Chairman - Dr. Fred Shank, FDA

Subcommittee Members:

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

FDA

Mr. Phil Derfler, General Counsel's Office

Mr. Jerold Mande, Executive Assistant to the Commissioner

AGENDA ITEM PAGE

Overview Presentations:

Introduction - Dr. Michael Friedman, FDA

Report of O157:H7 Outbreaks Caused by Juices -

Dr. Patricia Griffin, Centers for Disease Control

and Prevention

Concepts in Emerging Food-Borne Pathogens -

Dr. Robert L. Buchanan, Agricultural Research

Services (ARS)

Specific Microbial Concerns for Fresh and Minimally

Processed Foods - Dr. Douglas Archer, University of

Florida

Questions of Clarification

Odwalla Situation - Stephen C. Williamson

Greg Steltenpohl

FDA Findings

Facility Inspection and Follow-up - Dr. Frank

Scholl, San Francisco District Office

Laboratory Analyses - Dr. Richard Rude, Seattle

District Office

Findings in Washington State -

Dr. Russell Alexander, King County

Dr. Phil Tarr, Associate Professor of Pediatrics,

Children's Hospital - Seattle

California Findings, Packers & Growers Inspections -

Mr. Stuart Richardson, Department of Health Services,

California

Questions of Clarification

Labeling Issues - Dr. Edward Scarbrough, Center for

Food Safety and Applied Nutrition

Juice Industry Practices - Mr. Rick A. Kress,

President, Juice Processing Division, Seneca

Foods Corp.

Growing and Harvesting Practices -

Dr. Richard Dougherty, Washington State University

Dr. Eugene M. Kupferman

Mr. Paul Baker, Baker Farms

Organic Production - Dr. Harold Ricker, Agricultural

Marketing Service, Organic Standards

Questions of Clarification

Identify appropriate GMPs for the production and

harvesting of fruits and vegetables

Appropriate GMPs - Dr. Barry Swanson, Washington

State University

Future GMPs for the Apple Industry - Franklyn

Carlson, Carlson Orchards

Public Commentors

Adjournment

DR. SHANK: We have a full schedule, for those of you who have taken a few minutes to look at the agenda. It's going to be two full days, a lot of public participants, and that's exactly why we're holding this meeting, to get all the information on the record that is humanly possible.

Let us get started. I'll have some more introductory remarks to make about the operation of the meeting and those types of issues, but at this point I'd like to call on Dr. Michael Friedman, who is the Deputy Commissioner for Operations with the Food and Drug Administration, who is going to give us the introduction to the meeting. So let's go ahead and get started. Dr. Michael Friedman from FDA.

DR. FRIEDMAN: Thank you very much, Fred.

I want to begin by welcoming you all and thanking you for your interest in this public meeting on the safety of fresh juices. I recognize that at this time of year there are many demands that are placed upon your schedule, and I'm very gratified that you share our concerns, a fact indicated by your presence here in such numbers today.

The topic of today's meeting is the safety of fresh juices. The purpose of the meeting will be to provide an opportunity to evaluate the current science and to review the technologic and safety factors associated with the movement of fresh juices from producer to consumer.

Within this context, we will also be considering specific pathogens, such as E. coli O157:H7, which have caused a recent outbreak of food-borne illness, but in addition, also salmonella and other species of note.

This meeting is an important component of the consideration of whether and how FDA's regulatory program for fresh juice and juice products should be revised, to discuss and exchange information on relevant safety issues, to identify research needs where that's appropriate, to consider whether additional consumer education is necessary, and to consider other measures to reduce the risk of future outbreaks.

We are not here specifically to focus on one outbreak such as Odwalla. We must look to the broader context, the safety of a whole line of products; and while E. coli O157:H7 is a particularly virulent organism, it is not confined to one product category. It has also been found, as you know, in many products, unfortunately often after it has caused substantial harm.

But, again, this is not the only pathogen that is of concern to us, and we are asking you today to help us consider in this meeting the broader context of food safety. We would like to take a more global view. It is certainly not our intention to point fingers, assign blame, look at specific cases, only to the extent that it helps inform in a more general way.

Excuse me just a second.

 Pause

DR. FRIEDMAN: You may not be having trouble hearing me, but I was having trouble thinking. Thank you. Sorry.

Speaking for FDA, we are holding this public meeting to learn as much as possible from recent food-borne illness outbreaks involving fresh juices. As you can see from the agenda, we have invited a number of speakers who can provide a comprehensive overview of the current picture. Not only do we wish to learn about the recent outbreak involving apple juice and other apple juice-containing products produced by Odwalla, we're also interested in the entire area of food-borne pathogens, both emerging and those that we know about that may be associated with fresh or minimally processed juices. These issues must be factored into any agency action to enhance the safety of these products.

We are most interested in getting firsthand information from those in the apple and fresh juice industries, as well as those from the public health and academic communities. FDA wants to know about current manufacturing processes and how these practices may or may not contribute to microbial contamination of the product. We wish to hear from those who have real-world experience because you can provide us with important information on how vulnerabilities in these practices can be corrected without severely restricting consumer choice.

Not only is this meeting about the current manufacturing processes used by industry in order to minimize microbial hazards, we want to become more knowledgeable about promising new technologies and interventions coming on line that could enhance tomorrow's product safety.

During the course of the next two days, we will explore the science that is the essential foundation of any future action, and we will be learning what the current practices are, looking at new technologies that are coming, hearing opinion regarding optimal solutions. We will also be receiving comments from various individuals who have requested an opportunity to make a public statement, and that certainly will be offered.

Viewpoints will be presented on current juice industry practices from the perspective of both fresh and pasteurized juice producers. The producers of fresh juices and certain other products such as cider are generally small and local. Some of those producers are with us today, and we appreciate their participation.

We also have producers of pasteurized juices, and we expect a broad-ranging discussion of the techniques, such as processing temperature and the relationship to product stability and safety associated with these sorts of considerations. We will also address the question of what should we tell the consumer. The American consumer has a spectrum of perceptions with respect to juice products. Some believe that fresh and minimally processed juices are the healthiest and that organic production is preferable. Others prefer processed juices, and we recognize that are inherent risks associated with all practices.

Let me reiterate the purpose of the meeting: to establish a record of the current industry practices for the production of juice products and the science underlying the production of safe juices. FDA will use this record as the foundation of its critical review of our current practices, and it will hopefully form the basis of future actions.

I would like to remind you that the record of this meeting will remain open through January 3, 1997. There are copies of the Federal Register notice announcing this meeting available to you, and this provides specific information that you may wish to have for submitting additional written comments.

In closing, we're here to listen and to learn. We're optimistic that this exchange of information and this dialogue will facilitate the full and more complete review of our current policies. And while there will be consensus on some matters, there will undoubtedly be strongly held divergent viewpoints expressed also. I am confident, however, that everyone in this room shares the mutual goal of assuring, first, that products are safe, that consumers are provided with the number and variety of choices which they desire, and, third, that the number of outbreaks in the future should be kept to an absolute minimum.

We're very much looking forward to hearing from you and, again, I thank you for your participation and attendance.

On a personal note, I regret that I will not be able to be here for the meeting because other unavoidable activities are calling me away. I find that somewhat frustrating personally, but I'm very glad that there will be large representation from our Food Center to monitor, evaluate, and participate in the meeting. Certainly people from CFSAN are essential in this process.

We appreciate your consideration, we appreciate your participation in developing this important body of information over the next two days.

Thank you very much.

DR. SHANK: Thanks, Mike.

At this time let me take a little bit of your time and possibly put the meeting a little more in perspective and to introduce some people that we feel you need to know about.

On the design of the meeting, as you look through the agenda, you will see that we're starting off with a background on illnesses associated with juices. We'll then get into some more general information on pathogens in fresh or minimally processed foods. We will review the Odwalla situation. Then we will have a brief review of the labeling requirements that may have a bearing on fresh or minimally processed juices. We'll change our thrust then to looking at some of the practices, the current practices in the juice industry, as well as the current practices in the growing and harvesting of produce.

The program to this point is to provide a background for our further deliberations. It is to set the scene, so to speak, so that we can consider if changes are necessary and to start to think about how any necessary changes might be accomplished.

The remainder of the meeting then is to consider where we go from here. We will address appropriate GMPs for the production of fresh juice. This is to include from the farm to the table. It will include GMPs for growing and harvesting. We will give consideration to the identification of critical control points in the Hazard Analysis and Critical Control Point System.

We will consider whether or not there are new technologies or intervention strategies to control pathogens of concern and are there sanitizers or food additives available to ensure safe products and what are the appropriate uses of sanitizers and food additives that are available in their use in the production of juices.

Then we come to that ever important question: Is pasteurization of juices appropriate and necessary? What advice, if any, should be given to the consumer, and how should this advice be communicated? As an example, should this be through labeling? That will be another topic of consideration. And, finally, attention will be given to future research needs.

Let me make a few observations about our participants. As we consider what needs to be done in the future, that is, that portion of the program that I mentioned following the background, we have generally identified two speakers for each topic. The desire was to have presentations from different perspectives. We wanted to have a balance of academia, of industry, trade associations, and the public. And as Mike said earlier, this is a public meeting. We want to hear from all of you that have ideas on how to produce safe juices in the future.

More than three dozen so-called public participants have indicated their desire to make presentations, and if anyone desires to present that has not come forward to this point, please see the people where you signed in and get your name on the agenda.

We are requesting that you keep your presentations to preferably five minutes, and I recognize that some have asked for ten minutes. These requests and additional speakers from the floor will be accommodated as time permits.

At this point let me introduce the head table here from--the majority are from FDA, but to my immediate left is Dr. John Vanderveen, who is Director of the Office of Plant and Dairy Foods and Beverages with the Center for Food Safety and Applied Nutrition. Next to him is Mr. Phil Derfler who is from our general counsel's office. Dr. John Kvenberg is to his immediate left, who is the Strategic Manager for HACCP.

Morris Potter, Dr. Potter, is the Assistant Director for Food-Borne Disease, the Division of Bacterial and Mycotic Diseases, from the National Center for Infectious Disease, Centers for Disease Control and Prevention. And on his left is Dr. Joe Madden, Strategic Manager for Microbiology.

We have a group here in the front that are facing us. This is the Fresh Produce Subcommittee of the National Advisory Committee on Microbiological Criteria for Foods. I've got that list someplace.

 Pause

DR. SHANK: On this side over here is Mr. Charles Bartleson from the Washington State Department of Health. To his right is Dr. Bob Buchanan, Microbiologist, from the Agricultural Research Service, USDA, in Philadelphia. Dr. Kaye Wachsmuth, who is Acting Deputy Administrator for the Office of Public Health, the Food Safety and Inspection Service of USDA. Dr. Bob Gravani, Professor of Food Sciences from Cornell University. Dr. Neill, who is Professor of Medicine from the Brown University School of Medicine. Dr. Mike Osterholm, who is State Epidemiologist from the Minnesota Department of Health. Dr. Don Vesley, who is Professor, Environmental and Occupational Health, University of Minnesota. Dr. Bill Sperber, Senior Corporate Microbiologist from Cargill, Incorporated.

This subcommittee has been convened to look at fresh produce as an official function of the National Advisory Committee for Microbiological Criteria for Foods. They are here today in order to consider the deliberations of this meeting. They will consider the deliberations of this meeting in the future work of their committee, but I would underscore that FDA is holding this meeting for the agency's benefit to get that full comprehensive record of issues related to fresh juices.

I should also mention that there will be a full transcript of this meeting available. For this reason, and so that everyone can hear the full proceedings, we are asking that anyone desiring to speak to do so from a microphone.

I think that you all will agree with me that we have a very aggressive agenda for the next two days, and at this time I'm going to proceed with the agenda.

Our first presenter is Dr. Patty Griffin. Dr. Griffin is Chief of the Food-Borne Diseases Epidemiology Branch of the Division of Bacterial and Mycotic Diseases from the Centers for Disease Control and Prevention. Patty, do you want to come forward, please?

DR. GRIFFIN: Good morning. I'd really like to commend FDA for putting this meeting together. It's a busy time, and I know it took them a lot of time and resources to do it at a busy time of year. So I'd like to thank FDA from myself and from others at CDC.

In November 1991, four children from the Fall River area were admitted to the Massachusetts Children's Hospital, the Boston Children's Hospital, with HUS, a form of kidney failure that's caused by E. coli O157:H7. Their families spent a lot of time waiting while the kids were on dialysis, and they got together and decided that it was fish sticks that had made them all sick. The Health Department heard about the cluster and invited CDC to join the investigation of the fish sticks and other possible causes.

Before I tell you what the investigation found, I'm going to start my slides. So I'm going to give you an overview of E. coli O157:H7, which I'll call O157. I'll then talk about the Fall River outbreak and then about apple cider and juice outbreaks, both before and after 1991. I'll discuss an orange juice outbreak at a theme park and end with a summary and recommendations.

E. coli O157:H7 is so named because it has the 157th somatic or O antigen ever identified and the 7th flagellar or H antigen. This slide shows the sequence of events in infection. After O157 is ingested, usually three or four days pass while the organism colonizes the large bowel and multiplies. The incubation period can vary between 1 and 10 days. Illness then begins with non-bloody diarrhea and abdominal cramps. In many, but not all persons, the illness then progresses to bloody diarrhea, and in most persons, the illness resolves within a week. But in a few, about 5 percent, it progresses to HUS.

This slide lists features of patients with O157 infection that was severe enough that they sought medical attention and had their stools cultured. Over 90 percent had diarrhea, bloody stools, and abdominal cramps, but fewer than half had vomiting or fever, and this is typical.

Most O157 infections are not detected, and this is mainly because stools are still not cultured on the special sorbitol MacConkey medium needed to screen for O157, but also not all persons with O157 infection see a doctor or, if they do, even have a stool culture.

While most of our knowledge about O157 comes from outbreaks, this slide shows the complications of O157 in U.S. outbreaks. Overall, 22 percent of patients who are hospitalized, 5 percent developed HUS, and 1 percent died.

Now, the severity of illness varies widely with each outbreak. For example, in a nursing home outbreak in Canada, the death rate was 35 percent, and that's typical that you get more severe illness at the extremes of age, the elderly and the very young.

Hemolytic uremic syndrome was first described in Switzerland in 1955. It's characterized by low blood count and kidney failure. It's caused by O157 and other Shiga toxin-producing E. coli. It affects persons of all ages, but it's most common in children under 5 years old.

I'll just stop for a minute. Is there anyone having trouble hearing me? Raise your hand if you are. Okay.

HUS is a severe illness. Most of the affected children need a blood transfusion, 4 percent have a stroke, and 4 percent die during the acute illness. Half need a kidney machine in the hospital, and 4 percent still need it years later.

This little girl, like the little boy before her, survived HUS, but this little girl was in a coma for several weeks and now requires institutional care.

While I mentioned earlier that many O157 infections are missed, this slide shows the percent of U.S. laboratories that screened either all stools or all bloody stools for O157 by year. You can see at the end that even by 1994, only about half of labs were screening all stools or all bloody stools for O157. So even if a person developed O157 diarrhea and went to see their doctor and the doctor decided to have a stool culture, only about 50 percent of these people would have that stool culture looked for O157.

Now, you can see in the last two bars that screening increased in 1993 and 1994, and that was after publicity from the large outbreak in January of '93.

This slide shows the number of U.S. outbreaks by year, and you can see that it also increased markedly in 1993 and 1994, parallel to the increase in labs culturing for O157. So these data suggest that O157 infections have been grossly under-recognized for many years, and that part of the reason we're finding more outbreaks is that more labs are looking for O157.

This map shows in yellow states that have ever reported an O157 outbreak. Outbreaks are really just the tip of the iceberg. Most cases occur sporadically, so clearly this infection occurs nationwide.

This is a dairy farm, one of many dairy and beef farms, where O157 lives when it's not causing illness.

And this is a CDC epidemiologist doing one of the first investigations that linked O157 to cattle. O157 lives in the intestines of healthy cattle, deer, and sheep.

How is O157 infection acquired? This table shows the modes of transmission for the 75 U.S. outbreaks for which transmission was known. Foods from cattle accounted for half, with ground beef responsible for 43 percent, other beef for 5 percent, and raw milk for 3 percent. Non-bovine foods caused 19 percent of outbreaks, water 12 percent, and this was mostly lake swimming water that people swallowed; person-to-person spread caused 17 percent, and one outbreak was caused by an ill food handler.

The most famous ground beef outbreak was the multi-state outbreak in January 1993 in Washington, Idaho, Nevada, and California. Over 700 ill persons were reported, mostly children; 178 were hospitalized, 58 developed HUS, and 4 children died. The recall of hamburgers was based on epidemiologic data and is estimated to have prevented 800 more cases.

This slide lists non-bovine food products linked to O157 outbreaks. They include salad items like lettuce, ranch dressing, mayonnaise, pea salad, potato salad, fruit salad, sandwiches, apple cider and juice, punch, turkey, and cantaloupe--quite a varied list. I think the message here is that anything that could be cross-contaminated from beef or from cattle manure or from deer or sheep manure could transmit O157.

I want to return to that outbreak that I mentioned at the beginning, the HUS outbreak in Massachusetts in the fall of 1991. As I mentioned, there were four children with HUS from the Fall River area who were all admitted to the same hospital. O157 was isolated from the stools of three children, and there were reports of bloody diarrhea in family members.

When you have only four children ill, it's almost impossible to prove whether the cause was fish sticks or something else. So we set about case finding. We interviewed their ill friends and relatives. We reviewed charts in emergency rooms and physicians' offices looking for cases. We sent letters to physicians and labs asking them to look for O157 cases. And, finally, after we'd figured out the cause, we issued a press release.

We identified 23 persons with O157 infection. Now we had enough to do a case control study to determine the source. We used a standard questionnaire and compared items eaten by each ill person with items eaten by healthy control persons of similar age from the same neighborhood. Surprisingly, we found that ill persons were less likely than controls to have eaten ground beef. However, most ill persons, but few controls, drank cider from one cider mill, called Cider Mill A here, and all could have drunk cider produced on the same day.

Cider Mill A, which is shown here, used mostly drops, and that's apples collected from the ground. They weren't washed or brushed. A preservative wasn't added, and the cider wasn't pasteurized. Its pH was between 3.6 and 3.8. We wondered whether these practices were typical for the industry, so we conducted an anonymous survey of apple cider manufacturers in January 1992 at a meeting of the New England Small Fruit Growers Association. Forty-five growers were present, 80 percent of them completed the survey, and we found that all of them used drop apples, only 33 percent routinely washed and brushed their apples, and only 6 percent always used a preservative. So the practices at Cider Mill A were typical of other producers in the area.

To learn whether O157 was a plausible vehicle, we worked with Dr. Doyle's group at the University of Georgia. They inoculated cider with 10⁵ organisms of the outbreak strain. You can see that O157 survived in unpreserved cider for over 20 days. However, when we added 0.1 percent sodium benzoate, survival was less than 7 days, which was encouraging except that a lot of people consume cider quite soon after it's made.

During this outbreak, we reviewed the literature for other reports of outbreaks of cider and apple juice before 1991, and we found that in 1922 in France, 24 persons developed probable typhoid fever after drinking cider. The apples used in the cider had been rinsed with river water that had probably been contaminated with sewage. In 1974, in New Jersey, 296 persons developed salmonella diarrhea after drinking apple cider. The apples had dropped onto a manured field. And in 1980, in Ontario, 14 children developed HUS and one died after drinking apple juice at a fair.

We wondered after our outbreak in Massachusetts how frequently apple cider and juice caused illness, so we've been watching for other outbreaks, and we know of five apple cider and juice outbreaks after 1991. In 1993, in Maine, 213 persons developed Cryptosporidia diarrhea after drinking cider made from apples that had dropped from trees on the edge of a cow pasture. This cider had been prepared by school children. And this fall, in Connecticut, 10 persons developed O157 diarrhea, 2 had HUS, after drinking commercial cider. Well water used for rinsing the apples had coliforms.

This fall, in New York, 32 persons developed Cryptosporidia diarrhea after drinking commercial cider. Well water used for rinsing the apples had coliforms. And this fall, in Washington, six persons developed O157 diarrhea after drinking cider made at a church event. The apples had been washed in a chlorine solution.

And the last outbreak, the one that got us all together, was in western North America last month. I'll give you a brief overview, and others, I know, will be filling in details.

O157 was linked to consumption of Brand A unpasteurized apple juice. Most cases had consumed pure apple juice; 6 percent consumed blends of apple juice and other juices. All Brand A apple juice was recalled on October 30th based on epidemiologic data. It's important to note that the recall was five days before O157 was cultured from juice.

Cases occurred in British Columbia, Washington, California, and Colorado. Sixty-six juice-associated cases were identified, of which 14 had HUS and one child died. Fifty-eight percent of cases were children 5 years old or less. The transmission route for 61 was drinking juice, for one was spread from a person who drank juice, and for four, either of these routes was possible.

This graph shows the dates of illness onset for cases. The latest case shown on the far right was probably acquired from another person who drank the juice. The latest "enjoy by" date for the juice was October 24th. That was for the suspect juice. The recall was on October 30th, and the report of O157 in juice was on November 4th.

The FDA lab in Seattle helped the traceback immensely by culturing O157 from apple juice produced on October 7th. Subtyping demonstrated the same O157 strain in patients and juice. The juice produced on October 7th was made from apple lots X and Y. Many visibly poor-quality apples from one of these lots were discarded. Others may have gotten into the juice. Lots X and Y apples were used in juice blends produced between October 5th and 9th. Juice produced between October 5th and 9th could account for 97 percent of cases.

The production practices used for apple juice in this outbreak were more stringent than in previous outbreaks. Drop apples may have been used, although contracts with suppliers specified no drops. Apples were washed with a phosphoric acid solution, agitated, and brushed. To monitor juice quality, juice was tested for bacteria and yeast after distribution.

To summarize the nine outbreaks from apple cider and juice, of those with information available, 33 percent did not use drop apples, 88 percent rinsed apples, 60 percent brushed apples, 22 percent disinfected apples, and 11 percent added a preservative. Clearly, these practices have not been sufficient to prevent contamination and subsequent illness.

I'd like to change gears now and speak briefly about another juice that concerns us. I want to tell you about an outbreak of salmonella infections from unpasteurized orange juice in Florida in 1995. We identified 62 cases of salmonella in visitors to Theme Park A in Orlando. They had traveled there from 21 states. Their average age was 10 years, and 22 percent were hospitalized. Our case control study showed that illness was associated with drinking unpasteurized orange juice at character breakfasts. That's breakfast at which cartoon characters are present.

Plant A orange juice was shipped interstate. We and others cultured unopened containers weeks after the outbreak and found between 220 to 1,700 E. coli per 100 mls of orange juice. Eleven containers yielded salmonella of three different serotypes. The pH of the juice was 4.

The oranges came from many groves, but a major grove used surface water for irrigation. The oranges were often knocked from the trees onto the ground, and later, cultures of both soil and the surfaces of oranges yielded salmonella.

The plant investigation showed that the plant used a phosphoric acid rinse to clean the oranges. Salmonella strains were isolated from a toad and a frog outside the plant, and animal droppings were found inside the plant. This environmental work was done by Mickey Parrish of the University of Florida.

So, in summary, outbreaks from cider and juice have been recognized for decades. Sporadic cases are probably common but unrecognized. Unpasteurized cider and juice, even at pH 3.6 to 4, can transmit pathogens. Current production practices do not guarantee the safety of apple juice, apple cider, and orange juice. And product recalls based on epidemiologic data can prevent illness.

The challenges to control this problem include that deer, which can run through apple orchards, can carry both O157 and Cryptosporidia; that only a few organisms of O157 and Cryptosporidia are needed to cause human illness; that O157 and Cryptosporidia are acid tolerant and can survive in cider for as many as four weeks. Data on orange juice is similar. And adding preservatives to cider has had mixed results, at best.

One more. Good.

Our recommendations for apple cider and juice are to strengthen industry practices and regulations to assure that apple cider and juice shipped interstate is safe, which means an additional barrier to microbiologic growth, such as pasteurization, and to label unpasteurized juice and cider to indicate the risk of illness if these products are still permitted. We must also determine the practices and regulations needed to improve the safety of other juices.

My last slide shows the many collaborating agencies in the apple juice outbreak and in the orange juice outbreak.

Thanks for your attention.

 Applause

DR. SHANK: I'm going to ask you to hold your questions for Dr. Griffin until the question-and-answer period a little bit later this morning.

Our next speaker will be Dr. Bob Buchanan, the research microbiologist of Eastern Regional Research Center of the Agricultural Research Service. Bob is going to address some concepts in emerging food-borne pathogens. Bob?

DR. BUCHANAN: Thank you, Fred. And I've bypassed the need to use the slide changer. I have a more primitive form of slide changer.

 Laughter.

DR. BUCHANAN: What I've been asked to do for the next few minutes is to talk about some of the concepts that go into considering the emergence of a new pathogen, and it can be a rather complex process. I'm not going to be talking just about juices or just about E. coli O157, but I have tried to select some examples of different issues or different factors that influence it that are related to the area that we're talking about today.

Could I have the next slide?

It becomes apparent as you go back and look at the records that it's a changing world. If you go back 50 years ago, to a food microbiologist there were only basically five organisms that caused a lot of food-borne disease. They were sort of classic pathogens.

Next slide.

However, that's changed dramatically in the past 50 years, and now we have a list that these are just a few of the new ones, and, in fact, each year I add a new organism to the list as we have what are called emerging pathogens, new organisms that previously had not been considered to be a cause of disease associated with foods that have cropped up. This year we've added a new one, that second item, cyclospora. E. coli O157, of course, is one that we're focusing on today. But there has been a continuing emergence of new pathogens, and there has also been the re-emergence of classic pathogens in new situations. Both of them are of interest when we're trying to determine the public health impact in terms of food safety.

Next slide.

Now, when considering food safety issues and the emergence of pathogens, we always have a balance that you have to deal with, and you can't consider the organism by itself, but you always must consider it in balance with the people that are going to be affected and also the food. The pathogen will have different capabilities of causing disease which may change over time. The host may have different susceptibilities to disease. And, likewise, the food may either enhance or decrease the risk associated with an emergence of a pathogen.

When you change the balance, that's when you get emergence or re-emergence of a disease. When you change the genetics of the organism or you change susceptibility of the host or you change the way you manufacture and distribute foods, that is when we get the emergence of a new disease or the re-emergence of a known pathogen.

Next slide.

The factors that can contribute to the emergence of a new pathogen are very complex, and I don't expect anyone to read this. Actually, I'm going to go through this in a little bit more detail, giving specific examples, and this is just a small number of the factors that can contribute to the emergence of a new microbiological problem.

Basically, we can divide these down into three areas, representing those three I talked about: changes in the organism, changes in the host, or changes in the food.

Next slide.

Let's consider first examples of factors associated with the host, and the four I have highlighted up here are the ability to cause disease, that is, the pathogenicity of the organism; the geographical and temporal distribution and density of the pathogen in the environment; the ability of that pathogen to either grow or survive in the food; and then the ability to adapt to new niches and reservoirs. Each of these can contribute to the overall disease process.

Next slide.

Using the example of one of the organisms we're concerned about today is one that we have some really definitive, well-established proof in terms of its genetics. E. coli dates back to the dawn of food microbiology, and it goes back to the 1890s when it was first proposed as a non-pathogenic indicator of fecal contaminati on. And it rests as a non-pathogenic organism, and, in fact, still most E. coli that you isolate are non-pathogenic. However, in the 1940s, we started to have reports of infantile diarrhea associated with this organism. In the 1960s, we began to active food-borne cases associated with helabel(?), a cholera-like toxin, and then finally in the 1980s, we've had the emergence of the enterohemorrhagic E. coli.

Each one of these different classes of pathogens within the species represents the acquisition of a gene or genes that cause a virulence factor that induces a disease. So, for example, the 1960s represent the acquisition of a cholera-like toxin gene by the organism on a plasmid. In the 1980s, we see the acquisition of genetic material for Shiga-type toxin, for a number of other virulence factors that the organism has picked up from a bacteriophage. So we have the evolution of the organism, in this case subspecies that have become more pathogenic.

Next slide.

In addition to the genetic material, we also have the fact that the organism can be selected for to adapt to conditions, and certainly one of the things that has become known about the E-hax(?) is that they have a number of different systems within them that allow them to become resistant to things like acid and heat and a number of other factors. And, in fact, what happens is that if you don't kill them, you may actually induce them into a state of being more resistant to other factors. So this is an area that's fairly new. We're only starting to understand the physiological basis for it, but certainly we can demonstrate that we can induce these organisms to be quite acid tolerant.

Next slide.

The other thing that we have to consider when we're talking about the organism is not just the organism itself, but its reservoir. Where does it exist in nature? And how has that reservoir changed? Probably the best known that I hear that is an indirect effect is Lyme disease. Lyme disease is a disease that emerged in 1975 in Lyme, Connecticut, and it took awhile to figure out what it was, but it became apparent that in Lyme disease the natural reservoir for this organism is the deer population. And as the deer population in that region increased, the number of deer then increased the number of deer ticks, and the deer ticks are the vector that take the organism of concern, which is a spirochete, and transmits it from the deer population into the humans. So, obviously, here one of the ways of controlling this disease is not only through the control of the organism, but control of the deer population.

I think this one is a very relevant example to some of the issues that we're facing today because certainly, for O157, deer populations have been implicated as one of the potential reservoirs for the organism.

Next slide.

The other thing when we're dealing with emergence that we have to look at is where is its progression. We typically have the initial emergence of the organism, and there is some question about what the initial emergence was with this organism. But once you have it emerge and you have it passing through a population, it becomes biologically amplified. You have a much greater load within the environment, and then you'll have the organism, particularly if it's fairly adaptive, it will start adapting itself to new niches and new reservoirs. And I think that's one of the things we're seeing with O157 now. As the load of it in the environment increases, it's going to be spreading out to different places. It's really quite a competitive organism and can move and survive and actually thrive in a number of environments.

So we're seeing new products, new reservoirs, the area of potential person-to-person spread, and the humans acting as a reservoir is something that we have to consider now.

Next slide.

That brings us into the area of examples of host-associated factors, and there are a number of t hese. I'm not going to spend a lot of time on them this morning, but you can have differences in the susceptibility to disease, you can have the acquisition of immunity, you have effects of demographics. What is your population density? What is the population age? How does that match with susceptibility to disease? General socioeconomic factors can, in fact, impact the overall susceptibility to disease. And then one of the factors that is also sometimes underrated is the host manner in which they handle the food, prepare the food, their food preferences, et cetera. Certainly in the initial emergence of E. coli O157, the fact that a substantial portion of the population likes ground beef in a rare state, this certainly contributed to the initial amplification.

Next slide.

We also have the food. If the vehicle that we're moving this organism around is the food, then we have to consider how changes in the food will affect the potential emergence of a pathogenic organism. And this can either be because of the composition or other inherent characteristics of the food itself, or it can be changes in the technologies, either to produce, to process, to distribute, and even to cook the product.

Next slide.

I've just picked a couple of very simple examples here that might be pertinent. Certainly there was concern a number of years ago that as we become more proficient in making varieties of tomatoes, the pH of the tomato in certain varieties has risen up above the magic 4.5 that we currently use for calculating processes, thermal processes. And I know there was some concern that we would get the potential for bot outgrowth in these products if we made products from them, and then treated them as if they were the same tomato. So here changes in varieties can have an impact on changes in the composition of the product, which in turn affects its ability to resist pathogens.

Next slide.

Changes in technologies can be very simple, and this is one that came out of FDA's history. It's well documented that there were concerns with mushrooms because of the introduction of plastic wraps. Plastic wraps represent a barrier to oxygen. Mushrooms are a very rapidly respiring product that restriction of oxygen getting into it actually allowed the environment to become anaerobic to the point where it could support the growth of clostridium botulinum or also staph aureus. Here even a small change in technology, something as simple as what we put over the package, had an impact on the capability--the potential for the emergence of a pathogen, or in this case the re-emergence of a pathogen. The solution was equal ly as simple. They poked holes in the plastic wrap to let some oxygen in.

Next slide.

I also want to indicate that there is an inherent qualitative difference when we have to deal with high-dose and low-dose organisms. When you become--when you're working with pathogens that have to reach relatively high numbers, your basic thrust of food processing is to prevent the growth of the organism because you need a relatively high level before you're going to have a problem. When you're dealing with high infectivity organisms, particularly those that have severe symptoms, we get into a different mode where you have to not only control their growth but you also have to just control their presence. So you have to be able to control their survival or you have to be able to control just their mere presence. And as we get an organism that is more and more infective, that is, the lower and lower the number that you have to have someone consume to get a disease, the more and more we have to move to controlling just the mere presence of the organism.

Next slide.

The final concept I'd like to talk about is we also have in the emergence of disease geographical barriers. If you're someone looking at emerging pathogens and not doing it in food but in general, the place you look for is an isolated area that they're just building a road into. Because when you get a mixing of a previously isolated area, that's when you're going to find new pathogens. One of the classic places to see disease problems is in boot camp in the military when you mix people from all different regions, and these will lead to the emergence of disease outbreaks. Or probably the best example is they estimate that the HIV virus has been around for about 10,000 years, but it wasn't until roads went into that area of Africa where it was originally isolated from that it then became dispersed.

It's important to note here--could I have the next slide? It's a very different world. There's a tremendous globalization and regionalization of the food market, and basically we can disseminate an organism around the world in 24 hours, either in people or in products, and we ship food around the world.

And the last slide.

So there's two take-home messages when we're working with this. Any change in the biological agent, the host, or the food has the potential of resulting in the emergence or re-emergence of a food-borne pathogen. Then the other is nothing is constant. Change is something that we deal with all the time. So it's something that we have to consider. As you make changes, what is the potential impact on the emergence of a pathogen?

 Applause

Thank you.

DR. SHANK: The next presenter this morning is Dr. Douglas Archer. Doug is Professor and Chair of the Department of Food Science and Human Nutrition at the University of Florida. He's going to address some specific microbial concerns of fresh and minimally processed foods. Doug?

DR. ARCHER: Thanks, Fred. It's good to be here. It's given me an excuse why I don't have my Christmas shopping done.

I don't have slides this morning because I was waiting for Bob Buchanan to send me his talk so that we wouldn't overlap, and Bob didn't do that. So I don't have anything to show you. But I do have a few things I do want to say.

The topic that I was asked to talk about are specific microbiological concerns of fresh and minimally processed foods, and you've heard some of those concerns already. But I think what I'd rather do a little bit is stick with some basic truths, and they all are relevant to the issue of microbiological safety of foods.

The first one is that any potential pathogenic microorganism on a food that will receive no further processing is of concern because it is one step from the host. And we saw that a little bit graphically before from Dr. Griffin's presentation. The salmonella out in the middle of an orchard has a long way to go before it finds a human being, and it becomes a game of chance. Simple mathematics: Will it make it to the host, and will that host become ill?

We've been reminded lately that some microorganisms are inherently more virulent than others, ev en within their own genus or within their own species. And we're learning that the environment of food itself may modulate virulence. Dr. Buchanan alluded to that. An organism that has been exposed to an acidic environment or other kind of a stressful environment may well be more virulent for human beings than one that has been relatively pampered.

We are concerned with those organisms that Dr. Buchanan referred to as the very virulent microorganisms. Some of those are becoming fairly well known. Among the bacteria, those of most concern would be organisms such as Shigella, the causative organism of dysentery; salmonella, certain species or certain subtypes of salmonella; and certainly E. coli O157 and the other so-called virocytotoxigenic E. coli.

We've also become concerned with certain protozoans and microsporidiums such as Cryptosporidia, Giardia, and cyclospora most recently. And the viruses are always of concern because of their very, very low infectious dose for humans. These include hepatitis A and the Norwalk agent.

Now, when these are present in or on a ready-to-eat food, illness may well result. But we do ha ve to consider something, and that is that these organisms are becoming more widespread in our environment. In fact, salmonella, once referred to as a zoonotic disease, a disease associated with animals, has been declared a geonosis by the World Health Organization. That means it's everywhere in the environment, and we need to recognize that and deal with it.

The protozoa and the viruses and certain bacteria underscore how normally water-borne agents may contaminate food. Water frequently becomes a component of food, or water is used to sanitize food. And if that water is contaminated, the food will become contaminated as well.

