U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
November 19,1998


FDA Technical Scientific Workshop On How Citrus Juice Firms Can Achieve 5-Log Pathogen Reduction

CITRUS SCIENTIFIC WORKSHOP
FDA DISTRICT OFFICE
19990 MACARTHUR BOULEVARD
SUITE 300
IRVINE, CALIFORNIA
NOVEMBER 19, 1998

         (THE WORKSHOP BEGAN AT 8:30 A.M.)

         MS. ELAINE MESSA: GOOD MORNING. MY NAME IS ELAINE MESSA AND I AM THE DIRECTOR OF THE LOS ANGELES DISTRICT OFFICE THAT YOU ARE CURRENTLY SITTING IN IN IRVINE, AND I WELCOME YOU ALL HERE TODAY.

         I AM JUST GOING TO MAKE A COUPLE OF INTRODUCTORY REMARKS TO KIND OF ORIENT YOU TO THE FACILITY HERE AND LET YOU KNOW ABOUT WHAT WE ARE GOING TO DO FOR LUNCH.

         SOME OF YOU WERE IN OUR RECEPTION AREA; WE DO HAVE A PHONE OVER THERE. THEY WILL ACCEPT MESSAGES FOR ANYONE HERE AND BRING THEM INTO THE ROOM. THE STAIRWELLS IN THIS BUILDING ARE ALL LOCKED FOR SECURITY PURPOSES SO WE ENCOURAGE YOU TO USE THE ELEVATORS COMING IN OR OUT OF THE BUILDING.

         AT LUNCHTIME, WE HAVE A VERY NICE RESTAURANT DOWNSTAIRS WITH A BAR, WHICH IS DOWN TO FLOOR ONE DOWN THE ESCALATOR AND ACROSS TO THE BUILDING IDENTICAL TO US. THERE IS KIND OF A LESS FORMAL BAR AREA. WE ALSO HAVE A MAP OUT ON THE BACK TABLE THAT HAS LOCAL ESTABLISHMENTS; WE HAVE A TACO BELL DIRECTLY ACROSS JAMBOREE FROM HERE AND WE HAVE A NUMBER OF RESTAURANTS UP AROUND THE CORNER ON JAMBOREE AND BRISTOL, AND THEY ARE ON THE MAP BACK THERE. IF YOU DO CHOOSE TO LEAVE THE FACILITY AT LUNCHTIME, IF YOU ASK THE PARKING ATTENDANT ON YOUR WAY OUT FOR A PASS, THEY WILL GIVE YOU A RE-ENTRY PASS SO YOU WON'T HAVE TO PAY FOR DUPLICATE PARKING. ALSO, TODAY WE HAVE A COURT REPORTER HERE THAT WILL BE CAPTURING A TRANSCRIPT OF THIS MEETING. WE ARE GOING TO BE ASKING YOU TO USE THE MIKE. IF YOU DO SPEAK, SHE WOULD LIKE TO HAVE EITHER A BUSINESS CARD WITH YOUR NAME AND FIRM FOR CORRECT SPELLING, OR SHE HAS 3X5 CARDS OVER HERE ON THE TABLE SO SHE CAN COMPLETE THAT. AND I THINK WE'LL REMIND YOU ABOUT THAT AGAIN LATER ON.

         AND OTHER THAN A WELCOME, I WOULD LIKE TO TAKE NOW THE OPPORTUNITY TO INTRODUCE TO YOU OUR REGIONAL DIRECTOR, RICHARD BALDWIN. RICHARD STARTED IN PHILADELPHIA, CAN'T GO THROUGH WHAT HE DIDN'T WANT ME TO SAY TODAY, BUT RICHARD AND I AND A COUPLE OTHER PEOPLE STARTED IN PHILADELPHIA TOGETHER. RICHARD HAS ALSO WORKED IN THE EDUCATION AND TRAINING BRANCH AT HEADQUARTERS. HE WAS THE DIRECTOR OF THE DIVISION OF FIELD SCIENCE BEFORE COMING TO THE PACIFIC REGION AS THE REGIONAL DIRECTOR IN MARCH OF THIS PAST YEAR. SO JOIN ME IN WELCOMING RICHARD BALDWIN.

        

(APPLAUSE.)

         MR. RICHARD BALDWIN: THANK YOU, ELAINE.

         WE ARE KIND OF BUSY THIS WEEK. WE ARE ALSO DOING THREE TECHNICAL WORKSHOPS AND ONE FOR THE PHARMACEUTICAL REGION, AND THAT'S WHY I WAS OUT HERE. WE DID ONE IN SEATTLE ON MONDAY, ONE YESTERDAY HERE, AND WE'LL DO ANOTHER ONE IN OAKLAND ON FRIDAY. SINCE I WAS GOING TO BE HERE, I THOUGHT IT WOULD BE A GOOD IDEA FOR ME TO PARTICIPATE, AND I AM GOING TO TRY AND STICK AROUND FOR MOST OF THE DAY. I HAVE A FLIGHT LATER THIS AFTERNOON TO GET BACK TO OAKLAND TO PARTICIPATE IN A WORKSHOP TOMORROW FOR THE INDUSTRY. I THINK IT IS VERY IMPORTANT THAT WE HAVE THESE KINDS OF OUTREACH ACTIVITIES TO HAVE THE OPPORTUNITY FOR YOU TO PARTICIPATE IN THINGS THAT WE ARE TRYING TO DO TO MAKE SURE FOOD SUPPLY IS SAFE. I HAVE A SIMPLE MOTTO, IT IS LIKE A MANTRA THAT I USE WHEN I TALK TO FOLKS IN OUR REGION, IT IS: OUR BUSINESS IS TO GET THE GOOD PRODUCTS OUT INTO THE MARKETPLACE, AND IF THERE ARE BAD MARKETS, GET THEM TO THE CONSERVATIVE CHANNELS. SO I THINK THIS IS AN EXCELLENT OPPORTUNITY FOR YOU TO INVEST IN IMPORTANT ISSUES THAT ARE IMPORTANT BOTH TO YOU AND THE SAFETY OF THE CONSUMERS IN THIS COUNTRY.

         I AM NOT GOING TO SPEND A LOT OF TIME MAKING A LONG INTRODUCTION BECAUSE I AM GOING TO SAVE MY VOICE BECAUSE I AM GOING TO HAVE A FEW HOURS TOMORROW IN A WORKSHOP DOING SOME TALKING. I WOULD LIKE TO INTRODUCE PAT. PAT IS THE DISTRICT DIRECTOR OF SAN FRANCISCO. THE REASON I WANT TO INTRODUCE PAT IS THAT WAY YOU WILL KNOW BOTH OF THE DIRECTORS WHO HAVE THE RESPONSIBILITY FOR CALIFORNIA, PRACTICALLY A NATION UNTO ITSELF.

        

(APPLAUSE.)

         PAT: WELL, THANK YOU. I, TOO, WILL TAKE JUST A MOMENT TO GIVE YOU AN OPPORTUNITY TO PUT MY FACE TO MY NAME AND WELCOME YOU. I WANT TO THANK ELAINE FOR HOSTING THIS WORKSHOP TODAY, AND THANK ALL OF YOU FOR TAKING TIME OUT OF YOUR BUSY DAYS TO GET TOGETHER WITH US. I THINK THIS IS THE BEST WAY WE HAVE TO SOLVE PROBLEMS WITH THOSE OF YOU WHO ARE REALLY EXPERTS IN YOUR FIELD. I WELCOME YOU WHO ARE OUT OF CALIFORNIA TO CALIFORNIA, AND I KNOW WE'LL HAVE A GREAT SEMINAR TODAY. THANK YOU.

        

(APPLAUSE.)

         MS. ELIZABETH CAMPBELL: GOOD MORNING. MY NAME IS BETTY CAMPBELL, AND I AM THE ACTING DIRECTOR OF THE OFFICE OF FOOD LABELING OF THE FOOD AND DRUG ADMINISTRATION. AND THE REASON WE ARE HERE TODAY IS BECAUSE THE OFFICE OF THE LABELING DRAFT AND REGULATION THAT THE AGENCY PUBLISHED HAVING TO DO WITH THE SAFETY OF FRUIT AND VEGETABLE JUICES, AND THE REGULATION THAT WE PUBLISHED IN JULY, REQUIRES, AS YOU ALL KNOW OR YOU WOULDN'T BE HERE, REQUIRES A WARNING LABEL ON JUICE THAT HAS NOT BEEN TREATED TO REMOVE PATHOGENS. THIS IS THE WARNING LABEL. THIS IS THE STATEMENT THAT THE REGULATION REQUIRES. FOR ANY OF YOU WHO DON'T -- WHO HAVEN'T SEEN THE REGULATION WHO WANT TO SEE THE REGULATION, IT IS IN THE FEDERAL REGISTER. WE HAVE ATTACHED THAT TO OUR WEB PAGE, F D.A.'S WEB PAGE, THE FOOD WEB PAGE FOR F D.A. AND RIGHT NOW THAT TOTAL REGISTERED NOTICE IS ATTACHED TO AN ITEM THAT IS REFERRED TO AS, I THINK IT IS UNPASTEURIZED JUICE WARNING, SOMETHING LIKE THAT. IT IS A TOPIC YOU WILL RECOGNIZE. THE LAST TIME I LOOKED IT WAS UNDER "WHAT'S NEW". THE WARNING STATEMENT -- THE WARNING STATEMENT IS ONLY REQUIRED IF THE PRODUCT HAS NOT BEEN PROCESSED TO REMOVE PATHOGENS, AND THAT'S WHY WE ARE HERE TODAY IS THE PROCESSING TO REMOVE PATHOGENS. THE REGULATION SAYS: IF THE PRODUCT HAS BEEN PROCESSED TO REMOVE -- TO ACHIEVE A 5-LOG REDUCTION IN THE PERTINENT MICROORGANISM IN THE PATHOGENS, THEN IT DOES NOT NEED THE WARNING LABEL. THE BASIC PRINCIPLE IS IF THERE HAS BEEN A 5-LOG REDUCTION IN POTENTIAL -- IF THE PROCESS WOULD HAVE REDUCED AS MUCH AS 100,000-FOLD REDUCTION IN MICROORGANISMS IN THE PRODUCT, THEN A CLEAN PRODUCT COMES OUT OF THAT PROCESS. IF THE PROCESS IS VALIDATED TO ACHIEVE THAT REDUCTION, THEN A CLEAN PRODUCT COMES OUT OF THAT PROCESS AND A CLEAN PRODUCT DOES NOT NEED A WARNING LABEL. AND THAT WAS THE PRINCIPLE.

         TODAY WHAT WE ARE HERE TO TALK ABOUT IS HOW TO ACHIEVE THIS 5-LOG REDUCTION AND HOW TO VALIDATE IT. WHAT HAS BEEN DONE? WHAT HAVE PEOPLE BEEN ABLE TO DO TO ACCOMPLISH THIS? SOME PEOPLE HAVE ACCOMPLISHED IT AND THERE ARE HERE TO SHARE THAT INFORMATION WITH US. ONE OF THE THINGS THAT WE ARE NOT HERE TO DISCUSS, THOUGH, IS WHETHER THE 5-LOG STANDARD IS APPROPRIATE. F D.A. IS ALSO IN A PARALLEL MOVER AS THE BIGGER MOVE ACTUALLY HAS PROPOSED TO REQUIRE HACCP PRODUCTION CONTROLS FOR THE PRODUCTION OF FRUIT AND VEGETABLE JUICES. AND THAT REGULATION IS NOT YET FINAL. IN THAT REGULATION WILL BE ANOTHER EVALUATION OF WHETHER 5-LOG IS APPROPRIATE, WHETHER THIS KIND OF STANDARD IS APPROPRIATE. BUT RIGHT NOW WE HAVE THIS REGULATION THAT SAYS 5-LOG IS THE STANDARD, AND THEN THE LABELING STANDARD SAYS YOU USE 5-LOG OR THE WARNING LABEL. SO WE ARE HERE TO LEARN HOW TO USE 5-LOG SO EVERYONE CAN ACHIEVE THAT AND HAVE A CLEAN PRODUCT.

         THE OTHER THING WE ARE NOT GOING TO DISCUSS IS WHETHER OR NOT HACCP IS APPROPRIATE. THAT IS THAT, TOO, IS A PART THAT HAVE OTHER REGULATION THAT OTHER RULE MAKING AND IT REALLY IS NOT APPROPRIATE FOR US TO DEAL WITH TODAY. SOON AFTER WE PUBLISHED THE REGULATION IN JULY, THE CITRUS JUICE INDUSTRY, AND OUR FOCUS TODAY IS ON CITRUS JUICE, THE CITRUS JUICE INDUSTRY CAME TO THE AGENCY AND SAID THAT THE AMOUNT OF TIME WE HAD GIVEN THEM, WHICH I THINK WAS 120 DAYS, WAS NOT ENOUGH, JUST COULD NOT DEVELOP AND VALIDATE THE PROCEDURES NECESSARY TO ACHIEVE A 5-LOG REDUCTION, AND THEY REALLY NEEDED SOME HELP TO GET THAT DONE, SO THEY REQUESTED ADDITIONAL TIME. THE AGENCY, AFTER THINKING ABOUT IT AND TAKING INTO CONSIDERATION A NUMBER OF DIFFERENT FACTORS, DECIDED TO ALLOW ADDITIONAL TIME ON A FARM-BY-FARM BASIS FOR CITRUS JUICE FARMS THAT AGREE TO CERTAIN CONDITIONS. THE CONDITIONS IN THAT AGREEMENT ARE THAT THE FIRM WILL USE THAT ADDITIONAL TIME TO ACHIEVE THE 5-LOG REDUCTION AND TO VALIDATE THAT; THE FIRM WILL ESTABLISH INTERIM PROTECTIVE MEASURES USING HACCP PRINCIPLES, USING CULLING AND WASHING AND SANITIZING AND WHATEVER ELSE IS NECESSARY ON AN INTERIM BASIS, AND THIS IS NOT NECESSARILY ACHIEVING 5-LOG AND NOT NECESSARILY HAVING VALIDATED IT, SOMETHING A LITTLE LESS THAN THAT, BUT NONETHELESS MAKING A CLEAN PRODUCT IN THE INTERIM; AND THE FIRM PROMISES TO COMPLY AT THE END, AT THE END OF THE TIME. THE TIME WE ARE ALLOWING IS UNTIL JULY OF '99. THAT WILL BE ONE YEAR AFTER THE REGULATION WAS PUBLISHED. SO THAT AT THE END OF THAT ADDITIONAL TIME, THE FIRM GREASE TO EITHER HAVE ACHIEVED THE 5-LOG REDUCTION OR PLACED THE WARNING LABEL ON THE PRODUCT. THOSE AGREEMENTS WILL BE HANDLED BY THE LOCAL DISTRICT OFFICE. FOR MANY OF YOU, IF YOU ARE INTERESTED, IT WILL BE THIS OFFICE; FOR OTHERS, IT WILL BE THE SAN FRANCISCO OFFICE. AND FOR THOSE OF YOU WHO ARE NOT COVERED BY THESE TWO OFFICES, THERE WILL BE -- YOU WILL USE YOUR LOCAL DISTRICT F D.A. DISTRICT OFFICE AS A CONTACT FOR THIS AGREEMENT. THERE IS A COPY OF THE AGREEMENT ON THE WEB PAGE. THERE IS AT THAT SAME "WHAT'S NEW" WEBSITE ANOTHER DOCUMENT AND IN THAT DOCUMENT IS AN INFORMATION PIECE ABOUT THIS WORKSHOP AND ABOUT THE ADDITIONAL TIME AGREEMENT. AND THERE IS A COPY OF THE AGREEMENT THERE, IF YOU WISH, OR YOU COULD GET IT FROM THE DISTRICT. BUT IT IS A MATTER THE FIRM SIGNS THE AGREEMENT AND SUBMITS IT TO THE DISTRICT.

         WHILE WE ARE TALKING ABOUT 5-LOG REDUCTION, WE ARE TALKING ABOUT, TO BEGIN WITH, JUICE THAT'S NOT BEEN PROCESSED GENERALLY, SO THAT'S NORMAL -- THAT JUICE IS NORMALLY MARKETED AS FRESH JUICE. BUT WE ARE LOOKING AT PROCESSES HERE, AND WE NEED TO LOOK AT WHETHER OR NOT THE JUICE IS GOING TO REMAIN FRESH, BE ENTITLED TO THE WORD "FRESH" AFTER ALL OF THIS PROCESSING. THERE IS A REGULATION. FOR THOSE OF YOU WHO ARE INTERESTED IN THE CITES OF THE REGULATION, IT IS SECTION 101.95 IN FDA'S REGULATIONS. THE ESSENCE OF THE REGULATION IS THAT FRESH IS FOOD THAT IS IN ITS RAW STATE THAT HAS NOT BEEN FROZEN, HEATED OR OTHERWISE PRESERVED. OUR APPROACH -- THE REGULATION ALSO GIVES SOME EXCEPTIONS; THE PERMITTED WAXES OR COATINGS, POST-HARVEST USE OF PESTICIDES, MILD WASHES, APPROVED USES OF IONIZING RADIATION AT A VERY LOW LEVEL, AND REFRIGERATION. WAXES AND COATINGS AND PESTICIDES AND THESE WASHES ARE CONSIDERED TO BE TREATMENTS TO THE SURFACE OF THE PRODUCT AND NOT TREATMENTS TO THE PRODUCT ITSELF. AND TO THAT EXTENT, THE PRODUCT REMAINS FRESH. TAKING THAT PRINCIPLE AND EXTRAPOLATING IT TO THE CITRUS INDUSTRY, THE CITRUS GROUP, OUR APPROACH IS THAT TREATMENTS TO THE FRUIT BEFORE THE EXTRACTION OF THE JUICE WILL, IN GENERAL, NOT AFFECT THE FRESH STATUS OF THE JUICE. OF COURSE CULLING DOESN'T, WASHING, SANITIZING, BRUSHING, ALL OF THE THINGS THAT YOU DO TO THE INTACT FRUIT. UNLESS YOU WIND UP HEATING THAT JUICE SO MUCH THAT IT COOKS WHILE IT IS STILL INSIDE THE FRUIT, THEN WE HAVE TO LOOK AT IT AGAIN. BUT IN GENERAL, TREATING THE INTACT FRUIT RESULTS IN, UPON EXTRACTION, A FRESH JUICE. WHAT YOU HAVE TO LOOK AT, THOUGH, IS THAT ANY TREATMENTS TO THE JUICE AFTER EXTRACTION MAY VERY WELL DEPRIVE THE PRODUCT OF BEING FRESH, AND THE PRODUCT WOULD NOT BE ABLE TO SAY ON THE LABEL THAT IT IS FRESH. IT WOULD BE ABLE TO SAY, IF IT IS TRUE, THAT IT TASTES AS GOOD AS FRESH OR THAT IT HAS ALL THE NUTRIENTS OF FRESH OR WHATEVER CHARACTERISTICS ARE FRUITFUL AND NOT MISLEADING. THOSE LABEL STATEMENTS CAN BE MADE, BUT IT CANNOT SAY THIS IS FRESH JUICE, MEANING OF THE LABEL CANNOT IMPLY THAT THIS IS FRESH JUICE AFTER -- IF THE JUICE, ITSELF, HAS BEEN PROCESSED.

         NOW, THAT'S A STRICT INTERPRETATION OF THAT REGULATION. THERE IS SOME THINKING THAT WE MAY NEED TO BE MORE FLEXIBLE THAN WE HAVE BEEN IN THE PAST, AND THAT DECISION HAS NOT BEEN MADE. AT THIS POINT WE'LL EVALUATE, WHEN ASKED ON A CASE-BY-CASE BASIS, WHETHER OR NOT A PROCESS DEPRIVES THE JUICE OF USING THE TERM FRESH.

         OKAY. THAT'S JUST THE BACKGROUND TO GET US STARTED. JOHN KVENBERG, WHO IS THE DIRECTOR OF OUR DIVISION OF HACCP PROGRAMS, IS GOING TO RUN THE REST OF THE MEETING AND IS THE TECHNICAL EXPERT ON THIS. I AM HERE JUST TO TALK ABOUT THE REGULATION AND WHAT IT MEANS.

         SOMETHING ELSE YOU MAY WANT TO KNOW IS THAT ALSO ON OUR WEB SITE IS A QUESTION AND ANSWER PAPER WE PUT THAT OUT SHORTLY AFTER WE DID THE REGULATION. IT'S A GUIDELINE FOR SMALL BUSINESSES ON THE JUICE WARNING LABEL REGULATION, AND IT HAS 25 OR 30 Q AND AS ON JUST WHAT THE REGULATION MEANS AND HOW IT IS TO BE IMPLEMENTED.

         THANK YOU.

        

(APPLAUSE.)

         DR. JOHN KVENBERG: GOOD MORNING EVERYONE. AS NOTED, I AM THE INDIVIDUAL WHO IS GOING TO FACILITATE TODAY'S DISCUSSION, BUT I WANT TO MAKE IT CLEAR FROM THE OUTSET, THIS IS YOUR MEETING. AND WHAT WE REALLY ARE TRYING TO ACCOMPLISH IN A TECHNICAL WORKSHOP IS TO CREATE DIALOGUE AMONG FOLKS THAT ARE INVOLVED IN THE HARVESTING, PRODUCTION, TRANSPORTATION, DISTRIBUTION, AND SALE OF CITRUS JUICE PRODUCTS TO ADDRESS THE QUESTION OF THE 5-LOG REDUCTION.

