. This is not an easy problem microbiologically in some cases.

And, finally, just to mention that when we do a surrogate study we have to be able to inoculate the organism in a manner that is appropriate.

For instance, contamination on the fruit can occur in various crevices in the product or if you could get the organism underneath a waxy water repellant coat, for example, then to just do a surrogate study where you dip the fruit in a bacteria and have them on the surface may not give you exactly the same results that you may get in a real situation.

So with that I will stop and just state again this idea of the 5-log reduction we are trying to give the industry the maximum amount of flexibility in order to achieve this reduction and to assure the public safety. Thank you.

DR. KVENBERG: Thank you, Dr. Whiting. No discussion on a technical workshop in Florida about citrus and food safety would be appropriate without comment from the Florida Department of Agriculture and Consumer Services here in Florida.

Dr. Martha Roberts is the deputy commissioner. Martha and I have known each other for many years. And she is going to talk to you this morning about regulations that are applicable to citrus juice here in Florida.

Dr. Roberts?

DR. ROBERTS: Good morning. I'm here to talk a little bit about the status of what we have done over the last few years as far as what is regulation in the State of Florida. And I'm very delighted that we have some additional people here because we want our friends from FDA that are visiting today to know exactly what's going on here in Florida. They've been cooperators, but we also want them to know the personnel involved. Some of them maybe haven't in the past.

But I want to recognize today that we have with us Dr. Andy Laurent, director of our Division of Fruit and Vegetable Inspection here in Winter Haven; Lisa Rath, I think I saw come in in the back, our assistant director; and also from our Division of Food Safety that's up in Tallahassee, Dr. John Fruin and Dr. Wayne Derstine. So if there are any questions that they can help you with while we're here today. If I missed anybody else's that came in, I'm sorry.

One the main things that we want to say is that food safety has been paramount as one of the priorities of the agency ever since commissioner Bob Crawford was elected. And we need to look and, perhaps, go over the details of the past that are a bit of a horror story. As with you well know, there was an outbreak in May and June of '95 with Walt Disney World with some fresh unpasteurized juice.

Now, let's look at the time line as to what happened and how did the Federal, the state agencies and the industry responded to that outbreak, because we well know from going back then there was some things that those of us in food safety maybe had not appropriately known about the survivability of some of these organisms in fresh juice. Let's look and see how this outbreak, how we responded to it.

First of all, we heard a little bit about the outbreak just by rumor back in June. Quite frankly, our Department of Agriculture was not even notified until sometime the first of August and we found out about it officially through some of the quality control people at Walt Disney World.

Now, we immediately were in contact with the Food and Drug Administration. They were involved by this time and also by CDC. Quite frankly, by the first week in August we had joint inspections with the Food and Drug Administration, the Department of Agriculture inspectors and CDC and went in there and collected samples. It was split three ways between all the laboratories.

Now, it's very difficult sometimes, as you know, to analyze these organisms in a laboratory as you've found out over the last few years. But by August 18th of 1995, some results had started coming in. By August 15th, there was a food safety inspection team that visited five fresh juice processors making recommendations as to how some improvements could be made in those plants.

There was a press release regarding this on August 16th of '95, and a draft rule that, basically, was a cooperative effort of all the State and Federal regulatory agencies involved in food safety as well as industry input and partnership with the Florida Department of Citrus, a draft rule came about on September 19th, and this was actually presented to the Citrus Commission on September 20th.

Now, as you know in Florida, we have a public administrative procedures act. You have to go through certain hoops to get a rule in place. The Department of Citrus in their presentation to the Citrus Commission and the vote there was one of the first steps. Then it had to start going through the administrative procedures hoop. There was a public hearing on this on October the 23rd of '95, and the rule actually became effective January 1996.

Perhaps that is why I'm so disappointed in this last week's event. Here we had a rule that went into place through profound cooperation with the Florida Department of Citrus, the Florida Department of Agriculture and Consumer Services, the Food and Drug Administration, the local county health departments, the Florida Department of Health, CDC, the industry was an integral part -- was a wonderful example of coop.

So what did we just have come out in a recent Journal of American Medical Association, but a report of the outbreak of '95, with no mention of what occurred in '95 and '96, and then an immediate printing of U.S.A. Today that didn't even report the article correctly and said it was E. coli instead of Salmonella. I just, you know, want to point out the action line to you.

Basically, this was a HACCP based regulation. It was not HACCP, but it was based on the sound principles of science as to how to improve safety in a product and to make food safety as good as possible at that time.

It has stood the test of time. There have been no outbreaks since that time. There has been a great development through the Food and Drug Administration with the proposal that you see now, but I think it was good to remind you of the time line and that we've had this rule in place since 1996.

Now, it depend on whose figures you report, and I need to get some better data, but it is reported to us that we have anywhere from 1 to 4 percent of the juice produced in Florida that falls into the category of fresh, unpasteurized juice.

Of course, the vast majority of the production in Florida goes into concentrate, which goes through a heat kill step.

Let's look at this rule, Rule 20-64.020 of the Florida Administrative Code and let's see what this entails.

Now, what I'm talking about is the rule that is in effect, the rule that has been in effect since January of 1996. This is not what we're talking about.

But we did know, just to remind you there are some exemptions, but I want to remind you these are not technically exemptions.

These groups are exempted from the Florida Department of Citrus rule: Those that are squeezing less than 30,000 boxes, gift fruit shippers, retail processors and roadside stands.

However, if you read the specifics of the rule, it says that only these are exempted that have a proper permit with the Florida Department of Agriculture and Consumer Services under our Food Safety Division. And for those there is an exact requirement of sanitation, there is an adoption of CFR 21 relating to good manufacturing practices and they are covered in that way.

Now, the Florida Department of Citrus, again, as you well know, since you're operating under it, covers many things. The major categories of washing with an acid wash and roller brushing the fruit to the minimum 200 parts per million hypochlorite rinse and the water rinse just immediately prior to processing to ensure that any of the contamination on the fruit could have been removed.

Again, there's requirements that the whole processing area and the washing area be kept under good sanitation. And under the specific of quality requirements that the Division of Fruit and Vegetable Inspection imposes, again there is the requirement that there be no defective fruit that is processed.

Now, as you well know, your friendly regulator partners from the Division of Fruit and Vegetable Inspection are there in the packinghouses and they're in the processing houses, we have the U.S. Department of Agriculture providing inspection there.

But in the processing areas you have to remember that when you go from a fresh product to a processed product you've got to go into a very specific enclosed area and you've got to ensure that it's adequately sanitary, that it's cleaned both prior to and after production and that you've got an effective means of control and that you're applying sound science based principles for pathogen and other microbial reduction.

Then you've also got your finished product requirements. There's got to be a contingency plan for handling the juice if anything goes wrong. You've got to have a protected filling area. You've got to have sanitary handling of containers and you have to have immediate cold storage to ensure that if there are any microorganisms remaining they're not going to be allowed to reproduce.

More than anything else you have to have some verification of what you have done. You have got to have good quality control procedures but you've also got to have good food safety monitoring to ensure that there is freedom from pathogens in the production and you've got to do some daily checks with your aerobic plate count, your coliforms and trying to determine if there are any E. coli present.

You've got to prove what you've done. You've got to keep your records 90 days for any fresh product. If you were using any imported product, you've got to keep those records for up to two years. And you've got to have some way to track your production. You've got to have it properly coded. You've got to be able to -- if anything were to happen in a worst case situation, you have got to be able to go back and determine where did that fruit come from.

Okay. This has been a rule in place since January of '96. U.S.D.A. has the inspectors in the large processors. The Department of Agriculture has inspectors in the small processors, fruit shippers and retail.

Let's look at what we have found. Out of the last couple of years in looking at 452 samples, or 300 individual firms, we have only found 20 samples that were positive for E. coli, which is roughly about 4 percent of the samples, or roughly about 5 percent of the firms.

Now, if you actually look, that is something very similar to what we see with other raw types of processed products on the market such as the bag salads and things of that nature.

If you actually look at this per year, you can see that in '96, we looked at 43 firms, we had a total of four firms that were positive for E. coli. We'll look at the levels in a few moments.

In '97, again we had four firms out of 119. And this last year, the year we're in now, '98, out of 138 firms we have looked at so far, we have had nine positive samples from eight different firms. But for a total of the three years a maximum of 20 samples that had any E. coli present in them.

What type of firms were these E. coli detected in? Well, of these firms, 12 samples, or nine of the firms, were classified as gift fruit shippers, three of the firms were small markets, three firms or four positive samples were from retail chains, and one was from a small juice bar.

If you break it down even further, you'll see that four of the gift fruit shipper firms could be classified as a small processor, where five firms were just, basically, what we classify as a gift fruit shipper, maybe a small stand.

Now, the levels of E. coli were as shown here. Basically, 11 of the firms had E. coli that was, basically, at very -- excuse me, 18 of the firms had E. coli basically at fairly low levels, but you see that two of the firms -- one of the firms had E. coli over 100 per mil.

Now, the proposed juice rule, the proposed HACCP rule is going to be applied to any juice sold or used as a beverage ingredient. When the proposed rule came out Commissioner Crawford made comment to the agency basically saying that he did not feel the warning statement was needed and he felt that there should be a declaration of whether the juice was pasteurized or not pasteurized as part of the name. That particular part was not enacted.

But, again, you see the effectiveness of the date as far as the integration of HACCP into these firms and as Dr. Kvenberg indicated to you, they will be opening up again some comments on this HACCP rule.

Now, again, there are certain areas that were proposed to be exempted there within the proposed HACCP rule. But, again, the requirement of good manufacturing practices that I want to remind you was already enacted within the rule that was adopted by the Department of Citrus in January of 1996.

Basically, I'm putting these comments up here again to remind you that I think what we've done here in Florida has been a good example of wonderful State, Federal, industry cooperation.

There was a problem in late '95, mid-'95. The industry, the State and Federal government jumped on it and put in place the best regulation we could come up with to control the situation and to prevent any further situation.

Now, Ms. Campbell has already indicated to you if you do not have a 5-log reduction, the type of warning statement that would be required to be on the juice. We are pleased that some of the plants appear to be able to have that minimum 5-log reduction within the processes that you are conducting. And I would like to also say that I would hope, since the fact is that we have some of the juice being imported to this country that is not processed, that is not pasteurized that we also would, hopefully, be able to impose this type of regulation equally upon that juice being produced.

I think we have got some good opportunities before us to continue a job that was started by the January '96 rule. It's in all of our best interests, both regulator industry-wide to ensure that we have the safest possible product. The job is not done, but I think you can certainly pat yourselves on the back for the cooperation and effort. You took the bull by the horns, we came through with the regulation, it stood us in good stead today and now we can move forward with improvements.

Thank you.

DR. KVENBERG: Thank you, Dr. Roberts. At this point in our program it is time to make a shift into the actual outline of what we want to talk about today, beginning with the practices -- beginning with growing, the harvesting and packinghouse controls.

And we have -- we are fortunate this morning to have a panel of tech natural experts to address this issue and very fortunate to be in the location where we are and have a Florida Department of Citrus that has been actively engaged throughout the process on fresh juice.

So without further comment, I would like to introduce a gentleman I'm sure many, if not all, of you, know, Dr. Mohamed Ismail from the Florida Department of Citrus to address us at this time.

DR. ISMAIL: Thank you, Dr. Kvenberg, and ladies and gentlemen.

We are very, very pleased to be a participant in this workshop in order to share with you some of the work that our scientists have been doing over the past three years.

Generally, the Florida citrus industry is the No. 1 citrus grapefruit producing industry in the world and we are only second to Brazil in orange production.

The 1997-98 season Florida produced 244 million boxes of oranges, which is nearly 10 million metric tons, and 50 million boxes of grapefruit, almost 2 million metric tons.

Our industry has a monetary value of over $1.2 billion and its economic impact on the state economy sometimes reaches $8 billion.

Based on fruit utilization, we have four major segments of the Florida citrus industries and they are, No. 1, the juice processing industry, the segment of Florida citrus industry utilizing over 95 percent of the oranges and approximately 60 percent of the grapefruit.

It is comprised of 24 large citrus processing plants that produce primarily frozen concentrated orange and grapefruit juice and pasteurized not from concentrate juices.

All processing plants are under continuous inspection by the U.S. Department of Agriculture. Products' quality is regulated by the State of Florida, Florida Department of Citrus and enforced by the Florida Department of Agriculture and Consumer Services.

The second segment of our industry is the Florida fresh fruit citrus industry. This industry processes and packs fresh citrus fruit in various packages, mainly cartons, that are shipped from over 100 citrus packinghouses. And, again, all commercial citrus packinghouses are under continuous inspection by the U.S.D.A.

And approximately 5 percent of the oranges are processed fresh and about 40 percent of the grapefruit is shipped fresh to markets in all 50 states, Europe, Japan, Korea, Taiwan and many other Pacific Rim countries. These packinghouses also ship cartons, packed fruit to juice extraction facilities at retail in different parts of the United States.

It is important to note that all fresh citrus shipped out of state must be processed through a State licensed packinghouse continuously staffed by a U.S.D.A. Florida Department of Agriculture trained and certified inspectors.

The third segment of our industry is the gift fruit shipping industry. This industry is comprised of approximately 300 vendors ranging in size from a small one room store to large operations complete with packinghouse equipment and even candy manufacturing facilities and fresh juice extraction.

These businesses may sell bagged fresh fruit, bottled juice, candy, nuts, preserves and even toys to local residents as well as to tourists. They also ship fruit in gift boxes and baskets to customers all over the United States, Canada and some countries in Europe and Asia.

Almost all roadside gift businesses process and serve fresh squeezed orange juice and grapefruit juice for in-store sampling by customers and for takeout customers in various sized packages. It is not exactly known how much fruit is utilized for fresh juice processing by these businesses, since juice and fresh fruit sales are lumped together.

The fourth segment of the industry is the large volume fresh juice producers. These are fairly large processors of fresh squeezed juice who regularly process large volumes of fresh oranges and grapefruit year-round.

They operate under continuous inspection by the U.S. Department of Agriculture. And the volume of fruit used by this segment of the industry is estimated at about 2.6 million 1 and 3/5 bushel boxes per year or approximately 1.1 million metric tons.

Fresh juice is packaged in various size packages and shipped under refrigeration. Some of these businesses also ship fresh squeezed juice in refrigerated tankers for packaging elsewhere.

We are going to look at what are the harvesting and packinghouse operations that can provide control and actually give us some degree of significant reduction of surface microbial load in fresh fruit and greatly enhances safety of fresh squeezed juice.

Harvesting the fresh citrus is conducted manually using picking bags. This is placed in plastic or wooden bins and transported to the packinghouse. No domestic animals are allowed to roam through citrus groves, which greatly reduce the risk of microbial contamination. Exclusion of fruit dropped on the ground further ensures significant lowering of microbial contaminants.

In the packinghouse fruit is graded, washed, scrubbed, rinsed with potable water, waxed, graded again and packed in fiber board cartons.

Each of the above steps, both individually and collectively, contributes to the reduction of fruit microbial load and enhances the safety and shelf life of fruit as well as the juice made from that fruit.

The Department of Citrus surveys of commercial packinghouses have shown no E. coli or Salmonella on packed citrus fruit. Inoculation studies conducted on packinghouse lines using E. coli demonstrated substantial reduction of nearly four log cycles as fruit moves through the packinghouse. Juice extraction of E. coli and Lactobacillus inoculated fruit achieved an additional one and a half to two log cycle reduction in surface microbial load leading to greater assurance of juice quality and safety.

During the course of this technical seminar, the results of Department of Citrus scientific research program on fruit disinfection and fresh juice quality will be presented by Dr. Steven Pao. Control measures adopted by the Florida citrus packers will be introduced by Mr. Richard Kinney.

And it is worth mentioning that over the past three years the fresh citrus industry in Florida has adopted good manufacturing practices and standard sanitary operating procedures in their operations. Some businesses have already incorporated Hazard Analysis Critical Control Points programs into their systems.

Technology transfer and education is an active and continuous process undertaken by the Florida Department of Citrus in cooperation with the University of Florida scientists, Florida Department of Agriculture sanitation experts and Florida Gift Fruit Shippers Association officials. Over the past two and a half years we have conducted four half to full day education workshops on GMPs, SSOPs and on the fundamental principles of HACCP and we have published a large number of publications in refereed journals.

The data presented today is just part of our active and continuing research program aimed at developing scientific information and transferring that information to our constituents in the fresh citrus juice business.

I have a few slides I would like to share with you to just walk us through the packinghouse operation and at this time I would like to put them on and turn off the lights, please.

The harvesting is done manually on ladders and off fruit near the ground on the lower canopy of the fruit.

The fruit is transported to the citrus packinghouses in either wooden bins or in plastic bins.

Drenching is very common where the fruit is drenched with a mixture of fungicide and chlorine. This is a picture of how the fruit is introduced into this disinfectant, and that's mainly intended to reduce decay and increase shelf life.

Degreening is done during the early part of the season in fairly large degreening rooms. The fruit is exposed to 85 degree Fahrenheit and five parts per million ethylene to remove the green color that prevails on the fruit during the early season time.

The fruit is introduced into the packinghouse and it is washed with a mixture of soap, detergents and sometimes it contains SOPP, sodium orthophenylphenate, that can help in reducing certain types of decay.

Grading is done by a large number of people.

And the fruit is dried at about 115 to 120 degrees Fahrenheit and it is waxed. This is an additional fungicide treatment that is introduced prior to waxing.

And packing is done again manually into cartons and different sized packages.

This is one of our commercial citrus packinghouses. We just wanted to introduce this to some of the attendees from out of state so they might have an opportunity to see what goes on in citrus packinghouses. And palletized shipments such as this are shipped to various parts of the United States and sometimes to port warehouses where it is shipped overseas.

That concludes my presentation.

DR. KVENBERG: Thank you, Dr. Ismail for that excellent orientation for those of us who are not intimately involved with this part of the industry.

Now, our next speaker this morning is Mr. Richard Kinney. He is going to speak to us from the Florida Citrus Packers relative to the issue of grove harvesting and packing controls.

MR. KINNEY: Good morning, ladies and gentlemen. And we very much do appreciate the FDA officials conducting this workshop here. We very much appreciate the opportunity to be a part of this workshop.

I am going to do three things this morning. First, my comments are going to be brief. I'm going to describe who we are and why we're interested in this process, how it affects us, how this issue affects us. I'm going to describe briefly what we have identified in our packinghouses that reduces the pathogens to help reach the 5-log reduction, and Dr. Steven Pao is going to give you more details after I speak and what are our plans for the future leading up to July 8th, 1999, when this process will -- will come to a close.

We are -- I do represent Florida Citrus Packers. We are a nonprofit trade association. We have 65 packinghouse members and our packinghouses are located along the ridge of entire part of the state and on the Indian River. And the Indian River is Palm Beach north to Titusville, about 12 miles wide and 100 miles long. There is about 35 packinghouses down the river. They're heavier to grapefruit.

In the interior we have about 35 packinghouses, which is Lake County, which is north of here, Orange County south down to Okeechobee to about 14 houses here in Polk County. And that's who I represent, those commercial packinghouses. Mohamed showed a slide of one of our large houses.

Annually we ship about 70 million 4/5 bushel cartons. That's about $4 to $5 million FOB business packinghouse. And we're a very labor intensive business. Most of our packinghouses have to have 150 or so folks when they open the doors, so we employ about 15,000 folks annually. Our season runs September to June. It carries over into August when we store some fruit for the fresh squeezed business.

We are, as Mohamed indicated, the world's largest grapefruit growers and we are the second largest producer of oranges.

Our Florida citrus, fresh citrus, our citrus is known for its high juice content, higher natural solids and sugars by comparison to, perhaps, the desert variety citrus. It's been said we have a third more juice and that's because of our weather conditions. We have about 50 to 55 inches of rain a year, high humidity, high sunshine and so we do have a product that is sought for fresh squeezed because you get the higher yield.

And so -- so -- what does this represent, then, to us as an industry as far as business? Fresh squeezed, as Mohamed indicated, we can't exactly attribute a number to it, but we do think it's as much as 40 percent of our fresh oranges that move into commercial challenges, go into fresh squeezed and maybe as high as 3 million cartons of our fresh grapefruit goes into fresh squeezed. And we have heard projections as high as 12 million cartons or $40 to $50 million worth of FOB business annually that move into the fresh squeezed business.

Our customers -- we're commercial packinghouses. Our customers are the retail chain stores. They have in-store juicers, they juice -- they juice the fruit daily and they provide the product to consumers under a private label. And as such, with a private label, of course, they don't want to put a warning label next to that private label, so we're -- we're compelled to -- to try to bring to them a program that shows the 5-log reduction so they can avoid the warning label.

That in-store juicer is in the Produce Department. It's not in the Deli or the Meat Department. They have to assign a person, half person to it. It's very labor intensive for them, too. So we're trying to -- to work with them to develop a program that will -- will meet the requirement of this proposed rule or this rule.

Secondly, we have identified -- I would like to go over those very quickly. We have identified in our packinghouses that which reduces pathogens. The Department of Citrus, give them full credit, has jumped on this issue and they have done some research for us to help us reach the 5-log reduction. And I was here going to talk to you a little bit about what we do in a packinghouse, how we convey fruit through our packinghouse and what we do and the activities that we perform, but Mohamed did that very precisely so I won't get into detail. I will just say when it comes out the end of our packinghouse it looks like that, wherever that fruit is right down there. It looks like that down in front of the podium, and it's very clean fruit.

We are very highly regulated industry. We have Federal Marketing Order 905. We have FS 601, which is a citrus code. We have DOC rules. All of those provide for minimum quality of size and grade and firmness and wholesomeness and we impose those rules on ourselves.

We -- we asked for those regulations years ago and we have maintained those and even added to them to maintain that wholesomeness and good quality fruit. All of our packinghouses are licensed and, again, they're big facilities.

And as they pack this fruit, we, again, through the DOC's good work in the last few months, have identified some areas where we can reduce these pathogens using SOP guides of good manufacturing practices and I have given or I had 150 copies up front as requested, and I'll give copies to the FDA officials here today outlining some of that work that was done.

Essentially, there's three areas where they did identify pathogen reductions. No. 1, washing and rinsing with potable water reduce E. coli levels about 2.4 logs. And the waxing process, washing and waxing treatments were found to reduce service inoculated levels of generic E. coli by 3.4 log. And in the extraction process, using a commonly used commercial extractor, the reduction of E. coli and Lactobacillus was 1 to 2 log.