The more widespread these organisms become in the environment, the more likely it is that humans will encounter them and illness may result.

Now, there's an old saying when people try to compare two things that are not similar, and that is, it's like comparing apples and oranges. Now, that axiom recognizes that both are fruits, but they are different from one another. One could also say it's like comparing grapes and strawberries. They, too, are different, and I would hope that FDA and the Advisory Committee would recognize that juices are very different from intact fruit or vegetables from which they are made, and they're very different one from the other. They should not be compared, and the potential risks should not be assumed by comparison without data in hand.

There have been incidences of illness associated with fresh juices, and that is, juices which are not pasteurized. And that's why we're here today. We're here to discuss the problem and potential solutions.

There is the reality also that has to be recognized that there are a substantial number of individuals who prefer fresh over pasteurized juice products, whether these are fruit juices or vegetable juices. And we can debate pasteurization's effects on flavor, but even with hard data in hand, there are certain consumers that would not change their minds and would still prefer a fresh product.

Some consumers would forego juices entirely if they were processed in any way. So the issue is: Can they be made safe? And a sub-issue of that: Should all juices be pasteurized?

I can only offer my opinion as a former public health official and regulator, and now as an academic. I'll answer the questions as follows: Yes, unquestionably they can be made safe. And, no, mandatory pasteurization is not necessary.

We really need to define how safe is safe, and consider the denominator of the total volume of product that's consumed--meaning fresh juice--then consider the illness incidents that have occurred.

A frequent argument is, despite the large denominator of consumption, some illnesses may be occurring but not being detected. And that argument may be valid, but I think that argument could also be made for pasteurized or other processed foods as well. And I was reminded when I was thinking about this issue that the largest outbreak of urciniosis(?) ever in the United States was caused by a pasteurized product, and the largest outbreak of salmonellosis ever in the United States was also caused by a pasteurized product.

So pasteurization itself is not a panacea. Pasteurization can be defeated, and it can be defeated either by a high microbial load or by post-process contamination.

So can fresh juices be made safe? I believe they can. New technologies are available now, or will be shortly, and I think what we need to consider is how to fast-track some of these into being. Many of them, many of the processes of which I'm aware, will be classified in some way, shape, or form as a food additive; that is, they may become a component of the food itself. Where safety is an issue, if possible, those should be given priority and fast-track approval.

Later you will hear how Florida dealt with its problem. Now, Dr. Griffin alluded to Theme Park A outbreak, and we were painfully aware of that occurrence. But the Florida industry and the Florida state regulatory authorities got together and in a very excellent, cooperative environment, have worked through a series of regulations that everyone can live with and we believe goes a long way toward solving the problem.

Now, there is another basic truth, and that was alluded to in Dr. Griffin's talk. One of the problems is that we don't understand the ecology of the microorganisms with which we are concerned. It's only a very, very recent finding that deer and sheep are carriers of E. coli O157, and I would hazard a guess that that's not the end of the list of species that do. Clearly, we have to understand where these organisms are occurring before we can do anything about keeping them out of food.

There's another basic truth as well. Fresh juices can be made safe if the pathogens are removed before either the intact fruit or vegetable is crushed or squeezed or otherwise turned into juice. They can be made safe when attention is paid to basic sanitation principles. There is no intrinsic reason that fresh juices cannot be produced, distributed, and consumed as safe and wholesome products. So I would urge the Advisory Committee of FDA to go slow in this regard. I would define the concerns very specifically before I acted on any, and don't compare things that are not alike.

It's tempting to apply what may seem to be a quick fix, pasteurization, but it may also be unnecessary. There is no such thing as absolute safety in any product. Absolute safety, unfortunately, is a myth, and we've come to recognize that time after time.

If we can define a specific problem in a specific commodity, we can usually fix it. That's one of the basic principles of what has come to be known as HACCP, the Hazard Analysis and Critical Control Point System of assuring food safety. And few people would argue that manure and human food need to be kept apart. That's a given.

I think it would be very easy to look at this problem and say it's simple, we have a process, we can kill the microorganisms and everything will be fine. We could do that. We could easily commercially sterilize everything, and that would add even a greater margin of safety. But I don't think it would be very desirable.

I think one thing that we always need to remember is we're dealing with a very clever enemy. Dr. Buchanan alluded to that in terms of how these organisms adapt, evolve, and that's a constant process. It's been a constant process since the Earth was created. But one thing we should keep in mind is they don't have a brain and we do, and in most cases, we can figure out ways to deal with them effectively once we know the facts.

Thank you for the opportunity of addressing this group, and I'll put you back on schedule.

 Applause

DR. SHANK: Thanks, Doug.

This brings us to our first opportunity for questions. We will take questions from the floor for the speakers this morning as well as the questions from the head table or the subcommittee. Down here. Would you use the mike and would you identify the speaker to whom you're addressing the question, please?

MR. CHITTENDEN: My name is Eric Chittenden. I own the Cold Hollow Cider Mill in Waterbury Center, Vermont. I'd like to ask Dr. Archer, just for my own curiosity, he alluded to a couple of situations where in pasteurized products salmonella and other pathogens were found, if he could for me, and perhaps for others, give me that information. That was kind of interesting to me.

DR. SHANK: Patty, do you just want to come on down, too? I'm sure you're going to get questions.

DR. ARCHER: Well, in one of those situations in 1982, it was called the tristate outbreak, and it involved pasteurized milk. And the milk was fine, and the pasteurization process had worked and done exactly what it was supposed to do. But the milk bottles or the containers were put in cartons that had previously been on a pig farm, and some of the pig manure managed to drip down on the caps, by capillary action got up under, and once the milk carton was opened, it was instantly inoculated with ursinia aneracolita(?).

In the larger outbreak of salmonellosis, again, pasteurized milk was the product. This was post-pasteurization contamination within the pasteurizat ion plant itself. Salmonella had become lodged in a pipe that was very remote in the plant, and this was a plant with virtually hundreds of miles of piping. And something went wrong, and a slug of salmonella got through, survived, and caused, conservatively, about 400,000 illnesses. It can happen.

DR. OSTERHOLM: Fred?

DR. SHANK: Yes.

DR. OSTERHOLM: Mike Osterholm. Just as a point of clarification, I think it's very important for the audience to understand that we're not talking about a failure of pasteurization. We're talking about a failure of pasteurization system, and that the pasteurization based on time and temperature worked. It's just that any system--in fact, just not to correct our speaker, but the largest outbreak of salmonellosis is actually the Swan's Ice Cream outbreak, larger than the Jewel Dairy outbreak that you're referring to. In that outbreak, again, the product was pasteurized but then was subsequently hauled in trucks which also hauled raw egg product. And so, again, you could say that was a failure of pasteurization, but it was not. It was a failure of a system post-pasteurization. And I think just for the audience that's an important distinction.

DR. ARCHER: It is an important distinction, Mike, and it should be made. But it's also, I think, an important distinction to point out that when we were investigating the possible pasteurized milk outbreak involved Listeria, and when the actual laboratory studies were done, there was an incredibly narrow margin of safety within the process itself. And as you know, it's a logarithmic death of any organism when heat is applied, and it was calculated that had the load of Listeria or other heat-resistant organism been large enough to start with, pasteurization would not work.

DR. YURSTROBUS: My name is Dr. Yurstrobus  ph . I'm a consultant here in Washington. I had a question for the CDC--two questions, actually, points of clarification. It seems to me there are many different types of fruit juices--grapes, oranges, apples, grapefruit. The CDC presentation was largely on apples and oranges, but it itself noted that there were differences in the number of outbreaks, the sources of contamination, the organisms, the particular use of sanitary practices. And I guess I'd have two questions. One is I wanted to clarify whether the recommendations apply equally to all of these juices and whether the CDC has done a comparable spiking study to the Doyle study on orange juice that has been produced under the new State of Florida regulations that were installed after the Theme Park A episode.

And my second question is whether we can get a sense of what the denominator is, given the fact that a large number of people may drink juice on a daily basis in the United States, which would give us some sense of what the risk is.

DR. GRIFFIN: The first question I think was, Are the recommendations the same for other juices as what I made? I made specific recommendations for apple juice and cider, and that was to strengthen practices to assure that it was safe. And what I said for other juices is that we need to improve the safety of other juices, and I didn't recommend how that should be done. So I think that was a pretty broad recommendation.

The next question is, Did we do similar spiking studies on orange juice formulated under the new guidelines? In general, CDC doesn't do these sorts of studied unless we can't find anyone else in food microbiology who will do them. And we were fortunate in having Dr. Doyle's group, Dr. Larry Beauchat, working with us on the apple cider. And I think that people at the University of Florida, Mickey Parrish, may have done some work on orange juice, but I'm not familiar with any new studies on orange produced under the new regulations. Perhaps that will come up later in the conference.

Then as far as the denominator of people who drink juice, I don't have that sort of data. The only data that we do have is that some of you may have heard that CDC, with monetary assistance from USDA and FDA, has begun active surveillance for food-borne disease in five sites, and we have about 5 percent of the U.S. population under surveillance. And to try to understand more about food-borne illness and food consumption practices , we surveyed a random sample of people in those areas, and I looked--one of the questions we ask them is: Have you drunk apple cider in the past five days? And our data from this past March through September showed that a range of between five to nine respondents said they had drunk cider in the previous nine days. And that doesn't include data from October and November when we might expect it to be higher than 9 percent.

MR. SAPERS: My name is Gerald Sapers. I'm a food technologist with the Agricultural Research Service in Philadelphia. I'm a colleague of Bob Buchanan's. I'd like to make a comment about one remark that Dr. Buchanan made concerning low-acid tomatoes.

In the 1970s and early 1980s, we did a lot of research in this area, and one of the points that we made was that not only must we consider the inherent low acidity of some varieties, but also the fact that as the fruit became senescent, the acidity decreased. And more to the point, in the presence of certain fungal infections and areas of decay, the acidity decreased greatly so that the pH could reach neutrality in some cases.

This is relevant, I think, to the apple situation since in the micro-environment of decay areas in apples, it's quite possible that the pH may be greatly elevated. And, in fact, we do have some preliminary data showing that this is the case. And so this micro-environment might be an appropriate area where O157 might not only be able to survive, but to grow.

DR. SHANK: Thank you.

Caroline?

MS. DeWAAL: Caroline Smith DeWaal, Center for Science in the Public Interest. I have a question actually to all your panelists, but I'd be very interested in information from CDC specifically. You've said that we believe that O157:H7 survives in the manure or in the intestinal tract of cattle, deer, and sheep. I want to know specifically what is the data on survival in the live animal for deer and sheep. I'd also like to know whether CDC has done any data evaluation showing whether fields have been treated, fields which are associated with outbreaks, from O157 have been treated with cow manure or whether there's any traceback to the actual manure of deer or sheep populations. But I have heard that a lot of this data on deer specifically may be from small slaughter operations where you have cattle being slaughtered and deer being slaughtered and there may be cross-contamination issues involved.

DR. SHANK: Who wants to be first on that one? Come on up, Patty.

I would remind you, Caroline, that some of those issues may be addressed later this afternoon as we talk about the practices.

DR. GRIFFIN: You mentioned survival of O157 in cattle, deer, and sheep. I'm not sure that's what I would call it. It can colonize these animals, and when we go onto farms, we can culture the organism from the feces of these animals. We're much more likely to culture it from the young animals, the post-weaned heifers, than from the older animals, the cows. And when we go back to the same animals, we often find that their feces are negative for the organism, and when we go back again, they may be positive again. So the more you culture, the more positive animals you're likely to find on a particular farm.

The data on deer and sheep is very new data. We at CDC haven't done this ourselves, and it is in the medical literature. You can find that there are published articles on this, and I can help you find them if you have difficulty.

As far as fields associated with outbreaks being treated with cow manure, I don't think we've been successful enough in our tracebacks that we've found outbreaks and been able to trace an outbreak from a food to a particular field. However, some of the pioneering work on O157 in cattle has been done by Dale Hancock and Tom Besser in Washington State. And they've found some evidence suggesting that treating fields with a slurry of cow manure and the letting cattle go out and graze on those fields may be associated with cattle herds that are more likely to carry O157. We need a lot more work on the ecology of O157 in cattle and other animals.

DR. WACHSMUTH: I know during the orange juice outbreak we learned from the industry in Florida that this type of orange juice was growing in popularity and that that industry was expanding. It had been very small, and then it increased substantially in a very short period of time. So that's a little troublesome.

But what I'd like to ask Dr. Archer is: What is the bottom line of the Florida regulation? What was done to ensure safety? And when was that effective?

DR. SHANK: Before we take that question, Kaye, I think Bob has a follow-up to Caroline's question.

DR. BUCHANAN: Caroline, I think at this point the information on the reservoirs for the organism is one of the areas that is--we don't have enough data on it. There has been an assumption that the natural reservoir for this organism is cattle. This is based on what I would consider a very, you know, limited viewpoint that we haven't really gone out into the environment. My feeling is that cattle is either a secondary or a transitory reservoir. I don't think we've found the real one yet.

I assume that people here will be able to give more information, but with the limited areas that I've looked at in terms of apple orchards in the last few weeks, the raising of cattle and the use of cattle manure is not something that occurs in those areas. But the deer populations, everyone that I've queried about the deer populations has indicated a tremendous upswing in deer populations in the last ten years that they just run through the orchards.

Now, this again may not be the reservoir. The point is we can't look at these problems knowing that we have the solution ahead of time, because we'll be disappointed.

DR. SHANK: Doug, you had at least one or two questions there for you.

DR. ARCHER: Yes. I'd start with a comment. That is, I wouldn't be concerned about the expansion of an industry unless they're presupposing a problem with the industry. I think expanding an industry is a good thing.

The other thing I'd say is I think the regulations in Florida were enacted on--is Betsy Woodward here?--February 6, 1996? February 20th. Okay.

The bottom line of those regulations, I think it's a lot of good, common-sense sanitation. General sanitation principles applied rigorously. That's the bottom line. And I think that's really--going back to a lot of what we've heard, we're hearing about deer and cow and, you know, in the case of Cryptosporidium and Giradia, you might throw in beaver and elk and a bunch of other animals. Well, it just makes good sanitation sense. Manure and food need to be kept apart, and if it's unavoidable that they come in contact with one another, it has to be removed from the food before the food encounters human beings. And that's basic sanitation.

MR. MARTINELLI: Good morning. I'm Frank Martinelli from Orchid Island Juice Company. I'm the plant manager there, and I'd like to apologize in advance with regards to microbiological contamination and microbiological information. I am a layman. But I have a question for Dr. Griffin.

At Orchid Island Juice Company, we produced over 100 million servings of fresh squeezed orange juice and grapefruit juice and without any reported incident of food-borne pathogenic illness. And my questio n is: What level of safety are you trying to achieve? And could you put in perspective for the layman the risks that we're dealing with with regards to fresh squeezed juice as opposed to the risks a person takes when they get in their car to drive to the grocery store to get that juice?

DR. GRIFFIN: That's a good question. I wish I had the answer to it. I think I alluded to the problem when I said that we're recognizing more outbreaks from juice, but we think that sporadic cases are more common. It's very difficult for us to measure the number of illnesses from juice because it tends to be a quite widespread product and outbreaks tend not to be recognized. One of the reasons we have the new food-borne disease act of surveillance system with the five sentinel surveillance sites is to try to measure some of this sporadic disease.

So we're detecting more outbreaks from juice, but we think that those are just an indication that there are also sporadic cases. And when I said that we were looking for more outbreaks after 1991, when we had our first recognize outbreaks, it's because we've had the same questions that you have. How big a problem is this? And it's going to be difficult to measure.

When we had 55 cases of E. coli O157 infection in the city of Las Vegas associated with the 1993 big hamburger outbreak, that entire outbreak was missed in the State of Nevada. The only reason it was found is because the mother of a child who was hospitalized with kidney failure read in the newspaper about the outbreak in Washington State and said: Oh, isn't that funny? My child ate at one of those restaurants before she got sick.

So not only do we miss sporadic cases, we miss even big outbreaks. So it's very hard to measure the impact.

I think that right now it's clear that we have a problem with unpasteurized apple juice. We've had a problem with some unpasteurized orange juice made by particular methods. And I think that we need to look at the critical control processes that go into the making of juice to try to determine if juice is safe.

DR. SHANK: Burt, does your issue still hold?

MR. BARTLESON: I think the point that I wanted to make is that when we start looking at the ecology of E. coli, the more we look, the more we find. When we started looking, we looked at cows, and we found it in cows. And we discovered that a single cow could be a carrier and then not be a carrier and then carry it again later, and that you had a prevalence in herds of 1 percent and it was different cows at different times.

But when we started looking around the farm, we found that not only was it in the cows but it was in the water that the cows drank. It was in the flies that were flying around. It was in the dogs that were running around on the farm, in the deer, and it's all over the place. It's also in birds. So we can't just assume that if we control cow manure, deer manure, and sheep manure that we've got this problem licked. It's more complex than that, and there are other sources of contamination beyond just those three.

DR. OSTERHOLM: I think this question regarding what is the risk is a very important, relevant question, and there's really two parts to that. One is the numerator and one is the denominator, how many people are drinking the product, but how many cases are actually occurring. And, Fred, if you could indulge me, I just have two slides. Could I show them? You have the changer up there.

In Minnesota, where we have probably the most active--one of the more active statewide programs for E. coli O157:H7 infection--and I say that because this past two years we reported out more cases in Minnesota than in any other region of the United States combined to the CDC, and I do not believe it's because we have more incidence of disease or higher incidence. It's because really we have our laboratories looking for it.

The only point I want to make here is you can see 345 cases reported, which are really the tip of the iceberg. Most of them were summertime cases. Twenty-four cases of HUS were reported.

Fred, if you would go to the next slide, actually we'll do this quickly.

If you can focus that a little bit, you can see seasonally in 1994 we have this increase in the summer. Each red box is an isolate that our laboratory received a case report, 135.

Next slide.

In 1995, there was 182 with a big peak in the summertime. You say, well, what's going on out there? What we've actually done is taken this a step further and done a further characterization of these isolates, a clonotype analysis, where it's just not O157:H7, but now we can tell a John T. Smith from a John P. Smith from a John Q. Smith. And all E. coli O157:H7 are not the same.

Next slide, please.

If you look in 1994, that's that same graph you saw in all red, but each colored box reflects one particular strain that more than one isolate came through that was exactly that clonotype. And in those instances, you see there were 20. In 52 instances, a single white box represents a single unrelated molecular subtype, so in total here we really dealt with 72 different E. coli O157:H7s.

Next slide, for my last one.

In 1995, it was even more dramatic. What if you had looked at that big peak and you had assumed that that was all E. coli O157:H7 from one source? You have the lavender boxes; you have the pink boxes; you have the yellow boxes; you have the red boxes.

The point I want to make here is we're missing outbreaks all the time, because unless you're doing this clonotype-type work, you are truly mixing apples and oranges in your analysis. And this past summer we had an opportunity to have other states in the Midwest supply their E. coli isolates from their public health laboratory. The same pulses that went through Minnesota in the same week went through the entire upper Midwest. These are perishable food items that are coming through that are pulsing through the system, creating what we call a series of mini-epidemics, m-i-n-i epidemics, m-a-n-y epidemics. Processed juices, et cetera, clearly could be part of this.

Just as a final note to add here, in the outbreak with Odwalla, note that northern California was one of the five centers that Patty referred to for food-borne disease surveillance, yet that was not picked up in northern California despite the distribution of the product there in cases. It was picked up in Seattle-King County because they are one of the few places that have the combination, clinical expertise combined with this type of further identification.

So I think we have to, as Patty said, which very much supports her point, we're missing outbreaks all the time. Most of these did not come up to a recognize outbreak because we didn't have the resources to go and do additional follow-up, we had so few cases, that we could be having juice outbreaks or fresh fruit and vegetable outbreaks, or whatever, all the time. And these are not long-term kind of products in the market, as you can see. Many of these come through literally in a one- or two-week period, and they're gone.

Just as a final note to make on that, in Minnesota, just to give you a sense, the Swan's Ice Cream outbreak, which I referred to earlier, because of the fact that this ice cream was a home-delivered product, we had a very good opportunity to actually learn how many people had consumed it and got sick, because we could go back home by home by home. In Minnesota, based on the consumption and the number of illnesses, we estimate 30,000 cases conservatively occurred in Minnesota. In 1994, this was the number one Minnesota-based news story as determined by AP. So it was not that people were not aware of this. Yet out of those 30,000, only 151 cases were medically detected and reported to us, for less than 0.5 percent. So even in these boxes up here, every time you hear about 100 cases or 200 cases or 300 cases, remember the multiplier effect and realize what's coming through our system.

DR. SHANK: Thanks, Mike.

Yes?

MR. WOOD: I'm Richard Wood with Food Animal Concerns Trust. I was wondering if some of our presenters might give a rather subjective assessment in terms of how they view the level of research that's focused on O157:H7 in determining its reservoir and outbreak situations and related to some of the other questions. In terms of dollars and the amount of scientific literature that's out there, how does it compare to research on some of the other food-borne pathogens? It's my understanding th at the dollars haven't been there as they should be, and I'd like some comment on that, if possible.

DR. SHANK: Dr. Buchanan, do you want to take a stab at that one?

DR. BUCHANAN: Well, I can give you the party line. It's never enough.

We see two things going on here. The amount of information we need about O157 is very large, and it goes from very basic molecular biology all the way up through the ecology of it in the real environment. We have people doing little pieces of it all over the country. There are funds available for O157. It's never enough. I mean, the speed at which you achieve is directly dependent on the dollars you put in it. It is also one of the more important problems, but it's not the only microbiological concern. There are a number of them that are working through.

We also have the reality that there aren't many research food microbiologists in the country, and so there's only so much you can do. And, finally, field work is a real pain. Going around collecting deer feces is not the most exciting research, nor is it the most pleasant to do. But it's still one of those things that needs to be done.

DR. ARCHER: I'll take a crack at that from a different aspect. Being with a university that is looking for funding, having people out in the field scooping up feces, I think that's why the Lord in his wisdom invented graduate students.

 Laughter.

DR. ARCHER: So the labor force is there. But I would hazard a guess that if I applied for a grant from the Federal Government to go and try and methodically look at what the fecal carriage rate of E. coli was in various species, and that was next to a grant that was looking at the basic molecular biology of E. coli O157, I think I could hazard a guess which one would get funded and which one wouldn't. And that's just the reality of the times. The glitzier stuff seems to attract the money. Unfortunately, it's the grunt work that probably has more importance.

DR. BUCHANAN: And I would concur with that. If it's not sexy, it doesn't get funded, even though it may be needed.

DR. GRIFFIN: I agree with both of the previous speakers. In 1987, five years after the first O157 outbreak--and in that first outbreak O157 was cultured from the ground beef that caused the outbreak. In 1987, CDC sent EIS officers to do the first survey of cattle herds for O157 because it hadn't been done yet. And they were investigating an outbreak, and they really felt that the work needed to be done, and that was the study that showed that O157 can colonize many cattle and is more easily isolated from young calves than from older animals.

I think that the work being done now in Washington State, as I mentioned before, is very important, and we would very much like to see more epidemiologic studies on farms of the risk factors for some animals carrying O157 and other animals not carrying it, for some farms having animals with O157 and other farms not having animals with O157. We'd like to see epidemiologic studies on slaughter plants that look at the risk of contamination of meat during slaughter and processing, comparing the practices in plants that produce meat that's contaminated with microorganisms to those of plants that produce meat that is less heavily contaminated.

DR. SHANK: Dr. Potter?

DR. POTTER: Thank you, Fred.

A question for Dr. Archer. You stressed the differences between juices and fruits and vegetables from which they're derived and the differences among the various kinds of fruits and vegetables. What do you think the important characteristics are that would let us group those into relevant risk factors for focused control strategies? And are there control strategies that transcend those differences that could be generally applied? You seem to have a dim view of the public health benefits of pasteurization, and I wonder if you have other suggestions.

DR. ARCHER: I don't have a dim view of pasteurization. Pasteurization has saved countless lives over the past decades. But I do have a dim view of applying something if it's not needed. And I go back to the gentleman who asked the question before, producing 100 million units of the product and we've never heard a complaint, and the answer was, well, it's probably sporadic cases. I mean, I'd worry a whole lot more about the status quo of the water supply in the United States and the sporadic illnesses caused by that than anything else.

Now, to get back to your question, Morry, I think it, again, just becomes common sense, and in the terms of microbiology, I'd be worried about juices in which organisms could grow. I mean, all of life, microbiology included, is a numbers game. Even here where we're working with very, very infectious organisms, it's still a matter of a sufficient number of them have to get into the human being to cause an illness. That number may be very low in some individuals, but, nevertheless, if the population can expand, the risk increases. And so those juices--well, first of all, the epidemiology ought to go some distance in telling the story. If there's a documented problem, yes, attention should be focused on that.

Where there is no problem, and where I get a little nervous, is when we extrapolate between the juices and, okay, we've seen some information that fresh apple cider there have been some problems, and now we're jumping off into, say, grape juice because it's a juice.

I don't think that quite follows. I think we need to know a little bit more before we propose a panacea solution to all juices.

DR. POTTER: Doug, before you leave, could you expand on that just a little bit? If the fact that they're both fruit juices isn't the relevant characteristic, what might we look for so that we don't have to wait for an outbreak per product? Is there some way that we can say these juices have relevant characteristics that are similar and, therefore, we can view them as a group? Or do, in fact, we have to wait for an outbreak per product?

DR. ARCHER: Historically, that's been how it's been done, if I'm not mistaken. Unfortunately, we have had to wait for the outbreak and then figure out why it happened.

Can we do a little bit better job of prospective thinking? Probably we can. Again, going back to a common theme here, it seems to be manure. If you keep the product away from manure, it seems that it will be a little bit safer. Well, then, possibly food products that aren't going to come into contact with manure or have a very low probability might be ones you might not want to focus on.

But it's still--I mean, look at the number of causative organisms, and there's going to be some kind of a chain of events where they get into a food regardless. I mean, we've had hepatitis A outbreaks on fruits and vegetables, and, you know, it happens sometimes. Those are things that should be avoidable, but when people are involved, mistakes get made on occasion.

DR. SHANK: Bob?

DR. BUCHANAN: There's a variety of factors that have the potential for influencing it, but if we're dealing with a product that is relying on acidity to inactivate the pathogen, as in an acidic fruit juice, the key issues are: What is the pH, and what is the acid that makes up the major component within that fruit juice? So, for example, comparing apples and oranges is not appropriate is in reality true because they have two different acidulants. One is malic acid and one is citric acid. You also have to look at the characteristic of the fruit itself, its potential for internalizing a pathogen, the potential, for example, of taking an organism in the blossom end in the two respective fruits.

So there's a variety of things. I think we can do it in a more systematic manner, but that's just a couple of the areas.

DR. OSTERHOLM: This is a question really for Doug or anyone else in the group here, but we're concentrating on manure, but I think we also had an experience this past year or past two years with cyclospora and the issue there. And for those of us that have the belief that eimeria of birds and cyclospora in humans are the same bug, clearly bird droppings become a very important role. Anytime you're dealing with fruits or vegetables, you've got bird droppings also involved and the potential for contamination of the product that might go into juices. Could somebody comment on the issue of in addition to cow manure or any other animal manure but also bird droppings, which would not be a necessarily a ground-related issue?

DR. SHANK: I don't see any volunteers at this point. Kaye?

DR. WACHSMUTH: This goes back to the research. Just for public information, we have a multi-agency food safety research group formed, mainly at the behest of Mike Taylor, who is the Acting Under Secretary for Food Safety at USDA. That group did identify areas that we're raising here, the ecology and other things for all of the enteric pathogens, but also put some emphasis on the other enterohemorrhagic E. coli other than O157:H7 since we have no idea about the infectious dose. We do know there have been some outbreaks in other countries. So we're certainly not ignoring those things, and FSIS will take this agenda to ARS, which is a very large research service, with millions of dollars, and we hope to put some more of that money towards these very things, the ecology and some of the human incidence, even, if we can influence institutions like CDC and NIH.

DR. SHANK: Burt? And then our public commentor.

MR. BARTLESON: I think that what Dr. Osterholm showed us is happening all the time. We're seeing little tiny pulses of disease that are so small that because we only have one state doing the work, we can't get enough cases to do a case control study. And, you know, we looked at Odwalla, the outbreak, pretty heavily and what we discovered was that we had another little six-person outbreak from 300 gallons of juice that was pressed at a church dinner.

Now, if we hadn't been enhancing our surveillance and collecting more stool cultures, we wouldn't have found that at all. And I think that's what's happening all the time. If you put the money in the laboratory and you put the money in the research, you're going to find there are more problems.

The second thing I wanted to mention is I don't think that as epidemiologists in local health departments sometimes we ask the right questions. We look at two days of food history, and with low-dose organisms like E. coli, the incubation period may be seven days or longer. And so we may be totally missing the sources.

The other thing is, of course, people's memory isn't very good, so you've got to have enough people to actually figure out the outbreak.

MR. WILSON: My name is Dan Wilson. I run an apple orchard and a small-scale fresh cider operation in upstate New York. I have a question for Dr. Osterholm. I was interested to see your slides, and I wanted to find out a little bit more of the background information on what caused these outbreaks, because I understand--or I saw the peak, the very strong peak in July and August for outbreaks, but I know that in the upper Midwest apple season and, therefore, the bulk of the processing of apples doesn't occur until mid-September through November.

DR. OSTERHOLM: First of al, to answer your question, it's unknown. That's a lack of resources. We're fortunate to have this much done. We're able to pick up some of the bigger outbreaks, and I think what you heard just now from Burt was a good example. If we have three or four or five cases, often we don't have enough information to be able to pursue this further in a way that would allow us to understand that. So that's an area that's very deficit in this country and one that we all need to invest in, because without good surveillance data, you know, it's kind of like trying to run the O'Hare air traffic control tower with tin cans and string. You know, we're not very effective. And I think that's what we're kind of doing right now in this country, and we need better data that way to answer your question very specifically.

Seasonality-wise, we agree with you. There are some very interesting patterns there, but I think again the point is that just as those may not be fruit and vegetable outbreaks associated with your product or whatever, clearly they are occurring in the fall and we're missing even those. So as you just heard, the Washington outbreak with the church group in the pressed apples would never even have been picked up if the Odwalla outbreak hadn't occurred. We think we're missing them big-time in Minnesota, and if we're missing them, I can tell you the rest of the country is really missing them. And that I think is the key issue. Please don't come in here and say we've got nine outbreaks on record and that's all we have. That is true, but that would really defy the point, I think, of what is the true burden of disease and what's associated with what, and that's what we really have an obligation to find out.

DR. SHANK: Thanks, Mike.

Let me ask you to hold until a little bit later. We're eating into our break.

Let's take a quick break at this point and be back in 15 minutes, please.

 Recess.

DR. SHANK: According to my watch, it's 10:30. So if you could come on back in and take your seats, we'll get started.

Let me have your attention. I think that in view of the time we need to get started. We do have a full schedule, and we need to keep as close to schedule as we can.

You will notice that we have another person up front here with us since the break. Mr. Jerry Mande has joined us. Jerry is the Executive Assistant to the Commissioner, and so we welcome him to the front.

At this point we're on the program to review what has been called the Odwalla situation. We have two presenters. Your program indicates one. But we have Stephen Williamson, who is the chief executive officer for Odwalla. We also have Greg Steltenpohl, who is the founder and chairman of Odwalla. And so I would ask both of those gentlemen to come forward, and we'll proceed with those presentations at this time.

MR. WILLIAMSON: Hello. My name is Stephen Williamson, and I am the CEO of Odwalla. I would like to thank the FDA, the CDC, and all the state and local authorities for helping us through this crisis. I am very happy to be here today to share our story with you, and there are five things I want to talk about today: first, who we are, give you a quick background of who we are; two, how we responded to this crisis; three, how this experience has changed us; four, give you an overview of the HACCP plan we want to talk about; and, five, talk about consumer choice.

To start with, who we are. Slide No. 1, if we could. Thank you.

To understand us, you actually need to understand our vision statement. Key words in here are soil to soul, people to planet, nourishing the body whole--probably not a typical Washington, D.C. vision statement, but this is--

 Laughter.

MR. WILLIAMSON: --the fundamentals of our company. We believe we are a nourishment company, and that makes what we've gone through that much more difficult.

Okay. Patty, you were better at this than me. How do you work this thing?

 Pause

MR. WILLIAMSON: Core values, a couple things are important to understand here. Honesty, integrity, respect, leadership through creativity, innovation, example. These are key to us, and they were very important for us in handling this crisis.

Next slide, please.

A couple key facts about us. Last year we did $60 million in sales, $633,000 in net income. We have just under 600 employees, just under 200 routes, 4,600 accounts. We do all our own DSD. We did produce 37 million units last year. Since the inception of the company, we estimate we've had several hundred million servings. We have 24 different flavors and 80 different units we make. Our distribution system is shown here through seven states. We have 22 distribution centers.

Next slide, please.

All our own fleet, and we make deliveries seven days a week to our accounts. So I've given you a brief sense of who we are. What I'd like to do now is talk about the recall and how we handled that.

Next slide, please.

As I mentioned earlier, our crisis communication plan is totally based off of our vision and our core values. When this call came from Carl Osaki  ph in Washington State, we simply asked them, What do you need to know and what can we do? And what they said, very clearly, was it was an apple-related problem, apple juice, apple juice. And we said, well, do you understand that we also have apple juice in a lot of our blends? Immediately we said we'd recall all our apple juice, all our apple-related--even though epidemiologically they had said to us at this point it was only apple juice, we were not comfortable just pulling apple juice. If there's a problem in our apple juice, we thought it would probably be in our blends as well. So we immediately pulled everything off the shelf.

A couple of things to think about is how far do you go, and I think that we're an exception in that we went much further than people suggested. Not only did we take apple off, we took apple-related, and one day later we took all our carrot juice off, even though there was no epidemiological evidence with carrot juice. It was made on the same line, and consumer safety is our number one priority, and, therefore, it came off.

Immediately we also reached out to all the families through the media saying we will pay all medical expenses. If you were made ill from our juice, we'll cover the costs. And we I think very quickly established a very good working relationship with the FDA and the CDC and all the state and local authorities. Randy Wykoff  ph from the FDA set up daily conference calls with us which were really important for us because we didn't know what was going on, and having this one-hour conference call every day for the first ten days was extremely helpful. We needed to know information that people wanted, like our distribution records, the accounts, anything. We were there trying to supply the information to be responsive.

Then we had investigators in our plant from 11 days from the FDA and the CDC--I guess the CDC and the state and local authorities, and our attitude there I think is important to point out, which was, hey, nothing to hide, our records are open, you're going to find something with us or before us, that's okay, let's find out the issue here. And we were totally open. Anything you want, it's there.

Next slide, please.

Obviously the impact on our company was pretty substantial. In the Pacific Northwest where most of the press focus happened, our sales dropped almost to zero. That was augmented by some miscommunications in terms of what was being recalled. But the impact was pretty dramatic. It also instantly changed our distribution system from one that puts it out to one that brings it in, which is no small task. We made 4,200 stops in a 24-hour period. We had our total recall completed in 48 hours. Eventually we took over 40 forty-eight-foot trucks full of our product and had it destroyed. It was an incredibly tough period to go through.

I also want to point out Commissioner Kessler's comments in a press conference on the Friday after the incident. He was patched into a press conference in Seattle, and he said that this is not just an Odwalla problem, this is a fresh apple juice industry problem. And we appreciate that comment, but we also felt that was a very difficult comment because we know what we do and I've been around to many, many different fresh juice plants in the country. We didn't want to put the industry on notice, but we were also in a situation where--I have three children. I have a daughter who's 20 months. She drinks mango-tango every day, fresh apple juice every day. My two other children drink tons of apple juice. I'm a father. What do you do? I mean, this obviously freaked us out, and we felt that we needed to reach out and let people know this was an issue.

We've tried to conduct ourselves in a way that we think is both full of integrity and also trying to be sympathetic for all the other people in the business. And it's been no easy path. It seems either way we go we end up in a tough situation.

Next slide, please.

