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Transcripts of Public Meeting on Current Science & Technology on Fresh Juice, 17 December 1996

<< Juice HACCP Main Page 

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

 

NATIONAL ADVISORY COMMITTEE ON MICROBIOLOGICAL CRITERIA FOR FOODS
FRESH PRODUCE SUBCOMMITTEE

 

Volume II


 

Tuesday, December 17, 1996
8:37 a.m.

Washington Room
Doubletree Hotel
300 Army Navy Drive
Arlington, Virginia 22202

 

 

SUBCOMMITTEE MEMBERS PRESENT:

 

DR. FRED SHANK, CHAIRMAN

 

MR. CHARLES BARTLESON

 

DR. ROBERT L. BUCHANAN

 

DR. ROBERT GRAVANI

 

DR. JOSEPH M. MADDEN

 

DR. MARGUERITE A. NEILL

 

DR. MICHAEL T. OSTERHOLM

 

DR. MORRIS POTTER

 

DR. WILLIAM H. SPERBER

 

DR. DON VESLEY

 

DR. KAYE WACHSMUTH

 

C O N T E N T S

 

AGENDA ITEM: PAGE

 

What would the Critical Control Points be in a Hazard

Analysis and Critical Control Point System?

 

Dr. Robert Gravani

Cornell University

 

Dr. Joseph Speroni

Ocean Spray Cranberries, Inc.

 

Public Commenters

 

Mr. Robert Salter

Charm Sciences & Charm Bioengineering

 

Are New Technologies/Intervention Strategies Becoming

Available that Appear to be Effective in the Control

of this Organism or Other Pathogens of Concern, e.g.,

Irradiation, Pulse Light, Filtration, Ultra High

Pressure, Electromagnetic Field, etc?

 

Dr. John P. Cherry

Agricultural Research Center

 

Mr. Dane Bernard

National Food Processors Association

 

Public Commenters

 

Mr. Wayne Clark

PurePulse Technologies

 

Dr. Daniel Farkas

Oregon State University

 

Dr. Edmund Ting

Flow International

 

Mr. William Hoover

GEM Biomedical

 

Mr. John Richards

Alcide Corporation

 

Dr. Abraham Tenzer

 

Tim Raynor

 

Dr. Paul Hopper

Cornell University

 

CONTENTS, Continued:

 

Are Currently Available Sanitizers or Food Additives

for the Control of Pathogens of Concern?

 

Dr. Larry Beuchat

University of Georgia

 

Dr. Robert Hei

Ecolab

 

Public Commenters

 

James Elfstrum

 

Is Pasteurization of Fresh Juices Appropriate?

 

Overview:

 

Jenny Scott

National Food Processors Association

 

Supplier's Perspective:

 

Dr. William Sperber

Cargill

 

Processor's Perspective:

 

Dr. Donald L. Zink

Nestle USA, Inc.

 

Is it necessary in all Situations:

 

Mr. Joseph Nicholson

Red Jacket Orchard

 

Dr. Don Splittstoesser

Cornell University

 

Dr. Mark McLellan

Cornell University

 

Dr. Mohamed Ismail

Florida Department of Citrus

 

Public Commenters

 

Gerald Sapers

 

Peter Chaires

Florida Gift Fruit Shippers Association

CONTENTS, Continued:

 

Steven Justis

Vermont Department of Agriculture &

Vermont Apple Marketing Board

 

Robert Ochs

Nettie Ochs Cider Mill

 

Mickey Parrish

University of Florida

 

Marygrace Sexton

Natalie's Orchard Island Juice Company

 

Dan Wilson

Cider Producer, Upstate New York

 

Richard Wood

Food/Animal Concerns Trust

 

Joseph Zigler

Zigler's Apple Cider

 

Mark Isaacs

Sun Orchard

 

What Advice Should be Given to Consumers?

 

Betsy Woodward

Association of Food and Drug Officials

 

Carolyn Smith DeWaal

Center for Science and the Public Interest

 

Marsha Cohen

Hastings College of Law

 

Public Comments

 

Dr. William Sperber

Cargill, Inc.

 

Dane Bernard

National Food Processors Association

 

Dan Cleary

Middletown, Vermont

 

Adjournment

PROCEEDINGS

DR. SHANK: Good morning.

As we reflect on yesterday, I think we had a very good session yesterday, and we look forward to another very useful meeting today.

Let me remind you that the purpose of this meeting is to review the safety concerns, if there be any, relative to juices, to provide an open discussion of current manufacturing practices, and to learn about how we may improve those practices in the future, and to do what we can if corrective actions are necessary to address the fresh juice and limited processed juices for the future.

This meeting is an opportunity to get the information on the record. We want to hear from everyone. Yesterday, there were some people who intended to ask questions, and the agency will respond once we have all the information on the record. This meeting will not be that opportunity to respond. We want to get the record as complete as we can, consider the options, and then we will come back with a proposed regulation if that is necessary. Again, at that point in time, we welcome your comments on our interpretation of what the science and the proper actions might be for the future.

Unless anyone has any burning questions, we'll get started with this morning's program. The firs t topic for consideration this morning is what would the critical control points be in a hazard analysis and critical control point system, and our first speaker is Dr. Robert Gravani.

Dr. Gravani is a professor in the Department of Food Sciences at Cornell University. Bob, it's a ll yours.

DR. GRAVANI: Thank you, Fred.

It's a real pleasure to be here this morning to share some thoughts and perspectives with you on HACCP and this important consideration as we move ahead and try to put the pieces of this very, very complex puzzle together.

As we talked yesterday, we've got some major concerns about what is happening in terms of husbandry practices; we've got some major concerns about what's happening in the pressing situation. And this morning, what I'd like to do is provide some perspectives on HACCP and sort of take us back a step.

From my conversations with people yesterday and from some of the comments that were made up front and around the room, it was obvious to me and some of the other speakers this morning that we need to go back and look at where we are and where we've been and revisit the situation that we call HACCP.

I'd like to challenge you this morning to start thinking about a few items. One is how have we traditionally in the food industry controlled biological, chemical and physical hazards; what have we done to control these particular hazards in our food supply? And if we had adequate time for discussion, we would look at some of the issues that we have used to control these various hazards.

 Slide

First of all, we have used education and training of employees--and again, we can argue whether that has been effective or not, but we certainly spend a lot of time and effort doing that. We have indeed spent a lot of time inspecting facilities and operations, and we have done a great deal of microbiological testing of ingredients, finished products, and so on. Basically, all of these have had some impact, but obviously, the bottom line is that we still have foodborne disease outbreaks, we still have problems, and what is needed is a more proactive approach rather than, in my opinion, a reactive approach to these hazards and these problems. And that modified approach certainly is HACCP, and we are going to talk a little bit about this historically, and we are going to talk a little bit about this in terms of background to get some terminology straight, if you will , and to look at that.

HACCP certainly is preventive and systematic. It's an approach that we obviously want to use to assure the safety of the food supply. What it does is it provides an overview of the entire process and identifies those specific points critical to the safety of the product--an overview of the entir e process and identifies points critical to the safety of the product, obviously embodied in its name.

HACCP, as I think all of you recognize, is becoming a very greatly misused acronym. People are using the term "HACCP" to mean many, many, many different things, and some of those uses are indeed correct, as espoused in the HACCP Seven Principles, and many others are just being bandied about as a hot buzzword that gets a lot of people's attention today.

My goal this morning is to provide the very basics, to step back and look at what we really mean by this concept, what we really mean by a HACCP system, and provide the forum for our continued discussion of this very complex issue this morning.

 Slide

Let's just very briefly--one slide's worth--talk about the historical perspectives. You all reco gnize this was developed by the Pillsbury Company back in the late 1960s, so it's not new, but HACCP is an evolving process. What we knew back in early 1971 when it was first shared with the industry at the National Conference for Food Protection in Denver, Colorado has been evolutionary. We have learned through the implementation of HACCP, and at that time three principles, now seven principles, that this is an evolving process. It is not something that you develop and then forget about, and it just kind of keeps on going. It is an evolving process, and I think that that is one of the important take-home messages this morning. We don't know all there is about HACCP, and as well implement these strategies and this system and this concept, we certainly are learning more about it and learning how to deal with it in a much more effective way.

 Slide

It's a management tool, and I think that sometimes we forget that. It's a management tool to assure the safety of foods.

 Slide

I want to share with you a quote from the National Academy of Sciences' subcommittee report in 1985 because I think it embodies many of the thoughts and concepts that the National Advisory Committee has and also that many people in this room have. "HACCP provides a more specific and critical approach to the control of microbiological hazards than that achievable by traditional inspection and quality control procedures."

 Slide

What we are saying here is that this concept is different from the traditional ways that we have looked at and managed safety issues. It assures greater product safety with reduced end-product testing. I think this is very critical to our discussion. HACCP is not about additional or greater end-product testing. The whole reason for the system is to look at those points that are critical t o the safety of the product and control them very vigorously to prevent foodborne illness problems or injuries from those specific products.

You all recognize that there are three hazards, and we are going to focus today on the biological hazards--that is, the microbiological hazards--rather than on the physical or the chemical, for obvious reasons.

 Slide

I want to just lead you through what is happening in this evolution of the HACCP concept. The National Advisory Committee for Microbiological Criteria for Foods in 1989 issued revised and updated HACCP guidelines. In 1992, those guidelines were again modified, and the Hazard Analysis and CCP sections were strengthened.

As we speak, the committee is continuing to revise that document, looking at making it more user-friendly, providing more explanations of verification, validation and many of the other concepts that may have been a little foggy in the 1992 document, and hopefully that document will be reviewed by the entire committee and be out sometime in 1997. So there is a revision going on right now, again speaking to the evolutionary nature of this concept.

 Slide

What's happening out there? I think almost everyone in this room recognizes that the Food and Drug Administration has promulgated seafood HACCP regulations, and many people feel that this may be paving the way for regulation for the rest of the food industry. The U.S. Department of Agriculture back this summer issued their HACCP regulation, their pathogen reduction regulation, and the meat and poultry industry is now in the process of beginning to set up procedures for sanitation SOPs to comply with this regulation.

HACCP is also global; it's not just a U.S. phenomenon. If you look around the world at the European Union, at Agriculture/AgriFoods Canada, if you look at ISO 9000, if you look at Kodex Alimentarius  phonetic , you see embodied in all those organizations HACCP and indeed the proactive and systematic approach to food safety. So it's not just a U.S. phenomenon anymore.

 Slide

A couple of points that need to be made. first of all, HACCP is very product and process-specifi c. One size does not--does not--fit all, and we need to keep this in mind as we look at this whole concept and begin to apply it to all of our operations. There is no ready-made, off-the-shelf HACCP plan that's out there. There are some generic plans, but again, each product and process needs to be evaluated and individually.

There are a lot of people out there who have become "HACCP Are Us," selling plans and consulting and so on and so forth, without ever having stepped in a plant to look at the operation, to look at the product flow, and this is a very dangerous situation in my opinion.

I think we need to focus in on the product and process specificity of HACCP. And again, the development of a HACCP plan must be performed on a product-by-product, line-by-line, plant-by-plant basis. I know that may not be what everybody wants to hear, but that's the intention of HACCP and how it should function properly in our environment.

 Slide

HACCP should only be used for product safety. Yesterday, we heard a lot of comment that mixed quality and safety together. I think we need to keep those two separate because HACCP is specifically designed for product safety purposes. We'll talk about the quality issues related to GMPs in a few moments, and I'll try to provide you with some perspective on how that all adds up and fits together--and here it is right now.

 Slide

What I did a number of years ago to explain to plant workers what the differences were and what they were doing on a daily basis and what HACCP really meant is embodied in what I call the Food Safety Assurance Pyramid.

If you look at this pyramid, you'll see three major components at the top. You see total management commitment, which is definitely needed for a HACCP plan to be implemented. Without that total commitment, it is not going to happen.

HACCP also functions well when people have a very good understanding of biological, chemical and physical hazards, what are those hazards, how are they getting into the product, if you will, and how can we control them; so a good understanding of those hazards.

Education and training of everyone in the operation, from company management all the way down to hourly works, is critical to making this process work properly. Having a plan in a drawer somewhere without implementation does nobody any good.

Now, all of this is built upon a very solid foundation of a number of items. The solid foundatio ns are things like food temperature control, effective cleaning and sanitizing programs, attention and detail to personal hygiene, pest control programs. And if we had to characterize the base of that pyramid, I think we would all agree that those items down there really are good manufacturing practices.

And as we talk about good manufacturing practices, I'd like to ask you to think about this pyramid and use this analogy: HACCP is based on a very strong and solid foundation of good manufacturing practices. Without that strong foundation, HACCP will not work.

Let me give you an analogy. That is, it is like trying to build a skyscraper on a swamp. If you do not have a solid foundation, the building will fall down. As simple as it sounds, all of those GMPs in our industry need to be tightened up and need to be looked at very effectively before you can build HACCP and make it work effectively.

We have now embodied some terms called prerequisite programs. Prerequisite programs really are the attention to those good manufacturing practices at the base of that pyramid, ladies and gentlemen. And one of the take-home messages this morning is that we have to pay attention to all of those procedures and prerequisite programs, those GMPs that we heard so much about yesterday. Those are very important as we build HACCP, and in my mind, we have got to keep those separate.

Now let's take a look at the process very quickly--and obviously, this is not a long and detailed discussion of HACCP, but I do want to walk through the basic principles and the tasks involved in the preliminary aspects of HACCP.

 Slide

First of all, getting a team together. That may be a small team in some of your operations; it m ay be bringing in some folks who have expertise in microbiology and processing and so on. Next, looking at the food--and in your case, the products are very specific--and where is it distributed, how is it distributed and so on; identifying the intended use and consumers of the food--what is the shelf life, how long will the product last, what are the temperature requirements. Who is the population? Are you selling it to a nursing home, are you selling it to a day care center? Who are the ultimate consumers? Is it the general public?

Then, developing a flow diagram, much like we saw yesterday in some of the examples presented--a flow diagram, from raw ingredients to finished product--and looking at every step in the process, and then going back in and verifying that flow diagram on site to make sure that what you said was happening is indeed really the way the product comes together, if you will.

 Slide

And now we move into the seven principles. Again, as we look at those, we'll just take a few minutes to provide an overview of what they are.

The first principle is conducting a hazard analysis--that is, stepping back and looking at what t he specific hazards are in a specific operation, in a specific situation--and then identifying critical control points. And what I'd like to do now is go back and walk through these two before we move on.

 Slide

The hazard analysis should question the effect of a variety of factors on the safety of the food being processed. What re those factors? Where are the hazards coming from? And I am recognizing that in our situation, we are still investigating; we are still cogitating, we are still discussing on where the specific organism comes from and how it gets here. So that some of the pieces of the puzzle in our situation are still to be determined by research. But basically, it is looking at those factors and how they affect the safety of the final product.

 Slide

Next is looking at the potential significance of each hazard and assessing it by considering its risk and its severity. In other words, what is the likelihood that a problem will occur, and if that problem occurs, how severe will it be?

Well, if we are looking at a biological hazard, and we are looking at E. coli O157:H7, the severi ty of that hazard is very high, evidenced by what we have heard from our physicians and from the outbreaks that we have as historical perspective.

 Slide

Risk estimate are based on many things--experiences that we have, epidemiological data that come out of outbreaks that have been investigated, and certainly the technical literature.

Now, many people in this room, Dr. Buchanan being one of them, have said that HACCP only works for known hazards; so we really need to look at what those hazards are and constantly evaluate that situation to make sure that we are addressing all the hazards that are potential hazards that can affect the product. Again, the technical literature, medical journals, epidemiological data are all important as we look at this whole business of risk estimates and assessing those hazards.

Now, as we look at critical control points and control points, there is a distinction here which I want to take a few moments to make.

 Slide

First of all, a control point is any step in your process, basically, where biological, chemical or physical factors can be controlled. This is your normal flow chart, if you will, and these are the points in that process where things can be controlled. A critical control point--let me just drop back for a second.

 Slide

Those control points usually are low safety risks; they relate to things like GMPs, sanitation, equipment, facilities. Quality issues are all low safety risks and are considered control points.

 Slide

Critical control points, on the other hand, have a very specific definition, that is, there are p oints or steps or procedures where you can apply controls to a food, and a safety hazard can be prevented, eliminated or reduced to acceptable levels. In other words, these points are critical to the safety of the product, and we need to think about it in that context.

As we look at those points, where would they be?

 Slide

They would certainly be where the biological, chemical and physical hazards are, and we would call those points critical control points. The bottom line is that if we lose control at those poin ts, a food safety situation will occur--in other words, product safety will clearly be compromised if we do not control the hazard at that specific point. That is the difference between a critical control point and a control point.

 Slide

Let's look at the next three principles. Principle 3 is establish critical limits for preventive measures. In other words, we need to set boundaries of safety; we need to set limits. We need to then establish monitoring procedures at those critical control points. In other words, we have to make sure that they are in control and that those critical limits that we set are indeed being met.

Principle 5 is having written procedures, corrective actions, when there is a deviation from our critical limits. In other words, if we don't make a certain temperature or a certain pH or a certai n chlorine requirements, we need to have a procedure in place that says this is how we are going to correct that deviation so that now hazardous product goes out on the market.

 Slide

These critical limits basically are criteria for control; they are also called boundaries of safe ty. And basically, you are setting those based on research, based on current industry practices, based on the literature.

 Slide

Monitoring really is an observation of a CCP and its limits, and these monitoring results are the beginning of the recordkeeping process. You are actually documenting what is happening, those observations at those CCPs, and signing and dating those records. It is very important in a HACCP system.

 Slide

Each CCP requires a written corrective action, and this action must demonstrate that the CCP has been brought under control and must assure the safe disposition of the product. If there is a deviation, what is going to happen to that product where those limits have not been met? Is there a hold in disposition procedure in place--that's very important as well.

 Slide

As we look at the last two principles--recordkeeping and verification to make sure that the syste m is working, again, this has been an evolutionary process. In terms of recordkeeping, the HACCP plan should include things like team members, their responsibilities, descriptions of the food, what your hazard analysis looks like, your critical control points, your critical limits, your monitoring procedures, time and temperature logs, checklists, corrective actions, what your employee training records look like and procedures for verifying that the system is working--how do you know that the plan you have devised is actually working and preventing hazardous product from making it to the marketplace?

 Slide

Verification is probably the most misunderstood of all the seven principles, and the National Advisory Committee's HACCP Working Group is trying to clarify the terms and the procedures here so that people have a better understanding.

Verification consists of a number of different methods, procedures and tests used to determine if the HACCP system is in compliance with the plan. In other words, are you doing what you said you were going to do, and is it effectively keeping defective product off the market?

 Slide

Verification activities include constantly reviewing the HACCP plan, reviewing the CCP records, reviewing the deviations--if you are finding a lot of deviations, that means you have got to go back in and look at that process again; there may be something inherently a problem with it--visual inspections of operations, making sure that all those processes that you've set up are working. This does include sample collection and analysis on a random basis as a spot-check to make sure things are working properly; written reports of inspections, making sure that you are verifying what you said you were going to do is indeed being done and done properly.

 Slide

Now, HACCP plans are not static documents. As I mentioned a few moments ago, they evolve, and you need to conduct additional audits, you need to reevaluate the HACCP plan every time there are new nuances, new things that change, whether it's a new product, whether it's a new recipe, whether it's a new process, whether it's any new pieces of equipment or replacement parts for equipment. We can talk about that situation a lot, but each of these situations requires a thorough review and possible revision of the HACCP plan. When things change, the HACCP plan also needs to reflect those changes because your hazards may have changed as a result of some change in the process or product or formulation. This is again an important consideration for you all to think about.

 Slide

Now, I think the benefits are fairly clear. It demonstrates management commitment. This system says management cares enough about food safety to have a proactive, state of the art system in place to address safety issues. It also provides due diligence that a company has done everything possible to prevent those hazards from making it to the marketplace and causing an illness or an injury.

It also provides defensibility for your program and your process--if you have done it correctly. It also improves regulatory inspections because it is focusing in on those areas that will cause problems. It's not the floors, walls and ceilings inspections that look at aesthetics, but it clear ly focuses on the causes of illness or injury, and that is key in our discussion.

Lastly, there is indeed a product quality dividend. Quality and safety need to be kept separate, but if you install a very effective, good manufacturing practices program, and you build the strong HACCP plan on top of it, safety will improve, but quality will be a come-along dividend. Again, we want to keep safety and quality separate, but if you install effective programs both at the GMP prerequisite level and HACCP, there will be a product quality dividend that will come along as well.

 Slide

If we look at the biological hazards here--and our whole discussion, even though we are considering other organisms, is really E. coli O157:H7--if we look at some of the prerequisite programs and where some of these organisms are coming from--this was in a paper that Dr. Larry Beuchat from Georgia did, and I want to show it to you because I think it embodies all of the discussions that we had yesterday--we are not sure where this organism is coming from in our environment; what specific issue is bringing it to the product? Again, this is a complex diagram, and it is really open for discussion and research as to where all of these product contaminations can come from.

 Slide

The bottom line is that we need to look at what our GMPs are before we begin to develop HACCP plans. One of my take-home messages today is that we need to collectively look at those good manufacturing practices and tighten them up. Good husbandry practices--that's going to depend upon all the agriculturalists in this audience to think about how we can do an even better job of tightening those practices, for all the reasons we mentioned yesterday.

Certainly, the personal hygiene of workers, in the field, at the packinghouse, in the pressing operation and all through the operation needs to be addressed, and in my opinion, those are GMPs.

Sanitation of the pressing operation--we need to really look at that very, very carefully. How often are the cleaning and sanitizing procedures being done? How effectively are they being done--and so on and so forth.

And lastly, sanitation of the entire facility, looking at other areas where product contamination can occur, where this organism may indeed be coming in. And we have no idea where it's coming in right now.

 Slide

What are some of the potential CCPs? Certainly in the incoming wash tank, we need to look at chlorination levels, we need to look at the whole issue of detergent washing, brushing, et cetera. This is very, very important.

If you are inclined to pasteurize your product, that is a kill step, and certainly the pasteurize r, the temperature of that pasteurizing process, would clearly be a CCP. If indeed you decide not to pasteurize, then I think you need to look at some of the new technologies which we are going to hear about a little later today and decide whether they indeed are CCPs because you clearly want to control the hazard and prevent it from getting into the final product.

Those are some of the areas that I would look at. Again, many of the other issues that we talked about are good manufacturing practices. Certainly, tote bins, making sure they are clean and sanitized properly before and after use, using them singly for apple products or tree fruits and so on, as we heard yesterday--all of those, in my opinion, are GMPs.

 Slide

As we look at some other important considerations in this process, avoid the use of drops. I thi nk that that was made very clear in many of the presentations yesterday in unpasteurized products. Again, how many times do we have to say: Effective cleaning and sanitizing. It may be more frequently than just once a day, and I'll leave that to you to think about for your operations. Certainly, chlorinated water--if you use the wash water and the brushing situation as a CCP, you need to think about the levels of chlorine in that water, and you need to monitor that water very, very carefully.

 Slide

Also, the whole washing and brushing issue in a small operation needs to be done effectively.

 Slide

Wash water temperature, the temperature of the flumes, should be higher than the fruit temperature because we may get a vacuum effect where if there are organisms present in that water or on that fruit, if there is a temperature differential the other way, those organisms could indeed be drawn into the product. If you do pasteurize your product, I would certainly make the pasteurizer a CCP and monitor clearly the critical limits of that situation.

If you are not pasteurizing your product, as I said a few moments ago, you need to consider what these new technologies are to reduce the risk of foodborne outbreaks. Again, these are all very important considerations.

 Slide

With that, I hope I have provided you with a very, very brief overview of the HACCP concept, the strong importance of prerequisite good manufacturing programs as a solid foundation for HACCP, and I hope that we will continue our discussion and looking at preventing problems with this specific organism and all the products that you represent today.

Thank you very much.

 Applause

DR. SHANK: Thanks, Bob.

We have heard from the academician, and we will now turn our attention to the industry. Dr. Joseph Speroni from Ocean Spray will be the next presenter.

Dr. Speroni is Director of Food Science and Quality for Ocean Spray Cranberries, Incorporated.

DR. SPERONI: Thank you and good morning.

Ocean Spray is a major producer of canned and bottled juices and juice drinks and other products, all of which are shelf-stable and therefore pasteurized.

As Dr. Shank addressed, my title is "Director of Food Safety and Quality Science," which accurately describes what I do. I am regarded by my organization as a processing authority, and I will be part of the decision regarding the adequacy of any processing changes in the organization.

I am here this morning because I am leading an effort by my company to participate in the FDA HACCP pilot program. We are one of several members of the food industry who volunteered for this program. Many of those companies participating are very recognizable names in the food industry.

Since HACCP was an inevitable component of this agenda, it makes sense to have a company here today representing the shelf-stable pasteurized juice products for the HACCP pilot.

Let me briefly review with you some of the elements of the FDA HACCP pilot and why we elected to engage in this piloting process. About 2 years ago, FDA requested through the Federal Register public comment concerning whether and how the agency should develop regulations that would establish requirements for new, comprehensive food safety assurance programs for both domestically produced and imported foods. The "whether" FDA should develop regulations for all parts of the food industry is still under debate, but there is little argument that if regulatio ns are promulgated, the "how" will be under the umbrella of HACCP. Most will agree that HACCP is founded and must be driven by sound management and sound science.

Now, rather than rushing out and rapidly promulgating regulations for HACCP, the agency in its wisdom saw the need for pilots within several sectors of the food industry. We commend the agency for embracing the concept of HACCP and the opportunity to pilot or test ideas. While the concepts of HACCP are sound, as Bob spoke about this morning and as we saw a little bit yesterday, it is subject to much interpretation and definition, all of which can be tested and integrated before any regulation is written.

Furthermore, the manner in which the pilots have been conducted to date has given industry and the agency an opportunity to constructively create and engage in dialogue in a spirit of mutual alignment toward a common objective, that is, improving the safety of the American food supply.

Now, it is always politically correct to quote your boss in a public meeting. I am going to read a quote: "We have few greater responsibilities to the American public than to ensure a safe, adequate and sustainable food supply. While the U.S. food supply is one of the safest in the world, we still have a lot to learn. Research in this field, where we turn large dividends globally , and we must have the foresight to increase that investment."

I don't put that quote down just to suck up to the boss. I put it down because the statement was made in "Meeting the Challenge: A Research Agenda for American Health Safety in Food." It was made in February of this year and delivered to the Executive Office of the President, Office of Science and Technology Policy. I couldn't agree more with the statement, and much of the research that the quote suggests is under the umbrella of HACCP.

We have seen some precedent. We have seen in the past how industry, trade associations and the FDA have combined to shape and develop regulations. The so-called "low acid canned food regulation" published and codified during the 1970s is an excellent example.

The collective and integrated work of industry, trade associations and FDA led to the development of highly effective regulations that ultimately standardized and improved the safety of that industry. Now, the consequences of those hazards were clearly understood. The regulations are very similar to HACCP in philosophy and were certainly grounded in good science.

So in short, why were we interested in participating with the FDA in the HACCP pilot? We believe in HACCP as a preventive system to improve food safety, and the pilot provides the forum to proactively shape the direction of HACCP in this industry.

I must stress that we are only one member of the juice industry. Other members will and should look at HACCP differently. HACCP is evolving, and these pilots programs are only one part of that evolution. We must move toward a more common identification and understanding of the bona fide hazards in this industry.

Now, we look at HACCP as part of what we call our product safety and process control system. Dr. Gravani this morning talked a lot about systems; we wrap it all together into a system called product safety and process control. And I don't want to bore you with acronyms, but we affectionately call it PS and PC. Let me tell you a little bit about how PS and PC works.

PS and PC is a comprehensive preventive process control program that is based on HACCP principles where all phases of safety, processing, regulatory and quality are addressed. In PS and PC, the identification, monitoring and control of critical control points is the product safety, or the HACCP, part of the program.

The identification, monitoring and control of control points for each process step is the process control, or the PC part, of the program; a clear delineation between product safety and process control. The product safety part is the true HACCP.

PS and PC is designed to be a single source of food safety and process control information to eliminate food safety risk and reduce process variation to within product and process specifications. Importantly, PS and PC empowers the operators to be the owners of the process for product safety, process control and quality. IT places the controls upstream in the process, before a process can become out of control and produce costly, contaminated, or out-of-specification product.

If I could have the first overhead, please.

 Slide

Just to walk through with you, this is our PC and PC or HACCP program. Again, the true HACCP refers to the PS or product safety portion of that acronym. IT utilizes HACCP; it outlines operator control requirements; it specifies, and if you look, you'll see some similarity--t hose are the seven steps of HACCP.

Next overhead, please.

 Slide

I don't want to bore you, and I don't expect anybody to read this, other than that if you looked at some of the definitions that Dr. Gravani talked about, they are very similar, and if HACCP is evolving, we are evolving closer and closer to common definitions.

If you look at each of those, there are seven steps, and they are very close to what Dr. Gravani talked about this morning as the seven steps of HACCP.

Next overhead, please.

 Slide

PS and PC has several purposes and objectives. I won't read all of them, but I'll leave them up there for you to read. However, I do want to highlight a couple of them.

First and foremost, it provides preventive controls, and the key word there is "preventive" controls, that provide assurance for product safety--again, the HACCP portion--in conformance to processing, regulatory and quality requirements to process control. A lot of people refer to those as the GMPs.

For us, it very conveniently provides a single source of product safety and process control information. IT also provides a mechanism to document and verify that the process is in control and is producing safe and wholesome products within specification.

Very importantly, it provides tools to the operating to assure consistency in control process and consistency in specifications for product. If you don't get it down to the operator level, it isn't going to work.

Next overhead, please.

 Slide

It establishes process control upstream--way upstream--as far as you can go, where it has the most effect on product safety, cost control and meeting process and product specification--I can't stress that point enough, that it is upstream--to provide assurance to management that the process is in control and very conformance to the PS and PC plan and business plan; and lastly, to provide assurance that unsafe or out-of-specification product does not enter distribution. So the second-th e-the-last one is to management, and the last one is to the consumer.

Next overhead, please.

 Slide

The scope and the boundaries of PS and PC include all the processing steps in each unit operation for each process and each product--again, process and product-specific. It includes the critical control points, the control points and monitoring points, from receiving fresh fruit through processing and packaging to the distribution of the finished products to the consumer.

Next overhead, please.

 Slide

This just shows how we divide up some of the responsibilities for PS and PC, and this is working at the plant level. The plant manager is actually responsible that the PS and PC plan is complete, current and working. There would be a team leader assigned, and that team leader is to provide direction to that team.

The PS and PC team itself is responsible for the development of that plan, keeping it current, an d incorporating process and product changes.

The operator has the authority and the responsibility to assure conformance to the PS and PC requirements for food safety and process, regulatory and quality control.

Then, the corporate resource is really supplying the functional competency, the process authority --any changes that are made must come back through the corporate group; the final expertise is really provided there.

Now, we have developed a list of definitions as they pertain to HACCP, and we shared these thoughts with both FDA and NFPA, and let me tell you about a few of them.

Next overhead, please.

 Slide

I'm not going to talk about all the definitions that we have shared to this point, but there are a few that are extremely important. I do want to differentiate here between acute risk and chronic risk. You can read what the overhead says, but basically what we are trying to differentiate is that if you were to look at something such as excess fat ingestion--we all know that it is a health risk doing it over a long period of time--however, it is a chronic risk that occurs over a very long period of time. It is certainly not in the spirit of HACCP. HACCP is more in the spirit of acute risks--critical or severe incidence or conditions.

As we have defined "hazard," it is a biological, chemical or physical property that may cause foo d to be unsafe for consumption. It is a public health risk.

Next overhead, please.

 Slide

A control point is any point or step or procedure in the food system at which a biological, physical, chemical, process, regulatory or quality factor can be controlled and where the loss of control may result in a low probability of health risk. Control point relates to the requirements o f process, regulatory and quality control. They include process control points, regulatory control points and quality control points. Let me give you some examples.

We have a very strong control point program over the color of some of our products. We have a product that is derived, a natural color, with the anthacianins that are in there. We take great strides to control that color, and we do it through a control point program. It's a quality attribu te. The addition of vitamin C is certainly a regulatory control point. We aren't talking about a safety hazard here, we are talking about controlling the addition of vitamin C.

That's in deference to the critical control point, which is a point or a step or a procedure in t he food system where loss of control may result in the high probability of an unacceptable health risk and in which control can be applied and a food safety hazard can be prevented, eliminated or reduced to an acceptable level. They do relate to public health hazards and risks, and if it is not kept under continuous control, there may be a resulting high level of risk.

One of the examples we are going to talk about with the agency--and we have been talking to the agency--is glass. We are using that as an example of a critical control point.

Next overhead, please.

 Slide

Processing authority--that is, an individual or a functional organization, with the combination o f scientific knowledge and experience in thermal processing and food safety, is capable of designing and evaluating scientifically established food safety and thermal processes and is designated by the firm to approve or make determinations about the process schedule.

Now, process authority can reside within the company; it also can reside at the exterior of the company, such as the National Food Processors Association.

Prerequisite conditions--Dr. Gravani talked a little bit about that earlier. They are the preven tive conditions, programs or systems that must be in conformance with the specified requirements prior to production.

Some of the examples that you will see up there are very similar to the examples that Dr. Gravani talked about--certainly, a lot of the GMPs, sanitation, pest control, lot trace, code trace. All of these things you have to have in place before you even start the line-up. So those are the prerequisite conditions.

Positive release is a disciplined system within PS and PC to verify and document compliance to selected start-up and in-process requirements on a lot-by-lot basis prior to release for shipment. It's a checklist, if you will. You can't ship the product until you have checked off that all of th ese unit operations have been performed and have been performed to specification.

Next overhead, please.

 Slide

Now, in our generation of specifications, this is a little bit how we go through it--and it will look familiar, again. There are the seven steps of HACCP.

First and foremost is the process step, and that's the description of what happens in both proces s and product-specific. Control point--what is to be controlled at the process step and why. Limits--in the case of critical control points, you have to be talking about critical limits. Monitoring--how are you going to gather your data, what's the sample size, what's the frequency, where are you going to gather it, what are the corrective and preventive actions, what does the documentation look like, what is the verification. Again, I think verification is the area that is perhaps evolving the most. It is assurance that the system is working and in conformance with the plan. What are you going to do, and how are you going to do it.

