COMMITTEE MEMBERS
James D. Anders
Dane T. Bernard
Robert L. Buchanan
James S. Dickson
Catherine W. Donnelly
Michael P. Doyle
Mel W. Eklund
Daniel L. Engeljohn, Ph.D.
Michael G. Groves
Michael L. Jahncke
John M. Kobayashi
Earl G. Long
Roberta A. Morales DVM, Ph.D.
Nancy E. Nagle
Marguerite A. Neill
Alison D. O'Brien
Michael C. Robach
Leon H. Russell, Jr.
Skip Seward II
William H. Sperber
William H. Sveum
Bala Swaminathan, Ph.D.
Robert B. Tompkin
AGENCY REPRESENTATIVES
Janice Oliver, Deputy Director, Center for Food Safety and Applied Nutrition, FDA
Dr. Morris E. Potter, Vice Chair
Arthur P. Liang, MD, MPH, CDC Liaison
Lee Anne Jackson, FDA Liaison
E. Spencer Garrett, Commerce Department Liaison
LTC Scott Severin, Defense Department Liaison
Dr. Karen Hulebak, Executive Secretary
Jacque Knight, Advisory Committee Specialist
ALSO PRESENT
Dr. Larry Beuchat, University of Georgia
AGENDA ITEM PAGE
MS. OLIVER: Good morning, everyone. I'm Janice Oliver and I'm Deputy Director for the Center for Food Safety and Applied Nutrition. I'd like to thank the Committee members and our invited experts for making themselves available for the meeting. Over the next two days, we're going to have data that will be presented on production practices and safety issues associated with fresh citrus juice, and we're asking the Committee to provide us with sound scientific recommendations on how FDA can assure the safety of fresh citrus juice. We're not here to discuss specific juice outbreaks nor any policy matters. We're asking the Committee for your scientific input on performance criteria for the fresh citrus juice industry. And specifically the Committee is being asked to provide us recommendations in two areas: the internalization and survival of pathogens, and the application and measurement of the 5-log reduction standard. I'm going to read specifically the questions that are posed to the Committee, and you should also have a copy. The questions posed to the Committee are: On the internalization and survival of pathogens, is it valid to assume that there is no internalization of pathogens in citrus fruit? Is internalization of pathogens into citrus fruit theoretically possible? If internalization of pathogens into citrus fruit is theoretically possible, is such internalization likely to result in a public health risk? And the last on internalization, if internalization does occur and it results in a public health risk, are there techniques to assure that internalization of pathogens does not occur? And if so, what are they? The second group of questions we have deal with the application and measurement of the 5-log reduction standard. At what point in the production process should a processor begin to measure attainment of the 5-log pathogen reduction? For example, should fruit be cleaned and culled before measurement of the 5-log reduction has begun? And are there limits within which the 5-log reduction must be accomplished? Would using cumulative steps that are separated in time and location impact a processor's ability to achieve and deliver a 5-log reduction? Can the safety achieved by the 5-log reduction be maintained consistently if a processor does not package product immediately after attaining the 5-log reduction? These are the issues we'd appreciate your input on. I want to make a number of announcements now and talk about some of the ground rules for the meeting for the Committee and especially for those in attendance here. Dr. Wachsmuth may not be able to attend the meeting. She may be able to attend a portion of it. She sends her apologies if she is not able to be here, and, therefore, I will chair the meeting in her absence. Second, if you look over the agenda, you will note references to questions of clarification. This time is reserved for the Committee and our invited expert, Dr. Larry Beuchat of the University of Georgia, to ask questions of the various presenters. The sole purpose of this is to provide answers to specific points that were raised during the presentation and to clarify those points for the Committee members. And as a courtesy, questions may be taken from the floor if time permits. But so all are aware, the time is not intended to be used to debate issues, and the time is not intended to be used to raise subjects that were not a part of the discussion. They are questions of clarification. The Chair reserves the right to suspend the time allotted or to limit it for the questions of clarification if the conduct of the meeting is adversely affected. I would also say that the Committee will have time tomorrow also to ask additional questions of all of the presenters who will be here tomorrow to answer any additional questions that you may have. Third, there is a public comment period at the end of the day, and for those who preregistered to make a public statement this afternoon, I remind you that your time is limited to five minutes, and I will once again remind you in the afternoon. But if you did not register by December 1st, we may be able to take additional comments, but your time will most likely be limited then to two minutes. Lastly, Thursday's program, tomorrow's program, is reserved exclusively for the Committee to discuss the issues and formulate the recommendations or the response to questions that have been posed by FDA. The recommendations must be finalized tomorrow. There is a very full agenda on Friday on the presentation and discussion of FFSIAS E. coli 0157:H7, so we need to finish the issue on juice tomorrow. They are the basic ground rules. One other thing I would like to remind people is that today's session, as the rest of the Committee, will be transcribed. So if anybody is asking questions, if you could please say your name before asking them, it would really help our transcriber, and I will try to remind people during the session. Now what I'd like to do in the interest of time is to ask each of the Committee members to introduce yourself and to give yourself a short introduction, if possible, so we can get through the agenda. I'll start at that end. Bruce? DR. TOMPKIN: I'm Bruce Tompkin with ConAgra Refrigerated Prepared Foods. MR. LONG: Earl Long, Center for Infectious Diseases, CDC. MR. BERNARD: Dane Bernard, National Food Processors Association. MR. SEWARD: Skip Seward, McDonald's Corporation. DR. KVENBERG: John Kvenberg, Food and Drug Administration. MS. NAGLE: Nancy Nagle, Nagle Resources. MR. ROBACH: Mike Robach, Conti Group Companies. MR. DOYLE: I'm Mike Doyle of the University of Georgia. DR. HULEBAK: I'm Karen Hulebak, Food Safety and Inspection Service, and Executive Secretary of this Committee. DR. TROXELL: Terry Troxell, CFSAN. MS. JACKSON: LeeAnne Jackson, FDA, CFSAN. DR. LIANG: Art Liang, CDC, Food Safety Initiative. LTC SEVERIN: Scott Severin, Army Office of the Surgeon General. MR. ANDERS: Jim Anders, North Dakota Health Department Laboratories. DR. SWAMINATHAN: Bala Swaminathan, CDC, Foodborne and Diarrheal Diseases Branch. MR. BUCHANAN: Bob Buchanan, Food and Drug Administration, CFSAN. MR. SPERBER: Bill Sperber, Cargill. MR. GROVES: Mike Groves, LSU School of Veterinary Medicine. MS. O'BRIEN: Alison O'Brien, Uniformed Services University of the Health Sciences, Bethesda. MR. KOBAYASHI: John Kobayashi, Washington State Health Department. MR. JAHNCKE: Mike Jahncke, Virginia Tech. MS. DONNELLY: Cathy Donnelly, University of Vermont. MR. SVEUM: Bill Sveum, Campbell's Soup Company. MR. RUSSELL: Leon Russell, Texas A&M University. DR. BEUCHAT: Larry Beuchat, University of Georgia. MS. OLIVER: Thank you very much. I'd like to introduce the first presenter next, but before I do that, I just want to remind all of the presenters that you've all been given the times for your presentation, and we are going to have a timekeeper and keep people to their times because we have a very full agenda to the end of the day, and we have lots of people that are signed up for public comment. So our first speaker on the previous recommendations and rulemaking is Dr. John Kvenberg, Deputy Director, Office of Field Programs, FDA Center for Food Safety and Applied Nutrition. John? DR. KVENBERG: Good morning, everyone. As Ms. Oliver mentioned in the talk, my presentation is, if you will, the history of events on juice to include the National Advisory Committee recommendations and rulemaking. After the October 1996 apple juice outbreak from E. coli 0157:H7, FDA held a public meeting on December 16th and 17th of 1996 to consider the safety of all juices in light of the information and discussion provided during the public meeting on current science and technology on fresh juices. The Fresh Produce Subcommittee of this National Advisory Committee on Microbiological Criteria for Foods attended the public meeting and made recommendations to the full Committee. The Subcommittee risk conclusions were based on documented outbreaks of illness association with consumption of contaminated juices. These data were presented and discussed during the open public meeting. Based on the information presented at the meeting and on the Subcommittee's expertise, the Committee made several recommendations. The Committee concluded that: number one, the history of public health problems associated with fresh juice indicated a need for active safety interventions; and, two, for some fruit--for example, oranges--the need for intervention may be limited to surface treatment, but for others--for example, apples products--additional interventions may be required, for example, pasteurization or treatment of the juice. In addition, the Committee recommended to FDA the use of safety performance criteria instead of mandating the use of a specific intervention technology, such as thermal processing. At the time the Committee recommended that an adequate level of safety could be achieved by requiring interventions that have been validated to achieve a cumulative 5-log reduction in the target pathogen or the risk reduction in yearly risk of illness to 10-5, assuming consumption of 100 milliliters of juice daily. Finally, the Committee stated that HACCP and safety performance criteria should form the general conceptual framework to ensure the safety of juices and that control measures should be based on a thorough hazard analysis with validation of the process as an integral part of the framework. Based in part on these recommendations, in the Federal Register of April 24, 1998, FDA proposed to adopt regulations to assure the safe and sanitary processing of fruit and vegetable juices. In the proposed HACCP rule, FDA tentatively concluded that a preventive system such as HACCP appears to offer the most effective way to control the significant microbial hazards along with other hazards that represent juice-associated health problems. In addition, in the Federal Register of July 8, 1998, FDA published a final rule requiring that juice products not specifically processed to inactivate 5 logs of harmful bacteria bear a warning statement informing consumers of the potential risk of foodborne illness associated with the product. To avoid the warning statement, juice manufacturers must process juice in a manner that will achieve a 5-log reduction in the most pertinent microorganism of public health concern. However, certain citrus juice processors who applied for an extension were allowed additional time before the labeling requirement became effective to develop and validate intervention measures that achieved the 5-log pathogen reduction standard. Also, FDA held two technical scientific workshops in November of 1998 in Florida and in California to discuss and clarify issues related to the implementation of the agency's rule requiring a warning statement for certain juice products. In particular, the workshop addressed the pathogen reduction interventions that had been developed for citrus juice production and methods for measuring and validating such systems. The 5-log reduction performance standard that the Committee recommended also has been tentatively included in the proposed HACCP rule as a mandatory component of a valid HACCP system. As Dr. Troxell will outline later, the agency will once again be relying on the Committee's expertise and recommendations as it proceeds in its consideration of HACCP requirements for juice and juice products. To explore the use of HACCP in the production of juice and juice products, the agency has been conducting a HACCP pilot program with selected juice manufacturers in the context of the agency's manufacturing HACCP pilot program. To date, three manufacturers of juice and juice products have been involved in this HACCP endeavor. They are Ocean Spray Cranberries, Orchid Island Juice Company, and Fresh Samantha. Ocean Spray Cranberries and Fresh Samantha pasteurize their juice, while Orchid Island Juice Company is a fresh citrus juice producer. Our next presenter will share some of the observations and comments related to the HACCP pilot program with the firm. Thank you. MS. OLIVER: Thanks, John. As John mentioned, our next presenters will talk about the juice HACCP pilot program, and the presenters are: MaryGrace Sexton and John Martinelli from Orchid Island Juice Company, and Dr. Donna Garren from United Fresh Fruit and Vegetable Association. MS. SEXTON: Good morning. Sometimes a visual, I think, is more effective than not seeing this, but I really do want everybody to take--can everybody see this? Okay. I'm MaryGrace Sexton with the FDA pilot plant for fresh squeezed citrus juices for the United States of America. Orchid Island Juice Company has been in business for 10 years, successfully satisfying the customers and providing a safe product consistently. You will get the statistics of biological testing by a scientist. Mr. Martinelli is here to assist me in representing the FDA pilot program in the absence of the FDA. We requested that the FDA present the information about the pilot program, but they refused. They said their goal was to see if a HACCP plan could be implemented in fresh squeezed juices as it was done in fish. Their outcome was positive, and they were happy to say that it is possible. I need to remind you that E. coli 0157:H7 has never been in fresh squeezed citrus juices and never has ever been considered to be on the inside of the orange on the tree. We feel the FDA pilot program could be better utilized if you would direct questions and visits to the plant. We would have been able to inform you that fresh squeezed citrus processors do not immerse fruit. Two years ago, the same Committee requested that we go achieve a 5-log reduction in the killer organism E. coli 0157:H7. We have shown the FDA that we can achieve a 6.7-log reduction. We have made recommendations to the FDA and the USDA inspection services. The State of Florida is the only one that is regulated. They require that the Florida Department of Agriculture test all incoming fruit for integrity and fruit maturity standards. In the State of Florida, it is mandatory that a commercial fresh squeezed citrus plant have continuous on-site USDA inspection. If this is an issue between the agencies, it does not constitute holding up the process of initiating a mandatory inspection for all fresh squeezed processors in the United States of America. How can you outlaw a product before you place mandatory inspection on the entire country, not one State? Processors in question have a plant on the East Coast and