         NOW, THE OBJECTIVES OF TODAY'S WORKSHOP THAT WE ARE GOING TO ATTEMPT TO OPEN UP THIS DIALOGUE AS A FIRST STEP INCLUDE ACTIONS TOWARD HOW YOU CAN GET TO THE PERFORMANCE STANDARD SET AT 5-LOGS. AND I HOPE FOLKS THAT COME AWAY FROM HERE TODAY DON'T KNOW MUCH ABOUT IT WILL BE ENCOURAGED BY WHAT THEY ARE HEARING FROM INDIVIDUALS WHO HAVE BEEN WORKING IN THIS ARENA. I AM HOPING FOR AN OPEN DIALOGUE AND DISCUSSION OF THE 5-LOG USING THE TECHNOLOGIES THAT ARE AVAILABLE TODAY TO ACHIEVE THIS KIND OF STANDARD, AND IN THE DISCUSSION OF STRATEGIES THAT CAN BE APPROACHED TO ASSUME A CUMMULATIVE 5-LOG REDUCTION; IN OTHER WORDS, WHAT COUNTS TOWARD THE 5-LOG REDUCTION, WHO WOULD BE INVOLVED IN CONTRIBUTING TO THAT REDUCTION. SOUNDS LIKE A RATHER COMPLICATED ISSUE, BUT AS WE GO THROUGH THIS WITH CITRUS, IT IS BECOMING CLEAR THAT THERE IS AN AVENUE TO MOVE TOWARD PERFORMANCE STANDARD-BASED OPERATION OF HOW WE ASSURE SAFETY OF FOODS. SO THIS IS KIND OF A VERY NEW STEP, ACTUALLY, IN A DEPARTURE FROM A PRESCRIPTIVE TYPE OF REGULATION WHERE FDA TELLS THE INDUSTRY IN A DESCRIPTIVE MANNER, YOU MUST PASTEURIZE JUICE OR YOU MUST DO IT LESS THAN 7. OUR OBJECTIVE IS TO HAVE INDUSTRY MAKING FOOD SAFE, AND IT IS A SIMPLE OBJECTIVE OF A PERFORMANCE STANDARD TO PUT THE CHALLENGE FORTH TO INDUSTRY TO DO IT. AND FDA AND OUR FOOD DEPARTMENTS WOULD LIKE VERY MUCH TO WORK WITH THE INDUSTRY TOWARDS A COMMON GOAL IN PRODUCING SAFE FOOD IN THE UNITED STATES, AND THE IDEA OF WORKING WITH A PERFORMANCE STANDARD WITH CITRUS JUICE AS A DEVELOPMENTAL MODEL FOR WHAT THE FUTURE CAN LOOK LIKE.

         THIS IS THE SECOND OF TWO TECHNICAL WORKSHOPS THAT WERE POSED ON CITRUS. OUR FIRST ONE WAS HELD LAST WEEK IN FLORIDA, AND IT WAS QUITE A DYNAMIC OPERATION AT THAT TIME. WE HAD MUCH USEFUL INFORMATION PROVIDED TO US. I THINK, AS IT WAS MENTIONED, THESE PROCEEDINGS THAT WE ARE GOING THROUGH TODAY ARE BEING TRANSCRIBED. THE PURPOSE OF THAT IS TO CAPTURE ANY INFORMATION CONCERNS OR OTHERWISE THAT WILL HELP PROVIDE US GUIDANCE. AS BETTY MENTIONED, ALSO, WE ARE IN VERY SHORT ORDER PLANNING TO OPEN UP A WINDOW IN THE FEDERAL REGISTER TO DISCUSS BASIC HACCP RULE AND THE 5-LOG REDUCTION QUESTION, AND THOSE THAT HAVE SOMETHING TO CONTRIBUTE TO THAT I URGE YOU TO GIVE SERIOUS CONSIDERATION TO COMMENTING TO OUR RULE.

         SO WITH ALL THAT SAID, I GUESS WHAT I WOULD LIKE TO DO NEXT IS TO INTRODUCE OUR FIRST PRESENTER WITH ACTUAL FACTUAL INFORMATION THIS MORNING FROM THE FOOD AND DRUG ADMINISTRATION, DR. RICHARD DICK WHITING, WHO JOINED FDA RECENTLY. HE IS A RESEARCH MICROBIOLOGIST AND SCIENTIST WHO CAME TO US FROM USDA'S, UNITED STATES DEPARTMENT OF AGRICULTURE'S AGRICULTURE RESEARCH SERVICE. SO HE BRINGS WITH HIM A GREAT DEAL OF UNDERSTANDING TOWARD THE MICROBIAL ISSUES. HE WILL ADDRESS AN OVERVIEW OF THE 5-LOG REDUCTION TO GIVE US AN OPERATING BASIS TO TALK ABOUT THE ISSUE OF THE PERFORMANCE STANDARDS.

         SO WITH THAT, DICK, YOU CAN TAKE OVER NEXT.

         MR. WHITING: THANK YOU, JOHN.

         AS JOHN SAID, MY ROLE HERE TODAY IS TO SORT OF GIVE AN OVERVIEW AND TO PROVIDE AN INTRODUCTION TO WHAT THE REST OF THE DISCUSSION TODAY WILL BE BASED ON. THE PATHOGENS WE ARE TALKING ABOUT ARE FOUND EVERYWHERE IN OUR ENVIRONMENT; THEY ARE IN THE SOIL, WATER, AND THEY CAN BE IN AIRBORNE DUST AND ON ANIMALS THAT MIGHT BE IN OUR ORCHARDS, DOMESTIC AS WELL AS WILD ANIMALS. THEY CAN ALSO BE PRESENTED IN OUR PRODUCTS AS A RESULT OF INADEQUATE CLEANING AND SANITIZING OF THE PLANT OR RECONTAMINATION SOMEWHERE DURING THE PROCESS. NOW, SOME OF THESE PATHOGENS ARE EFFECTIVE IN SOME VERY LOW DOSES, 515787 IS ONE THAT HAS SHOWN TO BE IN RECENT YEARS, SO WE ARE CONCERNED ABOUT LOW NUMBERS BECAUSE, GENERALLY SPEAKING, THESE BACTERIA WILL NOT GROW IN ORANGE JUICE BECAUSE OF THE LOW PH AND THE FACT THAT YOU CAN KEEP THESE PRODUCTS REFRIGERATED FOR THEIR SHORT SHELF-LIFE. BUT EVEN THOUGH THESE PATHOGENS CANNOT GROW IN ORANGE JUICE, THEY CAN SURVIVE THERE QUITE WELL FOR THE TIME THEY ARE IN THE MARKET. SO OUR CONCERN IS WITH THE PATHOGENS BEING IN THE JUICE SOMEWHERE ALONG THE PROCESSING CHAIN AND SURVIVING UNTIL THE CONSUMER CONSUMES THEM.

         THIS 5-LOG REDUCTION THAT WE ARE TALKING ABOUT HAS COME ABOUT BECAUSE OF SOME DISCUSSIONS BY THE NATIONAL ADVISORY COMMITTEE ON MICROBIAL CRITERIA FOR FOODS AND THEIR PRODUCE WORKING GROUP. NOW, THIS ADVISORY COMMITTEE, ADVISORY COMMITTEE TO THE GOVERNMENT, IS COMPOSED OF LEADING MICROBIOLOGISTS FROM THE GOVERNMENT AS WELL AS INDUSTRY AND ACADEMIA, AND THEY SET THIS 5-LOG STANDARD THAT WE ARE TALKING ABOUT. AND UP HERE ON THIS PARTICULAR SLIDE SHOWS ONE BIT OF EVIDENCE OR LOGIC THAT THEY USE IN COMING UP WITH THIS STANDARD. THEY ASSUME THAT YOU CAN INITIALLY HAVE UP TO ONE PATHOGEN PER MIL IN THE JUICE. AND THEN IF THERE WAS A 5-LOG REDUCTION, WHICH WE CALL PERFORMANCE CRITERIA, THAT WOULD THEN GET YOU DOWN TO ONE TO 10 TO THE MINUS 5TH OR ONE IN 100,000 MILS, WHICH WOULD BE EQUIVALENT HERE TO, IF THE SERVING WAS LOCKED ON AS BEING 100 MILS, YOU WOULD HAVE ONE SURVIVING PATHOGEN IN EVERYONE 1000 SERVINGS. SO WHAT WE ARE TALKING HERE IS NOT A GROSS CONTAMINATION. ORANGE JUICE, BY ITSELF, IS SAFE. WE ARE TALKING ABOUT A RELATIVELY RARE EVENT, AND WE ARE TRYING TO MAKE IT EVEN MORE RARE. SO WE ARE TALKING ABOUT HOW MANY SURVIVORS DO WE HAVE IN PERHAPS A VERY LOW NUMBER OF SERVINGS, A VERY LOW, OCCASIONAL SERVING. AND OUR TARGET HERE IS ORGANISMS LIKES E-COLI AND SALMONELLA. NOW I DON'T WANT TO LOOK AT SOME OF THAT ORANGE JUICE THAT ALWAYS HAS ONE PATHOGEN PER MIL IN IT. I THINK OVERWHELMING NUMBER OF SIGNS HAS MUCH LESS, BUT I AM GOING TO SUGGEST THAT WITH THIS SLIDE HERE. THIS IS 10 TO THE ZERO IS ONE ORGANISM, AND THIS IS SORT OF THE DISTRIBUTION AND WE DON'T REALLY KNOW WHAT IT IS. WE DON'T HAVE GOOD DATA ON THIS. BUT MOST OF THE TIME OUR JUICES HAVE LOW NUMBERS OR NO PATHOGEN IN IT. AND WE ARE TALKING ABOUT THIS SHOULDER, THIS HILL UP HERE, THE OCCASIONAL TIME THAT THE JUICE WILL START WITH AN ORGANISM, AND THAT'S WHAT WE ARE TRYING TO WORK WITH. SO WHEN WE TALK ABOUT 5-LOGS OF REDUCTION, THIS IS SOME TERMINOLOGY BORROWED OVER FROM THE THERMAL PROCESSING INDUSTRY, THE THERMAL PROCESSING APPROACH TO BACTERIA.

         WHAT I HAVE HERE IS JUST A SLIDE THAT GIVES THE IDEA WE HAVE TIME HERE, SOME SORT OF UNIT OF TIME, AND WE HAVE LOGARITHM OF A NUMBER OF BACTERIA. SO THREE IS 10 WITH THREE ZEROES, 1000, 100, 10 TO THE ONE IS 10 ORGANISMS, 10 TO THE ZERO IS ONE ORGANISM. AND THIS INACTIVATION, WHAT WE ARE ASSUMING FOR EVERY UNIT OF TIME WE GET A 1-LOG REDUCTION OR A 90-FOLD REDUCTION IN BACTERIA, 100 TO THE 10 AND THEN 10 TO ONE. AND IN THE CLASSIC THERMAL PROCESS, WE GET A STRAIGHT LINE, NOT A CURVE LIKE THIS. EACH UNIT OF TIME, WHATEVER IT MIGHT BE, AND THIS WILL DEPEND ON THE ORGANISM, THE TEMPERATURE, AND THE FOOD THIS IS IN, BUT EACH UNIT OF TIME WILL REDUCE THE COUNTS OF BACTERIA 90 PERCENT, AND KEEPS ON GOING UNTIL WE APPROACH A 5-LOG REDUCTION HERE. THESE NEGATIVE NUMBERS, IF YOU JUST KEEP GOING, THIS IS ONE ORGANISM, THIS WOULD BE ONE TENTH OF AN ORGANISM. WELL, THAT IS NOT BIOLOGICALLY SOUND, BUT THAT COULD BE, INTERPRETED BY ONE ORGANISM IN EVERY 10 PACKAGES, SO WHAT WE KNOW IS A ONE ORGANISM IN EVERY 100 PACKS AND OR EVERY 1,000 PACKAGES, AND SO ON. WE NEVER ACTUALLY, IN THEORY, GET TO ZERO, BUT WE'LL TRY TO GET THE COUNTS DOWN TO WHERE THEIR LEVELS ARE NEGLIGIBLE.

         OKAY. NOW, WE HAVE TAKEN THIS SAME SORT OF APPROACH AND APPLIED IT TO A SITUATION LIKE WE HAVE WITH ORANGE JUICE AND WHICH WE ARE SAYING WE ARE NOT NECESSARILY GOING DOWN LINEARLY WITH ONE PROCESS. WE RECOGNIZE THAT MANY PROCESSES, LIKE WASHING AND OTHER NON-THERMAL SANITIZING EFFECTS, HAVE KILLING RATES VERY MUCH IN THE SAME WAY THAT THE HEAT PROCESS DOES. BUT WHAT WE ARE SAYING WITH THE ORANGE JUICE IS WE CAN SUM UP SOME OF THESE DIFFERENT PROCESSES. WE HAVE NOW THESE ARE INDIVIDUAL PROCESSING STEPS, AND IF IN THE FIRST STEP WE SEE ONE LOG OF REDUCTION, SORTING PERHAPS, NEXT STEP WAS A WASHING OF THE SURFACE, WE GET A 3-LOG REDUCTION. NEXT STEP DOESN'T HAVE ANY REDUCTION, BUT THEN WE GET ANOTHER LOG REDUCTION. THAT IF FROM BEGINNING TO THE END WE HAVE A SUM OF 5 LOGS OF REDUCTION, THAT WILL MEET THE CRITERIA. I SHOULD SAY, THOUGH, WHEN WE DO SOME OF THIS, WE ARE LOOKING AT INDIVIDUAL STEPS IN THE LAB, AND IF WE GET A 2-LOG REDUCTION FROM THE ONE STEP AND THEN WE TEST ANOTHER PARTICULAR TYPE OF INTERVENTION WE GET A 2-LOG REDUCTION, IF WE DO HAVE TO PUT THE TWO TOGETHER TO MAKE SURE THAT THE TWO IN SEQUENCE WILL STILL GIVE IN THIS CASE TWO PLUS TWO, 4-LOG REDUCTION, BECAUSE TWO WASHING STEPS, FOR EXAMPLE, MIGHT BE REMOVED IN THE SAME BACTERIA. SO WE DO HAVE TO LOOK AT BOTH OF THE INDIVIDUALS STEPS AS WELL AS THE ENTIRE PROCESS.

         SO JUST BACK TO MY ORIGINAL SLIDE THEN, THE THINKING OF THE NATIONAL ADVISORY COMMITTEE WAS THAT IF WHAT WE KNOW OF FRESH JUICE WITH A 5-LOG REDUCTION, WE SHOULD ARRIVE AT A POINT WHICH IS NOT TECHNICALLY ZERO, BUT WOULD ASSURE, FOR PRACTICAL PURPOSES, THAT WE HAVE A SAFE PRODUCT. AND BESIDES THE LOGIC HERE, WE HAVE QUITE A BIT OF EXPERIENCE WITH OTHER TYPES OF PRODUCTS, MEAT, EGGS, MILK, AND SO ON, WITH PASTEURIZATION IN THIS ORDER IS ALSO ACHIEVED, WHAT WE CALL AN ACCEPTABLY SAFE PRODUCT.

         NOW, WHAT THIS 5-LOG IS DOING IS SETTING THE CRITERIA, IF YOU WILL, FOR HACCP PROGRAM; THE SETTING THE TARGET AND SETTING THE OBJECTIVES. THE HACCP PROGRAM COMES ALONG AND FITS WITHIN THIS BECAUSE THIS LOGIC, OF COURSE, ASSUMES THAT YOU DO NOT HAVE A GROSSLY CONTAMINATED RAW MATERIAL, AND, OF COURSE, IT WOULD ALSO ASSUME THAT AFTER THESE INTERVENTION STEPS, DURING BOTTLING, FOR EXAMPLE, YOU DO NOT RECONTAMINATE THE PRODUCT. SO A 5-LOG REDUCTION DOES HAVE TO FIT WITHIN THE CONTEXT OF THE OVERALL HACCP PROGRAM.

         I WOULD LIKE NOW TO JUST MAKE A COUPLE COMMENTS ON THIS TOPIC OF THE SURROGATE MICROORGANISM BECAUSE IT IS GOING TO COME UP LATER IN SOME OF THE PRESENTATIONS TODAY. AND BY THE SURROGATE MICROORGANISM, WHAT WE ARE TALKING ABOUT HERE NOW IS THE NON-PATHOGENIC BACTERIA THAT CAN BE USED IN THE PILOT PLANTS OR PROCESSING FACILITIES IN PLACE OF THE PATHOGEN IN ORDER TO DETERMINE WHETHER THESE INDIVIDUAL STEPS ARE ACHIEVING THE 5-LOG REDUCTION. AND THE REASON WE HAVE TO DO THIS -- IN OTHER WORDS, WE DO NOT WANT THESE PATHOGENS ACTUALLY BROUGHT INTO THE PLANTS. WE CAN ONLY USE THESE PATHOGENS IN A WELL-CONTROLLED, LABORATORY-TYPE ENVIRONMENT. SO OUR SURROGATES THEN HAVE TO HAVE SIMILAR PROPERTIES TO THE PATHOGEN THAT WE ARE TARGETING, THINGS LIKE THERMAL RESISTANCE, GROWTH RATES, AND I THINK IN THE CASE OF OUR JUICE HERE, WE WANT SURROGATES THAT HAVE THE ACID SURVIVAL AND SENSITIVITY TO ANY ANTIMICROBIAL TREATMENT THAT MIGHT BE APPLIED TO THE ORANGES, SO YOU NEED THE EQUIVALENT. WE NEED TO DETECT THESE PATHOGENS TO THE NORMAL BACTERIA THAT ARE THERE IN THE PRODUCT, AND WE ALSO HAVE TO BE ABLE TO PUT THESE ORGANISMS ONTO THE PRODUCT IN A WAY THAT IS REPRESENTATIVE OF THE ORGANISMS THAT ARE THERE. FOR EXAMPLE, WE MIGHT NOT BE ABLE TO JUST DIP AN ORANGE IN OUR SURROGATE ORGANISM AND HAVE THAT BE THE SAME AS IF YOUR NATURAL PATHOGEN WAS DEEPLY IN A CREVICE OR STEM, OR IF THE PATHOGENS COULD GET UNDER A WAXY COAT OR SOMETHING LIKE THIS, OUR SURROGATES WOULD HAVE TO BE IN A COMPARABLE SITUATION.

         SO JUST TO SUMMARIZE THEN, FROM MY POINT OF VIEW, WHAT WE ARE TRYING TO DO IS GIVE THE INDUSTRY THE MAXIMUM FLEXIBILITY IN CHOOSING THEIR PROCESSES SO THEY STILL MEET THE SAFETY OBJECTIVE, AND THAT WILL THEN ENSURE THAT THE ORANGE JUICE WILL NOT CAUSE ANY OUTBREAKS OF ILLNESS.

         THANK YOU.

         DR. KVENBERG: THANK YOU, DICK.

         WELL, TO CONTINUE ON WITH SOME GENERAL REMARKS, WHAT I WOULD LIKE TO TURN MY ATTENTION TO NEXT IS THE FACT THAT IF YOU HAVE A PREVIOUSLY-EXISTING AGENDA, THIS IS WHERE IT BEGINS TO GET A LITTLE BIT CONFUSING BECAUSE WE HAVE REVISED IT THIS MORNING AND COPIES ARE AVAILABLE IN THE BACK OF THE ROOM, ALSO AT THE FRONT OF THE ROOM FOR YOU AT THE BREAK. ANY DISCUSSION OF WORKING WITH REGULATION OF A PRODUCT IN FOODS BY NECESSITY AND MY PLEASURE IS TO WORK WITH OUR SAFE PARTNERSHIPS. THIS IS TRUE IN MANY AREAS OF THE INDUSTRY, BUT PARTICULARLY IN THE STATE OF CALIFORNIA WHERE THERE IS SUCH A HIGH DEGREE OF PARTICIPATION WITH US IN THE AREA OF JUICE. FOR INSTANCE, WE ARE WORKING CURRENTLY HERE IN THE STATE OF CALIFORNIA ON A PILOT BASIS WITH THE COOPERATION OF THE STATE AND THE INDUSTRY UP IN LOCATION NORTH OF HERE IN CALIFORNIA ON RESEARCH ON APPLE JUICE-BASED PRODUCTS FULLY ENGAGED IN WORKING WITH A STATE AGENCY ON THIS. WE ARE FORTUNATE THIS MORNING TO HAVE MR. JAMES WADDELL FROM THE CALIFORNIA KEPT OF HEALTH SERVICES TO SPEAK TO US ABOUT CALIFORNIA'S PARTNERSHIPS AND HOW WE INTERACT WITH THEM ON THESE ISSUES.

         SO WITH THAT, JIM?

         MR. JAMES WADDELL: THANK YOU, JOHN.

         I APPRECIATE THE OPPORTUNITY TO BE HERE TODAY. I WOULD LIKE TO THANK FDA FOR BRINGING US SUCH NICE WEATHER FOR OUR MEETING HERE TODAY. AS YOU SEE ON THE AGENDA, STU RICHARDSON WAS SCHEDULED TO SPEAK, BUT HE WAS DETAINED WITH OTHER MATTERS AND ASKED ME TO FILL IN. HE ASKED ME TO SEND ALONG HIS GREETINGS TO MANY OF YOU HE HAS WORKED WITH ON FORMER ISSUES.