What I'd like to do now is take you through a little bit of how this experience has changed us, and what I want to do is start to give you a little bit of background about our plant.

We're really proud of our production facility. We're proud of what we've accomplished, and this has clearly been an incredible blow to us. A couple of facts here.

This year we were budgeted to process 155 million pounds of fruit, over 50 different ingredients. Orange, carrot, and apple are our largest poundage. It's approximately 10 million gallons of finished product budgeted for this year. Our production facility opened in August of '93. It's a 95,000-square-foot facility on 50 acres located in the Central Valley in California. We have approximately 175 employees, and we run six days a week.

Next slide, please.

This gives you a very simple line drawing of how our plant works. We have two primary juice-making operations: the extraction, which is for citrus, and the press, for carrot and apple. From there it goes into storage tanks where it's held for a matter of minutes or hours, and it goes into the mix and blend room where we add our purees, our water, our dried powders. It's mixed, it's blended, it's bottled, and it's put into our finished goods holding place where it's picked by route, shipped out. Approximately 60 forty-eight-foot trucks a week go out to our 22 distribution centers.

Next slide, please.

This is, again, a simple line drawing of our old press line. When fruit comes in, it's inspected. If it makes it past the inspection, it goes into storage where it's held for a matter of hours or days, depending on our volume. It's dumped on to a table. It's culled. After culling, it goes through a Van Mark scrubber where it is scrubbed, and it is sprayed with acid detergent. It's rinsed. It was ground, pumped, and filtered, and bottled, and we can go through--the next slide, please--to give you a little overview of the operation as it was prior to this.

It doesn't seem like that slide is focused. Can you see that? Is that focused?

VOICES: No.

MR. WILLIAMSON: Could we focus back there?

Okay. Well, anyway, I will keep going. What I'm trying to point out here is this is the old facility, and you'll see the sorting going on there, two people sorting. After that it goes into--this is a Van Mark scrubber. It's rated for approximately, I think, 24,000 pounds per hour. We were running it less than 50 percent of that, and in there was where the acid detergent was sprayed. It goes through this wall, and on the other side of this wall is our extraction operation.

Next slide, please.

Apples going through the sorting.

Next slide, please.

And here inside is the extraction room, our Hammermill grinder, and then the press.

Next slide, please.

Here is a recent survey from the U.S. Apple Associate that came out post this incident, and I think it's important to point out here, if you look at this, we think we answered this to the highest order. We do wash, we do brush. We use a Van Mark peeler-scrubber rated for apples at well below its capacity. We do not recirculate water. We cull before. We visually inspect, and we attempt to use no bruised and decay cuts or punctured fruit.

Next slide, please.

Just a quick overview of some of the sanitation and clean-in-place systems. Our CIP system is a six-step process. It's very thorough. Our equipment surface cleaning operation is a four-step process, and it has real-time verification. I'm going to talk mor e about that in a moment. And our in-process sanitation happens if our lines stop for more than ten minutes, and it's a three-step process.

Next slide, please.

One of the things that we use and we're very happy with and proud of--and, again, I want to make sure people understand I'm not a scientist, nor am I a lawyer, so I'm not necessarily good at answering lots of questions. But we used an IDEXX luminometer every day to help us, because one of the things we think in sanitation is real time is very important. If you do your sanitization process and you don't get your results for 24 hours, well, you've already run another day of production. So we used this tool to get instantaneous feedback on were we clean or were we dirty, and if we're dirty, we go through the process again. And we found it be helpful.

Next slide, please.

Our process controls and GMPs included these categories for pathogens, product less than 4.3. We had a rodent plan, an insect plan, spoilage and careful control of the cold chain for materials and finished goods, sanitation plan, and our product quality controls included--every batch was Aston Brix(?) pH tested. We did yeast and mold and aerobic plate counts on all our single-strength products and a rotation of our blends. We tracked consumer complaints very carefully, and our low-acid product is where we focused.

What we did is we looked at what we thought was the most dangerous product, which was--or the most potential for concern, which was vegetable cocktail. It was 70 percent carrot juice and the other 30 percent things like beets and celery, where we thought we had the highest risk. So we did testing for coliforms and E. coli on that every time it was made.

Next slide, please.

This is a slide showing our results over the last three years of our aerobic plate counts in apple juice. I guess the thing that's been so difficult for us about this is we really thought we had made a tremendous amount of progress, and we've taken our plate counts down from over 100,000 to 12,000, and we thought we were getting better. We had been continually investing in our plant. We put over $10 million into our plant. We've continually invested in a management team, and when this hit, it was clearly an incredible shock.

Next slide, please.

When we got the call, we reached out for help, and I really want to tell people, not that you ever want to go through this experience, but the FDA was incredibly helpful in putting us in contact with people. So was the CDC. Patricia Griffin was very helpful in getting me to Mike Doyle. John Vanderveen was very helpful in getting me to people that were helpful to try to help us understand what was going on here. We clearly needed experts.

Michael Doyle has been to our plant, Dr. Michael Doyle, and so was Dr. Nick Nickelson. They've been very involved in helping us re-emerge. The National Food Lab, and Sherry McIntyre from the National Food Lab is here, and we have results we want to share with you. I'm not going to put them on the screen, but anyone who wants them, we did do a series of thermal death time studies on apple juice. We took five strains of E. coli. We looked for the most heat-resistant and the one that thrived most i n apple juice, and we have the equation here. We'd like to share it with anyone who wants it. We were surprised that there is actually--that was the only research--it didn't exist. We had to go do it. And we want to share that with you today. Anyone who wants that, please come up and see me or Sherry McIntyre. We said that's public information and it should be out there.

Next slide, please.

I think a number of people have mentioned this, and I think this is important to point out. Apples, carrots, and oranges are different, and they have different things you need to consider: the sourcing, the shape, the ease of cleaning, and the method of processing. Each one needs to be considered. When we went about trying to emerge from this, they were very influential in how we emerged. Carrots are a fundamentally different industry than apples. With the advent of the baby peeled, the carrot industry has changed a tremendous amount. And I think you've got to consider all these things when you're trying to figure out how to make fresh juice safer, which I think this is what this is about.

Next slide, please.

I'm going to give you a quick overview of some of the changes we've made, some of the learnings from this experience. We were actually in the process of putting in an apple and citrus receiving station that's outside of the plant, the physical building, prior to this happening, but it went on line right after this. And what we're trying to do here is build more lines of defense, receive fruit outside the plant, wash it with a neutral wash, a neutral detergent, rinse it, do a primary sorting, put it into cleaned intra-company bins, plastic bins that haven't been outside the plant, and from there go into fruit storage.

Next slide, please.

This is a little overview of it.

Next slide.

An orange bulk truck being unloaded.

Next slide.

Next slide.

Sorting operation.

Next slide.

The loading into the bins.

Next slide, please.

So our new apple press line. When this happened, we did determine that we should put in more lines of defense, and we did make some changes quickly. The major changes are we switched from a Van Mark brush-washer--Van Mark peeler-scrubber to a flat table brush-washer. We spray a sanitizer now of chlorine solution, and we have put in a flash pasteurization system. So let's go through that quickly. I can give you an overview.

Next slide, please.

So this is a new table for brush-washing the apples, and you can see the Van Mark scrubbers in the background. Here's our sorting going. Remember, this is the second time it's been sorted at this point.

Next slide, please.

Another thing to point out, I'm sure that many of these people know about this, many don't, but, again, our belief is let's share standards to make things work better. These are undulating rolls where the fruit goes over, and what happens here is, if you look at fruit when it goes through a roller, it tends to just go end over end and continue. You don't get the top and the bottom, and this system here allows for a lot of rotation so you clean the top and the bottom, which tends to be where the most dirt ends up. That's an innovation that we came up with. I don't know how many other people use it, but it's been helpful for us in trying to get as much agitation in the process.

Next slide, please.

This is our flash pasteurization system we put in. Again, I referenced the thermal death time studies that we did with the National Food Lab. We've come up with a process where we extremely quickly raise the temperature, hold it for a very short period of time. Right now we're running it with many, many D-kill. There's my first use of some scientific words. And we drop it down extremely quickly.

Now, we went through a long series of taste testings to understand, you know, why do this. It's expensive, it's a process that we think retains a lot of the flavor. Curiously, there's not a lot of research that's been done on the effects of heat and the benefits of freshness. That's something my partner will talk more about.

Next slide, please.

Just a quick overview of our citrus operation. Again, it's received outside. It goes through one washing, one cull. It's put into our bins. It comes into the storage. When it's taken out of storage and put on to the operation, it goes through two scrubbings, two separate scrubbings with an acid detergent, a secondary sorting, a rinse, a sanitizing, and I'll take you through the slides.

Next slide, please.

So here we are, there are two different tables here for the sorting, Table 1, Table 2, and then you've got--for scrubbing, excuse me, washing and s crubbing where the acid detergent is sprayed. And then you've got your culling, and then it goes through the wall into the extraction room.

Next slide, please.

Inside our extraction room, we use FMC machines. We recently switched during the summer from another extraction method to the FMC method because we find this method gets much less juice contact with the skin. That's a very important consideration. And we have found our plate counts dropped accordingly.

Next slide, please.

So I said I would talk about five things: who we are, how we handled the crisis, how this experience has changed us, and I want to now talk about the fourth thing, which is HACCP. Pretty early on in this process it became clear to us in working with Dr. Doyle, Dr. Nickelson, talking to John Kvenberg from the FDA and John Vanderveen, that HACCP was going to need to be part of our operation. And so we are in the process of developing a complete HACCP plan. We're initially focusing on the microbial hazards. I'm going to show you in a moment our apple and citrus microbial HACCP plan containing the four critical control points.

I want to reiterate I think you need to consider each fruit and each vegetable separately. They all have their own characteristics. You know, when you make apple juice, you take the skin, you pulverize it, and that's part of the juice. It's hard to separate the skin from the apple. That's not the case in a carrot. A carrot is much more scrubbable. You can polish it, you can scrub it. The baby peeled actually is big carrots that are scrubbed down. That's where our primary source of ingredients comes from for carrots. And then I think it's also important HACCP is not the salvation in and of itself. It's got to be built off a system of good sanitation SOPs, good manufacturing processes, and process controls.

Next slide, please.

Here is our HACCP plan for apple juice. There are four points. We are in the process of getting all points in place. I think we're learning a lot. Point No. 2 on fruit hold and test, one of the things that we've learned which is very difficult is it is hard to test for this pathogen, and there's a lot of debate on whether Point No. 2 is going to be a worthwhile step. But we feel we should at least try it and pursue it, and we are working with Dupont and a few others from Michael Doyle's group on what actual testing methods we should use. We're in the process of experimenting with two at this point in time.

You can see in Point No. 3, the critical control Point No. 3, we believe it's not just flash pasteurization here. It is washing and scrubbing, sanitizing, the culling. All of that plays into this, and then finally, flash pasteurization. Then, of course, downstream from that, as a number of people have mentioned, you've got to make sure you don't reinfect.

Next slide, please.

I think the thing to point out here is on citrus you'll see on Point 3 we think fruit processing is fundamentally different in citrus versus apple, and, therefore, we do not at this point in time think at all that flash pasteurization is right for citrus. And I want to just go back and make it clear on apple. We don't think flash pasteurization is the answer for apple. It's what we have found so far to be a line of defense we're comfortable with, but there are other promising technologies. We've looked at pressure systems. We've looked at light systems. And we believe we will find something that works better and is fundamentally in line with our view of soil to soul and being a nourishment company. But at this point in time, flash pasteurization is in there. But if we find something else and we don't want to use it, we'll use something else. It's part of, again, the HACCP system.

The last slide, please.

So I'm going to turn it over in a moment to my partner, Greg Steltenpohl, the founder and chairman. What I do want to just close on are a couple of things I think are important. Safe, fresh juice is the issue. We need to create standards to ensure safety. We have been most impressed with Florida in how they deal with the citrus industry. We have looked to them to get good information and help us in our progress. Florida has been very responsive in moving forward.

We want to create a forum to share learnings, and as I said, we'll share our HACCP plan with anyone. We'll share all of our research on apple that we did at the National Food Lab. We think more research needs to be conducted, and again, I want to reiterate. You've got to understand the difference between a carrot, an apple, and an orange, and all fresh fruits and vegetables. We embrace HACCP. We're going to complete the chemical and the foreign object or physical side of the HACCP shortly, and we want to reiterate we have only adopted flash pasteurization as one of the lines of defense in our HACCP, and we absolutely believe in consumer choice.

At this point I'd like to turn it over to my partner Greg.

 Applause

MR. STELTENPOHL: Thank you, Stephen. I also would like to thank the FDA for allowing us to come and present, and to members of the CDC and state and local health agencies that have really been extremely respectful of our company during this whole crisis, and we sincerely appreciate that.

When our company was founded 16 years ago, I had the ideals of consumer health and wellness foremost in mind. And so as you can probably imagine, the irony of having this crisis affect a company such as Odwalla has made a deep and lasting impression. And we continue at this point to feel greatly saddened by the fact that there have been young children affected, and our thoughts and hearts continue to go out to those people and their families.

But in moving forward, we have to understand what we can do, and I come here today to really pose some questions to this group. And so in the spirit of inquiry and sharing, I'd like to share with you a few major dilemmas that we think are facing all of us.

Along with the emotions that we felt towards the victims, a lot of our organization has also felt proud, and I think it's important to mention that even before this incident our company had a history of cooperation, working with the FDA, the FDA had been in our plant as recently as two months before the outbreak, and we have always had an open record policy.

When this happened, we did several things that I would just like to add to that Stephen mentioned. In addition to immediately executing the recall prior to the bacteriological evidence, we also stopped making apple juice until just a little over two weeks ago when we introduced the flash pasteurization. We also to this date are not continuing fresh pressed carrot juice, and that's because we feel not all the information is in and that we hope to gain knowledge from this conference, in particular to help us put a better HACCP in for carrot juice.

By putting the public health first, we think that there's an important lesson for all companies here and that we can testify to the amount of overwhelming consumer response that has happened as a result of the way our company handled this crisis, and we think it's important to note literally thousands of contacts have been made to our company by consumers reinforcing the way it was conducted, our early recall, our proactivity, and, in fact, in a consumer study that contacted over 2,500 consumers conducted by Werthlin worldwide, we received a 96 percent approval rating of the company, and in many cases an increase in consumer perception about the brand value.

But this whole incident because a real life expression for what happens to a company with embedded core values, and we believe that this should be hopefully a strong signal to other companies that may encounter this type of situation in the future.

While we can be proud of our actions, you have heard from Stephen's presentation that we focused very strongly on internal activities that could eliminate or reduce this risk in the future. But these fundamental questions that have been raised by the introduction of HACCP and by the question of pasteurization is something I'd like to raise to all of you.

The first question I pose is: Can this group in this room, which is representing all the different factions from consumers to industry, the state and local agencies, the Federal Government, can we act much more proactively and not reactively to situations such as outbreaks? For example, today in Patty Griffin's talk, our company was interested to note that there were several other outbreaks occurring concurrently with ours that we were unaware of, and even though our company has been in the spotlight of the media, we were not informed of these outbreaks. We were informed of ones that happened prior, but this industry can benefit greatly from a synchronization and a connectivity of its operating groups. This way we can help cut off emerging hazards.

As one avenue, we would propose to catalyze the formation of a fresh juice industry trade association. We feel this could streamline the communications and create regular industry review of new technologies, best practices, and successful hazard reduction programs, possibly look at labeling issues as well.

We believe that HACCP programs must be individualized by those fruit industries that know how to handle and know the particular idiosyncratic features of those fruits or vegetables.

A clear precedent has been set by the seafood industry for successful proactive HACCP implementation together with the FDA. Based on what we're learning, we feel that mandatory pasteurization would be a premature and unnecessary step in light of the vast new technologies that are emerging. And I can assure you, since our company is located next to Silicon Valley, the amount of contact we've had from universities and from inventors and from research organizations has literally been overwhelming.

We believe there are a few promising technologies; in particular, the University of California at Berkeley and Lawrence Livermore Laboratories have several technologies that are ready for industrial application, and there are many more.

Another challenge and a secondary question is: How can we best understand the public health benefits of this industry that we are engaged in? Before pasteurization is considered as a final step, we believe that the nutritional benefits and, thus, the public health benefits of fresh juices are poorly understood. We believe more research is necessary. What are their specific nutritional attributes? Can we develop standards of nutritional identity? Early studies are promising. Our work with Corning Hazleton and National Food Laboratories leads in this direction, but we think clinical studies are the next step. There are several major universities that are interested in working with our company on large-scale population studies as well.

Additionally, because of the quantifiable nutrient levels present in fresh juices, they represent a unique public health opportunity to measure the effect of fresh foods because the dosages are clear and because you can have quantifiable dosages in a bottle that's definable.

Finally, and most important, is the question of balance. With public health foremost in mind, can we provide increasing degrees of food safety while protecting the nutritional and value and integrity of that same food supply? We must respond to the nation's changing health needs, to be sure, and as Dr. Kessler has pointed out, there is no better strategy than prevention. The number one cause of preventable death in the United States is poor diet.

We are hearing from thousands of Americans ranging from young children to consuming adults, and we would like to say that the fact is the story of Odwalla's history and, in fact, the outcome of our company was not determined by marketing calculation or advertising expenditures. The hundreds of millions of units that Stephen mentioned and the 37 million units that we achieved in distribution last year has been achieved by supplying a product that the public wants. That fact cannot be understated.

So I'd like to propose to this group that we could face the challenge for a win-win public health situation. So let's not remove the very same nutrients that are most needed to protect the immune systems of healthy people in this country in today's environment. So then we can move forward and hopefully have a healthy informed choice in the hands of the public.

Thank you.

 Applause

DR. SHANK: Thank you, Greg.

This brings us to the portion of our program where we're going to start looking at FDA findings. The first topic is the facility inspection and follow-up. Mr. Frank Scholl, who is Director of Investigations from our San Francisco District Office, will make that presentation. Frank?

DR. SCHOLL: I'll make this relatively brief since we're running behind schedule.

We first found out about this problem on October 30th. I got a call from our people in Seattle District in the late morning sometime. At that point there was the epidemiological link to apple juice, Odwalla apple juice, but we had no codes. We had a set of onset times, and we were starting from that point. We got somebody into the plant that afternoon. The state food and drug branch also got a couple people in that afternoon. At that point we were concentrating on collecting samples.

Because of the nature of this product, as someone mentioned earlier, there isn't a lot of--most apple juice is consumed fairly rapidly from the point it's purchased. We had no product containers or product left at that point. We collected about 11 samples. At the same time Seattle District went out to the Odwalla distribution centers and collected about a dozen samples. Those were put under analysis immediately.

That night I went home and thought I was done for the day, but Commissioner Kessler set up a conference call that started at 6:30 Pacific time and ran until past midnight. I don't have any idea how many people were involved in that call. They came and went. At one point about a dozen people from Odwalla were tied into it.

Initially, the health people from King County in Washington, CDC, Patty Griffin, the Commissioner, and our people from CFSAN discussed the epi information, made a determination that it was sound, and that we should go with the assumption that the apple juice was the causative agent, brought the firm on at about that point. I think it was an hour-and-a-half into the call, or two, explained the situation to them. They responded by agreeing to recall their apple products. The apple juices and their blended products, all in all I believe it's 13--13 different of their 24 items they have.

Subsequently, as Stephen mentioned, they pulled the carrot juice off--two carrot juices and the mixed-vegetable products off on the basis that they were manufactured on the same line as the apple juice.

The following day we got another investigator into the plant, the day after that two microbiologists, who would have been there earlier but they got lost. Dinuba is hard to find. We collected some more samples. All during this investigation, the apple juice operation was shut down, so all of this was a retrospective look at records and the equipment as it sat.

About that time--let's see. I think it was the 1st. We did get a report of an illness in Seattle, and it was the first time we had a container of product still existing and we connected with that. It was a confirmed case, and the manufacturing date of the product was 10/7, as it happened. We at that point pretty much had established we were looking at a span of time between about the 20th of September and the 20th or so of October, 21st. I think eventually we pushed it to the 24th. This was based principally an onset times. We had this one case now with a lot code that dropped it right in the middle of that span.

We started looking at records in the plant. There was a lot of product that was relatively low quality that came into the plant a few days before that and was used on the 7th. We did find a few areas on the chutes where there was some residue that the cleaning system hadn't picked up. Besides the finished product samples, we collected environmental samples in the plant, swabs and scrapings and what have you.

A couple days after that, as everyone knows, the Seattle lab got a hit, and we found O157 in a sealed bottle of apple juice. And it also was manufactured on 10/7.

All in all, the findings in the plant tended to indicate that the microbiological testing that the firm did with regards to apple juice wouldn't detect pathogens, as Stephen indicated, the yeast, mold, and total plate count. They do do testing on the carrot juice for E. coli and coliforms, but not in the apple juice. There were problems in the processing. This low-quality lot that came in, by the firm's own standards, should have been what's termed red-tagged, which indicates--puts it on a fast track to be used quickly and sorted more thoroughly, and that was missed.

There are always employee practices, no matter how good your HACCP system is, your people--I think training of the employees in the plant is crucial because if they make mistakes, your whole system goes down the drain.

All in all, again, as Stephen Williamson indicated, the firm recalled about 700,000 units, I understand. They were holding those so we could collect samples from them, and that became kind of a sticky issue, literally. The shelf life of the product is about 17 days, and this stuff was running well over that and starting to swell and explode. Eventually, there was 35, 40 semi loads of product that went down to southern California and destroyed down there.

I think at this point I'll turn it over to Dick Rude. He manages our microbiological laboratories in Seattle, and they handled the 120, plus or minus, samples that we collected. I should mention also that CDC collected another 40 or so samples, and the only positive one we got was the one sample of product manufactured on 10/7.

Dick?

DR. RUDE: Thank you, Frank.

What I'm going to do is just give you a brief overview of what went on in the laboratory. This is the chronology of what happened in the laboratory, and as Frank said, on October 30th, we were notified of this outbreak and were told that there was an investigator going out to the Odwalla distribution center at that time to collect samples.

That evening we received 11 samples from the Odwalla distribution center in Seattle. On the morning of October 31st, we began the analysis of these samples. Between 11/1 and 11/13, we received a total of 68 Odwalla juice samples and other related samples.

Some of the different samples that we ran consisted of apple juice, carrot juice, raspberry smoothies, blackberry fruit shakes, honey lemonade, orange juice, grapefruit juice, strawberry Sea Monster, Sea Monster, strawberry-banana smoothies, Serious Ginseng, Super Protein, and then we also ran some environmental samples that were collected at the plant as well as some powdered ingredients, and finished up with sampling their potable water system also.

On November 4th, we reported out the isolation of the E. coli O157, which was a sample that had been collected from the distribution center in Seattle, and it consisted of one intact container or apple juice with the use-by date of October 24th.

As a summary, in the laboratory we ran 68 samples. The number of analyses amounted to 400, and what that means is sort of--samples to us can mean two different things. In other words, there were 68 samples, but a lot of those samples may contain 10 units. In fact, they did contain anywhere from 10 units down to one unit of product, or with the environmentals, there were a number of environmentals that went over 10. So that's where these 400 analyses come from. It took us 870 analytical hours of analysis, and we only found the one positive sample.

This is a flow chart of the method that we used for isolating E. coli O157. This is a method that was published in the Journal of Food Protection in 1995 and was developed in Seattle District. The method that was around prior to this was not very sensitive, and so a couple of the analysts at the Seattle laboratory decided to look for a better, more sensitive method, and this method that we used is sensitive down to about one organism per 10 gm of product.

On the left side of the slide that you see up there is the actual method. The right side is we had some centrifuge tubes laying around and everything, and we decided, well, let's take--every once in a while we'll take some of these subunits, and we'll analyze them using this other method to see if that would make a difference and maybe possibly increase the sensitivity.

So we started out by taking and now used the positive sample as an example; 25 mLs from that sub were aseptic removed and put into a 225 mL what we call EHAC(?) enrichment broth, which consists of a modified tryptic soy broth and three different antibiotics--afixine, cefalodin, and bacomyacin(?), which are used to get rid of the background organisms. That is in a pint jar, which then went into a 37-degree incubator on a platform shaker where it was allowed to agitate. After six hours of agitation, it was removed, and we streaked it out to the TCSMAC plates, which is a sodium telurite(?) safime sorbitol MacConkey auger at the dilutions of 10^-1 and 10^-2. Then the containers were put back into the incubator for a 24-hour incubation. Again, we streaked on the TCSMAC plates at dilutions of 10^-1, 10^-4, and 10^-6.

Anything that we saw that looked suspicious on any of these plates after 24 hours of incubation were then taken to biochemical, serological, and PCR.

As I said, for some of the units, and with positive units--it only consisted of one unit in that sample, so we ran it with both of these methods--we took 200 mLs of that sub, put it in a centrifuge tube and centrifuged it at 10,000 gees for 10 minutes. It was then decanted, and we took the pellet, and the pellet was then also put into the 225 mLs of EHAC enrichment broth, and pH was checked.

The pH of this particular container of apple juice was 3.745. Whenever we put the 25 mLs into the medium and rechecked the pH to make sure that it didn't change, it still maintained a pH of about 7.0. Again, on this side, we also put it into the 37-degree Centigrade on a shaker, streaked the TCSMAC after six hours, and, again, streaked at 24 hours. With our positive sample, two isolates showed up from the six-hour streak using this 200 mL method.

On the 24 hours, we did not find any suspicious-looking colonies. At that point then we went in to the biochemical, the serological, and PCR. The biochemical tests that were used was an Indole spot test with these two isolates, and it was positive. They were put out to ESC methylene blue auger, and it gave us the typical green sheen seen with E. coli. We also put it under HC-MUG, and it turned--and it was MUG negative, as is indicative of O157. And with this particular container, we used the VITEK, which is a means of microbial identification, which can give you an answer in about 6 to 18 hours, depending on the organism, and the VITEK called it O157:H7.

Then we went into the serology. We had three different serology kits in the laboratory at the time, and just to be safe, we used all three. The kits we used were the Remel RIM E. coli O157:H7, the ProLab Diagnostics Prolex E. coli O157:H7, the latex test reagent kit, and the Difco Laboratory's E. coli anti-serum H7 kit. In all cases, the serology was telling us that this was an O157:H7.

While this was all going on, we started doing the PCR. The PCR has three steps, which I'm just giving sort of the titles here. I'm not going to go into the technical part. There's a template preparation, and this was done with each of the two isolates. It was then subjected to the multiplex PCR, and then on to the gel electrophoresis.

This is a slide of the actual gel. In lanes 1 and 2 are our two isolates that were isolated from the apple juice, and it shows here that the slt 1 and the slt 2 genes were both present in each one of these isolates. We had already done some work with patient isolates, and we knew that they also showed the presence of the slt 1 and the slt 2 genes.

Lane 3 is one of our controls, which is just an slt 1 genes, and lane 4 is another control showing the presence of slt 1 and slt 2 genes.

It was at this point, then, on November 4th that we announced that we had the E. coli O157 out of the apple juice. That same day we sent an isolate down to the Washington State public health laboratory where they began the fingerprinting of the pulse-field gel electrophoresis to see if we had a match with the Odwalla patients. This is the original Washington State lab gel image, and it's sort of confusing, so what we've done is, through computers, annotated these gels. And what we have here is lanes 1, 8, and 15 are control E. coli O157s. The "F" at the bottom represents the food isolates that were isolated from the Seattle District laboratory. "O" equals Odwalla patients, and the "N" equals a non-Odwalla patient.

You'll notice that there is one lane, lane 7, which doesn't have a symbol on it, and what that lane is is just a plain E. coli. You can see sort of the difference.

This next slide, we've scrunched it down a little bit more just to show you basically lanes 9 through 12 where we have the two Odwalla patients surrounding the food isolate patients, and from the lines by a visual match, you can see that the Odwalla patients and the food isolates are indistinguishable.

This next slide is just to give you a close-up and is an example of a difference between the non-Odwalla patient and an Odwalla patient. And you can see that in various places, the top box, there are two bands missing in the non-Odwalla versus the Odwalla; the next box down there is a band difference, and the last box down there's also a band difference.

At this point I'd like to acknowledge the Seattle District microbiology analytical resource team for their analytical support: Jay Lewis, from the Washington State Department of Health, Public Health Laboratory, for the PFG analysis of the food and the patient isolates; and the Seattle Products Research Center Species/Strain Workgroup for preparing and annotating these slides.

 Applause

DR. SHANK: This brings us to the findings in the State of Washington, and Dr. Russell Alexander will be our first presenter. He is Chief of Epidemiology, Seattle-King County Department of Public Health, Communicable Disease Control.

DR. ALEXANDER: Thank you. The background of when we were dealing with these cases, I want to start by really giving you the background of what we usually expect.

King County has a population of a little over 1.5 million, and these are the number of cases of E. coli O157 that we expect to see in such a population, reported cases, which, again, are just the top of the iceberg. You'll see that there are some outbreaks. For example, in the middle of August of '92, there was an outbreak that was related to a Mexican food restaurant. Actually, in that particular, one, we weren't using DNA fingerprinting, never found the specific food item that was involved.

You'll see December of '92, January of '93, and February of '93 were the large hamburger-associated outbreaks that Patty Griffin mentioned. There were 700 cases total. This was first recognized in Washington and was really recognized in January of 1993. And we weren't using online DNA fingerprinting methods at that time. If we had, we probably would have recognized it back in December when in late December we had an increase of cases.

Then you'll see there was another outbreak in August of '93. This was a salad bar in a fast-food restaurant where we had multiple DNA fingerprinting patterns, and this was a cross-contamination from a number of apparently different meat sources.

In February of '94, you'll see a little blip, and that was a multi-state outbreak, and we were just seeing one part of it. It was a hamburger-associated outbreak. Again, we were able to pick it up early because of use then by that time--we were using more frequently DNA fingerprinting methods.

Again, toward the end of '94, you'll see an outbreak where we identified a new source, salami, that had not been identified before, and this could be tied together by isolates from the specimen and from the patients matching isolate from dry, cured salami, which was now identified as a risk.

Then you'll see the background in October of '96 was we had had three sporadic cases, as all the rest of these are sporadic cases, where we do not identify types.

Next slide. If you could put that up a little higher so people could see?

Then we start with Monday, October 21st, with an HUS case in a child, and another one was from a--was in our laboratory, but actually was for another county. And we were just in the middle of investigating those when two days later, you'll see, on the 23rd--well, we had one on the 23rd and on the 24th another five cases. By this time there were three cases with hemolytic uremic syndrome, and we had five cases, and by this time we had--we use an RFLP DNA fingerprinting by Dr. Somatpor  ph , University of Washington, which is done very quickly and can usually give us results in 24 hours. And by this time we knew that all of these were the same DNA fingerprinting pattern, so we knew we had a common source. We knew we had three cases with hemolytic uremic syndrome.

Then, furthermore, one of these cases was a little child who never ate meat, was a vegetarian. Those things made us do two things. One is we sent a letter to providers because obviously with having three hemolytic uremic syndrome cases, we knew there were a lot more cases out there somewhere, and this was to urge them to look for this organism and to culture it and to report it in quickly to us.

Secondly, we went back, and instead of our usual questionnaire, which usually takes about 20 minutes to administer, we went to one that's based on Mike Osterholm's methodology, which is an enhanced questionnaire that takes about 45 minutes to an hour to administer, but goes into much more detail about their food intake. And, thirdly, we went to a more rapid turnaround.

By Monday, the 28th, when there were some more cases reported, we knew that, in analyzing the enhanced questionnaires, that of eight cases where we--all of the cases at that point had a history of apple juice. But we then realized we hadn't asked in much detail about apple juice, and we hadn't really asked about different kinds of apple juice. So we then went back again and added another supplementary questionnaire where we gave a list of all sorts of different brands of apple juice, and in the middle of that was Odwalla, which because we had already--I should have said that when we had eight cases that had apple juice in general, four of those specifically mentioned Odwalla. But now going back and asking with this long list what they'd had, we began to get a much clearer picture.

If we can go to the last of the overheads?

This is the picture that came out, and this is of the 13 cases which we had by the 30th of October, which is when we were ready to notify people, of those 13 cases, if you go to--that shows the county and the ages, and then the complications. The "H" are hemolytic uremic and the "I" is one little child who had an inter-susception(?), which is invagination of one part of the bowel and another. It's really a complication of a severe colitis.

If you go to the last two columns, the exposure to Odwalla apple juice, as you see, when we were trying to--early on the 30th, what we did do was notif y our Environmental Health Department, Carl Osaki, who then in turn discussed this with the state and with the FDA and with Odwalla Apple Juice Company at the same time to tell them that we were very suspicious of this. But at that time we had only seven of them with Odwalla exposure. The ones with parentheses were three where we didn't have the information in, or in two of the instances they didn't think they'd had that exposure. And it was while we were in the middle of talking to our colleagues in the State Health Department that we found out, in fact, that each of those three came back and said, Oh, yes, they did remember, and they could specify the time when they'd had this exposure. So now we had 10 out of 10 of those that we had the information on, had had this exposure, and then we had 12 cases that had the medical pattern. And it was on this basis that we felt very sure of ourselves.

I should have mentioned the one other thing that we had put into effect at the beginning of the week was to start a control study that Patty Griffin mentioned, going to neighbors with children of the same age or someone who was exposed who was of the same age, and asking this same enhanced questionnaire that Dr. Osterholm developed. And by the time we were making this decision, we had nine such cases, and none of those cases had Odwalla exposure. So you have 10 out of 10 with that specific exposure and none out of nine controls, and this was enough to then make--we then felt much firmer with an epidemiological association at that point.

As you know, and as was said before, four days later there was the isolation from the organism, and one day after that the RLFP pattern or the DNA fingerprinting Dr. Somatpor did at the University of Washington showed an identity, and we were able to show that.

Thanks.

 Applause

DR. SHANK: Thank you, Dr. Alexander.

Dr. Phil Tarr, who is Associate Professor of Pediatrics at Children's Hospital in Seattle, will also address us on the Washington State findings.

DR. TARR: Thank you, Dr. Shank.

Over the past several years, I've had the opportunity to observe a few outbreak investigations in western Washington, and I'd like to make the observation that if Michael Jordan were to come back in a future life as an epidemiologist, he would probably end up playing for the Seattle-King County Health Department, before being traded to Minnesota.

 Laughter.

DR. TARR: Seven weeks ago the fresh juice industry received a terrible wake-up call with the outbreak just described by Dr. Alexander. It's sad to see what happens when an organism with the appropriate complement of virulence factors gets into a vehicle that is widely disseminated, frequently to hosts, human hosts of very susceptible age--namely, children--where this organism can cause clinical disease with a very low inoculum, perhaps 1 to 10 bacteria, like Shigella. This organism acts, when it gets into such a vehicle, as a terrorist unless that vehicle is subject to a reliable kill step, which the incriminated vehicle was not.

The first slide, please.

In this talk, I'd like to review what we have learned by watching E. coli O157:H7 infections in Seattle as physicians taking care of too many children infected with this organism, and also as a personal research interest in the past 13 years after I was first notified of its existence by Dr. Peggy Neill.

Four years ago last month, E. coli O157:H7 entered the production screen at a fast-food restaurant chain's supplier, and relatively few E. coli O157 got into this product. It was then disseminated to multiple states, and several dozen, perhaps more than a hundred cases of E. coli O157:H7 infection occurred in December and early January of--December of 1992 and early January of 1 993 without any grouping of these clusters into an identifiable pattern such that public health authorities and industry could then find the source.

Next slide.

A fortuitous circumstance enabled several of us in the second week of January of 1993 to detect an unusual cluster of children with probable or definite E. coli O157 infections, and we immediately notified the appropriate epidemiologic authorities in the State of Washington and in Seattle-King County. Within several days, it became apparent that the incriminated vehicle was a widely disseminated, poorly cooked beef product, and prompt action by the State of Washington, in conjunction with the Centers for Disease Control, averted many additional cases. Had that hamburger continued to be sold over the next week or two at its rate of distribution without detection of this cluster in the State of Washington, in our population alone of several million in Washington, there would have been an additional 800 cases of E. coli O157:H7 infection, 80 more children with kidney failure, and eight more deaths. That is the good news.