a plant on the West Coast. Only the uninspected, the unregulated plants contaminate the product. This is an indication that continuous on-site USDA inspection is productive. This is an indication that it is not the process, it is the processor. We will show you technology available to make fresh squeezed citrus juice safe. I am not making light of food safety issues in America. I am trying to bring to your attention this is one that can be resolved by placing regulatory standards in place to verify complete safety to the consumer. Pasteurization is not a cure-all for the juice industry. I want to invite our next speaker to our processing facility to address her concerns and the concerns of the organization she represents. The science you will be exposed to will be of wide range, some indicative of the industry and some forced science to prove a point that has never, ever occurred. But you, ladies and gentlemen, are of the best scientific minds regarding this matter, so who better than you to listen to the following information? And I ask personally that you do not consider redefining the word "fresh" for the convenience of other processes. Fresh to the consumer means fresh. MR. MARTINELLI: Good morning. I'm John Martinelli with the Orchid Island Juice Company. The Orchid Island Juice Company has been in business for 10 years now, and we are one of the conscientious fresh squeezed juice producers in the United States of America today. We are also the Food and Drug Administration's pilot program, and in our documentation, in our presentations today, you will hear reference to the Florida inspection process. In the State of Florida, we have two inspectors in our facility at all times. The Florida Department of Agriculture checks our fruit for maturity and wholesomeness. They randomly sample it, and it is a zero tolerance on unwholesome fruit. The USDA randomly samples our product for quality and for packaging and labeling infractions. We microbially test every batch of juice at Orchid Island Juice Company's facility. Because of our commitment to our customers to squeeze our fresh oranges within 24 hours of when they are picked, we have also installed a satellite monitor so that we can monitor any weather patterns that might be detrimental to that effort. The first critical control point at Orchid Island Juice Company is preoperational sanitization. We swab-test fruit contact surfaces as well as juice contact surfaces for microbial activity. Strategically placed in our facility, we also have hand-sanitizing stations. Every associate on the production line is required to sanitize their hands before reporting to their workstation. Our processing facility is also roped off from any uninvited guests or people who shouldn't be in the processing area. The second critical control point at Orchid Island Juice Company is fruit acceptability. Our fruit acceptability requirement--and all of our harvesters know this--is there will be no dropped fruit and no unwholesome fruit in a trailer load, or it will be rejected. As the fruit comes into the processing line at Orchid Island Juice Company, we high-pressure spray it and saturate it with sanitizer. Throughout the entire facility, our processing equipment is doused in sanitizer throughout the entire day to inhibit microbial growth of any kind. When the Department of Citrus regulated fresh orange juice, one thing that they mandated is that there had to be 60 seconds' worth of contact time in the scrubbing and sanitizing aspect of the fruit. We installed a double-stack scrubber to facilitate that 60 seconds. Another thing that the Department of Citrus mandated--or suggested was a fruit return belt. This fruit return belt, if any piece of fruit misses an extractor, the fruit is automatically reintroduced into the beginning of the sanitizing process and regraded before it goes back to the extractors. Borrowing technology from the fresh fruit industry, Orchid Island Juice Company has installed a high--pressure sprayer. This high-pressure sprayer produces 300 pounds per square inch which accentuates any defects in skin surface problems and makes it much, much easier to grade the fruit out. Then the fruit is rinsed, and then another sanitizer is added to it on the final washing bed. On the final washing bed, we have also installed a top brush washer, and the top brush washer slows down the process of the fruit and increases the agitation for total surface contact. The Department of Citrus recommends scallop brushes so that the fruit doesn't turn on just one axis, but has a tendency to tumble across the washer beds. All of the washer beds at Orchid Island Juice Company are scallop brushes. Our third critical control point at Orchid Island Juice Company is the grading. Grading is essential in a fresh squeezed juice operation, especially in the State of Florida since the Florida Department of Agriculture allows zero tolerance when it comes to defective or unwholesome fruit in fresh squeezed orange juice. Our critical control limit on our graders is 12 graders on the line at any given time with four fruit inspectors. The four fruit inspectors are responsible; if, in fact, any of the sanitizer dilution alarms go off, they are to stop the line immediately and make an adjustment. They are also responsible for stopping the line if, in fact, the volume of fruit is incorrect. Our fourth critical control point is our sanitizer alarm system. These are audible as well as visual alarms, and the limits are set far above the recommended dilutions. We rinse the fruit and then send the fruit to our extractor room. The extractor room is enclosed, and the thermostats are set at 40 degrees. That's another recommendation by the Department of Citrus. Our juice is extracted from the orange and within seconds is reduced below 34 degrees. A Food and Drug Administration--not a requirement but a recommendation was for positive pressurization of our lines. So what we did was we--so if there was any transport of juice or cooling solution, it would be from the juice side to the cooling side, and not the inverse. We send it to our tanks, and then we bottle our juice in sanitary rooms, once again, enclosed and set at 40 degrees. Randomly throughout the day, the USDA inspectors--because we carry the Florida sunshine tree on our juice, the USDA inspectors are required by the Department of Citrus to check our juice, once again, for quality and packaging requirements. At the end of each day, we hand-clean the facility. Then we CIP all the processing equipment in the facility, and borrowing technology from the meat-packing industry, we foaming caustic all of our fruit contact surfaces. Then we rinse the surfaces with sanitized potable city water, and at that point in time, Orchid Island Juice Company contends that our juice, our processing facility is, once again, ready for use the next day. The Orchid Island Juice Company adheres strictly to the Florida model of inspections, and as you see when you walked through our facility, there was no immersion whatsoever. And in the 10 years of doing business at Orchid Island Juice Company, we've served over 350 million servings of juice, and over 1 billion pieces of fruit have passed through our processing line, and there has never been a detection of a human pathogen in our product. Dr. Garren? DR. GARREN: Good morning. My name is Donna Garren with the United Fresh Fruit and Vegetable Association. I would like to thank MaryGrace and John for sharing their time this morning with me. We represent the interests of growers and distributors of fresh juice and produce in general. I would like to provide comments on preliminary studies reporting the potential internalization or infiltration of pathogens into citrus fruit. Based on current preliminary internalization research conducted by the Food and Drug Administration, we believe it is premature for this Committee to reconsider its original recommendation of proposing 5-log performance standards to ensure the safety of fresh citrus juices or to not recommend mandatory preventative technology such as pasteurization. Supplementary research suggesting infiltration of pathogens into other produce items, such as tomatoes and apples, does not necessarily support the assumption that infiltration of pathogens can occur in citrus fruit. Preliminary internalization research on citrus fruit also did not reflect current industry practices, such as a 10-minute immersion of citrus fruit in a dump tank, which does not occur in citrus intended for juicing. Also, the use of dye to represent the potential for pathogen incorporation into citrus may not be an appropriate surrogate for the pathogens of concern. Decisions made by this Committee need to be based on sound science which truly reflect and assess industrial practices and result in fresh juice products. We encourage the development of more research based on current industry control practices before this Committee assesses the potential risks associated with pathogen infiltration into citrus fruit prior to juicing. We also believe that research data generated by the fresh juice industry indicating the infiltration of pathogens of concern is not likely to occur when control measures are strictly applied be seriously considered by this Committee and the Food and Drug Administration. Thank you for this opportunity to address the Committee. MS. OLIVER: Thank you very much. Next, Ms. Laurie Girand will present consumer concerns. She is the program leader for juice safety for STOP, Safe Tables Our Priority. MS. GIRAND: Could we turn off the slide projector? Thank you very much. Three years ago, in December of 1996, many of those here were invited to Washington, D.C., to discuss the state of unpasteurized juice. I remember that time vividly because when I learned that no juice victims had been notified or invited, I cried. Shortly thereafter, I joined a not-for-profit organization called STOP, Safe Tables Our Priority, which consists of victims of foodborne illness, their families and friends, who are committed to ensuring that the foodborne tragedies they have experienced are not needlessly repeated. My own intimate association with juice safety began in the fall of 1996 when my husband and I returned different from our parents-only vacation and our only daughter, a 3-year-old, had had diarrhea with stomach cramps for four days. My mother had told us that she had bought a couple of quarts of Odwalla apple juice while we were gone and that Anna had really liked it. In the night, the cramps would cause Anna to awaken in agony screaming. During the day, she would lie listless in my lap, moaning, "My tummy hurts, my tummy hurts." Because she was refusing to drink, her doctor asked us to push fluids, so we bought Anna more Odwalla apple juice. After all, the company slogan was, "Drink it and thrive." It wasn't until the eighth day of her illness, when Anna was finally hospitalized, that the doctors first told us of E. coli 0157:H7. On the tenth day of Anna's illness, they discontinued fluids of all kinds because her kidneys were failing and she was beginning to swell. They had to cut off her hospital bracelets because they were becoming constricting. She would beg us for water, but we could only give her one swallow per hour. Her lips became cracked and bloody, her speech slurred. Her urine turned what they call tea-colored. Then, because of an allergic reaction, doctors stopped her first transfusion, and we waited another 15 hours before they started a second. And then the face of death came to visit my only child, my baby girl. From the anemia, her lips and gums turned gray, her puffy face was ashen, and her blood work indicated that she should be dialyzed. Ultimately, our daughter was discharged, but we will never have the good fortune to be able to describe her as recovered. People who recover or who appear to recover from the initial HUS illness are at risk of developing chronic conditions such as complete kidney failure even a decade later. At least four of the surviving Odwalla children presently suffer from gastrointestinal ailments that suggest their colons have not recovered. Over half of the 70 Odwalla victims were under the age of 6. Another toddler named Anna died in that outbreak. Oh, great. Well, this was a slide with lots of outbreaks on it. When I learned that these children had been poisoned by unpasteurized juice and that government and industry had known it was possible that this would happen again, I was outraged. Parents should not be misled into believing that unpasteurized beverages are healthier for their children. Here, on the cusp of the millennium, with technology readily available, no one should have to die from drinking juice. Yet less than two months ago, three children's lives hung in the balance again from HUS caused by contaminated, unpasteurized apple juice. But today we're not here to rehash apple juice. We're here because the citrus industry has wanted to convince the FDA that orange juice is somehow different than apple juice. In fact, the two are different. In 1999 alone, unpasteurized orange juice has caused the two largest identified unpasteurized juice outbreaks in the world. This was supposed to be a list of known unpasteurized citrus juice outbreaks caused by U.S. producers in the United States. This data does not include additional outbreaks from insufficiently pasteurized citrus juices and concentrates. STOP is here today to describe the qualitative side of the numbers and charts you'll be shown and the human cost of outbreaks that is not typically measured. To epidemiologists and doctors at the CDC and to investigators at FDA, we are numbers and percentages for the purposes of reporting. Yet officials can't begin to count the people whose doctors simply don't culture diarrheal stool, and they won't follow up on miscarriages and stillbirths. They don't ask about children turned away from emergency rooms. And, importantly for you as you weigh risk factors, they do not begin to measure the long-term cost to people with kidney failure, chronic bowel problems, diabetes, or reactive arthritis that can result from foodborne illnesses. Juice victims are not just statistics. We have faces. Here are two. This is Brandi and Tenner Ulray. Brandi was eight weeks pregnant with her second child when she and her 2-year-old son went out to breakfast with her father. It was to be a joyful occasion. Brandi planned to tell her father for the first time about the pregnancy, and they would talk about her college commencement just nine days away. She had been attending night classes for three years to finish her degree. They were expecting 15 friends and relatives to come for the celebration. At the restaurant Brandi ordered orange juice for Tenner. As the meal unfolded and she told her father the good news, she took sips from Tenner's juice. The next night Tenner had diarrhea and abdominal cramping. His parents were awakened at 3:00 a.m. to the sound of Tenner screaming. He had thrown up all over his bed and pooped in his pants and was trying to make it to the bathroom. By the next day, Brandi was also sick with diarrhea, abdominal cramping, nausea, and headache. For the next four days, she held Tenner as he screamed and cried in between trips to the bathroom. When an attack was coming on, he would clutch his tummy and fall to the floor while crying, "Mommy, owee, owee, owee." During