         AS DR. KVENBERG HAS INDICATED, CALIFORNIA HAS WORKED A LONG HISTORY OF RELATIONSHIPS WITH FDA HERE IN THE STATE. WE HAVE A NUMBER OF CONTRACTS THAT WE HAVE OPERATED ON INVOLVING FOODS, MEDICAL GASES, MEDICAL DEVICES AND THE LIKE. WE HAVE ALSO HAD PARTNERSHIPS, WE HAVE, I THINK, SIX OR SEVEN DIFFERENT PARTNERSHIPS, FORMALIZED AGREEMENTS, TO WORK IN THE AREAS OF SEAFOOD, BIOTECH, LABORATORIES, AND THE LAST COUPLE OF YEARS WE HAVE BEEN BEYOND THAT WHERE WE HAVE CO-LOCATED SOME OF OUR OPERATION WAS FDA OPERATIONS. ONE OF OUR DISTRICT OFFICES CO-LOCATED WITH THEIRS. OUR LABORATORY IS CO-LOCATED WITH THEIRS. SO WE HAVE ALMOST A SEAMLESS GOVERNMENT, AND WE SEE THIS AS A VERY EFFECTIVE WAY TO DO BUSINESS. WE HAVE WORKED VERY CLOSELY OVER THE YEARS, AND IN THE PAST MOST OF THE WORK HAS BEEN EXCEPTIONAL AND REGULATORY ENFORCEMENT-RELATED, AS RICHARD BALDWIN MENTIONED. BUT NOW THINGS ARE CHANGING, WE ARE BEING FACED WITH SOME NEW CHANGES IN FOOD PROCESSING TECHNOLOGY, METHODS OF FOOD DISTRIBUTION, CONSUMERS DESIRES FOR FRESH, MINIMALLY-PROCESSED, AND MORE CONVENIENT TYPES OF FOODS. IN ADDITION, WE ARE SEEING EMERGING PATHOGENS; BUGS ARE SHOWING UP IN PRODUCTS THAT THEY DIDN'T USED TO SHOW UP IN, THEY ARE SURVIVING AND PRESENTING PROBLEMS. IN ADDITION, THE DEMOGRAPHICS OR POPULATION IS CHANGING. A LOT OF US ARE BECOMING GRAY-HAIRED AND MORE IMMUNE-COMPROMISED, AND THAT SORT OF THING. SO WE HAVE SOME NEW CHALLENGES FACING US. AND WE RECOGNIZE THIS AND WE NEED TO DO A DIFFERENT JOB IN TERMS OF PROTECTING PUBLIC HEALTH. THESE CHALLENGES MEAN WE NEED TO DO BUSINESS IN A DIFFERENT MANNER. IN THE SPRING OF 1996, WE HAD A SMALL SPRING MIX LETTUCE OPERATOR IN THE SALINAS VALLEY THAT WAS ASSOCIATED WITH A NUMBER OF E.COLI O157:H7 ACROSS THE COUNTRY. THIS WAS A VERY SMALL OPERATOR, HOWEVER THE DISTRIBUTION OF HIS PRODUCT WAS NATIONWIDE, AND SO WE HAD A SIGNIFICANT NUMBER OF ILL PEOPLE. WHAT WE DID WHEN WE STARTED INVESTIGATING IS FOUND THAT THIS WAS A FRAGMENTED AND UNSOPHISTICATED INDUSTRY. A LOT OF FOLKS HAD BEEN HARVESTERS AND TO SAVE MONEY BECOME ACTUAL PROCESSORS AND SET UP FACILITIES CLOSE TO THE FIELDS, BUT THEY WEREN'T REALLY ASSOCIATED WITH THE CONCERNS FOR PUBLIC HEALTH PRODUCTION AND THE NEED TO PROTECT THEIR PRODUCT; WERE THINKING IN TERMS OF AGRICULTURE, NOT FOOD PROCESSING. WELL, WHAT WE DID WAS TRY TO ROUND UP ALL OF THE INDUSTRY FOLKS WHO WORK FOR THE LOCAL INDUSTRIAL COMMISSIONERS TO TRY TO IDENTIFY SOME OF THESE OPERATORS AS SOON AS POSSIBLE, BRING THEM INTO A SETTING SUCH AS THIS, EXPLAIN THE ILLNESS OUTBREAK, THE NATURE OF THE ORGANISM INVOLVED, SOME OF THE PREVENTIVE STEPS THAT NEEDED TO BE TAKEN, AND WORKED WITH THEM, ASKED THEM TO WORK WITH US IN DEVELOPING METHODS TO PRESENT THE CONTAMINATION. THAT AND THE FORMATION OF A WORKING GROUP THAT THROUGH FDA, STATE, ACADEMIA, AND INDUSTRY REPRESENTATIVES ON VOLUNTARY GUIDELINES FOR PRODUCING FRESH PRODUCE, FOR FDA'S VOLUNTARY GUIDELINES FOR FRESH PRODUCE. SO I THINK THIS IS A PRETTY GOOD INDICATION OF A SUCCESSFUL AND EFFECTIVE WAY OF DOING BUSINESS, THAT'S WHY I AM VERY PLEASED TO BE IN THIS GROUP CONVENING HERE TODAY. YOU FOLKS, BEING EXPERTS IN THE INDUSTRY END OF THINGS, WE HAVE REGULATORS AND ACADEMIA HERE TO DISCUSS THE ORGANISMS AND HOW WE CAN BEST CONTROL THEM. WE LOOK FORWARD TO THIS.

         ANOTHER EXAMPLE, A SIMILAR EXAMPLE, IN THE FALL OF '96, THERE WAS A FRESH JUICE OUTBREAK FROM A CALIFORNIA FIRM. AGAIN, WE CALLED FDA, INDUSTRY, STATE AND ACADEMIA TOGETHER AND ANOTHER WORKING GROUP WAS FORMED AND AGRICULTURE COMMISSIONER IN EL DORADO COUNTY, DR. KVENBERG, REPRESENTED THE APPLE HILL AREA, WHICH IS JUST NORTH OR EAST OF SACRAMENTO, VERY ACTIVE AREA FOR SMALL JUICE PROCESSORS. BUT THE AGRICULTURE COMMISSIONER WAS REALLY A CATALYST IN GETTING THIS GROUP FORMED AND WORKING TOGETHER TO FORM A QUALITY ASSURANCES PLAN. SIMPLE 3-POINT QUALITY ASSURANCE PROGRAM FOR PRODUCING A SAFER JUICE THAT HAS GONE ON AND SHARED WITH INDUSTRY NATIONWIDE, AND AGAIN, ANOTHER EXAMPLE OF HOW THINGS CAN BE DONE TO REALLY SUCCEED.

         COUPLE OF ADDITIONAL EXAMPLES: THROUGH '96, '97, AND ON INTO '98, WE HAVE HAD A NUMBER OF ILLNESS OUTBREAKS INVOLVING FRUITS, ALFALFA SPROUTS PRIMARILY. AGAIN, WE HAVE WORKED WITH THE INDUSTRY IN CALIFORNIA AND 45 SPROUTERS THROUGHOUT THE STATE, AND WE IDENTIFIED THEM, BROUGHT THEM IN, EXPRESSED OUR CONCERNS, DEVELOPED A WORKING GROUP, WORKED WITH THE GROUP TO DEVELOP GUIDELINES. THE GUIDELINES WERE IMPLEMENTED THROUGHOUT THE STATE. WE WENT OUT AND CONDUCTED A SURVEY TO SEE HOW EFFECTIVE THEY WERE AND SOME ENFORCEMENT FOLLOW-UP AND THAT SORT OF THING. BUT NOW THERE HAVE BEEN SOME STEPS TAKEN AS A RESULT OF THAT. THROUGH WORKING WITH OUR DEPARTMENT PESTICIDE REGULATIONS, WE HAVE HAD TEMPORARY APPROVAL FOR THE USE OF SOME OF THESE. THAT LOOKS TO BE PROMISING OVER THE NEXT YEAR. SO AGAIN, THESE ARE COLLABORATIVE AND VERY COOPERATIVE RELATIONSHIPS, AND THAT'S THE WAY I THINK WE GET THINGS ACCOMPLISHED.

         WE HAVE HAD SEVERAL OTHER EXAMPLES. THE EGG INDUSTRY HERE IN CALIFORNIA, THROUGH WORKING ON QUALITY ASSURANCES PROGRAM OUT WITH THE FDA AND OURSELVES, WE HAVE 85 PERCENT OF THE EGG INDUSTRY HERE IN CALIFORNIA ON THE QUALITY ASSURANCES PLAN, AND THEY ARE DOING MONITORING FOR SALMONELLA, AND IT APPEARS TO BE A VERY PROMISING AND EFFECTIVE WAY OF IMPROVING PUBLIC HEALTH.

         WITH THAT SAID, I WOULD JUST LIKE TO SAY AGAIN THANK YOU FOR THE OPPORTUNITY TO BE HERE. I THINK THIS IS A VERY GOOD COOPERATIVE, COLLABORATIVE SETTING TO MAKE SOME REAL PUBLIC HEALTH ISSUES. THANK YOU.

         DR. JOHN KVENBERG: THANK YOU. THERE IS A VIEW FROM THE GOVERNMENT STANCE FROM THE FEDS AND FROM THE STATE FOLKS AS WELL, UNDERSCORING MY DESIRE TO OPEN A DIALOGUE AND ACTUALLY PUT INTO THE HANDS OF THE INDUSTRY THE ABILITY TO TACKLE AN ISSUE RELATIVE TO PERFORMANCE STANDARD.

         NEXT I WOULD LIKE TO SHIFT THE FOCUS OF THE DISCUSSION THIS MORNING TO THE INDUSTRY ITSELF, AND I AM ASKING FOR AN OVERVIEW DISCUSSION FROM MR. STEVE WILLIAMSON FROM ODWALLA COMPANY TO GET US STARTED IN THE AREA OF INDUSTRY PERSPECTIVE.

         STEVE? THANK YOU.

         MR. STEVE WILLIAMSON: THANK YOU, JOHN. I JUST CAME BACK FROM A TRIP BACK EAST AND I WAS LOOKING AT THE NUMBER OF CONFUSING MESSAGES I SAW ON COOLERS OUT THERE ABOUT WHAT IS FRESH JUICE AND WHAT'S GOING ON. IN ADDITION, COMING BACK TO E-MAILS FROM THE VARIOUS DISTRIBUTION CENTERS WE HAVE IN PORTLAND AND SEATTLE DOWN HERE AND DENVER AND TEXAS, AND THERE IS A FAIR AMOUNT OF CONFUSION OUT THERE AMONG THE TRADE AND THE CONSUMERS ABOUT WHAT'S GOING ON WITH FRESH ORANGE JUICE. AND I THINK THAT ONE OF THE THINGS THAT WE REALLY WOULD LOVE TO HAPPEN TODAY OR COME OUT OF THIS IS FOR THE GROUP TO LOOK, LISTEN AND COME FORWARD ON SOME SHARED PRINCIPLES BECAUSE THE CONFUSION THAT'S OUT THERE, TAGS ON YOUR COOLERS, PEOPLE SAY, "WHAT'S FRESH? WHAT ISN'T? IS IT SAFE? IS IT NOT? THAT IS NOT GOOF FOR ANYONE. AND I HOPE TODAY, WITH THE INFORMATION THAT LINDA FRELKA, OUR VICE PRESIDENT OF QA, IS GOING TO SHARE. AND MARC ISAACS IS GOING TO SPEAK, AND A NUMBER OF OTHER PEOPLE ARE GOING TO BE UP THAT WE CAN COME TOGETHER ON SOME BASIC PRINCIPLES.

         WHAT I WOULD LIKE TO DO IS SUGGEST FIVE THINGS THAT I THINK ARE KIND OF PARAMOUNT IN ACHIEVING THAT, AND THEY ARE: ONE, THAT WE COME TOGETHER TO AGREE ON WHAT IS A FIVE EVALUATION TEST, AND WE HAVE DONE NUMEROUS OURSELVES. THERE ARE MANY PEOPLE OUT HERE WHO HAVE DONE A BUNCH OF OTHER TYPE OF THINGS. WE SHOULD COME TOGETHER AND SAY HEY, WHAT IS THE WAY TO DO THIS? AND AGREE ON THAT SO WE ARE NOT ALL JUST REPEATING AND WASTING FRANKLY A GOOD DEAL OF MONEY, IS THAT PEOPLE ARE TRYING THIS WAY AND THIS WAY AND HEY, IF PEOPLE CAN COME TOGETHER AND WE ARE HERE AND HAPPY TO SHARE AND SHARE WHAT WE HAVE DONE IN OUR EVALUATION STUDIES SO YOU CAN SEE, AND MAYBE IT IS NOT THE RIGHT WAY, MAYBE IT IS, BUT IT IS BEST THAT WE COME TOGETHER AND AGREE ON THAT.

         POINT TWO IS I THINK THAT HACCP IS CLEARLY TO SOME A BUZZ WORD, TO OTHERS ABSOLUTELY A WAY OF LIFE. AND I THINK WHAT WE SHOULD COME TOGETHER ON AS AN AGREEMENT IS THAT ONCE YOU IMPLEMENT HACCP, HOW OFTEN IS IT AUDITED? DO YOU AUDIT IT WHEN YOU PUT IT IN? HOW OFTEN DOES THAT AUDIT GO ABOUT? AND HOW OFTEN DO YOU AUDIT IT? IN OUR CASE WE WENT THROUGH THREE AUDITS PRIOR TO SAYING WE WERE IMPLEMENTED. WE WERE IMPLEMENTED AND NOW WE ARE ON AN ANNUAL AUDIT BASIS. I THINK THE HERRINGS WE HAD IN THAT PROCESS WE WOULD BE HAPPY TO SHARE. IT IS NOT AN EASY PROCESS TO GO THROUGH. IT IS VERY PAINFUL AND COST US A GOOD DEAL OF JUICE THROWN DOWN THE DRAIN. IT IS NOT EASY. IT SOUNDS EASY. YOU CAN GET ALL THESE GREAT PROGRAMS, BUT ASK LINDA, WE PULLED A LOT OF HAIR OUT OVER THIS AND DUMPED A LOT OF JUICE.

         THE THIRD THING I WOULD LIKE TO SUGGEST GOING BACK, LET'S GET CLEAR ON THE FIVE, CLEAR ON HOW WE IMPLEMENT HACCP, HOW THE THIRD THING IS WHAT WE ARE DOING, IT MAY BE RIGHT, IT MAY BE WRONG, BUT THEN HERE, IN THE SPIRIT OF SHARING, WE STILL BELIEVE THAT THERE IS SOME VALUE, SOME TESTING, AND WE DO A DAILY TESTING, BATCH TEST ON EVERY SINGLE BATCH. E.COLI IS OUR INDICATED ORGANISM. IF IT COMES UP, MR. "X" VIEWS JUST A MIDDLE JUICE PASTEURIZED ABOVE THAT, WE DUMP IT. WE DON'T KNOW WHAT THE RIGHT STANDARDS ARE THERE. WE JUMPED OUT AND GOT THESE, THEY MAY BE TOO AGGRESSIVE; THEY NOT BE AGGRESSIVE ENOUGH, I DON'T KNOW. BUT I SUGGEST THERE IS SOME DAILY REASSURANCE FACTOR OF DOING THINGS, SO WE HOLD OUR FRESH JUICES FOR 24 HOURS WHILE WE GIVE THE E.COLI TEST.

         FOURTH IS SOME AGREEMENT ON WHAT PATHOGEN TESTING TO DO. WHAT RICHARD MENTIONED, THERE ARE MANY PATHOGENS. WHAT SHOULD WE BE LOOKING FOR? BECAUSE I THINK YOU CAN TEST THE OLD WAY AND STILL NOT BE DONE; 0157, SALMONELLA, AND THOSE ARE THE TWO PRIMARY ONES WE WORKED WITH.

         AND THE OTHER THING I THINK TO THROW INTO THE MIX THAT'S IMPORTANT TO US, PAINFUL, BUT I THINK IMPORTANT, IS A DAILY ENVIRONMENTAL TESTING, BOTH DURING PROCESS AND POST-SANITATIONS.

         SO THESE ARE THE FIVE KEY POINTS THAT I THINK CAN BE HELPFUL FOR US TO TRY TO EMBRACE STILL MAKING FRESH-SQUEEZED ORANGE JUICE. AND I DEFINITELY SAT ON THE FENCE FOR MANY HOURS AND HAD A GOOD DEAL OF CONVERSATION WITH JOHN KVENBERG AND OTHERS IN THE FDA AS WELL AS OUR TECHNICAL TEAM, DR. DOUG ARBOR AND G. NICKOLSON (PHONETIC) AS TO WHETHER IT MAKES SENSE TO MAKE FRESH JUICE. I DO BELIEVE WE CAN MAKE GOOD FRESH JUICE, BUT WE AREN'T GOING TO HAVE MUCH OF A MARKET UNLESS WE CAN COME TOGETHER IN SOME KIND OF COMMON PRESENTATION. AND I THINK IN MY CONVERSATIONS THERE HAVE BEEN A NUMBER OF PEOPLE AGREEING WITH THIS. THE QUICKER WE GET UNIFIED AND SEND A MESSAGE OUT SO YOU DON'T GET TAGS ON YOUR JUICE THAT SAY OLD FOODS OR WHATEVER, WHERE SOME STORE MANAGERS KNOW WHAT'S GOING ON AND PUTS A TAG UP THERE NOT PROPER OR IT IS NOT MEETING LEGAL REQUIREMENTS. AND WHAT THAT DOES TO THE BRAND, WHAT DAMAGE THAT BRINGS IS GREAT. SO I HOPE OUT OF FLORIDA, WHICH I UNDERSTAND WAS A GOOD MEETING, LINDA, OUR VICE PRESIDENT, WAS THERE. AND OUT OF THIS MEETING TODAY, IF WE CAN COME TOGETHER ON SOME PRINCIPLES HELPS EVERYONE. SO THANK YOU FOR LISTENING.

         DR. JOHN KVENBERG: THANK YOU, STEVE.

         ANY DISCUSSION OF THE TOPIC OF HOW WE ARE GOING TO APPROACH THE STANDARD REALLY OUGHT TO GO INTO TOTAL LOGICAL ORDER FROM THE TIME THE FRUIT IS HANGING ON THE TREE TO THE POINT THAT IT IS PROCESSED AND SOLD AT THE RETAIL STORE. AND I AM GOING TO HAVE TO BEG YOUR INDULGENCE ON A COMPLETE DISCUSSION OF PRE-HARVEST CONTROLS AT THIS POINT IN TIME BECAUSE ONE OF OUR SPEAKERS, MR. CHUCK ORMAND, FROM THE CALIFORNIA CITRUS CONTROL COUNSEL, HAD A BOARD MEETING THIS MORNING, BUT WILL BE ABLE TO COME BACK WITH SOME VERY SPECIFIC AND USEFUL INFORMATION ON CITRUS GROWING AND HARVESTING AROUND THEIR PACKING HOUSE CONTROLS. THEY DO PLAY A KEY ROLL IN TODAY'S DISCUSSIONS, SO THAT WILL BE AFTER LUNCH. BUT WHAT WE DO HAVE TO KICK OFF ON THE AREA OF PRE-HARVEST CONTROL IS SOMEONE WHO IS QUITE KNOWLEDGEABLE ABOUT FRUIT AND ITS PROCESSING AND HANDLING FROM A DIFFERENT CROP, I BELIEVE THE SAME PERSPECTIVE, AND THAT WOULD BE FROM DR. MARK MACAFFE. DR. MACAFFEE IS THE CALIFORNIAN HERE THAT HAS BEEN ENGAGED IN THE PRODUCTION AND HARVESTING OF APPLE PRODUCTS AND WE WOULD LIKE TO CALL ON HIM NEXT TO DISCUSS HIS APPROACH TO THE HAZARDS THAT ARE ASSOCIATED WITH PRODUCTS FROM HIS PERSPECTIVE.

         MARK?

         MR. MARK MACAFFEE: JOHN, THANK YOU FOR A REFERENCE. I WAS A PARAMEDIC FOR 14 YEARS, BUT I DON'T THINK THAT I HAVE OFTEN THOUGHT OF MYSELF AS A DOCTOR. AND LAST 10 YEARS I HAVE BEEN A FARMER, AND I WAS INVITED BY JOHN TO PRESENT SOME INFORMATION WHICH I THINK IS INNOVATIVE AND REVOLUTIONARY REVOLUTION, BUT OUR INITIAL EXPECTATIONS OF WHAT WE DID THREE YEARS AGO, TWO AND A HALF YEARS AGO WHEN WE STARTED DOING WHAT WE CALL FIELD HACCP, WHICH IS KIND OF A DISCLAIMER IN ITS OWN RIGHT, ENDED UP BEING THE ASSUMPTIONS WERE INCORRECT. WE ACTUALLY DISCOVERED SOME THINGS BEYOND OUR INITIAL OPERATIONS. BENEFICIAL. I AM AN APPLE GROWER AND I HAVE TO DISCLAIM THAT SOME OF THE THINGS THAT I HAVE TO SAY TODAY MAY NOT BE COMPLETELY PERTINENT, BUT MAY BE VERY PERTINENT TO THE ORANGE INDUSTRY. AND I INVITE EVERYONE TO ASK US SOME QUESTIONS AS POSSIBLE BECAUSE IN OUR COMPREHENSIVE EVALUATION OF RISKS WE THINK ARE IMPORTANT TO EVALUATE THE PHYSICAL, CHEMICAL AND BIO OF OUR PRODUCT FROM THE FARM ALL THE WAY TO THE CONSUMER. AND I THINK AS FAR AS PRIVATE SECTOR EVALUATIONS IS CONCERNED, WE HAVE HAD TO COOPERATE WITH THE GOVERNMENT, BUT THIS HAS BEEN PRETTY MUCH DONE IN THE PRIVATE SECTOR.

         WHAT I WOULD LIKE TO SAY AT THE OUTSET IS THAT WE FOUND SOME THINGS THAT ARE REALLY QUITE PHENOMENAL, AND I THINK THE INDUSTRY, IF I COULD JUST ASK EVERYONE PLEASE QUICKLY TO OPEN YOUR MINDS AND LOOK AT THIS AS A REALLY UNIQUE APPROACH, AND I AM SPEAKING DIRECTLY TO FARMERS HERE BECAUSE IT ADDS VALUE TO OUR PRODUCT, AND THAT IS A LOADED STATEMENT. WHEN YOU DO WHAT WE ARE DOING, IT ADDS VALUE, AND YOU CAN TAKE THAT WHERE YOU WANT. BUT THAT'S A REALLY, REALLY IMPORTANT THING, IF YOU THINK ABOUT IT. REALLY DON'T SAY NO, I CAN'T. SAY I NEED TO REALLY LOOK AT THIS BECAUSE WE ARE CHANGING, PATHOGENS ARE CHANGING. INNOVATION I THINK IS REALLY THE PLACE TO BE AS FARMERS, ESPECIALLY IN THE INTERNATIONAL COMPETITION. IF EVERYONE GETS APPLE JUICE REAL CHEAP, WE NEED TO THINK ABOUT HOW WE NEED TO SEPARATE OURSELVES WITH THE LIABILITY ASPECT, BUT ALSO IN THE VALUE ASPECT.