There are three levels of verification--at the operator level; at the plant quality assurance or quality control level; and again, at corporate. There are different frequencies with each one of those.

Next overhead, please.

 Slide

This is going to be a little bit busy, and I only show it to illustrate a point. This is how we collect and start to generate our specifications. If you'll look over on the left-hand side, you'll see aga in the seven steps of HACCP. The last two are combined into documentation and verification. This is the type of information that we generate to actually put together our specifications. This is a very helpful worksheet that we've employed in doing so.

Okay, you can turn the overhead off.

Now, after extensive dialogue with the agency and with NFPA about the hazard analysis as applied to shelf-stable juice products, we agree with the agency to use glass as an example of a potential hazard and follow its control in the HACCP pilot. We are very early in this process. We actually started doing this in September of this year. We have had some very good dialogue on this point, and again we're going to use glass as an example of how you truly control a critical control point using HACCP principles.

We strongly suggest that HACCP could be used with respect to the newly emerging biological issues in fresh juice products.

Thank you.

 Applause

DR. SHANK: Thank you, Jim.

We have had a request for one public presenter at this point in time. Robert Salter, would you please come forward and tell us who you are and whom you represent.

MR. SALTER: Good morning. I am Bob Salter, representing Charm Sciences and Charm Bioengineering, and today we will be presenting two new technologies which may be pertinent to the critical control of microorganisms in juice processing.

The first technology is an ultra short time heat exchanger called the Ultratherm. The Ultratherm is unique in that it can pasteurize juice without adverse effect on flavor or constituents.

The Ultratherm is currently used commercially to eliminate viruses and mycoplasma in very heat-se nsitive biologics such as monoclonal antibodies for injection and other blood products.

Can I have the first slide, please?

 Slide

Shown in this overhead is the heat profile of cider run through the Ultratherm at a peak temperature of 81 degrees Centigrade. The critical heating and cooling steps are those stages where we get a log reduction in E. coli, and that occurs in the second heat-up stage, which is very rapid; it takes just .7 seconds to heat the product from 38 degrees Centigrade to 81 degrees Centigrade. Then it is held for an exceedingly short time--just .001 seconds--and this is the shortest achievable by any heat exchange process. During that time, we only measure a .22 log reduction in E. coli. And then, in the cool-down phase, we cool the product back down to 38 degrees Centigrade in the first cooling process. That takes only .4 seconds, and we get a log reduction of 2.7 logs.

Now, this is just the generic E. coli that we measure in this process, but just looking at the NF PA data on O157 that was passed out yesterday, our data is probably within 20 percent of that data as far as the measured log reduction.

It is the very short hold time and the rapid process time that prevents flavor degradations that occur with more conventional pasteurization processes. The Ultratherm is a turnkey system that uses microwave energy to rapidly head fluid materials, and then it uses a conventional cooling process. It has been applied to foods in collaboration with Parmala  phonetic Corporation. In that application, we actually sterilized milk at 151 degrees Centigrade and demonstrated virtually no flavor or component degradation to the starting material. At this point with this technology, we are developing additional heat profiles which may look at other juice enzymes and other microbial strains and what their heat destructions are relative to the temperatures that we are able to achieve.

Next overhead, please.

 Slide

So pasteurization is one way of controlling microorganisms. The next technology that we are putting up here is an easy to use and safe to handle microbiology screening test called "Coligel"  phonetic . Now, if you choose not to pasteurize, screening is probably one of the ways that you can try to control the microbiology endpoint in your product, and whether you screen during your process or you screen end-product, that's probably something that you would determine. But what this does is it makes it very simple to test for coliform, E. coli, and salmonella simultaneously and give you a quantitative result in 28 hours.

Shown here, Coligel  phonetic uses semi-selective gel media with colorigenic  phonetic and fluoragenic compounds to create distinct colonies of growth which can be counted and discriminated. Coliform form blue colonies, Salmonella form black colonies, and E. coli form blue fluorescent colonies.

Also shown here is an additional feature--a disinfectant which can be introduced at the end of culturing; this kills the cultured bacteria without ever opening the container to the food manufacturing plant.

Could I have the next overhead, please?

 Slide

The features Coligel offers over other conventional techniques are listed in this overhead. With one test, you get three organisms in 28 hours. It is extremely simple to run, doesn't take any special training, and it uses minimal equipment--just an incubator and a pipette.

The disinfectant feature gives you some additional microbial safety in food plant. And the sensitivities you are able to reach are quite low--10- to 10,000 CFU/100 ml brackets some of the specifications that have been established for drinking water and bottled milk. And what's more, you are able to achieve those sensitivities without any special handling of the sample before you begin. There is no pre-handling of sample; you can just add. If you are testing the rinse water of your apples, you could add a full 100 ml; if you are testing juice product, at the end, you'd probably add up to 5 ml of juice to the test.

Lastly, coliform and generic E. coli and salmonella are all organisms which have been identified in existing HACCP programs which are in place now, and the control chart model I have up here is one way of monitoring your trend in manufacturing and in end-product. What the Coligel is doing is making it easy for you to do without a big investment.

Thank you very much.

 Applause

DR. SHANK: Thank you.

Are there any other public presenters for this portion of the program?

 No response.

DR. SHANK: If not, we are going to move ahead with the next subject area. This will address new technologies or intervention strategies that are becoming available that appear to be effective in the control of O157:H7 or other pathogens of concern.

Our first presenter is Dr. John Cherry. Dr. Cherry is Center Director of the Eastern Regional Research Center, a component of the Agricultural Research Center of the U.S. Department of Agriculture.

Dr. Cherry?

DR. CHERRY: Thank you, Dr. Shank.

 Slide.

I appreciate the opportunity to represent the research community of the USDA. As you can see, I am part of the Agricultural Research Service in Philadelphia. We are one of four post-harvest technology centers--one is in Peoria, the other one is in Albany, California, and in New Orleans is the fourth one. We have a strong emphasis on post-harvest technologies, and we are working with food safety and the Food Safety Inspection Service, and our scientists interrelate with the FDA, so I appreciate this opportunity to share and interrelate with this group.

 Slide

We spend a considerable amount of time working with intervention technologies, and the emphasis has been with the Food Safety Inspection Service, with the FDA, and meat and poultry. A significant number of breakthrough technologies have come in rapid methods, detection methods, and understanding how microbes grow in food systems and finding ways to control these microorganisms.

 Slide

We have been talking about sanitation technologies, and when I was thinking as a research scientist about how to put this paper together and the thought process of trying to help the apple industry with its problems and solving its problems, we think in terms of how we interrelate with our other constituents as far as meeting their needs and extending those technology and methods and concepts to other applications. And as you walk through this as a research scientist, you think in terms of what are your problems and how you go about developing innovative techniques and technologies. And as we have been talking--and it has been following through in the last day and a half--there are many developments occurring, and as you can see, we are talking the same language, and that is to eliminate and control these pathogens. And that is what you have got to come together to try to get a handle on where these microorganisms are coming from and what enhances their growth and ways of controlling that. This is the type of thing we look at, and of course, sanitation technologies are part of the process, and when you are developing new technologies, you are looking at ways to develop these things.

I also know, in looking at the fresh-cut industry in fruits and vegetables--and we have a program and have had a number of years of research in support of this area, so we have plenty of experience in working with fruits and vegetables, and a significant number of technologies have been developed. I noted that the International Fresh-Cut Produce Association has an extensive HACCP on how to deal with HACCP and guidelines in controlling microorganisms through sanitation techniques. So there are a considerable number of developments already there and coming along.

 Slide

This slide was shown earlier, and it brings into focus, really, where the complexity of this prob lem is, and it is in many areas, and it is very complex. Of course, feces, manure, as has been talked about, has been a major part of this, and it seems to be central to all of this discussion, and as y ou can see, it is sitting right there at the top.

I noticed one thing in looking at this slide last night--insects. I thought, gee, I haven't hear d anybody talk about insects and what their role is in carrying microorganisms and infesting fruits and vegetables as part of the whole process.

Well, all of this goes into the sewage, the water systems, the soil systems, and then it enters t he produce, and if you've got animals in the whole system, then you add another complexity to the whole picture. So understanding this whole cycle and this whole interrelationship becomes a major task and is ongoing. In our programs in meat and poultry research, this is ongoing. This is part of what we are doing.

I am sharing some of the developments that we are doing with a pork producer in Pennsylvania, and actually, this producer in Lansdale, Pennsylvania, Hatfield Meats, has actually allowed us to come into their facility and set up a laboratory. They have added a technician to the program, and we are actually working with them to understand how salmonella can get into their plant, how it can be carried from the farm, and the concept is looking at "farm-to-fork," as we are now talking about our programs; how do we understand where salmonella or E. coli comes from. It has got to come from the farm--or is it going back to the farm--are we carrying it back to the farm?

These are all the variables that we are including to our effort, and you can translate this to fr uits and vegetables, to fruit processing, and just change the words to fruit transport, and then preparing the fruit and so on and so forth.

 Slide

The end result is that they have changed their approach to bringing the hogs from the farm. What we have done is shown them clearly that the trucks--the transportation system is a problem area--tha t there is salmonella in those trucks, and not all farms are contaminated with salmonella, but once you get it into those trucks that are transporting, you are carrying it back and forth, so you are adding fuel to the fire and you are adding to your problems.

That is one of the things now that they are trying to change. They are washing and scrubbing down their trucks with each load. Maybe not all of the trucks will have salmonella contamination, but the point is that they are cleaning those trucks and cutting out another step that could be a potential problem in carrying and increasing the salmonella presence in their system.

 Slide

Now, there are many developments, many technologies, many advances in the whole area of chemistry, as disinfectants, water washing and cleaning up acidulants. We have talked about this extensively yesterday and today. Various chemicals are available, and much has been done to improve and enhance their applications, understand their applications. It is a matter of individually applying it and specifically applying it to specific instances, understanding what the sources of the contamination are, how to control them, and what best fits the specific need or the specific application. We have talked about chlorine washes, amount of chlorine washes, scrubbing the fruit, and these are all technologies that are also used in the meat and poultry industries as far as application.

The other area would be combinations of these components, and it's all part of the whole process.

 Slide

I borrowed this slide from the University of Georgia folks on their application of sorbate, sodiu m benzoate, and you can see the application works, and there is a way to control. Of course, this is an additive, and this is something that must be considered in the whole process of fresh cider versus processed cider, pasteurized cider, of extending shelf life and all the other applications.

One thing that has come about because of all this research is understanding the conditions in which the microorganisms grow, the various additives or chemicals that you can put in to slow down the process of it growing, understanding pH, understanding temperature. All of this interrelates. If you do a series of studies, you can get a sequence of events in the ability of the microorganisms to grow. Then you can take this data, this selected data, and you can project; you can develop multiple regression models that mathematically predict where and under what conditions a particular microorganism will grow. This is done with selected information. You don't have to run thousands of research experiments to get this data. You run selective, carefully planned experiments with specific conditions, and then you project it into this model, and then you predict. This is gaining worldwide attention in terms of helping to better understand HACCP and the application of HACCP conditions. This is a major breakthrough in advancing and understanding and controlling microbial growth and contamination.

 Slide

This is some of the data that you can get. You can get it from the lag log and phasing into the upper aspects of the growth and development of the microorganism. This is just a condition of 20 degrees Centigrade at 3 percent sodium chloride, ph 5.7 and 25 ppm of nitrite. With that specific data, you can predict. Now, you just run a few points and then project the rest of the data, and you can pretty well predict what's going to happen under these specific conditions within the processing.

 Slide

Quickly, just to run through some other aspects of fresh fruits and vegetables research that has been going on--and we are trying to get an understanding of extending the shelf life in minimally processed fruits and vegetables using ascorbic acid, cyclodextrin, ways of controlling polyphenols and polyphenol oxidases, and with mushrooms, we are understanding how pseudomonas grows and how these blotches occur in the mushroom industry. Here again, our scientists are working closely with the industry.

 Slide

Electron microscopy shows that in those lesions, the microorganism is rapidly is growing.

 Slide

And if you treat with hydrogen peroxide, you can readily control this blotching, extend the shelf life 3 to 5 days, which gives the grocer an added advantage in selling the produce.

 Slide

As you can see, we are right in the laboratories, working, and actually working in the plant in t he application of peroxides.

 Slide

The end result is definitely clearly, if you look at mushroom washing, water washing, that you ca n decrease significantly the bacteria in the surface of the mushrooms and as a result extend the shelf life.

 Slide

The catalases in the mushroom help to reduce the residue as far as controlling residue, which is obviously a question; obviously, you don't want residue left in the food.

 Slide

Extending the shelf life--you can see in the last column that you get an extended period of selli ng by slowing the spoilage process.

 Slide

These data are being expanded and extended to the fruit/apple industry as far as slowing the browning reaction in fruit juices--apple juice in this particular case--ascorbic acid, cyclodextrins , filtration, showing that clarity can be obtained in the process. Obviously, that's not of interest to the cider industry, but would be to the other pasteurized fruit juice industry.

 Slide

Just to touch on other developments, edible coatings, films--there is major interest in new technologies in protecting minimally processed fruits and vegetables. Many new types of components are used in forming barriers, forming films for surface protection of fresh-cut fruits and vegetables.

 Slide

This is just an example of the film that is formed from pectin. Pectin starch films can be forme d, and this extends the use in application of antimicrobials as far as controlling contamination. And of course, this possibility exists with proper research and efforts to understand their role in frui t juice applications and controlling microbial contamination or the growth of contaminants as far as their presence.

 Slide

A major thrust--and many of you know about irradiation, so there is no need to go into detail. This technology has been around for 40-plus years, and it has achieved approval by FDA for selective applications.

We have a cesium source at our center, and we are expanding our technologies and applications of irradiation for control of microbes in fruits and vegetables now, beyond the meat and poultry aspects, which is what our main emphasis has been for the past number of years as far as understanding how to control these microorganisms.

FDA has approved 1.4 to 3 kGy for fresh/frozen poultry and 1 kGy for fresh fruits and vegetables, 30 kGy for dry spices and vegetable seasoning as part of applications.

 Slide

This is our irradiation system, and as long as the strawberries are properly labelled, food technology is able to and has successfully sold strawberries in many markets.

 Slide

This is an example of extended shelf life. As you can see on the far right, if not irradiated, i t is already showing mold formation, and by 17 days, you have considerable mold.

Clearly, E. coli salmonella are destroyed rapidly, 99-plus percent, by 1 kGy, 2 kGy and 3 kGy; there is considerable destruction.

 Slide

Bob Buchanan was kind enough to lend me this slide, and maybe I'll ask Bob to come up and tell all about this. This is brand new, hot off the press. He was able to get a sample of the E. coli t hat was in the California situation and was able to do some specific studies with this E. coli strain with irradiation and has shown clearly that in the 1 kGy dose, you have a 5-plus log kill.

The key here is that if you grow this particular microorganism at pH 4.6 and then subject it to irradiation, it has an increased resistance to being destroyed by irradiation--am I saying that righ t, Bob? Right on target, he says. So the key here is that you have a variation here in the ability of these microorganisms to be destroyed by irradiation depending on their growing conditions. And this is a variable that is showing up in a number of our studies. So if you grow it a 7.2, it is mu ch more susceptible to irradiation destruction than if it were grown at 4.6. So there are mechanisms in that microorganism that are developing to help it survive at pH 4.6 that are carried through to irradiation and make it more resistant to irradiation.

So these are variables that must be taken into consideration in understanding how to destroy this microbe in our plant systems, and they may be popping up because they have developed a certain ability to be resistant under certain conditions which we don't know about, so now they are carried into the plant, they are carried through our processing processes and survive all of that because the prior resistance or capability of survival has occurred.

 Slide

A lot of new technologies are coming along, and this is what a lot of you have been waiting to se e as far as what is happening. When you look at the literature and study it--and we heard a presentation just prior to mine that talked in terms of Ultratherm processing--you can see that there are a number of processes out there being tested. The engineers are really working hard at trying to find new ways, new technologies of controlling microorganisms.

I think we all know about flash pasteurization and understand its applications. In fact, it has been extensively utilized in the milk industry for many years; it is nothing new in regard to this technology and its application.

The third one down, ultraviolet light sterilization--this technology was developed back in 1968. It was interesting to go back and look at that publication because in the early 1940s and 1950s, they talked about that it was important in cider processing that we maintain sanitation, we maintain quality apples, and we maintain proper temperature in process. That's nothing new. I mean, that's only 50 years ago already, so we have been talking about this for many, many years as part of the need for maintaining quality product, and at the time, they were using ultraviolet technologies to extend shelf life apple cider, and they were getting 99 percent kills. This is general plate count microbes, and I think they were just trying to extend the shelf life of the cider in the store. The y talked about 20- and 30-day extension, and they had done experiments leaving it at room temperature or higher than room temperature conditions. Of course, I like my cider cold, so it probably would add even more of an extension of shelf life.

That leads us into the high-intensity pulse light pasteurization. These technologies are coming, and I believe the PurePulse folks are here. They were with us last night and discussed the technology. It takes the wavelength range from ultraviolet to near infrared and extends to 20,000 times the intensity of sunlight, pulses it into the system, and you get a kill. And of course, what you are doing is hitting the microbes and destroying their membrane structure, an electrophoration  phonetic type process that breaks down the structure of the microorganism itself.

Electric pulse and poration pasteurization--this is pulse electrification. Here again, the techn ology shows that if you are using 13-16 kilovolts and subjecting the cider or juice with the microbes in it, you are destroying the microorganisms, particularly in the vegetative stage. But in the spore stage, it is much more resistant, and you don't have as much destruction. So that becomes a question.

Others have now extended the 35 to 70 kilovolts but now, wait a minute--you are destroying the microorganism and you are detecting changes in the quality of the product. You are getting some breakdown of protein and other constituents in all flavors that start to show up. And in fact, a 1996 paper that just came out on this technology suggests that there is a question that has to be looked at there if we're talking about extending the shelf life with this technology.

Microwave pasteurization--we are working with microwave pasteurization. Our engineers are getting into this area and have been in this are now for about 6 months. It's a new project, a new thrust, and we believe that we can solve or at least, we have some indicators, that we can solve some of this problem. That is essentially passing your juice--and we are doing it with fruit juice- -through a tube that is surrounded by water, so you've got microwave intensities, you've got temperature control, and the whole system just flows along, and you do it at 40 degrees, and you've got very little change in that temperature is what our data is indicating.

 Slide

You can see pyococcus is used in these studies, a model microorganism, and you can see a tremendous kill in the green as far as the number of passes as it circulates through the system. The temperature is maintained and controlled, and the quality of the product is maintained. So now you've got sort of a pasteurization, but no heat build-up, and you've got a significant destruction of the microorganisms. So it is a part of the process that we are looking at in developing this as a new application.

The other thing about microwave is that intensity, the in-depth--it can get into the system much more than--if you are talking about light systems and UV systems, you are talking about surface, and not thick layers of juice or materials; you are talking about, on the outer surface, the intensi ty of hitting that and controlling those microbes. Whereas microwave can enter and go deeper into the system.

So we think we have some very interesting developments.

 Slide

Now, a gentleman last night asked why not do surface pasteurization; why can't we just throw those apples in the machine, give it a quick blast of vacuum steam, and they come out the other end uncooked and unscathed by any process.

Well, with meat and poultry we can do that. This apparatus is now a prototype, and we are working with the poultry industry to apply it. In essence, the meat product goes into a chamber, and you can see--you are talking about milliseconds--a steam flush, a steam treatment, a second vacuum and removal. You are talking about a millisecond time frame that this apparatus is working in, and this is basically the structure of that system, and it works. We are quite excited about the potential of this technology and where it may lead us as far as controlling microbes on the surface of poultry.

If you can visualize it, the idea is that as you set this apparatus up--and we are estimating abo ut $50,000 for this piece of equipment--it sits at the end of a poultry line, where the chicken enters into the system, goes through it right into a package, and it is sterilized and not cooked; it's jus t like it's fresh, and it has a fresh look to it. That's the main idea of this.

Our engineers have reacted by saying that maybe this is a possible application for whole apple. I don't know, though. When you think about it, it's a lot of apples flowing, and in some of the pictures that I've seen over the last two days, that's a lot of apples, and it will take a lot of machine and a big machine, and I think scale-up might become an issue. So these are the kinds of things that I challenge the engineers to try to figure out how to extend this kind of application to other types of uses.

 Slide

Basically, bring it all together, as you can see, there is a lot of opportunity, and I think what it comes down to is that I can get up here and tell you all about different types of things that are happening and research that's ongoing, and each of us can do our little thing. It's a matter of sitting down and putting together some type of a workshop, a gathering, to really take a hard look with the scientists that are looking at these specific technologies and, really, where are they in today's application. What are their costs? Are they really cost-effective? Can they be utilized b y a small farmer?

For the big industries, that's a different story, but for the small processor, he has that issue now to deal with, and whether it's really reasonable to take these kinds of systems into their application. The microwave may have opportunity because you are talking about a basic microwave just like we use in our homes. You're putting that right into a line system, and you're flowing it right through, cold water coming through, and the fruit juice going through one tube intertwined with the other tubes, and you are cooling, and then you are running the system right into the packaging. That may have possibilities, and our engineers are asking those kinds of questions because our number one priority in ARS is to expand and help rural America, small farming communities, small farmers, to develop applications as well as the big major industries. It becomes a key thing.

But in all of these technologies, we need to be clear that we don't change the appearance, smell, taste, or nutritional properties. That's what we have been saying over the last day. We don't want to leave any residues with these new technologies. We want to make sure there is no threat to the environment in what we do with these new technologies. We want to make sure we don't encounter any objections from the consumer. The consumer has got to accept it, and that's one of the things that we are dealing with in irradiation. Irradiation can solve everybody's problems, but we've got the consumers asking questions. So it's a part of the process.

It has to be cost-effective and convenient to apply. That's a bottom line. If it isn't cost-eff ective, you're not going to accept it, you're not going to bring it into the company. I mean, it just doesn 't work. We talk about this all the time. It's nice to go into the lab and dream up all kinds of grea t ideas and come out with all kinds of technology, and then when you run the cost analysis, and you find it's costing $300,000 to $400,000, the small farmer is going to say, "Give me a break; I can't handle that." So it's obvious that that's not going to be part of the process. The big companies, yes; they will be able to take it and handle it and deal with it.

And then it must improve the shelf life by inactivating spoilage microorganisms as well as pathogens and extending the shelf life.

 Applause

DR. SHANK: Thank you, Dr. Cherry.

The next presenter is Dane Bernard. Mr. Bernard is Vice President of the Food Safety Program of the National Food Processors Association, and he too will address new technologies and intervention strategies.

Dane?

MR. BERNARD: Thank you, Dr. Shank.

Good morning. The challenge of being at this position in a program is trying to figure out what others speakers are going to say and what's going to be left for you to say. And based on what I figured John was going to say--and we didn't get a chance to coordinate much--and looking at the fact that there are 10 commenters after me who would like to come up--at least 10--and talk about their specific technologies, there isn't much left to talk about. But you're not going to get a break--I'm going to talk about it anyway.

 Slide

The first slide, when it comes up, is going to be a big "NFPA," which is going to give me a chanc e to tell you a little bit about what we are. You have heard us referred to a few times. Mr. Speroni in his talk referred to us as their process authority.

The National Food Processors Association is a nonprofit trade association. Our offices are here in Washington, D.C. We do the things that other trade associations do, with one unique aspect. If you weren't at the research meeting last night, you didn't get to hear me say that we have three laboratories. We started in 1907. Our first laboratory was established in Washington, D.C. in 1913 for one purpose, and that was to assist the food industry in producing safe foods. We have done research in food safety ever since, on behalf of the food industry.

Most of you think of us as a representative of large industry. Ocean Spray is a member of ours. True, most of the large food companies in the United States--not all, but most--are members of the National Food Processors Association. But 80 percent of our membership is small to medium-size processors and some very small. So we represent the range of food processing companies.

 Slide

I am going to talk about new technologies eventually. There is not much left. What I went through last night, as I looked at what was going to be presented and who was going to follow me, is okay, how can I focus in on a few things that may be not said by other speakers, so I'm going to get to that in a minute. But the first thing I want to do--because about 10 times yesterday, I was asked about what NFPA's position is on juice, so I'm going to show you what NFPA's position is.  Briefly shows slide. I'll bring it back because I know that most of you, lik e me, cannot read that fast.

A lot of people have asked me what our position is. When I came in, I had people asking me, I had microphones from the press, saying, "You people want everybody to pasteurize everything, don't you?"

The position statement I am going to show you has two components. One says pasteurize, and everybody gets stuck on that word "pasteurize." The other component is "or equivalent treatment." There are a lot of way to get to equivalence. That's an item that is going to be discussed and debated. Our take on equivalence is if you can provide a way to get to a minimal risk or a negligible risk of pathogens associated with the product, you have equivalence. That doesn't mean you have to put in expensive equipment. If you choose to do so, fine. If you have a mechanism, either through GMPs, processing steps, whereby you can develop a degree of confidence that you achieve the same objective, that is what the NFPA position statement wraps around.

 Slide

You can see the word "or" there, "heat pasteurization or an equivalent process"; the rest of it i s kind of techno-geek stuff that puts it into the context of risk minimization or risk negation. But I wanted to get that out because I know that if 10 people ask me, it's kind of like a food poisoning outbreak--if you get 10 hits, there are probably 100 that you didn't get. So I'm sure that everybody who was in here was either thinking or wondering what this was all about, so I thought I would at least bring it here and let you know what's up.

 Slide

Getting back to new technologies, there are a lot of people here with widgets that address contro l of vegetative pathogens in juice products. I'm going to give them just a very brief, top-level view of what some of these people are going to come up and dig into in depth.

We have a New Technologies Group within our group that is headed by Dr. Dilup Jonderana  phonetic , who has had liaison with most of the people who are going to come up here and speak. We have a project through our research foundation where we are going to try to provide funding to universities who are doing work to help advance some of these technologies so that they can be brought to commercialization and made available to the industry. Dilup should actually be here doing this talk because he is more familiar with these than I, but he was smarter than I and began his holiday vacation early, so I get to come here and do this.

The new technologies essentially can be broken down into two areas. I break them down into looking at newly-identified problems with existing technology. The E. coli incident is a fairly newly-identified problem although as Dr. Griffin said yesterday, if you go back through news clippings and accounts, that was probably the first outbreak of O157:H7 associated with apple juice in 1980 in Canada, but it is still fairly newly-recognized. The other area would be addressin g problems which are known with new technologies.

 Slide

Existing technologies--you heard a previous commenter talk about the process called Ultratherm. You have heard about flash pasteurization. I couldn't find a slide that had pasteurization temperatures on it, but this is a conceptual slide that shows you what's going on. It is merely the heating and cooling of product fairly quickly to achieve a specific end. In the case of pasteurizin g juice, it would be getting it to a pasteurization temperature capable of inactivating the organism for a very brief time and cooling it fairly quickly.

Why is this favorable to the product? Because microorganisms in scientific terms have what we call "inactivation kinetics." In other words, they go down at a certain rate. The nutrients and quality aspects of a product are reduced more slowly than the microbes, and if we can heat the product quick and cool it quick, we do minimal damage to the product. So that's the concept that everyone is working on.

Now, there are always new twists. The Ultratherm that was talked about, I don't know exactly how that process is delivered, but there are several pieces of equipment that are available which minimize, because of the way this is done, the degradation of the product. So there are a number of ways of getting to this.

 Slide

Looking at the new technologies area, those that are of most interest to the NFPA and where we have been focusing most of our interest and resources is this list here. I am going to talk about pulsed energy very briefly, but we have commenters including Dr. Paul Hopper who are going to come up here and talk about the specifics of these technologies.

Microwaves, you have already heard about from Dr. Cherry; high pressure processing, you will hear about a little bit later. Ohmic heating and microwaves are ways of providing thermal energy--i n other words, heat--to a product. So they are just different ways of achieving heating of the product and can be plugged into this high temperature/short time way of processing product.

 Slide

First of all, high pressure pasteurization, sometimes called "pascalization" will be talked about later, and I don't have a great deal of material to share with you except that we're putting product --and apple juice has been worked with--under very high pressures in excess of, say, 140,000 pounds per square inch, and we are essentially squishing microorganisms that happen to be in there; we are crushing the life out of them. And it is effective, although it is variably effective depending on what organisms you are working with, but it is very effective on vegetative cells.

 Slide

I mentioned pulsed technology, pulsed energy processing. PurePulse Technologies, who is here, owns many of the patents which are in use in this particular field. Pulsed light has already been hi t on just a little bit. Pulsed electric field is the one that appears to be most promising. We heard last night at the research meeting that there are units already built and shipped, and we are going to hear more about those later. Pulsed magnetic field is also under research. All of these are methods of cold pasteurization, possible cold sterilization, depending on the product you are talking about.

 Slide

Specifically on pulsed light, I know this is going to be talked about later, and I thought, okay, what can I say that's not going to be said later. You have already heard John Cherry say that the technology is called PureBright, trademark of PurePulse Technologies. It just uses a broad spectrum of light very similar to the spectrum contained in sunlight, except the flashes of light ar e about 20,000 times the intensity of that that we get from the sun. The pulses are very brief, less than a second in duration. As I said, it's a broad spectrum of light. It does have an antimicrobia l effect dealing with probably the UV spectrum and other effects from the light. If you are heating a surface--for example, the surface of a piece of meat, a grape, an apple or something like that--th ere is micro-heating at the surface of that which also contributes to the lothality  phonetic of the treatment. It can also be used on clear liquids.

 Slide

High-energy electrical fields--this is the one that I just mentioned, where we have already had units produced, and we found out last night that some are being shipped. CoolPure is the name of the technology.

 Slide

This is a slide that was loaned to us by Washington State, showing some results of their treatmen t of apple juice, and you can see that, according to their analysis of the sensory quality of that app le juice after being treated--it was very high-quality product--the gas chromatic analysis that you see on your right deals with the volatile compounds from the apple juice, which are very contributory to the flavor notes--these are the flavor notes that we pick up with the nose that are usually the first to be lost--and according to their analysis with the gas chromatograph, the pulsed field electrically-treated juice retained a very high percentage of the volatiles as compared with juices that were treated in other ways. So they did produce a very high-quality product.

 Slide

According to the Washington State information, they have used the technology to inactivate this list of organisms. You can see the one at the top is the one that has been the topic of most of the conversation at this seminar--Escherichia coli. And they did provide us some data on inactivation of E. coli. This is not in apple juice. It is in a fluid medium.

There are multiple curves there, and the reason I wanted to bring this up is because we heard las t night that the pulsed electric field technology is enhanced by elevated temperatures. And the rate of inactivation of the microorganisms is what I wanted to show here, the relative position of the curves. The higher the temperature of the juice, the faster the microorganisms were inactivated and the more effective the technology. Forty degrees Centigrade is a bit above body temperature, so that product is far short of what we have normally used in pasteurization, but it is certainly a little warmer than we would want to put it in a package, so it would require some cooling.

 Slide

This is a slide that they provided to us of a yeast cell, which is a common spoilage organism, as everybody knows, in juices, that has been treated with this particular technology, and you can see the cell on the right has actually gotten some holes in it and has begun to leak the contents of the cell, and that's the mechanism of inactivation; it just blasts holes in the cells, and the contents of the cell drain out into the medium.

 Slide

I also wanted to mention--and there is a whole variety of other technologies that we don't have time to explore--electron beam sterilization is a form of ionizing radiation. I'll talk a little bi t more about irradiation in general in a moment. But this particular form is generated by a machine very similar to, although much higher powered than, an x-ray machine that you might find in a dentist's office. The electron beams are generated with an x-ray machine striking a specific plate, which generates electron beams. It is ionizing radiation, but you can turn it on and off. You do not have to have a radioactive source in a plant. There is a lot of work going on, particularly with th e meat industry and other areas, to see what the utility of this particular technology is going to be for the food industry.

 Slide

There are going to be discussions of food additives, processing aids and other things coming up i n a moment, and there is a whole variety of those. Dr. Gravani provided me with something yesterday that I was not aware of. It is called "myox"--it was discussed last night very briefly-- generating ozone chloride and chloride free radicals for surface treatments. So there is a whole variety of chemical treatments, washes and so on that are available. We heard about enhanced chlorination. I assume we are going to hear more about those kinds of things.

As processors, what you have got to remember, however, is that for you to utilize something if it falls into the category of an additive or a process aid, it must have a legal status; in other words , it must be approved for that specific use. So that if someone comes to you with a new compound, you are obligated as a processor to find out the legal status of that--is it in fact approved for th at specific use; does there need to be an additive petition filed, or a use petition filed with the age ncy before it can be used?

 Slide

A note on irradiation. It is approved for certain uses--spices, treatment of potatoes to inhibit spouting. There are approved uses for meet and poultry--for example, control of trichinosis. There is a petition in on beef, and we are still awaiting regulatory approvals. Irradiation cannot be used unless it is specifically approved for use because irradiation legally is listed not as a proce ss but as an additive, so it is under the same provisions as other food additives.

 Slide

Which brings me to my commercial on irradiation. We seem to be stuck in a position of "overthink," not just on irradiation but on some other technologies. Some things are available, ready to be used, and we need to go ahead and clear the decks in terms of getting approvals and being able to utilize some of these things. I think that on irradiation--obviously, with my friends here on my left, maybe this is a little too commercial--but if you look at last year's situation whe re we had strawberries being implicated in a very widespread outbreak, and it turned out not to be strawberries, or maybe it wasn't strawberries, maybe it was raspberries from Guatemala--irradiation is another tool that we food safety specialists and food technologists would like to have at our disposal. We don't want to see these kinds of things happen. We want to have the tools necessary to be able to address them, and maybe with that kind of a situation, it's time to pu t more emphasis on additional approvals for the use of irradiation.

 Slide

How do we handle the future challenges? I think if we all work together and look at some of these technologies and be flexible in terms of what we mean on equivalence, we can get there.