that time she called the triage line four times in two hours, but they kept telling her that he hadn't been sick long enough. On the fourth day of Tenner's illness, the doctor said it was just likely a tummy bug. Though the doctor noted blood in his stool, she told Brandi that if Tenner still felt ill in three days, the doctor would request a culture then. While they were at the office, Tenner suffered a bout of cramping, and the doctor commented, "You know, little kids just don't understand what a tummy ache is, so it's scary for them. That's why he's screaming." A teenager suffering from this same outbreak was put on morphine for the pain. Brandi told the doctor that she was pregnant and asked if the illness could harm the baby. She was assured that the flu would not harm the fetus. Over the next several days, Tenner began to get better, but Brandi's condition deteriorated. On the eighth day, she vomited until she was dry-heaving and then collapsed on the floor of the bathroom. Her head ached so badly that she could barely move. Her stomach churned and gurgled. Her husband managed to get her into bed. She slept for four hours, and when she woke up, she had begun to bleed vaginally. On the tenth day, her graduation day, she woke up with contractions and diarrhea. She was bleeding heavily by this time and was in a lot of pain. Brandi's mother-in-law mentioned that she had seen news about the Sun Orchard outbreak and that the symptoms described matched what Tenner and Brandi had been going through. Brandi called the restaurant. The manager there assured her that they had never carried the tainted juice, all of their juice had been pasteurized, but he did say that just out of courtesy they had pulled all their juice from the shelves. Several weeks later, the family would have genetic fingerprint from Tenner's positive culture that pointed right back to the restaurant. That same restaurant is even today serving unpasteurized juice that is noted as fresh squeezed on the menu. Brandi never made it to commencement. Instead, she was rushed to the ER. Diagnosis: complete miscarriage. In addition to Brandi and Tenner, almost 500 other identified victims and countless others that were unidentified were affected by the Sun Orchard fiasco, victims who ranged in age from 2 to 88. One was an Alzheimer's patient in an institution. And Sun Orchard juice was implicated in the death of a senior citizen. You won't hear his name today because Sun Orchard has settled with his family. This man, a father, was taken out to a Father's Day meal and served unpasteurized orange juice. I think he deserves a moment of silence because three years have gone by since the 1996 juice meetings--three years of delay, three years of illnesses and death, three years of acting as if we haven't had enough science when a solution was available three years ago. [Pause.] MS. GIRAND: Let's talk about science and risk assessment for a moment. STOP has been skeptical about the strength of analysis behind the recommendation of a 5-log reduction as sufficient to render juice safe. We have repeatedly asked for data supporting it. A number of assumptions were made by this Committee, assumptions that in the last three years seem to have proven less and less valid. Here are seven key points that we believe refute the validity of 5 logs. We have data for these, and in the interest of time, we will distribute it later today. If you have any doubt in your minds after three years as to whether 5 is the right number or not, then you owe it to consumers to adopt more conservative recommendations. But let's put this question aside for the moment and talk about a series of issues that are being raised today. In developing the juice performance standard, the Committee treated the issue of organism reduction as a black box. Fruit went in, never mind its condition, temperature, or how much the pathogen load was on it. Juice came out at the other end. By not recommending any specific proven technology by which this standard could be achieved, you left FDA and industry the enormous task of defining what could and couldn't take place inside the black box. Because this Committee's recommendation was so unspecific, the industry has been developing ways to wash the fruit in Florida and juice it at a grocery store seven states away and claim that it has been treated for safety purposes as if it were heat pasteurized. Small operations, juice bars, and smoothie restaurants were declared exempt as if they had some unique way of keeping their juice safer, even though they played key roles in the Sun Orchard and Livesey (ph) Orchard outbreaks. The result has been that consumers have been used as guinea pigs. As you review the latest data over the next few days, we urge you to consider the following: Your charge is not to defend average consumers against the average juice producer; rather, you must produce recommendations that protect all consumers from producers that, through ignorance or negligence or economics, produce significantly contaminated juice. To assume that these factors are trivial matters of implementation is a luxury. Industry and consumers need a straightforward solution that even the smallest producer can implement. Today in this room we need applied science, not just a gadonkan (?) experiment. When this group addresses risk assessment over the next two days, STOP urges that you add a safety margin that takes into account the way some members of this industry have responded to the need for safety. Food safety is only as good as management's commitment to it. Mark Isaacs, president of Sun Orchard and former president of the American Fresh Juice Council, at the November Florida meetings last year publicly stated that industry had the most to leave from an outbreak when consumers pay with their lives. Many members of the unpasteurized juice industry want to produce safer juice. You must ensure that those that are not committed to safe juice produce safe juice as well. STOP believes the answer for juice today is a single-kill step prior to packaging, not a multiple-step Rube Goldberg contraption. With heat pasteurization, government and industry have settled on a safety standard for milk that has served consumers well for decades. Based on the juice outbreaks visited on consumers in the pursuit of more science, STOP has become convinced that in the United States today all juice should be heat pasteurized. Rather than start with a minimal standard and keep increasing it as outbreaks occur, we would urge this Committee to adopt a higher standard. The new juice performance standard must take into account that there is no mandatory minimum level of sanitation for fruit as an input to juice and that you in FDA are unable to guarantee it. The new performance standard must take into account a high level of pathogen contamination coming in on a large quantity of fruit growing higher under unrefrigerated conditions, potentially spreading and uptaking pathogens water, arriving at a juice that is less acid than expected. It should recognize that the juice will be produced at small orchards, large plants, restaurants, juice bars, and grocery stores. If you intend to continue supporting multiple-reduction steps, then you must increase the standard to take into account the risk of failure inherent at and between each step. Ladies and gentlemen, you decide. Either you are creating a safety net or it is just a collection of loopholes. If there is only one proven technology that achieves this performance standard today, you should recommend it. I'd like to close on this note. This year, my daughter is in the first grade, and she was asked to write about what she would like to do when she grows up. She doesn't really know what she wants to do, so she wrote this. It reads: "I like to save people from apple juice and get awards." You know, my prayer is that when my daughter grows up, we will not still be trying to save people from unpasteurized juice. Three years is much too long when the technology to solve the problem has been around for 100 years. The time has come to use it. Thank you very much. MS. OLIVER: Thanks, Laurie. Our next speaker will put the focus on the meeting. And that's Dr. Terry Troxell, the director of our Office of Plant and Dairy Foods and Beverages at FDA Center for Food Safety. DR. TROXELL: As Dr. Kvenberg outlined earlier, in December 1996, the Advisory Committee made several recommendations to FDA regarding-- MS. OLIVER: Terry, could you speak into the mike, please. DR. TROXELL: Sorry. In December 1996, the Advisory Committee made several recommendations to FDA regarding juice safety. After discussing data presented at the public meeting on juice safety, the Advisory Committee concluded that the history of public health problems associated with fresh juices indicated a need for active safety interventions, and for some fruit; for example, citrus, the need for intervention may be limited to surface treatment, but for others; for example, apples, additional interventions may be required. In addition, the Advisory Committee recommended the use of safety performance criteria instead of mandating the use of a specific intervention technology such as thermal processing. The committee recommended that an adequate level of safety could be achieved by requiring interventions that have been validated to achieve a 5-log reduction in the target pathogen. The Advisory Committee also recommended that HACCP form the general framework for the safety interventions. FDA subsequently developed and published, in April 1998, a proposed rule to require that juice be processed under a HACCP system. FDA proposed to require that juice processors include in their HACCP plans control measures that will produce at least a 5-log reduction in the pertinent pathogen. Consistent with the committee's recommendations, the Agency did not propose a specific intervention technology; for example, pasteurization, but instead proposed a flexible 5-log performance standard that theoretically could be met through cumulative steps and, at least for some fruit, for example, oranges, potentially through surface treatments. In the preamble is a proposed HACCP rule. FDA stated that pathogens are not reasonably likely to be present in the interior of sound, whole oranges or other citrus fruits and, further, that the acidic nature of citrus fruits may inactivate any pathogens that may be present. In the proposal, FDA further noted that steps such as culling, washing, brushing and sanitizing the surface of fruit, followed by extraction that minimized contact with the peel, could be used cumulatively to attain the 5-log reduction, as long as processors could validate the reduction under their HACCP systems. Comments to the proposed rule have challenged FDA in two areas related to the performance standards and its application. First, comments, as well as new information available to FDA, have questioned the assumption that pathogens are not likely to be found in the interior of citrus fruit and have further suggested that surface treatment of fruit alone may not be adequate to ensure the safety of juice. In addition, FDA has undertaken research that suggests that, under certain conditions, pathogens could be internalized into citrus fruit and could survive and grow once inside the fruit. Second, comments have requested that the Agency identify a starting point for the 5-log reduction. Therefore, FDA is asking the Advisory Committee to provide recommendations regarding these two areas of concern to ensure the safety of juice. The first area of concern, the adequacy of surface treatments, is limited to citrus fruit only. At the time of the proposal, the Agency did not consider surface treatments to be adequate for any commodity, other than possibly citrus fruits. The Agency received comments questioning the assumption in the proposed rule that pathogens are unlikely to be found in the interior of citrus fruit. As a result of these comments, the Agency conducted research to address the question of pathogen internalization in citrus fruit. This research will be described in more detail by Dr. Arthur Miller later this morning. As a result of comments challenging the Agency's assumption about the likelihood that pathogens could be found in the interior of intact citrus and the results of research undertaken by FDA to address the question of internalization of pathogens in citrus fruit, FDA has the following questions about internalization and survival of pathogens: Is it valid to assume that there is no internalization of pathogens in citrus fruits? If internalization of pathogens in the citrus fruit is theoretically possible, is such internalization likely to result in a public health risk? If internalization does occur and it results in a public health risk, are there techniques to ensure that internalization of pathogens does not occur? What are they? A second area of concern involves the application and measurement of the 5-log reduction. As mentioned previously, comments requested that FDA define a starting point for the 5-log reduction for the processing of all juice. The committee's original recommendation did not address this. In addition, comments have expressed concern that the 5-log requirement may be inadequate for particularly dirty incoming fruit. The Agency has the following questions about the application and measurement of the 5-log reduction standard. At what point in the production process should a processor begin measurement to measure attainment of the 5-log reduction? For example, should fruit be cleaned and culled before measurement of the 5-log reduction has begun? Comments have also expressed concern about the use of cumulative steps to attain the performance standard that would allow for potential cross-contamination of juice between steps. Comments maintain, and the Agency has concern, that although these steps could theoretically be combined to achieve a 5-log reduction, in actuality, there would be too many points for potential cross-contamination for a processor to consistently ensure the safety of the juice. Therefore, the Agency asks: Are there limits within which the 5-log reduction must be accomplished? Would using cumulative steps that are separated in time and location impact a processors ability to achieve and deliver a 5-log reduction? Can the safety achieved by the 5-log reduction be maintained consistently if a processor does not package product immediately after attaining the 5-log reduction? Some examples of the aforementioned situations include: One, operations that perform certain steps on the exterior of the fruit at one location resulting in a portion of the cumulative 5-log reduction and then transport this fruit to another location, where the remainder of the cumulative 5-log reduction is achieved; Two, firms that extract juice at one facility and then transport it via tanker, large drums or totes to another facility for packaging; or Three, firms that hold juice overnight or longer for mingling with other juices to attain desired quality attributes in the final product. The committee has been provided copies of the documents, the literature review and research papers related to the question of the adequacy of the surface treatments for citrus fruits. The speakers following me will provide more detailed information for your consideration in