Now, the bad news is that, despite a very aggressive State Health Department response and despite our ability to detect that something was happening, a few days in advance of the normal reporting mechanisms, 500 people, mostly children, got in and got infected under the radar with this organism before effective measures could be introduced.

We've had continuing experience with this organism in Washington State, and I'd like to share with you a few other observations. In late 1994, as Dr. Alexander just mentioned, there was an unusual time and space cluster of people, mostly but not exclusively children, infected with E. coli O157:H7 in a rather well defined area, north Seattle. With careful shoe-leather epidemiology, it became apparent that a large number of these people shopped at one store and purchased one product, namely, salami. At that time DNA fingerprinting technique was online in Dr. Somatpor's laboratory, and in collaboration with Dr. Alexander's office, it became apparent that there were linked isolates, therefore focusing the epidemiologic investigation, coming up with this rather improbable vehicle of low pH, high-salt salami as the incriminating factor. Another example of an alert Public Health Department in combination with a molecular subtypist who could then focus the labor-intensive epidemiologic investigations to find a common source.

I'm not quite certain how many cases of infection were averted by this, but this, too, was a wake-up call to any industry that sells to the public any product that has not undergone a reliable kill step.

I would like to share with you some of the challenges and opportunities in treating a patient with E. coli O157:H7 infection to show just how hard it can be to identify such a case, at least early on, to intervene and to stop the progression to life-threatening disease, and also to report it to public health authorities. This is a child who was not part of an outbreak, but could have been, who was infected in a community not very far from Seattle. On day one, she had an acute episode of abdominal pain, severe enough to keep her out of a church event, not severe enough to cause her to go to a doctor.

On day two, she had more abdominal pain and some diarrhea and a short-lived fever. Because there was somewhat more cramps than would have been expected with the average run-of-the-mill diarrhea, the family gave her Pepto Bismol and an anti-motility, anti-secretory agent that's available over the counter, loperamide. Once again this child was doing quite well other than the cramps, had no fever, was alert, urinating well, and this does not--this sounds like very many episodes of gastroenteritis that children and adults have all the time, certainly not requiring medical attention.

Diarrhea, as you know, is very common in the general population. The best studies have come from Houston and Charlottesville, at least in children, showing that in our country there are about two to four episodes of diarrhea, at least in children in day-care, per child, that are sufficiently severe to warrant the child to be removed from day-care for at least a day. So this is a very common background disorder. There is not enough money in all of the health care budget to diagnose all of these children, and, in fact, when we looked at the cost/benefit analysis of obtaining stool cultures in Seattle, in the late 1980s it cost over $20,000 from the health care budget to detect one case of Shigellosis, which, if you take a strict green-eyeshade type approach to bacterial diagnosis , is the only organism, at least in Seattle, that you would then say, Aha, I will write a prescription and the child will feel better within a day. So making microbiological diagnosis in individual cases of the very high frequency episodes of diarrhea is a very expensive proposition in aggregate.

On day four, the child had clear-cut bloody diarrhea noticed by her mother. Now, everybody would agree that this is a certain indication to visit a doctor, and everybody would agree in the medical profession that this stool should be cultured for a wide variety of bacterial enteric pathogens, including but not limited to E. coli O157:H7. And the stool was cultured, and in this institution the stool was automatically screened for E. col O157:H7. Is that in focus back there?

Dr. Griffin alluded to work that she and her colleagues published from the Centers for Disease Control earlier in the talk. Any given stool in the United States has only about a 50 percent chance of being sent to a lab that will screen for E. coli O157:H7 as a matter of course, or it will automatically implement a screening policy for grossly bloody diarrhea.

Now, E. coli O157:H7 is a very rare infection. The average practitioner, even in Seattle, will see a child with this infection but once every three or four years, believe it or not. So you can't really expect a physician to remember all the prime numbers that go into the request for such a stool culture, and in my opinion, a microbiology lab is the most important nodal point in a surveillance system, and this policy should be adopted uniform.

It is true that Northern States tend to have a higher frequency of recovery of this organism than Southern States; however, no state should consider itself immune from an outbreak of E. coli O157:H7 infection.

On day six, the laboratory reported that E. coli O157 was growing from a day-four culture. This was reported by the physician to the County Health Department, where an investigation was initiated. Fortunately, no household or school secondary cases were identified either on first questioning and none became apparent in the next several weeks. So this is a truly sporadic case.

This child went on to develop hemolytic uremic syndrome, one of the most dramatic consequences of food-borne infection that occurs. She spent a mo nth in our hospital. She was transferred to Seattle when it became apparent that she had kidney failure. She required 18 transfusions, 12 days of hemodialysis and peritoneal dialysis, and she had temporary pancreatic insufficiency, and the cost for her stay just at our hospital was $77,000. Fortunately, several years later, she is doing well without residual evidence of renal problems.

What have we seen in our fairly well defined population-based laboratory of the State of Washington and Oregon? Now, interest in this organism in our states predated the 1993 outbreak, and a reasonable number of laboratories were screening for E. coli O157:H7 in both Oregon and in Washington before 1993, and almost all laboratories, certainly all laboratories in western Washington servicing a childhood population screened for this organism. This is another good news and bad news slide. The 1993 outbreak data have been taken out of these slides. So we can see that, despite moderately increased frequency of screening for this pathogen, the rate of recovery is roughly stable over the past three or four years. That is good news. In fact, the frequency of recovery of E. coli O157 in reality has probably gone down a bit because more labs are screening for it. So the good news is this organism is not spiraling out of control, as had been feared a few years ago. The bad news is it has not gone away, either, despite the recognition of this pathogen and the institution of HACCP protocols in the fast-food industry.

Now, E. coli O157:H7, as you can see, is a stealth-like pathogen. It is not terribly difficult to realize just how such an organism can be missed. The doctor might not think of it. The disease could look like other disorders. The laboratory might not culture it. The laboratory might not be in a state that requires reporting. So the colitis form of this disease, even though it's dramatic--and this is the outside of a colon, a child undergoing an operation for presumed intestinal catastrophe. Even though the colitis is quite remarkable, it's not terribly surprising that it can be missed.

However, hemolytic uremic syndrome, with a profound life-threatening form of anemia and kidney failure, which is secondary to vascular injury from absorbed gastrointestinal toxins produced by E. coli O157:H7, is very, very unlikely to be missed in North America in 1996. Therefore, population-based data concerning E. coli O157:H7 conserves a surrogate indicator of the frequency with which susceptible hosts are ingesting a viable organism.

This organism, even though there are a few other potential pathogens out there that can cause hemolytic uremic syndrome, this organism remains the predominant and we believe nearly the exclusive cause of hemolytic uremic syndrome in North America. The 1994-95 data, nearly 80 percent of children in western Washington had E. coli O157:H7 isolated from their stool when they had hemolytic uremic syndrome. We've just reviewed the 1996 data, and it's about 90 percent. We think that most of the other 10 to 20 percent are due to missed cases rather than to other pathogens.

So by looking in our well-defined county, King County, with really only one hospital that can take care of children with hemolytic uremic syndrome, it is useful to look at trends. In the 1970s through the early 1980s, there did seem to be an increasing number of children from King County, Washington--this is not subject to referral bias, just looking at King County residents--treated at our Children's Hospital with hemolytic uremic syndrome, the surrogate indicator or the sentinel indicator of E. coli O157:H7 in the general population.

Now, I was cautiously optimistic that following the 1993 outbreak we were seeing truly fewer cases of hemolytic uremic syndrome. Now, this population of King County is steadily rising, and I was heartened to see that in 1993, '94, and '95 there were only two outbreak cases from King County children in each of those three years. Remember, we think that most cases are sporadic and not part of recognized epidemics.

However, I was saddened when we put these data together last week to note that in 1995 we have had five children with hemolytic uremic syndrome from King County exclusive of the Odwalla outbreak. So, once again, there's good news and there's bad news. This is not spiraling out of control, but the disease incidence is not plummeting.

What is disturbing is that it is my understanding from people in industry and from officials at USDA that the bacteria content of meat, like the bacteria content of fruit juice just shown to us, is declining dramatically, and we would have expected the disease incidence to plummet if this organism were being acquired solely by meat.

Finally, there is now considerable interest in trying to stop the pathophysiologic progression of E. coli O157:H7 infection from the diarrhea stage to the bloody diarrhea stage to the kidney failure that occurs in approximately 10 percent of children. As a physician, I'm interested by this and challenged by this, and we're working on studies to try to stop this cascade. However, I have to say, having seen a number of these children and watching epidemiologists in action and watching effective industry in action, the way to prevent HUS is to prevent ingestion in the first place. And until we have a more perfect microbiologic environment, until we can tell you with assurance how fresh fruits and juices can be sterilized and preserving consumer preferences, I think that--the next slide, actually--it is my hope that an increasing number of epidemiologists and other investigators will be able to be available to the rest of the country similar to the caliber of people we've had work with us in the State of Washington.

Thank you.

 Applause

DR. SHANK: Thank you, Dr. Tarr.

The next subject is California findings, and to make that presentation we have Stuart Richardson. Stuart is chief of the Food and Drug Branch of the California Department of Health Services, and come on up, Stuart.

MR. RICHARDSON: Thank you, Frank.

What I'd like to do for my part of this discussion is to share with you what we did as part of the investigation downstream from the plant, that is, the suppliers of apples, suppliers including the packers and the growers--that is, the traceback.

The California Department of Health Services Food and Drug Branch was notified, along with the federal officials, at the same time on 10/30 of the strong epidemiological association between the consumption of Odwalla juice and the illnesses. On 10/30, we dispatched staff into the facility. There were two investigators from the State of California, and then on 10/31, an additional five FDA-FDB scientist investigators were put in the plant.

Right at the very beginning we divided up the chores, with FDA taking the lead in the plant and the plant inspection, and you heard the discussion of that from Frank earlier. We provided assistance in that investigation, and FDB in turn took the lead in the traceback or the work downstream from the plant, that is, the production, harvesting, packing procedures.

As we got into the plant, first few days we did not have lot codes, we did not have good traceback information. That all began to narrow as we got information from the Seattle lab, which was a positive find from a 12-ounce container out of the Seattle warehou se. Each container possess two identifiers: an "enjoy by" date and a lot code. By cross-referencing those numbers, we were able to identify a production of that product on 10/7.

The 10/7 lot was of interest to us as well. Not only did it have the positive, but as Frank mentioned, the apples that came into the plant during that period of time for the 10/7 production had a high number of defects. In fact, on the press operator's log, it was indicated that it took three sorters instead of the usual one to deal with the incoming product. In addition to that, the mold, yeast, and the total plate counts peaked during that period of time.

With that in mind, we worked out through the record system to track where those apples came from. There was one packer, and that one packer had five farms which supplied apples to that packer. We developed questionnaires--and I'll talk a little bit about that a little bit later--both for packers and growers, and we instructed our scientists and investigative staff to search and be as creative and visionary as possible in looking at the various facilities to collect source water, processed water, finished product water that was used, and any other environmental samples both at packers and at the farms, and I'll a little bit more about those samples in a moment.

The findings, that is, the laboratory findings for E. coli O157 were negative, and the inspection of these facilities showed no specific source of contamination.

We expanded our traceback beyond that 10/7 date. As you heard earlier, there was some information regarding defect apples earlier as well. We expanded it to 9/14 to 10/15 period to encompass all the illness information that we had, dates of consumption, and then back-calculating from those dates of consumption to this window period, which we believe is a reasonable window period to include all those production periods that contributed to those illnesses.

The plant received 38 loads of apples during that period of time. A load may consist of five to six bins up to 48 bins. These are plastic or wooden bins containing about 900 apples. For those 38 loads, there were six packers representing 29 farms. Two farms shipped directly to the processor. We then dispatched investigative staff and scientists out into the field, both to those packers and growers--again, with a questionnaire and the same instructions regarding sampling.

Again, to date, all of our laboratory samplings to date have been negative, and we have not specifically found a direct source of the contamination.

I'll talk a minute about the packer questionnaires. Now, I might want to add a little bit of qualification here. In California, the harvest starts the 1st of September and goes to about mid-October, bottom of October. So we were in the system late in the season. A lot of the information we obtained was obtained through interviews of the growers and/or packers, and not necessarily by direct observation of the information.

We asked through our questionnaires for a complete description of the process, packing process, what water they used, what was the source, what chemicals were used, a step-by-step descriptive analysis of the pack ing process. We wanted to identify what farms came in during this period of time that they in turn shipped to the plant processor, and then to document where shipments went from that packer to other processors. And I might add at this point that only the one plant was unpasteurized, the Odwalla plant. All other shipments went to pasteurized facilities.

The packing operation consists of about two major components: one, apples are brought in, and then they go through a prewash drenching process with calcium chloride to prevent bitter pit, which is a green blemish on the apple, and a fungicide is added. Those apples are either retained for a moment to absorb those solutions and then go on to further processing. They may go into pre-cooling or out to the juicer for processing themselves.

If they're placed into for further processing, they're jumped into a water flume process. The apples are allowed to float to the surface, and then they go through various stages of brushing, both spray wash or bristle brush, ambient forced air, drying and waxing, hot air drying, sorting, sizing--I don't have a slide for this--and then final cull packing and then placed in cold storage and then subsequent shipping.

We went out to those 31 farms that I mentioned, the growers, and asked through another questionnaire process specific information regarding the growers. The growers were located, as far as southern California, down to the Ventura area, all the way up to northern California near Sacramento. Acreage varied from small parcels of 12 acres up to 1,000 acres, producing some seven-plus different varieties of apples.

The workers receive pay, as do all kinds of agricultural workers, very similar in that the year-round employees that were there receive an hourly wage. In some instances, contract work was brought in, paid by the bin. It was either in addition to the hourly workers or in addition to the workers that were there.

We asked specifically the source of irrigation water. We were quite interested in how the water was used and how the trees were indeed irrigated. Two major sources, deep wells, 100-feet-plus depth, and use of water from the Great San Joaquin Valley Canal, which is that major canal that works down the valley, takes water from the Sierras, and moves all the water down to L.A. for the L.A. citizens. Irrigation water is taken off that system.

Irrigation is handled in two ways. When they use the canal, they flood irrigate. When they use deep wells, they push the water through, pump the water through not a drip system but a microjet spray system. It's a flex plastic pipe that goes down to the tree rows, and the pipe sits on risers with a little spray on the top that sprays about two feet up and about two to three feet around the base of the tree. In both instances, the flooding of the fields as well as the spray irrigation, the apples are not in direct contact with irrigation water.

There was one exception to that. There was an experimental plot that had an overhead spray, and we're still looking at that.

Fertilizer, and we talked about and heard several comments this morning about fertilizer, what was going on with fertilizer. Two farms reported the use of animal fertilizer, animal manure, turkey, chicken, and bovine. We are in the process of looking at that a little further. Both growers indicate that the application of those manures occurred in December and January, post-harvest from the season.

Proximity of livestock and types of livestock. Cattle or livestock are not allowed to graze through these fields. These fields are well manicured. They're kept weed-free. Cattle coming through the field would damage the fields, indeed damage the irrigation systems. Growers did report seeing raccoons, coyotes, dogs, gophers, and in a couple instances reported seeing deer through the fields. One grower is adjacent to a wildlife preserve. Our investigators noted a lot of deer tracks in the field. We were unable to find droppings, and we are looking at the wilderness area next door to see if there's any connection at all.

The apples, on this slide, and how the apples are used. Indeed, the price of juice apples is attractive. Ground apples, those that are on the ground, are picked up, harvested by the grower, and they move directly to pasteurization. There was only one shipment that went to a packer. That packer reports that it went to pasteurization.

Tree-picked apples, apples that are harvested for the fresh marketplace, moved to the packers. There, their processes I described, sorted, and you'll hear more description of the practices later in much more detail--sorted, and then they either go to the fresh marketplace or those culls then move to the unpasteurized plant.

I mentioned environmental samples. We've taken over 100 water samples of processed water through the entire operation, both of the drencher, the flume process, all processed water. We've taken the irrigation water. We're working on taking other water samples, well-water samples as well. We took swabs of equipment surfaces, bird droppings, animal droppings, and in one case, apples, to date, and we're still running samples. They're all negative for O157.

Finally, what we're following up with--and as you can see, our investigation is still ongoing--we are looking at and combing all the questionnaires for information for us to turn back and become more focused in our investigation. We do have some laboratory samples we're continuing.

From the information we gain in these two days, we plan to go back to our farmers, back to packers and processors, and relay these findings of these two days, as well as what we learn, and work with them on a similar project that was for oranges in Florida.

Finally, it was quite obvious to us that four farmers for this practice, which is really the traditional--considered traditional agricultural prac tice, there needs to be a lot more educational information and understanding by packers, shippers, and growers as to food items and that they are indeed processing and it's no longer just a raw agricultural commodity.

Thank you very much.

 Applause

DR. SHANK: This brings us to that portion of the agenda that we will entertain questions for clarification from the speakers this morning.

DR. SPERBER: Thank you. I have a question for the presenters from Odwalla. I believe it was the second presenter who mentioned that there are nutrients in unpasteurized apple juice that protect the immune system. I'm wondering if you could briefly describe the nutritional benefits of unpasteurized juices. And how do you feel that heat pasteurization would be detrimental to those benefits?

MR. STELTENPOHL: I'm not a nutritionist and don't feel qualified to outline the nutritional benefits or characterize the differences between pasteurized and unpasteurized. My comments were focused on all juices, not apple juice. I believe every different fruit has completely different nutritional characteristics, and those characteristics need to be understood and defined. And that was my point.

Thank you.

DR. SHANK: Mike?

DR. OSTERHOLM: Just a point of clarification from, I guess, a number of the speakers. Supposedly, if I understand it now, there were no downed apples that should have theoretically come into the plant during that time, despite the fact that we had some apples that were noted to have been of poor quality. Can you clarify that? Also, what efforts were made to look at the packer-processor area where apples might have been theoretically coming in as downed or on-the-tree apples that would have gotten mixed in? Somebody from California or Odwalla, whoever.

DR. SHANK: Steve, do you want to take that one?

MR. WILLIAMSON: First, I apologize for being out of the room. I was speaking with one of the families in Seattle, the Codys, whose son had HUS, and one of the things Greg and I have done all along is reach out and talk to every one of these families. We think it's really important.

The specific question on dropped apples, I'm sorry, I didn't get the whole question.

DR. OSTERHOLM: I just want to clarify. We just heard from our colleagues in California and your presentation. I just want to make it clear that supposedly there were no dropped apples that were at least supposed to be coming in. We heard, however, about quality issues with at least one or two lots, and the question is: Do you have reason to suspect dropped apples came in? Or maybe you know they did. Or was there also a problem at the processor-packing level where we've known in the past product can get mixed and sorted where one intended for one stream may get into another stream?

MR. WILLIAMSON: Our specifications are no dropped apples. I haven't done the mathematics, but you're talking about, you know, hundreds of millions of apples coming in and can you guarantee one didn't hit the ground, particularly when it's not our tree, it's not our process. You can't guarantee it. You put that in your specs.

I think that also this goes to--I think that's a great question, because one of the things we've been confused about is in building our lines of defense, does culling out decayed fruit reduce the risk? We have not found any evidence that it's the decayed apple that causes E. coli. Everyone's focusing on a decayed apple. Show me the decayed apple is the problem. We obviously do cull it out, and I also would refer you, anyone who has questions, to our Form 483 response letter, which goes into detail through that specific load they're talking about.

DR. OSTERHOLM: Could I just do a follow-up, Fred?

DR. SHANK: Sure.

DR. OSTERHOLM: I guess the reason we're maybe emphasizing more the potential culled-out apple is an indication of the fact that there may have been a downed apple, not so much the health effect problem, and that may not be accurate. But I guess I'd ask maybe the California colleague then here, Stu, do you have evidence that these were downed apples through your investigation?

MR. RICHARDSON: That was the question that we pestered the growers with, while the growers would say that they were only tree-picked apples. As we inquired to them more specifically, could downed apples get to the marketplace in the context that you have just described? And their response was, well, we can't guarantee it 100 percent that when a picker goes to the tree, two or three will be accidentally dropped as he picks a clump, and he may pick those up and put them in his bin. In addition, if something looks good on the ground, he may pick them up and put them in the container.

We did ask those questions. We did and are continuing to look to see whether or not the distribution system that I described earlier was kept intact and the integrity was kept isolated.

DR. GRAVANI: Fred, I have a question for Mr. Williamson. That is, on your citrus fruit wash, you listed critical control point No. 3 in your HACCP plan as washing the fruit with about 200 parts per million for 30 seconds, and it didn't indicate with what. I assume it was chlorine, but could you clarify that, please?

MR. WILLIAMSON: The acid detergent. I'm not a scientist nor a chemist, so you're getting me on tough grounds here. But it's an acid detergent, and we have all the information on that. We go through an acid detergent wash, and then we sanitize with chlorine.

But I just would go further on that. One of the things that's been difficult for us is that we get so many--we've had so many different pieces of in formation come in. Some people say chlorine doesn't do any good. Some people say it does. I mean, we're out here looking for help because we're confused with the information we're getting back.

DR. GRAVANI: One other quick question. Did you have a HACCP plan in place before the situation that you described?

MR. WILLIAMSON: No. We had GMPs, process controls, sanitation SOPs, but we did not have a HACCP plan. We do have today--one of the creators of our HACCP plan is in the audience with us here.

DR. GRAVANI: Great. Thank you.

DR. SHANK: Go ahead.

DR. BUCHANAN: Steve, can I get you before you disappear? Do you have any idea what the pH of that acid wash is?

MR. WILLIAMSON: I don't, but I can get you all of that information. We have a group of chemists and scientists who have been helping us on this. I have all that information.

DR. BUCHANAN: And in your standard operating procedures, do you have any control over the relative temperature of your flume and wash waters relative to the temperature of the apple? Or is that uncontrolled?

MR. WILLIAMSON: It's uncontrolled.

DR. BUCHANAN: Thank you.

Fred, I'd also like to ask Dr. Rude a couple of questions, if I could. I got a little confused in the numbers you were putting up in terms of sampling. Of the specific suspect lot that was produced on 10/7, how many samples of that lot were actually sampled, intact samples?

DR. RUDE: You mean of the "use by" date of October 24th?

DR. BUCHANAN: I guess, or the one that you found the positive in.

DR. RUDE: Yes, the sample only consisted of the one intact unit.

DR. BUCHANAN: And so you only had--

DR. RUDE: We only had one container of that "use by" October 24th. There were other samples of the "use by" date of October 24th, but all of those were negative. I think in maybe--

DR. BUCHANAN: So out of how many samples of that specific lot turned out positive?

DR. RUDE: Just the one container.

DR. BUCHANAN: And you only had one that you sampled?

DR. RUDE: And we only had one container in that specific sample.

DR. BUCHANAN: And there was no quantitation on that sample, so we don't know what the--

DR. RUDE: No.

DR. BUCHANAN: The other question I had, again, to try to put in perspective the numbers, the enrichment broth that you use, it's a TSP with three antibiotics?

DR. RUDE: Right. It's a modified tryptic--modified TSP with the three antibiotics.

DR. BUCHANAN: Is that capable of supporting the growth of an acid-injured E. coli cell? And would you detect it?

DR. RUDE: I don't know. I am not aware--I'm not familiar with any of the acid tolerance studies that have been done and what has been done. I know Dr. Tarr has mentioned some to me, and I believe there are some other people doing acid tolerance studies with that culture that we isolated. But I don't know.

DR. BUCHANAN: We've done some, too, and I'm just wondering the extent of injury that may have occurred, whether you were able to grow it out because of acid injury.

DR. RUDE: I'm not sure.

DR. BUCHANAN: Thank you.

DR. SHANK: Let's get started over here on this line. Come on up, please.

MR. BARSOTI: My name is Gael Barsoti. I'm from northern California, a very small fresh juice processor. One of the questions I have: Is it possible to pick up E. coli O157 off a line that had been using another fruit? And I ask this because there's been nothing that's proved this has come from the apple. Fresh apple juice is taking a big hit on this thing. And as far as I know--have you ever found E. coli in apple juice in California to date since we've been making fresh apple juice here?

I understand from today that they don't do carrot anymore. Is it possible that the O157 was picked up from the carrot after they stopped that process and then ran the apple through and we're trying to find O157 on the apple that's not there? You know, we're being asked to consider pasteurization--and I actually do it because my biggest client wouldn't take any more fresh juice because of this incident--to kill something that's not even there.

MR. BARTLESON: I may be able to help you a little bit on that. In our small outbreak that occurred at the same time that we detected the Odwalla outbreak, we had a church group that pressed 300 gallons of fresh apple juice as a fund-raiser. They did it on equipment that had only been used for apples. And it came from a single source, which was a commercial source that didn't use dropped apples. So it looks like you can, in fact, get E. coli from apple juice from undropped apples, and six cases out of 300 gallons of juice.

MR. BARSOTI: Well--

DR. SHANK: Your point is well taken. Thanks.

Caroline?

MS. DeWAAL: Caroline Smith DeWaal, Director of Food Safety for the Center for Science in the Public Interest, and we represent over 850,000 consumers.

First, I'd just like to say that Odwalla--I'm very glad to hear from the representatives of Odwalla, and I just want to say to you the food here is not the enemy. It's the bacteria. In our mind, this is a manure-contact issue. At some point somewhere, an apple came in contact with manure, which is the source or the transmission vehicle for O157:H7. And consumers don't want manure in their food. They don't care if it's cleaned or sanitized. They don't care if it's boiled or pasteurized, or even irradiated. They don't want it in the food.

We will support mandatory HACCP, and you asked about a proactive approach to food safety. In the same year that FDA proposed HACCP for seafood processors, they also proposed mandatory HACCP for the food industry generally. What happened to that proposal?

One issue that I saw in the HACCP plan for Odwalla and a major question I have, I'm glad to see that you have a hold-and-test program, but what about end-product testing? You're batch testing your product for yeast and mold, but what about pathogens? We believe that is an essential component of a mandatory HACCP system. And I think it's a gap in your HACCP plan, which you've seen here.

I would like to commend to you the Jack-in-the-Box Company, the parent company food maker. This is a company that survived a similar outbreak, and they have done it through requiring extensive microbial testing of their products by their suppliers. We think it's a good model to look at. They have mandatory HACCP in their systems, and the company has survived. So we hope you'll look at their systems as well.

Thank you.

MR. WOOD: I would like to follow up on one statement that Caroline made. I'm Richard Wood with Food Animal Concerns Trust, and it is a question that I also would like to hear the answer to. That is, what is the microbe, or is there a microbe that is the marker you're looking at to see if your HACCP critical control points are effective?

DR. SHANK: Thank you. Next speaker?

MS. MILLER: I'm Cindy Miller from Dinetra(?) Products, and I'm here because a lot of our customers are wondering what is happening in the apple cider industry. Odwalla stated that they want to share their learning and their experience, and I wanted to just ask Mr. Williamson: Is he going to welcome the small fresh juice producers with open arms and answer all the questions that they also have in addition to the ones that he has? Also, about his process system, I wanted to know how long was the fresh juice held in storage before shipping? And how many shifts are run to produce their mega-quantity of juice that they make there?

Also, I wanted to know why was the Van Mark machine, the scrubber, removed. Maybe that's something we need to know about.

DR. SHANK: I would remind you that this is not a meeting to learn everything about Odwalla, but it's about the juice production in general.

Steve, however you want to handle those.

MR. WILLIAMSON: Okay. First off, as I said in our presentation, we're willing to share everything that we've learned about apple juice, the thermal death time studies--Sherry McIntyre, where are you? Stand up? She's here. She has all the results on the thermal death time studies for apple. They're available. I'm happy to talk to any apple producer about what we're doing. We'll welcome apple producers to our plant to go through what we're doing. It's an open book, absolutely.

MS. MILLER: I wanted to know why the Van Mark machine was removed. I thought it was a good piece of equipment.

MR. WILLIAMSON: The Van Mark is a very good piece of equipment. In our review of the process with our experts, we decided we would use the Van Mark on the front end solely for carrots and a brush washer for apples. But there was no indication there was a problem with the Van Mark. It's an excellent company and a great machine.

DR. SHANK: Any more over here?

MR. GIZDICH: My name is Mitch Gizdich. I'm an apple juice processor and grower. We're here to learn, so I want to know from Odwalla what they did, how they processed their juice prior to--I guess the slides we saw were what they're doing now, and so what did they do prior to so I or the fresh juice industry doesn't make the same mistakes that they did prior to? What were their changes?

DR. SHANK: We don't have time for the interchange and for all of these details. Odwalla will be here for the rest of the meeting. They'll be happy to discuss that with you.

Mike?

DR. OSTERHOLM: I think just a point of clarification here on the post-production testing. I know obviously that this has been a great debate in the meat industry, et cetera, but I would remind everyone that in every one of the major food-borne outbreaks we've had in this country, particularly with a low-level sporadic contamination, even when we know which product is involved by lot number, it's often a situation where fewer than 1 or 2 percent of the product will actually provide a positive result. And so that if you go the slip side on that and just test widespread willy-nilly any product coming off, statistically your chance of even picking up a pathogen, even if it's there, is virtually non-existent. And so that anyone who thinks that they can control product contamination by post-production testing is really in error, and there is no data in any outbreak that I'm aware of--and we've been involved with many--that would confirm or support that contention. So it's not that people if they don't do it shouldn't be viewed as not adding in a step, because I think there are many who feel that it's a false sense of security and does not offer you really any protection against a product going out contaminated.

DR. SHANK: We have a question here from Phil.

MR. DERFLER: Mr. Williamson, in your statement, you talked about the fact that apples are different than oranges and are different from carrots. But if we're looking towards possibly--you know, say possibly regulating here, then ultimately the question is whether there are commonalities among the various kinds of juices that would make a regulation worthwhile. And so my question for you is: Are there commonalities--recognizing the differences, are there commonalities in the processing of juice that you see?

MR. WILLIAMSON: I'm certainly no processing expert. I would answer by saying they're all fresh and they're all juice, but as I said in that one slide, you've got to look at the ease of cleaning and the method of processing, and they're substantially different, each one of those. And you've got to consider each one separately. Obviously an orange has a skin, and the juice is inside. Carrots are easier to peel, are polished prior to processing, and right now the industry standard for apple juice is to use the entire apple.

DR. SHANK: Bob?

DR. BUCHANAN: Yes, I'd just like to make a follow-up comment to Caroline. I would caution this assumption that this organism must be associated with manure. It is a free-living, saprophytic organism that can be involved in a number of different environments, and while certainly a high probability would be that it is in some way associated with an oral-fecal route, I would caution about assuming that because it may not be the case.

DR. SHANK: Burt?

MR. BARTLESON: This is a follow-up question to Mr. Richardson. A couple of things come to mind. Was there any link between the five source orchards and either the wildlife refuge that you mentioned? And the second question, was there any looking at proximity to feed lots? One of the studies that was done at Washington State University suggested that dust coming out of feed lots in the summertime--and certainly you might expect there would be some dust in September and early October before the rains hit--was a fairly good way of disseminating coliform organisms. Now, whether coliform organisms from a feed lot are the same thing as E. coli in dry dust is another question. But I'm wondering if they looked at feed lots, and I think that's an important area we need to maybe look at.

MR. RICHARDSON: Yes, Charles. We did ask that question at every location. In fact, we did a survey of the adjacent areas to try to determine what other environmental contributions might have been made to a specific orchard. One, there was a cattle facility nearby one location. We're looking at that. It's downstream. It's over a berm. It is not a feed lot in which you would generate lots of dust, and I agree there are feed lots that do that.

Your first question dealt with--?

MR. BARTLESON: The wildlife refuge.

MR. RICHARDSON: Oh, the wildlife refuge. We have one wildlife refuge, as I mentioned in our discussion, and it came through the second order of our traceback, and we are looking at that right now to see whether or not there's any contamination from that wildlife refuge.

MR. BERNARD: Hi. Dane Bernard, National Food Processors Association. Just a question for clarification from Stu. I hate to have you pop up and down like that, but during your presentation, Stu, you mentioned that there were at least two farms which did use manure, turkey, chicken, and bovine, I believe, but they had applied it after this year's harvest. I was curious as to whether that was an annual practice, because knowing the survivability of microorganisms in the environment, I was curious as to whether that was an annual practice.

And just for clarification, in any of your investigations did you see opportunity for livestock manure to have been connected with this? You mentioned wild animals in the environment. I was curious as to whether you had anything that would absolutely link the domesticated animals and use of manure to the situation.

MR. RICHARDSON: The two instances I mentioned regarding application of manure, from what we know it isn't an annual event. Our survey and our questionnaire did look at access to livestock, use of manure, and with the exception of those two growers, we did not see access, we did not--in fact, the growers discouraged a connection of livestock and migration of livestock or grazing of livestock throughout their fields for the reasons I mentioned.

MR. MARTINELLI: I have a comment pertaining to the questions posed by Dr. Porter and Mr. Dertner. I hope I pronounced your names right.

You've asked is there any processing difference between apples and oranges, and it's very important that we all understand that in an apple process, apple squeezing, by necessity the skin of the fruit is intact with--contacts the juice during the squeezing process. In the citrus squeezing process, there are extraction methods available that permit you to extract the juice without the juice ever coming in contact with any portion of the peel. That's very important. Because microbiologists in the University of Florida have informed us that they're confident that the E. coli O157 is not in the juice, it is a result of contamination on the peel.

Again, there are extraction methods that are available in which you can extract the juice without any portion of that juice ever coming in contact with the peel.

DR. SHANK: Thank you.

Kaye?

DR. WACHSMUTH: Just a question about industry practices or possibly the apple juice product, maybe even orange juice. Is refrigeration a barrier? Are these refrigerated during transport or in stores? I'm assuming some things like this.

MS. SEXTON: She asked about the temperature and the cold chain? Is that what it was?

DR. WACHSMUTH: Yes, I'm assuming there is a cold chain, but I haven't really--

MS. SEXTON: With fresh squeezed orange juice, it immediately is extracted from the orange; it then goes through a heat exchanger that brings it down to approximately between 28 and 32 degrees. It is then immediately shipped--orange juice is not inventoried. It is only squeezed per order. So when an order comes in, all our consumers know that they are being squeezed and shipped that immediate day. Tomorrow I'll have a slide presentation that will show exactly--it will actually show you the cups and the tube that comes up and takes the juice out of the orange. I went in--this is my first public speaking, but I went in and I got very, very close into the cup so you could actually see where the tube comes out and where the orange peel does not touch the juice. But cold chain--there's three things that are important in fresh squeezed orange juice: good fruit, good sanitation, and your cold chain. And every producer knows that.

DR. GRAVANI: Fred, I had a quick question for Mr. Williamson again.

DR. SHANK: This is the last time he's coming up, so anybody that has a question should get him now.

 Laughter.

DR. GRAVANI: Steve, could you give me a rough idea of what your cleaning and sanitizing schedule was before the situation occurred, roughly?

MR. WILLIAMSON: I don't have the specifics on that. I'd be happy to provide them, but I don't want to misquote. We have all those records, and the FDA and CDC and all the plant investigators have all--

DR. GRAVANI: I'm not trying to put you on the spot. I'm just trying to understand the situation a little better. Thank you.

MR. WILLIAMSON: It was very, very thoroughly documented, and you can also refer to the Form 483 and see there were no comments about the sanitation practices.

DR. GRAVANI: Okay. Thank you.

DR. SHANK: Yes, Burt?

MR. BARTLESON: My question was that in one of the photographs that you showed, the workers who were doing the sorting were wearing gloves. Was that the practice both before and after the outbreak?

MR. WILLIAMSON: Yes.

DR. SHANK: Next speaker?

MR. SAPERS: Gerald Sapers, Agricultural Research Service, Philadelphia. This question is for Mr. Richardson, and it concerns the use of the wooden bins used to transport apples from the grower to the processor.

My question concerns whether there is any management in the use of these bins to restrict their use only to edible apples and not to apples that might be decayed. Is there any likelihood that decayed apples might contaminate sound apples during the course of shipping, of transportation of the apples from the grower to the packer or to the processor?

DR. SHANK: Stu, do you want to take that question? Or do you want to hold that one for the current practices this afternoon?

MR. RICHARDSON: Yes.