 Slide

I did want to close with a short discussion. Since everybody else is going to handle new technology, which was my topic, I thought I'd resort to a little philosophy here. Where we go from here is probably going to depend on what we view as an acceptable level of risk from products. There is a risk--we can't deny that--there was enough dialogue yesterday to think that some people are not convinced that there is a hazard here. So we need to determine together, I suppose, what is the acceptable level of risk, and based on that, what is the acceptable level of protection that we need to provide to the foods that we are providing to the public.

 Slide

I'd like to close with this, that I often use in our HACCP workshops and food safety workshops. It is a quote by Lowrance: "In the end, safety is a judgmental quantity. Something is safe enough if society says it is." And we have to determine whether the product that we are making is in fact safe enough.

Thank you.

 Applause

DR. SHANK: Thanks, Dane.

At this point, let me suggest we take a 15-minute break, and if everybody will be back at 10:35, we will try to get started promptly.

 Break.

DR. SHANK: I will remind the presenters as they get started that there will be a complete transcript, so that even though everyone is not in the room, all of your words will be recorded, and we will make those publicly available following this meeting.

We do have 10 presenters. It's my understanding that the order has been negotiated a little bit by the individuals at the desk as to your desire as to who follows whom; I'm sure that not everyone was contacted, but Paul, it looks like you have the pleasure of going last.

As we mentioned earlier, we would like you to keep your remarks to 5 minutes. A little bit of leeway will be tolerated, but we need to stick as closely as we can to 5 minutes.

Let's start with Mr. Wayne Clark, if Mr. Clark would come forward, please. Following Mr. Clark will be Dr. Farkas, then Dr. Ting, and we'll get to the others a little later.

MR. CLARK: Good morning. I am Wayne Clark, and I am president of PurePulse Technologies in San Diego. Our company has developed a new process that I am going to talk to you about this morning that kills microorganisms in juice without changing the fresh juice flavor or nutritional properties of the juice itself, and I am really pleased to have the opportunity to tell you about that this morning.

 Slide

Basically, what we've been talking about here for the last two days is something that you could call "the fresh juice dilemma," and that is that fresh juice, as a number of people have pointed out , has very different taste and quality characteristics from pasteurized juice. Fresh juice just does not taste like pasteurized juice, and it has special nutrients which have a lot of value.

The problem is that there is a potential for safety issues, as we have seen and discussed, and th e shelf life is rather short. On the other hand, pasteurized juice has a longer shelf life and a high er safety level associated with it, but again, lower quality.

Next viewgraph, please.

 Slide

We basically have developed a way of resolving this dilemma, if you will. It involves using very short pulses of electrical energy. These pulses have a pulse duration on the order of what is calle d microseconds, millionths of a second, so a few millionths of a second apiece very effectively kills the vegetative microorganisms in juices and other liquid foods. It does that by exploding or lysing, destroying, the cell membrane of these vegetative microorganisms, and it doesn't affect the product itself--there is no heat damage to the product--so what you end up with is a fresh juice quality and safety and a longer shelf life.

Next viewgraph, please.

 Slide

This just shows schematically what is involved. There's an electrical system that generates a ve ry brief pulse of electrical energy. That pulse of electrical energy is applied to a couple of electrodes. The juice or liquid food flows between those electrodes, and as it flows through, a number of these pulses are applied to it.

Next viewgraph, please.

 Slide

This is a photograph of a system. Basically, we are now building and shipping systems to food companies that range in volume from 300 liters per hour to 6,000 liters per hour, and this is a photograph of one of them. It has a small treatment chamber that's this size and a larger system that generates the electrical pulse.

Next viewgraph, please.

 Slide

This shows some data on E. coli. This was taken in a buffer solution that was matched to the properties of juice product, and we inoculated this buffer solution with E. coli at a level of almos t 10 to the 8th microorganisms per ml, 100 million microorganisms per ml of E. coli. And as you can see, we killed everything in that solution with about 37 kV/cm electric field. So it is very effective, and very high levels of kill can be achieved.

Next viewgraph, please.

 Slide

This shows some data that was taken in orange juice. This data was with the naturally-occurring organisms that you find in orange juice. We started with more than 10 to the 5th, more than 100,000 indigenous microorganisms per milliliter in this orange juice, and we killed everything with, again, a little over 35 kV/cm electric field.

 Slide

So basically, what you have here is a process where you don't change the product itself--there is no change in vitamin C in orange juice, for example. We have looked very extensively, using milk as a substrate, to look for changes in product. Milk is a very complex product with a lot of functional and physical and chemical properties. There were no changes in any of those; no change in enzyme activity, which is a sensitive indicator of chemical change. Taste panelists cannot distinguish between treated and untreated samples of apple juice and orange juice. This technology was reviewed by the FDA and found to be acceptable for use on foods.

Next viewgraph, please.

This just shows a quick overview of the economics. The cost is about 0.4 cents per liter, or per quart of product, and about half of that is the cost of the equipment amortized, and the other is the electrical and maintenance cost.

 Slide

So that finally, basically, this is a process that can give you fresh juice quality, fresh juice taste and nutrients, high microbial kill, safe juice products, better shelf life than fresh juice, and the economics are favorable.

Thank you--and by the way, I have information in the back if anyone is interested in learning mor e about the process.

 Applause

DR. SHANK: Thank you, Mr. Clark.

Our next speaker is going to be Dr. Dan Farkas, followed by Dr. Ting and then Mr. Pflaum.

DR. FARKAS: Thank you, Dr. Shank.

 Slide

My name is Dan Farkas, and I am a professor and head of the Department of Food Science and Technology at Oregon State University. I have conducted research on the application of ultrahigh pressure to the preservation of foods since 1982.

I'd like to thank at this point the Oregon Department of Agriculture for their cooperation in putting together a quick demonstration of the use of ultrahigh pressure to inactivate E. coli O157:H7 in apple juice--or fresh cider, actually.

I would like to make three points, and these are benefits of the process. The first is that we d o have a process that will eliminate vegetative pathogens. Secondly, we have a process that will extend shelf life, and as part of this, we have shelf-stable, fresher-treated cider here, for those who want a taste. And thirdly, we find that in certain foods, there is an improvement in the flavor and mouth feel of the product.

Next slide, please.

 Slide

These are cider facts where we started--pH 3.6, a mix of three varieties from a local processor, one of these small micro cider mills. The before concentration of microbes in the juice was about 10 to the 4 on the aerobic plate counts, yeast and mold about 100 to the 4, lactics about 10 to the 3. E. coli, salmonella and Listeria were absent. This product generally has a shelf life before opening of 3 weeks and then one week after opening.

Next to that is a treatment by ultrahigh pressure for 10 minutes at 75,000 psi. We did this to, number one, clean up the juice prior to inoculation with O157:H7 and also, we needed a sample for sensory evaluation.

Next slide.

 Slide

Juice, as I said, was pretreated at 75,000 psi for 10 minutes at room temperature and resulted in no detectable microbes, vegetative cells. We then inoculated it with 10 to the 7 and 10 to the 3 counts of O157:H7 and reprocessed the juice at 75,000 psi for 20 minutes. This is an extreme process but one that, when you have one shot, you want to give it your best shot. More typically, you would find times perhaps under 5 minutes.

We carried out in parallel a nonpathogenic E. coli at 10 to the 6 and 10 to the 2 at two processi ng conditions--55,000 psi for 30 minutes at room temperature and 75,000 psi for 5 minutes.

Additionally, we did descriptor analysis on the juice after pressure treatment, and on the raw ju ice or cider after refrigeration for 6 days.

 Slide

These are the results of our microbiology tests. There was no survival of O157:H7 after now 6 days and using MacConkey agar and also an ELISA test. There was also no survival of the nonpathogenic E. coli at 6 days.

Next slide, please.

 Slide

I'd just like to make a note on the sensory descriptor analysis on before and after pressure treatment. In terms of odors, the fresh cider has a slightly green, musty, vinegary, fermented note with the flavor of slight apple, sweet, sour, fermented. These are really the notes that people loo k for in fresh cider with that cider mouth feel, kind of a grainy mouth feel.

Treated product--with pressure, you tend to get a blending and a cleaning up of some of the less desirable notes--a slight green note, clean apple, fresh apple and a sweeter taste. So you would find that there is possibly a desirable effect by pressure treatment.

 Slide

So to summarize, the use of ultrahigh pressure is now fairly routine, and we can go in our case into the laboratory, into the pilot plant and produce samples. We can run the necessary data for individual processors to determine the effect of pressure, time, temperature on various microbes such as pathogenic E. coli. We can then follow along the sensory attributes of the product to show whether or not there is a major change in flavor.

I would like to say that the technology now will be covered by Dr. Ting at Flow International, on commercial processing and new developments for ultrahigh pressure in juices.

Thank you.

 Applause

DR. SHANK: Thank you, Dan.

Dr. Ting?

DR. TING: Hello. My name is Ed Ting. I am Vice President of Research at Flow International Corporation. We are located in Kent, Washington, and we have been working in this area of high pressure food processing for the last four years.

In the brief time I have this morning, I would like to make three comments. The first point is t hat ultrahigh pressure is a commercial technology now. The second is to share with you the work that we have done and the progress that we have made, and third is to stress some of the things that the FDA can do to help encourage this new technology.

First a little bit about Flow International. Flow is a company that is based on high pressure technology. We have pumped millions of gallons of high pressure water for all sorts of commercial applications from trimming baby diapers, portioning chicken filet, cutting aerospace metal parts, removing old paint, reconditioning bridges and garages--for example, the JFK Center for the Performing Arts in Washington, D.C. was just done using high pressure technology to remove concrete.

We do all of these things in an environmentally-friendly manner, using nothing but high pressure water.

The first slide, please.

 Slide.

Here is a quick glimpse of where high pressure is already in use. These are some of the things that are done commercially, from removing concrete to heavy-duty cleaning in automotive plants to removing depleted oil platforms to cleaning ship hulls. These applications are done at pressures between 35,000 and 60,000 psi. Ultrahigh pressure is a commercial technology now.

 Slide

Ultrahigh pressure is also in the food industry. We are cutting everything from pizza to cake to chicken using nothing but pure water pressurized to these levels, and we are taking this technology and adapting it to hydrostatic food processing.

 Slide

As I said, the equipment for this technology already exists. There are commercial products, both in the United States and in Japan. However, the current industrial costs are high, and there are industry uncertainties and inertia that limit its implementation.

 Slide

Here is a shot of some Japanese jam products that are processed with high pressure technology. These are commercial and have been available for the last 3 years in Japan.

 Slide

This is the kind of equipment that has been used to process foods in Japan. This is a large pressure vessel system. The schematic basically shows you how it works. A pouch of food is inserted into a vessel, closed up, pressured, depressurized, and then the product is removed. This is a batch operation.

 Slide

The technology that we are working on at Flow is to use a semi-continuous pumping system in what we call an isolator. We think this is a much more cost-effective approach for the juice industry.

 Slide

In this technology, we use basically a pressure chamber into which we pump into and out of, so there is no removal of enclosures or anything like that. And you can see from the schematic, on the right, that this scale-up is just by multiplying the number of units used.

 Slide

As I said, the costs will be lower with this kind of equipment, and this can give us a continuous output that is much more compatible with existing juice technology.

We are building a piece of equipment for Oregon State University as part of a joint program to further investigate this technology, and that unit will be shipped to Oregon State possibly next month.

 Slide

This is a schematic, a drawing of that unit that's going to Oregon State. It will be capable of 80,000 psi, totally computer-controlled, with all the niceties and bells and whistles put into it.

 Slide

This is a schematic. This is an earlier prototype that was used at Flow International to do test ing. The results, which I'll show in the next slide, were generated with this unit.

 Slide

We processed fresh orange juice at 60,000 psi for both one minute and 5 minutes, and as you can see, we did receive a significant reduction in plate count. We think that this is the kind of processing that is of particular interest to the fresh juice industry.

 Slide

The cost issue is always important to a commercial process. There are many factors that control cost, and the most important ones are shown here. However, using the parameters shown in the previous slide, I suspect that production costs when commercialized can be as low as a few cents per gallon, depending on the process requirement.

 Slide

And lastly, I ask that the FDA consider this alternative technology when considering new policies . The FDA can also help the industry decide on new technology by clearly identifying labeling and process approval requirements.

Thank you for this time, and I'll be happy to answer any questions off-line.

 Applause

DR. SHANK: Thank you, Dr. Ting.

Our next speaker is Mr. Hoover, followed by Mr. Pflaum, and then John Richards.

Mr. Hoover, please.

MR. HOOVER: Good morning. I am William Hoover with GEM Biomedical. We are a company that makes diagnostic kits for pathogens such as O157:H7 in salmonella. Our sister company, MGM Instruments, makes luminometers for the chemical luminescent and bioluminescent technologies.

Rapid and specific screening for harmful microorganisms in fruit juices is available in new technologies. These new technologies can provide results in as little as 8 hours, thus real-time assessment in assessment of microbial contamination in food products is possible.

Delay in microbial assessment impacts many areas. Issues such as product release, product recall , shelf life, corporate reputation, cost control and customer confidence can be affected.

There are many organisms that can contaminate food and beverages. These organisms can cause debilitating illness or death in the very young, the elderly, or immuno-compromised individuals. One microorganism, E. coli O157:H7, can contaminate meats, foods and beverages. It is recognized as a primary cause of hemorrhagic colitis, hemorrhagic uremic syndrome.

Fruit juice products are hard to work with since they contain fruit pulp and residual products th at may interfere with test results. Contaminating organisms may also be in low quantities so you may miss them.

Past technologies used a pre-enrichment or incubation step, and it usually requires 18 to 24 hour s to increase microbial levels for testing. Technologies exist to collect and concentrate living microorganisms from fruit juice products in minutes. These residual products and components are removed, thus permitting accurate sample testing with live organisms.

Tests specific for E. coli O157:H7 and other organisms can be run in less than 7 hours using chemical luminescence enzyme amino assay. The combination of sample preparation technologies and specific test methodologies can provide rapid and accurate evaluation of fruit juices in a HACCP program.

I believe President Ronald Reagan in his negotiations for nuclear disarmament with the Soviets best coined a phrase that I think can be applicable to HACCP, and that is: "Trust, but verify."

Thank you.

 Applause

DR. SHANK: Thank you, Mr. Hoover.

Mr. William Pflaum?

 No response.

DR. SHANK: Okay. Mr. John Richards, please.

MR. RICHARDS: Thank you.

 Slide.

Alcide is a technology development company based in Redmond, Washington. Our business is infection control, and more recently, foodborne pathogen control by means of Alcide's proprietary technology.

My mission here today is to make both the industry and the scientific community aware of our technology so that as you work toward solutions to your problem, this excellent antimicrobial may be considered as an intervention in your HACCP plan. We believe that if the pathogens are on the surface of the fruit, Alcide technology will offer effective control.

 Slide

This is not a new technology. We have several established uses for it. The product has been approved as an FDA/EPA registered surface sterilant/disinfectant for the past 12 years. We also have a mastitis prevention teat dip that is used in the dairy industry. We treat about 2 million cows twice a day with the product.

Our poultry antimicrobial intervention--a food additive petition was filed with FDA in September 1994 and approved in April 1996. It is now pending USDA approval. In this particular industry, there are two hurdles for a company to cross, and we think we are close to the finish line.

We also have a human presurgical skin antimicrobial for which an NDA was filed in September 1994.

A beef food additive petition was filed last week, and I am sure Dr. Martin at FDA is paging through that now. We have pending a number of tests for an intermammary infusion mastitis cure to substitute for antibiotics in that particular field. We are about to begin IND testing for a hum an anti-infective oral medication, and we have a beehive antimicrobial under development. Many applications have been tested successfully.

On the technology itself, the entire range of antimicrobials are based on chlorous acid primarily and ClO2 generation secondarily through the reaction of sodium chlorite with a protic acid. In the poultry industry and in the beef antimicrobials, the protic acids that we have successfully used include malic, citric, phosphoric, and tartaric.

The degree to which chlorous acid forms depends on hydrogen ion concentration and the unreacted level of chlorite. We operate in a practical pH range of about 2.5 to 3.2, compatible with most food substances.

Through pH control and adjustment of the chlorite concentration, our formulations can be engineered to provide very rapid disinfection as a quick spray--for example, in the poultry operation, a 5-second spray is very effective at 500 ppm. We also have FDA approval in the poultry industry to use the product in the final chiller tank where the birds are immersed for half an hour to 45 minutes at a much weaker dilution, and we achieve the same results.

 Slide

Generally, the characteristics of our antimicrobials are that they are extremely broad spectrum-- we effectively kill salmonella, E. coli, campylobacter, Listeria--they are fast-acting, safe residue s, and the product is not usually overcome by organic load.

 Slide

These are just some very summary results of the work we have done in poultry. I know a chicken is not the same as an apple or anywhere close, but it gives you an indication of what kinds of reductions we can get with our chemistry.

The first test was a 60-minute chiller tank test. The next three were 5-second quick immersion tests. The control birds were all naturally contaminated, so the contamination levels were not high. What is consistent all the way through is that after treatment, be it a weak solution at 60 minutes or a more concentrated solution for 5 seconds, we knocked the final contamination level down to virtually nothing.

In the beef test, these were artificially contaminated samples. The microorganism that was used was O157:H7. We started with an initial population of 280,000 microorganisms and knocked it down to 7. This test was also a 5-second spray, but the spray was left on, and the meat carcasses were tested 60 seconds after application.

 Slide

We unfortunately have very little data on fruit. These tests were conducted several years ago using prototype solutions which have now been improved. We did test against pears, peaches and grapes--I don't know why not apples. Again the consistency is in the treatment column where, in all cases, despite what the initial contamination level was, we knocked the final microbial count down to less than 10.

 Slide

Our objectives as a company are to test our improved product under commercial processing conditions, to demonstrate that we are effective in food and vegetable substances, and then to submit a food additive petition for approval. Our product will require a secondary food additive petition approval.

I thank you for your attention, and I am free afterward to answer any questions you may have.

 Applause

DR. SHANK: Thank you, Mr. Richards.

Mr. Jerry Sapers is next.

MR. SAPERS: I'd prefer to make my comments later.

DR. SHANK: Later during this session, or the following session?

MR. SAPERS: In the following session.

DR. SHANK: Okay.

Dr. Tenzer, please.

DR. TENZER: Thank you for the opportunity to introduce our chlorine potentiator technology.

 Slide

This is a technology that has been developed over the past 7 years at quite an expense of hundred s of thousands of dollars and hundreds of thousands of hours, both here in America as well as in other countries, among them Mexico.

The reason why we decided to develop this technology is the same reason we are sitting here today, namely, to see what we can do to improve and to assist people to utilize the basic chlorine sanitation system that we have been aware of for the past 40 or 50 years.

One of the biggest problems that we have in the industry is the fact that most of the people who use chlorine don't understand how it works and as a result don't utilize it properly.

The second reason that we have problems with chlorine is that chlorine has never been introduced as an effective surface active agent, but rather as an antimicrobial and as such has a big problem staying in the solutions.

The third big reason is the temperature range. Chlorine is not effective at temperature ranges where it starts evaporating, namely, above 55 degrees Fahrenheit. In real life, when you go down to a packinghouse that packs citrus, apples, tomatoes, peppers, melons or anything else, you will never find the condition of a closed processing plant with temperatures at the range of 34 to 38 degrees Fahrenheit. However, we have introduced our technology both for the pre-cut industry, which is at temperatures of up to 50 degrees Fahrenheit and 100 degrees Fahrenheit.

This table summarizes and indicates what we can get in the way of stability as far as the product goes and the residual effect of the sanitation over a period of 2 to 3 days in the regular chlorine treatment, up to 6 to 8 days in tomatoes in bulk. And you can see for yourselves that what we have achieved here is a great increase in the efficiency of sanitation with chlorine, at the same concentration or even lower concentrations, and a residual effect in the case of bulk produces which is second to none.

 Slide

This is a test that was conducted at one of our clients, a pre-cut operation where they are using various carrots and lettuce and cabbage in the plant. The rest was conducted by FreshCheck, Inc., which is an independent laboratory in St. Paul, Minnesota, and they came in and picked up samples.

I would like to call your attention to Sample Number 2, which is the row head lettuce that was received from the field, and it was received with a standard plate count of over 21 million. If you take a look and see what happened to it after the treatment with our chlorine potentiator with chlorine at a concentration of about 35 ppm, in chopped lettuce, Number 5, it was reduced from 21 million to 11,000.

This operation started using us in 1992. This was a test that was conducted in 1993. They are still using us today. The plate count went down from over 150,000-200,000 and stays, as you can see, at 100,000, 200,000, 12,000 and 2,300 count. This was done in November 1993, one month before the other test.

It was applied by spray, and the time was 30 seconds. It is possible to utilize chlorine effecti vely, provided you use it with our technology. It is very, very difficult to use chlorine effectively jus t by putting it into water. Our technology basically utilizes emulsifiers and materials listed in CFR 21.173.315 and have been specified by the FDA for the past 40 years. That is the only specification that we have in CFR 21 that allows us to use chlorine and allows us to use some additional material.

We greatly believe that this technology could also be of interest to us, as you can see from the next slide--  Slide

--in dealing with E. coli O157:H7. These are preliminary results that we ran with the same FreshCheck laboratory, and they jumped to announce in about 10 days--it was run on December 9th, and a typo was made, and it says December 19th. But we spiked the cucumbers in this particular case to 10 to the 6, contact time 2 minutes, pH 7, temperature 90 degrees Fahrenheit.

One of the biggest problems we suffer in the industry is that in the packinghouses of bulk produc e and fruits, they are using chlorine the wrong way. They don't have any chlorine left 5 minutes after they insert it because of very high temperatures, and as a result, we do not get effective sanitation.

I would like to summarize and say that we have ways of utilizing chlorine today and next week--im mediately--to kill most of the microorganisms that are human pathogens as well as most of the organisms that are causing problems to the fruit itself.

I hope and wish that you will call us, and we'll be able to help you out and work with you in the future.

Thank you.

 Applause

DR. SHANK: Thank you, Dr. Tenzer.

Tim Raynor, please.

MR. RAYNOR: Thank you very much for the opportunity to speak here today.

 Slide

The title of my presentation today is "The Synergistic Effect of High Temperature and High pH on the Destruction of Salmonella enteritidis and Escherichia coli O157:H7.

 Slide

Between 1973 and 1987, gram-negative bacteria such as E. coli O157:H7 and salmonella caused approximately 69 percent of foodborne disease caused of bacterial origin.

 Slide

Therefore, the purpose of this study was to determine if high pH and high temperatures interact synergistically to rapidly destroy gram-negative foodborne pathogens.

 Slide

In the study, a sodium bicarbonate, sodium hydroxide buffer system was used. As we have talked about before, it's important that these compounds that we talk about are approved for use in food. Both of these are generally recognized as safe by the government. Sodium hydroxide is used in such applications as glazing pretzels, modifying food starch, aiding in the peeling of fruits and tubers, and refining in fats and oils and so on.

In addition, it is a superior alkalizing agent, it is relatively inexpensive and is more environmentally friendly than alkalizing agents that may contain phosphates, which can pollute waterways--and if you don't believe me, you can look at the Chesapeake Bay.

 Slide

Here are some of the results of the study. On the Y-axis is the log CFU per ml of the surviving E. coli O157:H7 cell population. The initial cell levels were 200 million CFU/ml, which is a lot of cells. And on the X-axis is time; the experiments were for 20 minutes. A dotted line simply indicates that at the next point we sampled, there were no more surviving cells.

As you can see, there wasn't much destruction of E. coli at pH 7 and temperatures at or below 45 degrees Celsius, but at pH 7 and 55 degrees Fahrenheit, the level of E. coli O157:H7 was reduced by 99.99999 percent after 8.5 minutes of exposure. I say that because you can never be absolutely certain that you have killed every, single cell.

 Slide

These experiments were done the same way, except at pH 10. Here, we observe a 99.99 percent reduction in E. coli O157:H7 cell levels after 7 minutes of exposure at pH 10 and 45 degrees Celsius,

In the previous slide, where experiments were done at pH 7, you will recall at 45 degrees Celsius , the cell levels were not affected by a 45 degree Celsius treatment. In addition, at pH 10 and no elevated temperature, the cell levels remain constant over time, so the raising of the pH is important.

 Slide

These are the same experiments, this time with pH 11. Here, we observe a 99.99999 percent reduction in E. coli cell levels after 4 minutes of exposure at pH 11 and 35 degrees Celsius.

It should also be noted that at pH 11 and 45 degrees Celsius, a 99.999999 percent reduction in cell levels is observed after just one minute of exposure at, again, pH 11 and 45 degrees Celsius.

 Slide

To give you an idea of what might be happening to cells exposed to these kinds of conditions, some electron microscopy work was done in a previous study. This is E. coli at pH 9 and 45 degrees Celsius after 5 minutes of exposure, and this would be an example of healthy cells. This is the DNA in here, the white material, the cell wall, and the cell membranes are all in tact. The large picture is from the scanning electron microscope, and the inset is from the transmission electron microscope.

 Slide

In contrast, these cells were exposed to pH 12 at 45 degrees Celsius for 5 minutes, and in the SEM, you can see the intracellular material is leaking out of the cells, the cells are beginning to rupture, and they are being killed.

 Slide

One practical application of this technology that is currently being used is in egg washing. The Code of Federal Regulations requires that shell eggs be washed in the United States.

 Slide

In another previous study in our lab, Clare Ellen Catalano  phonetic investigated the effects of pH on the survival of salmonella in synthetic egg wash water at 100 degrees Fahrenheit, and she found that when the wash water pH was either 9 or 10, salmonella would actually grow in the wash water; however, as long as the pH was kept at 11 and the temperature was kept at 100 degrees Fahrenheit or above, the cell levels rapidly decreased.

 Slide

This would be an example of a HACCP approach that is now being used in egg washing, and the United Egg Producers are using it as part of their 5-Star Quality Food Safety Program, which is basically their HACCP plan.

 Slide

The process has been fully automated so a machine like the one shown here automatically feeds pellets into the wash water to keep the pH above 11.

IN the past few months, there have been outbreaks of E. coli O157:H7 in unpasteurized apple cider. The contamination of the apples by E. coli and other pathogens most likely occurs to the apples before they enter the processing facility. Again, we aren't sure.

Good sanitation practices and destruction of E. coli O157:H7 during washing should greatly reduce or possibly eliminate the pathogen from apples and apple cider.

The technology I describe today lends itself readily to a HACCP approach as you saw in the egg washing example. It is proven to work, it is simple, inexpensive, and yet very effective in destroying gram-negative foodborne pathogens during egg washing.

The same technology may--and I should emphasize "may"--be highly effective in destroying E. coli O157:H7 on apples because the surface of apples is relatively smooth, relatively nonporous, and would allow this kind of treatment to make intimate contact with any kinds of pathogens that might be present. The high pH treatment is not likely to cause any quality defects because the skin of the apple is relatively tough, the treatment time is short, and the apples are then simply washed off with cold tap water. I actually tried some applies with the treatment. I couldn't tell the difference, and my boss couldn't tell the difference either. And it could be classified as a process aid, since any residual chemicals would be washed off.

This kind of treatment might be especially appealing to smaller producers who couldn't afford expensive pasteurization equipment and also to those producers who might be concerned about the loss of cider quality upon pasteurization.

This concludes my presentation. I have article reprints and a phone number where you can get hold of my boss if you want further information.

Thank you very much.

 Applause

DR. SHANK: Thanks, Mr. Raynor.

Dr. Hopper?

DR. HOPPER: Thank you, Dr. Shank, and I appreciate the opportunity to offer some remarks for this important conference.

My name is Dr. Paul Hopper, and I am an adjunct professor in food science at Cornell University and a consultant to the food industry. I helped to organize and served as the first chairman of the International Life Sciences Institute Committee on Microbiology. E. coli O157:H7 was just beginning to surface as a significant and potentially very serious health problem, and this organism had a second order of priority at that time--the urgent need to address the issues related to Listeria monocytogenes.

Major research dollars were diverted to helping develop rapid methods of detection and understanding the source of the outbreak and achieving solutions to the problems.

I am also a past president of the Institute of Food Technologists, with our 30,000 members representing the scientists charged with responsibility for assuring the production and distribution of a safe food supply from the farm to the table or, as Dr. Cherry said this morning, from the farm to the fork.

Food science has developed in a very rapid way, and as we are seeing more and more, we are entering the realm of high technology. We now have a better understanding of the composition and processing characteristics of foods, including advanced methods of preservation and improved techniques for retaining important nutritional qualities.

As I listened to speakers yesterday, there were many arguments for and against specific measures for the control of E. coli O157:H7, especially as it related to apple juice. A few spoke about microbial control being a much broader issue than just apple juice. I share that view. Dr. Buchanan made mention of a few of the emerging pathogens that are showing up in our food supply, and the ILSI committee I mentioned earlier had identified eight such pathogens. The list has expanded since then.

With this in mind, I wish to urge the policymakers and regulatory authorities to step back and to take a very broad view of the microbial problems in our food supply. It would be shortsighted to mandate a specific solution such as pasteurization as the only answer, especially for the juice industry. Doug Archer yesterday suggested that such an approach was just a quick fix.

You have heard speakers defend the important attributes of flavor and test of unpasteurized products. Our goal is to assure safety while maintaining product quality.

New technologies that accomplish that goal should be encouraged. I would like to go on record that the alternative technologies being presented here today and yesterday must be allowed to remain as choices for the food industry so that they may turn to these to solve their microbiological problems.

Of special interest to me is the use of pulse electric field to kill bacteria in foods and bevera ges. You heard a presentation earlier today on that process. It is highly effective, costs less than a penny per liter and preserves all the good-tasting qualities so important to consumer acceptance. It may be an ideal solution for fresh juices.

A new related technology is pulsed light, which has demonstrated effectiveness in prolonging the shelf life of certain fresh fruits. FDA has just issued a regulation approving the use of pulsed li ght. And I believe that although some design work may be required on the equipment that is currently in use to adapt it to the irregular shape of apples, its use on apples may be a solvable problem.

If, however, it is determined that E. coli contamination enters the core of the apples, pulsed li ght would not be effective since it is only a surface treatment.

In summary, I would strongly recommend a regulatory policy that does not mandate pasteurization. New technologies are either currently available or on the drawing board that should not in any way be precluded as alternatives and effective measures. Good food science would dictate the prudence of keeping all of our options open.

Dr. Scarbrough yesterday made mention of some of the labelling issues, and I think that as we approach the issues of new technologies, this is an important consideration. He mentioned the fact that there are certain exceptions to the "definition" of "fresh," and I would like to suggest t hat we take a look at these new technologies and be sure they are included as possible exceptions to the existing regulations.

We all have the same goal--good product, safe product. Let's work toward that goal.

Thank you.

 Applause

DR. SHANK: Thank you, Paul.

Let me check my notes. That's the extent of the public commenters for this portion of the program. Does anyone else want the mike?

 No response.

DR. SHANK: Okay. The next subject is "Are currently available sanitizers or food additives adequate for the control of pathogens of concern?"

We will start with Dr. Larry Beuchat. Dr. Beuchat is a professor of food microbiology for the Center for Food Safety and Quality Enhancement at the University of Georgia.

DR. LARRY: Thank you, Dr. Shank.

If I could have the first slide, please.

 Slide

As someone commented earlier this morning, the danger of appearing late in programs is that others have said what you intended to say and in some instances, some have also shown the slides that you intend to show. But maybe that's not all bad. This brings home to you a third time this morning the complexity of the situation in terms of where O157:H7 and other pathogens may enter the food chain, not only for fruits and vegetables but also for foods of animal origin.

I'd like to spend a little time on this slide, but also to inform you that what I intend to do he re this morning is to walk through a number of different phases in terms of, first, presenting to you some information, largely drawn from the literature, that will give you a better feel, if you don't alrea dy have one, about the occurrence of pathogens in various types of produce, mostly vegetables, because that in fact is where pathogens are most likely or more likely to occur and grow due mainly to the pH in unprocessed vegetables; then to go into the various sanitizers that have been used, tested, evaluated, most of which in fact are not to be legally used on produce, although some are; and then to finally introduce some of the more exotic or innovative technologies, only introducing them because, as you have heard already this morning, some of these have been explained in some detail.

So to present the first slide, I am using the words "animal" or "animals" here in the broadest sense. It really includes also fowl, birds, as well as reptiles, and when we get into a situation where birds and reptiles are allowed access into the processing plant, or certainly in fields, then we also flirt with the possibility of those creatures depositing feces and those feces contaminating the surface of produce that we may take from those fields.

It is a complex slide. Feces is at the top, sewage, water and soil, and all of these routes, all of these factors in the environment, can serve as vehicles to contaminate produce, fruits and vegetables included, and reach the consumer in that manner, and also through cross-contamination wit h foods of animal origin, and certainly in the case of O157:H7, contamination through contact of the fruit and vegetables or the processed juice with hands or directly with the meat--in this case, beef--that may contaminate the produce with O157:H7.

 Slide

Now, we talked about farm-to-fork, so we need to consider pre-harvest and post-harvest phases of produce in general in terms of where the pathogen may enter the scheme. I would also say that we need to consider prior to the farm--in fact, breeding--breeding of plants or producing certain fruits or vegetables with characteristics that are usually largely more resistant to drought, more resistant to infection by fungal pathogens, perhaps less acid, higher pH in the case of tomatoes. We need to go back even before the farm, and we need to talk about plant breeders in this total system sometimes of exploring the susceptibility of growth of pathogens certainly in the fresh produce and fresh produce products, such as juice, that consumers enjoy so much.

 Slide

So I'll go through some of the pre-harvest avenues, if you will, and I have listed some of these in the first slide--certainly, feces, soil, irrigation water, dust from the air both in the fields and at any phase after harvesting, wild and domestic animals, including birds and reptiles, and of course, human handling in the field prior to picking from the plant or from the tree and so on.

 Slide

This is a slide showing the animals, mammals and other creatures, from which Listeria monocytogenes has been isolated. I don't have one for E. coli O157:H7; certainly the observations and the reports are much less extensive there. But I think you can see from this slide, at least with regard to Listeria, that it can be isolated from nearly anything that flies or walks o r crawls. Listeria is certainly a lot different in terms of its prevalence in nature, its growth habi tats than is E. coli O157:H7, being capable and in fact liking to grow on decaying vegetation, so we get the possible transfer of the organism from decaying vegetation and living vegetation in the field to our produce as we pick it and take it to the processing plant.