making recommendations on all of these questions. Thank you. MS. OLIVER: Thanks, Terry. What I'd like to do is just remind the committee that in your package you have the questions that were presented to NACMCF, the questions that FDA would like answered. You also have in your packet the NACMCF recommendations to FDA on the safety of juices from the previous meetings that was referred to by Dr. Kvenberg. If you want clarification, refer to that. The next thing that we have on the agenda is questions of clarification. And once again, I remind everybody this is for the committee members first to ask questions of any of the previous presenters to clarify any of the points that were presented. And those who are not at the table that were presenting, I would ask those to come forward to the front of the room to respond to any questions that the committee might have. And for the committee members, once again, I'd ask you to introduce yourselves first so that it will help with the transcription. Thank you. Are there any questions from the committee at all on clarification of any of the comments or presentations by any of this morning's presenters? Bill? MR. SPERBER: Yes, I'm Bill Sperber with Cargill. I have several questions for Mr. Martinelli from Orchid Island. If possible, I'd like to learn a little more about your operations. Was the treatment of the incoming fruit juice--you mentioned several times that you have a high-pressure sanitizer spray. What type of sanitizer and what concentration are you using? MR. MARTINELLI: The high-pressure spray that I was talking about on the incoming fruit was the sanitizer that we use in that spray was CS-100 from Chem Systems. The concentration is, it's higher than--I don't know exactly what the concentration is, but I know it's higher than the recommended concentration by the manufacturer, sir. MR. SPERBER: I don't know what CS-1 is. Do you know that chemical? MR. MARTINELLI: Thank you very much for the question. I'm the executive vice president at Orchid Island Juice Company, sir. We invite people to come to our facility where someone can further explain all of the intricacies of all of the chemicals that we use in our facility. We offer that openly to everyone. MR. SPERBER: Sure. Then, my other question has to do with cleaning and sanitation of your extraction and further processing equipment. And perhaps you don't know the answer to this either, but I believe it's more important than the fruit treatment. You said that extraction equipment, et cetera, is CIP'ed at the end of each day, sanitized, and then rinsed with potable water, and it's ready for the next day's production. MS. SEXTON: The final rinse is not potable water, is it? MR. SPERBER: That's what you said in your-- MR. MARTINELLI: No, it's a sanitized--it's injected with CS-106, and it's potable water injected with a sanitizer, but that's not what's used in our CIP, sir. Our CIP is a caustic flush, and then it's a sanitizing rinse. MS. SEXTON: Are you with a pasteurizing company because-- MR. SPERBER: Cargill. MR. SEXTON: Because we also hand break down, if you want to go into the cleansing breakdown, we break down our extractors by hand every single day. MR. SPERBER: No, my major concern was that you would be rinsing equipment with potable water, letting it sit until the next day and then starting up production, and that would be a poor practice. MR. MARTINELLI: We don't rinse any of our equipment with just straight potable city water. We inject a sanitizer into it, and it's CS-106 from Chem Systems. MR. SPERBER: Okay. MS. SEXTON: Because we know the 5-log reduction we do realize was brought on by the subcommittee that it was stated that that was a water, a drinking water, regulation. So we know that there are hazards to drinking water. MR. SPERBER: Right. Okay. Thank you. MS. OLIVER: Alison? MS. O'BRIEN: I have a question for Laurie. MS. OLIVER: Can you identify, too, please. MS. O'BRIEN: I'm Alison O'Brien, Uniformed Services University of the Health Sciences. Thank you. Would you please review how many outbreaks there have been--that the slide did not show on your computerized graph--how many outbreaks there have been since the 1996 meeting and how many, to your knowledge, were due to unpasteurized orange juice. MS. GIRAND: There have been, in the U.S., two unpasteurized juice-related--it's an outbreak and a recall. Both were by Sun Orchard, in particular. There was also an outbreak in Adelaide, Australia, from unpasteurized orange juice that affected more than 400 people. MS. O'BRIEN: Thank you. MS. OLIVER: Mike Doyle? MR. DOYLE: Mike Doyle, University of Georgia. I have a question for Mr. Martinelli. Do you routinely test your juice for salmonella? MR. MARTINELLI: Yes, we do, sir. MR. DOYLE: And what procedure do you use? MR. MARTINELLI: We use a Tritech Laboratory procedure, and it is consistent with--when the CDC came out with their testing, after the first Sun Orchard outbreak, we sent that testing immediately to the Tritech Laboratory, and it is consistent with the CDC testing, the way of testing for salmonella, and E. coli, and other pathogens that might be in fruit juice. MS. OLIVER: Larry? DR. BEUCHAL: Larry Beuchal, University of Georgia. I would ask, also, John, do you test only the juice or do you also test the oranges for microbiological profiles? MR. MARTINELLI: We test our juice, sir. DR. BEUCHAL: What is the, over the period of a year, say, the range in temperatures of the juice, rather the orange or the oranges, and also the water that is used to rinse or sanitize the oranges? MR. MARTINELLI: The fruit temperature is always ambient temperature. It's water the outside environment temperature is, and the water is always ambient temperature tap water that we use. We don't use any heated water or anything like that. We use strictly sanitized water. DR. BEUCHAL: What is ambient temperature in your facility, in your area? MR. MARTINELLI: I would suggest, sir--I'm not an expert on this--but I would think that tap water would be somewhere around 70 to 80 degrees, and fruit temperature would be anywhere from, internal temperature would probably be 40 degrees to 75 degrees/80 degrees. DR. BEUCHAL: Thank you. Do you have an indication of pH range of the various cultivars, the various varieties of oranges that you would use in your product? MR. MARTINELLI: I do not. I think that I'm sure there's data out there in reference to that, sir, and I know we have logged pH ranges of our fruit during the extraction process. We don't do that any more since we found that it wasn't critical to the quality of the product. DR. BEUCHAL: And going back to the question raised by Dr. Sperber, the CS-100, is it? MR. MARTINELLI: Yes, sir. DR. BEUCHAL: Would there be anybody here that could tell us what the composition of that sanitizer is. MR. MARTINELLI: This is Dr. Dan King, from the Fresh Juice Company. DR. KING: Thank you. I just made a quick call to verify some numbers. The phosphoric acid base wash that they use at Orchid Island is about 100 parts per million minimum. As a point of comparison, at Fresh Juice, we use a citric acid wash at about 175 parts per million minimum. In addition, there are chlorine components involved; for instance, chlorine dioxide added as a commercial form oxine, which is at 15 parts per million minimum, which is the equivalent of at least 200 parts per million chlorine. DR. BEUCHAL: Are all of these in this CS-100 Chem-- DR. KING: No, the CS-100 is the phosphoric acid. DR. BEUCHAL: All right. But then the citric acid is used-- DR. KING: It's used in place of it. It's used particularly with organic citrus processing, organically grown. DR. BEUCHAL: And there is no surfactant, apparently, in any of these. DR. KING: No. DR. BEUCHAL: Thank you. MS. OLIVER: Dane? DR. BERNARD: Thank you. Dane Bernard, NFPA. I also have a question for Mary Grace or John. Hi. First, thanks for your presentation. One of the questions that we are asked to address deals with steps that are somewhat removed in the production process. And one of those steps is presumably when juice is extracted in one location and trucked or transported to another location. Does your company receive tankers and how common is that practice in the industry, even if you don't? MS. SEXTON: At Orchid Island Juice Company, we do not receive any tankers or provide any tankers. We do not inventory juice, also. Juice is processed, squeezed and is shipped immediately. So the tanks that you see are tanks preparing it to go into the bottling system. They are not inventory tanks, and that is very, very, very important. They are not. And, also, someone asked about lab tests. The Department of Citrus and the regulations in Florida have had us have--we were mandated that we had to use an outside lab. I believe it was between 5 and 6 years ago. So since then, and the scientists will show you the results, all juice has been tested by an outside independent lab. So this is an ongoing thing. DR. BERNARD: Any feel for how common, though, the practice of extraction in one location for transport to another location is? I also have a question for John regarding the-- MS. SEXTON: I just have to reiterate, I don't do tankers, I don't receive them and I don't ship them. So I'm not the expert on a tanker. DR. BERNARD: I've heard from yourself, and from Mary Grace and from Donna that you don't immerse fruit at your operation. Are there operations that do immerse fruit? And just for my information, could you describe your cleaning procedures for fruit. MR. MARTINELLI: It's Dr. Bernard, right? When the question first arose, we formed a consortium of competitive fresh-squeezed orange juice companies throughout the United States. We did a number of research information-gathering projects to find out who was immersing fresh oranges for utilization in fresh-squeezed orange juice. None of the people in the consortium immersed fresh oranges for production into fresh orange juice, and that was pretty much the standard that we recognized throughout the fresh juice industry was there is no immersion going on. And that is the reason why we have--that's the reason why, sir, we feel a little anxious about this whole thing is because most of the premise of the documentation that you are going to see is based on immersion of fruit, when immersion is not a common practice amongst the conscientious fresh juice providers of the country. MS. SEXTON: May I just restate one thing? Because I don't want to take the justice away of people that might possibly tanker. I don't think it's anything that's not publicly known. But the tanker that was contaminated was contaminated by Mexican water, if I understand the situation correctly. And a fresh squeezed juice processor is never, ever, ever allowed to add water, first of all, to fresh squeezed products. So there was a law that was broken, first of all, and then contaminated with an outside water, out of the country. So I'm not so sure it was the tanker, rather than the processor, again. MS. OLIVER: Earl? MR. LONG: Earl Long, CDC. Mr. Martinelli, could you describe briefly the extraction process for me, please. MR. MARTINELLI: See, sir, these are my strong points. These are in my sales presentation. [Laughter.] MR. MARTINELLI: In an FMC extractor, what happens in an FMC extractor is the fruit is tossed into a waiting cup, and the cups interlock. During the cycle, the cups clasp down on the fruit and a mechanism is stuck into the fruit, and then the orange is collapsed around the strainer tube. At that point in time, it's released, and you can take that skin, and except for the top plug, which is about the size of nickel, and the bottom plug, which is about the size of a nickel, you can practically reproduce that entire skin. Now, FMC has come up with a soft squeeze extractor, which does very, very, very little damage to the exterior of the orange as it's being squeezed. It puts some cuts in the skin, but the juice never comes in contact with the exterior of the skin of an orange during the extraction process. MR. LONG: Is that a standard procedure in the industry? MR. MARTINELLI: The conscientious fresh squeezed juice companies that we have in our consortium, we are all using FMC extractors. MS. SEXTON: And on those plugs, the whole plug does not touch the juice. They have a statistic review that the razor touches a very, very, very, very small percentage of the orange that pulls that plug away from the orange for the office tube to bring the juice out. So the plug is not involved the juice. It's the razor that cuts the orange. MS. OLIVER: Mike Jahncke, did you still have a question or was yours-- MR. JAHNCKE: My question was answered. Thank you. MS. OLIVER: Mike Robach? MR. ROBACH: Mike Robach, County Group Companies. You are involved in the pilot HACCP program, and one of the questions that we have before is regarding how you determine a 5-log reduction. And I was wondering if you could go through for the committee how you determined and validated that your process was achieving at least a 5-log reduction. MR. MARTINELLI: Thank you, sir. When the Food and Drug Administration made a 5-log recommendation, Orchid Island Juice Company and the Fresh Juice Company, and the other conscientious fresh squeezed juice providers of the country automatically went out to achieve what the Food and Drug Administration had asked us to do. The way we had our 5-log reduction validated was we took our entire squeezing protocol to a test laboratory, ABC Research Laboratory, under the direction of Keith Snyder, and we put together our protocol in our facility, and he went through systematically washing, and scrubbing, and extracting and adding all of the chemical sanitizers and all of those other things that we have during the process of our plant that you saw today. And we came up with a validated 6.73 log reduction. I have the test data in my--I'd be more than happy to provide that to you, sir. But then the question arose: Well, how can we equate that? How do we know that Dr. Snyder and all of the processes in the protocol that he went through were exactly replicated in our plant, the 26 steps that he went through were replicated in our facility? We got the USDA Consumer Services to come out and do an audit of the protocol that ABC Research Laboratory did in the facility. And during that audit, he went through each and every one of the 26 steps of the protocol that ABC Research Laboratory went through and documented the 26 stages were identically replicated in our facility as they were in the ABC Research Laboratory. So we don't ask anyone to assume that the Research Laboratory did their job correctly. We had the USDA come in and validate that the protocol was in order. MR. ROBACH: So USDA came in and took samples of raw fruit incoming and looked at micro numbers and load on the incoming fruit and then followed your process all of the way through the 26 steps, and then validated that you had a 5-log reduction from incoming fruit to final juice product? MR. MARTINELLI: No. I'm sorry, sir. I must have stated that confusingly. In the HACCP program, the first thing you do in the 5-log HACCP program, the first thing we did was we set out to validate a 5-log process. In the validation of the 5-log process, we recognized that there were critical areas where, if this didn't happen, then your 5-log would be interrupted, if this didn't happen, and those