DR. SHANK: Okay. This brings us to the close of the meeting this morning. We will resume promptly at 1:45. Thank you for your attention.

 Luncheon recess.

 1:44 p.m.

DR. SHANK: It's 1:40. If you all could come on in, we'll get ourselves in the position to resume the meeting.

Burt, where's the rest of the committee?

 Pause

DR. SHANK: Dr. Buchanan, you're going the wrong direction. Where's the rest of the committee?

 Pause

DR. SHANK: Let's go ahead and get started. We do have a full schedule for this afternoon. There are a large number of people who have asked to present at 5 o'clock, so we need to go ahead and get started. I'm sure the others will come in shortly.

The next topic for discussion is labeling issues, and this will be presented by Dr. Scarbrough. Ed is the Director of the Office of Food Labeling within the Center for Food Safety and Applied Nutrition. So, Ed, come on up and talk to us a little bit about labeling issues.

DR. SCARBROUGH: Well, thank you, Fred.

Fred asked that as a change of pace after lunch that I talk about a few aspects of labeling pertaining to juice and to the topics that are being discussed for these two days. But first let me state that labeling can be a critical adjunct to food safety, but labeling is not a substitute for good manufacturing or basic food safety practices.

Now, the Federal Food, Drug, and Cosmetic Act requires that a food be safe and wholesome and that its labeling be truthful and not misleading. Section 403 of the act states that a food is misbranded if its label is false or misleading in any particular. Now, we all understand what a false statement is, but misleading is a more subjective adjective.

However, the act goes further in defining what is meant by misleading in Section 201(N). It provides that labeling can be deemed misleading not only by including statements about the product, but also by failing to reveal facts material in light of representations made or material with respect to consequences which may result from customary or usual use of the food. Therefore, the act says that a label can be misleading by what it doesn't say as well as by what it says. The omission of a material fact causes a product to be misbranded.

Now, there is no statutory definition of material fact, and the term has not been defined in FDA regulations. We have, however, used this provision on several cases. The agency, for example, has required special labeling in cases where information was necessary to ensure that consumers were alerted to special health risks associated with the consumption of a product. As an example, there is a warning statement required for protein products intended for use in weight reduction. The warning states that very low calorie protein diets may cause severe illness or death.

Then last year the Center asked its Advisory Committee to evaluate the need for a label statement on foods containing stimulant laxatives. However, in neither of these cases was the product inherently unsafe. The label addressed specific patterns of possible use that could have serious adverse consequences. And the absence of necessary information in the light of representations made principle has been used to require other kinds of label statements as well. For example, in the new NLEA labeling regulations, we have included requirements for product- and nutrient-specific statements to further clarify broadly applicable claims such as "reduced" or "light." Now, this statutory authority is widely usable and flexible, but it does have its limits.

A label statement cannot be required unless it meets the statutory criteria of being necessary because of consequences that may result from customary or usual use of the food, or of being necessary to clarify existing label statements.

Now, with those introductory remarks, let's look for a moment at the use of a term such as pasteurized on food labels. The agency does not have specific written regulatory requirements for the use of the term pasteurized except in the one case of pasteurized orange juice. Section 146.140 in our standards of identity identifies--or defines pasteurized orange juice and specifies that the name of the food that must appear on the product is pasteurized orange juice. However, of all the juice standards, the standards of identity for orange juice are by far the most extensive, and this particular orange juice standard, pasteurized orange juice, appears to have been developed to differentiate the pasteurized product from orange juice, from canned orange juice, and from orange juice from concentrate.

With the current rethinking of food standards, it is unlikely that the agency would develop similar specific standards for other products. We would probably approach this issue now in a much more generic fashion.

FDA regulations, as another example, do not even require the term pasteurized on milk. We do have regulations that require all milk moving in interstate commerce to be pasteurized, and in the milk standards of identity, the term pasteurized may be used on the label. But there is no specific requirement in our regulations.

Now, we do have a compliance policy guideline on the identity of foods through the use of such terms as fresh, frozen, dried, canned, et cetera, in which we state that to avoid misrepresentation and to provide information needed to assure proper storage, food labels should include in the name or statement of identity appropriate descriptive terms such as pasteurized, canned, frozen, dried.

This CPG was issued in 1969 after grapefruit packers asked the agency to sanction the use of the designation grapefruit juice without modifying terms irrespective of whether the juice was pasteurized, canned, or otherwise processed. Agency investigation indicated that canned grapefruit juice packed in glass was being refrigerated and displayed under circumstances that implied that the product was fresh. We advised the packers that, to avoid deception, the name of the food should include the word canned when such a product was displayed in a manner suggesting that it was fresh.

So the primary motivation behind the establishment of this particular compliance policy guideline appears to have been to prevent deception and not to have been connected with product safety.

Recently, the agency has permitted the use of the term pasteurized on certain shell eggs or raw oyster products. However, in both these cases, the primary concern was that agency microbiologists could confirm the effectiveness of the processes being used to achieve the appropriate level of microbial kill in order to prevent the term from being used in a misleading manner. Therefore, these were permissive rulings by the agency and not requirements. To require the term pasteurized or, conversely, the term unpasteurized be used on a food label, FDA would have to determine that the use of the term meets the statutory requirement that the product would otherwise be misbranded because the label failed to reveal a material fact with respect to consequences which may result from customary or usual use of the food.

Now, this discussion of pasteurized raises a related issue: the use of the term fresh on juice labels. As a consequence of actions taken by Commissioner Kessler soon after he became head of FDA, the food industry requested that the agency provide more explicit interpretation of when use of fresh on a label would be permitted. With the regulations promulgated to implement the NLEA, FDA established 101.95 which defines the term fresh and freshly frozen. And the term fresh means that the food is in its raw state and has not been subjected to any form of thermal processing or other form of preservation. Thus, any juice that has been pasteurized could not be labeled as fresh. Parenthetically, a juice to which a mold inhibitor has been added cannot be called fresh.

However, a few exceptions are included in the regulation. For example, treatment of a raw food with ionizing radiation in accordance with applicable regulations does not preclude that food from being labeled as fresh. Therefore, some of the food-processing techniques that are to be discussed tomorrow will raise interesting questions of whether they, too, should be included in exemptions in the fresh regulation. Is a juice that has been subjected to ultra-high pressure or pulse-slide or an electromagnetic field still eligible to bear the term fresh on the label?

And a further consideration is that in the fresh regulation, FDA stated that the term fresh is permitted on the labeling of pasteurized milk because consumers understand that milk is nearly always pasteurized. Now, if all juices sold in interstate commerce were required to be pasteurized, could FDA make a similar finding and permit pasteurized juice to bear the term fresh? Or does the fact that fruits and vegetables in their raw state are commonly available to consumers to prepare their own juices, which they would certainly understand is fresh, make the juice case non-analogous to the milk situation?

These are just questions that we have to think about as we consider possible labeling approaches to the food safety question.

Now, on another but somewhat related topic, it is always suggested in situations of food safety, such as the one that we are discussing, that a warning statement might be appropriate. However, to require a warning statement, FDA would have to make the same finding as was discussed relative to pasteurization; that is, we would have to find that, without the warning statement, the label would be misleading because of a failure to reveal material facts associated with respect to consequences which may result from customary or usual use of the food. At the moment it is difficult to see how this finding would be made.

Additionally, FDA has traditionally advocated limited, judicious use of warning statements. Some research findings indicate that although consumers are aware of such warnings--that is, the label statements--these statements have little influence on consumer behavior patterns.

Then as a final topic, I would mention that the agency is now in the process of developing guidance on upgrading the labeling of foods which need to be held under refrigeration because of food safety concerns. Of particular interest are foods that become potentially hazardous if not refrigerated once they are opened. We believe, however, that this is a situation that can be addressed through labeling because the foods themselves are inherently safe and only become potentially unsafe if mishandled by being subjected to temperature abuse during distribution or storage in the home.

Now, this is a labeling, as I say, that would apply to some of the juice products or could apply to some of the juice products that are being considered at this meeting.

This has been a very brief look at some of the labeling topics. I hope it stimulates some discussion and thinking. But let me close by reiterating my opening statement that labeling is not a substitute for good manufacturing or basic food safety practices, although it can be a useful adjunct.

I would be happy to address any questions later. Thank you.

 Applause

DR. SHANK: Thanks, Ed, for a very comprehensive presentation on the labeling issue. I'm sure it will be something to be discussed later during the program.

Juice industry practices is the next topic for consideration. Dr. Rick Kress, President of the Juice Products Division of Seneca Foods Corporation, will make that presentation.

MR. KRESS: Probably the first point I need to clarify is I'm not a doctor. As Bob Gravani would know--and I'm not trying to date Bob, but when I was at school, I had to go get a job and get money. I couldn't keep going on.

DR. GRAVANI: I'm after you on the program, Rick, so be careful.

MR. KRESS: I understand.

Good afternoon. I'm Rick Kress. I'm President of the Juice Division for the Seneca Foods Corporation. I'm located in Marion, New York. Seneca Foods has juice processing and packaging facilities in New York, North Carolina, Michigan, Wisconsin, and the State of Washington. The comments and information that I intend to present today represent the basic methods and procedures used in the industry to process fresh apples into a shelf-stable finished product for the consumer.

The size of the industry today varies from operations that process 500 pounds per day into single-strength juice to operations that process 500 tons of apples into concentrate.

Apple juice production is divided into two segments for this presentation. The first stage is processing. That takes the fresh fruit to juice and/or concentrate. The second stage is packaging, where the juice and concentrate are then taken to a finished product for the consumer.

Could I have the first, please?

I'll walk through these various processing steps for juice. Apples are available to the processors directly from the orchard. They will come in from fresh fruit packing houses, or they'll come from storages. Storages can be in the form of what we call common storage, cold storage, or controlled atmosphere. The apples will be received at the operations in bins that generally are around 840 pounds, up to 20-ton bulk loads of apples.

The apples are introduced into the processing system starting with a receiving pit. This pit can be filled with water or it can be dry. It starts as the first step in the cleaning process. The apples are then directed through equipment that serves to remove leaves, stems, dirt, any other foreign material that might have come along with the fruit.

As the fruit goes through the scrubbers or the brush washers, it's a combination of mechanical action and water that cleans the fruit, and as dictated by the quality of the fruit or condition, detergents can be added as well. The apples are then subjected to high-pressure water sprays that will in turn remove any residual fruit. It is also at this point that manual inspection can be done as well.

It's important to monitor the water quality of the sprays and the receiving pits as it's needed, but we cannot lose sight of the fact that we don't have unlimited supplies of water that we can use. It costs money to buy the water, and it costs money to dispose of the water. So it's important to pay attention to the water quality.

An apple consists of a mass of cells, cell structures that contain the juice. The apples are run through a mill which literally breaks the apple down. It creates a mash. By macerating this apple, the juice is allowed to be freed from those cells.

This apple mash can be heated to 60 to 70 degrees Fahrenheit. The milling destroys a majority of the cell walls, but it may be necessary also to add enzymes to this mash that will in turn break down that cell wall. Time and temperature will help improve the extractability of that juice.

Juice extraction is accomplished through several commercially available methods. Probably the first process that was used is what's called the old plate and frame press. It's maybe still used in small operations. The mash is spread over a series of plates, put onto a frame, and through pressure on that total frame, the juice is extracted.

Belt presses can be used. That's the process of literally spreading mash between two belts, and through a combination of pressure and rollers, juice is extracted.

Screw presses can also be used. It's nothing more than creating pressure on the mash by a screw. Basket or bladder presses, again, pressure will extract the juice. And, finally, centrifuges can separate juice from the mash through spinning or centrifugal force.

Depending on the characteristics of the mash, the type of juice extractor, press aids such as paper or wood fiber can also be added to help give that mash what we call a base or a bite so that the pressure helps get the juice out.

Depending on the total juice operation that's involved and the desired use of the pressed apple juice, the fresh pressed juice can be heated to a temperature of 165 to 175. This heat treatment will improve the overall clarity of the apple juice through the process, but it also serves to kill microorganisms.

When apple concentrate is being made, it's subjected to various stages of heat treatment so as to remove the water or, in other words, transform the juice into a concentrate through evaporation. The flavor volatiles in apple juice are very susceptible to heat. As the apple juice is subjected to temperatures of 165 to 195 degrees Fahrenheit in four seconds, the flavor is flashed off or volatilized. Through this distillation process, the flavor volatiles are condensed and recovered.

If essence recovery is not done, then the stripper can be used as a first stage of evaporation. Depending on the size of the unit, the juice is preheated to 160 to 200 degrees. After this process step or within it, the juice is then cooled down to 120 to 130 degrees.

In the process of milling the fruit and macerating and creating a mash and the juice extraction, materials such as protein and pectin fibers can also be released. If not removed, these materials will cause a haze or a cloudy appearance in the finished juice. These materials are removed through a depectinization treatment with various enzymes at a temperature range of 120 to 130 degrees. Again, time will be a factor.

The suspended solids that are created in the depectinization process are removed from the juice biofiltration step. This step in the process differentiates the finished apple juice as a clarified product or as a cider product in the mind of the consumer. This filtration is done by a plate and frame unit and filter aids or through cartridge membrane systems. If the juice is going to be used in packaging, it is ready for blending or it can be directed to the concentrate.

If apple juice is going to be concentrated, it is heated to temperatures of 170 to 200 degrees of Fahrenheit. There's a range there because there's a range of concentrators that are available to the industry. The time is generally two to three minutes, and then it's dropped to lower temperatures as it moves through the system. The concentrate will exit the concentrator at a temperature in the neighborhood of 50 to 70 degrees.

Apple concentrate is measured as 70 brick or 70 percent sugar. Single-strength apple juice is generally in a range of 10 to 13 brick. That will depend upon the variety, the growing regions, and the growing season itself.

At 70 brick, the sugar level is high enough to retard yeast and mold growth. Apple concentrate can be stored at room temperature or refrigerated. Apple juice concentrate is a global commodity. It can be shipped in various size containers from 55-gallon drums to 17,000-gallon rail tankers.

Can I go to the next, please?

The second stage is the packaging process. Shelf-stable apple juice is found in the store. It can be made from single-strength apple juice, apple concentrate, a combination of both, addition of water. The essence that we recover can be added back. Additional ingredients can be added.

Each batch of juice is tested by quality control for the established specs and procedures for every processor. Each batch of juice will be polish filtered just prior to bottling to ensure finished product clarity. Again, plate and frame or cartridge type filters are used.

After filtration, the juice is given a final heat treatment prior to filling for the purpose of sterilization. Normal temperatures are in the range of 175 to 195 degrees Fahrenheit. Heating can be accomplished by various types of heat exchanges. It can be a plate heat exchange, a tube and tube, a tube and shell. Holding times in the heat exchange will vary by processor.

There are a variety of fillers and cappers used in the juice business, mostly dictated by the type of container that is being filled. There's glass, tin, or plastic. The juice is filled hot in the container with minimum fill temperatures of 175 to 195 degrees Fahrenheit. PET, or plastic containers, cannot withstand the higher temperatures that glass or tin packaging can.

After capping, the container is held prior to cooling to allow sterilization of the container, cap, lid, and head space. This hold time can be shortened by inverting or tipping the container. Hold times will last one to two minutes.

The package of juice will be cooled using water sprays or immersion coolers. The water will be treated with a sanitizer such as chlorine or iodine. Containers will be cooled to a temperature of 90 to 105 degrees Fahrenheit. It is at this point the quality control will do their final evaluations of all product, again, per the specs and procedures of each individual processor.

In summary, the key points related to the heat treatment of apple juice processing and packaging are as follows: Fresh apple juice directly from the extraction equipment or the presses can be heated to 165 to 175 degrees to improve clarity and kill bacteria. The first stage of the evaporator or stripper will be operated at 160 degrees Fahrenheit to 200 degrees. The concentrator operates at 170 to 200 degrees Fahrenheit for several minutes as the water is removed.

In packaging, glass or tin containers have a minimum fill temp of 180 degrees Fahrenheit, with a hold time of one to two minutes between closure and start of cooling. PET, or plastic containers, have a minimum fill temp of 175, with hold times based on container design and cooling process.

Processing and packaging of apple juice has a long history with excellent product quality and safety results. Proper control of the operation from receiving of the fresh fruit through processing to packaging ensures that there are no problems.

Thanks for the opportunity to present this information on behalf of the industry.

 Applause

DR. SHANK: Thanks very much, Rick.

This brings us to the growing and harvesting practices, and the first presenter there is Dr. Richard Dougherty. Dr. Dougherty is the extension specialist with the Department of Food, Science, and Human Nutrition at Washington State University. Dick?

DR. DOUGHERTY: Thanks, Fred. I'm being joined today in the presentation by Dr. Gene Kupferman, who is a post-harvest specialist in the Department of Horticulture, also at Washington State University. Dr. Kupferman is located in the metropolis of Wenatchee, Washington. Those of you who know the place understand that. Those of you who don't, you get the drift.

We're going to direct our comments today primarily to conditions and/or situations which might contribute or might be available to pathogens. However, we're not restricting it to that in any form.

Can we have some slides? Thanks.

What we plan to do today, if I can--just like everybody else, I have to learn how to make this thing work. There we go. Can we have the next one, please?

The sequence that we'd like to address will include orchard location, some cultural practices, harvesting, transporting, storage, and then packing houses.

Next slide, please.

In dealing with orchard location, some of the factors that we have heard already mentioned in the discussions this morning and early this afternoon include proximity of the growing areas to feed lots, dairy herds, et cetera.

If we could have the next slide, please?

When we talk about proximity to feed lots, this area of the world doesn't lend itself very well to that, although we can't say that there are none. Typically, the growing areas in the West are not in the same general vicinity as those. Gene, do you want to comment on that at all?

DR. KUPFERMAN: Yes, this is one of the larger plantings of apple orchards in the State of Washington owned by Mr. Ralph Brochie (?). It's about 4,000-plus acres, and it's all on dwarfing root stock. There is no place in this type of orchard for the grazing of livestock. There is no place in this area for any kind of manure treatment.

What we had in Washington State in the '60s and '50s were trees that looked like this. These are large-size trees in which potentially livestock could graze underneath it.

If we can have the next slide, you can see why we have changed from the kinds of trees that we used to have to these kinds of trees, because in the previous slide--if we can go back one, Dick--you can see that these fruit are the same age, this fruit comes from the outside of the tree, this fruit comes from the inside of the tree, and we were not getting consistent quality, quality that the market demands.

If we can go to the next slide, you will see the kind of fruit that is borne on dwarfing and semi-dwarfing trees. This is the kind of fruit that deer would enjoy eating. This is the kind of fruit that cattle would enjoy eating. The issues here are that we do not permit deer or cattle, and certainly not cattle--every once in a while deer get in here--to browse on it, and the farmers take appropriate, as they feel, action--together with the Department of Wildlife.

These are commercial orchards whose business it is to grow high-quality fruit for fresh market.

Next slide, please.

If the lights were a little bit darker, you could see these beautiful apples in which every apple on the tree was bagged individually using two bags, and this is for the Fuji apple. It's a high-impact, high-cost, high-hand operation. People are not going to allow livestock to coinhabit in an orchard with this type of investment.

Next slide.

This is a trellis system. You can see that we're protecting the fruit here from sunburn using these kinds of tarps. I'm afraid that any livestock that would be in there would be guillotined as they go through the field because there are wires and trellis systems there. This is modern apple production.

Next slide.

DR. DOUGHERTY: When we address cultural practices that might relate to E. coli or other pathogens, we typically would consider water sources, irrigation systems, fertilization, or lack of certain types of fertilization, and insect and disease control programs. Gene, you might want to chat about the irrigation systems here.

DR. KUPFERMAN: This is one type of sprinkler system. This is an over-tree evaporative cooling system in which the grower has decided that it's important to modify slightly the climate within the orchard, and it is applying water in order to evaporatively cool the fruit within the tree canopy. This is done by the sprinkler that you see here.

There's also under-tree sprinklers and drip and micro-sprinklers, as one of the previous speakers was talking about. We cannot grow fruit, as you saw from the previous slides of Mr. Brochie's orchards, we cannot grow fruit without irrigation. Some of this irrigation water comes from wells, and some of this irrigation water comes from ditches and irrigation systems that use water that's brought down from the mountains.

DR. DOUGHERTY: What's the primary type of fertilization?

DR. KUPFERMAN: Well, everybody uses commercial fertilizers. There's the concept, I think, among the audience that manure is widely used. Manure is not widely used at all. There was some kind of slight interest in manure, and the recent trials that have been monitored by Washington State University have shown no tree increase or no fruit quality increase out of the use of manure. And so this isn't going anywhere at this point in time.

DR. DOUGHERTY: How about composting?

DR. KUPFERMAN: Composting, likewise, is not used. Maybe grass clippings may be used in certain orchards, and, of course, we're talking in the range of 4,000 growers. To say that it is not used at all would be a misstatement. To say that it is not used as an industry practice would be accurate.

DR. DOUGHERTY: How about the insect and disease programs?

DR. KUPFERMAN: Well, the insect and disease programs come from meetings of research people and industry personnel to put out annual spray guides that advise the growers on the most appropriate methodologies to control insects and diseases. This is a fresh market production area, producing fruit for--35 percent of which goes to export for around the world. And so they don't fool around with regard to insect or disease control.

Where it's appropriate they'll use chemicals. Where it's not, they have monitoring systems now that allow us to determine precisely when the insects need to be controlled. But this is a very highly educated group that we're dealing with.

Dick?

DR. DOUGHERTY: When we talk in terms of the harvesting systems, in the West by far the most dominant system is harvesting by hand. In fact, we know of no other way, no other system that's being used presently in the State of Washington. You hear rumors there are a few other systems in use. However, most of them are just like this.

DR. KUPFERMAN: You'll notice that the picker here is standing on a ladder, which to me means this is one of the older orchards in Washington State. Most of the trees are just about this tall, as tall as the top of my hand here, and a vast majority of fruit can be picked from the ground. They're all hand-picked. I know of no mechanical devices that are being used outside maybe of a moving platform on which the pickers will stand. All the apples are hand-picked for fresh market, and they're picked into buckets like this, and then the fruit are carefully poured into wooden bins or plastic bins.

DR. DOUGHERTY: The typical modes of transporting fruit have already been stated earlier. It includes boxes, to some extent, although they're getting fewer and fewer all the time. Bins, trucks, and trailers. We have some examples of those here.

These are the typical bins holding, what, a thousand pounds?

DR. KUPFERMAN: Eight hundred, plus or minus, depending upon the variety, pounds per bin. This is a straddle carrier. This truck and these bins are used for nothing else than apples or pears. These are not used--well, they possibly could be used for peache s, but nobody's using them for peaches. But the point is that they're not used for any other commodity other than tree fruits.

These trucks will go down the road--next slide, please--and be unloaded at the packing house. This is a 72-bin truck that has brought fruit in from as far as 75 miles away, and it's undergoing its first sort of inspection. But in any case, go on, Dick.

DR. DOUGHERTY: As far as treatment of these transporting devices, sanitation, where these boxes and bins are stored, and their previous uses, if any, need to be monitored constantly and are. Do you have anything on those?

DR. KUPFERMAN: No.

DR. DOUGHERTY: When we look at typical apple storage, refrigerated storage is typically at 30 to 34 degrees. CA storage with oxygen levels around 2 percent, CO₂ below 3 percent, and again, under refrigerated conditions.

DR. KUPFERMAN: This is the kind of information that packers would be getting at our meetings in March in which we update the information from research and extension and industry trials. This is a large but typical sort of a controlled atmosphere or storage facility. The apples will be harvested into bins. The bins had been washed and cleaned after use the previous season, stored in our cold weather and only brought out to the orchards right immediately before harvest. The fruit are then picked into these bins, some of which will have bin liners or plastic bin liners, brand-new, unused plastic bin liners placed into it, depending upon the variety, and then stacked into either regular storage--in other words, refrigerated--or CA storage room.

People are paying, growers are paying $40 to $50 a bin to have these packing houses deal with this fruit. Therefore, the concept of picking up grounders and having less than reasonable quality fruit in the bin gets to be economically unfeasible.

Dick?

DR. DOUGHERTY: We need to emphasize that the vast majority of apples for fresh juice production, at least in the State of Washington, are from the fresh market culls. Therefore, it is at least appropriate for us to take a quick look at what goes on in packing houses throughout the state. When fruit is delivered to packing houses, they are typically dumped or removed into water. That water may be treated with soap and detergents, chlorine, acids, other sanitizers, or any other combination of those.

Gene, do you want to take those?

DR. KUPFERMAN: Yes. This is an older but typical bin dump in which the bin is put on tracks and placed under the water. Apples float. Pears take a floatation material in order to change the specific gravity of the water so that they float. But the point here is that the apples are floated out either in an acid wash bath of a pH of 2 to 3, and I took a survey of the industry on Friday before I came down here, and out of the 68 million boxes represented in the survey, 34 million of them would be dumped into this acid wash.

If they are not in an acid wash, they may be put into a chlorine dump, in which the chlorine is held at 100 parts per million or greater. And one of the impetuses for doing that is the possibility of shipping this fruit to Brazil, in which our treaty with Brazil, our agreement with Brazil has indicated that it would be in 100 parts per million or greater solution.

This fruit is then rinsed, and following the rinse, then a soap or detergent is applied through brushes. We thought you'd enjoy some pictures of actual apples and actual running of these apples. But the point is that they're scrubbed quite carefully. They rotated and revolve on brushes--next slide--and then reach the sorting tables. They're rinsed in here, and then they go over the sorting table.

Next slide.

Here is a sorter's hands, at least. She or he would be placing second-quality fruit here, juicers or culls on two other belts, depending upon which market they're intended for, and the garbage, which is no good, then would be put in a chute that goes to the landfill.

DR. DOUGHERTY: Is there any other color than red?

DR. KUPFERMAN: I'll leave that one alone.

In some cases, in order to make sure that we don't have any problems with decay--and particularly, growers have been very concerned about issues associated with fungal decay because it eats up the fruit--this is actually a waxing apparatus applying the wax that consumers seem to demand, but it's also the way alternatively in which chlorine dioxide is being applied in a number of different packing houses as well. Chlorine dioxide at a 5 to 7 part per million range under a vented-hood system.

This is the dewatering or the drying of the fruit so that this fruit is not wet when it goes into the pack.

Dick?

DR. DOUGHERTY: We also need to point out that when fruit does go through packing houses, it typically does lose its identity, its tie to the original grower. Sometimes it's very difficult to tie that back.

DR. KUPFERMAN: There are two types of packing houses in Washington State. There's a pre-size operation, and there's a direct pack operation. In the direct pack operation, the fruit started out in bins, and they are all sizes and grades and colors, or amounts of red, and at the end of the packing line, they're into boxes. In that case, we know exactly where the culls come from. In the case of the pre-size operation, that may be brought down to two or three different growers, depending upon when the culls were accumulated.

Dick?

DR. DOUGHERTY: If we were to make recommendations for fresh juice operations--this is fresh, not pasteurized--to better assure that the finished safe product was produced, we would suggest that the fruit be bought from reputable suppliers, not necessarily growers but suppliers; that they assure that the fruit does not contact the ground; that they transport the fruit in appropriate containers, meaning sanitized, kept clean; that grower identify, if at all possible, be maintained; wash and sanitize the fruit prior to pressing, and strictly adhere to GMPs throughout.

DR. KUPFERMAN: Thank you.

 Applause

DR. SHANK: Thanks, Dick and Eugene.

Our next presenter is Mr. Paul Baker. Paul is owner of Baker Farms and chairman of the board of the New York Apple Association. He, too, will address growing and harvesting practices.

MR. BAKER: Thank you. I'm really glad you could all come. To my recollection, I guess I'm the first growers you've actually met.

I'm kind of reminded of a scene from a movie that maybe you remember back, "Field of Dreams" with Kevin Costner, and there was a famous line in there where they built the ball diamond out in the middle of the Iowa corn field, or wherever, and it said, "If you build it, they will come." I feel a little bit with you people here, and after experiencing the Alar crisis, that my expression should be, "If you grow it, you will come."

My objective here is to give you a grower's point of view on the growing and handling of apples in the United States. More specifically, you've just seen the Western perspective, which is not--I want to illustrate and make clear to you--dissimilar from the Eastern United States. There's a great many similarities in U.S. apple production, and I won't elaborate on a lot of the details. They did a very good job going over it.

My key areas of discussion that I will go over quickly for you, I want to center on cultural, harvesting, storage, transport, and finally I'll quickly gloss over economic conclusions.

Could you go to the next one?

On the cultural, I think it's a key point to bring up to you that all of agriculture today in the United States is getting to be more and more specialized. The myth, the Norman Rockwell-type myth, that maybe you had of your grandfather down on the farm, you had a couple cows, a couple chickens, some sweet corn and all that--that's over. Today fax machines, modems, cultural rooms that control the CO, this is the state of the art. The industry that you may think of and hold dear is no longer a part. We are as scientific as the rest of the world. Our customers are not just you. We export, as Gene alluded to. Our customers are all over the world.

The world is getting smaller and we have to keep up with it. In order to do that, we have a tremendous amount of specialization. This is not only equipment, but of human resources. For us to be competitive, logic would tell you that we cannot be so diversified as I have heard people suggest that maybe we're grazing cattle in the middle of our orchards or something like that. Not to say that there may not be isolated situations, but practicality just precludes that this is not possible.

As a consequence, nutritionally, the choices that we make for our orchards are very much thought out, and animal waste products are not a viable alternative at all.

Human resources are a big factor in this industry. We make tremendous inroads every year in our marketing and everything else, and a key point with human resources is that this is not an industry where we scoop product off the ground. As Gene alluded to, our trees are chosen for their size and their ability to intercept light. This crop is hand-harvested. And when we say hand-harvested, we do not mean off the ground.

As Gene alluded to also earlier, there's a tremendous amount of up-front input costs going into a box of apples. When we refer to boxes in the East, unlike the West, we're referring to a 20-bushel container.

Orchard designs, as you've seen on previous slides, give us the ability to maximize sunlight. I think it's important to understand that the job of a farmer, in my estimation, is what I call sun management. What I mean by that--and I want to bring this point to you--is that as a farmer it's my ability to intercept the sun's energy that will give me a better product. You've heard the term before earlier by a previous speaker that the world is measured in bricks. If you do not enjoy the flavor of your apple or your apple juice, you won't come back and do it again. We want you to enjoy that.

As a consequence, it's our ability to harvest the sun. The point I'm trying to make here, it's impossible for us to have cultural practices that don't leave these trees wide open to the sun and the fruit will not fall onto the ground.

Applications of pesticides and herbicides I do not feel are actually the question here, but I think it's important to recognize, as also alluded to by the previous speaker, we're under strict guidelines to use products effectively so as to minimize insect and disease problems.

The next slide, please.

I think, again, I want to re-stress for the interest of this symposium that this is a hand-picked industry. We do not scoop the product off the ground, and economically it precludes that. The returns that we receive as growers economically go from the highest category, which is fresh, down to processing, down to what we call the ciders or drops or I believe the term that I heard over lunch was grounders in the West.

The grounders, for all practicality, many times aren't even picked up because economically they don't--they won't pay us for the cost of transportation and labor. So, again, as I sat in the morning lecture and I listened, many times this fruit isn't even utilized because it isn't financially--it doesn't expedite our ability to go after it.

You've already seen from previous slides the specialized bins used for the fruit, and, again, with the specialization of the fruit farm, it's safe to say that when we have apple bins, that is what they're used for. We don't--it's amazing the concepts that are out there. But they don't cross over into meat and everything else. These bins are specifically used for apple production and apple production only. The only crossover that I'm aware of in my particular area is they may store for a short time pears, which is another fruit product.

Regular and controlled atmosphere storages are important for you to understand that the fruit is not taken lightly. The fruit doesn't stay out. We have a sign in my packing house operation that you don't go to bed until the fruit does, the point being that when we harvest, that fruit has to be inside and in the cold, away from the elements and all the animal wildlife before we go to bed. And, believe me, some nights, the nights are very short in the fall.

Next slide, please.

I thought Gene did an excellent job of going over the packing house and processing of the fruit. I think the key point here that I'd like to leave with you is whether we're going for fresh or processed, the processes are very similar. Apples by their very nature float. As a consequence, whether we go into process business or into the fresh packing lines, the apples have a sanitation by going through the line, and, Gene, in our area we use mostly a chlorine dip in ours.

The apples are brushed and pre-cleaned. Most of what we call the utilities that come off of these lines are for cosmetic reasons, either they're undersized, they lack the color, or they might have a bruise. They're not--it's important to remember that the utilities, which then maybe go on for the cider or juice operation, are not there for non-nutritional reasons.

I want to leave you now with quickly some economic conclusions from a grower's point of view. Apples are an all-inclusive industry. Little crossover to non-fruit. I think that's important to understand. I can't think in my own recollection of one farmer that is diversified and is using manure or even has those kinds of entities. The degree of specialization and training of human resources and equipment is so specific that it's important for you to understand that these industries are developed that way.

The second point is that fruit is hand-harvested versus scooped up off the ground. As a consequence, we can't guarantee that there aren't deer walking through your orchards. But when the fruit is picked off the ground and we're intercepting the sun--this is what I call sun management--there's hardly any consequence of interception of manures. I heard someone allude to bird droppings, but I don't know, that seems rather remote from my point of view.

Cider or drop apples, or grounders, as I heard today, are non-viable economic commodity on their own. They're only possible as a by-product. No fruit farmer that I'm aware of would ever go out to invest in land and operation and trees to go out to produce cider apples per se. The economic justification just simply is not there.

Cider need not be pasteurized so long as it's derived from hand-picked versus ground fruit--grounders, again. Fruit that is harvested from off the ground should be sold only to juice operations that offer pasteurization. An earlier speaker from Seneca illustrated, I think very well, that there are very reputable juice operations that are moving the temperatures up to a level that is more than adequate to pasteurize your fruit. Cider operation in the East--I will speak directly to it--it's almost like a--it's one of the few things--let me choose my words here--that would still go with the seasons. People get excited in our area about sweet cider, and as long as we use good cultural practices and we are selective as to where we get this fruit, I think it can be still a viable choice.

Finally, the apple industry is open to any suggestions and practical ideas as to how to keep the fine products coming back to you. The one thought that I want to leave with you is I'm not standing up here saying that I have ten doors and I'm only going to open up eight to you. As an apple grower, I want all ten doors open to you as a customer. If you're not satisfied and you don't have the confidence that I'm out there producing the finest product that we can, you won't return.

Finally, as an apple grower, I appreciate the opportunity to come here and speak to you. Thank you very much.

 Applause

DR. SHANK: Thank you, Mr. Baker.

We'll change directions a little bit and talk about or consider organic production. Dr. Harold Ricker, who is program manager for the National Organic Standards Program of the Agricultural Marketing Service, U.S. Department of Agriculture, is going to make that presentation.

Dr. Ricker?

DR. RICKER: Thank you very much. It's a pleasure to be here. It's a little awkward time for me to be talking about the National Organic Program because we are very much engaged right now in developing the proposed rule for the program, so I have to be a little careful on what I say. But one of the reasons that we wanted to talk about the organic program is because the organic program seems to get mentioned when people think that the E. coli comes from cow manure or manure, and as the Washington Post and others tend to say, why, manure is a staple of the organic industry. I'm not sure how they get that.

But the organic industry is a growing industry. It's a rapidly growing industry, and I want to talk a little bit about that growth for just a minute and what we're trying to do and then get into the issue of manure management.

In 1994, we had done a complete census of the certified organic farmers, and at that point in time there were a little over 4,000 farmers, and about 500 handlers or processors of organic products. I know that number has gone up substantially since then. I don't have an accurate number on it because we haven't had an opportunity to do another census.

In terms of sales, the sales of organic foods have gone up from $1 billion worth in 1990 to over $2.8 billion in 1995, and it's probably about over $3 billion now. That's averaging about 22 percent a year growth, and it's also showing up in more conventional supermarkets. So it is a growing industry and a growing marketing opportunity.

There are currently 44 organizations that are certifying organic production and processing across the country. That's 11 states and 33 private organizations. Probably about 75 percent of the production, or 80 percent, is done by private organizations at this point in time.

At this point in time all have their own standards and requirements, although a number of them have modified their requirements to come in line with the Organic Foods Production Act of 1990.

