U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
November 12, 1998

ATTENDEES
JIMMY BENINCASA	JAY IVEY
ELIZABETH BERDIS	CHRISTINE JANSEN
DR. MARTIN BERRY	DEBORAH JENNINGS
JAMES BLOOD	DARRELL JENSEN
STEPHEN BOSSE	JEFF JONES
SCOTT CABES	MARJORIE JONES
DR. DANA CAHALAN	DR. FRANK KELSEY
SUSAN CAIME	ED KLIMLEY
TOM CAIN	ALAN LACROIX
PETER CHAIRES	MONICA LEWANDOWSKI
DEBORAH CHANEY	BUD LLEWELLYN
WILLIAM COLE	JOHN MAJOR
CHARLES CRISAFULLI	JERRY MASSINGILL
LISA CADENA	WAYNE McCLINTIC
LORRAINE CONOLEY	DAVID McKENZIE
AARON CORKUM	BRIAN MESKIL
CRAIG DAVIS	ERIC MIDDELEM
BOB DEMAREE	LYNN MILLER
JOHN DURAND	SCOTT MIXON
JIM FITZGERALD	GENE MIXON
SEAN FRIELICH	DR. EDWIN MOORE
SALVADOR GARCIA	GENE MULLIGAN
JASON GIBBA	JOHN R. NEISWANGER
JOHN GLENN	GREG NELSON
DR. BENNE GOODRICH	DAVE NICELY
KRISTEN GUNTER	SHERYL OWEN
PATRICK HADDEN	ALBERT PELL
KEITH HENDERSON	WILLIAM POOL
BOB POYNER	P. S. REDDY
JOHN PULLING	JOHN VELDHUIS
RICHARD ROBERTSON	JOHN ROBBINS
MATTHEW ROSEBERG	ELIZABETH SIEDEL
WITOLD ROSSCHACKI	MARYGRACE SEXTON
SUSAN ROWLAND	JOHN NEISWANGER
ANDRE RUMMAN	ALBERT PELL
DARRLY SELLERS	JOHN DURAND
JOE SEVERS	LUCINDA PRICE
DR. ANNA STAROBIN	TOM DROMLY
DR. WILLIAM STINSON	HANS KATROS
OVID VACHON	PAMELA FISCHER
DAVID VALLINA	LINDA FRELKE-ODWALLA
ROGER WATERS	LARRY KREMPEL
BEN GILLETT	CHARLES MAYBERRY
TOM MACK	T. L. BOB
PETER CHAIRES	WENDY PADGETT
KEN LIVINGSTON	JOHN ATTAWAY
ROLAND BOUDRIAS	W. WARDOWSKI
MICHAEL ZIEGLER	JOSE FLORES
GREGOR FOWLER	TOM YOUNG
ROBIN PFLUKE	JEB ANDERSON
DEB CHANEY	MARVIN ANTHONY
EDWIN SELBY	MARK THOMAS
JANICE SELBY	PATTY MOUZI
FLO MULLEN	LARRY MOUZI
JOHN MARTINELLI	TOM COLBORN
JEFF JONES	DON SABATO
RICHARD RUBINSO	WILLIAM HAMILTON
OVIDE VACHON	BILL RALEY
GENE MULLIGAN	ROB BELTON
LISA CADENA	WILLIAM CULVES
BEATRIZ CANE	DAN CAHALAN
BLAIR GIRARD	TOM EGGLESTON
BARRY WILSON	LISA RATH
ELIZABETH STEGER	RON SCHMIDT
KEITH SCHNEIDER	JAY ELLIS
TRICIA BAXTER	BURKE NEELY
NYAGO SUMMERS	RANDALL ST. JOHN
JOHN FRUIN	STEPHANIE BOJOKLES
WAYNE DERSTINE	JOSEPH GLEASON
JIM WALTERS	STEPHANIE BAKER
JOHN JONES	STEVE BOGEN
WAYNE McCLINTIC	BRIAN DUFFY
JOAN MARTIN	ANDY LAURENT
TERRY MENNIN	CORKY THEIN
WENDELL SMITH
JO PUGLIA
MICHAEL PLOWEY

       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.

       Betty?

       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.

       Comments?

       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.

       UNIDENTIFIED SPEAKER: What's the pH?

       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.

       Frank?

       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