Next slide.

 Slide

Somebody asked about survival of O157:H7 in the soil, in irrigation waters, perhaps sewage. I don't know of anything available on this, but here are shown some work, some data that are not from our laboratory, but from others, looking at the fields, soils, and the prevalence of Listeria i n those. There is also some information available on salmonella and the viability of salmonella in soils that have been treated with manure. I didn't bring that slide with me, but there are some dat a available on salmonella. I don't know of any available on O157:H7.

Next slide.

 Slide

Going then to post-harvest sources of pathogenic and other microorganisms, again feces, human handling, workers and consumers. We need to look at handling by the consumer as part of this total process of providing safe food as that food enters the human mouth. The consumer is not exonerated and should not be left out of this picture. Also, harvest equipment at any phase in the field; transport containers, field to packing shed; again, dust in air, wash and rinse water, and sorting, packing, cutting, drenching and so forth equipment in the plant.

Next slide, please.

 Slide

This is a continuation of post-harvest. Ice can be a vehicle through which pathogenic bacteria a re transported and come in contact with produce; transport vehicles; cross-contamination with other foods during storage, during processing, preparation and in display areas, certainly in restaurants, food service operations and in the home; environmental factors such as the environment within the wholesale and the retail purchase area.

Next slide.

 Slide

Occurrence of pathogenic bacteria on raw fruits--listed here are some of those. I should have al so listed Vibrial cholera  phonetic , which of course is a contaminant in some countries of fresh produce and can serve as a vehicle in those communities to increase the number of people suffering from cholera. Water, in fact, is the vehicle which is used to wash fruit, and then fruit is consumed without the killing of the vibrial  phonetic .

Some of those that are listed here include E. coli, not only O157:H7, but enterotoxigenic E. coli as well.

Next slide.

 Slide

I am going to show you a series of slides here. Most of these are vegetables, because that again is where most of the data have been collected. Individuals from around the world have selected, collected vegetables and fruits from the marketplace, and they have analyzed for various pathogens. In some cases, they have analyzed for pathogens, and they have not found any. I am not showing you those data, but in those cases where certain lots of, for example, beansprouts have been analyzed, they have found levels of in this case monocytogenese, up to 85 percent. You can read these as well as I can recite them here. They are actually listed in alphabetical order, not necessarily in terms of prevalence on the samples that were analyzed.

Next slide.

 Slide

This is Listeria, and the next slide continues on Listeria, which is perhaps more prevalent in ro ot crops if we look at these data as a composite, but not necessarily only on root crops.

Next slide.

 Slide

Going to staphylococcus, which is generally not considered and in fact probably not a real problem in fruits and vegetables, but we see lots of fresh, unprocessed fruits and vegetables being used in various dips, salads and so on, sometimes with reduced water activity. Staph is not a tremendously competitive organism among the pathogens and against natural microflora, but this is again to show you that  unintelligible positive Staphylococcus aureus does show up on fresh produce.

Next slide.

 Slide

Salmonella on raw vegetables. There is plenty of information to indicate that we do find salmonella on raw produce.

Next slide.

 Slide

This shows more salmonella on raw produce in different countries around the world.

Leafy vegetables, that is, those that have large surface-to-volume ratios, are likely to contain more natural-occurring microflora as well as pathogens. It just stands to reason that that is the case.

Next slide.

 Slide

Now, the O157:H7, Shigella and Campylobacter and also Bacillus cereus are shown on this slide, so this gives you an indication, at least from my search of the literature, what I can find. I shoul d tell you that this information was collected about 10 months ago, and there may be more now.

On the O157:H7 there out of Mexico, showing fairly high levels, there is some reason to believe that the methodology there may not have been up to what it should have been, but it indeed was reported that O157:H7 was isolated from cabbage, celery and cilantro. Again, I would caution you on these data because the methodology may not have been appropriate. Shigella, Campylobacter, Bacillus cereus not only present on fruits and vegetables but also certainly associated or linked with outbreaks by these organisms.

Next slide.

 Slide

Viruses are shown here. One of the most recent investigations that I discovered in the literatur e is the last one there, the enteroviruses, which can survive on radishes, tomatoes, lettuce and carrots at refrigeration temperatures for periods exceeding normal shelf life, whatever that is, but at leas t for periods of time that the consumer would be actually purchasing and consuming it.

Next slide.

 Slide

Now, there are many factors--some of them listed here, as well as others--that are used to contro l the growth of microorganisms, pathogens included, and also to kill, that is, to assist in killing, pathogens, microorganisms. Of course, time--the longer we give in terms of storage, the more likely, it the organism is there to grow, if the conditions other than time are the factor involved.

Temperature--refrigeration is a tool that certainly can be used to control the growth of organism s. If it's a high temperature, we can kill through pasteurization vegetative cells in fruit juices, vegetable juices, and perhaps on the surfaces of intact roots.

pH and acidity--there has been a lot of discussion here this morning by the previous speakers and also by the commenters on pH and acidity. There is a range within which every microorganism will grow and become tolerant outside those ranges to pHs, and also not just to pH, but the acidity, the type of acidulant present, whether it be malic acid in the case of apples, citric in th e case of citrus, and so on. It is more than just the pH; it is indeed also the acidity that we need to consider, the acidulant in terms of inactivation power, if you will.

Water activity--that's something we don't have much control over in fresh juices, nor in fresh produce or whole produce. Water activity is high enough to support the growth of nearly every pathogen, certainly.

Atmospheric gas content--modified atmospheric packaging can control the growth of some microorganisms; on the other hand, if it is controlled in terms of very low oxygen tension, we enhance the probability of some other pathogen--clostridium botulinum  phonetic , for example--growi ng, not having the competitiveness of the natural microflora that I have also listed there.

I have listed this competitive microflora because--and this was touched on earlier--bacteriosins and the production of small molecular weight compounds that are actually antimicrobial, other than acids themselves, do have a potential for application in controlling the growth of microorganisms on food or perhaps the incorporation of those chemicals into waxes, for example, or edible films that might be used for whole fruits.

Next slide.

 Slide

This is trying to depict some of the things that I just covered in the last two slides. IF we consider, for example, on the right, the pH, the water activity, perhaps not so much the oxygen tension or the redox  phonetic potential, temperature, nutrient availability, among the various factors that influence each microorganism in terms of growing and surviving, it sometimes--and often, in fact--will require more than one hurdle. Some of you have heard of "hurdle technology." It's really nothing new, but it is something that implies and in fact exists in terms of subjecting a microorganism to more than one stress factor simultaneously, to either prevent growth or to inactivate the organism. We heard about the combination of high temperature and alkaline conditions earlier this morning from one of the commenters; this is another example.

The point I want to make here is that if you add these hurdles, any number of them in combination--and they have to be hurdles that can be used in particular situations--processing or a particular product--the more hurdles you have, the less likely you are to have that target pathogen or pathogens in general to grow. On the other hand, you can use those hurdles to reduce the severity of, for example, heat treatment in arriving at a condition that will reduce the pathogens that may be present.

So it is a pendulum kind of thing. The more hurdles you have, the higher the stability of the product or the higher the likelihood that you will kill microorganisms that are targeted to be killed.

Next slide.

 Slide

I'll go through these more or less in order as I have listed them here, and this is getting to th e real topic that I was asked to speak on. I have divided them into three categories--chemical, physical and modified atmosphere--which is probably a combination of chemical and physical attributes or treatments that can be applied to control the microbial growth in all types of foods--chlorine and chlorine dioxide--of course, the bulk of information in the literature and in the field, in the processing plant, is knowing about chlorine--I'll say a little bit about natural antimicrobials, traditional sanitizers and bacteriosins--I have already talked a little bit about that--ozone; I won 't go much into the irradiation electric field, light and so on, because those have been covered; and finally, modified atmospheric packaging.

You will recognize already that some of these, of course, cannot be applied to certainly cut produce nor, in some instance, even whole apples or whole produce prior to processing or prior to development and marketing as whole products.

Next slide.

 Slide

These are some effects of the data, and this is drawn not from our research but from others. Thi s shows the effect of chlorine concentration on total microbial populations in minimally-processed salad greens or green salad. Giving you here the count, the log--I'd like to point out that rather than giving whole numbers, I have given logs, but consider when you see a 4, the 4 means 4 numbers to the left of the decimal place; in other words, 4.5 means somewhere between 10,000 and 100,000 and so on. Now, if the log count originally was from 4.5 to 5.0, and you treated with, for example, 200 ppm, then what happened was that the percentage of samples that you treated that way would--excuse me. I'll back up. If you started with the very high level, greater than 6.5, and you treated with 200 ppm of chlorine, active chlorine, you'd end up with 6 percent positive samples in that range of 4.5. In other words, as you increase the chlorine level, certainly you do reduce the populations on the product, but even at 200 ppm with a greater than 6.5 log number at the beginning, you certainly don't eliminate--only 94 percent of the samples would be in that range of 4.5 to 5.0.

Next slide.

 Slide

These short descriptions here I have really taken from a number of papers that have been presented and have been published, just to give you an idea of, number one, the difficulty of comparing information, apples to oranges, as was so often described yesterday, but also even within oranges, within apples, the observations that have been made by many laboratories.

I won't read all of these, but to give you some idea, some have looked at as low as 20 ppm micrograms per ml, in this case, 200 ppm. A contact time of 20 minutes does not change the aerobic count, and that's not terribly surprising. But 300 ppm reduces the total counts of lettuce by about 2 log.

In my experience in our laboratory and reading other reports from the various researchers, if one can get a 2 log reduction from the surface of fresh produce, consider yourself fairly fortunate. You would more likely be able to detect less than 2 log reduction, sometimes a little more.

Next slide.

 Slide

This is a continuation of some of the reports, approaching 300 ppm as the third entry there; treatment of whole tomatoes with Listeria does not affect growth of the Listerium during subsequent storage. This is actually some of the work that we did.

I am presenting observations here not only on E. coli O157:H7, because there are few, but some of the other pathogens. And while you cannot and should not directly control the observations, the behavioral patterns of other organisms, pathogens, to E. coli, sometimes we do learn, and we can with some note of assurance, transfer, translate information that we get, especially from gram-n egatives to O157:H7.

Next slide.

 Slide

These were actually some studies that we did with Salmonella montevideo on tomatoes, and this was in collaboration with CDC. This was with not ripe tomatoes, but with mature green tomatoes, and it actually came out of observations that there were some outbreaks associated with consumption of ripe tomatoes with salmonella in--I believe it was 1993 or 1994. Just to show you that even at 320 ppm on the surface of the mature green tomato--and also on ripe tomatoes, the same would hold--we don't get inactivation by much more than one log, that is, a power of 10. The letters that follow these numbers here, if the letters are different--the "A," for example is different from "B" and "B" from "C"--that means a significant reduction, 95 percent level.

We looked at the core, we looked at the tissue. I think Dr. Buchanan or someone else mentioned in the meeting that it makes a big difference in terms of the differential in temperature of the treatment water versus the fruit or vegetable that you actually submerge in that treatment water with regard to the possible uptake of the water and whatever may happen to be floating around in it--in this case, salmonella that we had actually put in that water.

Next slide, please.

 Slide

The basic phenomenon is depicted here. The temperature of the tomato in this case is 25 degrees. If, on the left-hand side, you put that tomato in some water at 10 degrees Celsius, you would probably have uptake of, in this case, salmonella into the stem/core tissue area. That is a more porous area on the tomato fruit.

If, on the other hand, the tomato was submerged at 25 degrees into a bath of 37 degrees Celsius, the likelihood is that the tissue within the tomato swells, you have gas formation, and you have a positive pressure outward. And we actually demonstrated this in the laboratory with salmonella in tomatoes, and it was an observation made several years ago about internal spoilage of tomatoes, and that is why the tomato uses packinghouse water bath temperatures; they try to use at least 5 to 10 degrees higher than the fruit itself.

Whether the same thing happens with apples, I do not know. I have not done any work on that, and I don't know of anyone who has. But the phenomenon may also transfer to apples and other fruits as well.

Next slide.

 Slide

There has been a lot of discussion about whether or not E. coli is in or on the fruit. This depi cts some studies done about 20 years ago on tomatoes. This is to show you that, for example, on the bottom left-hand corner, from 104 tomatoes in 3 fields, the percentage positive isolation within these various regions are shown. For example, the "81" there, just below the stem, means that 81 percent of the samples contained bacteria microorganisms. In this case, they weren't actually identified. But even internal, in the flesh and in the lacheal  phonetic area, one does pick up microorganisms. Whether they are there from the pollination of the flower and continue to be there and survive and can be detected at maturity, I don't know. Whether E. coli or salmonella could do the same, I don't know. But the possibility exists, and I think we need to try to determine whether or not this in fact could happen with pathogens.

Next slide.

 Slide

The point is that if they are internally, then surface decontamination processes may not necessar ily work. To drive the point home, this information is from cucumbers, showing the number of samples analyzed--there were 25 cucumbers per sample--the number of positive, internally-borne microorganisms up to 100 percent in the case of Sample 4, and the percentage of the positives that were enterobacteria are listed on the right. These reports are from the literature having nothing to do with pathogenic microorganisms; they are from horticulturalists who are looking at these vegetables in this case for very much different reasons than we are interested in here today, but I think they provide information that is useful in trying to explore and trying to complete this picture if we can on the behavior of E. coli O157:H7 and other pathogens in fruits and vegetables.

Next slide.

 Slide

We have done some work on alfalfa seeds and also on alfalfa sprouts, also in collaboration with CDC. As you may know, there have been a number of outbreaks of salmonellosis associated with consumption of alfalfa sprouts, and what we wanted to do here was to determine the efficacy of chlorine on the inactivation of salmonella, which we had inoculated onto the seeds.

AT 1,000 parts per million, we could detect salmonella after 10 minutes' treatment of the seed; w e could still detect salmonella at 37 CFU per gram of seed.

Next slide.

 Slide

This shows a little higher level, 2000 ppm, 4000 ppm. We could not detect at 2000 or 4000. These studies, however, were not done with enrichment, and we could isolate through enrichment processes salmonella that had been treated with 2000 ppm.

What is happening here is that salmonella in the treatment process is gaining access between the cotyledon and the testa, into areas where at least the chlorine active levels--is not active; it is not reaching that area where the salmonella may be lodged. So in a batch of alfalfa seeds, which are very small, you may have one or two damaged seeds, you may have one or two that have the seedcoat slightly cracked or something, and salmonella is entering there, and we are not getting the chlorine to that.

 Slide

This slide shows you what happens if you have relatively high levels of salmonella, and we inoculated the seeds, again at the beginning. The first olive-colored bar, the 6-hour bar, shows you the area in which the seeds are actually soaked before they are subjected to the next area, which is about 24 hours on a commercial level of germination. The seeds are then transferred to either individual trays or pots, and they produce the sprouts. You can get from a little above 10 to the 3, a little above 1000 per gram of seed, up to easily 10 to the 7 during that relatively shor t incubation period. If you hold the sprouts for an additional 10 days at 10 degrees Centigrade, not much happens; the salmonella lingers there 342 hours after actually preparing or producing the sprouts, which would simulate what would happen in the marketplace.

Next slide.

 Slide

Some of this information I think is applicable. We can learn from the observations here what might be happening in some cases in the O157:H7 area.

These data here do show O157:H7 on, in this case, alfalfa sprouts. We inoculated the sprouts--an d again, the letters above the bars indicate whether or not there are significant differences among treatments. The blue bar is the control--that is, inoculation of sprouts, analyzing the sprouts for the presence of O157:H7. The water is a wash water, just potable, sterile water.

Then we also treated the sprouts with 200, 500 and 2000 ppm of chlorine. We were not able to pick up any O157:H7 with the 2000 ppm treatment. We also looked at hydrogen peroxide, and I believe Dr. Sapers will have a little more to say about that on melons from his laboratory later. We got some efficiency, some effectiveness, with hydrogen peroxide, about the same, really, as chlorine--for example, 5 percent and 500 ppm. Seventy percent ethanol does a pretty good job, too, but it also causes problems in terms of desiccation of the sprout, and also you get some aromatics. There are also some problems with hydrogen peroxide in terms of foaming, so the answer isn't complete there.

 Slide.

That was sprouts. This slide shows you what happens on cantaloupe. We didn't have much success here. We used the same type of treatment--inoculation with O157:H7--and we got about a log reduction with 200 and 500 ppm of chlorine; a little more than that with 2000, and about the same with hydrogen peroxide. This is treatment of ripe cantaloupe cubes, inoculating with O157:H7, treating as you see here. So there is certainly a ways to go here in terms of decontamination, getting rid of the O157:H7 in at least cantaloupe cubes.

Next slide.

 Slide

We have also evaluated in our laboratory or are in the process of evaluating a product that has been developed not necessarily for the processing environment, but rather for settings in food service operations or, more specifically, in the home. It's a total systems project in terms of try ing to control the access of these pathogens to fruits and vegetables and trying to get rid of them, maintaining conditions which will prevent their growth, from breeding through consumption.

This product has been developed, and we are working with a commercial firm on this, but it is to be applied to the product immediately before consumption. All the ingredients are GRAS  phonetic , and it removes wax from the surface of the fruit or vegetable, also chemicals, dirt and microorganisms that naturally inhabit the surface of plants, fruits and vegetables included. As I say, it has been developed for consumer use or in restaurant settings. For apples for immediate use in processing of juice, it may also work quite well. If it going to be used, however, it needs to be used probably prior to--fairly soon before processing--because if you, for example, remove the wax and then store the apple or other fruit, you may get some degradation and some changes in the surface color and appearance that would not be desirable.

Next slide, please.

 Slide

This slide shows you the data that we have collected on apples--we have also been working on tomatoes and lettuce--with three pathogens shown here on the left. The initial levels--this is per square centimeter of apple. We had a water control. We also looked at chlorine at two levels, for O157:H7 and Listeria, and then the PWP, which is the Produce Wash Prototype that is being evaluated.

We do observe with this product that we get as good as, and in some instance significantly better , reductio of pathogens with the PWP compared to chlorine and water. So we are continuing this work, and if anyone would like to have more information on it, I'd be glad to put you in touch with the people who can give you that information.

Next slide, please.

 Slide

To give you some idea of why it may be so difficult to remove pathogens from anything, including fruits and vegetables, this gives you some idea of size. Human hair, depending on the fineness, is 100 micrometers; yeast, about 25 micrometers; bacteria, from 0.5 to 5--there are larger and there are smaller, but that gives you some range.

Next slide.

 Slide

Now, the surface of, in this case, a blade of wheat--this is actually lactic acid bacteria on fermenting wheat--you can see the topography of the wheat, the size of the lactic acid bacteria, which are the rods there, which are perhaps bit larger, yes, than E. coli or salmonella, but in the same range, but the difficulty with scrubbing, the difficulty in removing these microorganisms, these cells.

Next slide.

 Slide

This and the next two slides will show you the topography of apples as they are taken from the tree, with regard to deposition of the cuticle, that is, the waxing material that builds up on an apple while maturing, during growing on the tree. This is actually from Washington State University, data that was published many years ago.

This was a June apple. Notice the relative smoothness of the surface of the apple.

Next slide.

 Slide

In July, the topography has changed.

Next slide.

 Slide

And August.

The point to be made here--a gentleman earlier this morning indicated that apples are relatively smooth--yes, but relative to what? They aren't exactly the smoothest surface. They also have as a natural part of them lenticels, as do other fruits, the incorporation of air or the respiration equipment, if you will, that is a natural part of fruit. The point I want to bring home to you is t hat during the growing process, perhaps microorganisms that contaminate the surface of the fruit or vegetable, become lodged because of scratches that may occur, the roughing of leaves or birds or insects--you may have organisms that are attached and are not easily removed by water or even chlorinated water, so the necessity for perhaps a sanitation system that would remove wax and then begin from there. If you are going to remove the wax in processing the juice, you may be several steps ahead in terms of removing the natural microorganisms as well as pathogens that may be incidental to the surface.

Next slide.

 Slide

Chlorine dioxide--I don't have too much information on this. There hasn't been a lot, at least i n the public literature, although I know there are a number of people working on it, and I understand that it is used in tomatoes, especially in California, and to some extent in apples.

But to give you an idea on the relative kill, a lot of the work here has been done with fungal contaminants for the purpose of controlling fungal growth, usually in storage, but it is also active against salmonella in poultry, not permitted, as I understand for use certainly in cut produce, with the exception of potato, shell beans and pea--it can be used at a much lower level, certainly, then hypochloric acid and get similar effects.

There is a petition, or has been--and perhaps my last bullet is outdated; I don't know what the situation is now in terms of it being given the go-ahead to be used on fresh-cut fruits and vegetables in general rather than selected items.

Next slide.

 Slide

Tri-disodium phosphate, of course, has been looked at and can be used for disinfecting or sanitizing surfaces of poultry. We have looked at the use of TSP on tomatoes and found that we get, with different concentrations of TSP, a substantial reduction. Even at 4 percent TSP, we get a reduction of about 2.5 logs, and at 10 percent we get essentially total reduction--although again, this was not an enrichment procedure, but just to show you the magnitude of effect on the surface. In the core, it's a different story. This TSP just does not reach the core tissue area. T he mechanism here is largely an alkaline one, and the infiltration of that TSP into the core tissue are a of the tomato certainly is not as great or not to the extent that it will kill more than about 2 log s even with a 15 percent level in the dip bath.

Next slide.

 Slide

Organic acids--I have alluded to these before--certainly citric acid, which is a natural componen t of citrus fruits, and also malic and some of these others can be applied, can have beneficial effect s, have been demonstrated to be successful to an extent on meat produces and probably also could be for surface sanitation of fruits and vegetables, either cut or whole.

Next slide.

 Slide

In fact, these are data out of the University of Guadelajara in Mexico where they actually applie d fresh lemon juice to the surfaces of watermelon and papaya, with or without--the "without" being the minus here, and the "with" the plus--just applying fresh lemon juice, and the far right-hand column is the one that I'd like to bring your attention to. You can get some reduction in percent survival after treatment of the cubes with lemon juice, citric acid.

Next slide.

 Slide

This is some more work done out of Mexico, this time on Campylobacter, showing essentially--well, at least the same situation--in this instance, it's papaya and watermelon--although here, you get a reduction, and eventually, after about 6 hours, some recovery of the organism. But again, something as simple as the application of citric acid or, in this case, lemon juice, may be one of those hurdles in the hurdle technology process.

Next slide.

 Slide

This is salmonella, showing some similar data. I won't dwell on it, but just bring to your atten tion that--and we talk about cubes here, but it's really juice and fruits that we're talking about becaus e that is cut produce where the pathogen is floating around.

And incidentally, these were inoculated, not samples taken from the marketplace.

Next slide.

 Slide

Ozone, of course, can be used and is used in bottled water. I believe it can be used in water tha t has been used to wash produce, but not water that will be used for produce. But it does deserve some further look in terms of its effectiveness against not only parasites--and it seems to be quite effective against that group of microorganisms, more effective in water than in air--there have been people looking at the gaseous phase--however, we may get degradation especially in lipid components of flavor.

Next slide.

 Slide

This is some more information on ozone at fairly low levels. I'll bring you down to the third bullet. Treatment of dried peppercorns with 6.7 ppm for 10 minutes reduces E. coli, salmonella, staph, and Bacillus cereus by 5 logs. So you get a pretty tremendous reduction of population even in the dry state.

Next slide.

 Slide

Again, ozone. Cryptosporidium oocysts are much more--30 times more--resistant to ozone and also more resistant to chlorine dioxide than Giardia--that's a relative difference in the two parasites. But overall, probably ozone, at the effective level, would be more effective in killing oocysts than chlorine would and than chloride dioxide is.

Next slide.

 Slide

Just to pass over this briefly, there are a lot of naturally-occurring antimicrobial substances, compounds, in fruits and vegetables or stems or leaves that protect the plant in fact against invasion or, if invaded, proliferation of contaminants in the field, and we know a lot of those, and I think that maybe we should look at little more closely at some of these. Many of them are flavorless, colorless, odorless. They may not at this point in time be economically feasible in term s of using them for a natural applicant, but it's part of that hurdle technology. We've noticed over the years that the gram-positive effect of Listeria monocytogenes--and others have also--in the presence of carrot juice are actually killed--the carrot juice is toxic. We have noticed this also with O157:H7, but to a lesser extent.

So just to bring to your attention that there are compounds that are produced in nature by plants that are used by the plants to guard against invasion and proliferation of organizations. Can we not harvest or even synthesize and apply them in fresh fruits and vegetables or in juices?

Next slide.

 Slide

Physical treatments--I've gone through the chemical ones--these are the physical ones, and I'm no t going to spend much time. The information has already been presented. But I did want to again bring to your attention, in anticipation that others would present information, these alternatives.

Next slide, please.

 Slide

This is the high-voltage pulsed electric field. This is with Listeria monocytogenes, different f rom the slide that was shown earlier. I always have trouble with these three-dimensional things. The message to be taken home here is that the number of pulses, which is "N" here, the increase in the number of pulses, and the increase in the field--that is, chemical per centimeter--if those are increased, either independently singularly, or in combination, you get a higher kill; you get lower survival. The information is presented in percent survival and also log. This is Listeria monocytogenes.

Next slide.

 Slide

Preservatives--now getting to apple juice--and some of this information has been alluded to earlier--Fred, how many minutes do you want to give me?

DR. SHANK: Wrap it up, please.

DR. BEUCHAT: Okay--the program reads that I can continue after lunch, but I don't think I want to do that.

These are actually data from our laboratory, from Mike Dole's  phonetic work, showing you again here in this case, no preservative added to 5 lots of apple juice and then inoculating the apple juice with the O157:H7 and following whether or not we could detect it after 15, 20 and 28 days. In one case, after 28 days, the organism could be isolated. This was at, I believe, 80 degrees.

Next slide.

 Slide

Again looking at benzoate, 1,000 ppm, certainly you can reduce the time through which you can actually detect the organism.

The next slide will show you information on sorbate.

 Slide

Sorbate doesn't, on an equivalent weight basis, do quite as good a job as benzoate, but combining the two--next slide--

 Slide

--ppm each will show you that you can get with 7 days, perhaps even between 3 and 7 days' reduction of 10 to the 5 to undetectable levels.

Next slide.

 Slide

There was some other work in other laboratories looking at sorbate and benzoate also in apple juice--this is a report that was subsequent to Mike's work--also of 500 and 1000 ppm, which shows you quite different observations, that is, that the organism survive, at least at initial populations of 3 times 10 to the 4. However, as I read that report, these apple juices were purchased, commercial apple juices, and it was on the label that there was 1000 ppm sorbate or benzoate, or 500 ppm, but actually, I don't know whether the sorbate and benzoate were actually measured in the laboratory, so you have to take that into consideration.

Next slide.

 Slide

From that same laboratory, we see survival of O157:H7. Going across the bottom there, pH 2 is the triangle, and in fact, at 4 and 25 degrees, you have survival for 24 hours, at pH 2, also at 11, but not at 12. This was not in apple juice. It was in a laboratory broth.

Next slide.

 Slide

We have done work with O157:H7, inoculating onto cantaloupe cubes and looking at the levels in the populations through time out to 35 days in the case of the rind surface; also, watermelons stored at 5 and 25 degrees. We observed growth of the organization on the surface of cantaloupe and watermelon stored at 25 degrees under a high humidity environment. We observed that nothing much happened; it survived but didn't grow at 5 degrees--it's not too surprising that it didn't grow, but we were a bit surprised that it didn't die.

Next slide.

 Slide

On the cubes, there was growth on both cantaloupe and watermelon cubes within, I think, 4 days. This may be a bit stretching it in terms of days of storage.

Next slide.

 Slide

That's the last slide, to bring you a pleasant picture of fruits and to again bring home the poin t that I hope to make with you, that yes, we can learn a lot from the knowledge that we have on other pathogens; yes, we know very little about the ecology of O157:H7 in natural habitat, and what we do know is mainly with animals, mainly with cattle, but that the total approach, the total systems approach--I'm going back to the breeding program, through consumption--needs to be considered in developing good sanitation, good GMPs, and effective HACCP programs.

Thank you.

 Applause

DR. SHANK: Thank you, Larry.

There are a couple of housekeeping things before we break for lunch. It's important that you be back in an hour, which would be 1:25. You may want to take a little extra precautions while you are out. We will not have a break this afternoon; we will run straight through. So be back in an hour, if you would, and we'll go from there.

Finally, if Dr. Hei is in the room, I'd like to speak with him, please.

 Whereupon, at 12:25 p.m., the proceedings were recessed, to reconvene at 1:25 p.m.

AFTERNOON SESSION

 1:25 p.m.

DR. SHANK: Prior to our lunch break, we were in the process of talking about sanitizers and food additives that may assist us in this problem. Dr. Beuchat gave us quite an exhaustive presentation.

 Laughter.

DR. SHANK: You might laugh, but you've got to admit that it was a good presentation.

Dr. Robert Hei, who is a senior scientist with Ecolab, is going to also address that subject, and if Dr. Hei is ready, and if you could keep the noise at a minimum as you file in, we'll go ahead with Dr. Hei's presentation.

Again, Dr. Robert Hei, who is a senior scientist with Ecolab, addressing sanitizers or food additives that may be adequate for pathogens.

DR. HEI: Good afternoon. I'll try to get through this quickly, and if you have questions, we ca n talk about it after, but because of the time constraint, we will pace through this quickly.

I want to talk about some new research results which have come up in the area of flume sanitizing and transport water treatment. Yesterday and today, we've heard a lot of discussions about transport systems, the importance of maintaining a low microbial growth in these systems, and also we've seen various treatment chemical systems for these.

Now, on September 3rd of this year, the FDA approved a new antimicrobial agent for flume water treatment--it is peroxy acetic acid--and I am going to present some actual field test results and actual plant production results today.

I have noticed from the literature as well as some of the information presented over the last few days that the microbial reductions which were given were for potable water systems. I think most of the processors out there would recognize that their potable water system in a flume transport is not potable within minutes of operation. Many times, these things will actually go to being opaque in the water quality, and they will have total dissolved solids in the tens of thousands, and they will have turbidity measurements usually in the five to tens of thousands in terms of the turbidity.

Under these conditions, this is where many of the past adjuvants to flume systems have failed--th e chlorines and chlorine dioxides. What I'd like to present is some new information.

 Slide

We are going to go through this real fast. For those who aren't familiar with Ecolab, it's a worldwide supplier of cleaning and sanitizing products for the institutional and food and beverage markets. We have around 600 technical persons only, besides all the other sales and marketing staffs, in two world headquarters, and then there are many satellite technical service plants.

 Slide

Ecolab's food research stems from its leading position as a hard-surface sanitizer company. We have pioneered the use of many antimicrobials over our many decades of being a company--things like the chlorines, the iodines, the QACs, and there are 30-plus approved compositions.

At present, we are interested now in--and I am saying from the hard-surface sanitizing, the peracid-type compounds. One example is called Oxonia Active. There are other organic acid-based on es which we find in the dairy area, such as this Mandate. In the future, I foresee modifying these and going to a variety of mixed peracid systems.

Next slide.

 Slide

Now, technology leadership. What we have done is we have taken proven hard-surface chemistries in terms of sanitizing on a hard surface, and now let's get it over into let's call it t he water or a produce surface.

We can look at let's adopt old technologies, adapt them to our new use and then innovate them from there on. We can look at the older systems of, again, using organic acids. Then we can move on to the peracids, the Oxonia--a very proven and effective hard surface sanitizer. We can take that, and we can expand that kind of chemistry to a variety of applications. I have listed a few. In the farm market, this Oxy step is for treatment of hoof wart on cattle; in hatcheries, for egg treatment; in health care, there are a variety of applications. The fruit and vegetable processing, we have a product called Tsunami, on which I'll present data today; aseptic packaging, and there is a variety of others.

Next, please.

 Slide

Now what we need to look at is what is the current situation; what can we put out there--and I haven't listed everything. I believe that these three materials are the predominantly used material s on the market--the chlorines, the chlorine dioxides, and now peroxyacetic acid. All of these, as you should be aware, require a potable water rinse at this time.

Next slide.

 Slide

What I decided to show here, quickly, just for people's information, is what is peroxyacetic acid , and where does it go in the environment. We heard yesterday that, well, when we treat to high with sodium hypochlorite, we get too much sodium in the water, and there are problems. Peroxyacetic acid is synthesized from acetic acid, hydrogen peroxide, and a variety of catalysts which are in there. Its decomposition products are acetic acid, which most people recognize as the major ingredient in vinegar, and oxygen.

 Slide

You have seen pictures of flume transport systems. Again, this is what we're talking about, wher e we might have a variety of flumes which include a dump flume. These will contain a lot of soil matter and a lot of organic matter; they can be transferred throughout a plant facility by a variety of belts, you might see fresh water sprays, and go through a variety of flumes. These are the areas that we are talking about treating.

The importance here is that this is early on in the process. Many times, as we heard yesterday, they move these flume systems outside the facility, and you can effect, if you use proper chemistries, microbial keels early in the production scheme.

Next, please.

 Slide

Now we are going to get into an actual plant trial. This was a very large--nearly 100 million pounds per year--tomato processor, and they were utilizing chlorine dioxide in this system. It is i n a secondary flume, not the primary dump where the tomatoes are initially dumped, but this is the secondary system which transports them within the building. They were trying to utilize chlorine dioxide but were having problems of off-gassing and microbial control.

As you can see, they run around 10 to the 6 counts. This is total plate count here. We went in and treated with 30 ppm peroxyacetic acid. The counts have dropped down to around 10 to the 3, 10 to the 4, and more recently, you can find numbers down in the 10 to the 2 and 10 to the 3.

Next, please.

 Slide

Here is another field trial--now, you have to remember that all these have gone on since September, so we have been fairly racing around, and many of these have extended for up to a month's time. This is in the Midwest. They are treating whole cobs in a cooler, and sodium hypochlorite was being added between 50 and 100 ppm. This is the coliform. You can see that some days, they would get control, other days it was not so effective. It depended on soil load.