In addition to the 11 states that have certification programs, 28 states have--a total of 28, I shouldn't say in addition. A total of 28 states have organic labeling laws. And, in fact, there was just recently an instance where an organic, supposedly organic production or retailer was taken to court in Minnesota for fraudulently labeling the product by the State of Minnesota.

The organic program, as I say, is mandated by the Organic Foods Production Act of 1990, which is Title 21 of the Food, Agriculture, and Conservation Act, or the farm bill. It was requested by the organic community. This is an indication of a self-regulated industry. Part of the reason for the request was because there was fraudulent use of the term, such as I just alluded to, fraudulent use of the term organic.

Consumers are confused about the term and what it means. They thought it represents pure food when it's not necessarily residue free, or that it is more nutritious when there's no scientific basis for that.

There are variations among the certifiers that are out there in terms of the standards that they have and for requirements for labeling their products. Therefore, the purposes of the Organic Foods Production Act are to establish national standards governing the marketing of certain products as organically produced to assure consumers that organically produced foods meet a consistent standard and to facilitate interstate commerce in fresh and processed food that is organically produced. So we're calling for one national standard. It does not call for certifiers to have enhanced standards. It calls for a consistent standard to get away from the confusion of private and state organizations having different standards.

The program will operate this way. AMS, the Agricultural Marketing Service, which I'm part of, will accredit state or private persons to become certifying agents for the department to certify processors and handlers to the national standard. AMS will provide the oversight for the program to ensure that the purposes of the program are followed. Certification involves the process whereby a producer or a handler applies to a certifying agent to be certified. This includes providing a history of the farm and past record of substances used on the land in the previous three years. An organic plan and other information determined by the type of production or handling system to be certified.

When a certifying agent is satisfied that the information is complete, the agent will call for a qualified inspector to conduct a farm inspection to evaluate the farm's organic intent and program, and to provide a report to the certifier. Based on the application and the inspection report, the certifier determines that the producer or handler has certification status, what it is.

We have concerns based on the news articles, not only the one that I cited at the start, that link E. coli outbreaks to organic production when the products that are being sold do not claim to be organic. Part of the rationale seems to be that the organic industry is growing, and as I quoted from the other article, manure is considered a staple of the organic industry and, therefore, a problem.

In fact, the organic industry places restrictions on its use and requires certified producers to have an approved plan for the use of raw manure. Organic farming and handling is a system that is designed and managed to approach optimal productivity of soil life, plants, and animals. Farmers and handlers choose methods, cultural, biological, and mechanical, in preference to substances to fulfill any specific function within the system so as to maintain soil fertility, increase soil biological activity, recycle waste, and return nutrients to the land.

If a product is not organically produced on the farm, it can never be labeled as an organic product. The function of the distribution system from the farm to the consumer is to maintain the organic integrity while meeting all over food safety requirements. Therefore, production is the place to start, and one of the areas I'll start with is crop production, and here we're talking about organic--basically an organic farm plan.

The production management system that is the keystone of organic certification is the organic farm plan. For the producer, the farm plan provides a flexible, useful, and affordable tool for developing an ecologically sound, proactive resource management system on her or his farm. It includes things like crop rotation, nitrogen fixation, inter-cropping and so forth. It can't include prohibited substances. It can't use them on the farm.

It allows the producer to plan and evaluate farm management practices and make tangible improvements in the farming operation. For the certifying agent, the plan provides essential information for assessing compliance with the Organic Foods Production Act and the National Organic Program.

By focusing on a few questions, the plan addresses key elements of organic crop and livestock production that must be addressed by the producer, such as soil fertility, composting, and manure management. And to be very specific about it, the Organic Foods Production Act has specific language on manure in organic production. The organic farm plan, it says, must contain or shall contain terms and conditions that regulate the application of manure to crops. The plan may provide for the application of raw manure only to any green manure crop, any perennial crop, any crop not for human consumption. But for any crop for human consumption, if such crop is harvested after a reasonable period of time, determined by the certifying agent, to ensure the safety of such crop after the most recent application of raw manure. But in no event shall such a period be less than 60 days after such application. Therefore, it must be applied at least 60 days before harvest of any human food crop.

Generally, organic producers compost the manure before applying it to the field or crops. Composting is a process that creates conditions that facilitate the controlled decomposition of the organic matter into a more stable and easily handled soil amendment or fertilizer, usually by piling, aerating, and moistening. Such organic plan also shall prohibit the raw manure from being applied to any crop in a way that significantly contributes to water contamination by nitrates or bacteria.

I would like at this point to give you a couple comments from a large organic production farm on how they deal with fruits and vegetables.

Cascadian Farm is an organic fruit and vegetable industry leader. In fact, it just recently became a subsidiary of--I guess--I don't know. Subsidiary is not the right term, but tied in with the Disney operation. This is from Mr. Alec McErlich(?), who is the Director of the Horticultural Research and Development Program for Cascadian Farm. It says:

My comments relate to vegetable and berry fruit grown for Cascadian Farm. I cannot comment with any certainty on production practices for tree fruits as I have not worked with these growers, but believe current practices parallel those described for cane fruit--which is one of their bigger products.

Several of our growers do apply compost or weathered animal manures to fields contracted to produce crops. Our growers do not use compost teas. Weathered chicken manure is the only manure used. Composts are produced according to the certifying agent's standards. The time of application, the vast majority of manure applications of compost are made in the fall, just prior to the establishment of green manure or cover crops over the winter. We avoid spring applications wherever possible as they tend to introduce variability into the field due to the relatively unsophisticated application mechanisms on the spreaders.

Concentrated maturity is a critical aspect of growing crops for processing, especially when once-over single harvest machines are used. Fall applications allow for timely breakdown of the manure or compost which can then be utilized by the green manure crop. Warmer soil temperatures at this time of year also allow for greater soil activity compared to early spring temperatures.

Where spring applications of weathered manures or compost are used, applications are made before seeds are sown in the case of vegetables or at bud burst for cane fruit. In all cases, the 60-day withholding period re-establishment--required by certifiers is met. Strawberry growers apply manures or compost prior to foliage re-establishment, or two to four weeks after the h arvest, is another--and that's usually in the summertime.

Post-application management. In cane fruit, applied compost may be lightly incorporated into the soil or remain on the surface, depending on the fauna diversity desired. Incorporation generally sees a dominance of bacteria where fungi needed to proliferate--attended to proliferate if the compost remains on the surface. The predators of bacteria and fungi tend to follow the dominance of the decomposer groups. Thus, bacteria-dominated soils have a majority of bacterial predators, such as protozoas and bacteria-feeding nematodes, while fungal-dominated soils have a majority of fungal predators, fungal-feeding nematodes and fungal-feeding micro-arthropods.

The Organic Foods Production Act covers all types of livestock as well as all crops, and I'm not going to go through the details of the livestock plan at this point other than to say that it deals with livestock health, which becomes an important issue because in a traditional organic farm, livestock is an important or integral part of the total operation. But in today's time period, you don't see it quite as often. But it has plan--we have a livestock health plan which deals with antibiotic and para(?) insecticide use and the source of the livestock and the records that have to be kept for it.

The area that does address manure specifically is in feed availability, and here we have a requirement that our requirement will be 100 percent of organic feed for livestock. But livestock shall not be fed manure re-feeding, plastic pellets for roughage, or feed formulas containing urea.

In terms of the--as I say, those are the production practices in a very quick capsule. They go into considerably more detail in the regulation. But when you leave the farm, you get into processing and handling. Although some processing and handling could take place on the farm, we do distinguish a bit. And processors again have to have a special handling plan for dealing with organic foods. Again, the primary focus is to make sure that the food is not contaminated by commingling with fruit that has been sprayed from conventional sources or that just commingled to where it might lose its organic production source integrity. In other words, the primary function, again, from the farm to the consumer is to maintain the integrity of the product.

But the organic handling plan then requires a processor to maintain accurate records on the organic product and segregate its holding facilities to keep it from being commingled. It also requires, for example, that the processing apparatus be cleaned before the organic product is run through. And usually to get at that approach where you're doing both organic and conventional, they usually run the organic through first thing in the morning, followed by the conventional.

And, of course, there are the good manufacturing practices and in terms of labeling, the specific requirements in terms of how much organic product--the labeling is mostly how much of the product is organic versus non-organic, to determine the type of label that can be used. A hundred percent organic would obviously say organic juice. If it's blended with something else that is not organic, then it would be made with organic juice.

Nothing in the organic program, though, alters the authority of existing health and safety laws, and I want to emphasize that. The current food and drug laws do remain in effect as far as organic foods and as far as maintaining the organic--the health and safety of organic foods.

One other area I'll just mention briefly, but we are also required to have--I mentioned before you can't have prohibited substances. We do require the development of a national list of allowed synthetics that can be used in organic production and processing. Thus, you could not use anything in the processing of organic apple juice that would not be allowed on the--if it was synthetic, that would be allowed on the list--unless it's allowed on the list. If it's not on the list, it's a prohibited substance and the product could no longer be called organic.

And, usually, we could only use that allowed substance, synthetic substance, if there is no wholly natural product available that would fulfill the same requirement.

It's a complex program because it does deal with all organic product. In fact, we're in the process of developing these rules. We are working very closely with the Food and Drug Administration, the EPA, Environmental Protection Agency, and the Bureau of Alcohol, Tobacco, and Firearms, the Food Safety and Inspection Service, and numerous other agencies in trying to pull it together.

But the other point I should also mention is that there is a growing international market for organic products. In fact, indeed Cascadian Farm, the organization I cited earlier, is one that is exporting a number of agricultural products overseas. There will also be imports of agricultural products, and there's not a week or two that goes by that I don't have somebody from some other country coming in to talk about what's required to get organic product into the United States. And we will have to determine that they come from systems that are essentially equivalent to the ones we have now.

The standards we're developing will be performance standards, because it is not possible to prescribe production standards for every farm or handling operation due to variabilities in many of the microclimates around the United States and also in the availability of inputs. But the other point that needs to be made here is that one thing the organic program does have, and that is it does have a set of standards and it does have some regulations that it has to follow in treating all these things in addition to the regular, normal food safety standards.

Then the question that I get asked at least ten times a day, we expect to have a proposed rule out for public comment early in 1997, with a final rule at the end of the year or early 1998. Once the final rule is out, it defines organic. It has the force of law, and the purposes of the act will have been accomplished. Certifiers will have to begin certifying to the national standard, and producers and processors will have to be producing to the national standards.

Thank you.

 Applause

DR. SHANK: Thank you, Dr. Ricker.

Let's change the agenda here a little bit--we're running ahead of schedule--and take the questions for clarification pertaining to the previous speakers or the speakers we've had since lunch. Let's do that, I would suggest, before we take our break, and then that will make it a lot easier for the public commenters later no this afternoon.

Bill?

DR. SPERBER: Yes, I have a question on growing and harvesting practices for Mr. Baker and Mr. Dougherty and perhaps the other gentleman who spoke. You implied that there was little chance for contamination of the apples in the field because of the growing practices where cattle and deer are kept out, manure is not used, and drops are not used. Yet you went on to say that all of the fruits were picked by hand. So I would be somewhat concerned that perhaps the fruits could be contaminated during picking because humans can be carriers of salmonella and E. coli O157 and other pathogens. So I was wondering if you are using or if you could tell us what procedures you are using in the fields to prevent contamination during picking. Do you provide any toilet or hand-washing facilities for the pickers?

MR. BAKER: Yes, most definitely. There's very strict rules. For example, I personally--our personal farm is part of the H2A program, and before I could even get certified to bring in labor, I had to meet certain health code regulations. One of those regulations that we have to meet is field sanitation. So we have to have, for lack of a better term, portable facilities out there with hand-washing available.

I can't guarantee, no more than every employee in this hotel, that everyone complies, but it is there and, to the best of my knowledge, it is pretty well complied with.

DR. SPERBER: Thank you.

DR. SHANK: Anyone else want to comment on that?

DR. KUPFERMAN: I just wanted to say I've never been to a public health food safety meeting before, and it made lunch really a hard thing to order and choose what to eat.

Within the State of Washington, it's my understanding that all of the orchard workers have to have access to some kind of port-a-potty and every one of the port-a-potties must have clean, hand-washing facilities with soap available. Now, as Paul said, not everybody washes their hands every time, but I don't--that's as far as I'll go on that. They have to have it available.

DR. SHANK: Joe, do you have something to follow up on that?

DR. MADDEN: Yes, sir, I have a question for Mr. Kress, Seneca Foods Corporation. Temperature was thrown out, that is, as kind of critical, and I want to make sure I've got it down. But from what I understand, you said between a temperature of 165 and 190 degrees Fahrenheit flavor volatiles are driven off and must be added back. Is that 165 degrees Fahrenheit true? Did I write that down correctly?

MR. KRESS: Yes. In the concentrating process, when apple juice is into the first stage of heat treatment, that flavor volatile will be driven off. And that temperature range of 165 to 195 that I referenced, again, depends on the piece of equipment that's involved, the size, you know, the operation and everything else. But that flavor is driven off. It's recovered condensed, put into storage, and then when concentrate is added back, then it will be added back to the product.

DR. MADDEN: Thank you.

DR. SHANK: Bob?

DR. BUCHANAN: I have a question on the irrigation sources. We had heard earlier today that overhead irrigation wasn't used, but then we did see pictures of it here. How common is that on the west coast? And also, for Mr. Baker, what type of irrigation systems are used on the east coast?

DR. KUPFERMAN: Well, with regard to over-tree irrigation, it is used in many areas of the West. In some areas of Washington it is used in order to moderate the hot temperatures of the desert climate that are there, and it's applied as evaporative cooling to the fruit and to the environment of the tree.

In terms of the number of acres, I can't give you that information off the top of my head. The vast majority of water is applied under the tree as a sprinkler system in which large droplets of water are not applied to the fruit, are applied to the soil, microsprinklers or drip types of systems. The microsprinklers are the most popular new system that's out now. So I can't give you that information. If there is information that leads us to believe that there is some problem with that, then I'm sure that the industry would change. But at this point, we haven't seen any problems.

DR. BUCHANAN: I notice in your picture of the one very large farm you had an irrigation pond, or what appeared to be an irrigation--

DR. KUPFERMAN: That was a river. That was what we call--

DR. BUCHANAN: You had a river, and then there was a pond next to it.

DR. KUPFERMAN: Okay.

DR. BUCHANAN: Is that an irrigation pond? And does the runoff from the orchard come back to that pond and then is pumped back into the system?

DR. KUPFERMAN: The runoff--I don't know in that particular pond--I don't know in that particular orchard. The runoff of irrigation water--irrigation water is not applied as a flood system in California where there's a whole heck of a lot of runoff. There's underground collection in the sense that it will go through the soil and possibly even go back to the river. The pond is filled either from deep well systems, deep wells, or accumulations in the early part of the season for frost fighting in the springtime. And that's accumulated the previous year.

DR. BUCHANAN: But the irrigation water is from that surface water, even if it came originally from a well source. You pump it from the irrigation pond onto the land.

DR. KUPFERMAN: That is so--

DR. BUCHANAN: You don't pump it directly from a well.

DR. KUPFERMAN: Either case. Either case. It can either be accumulated or it can--both cases are correct.

DR. BUCHANAN: Okay. And is there any testing of that water?

DR. KUPFERMAN: Any testing?

DR. BUCHANAN: Of the irrigation water.

DR. KUPFERMAN: I can't say that I know that there's no testing of the water, but we--tell us what to look for, and I'm sure that we'll be looking for it. But there's no standardized testing program at this point in time.

DR. BUCHANAN: Mr. Baker, is the irrigation facilities similar on the east coast?

MR. BAKER: No; none whatsoever. In fact, in our particular situation, we feel it's a real penalty if we have to irrigate at all. On the east coast, we have an annual rainfall that averages probably 40 inches or more. So irrigation is--it's not as prevalent as over in Washington State where I believe your annual rainfall is less than 10 inches.

DR. KUPFERMAN: Eight to ten.

MR. BAKER: Eight to ten inches. So it's a totally different situation.

I've been in some of the orchards in Washington State, and it just fascinates me because they have these lush orchards, and then they go one foot beyond irrigation and there's absolutely nothing. We have just the opposite problem with the vegetation.

We're doing more with the research that we're working on with Cornell University on what we call fertigation, where we're putting in systems with drip irrigation where we're also incorporating in the nutrients at the same time.

DR. BUCHANAN: Is it a common practice, though, to have a pond that's somewhere on your land?

MR. BAKER: The reason I'm hesitating is there's all different dichotomies, depending on the topography in the East. As you well know, the topography is everywhere. I can think of situations where there are farmers that are pulling water by permit out of the Erie Canal. There's also farmers that are bringing water out of Lake Ontario. Probably--but I don't know for a fact--they're bringing it out of Lake Champlain. There's also farmers, such as myself, who have had to hook on to public water lines. And there's ponds. I mean, there is no standard.

DR. BUCHANAN: Okay. What do you do in a year when the level of rain--this year it has been amazing, the amount of rain we had.

MR. BAKER: Depressingly so, yes.

DR. BUCHANAN: Last year that was not the case, and much of the east coast was under a drought situation. What do you do in those situations?

MR. BAKER: Try to convince you to buy small apples.

 Laughter.

DR. SHANK: Thank you. Betsy, you've been standing quite a while.

MS. WOODWARD: Thank you. I'm Betsy Woodward with the Florida Department of Agriculture. I have two questions, one for the growers--well, I think I'll ask it first, and that is, in 1989 we banned Alar. One of the functions of Alar was to prevent premature drops. Has that affected the amount of drops that you see in your orchards?

The second one is for Dr. Ricker dealing with organic. I noticed that he mentioned 60 days after the application of a green manure before harvest. In Florida we call for 120-day composting of green manure before you can put it on a crop destined for human consumption.

Are there any studies that look at the survivability of pathogens such as O157 through the composting process?

DR. SHANK: Do the growers want to go first?

MR. BAKER: Since I'm the only grower, I guess I'm first.

 Laughter.

MR. BAKER: I'll be last, too.

As far as the drops with the Alar situation, no. No. And the reason is that since the Alar situation, the entire business of growing apples has changed. We've done a much better job of culturally, as I tried to allude to, sun management. We are much more sensitive to internal pressures of the apples. And, actually, the Alar crisis in a way has been a blessing. I believe actually we're doing a better job of managing fruit. So we're much more sensitive. If anything, Alar may have created a crutch.

DR. SHANK: While Dr. Ricker's coming up, remember, we've got Dr. Scarbrough here for any labeling questions that you may have.

DR. RICKER: On the question of whether there are any studies that have been done on the composting, there may have been some, but I haven't heard of them. I haven't seen a lot of it. And that's very timely in the sense that tomorrow we have a session over at USDA where some people are coming in to point out the lack of research that's being done in USDA on related issues for organic production.

DR. SHANK: Thanks.

Yes, Mike?

DR. OSTERHOLM: This is really to any of the producers, growers, et cetera. In two previous outbreaks of salmonellosis that we've worked up associated with tomatoes, we found that a potential source, or at least an important problem area was that of the water baths, and that despite the fact of trying to maintain anywhere from 100 to 200 parts per million chlorine, that was very quickly eaten up, and these were vine-grown tomatoes, never on the ground, same kind of situation where they should not have had the high kind of soiling content that would result in very rapid deterioration of chlorine levels.

That combined with the fact that what we found wa that as you picked a tomato, much like you might see with an apple, although the stem is primarily intact, what happened was the water bath may have actually contributed to the problem in that any small cuts in the product that were microscopic or in the stem area where the water could now get into that it wasn't getting into before, and that wasn't being polished. It's almost impossible to get into the bottom side of an apple and the top side of an apple. It's great to round it off, but can you actually get in there deep?

Can you comment on any research that's been doing looking at what goes on with the water baths? And I might add that in the outbreaks that we looked, we were actually looking at growers who reported one thing--and these were reputable growers who had good operations, but what was actually happening in those water baths on a day-to-day basis and what was actually being reported were two different things.

How well do we really know what goes on in these water bath areas, and what can you tell us about what role they might contribute to the problem itself?

MR. BAKER: I can make this real quick. As one man alluded to, I'm not a scientist. Secondly, as far as the tomato industry, I really can't comment on that. I'm not knowledgeable about that. As far as the water baths, it's just been good cultural hygiene on our part. But to give you technical data to answer your questions, I'm not qualified to do that, sir.

DR. OSTERHOLM: Right. I'm not really asking you to comment on the tomatoes. I'm using this as the example.

MR. BAKER: I understand that.

DR. OSTERHOLM: Because we went into the tomato side thinking that this was actually going to be a value-added part of the process, and in some case s the water baths very well may have been value-negative, meaning that some of the contamination may have been amplified in water baths that were not adequately being monitored in terms of chlorine levels, and combined with the damage that might have occurred to the product, even if it was microscopic, the water was now introducing material into the fruit itself. That's why I'm asking if anyone has any data on the apple side.

DR. GRAVANI: A follow-on question also would the temperature of that water as well, which Bob asked this morning, which I'm sure we'll talk about more as we go. But, Dick or Gene, maybe you want to address that. What's the temperature of those water baths?

DR. DOUGHERTY: I'll address the tomato issue first--take a stab at it, anyway. That is, in the case of tomatoes, as soon as you open them up, you really are introducing a very large volume of organic material into that flume water. And as soon as the high organic material or high organic level gets up, your chlorine typically decreases in effectiveness as that goes up. And that along with temperature and a number of other factors as well probably enter into that picture. Again, until you see the specific situation, it's a little bit hard to deal with, but that's--I would suggest that organic material is probably as important at anything.

DR. OSTERHOLM: But you're saying that's not the case with apples? That's all I'm asking.

DR. DOUGHERTY: You're trying to relate that to apples?

DR. OSTERHOLM: Yes. That's why I'm asking if there's any similarity to the water bath situation in the apples that we found in the tomatoes, because we were told that ed$ basically the water baths were a value added, but with tomatoes they were not. We're hearing from you today about water baths and scrubbing and disinfectants, and I'm asking, I guess, is this really a value-added? If monitored appropriately, you'd sure think so. But could it in some cases be a value-negative? That is, I guess, what I'm getting at.

DR. DOUGHERTY: I don't think we've seen it be a value-negative at all at this point, anyway.

DR. OSTERHOLM: But does anybody have data to show that? Has anybody really monitored this?

DR. DOUGHERTY: I can't answer your question. I don't know.

DR. SHANK: Dr. Kress?

DR. GRAVANI: Could we get to the other half of the question that had to do with temperature?

DR. SHANK: Do you have anything to add to that?

DR. KUPFERMAN: I've done surveys of the practices followed in--the post-harvest practices followed in the Washington industry. There's a couple of issues here. First of all, the chlorine is carefully monitored at 100 or above 100 parts per million, free chlorine in the dump tank. That is not the only treatment that this fruit undergo in the sense that there is either chlorine dioxide or a fungicide or some heat treatment of this bath that is done. It depends upon the packing house, and it depends upon the research they have available to them. So we're looking for guidance from this group as well as to what appropriate management practices would be.

In terms of the temperatures in the water baths, it depends upon which bath we're talking about. Many of them have fruit at 32 degrees put into them very early in the day, and we're looking at a cool temperature bath. Some of the producers heat that bath up, but that may be only as hot as 80 to 90 degrees, and it depends upon the particular producers.

As I say, we're interested in information from you folks as to what appropriate management practices would be.

Did that adequately answer your question?

DR. GRAVANI: Just a follow-up. In tomatoes and eggs, there's a common practice that you always want to have your water bath warmer than your product because if you do it vice-versa, you'll actually have a negative pressure and you'll suck things into the food product. Does a similar thing happen here with tree fruits?

DR. KUPFERMAN: We're putting fruit that is refrigerated at 32 degrees into a bath that is warmer. You don't have a hydrocooling effect.

DR. GRAVANI: That's true if you're bringing them out of controlled storage. But how about if they come right from the orchard into the factor?

DR. KUPFERMAN: For the most part, we're not running--except for a very small part right at the beginning of year, a few bins, we're running out of refrigerated stores or controlled atmosphere.

DR. SHANK: Don?

DR. VESLEY: Mr. Baker, you made a comment, a very good one, about the drop apples being used only for pasteurized products, and this morning the comment was made that pasteurized manure is still manure. And I was just wondering what the philosophy of the industry was on minimizing the amount of contamination even in products that are going to be pasteurized.

MR. BAKER: Pasteurized manure is still manure?

DR. VESLEY: Yes. It's still manure.

MR. BAKER: I think our industry's point of view is that if we have products that we feel have definitely fallen to the ground, they can clearly be earmarked, and they can be sent directly to a reputable processor that is pasteurizing. My understanding is that if you get to 160 degrees or greater Fahrenheit, then you will have pretty much stabilized this bacteria. Again, I'm not a scientist.

DR. VESLEY: The concern is not now for whether pasteurization works, but just the level of contamination in the amount--you know, in the soil that's still going to be in that product. Is there any attempt to minimize that or any standards that are used for minimizing it?

MR. BAKER: Are you talking about the soil or the product?

DR. VESLEY: Well, the soil in the product.

MR. BAKER: Well, again, I go back to the fact that--my comments were that if we're going to go to cider, a non-pasteurized product, I think it should be clearly held--the industry should dictate that the pro duct comes directly from hand-picked stuff that never hit--and fruit that never hit the ground, that never touched the soil. That clearly can be done with packing house utilities.

DR. VESLEY: Right, but I'm referring to the products that are going to be pasteurized because they're using products that have hit the ground.

MR. BAKER: I understand what you're asking me, but I'm trying to say that we can have two different directions, and we can clearly define those products. I hope I haven't danced around your--I don't intend to.

DR. SHANK: Caroline?

MS. DeWAAL: Caroline Smith DeWaal, Center for Science in the Public Interest. I have a question for the growers or people who know the industry. We've heard that in the Odwalla situation there are no guarantees that product may not have been dropped product. And I want to know to what extent workers in this industry are paid on a piecemeal or a piece approach, either by the bushel or some other manner versus hourly. And are there any incentives built in for pickers who have exceptionally high volume of product? I've heard from some of you that it's an hourly--that workers are paid hourly, but I want to know industry-wide is that standard, or are there incentives for people who pick an exceptionally high volume of fruit?

MR. BAKER: I'll speak to what I know best, and that's the Eastern situation. We don't pick fruit by the hour. If we pick fruit by the hour, we have a tendency that we get everything. We pick fruit according to quality. We work what we call in our industry a piecework. If they pick hand-picked fruit with no bruises, 5 percent or less, we'll pay, for example, 70 cents a bushel. With the processing industry, we may let them speed up, and the only reason we'll let them speed up and the only difference in the process business--we've got some processors here, and they won't like hearing this. But we will allow a little bit more bruising. That's the only difference.

If a picker--we have more disincentives in our industry than incentives, in a way. If a picker is caught picking up drops or commingling bad fruit because he's working on a piecework basis, we just--we set them down or we don't allow them to pick because the by-product is just too costly for us. We can't allow that. So, yes, we definitely do it on a piecework. There's an incentive. There's basically three different prices. And when the picker goes to the site, he knows specifically what he's doing, which product he's supposed to do and what the standards are.

DR. GRAVANI: Did you say less than 5 percent bruises and 75 cents a bushel?

MR. BAKER: For fresh fruit, yes, sir.

DR. SHANK: While Dr. Griffin is coming up, who's controlling the lights? I'm afraid that this group up here may be going to sleep. We need to get additional light on the subject. Thank you.

Yes, Patty?

DR. GRIFFIN: Yes, I'd like to thank the growers for their clarification of the industry. It has helped me to understand it a little bit, but I still don't understand a lot about it. And just for clarification, it would help me if instead of--if I had just come in to the afternoon meeting, I think I or a reasonable observer might have concluded that it wouldn't be possible to have contaminated juice. And yet we all know that it happened. And so could you focus, instead of on how it couldn't happen, on how it could happen? Because we know that it did happen.

One of the things to consider is the irrigation water that's been brought up, and after our traceback of cyclospora outbreak due to Guatemalan raspberries, we think that the Guatemalan raspberry producers should use only potable water to spray their raspberries, to mix with the pesticides that they spray on their raspberries. So I'd like you to consider that as one of the possibilities, but any other possibilities that you can think of for how we could end up with contaminated juice.

DR. RICKER: I don't know.

Let's start with if apples are picked--let's use some of the cases that we were talking about already. I'm talking about something other than Odwalla because I think the book's still out on that one in terms of exactly what happened. Is that fair? Okay.

Some of the others we know for sure, relatively sure, that drops were actually used without going through a packing house.

DR. GRIFFIN: We know that in some instances drops were used, and in other instances drops were said not to be used.

DR. RICKER: If drops were used, can we agree then that that's one way it can happen? When they say drops were not used, can we be guaranteed 100 percent that there were none there? I don't know the answer to that one, but I don't think I would go on record as agreeing that that is 100 percent sure.

Is there any other way that it can happen? When we get into any of the other possibilities, we start really stretching the odds out. I mean way, way beyond what we're doing when we're talking about the drop situation itself.

If you're talking about contaminated water, even if there is water that could possibly have been runoff water that was contaminated, will E. coli grow in runoff water? I question if it would, which means that you've got a tremendous solution factor there to plug into the picture. If you are thinking in terms of human handling, is it possible? Sure, it's possible. Is it probable? Don't think it's highly probable, even if an individual were infected at that point.

So is that beginning to answer the question at this point? Those are the primary places that at least we've identified.

DR. GRIFFIN: Let me just answer one--I think that's helpful. I don't think you have to postulate E. coli O157 growing in runoff water. We've had an early isolation from reservoir water outside Philadelphia in Abington, for those of you from Philadelphia. We've had outbreaks of O157 from municipal water and from people swimming in a lake. So that, clearly, low-dose, people can swallow the water. So you could imagine it being sprayed on a fruit and somehow then multiplying subsequently.

DR. KUPFERMAN: I'm an educator, an adult educator in Washington State, who--I put together an annual post-harvest conference in March. I think that t he Washington State industry believes in education and research to the point where they put up $3 million a year for research. I think that I would be fairly safe to say that nationally through the U.S. Apple Association or the Washington industry or whatever, I think these growers would like to sit down at the table, talk with you folks who know the research, about where the greatest risk areas are, partner with this industry, and then walk through the process of education before rulemaking occurs. And I think that they will listen.

DR. OSTERHOLM: I think one of the things that's very critical here, as I listen to the discussion today, I get the sense that the industry is here to share with us what is largely a very positive record in terms of the wholesomeness and really the viability of this industry. And I think those of us that talk about outbreaks tend to come in as if--we're perceived as we're out to basically do something here that you all don't want done. I think we're much more akin to what Ben Franklin once said. You know, we must hang together, or surely we shall all hang separately. And I think that there's a lot of truth to this, because if we don't take care of this problem, we could be coming up with two or three or four more outbreaks a year, even if they're small outbreaks, that in a numerator/denominator combination still would make you wonder why we're doing anything, I can tell you consumer confidence in any apple-based product is going to drop dramaticall y.

So it's in your best interest, it's in our best interest to make sure that we find out what the problem is, or problems, and put the stop-gap measures in there. And one of the same things that comes back to me over and over again is that if you can't figure out exactly why they're happening, then you're going to have to take broader steps that will cover a variety of situations, some which may seem to be overreaching or overbearing, but short of not knowing.

And so I think one of the things is--and I appreciate your last comment that we need to figure out what we can do together in partnership and research here, but I think you need to understand that from a public health perspective, we're sensing already a lack of public confidence in what's happening out there and that all of you have an interest in. And if you have some bad--quote, unquote--apples out there that are making the industry look bad, even if it's a small outbreak of only 40 cases associated with a cider in some regional situation, people are going to remember apple cider did it again. So I think that the industry is going to have to come together.

We've seen the same problem with the meat industry. The big meat packers have done incredible things in the last three to five years to deal with the issue of E. coli O157:H7. The biggest problems we have right now are in the small packing plants who do not want to have HACCP standards, do not want to approach this, and they're the ones that are giving the bad name right now to the entire meat industry.

So I think that's going to be an important--we have much more here in common than we have different.

MR. BAKER: I certainly appreciate your comments. Representing the growers, if we've said anything to offend you, I apologize. But as I commented up there, the way I look at it, there's ten doors. We come here exposing all ten doors to you. Hopefully you'll learn from us and we can learn from you. Because, again, if the consumers lose confidence in our product, we're nowhere. So we concur wholeheartedly.

MR. BARTLESON: One of the things that I think is kind of interesting is that we have pickers who are picking with bare hands, and we know that from past experience on our previous field trip that while we have wonderful port-a-potties out there, we may not have any h and-washing facilities with any water in them, certainly no soap and towels.

We find that tiny specs of feces, if they're from a person who is sick with E. coli, can harbor a heck of a lot of germs. And if you grind that up in a big batch of apple cider, I think you can have a lot of contamination from one food picker, shall we say, who doesn't have very good personal hygiene. So I think that's a real issue. We have lots of situations where agricultural workers are not subjected to, shall we say, premier living conditions. They may well be living in places where the sewage is running in the stream, where the housing is crowded, where the water systems are substandard. So it's entirely possible sometimes that the agricultural workers may be more likely to be infected with pathogens, and I think that there's the whole issue of education. Is anybody actually talking to the workers when they come into the fields about the fact that it really is important to wash your hands after you go to the port-a-potty? I don't know if that's happening. I kind of doubt it somehow.

MR. SEXTON: I'm Robert Sexton with Orchid Island Juice Company, but I'm mostly a grower. My wife runs the juice plant. We both own it together. But I'm mostly a grower, and I can tell you that's just what's happening. The laws are in place for the workers to do everything and have the port-a-potties out there. Real world, real life, you guys don't--regulators don't want to hear it. They're not being used. They go out to the field and people don't use them.

But I don't think that is the problem. I don't think your problem with E. coli is in the field and with the workers and with the water. Everything is the apple guys--now, I don't know the apple industry, but I can tell you if it's just like Florida, we're all doing basically the same thing. There's little variations as far as the horticultural process. That's not the problem. If it was, then you'd be seeing E. coli outbreaks every day. That's not it. I think you can isolate this whole problem down to plant sanitation and things that happen in the plant. You need to regulate it there, and that's where it needs to be controlled, because it's not a grower phenomenon. If it was, you've have a common denominator every single day from people--because we all do the same things every day, day after day. That's not it. When you have outbreaks that occur, generally you can go back to the plant and find where there was a breakdown or a letdown in the sanitation or the grading or the chilling system.

So I don't think the growers are the problem here, fellows, and I don't think we have to look far and wide about where to find and isolate this problem. I think if you have good manufacturing practices and monitor the plant sanitation, you can solve this problem.

DR. VESLEY: I'd like to come back and ask a question about water quality, the criteria that is used for washing apples again. Is the only thing that is a criteria is the amount of sanitation material in either chlorine or phosphoric acid or whatever else is being used? Is that the only criteria that you are using, or is there other criteria as to when you throw the water away and put in new water?

DR. KUPFERMAN: Okay, you can get rebuttal.

 Laughter.

DR. KUPFERMAN: The changing of the water in the packing house has, in part, to do with some interesting new waste water regulations that the Department of Ecology has put in regarding Washington State where they don't want you to get rid of the water.

On the other hand, you have an issue of trying to get rid of the water as frequently as possible because what ends up happening, obviously, is that the dirt begins to accumulate in the water.

So one regulating agency is telling you, you can't dump the water, and the other regulating agency is telling you, you better.

The criteria or the testing of the water, which I think is your real point, is only done with regard to chlorine levels, is done with regard to clarity, et cetera, but there's no microbial investigation of what is in the water, and we look to you folks to tell us what ought to be done.

DR. GRAVANI: A follow-on. A recycling of water, Gene, what's the industry practice? Give us a handle on that, if you could.

DR. KUPFERMAN: Well, X-number of bins will be run. There are five or six or seven water systems within the large packing house, and the most contaminated one would be the first one that is seen there. That has changed most frequently, but there are no standards as to how often this should be changed.

Now there are beginning to be standards with regard to the sodium accumulation from sodium hypochlorite and chlorine. Sodium levels and conductivity go up, you end up earning apples.