What are we going to do over the next several months leading up to July 8th, 1999, we are going to develop a retailers fresh juice squeezed handbook, and it's going to be for the retailers, everybody through this process handling the product. It will be a comprehensive overview of the process identifying SOPs and GAPs and GMPs and -- and we will also conduct additional research to match that research with the log reduction so that we can achieve this 5-log pathogen reduction.

And a very important part of this process, as indicated in the rule and by the FDA officials here, how we can validate those procedures that they're done as we -- as we indicated. That's what our challenge is over the next six or eight months. And the science has been done to date which gives us about a 4 to 5-log reduction. I think Dr. Pao is going to offer some greater details on that this morning.

Those are my comments, Mr. Chairman, and I appreciate the opportunity.

DR. KVENBERG: Thank you, Mr. Kinney. As you've just indicated, Dr. Steven Pao from the Florida Department of Citrus is now going to address us relative to controls at this segment.

Dr. Pao?

DR. PAO: Thank you. May I have the first slide, please?

Good morning. I would like to present the data and the experiment results on reduction of microorganisms on citrus fruit surfaces during packinghouse processing.

What we did the first thing is a packinghouse survey. We went into seven commercial packinghouses in Florida. At each packinghouse six fruit were sampled by hand using sterile gloves at each of the four sampling points and right after raw fruit receiving, after washing, waxing and hand packing.

The sampling was conducted in duplicate at each packinghouse and the samples were chilled at 40 degrees Celsius and mixed one liter of peptone. 41 percent peptone water was added to the bag. And the sample solution was shaken in a laboratory shaker for two hours before we tested this wash solution microbiology coating.

And you can see the first figure on top, figure A indicates the level of aerobic plate count, aciduric organisms and yeasts and molds during the packinghouse processing was greatly reduced. And this is based on a log scale of four mils per 10,000 microorganisms. The average aerobic plate count on fruit surface before washing were about 4.0 log CFU per centimeter squared and were reduced to 2.1 CFU centimeters squared by packinghouse processing.

The processes also reduced aciduric organisms and yeast and mold counts. Waxing alone reduced the average fruit surface aerobic plate count from 3.7 log CFU centimeter squared to 2.6. And final hand packing alone did not change surface microbial count.

And now let's look at the second figure, figure B. The packinghouse washing process did not reduce population of coliform or fecal coliform. However, average surface total coliforms was reduced from 35, most probable number, were center squared -- centimeter squared to 1.4 MPN by waxing. Fecal coliforms were also reduced by waxing and no E. coli were recovered from all the fruit samples collected at any packinghouse after packing, and no Salmonella were found on any fruit sampled of this entire study.

Because we see an interesting reduction step by waxing, therefore we conducted an inoculation study to confirm the reduction we found in the packinghouse survey. And in this study fruit were treated in different ways.

First of all, the fruit were inoculated by generic E. coli and then the fruit were washed and rinsed for the next treatment, and the following treatment fruit were washed with SOPP, which is a fungicide incorporated into detergent and rinsed with water. And then the next step would be washing the fruit with SOPP and rinse with 400 ppm chlorine and water, and the final treatment we add a waxing process. And the fruit sampled after each treatment were tested.

And here it showed A, B, C, D, E numbering is slightly different from the previous slide. For the A treatment it indicated the fruit had been inoculated with E. coli and the level is near 5-log. And after fruit washed with water we received a significant log reduction. The average E. coli count was reduced 2.4 log cycles by washing and rinsing the fruit with potable water.

Adding SOPP in the washing process and the chlorine rinsing solution did not further reduce E. coli population in our tests. And all the tests were done in triplicate.

The combination of washing and waxing reduced the level of inoculated E. coli from 4.8 to 1.4 logs CFU centimeters squared.

We also conducted a wax study. How can we receive that log reduction from waxing process? The fruit in this study -- the fruit were washed and inoculated with E. coli and dipped in wax at different pH and different temperatures and then the surface microbial E. coli counts were tested.

This figure showed effective curiocidal combined (inaudible) alkaline heat treatment was observed on handling orange surface. For example, microbial log reduction of (inaudible) was attained by heating the fruit into pH 11 wax at 50 degrees Celsius, or pH 10 wax at 60 degrees Celsius.

Wax treatments of fruit were less effective of stem scar area.

However, let me make a conclusion based on all this data. Commercial packinghouse procedures are generally effective in reducing fruit surface microflora. No E. coli was recovered at the end of packinghouse processing. No Salmonella were found during that entire processing.

Washing fruit with potable water can reduce inoculated E. coli levels by an average of 2.4 log.

The combination of washing and waxing was found to reduce surface inoculated levels of E. coli by 3.4 log CFU centimeter squared.

Cold fruit storage can slow down microbial growth during fruit storage. This is important because after packinghouse processing if the fruit sits at room temperature, the surface microflora can be redeveloped throughout the storage time.

However, if the fruit is kept under refrigeration, the surface microorganism will develop much slower, so we have better control on that.

And, finally, mildly heated high pH wax may be used on fruit to reduce surface microbial contamination.

This is the first part of my report for today. And I have a handout, 150 copies of the report. And this report was published in the July issue of The Journal of Food Protection. And it's outside the door. Thank you very much.

DR. KVENBERG: Thank you very much, Dr. Pao.

We're at the point in the program where I guess I would call this the ice breaker portion. And it's always difficult for people to come forward, but we are at the point now where we have gone through a perspective of growing and harvesting from the packinghouse point of view. After the break we'll be looking at sanitary controls and this will be primarily as it is seen from juice manufacturing based operations who see fruit directly coming from the trees, which will be a slightly -- as well as packinghouses, which will be a slightly different perspective as to how control is accomplished.

So I would like at this point in time to throw open the microphones which we have around the room for people who wish to make comment who may have questions from this morning's presenters, here's your chance. And we'll take questions as they come, at which time when you folks have kind of exhausted any comments or questions they may have, we will have a break. Everyone is looking forward to that when we get to this part of program.

So with that, I throw the floor open and I ask for people who would like to make a comment to please identify yourself by name and affiliation.


Somebody has got to break the ice.

MS. STEGER: I'm Elizabeth Steger from Citrus Consulting. My question is in the last scientific report we found that waxing can inhibit or kill and reduce the E. coli. My question is, is it because of reduction of oxygen? What activity have you studied the principle why it's reducing this microorganism?

DR. KVENBERG: Dr. Pao, can you respond to that?

DR. PAO: Yes. First of all, E. coli can grow without oxygen, so it's not because oxygen is eliminated by the wax we coated on the fruit surface. Plus, the wax we coated on the fruit surface does allow some oxygen to penetrate throughout the fruit.

Secondly, the -- it is the pH -- it is the pH because we have done pH -- different pH levels and we see if -- if the wax alone without a high pH will receive the -- the fruit -- the fruit surface microbial -- fruit surface E. coli level will reduce much less than high pH wax.

If I answered your question.

MS. STEGER: Is the lining on the outside peel of the orange, can that have any effect to help that, too?

DR. PAO: Well, there may be other reasons, but we did not determine it in our test.

DR. KVENBERG: Thank you. Other comments or questions?

MR. WILSON: Barry Wilson with Safe Chem. And I'd be interested in hearing more about the steps that could be taken to ensure and validate that contamination doesn't take place in situations where clearly it's been demonstrated that the packinghouse fruit is in good sanitary condition when it leaves the point of shipment, but my concern is once it's received at a particular juice extraction operation, say in a retail establishment, what steps are taken to ensure that contamination doesn't occur before, you know, prior to extraction?

DR. KVENBERG: Okay. I don't know if anyone this morning will be ready to actually respond to the question that you have just posed. It's my hope that through the presentations and other commenters today we'll work ourself through that issue, unless someone would have a comment on this morning's panel on that.

I point out the fact that extraction techniques and then retail perspectives and validation techniques may come into this discussion. I certainly hope that we will have that issue addressed. And that's one of the fundamental questions you just asked that I have also is relative to what can be put together to ensure that we've got an integrity of the system that demonstrates with 5-d.

Is there anyone on the panel that would like to comment?

DR. ISMAIL: I think one of the important things is proper storage of fruit. And as has been alluded to by Dr. Pao, low temperature is very important to ensure that no regrowth would take place. And also the sanitary conditions at the point of extraction is important.

And I think Dr. Kvenberg, as you mentioned, the extraction process, the sanitation in the use of the machine and the individuals that are operating the system are all part of the whole process. And the integration of all these processes will go a long way towards ensuring that what we do here in Florida will be carried on and will not be circumvented by improper operation elsewhere.

DR. KVENBERG: Thank you. Dr. Roberts?

DR. ROBERTS: As far as a concern for the sanitation of those people that might be squeezing at retail, we currently require them to have proper sanitary procedures, but the inspectors are not there daily in a retail operation. It's not an operation under continuous inspection.

And we do hope that there will be some additional information coming out as part of this workshop that may enable us to, you know, tighten up our appropriate procedures that we have with the retail food industry. They do a very good job, but you do not have someone under continuous inspection, but they do have specific sanitary guidelines that are imposed upon them now.

DR. KVENBERG: Okay. Any additional comments or questions at this point in time in the program?

MR. BENINCASA: My name is Jimmy Benincasa. And I have a question for Dr. Pao. I'm from Hale Grove in Vero Beach, Florida.

Dr. Pao, you indicated that a high pH with mildly heated wash is effective. And I was wondering what the -- would it also be true that a low pH mildly heated wash will also be effective? And if so, at what pH should we be trying to wash it and at what temperature and for what time should we be exposing the fruit during the wash?

DR. PAO: The temperature and pH alone both can kill E. coli. But when you use these two in combination you get a so-called synergistic effect that has been documented by other researchers in different institutes. So if we want to -- to get that benefit, we need to use a combination of both. And I think our commercial packinghouse processing lines already have these two elements in there. The wax we use is normally alkaline in nature and we have a drying system that has generated heat to heat the alkaline wax. So these two elements may be playing a role right now in our packing line to reduce some microbes, but we don't know for sure because my test was done in a laboratory. And I think it's worthwhile to investigate and to further develop this area.

MR. BENINCASA: But do you have an opinion as to whether or not a low pH is preferable to a high pH?

DR. PAO: The data we have so far indicates high pH wax will greatly reduce -- will reduce E. coli better than low pH wax.


DR. PAO: The data we showed on the slide was pH 11. The result of killing by pH 11 wax was significantly better than using a pH 8 wax. And we have done some preliminary studies using a pH 12 wax. And that's a very extreme high pH wax. And we see a very good result, but that was not done on the same date, so I don't want to compare.

MR. BENINCASA: Do you have any data that you could give us regarding the amount of time that the -- that the mildly heated wash would be applied to the fruit?

DR. PAO: Right. We have generated a complete report and this report is currently reviewed by The Journal of Food Science, and that report documents all the data I have. So I -- if anyone is interested, perhaps I can give you a draft.

DR. ISMAIL: It will also be presented. A summary of that report will be presented later on today.

DR. KVENBERG: Well, my watch says that it is 10 after. And, amazingly, we are at the appropriate point in the program to take a break. I wish the rest of the day will go so well. We will promptly begin at 20 after.

(A short break was held).

DR. KVENBERG: In an attempt to keep on schedule, and I think we're doing pretty darn good, I would like to move into the next section of the program this morning. Hopefully, folks in the hall will be coming in soon.

This section of the program is going to be addressing a very critical and key issue in two parts. First off, I guess I'd like to say on this part of the agenda I'm up here and Dr. Andrew Larin is not. I'm going to be taking his place in this section and, basically, abbreviating an overview section so that the speakers can get right into the topics. I think that will help us get on-line for the second half of the program.

Basically, this is in two parts, the sanitary controls that actually count in the log reduction and any technologies that may be employed. We have talked very specifically about fresh juice. And this agenda is aimed at treatments to the outside of the fruit.

I would note that when we get through questions and answers on the second segment, which is non-chemical treatments, or perhaps even the first section under chemical, if there are commenters that wish to address the idea of chemical or non-chemical new intervention strategies that could be applied to juice, per se, those are also welcome.

It's not an attempt not to address these things. We are quite aware that there are technologies that have been emerging in the last several years that might be germane to discussion on the record that we would certainly like to hear from.

So without further comment from me, I would like to roll right into the section under Sanitary Controls talking about sanitizers themselves and specifically chemical sanitizers.

We have Mr. Steve Hunter, who is here from Florida, The Fresh Juice Company, who is going to be our first presenter on the subject of chemical sanitizers. Steve?

MR. HUNTER: Thank you, John. I'll begin my talk telling you a little bit about our HACCP analysis as we are developing our HACCP plan.

And we found a potential source of pathogenic contamination occurs when the integrity of the peel is compromised in conjunction with a pathogenic source. So you have two things that you have to do. You have to remove the fruit that has had the peel compromised, like a hole puncture or whatever, and then you have to remove the pathogenic source, the potential pathogenic source, from the surface.

So here it's showing a grading operation. In washing and sanitizing the fruit you're going to be just removing. Here is where you are going to take out the pieces of fruit where there is a puncture and contamination has gotten into the juice sacs.

I had mentioned both washing and sanitizing the fruit. They're actually two different distinct steps. And fruit washing is where the potential contaminant is physically removed from the surface of the fruit. In this step probably more important than the chemical that you're using is the design of the brush washer you're using and the bristle design.

There's an orange over here. Let me sort of demonstrate what I'm talking about. If the bristles of the brush are straight up, the fruit has a tendency to move along without rotating, so the brushes need a slight curvature to force the fruit to the rotate. So you could actually, in a brush washer with a design with a straight up brushes, you could have a fruit ride all the way through with never being rotated.

This is in the sanitizing step you're removing the microbes by a chemical kill. In our system here we have 36 spray nozzles and an exposure time to the sanitizer of 83 seconds.

The type of chemical that's used, its concentration, exposure time are the critical elements. But one thing that needs to be said now, there are several combinations of these critical elements that will result in a successful intervention.

And so there is really no one answer to what's the best sanitizer, what's the best chemical, what's the best exposure time.

Here is another step in our process where the rules of the Florida Department of Citrus were mentioned, particularly the 2064.020, where in Florida we have the zero tolerance regarding breaks in the fruit integrity. So in our system we start out fresh washing the fruit, we have a primary grading, we have a sanitizing step, a brush washing step, then a zero tolerance culling step, a sanitizing step and then a clean water rinse before the fruit goes into the extractors.

Now, I said that there were several kinds of chemicals that you could use as sanitizers. In Florida for several decades acid fruit washes have been used. Over a couple years ago -- actually, when the rule 2064.020 came out, it required the use of a sanitizer that was equivalent in strength to 200 parts per million sodium hypochlorite.

What was found is a lot of these acid fruit washes that had been used would have to have been used at a very high rate to meet that equivalency requirement. As we started looking at that, we, in addition to using an acid fruit wash, we began using a sanitizer. And so two seasons ago when we began using the sanitizer, we found a significant reduction in our total plate count and an improvement in our shelf life.

In California they had been using chlorine for quite awhile as a sanitizer. And there's also now a relatively new system called -- a chemical system called chlorine potentiator and this is being tried in citrus plants in California and in Mexico. There is one test that I'm familiar with from California that showed similar results using this system as with using regular sodium hypochlorite.

I want to speak a little bit about ozone. We did some experiments in our plant surrounding using ozone. We had a small ozone generator that had been designed for using in swimming pools. And we were only able to get .5 parts per million ozone into the water, but with an exposure time of 30 seconds, we got a 1.08 log reduction.

Extensive work has been done out at Cal Poly regarding ozone on vegetables, particularly a lot of work has been done with lettuce. It's been done by Dr. Joseph Montecabo. And he's found log reductions as high as 4 and 5-log reduction with E. coli of 1.57 and with Salmonella using 1.0 to 1.3 parts per million ozone with an exposure time of 30 seconds.

One of the things, if you're a chemist, you might notice that most of these sanitizers are oxidizing agents and it seems like the stronger the oxidizing agent they are, the less you have to use of them.

See, like with ozone you might be talking about using 1.0 parts per million and when you move up to chlorine dioxide, you might be using 2.6 parts per million of residual chlorine dioxide, where with chlorine you're probably using 200 parts per million and then peroxyacetic acid, you might be using 300 parts per million.

They each have their own qualities about their effectiveness, though. I mean, with the ozone you might be using 1.0 parts per million, but you're losing most of your ozone. As soon as you separate it, you're losing it. So there's some other things that come into play. So like I said before, there's several combinations of chemicals, concentrations and exposure times.

Some plants -- some processors have tried using surface sanitizers. What they have been using before in their plant to clean stainless steel surfaces, they gave it a try on fruit and this includes ammonia compounds, iodophor and things such as that.

One of the concerns we had particularly in our plant, we do a lot of certified organic product, and so most of the acid based fruit washes contain phosphoric acid and, therefore, they're unacceptable for certified organic products.

The rest of the chemicals on the list are approved by QAI and most other certifying groups for organics. Quinary ammonia is not approved for the application on the surface of the fruit.

And the next presenter will be getting into the challenges surrounding the EPA and the FDA approval.

Thank you.

DR. KVENBERG: Thank you very much. Mr. Hunter just said one of the challenges when you're dealing with the chemical issues under sanitary controls is to jump the regulatory hoops that are involved. And it's fair to say that with recent Federal legislation and required regulation on raw agricultural products, or perhaps as they're known, there has been some relative degree of confusion as to chemicals and what their status are and, indeed, which agency regulates them.

So it is, I think, quite important as we think of addressing what is the appropriate control to be applied that it's in conformance with Federal and State regulations.

Our next speaker on the program this morning is Dr. Jur Strobos. He's also here on a consultant basis affiliated with The Fresh Juice Company. Dr. Strobos?

DR. STROBOS: I'm also an attorney and I worked at the FDA. It's nice to -- to, John, I think jokingly asked me to spend 10 minutes on, you know, describing the entire food additive pesticide chemical and various other regulatory paths here and then he continued the introduction by indicating that at least to him it was confusing. And, unfortunately, I don't think that we're going to be able to alleviate that confusion in the next 10 minutes. Certainly, if -- if he's confused, I'm not going to be any less confused about this.

Let me just say that -- and I'll put the slides on now if I could -- the issue here in this particular section is what is the legal status of -- of these chemical sanitizers which are, basically, antimicrobial agents that are applied on food? And the question really comes down to is an antimicrobial agent that you put on food a pesticide chemical which would be regulated by the Environmental Protection Agency in some circumstances or is it a food additive which would be regulated in all circumstances by the Food and Drug Administration?

And then the question becomes, you know, what -- what is the specific use of that particular product and does that particular use have a tolerance established for it as a pesticide chemical or is there a food additive regulation that permits it to be a component or come in contact with food?

A raw agricultural commodity is defined in the statute as any food in its raw or natural state, including all fruits that are washed, colored or otherwise treated in their unpeeled form prior to marketing. So technically it's a raw agricultural commodity until it gets in the consumer's refrigerator.

And a processed food is defined, basically, as anything that isn't a raw agricultural commodity. So it's got to be one or the other.

That said, in general antimicrobial agents, if they're applied to a raw agricultural commodity are going to be viewed as pesticide chemicals and if an antimicrobial agent is applied to a processed food, it's generally going to be a food additive.

With that, let me turn up the lights because this is where the confusion begins.

It's apparent to me from Steve's discussion and a lot of the work that I have done that some form of antimicrobial treatment is going to be required. As we will go through this it will become clear that, you know, in order to achieve your 5-log reduction, which you still have to validate, you're going to need a minimum of four steps, I think, one of which is going to be some sort of fruit grading or qualification, some sort of washing process, some sort of antimicrobial treatment, and then some sort of extraction technology. And, finally, the whole thing has got to be wrapped up in some systems that prevents or precludes contamination between any of the steps.

The -- the things were relatively simple, I think, until the Food Quality Protection Act was passed. I think that's, more or less, the truth. And there is recently a Federal Register notice that came out of both EPA and FDA that tried to elucidate some of the legal interpretations that came out of the Food Quality Protection Act. But in the Food Quality Protection Act there is an attempt, I think, to -- to sort of deal with these antimicrobial agents and one of the things that happened in that -- or there was, I think, the Food Quality Protection Act actually tried to simplify definition of pesticides and pesticide chemicals and make a unified definition of that.

In doing that they moved antimicrobial agent, which had typically been more handled by FDA people than by EPA people, they moved the antimicrobial agents into EPA pesticide jurisdiction, especially when they applied to raw agricultural products.

There just recently passed a technical amendment to the Food Quality Protection Act which attempted, I think, to sort of take some parts of the pesticide chemical definition and return it to the food additive definition.

In particular, in the particular area that I think is of most concern here, it has to do with water wash. And the new statute, basically, removed from the pesticide chemical definition water wash that is used in preparing, packing or holding food for commercial purposes. And there's some question as to whether or not this what we have described is antimicrobial treatments meet the definition of a water wash, but that's another issue that will have to be resolved, I think, as we go forward.

Now, there was an exclusion from that movement and the exclusion from that movement are substances, water washes that are used in the field or, you know, on some sort of shipment from the field to a processing plant or in a processing plant -- and this is where I am having a little trouble with the new statute -- but the way I read the new statute is it excludes from the exclusion, if it's a processing plant, that the thing that comes out of the processing plant is a RAP.

So what that means is, I think, that -- but we're going to wait to hear from FDA on this, I think it means that if you're a packer and you're doing your water wash in the packing facility and the product that leaves that facility remains a raw ag product, then the antimicrobial agent that you are applying in the packing facility remains a pesticide chemical and would be then subject to a tolerance. I'll be corrected by that, I'm sure, if I'm wrong.

But on the other hand, if it is an antimicrobial wash that is put on in a processing facility where the product comes out as a change and becomes a processed food, then it would be subject to the food additive regulations.

Now, there is a food additive regulation, 173.300(b)2 that relates to chlorine dioxide, which is one of the several chemicals that are up there. There's also a pesticide tolerance, I believe, for the -- the peroxyacetic acid.

And the food additive regulation for chlorine dioxide actually excludes the application of the water wash to a raw agricultural product. So the exclusion that's in the new version of the Food Quality Protection Act, which has to deal with a processing plant where it comes out as a processed food but may start as a raw agricultural product isn't in the 173.300(b)2. But I think that probably with some minor changes to 173.300(b)2 that could probably be taken care of.

I think the question is with all the sort of confusion that's out here is what's the answer for people in the audience here?