We started treating with peroxyacetic, which you can see about halfway through the graph. The coliform counts have dropped down. They had a spec limit of around 100 that they liked to maintain, and now with peroxyacetic, they are below that level all the time.

Next, please.

 Slide

Here is another corn count. In this case, it's not a cob cooler. One reason I am throwing these out is that the first one, the tomato, the water temperature and the soil type are quite different. The water temperature in that case was around 75 degrees. The cob cooler in the last one was around 37 degrees. In this case, it's a corn water flume, and here, it is running more like 90 degrees Fahrenheit.

In this case, this was a side-by-side trial against chlorine dioxide, and currently, we are runni ng the whole plant on peracetic. But we went in, and on a side-by-side sister trial, we compared the two. What we find here is that in the coliform, you can see the upper curve. That is the chlorine dioxide-treated curve. What they had wanted to have was a coliform number under 1,000 consistently, and the lower one is the peroxyacetic treatment. Both of these were done on an equal cost-to-use basis.

Next slide.

 Slide

This is that same field trial, and instead of being in the water--the last one, we were talking a bout the flume transport water--this is the cut corn now, the surface of the cut corn that comes through this flume. What you can see, again, looking at coliform under the chlorine dioxide system, they had very sporadic results. Under peracetic acid, it's easier to stay within--and in this case, they want to be under 200 counts--it's much easier with peracetic acid.

Next, please.

 Slide

This is some very recent data, and it is in an onion cooler. Again in this case, it's a very col d water system running right around 34 degrees. They have looked at chlorine dioxide, and it does work in this case. You have a very cold water temperature. It is a relatively clean system that's just used for cooling an onion core. We went in with peracetic, and you can see the two treatments. On the SPC, with 30 ppm treatment of peracetic, we get around a 2-3 log reduction in the water, and the coliform, again, around a 2 log reduction. We are getting some surface onion results that look very promising, and it will be within the spec that's required in this application.

Next.

 Slide

This is a case of a potato cutter flume. It's actually a mix of a sorter and a potato cut. Here again, just looking at various microbial counts in the water--you'll have to excuse me--I'm an organic chemist, and E. coli to me is like an organic chemical--but without treatment, you can see the SPCs.

When people were talking--this is why I was disturbed by seeing clean water. This is the background water. This is within minutes of starting up this flume process. You are in the 7 log area. With 45 ppm treatment, we go down to about 3 log. The coliform goes from around 10 to the 5 count down to less than 1, and the E. coli goes from 10 to the 4 down to less than 1 in this system.

One thing to note is that the potato surface reduction here is around 1.5 to 3 logs.

Next slide.

 Slide

Now, before we move on to the so-called "fresh-cut" situation, I'd like to state that I don't hav e apple data or other fruit data other than the tomato given earlier today, but I really believe that it's reasonable to assume that application of peracids, products like this, to other produce in a flume system, transport water, a washer or some type of holding tank, might yield very similar results.

This is also some data that we are just exploring now, and this is the treatment of fresh-cut, th e other being what we call "post-processed." But right now, as of today, as I understand it, the only available material out there is chlorine, and it does require a potable water rinse.

Next slide.

 Slide

We did some tests, inoculating some tomatoes with salmonella. We just got them from a distributor, and we inoculated them and refrigerated them. Then we treated them with the peracid material and then subcultured them.

Next slide.

 Slide

We heard earlier that it is quite difficult to actually achieve around a 1 log reduction, and I w ould agree that that's the case, and most of our research indicates it is the case. What we found, though, was that with 25 ppm chlorine, we barely got half a log. With 25 peracetic, we got nearly 2 log--this is in a 5-minute contact time--and with 50 ppm peracetic, we get up to 2.3 log.

This is all the data I have. It is very preliminary, but we feel that it is also very promising.

 Slide.

Finally, some of the things that we plan to be doing. One is to expand over to other pathogenic materials, and our Microbiology Department will handle that along with various university contacts. We are also optimizing the system right now. It's an overall process. You can't just deal with a chemical here. It is how you apply it, how you monitor it, and the whole system approach.

We are also looking at new compositions which we hope to bring out, actually, within the 1997 year, and what we're seeking are some additional regulatory approvals that would allow us to treat with some even more impressive compositions.

That's all I have.

 Applause

DR. SHANK: Thank you, Dr. Hei.

We are at the public comment period for this particular segment of the program.

James Elfstrum, please.

MR. ELFSTRUM: Good afternoon. I want to thank the members of the panel for allowing me to present some information on trisodium phosphate.

 Slide

We call this the Assur-Rinse Antimicrobial System.

Next slide.

 Slide

I want to give you a little update on where we stand with respect to the approval for TPS. We have USDA, FDA and Canadian approvals for meat and poultry use of this substance, and it is currently being utilized quite a bit in the meat and poultry area, particularly in poultry, right no w.

 Slide

This material is trisodium phosphate--it's actually trisodium phosphate dodeca  phonetic hydrate --and, as was mentioned earlier, it's an alkaline phosphate salt that has a pH of 12.5. It is food grade, FCC grade, it has a long history of use as a processing aid that's safe and effective, and it 's used in cheese at about 2 percent level as is, and we sell about 10 million pounds per year in this area.

 Slide

In the poultry industry, we have conducted extensive testing of trisodium phosphate over the last 2 or 3 years. We have several plants that are using it. We have treated over 10 million carcasses with the substance, and we have had very good analytical results, as you'll see at the bottom. We have reduced salmonella to less than one percent, E. coli to less than one percent, campylobacter to 15 percent, and we have done better than that recently--almost to the same level.

 Slide

What I want to show here is some data we developed with respect to TSP's use to reduce the level of E. coli O157:H7. We did a study with Dr. Brown's group at ABC Research Labs in Gainesville, Florida. You can see that in this particular study, we used at various times treatment at 1.5 percent concentrations for citric acid, acetic acid, lactic acid, TSP at 1.5, TSP at 10 perce nt in saline. We had inoculum--this is in an in vitro study--of 1.2 times 10 to the 7. You can see th at the citric didn't do too well; acetic acid didn't do too well; lactic acid did pretty well; TSP redu ced both at 1.5 and 10 percent to less than the level of detection in this particular system, and I have a graphical chart as well. The same data is in graphical form, and you can see the dramatic reductions that TSP will give you in this system.

We find E. coli O157:H7 to be extremely sensitive to alkaline conditions such as encountered with TSP, and although we haven't done any work in the apple juice treatment area, we look forward to helping in that area and doing some work if it is required.

Thank you very much.

 Applause

DR. SHANK: Thank you.

This brings us to the topic of pasteurization. The first presentation will be an overview by Ms. Jenny Scott, the Senior Director of the Food Safety Program for the National Food Processors Association.

MS. SCOTT: Thank you.

 Slide

As Fred indicated, we have come to the part of the program where we want to ask the question: Is pasteurization of fresh juices appropriate?

I want to talk not only about the science and technology of pasteurization, but also about developing an appropriate pasteurization process.

 Slide

But the first thing we have to do is define what we mean when we say "pasteurization." There is a lot of confusion out there as to what a pasteurization process is. Many believe that it is a specific time and temperature heat treatment, and this probably derives from the fact that milk pasteurization is defined in the pasteurized milk ordinance as "the process of heating every particle of milk to a specified temperature and holding for a specified time." These include 145 degrees Fahrenheit for 30 minutes and 161 degrees Fahrenheit for 15 seconds, as well as other specified combinations.

 Slide

Stumbo, in his book, "Thermal Bacteriology," defined pasteurization as "a mild heat treatment given foods that, because of their nature, will not support growth of more heat-resistant organisms and that are then refrigerated, frozen, concentrated or dehydrated to prevent growth of the more heat-resistant organisms."

 Slide

Potter, in his book on food science, defined pasteurization as "a comparatively low order of heat treatment designed to destroy pathogenic organisms that may be associated with the food and could have public health significance and to extend product shelf life from a microbial and enzymatic point of view." This is probably the definition applied by most food microbiologists, that is, as a heat treatment sufficient to kill vegetative cells or pathogens and extend shelf life.

There is one definition of pasteurization in the Code of Federal Regulations, and that is for pasteurized orange juice in 21 CFR 146.140: "orange juice treated by heat to reduce substantially the enzymatic activity and the number of viable microorganisms."

So, strictly speaking, pasteurization is a heat treatment. That's the way it was used by Pasteur . However, the term has been applied to other treatments that accomplish the same thing. That's why you will hear about irradiation pasteurization, high pressure pasteurization, et cetera. There is a great variety of pasteurization process applied to a great many different food items.

 Slide

For example, shelf-stable juices have been heated sufficiently to destroy all organisms capable o f growing in the product. Refrigerated juices are generally heat-treated also, but to a lesser extent , to extend shelf life. Both products would be considered pasteurized, but they are very different products in terms of stability.

 Slide

Different heat treatments result in different flavor profiles based on the changes that the heat causes--the driving off of volatiles, the creation of malar  phonetic reactions, et cetera.

 Slide

Heating also destroys enzymes which can adversely affect color, texture and flavor. Thus there may be quality as well as safety considerations for pasteurization.

 Slide

It is possible to optimize the heat treatments to obtain the appropriate destruction of microorganisms in enzymes, while maximizing retention of the desired quality aspects.

 Slide

What we want to do here is define the food safety objective. For juices, we are concerned with reducing the risk from pathogens associated with the food that could have public health significance in the product. Thus, for example, although spores of Bacillus cereus or Clostridium botulinum may be associated with a component of an acid juice product, we need not be concerned with destroying them because they can't grow in products of that pH, and their presence alone doesn't constitute a hazard.

What are the organisms of concern?

 Slide

In the past, we would have said none. However, more recently, it has become clear that some enteric pathogens can survive in the acidic environment of juices for extended periods of time, and we heard Dr. Griffen tell us yesterday that we had had outbreaks of illness from salmonella in fresh orange juice and from E. coli O157:H7 in cryptosporidium in apple cider.

I am going to focus here on E. coli O157:H7.

 Slide

What is the level of inactivation desired to meet the food safety objective?

 Slide

First, we have to determine the maximum number of cells of the target organism expected to be in the product, and then we would add a safety factor to account for variability.

 Slide

This becomes the performance standard to meet, and how this performance standard is met should be flexible.

I want to look at some examples of how this has worked for E. coli O157:H7 in other products.

 Slide

First, in cooked beef patties. In considering FSIS's proposed cooking requirements for beef patties 1988 and 1989, the National Advisory Committee on Microbiological Criteria for Foods recommended a 4-D process based on documented maximum levels of E. coli O157:H7 at that time of 10 to the 2 per gram and adding a 2 log safety factor.

 Slide

In addressing the problem of E. coli O157:H7 in fermented sausages, FSIS has required processes that inactivate 5 logs of the organism based on new data indicating levels as high as 10 to the 3 per gram and adding the 2 log safety factor.

 Slide

With flexibility and allowing approaches that assure either a 5-D inactivation or that the level of O157:H7 in the final product is less than 1 CFU/100 grams--there is an error on this slide--this allows for a combination of inactivation treatments and for testing the raw ingredient, or batter, t o detect less than one organism per gram, and if none is detected, combining the batter with the 2-D process.

 Slide

So, what might be a performance standard for E. coli O157:H7 in apple juice? Well, first we have to ask the question, what is the maximum number of E. coli O157:H7 in apple juice, and this is something we just don't have the answer to.

 Slide

In the absence of such information, a conservative assumption of maximum level is usually used, and as a guideline, an appropriate performance standard might be a 5-D inactivation of this organism. This is probably overly conservative, but it at least serves as a benchmark for this discussion.

 Slide

Next, we need to determine how to meet the performance standard to achieve the food safety objective. One approach is to consider a pasteurization step. Stumbo indicated that any given pasteurization schedule should be based on the best available death kinetic data for the organisms of concern in the specific product to be pasteurized. So that means that the next step is to determine the heat resistance of E. coli O157:H7 in apple juice, and this has been very nicely done in a publication by Splittstoesser, McLellan and Churi  phonetic that was published earlier this year in the Journal of Food Protection.

 Slide

In determining the heat resistance, one generally tests multiple strains including in this case t hose isolated from apple juice and other acid environments to determine the most resistant strain. Splittstoesser et al. tested a single strain that was a patient isolate from the Massachusetts apple cider outbreak. At the time they were doing this work, there had not been a lot of E. coli O157:H7 in acid products.

The NFL, as you heard yesterday, has recently done some testing of E. coli O157:H7 in apple juice, and they used five different strains. They included several apple cider strains, and they al so included the salami strain, which proved to be more heat-resistant than the cider strains.

In conducting these tests, it is necessary to consider the factors that may influence the heat resistance, and this is exactly what Splittstoesser et al. did.

 Slide

They looked at the pH of the product and found that E. coli O157:H7 has greater heat resistance at pH 4.4 than at pH 4.0 or 3.6.

 Slide

They looked at the degrees Brix, and they found that for product that had 11.6 to 16.5 degrees Brix, there was no significant difference in heat resistance; however, the resistance of O157 significantly decreased in a concentrate of 45.6 degrees Brix.

 Slide

They also looked at the effect of the concentration on malic acid and found that increasing the concentration of malic acid resulted in decreased heat resistance.

 Slide

They also looked at the effect of preservatives and found that as the preservative concentration increased, the heat resistance decreased. This was especially significant with benzoic acid.

Now, in doing such studies, it would also be appropriate to consider the growth conditions of the organism prior to testing because acid adaptation and stress-induced frost protection can affect heat resistance. We have seen this in terms of affecting irradiation resistance earlier today.

Also in doing these tests, one would want to be conservative with respect to the factors that would be expected to vary with the product under consideration. For example, if pH were expected to vary, one would conduct the test at the maximum pH because that's where the resistance is likely to be maximum.

 Slide

Once you have the heat resistance data, one would calculate the temperature and time required to achieve the desired log reduction--and in our example, we are looking at a 5-D reduction, and these are combinations of times and temperatures that would give a 5 log reduction, and this is based on the Splittstoesser data, with the D 125.6 degrees Fahrenheit and a Z of 18.6 Fahrenheit--th ere was a D value of 18 minutes. And using that Z value, these processes were calculated.

The processes that would be calculated using the NFL data would be somewhat higher. However, the combinations to achieve a 5-d process are really considered quite mild processes and might result in quite acceptable product flavor-wise.

 Slide

Now, alternative approaches such as pulsed light or high pressure may be used in lieu of or in conjunction with heat, provided they are controlled and meet the same performance standard. We are just beginning to obtain data on the effects of these novel technologies on foodborne pathogens, including E. coli O157:H7, so these options may be a longer-term approach than applying the pasteurization step.

 Slide

The next step would be to decide how the process will be delivered and controlled. Generally, heat processes are delivered as either batch processes or continuous processes. Batch processes are simple--they generally require simply a heated kettle--and because of that, they are quite less expensive. However, the product does get heated for a longer period of time because of the come-up time, and this is generally more detrimental to the quality attributes of the product.

Continuous processes are delivered in plate or tube heat exchanges, or by steam injection and steam infusion systems. This allows the use of higher temperature, shorter time processes, which have a greater preservation effect on quality factors. The processes can also be more tightly controlled; however, they are more costly.

 Slide

In conclusion, the science of pasteurization is well-established, and it does work; end-product testing does not. Mild pasteurization treatments can be designed to inactivate the pathogens of concern in juice while maximizing the retention of quality parameters such as flavor.

Other treatments may be considered in lieu of or in conjunction with heat to achieve the desired food safety objective. Thus, while heat pasteurization is an appropriate option, it may not be the only one. Any performance standard set to achieve the food safety objective of reducing the risk from vegetative pathogens such as E. coli O157:H7 should allow flexibility in how the performance standards should be met.

Thank you.

 Applause

DR. SHANK: Thanks, Kenny.

Continuing in the area of pasteurization, from a supplier's perspective, we have Dr. Bill Sperber . I would remind you that he is the senior corporate microbiologist for Cargill.

Dr. Sperber?

DR. SPERBER: Thank you. Good afternoon.

We are very pleased for this opportunity to comment at an important public meeting such as this. Cargill, a global food producer headquartered in Minneapolis, Minnesota, has been asked to participate in this portion of the public meeting as a supplier member of the National Food Processors Association. We are an international producer of a variety of fruit juice products, with plants in North America, South America and Asia. We supply juice packers and marketers throughout the world.

Cargill is highly committed to food safety in each and every one of its plants worldwide. the control of microbial pathogens is the highest risk that our industry must manage. Therefore, each of our plants is required to maintain a hazard analysis and critical control points, or HACCP, system of food safety. We manage critical control points that assure the destruction of microbial pathogens in each of our juice plants.

The organizers of this meeting asked us to consider four questions. Question 1: Is pasteurizati on of fresh juices appropriate? In our opinion, yes. Outbreaks of foodborne illnesses caused by unpasteurized juices have shown the necessity of critical control points to prevent future outbreaks.

Question 2: Can fresh juices be prepared safely without pasteurization? In our opinion, no. Whi le most fruit can be handled and process so that the resulting juice is free of pathogen contamination, this is not always the case, as demonstrated by the several outbreaks of illness. Therefore, a pasteurization treatment is necessary to assure the elimination of vegetative pathogens.

Question 3: How is pasteurization defined? There are two definitions of pasteurization in common usage. The first definition is commonly applied by public health agencies, that being pasteurization is a process that will eliminate all microorganisms of public health concern in a particular food.

The second definition is commonly used in the food industry--pasteurization is a process that wil l eliminate all microorganisms except resistant spores in a particular food. This definition of pasteurization, common in the industry, is more stringent than that used by public health agencies, and I believe this is an important point. We in the industry must be concerned both with food safety and food quality. Therefore, our pasteurization processes are usually designed to assure the elimination of not only microbial pathogens, but also of vegetative spoilage microorganisms and enzymes native to the food.

It is also important to note that pasteurization processes are not necessarily limited to heat treatments. Other processes that could eliminate pathogens include proven technologies, such as filtration and irradiation, as well as less developed technologies such as pulsed electric fields or high-pressure treatments. With proper validation, these processes could be used instead of heat treatments. they could then be legitimately defined as pasteurization treatments.

Question 4: Does the food industry have performance standards for food safety? Let me give this to you in plain Minnesotan: You betcha. In plain English, that's a yes.

However, our performance standards are not based on finished product testing, since finished product testing can never assure that a particular lot of food is free of pathogen contamination. Rather, we rely on the documented control of processes to assure the elimination of pathogen contamination. That is, we rely on our HACCP system.

At Cargill, our principal performance standards are: 1) validation of the HACCP plan to be certain that critical control points will accomplish the intended elimination of pathogens, and 2) documented compliance with the critical limits established at each critical control point.

A little later in this session, Professor Splittstoesser will present results of his research. T he heating conditions he determined necessary to effect a 5 log reduction of E. coli O157:H7 in apple cider are greatly exceeded in all of the pasteurization CCPs used in Cargill's juice plants. While I cannot speak for the entire juice industry, at Cargill, we significantly exceed the scientifically determined requirements in our production of apple, pear, orange, tangerine and pineapple juices, as well as in the production of orange juice not from concentrate.

Finally, by now, everyone in attendance at this meeting must be aware that properly pasteurized juice products can be recontaminated with microbial pathogens during packaging. Therefore, each juice processor or packer, in addition to implementing an effective HACCP system to assure pasteurization, must also implement good manufacturing practices to minimize the chance that properly pasteurized juice might be recontaminated either by raw juice or from environmental sources.

Neither HACCP nor GMPs can be used alone to assure food safety; they must be used together.

Thank you.

 Applause

DR. SHANK: Thanks, Bill.

Next, on pasteurization from a processor's perspective, we'll hear from Dr. Don Zink from Nestle, Incorporated.

DR. ZINK: First, I want to add by thanks to those of others to the FDA for this forum. This is a very useful way of handling this, and I think they did a lot of work, and it has been very benefici al for me to get a balanced perspective from all of the parties involved.

I want to make it clear that I am here today to state the views of Nestle USA as perhaps a typica l processor of juices. I want to say in a manner of speaking that my dog is not in this fight. We produce all pasteurized juices, and these juices are pasteurized to render them shelf-stable to accommodate our mechanisms of product distribution. But nevertheless, we have a very great interest in the safety of all foods. Whenever a failure occurs with anyone, large or small, it hurt s all of us, and in this most recent incident, we saw quite an increase in calls to our consumer safet y people, and we saw an impact in sales as well. Everybody is affected when something like this happens.

Now, before I dig into my presentation, even though Fred is not going to give you a break, I have been sitting here, taking all of this in, and I have tried to really distill down everything people have said into what I call the seven steps for assuring apple juice safety. I picked seven because it's like the seven steps of HACCP, to help you remember it.

First, I think we could grow fruit in a controlled area. I think something like the Seattle King Dome would be good. I understand it's going to be torn down, so if you move fast, you'll get a good deal on it--and for those of you in Washington State, you won't have to haul it far.

We should then harvest groups with gloved hands into sterilized bins.

Third, I would wash with hot, pH 11 water, then wash with chlorinated water containing appropriate emulsifiers and surfactants.

We should then extract the juice carefully on sterilized or sanitized equipment. I would then ad d benzoate sorbate, pass the juice through a high-pressure, bright light plate heat exchanger, and cool it down to about 35 degrees.

Let's not forget water activity here. We could spray dry the juice and really improve stability quite a bit.

Finally, I would aseptically package it in a form, fill and seal machine and irradiate it through a Cesium 137 source.

There are some down sides to this, I realize.

 Laughter.

DR. ZINK: First, Ed Scarbrough says you can't label it as fresh, and we have the final problem that we really don't know who is going to reconstitute this with potable water or not; you've got no control. So it's a difficult problem.

Could I have the first slide, please?

 Slide

Now, I should explain that my role with Nestle is to determine food safety policies and procedures, and I share this role, in contrast to some small producers, with a very substantial group of scientists and technologists throughout our worldwide operations. We devote staggering amounts of money and resources to food safety, and I have to tell you, it seems like it's almost never enough. So often we are faced with having to make a decision about a process or a procedure, and we don't have as much data as we would like to have or want to have. It's a tremendous challenge. We are in a very technical business.

I have friends in the computer industry who think I'm in a really high-tech business. All they do, they say, is etch silicone and package it. But you know, when Wall Street talks about high-tech stocks, they aren't talking about the food industry--but we are in a very technical, complex business.

We make decisions, like a lot of other people, with a set of governing principles. These are not always formalized, but nonetheless they are things that are always on our minds.

The most important principle is that food processing and safety decisions must be based on credible science. I say "credible science" because not everything that appears in the literature is well-done. You heard an earlier allusion to a Mexican study that reported a high incidence of E. coli O157:H7, but the methodology used really wasn't appropriate for clarifying that that was E. coli O157:H7. So it has to be credible science. And science isn't infallible, but without objectiv e science as a basis, I think our decisions are unduly influenced by ill-considered opinions and market pressures.

At this point, I'd like to digress a moment and comment on end-product testing. I strongly believe--in my 20 years in the food industry, I have seen that end-product testing serves the consumer very badly, and I am concerned about these voices, much more eloquent than mine, endorsing end-product testing. If someone could spend 6 months looking over my shoulder and seeing what I see, seeing the data I see, they would understand that consumer testing is almost valueless. And in cases where companies have chosen to take a high-profile position of end-product testing, I think they have done so because of perhaps political and public pressure rather than good science.

You have all seen that the U.S. has an excellent disease reporting system, but I think it has bee n very well explained here that an absence of risk data does not mean an absence of risk. I have people tell me that I haven't had any complaints in years, or that I have sold millions of packages. I think it should be clear from the presentations of others that we must consider what is possible, not merely what has happened in the past, and that's very difficult because you can let your imagination run wild to the extreme. So I realize the difficulty of that.

Risk, too, is very difficult concept to communicate. Different people view risk differently, and we have heard some references to that here. I think that generally, everyone knows that life entails certain risks, but they expect preventable hazards to be controlled. I think our food policy procedure should be conservative at best.

I have to say that within my company, we don't have any standard of acceptable risk. It is not acceptable to us to have any probability of consumer illness or injury; I have never heard anyone suggest it, and I can't imagine that anyone would. We try to deal with all controllable risk.

When we have to communicate risk or handling instructions to consumers, these risks should be communicated in a meaningful way. For example, I doubt that many consumers have a clear understanding of the term "unpasteurized" in all of its implications. I do believe that we have to label and inform people, and there is a segment of the consumer out there that reads labels very carefully for good reason. I think people with particular needs like food allergies would be a good example. But I think food industry and food safety professionals tend to have what I call an "upper middle class perspective." We have to serve the interests of all of our consumers. If you talk to folks with the California Food and Drug branch, for example, they brought me up-to-date on an interesting fact--that 17 percent of the people in the Los Angeles area don't read English, and this is a growing trend in some areas of the country, and I suspect that even though 17 percent of them don't read English, quite a goodly number of those who can read English probably don't. So you can only carry labeling so far.

 Slide

I think that we do have to take a lesson from recent experiences, and I have been very much benefitted by the CDC's summary of recent outbreak history.

When I began my career in food safety about 20 years ago, conventional wisdom said that harmful bacteria didn't survive in acidic foods and that very large numbers of bacteria were needed to cause an infection.

We now know differently. In fact, in the last 20 years, as you have heard, we have identified th e leading cause of bacterial foodborne illness and one of the most virulent forms of E. coli. Specifically, we do know--and I am convinced that the data is irrefutable--that E. coli O157:H7 and salmonella can survive and remain infective in chilled acidic fruit juices. But I am more concerned about what we do not know about E. coli O157:H7, to be specific. I think we have insufficient data on the ecology and distribution of E. coli O157:H7, and we urgently need to fund more research in this area.

I'd like to take a minute here to plug the efforts of Paul Hopper in founding the ILSI Micro Committee. Years ago, International Life Science Institute microbiology group at its inception, at Dr. Hopper's urging, began to fund research in E. coli O157:H7. We in part funded the work of Dale Hancock, whom you have heard made reference to, in part, Philip Tarr, and this work has been very valuable, but there just hasn't been enough money or resources to do all that we want to do. We recently sent out letters asking for additional funds, and if any of you are interested in making a contribution to this effort, we plan to fund a new round of E. coli O157:H7 research in the coming year, just as soon as we can get the funds necessary to do that. Much more is needed.

In my opinion--and I think Jenny Scott stated it very well--a minimal pasteurization treatment wi ll have a modest quality impact on those juices, but it is difficult and requires quite a lot of technology to deliver that heat process in a way that is truly meaningful.

 Slide

There are many difficult issues which have been brought up here. I have made light of some of them, but it is particular important to take all of this in when you decide how broadly to apply a process like pasteurization.

I think that knowing more about the ecology of E. coli O157:H7 would be very helpful. How commonly is this organism found in fruit orchards, and how does it get there? Does the organism colonize fruit and juice processing equipment or the processing plant environment? I haven't head any here say they have ever isolated it from fruit. And while I will admit I'm deeply suspicious that the organism has entered fruit juice from the fruit, it remains unproven, and I have plenty of experience that tells me microorganisms can and do colonize the food processing environment and can contaminate products there, and they can be very difficult to find.

I appreciate how much work the Food and Drug Administration and other agencies did in investigating the recent outbreak. They took 68 samples, I believe, 400 some-odd tests, 870 hours, but it is not uncommon for us in one of our factories where we have a sensitive environment to take as many as 1,200 or 1,500 environmental samples a month, and sometimes we'll go many months without finding anything even though we know something is lurking in that environment. These microorganisms can hide, and they can hide really well. And bear in mind that in salmonella, the example I am giving you, the culture methods for salmonella are far better than they are for E. coli O157:H7. I am suspicious that we haven't' done a good enough job yet of assessing factory environments in a really thorough way to make certain the source of this organism isn't something other than what we suspect it is.

I think we need to develop an understanding of the relative risk associated with different fruits and processing technologies. I will concede that it's very likely that apple juice presents a great er risk than do citrus juices. And when I say that I believe that pasteurization is the way to go for fresh fruit juices, I say that with a heavy measure of qualification because so much further study i s needed.

 Slide

Also, I am very sensitive to the remarks that have been made earlier that we cannot hope to enforce pasteurization for all retail juice products. If we come out with an ill-considered policy, it is quite possible that we'll drive the distribution of unpasteurized fruit juices into a less contro lled venue than we're in now.

 Slide

Finally, I think that what you want to hear from me is the bottom line, with all these qualificat ions. I say today's bottom line because I am troubled by the lack of information we have but realize that sometimes you are forced to make decisions or recommendations without all the information you would like, and there certainly, in my opinion, is not enough credible science right now to support a broad policy. Nonetheless, speaking as someone from Nestle, as a juice processor, if someone came to me tomorrow and said, "Look, I want to sell some fresh juice with the Nestle name on it; what would I require?" I would require that it be pasteurized. I have gotten a little bit more comfortable after what I've heard the last 2 days with citrus juice. I think I'd look at that citru s juice producer awfully darned hard and see what he is doing, but the fact of the matter is, from what I have heard, the Odwalla operation is absolutely state of the art, probably in the top one percent of its industry--I haven't seen it, but that's certainly the impression I get. And how coul d I say you can go out there and deal with an assortment of copackers and licensees producing fresh apple juice and have any confidence that it would not be contaminated?

The fact is we really don't know where this contamination came from; all we know is that it wound up in the juice. And by pasteurizing this juice, I can eliminate questions about all that went before and focus my worries on the post-pasteurization packing of the product.

I think that pretty well summarizes our position, Fred.

 Applause

DR. SHANK: Thanks, Don.

We are now going to spend some time on the topic, "Is pasteurization necessary in all situations? "

Let me call on Mr. Joe Nicholson from Red Jacket Orchard.

MR. NICHOLSON: What I'm going to try to do is give you a profile of a medium- to small-size cider operator in the Northeast, which we are, and I'll talk a little bit about my operation and som e of the commonality that you find with these operations.

We are located in the Finger Lakes in western New York, and we are probably one of about 100 cider producers in the State of New York. We have approximately 300 acres of dwarf apples and about 100 acres of stone fruits, and we market cider as one of our products along with a lot of our tree-ripened fruits. So a lot of our customers, which are 100 or more in the Northeast will take cider along with apples, packed apples, or apricots or peaches or various other commodities. Our niche is to provide that customer with upscale produce, meaning that this produce is tree-ripene d, as opposed to what you normally would find coming from the West Coast, which tends to be picked less mature although shelf-stable more than ours.

Our operation is integrated into growing, packing; we also retail, and we have this cider operation, and we produce between 150,000 and 200,000 gallons a year. We have been making cider for about 25 years, and we are striving for a niche in the market, which is quality juice.

Our cider operation consists of a rack-and-cloth press, which is a system very similar to what yo u have seen in the old Colonial days; however, today it is updated with hydraulic systems and plastic instead of wood and is much more sanitized.

Inspection, washing, clean, sanitized stainless steel equipment and refrigeration are all parts o f our formula for quality cider, and most important is good, juice-quality apples. That's what we depend upon, and we get that from our own orchards, and we also buy it in.

We practice good management procedures, starting with refrigerated product out of storage. It comes in from the field and goes under refrigeration and comes out, and we ensure good inspection of the product through washing with potable water. There is scrupulous inspection of all equipment to ensure that things are sanitized and then testing of the product to ensure that we have the proper flavors. We aren't as scientific as some of the big guys, but we are looking for a high-quality juice, and that has to taste good. So if it's a little sweet, we're looking for an app le that is tart to put in there to raise that acid sugar level to a point where a consumer will say, "Wow, this is a product that I'm not used to getting." That's the segment of the market that we are after and where we are headed.

So we are altering this variety and mix on a constant basis. We are a smaller producer like many of the people I'm talking about who, because we are smaller, have the ability to alter varieties and change the situation to maximize quality as opposed to a big producer who, just by his very nature, cannot execute that detail that we do.

We are also involved in managing juice apples coming in from the orchard, buying and selling that product, storing it and coming up with the final disposition of it.

In short, we are trying to make that product which I just mentioned the "Wow" product, which is our segment of the market.

Our raw product varies from fresh-packed packing line sorts to low-colored fruit to undersize fruit to drops and wind falls. Drops and wind falls are currently considered a high risk in the unpasteurized portion of the operation. Heretofore, they have been a source of fruit in the fall when demand for our product is extremely strong. Historically, moving wind fall fruit into the pressing operation has been incorporated with the last picking of the fruit--in other words, we pick the fresh off the trees, and now we are going in and picking that remaining fruit and then picking up the drops, which largely have resulted from falling to the ground because of the harvest process--the picker went for one apple and dropped one apple, that sort of thing.

We place this fruit that is part of that last pick into storage, and we normally try to use that fruit within 5 to 7 days. The fruit is usually very good quality for cider. It is tree-ripened and has excellent flavor and is a good product. However, it has several weaknesses. One is poor shelf life and the microbiology problems associated with it.

This type of product is part of normal operations and part of being in business, and it represent s about 10 or 15 percent of our total production and requires additional management to ensure that the product is used within that 5- to 7-day period. Should overload occur, this product is normally sold to a processing pasteurizing plant.

This is essentially a profile of our operation and many similar operations in the Northeast. In view of what has been taking place in the last several years, our market is becoming threatened. Reports of E. coli contamination in cider send concerns through all areas of our industry. We believe that juice from good, sound, ripe apples produces the best product for the consumer. The cloud, maroon, brownish liquid is at its best when it is fresh, refrigerated and unadulterated--a favorite in this country since Colonial days.

I am kind of old-fashioned, I guess, but anything done to that juice after it is squeezed natural ly from an apple tends to lower the quality of that juice. I'll go to the supermarket and get some fresh-squeezed orange juice, and it's the same thing. It's a unique product that the consumer is willing to pay a premium for.

Pasteurization lowers the quality in that the flavor starts to impact toward a caramel flavor or taste, depending on how long you cook it and so on. It is my opinion that pasteurized cider will lesson substantially our consumers' desire for our product and will participate in weakening market share for operations like ourselves.

The likelihood of these small businesses surviving in a mandated pasteurized market is not very good. These are small businesses, limited capital operations, very focused to go after that one segment of the business, so that is a major concern for that whole area.