are what we call our critical control points. In a HACCP program, the reason why a HACCP program is a HACCP program is because, in the validation studies at ABC Research Laboratory, if, in fact, one of these steps missed, then you wouldn't have your 5-log. At the ABC Research Laboratory, we validated our study, we implemented a HACCP program to make perfectly sure that the steps of that study were routinely followed on a day-to-day basis and, subsequently, the information that we got from ABC Research Laboratory was supported by our HACCP program. MS. SEXTON: And I just wanted to verify, we did not use-- MS. OLIVER: Mary Grace, if you could speak into the microphone. I'm sorry. And I know-- MS. SEXTON: And I want to reemphasize, we did not use a surrogate. We used what you asked us to use; E. coli 0157H7. We did not, you know, pansy around. We used exactly what you wanted to kill. MS. OLIVER: If we could restrict, for now, but we will open it up for other questions later, if we could restrict it to the presenters. DR. STROBOS: I just wanted to address the 5-log question because we worked together on this. MR. MARTINELLI: This is Dr. Jur Strobos. He was one that was instrumental in bringing together the consortium of fresh squeeze orange juice companies that have validated their 5-log and do make a fresh-squeezed product. DR. STROBOS: I just wanted to answer the specific question about several different companies have done it several different ways. In the docket, in November 19th, we submitted basically 40 copies of not only the Florida regulations, which actually address many of your questions. Exactly what the sanitizers are, for instance, is specified in those regulations. Additionally, in that docket, also we submitted experimental data from 5-log reductions. Different companies did it different ways. That data on how different companies had achieved it was the subject of seminars in Florida and California. Transcripts of those were also submitted to the docket. Just to briefly go over it, however, Orchid Island did studies with regard to E. coli. We, at the Fresh Juice Company, using a surrogate, we did exactly what you had described; in other words, tested incoming fruit for the surrogate, validated the surrogate reduction through the process to about a 6-log reduction to the final juice. MS. OLIVER: Next, John, you had your hand up quite a few times. Did you have your question answered? MR. KOBAYASHI: Yes. MS. OLIVER: Next who had their hand up, Peggy Neill? MS. NEILL: Good. MaryGrace or John, tell us a little bit about the labeling of your juice bottles with respect to lot numbering, sell by/enjoy by date, and can you give us any profiles of what data you might have on length of time from production to consumption? MR. MARTINELLI: Ma'am, a lot of what you're asking was covered--was made in a recommendation by the Department of Citrus about 4 or 5 years ago, and the Department of Citrus wanted us to have the ability to trace back to the grove each jug of fresh orange juice that we produced. Our coding on our juice, not only tells us what tank the juice came from, it tells us who the person was who handled the jugs that put in on the line. It tells us who was in operation at the bottler at the time, and it does tell us--it puts a 17-day code on it. Now, the 17-day code is mandated by the Florida Department of Citrus, and that is a quality requirement mandated by the Florida Department of Citrus, and we're not allowed to go over that 17-day code. MS. OLIVER: Okay. Scott Severin. MR. MARTINELLI: Ma'am, was that-- MS. NEILL: Sort of. I remember your presentation in '96, and I remember some of the slides, and as I recall, the coding also included what essentially would be your product with something like only one day's--a lot was one day's production or a segment of a day, and the you had further subsets from there, so you could tell who had handled it, what line, what tank, et cetera, with the idea that that is information or greatest relevance for trace back, occasionally for trace forward. MR. MARTINELLI: Right. MS. NEILL: Can you elucidate on a trace forward? In other words, can you--I realize some of this might be market data, but can you tell us something about what you might known on estimated length of time from production to consumption? MS. SEXTON: Our customers, when you have--we're very proud, we have the best customers in the world. And they are trained, and we work very closely with them that they don't inventory juice. Customers as far as Boston will get two-time a week delivery, so they rotate that juice every two to three days, and then they get their new shipment in. We train our customers to keep it so tight, but not everyone has to do this. If they go short we fly the juice in, because we like fresh. But we do have a 17-day shelf life that has been mandated. MR. MARTINELLI: The time from production to consumption, ma'am, in a wholesale application such as a food service distributor, I would say that they're probably going to be getting the juice into the restaurant's hands within 4 to 5 days after production. The restaurant will probably consume that product within two days, two or three days. In retail applications where we deliver directly to a distribution unit, the distribution unit will get the juice, in most situations, the day after, so it will be two days into the distribution unit. They'll get it out in 3 days, so it will be on the shelf in 5. A lot of our retailers, because of the regularity of our deliveries and the fact that we ship the juice as soon as we squeeze it, have actually had us change the code to a 14-day code, so they're pulling the juice off the shelf even when the customer still can consume the juice for 3 more days, or they could have it on the shelf for 3 more days. MS. NEILL: So my last point would be that you would estimate that something that's a small minority of the product--I don't know what it is, maybe 10 percent of the product--is actually consumed, let's say, in the latter one-third of your 17-day window. You presumably have something in which the majority, over 50 or 60 percent, is going to be consumed probably within 8 days, within half of your 17-day window? MR. MARTINELLI: Yes, ma'am. And I think that's a very good estimate. I think there will be some that will be shorter and there will be some that will be longer. We like distributing into like home delivery dairies. They're a very good application for us, because they get the juice in, and the next day it gets delivered to the consumer, and the consumer is drinking the juice in 3 to 4 days. So the more direct the supply line, the better it is for the consumer and the distributor also. MS. NEILL: Okay, Scott? MR. SEVERIN: Scott Severin, Office of Surgeon General. John, you were talking about your HACCP plan, and I believe you said your second critical control point had to do with harvest delivery, harvester verification on drops specifically? MR. MARTINELLI: Right. MR. SEVERIN: And you said that if they have drops, that they whole load is rejected. How do you verify that? MR. MARTINELLI: Thank you. Good question. The second critical control point in our HACCP program, sir, is our food acceptability. What we do is in order to test a sample of our truck, we go and visually observe the truck. In a stem scar scenario--and we'll be hearing a lot about stem scars--in a stem scar scenario, when the fruit is picked off the true you'll see a fresh stem scar. It's almost like cutting the stem of a rose. You can see a fresh one. After a certain number of hours, that stem scar will start to keel over and almost become callous. The fruit will start to wilt and in some scenarios it will turn brown and even have a little sand on it. If we see any of that in a truck, we know that there was no integrity put into the harvesting of that product, and we reject that trailer immediately because our growers know that there's--our harvesters know there's plenty of places to take that kind of fruit, but Orchid Island Juice Company is not one of them. MR. SEVERIN: Well, what type of other sources or delivery sites would they use that type of fruit for? MR. MARTINELLI: Something, sir, that has--something, sir, that can really impact-- MS. SEXTON: A pasteurized company has a tolerance for that. MR. MARTINELLI: Pasteurized companies have more of a tolerance for using dropped fruit and unwholesome fruit than fresh squeezed juice companies do. And, sir, one of the reasons why that is, is because, as you saw in Florida in the Florida model of inspection, we have the Florida Department of Agriculture in our facility every single day, and there's a random sampler in line with our production line. And what it does, is it takes a piece of fruit randomly from the production line, and then sample it into the Department of Agriculture office. The Department of Agriculture has set a zero tolerance for fresh-squeezed orange juice as far as unwholesome or decayed fruit. And we think the Department of Agriculture is serious about that, and that's why we have, in a facility that is one-third the size of Odwalla's, we had--I think Odwalla, during their outbreak, sir, had three graders on the line, and we have 12, and we're one-third the size of Odwalla. So we--and it's all because of MaryGrace's inspiration. We try and make a product that is safe enough to our children because, you know, I have to go home and look at my child every day too, and I don't want any kind of incident to happen there. So food acceptability is the second part of our critical control point. MR. SEVERIN: Thank you. MR. MARTINELLI: Thank you, sir. MS. OLIVER: John Kvenberg. DR. KVENBERG: Thank you. I have a follow-up question for John. MS. OLIVER: John, if you could get closer to the microphone. DR. KVENBERG: I'm sorry. For John Martinelli. It's a follow-up question to what Dr. Sperber asked earlier relative to the sanitizers that are in use. And I realize the question was out of the context of your presentation this morning, so if you don't have the answer now, maybe you could answer it later. But is it not true in the final sanitizer application, you're using a parasitic acid-- MR. MARTINELLI: Absolutely. DR. KVENBERG: Brand new Tsunami? MR. MARTINELLI: Tsunami, parasitic acid. DR. KVENBERG: Yeah, that's my memory. Thank you for sharing that because that is much different then phosphoric acid. MR. MARTINELLI: And in the original testing at ABC Research Laboratory, we did not us parasitic acid as our final sanitization step, we used something else. But the Food and Drug Administration, on the Food and Drug Administration's recommendation, we checked into that product--and I forget what product that was. I think it was--I don't know what it was. But we changed it because it was not approved for raw agricultural commodities, to be used in the sanitization of the exterior of a raw agricultural commodity. We changed to parasitic acid, and parasitic acid has done an excellent job in the exterior sanitation of the fruit. MS. SEXTON: We revalidate every time we change something. MS. OLIVER: That's what I wanted to know. MR. MARTINELLI: Is that the question you were going to ask? MS. OLIVER: That's what I was just going to ask, if they revalidated-- MR. MARTINELLI: And Dr. Nagle was going to talk about the revalidation. If any process in our facility is changed, if we--as a matter of fact, if we wanted to reduce the number of graders we had on a line, that would be a critical control point. It would take a revision in our HACCP plan, and it would have to be documented as a revision, and we were taught that by the Food and Drug Administration. MS. SEXTON: And then it would be reverified by the outside lab also. MS. OLIVER: Phil Sveum? MR. SVEUM: Phil Sveum, Campbell Soup Company. I have a question about your process control program. You mentioned at length that you have these alarms for the sanitizers. We talked about that. You talked about finished product testing. Do you have any environmental control program where you're monitoring for target organisms or a pathogen during the process of after sanitation, so we have a level if you ever do get challenged by that organism? MR. MARTINELLI: Good question, sir. Not on-site, and the reason being is because when we were trained on our HACCP program, a true, pure HACCP program puts into place critical control points where the juice or the fruit can be contaminated, and we would lose our 5-log validation. In a HACCP program, we monitor our critical control points regularly, and sometimes with visual and audio alarms. We also give the graders the capability to shut the entire facility down if in fact the dilution of our sanitizer goes out of specifications, or the volume of fruit is incorrect. We do all these things because the way we were trained, HACCP is a process by which you monitor your critical control points once they're in place and once they've been validated, and as long as those critical control points are within the specifications, you are achieving the safety level that you set out to achieve. MR. SVEUM: As a follow-up then, you don't have any existing in-process microbiological verification program of these controls? You validated it and then that's it; you're just going by the alarms? MR. MARTINELLI: In our-- MS. SEXTON: Does he understand we have the pre-sanitizer? MR. MARTINELLI: Sir, you don't understand. Our first critical control point was bioluminescence testing of our fruit surfaces and our juice surfaces. MR. SVEUM: Yeah, but I asked specifically if you monitor the environment for-- MR. MARTINELLI: During the process. MR. SVEUM: --a pathogen at any time or a target organism. MR. MARTINELLI: Can he step up? He's a doctor. I'm executive vice president in charge of operations. MS. OLIVER: What I'd like to do is--there are like 7 more Committee members that have questions. I'd like to restrict it to hear yours on the program later, and we can ask additional questions tomorrow if we can, but-- MR. MARTINELLI: Yes, we do, sir. MS. OLIVER: Okay. Bala? DR. SWAMINATHAN: Bala Swaminathan, CDC. It's been very confusing to me because you keep going back and forth between quality inspections and food safety concerns. There may be some overlap, but we are primarily here to discuss food safety. And from what you have described, it seems to me that your premise is that any contaminant is present on the outside of the fruit, and so if that's taken care of, no more problems exist. Is that correct? MR. MARTINELLI: The data that we have collected, sir, and the fact that we have--and I don't know if this is a scientific test or not--but we've done over 1 billion pieces of fruit, and we have not--through outside independent laboratory testing over the last 5 years, we have not had any internalization or we've not had any pathogens in our product. I would say my answer to that would be yes. MS. SEXTON: But you have to clarify that we do a visual inspection and touch every piece of fruit, you have to understand, so what you're stating is that once we wash it, we're finished, and that's not correct. You have manual people inspecting visually every single piece of fruit. DR. SWAMINATHAN: Visually I couldn't detect E. coli 0157 or salmonella on fruit; can you? MS. SEXTON: No, but your 5-log reduction's already killed it. MR. MARTINELLI: That's a good question, sir. When the Food and Drug Administration initially put forth