         I WOULD LIKE TO SHOW A SHORT VIDEO, AND THEN KIND OF GO THROUGH SOME OVERHEADS. AND THEN FROM THAT, WE'LL OPEN THIS UP TO SOME DISCUSSION SO I CAN ANSWER YOUR 20 QUESTIONS BECAUSE I REALLY WANT 20 QUESTIONS TO ASK ABOUT THE TECHNICALITIES OF WHAT WOULD BE -- CAN YOU SHOW THE VIDEO? THIS VIDEO SHOWS SOME SNIPPETS OF WHAT WE DO ON OUR FARM. IT IS IN COLLABORATION WITH ODWALLA.

         (A VIDEO IS PLAYED, BUT NOT TRANSCRIBED.)

         THERE ARE A WHOLE LOT OF THINGS GOING ON HERE THAT YOU MAY NOT APPRECIATE, AND I WILL HAVE TO KIND OF EXPLAIN THEM LATER. BUT LOOK DEEPLY INTO WHAT'S GOING ON HERE. AT EACH POINT APPRECIATE SOME CHANGES THAT MAY NOT BE SOME NORMAL FORM OF PRACTICES. NOTICE THAT OUR APPLE BINS DO NOT TOUCH THE GROUND. THEY ARE FORK-LIFTED DIRECTLY TO A HYDRO-WASH TRUCK.

         THIS IS REPRESENTATIVE FROM A VALIDATION AND AUDITING COMPANY, PRIMUS LABS OF SANTA MARIA, CALIFORNIA. COMING OUT ON THE SPUR OF THE MOMENT WITHOUT NOTIFICATION TO US TO INSPECT, ASK QUESTIONS OF THE WORKERS, AND ACTUALLY SEE WHAT'S GOING ON. AND ALL OF THIS INFORMATION IS BEING POSTED ON THE INTERNET FOR ALL TO SEE. THE LOCATION OF THE TOILET IS NOT IN THE ORCHARD, IT IS ACTUALLY ON THE ROAD OUTSIDE THE FIELD.

         (END OF THE VIDEO.)

         WE HAVE BEEN DOING THIS FOR ABOUT THREE YEARS NOW, GOING INTO OUR THIRD YEAR. AND AS WE INITIALLY ESTABLISHED OUR PHILOSOPHIES AND THEN WHY WE WERE DOING WHAT WE WERE DOING, WE HAVE LEARNED A LOT OF THINGS. TO QUOTE DR. BOB STOVACHECK (PHONETIC), WHO HAS HELPED ME ALONG WITH SOME SIGNIFICANT CONTRIBUTIONS FROM SOME OF THE ODWALLA STAFF TO CREATE SOME OF OUR PROGRAMS IN THE FIELD, HE SAID, "MARK, YOU GET A LOT OF CREDIT FOR COMMON SENSE, AND THERE'S BEEN A LOT OF TALK ABOUT HEY LISTEN, YOU CAN'T DO THIS BECAUSE YOU DON'T KNOW HOW VALID IT IS OR YOU CAN'T DO THAT BECAUSE WE DON'T KNOW HOW SOPHISTICATED OR HOW TECHNICALLY SIGNIFICANT THAT CONTRIBUTION IN YOUR PROGRAM MIGHT BE. WE THREW ALL OF THAT OUT AND WE HAVE THIS THAT MAKES SENSE. LET'S DO EVERYTHING THAT MAKES SENSE. AND LET'S MEASURE THE RESULTS AFTERWARDS, AND IN THAT PROCESS LET'S THROW IN A WHOLE BUNCH." WE LEARNED A WHOLE LOT AND WE LEARNED A BUNCH OF STUFF WE DIDN'T KNOW WE WOULD LEARN. SO THAT'S KIND OF THE OUTLOOK MACAFFE GARDENS TOOK, WHETHER WE SHOULD VERUS GET HEADLONG INTO IT AND LEARN AS YOU GO. SO IT'S BEEN SORT OF AN INNOVATIVE APPROACH. WE BELIEVE THAT THERE'S FOUR PARTNERS IN THE FOOD CHAIN BUSINESS, AND A VERY IMPORTANT FIFTH PARTY. THE FARMER IS DEFINITELY A PART OF THE FOOD CHAIN, AND I THINK THE FARMER HAS BEEN OUTSIDE OF THE LOOP FOR A LONG TIME. REGULATORS, PEOPLE TALKING ABOUT CLEANLINESS, SPEND A LOT OF TIME IN THE PROCESSING PLANT AND THEY HAVE NOT REALLY GONE BEFORE THE PROCESSING PLANT AND LOOKED INTO THE FIELD. AND THERE IS A WHOLE LOT OF STUFF THAT CAN BE DONE IN THE FIELD WHICH CHANGES EVERYTHING GOING INTO THE PLANT TREMENDOUSLY. IN OUR PACKING FACILITY, WE SEND OUR FIELD HACCP GROUP TO DO THE PROCESS AND ALSO TO THE PROCESSING FACILITY PLACE THAT IS WHERE WE SEND OUR PRODUCT. WE PUT THE FRUIT IN THE DUNK TANK, WHICH IS A BIG DETERMINATION OF HOW THE CHLORINE WORKS, WHICH IS A TREMENDOUS STORY IF IT'S DONE RIGHT. THE NON-HACCP, AFTER EIGHT OR NINE MINUTES HAVING BEEN DUMPED IN THE DUMP TANK, THE DUMP TANK WAS BROWN FROM DIRT, AND THAT WAS INTERESTING TO US BECAUSE WHEN WE PUT OUR BINS IN THE DUNK TANK, 90 BINS WENT THROUGH AND IT STILL LOOKED VISIBLY CLEAN. NOW, THAT TELLS US A LOT ABOUT WHAT'S GOING ON WITH CHLORINE AND ITS ACTIVITY AND ALSO ON WHAT MAN HAS DONE TO THE NORMAL BIO-LOAD OR DIRT LOAD, FILTH LOAD FROM THE FIELD WAS. IN OTHER WORDS, MANAGEMENT HAS EVERYTHING TO DO WITH HOW DIRTY THAT WATER GETS IN THE CHLORINE TANKS. SO THAT'S A TREMENDOUS THING THAT WE LEARNED WE DIDN'T REALLY THINK OF WHEN WE FIRST STARTED. SO OUR HOPE HERE IS TO CUT A PATHWAY FROM WHERE IT IS ON THE TREE IN THIS PRISTINE BIO-LOAD STATE IT IS AT TO GET IT TO THE NEXT STEP IN THE PARTNERSHIP CHAIN WITHOUT CONTAMINATING IT FURTHER OR CROSS-CONTAMINATING IT FURTHER. AND THAT'S REALLY SOMETHING THAT'S BEEN A PHENOMENAL THING THAT WE HAVE LEARNED. WE ALSO BELIEVE THAT THE PROCESSOR PACKING FACILITY'S CLEANLINESS STEP WORKS THAT MUCH BETTER BECAUSE NOW THAT WE DON'T HAVE FILTHY FRUIT THEY HAVE WHATEVER NORMAL BIO-LOAD IT IS AT A FAIRLY CONSTANT LEVEL COMING INTO THE PLANT, THAT THEIR STEPS WORK THAT MUCH BETTER. AND SO WE REALLY THINK THAT IS A VALUE ADDED TO A PLANT-CLEANED FRUIT VERSES GOD KNOWS WHAT. SO THAT IS KIND OF AN INTERESTING PERSPECTIVE ON WHERE WE SIT.

         AT OUR FARM WE HAVE FORMED PARTNERSHIPS WITH PACKERS AND PROCESSORS, DISTRIBUTORS AND ALSO INTIMATE RELATIONSHIPS WITH THE CONSUMERS. AND IT WAS ONE OF MEETINGS LIKE THIS IN SACRAMENTO THAT FORMED A VERY CLOSE RELATIONSHIP WITH A PERSON WHO WAS A CONSUMER AND A CONSUMER ADVOCATE, AND I HAVE GOTTEN A LOT OF GUIDANCE FROM HERE ABOUT WHAT SHE WANTS TO SEE IN THE PRODUCT. SO, THE FIFTH PARTY HERE, THE SILENT PARTNER, IS THE FOOD STATION AUDITING. VERY, VERY IMPORTANT. WE HAVE SEEN A LOT OF PEOPLE SAY WE DON'T WANT OUR INTERNAL DOCUMENTS OR OUR TESTS TO BE SHOWN, ESPECIALLY AT THE FORUM LEVEL BECAUSE THEY ARE SHOWN ABOUT WHAT MAY OR MAY NOT BE SHOWN. WE DO IT BECAUSE WE FEEL THERE IS BRAND EQUITY ASSOCIATED WITH IT. IF YOU HAVE TO HIDE SOMETHING, THEN SOMEBODY IS GOING TO FIND OUT. FROM OUR PERSPECTIVE, WE HAVE SAID OKAY, WE ARE GOING TO HAVE BRAND VALUE EQUITY THERE AND WE HAVE TO PROTECT FROM A FOOD SCARE IN SOME OTHER COUNTRY, SOME OTHER FOOD CRISIS AT SOME OTHER FARM THAT HAS A PROBLEM. BRAND EQUITY THAT WE CAN DEFEND OUR PRODUCT ALL THE WAY TO THE LIMIT. WHEN SOMEBODY ELSE IS HAVING A CRISIS, WE CAN BE SEPARATED OUT AND WE ARE BEYOND REPROACH BECAUSE OF THE WAY WE HAVE BEEN AUDITED. THAT'S A VERY BIG REASON WHY WE DID BECAUSE OF WHAT HAPPENED, A CHEMICAL ISSUE THAT HAPPENED IN THE MID-80S THAT KILLED WASHINGTON FOR A WHILE, AND THAT HAPPENED IN STAWBERRIES, COST $400,000,000 TO PERFECTLY INNOCENT STRAWBERRY GROWERS HERE IN OUR OWN STATE. SO YOU CAN SEE HOW SOMEBODY ELSE'S PROBLEM CAUSES YOU A PROBLEM YOU DIDN'T REALLY WANT, AND THAT'S ONE OF THE BIG REASONS WE DID WHAT WE DID IN OUR SAFETY PROGRAM.

         SOME OF THE DETAILS OF EACH OF THE POINTS THAT WE DO IN OUR FIELD HACCP PROGRAM IS WE HAVE ASSIGNED WHAT WE CALL FIELD HACCP IS. I DON'T THINK THERE IS ANY DEFINITION IN ANY WORK YOU CAN FIND FOR FIELD HACCP; WE HAVE TO CREATE IT OURSELVES BECAUSE IT DOESN'T -- THE HACCP, I AM NOT GOING TO SAY IS 5-LOG, I AM NOT GOING TO SAY WHATEVER IT IS. I AM SAYING WE ARE CHANGING THE MEANING OF HACCP BY HIDING THE FIELD IN FRONT OF IT BECAUSE IT REALLY OPENS A CAN OF WORMS. WHAT WE ARE SAYING IS PEOPLE REALLY UNDERSTAND WHAT HACCP IS. HACCP IS A REDUCTION OR ELIMINATION OF BIOLOGICAL PROBLEMS OR PHYSICAL PROBLEMS OR CHEMICAL PROBLEMS SO YOU HAVE A SAFE END-PRODUCT. BECAUSE WE ARE DEALING IN A BIOLOGICAL FREE OR ALL OUT IN THE FARM WHICH NEEDS TO BE BECAUSE THAT'S WHERE THINGS GROW, WE HAD TO DEFINE, IN FACT, WHAT WE ARE DOING. THERE IS NO GUARANTEE IN THIS. IT IS JUST A BEST EFFORT, USE THEM OR ELIMINATE THEM.

         ANOTHER IMPORTANT THING IS I THINK A PLAN IS ONLY SITE-SPECIFIC; IT IS FARM-BY-FARM. YOU MAY HAVE A PARTICULAR RISK ON ONE FARM, YOU DON'T HAVE ON ANOTHER FARM. SO IT IS SITE-BY-SITE, RISK-BY-RISK EVALUATION. YOU KIND OF HAVE TO GET A CONNECTION WHERE WE ARE COMING FROM, THREE COMPONENTS. MANAGEMENT OF CRITICAL CONTROL POINTS, WE HAVE TWO OF THEM. ALL THE SSOPS, WHICH DERIVE THE GENERAL CLEANLINESS OF THE RANCH AND FARMING PRACTICES, AND THEN AUDITING BY THE THIRD PARTY. THOSE ARE THE THREE COMPONENTS. OUR TWO CRITICAL CONTROL POINTS ARE CERTIFIED WATER SOURCES. WE HAVE COMPLETE TESTS OF IRRIGATION, FOR DRINKING AND FOR WASHING AND FOR SPRAYING, SO WE ARE NOT TAKING SOME BIOLOGICALLY-LADEN WATER AND SPRAYING IT ON RIGHT BEFORE HARVEST OR WASHING OUR WATER WITH CONTAMINATION OR NOT MAKING OUR FIELD WORKERS DRINK BAD WATER. WE ARE NOT PUMPING IRRIGATION WATER THAT'S GOING TO CONTAMINATION. SO ALL OF OUR WATERS ARE CERTIFIED TO BE E.COLI-FREE AND COLIFORM-FREE. SO THAT'S FAIRLY IMPORTANT AND FAIRLY EASY TO DO IN OUR ENVIRONMENT.

         THE OTHER THING IS MUCH MORE DIFFICULT, BUT WE HAVE TO IDENTIFY THIS BECAUSE WE FELT IT WAS THE MOST IMPORTANT THING OTHER THAN WATER TO WASH, AND THAT IS WORKER BEHAVIOR. I DON'T WANT TO BE TOO POLITICALLY -- I DON'T WANT TO CAUSE TOO MUCH TURMOIL. HERE IN THE PAST, MY OWN EXPERIENCE WAS FIELD WORKERS DIDN'T WANT TO GO TO THE TOILET. THEY DIDN'T WANT TO GO IN THE FIELD BECAUSE THE TOILET WAS A FILTHY PLACE AND I DON'T BLAME THEM BECAUSE IT WAS A MESSY PLACE. IT HAS FLIES, IT WAS NASTY. AND YOU WALK THROUGH OUR ORCHARD FOUR YEARS AGO AND YOU WOULD FIND HUMAN WASTE ONCE IN A WHILE. IT DISGUSTED ME AND I, BECAUSE I WAS RAISING FRUIT, I DIDN'T CARE ABOUT THE OTHER THING. WELL, I WILL TELL YOU, HUMAN WASTE IS EXTREMELY TOXIC, AND ESPECIALLY WHEN YOU FIND DIARRHEA IN THE FIELD. THESE PEOPLE HAVE STUFF GOING ON IN THEIR GI TRACTS. WELL, WE SAID TO OURSELF THAT'S SERIOUS. WE HAVE TO BE INNOVATIVE. WE ARE GOING TO CLEAN OUR TOILETS EVERYDAY AND WE ARE NOT GOING TO SAY PLEASE USE THE TOILET. YOU MUST OR WE'LL FIRE YOU ON THE SPOT IF YOU DON'T. BUT WE ARE GOING TO HAVE THE CLEANEST TOILETS IN THE WORLD. SO WHAT WE DID IS CLEAN UP THE TOILETS EVERYDAY, COMPLETELY WASHED OUT AND PRISTINE PLACES. I CAN INVITE ANYBODY. I CAN INVITE JOHN KVENBERG TO GO TO. YOU ARE INVITED. WHAT WE FOUND WAS EXTREMELY EXPENSIVE TO DO. TO HAVE SOMEBODY COME OUT TO CLEAN THE TOILET WOULD BE LIKE 30, 40, 50 BUCKS A DAY TO CLEAN ONE TOILET. HOW ARE WE GOING TO DO THIS? THE HEALTH DEPARTMENT COULDN'T EVEN HELP US. WE DID SOMETHING REAL CREATIVE AND PUT IN AN ON-SITE SEPTIC SYSTEM ON OUR FARM, REMOTE SITE. TAKE EACH OF OUR TOILETS OVER THERE TO THE SEPTIC SITE AND CLEAN THEM OURSELVES. WE DID THAT AND THAT SEPTIC SYSTEM HAS BEEN ABLE TO HANDLE THE LOAD FOR THE ENTIRE YEAR OUT OF OUR TOILETS AND I HAVEN'T HAD TO CLEAN OUT THAT SEPTIC TANK UNTIL NOW. SO IT IS 150 BUCKS PLUS LABOR, WHICH IS ABOUT FIVE MINUTES PER TOILET TO CLEAN TOILETS, WHICH IS NEGLIGIBLE TO HAVE SOMEBODY COME OUT AND CLEAN TO A MAYBE AN OK-LEVEL IN TERMS OF GETTING THE TOILETS CLEAN. AND NOW WE HAVE PRISTINE, COMPLETELY CLEAN, CLEAN TOILETS EVERY MORNING, AND THEY WILL GO THERE WITHOUT A PROBLEM AT ALL. AND THAT CHANGED THAT WHOLE BEHAVIOR ISSUE A LONG WITH IT. SO THAT IS AN INNOVATIVE THING WE DID, COST-EFFECTIVE, AND MADE TOILET USE LITERALLY 100 PERCENT.

         WE CERTIFY ALL OF OUR CREWS. WHEN A CREW TURNS UP IN THE MORNING, THEY DON'T HAVE THEIR CERTIFICATION CARD AND THEY ARE NOT TRAINED, THEY ARE SEPARATED FROM THE CROWD AND THEY ARE TRAINED IMMEDIATELY RIGHT THERE. WE DON'T ALLOW ANYBODY TO WORK THAT'S NOT CERTIFIED. THAT CERTIFICATION ISSUE HAS A WIDE RANGE OF SOCIAL PRINCIPLES HOW A CREW WORKS. THEY FEEL LIKE THEY ARE THE SAME TEAM TOGETHER AND THEY ARE CERTIFIED VERSES GOD KNOWS WHAT THEIR BEHAVIORS MIGHT BE IF THEY ARE NOT CERTIFIED. THAT PROCEDURE IS USED IN THE FIELD. DO YOU OR DO YOU NOT HAVE YOUR CERTIFICATION TRAINING AS PART OF THAT? SO WE HAVE BEEN ABLE TO GET BEHAVIORS NOT PERFECT, BUT DARN NEAR PERFECT IN TERMS OF WHAT WE WANT THEM TO DO IN THE FIELD AND HOW WE WANT THEM TO WASH THEIR HANDS, USE THE TOILETS, AND DO ALL THE THINGS WE WANT THEM TO DO. AND THAT'S A BIG STEP BECAUSE THERE HAVE BEEN PEOPLE WHO TRIED TO DO A CERTIFICATION ON A BROAD BASIS AND TRAINING EVERYBODY AND THEY DON'T TURN UP, SOMEBODY ELSE DOES. AND WE HAVE BEEN ABLE TO GET BY THAT BY SAYING WE HAVE BEEN COMMITTED TO HAVE CREWS COME TO OUR FIELD, ESPECIALLY WITH LABOR BEING SHORT AND SO ON AND SO FORTH, THAT'S KIND OF SUPERFICIAL CUSHION OF OUR CRITICAL CONTROL POINTS.

         LET'S GO TO THE SSOP. THESE ARE OUR SSOPS, AND EACH ONE WEEK HAVE AN IN-DEPTH DISCUSSION. I AM NOT GOING TO, BUT I AM JUST TOUCHING BRIEFLY ON THE EACH OF THE ISSUES THAT WE HAVE. BIRD CONTROL THAT WE CONTROL AFTER HARVEST, IT IS VIRTUALLY IMPOSSIBLE TO CONTROL THEM OUT IN THE FIELD. BUT EACH ONE OF THESE ISSUES I WILL SHARE THEM WITH YOU AT SOME LATER TIME TODAY. AND THEN THE THIRD PARTY AUDIT, OBVIOUSLY EACH OF THESE ARE VERY DETAILED INVESTIGATED AND THEN THE INFORMATION IS POSTED ON OUR WEB SITE, WHICH IS COLOR, FULL AND INTERESTING, AND WE REFER TO IT THE WAY WE SET OURSELVES APART IN THE BRAND AND VALUE AND IN RECOGNITION AND IN THE FACT THAT SOMEBODY ELSE SAID WE DIDN'T. AND IT REALLY HELPS OUT. THE INTERNET IS BECOMING A VERY, VERY STRONG MEANS TO DISTRIBUTE INFORMATION AND REFER TO IT IN MARKETING, REFER TO IT NOW, ALL KINDS OF NEAT WAYS, A LOT OF PEOPLE HAVE THE ABILITY TO ACCESS THEM.

         THIS IS A VERY CONFUSING STUDY SHEET HERE. IT SHOWS OUR FLOW CHART. AND WHAT IT DOES IS BASICALLY GIVES A VISUAL ANALYSIS OF HOW THESE PRINCIPLES ALL INTERACT WITH OUR PRODUCT. THE GROWN ON THE LEFT SIDE OVER HERE AND ENDING TRADE PARTNER ON THE RIGHT-HAND SIDE OF THE PAGE, AND I WON'T GO INTO DETAIL INTO THIS. I DO HAVE A HAND-OUT FOR EVERYONE THAT KIND OF HAS THESE OVERHEAD PRODUCTION PROJECTIONS, IF YOU ARE INTERESTED IN. IT IS NOT MANAGEMENT-INTENSIVE, WORKERS ABSOLUTELY LOVE IT, AND THE PUNCHLINE, I HAVE TO SAY IT, IS IN OUR SETTING, WHICH IS NOT YOUR SETTING, BUT IN MY SETTING I WAS ABLE TO SPEND 22 PERCENT LESS ON HARVEST COST THIS YEAR AND LAST BECAUSE OF SOME VERY INTERESTING THINGS WE DISCOVERED; WORKER BEHAVIOR PATTERNS WORKING IN THIS KIND OF ENVIRONMENT. SO IT IS ACTUALLY SOMETHING I CAN'T AFFORD TO DO OR NOT TO DO NOW. SO NOT ONLY DO YOU GET VALUE ADDED, BUT WE HAVE EFFICIENCY IN OUR SETTING.

         AND YOU CAN HOLD THE QUESTIONS UNTIL WE HAVE THE OPENING OF THE QUESTION SESSION, BUT I AM VERY INTERESTED IN BEST WAY THE GROWERS CAN LEARN FROM EACH OTHER.