Yet I believe something should be done to ensure consumer confidence, and my suggestion to FDA is that somehow it encourage training, testing and licensing of cider operators throughout the Nation. One bad apple ruins it for the rest of us, so the weakest link in the chain is the one that we have to try to compensate for.

Through training, through testing and through licensing, that system has taken place--EPA has done that with pesticide applicators, and it has improved the safety and awareness of the whole fruit and vegetable business on the production end. It has worked well, and I think maybe there is some crossover there.

This program should include HACCP and GMP procedures, as mentioned, biological testing of the product should be encouraged by the operations, and training seminars should be conducted to introduce the latest science that's going on and should be spearheaded by State universities and extension services.

These steps and pending advances in food science would ensure a better and safer product in the long run, preserving also this great drink called cider, which has been around since Colonial days.

Thank you.

 Applause

DR. SHANK: Thank you, Mr. Nicholson.

We are going to move now to two presenters from Cornell University. Dr. Mark McLellan is a professor in the Department of Food Science and Technology with the New York State Agriculture Experiment Station as well as Cornell University. And Dr. Don Splittstoesser is professor emeritus at Cornell University, in the New York State Agriculture Experiment Station.

Could you two gentlemen come forward and make your presentations, please?

DR. SPLITTSTOESSER: I am Don Splittstoesser. I've got several overheads, Bob, and you can put the first one on if you wish.

 Slide

I want to tell you that we do have some support on a USDA competitive grant for this study. I should also say that we have many friends in the apple industry, but they haven't given us a nickel to date. So that's where we stand.

Next slide, please.

 Slide

A few years ago, Zhao  phonetic , Mike Doyle and Besser published on survival of E. coli in ciders, and at the time, I told Mike Doyle I didn't believe the data, so we had to repeat it, and what he showed was that benzoic acid had a much greater effect on survival than did sorbic acid. I had always thought these two preservatives had very similar activity, and if anything, I thought sorbic acid should be the more active compound--it isn't, and we have repeated this many times.

The other thing that I am showing in this slide is that the temperature that you hold the cider a t makes a big effect on survival rates, so at a refrigerator temperature--and I think all of the microbiologists in the audience know that a D-value is equivalent to a 90 percent die-off--at a refrigerator temperature with no preservative, a typical D-value is 10 to 12 days, and that's simila r to the results that were observed by the Georgia researchers. Adding a preservative such as benzoic acid in particular or accelerates the die-off rate significantly. Now, at 20 degrees Centigrade--and we've got kind of a spread here as far as die-off rates, apparently depending upon the kind of cider and maybe the strain of E. coli. We have worked with a number. But just looking at this 4-hour D-value, if we found that most E. coli in most ciders had a 4-hour D- value, that would say that, hell, our problems are all over; we can just hold cider for 24 hours before we market it, and that would be a 6-D reduction in viable numbers, and that's as good as we hope to do with a thermal treatment. So that's a possibility.

Then, I don't think anybody in the real world would hold their cider at 40 Centigrade, but if the y do, we hasten death that much more. So now we are less than one hour to kill and 90 percent of the E. coli.

Next slide.

 Slide

We were talking about at 20 degrees Centigrade, it was a matter of days for D-value. I just want to show that apple juice seems to be somewhat unique. These are results that we've obtained with juices from different grapes. As you can see, the pH is in the range of what we find in our good, crisp, New York-grown apples, and so it's not a pH effect. The Brix, of course, is higher here, but I'm sure that isn't what's causing the death. So there are other factors besides just pH and perhaps type of acidity that affect survival rates in a juice. And here, in grape juice, instead of talking about days, we have a D-value of less than 24 hours with all of these different grape varieties. These are all white grapes, and these are all red grapes, so the results are about the same, and it doesn't matter what the color of the grape is.

Next slide, please.

 Slide

Jenny Scott gave some of my data earlier. Thank you, Jenny. She did much better than I could do. Anyway, this merely shows some of our more recent work, this season's work, where we have made different ciders in our pilot plant and determined heat-resistance at a very low temperature.

Now, our goal here is not to produce a shelf-stable beverage that you can put on the grocery stor e shelf. We are looking at merely a pasteurization that would be analogous to milk, where we are trying to eliminate a particular organism, and here it is E. coli O157:H7.

What I am trying to show you is that we are getting quite a difference--in spite of my earlier wo rk where we intentionally altered pH and level of malic acid and so on and frequently didn't get a big effect--here, we are getting some rather marked differences in thermal resistance in different ciders. We don't know as yet, or we can't explain these results. It is certainly not just pH, because here, in this Northern Spy juice--and this has been repeated a number of times--we kill them off quite rapidly compared to Macintosh, which has a very comparable pH. So there are some other factors that are involved here, and we are working on it, but we don't have the answer as yet.

Next slide, please.

 Slide

So, where this is different from what we published before is that we are using low levels of benzoic acid, only 200 ml/L, and you can see that even a low level of benzoic acid sensitizes E. coli--this is the strain up here--to heat, and the death rates are about 5 times greater in the presence of 200 ml/L benzoic acid compared with when we leave the preservative out of the cider.

So the bottom line is that it doesn't take a heck of a lot of heat if you've got this preservativ e present. Now, Joe Nicholson could probably say that only 200 mg/L benzoic acid is too much from the flavor standpoint, and perhaps he is right. We haven't gotten to that stage yet.

Next slide, please.

 Slide

In New York State, Ag in Markets  phonetic is recommending that perhaps cider should be heated to 160 Fahrenheit; it's a recommendation, not a rule or a law. Anyway, we have calculated, based on the heat resistance that we have observed in these different ciders, the length of time to give us a 5 log reduction. And as you can see, these organisms have very little resistance, so it's everything from 1.8 seconds to 10 seconds or so to give a 5 log reduction, and I think most people, as Jenny explained, would say that that's probably an adequate process.

Okay, one last slide.

 Slide

I wasn't here yesterday, and maybe this compound was discussed, and maybe you are aware of it, and maybe you aren't. Dimethyldicarbonate is a permitted additive for table wines. I think it is now--and Fred can correct me on this--permitted for canned peas, and I'm not sure if there are any other foods or not. It has been looked at for sports beverages, but whether it has been approved, I don't know. But this compound rapidly hydrolizes, breaks down, and you get a trace of methyl alcohol in your product, but no more than when you use a pectinase in your juice extraction.

Anyway, what we are showing here--and this is fairly recent data--is that 250 ml/L will give us a 3-plus log destruction of E. coli. So this may be an alternative. That's the good news.

The bad news is that this material is sold by Bayer via Miles and I don't know who else, and the trick is to meter it into the beverage and mix it in thoroughly before it hydrolizes, because it breaks down very rapidly, so you've got to make contact between the bacterium and the compound in a very short time.

The bad news is that the present device that is being marketed to administer this material into a beverage costs $75,000, so it isn't something that Joe Nicholson or some of these smaller cider people are going to adapt to very readily, although--who knows? It's hard for me to believe that you couldn't in some way or other, with a lightning mixer and so on and a batch process, dip this compound into the beverage and make it work without spending $75,000 for the equipment.

That's my story. Thank you.

 Applause

DR. McLELLAN: As Don mentioned, our current work is supported by a USDa project, and we are very pleased to have had them come on board during the past year to help us out in getting into this work.

 Slide

I want to start at this position in the program to sort of pull us back for a second and remind u s all about exactly what we're looking at. And let's start by reminding ourselves what are the products out there, the product categories, if you would, that define this whole area.

We have come up with four distinct ones, and if you'll go to the next slide, I think that will he lp put it in perspective.

 Slide

The four categories related to juice/cider are laid out in this overhead, starting with the colum n to the left, which is unpasteurized apple cider, otherwise known as "raw" apple cider. This is clearly untreated in any way, shape or form; it is strictly pressed out of the apples. It takes minimal equipment. There are no particular forthcoming steps in order to reduce risk. It's a very simple process.

We do define this as what is commonly accepted in the U.S. as cider, and it takes us over to the next column, which is labeled simply as a "pasteurized apple cider." This is a fresh-pressed juice that has undergone some sort of thermal process. We identify the risk reduction as fairly significant, but not complete, due to the fact that this would typically be done in an open system; it would be to eliminate the risk immediately and then to go on and deliver the product as an apple cider type product, an open jug type filling.

The next category brings us into what we define as the "juice" categories. These are in effect commercially sterile. The juice is put hot into the bottle, handled aseptically, and in the first column there, we are talking about a natural style for all intents and purposes. It looks like a cider, but this is a shelf-stable product.

And then, finally, a "fully-clarified" product on the far right.

These four categories are just to remind you, really, about the major areas that we are talking about. And of course, immediately, you go to this side of the chart and just take it out of the equation because they are a thermally sterile product.

The questions remain in terms of these two areas.

Next slide, please.

 Slide

So what is our current situation? Well, what we have come across is the fact that we've got E. coli in our apple cider. This is not--repeat, not--a normal constituent of apple cider. Let me assure you that if we took clean, ripe, fresh apples and squeezed apple juice from them, it would be a safe product. E. coli indicates that we have a contamination problem, and that is the issue that we have got to go after in this matter. It is not simply a contamination problem, it is a feca l contamination problem, which defines maybe a more insidious problem, but nevertheless it is a contamination; it is not a natural constituent of fresh apple cider.

So our goal clearly is to remove that source or remove that threat of E. coli, and our natural tendency seems to be to go after the threat by any means possible, whether it's a sledgehammer or whatever.

But in fact I'd like to make the point that I think the more intelligent approach by far is to go after the source, and in other cases of contamination, that is a very smart procedure and is one that has been used many times to help retain the product category and eliminate the risk or reduce the risk and still come up with a satisfactory quality and high safety in terms of the product.

Where do we go from here? Well, our natural questions start to talk about the source of this contamination and how do we reduce the risk.

Next slide, please.

 Slide

Let's talk about that, and let's talk in terms of reducing risk in this product. If you rode wit h me in the taxi as he rounded the corner over here on two wheels, let me tell you I know what risk is about, and that was a very risky concern of mine.

But this too is a risk, and of course, risk, as we have heard other people describe in these presentation over the last 2 days, is a very difficult one to grasp and put our hands around. In general, we tend to want a zero risk or absolute minimal risk in our food.

So our best approach here is always to look at means of reducing that risk. And I have started i n this slide from the orchard level, and I have done that very purposely because, as I am sure you heard some people talk about yesterday--unfortunately, we were not able to be here yesterday--contro l at the orchard level and production level in a product such as unpasteurized apple cider is critical. In fact, I daresay it is probably the critical step in terms of ensuring safety. Let's t alk about this a little bit.

First off, we want to look at source of E. coli possible in terms of a contaminant source at the orchard level, and you can start by looking at animal grazing, restricting that. Anyone who has had deer in his neighborhood knows how difficult that can be--it's an extraordinary challenge--and yet we know that that can be a very viable source of E. coli.

Diverting fruit that has been soiled by roosting birds is becoming more of an issue, but clearly one that if you talk to growers, they are aware of, they are sensitive to, and they know if they've got a problem in that category. But there are others, too, that you might want to be concerned about. Agricultural water quality is an issue that comes to bear, particularly depending upon the neighborhood that this orchard is associated with. And manure contamination control--this includes airborne contamination. These become difficulties where you the processor or you the consumer, no matter how much good information you have about the definition of the fruit you have purchased, do not know the history or the risk reduction associated with the growing of that fruit. The grower knows. The grower is a critical piece in delivering a safe, fresh commodity such as apple cider.

Let's go on to harvest control. Obviously, we have had a lot of discussion about drops versus tr ee fruit, and in order to ensure a higher degree of confidence in the safety of your product, tree frui t would be the option you would go for. But clearly, if you have seen an operation involving a very careful use of drops, a quality operation, there are many times where you could not differentiate the quality of that fruit when carefully done. But that implies again that at the orchard and at th e harvest level, there are very critical controls that take place in terms of ensuring a safe product coming out at the far end.

On fruit cleaning and inspection, we have heard a mountain of information and data and some very exciting options for us. Clearly, this is going to continue to be an important role in ensurin g the delivery of a safe product.

And finally, the processing and retail--and of course, Don just reviews with you some of our thermal processing information, and we have also heard others talk about cold storage. It is the entire picture that becomes the controlling element of the safety of something that is called fresh cider unpasteurized. I make the point to you that I believe some of the critical control of safety occurs back here, prior to when the processor ever sees the commodities coming in the door.

Next slide, please.

 Slide

So just to remind you in terms of delivering a safe product, who is doing some of the critical control here. Look back to the grower level where you have issues of production environment, issues of water quality, issues of contamination control and issues of selection of fruit, and if yo u are going to retain a product such as unpasteurized cider, this becomes a major control point. That does not lower the issue in terms of importance with the processor and the retailer. It is jus t another level of focus, if you would.

Next slide, please.

 Slide

So, do we do pasteurization? That becomes the question. Let's remind ourselves of exactly what we are talking about. If you are talking about taking a 10,000-gallon tank of fresh-pressed cider and pasteurizing that and then allowing that processor to draw off that and deliver that as a fresh cider that has simply been heat-pasteurized, it raises the issue of recontamination, particularly if that location of processing is anywhere near any other sources of contamination. And you are probably aware to some extent that there has been work done showing that even the common house fly is a carrier of E. coli.

It does raise the issue open tank systems, and we might run headlong into saying that pasteurization is a panacea, but it is not necessarily the silver bullet that is going to answer everything, and here is a clear example.

In New York State, we found upward of 180 cider manufacturers in the State. There are probably about 10 who are equipped with sophisticated pasteurization at this point. Even if you could implement pasteurization tomorrow, there is a fairly small fraction, maybe 20 percent of those remaining, who would go into pasteurization right away; the others would have a very difficult time. Likely they would have to ship their product out.

Okay. Pasteurization also occurs hot into the bottle, commercially sterile. It takes care of al l the issues and reduces the risk completely. But do we still have cider? And of course, you have herd a lot of discussion, and we aren't going to get in the middle of that right now. Some of the work with this project that we are currently being funded by USDA is to help address the issue of quality differential based on the type of pasteurization, and in our work over this next year, we'll be looking at a full span of pasteurization temperatures and times and impact on quality.

And then, finally into a sterile product--at what cost, and how do you implement. And if we go t o the next slide, it will help us take a closer look.

 Slide

Clearly, pasteurization is an effective tool; it does work, and our work has proven that. And based on our 1995 data, we had a 5 log cycle reduction, 160 degrees Fahrenheit and approximately six-tenths of a second. Our recommended process was 10 times that, and we believe it is an effective process.

If you look at commercial pasteurizers, what are we talking about in terms of getting into the ba ll game? At a minimum, at the size of a 2- to 5-gallon flow rate--this is the absolute minimum, if you would--you are really talking about a system that is ready to go, with recorders, controllers, et cetera, effective heat exchanges, an investment of at least $20,000.

Very low temperature pasteurization, we think is possible, is reasonable, and as we investigate those and look at those, we may be able to deal with this investment figure at another time and go on from there.

Let me finish up with some very explicit observations and recommendations that we think will impact the issue at this time.

 Slide

Clearly, pasteurization is effective, but we do not stand here and say it is the only game in tow n. We have heard some very exciting process technologies and process methods, issues, raised over these last 2 days. Most of the process technologies, you have heard today. The process method descriptions were coming up yesterday as we looked at a continuation of this unpasteurized cider product category and what could be done.

Clearly, labeling is a must. We have to identify our product categories if we are going to maint ain these four categories, and we have got to label them effectively so the consumer understands precisely what they are buying. Someone made the comment earlier about how well labels are read, and I believe those comments were very accurate. A large majority of consumers are very carefully reading labels, and to those consumers, we must do an effective job of labeling.

Education is the next step, and that means to the grower, the processor, retail and consumer. An d you'll notice I started with the grower because if we are looking at a continuation of the product category called "unpasteurized cider," that is a very critical control point. If we take that out o f the picture, then it becomes a minimal one; your critical control point moves forward, if you would, to the processor level in terms of a pasteurized product.

Consumers should be made aware, if we retain an unpasteurized product, that this may not be ideal for the very young, the very old, or the immune-compromised. And consumers are smart enough to recognize cautionary notes in those matters.

A high degree of selectivity in terms of raw material is a must. We have to implement a program that looks at what material goes in. The old adage, "Garbage in, garbage out," applies not only to computers, but to food as well.

So that tree fruit going into a product that we retain, called unpasteurized apple cider, is very appropriate. Fruit that has dropped to the ground, there is some question there, and that would need to be looked at more seriously.

We talked earlier about HACCP, and if this isn't a clear case for farm-to-fork HACCP application, I don't know what you need to define as a clear case. This is a great opportunity to implement a system where the grower, the processor, the retailer and indeed the consumer all recognize the role they play in delivering a safe product.

Clearly, with the number of questions that have been raised, we have a number of efficacy studies that have got to be run--efficacy studies that span from the very simple--how effective is the brush system--all the way on through to high technology, looking at pulsed light or whatever the technology may be and how effective that is.

The source of E. coli contamination--and remind yourself again that it is a contamination problem--must be tracked down. That is the culprit, that is the issue. Get on that, track that, an d then you have a better sense of exactly how to control it. As we have said over and over again, we do not know the precise source. We guess at probabilities in terms of sources of the problem, but we truly do not know.

Finally, use a clear sense of risk assessment. Deliver the safest possible product without throw ing the baby out with the bath water.

Thank you.

 Applause

DR. SHANK: Thanks to Mark and Don for those very nice presentations.

Our last presenter prior to the public commenters is Dr. Mohamed Ismail from the Florida Department of Citrus.

DR. ISMAIL: Thank you, Mr. Chairman.

The purpose of my presentation this afternoon is to highlight the Florida Department of Citrus and the Florida citrus industry's efforts to enhance the quality and safety of fresh-squeezed citrus juices in the wake of the 1995 salmonella contamination and to show you how it was possible to preserve this small but viable and important segment of the Florida citrus industry.

The Florida Department of Citrus is an agency of the State of Florida, and it is the executive ar m of the Florida Citrus Commission. Chapter 601 of the Florida statute embodies all the legal requirements governing the Florida citrus industry. The official rules of the Florida citrus indust ry are those rules adopted by the Florida Citrus Commission ever since it was established in 1935. The commission is appointed by the Governor, and its 12 members represent growers, packers and processors of Florida citrus.

Most of the rules governing quality of Florida citrus are contained in the official rules pursuan t to Chapter 601 of the Florida statute.

Mr. Chairman, I would like to leave with you a copy of the official rules of the Florida Department of Citrus and the Florida Citrus Commission.

Of special interest to these proceedings, I would like to bring to your attention Rule Number 20- 64.020, which governs the sanitary requirements for fresh-squeezed citrus juices, outlining good manufacturing practices, sanitation and quality control; also, Rule 20-64.0081, which governs quality of fresh-squeezed orange juice, including the specific maximum allowable shelf life.

Following the discovery of salmonella in nonpasteurized orange juice in August of 1995, the Florida Department of Citrus, along with the Florida Department of Agriculture and Consumer Services, and in close cooperation with the Centers for Disease Control and the University of Florida, started investigating the cause of the problem. The Florida Department of Citrus initiated the rulemaking in a very relatively short period of time. The rulemaking was aimed at enhancing the quality and the safety of fresh-squeezed nonpasteurized orange juice through adoption of sanitary practices at fresh-squeezed juice operations.

A public hearing was held at the Florida Department of Citrus headquarters in October 1995, and a final rule was passed by the Florida Citrus Commission in January 1996, and it went into effect in February of 1996. The whole process took approximately 6 months.

The rule stipulates--and I will read from the rule and also some modification--that the following good manufacturing practices as well as those described in Title 21 Code of Federal Regulation Part 110, April 1994 edition, incorporated herein by reference, shall apply to facilities preparing single-strength, ready-to-drink citrus juices that will not be treated by heat or other approved kil l step to reduce the enzymatic activity and the number of viable microorganisms.

These good manufacturing practices are in the following areas: a) the wash area; 1) acid-washed fruit and roller brushes use a minimum of 200 ppm hypochlorite rinse or other commercially-equivalen t bactericide. Water rinse just prior to entry into the process area. Belts, rollers, brushes and conveyors are to be maintained free of soil, dirt and extraneous materials. Entire wash area should be maintained free of excess debris, pests and potential pest harborage, including standing water. Grading must eliminate unacceptable fruit, i.e., fruit with cuts, splits, punctures, black heart and other defect. And--this is an important item here--drops are unacceptable for use in unpasteurized product.

In the process area, the process area must be completely enclosed. All food contact surfaces mus t be cleaned and sterilized after production and prior to the start-up. Appropriate cleaning and sanitizing agents must be used as prescribed by equipment manufacturers for the specific finished food product.

Effectiveness of the cleaning and sanitizing procedures must be verified and documented by the plan's own quality control program or HACCP, or good manufacturing practices as described in Title 21 Code of Federal Regulations Part 110, April 1994.

Number 4, if product residue or buildup of organic matter remains on equipment, additional chemical treatment shall be used to remove such residues and buildup. All lubricants must be of food grade quality as approved by the USDA. Back siphonage protection devices must be provided on any water outlet where a hose can be connected.

On the finished product requirements, a contingency plan for inline surge tank juice during breakdown must be in place to get juice chilled or disposed of. Cleaning and sanitizing procedures must be performed prior to starting operation after extended breakdowns. Filling area must be protected from the outside environment. Containers must be sanitarily handled and protected from contamination. When containers are removed from protective wrap, they must be covered, if not immediately used. Finished product must be immediately moved to cold storage.

On the quality control procedures, we specify in our rules that water certificate shall be obtain ed from HRS-approved laboratory on an annual basis.

Finished products. A documented quality control program shall be established to ensure that products without a microbiological safety barrier--and in this case, we mean no heat treatment and monitored for food safety. The program must include a microbiological monitoring component using standard plate count, coliform and E. coli as indicators of process control that is sufficient to establish a baseline for the specific plant process to ensure freedom from potential pathogenic microorganisms.

Each production lot, or each day's production, whichever is less, shall be monitored for compliance with baseline data previously established for the processing plant. Quality control records and records of process deviation shall be maintained after processing for a minimum of 90 days for fresh products and for 2 years for frozen products.

Establish a recordkeeping system that will a) track finished product to the fruit used in the production; b) tie products to specific periods of production; c) enable a recall procedure for unwholesome, unsafe products.

On personnel and sanitary facilities, plants shall take all reasonable measures and precautions t o ensure that good manufacturing practices are followed with respect to cleanliness and disease control.

During the public hearing held in conjunction with our rulemaking, the need for research and education became apparent. In addition to adoption of the rule, the Scientific Research Department of the Florida Department of Citrus, in cooperation with the Florida Gift Fruit Shippers Association, the Florida Department of Agriculture, and the University of Florida in both Gainesville and Lake Alfred, organized a workshop on the quality and safety of fresh-squeezed juice and minimally processed products. It was held on April 3 at Lake Alfred. The program included presentations on safety and quality. The case study of the fresh-squeezed orange juice contamination was presented; quality and microbiological safety of fresh-cut citrus was also dealt with. Florida food safety regulations as I presented it to them were also explained to those in attendance, and the fundamentals of sanitation were clearly explained by University of Florida professors Ron Schmidt, Charles Simms and Mickey Parrish.

Maintaining quality of fresh-squeezed orange juice through optimization of fruit-handling and extraction machinery was the topic of a presentation by an FMC engineer.

Furthermore, the Florida Citrus Commission approved funding of a research project by Dr. Mickey Parrish, Associate Professor of Food Microbiology with the Citrus Research and Education Center, University of Florida, to study the survival of salmonellae in citrus juices. We have also added to our staff a full-time food microbiologist, who is here today, and we are establishing a food microbiology laboratory devoted to citrus fruit and citrus juice products.

The Florida Department of Citrus has also sponsored and jointly prepared a HACCP plan for small-scale fresh-squeezed, unpasteurized citrus juice operation and, I must add, a model HACCP plan. The document is almost ready for distribution, and even though it is not finished, I have a copy of the rough draft, and I will leave it with you, Mr. Chairman.

Citrus juices, both orange and grapefruit, are compositionally different from apple and other juices. Pasteurization has been effectively used to ensure microbiological safety of the vast volume of orange juice sold in the United States. Pasteurization may not be the sole answer to the problem of microbial contamination. Strict adherence to good manufacturing practices and implementation of a sound and dynamic HACCP plan should provide microbiologically safe fresh-squeeze d citrus juice products. Exploring and researching new technologies that may be applicable to fresh-squeezed juice operations should continue to provide safety equivalent to thermal treatments.

The Florida Department of Citrus will continue to guide the fresh-squeezed citrus juice industry through research, education, and technology transfer to enhance their capabilities to produce the safe and wholesome citrus products they have been producing for over 100 years.

Thank you, Mr. Chairman.

 Applause

DR. SHANK: Thank you, Dr. Ismail.

This bring us to our public session. Let me start off by checking with Jerry Sapers. You did no t want to go earlier; do you want to go ahead at this point? Are you available?

MR. SAPERS: Yes.

DR. SHANK: Our first speaker, then, will be Jerry Sapers.

MR. SAPERS: Actually, my remarks have to do primarily with the application of sanitizing and disinfecting agents, not pasteurization, so it's a little out-of-place, but I'm really addressing so me comments made earlier by John Cherry and then later by Larry Beuchat.

This has to do with the use of hydrogen peroxide as a sanitizing agent for fresh-cut fruits and vegetables and its applicability to apples.

In our earlier work with mushrooms, we found that a hydrogen peroxide addition to wash water was very effective in eliminating bacterial blotch that would normally result from washing mushrooms and then stirring them over a period of 4 or 5 days. We were successful in extending the shelf life. We found that there was no peroxide residue in the mushrooms which were washed, primarily because of the presence of the enzyme catalase in mushrooms, which will decompose any residual peroxide to oxygen and water. This is an important point with regard to the regulatory status of this treatment, which is still an experimental treatment.

Now, in experiments that are still in progress with fresh-cut cantaloupe, we found that we obtained our best results when we applied the hydrogen peroxide wash to the whole cantaloupe, so that we were addressing the problem of bacterial contamination of the rind. And if you recall seeing Dr. Beuchat's micrographs of the surface of an apple, visualize what the rind of a cantaloupe looks like, with all of the many opportunities for microorganisms to attach to the crevices. And if this cantaloupe has been lying on the ground, also visualize opportunities for bacterial film formation.

For this reason, in our initial work, we found that we were getting very inconsistent results. W e are now using a wash that contains a surfactant, and we believe this experience might be applicable to the apple situation.

We also find that we will probably need to use a two-stage treatment, one stage of which will apply to the whole melon prior to cutting and a second stage, possibly with a lower concentration of peroxide applied to the cut surface of the cubes.

Now, with apples, we have only carried out one very brief experiment, which produced rather unencouraging results, but we are very much concerned that the problem there is that if E. coli is within the surface of the fruit, as has been postulated by several different people, then one would not expect a peroxide wash to be effective against organisms under the surface of the fruit.

A second issue that would have to be addressed is the question of peroxide residues, and in our initial results, we were concerned because we detected peroxide residues in treated apples even after what we thought was thorough rinsing. This turned out to be a false alarm, we think, primarily because when we tested for the presence of peroxide residues in control apples, we found it, particularly after homogenizing the apples in preparing our samples, and we believe that what we are seeing is simply the hydrogen peroxide as the end-product of normal enzymatic oxidative reactions that occurred when the apple tissue was broken down by blending.

So in our future work, we are going to have to differentiate between hydrogen peroxide that may be residual from the treatment and hydrogen peroxide that is simply there as a consequence of sample preparation.

With these few comments, I wanted to bring you up-to-date on what we are planning to do with our peroxide treatments on apples.

Thank you.

 Applause

DR. SHANK: Thank you very much.

Peter Chaires is next, and following Peter will be Bob Grant.

MR. CHAIRES: First, my appreciation to the chairman and the panel for this opportunity that we have been given here today.

My name is Peter Chaires, and I represent Florida Gift Fruit Shippers Association. The name is a mouthful, but to help you understand a little bit more about who we are and what we do, Florida's gift fruit industry is comprised of roadside retail shops and stands which offer fresh citrus fruits and fresh-squeezed juices for sale directly to the consumer. Although famous for our home delivery of citrus gifts, our real roots remain in roadside retail. The main attraction at a roadsi de retail shop in Florida is now and will always likely be fresh-squeezed citrus juice.

It is really kind of the engine that drives our industry. The fresh-squeezed juice is the attrac tion that pulls people into our shops, and it is our shops which drive the orders for our home-delivered product. It all kind of cycles together.

Roadside retail shops in Florida are really the hallmark of Florida's citrus industry and have be en since the industry's inception, and really remain synonymous with Florida's identity. We believe that 75-plus years of small fresh citrus juice production in the State of Florida without a reported incident is no accident. Small producers respect the position that this reputation affords them, and they have worked very closely with the outstanding scientific resources of the Florida Department of Citrus, the Department of Agriculture, and the University of Florida's Institute of Food and Agricultural Sciences, to seek continuous improvement as regards food safety and production practices.

Florida Gift Fruit Shippers Association believes that it is highly desirable to continue efforts to minimize the risks associated with nonpasteurized, ready-to-eat foods, including fresh-squeezed juices, and that this can be accomplished through sanitation methods other than pasteurization.

Scientific indications are, and practical applications verify that the risk of consuming ready-to -serve nonpasteurized juices produced under well-controlled conditions is minimal as compared to most foods. The record is good, and the record is there. This is and continues to be a healthy product.

The market for fresh-squeezed juice in Florida at roadside is well-developed. Tourists and local residents frequent these shops and purchase small quantities of juice quite frequently and quite often. The shops produce what is needed on a daily basis, and they emphasize and educate their customers that frequent purchase is best, as the product is not designed or intended for long-term storage.

The product is unique to the shop itself also, as the producer blends a unique mix of varieties t o achieve a flavor found nowhere else--it is unique unto that shop. And we have found that the product is purchased for its taste, its health benefits, and because it is locally produced. The consumers believe that they receive greater vitamin and mineral assimilation from the fresh-squeezed product as compared to thermally treated product.

We also know that when you witness the fresh production of the juice, the fresh production becomes not only a novelty but a factor of trust. Knowing the producers personally and witnessing the fresh production of the product itself both drives sales and consumption of the juice.

Florida's fresh-squeezed industry has been and continues to be a self-policing industry. It was the industry itself which requested and received additional research on the survival of salmonella in citrus juices. It was the industry itself which requested and received inspection from the Florida Department of Agriculture's Division of Food Safety and a unique inspection system for small operators is in place today as a result of that.

It was the industry which jointly recognized the need for educational support and received such from the April 3 workshop that was outlined by Mohamed Ismail a short time ago, toward improving the safety of fresh-squeezed juice and minimally processed citrus products. It was after the April 3 workshop, when small operators learned of the many benefits that could be available to them through HACCP programs, that a model HACCP program as was described was put together. This is now in operation; the first one came on line I believe in October, and we are very excited about that.

Small farm family businesses face unique challenges in cost-effectively implementing sanitation and process-oriented programs that were originally designed for larger-scale production; but these small operators, rest assured, seek the same safety and sanitation goals.

The Florida Department of Citrus and the Institute of Food and Agricultural Sciences has responded to this request time and time again through these education programs, and we have found these education programs to be very well-attended by the industry.

Evidence that there is a health problem in Florida in the fresh-squeezed industry remains questionable. However, the industry has done nothing but bolster its efforts to improve the safety record that we believe was already admirable.

Ties with State and regulatory agencies have been tightened as teamwork definitely will pave the way to success. Any steps to consider mandatory pasteurization in the face of such industry response and cooperation we believe would be tragic.

Florida Gift Fruit Shippers Association is not disillusioned in believing that America's food sup ply can be made 100 percent safe. No amount of money, effort or research could accomplish such a lofty goal. However, we also believe that 75 years have proven that a clean, sanitary environment and safe, monitored and inspected production processes can and will result in a healthful product.

Current efforts by State and regulatory agencies will only serve to improve the safety of the product itself and consumers' confidence in the fresh-squeezed industry.

Pasteurized and thermal products and processes are not the answer and don't provide 100 percent safety against foodborne illness, and we believe that this would be overkill and is not warranted or justified.

Thank you.

 Applause

DR. SHANK: Thank you.

The next speaker is Bob Grant. Is Bob Grant here?

 No response.

DR. SHANK: Is Steven Justis here?

MR. JUSTICE: Yes.

You heard earlier this afternoon from those small local juice producers, Nestle and Cargill. I'd like to give you a different perspective on cidermakers from Vermont. Some of you may know Vermont as that small, multinational corporation just south of Montreal and north of Boston. With all this talk about acetic acid today, I had to get some out.

Good afternoon. My name is Steve Justis. I am a marketing specialist with the Vermont Department of Agriculture and also the chief executive officer of the Vermont Apple Marketing Board. I have spent more than 12 years working with agricultural marketing, but I also have a science background, including a master of science degree in plant pathology. Through my 20-year ass ociation with the Vermont Department of Agriculture and the State's dairy industry, I have gained some insights that I think maybe we can relate to the cider industry and the fresh juice industry. We also have had a certification program in Vermont for the last 3 years in which we have had good cooperation from the Vermont Department of Health and other organizations in the State.

Vermont's apple industry is relatively small compared to the rest of the United States. Within t he State of Vermont, however, the apple industry is very important, generating over $12 million in farmgate sales alone. The fresh cider industry is a substantial part of our apple industry.

In Vermont, a State with a population of just over half a million people, fresh apple cider sales generate more than $3 million in farmgate sales. We have about 30 commercial cider mills in the State. Mandatory pasteurization would probably eliminate 90 percent of the producers and further damage an already fragile industry. That would likely be the case for most of the other New England States as well.

Economics, however, is not the only factor in our State's opposition to mandatory pasteurization of fruit juices. Protection of public health is our priority, and it is an imperative, but it must be done in a manner that is based on sound science, not ignorance and fear.

In the winter of 1989, the media and a public relations firmed fanned the flames of craziness in the well-known alar scare. Parents were afraid to give their children apples or apple juice. Responsible health organizations half-heartedly came to the apple industry's defense--but in America, when it's media against science, science tends to lose.