the 5-log safety standard, we set out to prove that it could happen in citrus juice. It was on the exterior of the fruit because internalization has never been proven in a normal setting. We did. We set out, and through our protocol we achieved a 6.73-log reduction on E. coli 0157:H7. No, sir, we can't see--we cannot see E. coli 0157:H7, but I don't think you can see listeria on fish either, but the HACCP program in the fish industry has worked very, very well to stop that from happening. DR. SWAMINATHAN: My next question: are the details of this testing done by the outside laboratory available for the Committee? Could we see what are the tests that are being done, or is the product being tested for indicator organisms? Do you have specific action levels if the testing company finds something positive in your product? And finally, has the company ever found pathogens, whether it's listeria or E. coli 0157, or salmonella in your products since the testing began? And my last question is: What are your specific objections to pasteurization? Thank you. MR. MARTINELLI: Has Tritech Laboratories ever found listeria, E. coli 0157:H7 or salmonella in our product? No, they have not. In the last 5 years the consortium--I can give you the data of the consortium, sir. The consortium that we put together of competitive fresh-squeezed orange juice companies has squeezed, in the last 5 years, 2.7 billion oranges. We've done 17,000, over 17,500 microbial tests in laboratories, and have not had a salmonella or E. coli or listeria hit in our test results. Our objection to pasteurization, sir? MS. SEXTON: May I answer that? MR. MARTINELLI: Our objection to pasteurization? MS. SEXTON: Yes. The objection to pasteurization is that people think that's a cure-all and it's safe, and that that's the end road. They have many recalls in pasteurized products, many, more than fresh-squeezed juice will ever have. For the consumer, all you want to do is blanket the problem, and my children are too important to say pasteurization is safe for everything, because we know it's not. We know on a child's menu hamburgers kill them, hot dogs kill them, cereal has salmonella in it. Well, you can't simplify the fact: food processors have to be responsible, whether they heat it, whether they bake it or whether they cook it. MS. OLIVER: Okay. Next I'm going to call on Dr. Larry Beuchat. We have about a minute for questions before our break, and Dr. Beuchat will not be here tomorrow. The--I believe our presenters will also be here tomorrow, so that when the Committee is asking questions for clarification tomorrow, you will be available also, since there are a number of questions unanswered, correct? MR. MARTINELLI: Yes. And I'll also have the documentation of our study tomorrow if that's okay, Doctor? MS. OLIVER: Dr. Beuchat? MS. OLIVER: Thank you. Actually, Dr. Swaminathan was touching upon this question. Do you know the procedure, detailed procedure for applying this surrogate E. coli, I assume, to the orange? Do you know the details on that procedure? MR. MARTINELLI: Well, first, sir, it wasn't a surrogate. It was the actual pathogen in the ABC Research Laboratory. And do I know the application? DR. BEUCHAT: Yes. What was the procedure? Can you help us? MS. SEXTON: We have the whole protocol. MR. MARTINELLI: I have a copy of the protocol. DR. BEUCHAT: That will be helpful. MR. MARTINELLI: If that's okay. I mean, sir, I'm not a scientist by any stretch of the imagination. I don't even think I took many science classes. MS. OLIVER: Okay. We're going to take a break now, but I know a number of the Committee members still had questions. And our presenters will be here tomorrow, so if there are additional questions that you have for them, they'll be available then, or if we have time later in the day, we'll revisit this. Thank you very much. We'll convene at 9:50. [Break from 9:35 to 9:47.] MS. OLIVER: I just want to make a couple of announcements based on some questions I got from the Committee. If someone could close the door or ask people to come in, please? Thank you. A number of questions arose about the Florida regulations and Jur Strobos told me that he will be addressing that during his talk. Some other questions arose surrounding the Orchid Island and their procedures, and Orchid Island has agreed to supply their validation data, and I'll be talking to them later to see if they can answer more specifically some of the questions that were responded to this morning--or after this morning so they can have it for the Committee tomorrow, so I will do that, and they will be here tomorrow. And trying to move on and get us back on track, the next speaker is Dr. Mary Lu Arpaia from--a post harvest plant physiologist from the University of California at Riverside, and she is going to speak top us on factors affecting the integrity of citrus fruit. Dr. Arpaia? DR. ARPAIA: Thank you. Can you hear me? Good morning. As I was introduced, I'm Mary Lu Arpaia. I work for the University of California. I'm a cooperative extension specialist in the Department of Botany and Plant Sciences at the Riverside Campus. I work with citrus and avocados predominantly, and I work with both pre and post-harvesting handling systems for those two commodities. Today, what I thought I would do in the 30 minutes that are allotted to me, is to briefly review how fresh fruit are handled in California. Approximately 80 percent or greater of all the citrus that is grown in California is sold as fresh product, and the remaining is sent to processed products. So an overview for the presentation I'm going to give you today, I want to talk very briefly then about the California citrus industry, to give you a background on why we do things the way we do. I'm going to give you a very brief overview about post-harvest biology of citrus. The underlying premises in which we have structured how we handle the fruit is due to disease susceptibility to plant pathogens, so I want to cover the plant pathogen management for fresh marketing of citrus. I'll give you some examples of some grade defects, and then I'll quickly review handling procedures in a packing house setting. So in California we grow citrus, it's grown throughout the state in a wide variety of environments from Southern California near the Mexico border up through the Sacramento Valley north of Sacramento by about 50, 60 miles. So they're grown in diverse climates and under different conditions. Approximately 75 percent of all the citrus grown in California are oranges. Navel oranges account for approximately 50 percent of the entire state's acreage, Valencia oranges about a quarter, about 25 percent, lemons accounts for about 18 percent of the total acreage, with grapefruit about 5 percent. Citrus is very important to the economy of California. You can see here in the 350--this is actually agricultural commodity listed by the California Department of Food and Agriculture. Oranges ranked in 1997 as the 11th most important commodity, lemons number 20, and grapefruit number 56. So you can see that in terms of the big picture, California citrus is very important to the economy of the state. We harvest fruit year-round, I just want to point out here real quick. Navel oranges are harvested from about mid October through the month of about June; Valencia oranges starting in the Cochilla [ph.] Valley are picked in February, and harvest of Valencia oranges extends then into the fall months. So essentially we have citrus harvested, and oranges in particular, 12 months of the year. So moving on then to post-harvest biology, plant pathology and disease management. The two underlying principles from a citrus perspective in terms of post-harvest handling is that the fruit are non-climacteric. This is a characterization of fruits that--in the post-harvest arena--into either climacteric fruit such as apples, kiwi fruit, pears, tomatoes are climacteric fruits. These are fruits that typically will undergo distinct ripening changes either on the tree or after harvest. So a great example would be the tomato turning from green to red during the ripening process, or a banana. Conversely, products such as citrus and grapes are considered non-climacteric. These fruit basically is what you harvest off the tree is what you get. They do not show a increase in respiratory activity following harvest, and their response to ethylene varies from climacteric fruits. The other key characteristic of citrus as a group is that they are chilling-sensitive. This means that we are limited by the storage temperatures that we can hold the fruit, and typically, most citrus--not all citrus, but most citrus, cannot be safely stored for prolonged periods below about 35 to 40 degree Fahrenheit. This is an example of chilling injury, low-temperature damage on navel oranges, and you can see this occurred after six weeks of storage at 1 degree Celsius, and you can see the sense of pitting occurring on the peel of the fruit. Typically we do not store our fruit for that period of time or at that low of a temperature. This was an experiment we were doing to look at potential for chilling injury. Lemons have a unique form of chilling injury called membrane staining, in which the segment walls will become stained, and this usually occurs at temperatures below 5 degree--50 degrees Fahrenheit, but typically we do not store our green lemons at temperatures below 50 degrees. This is just to give you an example of the respiratory response of lemons to ethylene, which illustrates the non-climacteric behavior of the fruit. Again, the fruit respiration of the fruit varies between temperatures. This is fruit held at 20 degrees Celsius , 10 degrees and 5 degrees, and so, as you would expect, the rate of respiration of the product is decreased as you lower the temperature. These two curves here, this curve and this curve, is the respiratory activity of the fruit when the fruit have been treated with 10 parts per million ethylene, and, again, the increase in the rate of respiration is dependent upon temperature, but in a climacteric fruit, you would have the stimulation of ripening and ripening behavior and a much larger increase in the rate of respiration, but in non-climacteric fruit, this is minimized. This bottom graph is lemons that were held at 20 degrees Celsius and given ethylene at three different times, and you can see that the response in respiration is transitory, another characteristic of a non-climacteric fruit. By and large, though, the most limiting factor to the post-harvest life of citrus is plant pathogens and the havoc that they can wreak upon the quality of the fruit, and so we can break out post-harvest citrus diseases into two categories. One is those diseases arising from pre-harvest infection. They are listed here, and I have some slides to show you what these are. Typically, these pathogens will infect the young fruitlet on the tree, and then these infections remain quiescent until the fruit are mature and harvested and put under stressful conditions. Fortunately, for us in California, diploidea and phomposis, because of our environmental growing conditions, are not a problem. We do occasionally have problems with alternaria and phytophthora, and in long-term storage of lemons, we may have problems with botrytis. Anthracnose also can occur in California, but that will occur in the field, and the fruit will be graded out at the packing house. So this is an example of tear-staining on navel oranges. This is anthracnose on fall-glow mandarins, and this was provided to me by Dr. Eldan Brown from the Department of Citrus in Florida. Below, you see an example of botrytis. It can be a problem in long-term storage of lemons, and we do store lemons in California. I can talk about that later in the question-and-answer period if you have questions. Phytophthroa fruit rot or brown rot can be a problem, especially when we have cold wet weather. It is caused by the spores splashing up onto the fruit during rainy weather and can cause fruit decay like this. Typically, these fruit will fall from the tree in the field, and the fruit are left on the ground and not harvested. We can have it develop subsequent to harvest, but we use post-harvest management schemes to help control brown rot in the packing house. Again, this is an example of phomposis and diploidea stem-end rot, both which are not serious problems for California fruit. Alternaria can be a problem in lemons stored for prolonged periods of time, but we do control that by a pre-storage application of 2,4-D at a rate of about 250 parts per million, and this controls the abscission of the button of the fruit, and there is very good data showing that if you maintain the vitality of the stem of the fruit, the stem end or the button of the fruit, then you can control the development of alternaria stem-end rot in storage. Navel oranges can have a problem with alternia rot, primarily through the navel end. We have more of a problem with this when we have had very cold weather or freeze events like we had last year, but, again, the problem is not considered to be a serious problem. Specifically, you can detect this at the packing house during the grading process. More serious for California fruit is those citrus diseases which arise from post-harvest infection, and by and large, the most important disease that we have to deal with is green mold caused by Penicillium digitatum, and you can see all these pathogens occur because of fruit injuries. So the guiding light or the guiding principle of citrus fruit handling, at least in California and I am sure in Florida, is to do anything possible to minimize the damage to the fruit because, if you do not minimize damage to the fruit, you are going to have problems with these pathogens, and in particular, green mold, Penicillium digitatum. We also have problems with sour rot occasionally. This is more of a problem on lemons that go into fruit storage, and trichoderma, again, is a problem associated with lemon storage. This is a picture, then, of green and blue mold, and, again, green mold is the more important one for us. Blue mold is controlled very well by the fungicides that we use in the packing house. This is a slide actually I took in Chile out in the field where a grower had clipped their fruit, but had left the stems of the fruit about a quarter of an inch and then left the fruit in the bins and treated the fruit with ethylene and had all kinds of fruit decay. So this is not typical California fruit, but this can show you what will happen if you wound the fruit, and these are green mold lesions developing. Another problem why we need to control green mold, then, is you have the direct loss of a fruit, but also if the fungus begins to sporulate, you can have a spoilage problem, and this causes one to have to repack the fruit. Again, we do not want to have to repack the fruit and the spores also contaminate the packing house. This is a picture of sour rot, again, entering. This is a lemon, entering the fruit through a wound. Sour rot can be very serious because the organism exudes a peptolytic enzyme that can basically dissolve the neighboring fruit. So the organism spreads from fruit to fruit, and once it gets going, it really does not need wounds. It is usually only a problem in long-term lemon storage when we have had very wet weather. This is trichoderma and rot. Again, it is