And the answer is that you need to make sure that the company or the agent that you are purchasing an antimicrobial wash from has an appropriate approval for the use of that product in the specific circumstances in which you are using it. In other words, the product that you are purchasing should be labeled for the particular use.

In general, if you're using -- if you're in a packing plant, the antimicrobial agent should have a pesticide tolerance for it from the EPA and in general, I think, if you're a processing plant, the antimicrobial agent should probably have a food additive regulation that permits its use.

And I think that's about as far as I'm going to be able to go at this point other than to stress the fact that you need to make sure yourselves with your own legal counsel that the particular antimicrobial wash you are using meets the regulatory standards.

DR. KVENBERG: Thank you, Dr. Strobos. Our next speaker that I would like to introduce is Mr. Frank Martinelli with the Orchid Island Juice Company. I got to know Frank over the last year or so. The Orchid Island Juice Company is one that is directly working with the Food and Drug Administration through our HACCP pilot based operations so we have gotten to know that operation quite well and are looking forward to your speech here on sanitizing systems.


MR. MARTINELLI: I thought 5-log would be hard. Compared to what Dr. Strobos has to do, it's a cakewalk.

My brother never misses an advertising opportunity.

My name is Frank Martinelli. I'm the plant manager at Orchid Island Juice Company. Our CEO, Marygrace Sexton is fanatical about consumer safety. Consumer safety has always been Orchid Island Juice Company's primary concern. Consequently, when the FDA came out and said get 5-log, we started trying.

I'm here -- well, to make a long story short, we have done it and I think we have done it in a very convincing manner. I'm here today to offer you some -- some ideas on how to use chemicals to achieve this goal.

I think Linda Beasley is going to stand up here a little while later and say that her company's pinpoint extraction technique gives you somewhere between 1.1 to 1.7 log reduction. If that's the case, then Orchid Island Juice Company's chemical, sanitation -- cleaning sanitation effort gets us somewhere in the range -- something greater than 4-log reduction.

We have four simple -- I was going to say simple rules. For this audience they're very simple rules. But four simple rules that we have learned in trying to use chemicals most effectively.

Rule No. 1: You can't sanitize a dirty piece of fruit. There are a lot of chemical companies around that will come and help you select chemicals, cleaners in this case, that are very effective in cleaning your fruit. You have to get the fruit clean before you can consider having an effective sanitation effort.

What we have learned is focus on the stem end. If your cleaning process is consistently getting the stem end clean, then you've probably achieved the level of cleaning necessary to start your sanitizer protocol.

We found that pressure rinsing helps. I think that goes along with what Dr. Pao said about the power of water to flush contaminants off the surface. I'm concerned that when I get back Marygrace is going to make me turn my chemicals off because he is getting so much of a log reduction with just water.

We have learned that what Steve, Dr. Hunter, just said that you have to really focus on the shape and contour of -- of your brush washer bristles and you also -- in addition to the bristles themselves, you look at the shape of the brush. There's a tendency for some fruit to roll about the longitudinal axis and it's very important that if you're going to get that stem end clean, you have to have brush washing capability to clean the orange in all three axes.

A word of caution regarding rule one. If you can't sanitize a dirty piece of fruit, you darn sure can't sanitize an unwholesome piece. Just like Steve said, you have to be fanatical about grading if you're going to produce a safe fresh juice product consistently.

There's a variety of ways to -- to undertake that challenge, but the bottom line is you have to comply with the Florida Department of Citrus rules that says zero tolerance, no unwholesome fruit if you're going to consistently produce a safe fresh juice product.

Simple rule No. 2: You have to give the cleaners and sanitizers a chance to do their job. When you speak to representatives from chemical companies, they'll -- they will decipher what a label says and it probably behooves you to read that label yourself and get a good understanding of what the contact time requirement is for that cleaner or sanitizer to do its job.

My brother, our chief engineer, Little Willie, when I explained to him I said, "Willie, if we're going to do this 5-log, we're going to have to have more contact time." And basically, that meant modifying our production process in a major way. He had to take out the grinder and start going to town. It was a very time consuming effort, but nevertheless, it was necessary to satisfy the chemical requirements for them to do their job.

Maintain your concentrations. Another thing that you have to focus on with regard to the chemical usage is maintaining the concentration that is recommended on the label, recommended by the manufacturer. If you don't do that, then obviously you can't expect the chemical to do what it's supposed to do.

And, then finally, and this leads me into simple rule No. 3, is you have to replenish. You have to replenish your product.

Simple rule No. 3: Select strategic application point. Look for opportunities to obtain spherical coverage.

I missed a point back in item two. Item two, obviously, before you go and extend your processing line, make sure that you're using every moment, every moment of your line's time to apply your cleaner or let it work or apply your sanitizer or let it work.

So back to rule No. 3, select strategic application points. Look for spherical coverage opportunity at reapplication points. In other words, at -- at the base of that cleaning belt where your fruit is churning, there is an ideal place to be applying a cleaner or a sanitizer because you'll have more of a chance of getting the spherical coverage.

Up on your trash eliminator belt where the fruit is spun rapidly is another ideal place to apply your chemicals because you'll be getting spherical coverage.

On your -- on your brush washers, there's another opportunity where the fruit is spinning to be applying or reapplying chemicals because you want to get spherical coverage, give the chemicals the opportunity to do what they do on the entire surface of the orange. And then you want to rinse and reapply.

And that kind of leads us into simple rule No. 4: Familiarize yourself with the chemicals that you've considered. We -- we've gotten enormous benefit from chemical salespeople and their technical reps coming around and helping us. I can't say enough about that.

At the same time when you have a chemical salesman there always realize he is a salesman, like my brother, and they'll shade it a little to make that sale.

Here are some of the things we've learned: We've used now every chemical that Dr. Hunter mentioned, every category. We have used something from every category. And over the course of that experience in our effort to achieve 5-log, we've -- we've learned that there are times you have to deal with odor issues with regard to chemicals. We had a wonderful chemical, it was doing a great job. Of course, it made half of our graders sick, and so -- if you're talking about using that chemical, you would also be talking about a heavy duty ventilation system.

You have some chemicals that are effective that have corresponding OSHA concerns and so you want to familiarize yourselves with them, in some cases ventilation, some cases concentration limits, et cetera. You want to be familiar with that before you integrate a chemical into your protocol.

Some chemicals are incompatible with other chemicals. We had a really great line cleaner and we were interested in this really great sanitizer, unfortunately, the cleaner would neutralize the sanitizer.

And, yes, we could put a rinse in between there, but remember that rinse, the time that you spend in that rinse is contact time, potential contact time, that you're not utilizing for a chemical to do its job.

Some chemicals have preactivation requirements. Probably nothing -- nothing that is overly demanding, but something to consider.

There are some chemicals that if you use them they're very effective, but there's staining considerations, particularly with iodophors, if you use it you're going to stain whatever that's touching, including your floor surfaces. And some chemicals are just hard on your equipment.

FMC has been telling us for years don't use chlorine because it -- it slowly damages their extractors. Well, certainly, don't use chlorine in the magnitude that Marygrace uses it.

And then the last -- the last issue is what Dr. Strobos addressed and that is the FDA/EPA issue. It's challenging enough to be out here and attempting to get 5-log and then there's kind of a big curve ball thrown at you in that some of the chemicals that you are using which seem to be applicable now with the Food Quality Protection Act it's -- it's questionable as to whether or not you can use them.

So that's something that it's a very current issue right now and you want to stay abreast of it, what -- what can you use and what is appropriate and what is acceptable?

In conclusion, I'd like to suggest that 5-log is doable. I don't think there is any doubt about that. 5-log is challenging. We're convinced of that at Orchid Island Juice Company. And then if you're going to do 5-log, my recommendation to you would be you can't start too soon because, believe it or not, when you start this undertaking July 8th is going to come up real fast.

Thank you very much.

DR. KVENBERG: Okay. So that is an overview of the sanitary controls relative to chemicals.

At this point in the program those that have questions of the presenters or have comments it will be appropriate to do that now in the area of chemicals.

So if anybody would like to speak at this point or ask a question?

(No response).

DR. KVENBERG: Gee whiz, I see nothing.

Well, that's okay. We'll just move ahead with the program into the second half of this. And if you've got -- the offer still holds, if something is mulling around in your mind and it pops in at a later point, you can.

Okay, we have one now. If you could come to a microphone, please. I understand people in the back of the room have some difficulty hearing if you don't speak into the microphone.

MR. DeCASTRO: Tony DeCastro. I'm the general manager of Blue Lake Citrus here in Winter Haven.

A question probably for Frank and that is you indicated that you have done it, and I certainly congratulate that. I would be very interested to see what you're able to share about specific strategies that were successful in terms of chemical strengths, types, et cetera that -- to achieve that.

MR. MARTINELLI: At the present time Orchid Island Juice Company uses chemicals from three of the four providers that we're aware of in this area in Florida, and equipment from four of them. So we have a very diverse program.

Is it appropriate for me to mention specific chemicals?

DR. KVENBERG: It's open to the record and it's your choice. If you'd like to, go ahead.

MR. MARTINELLI: Any chemical providers have any objection to me stating what specific chemicals we use?

(No response).

DR. KVENBERG: Go ahead.

MR. MARTINELLI: Our -- our protocol is -- is based for the actual processing line -- this is what we process the fruit with -- we use a phosphoric acid, anionic surfactant cleaner, we use a phosphoric acid sanitizer, and then we follow it up with a parasitic acid microbial reduction agent.

Our contact time for all three combined chemicals is no less than -- I believe it's 181 seconds. And that's -- that's worst case.

Anything else?

MR. DeCASTRO: Can you speak somewhat to the -- the actionable types of levels for those chemicals?

MR. MARTINELLI: No. Let me tell you why. We -- we have -- when I say very convincing 5-log, what I mean is in our initial study we achieved 5-log, but there was sufficient variation in there that one day you might have -- you might achieve 5-log, the next day you might not have.

Our most recent study with nationally renowned ABC Laboratories and Dr. Keith Schneider, we achieved a cumulative 6.73-log. And we did a cumulative study. We're a small company. We have limited resources. We didn't break it down to each step achieves this -- this much.

That's why I mentioned Linda Beasley. If their extractors are giving us 1.1 to 1.7-log, then you deduct that from 6.73 and -- and then saying your chemicals and your culling -- are achieving the remainder. But we did a comprehensive reduction and we -- that's what we achieved and that's what we attribute something greater than 4-log to the chemicals.

MR. HUNTER: Tony, we had also achieved a 5-log reduction in our plant. We got approximately slightly over 4.0 in the brush washing and sanitizing steps and then we picked up another 1.92 in the -- at the extractor.

We have since done -- since we did our study we have added in another brush washer and another sanitizing step, so -- so we haven't completely tested that, but as far as our chemicals that we're using, we were using the acid free wash at about 80 parts per million and then we were using chlorine dioxide at about 2.6 residual chlorine dioxide.

And we're doing further studies now. We're doing a qualification of peracetic acid and we're going to be working on that. And we're also going to qualify our new brush washer that we just put in.

And we have also done some tests at our California sister company where they're using, essentially, the same chemicals. The application might be a little bit different. Hanson's, in their sanitizing step alone were getting almost a 4-log reduction. But part of that was because we had designed the sanitizing step so it looked like a car wash. We had a spray nozzles all in it all over the place and so we were thinking in addition to the chemical effects we were getting a lot of physical effect from the particles just getting blasted off the fruit.

DR. KVENBERG: Are there any additional comments or questions?

(No response).

DR. KVENBERG: Staying within the same subject area, but moving away from chemicals for the moment, other approaches would be the non-chemical treatments, whatever they may be. And our first speaker has spoken already. Again from the Florida Department of Citrus, let me reintroduce Dr. Steven Pao.

DR. PAO: Good morning again. May I have the first slide.

In this presentation I would like to address how to reduce fruit surface microorganism by hot water immersion treatments. This was done with Craig Davis.

And in this study what we did is we first inoculate washed orange fruit first and then we keep the fruit in hot water. And we thank the agency for providing the material for this study. And then we test the fruit surface for the level of E. coli left on the fruit surface.

And in this figure it shows the reduction at 17 degrees Celsius, and that's equivalent to 158 Fahrenheit. E. coli was effectively reduced by hot water immersion treatment based on this data. This figure shows that hot water treatments were more effective at non-stem scar area and less effective at stem scar area.

In this figure the red color, you may not see very clearly, the red color line shows the result of the reduction by hot water at non-stem scar area and green color indicates reduction at stem scar area. Stem scar area is the button area of the fruit.

Overall speaking, a calculated 5-log reduction of E. coli was attained by immersing inoculated fruit in hot water at 70 degrees for two minutes. And when we increase the heating temperature, the water temperature, of course the reduction would become more dramatic and we require less time to sanitize the fruit.

And in this figure it shows that if we immerse the fruit into hot water at 80 degrees Celsius, or at 176 Fahrenheit, for just a minute can achieve 5-log reduction. If you focus on the white color overall surface.

The first thing we did was inoculation study, but we also investigated the surface of natural microflora. In this study non-inoculated fruit were used to provide a treatment effect of natural surface microflora. The overall surface on washed fruit in this case was about 0.2 log CFU centimeter squared. And we see a washing did not significantly reduce the overall surface microbial count based on the aerobic plate count.

However, hot water treatment at two different settings were able to significantly reduce microbial count at any area of the fruit surface.

We were also interested in how many microorganisms actually landed in the juice. And we found that the juice extracted from fruit just picked without any treatment had microbial load of about 2 to 3-log. However, if we wash the fruit, we rinse the surface, in our case we actually get higher count in our juice. The washing did not help in this case. We washed with water and common detergent.

And, again, we see hot water treatment can benefit to the reduction and in both settings we see very good reduction.

Just to confirm that this hot water treatment did not damage the fruit juice, we did a thermal study. Hot water increased temperature quickly in the outer part of the fruit. However, the peel prevented the heat from penetrating to the pulp and the juice. Maximum temperature within the pulp was about 35 Celsius for fruit submerged in 80 degree Celsius water for two minutes.

The slow rate of heat transfer and the short exposure time prevents juice temperatures from raising to high temperature to effect the original sensory quality of fresh juice.

We also conducted a sensory evaluation. In this study triangular tests were performed to compare juice extracted from heated and non-heated fruit. Juice was evaluated by a sensory panel of 25 judges. The result indicates that no flavor differences of juice extracted from -- from non-heated fruit versus heated either at 80 degrees Celsius for one minute or 70 degree Celsius for two minutes.

However, significant sensory quality differences were found between juice extracted from non-heated fruit and fruit that had been treated with hot water treatment for a longer time. Additional study is needed to understand the flavor change in this case.

To conclude this presentation, fruit surface microbial population can be minimized by hot water treatments. Approximately 5-log reduction was attained by immersing fruit at 80 degrees Celsius for one minute or 70 degrees Celsius for two minutes.

Rapid hot water immersion can kill fruit surface microbes without altering original sensory quality of fresh juice.

Rapid hot water immersion can enhance fresh juice quality by reducing initial juice microbial loads. And this will help shelf life of the product.

Hot water immersion may be modified to a separate or a steam process in future research.

I'm sure the following presenters will cover this area. But we have done a test with a processor, fresh juice process on hot water spray technology and we were able to achieve 5-log reduction less than one minute. And at this time I would say approximately 30 seconds at 200 Fahrenheit hot water spray can -- is our initial data, can achieve 5-log reduction. But we need more tests to confirm.

Thank you.

DR. KVENBERG: Next scheduled we will have a discussion of these non-chemical treatments from a processor this time, from Mr. James Blood from Blood's Hammock Groves.

Mr. Blood?

MR. BLOOD: Dr. Kvenberg said earlier that those of us on the panels had stepped forward and done this to help the industry proceed with some of these issues. I want you to know that some of us were drafted, so. . .

Our company is looking at the hot water treatment as a means to sanitize the fruit. We haven't gotten the system up and running yet, but I was told that the information that I had might be beneficial here. And so in order to fill my time and give people an idea of how we got to where we are, I'd like to give a short background of my company and why we are looking at heated water as a means to help sanitize our fruit before squeezing.

And as I say, this effort is just getting started. You know, we're just on the ground floor here getting ready to move ahead.

The only question that's really been answered is, as Steve pointed out in his presentation, that the hot water treatment does work.

Our business is seasonal in nature. It runs from November 1st through June. Freshly squeezed orange juice makes up about 25 percent of our total sales and we sell all of our juice retail through our store.

The fresh juice part of our business began in the '60s when we would sell fresh squeezed juice by the cup. This juice was produced by the old hand reamer and the type that's found in many homes today.

During the '70s we began to sell fresh juice in containers, a gallon and half gallon size and the volume began to grow. And then we moved to mechanical means to get the juice out of the fruit.

In the 1980s, the volume of our juice business surpassed the capability of our small machine and we expanded to a five head FMC extractor which we use today.

This part of our business was developed as a means to use blemished fruit that was wholesome but not saleable. The main part of our business is gift fruit. We do retail sales and gift fruit shipping across the country. The taste and the freshness caught on with our customers and the business grew.

Often, we run our fruit ahead of time through our regular processing line we use for our gift fruit, and we store it for a day or two before release. We do not have a separate processing line for our juice fruit. We juice anywhere from three times a week to daily and from three hours to seven hours a day. Before bottling our juice goes through a chiller and then to holding tanks to refrigerator. We are on our third year with the HACCP plan.

Because of holding our fruit for one or two days before squeezing, I began to look for some means to sanitize our fruit one last time before juicing as an added safety precaution.

I'm most seriously concerned about E. coli 015787 because so little is known about it and how it acts in our flora environment. I feel good sanitation practices go a long way towards preventing pathogens from getting in juice.

I see this problem is one of contamination. As long as our fruit is not contaminated by something like E. coli or Salmonella, there is no problem. It's obvious. So the first goal of our juice safety program is to prevent this contamination from ever happening.

The second issue, as I see it, is a matter of statistics or chance, if you want to call it that. No matter how hard we try, sooner or later there is a chance that something could happen that could contaminate an orange or a grapefruit or a piece of equipment.

The object of a good sanitation program is to have barriers in place to prevent that contamination on the equipment or fruit from ever having a chance to get close to any juice.

The better the barriers in place the better the odds are that there will never be a problem of this kind in the future. Fresh squeezed juice, orange and grapefruit juice, has been safe in the past and these steps ensure it will continue to be safe in the future.

In our business I felt the need for a good sanitizing step or barrier just before squeezing to create that extra hurdle or margin of safety.

The only option open to me was some kind of treatment of the washed fruit. Last season we opted for dipping or dunking each bin of clean fruit in 200 parts per million chlorine for two minutes before juicing. Basically, we have a rack, we have a tank, a rack, we put the bin in the rack, dip the rack in with the fruit and it's dunked.

I was comfortable with this final step until I began to see the research that was done at Lake Alfred, Dr. Pao, University of Florida with Dr. Parish, and it showed that this chemical treatment was probably not as great or as effective as I had assumed.

And, please remember, I'm trying to dip one -- a one shot treatment without any mechanical brushing and not a series of treatments with scrubbing and brushing as many large producers are capable of doing.

The same research that made me aware that my chlorine treatment was not working as well as I had hoped, also showed the hot water got the kind of results I was looking for. So I decided to pursue the hot water option. We are working on this now.

To convert our chlorinated water tank to a hot water tank we have attached a 500,000 BTU natural gas, what I call an open system boiler, which recirculates the water similar to a pool heater. The operating range for this heater is 105 to 230 degrees Fahrenheit and the total water volume of the tank is about 800 gallons.

We're going to have the system set up so that it will start on timer several hours before we begin juicing to allow the water to warm to the proper temperature.

The tank has been insulated. It has an insulated lid which is in place at all times. It's both to conserve heat and act as a safety cover.

The dunk tank is split into two sections. Previously we dipped the fruit on both sides, but with the heated water we're going to use one side as a water fill and act as a heat reservoir in order to compensate for cold fruit.

As of today the system is not on-line. We spent a considerable amount of time trying to figure out what kind of unit to actually heat the water with. So that -- we knew from the start it was going to be gas and, actually, the gas line is the reason we're not up and running today is because we haven't got the gas line in yet.

But the -- there's not a lot of support out there to -- when you're looking for something like that and it's not been done that often, you have to -- there's a lot of ideas and -- and it takes awhile to get to the right answer.

Issues that must be addressed as we go forward on the -- on the hot water dip, the proper temperature operating ranges to ensure water temperatures that will sanitize the fruit, but not change the taste of the juice, consistent and complete temperature distribution within the fruit in the beginning, proper timing of the process, the effect on the quality of the juice and the cost of operation.

I know the hot water will sanitize fruit, but the above questions and others that come up must be addressed.

And I'm hopeful that through workshops like this and -- and all the hard work that the folks have done we'll come up with answers. This may not be the answer, but it may be part of an answer. So that's what we're looking at.

Thank you very much.

DR. KVENBERG: Our next speaker, like myself, is from uptown, way uptown. I have known Mr. Mark Isaacs from Sun Orchard in Arizona for some time. And he also says his full time job is actually with the Fresh Juice Council and part-time he makes juice. Is that right?

So, in any event, another speaker today will be Mr. Isaacs on the subject of his experiences and work in the area of non-chemical treatments.

Mr. Isaacs?

MR. ISAACS: Thank you, John. In addition to running a juice company in Arizona and California called Sun Orchard, I am here as well in -- in connection with my work as the chairman of the Fresh Juice Council, American Fresh Juice Council. But these two roles have qualified me for a third position, which is a weekend position as a referee for the World Wrestling Federation. So I'll do my best here to just give a brief overview as to what we have done at Sun Orchard.

I appreciate the opportunity to share Sun Orchard's process as to what we have done to ensure product safety for our customers and how we've, you know, achieved a 5-log reduction.

As all the speakers have indicated earlier, this has been a long process and over the last two years all of us have been working very diligently to upgrade the -- the product safety within each of our operations as well as across the industry.

At Sun Orchard we reviewed and changed as necessary, upgraded our SSOPs and our GMPs and have taken that to a point where we also developed and implemented a full HACCP plant.

Many times in going through this process the HACCP plant, obviously, is -- is a working document that is changed on an ongoing basis and we have learned quite a bit in that process, specifically for -- for people that are putting them together, is to limit, really, the -- the HACCP plan to the critical control points that you can have an impact on, you can control and that if there were a breach of the critical limits to have, you know, a dramatic possibility for contamination. All other issues which are just as important would fall into the -- the GMPs or the SSOP areas.