In October of 1989, the Wall Street Journal reported about how the PR firm involved with this incident had actually bragged about how it had manipulated the media. The apple industry was sacrificed to further the agenda of the PR firm's clients. The damage to the apple industry was done.

The U.S. apple industry is still living in the aftermath of losing a valuable harvest aid, which has since been exonerated by health officials, including the World Health Organization.

Fresh cider is part of a strong tradition in New England and other parts of the country, going ba ck more than 300 years. New England cider producers are not willing to be sacrificed to the gods of expediency for the benefit of major industry processors. As we have heard today, pasteurization is not the silver bullet that will make foodborne illnesses disappear. Mandatory pasteurization wil l not keep apple juice and apple cider out of the headlines.

Despite efforts of the poultry and beef industries, salmonella and E. coli O157:H7 still make the ir way to Thanksgiving tables and backyard barbecues. We do need to ensure, however, that neither government nor society overreacts to the recent outbreaks of E. coli and cryptosporidium as we did with alar. However, we do need to take some thoughtful, reasonable measures to further ensure the public that commercially-prepared apple juice and cider is fresh and wholesome.

Recently, the Commissioner of Agriculture assembled a Cider Task Force including representatives of the Vermont Department of Health, the University of Vermont, and the State's apple industry. The task force has not yet formally met, but I have had an opportunity to review our recommendations with each of the members.

Our first recommendation to FDA is as follows. Mandatory pasteurization is an unnecessary and unreasonable step for the fresh fruit industry. Fresh apple juice and apple cider are not inherentl y dangerous products. E. coli O157:H7, cryptosporidium, salmonella and many other organisms linked to human diseases are carried by animals and animal waste. Human illnesses relating to fresh juice and cider are the results of people contamination problems. I think we have had that fact pretty well-established over the last couple of days.

Every commercial processor of fruit juice and cider should be required, if not by the government, then by his product liability company, insurance company, to develop and implement a HACCP program for his or her operation.

Next, industry and government need to work together to identify specific research needs for the fresh juice and cider industry. There is little literature available on the effectiveness of fruit and equipment disinfectants, brushing and washing or chlorinated washing in controlling E. coli and some of these other organisms, although I think this forum has been good in bringing some new technology to the forefront.

I would encourage industry leaders and the scientific community, however, to work on two different tracks. Last night, we had a discussion of both of those tracks--the fast track, that we are looking at an industry that needs to be able to get back in production fairly quickly. So I thi nk we need to look at some short-term goals, but also some longer-term research goals in which graduate and those kinds of things that were discussed last night can be funded. But I think we have got to realize that we are talking about small, fragile family businesses in a lot of cases.

Although some industry members are likely to discount the value of product sampling, sampling has been an important part of the dairy industry for years. Vermont is basically a dairy State, and we have had quite a good history of milk testing.

The sampling that I recommend is not to detect the hyper-virulent strains of bacteria or other pathogens. Instead, frequent, routine testings would be used to determine threshold levels and detect breakdowns in the sanitation process. If a juice or cidermaker is not doing an adequate job of washing apples or some other process in the routine, then those results will be found in the end product. Also, in the dairy industry, as we have seen in the literature and comments during the last couple of days, the rinse water is another area, and that is also routinely tested by dairy inspectors in the State of Vermont and I'm sure other States as well.

So I think that is something that we need to do to standardize, and I know it's not the silver bu llet, but I think it relates to our last recommendation, on developing mandatory HACCP standards.

Finally, I would like to encourage FDA and the other States to develop juice and cidermaking guidelines for distribution both to homeowners and more in-depth publication for the smaller cider producers. We have some experience in that--I know there is not one HACCP system that fits all businesses, but I think we can provide some background that will make it easier for the smaller cidermakers and juice producers to stay in business and develop their HACCP plans.

I don't know if any of you saw the stories in the papers about yesterday's session, but one of th e headlines is "E. coli Bacteria Threats Grossly Under-Recognized," and the other one is "Juice Makers Argue Against Pasteurization." I was thinking yesterday that the comments were going so that we were looking at HACCP as being the standard that we would go, but the media said that we are grossly underestimating the problems. And then I was just remembering that my wife and I had a vacuum cleaner salesman come to our house about a year ago, and they went around and where showing us how much better their vacuum cleaner was than the one we already owned. They went around and checked everything that we had already vacuumed--of course, we vacuumed before they got there--but they showed us all the places that their vacuum had gotten, and then, they showed us these big electron microscope photos of dust mites and other things that were living between our sheets, under the bed, and so on. So that first night, I was thinking about all these microorganisms and giant dust mites that were under my bed, and it was pretty hard not to itch or whatever.

So I think the public is very impressionable when it comes to suggestions about these problems with their food supply. I think we do need to make some improvements in Vermont. Even if the Federal Government doesn't do anything, we are probably going to go to a mandatory HACCP program. But I also think we have got to realize that we do have a substantial impact with each of the smaller growers in the State and throughout the country.

If we are up to the Nestles and the Cargills of the world, I imagine we would all be giving our kids UHT milk.

Finally, I'd like to conclude by saying that a recent article in U.S. News and World Report reported that the United States ranked 28th among countries around the world in individuals' science training and abilities. Ignorance leads to fear, and fear leads to irrational behavior. I' d like us to take the high road on this issue. We will be doing a greater service to both the general public and to the fresh produce industry by acting in a thorough and responsible manner guided by sound science, not by ignorance and fear.

Also, I'd just like to throw in that I agree with Mr. Nicholson that I'd like to work with our industry in producing a "wow" product.

Thank you.

 Applause

DR. SHANK: Thank you.

Next is Robert Ochs, and Mickey Parrish will be next.

MR. OCHS: Good afternoon. My name is Robert Ochs. I own and operate Nettie Ochs Cider Mill, located in Livingston, New Jersey. I have a few comments before I read my brief statement.

I do not have a Ph.D., but I do possess an amazing grasp of the obvious. I was told that the members of the FDA and the CDC were the bogeymen, and I am glad to see that they aren't and thank them for allowing me to come in and talk today for a few minutes.

Basically, if you can't eat the apple, you shouldn't be drinking it. We need more common sense i n production practices; I think we need more positive statements from the CDC and the FDA about the benefits and the very low risks involved with pure apple products. About the last thing we needed was the Odwalla people being quoted in USA Today and The New York Times, 2 weeks before Thanksgiving, saying, "We encourage all producers of apple juice and cider to stop production until we find the source of the E. coli." Well, we still don't know where the E. coli came from, and I hope it's okay that I went back to work.

We all know the apple cider industry is going through some tough times right now. Why? Because too many people who are involved in the industry felt that the status quo was good enough, season after season, year fitter year. Well, welcome the nineties. Odwalla, California, Cheshire, Connecticut, Berkshire, Massachusetts--it doesn't matter which State we talk about, we need to talk about the state of our industry. We need to clean up our image, and in order to do that, we must clean up each and every cider mill/apple juice facility that is serious about producin g safe, nonpasteurized juice.

My family has been making cider in Livingston, New Jersey ever since my great-grandfather came from Germany in 1965. Most cider at our mill that was sold or bartered for at that time was hard cider. It wasn't until the late forties that sweet cider was offered fresh daily from October throu gh Christmas. At that time, my father got tired of waxing the press top and thought there had to be a better way, so he contacted a metal fabricating company, and stainless steel press coverings were made, and that started something.

The following year, the wooden collecting vats that sat under the press were replaced with new stainless steel ones. Next, the siphon hose was replaced by a stainless pipeline and a transfer pump. A few years later, the wooden barrels became obsolete, and they were replaced by stainless bulk milk tanks.

Since I got involved in the business in the late sixties, a 22-foot long stainless steel elevator lifts the apples from the first floor to the second floor, into a new blade mill.

A forklift was purchased in 1974, and the old paddle-wheel washer was replaced by nylon brushes and a series of water jets that comprised the new washer.

However, if I had to choose the piece of equipment most responsible for removing the junk, the leaves, the twigs and so on, it would be the water dump tank that people have already talked about. All the fruit used in our operation is tree-picked--all of the fruit is tree-picked. Most o f it is washed and graded at the orchards. Some apples that we get are orchard run; if the growers feel the size or color doesn't warrant grading them, then we get them. The bin-dumper transfers the tree-picked apples to the water-filled dump tank. Anything that doesn't belong in the cider, such as sticks, leaves, anything else that finds its way into the apple bin, is separated before the washer. The apples are elevated from the dump tank onto a sort roller for visual inspection. Any suspect fruit is removed, and the rest of the fruit goes through the washer and onto the grinder.

So let's face a few facts here, the first one being that although it's not a popular fact, it's a fact nonetheless, with these cider/juicemakers who also grow their apples, drop apples do not make the same high-quality juice that tree-picked fruit makes. Second, E. coli is in feces found on the orchard floor, and I don't think we have to say too much more about that; enough has been said.

Requiring pasteurization of properly-made fresh-pressed cider is like closing the barn door after the horse ran out. Not only is it not necessary for producers such as myself, but I believe it is wrong. It is wrong because we already do not eat or drink enough pure, natural foods. Chemical preservatives, additives, and other shelf life extenders have created a whole host of health problems in a large segment of our population. Necessary vitamins and minerals that are cooked out of our foods are sometimes reintroduced in synthesized forms to satisfy food scientists or nutritionists.

When food or drink can be offered and enjoyed in a pure, natural, safe way, would;'t you choose that over some tasteless, silver-processed product?

Anyway, getting back to production, the best equipment in the world will not make the best cider unless it is kept spotlessly clean. It takes 2-1/2 to 3 hours every day to clean everything in our mill, and I think it's the most important job on the premises.

Year ago, when New Jersey State officials inspected all cider mills in the State on a yearly basi s--not just wholesale operations--a 5 percent bleach solution was recommended for sanitizing equipment. It still works--at least, I think it works--after all this, who knows?

In 1985, the FDA did a spot-check on our cider for pesticide residues. None was found, but when the inspector gave me the results of the testing, which also included bacteria levels, his comment was: "Your levels of bacteria in your cider are very low, close to a pasteurized product. That tells me you run a real clean operation."

As I mentioned earlier, our cider is made fresh daily from mid-September through January. Making cider every day means cleaning up every day. I don't know how many cider mills in the country have a washer and dryer for cleaning the cider cloths, but all of them should. And you can talk about cleaning the cider racks. I use a machine that's called a Strominum 6000. It is a pressure-boosting system with a bleach injector system on the side of it. It does a great job, not only on the racks, but on all my equipment and on all my surface areas that come in contact with food product. I think it is the best machine out there.

To sum up, pasteurization is not necessary if you use only tree-picked fruit, you have easily-cle anable equipment that is FDA-approved, you use a bleach solution in your daily cleaning operation. Keep your fruit refrigerated prior to pressing, and keep your juice refrigerated.

In our parts per billion society, we need to really take our industry seriously. Producers shoul d upgrade something in their plants every year. I am all for less government in our lives, but we need State and/or Federal inspectors who can enforce sanitary guidelines that all producers should follow.

Pure apple cider has been a part of the full tradition since our country was founded. Thomas Jefferson's favorite apple was the Espo Spitzenberg  phonetic . I haven't squeezed any of those, but I hope I can continue squeezing other varieties until my children, who are the fifth generation, can take over the business.

Thank you.

 Applause

DR. SHANK: Thank you.

Mickey Parrish is next.

MR. PARRISH: Thank you, Dr. Shank.

My name is Mickey Parrish, and I am an associate professor of food microbiology at the University of Florida. I would point out that the University of Florida and the University of Georgia are athletic rivals, and I am wondering why, in Larry Beuchat's slides, he misspelled the word "alligator." We may have that discussion later, Larry.

 Laughter.

MR. PARRISH: I am going to limit my comments to citrus. Freshly-extracted orange and grapefruit juices provide consumers with a desirable product having enhanced flavor values compared to pasteurized juices. Mark McLellan indicated the possibility of looking at 140 degrees for extended times as a pasteurization regime. According to my sources in the industry, 140 degrees will definitely affect the flavor of orange juice.

Before pasteurization requirements are implemented for all fruit juices, let us consider and understand that nonpasteurized juices which are safe are being produced currently. There is strong empirical evidence to support this.

First, prior to 1995, nonpasteurized, freshly-extracted citrus juices had been consumed commercially for many decades without document incident. It is important to note that the salmonellosis outbreak from orange juice in 1995 was the first documented foodborne illness traced to a citrus processing facility.

Second, there is substantial evidence that this outbreak would likely have been prevented by a more tightly-designed facility coupled with scrupulous sanitation practices. My laboratory was intimately involved with the research efforts related to the investigations within this implicated processing facility. We sampled numerous points along the processing chain, swabbing belts, equipment, and pulling juice samples from various points, these activities being conducted on 2 days during commercial production, another day after the plant had suspended operations, and a final time, when the facility was operating a trial run where all equipment had been very thoroughly sanitized.

Unopened bottles of finished product from various production dates, including the trial run, were obtained at the plant and from retail sources. Analyses were conducted for total aerobic plate counts, coliform and E. coli. Additionally, all juice samples and selected environmental and facility samples were tested for the presence of salmonella.

There were large total plate counts and substantial numbers of E. coli in most juice samples from the commercial production dates. This is obviously unacceptable.

Juice produced on the date when we know that sanitation procedures had been thoroughly conducted contained 10 to 100 times fewer total microorganisms and no detectable E. coli or salmonella. According to my conversations with epidemiological experts, the salmonella isolated from patients in the outbreak, which were Salmonella Hartford, Gamonara and Rubislov, are seldom associated with disease outbreaks and were therefore likely of environmental origin rather than the more common human or domesticated animal sources.

Interestingly, we isolated Salmonella Hartford from an amphibian captured in close proximity to the processing area. Other salmonella strains were also isolated from amphibians in a nearby structure. These data suggest that the plant design and hygiene were insufficient to prevent contamination from environmental sources.

There is reason to believe that stringent adherence to good manufacturing practices, coupled with an effective HACCP program, will prevent future outbreaks. Further research is warranted to address this position.

Other than the 1995 event, the only other documented salmonella outbreaks which I could find in the literature attributed to orange juice consumption in the U.S. occurred due to contamination of juice with Salmonella type  phonetic from asymptomatic food-handlers at a New York restaurant in 1989 and a Cleveland boardinghouse in 1944. These are the types of incidents in which any contaminated food product, pasteurized or not, could pose a threat to public health.

I respectfully suggest that at this point in time, according to the available information which w e have, mandatory pasteurization of citrus juices is an overreaction to a very sensitive and difficult issue. While it is desirable to minimize risks associated with ready-to-eat foods, we should note that such risk might be minimized using methods other than pasteurization. Appropriate production practices which emphasize fruit quality and strict sanitation standards should be able to achieve a relatively safe juice product with minimal risk of illness. Additionally, innovative nonthermal methods to enact microorganisms are being investigated, such as several of the items which we have heard about earlier today.

For example, our laboratory is currently conducting research on the use of isostatic high pressur e to inactivate microorganisms in foods. This technology produces very high-quality food products with extended shelf life in which virtually all vegetative microorganisms are destroyed. There is every reason to believe that this alternative to thermal pasteurization will also inactivate pathoge ns in fruit juices. We have run some recent tests using salmonella in orange juice and found this to be true; we will continue to look in that area. I would point out that more information is obviously necessary.

In summary, it is important to remember that our overall food supply will never be 100 percent safe, 100 percent of the time. No method of food production, including pasteurization, is foolproof. We must continue to strive toward the implementation of industry practices which provide the safest possible food supply, while maintaining the flexibility to produce a wide variety of wholesome and nutritious food products for the American consumer. Nonpasteurized fruit juices can be produced so they are a part of that wholesome, safe food supply. Continued research efforts--and increased funding, incidentally, to my FDA and USDA colleagues--for those efforts are needed to address these important points.

Thank you.

 Applause

DR. SHANK: Thank you.

You all have been great, sitting here all afternoon, and we still can't have a break, but you may want to stand up just for a moment in your places while I make a couple of announcements.

We are halfway through the public commenters on the pasteurization issue. The time clock is getting us into a little trouble, and I want to make one change in the agenda. I am going to ask Betsy Woodward to come up and give her presentation on what advice should be given to consumers. Immediately following this one presentation, we'll go back to the original program and finish up the public commenters on pasteurization; then come back into the program with what advice should be given to consumers.

We just need to get Betsy out of here, so come on up, Betsy.

Now, don't think that FDA is being heavy-handed. She requested to be moved up on the time frame because of other obligations. Ms. Betsy Woodward is with the State of Florida, but she is here today as president of the Association of Food and Drug Officials and has some information for us on what advice should be given to consumers.

Betsy?

MS. WOODWARD: Thank you, Dr. Shank.

The capitol of the State of Florida is located in Tallahassee, and somehow or other, the airlines have decided that that isn't a very good location for a hub, so if I leave a little over 5, I'll be home by 10 tonight. So the last flight out is the reason why I requested to be moved up from the time slot assigned to me.

On behalf of the Association of Food and Drug Officials' board of directors, I would like to than k the Food and Drug Administration for the opportunity to participate in the discussion and information gathering activities of this meeting on fresh juice production and the topic which was assigned to me--What should we, the regulatory community, be advising and telling our consumers.

Let me first give just a little intro into the Association of Food and Drug Officials. AFDO was organized in 1896, and its membership includes local, State and Federal food and drug officials and representatives of industry and academia. One of AFDO's main missions is to foster the development, implementation and enforcement of uniform requirements for food safety across the 50 States, Canada and Mexico.

Because AFDO comprises food regulatory program administrators from State and local programs, it is uniquely structured through its six regional affiliates to rapidly disseminate information impacting food safety regulation at the State and local level to those programs and their consumers. Our involvement here is important because the local and State officials represent front-line regulatory contact with the consuming public.

Consumers are understandably confused. On one hand, they are being told and encouraged, and rightly so, to consume more fresh fruits and vegetables for better health; and on the other hand are now being told that some of these products may in fact make them sick and, for some, cause serious, life-threatening illnesses and even death.

It is not surprising, then, that a recent report from the National Association of State Departmen ts of Agriculture indicated that the consuming public has lost confidence in government's ability to protect the food supply.

Certainly, part of this distrust is the result of these mixed messages, along with the recent rep orts of foodborne illness associated with multi-State outbreaks involving Salmonella enteritidis, cyclospora and E. coli O157:H7. The most recent incident and the one that has been talked about so much here implicated fresh, unpasteurized apple juice.

What should we say to consumers? More importantly, what is the basis of what we say to consumers? This is a particularly frustrating issue for the regulatory community and public health officials and one with which the AFDO Board struggled. On the one hand, we know that there is no absolute safety in any food, and on the other hand, we are charged to protect the public health from unacceptable risks which result in harm.

The challenge is threefold--first, to determine the risk associated with these emerging pathogens ; second, to determine what level of risk is acceptable--and here is where society's view of that risk comes into place; and third, to determine what action is best to advise or warn consumers, or to minimize or mitigate the food safety risk.

First, we think that we must honestly tell consumers where we are, what we know, what we don't know and what we are doing. Fruits and vegetables are grown in a naturally contaminated environment which creates a potential for risk, albeit, we think, a very small one--the risk of a consumer encountering a pathogenic microorganism.

Fields and orchards are not enclosed--unless we quickly buy an arena--to preclude the presence of birds, animals and vermin and their excrement. So with any raw product, there is a risk of microbial contamination.

The types of pathogens causing illness have very low infectious doses. Children, the elderly and immune-compromised individuals are much more susceptible to illnesses and serious complications. These individuals are therefore at greater risk for illness when exposed to a pathogen, and children in particular are especially vulnerable to E. coli O157:H7 infection.

Minimally processing fruits and vegetables such as in fresh juice production may increase the ris k from the natural contamination in the environment through commingling larger numbers of fruits and vegetables, which may spread the contamination of a single piece. On the other hand, processing controls such as washing, brushing and sanitizing may in fact lower the risk. We simply have no data.

The regulatory community must face the difficult dilemma of balancing our mission to assure safe food to all consumers, including high-risk individuals, and making fresh or minimally processed foods available to those consumers who want them.

Part of the frustration here is that we are in serious shortage of risk assessment data on raw fr uits, on the ecology of E. coli O157:H7 in particular, and we certainly have no data on the impact of minimally processing on that risk.

We do have, however, intuitive knowledge on process critical control points based on experience, such as precluding the use of ground drops and sanitizing fruit and fresh juice production. But more research is needed to ensure that control measures are effective.

Before we can make sound science-based decisions, we need to have more complete data than is currently available. In the absence of good data, we need to be very careful that we don't trade one problem for another or make what later turns out to be a less than prudent decision.

The fresh juice industry was initially small and local. Historically, these products have not be en regulated for microbiological safety. Specific processing critical control points and product safet y control measures for fresh juice are currently evolving, and only a few States require much beyond general good manufacturing practices for fresh juice production--and I was very pleased to learn that Illinois, Vermont and Michigan are looking at such improved controls.

There are no special Federal requirements. Only two States have enacted or are using specific processing standards for fresh juice that we are aware of. Florida has its mandated rule about which you heard today, and Massachusetts developed guidelines for fresh cider production which require specific fruit-culling and processing controls, which you heard about yesterday.

The AFDO Board recommends that fresh juice production be carefully controlled and monitored to reduce risk. We support and recommend that the FDA study the effectiveness of some of these mandatory process controls, both existing and proposed, HACCP systems and other guidelines for their effectiveness, and make recommendations on improving critical food safety controls in processing as quickly as possible.

With respect to mandatory pasteurization, the AFDO Board recommends that we not rush to this restrictive solution. We recommend that risks be scientifically evaluated and that controls to minimize risk be tested for efficacy and feasibility and that the industry be given the opportunity to demonstrate that they can indeed produce a safe, fresh juice product by the establishment and adherence to performance standards, HACCP systems or other means before considering a mandated pasteurization requirement.

AFDO has a long history of promoting uniform industry standards or acceptable processing guidelines to the States and industry. Today AFDO offers to play a role in facilitating the development and adoption of approved uniform processing standards for fresh juice State-to-State.

In addition, AFDO through its regional affiliate structure offers its resources and experience to assist in providing uniform education and training for both regulators and small industry in understanding the food safety risk and the operation of these particular fresh fruit systems. Consumers need to know that we are moving quickly to assure that current fresh juice production is under good manufacturing practice control as far as we know that the good manufacturing practices will control some of the risks.

In the interim, risk of illness, especially that of very young children, should be communicated t o consumers. However, here is where the States are divided on how to accomplish this, and the division is largely due to the frustration of not having enough information. Some leaders of food safety programs believe that a warning label is necessary which clearly identifies the risk to children and other susceptible populations, especially if the frequency and severity of the illness are significant. Other State officials feel that we may be fast approaching the "Chicken Little" stage of warning messages on food labels and that other, more inclusive means of education and information must be used.

We know that the FDA has recently concluded some consumer focus group studies regarding the use of advisory and warning messages to consumers, and that study was associated with the food code. The AFDO Board recommends that the FDA use the information from consumer focus groups and professional educators to determine the most effective means of educating and informing consumers of any risk associated with a specific fresh juice. A primary objective should be to lesson the risk to young children and the susceptible populations.

During the recent outbreak, consumers were especially frustrated in their inability to differenti ate unpasteurized juice from pasteurized, using the label information provided. Clearly, consumers demand information, particularly when it impacts their ability to make personal decisions regarding what they are going to consume and their perception of the safety of what they are fixing to consume. Therefore, the AFDO Board recommends that label information be provided to consumers which clearly discloses whether or not the juice is pasteurized.

Industry has the primary role in assuring consumers that their minimally processed products, especially juice, are being produced under the most effective process controls to minimize any risk. If these products are to remain in the marketplace, government must maintain oversight to ensure that the industry adheres to effective, good manufacturing process control measures. The government must also work cooperatively with industry to evaluate new technologies and process controls which demonstrate they can reduce risk and improve product safety. Only if it is demonstrated that with these controls, fresh juice cannot be processed within acceptable safety standards should a terminal preventive step such as pasteurization or preservative be mandated.

Consumers must become informed, not alarmed. they must make appropriate food choice decisions, and those decisions have to be based on education, product label information, risk-benefi t information, and a knowledge of susceptibility to illness. Our role is to provide consumers with timely and accurate information so they can make these informed decisions.

Thank you.

 Applause

DR. SHANK: Thanks, Betsy.

Let's return now to the public comment portion of the program where we were considering pasteurization of fresh juices.

The next speaker will be Marygrace Sexton. Following Marygrace will be Dan Wilson.

MS. SEXTON: Good afternoon. I am Marygrace Sexton, president and owner of Orchid Island Juice Company located in Fort Pierce, Florida. I am the mother of two little girls--Natalie, after whom the company is named, and Lucy.

I do not think it is appropriate to outlaw fresh-squeezed orange and grapefruit juices. To ensur e consumer safety, the Florida Department of Citrus stringently regulates my facility; it does not eliminate me, it regulates me. Regulation of the commercial producer is feasible and acceptable. It is impossible to regulate the bathroom of every restaurant or hotel.

Our company is aggressive with sanitation because we believe we are responsible for the safety of our consumers. Florida is the only State mandating the constant regulation of fresh-squeezed orange and grapefruit juice. We are regulated and inspected by the USDA.

We have documentation that indicates that proper sanitation and good manufacturing practices can eliminate risk in fresh-squeezed orange and grapefruit juices. Fresh juice is a pleasure that some of America demands. We are responsible for their well-being.

The following slides of my facility, taken by me during a normal production date, Tuesday, December 10th, should convince you that there are procedures and regulations that can and must be implemented nationwide to keep the consumer safe.

Because of my company's efforts and the regulations of the Florida Department of Citrus, I do not have a fear of failure in my product.

Mr. Martinelli, the plant manager, will show you slides of our efforts.

MR. MARTINELLI: Good afternoon.

 Slide.

The first thing you notice when you enter our facility at Orchid Island Juice Company is that we have sanitation barriers to ensure that no production worker can get to his or her production line without first sanitizing their hands in our automatic sanitizer.

 Slide

Employees are taught to insert their hands and complete the cycle, and when their hands come out, they are pathogen-free.

 Slide

Here is an example of an employee dressed in a production line worker's garb, utilizing the hand sanitation device.

 Slide

This is outside of our facility, and it is immediately after the fruit is unloaded off the truck. We completely saturate the fruit with sanitizers and cleaners at various steps in our production line.

 Slide

An important note that I'd like to make is that we not only sanitize the fruit, but we also sanit ize every belt to ensure that there is no potential for recontamination during our process. This is the third application of sanitizer before our fruit gets to the wash bed. On the wash bed, 35 rapidly-s pinning bristle brushes of different length and texture wipe off all the contamination that exists before it receives a thorough freshwater flush and then goes onto a grading table where we literally have an army of experienced, highly-trained graders who we insist touch each piece of fruit to ensure that no unwholesome fruit gets past the grading table.

 Slide

After that, our fruit receives another application of sanitizer. Again, if you notice the strate gic position--it's as the fruit tumbles off the grading table so that we get maximum coverage with this application.

 Slide

Then the fruit goes up, and 10 high-pressure, freshwater nozzles ensure that all the chemical residue is eliminated before they go into our sanitary extractor room.

 Slide

We have several sanitary rooms--we are in one now--which are actually buildings within buildings where we can maintain strict compliance with sanitation concerns. Here, fruit is being graded by a roller grader and going into an extractor feed.

 Slide

This is a picture of an extractor cup. One of the main points that we'd like to make for the cit rus industry that makes us different from the apple industry is that our cups and our extraction devices minimize any contact of the juice with the peel.

 Slide

After that, the juice is taken out of the extractor room through sanitary pipes and headers, and within a matter of seconds is chilled to less than 30 degrees Fahrenheit.

 Slide

After that, it is maintained in stainless steel, refrigerated holding tanks for a brief period of time until it is bottled.

 Slide

This is inside our sanitary labeling room. Inside each of our rooms, the only liquid that is permitted in there is iodine solutions that, wherever we spray to clean, we are also sanitizing ever y time an employee picks up a nozzle to clear a particular area.

In the labeling room, we take in sanitized jugs inside sanitary wrappings, and only when they are inside the room to we unwrap them and place them on the line.

 Slide

Then, the go into our filler room, where we have state-of-the-art equipment, where it's virtually a hands-off operation to minimize any potential contamination from human sources.

 Slide

Our operators basically stand back and watch our filler machines work, and when necessary, they make adjustments on the stainless steel panels that are in front and to your left of this operator.

 Slide

After that, the juice comes out of the sanitary bottling room and is expeditiously packaged and palletized by very experienced workers, and then whisked off to our cooler, where we maintain a day's inventory and ship.

 Slide

It is very important to note that every day, we'll fill this cooler, and then, in the evening, w e will ship it all out. We do squeeze-to-order only, and we maintain no inventory.

 Slide

After we are all done, every night, we manually disassemble our machines and physically, manually clean them before we reassemble then and use an automated, clean-in-place device that uses freshwater rinse, a very hot, 180 degree Celsius caustic treatment, followed by a sanitation treatment that stays in our pipes overnight to eliminate any potential for sanitized surfaces being recontaminated.

 Slide

These are some pictures of our production facility after the clean-up on Tuesday, December 10th. This is the condition that we leave the plant every night before we go home.

 Slide

In conclusion, I would like to say that we at Orchid Island Juice Company firmly believe that producers who are willing to put fanatical emphasis on sanitation, well-integrate their GMPs into their employees' behavior, and are willing to have zealous maintenance of their cold chain integrity can produce fresh-squeezed products that are both safe and wholesome.

Thank you very much.

 Applause

DR. SHANK: Thank you.

Our next presenter is Dan Wilson, and he will be followed by Richard Wood.

MR. WILSON: Thank you. I am actually happy that you placed me at this point on the agenda because by implication, it means you're giving me the final word on these matters.

My name is Dan Wilson, and I am a small-scale cider producer in Upstate, New York. Yesterday, Paul Baker, also a New York State grower, described the 10 doors, the 10 rooms that need to be opened to describe New York State production, and I feel like I am about, with my comments to open door number 11.

In any case, thanks for your endurance, those of you who are still here.

As a producer of fresh unpasteurized apple cider, I hope to add perspective to your discussion of the issues at hand from the standpoint of small- to midsize operations like mine. Located just south of Lake Champlain on the Vermont border, we are New York's oldest U-pick orchard and have been selling our fruits and related products directly to local customers since 1905.

I'd like to ask how many of you have been to a U-pick orchard?

 A show of hands.

MR. WILSON: That's the right direction. To the rest of you--get out of the city.

Our orchards comprise 75 acres of our farm, and we employ 40 local residents seasonally. We enjoy a widespread and loyal clientele who associate our farm's name with high-quality produce, fine service and longstanding family tradition. And while I think our business is special, I don't think it's at all unique. As Steve Justis pointed out, there are a lot of other smaller producers. I believe in our area, they are mostly in the eastern corridor of New York and in New England. But I would hole that perhaps the majority of apple producers in our area are more like mine than what you might have seen in Washington State yesterday.

Currently, we produce about 15- to 20,000 gallons of fresh apple cider during our 2-month harvest season and into the winter, as our supplies and market dictate. Apple cider is the cornerstone of our business and represents not only a significant portion of our income, but an essential element of our harvest management. In any given year, less than perfect fruit and especially dropped apples constitute upwards of 30 to 35 percent of our crop. This is partly because we are a U-pick operation. And that is barring weather-related disasters that can reduce a great crop to cider apples overnight.

Many of our customers wait to buy cider until we start including dropped apples in the mix because it is commonly understood that these apples have a higher sugar content and therefore make a superior product.

Now, U-pick operations like mine have many advantages and some disadvantages. Compared to standard commercial operations, on the one hand, we have greater control over the pricing of our fruit, but on the other hand, a lot of apples do end up on the ground. From what I have been able to gather from other orchards in our area, it's not uncommon to have 30 percent of a crop fall to the ground. This may also be a result of the predominance of Macintosh apples in the Northeast, which do have a tendency to fall just as they are ripening or before they ripen. However, Macintosh apples do produce the best apple cider.

After we allow public picking in a block of trees, we'll close it, and our pickers will clean up the usable fruit--and that is very carefully graded--from the trees and from the ground. We also use seconds from our grading line and sometimes buy fruit from other orchards or packinghouses.

This fruit is placed in cold storage adjacent to our cider mill and then, before we make cider, i t is again hand-sorted before it goes into our washing and brushing machine, and then ground-pressed and refrigerated until we bottle it to sell. We maintain low volumes of the product to assure freshness.

There are three alternatives for dropped apples in operations like mine. Preferably, we make cider. This allows us to see a profit above the costs of production, harvest and storage of this fruit, as Dan Corey mentioned yesterday. Our ability to use dropped apples in cider can easily mean the difference between a profitable and an unprofitable year, especially in the case of marginal crop years.

Secondly, or on the other hand, these apples can be sold wholesale to large juice manufacturers, and that has been a suggestion that has been mentioned several times in the last 2 days, but it is not as easy as that because in our area, there is one large-scale juice processor, which is in Massachusetts, and they can or will not accept our apples, depending on market conditions. That means that if the international juice concentrate market says that our apples are unaffordable, they won't buy them. So there are times of the year, and there are years when we can't give that fruit away.

This is an uncertain prospect, and in some years, we cannot give it away, and in any case, we never come close to recovering our cost of production.

The final option if neither of those two is available is that we can throw these apples away. An d if we could extrapolate from the experience of our orchard, that means that across the Northeast, we might have to find disposal for tens of thousands of bushels of apples, which creates other problems.

The prospect of mandatory pasteurization of apple cider would put an extraordinary burden on businesses like ours in at least two ways. Most obviously, the expense of necessary equipment would push most cidermakers out of business. As Steve Justis mentioned, 90 percent of Vermont's apple ciders would possible immediately have to go out of business, and I think that Mark McLellan's estimate of 80 percent of New York apple cider producers might be a little bit conservative.

For those cidermakers who do proceed with pasteurization, the next hurdle--and this is a major hurdle--to cross would be to try to market a product that is generally perceived to be less flavorful, fresh and nutritious than unprocessed cider. Many customers flat out tell me that they would not buy a pasteurized cider.