         SO THANK YOU VERY MUCH. I APPRECIATE YOUR TIME.

        

(APPLAUSE.)

         DR. JOHN KVENBERG: AN ANNOUNCEMENT: THERE ARE ADDITIONAL HANDOUTS THAT ARE ON THE TABLE AND AVAILABLE AT THE BREAK. GENERALLY, AT THIS POINT IN TIME WE BEGIN -- THE FACT THAT WE START TALKING ABOUT CITRUS BECAUSE WE HAVE HAD A GENERAL OVERVIEW, WE HAVE HAD A DISCUSSION FROM A LIGHT COMMODITY. I WOULD NEXT LIKE TO INTRODUCE TO GIVE US AN OVERVIEW AND GET US INTO THE SUBJECT OF SANITARY CONTROLS AND TECHNOLOGIES AVAILABLE, AND THEN TO PLANT OPERATION ITSELF IS MR. MARC ISSACS FROM SUN ORCHARD. MARC COMES TO US FROM THE OTHER SUNNY STATE, ARIZONA, I BELIEVE.

         MR. MARC ISSACS: THANK YOU, JOHN.

         MY FIRST BRIEF DISCUSSION WILL INVOLVE BASICALLY MY ROLE AS THE CHAIRMAN OF THE AMERICAN FRESH JUICE COUNCIL. AND WHAT JOHN ASKED ME TO DO IS GIVE AN OVERVIEW AS TO WHAT THE INDUSTRY, AS WELL AS OUR MEMBERSHIP, HAS DONE TO ADDRESS NOT ONLY PRODUCT SAFETY, BUT ALSO SOME OF THE ALTERNATIVES THAT ARE AVAILABLE TO ACHIEVE THE 5-LOG REDUCTION IN REGARD TO THE WARNING LABEL PROVISIONS.

         AS A GROUP WE HAVE BEEN VERY PRO-ACTIVE, AND THE NUMBER OF OUR MEMBERS HAS MOVED FORWARD VERY QUICKLY, DEVELOPED ALTERNATIVES TO THE 5-LOG REDUCTION, AND A NUMBER OF THEM WILL BE PRESENTING THEM TODAY. THOSE MEMBERS INCLUDE BEAUMONT JUICE COMPANY, THE FRESH JUICE COMPANY, AND IT IS RELATED TO KENNEDY HANSEN, ORCHID ISLAND JUICE COMPANY IN FLORIDA, AND THEN SUN ORCHARD AS WELL. MY POINT THAT I JUST WANT TO OPEN THINGS UP WITH IS THAT WITHOUT A LOT OF GREAT -- WITHOUT A LOT OF DIRECTION, THIS GROUP, OBVIOUSLY ALL OF US, MAKE OUR LIVELIHOOD ON THE BASIS OF PROVIDING OUR CUSTOMERS WITH AS SAFE AS POSSIBLE PRODUCT. AND WE HAVE IN A VERY SHORT PERIOD OF TIME COME UP WITH SOME ALTERNATIVES THAT WILL ALLOW NOT ONLY THE MEMBERS OF THE JUICE COUNCIL, BUT ALSO ALL INDUSTRY MEMBERS, TO PROVIDE THEIR CUSTOMERS WITH SAFER PRODUCTS. OBVIOUSLY, AS STEVE HAD SAID EARLIER, THE BENEFIT TO ALL OF US IS THAT WE ALL ARE PROVIDING SAFE PRODUCTS SO THAT THERE IS NOT AN ADDITIONAL OUTBREAK THAT HAS ADDITIONAL IMPACT ON EACH AND EVERY ONE OF US.

         GETTING STARTED, OBVIOUSLY THERE WERE A NUMBER OF WAYS THAT WE COULD APPROACH THIS. AND IN ADDITION TO JUST LOOKING AT SOME OF THE ONGOING TYPES OF ACTIVITIES, INCLUDING FRUIT SPECIFICATIONS, GRADING, BRUSHING, ETC., TO MOST OF US THE APPROACH IS TO HOW CAN WE MAKE THE LARGEST IMPACT POSSIBLE IN ADDRESSING THIS 5-LOG COMPONENT IN CUMMULATIVE CALCULATIONS. WHAT YOU WILL HEAR SHORTLY IS THAT THERE WERE A NUMBER OF DIFFERENT APPROACHES THAT WERE TAKEN. SOME OF US LOOKED AT IT FROM THE STANDPOINT OF CHEMICAL SURFACE TREATMENT. OTHERS LOOKED AT IT FROM THE STANDPOINT OF HEAT SURFACE TREATMENT. OBVIOUSLY, AS LONG AS IT WORKS AND IT PROVIDES A SAFER PRODUCT, IT REALLY DOESN'T MATTER WHICH METHOD IS APPLICABLE TO YOUR PERSPECTIVE OPERATION. SO YOU WILL HEAR OBVIOUSLY THIS IS AN ONGOING PROCESS. THERE ARE NO CORRECT ANSWERS. BUT WHAT IS MOST IMPORTANT IS WHAT YOU DO IN YOUR OWN PROCESS TO ADDRESS SOME OF THESE ISSUES AND ACHIEVE A 5-LOG. CLEARLY, THE OTHER STEPS OF THE PROCESS WILL NEED TO BE ADDRESSED BY THE FDA, BUT AS WE MOVE FORWARD THIS MORNING, I WILL BE TAKING -- I AM THE NEXT PERSON THAT WILL BE ADDRESSING THE CHEMICAL AND SANITIZING SIDE OF THE EQUATION. AND THEN DR. ISMAIL AND I WILL ADDRESS THE SURFACE HEAT SIDE OF THE EQUATION.

         SO WITHOUT FURTHER ADO, JOHN?

         DR. JOHN KVENBERG: THANK YOU, MARC.

         AS YOU STATED, GOING THROUGH THE DISCUSSION OF SANITARY CONTROLS IN THE AREA OF CHEMICAL SANITIZERS, WE HAVE HAVE MR. STEVE HUNTER TO SPEAK TO US THIS MORNING FROM THE FRESH JUICE COMPANY, A FLORIDA-BASED OPERATION, AND TALK TO US ABOUT SANITIZERS FROM THE EXPERIENCES THAT THEY HAVE HAD.

         MR. STEVE HUNTER: THANK YOU, JOHN.

         AS YOU CAN IMAGINE, I AM FROM THE FRESH JUICE COMPANY, AND WE ALSO ARE JOINED BY HANSEN JUICES IN PARTICIPATING IN THIS.

         IF WE CAN HAVE OUR FIRST SLIDE -- OUR HAZARD ANALYSIS AS PART OF DEVELOPMENT OF OUR HACCP PLAN, WE FOUND OUT THERE WERE TWO THINGS IMPORTANT SURROUNDING THE PROCESSING OF FRUIT, AND WE FOUND OUT THAT THE POTENTIAL FOR PATHOGENIC CONTAMINATION OCCURS WHEN THE INTEGRITY OF THE FRUIT IS COMPROMISED IN CONJUNCTION WITH A PATHOGENIC SOURCE. SO THERE ARE TWO WAYS THAT YOU CAN ELIMINATE THE PROBLEM. ONE OF THE WAYS IS TO GET THE FRUIT THAT HAS ITS SURFACE COMPROMISED WHERE YOU HAVE A HOLE IN A PIECE OF FRUIT, AND THEN THE OTHER ONE, OF COURSE, IS REMOVING THE POTENTIAL PATHOGEN FROM THE SURFACE EITHER BY WASHING AND SANITIZING THE FRUIT. I MENTIONED TWO SEPARATE THINGS, I MENTIONED WASHING AND SANITIZING. WASHING IS WHERE YOU REMOVE THE CONTAMINATE IN A PHYSICAL METHOD, EVEN THOUGH HERE WE ARE SHOWING CHEMICALS BEING SPRAYED ON THE FRUIT IN A BRUSH WASHER. EVEN MORE IMPORTANT THAN THE CHEMICALS IN THIS STEP IS THE DESIGN OF THE BRUSH BRISTLES AND THE WASHER PAD. THE BRISTLES SHOULD BE SLIGHTLY CURVED SO THAT THE FRUIT IS PUSHED ALONG IN THE WASHER BED RATHER THAN BEING STRAIGHT UP BRISTLES WHERE THE FRUIT WILL HAVE A TENDENCY TO RIDE ON THE SURFACE AND NOT BE COMPLETELY ROTATED.

         HERE IS THE SANITIZING STEPS, AND THIS IS WHERE THE MICROBES ARE KILLED BY EXPOSURE TO CHEMICALS. IN THIS PARTICULAR DESIGN WE HAVE 36 SPRAY NOZZLES AND AN EXPOSURE TIME OF 84 SECONDS. WHAT'S IMPORTANT IN THE CHEMICAL SANITIZING IS THE TYPE OF CHEMICAL USED, ITS CONCENTRATION, AND THE EXPOSURE TIME. THESE ARE THE THREE CRITICAL ELEMENTS. BUT I WOULD LIKE TO SAY NOW, THOUGH, THAT THERE ARE SEVERAL COMBINATIONS OF THESE THAT WILL RESULT IN A SUCCESSFUL INTERCEPTION, SO YOU ARE GOING TO HEAR VARIOUS PEOPLE SPEAK ABOUT WHAT THEY DO AND ALL OF THAT. BUT THERE ARE SEVERAL WAYS OF GETTING THERE.

         I KNOW WE HAVE SEEN A LOT OF PICTURES OF GRADING, BUT AT OUR PLANT, PRIOR TO GOING THROUGH THE EXTRACTOR, THERE IS ONE FINAL GRATE, AND WE ARE STILL WORKING ON THE COMPROMISING OF THE INTEGRITY OF THE FRUIT. THE FLORIDA DEPARTMENT OF CITRUS HAS A ZERO TOLERANCE RULE FOR FOOD GOING TO THE EXTRACTOR, A ZERO TOLERANCE RULE. AND IN OUR CALIFORNIA PLANT WE MADE THAT A PART OF OUR HACCP PLAN, TOO, A ZERO TOLERANCE. AND IN FLORIDA WE HAVE SEVERAL STEPS IN THE PROCESS. WE BRUSH WASH, GRATE, SANITIZE, BRUSH-WASH, GO THROUGH THE ZERO TOLERANCE CULLING, SANITIZE AND THEN POTABLE WATER RINSE BEFORE THE FOOD GOES INTO THE EXTRACTOR. IN CALIFORNIA, OUR FRUIT COMES TO US THAT'S ALREADY BEEN BRUSH-WASHED AND GRATED SO OUR FIRST STEP IN CALIFORNIA IS AN INSPECTION STEP. WE LOOK AT THE BINS OF THE INCOMING FRUIT, THEN WE GO THROUGH A SANITIZING STEP, A BRUSH-WASHING STEP, THE ZERO TOLERANCE CULLING, A SANITIZING STEP, AND THEN A POTABLE WATER RINSE.

         LET ME TALK A LITTLE BIT ABOUT THE KIND OF SANITIZERS THAT ARE AVAILABLE. IN FLORIDA, THE FLORIDA INDUSTRY PRETTY MUCH STARTED OUT ON USING ACID-BASED FRUIT WASHES. THEY HAVE BEEN USED IN FLORIDA FOR LIKE 40 OR 50 YEARS. ALTHOUGH NONE OF THEM OR VERY FEW OF THEM ARE ACTUALLY REGISTERED WITH THE EPA AS SANITIZERS, THEY DO HAVE SOME SANITIZING EFFECT WHEREIN CALIFORNIA PRIMARILY EVERYONE WAS USING CHLORINE OR SOME CHLORINE-BASED COMPOUND. ONE OF THE THINGS THAT WE DID FIND IN FLORIDA AS WE WERE DEVELOPING OUR HACCP PLAN WAS THAT THE FLORIDA DEPARTMENT OF CITRUS HAS A RULE SURROUNDING USING A SANITIZER THAT'S EQUIVALENT TO 200 PARTS PER MILLION SODIUM HYDROCHLORIDE. WE FOUND IT REALLY DIFFICULT TO FIND A FRUIT WASH THAT WE COULD USE AT THAT LEVEL, AND SO THAT'S WHEN WE BROUGHT IN THE USE OF THE SANITIZER ALSO. AND THIS IS LIKE WORKING THREE OR FOUR YEARS AGO AND THE KIND OF KNOWLEDGE THAT WAS GAINED OUT OF THAT BY BRINGING IN A TRUE SANITIZER WAS THAT WE REDUCED OUR TOTAL PLATE COUNTS, SAW AN EXTENSION OF SHELF LIFE, ALL OUT OF BRINGING IN A SANITIZER.

         LET'S TALK A LITTLE BIT ABOUT OZONE. WE DID SOME TESTING IN FLORIDA USING OZONE. THEY WERE VERY SIMPLE TESTS. WE USED A SWIMMING POOL OZONE GENERATOR TO DO OUR OZONE TEST WITH. WE FOUND OZONE LEVELS AT LIKE .5 PARTS PER MILLION WITH AN EXPOSURE TIME OF 30 SECONDS. WE COULD GET ABOUT A 1.08-LOG REDUCTION. BUT EXTENSIVE WORK IS GOING ON AT CAL POLY BY A DR. JOSEPH MONTECAFO (PHONETIC) CONCERNING THE USE OF OXIDIZED WATER, AND HE'S FOUND LOG REDUCTIONS IN 0157:H7 AND SALMONELLA IS 4- AND 5-LOG REDUCTIONS HAVE BEEN APPROACHED WITH 1.0 TO 1.3 PARTS PER MILLION OZONE AND EXPOSURE TIMES OF 30 SECONDS. MOST OF THE SANITIZERS ARE OXIDIZED AGENTS, AND THEIR EFFICIENCY AS A SANITIZER IS DEPENDENT UPON THEIR STRENGTH AS AN OXIDIZER. AND SO YOU MIGHT BE ABLE TO USE ONE PART PER MILLION OZONE TO GET THE SAME EFFECT AS MAYBE 2.6 OR SO PARTS PER MILLION OF CHLORINE DIOXIDE, RESIDUAL CHLORINE DIOXIDE, WHICH WOULD BE EQUIVALENT TO ABOUT 200 PARTS PER MILLION CHLORINE OR MAYBE 300 PARTS PER MILLION PEROXYACETIC ACID. WE ARE CONCERNED THAT BOTH OF OUR PLANTS SURROUNDING THE USE OF SANITIZERS AND MANUFACTURING CERTIFIED ORGANIC PRODUCTS, PROBLEM CAME UP WITH THE ACID-FREE WASHES. MOST OF THE ACID-FREE WASHES ARE PHOSPHORIC ACID-BASED. THERE ARE SOME THAT ARE CITRIC-ACID BASED. THE REST OF THE FOUR CHEMICALS THAT ARE LISTED THERE WERE ALL APPROVED FOR USE BY QAI AND MOST OTHER ORGANIC-CERTIFYING GROUPS.

         LET'S SORT OF CHANGE SUBJECTS NOW AND TALK A LITTLE BIT ABOUT THE ETA AND FDA APPROVAL OF SANITIZERS. THE FOOD QUALITY PROTECTION ACT OF 1996 REDEFINED THE WORD PESTICIDE CHEMICAL TO ADD ANTIMICROBIAL AGENTS. AND AT THE TIME THEY PUT THE JURISDICTION FOR THESE MATERIALS UNDER THE EPA ON THE USE ON RAW AGRICULTURAL COMMODITIES, AND THIS IS THE DEFINITION THAT WAS GIVEN FOR A RAW AGRICULTURAL COMMODITY: A RAW AGRICULTURAL COMMODITY IS ANY FOOD IN ITS RAW OR NATURAL STATE, YOU CAN WASH THE FOOD OR COLOR IT OR OTHERWISE TREAT IT, BUT DON'T PEEL IT, AND IT IS PRIOR TO MARKETING. SO THAT IS THE DEFINITION THAT WAS GIVEN FOR A RAW AGRICULTURAL COMMODITY.

         ONE OF THE THINGS IS A BOX OF GIFT FRUIT. THAT WOULD BE A GOOD WAY TO THINK ABOUT IT, THE LAW AGRICULTURAL COMMODITY. IT IS GOING OFF TO THE MARKET THAT WAY. GO BACK TO THE PROCESSED FOOD. PROCESSED FOOD IS ANY OTHER FOOD OTHER THAN A RAW AGRICULTURAL COMMODITY THAT IS SUBJECT TO FURTHER PROCESSING, SUCH AS CANNING, COOKING, FREEZING, DEHYDRATION OR MILLING. AND THIS YEAR THEY CAME OUT WITH THE ANTIMICROBIAL REGULATION TECHNICAL CORRECTIONS ACT. IN THIS ACT THEY REMOVED FROM THIS ACT SUBSTANCES NO LONGER CONSIDER THEM AS PESTICIDE CHEMICAL SUBSTANCES THAT WERE GOING TO BE USED ON FOOD OR APPLIED TO THE WATER OR FOOD IN THE PREPARATION OR PACKAGING OR HOLDING OF FOODS FOR COMMERCIAL PURPOSES. SO NOW IT MOVES INTO THE ANTIMICROBIAL AGENTS USED ON FRUIT THAT ARE GOING TO BE JUICED. THEY SORT OF SLIDE OUT OF THIS RAW AGRICULTURAL COMMODITY CLASSIFICATION AND MOVE DOWN INTO THE PROCESSED FOODS CATEGORY. AND SO THEN THEIR USE NOW BECOMES REGULATED BY THE FDA AS A FOOD ADDITIVE. AND ONE OF THE ONES THAT THIS REALLY AFFECTED WAS CHLORINE DIOXIDE. CHLORINE DIOXIDE PREVIOUSLY TO THIS ACT HAD BEEN APPROVED AS A FOOD ADDITIVE BY THE FDA FOR NON-RAW AGRICULTURAL COMMODITIES, AND NO TOLERANCE LIMIT FOR IT IS SET BY THE EPA. SO WITH THIS ACT GOING INTO PLACE, IT NOW BRINGS THIS INTO THE JURISDICTION OF THE FDA.

         ONE OF THE THINGS, IN SUMMARY, ON WORKING WITH SANITIZERS, YOU NEED TO TALK TO YOUR CHEMICAL SUPPLIER, YOU NEED TO READ THE LABELS CLOSELY TO BE SURE THAT YOUR APPLICATION IS COVERED WHEN YOU ARE SELECTING A SANITIZER. IT WOULD BE A SHAME THAT YOU GO THROUGH ALL THE WORK DOING A 5-LOG VALIDATION STUDY AND THEN FIND OUT YOU DON'T HAVE APPROVAL OF THE CHEMICAL.

         THANK YOU.

        

(APPLAUSE.)

         DR. JOHN KVENBERG: THANK YOU, STEVE. I REALIZE THIS IS A LONG MORNING FOR EVERYONE TO SIT IN PLACE AND LISTEN TO A BUNCH OF FOLKS TALKING. WE HAVE ONE MORE SPEAKER, AND THIS IS GOING TO BE ANOTHER IMPORTANT TALK ON SANITIZER SYSTEMS. WHAT I PROPOSE WE DO THEN, WE BREAK THEN AND THINK ABOUT QUESTIONS YOU HAVE THEN FOR THE SPEAKERS. AND WHEN WE RECONVENE AFTER THE BREAK, WE'LL ENTERTAIN QUESTIONS BEFORE WE GET INTO THE NEXT SESSION. SO LAST SPEAKER BEFORE THE BREAK, NOT TO PUT THE PRESSURE ON YOU, LINDA, IS LINDA FRELKA, WHO IS GOING TO TALK TO US ABOUT SANITIZER SYSTEMS AND THE EXPERIENCES WITH ODWALLA.

         LINDA?

         MS. LINDA FRELKA: WHAT AN HONOR TO BE THE ONE WHO GETS TO SPEAK RIGHT BEFORE BREAK. I AM GOING TO TALK TO YOU TODAY A LITTLE BIT ABOUT THE SPECIFIC SYSTEM OF FRUIT SANITIZING THAT ODWALLA USES, AND THIS IS REALLY AN IMPORTANT PROPERTY OF OUR PROCESS BECAUSE IT IS TWO OF OUR CRITICAL CONTROL POINTS OF OUR HACCP PLAN. WHEN OUR HACCP TEAM FIRST STARTED TO EXPLORE THE WORLD OF CHLORINATION, BIG PROBLEM, AN OXIDATION REDUCTION POTENTIAL, OR ORP AS IT IS COMMONLY HEARD OF, WAS REALLY NECESSARY. BEYOND THAT, IT WAS REALLY EXTREMELY IMPORTANT FOR US TO LEARN HOW TO AUTOMATE THIS SYSTEM. IT WAS CRITICAL FOR US TO HAVE SOMETHING THAT WAS AS CONTINUOUS AS POSSIBLE AND COULD PROVIDE US WITH A PERMANENT RECORD OF WHAT WAS GOING ON. SO WE'LL TALK A BIT ABOUT ORP.

         YOU ARE ACTUALLY GOING TO GET A COUPLE OF CHEMISTRY LESSONS TODAY. ORP INVOLVED TWO CHEMICAL REACTIONS, OXIDATION AND REDUCTION, HENCE ITS NAME. THESE REDUCTION ACTIONS ALWAYS OCCUR TOGETHER. THE TERM OXIDATION IS REFERRED TO ANY CHEMICAL ACTION IN WHICH ELECTRONS ARE TRANSFERRED BETWEEN ATOMS. ELECTRONS I AM SURE WE ARE ALL FAMILIAR WITH. THE ATOM WHICH LOSES AN ELECTRON IS SAID TO BE OXIDIZED. THE ATOM WHICH GAINS AN ELECTRON IS SAID TO BE REDUCED, BECAUSE IN PICKING UP THAT EXTRA ELECTRON THE ATOM USES ELECTRICAL ENERGY WHICH MAKES IT ATTRACT OTHER ELECTRONS. SO WHY DO WE LIKE CHLORINE? CHLORINE IS A GREAT OXIDIZER, AS STEVEN MENTIONED. IT IS AN AGENT TO OXIDIZE OR STEAL ELECTRONS FROM OUR SUBSTANCES, LIKE BACTERIA, WHICH KILLS THEM. HEY, THAT'S WHY WE LIKE IT. IN THE ACTION OF OXIDIZATION, CHLORINE IS REDUCED, WHICH MEANS IT LOSES ITS ABILITY TO STEAL ELECTRONS AGAIN. SO IT IS IMPORTANT FOR CHLORINE SOLUTIONS TO REMAIN CHARGED WITH ENOUGH OXIDIZING CAPABLE FOR FREE CHLORINE.