Quality issues we're all very concerned about, obviously are the foundation for a HACCP plan in the SSOPs and the GMPs. We have had the HACCP plan reviewed and tested by an outside third party, a major university with a large food science department. And as we went through the process, we came up that the last step in the process clearly was the performance standard.

And the 5-log reduction, obviously there's been a great deal of confusion in regard to that as to how, you know, how do you achieve it, how do you validate it and what do we do, all of those -- you know, what do we all do to make sure that we are complying?

In addition to the -- the fruits' effects in handling and grading requirements as well as extraction, what we did at Sun Orchard is we tried to isolate two steps that would have the greatest impact on reducing potential pathogens in our product for our customers.

One is the -- the fruit sanitizing and washing system and secondly was a surface heat treatment system.

Most of the previous speakers have talked about the -- the chemical approach, and I'll just take a little bit of time on it.

We -- we use a system where the rinse water is stabilized to a certain pH level on an automatic basis and then we apply 50 parts per mil to the surface of the fruit for a contact time of 20 to 30 seconds.

The benefit here has been obviously the fact that the water is stabilized to a certain pH level and it enables the -- the chlorine application to have its most effective benefit on -- on the reduction, the elimination, if you will, of any potential pathogens.

The second process that I did mention is the surface heat treatment. And what we did is we -- we built a steam tunnel that we have installed and is operating in our facility. It's stainless. It's fully enclosed with the exception of the entry and exit portions for the -- as the fruit goes -- goes through it. We have -- we have been exposing our fruit to the heat treatment at 190 degrees for approximately 20 to 30 seconds.

We have also found, as Dr. Pao noted, that there's minimal impact on the interior temperature of the fruit or juice, no impact on taste, and we've had this -- these steps, as well, or these aspects of the process proven in-house as well as out house.

As it relates to the validation of the 5-log reduction, we did have an independent food science department of a major university come into our facility, as well as establish in their laboratory our two processes. Both the chlorine application system, as well as the steam tunnel. They fabricated one of their own and then also installed our -- our chlorine application system.

What they used as a test pathogen was E. coli 0157. And the results that we received was that the chlorine treatment produced a 3-log reduction. On the basis of 10 tests, the average was a 3-log reduction.

In addition, the steam application for 10 seconds of exposure provided a 2-log reduction and for 60 seconds the full inoculation of 7.6-logs was eliminated.

So what we've been able to find is that in our process just on the steam portion of our process we were able to reduce the -- provide a 3.7-log reduction.

The results of this study will be published probably in June of 1999. And when you add this to the benefits that you get from packinghouse eliminations, from an adequate grading and, you know, wash brushing system, as well as the benefits of an extraction and chlorine system, we have been fortunate to -- to achieve well over a 5-log reduction.

Two final editorial comments. One is as everyone can tell, there's been a number of us in the industry that have done a great deal of work to provide the safest possible products for our customers. I would encourage each and every processor to make sure that you have gone back and taken a look at all of your operating procedures, all of your DMPs, implement or develop a HACCP plan, put it in place and then the -- the last step of performance standard will -- should come together fairly simply. You know, we, as always, have the most to lose and, you know, the newspapers and the press seem to forget that. But, you know, I would encourage everyone, each and every processor, to do their best to upgrade the safety of their product.

The last item is, you know, since all of us in the industry are doing our job, we really would encourage the FDA to get out there and inspect all processors on a fairly expeditious basis and if they're not complying, then something needs to be done because, you know, we're in this together and it's important that -- that there is some -- I mean, the biggest piece of the puzzle is definitely the -- the enforcement of these regulations that we've all worked hard to put in play.

Thank you very much.

DR. KVENBERG: This brings us to the point in the program where we throw it open again to any comments or questions. And since we have the entire panel up here, anything that you folks would like to bring forward on the topics that we have covered either on the chemical or the non-chemical treatments are welcome at this time.

Do we have any comments?

MR. MACK: My name is Tom Mack.

In the -- this is for Mr. Isaacs. In your steam tunnel are you rotating your fruit or does it just sit on a standard conveyor?

MR. ISAACS: It is being rotated with live stainless belts, so the fruit is being exposed to the steam during that process at all points, if you will. But it's a live roller.

MR. MACK: Thank you.

MR. BENINCASA: Jimmy Benincasa from Hale Grove. For Mr. Isaacs I have a question.

Mr. Isaacs, the steam injection tunnel, can you tell me if the steam is applied on the top of the fruit or the bottom of the fruit or do you do both?

MR. ISAACS: Well, the entire environment produces the temperature, so it's -- it goes through, you know, from the beginning to the end it is at 190 degrees.

MR. BENINCASA: But I mean is the steam -- is the steam coming from the bottom in your tunnel or is it being injected from the top?

MR. ISAACS: It's from the side.

MR. BENINCASA: From the side?

MR. ISAACS: Right.

MR. BENINCASA: Okay. And can I also ask you, you said it was 20 to 30 seconds. You used a time of 20 to 30 seconds. Why is there a variation?

MR. ISAACS: Well, we have it set. I didn't have the exact number. I could say 25 seconds. But, actually, we shoot for 30 seconds is what we use.

You know, it's been in operation for probably about two weeks now and as we went along we were adjusting the -- the -- the time and the temperature.

MR. BENINCASA: Do you mind telling me who manufactured the tunnel for you?

MR. ISAACS: We made it ourselves.



MR. MACK: Tom Mack again. With the steam tunnel as comes out of the tunnel are you directly putting it into the extractor or --

MR. ISAACS: It is the last step in our process. I think it does go through -- I'm sorry, it does go through one last grading process. We do have people right before the extractors, so there is one last grading process.

MR. MACK: Thank you.

DR. KVENBERG: Okay. I see no more hands at this point in time. That's probably wise. I have about 20 minutes until 12:00. And since folks have to eat lunch off site, it gives you enough time to have a decent lunch. I would ask for folks that are coming back after lunch to please be here by 1:00 or thereabouts. I intend to start promptly at 1:10.

Thank you.

(A short break was held).

DR. KVENBERG: The afternoon is going to begin with a discussion of the actual extraction techniques that are employed in extracting juice. We have at the front table presenters from FMC Corporation, Linda Beasley and, again, Dr. Steven Pao from the Florida Department of Citrus to discuss information.

And, again, I would have you note on your program any questions, answers or other comments of these equipment manufacturers or others who would like to make statements on this section on extraction techniques, there certainly is time to do that. So let us know.

So with that as an introduction, I would like to turn the podium over now to Linda Beasley of FMC.

MS. BEASLEY: What I'm going to present is how the FMC extractor works so that you understand the issues about what's on the peel and what gets -- what does not get exposed to juice.

First of all, I want to cover what we're going to talk about in specifics. We're going to talk about fruit requirements going into the extractor. Then I'm going to talk about the FMC extraction principle. Next I'll about the sanitary operation of the FMC extractor and then I'll discuss the FMC fresh 'n squeeze extractors.

There is a picture of that beautiful machine. It's a five head machine for oranges. It's actually called also the in-line extractor. There can be a line of maybe 12 of them. Some rooms in Brazil have like 200 of these extractors going simultaneously.

Those aren't for fresh juice, though.

The first point that I want to make is -- and it's been driven home, I think, this morning several times, you have to have wholesome, clean sanitary fruit going into this machine. We can make sanitary juice with this machine, but the fruit absolutely has to be wholesome, uncompromised fruit. And this picture is the fruit in the fruit hopper right before it goes in the machine, so this is the last point where you have the last chance to have the fruit, wholesome fruit, going into the machine. That's a view from the top. You can see the five lanes feeding into the cups.

This is a -- if you were to cut the extractor in half and looking down the side of the extractor this is what this depicts. This just shows the different parts of the extractor. You have the upper and lower cups and then each cup is associated with a cutter, upper and lower.

You see the strainer tube there. That's where the juice -- the sanitary juice comes through. It's strained through a strainer ahead of time and gets rid of all the seeds and pulp and -- and other things that we don't want in the juice. That juice goes into that juice manifold.

Now, the point here is that once the juice is extracted it goes into an enclosed juice handling system, so it's not exposed to contamination from the air or whatever.

The orifice tube is the place where the -- the membrane material and the seeds and anything else goes down through.

So I'm going to take you through how the machine works as simply as I possibly can because it's a pretty complex machine.

What happens is the upper cup is actually moving and the lower cup stays stationary. The upper cup, the fruit is thrown into the lower cup, it's seated in the lower cup and then the upper cup starts coming down and the fruit actually takes the -- the shape of the cup.

The cup fingers, we call them fingers, support the fruit all around and it starts squeezing the fruit. At the same time the caption on the right shows the -- talks about the oil cells bursting. We also can collect oil simultaneously on this machine, but fresh juice can still do that, so I won't discuss that further.

As the upper cup is descending a peel plug is cut from the bottom in the lower cutter because the pressure is exerted on the bottom of the fruit onto that cutter. And so we get an open hole in the bottom of the fruit.

So that hole in the bottom really is the point of least resistance as the pressure is coming all around on that fruit. The interior of the fruit, it's through that hole that's cut in the bottom.

Just about simultaneously a cut is -- the upper cutter cuts, because of pressure, through the top of the fruit. Remember, these cups are converging. We have to do that so we can get the peel off the top. So the upper cutter cuts and that helps us eject the peel out of the top of the machine.

As the juice -- I hope I'm not jumping around too much, but as the juice comes through inside that tube, there's pressure inside there and it forces the juice out through that strainer and it goes into that manifold.

Now, all the things such as the -- the rag, the membrane, the core, the seeds, they all go down through this orifice tube that's through the bottom. While all this stuff is happening simultaneously, the orifice tube is moving up to exert pressure into that strainer tube so the juice comes out into the manifold.

So this is depicting those different streams. As I said, the peel is -- it travels through the peel clearance and it's ejected outside of the machine. So there is minimal exposure of the peel to the juice.

That oil that I discussed in some little clippings called frit from the peel goes out the side. That's not exposed to the juice either. And the pulpy juice is -- right now it goes into that manifold and it goes into the sanitary juice handling system and then all the other rag feel -- excuse me, not peel, rag and pulp and cores all go through the orifice discharge and is discharged into waste stream.

So this is a different picture of all the different streams that come out of that machine simultaneously in about a quarter of a second per stroke. You see the orange on the left and the peel is cut there because of the fingers, the pressure on the fingers. And as I said, that peel is ejected out the top of the machine. Out the top and sort of back.

And then we have a stream of oil emulsion, pulpy juice, and the core material is in the upper right hand beaker. And there is a picture there of the -- the peel plugs. And so it's minimized. Actually, that's the minimal part of where potentially juice could touch the peel, just that peel plug.

So the important sanitation issues for the machine, we think, is that, No. 1, there is an instantaneous extraction, that's about a quarter of a second. The fruit interior is separated from the exterior of the fruit. The juice handling system is enclosed, as I said. That minimizes any other contamination that could happen.

The juice contact with the surfaces can be cleaned and sanitized and it's a sanitary system.

The cleaning and sanitation of the machine is easily accomplished. There are not only automated systems, but many manual systems work very well to clean this machine, to clean and sanitize the machine. And as I said, the minimal contact of the juice to the peel is an important point.

So next I'm going to move on to the fresh 'n squeeze juicers. I said the other machine is our commercial extractor. This machine is more for point of sale, smaller retail establishments, that kind of thing.

The important points for this machine is that the fruit loading is sanitary also. You have to, again, give that clean, sanitary wholesome fruit into the machine before you start extraction. It goes in that enclosed hopper, about a carton of fruit each time.

It juices by the same method that I just discussed. And the juice comes out into an enclosed nozzle into the reservoir which can be taken off the machine, cleaned and sanitized also. And the waste bin is also enclosed to minimize any contamination.

This shows that multi fruit juicer also that it -- it goes by the FMC extraction principle that we just discussed. It also has the enclosed operating system to minimize contamination. It has a solid cast frame. There are no cracks or crevices where you can get contamination in the juice somehow. It's all cast, so it's very easy to clean and sanitize.

This is showing that the components on this machine come out and they can be separately cleaned and sanitized. The components also on the other machine can come out and be cleaned and sanitized in the manual method. But it's very easy to disassemble the machine and get it clean.

So the sanitation issues for this machine are similar to what I discussed before. We call this instantaneous. It's a little slower. This machine is just one head and it goes a little slower than the other machine, three seconds. But also basically instantaneously separates the interior of the fruit from the exterior. It has an enclosed fruit and juice handling system. We have the sanitary juice contact surfaces and it does have NSF approval. Cleaning and sanitation is easily accomplished on this machine. And, once again, we have minimal contact of the peel to the juice.

So in summary, I'd like to share with you that we think that FMC citrus juice extraction is very definitely sanitary juice extraction.

DR. KVENBERG: Thank you. And, again, for a third trip to the podium, Mr. Steven Pao is going to discuss the extraction procedures, as well.

DR. PAO: Good afternoon. Thanks for Linda for the plans and detail of the extractor. Understanding the extractor will be very useful for understanding the data I'm going to present this afternoon. And I also want to give thanks to other members in FMC who prepared many materials for me to conduct this research.

Again, in this study what we did is an inoculation study. First, we washed fruit and the inoculant we selected for this study was E. coli, generic E. coli mixture and Lactobacillus, and the juice was, after inoculation, the juice was extracted and the microbial content was determined.

Generally speaking, there are two major types of equipment we used. One is commercial in-line extractor. The other one is fresh 'n squeeze. However, there are many different settings. I actually learned quite a bit during this study.

The industrial citrus extractor was set up in our study in three different ways. STD, that means using standard cup, one inch cutter, .025 strainer tube and we also have 3/4 inch cutter for STD-3/4 inch and we also have a different type of cup, that's premium juice extractor cup and using a slightly larger strainer tube. And the fresh 'n squeeze extractor was set up, you know, just one way.

Another place I learned quite a bit is how to calculate because we cannot just simply base it on surface count versus the juice count because the juice volume in surface is centimeters squared. So there are different ways to calculate.

One way to calculate is to assume all the surface contaminant will 100 percent go to the juice and count that as an initial level and then compare to the juice microbial count after extraction.

And in our study this is the way we used for this test. And fruit volume was calculated of approximately 134 centimeters cubic per fruit. This was based on a 2.5 inch fruit. And the fruit volume was based on calculating -- was calculated in to obtain the result based on the equation shown on the screen.

And 6 would contain approximately 483 mil of juice, and that's because we assume 60 percent of the orange is juice. An orange contains about 80.5 mil of juice, based on the calculation.

So at this point we consider all the organisms we put on the fruit surface were going to the juice and, therefore, we count the initial -- we see the initial level using the unit CFU per mil of juice. And in our study each time we tested six inoculated fruit, you know, in a bag and then we wash with 950 mil .1 percent peptone. The peptone water was cold, 4 degrees Celsius. And the whole system was on a shaker in a cold room for approximately one hour.

The correction factor, dilution rate, the correction factor used was 1.97.

The first slide shows the inoculation level of E. coli and the reduction of E. coli from fruit juice to the extracted juice. And we can see, first of all, we used a center cup, one inch cutter and we have a high inoculation level and relatively low inoculation level.

And the high inoculation was near 5 and the low inoculation was a 4. And after we extracted juice we have reduced the E. coli load to about near 2 and then higher than 2.5 for the high inoculation load. The minus 2.1 on the chart means the difference between the two bars.

And there's no difference between using high inoculation load versus low inoculation for the initial -- for the initial juice.

And the second part we want to see the second part and the third part and we see when we use a smaller cutter, a 3/4 inch cutter, it's the same standard cup and we get 1.9 log reduction. And, however, statistically there is no difference between these three sets.

This figure shows the reduction of Lactobacillus by using extended cup, standard cup, one inch cutter. The N after the STD-1 is nutrient broth. That's the broth to prepare the inoculant. And then we diluted with nutrient broth and then we inoculated the fruit. And to get minus .18 log reduction. However, used in that setting we dilute the original culture broth with peptone solution at 1 percent. 1 percent of bacterial peptone water to get statistically less reduction. We get 1.3 log reduction.

And compared to the second set and the third, the last test you see we used two different inoculation levels. The red bar is higher than the last red bar and we see the reduction was similar. There was no difference between using slightly higher inoculation than versus a slightly less inoculation.

This figure also shows the reduction of Lactobacillus after juice extraction. What I want to try to show you here is using different cups the first set of bars indicates the test was done by using so-called premium juice cup. And that setting was by using 3/4 inch cutter and the other one is a standard cup and a one inch cutter. And we both used the nutrient process, the broth to prepare the final inoculant. And we see that there was no difference compared to each other on the reduction.

And this figure shows the difference between using different tests, microorganism.

The first set of bars indicate the reduction by using Lactobacillus and the second part indicates the reduction using E. coli. And we see, based on this data, we see a difference, and using E. coli we can get slightly higher log reduction.

This last figure shows some results from fresh 'n squeeze multi fruit juicer. This is actually a single cup smaller extractor. And we -- we didn't intend to compare these two microorganisms on this figure because the inoculation level initially was too much different, so we look at them separately. We see a 1.3 log reduction of Lactobacillus and 1.7 log reduction of E. coli.

In conclusion, about 1.3 to 2.1 log microbial reduction can be expected from the tested fresh citrus juice extraction process. Microbial reduction was not significantly affected by cutter size when we compare 3/4 inch cutter versus one inch cutter. And cup and strainer tube -- and this should be one word, cup and strainer tube set up -- that means a standard cup set up versus premium juice extraction cup set up, there was no difference between these two. These two has been used quite a bit in our industry.

And inoculation level, when we look at E. coli in two different inoculation levels, as well as Lactobacillus at two different inoculation levels you can see significant difference in the -- in our experiment design because if we use extremely high or extremely low inoculation level we may see some different results. I don't know at this point.

Microbial reduction may be influenced by inoculation broth used or prepared in final inoculant. The nutrient broth generally has more solid in there and peptone water 1 percent we use less solid in the broth. And test organisms can be a factor influencing the test results.

That's my conclusions. Thank you.

DR. KVENBERG: I guess at this point before I throw it open to questions and answers, I would just like to mention the fact that what we have heard so far is FMC equipment both in manufacturing and retail level operations and we are aware of other equipment manufacturers such as Brown, which is an industrial unit, the cut and ream type system, Juice Tree and Automatic are several companies that we are aware of. The latter two, I believe, are retail units.

I had a brief discussion with some folks at Brown and they are interested in -- in this issue and also with Juice Tree that, basically, supplies retail marked units. But I don't know if they're at a point where they can enter into a discussion or, indeed, if any representatives are here from those operations.

So I'll throw it open to questions. And, particularly, if there is anybody that, in addition to having questions or experiences with the FMC operations, I'm eager to hear about any other units or -- or plans we might have for the future.

MS. BERDIS: My name is Elizabeth Berdis. I'm with SunPure, Ltd. I have a question.

If we're going into a system, the fruit inside the orange -- the juice inside is sterile, so what you're saying is if we have a microbial load on the fruit, which is sterile juice is actually being contaminated during the extraction process, so what we need to do is come in with a cleaner fruit, regardless of what extraction technique we're using; correct?

DR. STROBOS: There are several answers to that. One is it -- you know, as -- as many of the speakers have indicated before, the integrity of the fruit to begin with is very important, so the assumption is, yes, when you start with a fruit that doesn't have any surface problems and it is an intact orange, that the interior of the fruit is okay.

MS. BERDIS: Okay. And I guess what they're comparing is the outside of the fruit microbial load to the inside of the fruit, which, I guess, looking at this shows that it was contaminated during the extraction process?

DR. STROBOS: You're always going to get some contamination when the juice pours over the fruit surface. And the question is can you reduce the amount of that exposure? And you can reduce the amount of that exposure by reducing the load of organisms on the fruit surface, ensuring that the fruit surface is intact and also by ensuring that there is a minimum contact.

So it's -- it's not only the volume of contact, but the time of contact would also be an issue. You have a longer time exposure you might also extract more organisms from the fruit surface.

But I'll let other people comment.

MS. BEASLEY: Elizabeth, I would answer it that the cleaner the fruit going into it the safer the juice would be.

MR. DWYER: I have a question to Linda. On your research with the FMC machine, is there any temperature recommended for squeezing that fruit, like say 40 degrees the fruit going into that machine versus 70 or 80 degrees? Did you do any work with that?

DR. KVENBERG: Can I ask you to identify yourself?

MR. DWYER: Tom Dwyer.

MS. BEASLEY: We did no testing on the effect of temperature of the fruit going into the extraction process. It was all ambient temperature when we tested.

DR. PAO: However, I think it depends on how many -- do you have a chiller? If you don't have a chiller -- this is not a safety issue, but if you don't have a chiller, if you use warm fruit, then the fruit can be spoiled easier because of the time it takes to refrigerate the fruit juice in bottles is much longer than in the chiller.

MR. DWYER: I understand chilling juice. I'm not referring to that. I'm referring to surface contact of that fruit.

DR. STROBOS: We have looked a little bit at it and if the -- if the temperature of the -- of the surface of the orange going into the extractor is higher rather than lower, then, you know, we haven't finished doing all of our data, but our belief is, based on what we have done, that if the exterior surface of the fruit is warm going into this particular extractor that you can get higher levels of organisms.

And the -- and as Linda has shown, you know, the way in which this extractor works by compressing the fruit, you do want to have a certain amount of tension in that fruit so that it -- it -- the machine works the way in which it was designed to work.

So if you have sort of a soft, you know, warm orange, then you're going to have more problems getting this kind of load reduction.

MR. DWYER: That's exactly my point. I was just referring -- the colder the fruit surface, then the less problem you would have with the reduction.

MR. MARTINELLI: I'm Frank Martinelli from Orchid Island and this question is for Dr. Pao.

Dr. Pao, you put some values up there from the log reduction that you can expect from the point reduction that the FMC uses. Were they averages? And if they were, what kind of variation did you experience in the data that you collected and what was your low -- your low end reductions?

DR. PAO: That was done in triplicate and each time 100 fruit was used as a composite sample. And the deviation, unfortunately, the program we used we're not able to show you.

I hate to come out -- in general it's less than half, but each set is different. I don't remember. If you need data, I can tell you.

It came out, from my experience, quite reasonable deviation.

DR. STROBOS: I have a slide up that has our results and I don't know if the person with the slides if you could put that one up.

We did statistical analysis on ours and I think you can see the standard deviation bars up at the top there and it's really quite narrow and the statistical significance is quite tight. This is using the FMC extractor cold fruit and using Lactobacillus fermentum as the surrogate test organism and we've done this just about the same amount of times.