DR. OSTERHOLM: Again, as an epidemiologist, I come back to trying to learn from our previous examples. We heard this morning about the Odwalla situation. How can we relate something about water or change in practices or a facility that was not well run or hygiene problems to that outbreak?

I don't know, but from what I saw this morning and from what I know about the reestablishment of the investigation, I think many of the plants in these United States would be so lucky to run as well as Odwalla did and how they do their thing, and yet, that outbreak occurred there.

So I think that that's interesting to have this blanket, you know, if we just improve, we'll be okay. It's your comments here about the issues around the water and if we're not watching it close enough. There was nothing here that appeared to change in our line.

In asking further follow-up questions, product coming in seems to be a bigger determining factor than a sudden change in plant practice, plant hygiene, and that's where I think, again, we come back to. That doesn't seem to be enough.

DR. KUPFERMAN: Let me just clarify something. The packing houses I'm working with are the fresh market packing houses. They are not the processing industry.

I would love to have you come on out in March and tell us what we ought to be doing in that area.

DR. OSTERHOLM: But if it's happened in the fresh situation like that, obviously, it could happen where you're actually packing it and putting away that kind of thing. There is really not a whole lot of difference here in terms of one is just a different vehicle, it's immediate, it's now, it's in the product, it's out there. Another one may mean a delay before it hits the public kind of thing.

DR. BUCHANAN: Can I ask for something? I have visited a limited number of apple plants and also other fresh fruits and produce, and there seems to be a propensity for putting catwalks over flumes. Is that a common practice where you actually have a metal grate catwalk over the flumes where the product is moving?

DR. KUPFERMAN: If you have to go from point A to point B, that is done. They are not put there capriciously, and they are not put there -- this is done within a plant in order to get from point A to point B.

DR. BUCHANAN: But they are usually open grate.

DR. KUPFERMAN: They are open grate.

DR. BUCHANAN: What kind of footwork controls were there in these types of plans?

DR. KUPFERMAN: Tell us about what should be there.

 Laughter.

DR. SHANK: John?

DR. KZENBERG: Yes. I had a follow-on question. A lot of discussion had gone already on chlorine levels. In addition to chlorine, I realize we are going to be talking about sanitizers tomorrow.

Are there other effective means for maintaining a sanitizer or residual at higher levels? Would you care to comment on some compounds that may be effective, given high organic loads?

DR. RICKER: Other compounds other than chlorine, per se?

DR. KZENBERG: Yes, sir.

DR. SHANK: You can dodge that one and say we'll get to that tomorrow if you want to.

DR. RICKER: I'd rather do that.

 Laughter.

Actually, just two things, John. First of all, chlorine dioxide is used to some extent, but not as much as it used to. The other one, there are QUATS used after hours, but of course, that is not something that you can put right on it right away.

Other than that, I don't know, and I will defer until tomorrow. Is that okay?

K: Okay, thank you.

MS. SEXTON: This is just in referencing to get your Florida citrus processors license. You have to have water potability tests done and given to the USDA before they will even consider giving you or renewing your citrus processing license. So the water is checked as far as Florida goes.

DR. TENZER: To answer the question about the concentration of chlorine and to maintain it at a sanitizing level under real conditions, I would like to address this issue by saying that about seven years ago we had developed a system that potentiates chlorine, and hopefully, tomorrow, I can give you more details about it, but it is available.

DR. SHANK: Good.

Yes, Bob.

DR. BUCHANAN: Can I ask, do you know of any common market defects that would result in an increase in pH in a localized area in the apple?

DR. RICKER: Bob, all I am going to do is clarify a little bit. When you say localized area of the apple, are you talking about the individual fruit or the area?

DR. BUCHANAN: The individual fruit. Are you aware of any market defects, fungal infections, et cetera, that might get a juice apple with an increased pH?

DR. RICKER: I don't know. I really don't.

Do you know, Paul? I don't know.

DR. SHANK: Okay. Let's take a break. If we take a 20-minute break, then that will still put us about 10 minutes ahead of schedule. So five minutes after 4:00, let's reconvene, then, promptly, please.

 Recess.

DR. SHANK: I said earlier today that the program up to this point was primarily designed to do two things, and that is to give us a background of the situation, a better understanding of the pathogens, the emerging pathogens, what went on during the Odwalla situation and other practices relative to the production of juices and in the growing and harvesting practices for the products that are destined for further processing.

From here on, we are going to be talking about or considering what the appropriate actions might be. We are going to start off with the appropriate GMPs, and to get a few more in, I am going to quit talking and introduce our speaker.

As you know, you have got to try to do anything at 4 o'clock in the afternoon to get the group back together.

Our next speaker is Dr. Barry Swanson, and I am going to go ahead and introduce him now. He is the individual who has to catch a plane, yet, this afternoon.

Dr. Swanson is professor, Department of Food Science and Human Nutrition at Washington State University, and he is going to address the subject of appropriate GMPs for the production and harvesting of fruits and vegetables.

Barry?

DR. SWANSON: Thank you very much, Dr. Shank.

I appreciate the opportunity to give you a few opinions and perspectives of mine about GMPs and appropriate GMPs for the fresh fruit juice industry.

I think the things that I have put on these overheads in most cases are very apparent. In this case, of course, we have just heard from a grower and understand that fresh fruit is very safe. I think this is a matter of risk, a matter of looking at potential contamination, and also partially because the fear consumers have of not only pesticide residues, but other microbial contamination, but they have been educated to wash fresh fruits and vegetables quite well. So there is a limited contamination or limited number of incidents associated with fresh produce or fresh fruits and vegetables.

The principles of sanitation are generally followed very well with produce we know comes from the ground.

We also know that adequately pasteurized fruit juice is a safe product. The key here, of course, is adequately pasteurized and not contaminated following pasteurization, but we do know that if we pasteurize fruit juice, it is safe with respect to E. coli and Salmonella and a few other of the heat-sensitive organisms.

I think the last statement on here is one that you have beat around with questions this afternoon, and that is that it is necessary to educate the consumer that safety does not necessarily mean risk-free; that safety or risk-free don't necessarily mean that we're not consuming microorganisms.

In my judgment, the consuming population has a very poor understanding of what microbiology means. When you can't see it, I guess you don't pay too much attention to it, but I think we have in many cases found it more difficult to explain than to just ignore what is going on with microbiology and our food products.

We do have a long listing, of course, of GMPs, good manufacturing practices to deal with sanitation. They deal not only with sanitation practices in the food processing plant, but also with raw materials and ingredients that go into our foods.

I believe, anyway, that these manufacturing practices do, in many cases, for the most part, anyway, fulfill their goals or we would have a lot more problems with food-borne diseases, and these GMPs, of course, state that the sanitary practices must be adequate to accomplish good public health practices; that the food products produced shall be safe for the consumer; that we should be looking at these practices not only as I mentioned for the processed material or in a processing plant, but they should go from, in this case, the orchard to the consumer.

We should control this product from the orchard to the consumer, and in the case of apple juice, of course -- and I just stuck apple juice in here -- the GMPs are to assure that human consumption of this product is safe.

These things now mean that we have a fresh fruit juice industry that is not safe. I don't believe that is the case. I believe there is a niche for the fresh food industry and that we should, if we can, provide some GMPs for the small processors, perhaps for some people who aren't as aware of microbiology as are the large processors who we heard from earlier today.

So, for making apple juice -- and I just use apple juice as an example, although I understand we're discussing different pathogens and all of the fruit juices -- if we look at fresh apple juice, we have a list of properties, commodities, unit operations that we must take into consideration. We have to take a look at the apples, of course, and the source, and we have discussed that at length, and we will talk a little bit more about it.

We must look at transporting, sorting, cleaning and sanitation, pressing -- preservatives, I believe should come into this, and packaging and shelf life. So there are a lot of different areas that must be addressed by the GMPs.

When I was asked to do this, the first thing I did was to take a look at what was in the literature, and this will answer one of the questions that came up earlier. There are some research manuscripts. As you will note, this one on top from Goverd is from a few years back, 1979, the Journal of Applied Bacteriology. Then, there is one from Mike Doyle's lab in Georgia, 1993, and there is a third article from Cornell, 1995, I would like to address.

This first research manuscript was basically a study done in England, and it was done a number of years ago. So it is probably not as appropriate as we might like to think. The study was done on groundfalls or grounders or whatever we want to call them. Using groundfalls for cider is a common practice in England for their production of juice, and they went so far as to say that they felt that coliforms -- not E. coli 0147, but coliforms were perhaps a natural flora of groundfall apples in England.

They also indicated that in dry years when there was not as much moisture in the orchard, they reduced the microbial loads on those apples. This is the part of the manuscript, at least is answers part of a question. There is some research done on loads in the flume water in some of the cleaning facilities that they used in England. These were unacceptably high, and it was attributed primarily to recycling the water and adequate chlorination or sanitation of the water.

They also made some comments that they believe for cider to be safe that the pH should be 4.5 or below, and I believe this was being quite generous, as I will discuss in a minute.

The second manuscript, just to summarize quickly, from the University of Georgia indicated, as was recently in Food and Chemical News that E. coli does survive to a great extent at low temperatures rather than a higher temperature, 8 degrees C. in this case rather than 25 degrees C. This was also shown for E. coli survival in water, and I presume that Larry Beuchat will address that somewhat tomorrow, or someone will from Georgia.

They also indicated, then, that benzoates and sorbates did sensitize E. coli to heat, so that it may be beneficial for us to put a benzoate or a sorbate in a fresh apple juice product.

This last article, just to give you the reference for it, it's from Cornell. It was in 1995, and it just appeared in the Journal of Food Production recently.

The summary of this article basically established some D-values, which are thermal inactivation values for microorganisms at 126, 131, 136 degrees Fahrenheit, which are relatively low temperatures. They showed that increasing the solids content of apple juice did not affect the thermal resistance of those microorganisms.

They also showed that if they reduced the pH, they sensitized E. coli to heat, and if they used benzoate acid in the system, it sensitized E. coli to heat.

So, looking at all these things and how E. coli reacts on the fruit and in the products, at least I made an attempt at coming up with some ideas for appropriate good manufacturing practices that could be applied more specifically to the fresh fruit or fresh apple juice industry.

I think it's important that we look at the GMPs that are there, which suggest that we should have records of fruit origin.

As was discussed earlier, in large operations, anyway, much of the fruit origin is lost or the names or the orchards from which the fruit originates is lost during the packing house operations.

When all of those applies that you saw in the slides are dumped into a common flume water, it's very difficult to trace those apples back to a farm, to an orchard, and it would be advantageous to do this, especially if we are producing a fresh apple juice.

If the fresh cider is produced, if the apples are growing and the cider is produced on a single farm, that would be an ideal situation, of course, but it's not necessarily the only situation that exists in reality.

We talk about cleaning fruit. It's imperative that we clean the fruit. It's imperative that we wash the fruit and brush the fruit, as you will hear in the next presentation, where it has been a success at least in one State.

It is also imperative that we keep the flume water sanitized. Flume water, as we have heard, is recycled. There is a lot of discussion about keeping 100 parts per million chlorine in the flume water. This is a very difficult thing to do if you have gone out and have seen the large water baths that are available, trying to keep an organic load balanced with chlorination.

There is a discussion of using chlorine dioxide, which is more expensive, but perhaps a little bit more effective. Maybe these are some of the things that GMP should direct as to what levels the sanitation, what levels of chlorine, what needs to be looked at in this flume water.

I believe that in many cases, the flume water, of course, which is the first exposure of most apples to assist them that they can become a soup or a microbiological media, flume water is probably the area of significant contamination.

Then, to address a few other issues, the good manufacturing practices should address cleaning and sanitizing totes. It should discuss where those totes originate or the transport originates. GMPs should address both pressing and packaging equipment. As it was discussed earlier, perhaps we could solve all the problems by cleaning and sanitizing processing plants. I don't think that has been the case in the past, nor will it probably be the case in the future.

The hygienic practices of employees is interesting. I don't think anywhere from the orchards to the processing plant we will ever be able to, 100 percent, control the hygienic practices of employees. It seems that there is a double standard.

I have always heard the story that there is the employee in the rest room that was running out to get back on the floor, go from the rest room back down the hallway, without washing his hands. So his boss went and tapped him on the shoulder, and the response of the employee to the boss saying, well, you didn't wash your hands before going back to work. Well, he wasn't going back to work. He was going to lunch.

 Laughter.

DR. SWANSON: So it is just kind of a double standard. You are encouraged to wash your hands. You wash them. If it's because you are afraid of the microorganisms, that is something completely different. I think we somehow have to educate employees and personnel to know that this isn't a double standard, that it is imperative for sanitary purposes that they wash their hands and maintain good health.

Also, it may be necessary to put in some good manufacturing practices that do establish a pH that is appropriate for fresh fruit juices, perhaps a pH at least less than 4.0 and perhaps lower than that both for the reduction in the number of microbial to the microbial load and in juice products, but also so they are not just going to grow it under any conditions.

I think it is probably also appropriate that we address GMPs to preservatives, such as benzoate acid and sorbate acid and perhaps others that may be beneficial in reducing E. coli and other pathogen counts in fresh juice.

That is my attempt at running through a number of appropriate GMPs that might be used, and I think, as I mentioned, there is a niche, at least in my mind, for the fresh fruit industry. I think the GMPs we have in place in many cases would benefit or would allow small cider mills and fruit processes to work with more sanitary -- under more sanitary conditions.

I think if we just applied those GMPs, perhaps more specifically, instead of such large volumes as they are presented at the present time, that the small processor may be able to sort through these and work with them a little bit more accurately and precisely.

Thank you very much.

 Applause

DR. SHANK: Thanks, Dr. Swanson.

Our next speaker is Frank Carlson from Carlson Orchards. He will be speaking about some future GMPs for the apple industry.

MR. CARLSON: Thank you, Dr. Shank.

I guess there are a couple of things that we should probably -- or I should probably set straight before we get started. First is I don't have a Ph.D. before or after my name, and number two is that I am not a real professional public speaker. So, if you can bear with me, we will probably get through the next few minutes just fine.

As the previous speaker, as Dr. Shank said, I am from Carlson Orchards, and we are in the lovely little State of Massachusetts, Harvard, Mass, about 30 miles west of Boston. My two brothers and I run a family fruit corporation where we grow, store, pack, and ship apples from about 150 acres, and we produce around three-quarters of a million gallons of fresh cider, unpasteurized fresh cider annually.

At present, I am chairman of the Massachusetts Cider Guild, trustee of the U.S. Apple Association, and chairman of our Cider Subcommittee. I would like to thank this committee for allowing me the opportunity to take a few minutes to present some information to this very important meeting.

Every other speaker today has brought something different to this group, and I guess I want to continue along that course. I am going to step back to the winter of 1991-'92 when, to my knowledge, we had back in Massachusetts the first incident of an E. coli outbreak that was related to apple cider.

I believe it was around January 3rd, I got a call from our commissioner of Agriculture, and he said that he had just been notified by our Food and Drug Department that we had an outbreak that they had isolated to some production of apple cider.

This outbreak had occurred in the fall, and here it was January 3rd and we as a grower or producers were just being notified of it.

So FDA, the Food and Drug Division of the Public Health in Massachusetts, called a meeting, and at that time, they suggested that our Cider Guild -- we had a Cider Guild that had been formed a few years previous for the purpose of the promotion of fresh cider in the Commonwealth.

They suggested that our Cider Guild take some steps to self-regulate our own industry, and the bottom line after some discussion with them was that if we didn't do it, they would kind of step in and do it for us.

The committee from the Cider Guild thought that we had an opportunity to seize here, and we basically felt that we had an opportunity to start a certified cider mill program in the State that would set our cider apart from other cider producers in the State if people wanted to be part of our organization. So we set up a certified cider mill program.

We also went to fruit meetings a few weeks later from that first original meeting with Food and Drug, and at that time, Food and Drug and the CDC conducted a survey at that meeting. It was a meeting of New England Fruit Growers. So we had a good representation of cider producers from around New England.

One of the significant results of that meeting and the survey was that we discovered there was a fairly large percentage of cider producers in New England that were not washing and brushing their apples prior to pressing, and that came as kind of a surprise to a lot of us that have been producing cider for a number of years, all along thinking everybody was using washers and brushes, but to discover that they weren't was kind of an eye-opener to all of us.

As a result of those surveys, we basically formed a certified cider mill program. At that time, the Cider Guild hired an individual on a per diem basis, Mr. Robert Smiley, and he is here for two days.

Bob, if you would just put your hand up in the back there.

We hired Bob as our certifier. He accompanied inspectors of Mass Food and Drug for three days. He actually had three different inspectors. He was with the three different inspectors on each successive day, and they went through with him what they would do if they did an inspection of a cider mill.

Basically, the Cider Guild adopted the inspection checkoff sheets that Mass Food and Drug uses when they do wholesale cider mills.

I guess it might be good to point out that in Massachusetts, the inspection procedures for the Department of Food and Drug is that the State inspects wholesale mills; that is, a mill that produces cider and sells to other resellers, and it is up to the individual communities and their boards of health to inspect what we call retail mills. Those would be on-farm cider mills that don't wholesale, that sell direct farm sales at the door.

So we basically adopted their checkoff sheet. I must say that after the last discussion this afternoon that a water test is mandatory for a certified cider mill program in Massachusetts. That's one of the minimum criteria.

Our Mass Cider Guild certifier has no regulatory authority. If the certifier finds irregularities in a mill when he goes to do an inspection, we notify -- if it is something that can't be worked out with the producer, we notify Food and Drug.

This is an arrangement that we had with the Food and Drug people when we first started because we said to them how could we enforce or how could we make a program work.

So, basically, they told us put the responsibility back on to them, and that is where we want it because we don't have regulatory authority.

So, if we have a problem, and we have had a couple, Bob makes the call to the State people in Boston, and they follow up either with a State inspection or they bring in the local board of health and correct the problem at that level.

We have a $100 first-time certification fee, which includes a sign for the cider mill and the certification mill, and the annual fee thereafter is $75 a year.

Before the cider mill program went into effect, we had one big problem when we first started out. There were three different lists circulating in the Commonwealth. Food and Drug had a list of producers. Food and Agriculture had a list, and the Mass Fruit Growers or the Cider Guild had another list.

It now appears that we have got just one good list within the Commonwealth, and now everybody is working from the same list.

It is estimated that there were some 108 sites that produced cider back around 1992. Now, we say sites because some of these places produced as little as 400 gallons a year, and some of them produced 5-, 600,000 gallons a year. So you have got all types and sizes of operations here.

In '96, we have less than 80 sites, and we have got about 35 certified mills in the Commonwealth. Most of those 35 -- the 35 comprise most of the volume in the Commonwealth right now.

I might point out that there is a case study in cooperation that the Mass Division of Food and Drug wrote as a paper; that they wrote on food safety program and the Mass Cider Guild. This was a cooperative effort between the two, and it was published in their Food and Drug Reporter that goes around to different food and drug divisions around the country.

Regional approach. Recently and obviously since this last fall, there has been a great deal of interest at the present to expand our Mass Cider Guild into a regional New England guild, with a certified program in all six New England States.

There is already a meeting scheduled for our winter fruit meeting on January 23rd at which time a proposal will be given to those in attendance, and there will be representatives from all of the New England producing States there.

It is very possible that a formal vote will be taken or could be taken by June so that a regional certified program could be implemented by next fall. This is moving along, I'd say, with great rapidity right now.

Mass Cider Guild currently has an existing flow chart or a draft -- we call it also a draft HACCP plan -- that we use when Bob goes to the mills.

Depending on the outcome of these meetings, these hearings here today and tomorrow and some of the new processes that are being introduced, we can very easily inject any of these proposals into our flow chart or our HACCP plan, making them a mandatory part of the certification process or the whole certification program.

It is also quite apparent that each mill will basically have to have their own HACCP plan for each particular site.

As far as testing, the Cider Guild has been investigating on-site testing where the producer could test samples of his product, maybe hold them for 24 hours while the samples are being incubated, and then results obtained. Obviously, E. coli is one of the primary ones that we would be looking for, but there are other items that could be monitored and obtained, also.

The goal of the Mass Cider Guild -- or the Mass Cider Guild has one very important goal, to help or assist our producers, to produce the safest, most wholesome, high-quality apple cider possible.

To continue on this goal, we are ready to adapt to whatever new processes that are developed or recommended to produce an even safer product. Pasteurization has and will be touted as being a cure-all for some of the recent juice problems, but we have to take a good, long, hard look at the history of apple cider.

We also have to look at the increase in demand by consumers of fresh, unpasteurized apple cider in recent years.

Personally, in our own operation, we have been having some of our product pasteurized, and even though the product has not changed significantly, when it is processed by flash pasteurization, there appears to be significant changes in flavor within a week or two, leaving some of our consumers with a bad taste to what they usually get as a high-quality fresh apple cider.

The Cider Guild will be happy to try to answer any questions the committee may have now or in the future upon making some of your recommendations.

The U.S. Apple Association, here in Washington, is in the middle of a research project on unpasteurized apple cider safety, and the U.S. Apple Association will be more than happy to work with the committee and the Food and Drug agency to obtain whatever we have to do to come up with a real safe apple cider.

Thank you.

 Applause

DR. SHANK: Let's move, then, into our Pubic Commentors.

The first person that I have identified is Dotson Bennett.

MR. BENNETT: Thank you for the opportunity to address the meeting.

My name is Dotson Bennett. I am the CEO of Paramount Premium Juice Company in California, Southern California to be exact. I am going to talk about basically five areas of a subject which we think is very important to us as fresh juice producers.

I will tell you about who we are, Paramount Premium Juice Company, an overview of the fresh juice industry in Southern California and Nevada, our position on regulation, and the consequences of requiring pasteurization of a fresh juice product in our opinion.

Paramount Premium Juice Company is the successor company from a much larger company called Paramount Citrus. We acquired the company over a year ago, myself as a major officer and employee of that company, along with some of, we think, the qualified employees to form Paramount Premium Juice Company, and have continued to serve the customers that we were serving as our predecessor, plus added to our customer base.

Our company does about 30 million servings a year. That translates into about 300,000 gallons. We are a food service company primarily. We rarely do sell to anyone that is retail, and our market area is primarily Southern California and Nevada.

We produce and we sell to about 70 percent of the consumers in the fresh juice market and food service in Las Vegas, as an example.

Our market is exclusively food service, and about 70 percent of our marketplace buys our products in gallon jugs.

Our market is in orange juice, grapefruit juice, which has a shelf life of about 12 to 14 days when refrigerated between 32 and 36 degrees and with lemon or lime fresh juices that last about 30 days under the same refrigeration. So we must be cognizant of not only ourselves in terms of making sure that the product maintains its shelf life, but that it arrives to the consumer in time to consumed in a quality that they are expecting of fresh juice.

Somewhat of an overview of the fresh citrus juice industry in Southern California will allow us to understand that there are about three major producers in Southern California that extract bottle and ship either to distributors or directly to food service operators. There are probably two or three other minor operators.

The three major operators produce about 100,000 gallons of juice a week in which they distribute either themselves or through distribution companies.

The minor operators probably produce around 15-or-so-thousand, and this is a year-round business in which we use fresh fruit and juices available, depending upon what part of the country they are coming from.

About 20 percent of the tens of thousands of food service operators in Southern California squeeze their own juice, all the way from small restaurants to some larger hotels, and this is a significant issue and thing to remember because many food service operators, certainly more than 20 percent of the industry, food service operation industry, used to squeeze their own juice before people like ourselves came into business, and that is probably what will happen if pasteurization occurs.

There are literally hundreds of street corner operators in the Southern California area that sell fresh fruit and some fresh-squeezed juices. They buy some of these juices from commercial operators like ourselves, and we suspect that they squeeze some of their own.

In addition to that, there is a growing industry in Southern California and Nevada of juice bars, which extract their own fruit for the most part, although they do buy some of it from commercial operators.

The major extractors, bottlers, shippers in Southern California conform to industry standards that can well be described as good manufacturing practices, and most all of us are in the process of adopting HACCP plan to some degree.

The industry appears to be determined to keep producing a quality, fresh-squeezed citrus product to provide to those millions of visitors and residents in our market area.

The producers are currently inspected by either the State, County, or local health departments in addition to the FDA, which can come in at any time, and other inspection agencies.

Our own company voluntarily subscribes to KSA, which is a Kosher supervision authority of the United States, and we like to say that we report to even a higher authority than the FDA.

 Laughter.

MR. BENNETT: The rabbis are in our plant frequently testing the product, looking at our sanitation processes, and getting some free samples.

 Laughter.

MR. BENNETT: They do an excellent job, and we are very pleased to be able to know that we are approved by the KSA, which is the national Kosher Supervision Agency.

The enforcement by the health departments, whether they be city, county, or a State within California, they enforce the sanitation standards by statute that we, too, must comply with, and they are not bashful about coming in and letting us know how they feel about how we are operating.

So we advocate as a company standards that are acceptable to the industry, and if they are uniform on a national basis, we have no objection to that. We are looking to embrace practices that will ensure us that everyone in our business conforms to a practice that will produce a safe, fresh-squeezed product.

We oppose pasteurization without hesitation and without reservation. We oppose it for several reasons. One, we got a business. We think that is a fairly good reason. Secondly, we oppose it because it won't work. And why will it not work? While our business is only on the food service side and we do not sell to retail, not knowingly do we sell to a retail operator, every food service operator in Southern California and Nevada that I have knowledge of -- and I know thousands of them -- sell fresh-squeezed orange juice and grapefruit juice and other citrus products at a profit margin that far exceeds their liquor.

They will buy what is equivalent to a serving of one of these fresh juices somewhere between 8 cents and 32 cents a glass, and they will sell it from anywhere from $1.75 to $4.40. I assure you that if there are regulations that require pasteurization by the industry, what will happen is that those operators will squeeze the products in their back rooms, and it will be impossible to enforce standard regulations for them.

Thank you for your time.

 Applause

DR. SHANK: Thank you.

William Brinton.

MR. BRINTON: Thank you very much.

I am going to read a statement. Before I start with my comments, I would like to thank all the various people involved with this conference for putting it together. It has already been very enlightening and interesting to me. I learn about new different things that we can bring into our factory, and this is really positive.

As we learn more things, we would be very willing to share the information that we learn with other people in the industry to help product safety become more enhanced.

We are doing some tests this week, and if they become promising, we'll certainly share that information with people.

My speech will talk about our company briefly, and then I would like to talk about a couple of policy issues that have been raised in the last 30 days.

My name is Bill Brinton. I am the president of the Wine and Beverage Company in the San Francisco area. We are a fresh and fresh-blended juice company. This includes fresh apple juice. However, apple juice does not play a major role in our overall revenue stream.

Our company was founded in 1988 by another individual. Our trade area is northern California. We currently employ 65 individuals utilize a DSD system, and our trucks service 20 routes, 6 days a week.

I have been in the food business since 1988, when I and two others purchased Homestead Foods, a fresh and frozen pasta products and sauce company that operates a USDA plant, also in San Francisco.

I would like to make some brief comments about our apple processing and quality and safety programs. We purchase apples from the State of Washington, and the comments earlier from the different gentlemen from the Washington State was very interesting. I was happy to see all the different things going on up there. I did not know about all that, but we had been trying to find out as much as we can. I think this forum is excellent for this kind of exchange of ideas, and I hope that we can do it again sometime in the future.

The apples we use are picked from trees and basically are the same apples that are in the supermarkets. We practice GMP, and we have developed a quality assurance department in our company staffed by individuals with many years of experience dealing with food processing, quality and safety issues.

We are just about to complete our HACCP process and issue our first HACCP plan. We regularly do microbiological testing, sampling and analysis that is outsourced to a large independent testing laboratory in that area.

Shortly, we will have some in-house facilities for testing for different food-borne pathogens. We visit our fruit and vegetable suppliers and consider the relationships with them, with these suppliers in partnership. We like to know what they are doing, they like to know what we are doing, and we like to have good exchanges of ideas going back and forth between us.

Our agreements with suppliers specify no grounders in the apples orchards are not grazed by livestock according to the policy of the packing houses that we use in the State of Washington.

We have had an ongoing program utilizing outside consultants to inspect our plant operations much the way an outside auditor issues reports and opinions on financial statements.

The apples we process are hand-inspected, chemically washed, and power-scrubbed and rinsed in our plant before they are pressed into juice. We believe our apples have been inspected, sorted, cleaned, and are scrubbed about seven to eight times before they are pressed. In short, we believe that our procedures are adequate to ensure the quality and safety or our product.

On November 18th, we were very dismayed to be essentially indicted as part of the apple juice industry by the company that was the subject of the FDA investigation. We felt that this indictment of the industry was somewhat ironic.

The instances of E. coli 157:H7 in fresh juice and product are relatively rare compared to the total volume of juice and produce consumed in this country. No matter what we do, no matter what we did, no matter what the source of our fruit, the inference was that we should immediately halt production of fresh apple products.

This November 18th date is important for it was about this time that the FDA report on the plant in question was released. The apparent strategy of talking about the industry and having the report come out about the same time, we think, was intertwined very carefully by this company.

The apparent strategy worked. It reflected a little bit of opinion from their company. Our papers finally broke the story about the FDA report after they found out about the report via a Seattle Times article. Prior to that, local newspapers had been filled with industry and trouble stories in the resultant apple hysteria of 1996.

So, in conclusion, what can we learn from all this? One is, food companies selling products to the public, we have a responsibility for our actions and to be careful in what we communicate to the public, via labeling, advertising, and through the news media.

We recently had a competitor in our market that put labels on its fresh products that said contains no water. When this was brought to the attention of the appropriate California authorities, they initially said, "So what? It's an accurate statement."

The company bringing the complaint said, "But if this is next to my fresh product without the label, what will the public think?" The agency agreed to think about it further and later called the complainant company and agreed that the labels were misleading because a fresh product, by definition, would have no water in it.

This was six or seven months ago, and I'm not sure exactly what's happened, but I would hope that out of these kinds of things, public agencies would be more strongly proactive in the future with regard to labeling claims.

Well, when labels come out that say "contains no apples," appear next to products that contain apples, fresh or pasteurized, what is the public to think? Are apples evil? Are apples intrinsically bad for consumers? They, the public, showed what they thought and bought a lot less totally safe apple products because one party in the industry had caused great alarm in the marketplace through labeling and public comments.

My second and final conclusion is that a company should be careful about the statements they make about nutrition. Fresh apple juice is not materially more nutritional than pasteurized. It just tastes better, but to hear comments about pasteurization nutritionally degrading products just isn't supported by the facts. A company should be careful to separate marketing from science in the future. This is owed to the consumer in the future.

In conclusion, we will be continuing to explore new technologies and processes to improve what we do to make the highest-quality, safest, most nutritious, best-tasting products available. When we find out about more useful technological information, we will be pleased to share it with everyone here.

Thank you.

 Applause

DR. SHANK: Thank you, Bill.

The third person that asked to speak, at least on my list, is Mitch -- I'm going to let Mitch help me with his last name.

MR. GIZDICH: Gizdich.

DR. SHANK: Okay. Come on up here to the microphone. Then we can all hear you.

MR. GIZDICH: My name is Mitch Gizdich from Watsonville, California. I am an apple grower, juice processor. Our ranch is also open to the public. They come in and watch us make apple juice on Saturdays. They could also pick fruit during the season.

My main concern is being able to keep making a fresh apple juice for the public, and by doing so, by using the fresh apples from the trees, with all this going on, I haven't -- you know, if it's coming down to, you know, is it apples, is it apples with bird droppings, there hasn't been anything -- no one has gotten sick from eating fresh apples. I think we could make a good-quality apple juice by using quality fruit.

Everything else that we have been talking about as far as the sanitation wash and keeping the juice cool, at the proper temperatures, in-house testing -- and training the employees out in the field, in California, the employees -- excuse me -- the employer -- we're responsible for training the employees for safety standards at the job prior to working, and in that training, we train them also on sanitation.

Out in the strawberry fields, there has been a big thing about having enough outhouses for workers and being close enough so they don't have to walk far. Well, there has been a lot of A commissioner offices and people coming out and inspecting the fields in the Paharo Valley area, which is where I'm from, and there have been cases -- we have been inspected so frequently that other farmers have been cited for no toilet paper -- is $500. There have been other cases, but already, the sanitation as far as in the field, we have been inspected and have been trying to keep up with the new rules in that area.

Labeling and educating the customers is definite, and that's an ongoing process. Having the customers that come out to my ranch, they have got questions everywhere from anything on the bush berries. Well, how come you are growing raspberries and blackberries on the same bush? Well, they don't even understand that they are not ripe yet.

When a customer drinks fresh apple juice, that's -- eight ounces of juice is like eating three apples, three or four apples. It is tough for anybody to digest that quantity of apples.

So, young or old -- myself, I've got kids. I've always given them fresh apple juice, but I mixed it 50/50 just because it was such a concentrated product.

Also, customers want the fresh apple juice for making hard cider. I've got a lot of customers who will take the juice home and set it on their counter and let it sit overnight to get a little natural fizz to it, and they will put it back in the refrigerator to hold it, being that is how they used to drink their cider. They like the natural bubbles to it.

People like to make wine out of it, home vinegar. So adding any preservatives or doing anything else to the product will eliminate these other products that the public likes to make.

I do want to add, I am a member of the Micro Juice Guild, and getting together with other juicers has been a great help as far as making the product safer and getting ideas.

Anyway, there is a large demand out there, and I believe we, the juice processors, could continue making a fresh product for them. Thank you.

 Applause

DR. SHANK: Thank you, Mitch.

Our next speaker is Leonard Friedman.

MR. FRIEDMAN: My name is Leonard Friedman, and I am from Ashland, Oregon. I have a small juice company there.

After the outbreak of E. coli, I spoke to my representative from the Oregon Department of Agriculture, as well as Roger Lowell from the FDA in Seattle. He recommended that a small -- an association of small juicers, juice companies, fresh juice companies be formed. At that time, I sent notices. I got a mailing list. I sent notices to as many companies that I knew at that time that made fresh juices.

In the last two weeks, I have had responses and membership from 19 companies representing six States and British Columbia, and we call ourselves the Micro Juicers Guild. The purpose of this guild is to exchange information and to try to solve any problems that may arise and also share information that would benefit ourselves and increase the safety of fresh juices.

I make fresh juices and have been doing it in Southern Oregon since 1975.

Speaking with the guild members, we have an incredibly safe history and have for some companies as much as three generations going back for 100 years.

What we would like to do, we would like to stress the importance of offering the consumers a choice between freshly squeezed and pasteurized juices.

Our consumers believe that fresh juices offer greater flavor, more nutrients, enzymes, and many health benefits, and for this reason, we believe we have a customer base and this is what they want.

In order to increase the safety of our products to the public, as a result of the recent outbreak of E. coli contamination of apple juice, the Micro Juicers Guild will institute the following measures to ensure the safety of our juices.

First, we will have a contract with our apple growers which will stipulate purchases of only tree-picked apples and proper orchard management.

All apples will be bathed in a sanitized solution and sorted prior to processing.

An ongoing testing program of E. coli and other pathogens will be implemented. A temperature control is of the utmost importance for safety, apple juice will be immediately refrigerated after processing and kept cold during handling and distribution.

We will establish a sanitation program which will ensure the safety of our products by identifying the critical control points of good manufacturing procedures and sanitary SOPs.

In addition, the Micro Juicers Guild supports continued laboratory testing by the FDA and private industry to help educate Micro Juicers regarding the source and characteristics of E. coli 0157:H7.

I would like to stress the truth in labeling that has been mentioned. We recommend that all juice products will state whether they are freshly squeezed or pasteurized, and it should appear on the front label.

I would like to also mention the economic impact of pasteurization upon the fresh juice industry and the Micro Juicers Guild.

If the FDA requires that all juices be pasteurized, many of the members of the Micro Juicers Guild have stated that they will either try to sell their business or be forced to close it. Those companies that are financially able to invest in the pasteurizing equipment have stated that their customers expect a fresh product and want to continue to enjoy -- to offer their customers the products which they have expected and enjoyed in the last three to a hundred years.

In summary, we believe that our products have been safe for many years. In order to ensure the continuation of safe procedures, the sanitation measures which the Micro Juicers Guild have proposed will ensure the safety of their products and continue to offer choices to the public. Many of our customers have requested and insisted that fresh juices remain available for their consumption.