         I AM GOING TO TALK A LITTLE BIT BOTH ABOUT FREE AND TOTAL CHLORINE BECAUSE I THINK IT IS REALLY SOMETHING THAT WE HAVE TO UNDERSTAND THE DIFFERENCE OF AND I WILL GO INTO THAT A LITTLE MORE.

         OKAY WE HAVE ONE MORE LETTER, O, R AND NOW P, POTENTIAL. WHAT DOES THAT MEAN? REALLY THAT IS THE CAPABILITY OF THE SOLUTION TO BE ABLE TO -- IT SHOWS THE AMOUNT OF ELECTRICAL POTENTIAL AND WE MEASURE THAT IN MILLIVOLTS, WHICH WOULD BE AVAILABLE IF CALLED UPON. SO IT TELLS US WHAT'S THERE OR WHAT POTENTIALLY COULD BE THERE. WHEN IT IS PLACED, TINY ELECTRICAL CHARGES ARE GENERATED. AN ORP USED A MILLIVOLT METER MEASURING THE VOLTAGE ACROSS THE CIRCUIT FORMED BY THE REFERENCE ELECTRODE AND THE MOTHER ELECTRODE WITH THE OXIDIZING SOLUTION OR OUR CHLORINE SOLUTION IN-BETWEEN. THE ELECTRODES PROVIDE AWAY TO MONITOR THE EFFECTIVENESS OF THE OXIDIZING AGENT. GENERALLY IT MUST BE GREATER THAN SIX 50 MILLIVOLTS. ODWALLA HAS SET A MINIMAL CRITICAL LIMIT IN OUR SANITIZING LIMIT AT 700 MILLIVOLTS. THESE LIMITS ARE CHOSEN BECAUSE THEY HAVE BEEN PROVEN IN OUR SYSTEM OVER YEARS WORTH OF DATA TO PRODUCE ONE PART PER MILLION OF FREE CHLORINE AT ALL TIMES.

         THE OTHER CHEMICAL FACTOR WHICH REALLY AFFECTS HOW WELL AN OXIDIZER WORKS IS PH. THE HIGHER THE PH OR THE BASIC SOLUTION, THE LOWER THE MILLIVOLT READINGS OR LESS EFFECTIVE SANITIZING. LOWER MILLIVOLT READINGS, LESS EFFECTIVE. THE LOWER THE PH OR ACIDIC SOLUTION, THE HIGHER THE MILLIVOLT READINGS AND MORE EFFECTIVE SANITIZING. ALTHOUGH ORP READINGS ARE NOT DIRECTLY EQUIVALENT TO FREE CHLORINE READINGS, THERE IS A CORRELATION. BY KEEPING THE PH BELOW 6.8 WITH A MINIMUM OF 700 MILLIVOLTS, ODWALLA HAS SEEN GREAT RESULTS ON FREE LEVELS OF CHLORINE. IT IS IMPORTANT TO RECOGNIZE THE DIFFERENCE BETWEEN FREE, ALSO TERMED AVAILABLE CHLORINE, AND TOTAL CHLORINE, ALSO CALLED COMBINED CHLORINE.

         OKAY. ONE MORE CHEMISTRY LESSON. I NEED THE NEXT SLIDE PLEASE. SODIUM HYPOCHLORIDE, WE ALL KNOW WHAT THAT IS. WE PURCHASE 12 A HALF PERCENT SODIUM HYPOCHLORIDE AND WE ADDED IT TO WATER. THIS IS WHAT HAPPENS, IT CREATES SODIUM HYDROXIDE, WHICH HAS A VERY HIGH PH. WE USE THAT AS A BUFFERING SYSTEM AND IT ALSO MAKES HYPOCHLOROUS ACID. HYPOCHLOROUS ACID IS THE CHEMICAL WHICH IS CAUSING OUR KILLING ACTION. IF, HOWEVER, WE ALLOW THE PH TO CONTINUE TO GO UP WAY INTO THE IN THE SOLUTION, WE END UP WITH A FURTHER REACTION, HYPOCHLOROUS ACID BREAKS DOWN INTO HYDROGEN IONS AND HYPOCHLORIDE IONS. SOMETIMES YOU SEE THE CHEMICAL WRITTEN AS OCL MINUS, AND BOTH OF THOSE ITEMS ARE FREE CHLORINES, BOTH HYDROCHLORIDE IONS AND HYPOCHLORIDE ACID IS FREE CHLORINE, BUT IT IS HYPOCHLOROUS ACID -- I SHOULDN'T SAY ONLY, IT IS A MORE EFFECTIVE SANITIZER.

         I WOULD LIKE TO SHOW YOU THE NEXT SLIDE JUST AS A RELATIONSHIP TO -- YOU CAN SEE ON THE LEFT SIDE HYPOCHLOROUS ACID GOES FROM ZERO PERCENT UP TO 100 PERCENT, AND THE PH SCALE ON THE BOTTOM. SO YOU CAN SEE AT PH 5 YOU HAVE 100 PERCENT OF YOUR SOLUTION IS AVAILABLE AT HOCL, BUT AS YOU MOVE UP THE PH SCALE, YOU START TO PUSH THAT CHEMICAL REACTION INTO HYPOCHLORIDE IONS. SO IF YOU ARE NOT CONTROLLING THE PH OF YOUR CHLORINE SOLUTION, YOU ARE NOT NECESSARILY GETTING THE KILLING ACTION THAT YOU NEED. ODWALLA HAS CHOSEN TO PICK 6.8. YOU KNOW, WHEN I WORKED IN CHICAGO, OUR WATER WAS 7.0. PEOPLE IN FLORIDA, SOME OF THEM HAVE 9.0 AS THEIR WATER. SO REALLY DEPENDS ON WHERE OUR SOURCE OF WATER IS. SO AT 6.8, WE ARE TALKING ABOUT 80 PERCENT, AT THE BARE MINIMUM OF OUR SOLUTION WILL BE HOCL. SO THAT'S A CHOICE THAT YOU HAVE TO MAKE ON HOW MUCH CHEMICAL YOU ARE GOING TO PUT IN THERE TO KEEP THE PH AGENTS WHATEVER YOU WOULD LIKE. THAT'S A COMPLETELY INDEPENDENT CHOICE THAT YOU CAN MAKE. WE CHOSE 6.8.

         NOW, I EXPLAINED FREE CHLORINE, BUT WHAT'S TOTAL CHLORINE? SINCE CHLORINE IS SUCH A GREAT OXIDIZER, BINDS NOT ONLY TO WATER AS IN THE PREVIOUS REACTION, IT ALSO BINDS TO DIRT, LEAVES, ORANGES, WHATEVER ELSE IS IN THE SYSTEM. IF THE RECIRCULATING SYSTEM IS CHLORINATED AND BINDS -- THE CHLORINE BINDS TO ALL THE DIRT THAT HAPPENS TO BE ON THE FRUIT, THEN YOU ARE USING UP ALL OF YOUR CHLORINE. TOTAL CHLORINE IS THE SUM OF WHAT'S FREE AND WHAT'S BOUND, BOUND TO THE DIRT, BOUND TO THE BACTERIA, AND THEREFORE IT IS NOT USEFUL AT THAT TIME. SO IT IS REALLY IMPORTANT THAT WE LOOK AT CONCENTRATION OF FREE CHLORINE, NOT JUST TOTAL. YOU CAN HAVE 200 PARTS PER MILLION TOTAL, YOU WOULD THINK YOU ARE KILLING THAT STUFF ON YOUR FRUIT TO NO TOMORROW, BUT YOU MIGHT HAVE ZERO, NADA, FREE CHLORINE. IT IS THAT FREE CHLORINE THAT WE NEED, AND THE BEST WAY THAT I REMEMBER IT IS FREE, IT IS FREE TO PERFORM MORE KILLING ACTION FOR US. SO IF YOU ARE NOT MONITORING FREE CHLORINE, GO AFTER A TEST KIT TO DO IT. IT IS REALLY SIMPLE. YOU WILL NOTE EXACTLY WHAT'S GOING ON IN THE PROCESS.

         LEVELS OF FREE CHLORINE? WHAT ARE WE TALKING ABOUT? WE DON'T TALK ABOUT 200 PARTS PER MILLION FREE. ONE TO 10 PARTS PER MILLION ARE VERY EFFECTIVE. WE HAVE PUT INTO OUR HACCP PLAN THAT WE WON'T RUN ANY FOOD LESS THAN ONE PART PER MILLION. AND THAT'S WHERE WE DID OUR VALIDATION STUDIES WHICH HOPEFULLY WE'LL GET TO EXPLAIN LATER. ALL OF OUR SYSTEMS AT ODWALLA ARE ALL AUTOMATED. THE OXIDIZER INJECTS THE WATER TO KEEPS THE MILLIVOLTS AT THE CRITICAL LIMIT. PLUS, FOR THE PH BALANCE BELOW 6.8, THERE IS A SANITIZING SOLUTION WHICH ARE SET SLIGHTLY ABOVE 700 MILLIVOLTS, WHICH IS WHERE WE SET OUR CRITICAL LIMIT. WE DON'T WANT IT TO RUN DOWN TO 700 OR BE AT 699. WE HAVE AN HACCP DEVIATION AT THAT POINT, SO WE SET AN ALARM LIMIT WHERE WE HAVE A FLASHING BEACON GO OFF AT 750. SO THE LINE OPERATOR KNOWS, OKAY, I AM APPROACHING THIS LEVEL. I NEED TO SEE WHAT'S GOING ON. IF IT STARTS TO GET TO 725 OR 710, IT AUTOMATICALLY WILL STOP. ALL THE CONVEYER BELTS WILL STOP RUNNING AND THE SYSTEM WILL NOT TURN BACK ON. AND THE SYSTEM IS KEYED WHERE OUR MANAGER OR I ARE THE ONLY ONES WHO HAVE A KEY AND THE ONLY WAY TO OVERRIDE IT IS IN MANUAL MODE WITH OUR KEY. THIS IS THE WAY WE ENSURE WE DO NOT RUN FRUIT THAT HASN'T BEEN PROPERLY SANITIZED. SAME GOES FOR PH. IF THE PH JUMPS OVER 6.8, WE HAVE THE SAME TYPE OF SYSTEM.

         WELL, I THINK THAT'S ABOUT ALL I HAVE TO TELL YOU. I HOPE I HAVEN'T BORED YOU TOO MUCH WITH THE CHEMISTRY LESSONS FOR THE DAY, BUT ORP IS A REALLY NEAT WAY TO MONITOR AND MAKE SURE YOUR SYSTEMS ARE IN CONTROL AND I ENCOURAGE YOU TO TAKE A LOOK AT THAT. THANK YOU.

        

(APPLAUSE.)

         DR. JOHN KVENBERG: OKAY. AS I HAVE PROMISED YOU, HAVE BEEN A GOOD AUDIENCE AND THE KEY PART HERE IS AUDIENCE, BECAUSE YOU HAVEN'T HAD AN OPPORTUNITY TO ACTUALLY ENGAGE IN A DIALOGUE. AND I HOPE I AM MAKING THE RIGHT MOVE AND I HOPE I HAVE BACKING FOR IT RIGHT AT THAT POINT IN TIME. I THINK I DO. I WOULD URGE YOU IF WE TAKE A 15-MINUTE BREAK, AND IT IS NOT QUITE HALF PAST THE HOUR, THAT WE ARE BACK PROMPTLY AT A QUARTER TILL. THE SPEAKERS WILL BE AVAILABLE, OBVIOUSLY, DURING THE BREAK AT SOME POINT, AND WHEN WE COME BACK IN, I WOULD LIKE TO HAVE AN OPPORTUNITY FOR QUESTIONS, ANSWERS AND COMMENTS ON WHAT'S BEEN COVERED SO FAR.

         PLEASE REMEMBER WHAT WE SAID EARLIER, FOR THE CONVENIENCE OF THE TRANSCRIBER, IF YOU WOULD LIKE TO HAVE INFORMATION WHO YOU ARE.

         SEE YOU IN 15 MINUTES.

         (BREAK.)

         DR. JOHN KVENBERG: I WOULD LIKE TO THANK ALL OF THE SPEAKERS AS OF THIS MORNING FOR THEIR EXCELLENT PRESENTATIONS, AND, AS PROMISED, AS WE GET BACK INTO THE SCHEDULE BEFORE LUNCH AND OUR NEXT SESSION, THERE IS TIME FOR COMMENTS OR QUESTIONS AT THIS POINT FOR THE INFORMATION THAT WAS PROVIDED SO FAR. SO LET ME JUST LEAVE THE FLOOR OPEN TO ANYONE THAT WOULD ALIKE TO ADDRESS A QUESTION OR HAVE A COMMENT ON SUBJECTS THAT HAVE BEEN COVERED THIS MORNING. AND IF YOU DO, PLEASE SPEAK INTO THE MICROPHONE OR IDENTIFY YOURSELF SO THAT THE TRANSCRIBER WILL HAVE AN OPPORTUNITY TO SPEAK.

         IF YOU WILL COME TO THE MICROPHONE, PLEASE?

         DR. ABE TENZER: I WOULD LIKE TO COMMENT ABOUT THE DISCUSSION THAT LINDA MADE A VERY ILLUSTRIOUS WAY, DISCUSSED ABOUT THE IMPORTANCE OF ORP TO ENSURE SANITATION. WITHOUT THE HYDROCHLORIDE ACID, WE DO NOT HAVE SANITATION. AND FOR THE PAST SEVEN YEARS, MY COMPANY HAS DEVELOPED A PRODUCT CALLED CHLORINE POTENTIATE, OR THAT BINDS WITH A CERTAIN AMOUNT OF HYDROCHLORIDE ACID OR STABILIZES IT AND INCREASES THE ABILITY OF THE HYPOCHLOROUS ACID TO BE PREVALENT IN A PH RANGE BETWEEN SIX AND 10 RATHER THAN AT THE VERY, VERY LIMITED ACIDIC VALUE THAT SHE SHOWED US ON THAT CHART. AND THIS IS A VERY, VERY IMPORTANT ELEMENT ADDITIVE TO CHLORINE. AFTER ALL, YOU HAVE TO REMEMBER THE SANITATION IS AS EFFECTIVE AS THE ABILITIES OF THE SANITIZER TO KILL THE MICROORGANISMS, AND WE SHOULD DO THAT.

         THE SECOND THING IS THAT ORP IS DIRECTLY RELATED TO THE HOCL MINUS OR THE HYPOCHLOROUS ACID IN A RANGE OF UP TO 40 TO 50 PPM CHLORINE, AFTER THAT THERE IS NO REMUNERATION. AND I WILL BE VERY HAPPY TO EXPLAIN IT TO WHOEVER WANTS TO HEAR IT, AND I HAVE ABOUT FIVE PAGES OF MATHEMATICAL CALCULATIONS TO PROVE IT. IN ORDER TO GET 200 PPM OR EQUIVALENT OF 200 OR 300 PPM CHLORINE OR 100 PPM CHLORINE, YOU COULD NOT RELY ON THE ORP MEASUREMENTS AS SUCH. YOU NEED A SPECIAL SENSOR, OR ANY OTHER THING THAT MAY HAVE BEEN DEVELOPED. WE HAVE ONE IN OUR AUTOMATIC MACHINE THAT CONTROLS IT AND CHECKS IT EVERY FIVE SECONDS. AND ALSO, BECAUSE WE ARE USING A COMPUTER PROGRAM, WE'LL TAKE INTO CONSIDERATION THE CONCENTRATION OF CHLORINE AND THE PH AND THE CONTACT TIME, WHICH NOBODY MENTIONED HERE, AND IT IS VERY, VERY IMPORTANT. I HOPE TO HAVE AN OPPORTUNITY LATER ON TO DISCUSS IT, TOO. THANK YOU.

         DR. JOHN KVENBERG: THANK YOU VERY MUCH. WE, FOR ONE, WOULD BE INTERESTED IN YOUR INFORMATION. COULD YOU STATE, FOR MY BENEFIT, YOUR NAME AGAIN AND AFFILIATION?

         DR. ABE TENZER: MY NAME IS DR. ABE TENZER, T-E-N-Z-E-R. MY COMPANY IS BONAGRA (PHONETIC). AND WE HAVE OUT THERE A SMALL BROCHURE, VERY COLORFUL BROCHURE, THAT DESCRIBES OUR TECHNOLOGY. AND WE HAVE BEEN USING THIS TECHNOLOGY FOR THE PAST SEVEN YEARS, AND IT IS GAINING MORE AND MORE RECOGNITION BECAUSE IT DOES A VERY GOOD JOB IN INCREASING THE SANITATION CAPABILITIES.

         DR. JOHN KVENBERG: THANK YOU VERY MUCH.

         ADDITIONAL COMMENTS?

         MRS. GAIL TENZER: YES, MY NAME IS GAIL TENZER AND I AM NOT GOING TO ADDRESS THE SAME THING MY HUSBAND DID.

         I HAVE A NUMBER OF QUESTIONS -- FIRST OF ALL, I WAS VERY, VERY PLEASANTLY SURPRISED BY ALL OF THE FAVORABLE WORK THAT MR. MACAFFE WAS ABLE TO DO WITH THE EMPLOYEES AND WITH COMPLIANCE AND IN THE FIELDS. IT'S BEEN A LARGE PROBLEM AND A CONTRIBUTOR TO CROSS-CONTAMINATION PROBLEMS. ONE OF THE THINGS THAT I WANTED TO ASK, SINCE WE ARE HERE WITH THE REGULATORY AGENCIES, IS THE QUESTION OF THE CLEAN WATER RINSE AFTER USING THE SANITIZER. WE HAVE A PROBLEM WITH OUR WATER SUPPLIES, AND VERY OFTEN THAT SUPPOSED POTABLE WATER RINSE THAT WE ARE GOING TO DO AFTER SANITIZING MAY, IN FACT, BE RECONTAMINATING A PERFECTLY CLEAN PRODUCT, BECAUSE EPA CANNOT GUARANTEE THAT THE WATERS THAT ARE COMING THROUGH OUR WATER SUPPLIES ARE TOTALLY FREE OF CONTAMINATES. AND I THINK IT WAS IN MILWAUKEE WE HAD A PROBLEM WITH CRYPTOCRITIUM (PHONETIC) IN THE WATER. AND IT IS REALLY NOT FEASIBLE FOR EACH FARMER OR PACKING HOUSE TO GO AHEAD AND PUT THEIR OWN WATER TREATMENT PLANTS ON SITE. HAS FDA AND EPA THOUGHT OF WHAT WE SHOULD DO ABOUT THIS PROBLEM, BECAUSE THERE IS A CONCEIVABLE BREAKDOWN IN THE ENTIRE HACCP IF AFTER ALL OF THE CARE THAT WAS TAKEN WE THEN GO AND RECONTAMINATE A CLEAN PRODUCT WITH WATER THAT MAY BE CONTAMINATED.

         AND THE OTHER QUESTION THAT I HAVE IS THAT DR. LARRY BRUSHOT (PHONETIC) AT THE UNIVERSITY OF GEORGIA CENTER FOR FOOD SAFETY AND QUALITY ENHANCEMENT IS NOW WORKING WITH LEVELS OF CHLORINE OF 2,000 AND 4,000 PPH, AND I BELIEVE THAT ONE POINT IN THE ALFALFA SPROUTS, EVEN 2,000 PPM CHLORINE WAS NOT WORKING. SO I WANTED TO FIND OUT ABOUT THE HIGHER LEVEL USES OF CHLORINE IN LIGHT OF THE PERILS THAT WE ARE DEALING WITH THESE ORGANISMS. THANK YOU.

         DR. JOHN KVENBERG: THANK YOU. AGAIN, MY FIRST REACTION WOULD BE TO CALL ON OTHERS, BUT I WILL TAKE A SHOT ON THE INITIAL FIRST QUESTION OR COMMENT THAT YOU PUT OUT RELATIVE TO THE QUALITY OF THE WATER ON POTABLE WATER RINSES. THIS IS OBVIOUSLY SOMETHING THE AGENCY IS AWARE OF, OR HAS ADDRESSED IN GENERAL TERMS THE IDEA OF GOOD AGRICULTURAL PRACTICES, GOOD MANUFACTURING PRACTICES, AND AN OVERALL VIEW THAT THIS IS AN AREA THAT COULD BE CRITICAL TO DEVELOPING RECONTAMINATION OF THE WATER SUPPLY SYSTEM OF THE PRODUCTS. AND MY PERSONAL VIEW, IT COMES TO THE CONTEXT OF BASICALLY COMING UP WITH WAYS OF LOOKING AT DIFFERENT WATER SYSTEMS TO ASSURE THAT THE WATER QUALITY IS NOT MAKING THE PRODUCT WORSE, WHETHER IT HAS TO BE -- IT IS A GOVERNMENT RESPONSIBILITY OR INDIVIDUAL INDUSTRY'S RESPONSIBILITY, SOMETHING THAT DEFINITELY HAS TO BE TAKEN INTO ACCOUNT IN ORDER TO PROVIDE A SITUATION THAT WILL ASSURE YOU ARE NOT RECONTAMINATING THE PRODUCT. RELATIVE TO THE HIGHER LEVELS OF CHLORINE, I DON'T KNOW IF WE HAVE TECHNICAL EXPERTISE TO TALK ABOUT THE ACTUAL LEVELS. BUT I DO KNOW HERE IN CALIFORNIA THE NUMBER HAS ACTUALLY GONE TO AN EPA APPROVAL OF 20,000 OR TWO PERCENT.

         MS. GAIL TENZER: HOW ABOUT THE PRODUCE? HOW MUCH IS THE LIMIT?

         DR. JOHN KVENBERG: I DON'T HAVE ANY INFORMATION ON THE LEVEL OF CHLORINE TO THE PRODUCTS. DOES ANYONE HAVE AN ANSWER TO THIS QUESTION?