We are seeing some separation in the reductions depending upon which of the tubes you use, whether you use one inch, the one and a quarter inch and the three quarter inch. With these kind of numbers and the similarity of the numbers that Dr. Pao is getting, one question I have is, you know, if you were actually to try to look at the differences between the different tubes, you know, the power or the number of oranges that you would have to run in before you actually would see some separation would be probably a good bit larger than either one of us has done. But the data is really pretty tight.

DR. KVENBERG: Thank you. Other comments?

MR. PELL: Can we back up a question? Are you saying, then, that the orange hot has more contamination when you squeeze a hot orange, than if we treat with hot water then we've got to cool the orange before we treat?

DR. KVENBERG: Can you give us your name, sir?

MR. PELL: Albert Pell. Pell Citrus and Nursery.

DR. KVENBERG: Thank you.

DR. STROBOS: I don't know the answer to that, but my suspicion is, based upon some of our data, that that is true that you would have to cool the fruit down and you would also have to make sure that the -- you know, a second question, which we haven't looked at at all is -- because we haven't used hot fruit at all, but whether or not the change in the surface, the temperature treatment of the surface would also affect it. And I don't have any data on that.

MR. PELL: But you also have a chance of recontamination between the hot water treatment and the cool and the squeezing process then?

DR. STROBOS: Well, not if you're using a potable water rinse and cooling them down, I don't think that would be an issue.

DR. KVENBERG: Other comments?

MS. STEGER: Just one question. My name is Elizabeth Steger from Citrus Consulting.

My question is in your testing did you test, after several hours, that machine was running to see the effect on log reduction like after several hours of working?

DR. PAO: In the last test we did in 10 minutes. We intentionally tested the microbial load in the juice in 10 minutes after extraction.

MS. STEGER: But was the extractor running like for several hours before you did your test?

DR. PAO: No. Each time the extractor was completely sanitized before we --

MS. STEGER: So you did not test after several hours?

DR. PAO: No.

MR. BENINCASA: My name is Jimmy Benincasa from Hale Grove. I have a question for Ms. Beasley.

I thought I heard you say, I'm not sure that you didn't say this, but did you say there was some kind of an automatic cleaning system for your machine?

MS. BEASLEY: Yes, depending on what machine you have. The commercial extractor we have automated systems for the large processing plants.

MR. BENINCASA: What does it clean? I mean, you still have to take the --

MS. BEASLEY: It cleans all juice contact surfaces.

MR. BENINCASA: You still have to take the strainers out.

MS. BEASLEY: They all have to be cleaned manually.

MR. BENINCASA: And that has to be done by hand, doesn't it?

MS. BEASLEY: Yes, it does. Well, that's a complicated question to ask.

In the in-line system for processing plants it is all done in-line. They do take out the strainers to get rid of some of the residual on the strainers to get hesperidin out.

MR. BENINCASA: So how do you find out information about that system? Our sales rep?

MS. BEASLEY: Yes, that's who you would contact. But, really, for a very small operation it's not -- you want to do it manually. You would more likely do it manually.

MR. BENINCASA: You wouldn't do it for one five head extractor?

MS. BEASLEY: I wouldn't. I would do it manually.

DR. KVENBERG: Other comments or questions on extractors?

MR. CRISAFULLI: My name is Chuck Crisafulli from Crisafulli Groves for Dr. Pao. In your tests your final reading, was that taken from the juice itself or from the skin of the fruit?

DR. PAO: That was from the juice.

MR. CRISAFULLI: Okay, that's from the juice.

If I'm not mistaken now, your -- when you inoculate do you inoculate somehow the whole orange, a portion of the orange? How is that accomplished?

DR. PAO: The inoculation process is placing submerged fruit completely in the --

MR. CRISAFULLI: And, conversely, you might run a million oranges -- let's say a thousand oranges before you actually -- let's see, before you actually contaminate your machinery and at which point the blade is what we're worried about when it touches -- that's the only part that's really touching the juice, actually, and if -- so theoretically if -- if your fruit is perfectly clean, there is no way -- there is not going to be any contamination of the juice at all, right?

DR. PAO: Well, if there is no other source of contamination --

MR. CRISAFULLI: Assuming the machine is clean.

DR. PAO: Yes, you are right. But the organisms that we dealt with was E. coli and Lactobacillus. That didn't cover other spoilage and other things. So you will still get some contamination from --

MR. CRISAFULLI: I just wasn't sure if that last reading came from the peel or the juice itself.

Thank you.

DR. STROBOS: Let me clarify this. If you were to pasteurize or sterilize the surface of the fruit, then I don't believe you would see any contamination during the extraction process. Does that answer it?

DR. KVENBERG: Any other comments on extraction procedures?

(No response).

DR. KVENBERG: Seeing none, changing our focus a bit, we'll turn to the next area, which I think is a very critical area, we saved it for the end position here, and these are validation techniques. I guess we could change the guard at the table.

The first speaker is going to be Frank Martinelli from Orchid Island. He's going to be speaking about laboratory approaches for studies, followed by Jur Strobos, who is currently at the front table, and Mr. Steve Hunter who was here this morning. Mr. Tony DeCastro from Blue Lake Citrus is also scheduled for comments. And I'd like to roll that together and have Dr. Jill Hollingsworth with retail perspectives all at the same point with one panel.

So I would like to turn it over to you, Frank.

MR. MARTINELLI: I'd first like to ad lib a comment. I think there are two incredible things going on here today. The first one, I thank the FDA for sponsoring this and the Florida Department of Citrus for hosting this. I think they should be commended. I'm seeing an unprecedented level of cooperation within our industry and that's very encouraging.

The other amazing thing is when I was sitting up here at this table I noticed Kevin Mikus over there and he's typing so fast you wouldn't believe it. He's typing every word we say. As fast as you can talk, he's typing. Amazing; it's truly amazing.

I'm Frank Martinelli. I am still the plant manager at Orchid Island Juice Company. I expect to get through this little talk and then I can resume my normal activities.

I have the privilege of talking to you about in lab pathogen reduction validation. Before I start I have to know one thing. How many people in here have seen Star Trek? Show of hands, please.

Thanks. Because I worked one joke in here and it involves Star Trek.

Orchid Island Juice Company CEO Mayor Grace Sexton is a strong proponent of in lab testing. Valid arguments can be made for both in lab and in plant testing. In either case you're dealing with assumptions. In the case of in plant verification you assume the surrogate will model a target pathogen in all pertinent regards.

In in lab testing you're assuming that you can sufficiently replicate your process in a laboratory to achieve the 5-log target performance.

Orchid Island Juice Company chose in lab for several reasons. First, we weren't confident that a suitable surrogate for E. coli 015787 could be identified in time to achieve the original warning label deadline.

Secondly, we were concerned the FDA would not accept the surrogate based validation. And my hat goes off to Steve Bognon and the Fresh Juice guys because they had the courage to undertake that aspect of validation and from what I understand it's very successful. So I think they're to be commended. We weren't confident that that would be an acceptable way to do it.

And then the third was we wanted to err on the side of safety and we were confident that we couldn't be as effective in the laboratory as we are in the plant. So any results you achieve would actually understate our capability. And, basically, that's how we went through this whole process. We worst cased everything so that whatever -- whatever value we did ultimately come out with was, in fact, the worst that could ever happen.

Some of you are probably asking why E. coli 015787. We have several reasons. First of all, in the FDA warning label advance notice of proposed rulemaking they listed E. coli 15787 and Listeria monocytogenes as target pathogens.

Before the Department of Citrus imposed stringent rules, the Florida Department of Citrus, imposed stringent rules on fresh juice producers in Florida, Salmonella made some people sick.

E. coli 15787 killed a little girl in Colorado in 1996. I think we're dealing with two different levels of virulence here and we wanted to, again, worst case our study.

0157 hasn't been linked to OJ yet, but it's sure turning up a lot of other places. And I guess that's why they call it an emerging pathogen.

I read this, I can't quote the source, but they used the word exception. 0157 is exceptionally acid tolerant. Of course, one of the things that makes us fairly confident that our fresh juice, fresh citrus juice, is safe is that we have an acid product, but in this particular instance 0157 is exceptionally acid tolerant.

And then, identifiable finally, Dr. Parish, he's -- he's taught me a lot about things that we're dealing with and one of the things that he advised me was that he had -- I don't know if he did the studies or if he -- if he just was reiterating to me studies that he was aware of, but he informed me that E. coli can survive in orange juice. They have data to indicate E. coli can survive in orange juice. And I see some people back there nodding their head, so I assume somebody else knows that, too, which is good.

Okay. How do you go about in lab validation? The first thing, and this is a real important point, when you're going to do in lab validation the first thing you do is spend as much time as is necessary getting your cleaning and sanitation process optimized. That's talking about some of the things we talked about this morning, how do you maximize the utility of your chemicals? That's the most important thing that you can do if -- if you have limited resources prior to going to a laboratory.

There are a lot of no cost resources to assist you in your optimization efforts. There is no low cost way to conduct your laboratory studies. You want to have a fully optimized sanitation system that you have a high confidence level in before you go to the laboratory. In other words, you want to avoid the expense of multiple laboratory validation efforts.

Back to the no cost optimization of resources. Here's some of the resources. This certainly isn't an entirely unabridged list, but here's some of the resources that you have at your disposal to -- to help you optimize your system.

Lab microbiologists. Some of us in here are under Department of Citrus requirements to test our juice on a daily basis, each production day. If you're paying a laboratory to do that, I think it is reasonable for you to expect the microbiologist in that laboratory to provide you with some technical insights as to how you can maximize the effectiveness of your cleaning and sanitation process and how you can minimize your -- your micro counts.

Researchers at the University of Florida, Department of Citrus, my recommendation is -- and I hope this isn't going to overwhelm Dr. Ismail and Dr. Pao and Dr. Parish and Dr. Archer, but my recommendation is call them up and ask them questions. They know a lot of stuff.

Next is chemical providers. I can't tell you the enormous benefit we've had from chemical providers. As I said, I know of four chemical providers in our area and each one of them has provided us with products and each one of them has provided us with enormous beneficial insight into how we can optimize our process.

Extractor company tech reps. Linda Beasley will come into your plant and do an incredibly detailed audit and provide you with enormous beneficial feedback on how -- I guess that's if you have FMC extractors -- enormously beneficial feedback on how to optimize that process. So by the time you go to the laboratory you're going to be successful.

Quality assurance inspectors. One of the things I love about being the plant manager at Orchid Island Juice Company is my brother John constantly brings entourages of prospective customers through and customers who are coming to check how we do things. And I try to never miss the opportunity to sit down with the quality assurance people that he brings in and say, okay, tell me -- tell me how we're doing, tell us how we can do better. And we've been -- we've been benefitted from a great deal of good information from these customers and prospective customers. They're quality scientists coming through and saying, well, have you thought about this or have you done this? That's another no cost way to -- to get information.

And then the last thing I'd suggest is cooperative arrangements with regulatory agencies and educational agencies. We are the pilot plant for the FDA for fresh juice and I cannot tell you how much we have benefitted from having the FDA come in, review what we're doing and comment on what -- what they observed.

The same thing with working with Dr. Ismail and on occasion with Dr. Parish. It's another wonderful way to get tremendous insight into how you can do things better at no cost.

Okay. After you have optimized your sanitation system and have a high confidence level in your pathogen reduction efficacy, you begin a simultaneous effort for the sake of expedience. Believe it or not, for some of you who are going to jump out there and start doing 5-log and don't have a big head start on it now, July 8th is going to come fast. While you, as in me, the plant manager are busily developing the laboratory protocol, your chief engineer is constructing a miniature replica of the processing line.

Now, that might seem overwhelming and it was for my brother Little Willie. It probably doesn't have to be, but it was. And a word of caution, when you call that chief engineer to say now here's what I need. See all this equipment that you built and have running out there? Okay, see all that? Now, here's the footprint of a laboratory, notice the dimensions. I need you to create that in a miniature version to fit in here. And he's going to look at you and, to use a Star Trek analogy, he said "I can't take it, Captain. I'm giving it all I got."

Now, if you saw the machine -- if you saw the machine we're talking about you would say, whoa, look at that thing. But for us it's a technological marvel. And once we get done using it we're going to put it in a special display case. But what it permitted us to do was to go into the laboratory and replicate a protocol.

Now, protocol development that initially stymied me. I thought, whoa, protocol development? And I didn't know how to go about developing a protocol. And so what I did was I took a big sheet of paper and down the side of the paper I wrote the things we do.

We -- we put on -- put on cleaner and the cleaner has a residual time, a contact time. We do some rinsing, we do some brush washing, we do some pressure flushing, we do some -- basically, that's about it. Those are the events that happen. And then across the top of this four page document, we put times. And so what we did was said, okay, we're applying chemicals here at time zero to time 10, which was 10 seconds. And then we're rinsing those chemicals off from time 10 to time 12 and so forth.

Now, that seems pretty simple, but where it gets complicated for Dr. Schneider in ABC Laboratory was when we sent him this document, well, here you're putting chemicals on, here you're rinsing them off, here is a brush washing phase, here's another pressure flushing phase, here's a contact time for this chemical and other chemicals and it created quite a challenge for the guys at ABC Research Laboratory. But, basically, that's how we did it. Again, we did a worst case study.

I can't tell you how many hours we spent there timing oranges going across a grading table or going across a brush washer or going underneath a pressure flush system to determine how quick could the fastest possible piece of fruit get through there. And then we compiled all of these times, developed this graph, sent it to Dr. Schneider said this is what we do. These are the chemicals we use, this is the concentration and with that he took the ball and ran with it.

I have this next card here, I kind of drifted off a little.

Actually, Orchid Island Juice Company was successful in our effort because of our chief engineer, my brother, Bill Martinelli, and Dr. Keith Schneider of ABC Laboratory.

To me, I can't say enough about their efforts because that is our livelihood. All we make is fresh squeezed juice. And if we are not permitted to do that, well, I'll share you a secret, my kids are all addicted. Three times a day they come to the table and they want something on it, so my job is important to me.

MS. BEASLEY: Is your time up?

MR. MARTINELLI: Time's up. She was really a pitch man. She brought me into my conclusion.

It's my sincere hope that no one will have to go through this costly and time consuming effort. I'm hoping that now that it is more evident that 5-log is not going away, the Department of Citrus will provide the industry with acceptable cumulative 5-log protocol.

When we had the Salmonella event, the Department of Citrus came out with these requirements and they satisfied the -- the concerns and it was a done deal. I hope for the benefit of everybody here that you don't have to go through what I just described.

In the absence of that standardized protocol, Orchid Island Juice Company would like to offer the industry two things. First of all, encouragement. It can be done. And for a long time over the past years, while we're trying to do it, fresh juice companies, Marc Isaacs, Sun Orchard, we read in the paper a lot and we hear a lot from very knowledgeable people it can't be done. And that caused many nights of restless sleep. It can be done.

And the other thing I can offer you is .62-log. While every company has to develop their own protocol which is consistent with their own process right now, one thing that is standardized throughout our industry is a cull study that we did. If you're complying with the Florida Department of Citrus requirement for zero tolerance and you, over the course of a year, have a 15 percent cull factor, then our study would apply to you.

And we would be more than willing to offer you that portion of the study, so you don't have to go back and do a pathogenic study on the effectiveness of -- of your culling process. You can limit it to your -- the reduction that you get with your wash, your brush washing, your sanitization effort and your end point extractor technology or whatever technology that you have.

Aside from that, now it is the end. Thank you very much.

DR. KVENBERG: Our next speaker is going to talk to the other issue that we've discussed roundabout and now we're going to reach it head on, the use of surrogate organisms in plant operations. And, again, I will reintroduce Dr. Jur Strobos.

DR. STROBOS: My recollection was that the headline writer for U.S.A. Today has discovered an E. coli epidemic for orange juice, but other than that, I don't think there are any E. coli associated with it.

Let me just say that my background originally is in biological products industry. Sort of human insulin, TPA and stuff like that and all of these products come, vaccines, they're biological products a lot like orange juice and they're injectable products so they have to be sterile. And there is a process by which you, you know, arrive at a production process that ensures sterility.

And it is, in general, a combination, I would say, of laboratory experimental validation as well as in plant validation. Ultimately, you have to get the in plant validation because you have to know in your HACCP plan what's going on at each one of your steps and you need to know in your plant what's going on so it will allow you to feedback into your HACCP system, especially when you identify incidents which will generally happen in a production process at any time.

With that -- and to a certain extent when I first got involved with this with Steve Logan two years ago, I had the benefit of having Steve be sort of a quality and we had a very nice process in place and, therefore, I thought it was worth the risk to try to go ahead and try to do an in plant validation right from the get-go, even though the time was fairly short.

With that, let me turn on the slides here and go through what I think of as the principles behind in plant validation of microbial load reduction and then Steve Hunter is going to spend a little time going through our actual data.

One of the sort of basic reasons is why you do in plant validation at all and what are the principles of identifying a surrogate, again in both settings you're creating assumptions and have, as Frank pointed out, you're trying to model the circumstances as best you can within -- with experimental validation you're actually modeling your production process. With in plant validation what you're doing is you're trying to model the organism.

In doing that you do also make conservative choices. The first conservative choice you have to do is you have to identify a surrogate organism that is appropriate that you can use. And in doing that modeling and that analysis you have to do what's called surrogate qualification. And in doing surrogate qualification and running the statistics and the numbers on that, you always have to be sure that for whatever characteristic you're evaluating your surrogate for that your surrogate is a little tougher than the pathogenic organism that you're looking at.

Additionally, in plant -- in plant has -- reduces some of the problems that were identified earlier that were detected. When you clean a plant, when you initially set it up, when you do your first runs you're going to have less variability than as your production process goes on. The nice thing about in plant validation is that you basically run your validating in the plant side-by-side with production oranges and during the production process. I mean, you may set aside some time, but it does give you a sort of worst case scenario in terms of how your plant is operating, as well.

Then the question is what is a surrogate organism. I actually stole this definition from the FDA Q and A, because I kind of like the definition. I made a few modifications. When you're dealing with a food product the non-pathogenic organism that has to -- that you're looking at has to be GRAS and it has to behave similarly to the pertinent microorganism under each and all of the conditions you examined.

That doesn't mean that you can't -- in other words, you can take individual sort of things like the sanitization and you might find one surrogate for the sanitization and that that surrogate, say, doesn't work for your brush washing, so you might end up with using different surrogates.

What Dr. Pao has been doing in the laboratory is, in fact, looking at surrogates, as well, since he's been using non-pathogenic E. coli and that would also be a surrogate analysis.

So the first thing you want to do in identifying a surrogate is try and figure out what the pertinent microorganism is. Frank was very correct in saying that the FDA preamble sort of set out a blueprint for that, as did the advisory committee on microbiological issues in food.

They, basically, said that because of -- this was sort of a more general document dealing with all juice. And they said as a matter of fact if you couldn't identify an organism that was sort of specific to your particular juice product that the default organisms you should use as your target organism is E. coli, the pathogenic E. coli or -- or Listeria monocytogenes.

Our view was that when we did the analysis -- and this analysis actually should be part of your report because the FDA document does suggest that you do some analysis of what you're target organism is.

When we did that analysis with the single outbreak from process juice with Salmonella, when we looked at the issues of if you take -- if you take the Florida regulations that Martha Roberts reviewed this morning talking about using only tree picked fruit, if you look at the environment that we're talking about here in Florida and you look at the microflora and the fauna here, we're talking about, basically, fecal contamination of the orange surface.

And the most likely fecal contamination is going to be, in this particular environment, either avian, amphibian or reptilian. And our view was, and there was a fair amount of documentation, that the organism that is endemic in these populations is Salmonella.

All you have to do, actually, is go back to an FDA rule on turtles and there is a whole discussion of endemic Salmonella in these populations. And so we decided that Salmonella species was the organism, the target organism.

We then looked, as did Frank -- you know, the in plant and the -- I have to agree with him, there is not a whole lot of difference in terms of some of the modeling that you do.

In our analysis and I think it has become plainly evident from today's meeting, it's our view that you really cannot achieve this kind of 5-log reduction unless you have these minimum four steps. I think you need more. You need to have those four steps packaged in a step in which you are preventing cross-contamination or new contamination and that once you extracted your juice, you know, your -- you're maintaining it in a fashion in which it cannot be contaminated either.

But you need to have, I think the FMC people pointed out and I have pointed out before you have to have some sort of fruit qualification selection criteria. You then have to have some sort of a system whereby you -- you eliminate, you know, surface materials that you can get rid of with a brush washer.

We have now done validation, in plant validation, using Lactobacillus fermentum in three different plants several different times and we have identified variations depending on how you do your brush washing, how you do your extraction, what kind of sanitizing solutions you have.

So let me reiterate, you know, as part of this FDA meeting that -- that -- and as Frank said you have a very limited amount of time in order to prove you have a 5-log reduction. You have to have your system in place now, I think, in order to be able to do the experimental work that you're going to need to do to prove that your particular setting will achieve that reduction.

And the nice thing is that if you're using the FMC equipment I think that at least you can build that in.

But you have these four steps, which is the wash and the sanitization and the pinpoint extraction. I was very intrigued by the heat treatment, but I have a suspicion that that's unlikely to be a single step either.

When we looked at that we said, well, what do we have to do in terms of surrogate validation? What do we have to prove the similarity of our Lactobacillus fermentum species to the target organism? And we looked at inoculum comparability, just as Dr. Pao has done. We looked at surface retention of the inoculum. We looked at the surface adherence on brush washing. This is another example of modeling.

You can't do the surface attachment comparability assessment in plant. You have to do that in the laboratory, so you have to do some sort of evaluation in the laboratory of the effect of brush washing.

You have to look at the response to the sanitizer. The nice thing about most sanitizers that we have discussed is they're fairly indiscriminate in the way in which they kill organisms. In other words, there won't be a lot of difference between gram-negatives and gram-positives as there is, say, for instance in antibiotics. And you want to look at surface adherence on extraction, which is the issue with regard to the FMC extractor.

The other thing you have to do is figure out how you're going to do your assay. Dr. Pao talked about dipping the oranges in saline, figuring out how much surface contamination there was and then, you know, back calculating what the amount of contamination there is per orange.

We did some initial studies looking at, you know, looking at how our plant operated and also looking at, you know, what's the best way to actually get the organisms off the surface.