caused by fruit wounds, and it is considered only to really be a problem in long-term lemon storage. Packing house practices and treatments to reduce decay. The first thing is we try to destroy any inoculum on the fruit surface. We want to inhibit the development of latent infections by our management strategies as to how we handle the fruit. We do everything possible that we can do to prevent infection by wound-invading pathogens by using good sanitation. We protect the fruit's surface from subsequent infection through wounding, as much as possible, and then we try to use materials that will inhibit sporulation and the spread of the disease to healthy fruit. So reduced decay, then, is achieved by, then, good sanitation practices in the field and packing house, including chlorination of all wash waters. All water except in one instance which I will talk about in a few minutes are chlorinated in California packing houses at a concentration of 100 to 200 parts per million. We have routine washing of the packing line floors in cold-storage facilities and de-greening rooms, and we monitor for plant pathogen resistance to fungicides. Gloves are used in all handling situations. We use sanitizing agents in the packing house. We use fungicides, and we try to minimize the time between harvest and packing to us in 24 hours, and then also minimize the time the fruit is processed in the packing house to a consumer. Control of post-harvest citrus diseases in California are achieved by primarily the use of Imazalil and Phyobendasol, or TBZ for the blue-green mold complex. We use sodium otherphenilphynato, SOPP, for control of sour rot. We use an application of 2,4-D as the primary mechanism to control alternary stem-end rot, and then broad spectrum materials that are used in the packing houses would include soda ash or sodium carbonate, sodium bicarbonate, borax, boric acid, lime sulfur that was registered in 1998, and then the use of chlorine. We also have two biological control agents that can be used to control blue-green mold, but these have very limited use currently in California. An example of grade defects. I went to a packing house just this last Wednesday, and they provided me fruit from the floor. This would be the first grade fruit, choice grade, and then this is a fruit destined for a processed products. The choice grade fruit, this is where the fruit going to fresh juice processing would come from is out of this grade. Our grading is done primarily for cosmetic blemishes, and again, I will show you some more slides. Grading, then, is mainly based on cosmetic appearance, including the absence of scarring, pests, and diseases. Fruit with cracks such as a split navel, punctures are excluded, and they go to the cull bin. Peel texture and thickness are also considered in the grading of fruit. This is an example of puff and crease, which can be a problem on both navel and Valencias. This fruit would go to processed products. This is some examples of fruit that sunburned, a split navel that is not too bad, uneven coloring, and different types of surface abrasions. This fruit would be sent to processed products. This is scarring due to insects, wind, and limb rub, and these are defects due to fruit shape. Again, these are the types of fruit that would be sent to processed products. We do occasionally, unfortunately, have freezes in California. A freeze can cause ice-marking on the fruit here. This fruit, again, would be diverted to processed products, and last year, when we had the freeze, we had quite a bit of internal damage to the fruit. Depending on the grade standard of the fruit, the amount of damage, most of that fruit would either be dropped on the ground when damage is very severe or sent to processed products. These are examples of fruit that would be sent to the cull bin, which would be diverted then to either feed or landfill. These would be the split navels, which could harbor alternaria, or fruit with puncture wounds due to long stems or the fruit being punctured by thorns on the tree. So now I would like to cover post-harvest handling practices. First, we assess minimum maturity in oranges in California. We have a minimum maturity based on an 8-to-1 sugar/acid ratio, and most of the time, this is a portable Boswell press and titration unit so that this can be assessed in the field. Orange harvesting. We picked the fruit into 40- to 60-pound picking bags. Gloves are used. Here is a guy wearing gloves. The fruit in California are all clipped. This is a picture of the clipper. The fruit are then dumped into approximately 1,000-pound bins. We do not allow fruit to be picked up from the ground, and many growers actually skirt-prune and lift up the fruit from the ground so that no fruit are touching the ground. Sanitary facilities are provided in the fields for the field workers, and the fruit are transported to the packing house on the day of harvest. Care is taken in the field during harvest to minimize damage because of the potential for fruit decay, and the consequences of mechanical damage then are increased decay, enhanced water loss, and subsequently, if we are not very good at handling the fruit, we can end up with fruit coming out of storage with pitting and rind breakdown here at the stem end due to incorrect clipping and handling of the fruit. Some of our fruit are early-season navels, and late-season Valencias can be de-greened or treated with ethylene, and the ethylene de-greening process will remove the chlorophyl from the peel of the fruit so the fruit looks orange. This is an example of a de-greening room facility at a current packing house. After the de-greening or without any de-greening, the fruit then are dumped onto a packing line. In this packing facility, they have an exhaust fan. The exhaust fan would take off. If there was any decayed fruit in the bin, the exhaust fan in the dumping process would hopefully draw off any spores that would be on the fruit. Right here, we have a chlorine wash. So the fruit are dumped, go onto a chlorine wash, and we have a trash eliminator here. Here is a picture of the chlorine wash, and, again, 100 to 200 parts per million chlorine are used with oranges. After the dumping, then the fruit will go through a pre-grade process, and here, then, this middle line would be fruit that would be going to processed products. These white PVC pipes here, then, are fruit that would be either decayed or split or for other reasons that I showed you, and these would be dropped into a flume system that would take the fruit out to culls. So the fruit that go to juice are conveyed on a conveyor belt away from the remainder of the packing house into a large accumulation bin, and then this fruit is picked up into bulk trailers and transported to the processed products plant. The fruit that are culled because of decay or other major defects, then, are dropped into a flume system and are carried underground--in this packing house, anyway, carried underground to an area isolated downwind from the packing house where they are put into these types of containers and transported away either for landfill or for feed. After this pre-grade period, the fruit go through a pony-sizer, and then in the case of this packing house, the fruit are dumped into a tank treatment. I will talk about this. The tank treatment is optional. Not all packing houses have tank treatments. The type of solution that is included in the tank varies from packing house to packing house. Some tanks are equipped so that you can actually heat the solution, but the bottom line is in this case the fruit are submersed in the tank for a period of 2 to 3 minutes, maximum. Tank treatments. Options for the tank mixture varies, about a 50/50 split between sodium carbonate at a 3-percent concentration. In sodium carbonate, the water will be heated to 105 degrees, and the Ph is maintained at about 10.5. The other major one is sodium bicarbonate, again, at 3-percent concentration. In this case, the sodium bicarbonate is usually chlorinated at a concentration of 200 parts per million, and the temperature of the tank is usually run between 68 and 80 degrees Fahrenheit. We also have a few houses that will use borax/boric acid at a total concentration of 6 percent. These tanks are heated to 105, and the Ph is maintained between 10 and 11. We have lime sulfur which was registered in 1998. Currently, no houses are using lime sulfur. The average duration for a tank treatment is 1.5 to 2 minutes, 3 minutes maximum. Tanks are generally heated overnight when the packing house is not operating to about 140 degrees, and usually, these tank mixtures are changed about every 2 weeks. Tanks are used in about 30 percent of the orange houses approximately and less than 20 percent of the grapefruit houses. If the fruit are not treated in the tank, then often the fruit will go over a series of brush beds, and OPP will be applied with just another sanitizing agent. After either the tank treatment or the OPP wash, the fruit then are passed through a high-pressure washer. This was shown to you by Mr. Martinelli, but this is a California high-pressure washer. I just wanted to talk a little bit about the high-pressure washer because this is a very nice innovation and introduction into handling of citrus that has occurred in the United States in the last 5 years. High-pressure washer technology was developed in South Africa and Israel about 15 to 20 years ago because they had developed resistance to pesticides for scale control. It was introduced commercially into California within the last 5 years. Most houses now, and I have been told close to 100 percent of all orange houses in California, have a high-pressure washer unit. Houses without the high-pressure unit will use OPP over the first few brushes or detergent with neutral cleaner to clean the fruit, but, again, this is the minority. The primary purpose of the development of it was for removal of California red scale, which is controlled in the field by biological and chemical means. This high-pressure washer does a very good job in removing the scale from the surface of the fruit. We have done extensive tests in California to comie up with recommendations to the industry on what pressures to use to avoid damage to the fruit. So we use 80 to 300 psi. The water is chlorinated. We have some packing houses starting to add sodium bicarbonate into this wash water. It is a recirculating water system. The water is filtered to remove particulate matter, and the water is replenished on a regular basis. After the high-pressure washer, then we have another pre-gray area. Again, as Mr. Martinelli indicated, after that fruit goes through the high-pressure washer, if there is any rots, that rot is blasted out of the fruit and is very easy to see any decayed fruit. So that fruit can be culled out. Also, you can see defects better. In this case, they are grading under black light so that the decayed spots will show up more readily. After that, the fruit go through electronic sorting. About 25 percent of our houses now have some sort of electronic grading, and this is great and the trend is increasing. Then we can divert fruit, then, that are graded as too green or ready to go to processed products that can be diverted to bins from the electronic grader. Following the electronic grader, the fruit are waxed, and there is a lot of reasons why we wax fruit. Wax typically have a Ph of 8 to 9, and we have different combinations of wax that we use. Following waxing, the fruit will go through a dryer of 3 to 5 minutes, and the dryers are normally run from 90 to 140 degrees Fahrenheit. Following waxing, the fruit have their final grading into first choice processed products in culls, and following this grading, again, you can see these are the fruit that would go down into the flume system out for culls. The fruit then are electronically sized and stickered and are passed by machine into accumulation bins. We pack our fruit in California either by pattern packing, which is all automated, or there are houses that will also pack by hand. Once the fruit are packed, they will go through a box sealer. They are palletized and go into short-term storage. Typical turnaround time after packing is 24 to 48 hours and the fruit is out of the packing house. Alternatives to packaging would be choice fruit going into these tri-wall bulk bins or into either poly or net bags, and, again, then packed into large cartons. A lot of this fruit now is going to places like Costco and Super K-Mart, et cetera. Other considerations, then, that I would like to do in summary, packing house sanitation is a guiding principle to everything we do. We use quaternary ammonia or isopropyl alcohol to sanitize the packing house and the packing line. We use high-pressure washing of the bins to clean the bins. We monitor for plant pathogen levels on a regular basis for fungicide resistance. The brush beds are often cleaned during breaks and at the end of the day with quats or isopropyl alcohol. The pack line is typically cleaned at the end of the day. Cull drums are cleaned routinely. It varies from house to house. The harvest bins, again, it varies how often they are cleaned, and the main key, though, is that in a citrus packing house, we try to isolate the different tasks. Fruit that could potentially be contaminated or rotted or have splits or things like that, all that grading is usually done in an area isolated away from the fruit that is ultimately going to go to the consumer. Rodent control is actively practiced in our packing houses. Facilities are provided for our workers for separate areas for lunch and sanitary purposes, and in California, we do have an active safety training for all our workers on hygienic behavior and etiquette. So I have finished in 30 minutes. MS. OLIVER: Right at 30 minutes. Thank you very much. Once again, I will ask the committee if they have any questions for clarification. MS. DONNELLY: I am Cathy Donnelly from the University of Vermont. I really enjoyed your presentation, and particularly the fruit grading. I think it is very helpful to our discussions. Could you clarify of the three grades, choice, first, and processed products, is there a distinction made between fruit intended for process that might involve pasteurization versus fresh juice without the benefit of pasteurization? DR. ARPAIA: Preparing to come here was a very interesting experience for me because I never think of fresh juice. My fresh juice is what I squeeze at home. So I had to start asking questions. The processed products fruit goes to processed products, to like the major juice plants where they do whatever they do. I am not a specialist in that. So I cannot address that. In asking these questions to a variety of people in the California citrus industry, I was told that the fruit that is sold for "fresh juice," that would go to the juice bars or whatever, that is coming out of the choice grade, and that accounts for some of those bulk packs. MS. DONNELLY: With those grades, are you aware of any microbiological data that breaks down standards based on human pathogens in each of those grades? DR. ARPAIA: No. I'm sorry. I am not. MS. OLIVER: Mike? MR. JAHNCKE: Mike Jahncke, Virginia Tech. I have a question. On one of your slides, you showed in the packing house, there is some submersion for the cooling, I believe, of the fruits. Is that