         MS. GAIL TENZER: NOT GENERAL -- JUST GENERALLY.

         DR. JOHN KVENBERG: I GUESS THAT'S SOMETHING I COULD GET BACK WITH YOU. I DON'T HAVE THE INFORMATION.

         MR. MARK DAWSON: I COULD ATTEMPT TO ANSWER THE QUESTION.

         DR. JOHN KVENBERG: COULD YOU GET CLOSE TO THE MICROPHONE?

         MR. MARK DAWSON: MY NAME IS MARK DAWSON. I WORK FOR ALFALFA CORPORATION AND WE ARE IN MONROVIA, CALIFORNIA. OUR BUSINESS IS THE SANITATION AND TREATMENT PROCESSING OF FRESH FRUITS AND VEGETABLES. WHEN I SAY FRESH, THE APPLICATION THAT YOU INQUIRED ABOUT WITH THE CHLORINE ACTUALLY FALLS UNDER PESTICIDE REGULATION SCENARIO EPA AND THE LIMIT THAT IS ALLOWED IS COMBINED BY EACH INDIVIDUAL PESTICIDE LABEL. SO I DOUBT IF THERE ISN'T ANOTHER POLICY TO THE TOTAL CONCENTRATION, ACTUAL CONCENTRATION LEVEL.

         DR. JOHN KVENBERG: I THINK THE ANSWER WAS IS IT SPECIFIC TO THE AGRICULTURAL COMMODITY THAT THE EPA REGULATES.

         MR. MARK DAWSON: CLOSE ENOUGH.

         DR. JOHN KVENBERG: SO OBVIOUSLY THAT IS A POINT THAT I WANT PEOPLE TO UNDERSTAND HERE THAT THERE IS A JOINT JURISDICTIONAL QUESTION WHEN IT COMES TO PESTICIDE SANITIZERS THAT INVOLVES THE EPA. AND I THINK, AS SAID BY STEVE HUNTER EARLIER, LABELED INFORMATION IN DEALING WITH THE CHEMICAL ROUTES THAT ARE SUPPLYING THE STUFF FOR THE BEST ANSWER TO THE SPECIFIC SITUATION. BECAUSE WHAT YOU DON'T WANT TO DO IN A SITUATION ATTEMPTING TO ESTABLISH PERFORMANCE STANDARD IS USE A WRONG CHEMICAL THAT'S NOT REGISTERED OR AN INCORRECT LEVEL THAT DOESN'T HELP THE SITUATION.

         ARE THERE OTHER COMMENTS BEFORE WE GO TO --

         MR. STEVE LOPES (PHONETIC): YES, I WOULD LIKE TO.

         DR. JOHN KVENBERG: THERE IS A MIKE BEHIND YOU.

         MR. STEVE LOPES: WELL, MAYBE EVERYBODY CAN HEAR ME. STEVE LOPES. I AM WITH SIM SEPARATION, INC. AND WHAT WE HAVE IS A SYSTEM THAT WE HAVE BEEN WORKING WITH FOR FIVE YEARS, BASICALLY LINDA TOUCHED ON IT, WITH SODIUM HYDROCHLORIDE, YOU KNOW HOW YOU ARE ADDING A CHEMICAL, BASICALLY, AND YOU ARE ALSO STRIPPING AWAY ELECTRONS FROM THE FLUID. WE STRIP AWAY ELECTRONS, BUT WE DON'T ADD CHEMICALS. WE EFFECTIVELY BREAK THE CYCLE AND BASICALLY ROB THE BACTERIA OF THEIR NERVOUS SYSTEM, IF YOU WILL, AND IT KILLS THEM. WE FOUND THAT THIS IS WORKING EFFECTIVELY IN APPLICATIONS, FOR INSTANCE, ON AN IRRIGATION SYSTEM UP IN NORTHERN CALIFORNIA IN MARYSVILLE. WE BASICALLY WERE THROWING 1,000 GALLONS A MINUTE OF WATER TO A DRIP IRRIGATION SYSTEM, AND WE FOUND THAT, AS A RESULT OF USING THE SYSTEM, OF COURSE WE HAVE REDUCED THE BACTERIA AND ALGAE IN THE CHLORINE WATER. WE HAVE HAD ONE MILLION UNITS OF BACTERIA GO INTO THE SYSTEM, FIVE FEET LATER WE COME UP WITH LESS THAN ONE LIVE BACTERIA. WE ALSO NOTICE THAT AN EFFECT THAT IT HAD, AND OF COURSE THROUGH TESTING WE ALWAYS DISCOVER THINGS, WE ALSO KNOW THAT THE WATER -- WE WENT TO THE PLANTS AND WE FIGURED THAT THE WATER IS -- WATER BASICALLY IS GOING TO BE UP TO THE PLANTS TO GO FASTER AND CONSEQUENTLY THE THERMAL BARRIER IN THE LEAVES OF THE PLANTS COULDN'T HANDLE THE HEAT, HEATING WOULD NOT TRANSFER AS QUICKLY OR AS WELL TO THE BOTTOM OF THE LEAF. WE CONSISTENTLY TOOK TESTS AND FOUND THAT TREATED PLANTS OVER 250 ACRES OF PROCESSED WATER VERSUS 250 ACRES OF UNPROCESSED PLANTS OR WATER GOING INTO THE PLANTS, WE FOUND CONSISTENTLY THAT THERE WAS A 10 DEGREE DIFFERENCE IN THE TEMPERATURE ON TOP OF THE PLANT AND TEMPERATURE BELOW THE PLANT VERSUS THE OTHER PLANTS THAT ONLY HAD A ONE- AND TWO-DEGREE DIFFERENCE. CONSEQUENTLY, WE DETERMINED THAT POTENTIAL WAS YOU WOULDN'T HAVE TO PRUNE, AND SO WE DIDN'T, IN FACT, PRUNE THESE PLANTS. IT WAS THE FIRST YEAR IN DOING KIWIS, HE INCREASED HIS CROP BY TWO-THIRDS, AND SO THAT WAS PRETTY SIGNIFICANT. NOW, AS FAR AS THE WATER GOES, PRESENTLY WE TREAT WATER AND WE KILL ALL THE BACTERIA IN THE FLOWING WATER WHERE WE HAVE TWO LOCATIONS NOW WHERE WE ARE WORKING WITH JUICE AND WE HAVE BEEN ABLE TO GET IN SOME CASES 100 PERCENT KILL ON THE FLUID AND OTHER CASES 50 PERCENT. LIKE I AM SAYING, IT IS NOT MAGIC, STRIPPING AWAY ELECTRONS AND ROT THEM INTO THE GROUND. IN ONE CASE WE HAD TO RUN A RATHER LONG GROUND CABLE AND WE HAD TO PUSH THOSE ELECTRONS. BUT IF ANYBODY HAS ANY QUESTIONS, I WOULD BE MORE THAN HAPPY TO ANSWER THEM FOR YOU. WE HAVE ALL THE TEST DATA THAT PROVES WHAT WE ARE SAYING. WE ARE WORKING WITH THE WATER DISTRICT NOW, AND IF I CAN ANSWER YOUR QUESTIONS, I WOULD BE MORE THAN HAPPY TO.

         DR. JOHN KVENBERG: THANK YOU VERY MUCH. AND WE WOULD LIKE TO HAVE THE INFORMATION YOU SPOKE ABOUT OURSELVES.

         IF THERE ARE NO OTHER QUESTIONS, I THINK THE PREVIOUS COMMENT WAS AN EXCELLENT SEGUE, IF I CAN USE THAT WORD, INTO THE SUBJECT OF NON-CHEMICAL TREATMENTS ON JUICE PRODUCTS. WE ARE FORTUNATE THIS MORNING BECAUSE OF HIS TRAVEL SCHEDULE TO HAVE DR. MOHAMED ISMAIL OF THE FLORIDA DEPARTMENT OF CITRUS WHO CAN BEGIN DISCUSSION ON THIS TOPIC.

         DR. ISMAIL?

         DR. MOHAMED ISMAIL: THANK YOU, DR. KVENBERG.

         LADIES AND GENTLEMEN, A WEEK AGO WE PARTICIPATED IN A SIMILAR TECHNICAL SESSION IN LAKELAND, FLORIDA, WHICH WAS ATTENDED BY OVER 150 PEOPLE. SOME OF YOU WERE THERE AND I AM SURE KNOW WHAT I AM TALKING ABOUT. I WAS VERY IMPOSED OR SURPRISED BY THE OVERWHELMING DESIRE OF THE PART OF THE INDUSTRY TO ACHIEVE THE 5-LOG REDUCTION IN MICRO-CONTAMINATION. I WAS ALSO VERY, VERY IMPRESSED BY THE FREE AND UNLIMITED EXCHANGE OF INFORMATION, INCLUDING SOME VERY, VERY EXPENSIVE STUDIES AND DATA THAT WAS GENERATED AT A VERY SUBSTANTIAL EXPENSE FOR SOME COMPANIES, DATA THAT COULD HAVE BEEN PROPRIETARY IN NATURE. IN PARTICULAR, I WOULD LIKE TO TAKE THIS OPPORTUNITY TO THANK THE COMPANY AND ALSO THE ORCHID ISLAND JUICE COMPANY FOR BEING LEADERS IN TAKING THE INITIATIVE TO DO THE WORK AND TO ALSO SHARE THE DATA THAT THEY GENERATED WITH THE INDUSTRY AT LARGE.

         THE FLORIDA DEPARTMENT OF CITRUS IS AN AGENCY OF THE STATE OF FLORIDA. IT IS HEADQUARTERED IN LAKELAND, AND IT HAS A SUBSTANTIAL SCIENTIFIC RESEARCH DEPARTMENT, ABOUT 35 SCIENTISTS, TECHNICIANS. BUT IT IS HEADQUARTERED WITH THE UNIVERSITY OF FLORIDA AND THE CITRUS RESEARCH AND EDUCATION CENTER IN LAKELAND, FLORIDA, WHERE WE HAVE PERHAPS THE LARGEST GROUP OF SCIENTISTS WORKING ON CITRUS ANYWHERE IN THE WORLD. FOR OVER 50 YEARS THE FLORIDA DEPARTMENT OF CITRUS AND THE UNIVERSITY OF FLORIDA HAVE CONDUCTED RESEARCH ON ALL ASPECTS OF GROWING, PACKING AND PROCESSING CITRUS FRUIT. THE RESEARCH INCLUDED MICROBIOLOGICAL STUDIES OF PATHOGENIC OR NON-PATHOGENIC ORGANISMS THAT WERE IMPACTING THE QUALITY OF THE PRODUCTS. THESE EFFORTS WERE GREATLY INTENSIFIED DURING OUR WAR ON A PROJECT TO DEVELOP FRESH CUT CITRUS, FRESH CUT CITRUS FRUIT TECHNOLOGY TO DEVELOP READY-TO-EAT CONVENIENT FRESH CITRUS FRUIT. AND ALSO THE EFFORT WOULD INTENSIFY SHORTLY AFTER THE SALMONELLA FOOD POISONING INCIDENTS OF JUNE OF 1995 AT WALT DISNEY WORLD, WHICH WAS LATER TRACED TO FRESH, NON-PASTEURIZED, LATE-SEASON-PRODUCED ORANGE JUICE, AND THAT PLACE THAT PRODUCED THAT JUICE IS NO LONGER IN BUSINESS. I THINK THEY NEVER WENT BACK INTO BUSINESS AFTER THAT INCIDENT. TODAY I WILL TRY TO GIVE YOU A BRIEF INSIGHT AND AN OVERVIEW OF OUR STUDIES TO IMPROVE THE STUDY OF FRESH CITRUS AND FRESH CITRUS JUICE TO ACHIEVE A 5-LOG, 100,000-FOLD REDUCTION IN E.COLI AND ALSO USING, IN SOME CASES, BACILLUS. THESE STUDIES WERE CONDUCTED BY FOOD MICROBIOLOGIST DR. STEVEN PAO (PHONETIC), STUDIES OVER THE LAST SEVERAL YEARS INCLUDES PACKING HOUSE SURVEY, WHERE WE EXAMINED FRUIT AND FRUIT SURFACES FROM SEVEN COMMERCIAL PACKING HOUSES. AND I AM VERY PLEASED TO SAY THAT WE DID NOT FIND EITHER E.COLI 0157:H7 OR SALMONELLA IN ANY OF THESE PACKING HOUSE FOODS. WE ALSO STUDIED SANITIZERS AND THEIR AFFECT ON MICROBIAL CONTAMINATION, AND STUDIED THE EFFECT OF THERMAL TREATMENT ON MICROBIAL CONTAMINANTS. AND WE FINALLY DID SOME STUDIES VERY, VERY RECENTLY, AND PERHAPS SOME OF THEM WERE DONE AS RECENT AS YESTERDAY, OF SOME DIFFERENT MACHINES TO SEE WHAT IS THE EFFECT OF THE JUICE EXTRACTOR, THE EXTRACTION PROCESS ON THE MICROBIAL LOAD IN THE FRUIT AND IN THE FINAL PRODUCT, THE JUICE. I DO HAVE COPIES OF TWO OF THESE STUDIES; ONE HAS ALREADY BEEN PUBLISHED, THE OTHER ONE IS IN A DRAFT FORM AND IT IS ALREADY IN THE HANDS OF A GERMAN EDITOR, AND I BELIEVE IT IS GOING TO BE IN THE JOURNAL OF FOOD PRODUCTION ON THE ENHANCING MICROBIAL SAFETY OF FRESH ORANGE JUICE BY HOT WATER AND SANITIZERS.

         WHILE THE FRESH JUICE INDUSTRY IS VERY IMPORTANT TO FLORIDA CITRUS GROWERS AND 300 FRUIT SHIPPERS, AND THEY ARE ENGAGED USUALLY IN SELLING CITRUS FRUIT AND IN SELLING CITRUS JUICE, THE MAJORITY OF FLORIDA-PRODUCED ORANGE AND GRAPEFRUIT JUICES, WHICH IS ABOUT 99 PERCENT, ARE PASTEURIZED AS SINGLE STRENGTH ORANGE JUICE OR GRAPEFRUIT JUICE OR AS FROZEN CONCENTRATES. FOR THE NEXT FEW MINUTES, I WOULD LIKE TO SHARE WITH YOU SOME OF THE DATA GENERATED ON THE EFFECT OF THERMAL TREATMENT OF CITRUS FOOD PRIOR TO JUICE EXTRACTION IN HOPE OF ACHIEVING A SIGNIFICANT AND SUBSTANTIAL REDUCTION IN MICROBIAL CONTAMINATES. AS I MENTIONED, THE WORK WAS DONE BY DR. STEVEN PAO OF THE FLORIDA DEPARTMENT OF CITRUS AND BY HIS ASSISTANT, CRAIG DAVIS. THE WORK INVOLVED WASHING THE FRUIT AND INOCULATION WITH A VARIETY OF E.COLI. FOLLOWING THAT, THE FRUIT WAS ALLOWED TO AIR DRY PRIOR TO HOT WATER DIPPING, AND FOLLOWING THAT WE HAD MICROBIAL TESTING TO SEE, TO ASSIST THE IMPACT OF THE TREATMENT. OKAY. THIS SLIDE HERE SHOWS THE REDUCTION OF E.COLI IN VALENCIA ORANGES THAT WERE INOCULATED AND DIPPED IN 70 DEGREE CELSIUS, OR 158 DEGREE FAHRENHEIT, AND WE FIND THAT THE MAJORITY OF THE SURFACE IS TOTALLY STERILIZED AND A 5-LOG REDUCTION IS ACHIEVED IN TWO MINUTES. THERE IS ONE AREA ON THE SURFACE OF THE FRUIT WHERE THE ORGANISM MIGHT BE A LITTLE MORE PERSISTENT, AND THAT IS THE BOTTOM AREA WHERE THE STEM SCAR, AS WE CALL IT SOMETIMES, OR THE CALIX, AND THAT MIGHT TAKE A LITTLE BIT LONGER TO ACHIEVE THAT. BUT IT IS SO INSIGNIFICANTLY SMALL THAT THE OVERALL SURFACE REDUCTION IS STILL ACHIEVED IN ABOUT TWO MINUTES. IF WE USE HIGHER TEMPERATURE THAN 70 DEGREES CELSIUS, 158 DEGREE FAHRENHEIT, WE GET EVEN MUCH MORE EFFECTIVE ERADICATION BY ACHIEVING THAT 5-LOG REDUCTION. AS YOU CAN SEE ON THE Y AXIS HERE, THE NUMBER OF COLONY-FORMING UNITS IN A SQUARE CENTIMETERS IS ABOUT AT THE LEVEL OF ABOUT 5 AND A HALF LOG AND IT GOES DOWN TO HALF A LOG IN ABOUT ONE MINUTE. SO WE DO HAVE A SINGLE TREATMENT THAT CAN RESULT IN THAT TYPE OF ERADICATION. ONE MIGHT ASK THE EFFECT OF THAT TEMPERATURE ON THE FRUIT AND THE COMPONENTS OF THE FRUIT. AND AS YOU CAN SEE FROM THIS, FROM THE TOP LINE SHOWS THAT WHEN THE TEMPERATURE OF THE FRUIT IS AT ABOUT 172 DEGREE FAHRENHEIT, THE WATER -- WE SEE THAT THE SURFACE OF THE FRUIT IS HEATED, BUT WE DO NOT EXPERIENCE ANY SIGNIFICANT INCREASE IN THE TEMPERATURE OF THE PULP. THE PULP AT ONE CENTIMETER OR THREE CENTIMETERS DEPTH REMAINS IN A CONDITION THAT IS NOT APPROACHING OVER-HEATING OF THE FRUIT. SO THE FLAVEDO AND THE ALEVA (PHONETIC) TISSUE, OR THE RIND, AS WE CALL THEM COLLECTIVELY, ACT AS AN INSULATOR AS FAR AS THE INNER EDIBLE PORTION OF THE FRUIT. THAT IS ONE DISTINGUISHING FEATURE THAT PERHAPS SEPARATES CITRUS FROM OTHER COMMODITIES. YOU CAN'T COMPARE APPLES WITH ORANGES. I THINK WE CAN SAY WE CANNOT COMPARE ORANGES WITH APPLES. THE EFFECT OF THAT HEAT TREATMENT, WHETHER IT IS 158 OR 176 DEGREES FAHRENHEIT ON THE FLAVOR OF THE FRUIT OR THE JUICE EXTRACTED FROM THAT FRUIT IS MINIMAL. WE DID TASTE-PANEL EVALUATION, SENSORY EVALUATION, AND WE FOUND THAT REALLY THERE WAS NO SIGNIFICANT FLAVOR CHANGE IN THE JUICE ITSELF. IT WAS DONE DURING THE TRIANGLE TEST AND THE RESULTS INDICATED THAT NO SIGNIFICANT CHANGE IN THE SENSORY QUALITY OR ORGANIC QUALITY OF THE FRUIT OR THE JUICE.

         IN CONCLUSION, SURFACE MICROBIAL POPULATION CAN BE MINIMIZED BY HOT WATER TREATMENTS. AN ESTIMATED 5-LOG REDUCTION WAS ATTAINED BY IMMERSION AT 176 DEGREES FAHRENHEIT FOR ONE MINUTE OR 158 DEGREES FAHRENHEIT FOR TWO MINUTES. RAPID HOT WATER IMMERSION CAN KILL FRUIT SURFACE MICROBES WITHOUT ALTERING THE SENSORY QUALITY OF FRESH JUICE. AND RAPID HOT WATER IMMERSION CAN ENHANCE FRESH JUICE QUALITY, REDUCING INITIAL JUICE MICROBIAL LOADS, BECAUSE WHEN WE ARE KILLING THE ORGANISMS THAT MIGHT CAUSE ILLNESS, WE ARE ALSO ELIMINATING YEAST AND MOLD THAT ACTUALLY CAUSE DETERIORATION OF THE QUALITY IN THE FIRST PLACE. AND HOT WATER IMMERSION BY MODIFYING A SPRAY OR STEAM IS UNDER CONSIDERATION. THIS IS ON OUR PLATE TO STUDY THE EFFECT OF ON-LINE TREATMENT WITH STEAM OR A CONTINUOUS HOT WATER TREATMENT SYSTEM. I SEE SOME SIGNS WITHIN OUR INDUSTRY AND WITHIN OTHER STATES WHERE THIS TECHNOLOGY IS BEGINNING TO BE ADOPTED.

         THANK YOU VERY MUCH.

        

(APPLAUSE.)

         DR. JOHN KVENBERG: I WILL HAVE TO DO DOUBLE DUTY AND ALSO RUN THE LIGHTS AND MICROPHONE THIS MORNING.

         IN REGARDS TO RUNNING THE DOUBLE DUTY, MAY I AGAIN CALL ON MR. MARC ISAACS AT THIS TIME TO TALK ABOUT THE TECHNOLOGIES THAT YOU ARE DOING AT SUN ORCHARD.

         MARC?

         MR. MARC ISAACS: THANKS AGAIN, JOHN.

         I APPRECIATE THE OPPORTUNITY TO SHARE SUN ORCHARD PROCESS TO ENSURE PRODUCT SAFETY FOR YOUR CUSTOMERS AND HOW WE ACHIEVE THE 5-LOG REDUCTION IN OUR PRODUCTS. SUN ORCHARD IS A FRESH CITRUS JUICE MANUFACTURER OR DISTRIBUTOR WITH MANUFACTURING FACILITIES IN TEMPE, ARIZONA, AND CENTRAL CALIFORNIA. OVER THE LAST FEW YEARS, AS MANY JUICE COMPANIES HAVE DONE, WE HAVE TAKEN A FULL LOOK AT OUR ENTIRE SYSTEM AS IT RELATES TO PRODUCING A SAFE PRODUCT. IT IS -- IT'S BEEN A LONG PROCESS; IT'S BEEN ONE THAT IS EVER-CHANGING AND OBVIOUSLY THE FIRST STEP IN THE PROCESS IS TO MAKE SURE THAT YOUR PREREQUISITES ARE IN ORDER. WE REVIEWED AND UPGRADED ALL OF OUR STANDARD SANITATION OPERATING PROCEDURES, AS WELL AS OUR GMPS AND DOCUMENTED ALL OF THOSE PROCESSES WITHIN OUR FACILITIES. WE ALSO DEVELOPED AND IMPLEMENTED A HACCP PLAN. AND IN LOOKING AT THAT AS OTHER SPEAKERS HAVE SAID THIS MORNING, IT IS A LIVING DOCUMENT; IT IS A PROCESS THAT DOES CHANGE AND HAS TO BE ADJUSTED BASED ON CRITICAL CONTROL POINTS, CRITICAL LIMITS WITHIN THAT HACCP PLAN, AND CONTINUING TO BASICALLY EXPAND THE CAPABILITY OF THE HACCP PLAN.