We discovered when we used the bag technique that we were getting a marvelous result. And one of the things we think was anomalous was due to the oil content in the -- in the orange surface and how vigorously you shake the bag and what the pH or the salinity content of the solution is that you're using in the bag.

So we went to a swab technique, which is sort of a more typical microbiological technique, because we thought that that, when we did it repeatedly, we were getting more consistent results and consistency is usually something you want to try and strive for.

I wanted to discuss a little bit about mimicking the contaminant because we're talking about 5-log reductions here and all of our mimicking modeling that both Dr. Pao has done and I believe was done also by Frank involved basically taking a uniform concentrated inoculum that has about 10 to the 8, 10 to the 9 organism and putting that on the surface of the orange as an inoculum.

Again, let's go back to the natural circumstance. The natural circumstance you're going to have some sort of fecal contamination on the surface of the orange. If you look at that inoculum you're talking about an inoculum that is closer to 10 to the 11 or 10 to the 12 because when you have a fibrous fecal material you can get much higher concentrations of organisms, that's typically the concentration of organism in the kind of fecal contaminant that you're talking about.

So to a certain extent all three of us have been using a very conservative model of inoculum.

Again, reiterating what Frank pointed out, you have to start off with an a priori study design. The concept here is that you get results and then figure out that you're only going to take certain results. The whole principle behind a good study is you look at all of your results and you try to figure out what's going on with them rather than just picking and choosing your results which is sort of, you know, testing your way into compliance. You have to do a sufficient number of replications to achieve statistical validity.

Again, you know, some of the comments I made earlier about comparisons are not necessarily statistically valid because you need to have enough replications to say that. You can look at trends, but when I'm talking about the 5-log reductions that we have achieved, and I think Steve will go through this, we've -- we have, basically, repeated them until we have achieved very, very narrow changes in terms of what we're seeing in terms of our log reduction result.

The next thing I have heard some discussion about and I sort of wanted to clear the air on this, is this business with cumulative versus sequential analysis steps. I can't criticize anybody who decides to approach it initially looking at cumulative results. There are a number of problems with doing that. One is it doesn't -- it creates a problem for you in your eventual development of a HACCP plan because you won't be able to figure out what are the critical control points on each one of your steps because you will only have a cumulative analysis and you won't have broken it down.

Additionally, in this -- in this world of -- of microbial load reduction it is generally viewed, and, you know, this is after many years of experience, that sequential analysis is appropriate where the mechanism of microbial load reduction is independent.

In other words, if I'm looking at sanitization, I heard someone mention earlier today that if you have two brush washing steps you can't really look at each brush washing step independently. That's because each of them is operating by the same mechanism and there is this concept there that if you look at each of those independently they're both sort of doing the same thing and you can't -- you have to look at them cumulatively. That is not true when it comes to looking at independent activity.

The concept is there may be some organisms that say are highly resistant to brush washing, but those same organisms wouldn't be the ones that would be highly resistant to the sanitizing material.

So it's generally accepted that you -- you do these studies on an independent basis, at least at some point.

Finally, another reason to support doing it independently is test validity. When you're starting an inoculum concentration of 10 to the 8, and you're doing a cumulative evaluation and you're there dropping to either sterility or 10 to the 3 or 10 to the 2, you're dealing with count levels and you're finding results that make it extremely difficult for you to achieve statistical validity. You need to -- you need to -- and that's just because your microbiological assays at that level become highly inaccurate when you're looking at load levels of one or two organisms per. . .

This is the actual sanitization study we performed. We used Lactobacillus fermentum from the ATEC type 9338, I believe in this particular evaluation. In our in plant testing we have used both wild type Lactobacillus fermentin as well as the same ATEC strain and the results are more or less the same.

This data here shows, and we have done a fairly sophisticated statistical analysis, but it shows that exposure of this particular sanitizer, which is chlorine dioxide, the concentration and times that we apply in the plant has identical effects or statistically and distinguishable effects on the Lactobacillus fermentum as it does on the Salmonella.

There is some slight variation on the numbers at the top that relate to the artifact colony forming units in Lactobacillus which is a chain duplicating organism which is Salmonella, which duplicates slightly different facts -- replicates slightly different.

This is our analysis of inoculum retention and attachment after brush washing and you will see, again, that you get statistically identical reductions. You get -- using the same inoculum strength you get the same retention of organisms on the orange, you get the same reduction of that retention following brush washing.

Again, the minor difference that you see there, which was actually washed out in the statistical results is due to the differences in the way in which colony forming units are counted on a plate. Lactobacillus, when it replicates, forms six units and then -- six to eight units and then divides into a new colony forming unit so that you would expect to see a difference of six to eight fold in these sort of log numbers that we're looking at. Those type of differences are washed out, but I just wanted to be sure that everybody understood that.

And that's -- you know, our goal here at this meeting and, you know, one of the things that the FDA has indicated is that other companies can rely on publicly available data and develop their own validation studies. I think we have established that through these kind of processes and these kind of sanitizers that this particular Lactobacillus fermentum species 9338 is the equivalent of Salmonella type. And I think that information is now publicly available so if you want to do your own in plant validation studies you have accessible organism to do that.

And with that I would like to thank you for coming. And I think we're going to let Steve discuss the actual in plant validation.

DR. KVENBERG: As just indicated by Dr. Strobos, Steve Hunter again returning to the podium to discuss how the in plant testing was done in his hands at The Fresh Juice Company.


MR. HUNTER: I'll talk a little bit about the most conservative of our studies. We had done four validation studies and this is the most conservative. And the reason I say it's the most conservative is this is where we used a wild Lactobacillus instead of using an inoculum.

These organisms had become acclimated to being on the surface of fruit and so that would make it more conservative than having dipped them into inoculum so we think that any kind of thing in the attachment process that had been going on for quite awhile.

And the way we started out first was to have a starting point. And so we -- we took 15 oranges from a pool of 100. In fact, I can use one of these here to demonstrate it.

We took a 10 centimeter square template, which is sort of interesting. We made the template out of the Post-it things and so we just cut a square. Okay, and then we put that on the fruit.

And then it was with -- then we took a sterile cotton swab, put that into 10 mils of neutralization broth and then later on that was checked for the presence of Lactobacillus.

For our starting point we took 15 oranges and we mounted the Lactobacillus on the surface. We had the diameter of the fruit. And we came up with a total surface area and then we just multiplied it up so that we came up with the number of organisms per orange. And you see there that we started off at 8.08 log with a relatively small standard deviation for the group.

The first process that we went to validate was the fresh washing step. In brush washing we had 23 seconds of contact time in the brush washer with the 2.6 parts per million residual chlorine dioxide, 80 parts per million of the acid fruit wash. And I did the same process, just logging all of that.

We came up with a 5.62. And so the difference there is a 2.46-log reduction. And there you see it there, the baseline and the post brush washing.

We did the same thing for the sanitizing step. There was 83 seconds of exposure time to the two chemicals that were mentioned earlier. We came up with 6.54-log which -- I'm having to do this in my head real quickly trying to calculate that out. I wrote it down somewhere.

That comes out to be a 1.64-log reduction. And here again -- this pretty much here this is the extraction step and our results almost exactly duplicate what Steven Pao had come up with. We came up with a 1.92-log reduction.

And so the total log reduction for the process was 5.92, which really is important to notice here is the very small standard deviation. And so when you do the 95 percent confidence interval, the log reduction could have been anywhere between 5.44 and 6.39. And that's why we felt like with that 95 percent confidence interval there was no need to continue testing.

Thank you.

DR. KVENBERG: For another perspective relative to coming into this food product testing food systems approach on plant validation is Mr. Tony DeCastro with Blue Lake Citrus, who is our next presenter.


MR. DeCASTRO: Good afternoon. I think it was James Blood that said earlier not all of us were volunteers, but I'm still happy to be here. And as consequence to that I think it was Dr. Ismail who said what's the title of your presentation going to be? I picked, hopefully, a suitably confusing enough one for this particular audience, Reducing Microbial Risk in a Bulk Fresh Citrus Juice Processing Plant.

By way of a quick introduction, I want to describe Blue Lake Citrus products as it relates to fresh juice. We're somewhat unique in that we deal with bulk unpasteurized citrus juices. What I mean by that is we are a bulk provider to fresh citrus juice bottlers.

We do not actually execute bottling operations at our facility. We do, however, go through all the other steps that other fresh juice processors do in terms of receiving the fruit, processing it under the conditions it needs to be processed in and getting it to the customer in a condition by which they can bottle it confidently.

Towards that end we do ship it out in tankers and the vast, vast majority of the fresh juice that we ship is also somewhat unique in that we're shipping it out of state across the country. The other bit is just a little bit on what else that we do.

I want to preface my topics of discussion by stating, first of all, although I'm not a volunteer, I am happy to be here because I do feel that it's very important that we open to discussion all strategies that are available in order to successfully execute a 5-log reduction for the entire fresh juice industry.

And, No. 2, and I'm happy to see some of the discussion taking place that's specific enough to allow us to come to a specific criteria by which to validate that 5-log reduction.

On my first point I am going to talk about an example of a HACCP plan. This is relevant, obviously, a couple of fold. First of all, it is one of the criteria by which to meet the time extension in order for -- the time extension of the warning label requirement. And HACCP also is the fundamental mechanism by which one would ensure that a process designed to achieve a 5-log reduction is actually maintained.

So I'll be talking about specific critical control points that we have identified for our plant and the way that we actually go about implementing that plan on a daily basis.

So, hopefully, this is going to be some practical information that those who are undergoing this effort will find useful.

And I'll briefly mention other considerations, harvesting and in plant fruit handling. As it's been stressed over and over and over again the quality of fruit going into your plant is extremely critical in ensuring the success of the process.

This is a process flow overview. It's a pretty standard approach to taking a good snapshot picture of what the HACCP plan entails.

I also need to state that HACCP does assume that some fundamental things are already in place prior to getting to this point.

You do need proper execution and documentation that the manufacturing practices per 21 CFR, part 110, you need standard operating procedures for your sanitary programs. And Florida Citrus Rule 20-64.020, obviously, addresses that. That is a fundamental assumption in going to this point.

At Blue Lake Citrus we start with fruit sourcing. Fruit sourcing to us is very critical because of the fact, again, you've got to have clean fruit to start with to help that situation out. That fruit is picked and placed in the field bins, much the same strategy as a packinghouse whereon harvest fruit, as opposed to juice -- fruit for juice processing plants.

Just running quickly down through the process here, we receive the fruit, weigh it in, unload it, it goes through a high pressure brush washer, a sanitizing rinse -- and I'll go into some specifics on these in the next slide -- fruit grading, another sanitizing rinse immediately fruit grading, through a sizer, a potable water rinse immediately prior to juice extraction, and that rinse is taking place on the tilted feed belt, and passing through the finisher, a surge tank, we chill the juice down, we hold it in refrigerated tanks prior to loading them out on tankers.

This is the upshot description of our HACCP plan. The hazard being pathogenic organisms. The one of public health concern being the E. coli 787 and more recently if you call three years ago recent, Salmonella.

We have critical control points. One being defined as pre-start up sanitation. The basis behind that fundamentally being if you're not clean to start with you have the potential to pass something on. How we go about taking a look at that is making sure that our clean up SOPs are rigidly in place.

And, again, with the eye towards sharing a specific approach on how we actually do that, I'll show you some of the documentation on how that's recorded on a daily basis.

The second critical control point is the washing and rinsing. The third one being grading. Again, we can't stress critically enough how important that is. Juice chilling in terms of preventing any increase of -- of a situation of concern for one that's critical. And then tanker load out.

Implementing HACCP is not an easy thing to do when you take a look at trying to do everything in a way that fully addresses the task but at the same time something that's completely doable and comfortable and manageable.

What we -- how we approached it is trying to take a look at the recording of the critical control points from start to finish of the process and by which a person who is going about the plant so to speak is validating that process in a logical fashion. So you can go through the hazard analysis, identify your critical control points, but at the same time the -- the HACCP plan itself may not be -- might not lend itself towards being looked at in a very easy fashion.

So you've got to kind of flip your thinking at this point once you have done your hazard analysis and you've got your plan essentially in place of what your critical control points are, what your criteria are, then you can move forward with actually living with it on a day-to-day basis. And this is what we're trying to do here in terms of living with what's going on.

CCP No. 1 being start up sanitation, our criteria being that anything that fails through here needs to be corrected and needs to be corrected prior to going forward. It's easier than it looks.

We take, basically, before we start up we're taking a look at our sanitation chemicals, our fruit receiving area, our grading and sizing area, making sure personnel are following appropriate GMPs, our juice extraction area. To those of you unfamiliar with RLUs, that refers to relative light units using a term known as an ATP detector is probably the easiest way to describe it.

Is it, basically, using violet luminance to detect the presence of ATP on a surface. It's literally a pass/fail type of situation to determine whether or not there is something on that surface. It's most valuable in determining whether or not that surface is clean or not.

Going forward to our juice chilling and tank area and down. So, basically, we're baby-sitting the whole process all the way through prior to starting and making sure that all the conditions that we are assuming that should be there ever, in fact, are there.

Okay, we've started up. Now we need to make sure that we're running correctly. So we have our process control record by which a very high level of inspection basis we're taking a look at at least every four hours. Here again to my point earlier about your plan versus the actual execution of it. In this control record we're combining several critical control points. They are clearly outlined with the criteria as far as knowing what you need to do should something not so good happen.

Critical control point No. 2 relates to the washing and sanitizing. And, again, we're recording the -- against the criteria every predetermined time period.

Grading, this is a critical area. I want to just make a quick note about how important it is to make sure that not only the right number of people are there, but at the same time that those people are appropriately trained and they, in fact, know what to look for and we don't just have random culling taking place, we have smart culling taking place that is efficacious in ruling in a log reduction that's assumed at this point.

CCP 2 is related to washing and sanitizing, but in terms of how you're walking through the process, it's happening after grading in our -- in our example. So we're taking a look at it here.

There are some other quality control points that are being looked at also during the process that are not significant, but they are recorded also.

And then CCP 4, which is essentially temperature is being monitored at this point.

Our critical control point five I've labeled tanker load out. Again, this is where we're a little bit different than some of the other processors because we're not bottling, but this, in a sense, is our package. Here.

We're summarizing basically what's happening and trying to combine a couple of objectives here and fully recording what needs to be monitored vis a vis the HACCP plan, but at the same time relating some very relevant operational and quality information into it.

The CCPs are identified here, so we know which criteria applies to which to behave against if there is an issue.

From start to finish we're looking at how long it takes us to load. We are, again, testing the clumsiness of all the product contact surfaces that we looked at. Again the transfer hose fittings, the rear valve of the top hatch of the tanker itself, and then part of the tanker load out CCP is temperature and pH.

And to wrap it all up, this is our record pulling together all of the HACCP documentation.

Going to item two, and this is related to product testing in our plant, these are the results of what happened while performing under the plan that I just described to you.

This is more of just overall interest, I guess, and just the general outcome on a complete seasonal basis.

Blue Lake Citrus products produced fresh orange and tangerine juice tankers throughout the '97 '98 season. As you can see, we did, in fact, take a look at Salmonella, E. coli 157H7 specifically throughout the season and didn't find anything, thank goodness.

We -- the part of our uniqueness lends us a bit of a safety factor in that we can sample that product while it's on the way to the customer and before it gets anywhere we, essentially, know what's happening with it. So we're not in a position to pass along anything that should -- shouldn't be passed along.

Generic E. coli you see also that there was negligible detection. Total coliforms, total aerobic, yeast and mold are indicated here.

Nothing overly unusual to point out, but, again, it's comforting to see that specifically looking at Salmonella and E. coli 157H7, the organisms of pathogenic interest, we didn't see anything throughout the season and, again, attest to the fact of having a HACCP plan in place as part and in concert with validation of a 5-log reduction is essential.

I have some questions I wanted to answer for myself, as I'm sure members of the audience did also prior to coming in to this forum. And it's comforting to know that, at least from my perspective, a lot of these have gone a long way towards answering those questions.

My questions related to identification of the appropriate surrogate organism and making sure that we as an industry and certainly individually are very confident that that organism is, in fact, appropriate.

The inoculation level, sampling rate and organism recovery method all relate towards statistical validly at this of asserting that one has a 5-log reduction. Again, I'm very pleased to see that there is some very valuable information related to that that's already been presented. So I won't go into that.

That's all I have. And if -- I did not bring all the copies that I needed to bring. If anybody does, in fact, need a copy of my presentation, I'll be happy to give you one. Just come see me and drop me your card and I'll give you anything you want.

DR. KVENBERG: Thank you, Mr. DeCastro.

Before we go into question and answers, I think we need to hear from a perspective that is an interesting one that hasn't been addressed yet today and that is the retailers perspective, both in the arena of receiving juice from processors and their needs in that regard and also receiving fruit and processing it specifically into juice products at the retail environment.

We're fortunate this afternoon to have Dr. Jill Hollingsworth, formerly a U.S.D.A. colleague of mine, and currently with the Food Marketing Institute in Washington, D.C. speaking for retail.


DR. HOLLINGSWORTH: Thank you. Thanks for the invitation to be here today to share with you some of the challenges that we're facing in the retail industry regarding the safety of citrus juices.

I have up here three options, and actually there is a fourth one and that is actually selling the juice with the warning label.

I didn't put that on here initially because we were not able to get a good feel for how many retail stores might opt to choose that. As it turns out, there are those who even, as of today, have signs and placards up with the warning statement, but we have not gotten any feedback from them yet on whether or not that's had any impact on sales and how consumers are reacting to that. So I'm not going to address that option at all.

And, of course, the first option, which is sort of the simple and obvious way to go, and that is just to only sell pasteurized juice. I put that one up here because we have been informed by some of our retailers that they, in fact, will choose this option and just discontinue selling fresh juice. But I want to focus today mainly on options two and three.

The first one of those is No. 2, which is selling fresh, unpasteurized juice that is manufactured by another supplier. From the retail perspective we would take the assumption that this product has already been validated and demonstrated to be shown that it has, in fact, achieved the 5-log reduction. In that case we have sort of two different ways we deal with this product. One is when it comes in already pre packaged and ready for direct sale to the consumer.

In that case the responsibility of the retailer would be mainly one of just good handling, keeping the product refrigerated and maintaining it so that there is not any potential for cross-contamination or temperature abuse.

The other way we deal with this kind of product would be something like was just discussed where it comes in in bulk tanker trucks and then at the retail level or at a central kitchen or commissary it's packaged for retail sale. In those situations it does add an additional safety step for the retailer and that is to just maintain the integrity and cleanliness of the containers and to make sure that the packaging of the juice is done following GMPs and then the additional steps of temperature and reduction or prevention of cross-contamination.

So in this -- in this situation where we're actually buying the unpasteurized juice, our real concern would be how would a retailer be able to demonstrate to the state or Federal government that, in fact, the juice they are selling meet the 5-log reduction?

We are going on the assumption that FDA would not go into a licensing business, if you will, and provide licenses to accompany this product and so we would have to assume that a letter of guarantee or some kind of a contract between the supplier and the retailer would suffice to show that the product coming in for retail sale, in fact, has met 5-log reduction. That is something that we will hope to work with FDA and the states on because our retailers are going to be in a situation where they have a piece of paper from a supplier, they'll need to know that the state or FDA will accept that piece of paper, that, in fact, the product they're selling has met the 5-log reduction.

The third option, which is where the retailers would actually want to produce the orange juice or citrus juice themselves, becomes a little more complicated.

We are also very hopeful that there will be a series of steps that when put together can achieve the 5-log reduction. And, in fact, from our perspective, the more of those steps that are achieved before the product comes to retail, the better off it would be.

We would like to see that the retail level that the steps that we take add to the level of safety, but that the closer we already are to 5-logs on the fruit, the safer we can expect the final product of juice to be.

The kinds of things that we would need to know, though, at retail are what combination of steps are achieving what level of reduction?

We have heard a lot today about things like washing with detergent and waxing or hot water wash or steam washing or washing, sanitizing brushing combinations.

The problem for us, though, will be what will be the total effect of those by the time the fruit comes to retail and how will we know. The fruit that comes to a store to be squeezed would have to be somehow identified as to what level of reduction had already been met.

In fact, the supplier of the fruit can certify that that fruit has, in fact, a 5-log reduction, then our role becomes one of maintaining that level of safety and, perhaps, even enhancing it by steps that we can do at the retail level.

One of the things that we would also need to know is some standardization of the terminology. For example, there's a lot -- there seems to be a general understanding in Florida what it means to be a licensed packer, but we're not sure if that same kind of concept carries through to other states. And, in fact, if the packer is licensed in one state, does it mean the same thing as a packer licensed in another state?

Also, the concept of certified fruit has come up from time to time. And I have even heard retailers tell me that, oh, they're only buying certified fruit. But I'm not sure that that means a 5-log reduction or whether it will mean that in the future.

So we would like the FDA and the industry for standardization of those definitions and what that really means.

But, again, we would be challenged with how is the information transmitted to retailers and how do those retailers prove or demonstrate the safety level that has been reached of the fruit that they are purchasing?

If, in fact, they are purchasing fruit that has less than a 5-log reduction, then the next step we would most likely turn to is the equipment manufacturers. And we've already heard quite a few discussions today about how the equipment extraction process can actually also add to the overall log reduction.

We would then be in a situation where, for example, a retailer might have some type of a document that certifies that the fruit has achieved a 4-log reduction and that the extractor can achieve an additional one log. And put together we would have a 5-log.

But to try to demonstrate that at the retail level will not be easy and will involve quite a bit of paperwork and that's one area where we're concerned that there be an understanding as to how that 5-log reduction can be documented and assured.

At retail we believe that we can maintain a 5-log reduction if the fruit already arrives at that level or if it requires the addition of the extraction equipment to achieve the 5-log.

This is a very simple diagram of what might happen at the retail level when juice is being produced at that location.

One of the things that we would have to question is whether or not the wash and intervention step would be necessary as part of the overall 5-log reduction process or if retailers could choose to use washing or intervention steps as an add on to the 5-log that would already have been achieved.

Also, we feel that by using this kind of a process of flow chart guide that retailers can assure and maintain the integrity of the safety level that was achieved at the packinghouse.

For example, keeping the fruit under refrigeration, assuring that the equipment is clean and sanitized according to the manufacturer's directions, making sure that the product is put only in clean containers, eliminating cross-contamination, keeping rodents and pests out of the area where the juice is processed will all be part of a system that will maintain the safety level.

But, again, we would have to wonder how can we assure that if we're doing this that an inspector who comes into a retail store would be able to show or be -- have demonstrated to them that the 5-log reduction is in place?