used for fresh? Some of those that submerge, does that go into the fresh market, or is that all pasteurized? DR. ARPAIA: Let me clarify the submersion. The submersion only occurs in those tank treatments. About 30 percent of our houses have tank treatments. The tank treatments, the water either contains typically soda ash or soda carbonate os sodium bicarbonate. In the case of the use of soda ash, the tank is heated to 105 degrees Fahrenheit. So the water is heated. That is to help the efficacy of the soda ash. The soda ash basically--I would not say it sterilizes any fruit wounds on it, but it basically helps protect the fruit against subsequent decay by blue and green mold. When the sodium bicarbonate is used, the sodium bicarbonate is not heated. The tank is usually between 68 and 80 degrees Fahrenheit, the water temperature. That water also has 200 parts per million chlorine added to the water. Hopefully, the bulk of that fruit will end up in the fresh market. MR. JAHNCKE: Just another follow-up question. You had slides where you showed the brush with high-pressure wash and things. Do you have any data to show the effect perhaps of the high pressure, if there are pathogens on the outside of that? DR. ARPAIA: Human pathogens? MR. JAHNCKE: Human pathogens. Is that sufficiently high pressure enough, perhaps, to have that internalized inside the fruit? Are you aware of any data? DR. ARPAIA: I do not have any data on human pathogens, but when we were developing this technology for California, I worked with the entomologists who were interested in scale removal aspects with looking at fruit quality. Typically, you can get in excess of 95 percent of the scale removed, both live and dead scale removed, at pressures at around 200 psi. In the 3 years that we conducted work with navel oranges, which is much more susceptible to damage than Valencia oranges, we did not see severe damage to the peal of the fruit at that type of pressure. The type of damage that you would see, you could get pitting of the peal. The pits typically were not very deep. We know that when you put the fruit through the high-pressure washer, you remove about 80 to 90 percent of the natural wax of the fruit. So you basically are removing the surface, the very surface of the fruit. Typically, at least visually, at the pressures we are using, you are not going to see visual damage. MR. JAHNCKE: Thank you. MS. OLIVER: Alison? MS. O'BRIEN: Alison O'Brien, Uniformed Services University. I would like to just follow up on Michael's question about submersion in 30 percent of the plants that do use the submersion technique. You just said that the majority of that would go to, if I understood you, fresh-squeezed kind of products? DR. ARPAIA: Well, no. They are graded as for fresh. MS. O'BRIEN: Okay, so first, choice. DR. ARPAIA: So it would be either choice or first grade. MS. O'BRIEN: But some would go to the fresh-squeezed juice? DR. ARPAIA: Yes. MS. O'BRIEN: So, in California, at least there is some submersion of citrus that would go into fresh squeezed, if I understand that. DR. ARPAIA: I want to make it very clear that the submersion environment in which we are submersing fruit is very, very different than the submersion of those dye uptake tests because we are not putting cold fruit into warm solution. The fruit are typically--when we run through the line, the minimum temperature you want the fruit to be is 50 degrees, maximum about 80 degrees. The reason for that is that if you are below 50 degree Fahrenheit fruit temperature, you do not get a good wax application. MS. O'BRIEN: Okay. Thank you very much. DR. ARPAIA: So we never put cold fruit, and we never use cold water. MS. OLIVER: Bob? MR. BUCHANAN: Thank you. I have a couple of questions to get some additional information about-- MS. OLIVER: Bob, can you say who you are? MR. BUCHANAN: Okay. Bob Buchanan, FDA. Two general questions that I have for further clarification. Do you have an estimate of what percentage of fruit coming from the packing house will wind up in juice production? DR. ARPAIA: You mean fresh juice? MR. BUCHANAN: Fresh juice particularly. Let me give you all the questions. Two, how long is this fruit likely to remain in storage before it would wind up at a juice plant? Number three, you mentioned several vectors for the transmission of disease in the field while the fruit is still in the tree. Could you give us a little bit more exhaustive list of how contamination is likely to get onto the fruit in terms of these plant pathogens? So it is percentage of fruit going to juice out of a packing house, what are the storage conditions and how long is that fruit likely to be stored prior to production of juice, and then, finally, what are the vectors and modes of transmission for plant pathogens in the field. DR. ARPAIA: Oh, vectors of plant pathogens? MR. BUCHANAN: Right. DR. ARPAIA: When we look at the statistics for the California citrus industry, about 80 percent of the fruit are marketed as "fresh fruit." Twenty percent, approximately, goes to processed products. So the processed products I'm talking about is the standard juice plant that has to pasteurize juice and everything else that goes with that. So then we are dealing with that 80 percent. That 80 percent can be either graded as choice or first grade. The fruit that would go to a fresh juice operation would comie out of predominantly the choice grade. When I have asked the representatives from Sunkist and other independent marketers of citrus in California, they say that many times when they put that fruit into the bulk bin and they sell it, they do not know if it is going to end up repackaged at Costco or K-Mart or something or on the street in Los Angeles or whether it will go to a "fresh juice" operation. So those numbers are very hard to get at within how we handle our fruit because we do not have a grade of fruit that goes to fresh juice because that is siphoned off the choice grade. Storage conditions. Typically, what we like to have is the fruit picked on day one, potentially held overnight under shade or in a heated condition, again, because we want to run the fruit in that range of temperatures between 50 and 80 degrees approximately, and then the fruit are run over the packing line even in that large operation that I showed pictures from. That fruit typically is on the line probably 15, 20 minutes, and the accumulation bin may be an hour at the most. Those accumulation bins at the packing operation are constantly being filled and emptied. Then the fruit goes into short-term storage. They like to move the fruit in and out of that storage room within 24 to 48 hours. So then it leaves the packing house. What happens after the packing house, again, is not really under the control of the citrus industry, that person who is receiving the fruit. Oranges have a fairly good shelf life for a number of weeks. After harvest if you hold them between about 37 and 41 degrees Fahrenheit, you can hold the fruit for 3 to 4 weeks with minimal problems. I don't know. Does that answer your second question? Do you want clarification on my answers? MR. BUCHANAN: Yes. Let me ask you a little bit further. Of the oranges coming out of packing houses, you harvest all year long in California based on your slide. Would the oranges that wind up in the fresh juice industry be only of one variety or would they be a mixture of both the navel and the Valencia, and if they are restricted primarily to the Valencia, which as I understand is more of a juice orange, how do they handle the fact that they have a limited season? Is there any technologies for extended storage of these so that there would be oranges available for fresh juice throughout the year? DR. ARPAIA: Navels are not the best for juicing, especially early-season navels, but navels do go through juicing to fresh juice. In the literature, you can find references to controlled atmosphere storage of Valencia oranges, but, to my knowledge, there is no one that is storing oranges for extended periods of time. You are thinking like weeks and months, right? Like apples? To my knowledge, no one is holding oranges like apples. MR. BUCHANAN: Then does that imply that we would have to have, for example, fresh juice manufacturers in California would have to be bringing their oranges in from another harvest location, or would they rely on the navels? DR. ARPAIA: This is not an area I work in. I would imagine you have enough Valencias scattered throughout the year into the fall that you could get fresh oranges. I would suspect that they bring some oranges in from Florida during the low times of the year. I don't know. The processed products and the juice side of the industry is not an area that I work with intimately. I will move on to your third question about vectors for plant pathogens. For post-harvest diseases, again, the major problem we have is with the wound pathogens which is blue and green mold, and any type of wounding to the peel of the fruit can cause blue and green mold. Blue and green mold are present in the field. They have done a lot of isolation of strains of blue and green mold, both from the field and from the packing house. So the vector would be man, of course. It could be the tree because citrus trees do have thorns, although they are small. Sometimes you have dead wood on the tree which could abrade or wound the fruit. Fruit, of course, can be wounded during harvesting. So those would be the vectors. In terms of insect vectors, I cannot think of anything that would be an insect vector, per se. The major insects that attack the citrus are citrus thripps, but they attack the young developing fruit, and they cause scarring or periderm formation on the peel of the fruit. Again, that is when the fruit are very small. You have the California red scale that will be present on the surface of the fruit. Again, we have katydid damage, but, again, that usually occurs when the fruit are very small and those effective fruit will either drop off the tree, or if the fruit survives, you have a large callous-type tissue develop where the fruit was abraded by the insect. MS. OLIVER: Mike Doyle? MR. DOYLE: Thank you. Mike Doyle, University of Georgia. Two questions, Mary Lu. From your perspective, what is the likelihood that intact oranges could be internally contaminated by bacterial pathogens? DR. ARPAIA: I think very low or nil. MR. DOYLE: Nil, okay. Secondly, more of a technical question, what is the pH of a solution, the 3-percent sodium bicarbonate? DR. ARPAIA: We run it at a Ph 10, 10.5. MR. DOYLE: What is the purpose of adding 200 parts per million chlorine to that? DR. ARPAIA: The soda ash is run--actually, I will have to defer real quick to Chuck. For sodium bicarbonate, what would be the Ph? AUDIENCE PARTICIPANT: It is also close to 10. DR. ARPAIA: It would be close to 10. The purpose of adding chlorine is just that we like to chlorinate all of the water we use. The only place where we do not chlorinate the water in the packing house actually is when we use soda ash because the two are not compatible. MR. DOYLE: How effective would 200 parts per million chlorine be a Ph 10 in terms of killing packages? DR. ARPAIA: I am not a microbiologist. So I cannot answer that question. MR. DOYLE: I do not know that it would be very effective. So you may want to look at that a little more closely. Thank you. MS. OLIVER: Larry? DR. BEUCHAT: Larry Beuchat, University of Georgia. Preceding visual evidence of the growth of plant pathogens, the molds, either in the field or post-harvest, do you have any feel for changes in pH of the tissue in which those molds are actually growing? DR. ARPAIA: There has been quite a bit of work done in Israel on the Ph of the issue in response to plant pathogens. I do not have that information at my fingertips, but Dr. Shimashan Biyoshiwa from the Volcania Institute has done quite a bit of work, and the group there has done that. In addition, Dr. Eckert from the Department of Plant Pathology at UC-Riverside has posed extensively what makes the fruit susceptible to post-harvest decay. They have looked at those issues, but I do not have that information at my fingertips. DR. BEUCHAT: Generally, as I understand, it suggests the pH increases upon growth of molds on fruits or vegetables. DR. ARPAIA: I do not feel comfortable answering that. DR. BEUCHAT: With regard to the two commercial products that are applied for the purpose of controlling, I think post-harvest plant pathogens--those are yeasts, as I understand. Do you have any feel for the change in pH there? It is a competitive inhibition process. DR. ARPAIA: First of all, 99.5 percent, probably, of all the fruit handled in California are still treated with either Phyobendozal or Imazalil. There are only two packing houses that I know of that are using biological controls to control blue mold. In the one house that I am more familiar with, they use sodium bicarbonate and sodium carbonate, also, prior to applying the biological control agent. So they "try to sanitize" the fruit surface, and then they apply the biological control agent, but they have not been successful in the level of control that you get with the biological control agent. It does not even approach at all the efficacy of the fungicides. DR. BEUCHAT: Thank you. MS. OLIVER: We have about 5 minutes left for questioning. We have a number of people still who want to ask questions. Jim Anders? MR. ANDERS: Jim Anders, North Dakota Health Department. I just want to quickly run through the process here again because I am getting a little confused here. You have an original chlorine wash, right? DR. ARPAIA: Yes. MR. ANDERS: Then some 30 percent go to tank treatments? DR. ARPAIA: Yes. MR. ANDERS: The rest of it gets a high-pressure wash after that, or do they all get a high-pressure wash? My question is going to be on the high-pressure wash. DR. ARPAIA: Close to 100 percent of the houses now in California have some form of high-pressure washing. MR. ANDERS: Then my question on the high-pressure wash is the type of water that is used there and is that water treated. DR. ARPAIA: The water is chlorinated, and there is an increasing trend to also add sodium bicarbonate to that wash water. MR. ANDERS: Which means, again, the pH of the chlorine is going to be at around 10. DR. ARPAIA: Yes. MR. ANDERS: I agree with the comment. I do not think at 10, chlorine is going to do much. MS. OLIVER: Dan Engeljohn? MR. ENGELJOHN: Dan Engeljohn with USDA. Of the various recycled solutions that are used in the tanks, which you said are filtered before they are dumped at the end of the week, I believe, are any of them analyzed for microbial contaminates or fecal coliforms? Is the starting water potable, or is there a standard for that water? Does it meet the U.S. drinking water standard? DR. ARPAIA: First of all, let me clarify the disposal issues of the water. In the houses that have tank treatments, those tank solutions are typically changed very week or every 2 weeks, maximum. In the high-pressure washer system, that is a continuous recycling system, but because there is a lot of water lost, you are continually adding water to the system. At the end of the day, the water is completely replaced in the high-pressure washer system. The source of water would be city water. So it is going to meet those standards, and in terms of sampling, to my knowledge, no one is sampl