We have been safe. We will continue to be safe, and this is the product our customer wants. Thank you.

 Applause

DR. SHANK: Thanks, Leonard.

Our next speaker is Steven Bogen.

MR. BOGEN: Thank you, Mr. Chairman and members of the Panel. My name is Steve Bogen. I am the CEO of the Fresh Juice Company.

We are based in Florida with $40 million of mostly fresh-squeezed orange juice sales throughout the United States. I will make a few remarks, and I want to submit the remainder of my testimony for the record.

I started in this business over 11 years ago because of the continuing belief that fresh-squeezed orange juice is good for you. It tastes better, and the public wants it.

We all want safe products, and we're all on the same team. I have two messages about citrus juice. First, pasteurization does not solve any of the problems discussed here today. Second, a good HACCP plan does.

For consumers, the most important point may be that pasteurization changes the flavor. Pasteurization is not the solution.

When orange juice is pasteurized, it's before the final bottling. So, unless the rest of the process conforms to a good HACCP plan, contamination can be introduced after the pasteurization.

For instance, the only known episode of Salmonella in orange juice came from improper processing. The plant was near a marsh, open to nature, and I understand Salmonella was probably introduced from frogs in the plant.

Pasteurization would not have solved that problem. A properly followed HACCP plan would have, and as we all know, food handlers can introduce contaminants into any food at the point of preparation. That risk is increased when the food handler has to reconstitute or squeeze juice that doesn't service, as ours does, ready to pour.

Please, just remember pasteurization is not a 100-percent kill.

Second, a good HACCP plan does work. We use one in Florida that is supervised by the government, and we have a USDA inspector on site at all times, and this may explain why there has never been a problem with our juice. We don't use drop fruit. All of our oranges are graded, inspected, and sanitized with the USDA-recommended solution. The strength of the fruit wash solution is monitored continuously with an on-line meter, fitted with an alarm, and through the entire process, the juice is kept clean, cold, and consistent.

Most importantly, all juice is thoroughly tested for microbial contamination to assure that our system works. Our product is proven to be free of harmful bacteria. The Florida Department of Citrus Regulations state the program must include a microbiological monitoring component using standard plate count, coliforms, and E. coli indicators of process control that is sufficient to establish a baseline for the specific plant's process to ensure freedom from potential pathogenic organisms.

Each day's production, whichever is less, shall be monitored for compliance, stated. To summarize, a good HACCP plan works. Now, that said, a working HACCP plan may be easier for oranges than applies. Apples have crevices. The skin is thinner and subject to puncture, and the apple skin is included in the final juice.

In conclusion, first, we must make sure the plant followed a good HACCP plan. That's my job.

Second, educate the public of the potential risks, and that's your job. Although there are risks, we don't ban raw oysters or steak tartar, although the risks are much higher, nor do we mandate that they be cooked because it changes the flavor.

With fresh orange juice, I believe that it is your responsibility to inform the public that this risk is almost nil. Otherwise, the public will be misinformed, and you will have harmed the industry and the people who enjoy our juice all because you were trying to compare apples with oranges.

Thank you.

 Applause

DR. SHANK: Thanks, Steve.

Our next presenter is Paul Weller.

MR. WELLER: Thank you, Dr. Shank. We appreciate the opportunity to be here. My name is Paul Weller, and I am president of the Apple Processors Association, and we appreciate the opportunity to present brief remarks here before this forum.

The Apples Processors Association is the national trade association for the manufacturers of quality apple juices and products from the whole apple. Our member firms operate either as farmer-owned cooperatives or produce a proportion of the apples used in their processing plant.

Our members produce more than two-thirds of the apple juice processed in the United States from whole apples.

All of the apple juice processed and marketed by our members is pasteurized to ensure consumer safety. APA member firms are committed and dedicated to producing a helpful product for American consumers and, accordingly, applaud FDA in its efforts to ensure consumer safety.

Apple juice is the second most frequently consumed juice in the United States. Processed apple products have enjoyed an upward consumption trend in the United States since 1970. Approximately half of this apple juice now sold in the United States comes from fresh whole apples. The remainder is reconstituted from juice concentrate.

During the past 10 years, apple juice consumption has reached an all-time high and is now served as 17 percent of all the meals consumed in the United States.

In summary, apple juice is a major food product of the American diet, and our apple processors take their responsibility to ensure safe high-quality products very seriously.

The Apple Processors Association supports FDA's current definition of good manufacturing practices. Apple processors employ good manufacturing practices to ensure the cleanliness and safety of their apple products. Each apple that enters our APA processing plants goes through a mechanical process that includes brush washing, pressing, filtering, and pasteurization. Our members pasteurized their juice at 190 degrees Fahrenheit for between 2 to 4 minutes. Studies at Cornell University have proven this to be more than sufficient to eliminate the possibility of any existing bacteria such as E. coli.

Sterile bottles are then filled with a pasteurized juice and are sealed from the elements. Taken in total, these factors ensure a safe, nutritious product for American consumers.

We have two recommendations to make to this forum this afternoon. One, that pasteurization of apple juice should be mandatory to protect the consumer. Although apple juice itself does not contain E. coli bacteria, improper harvesting, processing, and handling practices can introduce E. coli and other contaminants into the juice.

The pasteurization process destroys potentially harmful microorganisms that may enter as contaminants. APA members take the protective process one step further. They fill sterilized apple juice containers while the juice is still heated from pasteurization. This additional step of hot filling ensures that no apple juice is contaminated with bacteria after the pasteurization process is completed.

Number two, the Apple Processors Association recommends that American consumers be given information on the product label when extra measures such as pasteurization for safe processing have not been taken by the manufacturer. We believe in an educated consumer. In other words, we believe that unpasteurized juices should be so labeled to alert the consumer to potential food safety problems so that they, the consumer, can make their food choice accordingly.

Apple processors face a challenge today, and that challenge is of ensuring American consumers of the safety of apple juice and products available in the marketplace. We can look back to the disastrous situation of alar, just 7 years ago, to see what misinformation or lack of information can do to our products. The American public must be assured that pasteurized apple juice is adherently a safe product, and this task must be a joint Government and industry effort.

When all possible safety procedures are not complied with, consumers must have the tools to make the wise food choices.

The Apple Processors Association appreciates this opportunity to present this testimony. The safety of the food supply is best ensured by the Federal Government establishing strong, consistent safety standards, monitoring the food supply, and enforcing the standards.

Thank you, again, for the opportunity.

 Applause

DR. SHANK: Our next presenter is Gael Michael Barsotti.

MR. BARSOTTI: I'm Gael Michael Barsotti. I didn't really know who I'd follow.

 Laughter.

MR. BARSOTTI: If you've ever seen a house that just pasteurizes or does what we call "hot fill" -- that's where you go into glass at 190 degrees -- you'd probably never drink apple juice again. That's where our grounders go.

 Laughter.

MR. BARSOTTI: I come from a retail market area outside of Sacramento, halfway between Sacramento and South Lake Tahoe, with about 45 members in our Growers Association. We do about a million gallons of fresh apple juice a year, never had a problem, you know, but everybody said that's okay, there's still a problem out there, but I think we've got to be careful with as few problems as there's really been with some of the literature that actually says it's not easy to get this E. coli 157 into the apple juice.

We know it's not there unless somebody puts it there or somebody makes a mistake. I don't agree with pasteurization. I've run some tests myself. Granted, the flavor hasn't been changed that much. I just hope some day we do some research on the benefits of apple juice, with the pectin and the enzymes and the things like that.

You know, somebody brought this up, and it was a good point. You know, if you are buying cannery-grade apples, an apple that goes through this line and goes to the open market -- and you can certainly hear anything about the fresh apples -- there's never been a problem in eating a fresh apple -- these are the same apples that we're using to process juice. If there's a mistake, it's a mistake with the operator.

If I make a mistake in my plant, it's my fault, not somebody else's, and I am not going to try to blame somebody else, and I am not going to try to blame the apple for a mistake I make. I've got a three-year-old granddaughter that has been drinking this stuff ever since she could start. She's either allergic to E. coli 57 or she's doing very well, and I can tell you, she's doing very well.

 Applause

DR. SHANK: Thank you, Gael.

Patrick Boyd?

PARTICIPANT: He didn't make it.

DR. SHANK: He didn't make it.

Eric Chittenden?

MR. CHITTENDEN: I do have a "doctor" in front of my name. My name is Donald Richard Eric Chittenden, and I sign my name D.R. Eric Chittenden.

 Laughter.

MR. CHITTENDEN: Years ago when I was in a Paris hotel, I was taking a crash French course, and after a couple of weeks there and raising all kinds of hell, I left and the keeper of the house, the lady of the house, was very polite, and as I left, she said -- I don't know how she could have been so polite to me, but she said to thank you for staying with us, Dr. Chittenden. Now I know the deference that you doctors get.

 Laughter.

MR. CHITTENDEN: I have to say the FDA has been pretty busy today. I called my plant during the break, the last break, and your crew had just left our cider mill. You had just done an inspection of the cold hard cider mill in Vermont. So I'll be anxiously awaiting the results.

 Laughter.

MR. CHITTENDEN: I've heard you do great work.

 Laughter.

MR. CHITTENDEN: Can I buy you dinner tonight?

 Laughter.

MR. CHITTENDEN: I am going to try to give you a little perspective on the small cider makers' view of this whole operation. It's kind of nice to hear a few of the last speakers. Some of the folks here who are technicians or doctors are almost falling asleep, I noticed, but when people asked me how much cider we produced, up until today, I have told them that I produce about a half-a-million gallons a year.

I did some quick math, and going into the servings, it sounds a lot better. We do about 10 million servings a year.

 Laughter.

MR. CHITTENDEN: Proudly. And we distribute interstate a little bit. We go to New Hampshire, Massachusetts, Vermont, pretty much exclusively, and a little bit in Maine.

I would like to explain a little bit -- a difference between what at least in New England we perceive the difference between apple juice and apple cider to be, and with all due respect to apple juice -- I think I remember drinking a cup of it when I was a child -- I forget which presenter it was that discussed the process for making apple juice, but he went into the heating.

I'm not a scientist, but my understanding, heating destroys Vitamin C and possibly other nutrients. They talked about depectinization. It's sort of answering the question the gentleman second from the end asked earlier about what processing, what pasteurization and the processing of apple juice can do to a nutritional value, but depectinization, according to the Surgeon General -- our apple juice apples have a high degree of pectin, and pectin is known to lower cholesterol.

So I suggest that the apple juice people stop filtering that product. Filtration removes a lot of food values, as we know. The solids, the food solids are removed from the value.

In the end, apple juice and apple cider simply don't look alike, and they certainly don't taste alike. They are different products.

This has been a very enlightening conference for me. I am going to walk away from here with a lot of very valuable information and a lot of networking.

Along with my wife, Francine, I created and developed the Cold Hollow Cider Mill located near Stowe, Vermont. Since 1974, the Cold Hollow Cider Mill has become the largest producer of fresh apple cider in Vermont.

I was raised on a dairy farm in Vermont. I have been a merchant mariner involved in international shipping since 1962, most of that time as a deck officer.

Cold Hollow employs 30 to 50 people. We have a retail, about a 10,000-square-foot retail area, a wholesale business of about 10 million servings, and we have a direct mail business. We print about 350,000 catalogues, and we do ont sell the cider through the mail. We do a very little bit, but it's expensive, and it's not something that we actively pursue unless somebody really desperately wants it, and it may be the only way we can sell it pretty soon.

I do rubber stamp my thanks, though, for providing the opportunity to share my perspective on the industry. Fresh apple cider holds a unique place in America, and especially New England.

Before the early settlers built their homes, they planted apple orchards, and apples and fresh apple cider were staples that helped maintain the early settlers. This traditional healthy natural product needs to be protected and nurtured, and its health benefits should be touted.

I am categorically opposed to pasteurization, and I am also categorically opposed to any labeling that indicates unpasteurized on fresh apple cider. The product simply does not need to be stigmatized.

The reasons I am here, one, to ensure that the hundreds of small fresh apple ciders from our region have a voice in this process; also, to encourage the FDA to make well-thought-out decisions that I have seen the benefit of a process; in other words, to caution against overreaction; to ask the FDA to fairly and accurately portray to the country the health benefits versus the risk of consuming fresh food, particularly apple products; to make recommendations as to how our industry could improve processing practices; to encourage the FDA to put its energy towards identifying and destroying the sources of E. coli 0157.

The average person in America, it is said, will consume in a lifetime about 27,000 apples or the equivalent of that. Most of those or many of those will be raw apples eaten, as our previous speaker mentioned, and we have not addressed that.

We have used in our industry, by the way, at our cider mill hand-picked fruit for our fresh apple cider for about 15 years, and it's virtually the same apples that are going on the store shelves. They are simply too big, too small, not enough color, et cetera.

Not to unfairly compromise the healthy image and healthy reality of naturally grown and produced food products, whether they be unpasteurized, unprocessed or organic, a large segment of the general public simply feels that our food chain is already overprocessed.

At Cold Hollow, we follow, we hope, adequate good manufacturing processes aiming to produce and market healthy, safe, fresh apple cider. Annually, nearly 300,000 visitors come to watch our presses in operation, and since day one, we've taken pride in advertising that the visitor can watch our process from the apple to the cup.

This alone forces us to use GMPs. We use only tree-picked apples. We press our fruit on a stainless steel rack-and-cloth press with synthetic pressing racks. The apples are trucked in 20-bushel bins, not trailer-loads, and this allows for a better preinspection.

All fruit is brush-washed, most twice because of a high percentage of packed-out fruit. Our fresh cider is immediately cooled down to approximately 35 degrees Fahrenheit. Potassium sorbate has been added to maintain quality, for about 3 years now.

Our press clothes are washed daily. Our distributors include ourselves, dairies, produce companies that are used to handling perishable products.

Our company's recommendations to the FDA include -- and this is, first, recognizing that there may be many cider producers or some cider producers out there who may not be practicing adequate sanitary standards, and that having been said would suggest that the FDA, one, recommend that producers start with clean fruit, possibly only tree-picked fruit; two, recommend clean, animal- and rodent-free apple storage areas; three, recommend that apples be brush-washed immediately prior to processing; recommend stainless steel equipment along with synthetic racks and cloths; recommend personal hygiene practices; recommend cooling and sanitary packaging procedures; recommend frequent periodic testing at all fresh apple cider facilities; recommend restricted use of cow manure in apple orchards and recommend that cattle be restricted from grazing in orchards.

To summarize, we are the largest producer -- I should say "major." When I say "largest," people look at me and agree. We are the major producer of fresh apple cider in Vermont. Despite that, if the FDA were to mandate pasteurization, there is a 50/50 chance that we would forego the conversation and go on to other professions.

If pasteurization is not feasible for us, chances are it is not feasible for the other 30 or so cider makers in our State, and it is possible that we will witness the death of an industry in our State, and of a culture.

Realistically, the FDA is in the best position to know about the health benefits of fresh vegetables, fresh fruit, and fresh fruit juices, as well as properly raised and slaughtered beef. If the FDA determines that fresh apple cider is inherently safe, it needs to make public statements to that effect.

If policies and recommendations are mandated which have not been well thought out, a disservice is done to the general public, apple growers and processors and perhaps the decision-masking process itself.

Pasteurization is a great expense that is likely in one fell swoop to prohibit hundreds of fresh apple cider makers from continuing with their operations. For many of these small agricultural enterprises, fresh apple cider provides an important income, without which they could be put out of business.

In many cases, orchardists will lose important buyers to their fruit. Family farms are already at risk across the country and do not need added stress.

Additionally, my feeling is that it would also funnel the profits from the apple juice industry into the hands of a very few people.

Suggestions of off-premises pasteurizing, it's been recommended by some that cider be sent to dairies and so on locally for pasteurization. That is totally unrealistic for a multitude of reasons, not the least of which is the creation of one more critical control point entrusting third parties who may not have your interest at heart.

We would like to see the FDA come out with a statement that reads along the lines of, "If you know that your cider, fresh apple cider producer is using clean, safe, and healthy processing practices, fresh apple cider not only can be safe, it will be more nourishing and healthier than pasteurized, filtered, or otherwise heavily processed apple juice."

We look at this juncture as an opportunity to further improve fresh apple cider production, and we are all interdependent on each other maintaining the highest standards possible.

Again, thank you for this opportunity to express some of our concerns relative to one of America's favorite foods, healthy, unpasteurized, fresh apple cider, and I would like to close by saying that I'd like to support -- and I just hope the FDA can come out with some kind of a statement.

After hearing Odwalla and the tremendous efforts that they've made, I'd like to see the FDA come out with a public statement to the effect that Odwalla has gone way beyond the call of duty here.

Thank you.

 Applause

DR. SHANK: The next speaker is Randy Graham.

MR. GRAHAM: My name is Randy Graham. I represent members of the Illinois State Horticultural Society, which is under the umbrella organization of the Illinois Specialty Growers Association. I am also an orchard co-owner and cider producer myself.

The names of my associations may not mean much to you. So let me be more specific. We are small business people running mostly family farms with apple orchards are our primary source of income. A substantial portion of each crop is pressed into fresh, unpasteurized cider each season.

Many of our farms are educational entertainment farms. We give tours to thousands of school children each year, teaching them about apple production and general agriculture.

Families visit our orchards in the fall to pick their own apples and other produce, to shop in our country stores, play on our playgrounds, eat at our restaurants, enjoy our bakeries, and to drink our fresh apple cider.

We believe our businesses are valuable and even cherished assets in our communities. Suddenly, though, we find our businesses in jeopardy. This year's outbreaks of 0157 have undermined the public's confidence in fresh apple cider and apple juice. We as an industry are eager to have the public's confidence restored, but we feel certain based on the information being presented here that a solution other than pasteurization can be found.

We are not opposed to the benefits of pasteurization, but there are some serious drawbacks to such a requirement that should be considered.

First of all, the two products don't taste the same, but that's been pointed out already. The full-bodied fresh flavor of -- fresh apple flavor of our juices that consumers love is what keeps me and my constituents in business. This is lost in pasteurization, and with it, our market edge.

Secondly, the nutritional qualities may be altered. Many of our customers drink our cider because they believe fresh juice is better for them. We agree.

Health officials have been telling us for years that fresh fruits and vegetables and their juices lead to better health. A pasteurization requirement would amount to prohibition for the fresh juice industry. This is a course we must not take if there is any way to avoid it.

Lastly, many small producers will go out of business if pasteurization is required. Most of us operate 3 or 4 months out of the year and produce less than 30,000 gallons of juice per year. At $50,000 to $100,000 for pasteurization equipment, we simply cannot afford it.

We believe there are alternatives. Illinois has been working to ensure safe cider for several years now. In 1994, in response to concerns borne from the investigation of the 1991 Massachusetts E. coli outbreak, the Illinois Department of Public Health pulled 80 cider samples from around the State to determine the quality of Illinois cider.

No E. coli or Salmonella was found, but coliform counts suggested that sanitation and production procedures needed improvement.

The Illinois State Horticultural Society worked with the Illinois Department of Public Health to revise the good manufacturing practices for Illinois producers.

Going a step further, the Horticulturist Society with the help of the Department of Public Health sponsored a cider making school prior to the 1995 season to make sure that producers understood how to implement the new procedures.

Follow-up testing in 1995 showed a dramatic improvement in the quality of Illinois cider. A second school was held this year, and a proposal has been made to develop a cider producer certification program based on a HACCP system. In fact, I hope to talk to Mr. Carlson a little bit later and borrow some of his ideas so we don't have to reinvent the wheel.

In short, we believe that clearly defined manufacturing and sanitation procedures combined with proper education of producers is the single best way to ensure safe cider.

In addition, we must examine everything science and technology has to offer. Small producers are especially interested in technologies that guarantee the microbial safety of cider while maintaining the health and flavor characteristics of the product.

The small cider producers of Illinois are confident that the FDA will find ways to guarantee safe, fresh cider without destroying the characteristics that make it so appealing and affordable to produce seasonally, and we sincerely hope that pasteurization as a requirement, a move that would put an end to the fresh juice industry, is being discussed only as a very last resort.

Thank you.

 Applause

DR. SHANK: Thanks, Randy.

Our next presenter is Carlton Heyser.

 No response.

DR. SHANK: Glenn Krum.

 No response.

DR. SHANK: Daniel Querrie.

MR. QUERRIE: Hi. My name is Dan Querrie. My wife, Judy, and I are owner/operators of Burnham Hollow Apple Orchard in Middletown Springs, Vermont. We farm approximately 130 acres, 50 acres of which is in apple production.

We grow 19 different varieties of apples on 4,800 trees. About 10 acres is under replant.

I'm a little nervous. I've never done anything like this before, but what cider production means to me, my family, and to my operation makes me being here a must. Without the ability for me to make cider, it would definitely put me out of business.

To put our entire industry in the State of Vermont into size perspective, we've been shown here today what are the standards of operation for our industry. The orchard that we saw in Washington is larger than our entire State's production.

Mr. Kess and his operation could process our entire State's crop in one day.

Mr. Baker said he was the only farm here from New York. Well, I'm the smallest farmer producer here today. That, I guarantee you.

The difference in price between a bushel of processed apples and the cider they produce is about $9.65. If I take that difference and multiply it by the amount of apples that we process in a year, that's more than my entire net income.

If cider is taken away from my, I'm out of business. Over the past seven fall seasons, we've put a lot of effort into promoting our farm and the products we produce there. Our cider has no preservatives, and it's made from quality apples. This gives us a cider that tastes good and lasts about 17 days in the refrigerator.

People come to our farm looking for this fresh-tasting quality product. If pasteurization becomes mandatory, this quality product no longer exists.

In the fall, we open our farm to pick your own apples. We give hayrides. We have a farm store in our barn where we sell apples, cider, and other Vermont products.

The public is welcome to come and watch us make cider. So that guarantees that we have a clean process, all of our standards are met, because we're open to the public. They can watch us do it.

Locals come. Tourists come. This is all part of what they experience coming to our farm.

We also have hundreds of school children visit our farm every year. Tourism is a leading industry in Vermont. September and October, Vermont sees about 20 percent of the year's annual tourism. Our farm and the 35 other orchards like mine, open to the public, represent a large part of what those tourists do during the fall.

We sell our apples on a pick-your-own basis. About 25 percent of that fruit is left in the orchard after the public is done picking. It's that fruit and our picking line seconds that we process into cider. If we could not make a cost-effective cider from this fruit, the gain from selling our product on a pick-your-own basis would be lost.

To pasteurize our cider would not be a cost-effective use, and we would be out of business.

Well, you might be saying to yourself, close the orchard to the public. The tourists will find something else to do. Load your apples onto a truck. Send them off to your State co-ops. Have them pack, sold for you.

Well, that co-op is no longer in business due to the low price return on wholesale apples. I've been told that's because of a surplus of South American fruit in our market. That's no longer an option for me.

Over the past three years, the growers from the co-op averaged a $5.50-per-bushel return on the same apple that cost them about $7.00 to grow. If I had to close to the public, I'd have to close my business.

A few years ago, the Vermont Department of Agriculture and Department of Health established standards for cider production in our State. About four weeks ago, the producers in Vermont met at the Department of Agriculture, one, to review these standards, and two, to ask the State to check into the possibility of turning those into regulations.

If they were turned into a regulation, every producer would have to follow them, then, and now our State would be guaranteed to produce a safe product that we're all proud of.

I believe this is the avenue to take in guaranteeing the future of our product, not through mandatory pasteurization.

For over 300 years, Vermont has produced cider with not one reported case of bacteria contamination. If pasteurization is mandated, it will put an end to a pretty impressive history of cider production, and yes, an end to my farm.

From there, these effects will ripple through the tourist industry, the implement dealers, the tractor dealers, the fuel dealers, et cetera.

The only winner in this would be the large producers. They would no longer have to battle with my little farm for that small share of the market.

My only hope is that some day my son gets to make the decisions about my cider production because you made the right decision here and we're still in business.

Thank you.

 Applause

DR. SHANK: Thanks, Dan.

Ellen Terpstra?

 No response.

DR. SHANK: Gerald Wojtala.

MR. WOJTALA: My name is Gerald Wojtala, and I am speaking on behalf of the Michigan Department of Agriculture.

I'd, first, also like to thank the Food and Drug Administration for coordinating the response to finding safe and practical means to produce juice and cider.

As one of the largest apple-producing States, Michigan has a great interest in safety of raw and processed agricultural commodities.

The issues involved may not be unique to cider, the cider industry. So the resolutions could serve as a precedent for other fresh fruit and vegetable industries.

Central to the issue of unpasteurized juice and cider is the assurance of safety to the consuming public. In meeting that objective, policies need to be science-based with consideration of acceptable levels of risk, as well as the cost and practicality of the solutions.

The majority of unpasteurized cider operators in Michigan do not distribute their products across State lines, pointing out the need to keep the States involved in this process.

A coordinated response will avoid duplication of effort among the States and allow industry, State and Federal, and academic resources to be drawn out.

At the urging of the Michigan Apple Committee, the Michigan Department of Agriculture has formed an Apple Cider Advisory Committee in Michigan. The committee consists of cross-section of apple growers and shippers, cider processors, industry associations, FDA district personnel, extension and university specialists.

The committee has met and identified issues to resolve in four general categories: cooperative development of good manufacturing practices, technology and research needs, gathering of baseline data on industry practices, and both consumer and industry education.

We are here to offer our full assistance and hope this will be a reciprocal process.

I would like to, just as a side note, mention that in Michigan, we have approximately 200 licensed cider mills. Some of the baseline information that we're interested in looking at is something that we see in terms of what we call custom presser. These are pressers who perhaps don't have orchards of their own, but different growers come in and use their press and they offer this service to press for growers who then market their product. So we're looking closely at that practice.

Also, as a side note, in November of this year, we sampled apple cider from all operating cider mills, and we tested for E. coli 0157:H7. We also wanted to run some baseline data. So we looked at coliforms and plate counts as well as the pH, which we found in our samples range from 3.2 to 3.8.

Thank you very much.

 Applause

DR. SHANK: Thanks, Gerald.

Joseph Zeigler?

 No response.

DR. SHANK: Catherine D'Amattio?

MS. D'AMATTIO: Thank you.

I am not an apple grower, producer, or processor. I am Chatiner D'Amattio, the executive director of the Organic Trade Association. Our association represents 400 businesses and farmer associations which represent the breadth of those in the organic community from half-acre-or-less farms to 3,000-acre farms to processors, handlers, brokers, distributors, manufacturers, and retailers.

We are all concerned about organic production systems and the sale of organic food and producers to consumers who want that choice.

I have written remarks, but I think I need to say some things about what organic is and debunk some myths based both on what I've seen in the press about organic in relation to this apple juice situation and also the comments that I've heard around me today in the room about organic and while I was at lunch.

So just some information about organic, Dr. Ricker explained a bit about the Organic Foods Production Act and some of the rules and regulations that will obligate our industry to certain practices.

One, our industry is an agricultural production system industry. What we attempt to do is to have agricultural production practices that balance the ecology of nature with the interference that farming has with nature. Farming is not a natural process. As soon as you disrupt the land or plant a tree or cut down a tree to plant a different tree, you are disrupting natural processes and disrupting balance.

So organic production systems are trying to work farming into the natural system that keeps balance and keeps -- and maintains balance and soil and natural environmental health.

So we are often seen as a food safety industry, and many people maybe feel threatened because people believe that our production system is better than, quote/unquote, "the conventional system."

I want to tell you that our basic underlying principals are how to produce food in harmony with nature and not necessarily a food safety issue. So I find it interesting that when this food safety crisis has come up, organic production wanted to be tied or linked to this food safety problem.

Organic production practices do not prohibit pasteurization, do not require you to just have unpasteurized product. That's a choice of the juice manufacturer. They can pasteurize or they can choose not to pasteurize their product. That's not an organic production requirement.

The use of manure, which has come up often today and had came up often in terms of organic -- the organic label, you can use manure or you can choose not to use manure.

What you can't choose to use is a chemical-based fertilizer. That, to us, would be not operating within the ecological systems of nature. So people do use compost manures. People use other cover crops, other nitrogen sources to fertilize their land and to fertilize their orchards, but what we don't use is chemical-based manures.

As Dr. Ricker pointed out, we will be regulated in terms of raw manure use, and in the history of the organic industry which has been self-related for 15 years now, that use of raw manure is discouraged, limited to, as Dr. Ricker pointed out, 60 days prior to the harvest of any product for consumption, and we do prescribe composted manure and compost from vegetable matter as the better source of fertilization.

We are interested in safe food, as is all the food industry, as many people have testified today, and we do not impose restrictions on creating a safe food production system or food-processing system. We try to actually enhance that and meet the demands of the consumers who want to use organic food because it has less preservatives or less chemical treatments on it.

It makes out job even more difficult to find a balance between safety systems in food and these demands of the consumers who are associating organic with the type of food that they would see as "pure" -- I put that in quotes -- food.

Our system of production and our system -- our principles of organic agriculture are based on inspection and planning, and Dr. Ricker pointed out that the Organic Foods Production Act of 1990 does include a requirement that the farm have a farm plan, all handlers have a handling plan, and both are required to have on-site inspections.

Currently in the industry and for the past 15 years, that has been done on a voluntary basis and has been industry-regulated. So we are very, very much accustomed to this system of good manufacturing practices, good farming practices, the idea of hazard analysis critical control points. This makes it possible for our farming and processing community to find alternatives to chemical-based fertilizers or pesticides or processing aids, and this will also make it possible for all our processors to comply with safety requirements that are imposed by other food safety regulations.

I think that, as many people have pointed out, the FDA can help this situation. We need more information. We need more information about E. coli, about the source of E. coli, and more information about these persistent outbreaks, the many that we haven't heard about until it becomes a major crisis.

So that, as part of the food industry, all of us are trying to work on solutions. I would encourage you to think about and establish passive systems instead of additional requirements and chemical treatments as a way to deal with this current situation, if you feel it is necessary to add any additional demands on the apple juice or fresh juice industry.

As organic producers and processors, we are familiar with those procedures. We find that they work for us. We find that we would be very easily able to adopt to other requirements that would be imposed in that manner on our industry.

Thank you very much.

 Applause

DR. SHANK: Our next presenter is Caroline Smith DuWaal.

MS. DuWAAL: Caroline Smith DuWaal, director of Food Safety for CSPI.

First of all, I want to thank FDA for convening this meeting. It's a very impressive brain trust that you have here to solve this very difficult public health problem. I look forward to the next meeting you'll convene. I'd like to recommend that you hold it on raw shellfish, which has killed 19 people this year alone.

I also want to congratulate FDA on taking prompt action in the Odwalla situation to actually urge that the product be recalled prior to getting all of the usual data in and absolute proof of the bacteria in the product.

I think the agency acted appropriately and promptly and probably saved a number of illnesses.

I think the agency has not been as good about alerting consumers about what the real hazards are. I think the agency in situations like this should alert daycare centers and nursing homes; that they should not be serving these products.

There are high-risk groups which are particularly vulnerable, and those people should be informed of the risk as early as possible, and you should do it nationally. If these products aren't safe for children, then let's just call it the way it is.

Everybody likes a kill-step, and pasteurization of fresh juices is an easy kill-step. However, it's not necessary to solve this problem. In fact, the issue is broader than just juices. We've had lettuce outbreaks this year, and we don't want to see FDA take an outbreak-by-outbreak approach to solving food safety problems.

HACCP has been proposed as a mandatory element in food safety regulation. We have supported it. Consumer groups, far and near, have supported it. I wrote comments supported by, I believe, 11 different consumer groups, including the families who have been most affected by E. coli 0157:H7.

I am concerned that HACCP should be not put in place in the juice industry, and then we're going to have next year a problem dealing with lettuce or fresh produce or other products. Let's move forward with mandatory HACCP.

I also think that we need to make a distinction between raw products and processed products for HACCP implementation. HACCP is currently mandated for low-acid canned foods where there is a definite kill-step. It is also mandated for seafood products and meat and poultry products. Those HACCP systems are not yet on-line. They aren't going to go on on-line for another year, but clearly, there are distinctions between fully processed products which should be absolutely safe and raw products, and I think that distinction is an important one in this debate.

Raw product HACCP doesn't guarantee safety. The goal is to minimize hazards, and microbial testing -- I'll say it again -- is essential to assuring consumer confidence on raw product HACCP systems. We've had this debate in the meat and poultry industry. We failed to be persuasive on the seafood rule, but I think it is very important here.

End product testing for process control doesn't guarantee safety either. It will, however, give you an indication if your process isn't working, and that's what we need to design.

If you test, if you're a juice manufacturer, you test for pathogens and they don't show up, it doesn't mean your product is absolutely safe. It simply means that your process is likely under control, and you'll gather enough data. You'll begin to be able to see if your process isn't under control.

If you do find a pathogen, that is a clear indication your process is out of control, and it is a key to making HACCP work in your industry.

I will note, also, that Florida has a HACCP -- a mandatory HACCP system for fresh-squeezed orange juice, and they mandate testing for both Salmonella and E. coli as part of that HACCP system.

The final point here is that fresh juices, even when HACCP is implemented fully, if that's ever the case, and even with microbial testing, may still not be safe, and that is where appropriate consumer labeling comes in. Labeling can be an important part of a HACCP system, and I'll talk more on that on the labeling panel.

Thank you.

 Applause

DR. SHANK: Okay. That's the end of my list. Is there anyone else who wants to speak today?

Come to the microphone and identify yourself, please.

DR. BROWSON: My name is Allen Browson. I have a Ph.D. in front or in back of that, whatever the heck that means. I never was impressed by piled higher and deeper, but if you are good -- I'd like to propose two questions, basic stuff to think about that I wrote down at the start of the meeting, and I think it's still totally appropriate.

We spent a lot of time talking about apple juice, but, in fact, the biggest fresh juice is orange, and oranges and apples are, as people pointed out once a long time ago, quite different. In fact, oranges are grown specifically for juicing. They're called Valencias. They have an eating orange. It's called a Naval, although it was probably an order.

Apples are not really grown for juicing. They're grown for table fruit, and despite anything anybody says, most of the apples that are able to be used for table fruit will be, and in fact, apple juice is made from nothing but rejects. The trick isn't to eliminate rejects. The trick is to grade them and enforce QA or HACCP or whatever you want to call it, and that sparks the question of whether we should consider treating apples and oranges differently in our regulatory approaches.

Now, the other question is assume you have decided that you can solve the problem with this simplistic notion -- and I call it a simplistic notion of pasteurization. Who is going to enforce that the pasteurization occurs? It sure as heck ain't going to be FDA, and it probably isn't going to be the States because neither of them got the bodies to do it. So you can rely basically on voluntary compliance.

Therefore, it's probably to your advantage to insist that mandatory compliance with HACCP and good manufacturing practices, as Florida is doing, occur, and it's probably more appropriate to educate, if you want to call it, the manufacturers than the public because it doesn't matter if you educate the public about it. If you educate the manufacturers that they have to rigorously grade their fruit and rigorously wash it -- and I guess a little common sense there. You know, if you're going to have a brush machine, that's nice, but you've got to check to see the brushes are clean, you know, little simple things. Maybe that will do a little bit more to keep this down.

I have a number of clients. We test juice. I run a laboratory, and we test juice, and mostly, we test it to see if it's really juice, not if it's safe.

 Laughter.

DR. BROWSON: For some of you that remember some of the cases, you know what I'm talking about, but basically, you can't test the juice after, and you can't even test it before, but it's good, as the lady from CSPI pointed out. It's a god indicator at least, but you're going to have to educate your manufacturers, and probably a mandatory program like the State of Florida is doing may represent your best solution, and I'm sure Betsy Woodward will have something to tell us about that tomorrow, but it's really got to be the issue because if you go to pasteurization, where do you get the bodies to do it?

DR. SHANK: Thank you.

 Applause

DR. SHANK: Anyone else?

 No response.

DR. SHANK: It's been a long day. Let me take this opportunity to thank all of the speakers, those who were on the agenda as well as those of you who came forward with your comments today. They are very much appreciated. It's been a hard day. It's been a full day. Tomorrow will be another of the same. Thank you very much.

 Applause

 Whereupon, at 6:00 p.m., the meeting concluded.