One of the things that FMI, the Food Marketing Institute, is looking at doing now is putting together a guideline. And I was very happy to hear Richard talk about doing something like that. And we'd like to work with the Florida people in order to develop a type of guidebook that a retailer could use and knowing that they follow the steps in the guidebook that they, in fact, would be able to document that they have achieved the 5-log reduction.

Whether that includes documentation from the packer or use of a certain kind of extracting machine or certain type of washer intervention at the retail level, whatever option they choose cumulatively they will have the necessary documents to show that they have achieved the goal.

We hope that such a guideline would be usable in all 50 states. It's very encouraging to see and hear what's happening here in Florida and that makes it a lot easier for us at retail to see how this may all come about and we'll be in a position to use any of these options that we might choose. But we also need to be sure that this is carried over and that whatever works in one state can also work in another state because we have stores, as you probably know, in all 50 states and retail stores are going to need to know that what they do in one location will work at another location.

And, lastly, one thing that I wanted to bring up, and since, John, it wasn't in the list of don't discuss, we're also still unclear on how retailers can demonstrate that they are meeting the requirements during the interim period to continue to produce fresh juice.

We would also hope that during this interim time the fact that the packers are washing, sanitizing and waxing fruit would be sufficient to allow our retailers to continue to fresh squeeze juice, provided they meet these kinds of standards, GMPs, to keep the area clean and sanitary, to maintain temperature and eliminate cross-contamination.

Thank you. I appreciate it.

DR. KVENBERG: Thank you. This is, again, an opportunity for anybody that would like to question or make additional comments relative to the discussion we had this afternoon on the validation techniques.

MR. FOWLER: My name is Craig Fowler. I'm with Fantasia Fresh Juice Company. We're a fresh juice processor out of Chicago, actually, and we have kind of fallen between two different areas. We're fitting more into the retail side because as an out of Florida state juice squeezer we can only source packhouse fruit.

And I'm not sure of the best person to answer this question is, but is there going to be any further studies about what Dr. Jill was talking about as far as the validation that a packhouse gives to fruit, as I bring into my plant, what do I have to further do with that fruit before squeezing to achieve my 5-log?

DR. KVENBERG: Well, let me take a chance to answer the question by saying one of the tricks I had up my sleeve was after a very brief discussion and people, not just to -- we're going to break into informal groups in a bit, and what we really need to hear back through a consensus type opinion through this informal discussion is what are the next steps going to be? What are the needs that we have and what are some recommendations for us getting there?

Frankly, one of the opportunities of a public meeting like this is for input from you folks into what the needs are and how they might be addressed. So I'm looking forward to that. I certainly hope when we have this afternoon's set of presentations which are now drawing to a close that you don't leave us and go on back. I know it's been a long day.

But I think discussion groups would be useful and us receiving information on what next step needs are, that's a big one relative to guidance to small processors and retailers, what the next steps ought to be or how you would make a recommendation for what and who ought to pursue it.

Does anyone else have any comment on that?

(No response).

DR. KVENBERG: I guess not. Are there other points on validation?

MR. BOGEN: Steve Bogen, Fresh Juice Company. I just want to ask if the FDA takes a stand to make sure that people that choose to use a warning label don't think that it's a license to produce unsafe product because we have spent a lot of time and effort to make sure we get there. I just wanted to make sure that was enforced to some degree.

DR. KVENBERG: Thank you.

Other comments?

MS. FRELKE-ODWALLA: This is Linda Frelke-Odwalla. My question is to Steve Hunter at Fresh Juice.

How do you account for that 10 to the 7th wild Lactobacillus on your oranges and is that typical?

MR. HUNTER: Yeah, these were fruit from the end of the season and, yes, we do feel like it might be typical at the end of the fruit season. They were Valencia right from the end of the year.

MR. DeCASTRO: Linda, I can add to that, too. We have some very preliminary results, so please take it in context, but current season Lactobacillus on the order of 10 to the 4th organism so there may be something inherent in seasonality, but that's total Lactobacillus.

DR. STROBOS: That particular organism you're going to find in almost all fresh foods at some point.

MS. FRELKE-ODWALLA: I find that at 10 to the 7th that's a really high number to have in any fresh food and certainly will cause off flavors and gassing if it were in your juice at that level, but obviously you guys are washing it off.

MR. HUNTER: Linda, when we did our studies in California -- I know why you're surprised at that number being so high is that our testing, all of our testing in California we had to do with inoculated fruit because we could never find anything higher than about 10 to the 3rd, 10 to the 4th.

MS. FRELKE-ODWALLA: That's right. In California we're not finding that at all.

Just one more follow-up question. When you guys are talking about Lactobacillus and being in the 10 centimeter square area and you have such a great even distribution, at least from what it seemed like on your data, if it's evenly distributed across the whole orange, how does that necessarily represent a fecal material contamination?

DR. STROBOS: It doesn't.

MS. FRELKE-ODWALLA: A once in a blue moon type of thing?

DR. STROBOS: It doesn't. There are two ways in which it does. When you have fecal contamination, the level of pathogenic organisms that you get in a fecal contaminant is usually in the 10 to 11 or 10 to 12 range. The concept is that the surface of the orange is a medium upon which the organism can migrate and then the question becomes if you have, as you do in Florida, a relatively humid environment so that you have water on the surface of the orange or at least humidity on the surface of the orange, can you get transmission of that?

And one of the things we tried to do is tried it figure out what's the maximum concentration of organism that we can actually get uniformly spread around? And the maximum that we can develop is in the 10 to the 7, 10 to the 8 range. And that has to do with just competition of the organisms, growth rates in that kind of a medium.

So on the one hand it's not realistic in the sense that you can get peak concentrations from fecal contaminant that are much higher, but one would expect in a relatively humid environment that if you did have a peak concentration of 10 to the 12 or 13 at one point, that on the other side of the fruit you would also have organisms, as well just from the spread of the organism along the surface of the orange.

Let me just -- did that answer your question?

MS. FRELKE-ODWALLA: Yeah. And also, why did you originally start with Lactobacillus versus an inoculant like Enterobacter or something like that which is gram-negative, compared to Lactobacillus which is gram-positive?

DR. STROBOS: The reason I did that is twofold. One is when you look at the kind of agents that they're looking at and you compare -- you know, you're sort of generally aware of microbiological sensitivities, it was my view that we probably wouldn't find any differences with Lactobacillus from Entero, which turned out to be the case, but that was sort of a lucky shot in the dark.

The other reason that we chose Lactobacillus was that it is identified as GRAS through a GRAS regulation put out by the FDA so that I didn't have to worry about any issues relating to its status when I put -- when I artificially introduced this organism into a food processing plant.

With regard to -- there is a -- I just wanted to point out that with regard to the retail stores there is a guidance for inspections that has been put out by FDA that indicates that the entity having a product which is labeled as fresh squeezed that is selling at the retail level, if it's their own labeled product there is a description of the documents that the investigator should be looking for when the investigator goes to identify whether or not a 5-log reduction has been achieved.

So if you are doing your own label processing and trying to sort of accumulate data from a packer, I would think that you would have to obtain from the packer the documentation information relating to their log reduction and then additionally add into that your own documentation with regard to additional log reductions that you might be able to achieve at the retail level. And there is some guidance on what those documents should sort of look like from FDA.

DR. HOLLINGSWORTH: If I can address that further.

MR. DWYER: Tom Dwyer, Norwood Groves. I have a question for, basically, the FDA this afternoon. A lot of us are small retailers here, which I am, I produce fresh juice year-round, down in the gold coast. I work with the health inspector, I call him in twice a year, he spent some time with me going over -- I have a pie making operation, I have a snack bar and I do all this food service type work. I serve alligator meat and we actually have alligators on the property.

I work with students at the schools. I think about 120 students a day come through on an educational program and a lot of mothers and parents come through as chaperones and the question I'm getting at now is Tom, what is this warning they want put on your juice? And I said I really don't know. And so I went to my health inspector and asked him to fax me the problems in Palm Beach County.

Last year we had 782 people with food poisoning. This year alone 172 with food poisoning. Breakers, five star hotels, food poisoning.

I want to know from the FDA is orange juice going to be so deadly that we are going to kill off the population? Are we in the same category as cigarettes, alcohol? Because a lot of us would like to know the answer.

DR. KVENBERG: I'll be glad to take one shot at it.

MS. CAMPBELL: The FDA has already answered that question. The finding we made in establishing the final labeling regulation was that there was enough potential health hazard in juices without isolating a particular juice to warrant the warning label as a public health measure. That decision has already been made and all the reasoning on it is in writing.

And we don't have a copy of that final regulation here, you can obtain it from the web. That information is available to everyone. It was not targeted to orange juice, but it deals with all fruit and vegetable juices.

MR. DWYER: So then you're saying this label should be on every restaurant salad bar, et cetera?

MS. CAMPBELL: Restaurants and salad bars are not covered by this regulation.

MR. DWYER: Why are we being singled out? That's my question. Why are we singled out? Because, as he stated, we have more problems in the restaurant industry than we have in the fresh juice industry, yet we're being singled out. And I'd like that answered in a manner that in layman's terms that we can understand.

MS. CAMPBELL: I'm sorry. We are here to work with you today, but not on why the regulation, not on the justification, not on the health hazards. It's too late for that. The labeling regulation is legal and it's on the books. Your opportunity to discuss that was between April and -- was in April and May. And, fortunately or unfortunately, the decision has already been made and I don't think a debate on that issue is going to help any of us achieve the goals we had for today. I just don't see that there is any point in it.

The fact is there is a regulation and the fact is the warning statement is required. And that's what we need to deal with. If you don't want to use the warning statement, we need to work on how to get the juice to the point that it doesn't require the warning statement. And that's why we're here today.

DR. KVENBERG: The only thing I would add to that is the fact that we would not be here today if we didn't think the goal that is being put out here is an attainable one. That is to achieve a performance standard and not label the products.

The idea of coming up with a performance -- performance criteria as we've designed it is to protect the public health. And I think it's an attainable goal. We are convinced because industry has come to us in the area of citrus and saying it can be done. And so we listen to the comment that it could be done as opposed to labeling the product as a hazard.

That's not a best choice in any event. Labeling -- labeling of foods and telling a consumer that he should possibly avoid them is not the best option. In the hands of the -- the industry at whatever level, the retail or the manufacturing level, the preferred option is to produce safe food.

And so we're here to work cooperatively with people to do that and so that's what we hope to do.

MR. BENINCASA: Jimmy Benincasa from Hale Grove.

The FDA will individually look at each processor when he submits his validation material and is there any kind of parameters or protocol as far as this validation is -- how it's going to be checked, what you want to see, how many -- how many times we have to run lab tests, swabbing methods? I mean, is there going to be any kind of guidelines for us to follow?

DR. KVENBERG: The short answer to that is, no, not at this time. But we're here today to open a dialogue and as far as what we may need for next steps and how we could build that. Perhaps we could do it cooperatively. I would like nothing better than rather than have a government dictation of this is get the facts and the science and make the sense out of it through workshop type operations like this and some continuing effort would be really wonderful.

If we can get beyond the phase of having the single day meeting and have the government engage with the industry relative to working to a system that's going to put this process in place, that's a good thing.

MR. BENINCASA: But if I've got a validation, I did the test at my plant and I want to validate it, I'm going to send that to FDA, I'm going to send that report on FDA.


MR. BENINCASA: How is the decision made whether or not my validation effort was with merit or without merit?

DR. KVENBERG: Okay. Well, let me answer that by saying we don't approve process in a premarket approval type sense on your validation process. We will only take exception with that with which we wish to take an argument with.

Again, working in a cooperative manner like that that we are doing today and having an industry consensus built about proper validation is going to, I think, put in the hands of people who are producing the foods the mechanism to assure themselves that they have a valid process in place. And the body of evidence is building on that, as you've heard today.

The Food and Drug Administration is going to review processes during inspectional procedures and if we have questions about the process that's being applied or the validity of it, we'll work that on a case-by-case basis.

MR. BENINCASA: So you intend to check each plant in their process on a case-by-case basis?

DR. KVENBERG: Do you want to address that?

MS. CAMPBELL: It sounds like there's an expectation that FDA is going to review the process in every plant. That won't happen.

As with any other regulation that FDA has, the firm is responsible for knowing what to do and for doing it, but the firm is not responsible for submitting documentation to FDA on how it has accomplished what it needs to do.

In that respect, this is just like other requirements. You have to have a sanitary plant, but you don't have to submit your sanitation records. You have to do certain things, you have to not use unapproved food additives, but you don't have to send us documentation.

There are -- this regulation does not differ in that respect. You are responsible for meeting certain requirements, but you don't have to submit them to us in advance and we will, to the extent we have resources, we will do inspections and we will look at what's going on in a plant.

MR. BENINCASA: Will you also be validating it? Will you be taking samples and validating it?

MS. CAMPBELL: To the extent that we believe a plant has attempted -- and this comes from our instructions on our enforcement instructions that are available to the public, we are telling the inspectors that if there is a -- if the plant has attempted to reach 5-log and -- and there is any reason to believe that it -- it may not have, then do a full inspection to document everything that's going on and bring the information in to us and we'll evaluate what was going on in the plant.

MR. BENINCASA: Do you have a test protocol you're going to use?

DR. KVENBERG: Let me address that one, too, from the standpoint of what we are doing is that instead of -- in a general sense we have to have the science ourselves. And the information that's being developed by industry initiated programs is something we are looking at in a general sense. We are going to be looking at the surrogate question, inoculation and destruction techniques in our own laboratories.

We have facilities in Washington, D.C. and Chicago, Illinois and I think getting into the area of where we will be having additional work in our future in citrus is on the research plan, as well.

We -- we feel quite strongly that the 5-d is an attainable process in addition to the data that the industry is gathering, we're going to be doing work ourselves relative to backing up the science on -- on how processes are affected with producing of 5-d.

MR. BENINCASA: So on July 9th, 1999, our company, if it wants to continue to process without the warning label, we have to do what? Send you a letter saying that we've got a -- we validate a 5-log reduction? Is that all that's necessary?

MS. CAMPBELL: No, you don't have to do a thing.

The way the law works the burden falls on FDA to enforce its requirements. And we would have to come into your plant and find that you are not, in fact --


MS. CAMPBELL: -- achieving a 5-log reduction in the absence of a warning label and, therefore, are in violation.

There again, that's the way our law works and that's the way all the other requirements work.

MR. BENINCASA: I had a question for the gentleman from The Fresh Juice Company.

I'm confused about how you swab the orange. Did you mark an area on the orange that you swab and that's the only area you swab or did you swab the entire orange?

DR. STROBOS: No. The -- typically what you do in this kind of microbiological assay is you create a template just like a silk screen when you're silk screening and you're painting something and so you have --

MR. BENINCASA: So you paint something onto the orange?

DR. STROBOS: Well, what you do is you create a template which has a hole in it and what you do is you take your typical swab that a doctor would use to swab your throat, which is something I probably need today, but you take that swab and you swab the area that is open on that template to ensure that the area that you're swabbing is always the same, plus you use some sort of a liquid medium in order to ensure that you're picking up everything.

MR. BENINCASA: So these templates are available that you can buy from a laboratory supply house?

DR. STROBOS: You can just make them. You just have to measure them and make sure that they're the same.

MR. BENINCASA: Is there any science -- is there any science behind the size of the template we're going to use? Like could we use half an orange or --

DR. STROBOS: Well, there actually is a little bit of science because there should be a relationship between the size of the template and the size of the orange so that you're -- so that there's some accuracy involved and there is some -- some data on that.

But, generally, you're talking about you need to swab the area, about a 10 percent area.

MR. BENINCASA: 10 percent of the surface of the orange.

DR. STROBOS: 5 to 10 percent.

MR. BENINCASA: And did you guys --

DR. KVENBERG: We have another question.

DR. STROBOS: I just wanted to --

MR. MACK: Tom Mack. I have a question for Ms. Campbell.

In order to meet a compliance standard where you would come in and look at the operation of the facility and what's going on, perhaps this is something we will develop later on, is that -- are you going to have a process that you go through or are we going to need to submit our documentation or put our microbiologists up to talk to your microbiologists or exactly how would that go forth?

MS. CAMPBELL: Other than signing the agreement that gets you the additional eight months, you do not have to submit a piece of paper to FDA with respect to complying with this regulation.

If we seek information from you on a firm by firm basis, based on an inspection, then the information you have developed in -- in adapting and achieving your 5-log in validating that you have achieved the 5-log is the information you would want to provide to us at that time. And that's when a dialogue starts is if we are challenging your conclusion that you have achieved a 5-log.

DR. HOLLINGSWORTH: That's after July, right?

MS. CAMPBELL: That's after July, yeah.

Now, that doesn't mean there won't be some inspections before July to see that things are in order as agreed to because the agreement has certain responsibilities on your part. And there are certain things that have to be occurring between now and July. 5-log is not one of them.

Trying to achieve 5-log is one of them.

MR. MACK: I understand that, but in listening to the presentations earlier, there is a vast difference in achieving the same end, and I suspect that depending on the size of your operation, the type of fruit you process, where you're getting it from, the harvesting, all of the variables that are occurring will pretty much set a unique process to qualify to meet the 5-log.

In looking at it from that standpoint, my operation would be different than someone down south -- maybe not dramatically, but subtly. And in order to -- to prove that, it's kind of like what questions will you be looking to ask or to answer and where the dialogue goes or do I just have to go out and hire an expert or experts and develop what I need to develop and hope that it meets all the answers to your questions?

MS. CAMPBELL: Well, we're not going to develop a written set of guidelines for what is adequate documentation for a validation of a 5-log reduction.

Today's discussion was intended to help everybody to figure out what they're going to need in their own plant.

You're right, it's not going to be identical across the board. There will be some aspects that can be used in common and other aspects that will have to be tailored. And to the extent that your plant uses a control measure that has been validated elsewhere to the extent you are using it identically to that validation to the way that validation was carried out, then, perhaps, you can do -- use that validation and not have to do your own.

To the extent that tailoring it to your plant requires any deviation, you're going to have to validate in your plant that that deviation didn't -- did not disrupt the pathogen reduction -- the pathogen reduction remains. So you are going to have to tailor it to your operation.

MR. MACK: So I guess I need to go back and get my micro degree, I guess.

DR. STROBOS: Well, there's some confusion, I don't know maybe whether I'm going to make it more confusing, but, you know, we're in the midst of sort of a national food safety initiative that involves a lot of food products, not just orange juice. This particular rule involves all different kinds of juice, not just orange juice.

In the careful evaluation of apple juice it became clear that the option of being able to achieve a 5-log reduction was not possible for apple juice no matter what kind of control measures you put in. So the options available functionally for the apple juice industry are either to use the warning label or to pasteurize the juice.

I think what FDA is saying here today is that at least for the orange juice industry there is a third option.

Additionally, there is a September 21, 1998 memorandum going out to the district offices that gives some description to the investigators who will be going out to the individual plants that does describe to a certain extent the kind of documents that the investigators should be looking for.

And it might be useful for those people who are going to engage in 5-log validation to review that to make sure that whatever documents they do have sort of meet what the investigator will be looking for if the investigator were to come to your facility.

MS. CAMPBELL: That document you just referred to is our enforcement assignment to the districts, but I think we revised that more recently than the September date because we put in it this additional eight months and the agreements and we updated it to take it into account the things -- the new procedures, the flexibility for the citrus juice industry. So that is in it. The document you have probably doesn't address -- okay.

But I don't want you to get that document and read it and find yourselves left out. Your eight months extension is in the new version.

MR. MACK: What's the date of the current document?

MS. CAMPBELL: John, what's the date of the current document?

MR. MACK: November 3rd.

MS. CAMPBELL: November 3rd.

Is it on the web?

MR. MACK: That, I can't answer. I don't think so because it usually doesn't go on the web.

DR. KVENBERG: I guess the question was where do we get it and how do we get the information? That's feedback and for your purposes we're about to go into a break and we'll get you to the fellow that has it in the room.

We're coming up on 3:40, and as I had mentioned earlier, I hope you people -- it's been a very long day so far. You've done a lot of the listening, you've been patient and the questions have been good.

It's our hope that we will go now into a period of a half hour break for individuals to get together, and I would recommend concerned groups such as the packers, the retail community, the juice manufacturing operation people have a discussion or a caucus and then we will reconvene briefly for whatever duration you folks would like to run the meeting. We have an extension to 5:30.

It may not run that long, to get feedback on what your thoughts and next steps ought to be. This is our opportunity to hear from you. And what we would like to have is if you can get a collection of thoughts in these informal discussions that you're going to have over the next half hour, give us an accumulation of -- of next steps that would be recommended or how you -- you think we would evolve past today, what would be the role of the Federal and State regulators from your perspective, what you would like to see from us as far as further information and work, what you're going to do, what the plan is for the state organizations, that kind of business. And we will take that back and take it as -- as information and feedback from the meeting.

So why don't we take a break right now and we'll meet you at 10 after?

(A short break was held).

DR. KVENBERG: It's time to hear from you folks about the next steps. We have gone through, I think, what was somewhat of an exhaustive grilling and intensive day of presentations and discussions, but to me this is the payoff at this point in time is that I hope and it is my desire that this is the initiation not just of a consideration of how an individual can personally go back and do his job, but what can be built as far as next steps in order to have the citrus industry address the issue of the 5-log issue.

It was noted by several people who approached me, hey, you were on the program, you didn't talk about the 5-log reduction.

Well, there is nothing much I can do except to summarize the comments of the presentations that were already here today talking about what constitutes a cumulative 5-log reduction.

Let me tell you that what I have heard, I think, is quite encouraging. The individual processes that have been described and the work that's been done so far is very encouraging. The question that a lot of people have is where do we go from here and how do we build a sound system for processors and including a schematic for the fruit packers and the retail establishments?

At this point I would like to throw the microphones open. And I hope that you folks, in your discussion groups, have appointed somebody to speak for the group. At this point in time I guess this is part of the generic discussion for consensus. You can identify yourself if you want. If you don't want to be specifically identified, because it was a group discussion, that's okay, too. Let's just have open comments relative to next steps and your views of where we should go from here.


MR. MARTINELLI: I'm Frank Martinelli from Orchid Island Juice Company. And, Ms. Campbell, I have a concern I would like to mention. You -- before you mentioned that it's possible that the FDA will reevaluate fresh labeling requirements or the processes that will permit a person, a company, to label a product as fresh.

