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
P R O C E E D I N G S
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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?
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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.
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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?
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Electron microscopy shows that in those lesions, the microorganism is rapidly is growing.
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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.
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As you can see, we are right in the laboratories, working, and actually working in the plant in t he application of peroxides.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Therefore, the purpose of this study was to determine if high pH and high temperatures interact synergistically to rapidly destroy gram-negative foodborne pathogens.
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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 simpl