Certainly, I am concerned about the problem of contaminated juices. We need clear standards set for labeling of juices, be they pasteurized, filtered, preserved or natural, and I believe those guidelines could be established in a way that doesn't stigmatize a fresh juice.

We need performance standards, which currently don't exist, set for fruit cleaning and juicemakin g equipment. And, as everybody has alluded to, we need more research to find the attributes or the causes of contamination with greater certainty, and well-reasoned and reasonable ways for us to comply with new standards of sanitation.

What our segment of the apple industry cannot abide is the categorical rejection of our ability t o use drops. There are alternatives--in our case, perhaps fencing the orchard might be preferable to disallow deer coming in. Nor can we abide a mandate to across-the-board pasteurization.

But I don't believe--in fact, I am sure that we are not an accident waiting to happen. With few exceptions, we are extremely conscientious business people. We have to be because, more than any of the other businesses that you have heard from in the last 2 days, those of us who have roadside operations and sell directly to the public know our end-users, and the converse is also true--the know us, and they know where we live.

So we are anxiously awaiting positive change. We need affordable technology. Affordable in our case means something in the range of $1,000 to maybe $25,000. We need greater organization--and I b elieve that that is starting to happen and is being generated from meetings like this and from organizations like the Micro Juice Producers Guild and others that I have heard about. And we need well-considered guidance.

What is at stake here is the survival of hundreds of small farms and roadside operations across t he country. There are many concerns to weigh here, and while it is morally difficult to balance the life of even one individual against the livelihoods of one or 1,000 families, please understand that the decisions you make from these proceedings have the potential to forever change the face of apple production in the Northeast and around the country, either by helping us to improve our facilities and products or by eliminating us.

I'd like to end on a little more positive note. I was recently talking with a person formerly in a large juice industry concern, and she was describing that their efforts to make a high-quality apple juice used as their gold standard what we are currently making. So I do believe that fresh unpasteurized juice is the gold standard.

So please give us guidance, education and support so we can continue to produce this healthy, flavorful and superior product.

Thank you.

 Applause

DR. SHANK: Thank you.

Richard Wood is the next presenter, to be followed by Joseph Zigler.

MR. WOOD: I thank you for this opportunity to make comments today. I am Richard Wood, the Executive Director of Food/Animal Concerns Trust. We are a not-for-profit organization with a nationwide constituency addressing food safety issues. For the last several years, we have been working with the regulatory agencies on the development within USDA of the foodborne pathogen HACCP program focused on the meat and poultry industry.

We also have developed and operate a model egg farm system with 12 farms in Pennsylvania, which include a Salmonella enteritidis testing and control program.

I come here recognizing that we all face common concerns when addressing food safety no matter if the product is from beef cattle, dairy cows, poultry or apples. I'd like to raise or respond to and address two basic questions that we have been talking about throughout these last 2 days.

The first question is are on-farm HACCP controls necessary. Should orchards be required to establish HACCP systems, including microbial testing?

Well, we believe at FACT that HACCP is necessary and a useful tool for producers. We also recognize, though, that HACCP is not required for livestock and poultry producers in the pathogen and HACCP controls that were adopted by USDA in July. We worked hard to have controls included for producers in those rules, but we were not successful.

Although still, meat processing plants in those rules are required to identify potential hazards that the producers may bring to the processor's door, and then the processor is to figure out ways to control those hazards, so it may move back to the producer and to the farm anyway.

In addition to mandatory HACCP controls among growers, we would also support with this kind of HACCP response that kind of required hazard analysis and control as apple processors receive apples from their suppliers or as the processing begins in an establishment that processes its own apples.

Regarding voluntary producer participation, as we have looked at the meat and livestock industry, we have found that when it is left to be voluntary, at least at the present time, a large proportion of the producers may not participate as is the case with livestock and poultry producers at the present time. There also may be little standardization from one producer to the next and, for many livestock and poultry producers, if they do have on-farm HACCP programs and systems, they are more likely to address the chemical and the physical hazards and not the biological ones. You would have to be the judge to see if that would be true as well for growers.

The second question is should HACCP be mandated for apple processing plants in the cider and juice industry. FACT supports such a requirement. In the face of E. coli O157:H7, standardized, industry-wide pathogen controls are necessary. These HACCP systems, as we have been talking about for the last couple of days, should also include microbial testing to verify whether or not th e HACCP system is working.

In addition, we would also ask that you all explore the feasibility of linking testing for contamination to pasteurization as a part of a larger HACCP system. Here, the milk program, the Grade A pasteurization milk ordinance, could be a model for you to take a look at, where testing precedes, and in the case of apples may well determine, the need for pasteurization.

Where testing finds no contamination or, in Dane Bernard's words, where there is "minimal risk," no pasteurization would be required. The plant could mill the apples as cider or as unpasteurized juices or even pasteurize them. Where contamination is found, pasteurization would be required.

Now, in the milk model, higher levels of contamination would require that the product not be pasteurized and not marketed when there are high levels of contamination. All milk that is produced is not automatically pasteurized and marketed. If the level of harmful bacteria in milk is found to be too high, among other criteria, then it is judged too dangerous to be consumed by the public even after pasteurization.

Now, pasteurization of apples at the appropriate heat levels may kill O157:H7. I don't know the science on that. And apple juice and milk may not mix at that point. but the milk program is a successful program and warrants your serious review.

Now, to mix apples and eggs, FACT has a project where we sell raw shell eggs in supermarkets, major markets along the East Coast. We test for Salmonella enteritidis throughout the laying cycle on the farms that we work with, and if we find salmonella, all the eggs from that flock are diverted to the "breakers," as we call them--they are pasteurized, and then they become egg products. Otherwise, if there is no salmonella, we sell the eggs raw in the shell.

If the apples are clean, they can become cider apples, unpasteurized; if not, they should be pasteurized.

Together, HACCP and pasteurization may provide the necessary tools to bring a safe product to consumers.

Thank you.

 Applause

DR. SHANK: Thank you, Mr. Wood.

The next speaker is Joseph Zigler, and he will be followed by Mark Isaacs.

MR. ZIGLER: I appreciate the opportunity to share some thoughts with you today and share a little bit of a story about Zigler's Apple Cider. For those of you who don't know anything about Zigler's Apple Cider, we are a business that has been in business since 1932; we are going to turn 65 years old this year. My grandpop started the business, and we are a third-generation family business.

Through all those years, we have specialized in making premium-quality apple cider. Grandpop taught my dad and my uncles, who passed down to the current group of six cousins of the third generation, how to make good-quality product with the essentials, the essentials we have heard about all along here--washing, brushing, chilling, making sure you have good-quality fruit--all of those things. And through the years, as we have focused on that, we have had the opportunity to grow.

At this time, we serve 25 States with apple cider, mostly on the Eastern Seaboard of the United States, very little in the West. And by the way, remember that, of course, "apple cider" is the name for what Odwalla calls "apple juice" and other companies in the West call "apple juice"; here in the East, it is called "apple cider." In the Midwest, it is called "apple cider." So we service 25 States.

As you know, cider is a very seasonal item, with extremely high seasonal sales volume, enough that it's a top-selling item in the produce department of many supermarket chains throughout the entire Eastern Seaboard.

In what I am going to say, I will focus on the apple and on apple cider and on apple juice. I do n't comment on orange, I don't comment on carrot. I comment on apple.

These last 2 days, yesterday and today, as we have heard many perspectives and concerns, it is very clear the number one, this is helpful, but also, number two, it has become clear that it raises a lot of questions. In fact, the more we discuss and the more we talk, the more we realize how little we know regarding certain pathogenic hazards out there facing our industry.

What I'd like to do is just tell you the story of what's been happening with us in the last coupl e of years, how we have addressed certain things and what has been happening behind-the-scenes in our company as our family has sought to struggle with what we would call a very significant threat to our business. It's one thing if you're a small cidermaker, making cider for just a few months of the year; it's another thing if it's your primary business, and it is the primary business of Zigler's.

When Fall River, Massachusetts--which was the first instance of E. coli O157:H7 being isolated in apple cider--happened--actually, that was released in early 1992; it happened in 1991, but its big release was in JAMA, the Journal of the American Medical Association, in May of 1993. In fact, it was my birthday, May 5th, that they came out with that. That led to a lot of media attention, and it led to a lot of what we considered, as we realized it, major ramifications for us.

That cidermaker in Fall River made 3,000 gallons a year; we make more than that in an hour during the fall. He did not wash and brush his fruit, and certainly there were many issues cited where he did not follow good manufacturing practices.

So we looked at that, and we realized it had major ramifications for us because there are literal ly hundreds--I mean, more than 600 or 700--cidermakers in this country, many of whom are extremely small, many of whom are doing a fine job, as many who have spoken here today and yesterday are doing a fine job. But there are many who are not. I have been in many who are not, and where good manufacturing practices are not being followed, and there are no real serious inspections of their facilities, that is serious concern. We knew that all it would take was one o f them who did not do things right, and it could bring us to the point where, as the media picks it up, and even if you look at articles in the paper today--I was just reading them back there--it becomes an issue of do you pasteurize--yes or no. It literally became that issue with Fall River. Consumers called and asked, "Do you pasteurize--yes or no?" and if it's no, whoops, but if it's yes, then it's okay.

And while we agree with everyone that it's not a one-issue answer, certainly that threat led us t o take a specific action, and that action was to--you see, you hear different people talk about flash pasteurization, what it does to the flavor of the product, what it does to the quality of the product, how much it costs to install and so on. The question we would ask is, How closely have you looked into that, because as we started looking into the flash pasteurization issue, we decided to install a pasteurizer that could not handle our volume, but we installed it specifically as a pil ot in order to understand ourselves what flash pasteurization would indeed do to the flavor of the product. We have taken it through a lot of tests over the last year and a half, and we found that when it comes down to blind taste tests, the truth is that many, many people can't distinguish the difference in the flavor, and for those who can, some prefer the unpasteurized and some prefer the pasteurized. Actually, there are some who prefer the pasteurized, and that is what we have found.

Also, in terms of the product changing, some think it almost turns it into an apple juice, and it doesn't turn it into an apple juice. I encourage you--well, I'll get to that in a second.

We decided in the midst of that--and we debated for a while whether we should spend the dollars we needed in order to bring in the tanks and increase the pasteurizer size and the chilling system to adequately pasteurize the product, viewing it more or less as an insurance policy, not because we felt we needed it--we thought it was from an issue of lack of good manufacturing practices that prior instances had happened, and we have never had a problem with our product, millions of gallons every year and we've never had a problem with our product. So we decided to go ahead, and we went ahead, and that installation was completed in September of this year.

The events of October were a shock, quite honestly. Odwalla being, as has been said, a well-rega rded, high-quality juicemaker that washed and brushed its fruit; another instance in the East, in Connecticut, where we got some attention--these things shocked us in a sense because they were washing and brushing their fruit.

At that point, we had already been debating in our midst, in the family, and in our family, we sa y that cider flows in our veins--we are idealists, we are cider connoisseurs, we love the product; we have grown up with it since as early as we can remember. So there was a debate--should we go into it, should I just begin doing it proactively, or should we not. And as we were debating that, the events of October occurred, and as the events of October happened, Zigler's made the determination after some discussion that, with the pasteurization system there that could flash-past eurize the product, we would engage the system. We engaged the system, actually, 7 weeks ago and have sold nearly 2 million units of product.

We have a big following of people who love our product, and the big fear we felt--and I think it' s easy for anybody in the cider business to see pasteurization as almost like a monster in the closet- -but we realized that there was a real concern. How many consumers would call or talk to us about the change in flavor of our product? Out of 2 million gallons sold--I'm sorry--out of nearly 2 million units sold, we haven't had one, single complaint regarding flavor change. We have had two total calls regarding the fact that we are destroying some enzymes, but we haven't had one complaint regarding flavor change.

We do not believe that flash pasteurization is an end-all, but we truly believe--because it is no t to be a cover-up for poor processing practices, it is not to be a replacement for GMPs; the HACCP program is an important thing, and it was interesting to hear all of that discussed--but we are at the point where we believe that flash pasteurization is an important component within them.

And it is important not to become polarized on this issue, where we say, okay, mandate pasteurization, and others say don't mandate pasteurization, and we get to that point. But the final word--and I just have a little bit to read, and then I'll close--the final word rests with the consumer and, in many cases, the retailer, because retailers have some liability issues here. And there is no doubt that the vast majority of consumers want safety first and the additional assurance of safety that flash pasteurization can provide.

Consumers care more about safety than they do about costs we incur to assure that safety. And let me remark that a large manufacturer incurs large costs for a flash pasteurization system, and a small manufacturer incurs much smaller costs. We heard about a cost of $20,000; that's a lot less than it costs to buy a cider press.

Consumers care about safety now, and we must answer the "in the meantime" between now and the time when we arrive at alternative treatment solutions that will be acceptable to the hundreds of members in our industry. It is very evident that flash pasteurization is the best immediate measure that can be taken to protect the final consumer and guard the reputation of apple cider as a wholesome, healthy product. If we do not do something now, the "in the meantime" may lead to additional outbreaks that will cause further loss of consumer confidence in our industry's abilit y to resolve this safety issue.

We understand and sympathize with the plight of many unpasteurized producers who feel they cannot implement pasteurization due to costs; yet it seems that it will take a great deal of time to identify the final source of the problem and appropriate methods that will eliminate the problem in a cost-efficient manner that is suitable for everyone.

Many new technologies being discussed appear more expensive than pasteurization, which already poses cost problems. In the midst of all we say, we have a solemn responsibility to the final consumer to do all we can, both now and into the future, to maximize the assurance of consumer safety.

Thank you.

DR. SHANK: Thank you.

Mr. Isaacs?

MR. ISAACS: I will be brief. I think the hotel has already started a high-temperature, short-ti me pasteurization process of its own.

First of all, good afternoon. My name is Mark Isaacs, and I am the chief executive officer for a company called Sun Orchard. Sun Orchard is a manufacturer and distributor of fresh unpasteurized citrus juices, and we have manufacturing facilities in Arizona as well as California.

Sun Orchard has been in existence for over 14 years, and over the last 3-plus years, we have manufactured and distributed over 10-plus million gallons of fresh unpasteurized citrus products. I don't know how many services that is, but I do know that it's a great deal.

Sun Orchard's top priority has always been a high-quality product that obviously is safe for all of our customers and consumers. The most recent outbreak was, I think, a wake-up call for many people in the fresh juice industry because there was some belief that a high-quality facility with good manufacturing practices, coupled with some of the acid and pH levels in the juices, would not cause any harmful problems for our consumers. Obviously, unfortunately, we were wrong, and we as an industry need to focus on doing whatever we can to minimize the risk associated with our products.

Sun Orchard welcomes and admires the FDA's efforts to improve the conditions under which fresh juices are manufactured, and we applaud their efforts to minimize as much risk as possible to the consumer. Over the last 45 days, however, I do have a couple of concerns, indicating a rush toward the pasteurization of fresh citrus and fresh juice products, specifically apple juice. I, li ke many people this afternoon, have a large, large problem with that.

As we have all seen, the fresh juice industry is made up of a number of small companies, and ther e are a number of families whose livelihoods depend on this industry. We have over 65 employees who depend on the fresh juice industry for their livelihood.

Initially, based on the number of outbreaks in conjunction with the consumer transactions, I thin k that a rush to mandate pasteurization is an overreaction, and we would be strongly against that.

My recommendations are similar to many that we have heard today and yesterday. Our first recommendation is that we go forward with a mandatory HACCP program whereby the FDA as well as the State and local regulatory authorities require for each juice processor a detailed program that outlines the risks and what control points will be addressed with respect to these risks in their respective operations.

Secondly, I would recommend that we encourage the fresh juice processors to join together in an association so that they can encourage each other to improve the standards within the industry as well as coordinate the activities and the communication process with the regulatory agencies.

The last item that I would highly recommend is that we do not require mandatory pasteurization for the fresh juice industry, as there is still a great deal of information that needs to be determi ned to see if that is the best way of eliminating all risk, and I think that with a good HACCP program, we can eliminate many of these risks as we go forward.

Thank you very much.

 Applause

DR. SHANK: Thank you, Mr. Isaacs.

This concludes the list of public presenters that I have for this portion of the program. Let me point out that there will be another opportunity for public participation after the final section of the program, and with that in mind, I'd like to move ahead now with what advice should be given to the consumers. We have had our first presentation, as you recall, from Betsy Woodward.

I am going to call now on Carolyn Smith DeWaal at this point in time. She is the Director of Food Safety for the Center for Science and the Public Interest.

Carolyn?

MS. DeWAAL: Thank you, Fred. I am going to be brief because it has been a long day for everybody.

I must say that I am impressed with this little industry. Many of the remarks I was going to mak e have been made by the last two speakers even.

Basically, this is a wake-up call for your industry. Your customers expect a safe product, and they will not accept excuses--any excuses--as a response. You know now that this very serious, very hazardous bacteria can appear in your product, and you need to address that problem. That is your responsibility, and your customers are not going to take anything less as acceptable. They are not going to trade nutrition for safety; they are not going to trade taste for safety. They wan t safety first, and everything else will come second.

There is no excuse, and I know the people in this room know it, for frogs and toads in the plants , as was documented with the salmonella outbreak in orange juice, for workers not using restroom facilities and not washing their hands when they are picking fruit or processing it, and I think the re is even support for the idea that they shouldn't be using dropped fruit for fresh juice.

We have seen examples of new technologies and old technologies that would make these products safe and probably would not cost the industry much money. And to the industry, I would simply say: Do it now. Make it safe. Do it. Figure it out. Whatever you want to use, whatever you want to invest, it is going to pay you back in the long run in terms of consumer confidence in your product.

To the agency, particularly to FDA in analyzing this, I am going to urge that the agency take an incremental approach, and by that, I would strongly urge that the agency mandate that the fresh juice industry and others in the food industry implement HACCP. We need mandatory HACCP in the food industry. We shouldn't wait for every outbreak. We should do it now and make the industries address the hazards in their foods.

One of the reasons why it is hard to just support mandatory pasteurization for this one product i s that we have a problem in lettuce, and I think that we may address more problems by not mandating pasteurization if we mandate that the industries go back and actually figure out what the problem is--what is the source of the bacteria in these fresh products--and make them do the leg work.

There is an easy solution here, and it is one that the cider industry is probably going to implem ent. There is not an easy solution for lettuce. So let's make them go back and do the work, and we may in the long run save more lives by doing that than we would by taking a quick fix to this one problem.

I do urge that any HACCP system for raw products include microbial testing. We have heard many scientists from big companies get up and say that they don't support end-product testing. I have got to tell people who may not have used HACCP in their plants that you've got to remember that pipe with salmonella. You can design a HACCP system, you can think up to the best of your ability all the hazards you can come up with, and you can still have a pipe buried deep in your plant with some little nest of salmonella in it that is contaminating your product, and the best hazard system and the best recordkeeping in the world isn't going to tell you that. You need to test the product.

This is essential for HACCP validation, which was not discussed today, as well as ongoing verification, particularly for raw products.

And I do want to make one comment about Cargill. Cargill has had one of the top HACCP systems in place for red meat products for a number of years, and I have gone to their plant, and I have seen the labs. They do E. coli testing on red meat products to verify their HACCP systems. They use it--they didn't get up and tell you about that--and I'm sure Nestles uses it as well. I'll bet the big companies are using it. And juice is a good candidate for testing. Again, it won't tell yo u that it's safe, but it will tell you if you have a problem, and it may give you the first warning si gns. So we believe that that is essential.

Also, FDA can urge the companies to use pasteurization, but they should mandate labeling. And consumers need to know that these products, unfortunately, are no longer safe for kids and the elderly and people with any kind of suppressed immune condition. That information has got to get out to consumers. We think the best way to do that is a label.

If products are pasteurized, they don't need the label, and if the industry can come up with a solution short of pasteurization, in the long run maybe there will not need to be a label on these products, but in the short run, we have an urgent consumer education job that has got to be done, and I think labeling is the appropriate way to do it, and ultimately, I think labeling will drive th e industry to do the right thing if they have to honestly label the product as to the hazards.

Those are my short remarks. On the label, I think it has got to mention that the product should not be consumed by children, the elderly, or those with suppressed immune conditions.

Thank you.

 Applause

DR. SHANK: Thank you, Carolyn.

Our next presenter is Ms. Marsha Cohen. Ms. Cohen is professor of law at Hastings College of Law.

Marsha?

MS. COHEN: I don't remember who said he was pleased that he was getting the last word; it's the consumers who are getting the last word, either because Dr. Shank wanted it that way, or he figured that everybody would be gone.

But thank you for inviting me to participate in this meeting. Unlike my two colleagues on the consumer panel, I am not a representative of a an organization. I am a law professor who has been involved in or causing trouble in the food and drug world since I worked for Consumers' Union in the 1970s as a member of various FDA boards. I was involved as a pharmacy regulator in California, and I was on the Food Advisory Committee when it first went into effect.

I also have two apple trees that drop lots of apples, and in a good year, I make a lot of applesauce.

I am also a San Franciscan, and by chance, my son and Steve Williamson's son are classmates and good buddies, so I have watched the Odwalla incident up close an personal.

I have a number of fairly disjoined comments to make. First, on the very big picture level, when bad things happen, and they are all over the press, the protective power and potential of government is actually very comforting to the public, and I think it is helpful to industry, as a fe w of you have admitted. Only government can protect consumers and help industry solve its problems in a way that ensures a level playing field for the big people and the little people playin g in the industry.

I hope you will remember that when invective is hurled at big government; it is helpful. I am no t fan of stupid or excessive regulation, but surely the safe food supply that consumers in this country take for granted--and that is actually one of our problems; consumers feel the food supply is so safe that when there is an outbreak of foodborne disease, it takes on huge proportions, and I think that in part our feeling of safety is attributable in no small measure to regulatory oversight .

Second, American business must be cautious because our legal system enables persons harmed by defective products to be compensated for their injuries. I am a torts professor, so this is a subje ct of interest to me. I am also no fan of excessive litigiousness, but the oft-reviled tort system doe s both encourage appropriate caution on the part of you and your competitors and provides compensation for those few who suffer from either inadequate caution or from mysterious happenings that somehow defy what looked like reasonable prevention.

A related thought--I wonder what liability insurers think about the E. coli risk? I actually ask ed FDA about a week ago whether they would be invited to the table. I hope they are listening to these deliberations because in many ways, their view of the risk and what should be done about it, hopefully based on a science base, can prove a whole lot more important than any of our views as to what ultimately is done out there--unless, of course, you are uninsured, in which case, if you are selling fresh juice, you are, as they say, "betting the farm" every day.

On the more specific issue, it is clear to me that consumers like fresh juice products, the traditional ones like apple cider, that have been around and seasonal for years and the many that have proliferated in recent years in the refrigerator cases of supermarkets. The like them for thei r taste and, certainly in northern California, for the aura of nutritional superiority that, while fra nkly, I think is generally undeserved, nevertheless surrounds them.

Although the larger businesses like Odwalla and Zigler's may choose to sacrifice some of the tast e to the improved safety of heat treatment, I realize that pasteurization is not considered an option for the legions of small juice producers who sell at farm stands--and certainly we haven't heard from any juice bar people here at this meeting. We have heard of other methods of reducing pathogens, but those also don't sound very cheap to me, and certainly none of them is easily and currently available.

Nothing that I have heard over these 2 days makes me feel that we must now mandate pasteurization or its equivalent, but I do feel strongly that HACCP procedures or their equivalent ought to become a required standard for juice producers and should also be required for all food producers. After all, as Carolyn just pointed out, fresh produce poses similar risks, something that is not really well-known to the consumer population. Most consumers in this country buy their food from pristine-looking supermarkets and have very little sense that they come from fields and that there are insects in those fields, there are rodents in those fields, and other mammals sharing those crops with us. We forget how urban we have become.

FDA and State regulators I think need to work together with industry to develop clear guidelines and assure that they are being followed. I heard some concern about that from small producers. They need to be enforced in all the highways and byways. We also need to maintain surveillance thereafter to see if in fact the incidence of harm from these products is in fact going down rather than up, and we may after all, if it continues to go up after HACCP and time for those things, we may need to force heat treatment or something similar down the road.

One suggestion that a consumer group scientists asked that I make is that producers keep their lots as small as possible and make sure that even the littlest producers using a good coding system to maintain ease in any post-production recalls that are needed, because that alone, as the Odwalla incident indicated, can save a lot of harm. I am sure that insurers would also appreciate steps to maintain grower identity if possible in your lot production, because the insurers who insure you want to know "who done wrong" when harm comes. I have actually been in touch with Insurers' Council for the sausage maker who is concerned with just that problem of multiple sources worked in together.

The question that remains is, if we don't have pasteurization, whether there is too much remainin g risk. Americans have a bizarre sense of risk, and I think we have got to keep that in mind. A nutritionist friend in Alabama tells me that since the Odwalla incident, they have been inundated with telephone calls from consumers worried about whether the juices they are buying are or are not pasteurized. People don't understand that all that stuff on the shelves for months is in fact pasteurized.

This is 2,500 miles away from action central in the Odwalla incident. Surely, some of these consumers have put down their cigarettes to make their phone calls about pasteurized juice. Simultaneously, people are incredibly risk-averse and incredibly risk-preferring. We see that all the time. Of course, risks to children are central in this particular juice situation concern, both because of who drinks juice and because of who appears to be more seriously harmed by the pathogen, at least the E. coli. And people are especially concerned about their children's safety even when they are not concerned about their own and except when they don't insist on them sitting in their car seats. So there is a very strange mix in perception of risk.

Nevertheless, in this area, I think there is a disproportionate risk of these products, as Caroly n indicated and as Betsy indicated before here, to children, the elderly and the immune-suppressed. Someone's slide yesterday showed that very graphically. It was the young children--the one with zeroes in the first number--whose E. coli infection did progress to HUS.

I think two approaches are necessary. One is to help ensure that consumers can differentiate between pasteurized and nonpasteurized products by requiring, I think, the labeling of the unpasteurized juice products.

The other is that we need to educate consumers to understand the differential risk--to understand that if they are not labelled "unpasteurized," they are pasteurized--and to act upon it.

I am not confident that that education would be effective without the use of the product label to convey the critical information at point of purchase. Now, I do realize that there is a very defini te matter of diminishing returns from warning labels all over our society, and perhaps such labeling could be temporary, until studies show consumer awareness of the difference to a sufficient degree, although I realize that that, too, poses a problem because when those warning labels disappear, maybe people will be confused and think the risk is gone.

In any case, warnings to protect children may turn out to be more effective than other warnings, especially since I would imagine that people who are feeding unpasteurized juice products, with their premium prices, to their children may well be those who are making a special effort to get the best for them--which is to say, yuppies. These are expensive products, and I for one would never let my children chug stuff that costs so much by the gallon. So I think you would find that there is probably a relationship between perhaps even education and certainly finances.

I do wonder whether the "education but no warning label" approach to the problem of infant botulism from honey has been effective. That might be an interesting thing to look at. My understanding is there never was any warning label, there was just consumer education. Has the incidence been reduced to the point of essentially eliminating the problem? We could learn from that whether education alone is sufficient.

I should add as a law professor that using warning labels is not a guarantee against tort liabili ty if the warning goes unheeded. But I can also say that it is a better defense than no defense at all in the case of a lawsuit.

More general consumer education about food safety would also be helpful. Given the increasing emergence of microbial pathogens, I think we should bring greater attention to home sanitation, to employee sanitation throughout the food service industry. As a mom, if I have said "Wash your hands" 1,000 times, it has been 10,000 times in the lives of my three children over 19 years--" Wash the apple," "Did you wash the grapes?" But I think that children growing up hearing this think this is just mom's squeamishness or a desire for excessive cleanliness on the order of "Keep your room clean" that causes you to say this over and over, and I think that some societal reinforcement of the real health need for personal hygiene would be very, very helpful.

And I think I should also point out that not all moms are so insistent. I live in a very muiltic ultural community, and many of the people that I live with, many of the Americans in San Francisco, were not born here, and their moms were not born here, and they may have been raised where sanitary facilities are just not every 3 feet, and so their habits and concerns would be different. Their struggles were very different than ours for our level of concern.

I also recommend reconsidering field worker sanitation. Yesterday people said,well, the growers all have field facilities available for their workers; we also heard--what as it--70 cents per bushe l piecework. If you are earning 70 cents per bushel, you may not have a lot of incentive to take the time to walk to those field facilities and use them. I suspect that it does not happen, and I think we need to reconsider in that area how we are compensating field workers.

Turning once again to the big picture issue. Microbes, scientists proclaimed here yesterday, even though they are brainless, are very adaptive, so we are, for example, seeing E. coli O157:H7 in very different places than ever before, even where we thought it could not survive, and we are seeing this in lots of other contexts.

We have been complacent, I think, for far too long about microbial pathogens. Twenty years ago when I worked for Consumers' Union, we were jumping up and down and expressing concern about the then theoretical impact of animal husbandry practices, including low-level feeding of antibiotics, on the strength of the microbe population to come.

Yesterday someone had up on the screen a super microbe. So that seems to be now an acceptable concept. The issue has graced the covers of national news magazines within the last year. The cost of change could be significant to industry, but the cost of continuing to act in little areas o f the economy only after crises in those little areas, I think will probably cost more in the long run .

So I would like to make a pitch and ask how many wake-up calls do we need. I think that it's time for FDA to bite the bullet and force some sustained, broad attention to what is actually a multifaceted and difficult problem far more than a problem in the juice industry.

Thank you.

 Applause

DR. SHANK: Thank you, Marsha.

We come to another portion of the program where we are open for public comments. Is there anyone from the audience--I do not have a list of those who have indicated a desire to speak at this time, but if we missed anyone, now would be your time to do so.

Is that a question or a participant or--

DR. SPERBER: I'd like to make a comment.

DR. SHANK: Come on up, Bill.

DR. SPERBER: Thank you. I'm Bill Sperber from Cargill.

One of the previous speakers criticized me for not telling you that Cargill tests its beef operat ions for E. coli. What I said in my prepared remarks was that Cargill does not use finished product testing to assure the absence of pathogens in any particular lot of product. That is quite differen t from using E. coli or coliform or total plate counts as an indicator of process control or sanitary conditions.

We do test for generic E. coli in our plants to monitor sanitation and to assure the operation is going as planned and that we can take corrective actions where necessary. That is quite different from testing every lot of beef trimmings for E. coli O157.

I now know the wisdom of the old proverb, that sometimes a half-truth can be as damaging as a lie. But I am making this comment here just to set the record straight. We do not, in any of our roughly 200 food production facilities around the world, use finished product testing to assure the absence of pathogens.

I am making this comment primarily because I don't want any of you to go home thinking that you can use finished product testing as a substitute for a legitimate HACCP program.

Thank you.

DR. SHANK: We've got a run of industry representatives. Dane?

MR. BERNARD: The only reason I'm here so that the panel up here in front has got to sit here for another few minutes.

I have a couple of clarifications. First of all, if anybody came to the meeting thinking they we re interested in pasteurization, there have been enough spitballs thrown at pasteurization in the past couple days that you might be a little confused.

I just want to clarify: Pasteurization works. I am not up here pitching it. I know that that i s a debate for another moment. But I just want to be clear that a properly-designed, well-executed pasteurization step will kill every E. coli, every salmonella you put through it. There have been some notable failures, but those have been failures to execute properly, not the failure of pasteurization per se. So it does work--just a clarification. It may not be the answer that you want to hear, it may not be necessary in all situations, but that's another debate. I just want to clarify that it does work.

NFPA has been in the position of being a process authority since 1923 when we put out our first bulletin on how to do processes correctly. We have probably done over 100,000 individual processes, not one of which has resulted in a failure which has hurt anybody. We are very proud of that record. So that when we say pasteurization works, I think we have a little bit of credibili ty there.

The other thing I have is a question for Fred. Has FDA's statutory authority changed?

DR. SHANK: Regarding?

MR. BERNARD: There has been a lot--and I am confused myself--there have been a lot of FDA mandates pasteurization from small operations which obviously do not ship anywhere, but sell to whomever drives into the store which is in front of the orchard. As far as I understand, your authority is for product in interstate commerce.

DR. SHANK: That's correct. It depends on how you define "product."

DR. BERNARD: I just wanted to get that straight.

I have a couple more things. HACCP--Bob did a good job of clarifying what HACCP is, et cetera. We have heard that HACCP is what we need, not mandatory pasteurization or whatever. I would like to remind everybody that a HACCP plan is not even worth the paper it is written on unless a HACCP plan embraces effective controls. If the HACCP plan is nothing more than a regurgitation of what you were doing in the first place, and what you were doing in the first place did not work, HACCP is not going to fix the problem. A HACCP plan must embrace controls that are effective in addressing the hazard of concern.

When I mentioned the NFPA position earlier, I meant what I said--pasteurization is the position, or equivalent treatment. If you can get there some other way, that's fine, but you've got to have effective controls, and it gets back to the research discussion that was held. Until somebody figures out where the bug is coming from--obviously, there is a link to fecal material, but how is i t getting into the product, what's the route--until you can figure that out and put in some effective control, you don't really have a basis for a valid HACCP program.

I think I'll stop there.

DR. SHANK: Yes?

MR. CLEARY: I'm Dan Cleary from Middletown Springs, Vermont. I am one of those small producers that doesn't ship out-of-State, but in respect to the FDA, in our State, your decisions carry so much weight that what you decide is good for product that is shipped interstate, our State feels is good for us, too.

So that is why those of us who are small producers who don't ship out of our State felt that we definitely needed to come here and present our case.

Thank you.

DR. SHANK: We appreciate your being here as well.

Are there any other commenters?

 No response.

DR. SHANK: For those of you who are following the program, this would lead us to considerations for future research, a speaker to be provided by the U.S. Apple Association. That portion of the program is going to be eliminated. As the recommendations for future research evolve, they will be made available to us, and we will in turn make them available to everyone who is interested. But there is nothing for consideration at this meeting at this time relative to further research.

Are there any other public comments? This is your last chance.

 No response.

DR. SHANK: Okay. Let's thank all of the presenters, and we appreciate all of you being here over the 2 days.

Thank you.

 Whereupon, at 5:30 p.m., the proceedings were concluded.