         ONE OF THE ITEMS THAT WE, AS MANY PEOPLE I AM SURE, STARTED OUT, WE ASSUMED THAT THERE WERE MANY MORE CRITICAL CONTROL POINTS THAN THERE ACTUALLY ARE. AFTER SOME TECHNICAL ADVICE OUTSIDE OF OUR FACILITY, WE DID END UP NARROWING THE NUMBER OF CRITICAL CONTROL POINTS AND ADDRESSING SOME OF THE CRITICAL ITEMS AS GMPS OR SSOPS VERSUS CRITICAL CONTROL POINT. QUALITY ISSUES ARE OBVIOUSLY MORE ATUNED TO THE GMPS AND THE SSOPS WHERE CONTAMINATION POINTS WITHIN THE PROCESS NEED TO BE ADDRESSED THROUGH THE CRITICAL CONTROL POINT PROCESS. IN DETERMINING THE APPROPRIATE PROCESS TO ACHIEVE A 5-LOG REDUCTION, WE ANALYZED EACH STEP IN OUR PROCESS AND TRIED TO ISOLATE ONE OR TWO STEPS THAT WOULD HAVE THE MOST IMPACT ON PROVIDING A SAFE PRODUCT FOR OUR CUSTOMERS. THAT DOES NOT MEAN THAT THE -- THAT SOME OF THE STANDARD STEPS, SUCH AS GRADING, EXTRACTION, FRUIT WASHING, ETC., ARE TO BE EXCLUDED, BUT WHAT WE TRY TO FOCUS ON ARE A COUPLE OF STEPS THAT WOULD ADDRESS THE 5-LOG AS COMPLETELY AS POSSIBLE. THE TWO AREAS THAT WE LOOKED AT, AND I WANT TO THANK LINDA FOR DOING AN OUTSTANDING JOB OF OUTLINING OUR FIRST STEP IN THE PROCESS, AND THAT'S THE OXIDATION AND REDUCTION POTENTIATOR SYSTEM. THAT WAS ONE OF THE STEPS THAT WE HAVE ALSO USED TO A VERY BENEFICIAL RESULT AS WELL AS SURFACE HEAT TREATMENT PROCESS. IN REGARD TO THE CHLORINATION SYSTEM, THE APPLICATION, WHAT I LIKE TO INDICATE IS THAT THE SYSTEM THAT WAS DESCRIBED VERY WELL PREVIOUSLY BASICALLY STABILIZES THE WATER AND IT IS SUCH THAT THE CHLORINE APPLICATION IS VERY SPECIFIC AT THE TIME OF APPLICATION. WE ALSO USED SODIUM HYDROCHLORIDE, AND OUR CRITICAL LIMIT WAS SET AT A PH LEVEL OF SIX AND A HALF OR LOWER. AGAIN, I DON'T THINK IT IS -- EACH PROCESS IS DIFFERENT AND WHAT'S EFFECTIVE FOR EACH SYSTEM IS WHAT'S IMPORTANT. WE ALSO -- WE APPLY THE CHLORINE AT THE LEVEL OF 50 PARTS PER MIL FOR APPROXIMATELY 20 SECONDS. THE SURFACE HEAT TREATMENT IN OUR FACILITY WE DEVELOPED AND FABRICATED A STEAM TUNNEL AND IMPLEMENTED AND BASICALLY HEADED AN OPERATION AS OF THE FIRST OF NOVEMBER. IN ADDITION, WE VALIDATE BOTH OF THESE SYSTEMS BY AN OUTSIDE THIRD PARTY. THE STEAM TUNNEL IS RUN AT 190 DEGREES FAHRENHEIT. I HAVE INFORMATION FROM ANYWHERE FROM AN APPLICATION TIME OF 10 TO 60 SECONDS, AND AS DR. ISMAIL INDICATED, WE HAVE DONE TESTS THAT INDICATE THAT THE INTERIOR TEMPERATURES OF THE FRUIT IS BASICALLY UNAFFECTED. THERE WAS NO IMPACT AS WELL ON TASTE, AND THIS HAS BEEN PROVEN BOTH IN-HOUSE AS WELL AS OUTSIDE OF OUR FACILITIES.

         IN REGARD TO THE VALIDATION OF THE 5-LOG REDUCTION, WE DID HAVE AN INDEPENDENT WELL-KNOWN UNITED STATES FOOD SCIENCE DEPARTMENT DUPLICATE BOTH OF THESE PROCESSES WITHIN THEIR LABORATORY, AND WE USED E.COLI 0157:H7 AS OUR TARGET PATHOGEN.

         IN REGARD TO THE SANITIZER APPLICATION SYSTEM, BASED ON WHAT WE WERE DOING, THE 50 PARTS PER MIL WITH THE STABILIZATION OF THE PH AND A 20-SECOND APPLICATION TIME, WE BASED THAT ON 10 TEST RESULTS THAT GENERATED A 3-LOG REDUCTION IN OUR PROCESS. THE STEAM TUNNEL AND THE STEAM APPLICATION IS BASICALLY A STAINLESS STEEL COMPARTMENT THAT IS NOT NECESSARILY APPLYING STEAM TO EACH AND EVERY PIECE OF FRUIT, BUT ONCE IT ENTERS THE TUNNEL, THERE IS A TEMPERATURE OF 190 DEGREES THAT IS OUR CONTROL POINT, AND THE APPLICATION THAT WE USE IS 30 SECONDS. THE RESULTS OF THE VALIDATION OF THE STUDIES THAT WERE DONE OUTSIDE OF OUR FACILITY INDICATED THAT A 10 SECOND EXPOSURE WOULD GENERATE A 2-LOG REDUCTION, 20 SECONDS WOULD GENERATE 2.5-LOG REDUCTION, 30 SECONDS THAT WE INTRODUCE GENERATES A 3.7-LOG REDUCTION, 40 SECONDS WAS 4.-LOG REDUCTION, AND THEN BASED ON INOCULATION LEVEL OF ABOUT 7.6, AT 60 SECONDS, THE BACTERIA WAS 100 PERCENT. IT WAS THE FULL REDUCTION OF THE PATHOGEN. THEY WILL BE PUBLISHING THE RESULTS OF THESE TWO STUDIES IN JUNE OF 1999, AND OBVIOUSLY WHEN YOU ADD THE TWO IMPORTANT STEPS THAT WE TOOK TO THE OTHER VERY IMPORTANT STEPS IN THE PROCESS, WE ARE VERY COMFORTABLE THAT WE ARE WELL OVER THE 5-LOG REDUCTION. AND THAT WITH MANY OTHER ORGANIZATIONS, AS SOME OF YOU HAVE SEEN TODAY, AS WELL AS OTHERS CAN TAKE, USE THESE PROCESSES TO GENERATE A 5-LOG REDUCTION WITHIN THEIR OWN PRODUCTION.

         LAST AND FINAL COMMENTS, EDITORIAL COMMENTS I WOULD SAY, ONE IS I WOULD ENCOURAGE ALL JUICE PROCESSORS TO, IF YOU HAVEN'T ALREADY, IMMEDIATELY UPGRADE AND ENHANCE YOUR SSOP AND GMPS AND IMPLEMENT AS SOON AS POSSIBLE A HACCP PLAN. IT HAS BEEN VERY BENEFICIAL FOR OUR ORGANIZATION AND OBVIOUSLY, FROM AN INDUSTRY STANDPOINT, NONE OF US CAN AFFORD TO GO THROUGH ANOTHER OUTBREAK. IN ADDITION, ONE OF THE THINGS THAT I THINK WAS MENTIONED EARLIER IS THAT, YOU KNOW, THE FRESH JUICE INDUSTRY NEEDS TO BE MUCH MORE COHESIVE. THE COMPETITION, IT APPEARS, SHOULD BE IN THE MARKETPLACE. AND AS IT RELATES TO THIS, WE SHOULD WORK AS MUCH TOGETHER AS POSSIBLE TO ENHANCE THAT PROCESS AND MAKE IT AS QUICK AS POSSIBLE.

         LASTLY, I WOULD ENCOURAGE THE FDA TO DO TWO THINGS: ONE IS TO PROVIDE CERTAIN LEVELS OF GUIDELINES THAT WE CAN UNDERSTAND AS WE MOVE FORWARD; IN OTHER WORDS, WHAT IS AN ACCEPTABLE SURROGATE, WHAT IS THE TARGET PATHOGEN THAT WE NEED TO LOOK AT, WHAT KIND OF GENERIC COMMUNICATIONS CAN OCCUR SO THAT A CONSUMER KNOWS WHAT KIND OF PRODUCT THEY ARE DRINKING AND THERE ISN'T A GREAT DEAL OF CONFUSION BOTH AT THE MANUFACTURER LEVEL OR AT THE CONSUMER LEVEL.

         AND THE LAST ITEM IS THAT ONCE THERE IS A DECISION TO BE MADE AS TO WHAT ARE THE LEVELS AND EXPECTATIONS, INSPECT THE FACILITIES, MAKE SURE THEY ARE ADHERING TO THOSE LEVELS, AND IF NOT, TAKE QUICK ACTION TO CORRECT THE SITUATION. OBVIOUSLY, IT IS IN ALL OF OUR BEST INTEREST. WE HAVE ALL INCURRED A GREAT DEAL OF EXPENSE AND TIME TO FURTHER ENHANCE THE SAFETY WITHIN WHAT WE FELT WAS ALREADY A SAFE INDUSTRY. BUT IT IS IMPORTANT THAT WE GET SOME SUPPORT FROM THE STATE AND FEDERAL REGULATORS IN MAKING SURE THAT WHATEVER WE DO DECIDE COLLECTIVELY IS IMPLEMENTED. THANK YOU.

        

(APPLAUSE.)

         DR. JOHN KVENBERG: THANK YOU, MARC.

         WE'LL GET TO A POINT THIS AFTERNOON IN THESE LAST REMARKS THAT MARC MENTIONED WHERE WE WOULD LIKE TO HEAR FROM YOU RELATIVE TO WHERE WE GO WITH THE NEXT STEPS. AND SINCE WE HAVE A FEW MOMENTS NOW TO JUST SORT OF PREVIEW THAT, WITH REGARD TO WHAT'S GOING ON IN FLORIDA AND WHAT'S GOING ON HERE IN CALIFORNIA, COLLECTIVELY, I THINK IS A LARGE BODY OF KNOWLEDGE TO ADDRESS THE ISSUE OF SAFE PRODUCTION OF CITRUS JUICE IN AN EFFECTIVE WAY. AND I WOULD RESPOND, MARC, THAT WITH REGARD TO WHERE THE FDA IS AT ON THIS ISSUE IS WE ARE OPEN AND HOPE TO WORK WITH A DIALOGUE WITH THE INDUSTRY TO DEVELOP THE THINGS YOU MENTIONED RELATIVE TO PERFORMANCE STANDARD INFORMATION ADEQUATE CONSUMER ADVICE ON ISSUES. ALL OF THIS HAS TO BE BUILT AND HOPEFULLY IN SHORT ORDER. HASTE IS OF THE ESSENCE HERE IN THAT I PERSONALLY FEEL A LOT IS RIDING ON THE EXTENSION PERIOD THAT WE HAVE BETWEEN NOW AND JULY TO MOVE THAT AHEAD.

         LET'S THROW IT OPEN SHORTLY TO ANY QUESTIONS YOU MAY HAVE ON THE ISSUE OF NON-CHEMICAL TREATMENTS, BUT I NOTICED IN THE PROGRAM, AND I HAVE TO, I GUESS, MAKE A STATEMENT OF APOLOGY BECAUSE WE COULDN'T PUT TOGETHER ANOTHER ISSUE THAT BEARS ON THESE GENERAL TOPICS AND YOU HEARD BEFORE AND AFTER THE BREAK, AND THAT INCLUDES THE SUBJECT OF CITRUS THAT GOES THROUGH PACKING HOUSE OPERATIONS, THAT GOES THROUGH A WASH AND WAXING-BASED OPERATION. THAT'S NOT BEING SPOKEN TO HERE IN CALIFORNIA. IT WAS IN FLORIDA. AND I JUST WANT TO MAKE YOU AWARE THAT ADDITIONAL WORK IS GOING ON RELATIVE TO CONTRIBUTION OF THE DEVALUE IN CITRUS FRUIT THAT HAS GONE THROUGH PACKING HOUSE WAXING OPERATIONS BECAUSE THERE IS TECHNICAL DATA THAT IS BEING GENERATED IN FLORIDA ON THAT ISSUE AND IT WILL BE A CHALLENGE MORE IN CALIFORNIA AS WELL FOR THOSE SPECIFICALLY SMALL PROCESSORS OR IN-STORE RETAILER PROCESSORS THAT ARE EXTRACTING FRUITS. I THINK THIS MAY BE AN IMPORTANT ISSUE AS WE GO THROUGH A PERIOD TO TAKE INTO ACCOUNT BECAUSE THERE IS AN ADDITIONAL TREATMENT THAT GOES ON THAT TYPE OF PACKING HOUSE FRUIT THAT'S BEEN PREPARED FOR RETAIL SALE OF SUBSEQUENTLY DESIGNATED FOR JUICING THAT PRESENTS A DIFFERENT PROFILE AND STRAIGHT FRUIT THAT GOES THROUGH THE SYSTEMS. I JUST WANTED TO MENTION THAT FOR THE RECORD, AND WE'LL NOT BE TOTALLY COVERING IT HERE; HOWEVER, THERE WILL BE A TRANSCRIPT OF THE FLORIDA AND THE CALIFORNIA MEETINGS, AND WE PLAN TO PUT THE INFORMATION THAT COMES FROM THIS ONTO THE WEB. AND NOT TO GO ON ANY FURTHER ON THESE ISSUES, JUST TO SAY I HOPE THIS IS THE BEGINNING OF SOME CONTINUING DIALOGUE BETWEEN THE INDUSTRY AND THE GOVERNMENTS AT THE FEDERAL LEVEL AND THE STATES.

         ARE THERE ANY COMMENTS THAT FOLKS WOULD HAVE AT THIS TIME ON THE ISSUES?

         MRS. GAIL TENZER: I WOULD LIKE TO ASK DR. ISMAIL ON THE HEAT RAPID HEAT TREATMENT, IT'S MY UNDERSTORING SOME STUDIES HAVE BEEN DONE THAT IN A RAPID HEAT TREATMENT THERE MIGHT BE A SURVIVAL OF SOME PATHOGENS, AND THAT THOSE PATHOGENS THEN DEVELOP FURTHER HEAT RESISTANCE; THEY ARE MORE HEAT-RESISTENT THAN THE ORIGINAL PATHOGENS. AND WITH YOUR RAPID HEAT TREATMENT, IS THAT ENOUGH TO ELIMINATE ALL OF THE PATHOGENS?

         DR. MOHAMED ISMAIL: I AM NOT AWARE OF ANY STUDIES OR INFORMATION THAT WOULD SHOW THAT THERE ARE SOME SURVIVORS. WE CAN ACTUALLY ACHIEVE ALMOST TOTAL ERADICATION. AND IF THERE ARE ANY SURVIVORS, IT MIGHT BE IN THE TYPE OF YEAST AND MOLD MORE SO THAN OTHER PATHOGENIC OR MORE SO THAN PATHOGENIC MICROBES.

         DR. JOHN KVENBERG: I THINK THE PHENOMENA YOU ARE REFERRING TO, WE ARE TALKING ABOUT HEAT SHOCK PROTEINS BEING DEVELOPED IN RELATION TO THE --

         MRS. GAIL TENZER: SOME OF THEM HAVE DEVELOPED RESISTANCE AS A RESULT OF --

         DR. JOHN KVENBERG: COULD YOU PLEASE STATE YOUR NAME AGAIN?

         MRS. GAIL TENZER: GAIL TENZER WITH MICRO-TECHNOLOGY. AND ALL OF THE CONSTANT MONITORING THAT I DO ON FSNET AND PRONET AND NETSCAPE, I DO REMEMBER SEEING SOME ARTICLES WRITTEN CONCERNING PATHOGENS THAT DO SURVIVE A HEAT TREATMENT IN THAT WHEN THEY DO, THEY BECOME EVEN MORE HEAT-TOLERANT THAN THE ORIGINAL PATHOGENS. I WOULD HAVE TO LOOK THROUGH ALL OF MY PAPERS TO SEE WHERE I CAN FIND THAT REFERENCE, BUT IT CONCERNS ME ONLY BECAUSE IF YOU HAVE A LONG HEAT TREATMENT, THEN THE LIKELIHOOD OF THAT HAPPENING IS PROBABLY NIL. BUT WHEN YOU HAVE THE FLASH KIND OF PASTEURIZATION OR A RAPID HEAT TREATMENT, THEN THERE IS A POSSIBILITY OF A SURVIVAL OF AN ORGANISM WHICH HAS NOW MUTATED TO RESIST A HIGHER TEMPERATURE FOR A LONGER PERIOD OF TIME.

         DR. JOHN KVENBERG: THANK YOU.

         DR. WHITING, DO YOU HAVE A COMMENT IN REGARD TO THAT?

         DR. RICHARD WHITING: YES, A FEW COMMENTS. THERE ARE A COUPLE THINGS THAT CAN HAPPEN. I MEAN PASTEURIZATION IS BEING DONE IN A LOT OF OTHER FOODS, WE REALLY HAVEN'T SEEN THIS AS A PROBLEM WITH MILK OR SOME OF THESE. YEAH, IF YOU DO HAVE SOME IS YOUR SURVIVORS OUT OF A POPULATION, THOSE THAT SURVIVE ARE A LITTLE BIT MORE ON THE RESISTANT SIDE OF THE ORIGINAL POPULATION. BUT I DON'T THINK THIS REALLY WOULD BE A PROBLEM IN THIS CASE BECAUSE THESE ORGANISMS AREN'T GOING TO HAVE A CHANCE TO GROW AFTERWARDS. YOU CAN HAVE SOME HEAT ADAPTATION WHICH CAN OCCUR, BUT AGAIN THESE ORGANISMS ARE NOT GOING TO HAVE A CHANCE TO GROW IN APPLE JUICE OR ORANGE JUICE.

         BUT I THINK WHAT OTHER ASPECT, ANOTHER THING PEOPLE WHO ARE DOING THESE STUDIES SHOULD PERHAPS BE AWARE OF IS WHAT WE CALL INJURY. WE COULD HAVE A PASTEURIZATION TREATMENT LIKE THIS, YOU CAN KILL SOME OF THE ORGANISMS, BUT THERE ARE A FEW THAT WE CALL ARE INJURED, WHICH MEANS THEY DON'T GROW OUT ON SELECTIVE MEDIAS. AND OFTEN WHEN YOU DO THE STUDIES, YOU THINK THEY ARE DEAD, BUT THEY ARE NOT REALLY. BUT AGAIN, WITH A PRODUCT LIKE ORANGE JUICE, IF THEY ARE INJURED AND THEY ARE IN AN ACID PRODUCT, KEPT REFRIGERATED, THEY ARE PROBABLY GOING TO STAY INJURED, NOT LIKELY TO GROW AND BE A HAZARD. SO I THINK THESE ARE THINGS TO BE AWARE OF. I DON'T SEE THEM AS LIKELY TO CAUSE. I AM NOT AWARE OF ANY INFORMATION SAYING IN HEAT TREATMENTS AND CREATING A POPULATION OF PERSISTENT ORGANISMS. IT IS NOT THE SAME TYPE OF THING I WOULD SEE WITH ANTIBIOTICS.

         DR. JOHN KVENBERG: THANK YOU.

         ARE THERE ANY ADDITIONAL COMMENTS AT THIS TIME? IF NOT --

         DR. MOHAMED ISMAIL: I WANT TO ADD ONE COMMENT, PERHAPS IN SUPPORT OF WHAT YOU MENTIONED EARLIER, THAT IS PACKING HOUSE OPERATIONS HAVE BEEN SHOWN TO RESULT IN A 3.4-LOG REDUCTION IN MICROBIAL CONTAMINANT ON THE SURFACE OF THE FRUIT, BOTH IN NATURAL MICROFLORA AS WELL AS IN INOCULATION TESTS THAT WERE CONDUCTED AT LABELING. AND ONE OF THE MOST EFFECTIVE TREATMENTS WAS THE WAX APPLICATION BECAUSE OF THE ALKALINITY AND THE COMPOSITION OF THE WAX WE HAVE SEEN SIGNIFICANT REDUCTION IN E.COLI THAT WAS PUT ON THE SURFACE OF THE FRUIT AND ALSO THE WASHING OF THE FRUIT TO START WITH. SO WASHING, RINSING, AND WAXING, AND FOLLOWING THE WAX APPLICATION, USE OF THE DRYER, RESULT IN A 3.4 REDUCTION AND THAT'S DOCUMENTED IN THE COPY OF THE PAPER PUBLISHED IN THE JOURNAL OF THE FOOD PROTECTION THAT I GAVE YOU.

         DR. JOHN KVENBERG: THANK YOU. AND I THINK THAT MAY COME UP AGAIN THIS AFTERNOON WITH EXTRACTIONS. THANK YOU FOR RE-ENFORCING MY COMMENTS.

         AUDIENCE MEMBER: YES, ONE LAST COMMENT TO RESPOND AND THE FOLLOWING OF DR. ISMAIL'S COMMENT. I HAPPEN TO BE ONE OF THE VENDORS THAT SELLS THE PRODUCT