And what I wanted to say was some of the changes that the traditional fresh juice industry are accomplishing in order to achieve 5-log are quite costly. And I think there would be a tremendous disadvantage to change the labeling because if we've had people come to your plant and say, well, just put in this pressurization unit and you can achieve your 5-log or put in these IR lights in your juice lines and you can achieve your 5-log.

And if, in fact, we decided to do that, then we could probably get rid of 90 percent of our graders, we could probably get rid of -- reduce our chemical utilization by probably in the order of 90 percent, we could reduce our processing line, cut down on our electric bills and maintenance expenses significantly by doing that.

My question is if you're going to give people the latitude to process the juice and label it fresh, it's basically going to force people to embrace that technology to stay competitive with regard to their costs.

MS. CAMPBELL: I did say that the Agency was probably going to have to think about whether to maintain its current position. The interpretation I gave you this morning is a literal interpretation of the regulation on fresh as it exists now and that is that treatments within limits -- treatments on the fruit as opposed to treatment of the juice leaves the juice fresh. And when I say within limits, if you heat that orange enough to cook the inside, I think that's fresh juice. But as long as you're just heating the skin, you're just treating the skin, then I think you've still got fresh juice under the current regulation.

The question that arises and we haven't dealt with this in detail at the agency but the question that arises is whether or not it is -- it would be good public policy to allow the term fresh on products that receive the treatments that you're talking about, the post extraction treatments. As opposed to the literally labeling interpretation of the word fresh. It is something that we are going to be forced to make whether we want to or not, and if you've got input on that we would appreciate having it in writing and if it's in the form of a petition or just in the form of a well reasoned position letter, okay? That's not something that we're going to decide in two days. It's -- it's just not -- it's not going to be an easy decision to make. But a well reasoned position in a letter would be helpful.

And I recognize that there are two different opinions, at least two different opinions in this room, not just one, at least two different opinions on that. And so more than one letter would also be helpful.

DR. KVENBERG: Okay. One of the observations I had for the close down discussion would be taken as the process flows one of the things I was greatly encouraged about was Florida coming up with good documents relative to harvesting and production. Likewise, for your information in California, Sunkist was somewhat in the same position as Brewer organization here in looking at processing information.

One of the questions I would have relative to next steps is where do we take these kinds of things? You've got citrus being produced in several locations in the United States. Where do we start?

Any comments or thoughts relative to the production, harvesting and transportation guideline information that Florida has? Where do we go with that? Does anybody have a comment on that?

I mean, my desire would be to have --

MR. MARTINELLI: John, I would mention that we are communicating that which we have produced, Florida Citrus Packers and the Department of Citrus, the document that we have produced I have sent to Sunkist Growers and to Texas Citrus Mutual and to the extent that we can get together and they would accept what we would put together or modify it for their particular circumstances, we would certainly hope they would do that. We have been trying to keep them up to speed.

They certainly supply our customers off-season when we're not in the marketplace, so we're attempting to do that and we're going to do it in a much more deliberate fashion after this date leading up to July 8th.

DR. KVENBERG: Thank you. I think that would be quite useful because if we had some sort of national industry developed guidance or guidelines for practices that would be very useful.

MR. CHAIRES: Peter Chaires, Florida Gift Fruit Shippers Association.

I would like to take that same concept, though, and move it beyond harvesting and transportation. We represent primarily very small producers, part-time producers, but this product still is -- is very important. It's a significant part of their business. But we are working together as a team and working cooperatively with the American Fresh Juice Council and the Florida Department of Citrus and the University of Florida and the Florida Department of Agriculture to cooperatively examine and study each individual step in our process and certainly take advantage of any research or information that is shared pertaining to each of those steps.

And we would like to work cooperatively, not only within Florida, but also with the other citrus producing states and hopefully with the Food and Drug Administration, to put together some type of an operational reference manual specifically dealing with each module, each step in the process that then the small producers can reference or take advantage of certain cumulative reductions that are available to them if they replicate that process in their local -- local operation.

DR. KVENBERG: Thank you. Well, that's sort of a general recommendation for developing materials from through the whole entire process.

I guess another question --

MS. CAMPBELL: Let me just follow up on what Peter has said so there is no confusion because I was a little frustrated that you asked about where do I go from here? Do I have to hire a consultant? We in representing fresh packers, the commercial packers through the Department of Citrus are doing some baseline data for us and in verifying how we can achieve a 5-log reduction, certain processes through our packinghouse, et cetera.

It is our perspective that we would take that system and offer it to our packinghouses to the extractor people, you know, to the in store, whatever, from the grove, the packinghouse and they would make that applicable in this process and they would not have to go out and, therefore, hire, you know, consultants and all these extra people.

They could take this data -- the gentleman was asking the question here -- take the data, apply that data or that process to their system and -- and so long as that's there in place and they document during -- they can document that and that will suffice for this 5-log and to meet the rule or the intent of the rule as of July 9th, 1998.

MR. CHAIRES: That's absolutely essential for the small producer.

DR. ISMAIL: '99.

DR. KVENBERG: Two other issues I'd like to hear comment on would be in the area that we covered today relative to chemical and non-chemical treatments and what kind of information would be involved in next steps in development given the information we've all heard and shared today relative to -- are we where you all feel we're comfortable?

Are there next steps and people have recommendations on further development of that technology? Where does it stand? Does anybody want to speak to the chemical and non-chemical issue?

(No response).

DR. KVENBERG: I don't hear a word. Maybe we're where we need to be. I really don't think we are, but does anybody have any words on that or suggestions of where we take it?

MR. MACK: Don't go away on that one yet. Tom Mack. I don't know enough to give you an answer and I'm not sure if I speak for everybody else in here, but there was a lot of data presented this morning and this afternoon on both sides. Both methods allow you to come into compliance at some level to meet a log reduction through the process. And to go back and there was an a la carte menu to select from if you followed this process through that you would meet the 5-log reduction whether you're a large processor or a small processor, you now comply chemically or non-chemically.

So perhaps there needs to be additional research to determine how each process works so that you could pick from it. Right now I don't really know what I would choose to put into an operation. Certainly, the chemicals work, you can see that they do. There's also some excellent presentations on hot water techniques that looked really good that I'd like to go see them.

So from that standpoint I think you need to continue looking at it so that those of us in different parts of the state can pick something.

DR. KVENBERG: Okay. Thank you very much. I appreciate that comment, too.


MS. HOLLINGSWORTH: One of the things that I think might remain a difficult issue to overcome and that's the lack of any kind of a clearinghouse, if you will. I have heard stories about people showing up, for example, at retail stores with a set of scientific documents, charts and graphs and things that look real good and some procedure, you know, short of throwing feathers in the sky saying this works, I have proven it and I promise you you can use it and all you need it this letter and you've got a 5-log reduction.

I have a lot of calls coming to me from retail stores, grocery stores, saying do you know if so and so's procedure, in fact, does have a 5-log reduction? Getting handed a stack of charts and graphs and micro data doesn't necessarily mean you have proven anything, but there is no way at the retail level to validate that. There is no one to call and verify it.

And without a clearinghouse, if you will, how do you know that you may, in fact, be buying into something that is legitimate? Would we need to call FDA and ask them to go check this person or this process out?

There was one, in fact, that we did call FDA about, a procedure that somebody was going around selling. It was reported to me, I called FDA and asked them and they told me don't do it because it's actually an additive and you would have to change the label, it's not fresh anymore.

So how are we going to know this? I mean, would we just have to keep calling FDA and asking for every new person that comes along with a set of data?

DR. KVENBERG: I'm not going to answer questions, Jill, but I'm going to register the fact that the concern was there and a suggestion of a clearinghouse or how to vet out information so producers know it is duly noted. I appreciate the comment.

MR. ISAACS: John, following up on that, the people that do go through all the process and the expenses as Frank had mentioned, you know, how do we educate the public as to what and who has -- you know, we need some direction on that. I mean, there may be people that aren't warning labeling their product that have done nothing, we have done the same thing and, sure enough, you know, we're tainted with the same -- same classification?

DR. KVENBERG: Okay. So if I get this comment in, what you're saying is there is a need for consumer education relative to what's going on in citrus juice in the process. Is that --

MR. ISAACS: I think definitely that, taking Jill's comment where some sort of mechanism for a common understanding that there has been a standard achieved and then you take it to the next level to the consumer.

DR. KVENBERG: Thank you. Good comment.


MR. FRUIN: I want to join in on that. From the regulatory standpoint we will need to be able to find out, particularly those locations out of state, who has achieved the 5-log reduction so that we can do a proper regulatory job in the food stores.

DR. KVENBERG: So if I interpret that comment, basically there needs to be a cooperation of Federal and State governments and a reciprocity and understanding of what's going on in another jurisdiction?


DR. KVENBERG: Thank you.

DR. ISMAIL: John, would you please ask each individual to identify themselves?

DR. KVENBERG: For the record, let's go back then for the previous stations. That was John Fruin.

MR. FRUIN: John Fruin.

DR. KVENBERG: And prior to him it was Marc Isaacs. Who was prior to Marc?

DR. HOLLINGSWORTH: Jill Hollingsworth, Food Marketing Institute.

DR. KVENBERG: I can't go back any further. I forgot who spoke before that.

MR. MACK: It was me, but I said who I was. In case you're wondering who me is, it's Tom Mack again, for the reporter.

DR. KVENBERG: Okay. I hope that cleared part of the record up.

Thank you.

Okay. Additional comments?

MR. DeCASTRO: The upshot, as I understand it, after trying to digest everything that's transpired this morning and this afternoon is that compliance against 5-log reduction the onus remains on the processor in order to establish for themselves that they have, indeed, achieved that 5-log reduction much in the same way that they need to establish for themselves their own HACCP plan, which, again, is process and product specific.

That being the case, the gap here is in knowledgeability of how to achieve 5-log reduction. And where I see the need is is in terms of industry education in addition to consumer education as far as how is the industry validating for itself, what are those strategies specifically that result in a successful 5-log reduction?

So I'm somewhat at a loss as to where that's going to end up being. I know I spent a lot of time on the web with every search engine I could think of to dig that stuff up. Hopefully, we can try and figure out something that's a little more accessible both to the industry and to the public so that we can be more effective in complying with 5-log reduction, especially within the time frame that's imposed upon us at this time.

DR. KVENBERG: That was a very useful comment. That was Mr. DeCastro.

MR. BENINCASA: Jimmy Benincasa from Hale Grove.

Is there any likelihood that FDA will be defining for us the pertinent organism within the next eight months?

DR. KVENBERG: I guess I think you can express that in terms of what you'd like to have as a next step. I mean, obviously I understand the question of the likelihood of us doing it. I -- I think that -- that hopefully what I've tried to get across is that you have the latitude or the freedom to do certain things with the way we're operating under this program.

If you seek guidance or if there is a need to come to a consensus on the appropriate organism of concern, we would be happy to engage in that or examine the issue.

It's quite clear there were several approaches here. I'm not sure scientifically, and I guess we could get comment from Dick Whiting or anybody if we're that far off on the mark on 5-d measurement process. It probably depends on the activity that you're putting to it. If it's heat there may be some difference. If it's a chemical control, I don't know.

The question of which organism is the most stringent one, I think, was addressed today and it seemed to be a consensus opinion was the most stringent test was 01507 E. coli in this case and another interpretation was that Salmonella, which of the demonstrated organism was one that was put out there.

I'm open to that and I think it should be resolved as to what is the most stringent and standardized organism. Would that be your recommendation that there needs to be one standardized organism for the industry?

MR. BENINCASA: Yeah. Otherwise, the validation procedures are all different. I mean, you don't have a standard or uniform target to go after.

DR. KVENBERG: That's a comment I can work with and take it back to consider we need a standardized organism for 5-log validation.

Thank you. I got it.

Additional comments?

MR. POOL: Bill Pool, Wegman's Food Market. Just to follow up on that, maybe it's not just one organism, though. Maybe there should be choices and, you know, it might be Salmonella, it might be 587. Either of those could be through the proper validation demonstrates that you achieved and you are producing a safe product.

DR. KVENBERG: I think someone said research to something, and I'm not taking it lightly, but it could be done through research that you could probably look at different regimes and make a determination of one versus the other of two organisms. But I understand the comment. And I think we can work with what you said.

MR. MACK: Tom Mack again. Do we have enough information that between Department of Citrus, the Department of Agriculture, the FDA, gift shippers, the Florida citrus packers, as a consortium, for lack of a better word, to put together a -- an operating standard or standards that we can all live with at this point in time?

DR. KVENBERG: Thank you. I guess we -- you know, I'm not really here to answer questions.

MR. MACK: I understand as a facilitator you don't answer the question, but I'll put it open to the rest of the group. Do we feel that we have this amount of information available to us that we can move forward now because FDA, from what I can tell is not going to come down with a set of enforcement standards.

It sounds like they expect us to generate something that we want to be governed by. If that's the case, let's set our own governing standards and be on with it. If we have enough information to do that, let's do it. If not, let's get the information so we can. Otherwise, we're just wasting a day that's been pretty productive so far.

DR. KVENBERG: Yes. Dr. Ismail?

DR. ISMAIL: On behalf of the Florida Department of Citrus, I would like to say, yes, we are definitely willing to be a member or part of a consortium or an alliance of other scientific organizations, technical organizations, trade organizations to define areas that need to be worked on to gather information that are already available and put it together in a usable meaningful way.

We are very, very fortunate that we did start working on this problem immediately after the outbreak of the 1995 Salmonella incidents and we have not only done the research in many areas, but it is published in refereed journals and that is an excellent test of the quality of the work that has been done.

We would be more than happy to work with California, more than happy to work with Arizona and with Texas, all of us as a U.S. citrus industry. We are, very, very glad or would be willing to work with the Food Marketing Institute and develop whatever documents and information that would be needed to get beyond that July 8th deadline and put that in a strong footing that would enable it to provide a wholesome, clean product.

DR. KVENBERG: I guess I could only add to Dr. Ismail's remarks that FDA does have a mechanism where we could participate in such a consortium and that would be through FDA's center in Chicago called the National Institute of -- I think it's Science and Technology, where we have an affiliation with the Illinois Institute of Technology and with the industry and this consortium could network in some sort of task force if there was a desire, if there was a will to do that with industry here in Florida and California and elsewhere, that would be possible. We do have a mechanism to continue that dialogue that way.

MR. MARTINELLI: Frank Martinelli, Orchid Island Juice Company.

Dr. Kvenberg, I would like to take you back on what some of the other respondents said and I would suggest that the FDA, instead of specifying a target pathogen, if you are going to go through that effort, specify an appropriate surrogate and I think that would reduce everybody's costs here in that they wouldn't have to go through the replication effort in the laboratory they just have to run the inoculate fruit through their plant, send it to the laboratory and get the test results.

DR. KVENBERG: Thank you for that comment.

UNIDENTIFIED SPEAKER: I would like to piggyback on that. We would prefer not to have any 01587 through our processing plant, big or small, here in Florida.

DR. KVENBERG: Duly noted, John. I don't want that either.

MR. MACK: Tom Mack again.

What does the group think would be the time line to put together a consortium and should we meet back at IFAS at this particular center to do it? Any comments? Since I'm not a facilitator, I can ask a question.

DR. HOLLINGSWORTH: The only comment I would add to that is I think we need to be careful that it doesn't become a Florida consortium. I think the comment Dr. Ismail, that it's the U.S. citrus industry needs to be emphasized. To that end I think we need to wait until after the California public meeting, but probably any time thereafter.

I don't think there is one planned for the southwest Texas, Arizona area, I don't know maybe they're going to be included in the California one, but I think after that would be an opportune time. And I would also say probably locating the next meetings someplace other than in Florida or California might be advantageous so it doesn't appear to be just a state issue or even a regional issue.

DR. KVENBERG: Thank you for that comment.

Mr. DeCastro?

MR. DeCASTRO: All of this is helpful in addressing it, but from a practical standpoint I think it needs to be noted that all due speed is absolutely critical, especially for those who are not very far along in the process. There are those of us who obviously are and can express some degree of comfort as a result. But at the same time our brethren in the industry, so to speak, have until just mid next year with which to comply.

So my request is at this point in time can we at least even establish whether or not, A, FDA is in a position to specify a target pathogen and/or a surrogate and, B, if they are not in a position or if they are in a position, at least know when a decision on those two questions can be rendered, that is going to -- that sense is a jumping off point by which we can all work with.

Otherwise, we're going to be left trying to form a consortium that's going to be banded together too late to do anything about it.

DR. KVENBERG: Thank you. All due haste is the message.

MR. MACK: Tom Mack. And I concur. All due haste.

MR. CHAIRES: Peter Chaires again.

Just to give you our time line our plan as a group for small producers and even on the grocery level is to, immediately follow the meeting, not today, but even next week to begin work on assembling data that we can reference that's already done and identifying those steps that we need to actually complete the research and ought to begin putting together some type of a handbook document so that the sooner the FDA can move on that the more beneficial it will be for everybody.

DR. KVENBERG: Thank you.

MR. ISAACS: Marc Isaacs again. A question, John, that you might be able to answer, you were going to meet with the 50 states to talk about some delegated authority in regard to the inspection question for the juice processors.

Where does that stand at this point?

DR. KVENBERG: I wasn't at the last call. Betty, were you involved in the last 50 states call? I can't answer his question because I wasn't involved.

MS. CAMPBELL: Yeah, I was there and I was more answering questions than talking about delegation of authority. The states were more interested in what our position was and what our instructions to the districts were and that sort of thing. There is not an official delegation of authority, but there is a variety of partnerships between our district offices and the states that they work with. And so there may very well be some state activities and enforcement along these lines.

DR. KVENBERG: Okay. I got a very good sense from this last discussion it was quite useful.

Are there any additional comments that people have?

MS. BOJOKLES: I'm Stephanie Bojokles, head of the Tropical Fruit Shop in Palm Beach. The store has been there since 1915 and always had fresh squeezed juice. And we've been open a couple of weeks now and just a couple comments that are coming from our customers.

Florida is in a unique situation where when you go to New York you go see a play, you go to Aspen you ski, when you come to Florida you drink fresh squeezed juice. People get off that plane and one of the first things they do is go buy their juice. At least in our town they do.

And a lot of the people that are coming in are asking about this issue of the fresh squeezed juice problems and obviously in other states it's being broadcast all over the place, especially New York. Most of it is coming out of our New York customers, and I think we're ending up with a public relations nightmare here because there is -- Florida juices are great.

People go to all kinds of lengths to make them great from the growers all the way to me who actually hands them the cup. And what's happening is people are questioning it and, you know, there's a housewife who has got a tree in her backyard, if she squeezes juice for her children in the morning, you know, she is scared. And there is a scare tactic going on that people are questioning fresh juices and not that they shouldn't question what they put in their bodies, but as an industry, this is something that's so unique to Florida and to lose that, I mean, my store since 1915, generations have come in there for fresh juice and we don't want to lose that.

And I think that today I heard on the radio on the way here about the Disney incident again like it's three years old. Give it up. And, you know, the industry has changed. And whatever the FDA is putting out or whatever the Government can do that right now what's been put out there is, you know, people are starting to question and be afraid of fresh juices. And that's awful.

DR. KVENBERG: Okay. Can I summarize?

I think it was an earlier comment and you just underscored it that one of the main activities that needs to be done here is consumer information and consumer educational efforts relative to citrus juice would be useful and as we said, is an urgent matter that you feel needs to be done?

MS. BOJOKLES: And, fortunately, we have a Department of Citrus in Florida who does a wonderful job and the gift fruit shippers and, you know, Florida is just unique because they do a great job as a whole. And for all of these years and just to have an incident or two ruin it for people is -- is awful, terrible.

DR. KVENBERG: Yeah, I think you're -- we understand your remark and I think that it goes to the question of consumer guidance, consumer information and confidence in Florida orange juice that --

MS. BOJOKLES: To restore the confidence in Florida.

DR. KVENBERG: I understand. Thank you.

Any other comments?

DR. ISMAIL: John, I would like to bring the issue of how can we arrive at the 5-log reduction. I have heard many times today that we can accomplish that task by adding the pieces that we accomplish individually in how we harvest, how we grade, how we wash, scrub, sanitize and maybe even treat with the hot water or in the case of packinghouse fruit, how it is waxed, what type of wax, perhaps, and what type of -- of log reduction has already been found in -- in these processes.

So with that I would like to get some guidance, maybe some input from the Food and Drug Administration. This is an issue that needs -- we need to know, along with what Tony DeCastro mentioned about the surrogate organism. These two issues are extremely important to us.

DR. KVENBERG: Your point goes to policy clarification by the Agency, right?


DR. KVENBERG: Okay. I think we -- obviously, what we need is the science, so I would go back to the idea that in order to come up with the information we need to help the industry develop data, the scientific information that's been developed here in Florida in your department, working together to put together the facts that, basically, could -- you know, the policy makers could review the facts.

So going to the -- I have to be a little careful here, because we haven't done our California meeting, but there's been some useful suggestions on how we can put that together and I clearly heard time is of the essence. We have to move quickly. But Dr. Hollingsworth's point was also well taken in that it need to be national in its basis and we need to have another meeting in California to move ahead. I think we'll take what you said and roll it into the charge that I have heard relative to proposals for next steps.

DR. ISMAIL: Another point I'd like to maybe repeat if somebody -- and that is regarding our role, the Department of Citrus' role, the other academic and scientific organization's role in developing information and data on behalf of small operators, small businesses, packinghouses that do not have either the means or the technical know how to develop that information.

DR. KVENBERG: Okay. This goes to the question of small business, which is also something I hear what you're saying that needs to be considered. Good comment.

Are there any others? I think if not, let me have a word. And that is I want to thank everybody that came today, those that have already gone and specifically those faithful that stayed until this point.

We really at the Food and Drug Administration value the opportunity to come and do this. I am excited about a proactive program where we're in a cooperative type basis to being a problem-solving situation where we've got a better food supply, a safer food supply and more confidence by operators that they're doing it right.

I think we have some steps ahead of us. It looks like we have a direction to where we can move away from -- from here and have further developmental steps. And I want to thank you all very much for coming today.

Thank you.




I, KEVIN P. MIKUS, Registered Merit Reporter, certify that I was authorized to and did stenographically report the foregoing meeting; and that the transcript is a true record of the testimony given by the participants.

I further certify that I am not a relative, employee, attorney, or counsel of the parties, nor am I a relative or employee of any of the parties' attorney or counsel connected with the action, nor am I financially interested in the action.

DATED this 22nd day of November, 1998.


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