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FDA Technical Scientific Workshop On How Citrus Juice Firms Can Achieve 5-Log Pathogen Reduction -- November 19, 1998

<< Juice HACCP Main Page 

 

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 PRODUCTS THAT DR. ISMAIL WAS REFERRING TO. I WOULD JUST LIKE TO FOCUS BACK ON THE PREVIOUS SPEAKER'S COMMENTS WHERE HE ACTUALLY, IN PRACTICE, UTILIZED TWO BIOACTIVE PROCESSES, HEAT AND CHLORINE. COMING FROM THIS SIDE OF THE BUSINESS, I CAN REFER YOU ALSO TO TWO OR THREE OR EVEN FOUR SEQUENTIAL CHEMICAL PROCESSES. FOR EXAMPLE, THE USE OF THE CHLORINE. SO I THINK IT IS VERY IMPORTANT HERE IF YOU ARE THINKING ABOUT THE LONG-TERM EFFECTS OF THE PROGRAM AND THE DELETERIOUS AFFECTS OF CHANGING THE ACTION CHARACTERISTICS OF PROPAGATION THAT WE DEAL WITH THAT WE REMEMBER THE PRINCIPLES THAT COME FROM THE FARM INTEGRATED PEST MANAGEMENT. WE DON'T A RELY ON ONE CHEMICAL, ONE HEAT TREATMENT, ONE WHATEVER. BUT WE HAVE A SYSTEM, AND OUR RESULTS ARE AS EFFECTIVE AS THE SYSTEM.

DR. JOHN KVENBERG: THANK YOU.

MR. MARK MACAFFE: I JUST WANT TO ENCOURAGE EACH ONE OF THESE GROWERS TO GO INTO THE NO MAN'S LAND OF THE GROWERS ENVIRONMENT AND TRY TO ENCOURAGE THEM TO DO SOME THINGS OUT THERE, BECAUSE THERE ARE SOME REALLY NEAT THINGS THEY CAN'T APPRECIATE THAT REALLY ARE THE BEST FRIENDS RIGHT NOW AND WOULD REALLY IMPROVE WORKING CONDITIONS FOR THEIR LABORERS WHICH THEN HAS A WHOLE TRICKLE-DOWN EFFECT OF ECONOMICS, AND GET FURTHER ADDITIONAL LABOR AND SHORT LABOR ENVIRONMENT AND A WHOLE BUNCH OF OTHER THINGS WE HAVE DISCOVERED WHICH ARE REALLY, REALLY VALUABLE NOW FOR GROWERS, AND THE UPSHOT BEING IMPROVED SANITATION AND THE INCREASE EFFECTIVENESS OF THE STEPS WE ARE TALKING ABOUT TODAY. SO I REALLY WANT TO ENCOURAGE GROWERS TO NOT FEAR THIS AREA THAT HAS NOT BEEN WELL-ADDRESSED.

DR. JOHN KVENBERG: ANY ADDITIONAL COMMENTS BEFORE WE BREAK FOR LUNCH? I DON'T SEE ANY.

I HAVE ONE ANNOUNCEMENT, AND THIS IS MY LOST AND FOUND ANNOUNCEMENT. IF THERE IS SOMEBODY THAT IS MISSING A PEN WITH A PIECE OF PAPER ON IT, SEE ME.

WE ARE SCHEDULED TO RECONVENE AT 1:15, AT WHICH TIME I HOPE MR. CHUCK ORMAN FROM SUNKIST WILL BE AVAILABLE. HE SAID HE WAS TIED UP IN THE MORNING BUT WOULD BE ABLE TO BE WITH US THIS MORNING.

AND WE'LL BREAK NOW FOR LUNCH AND THANK YOU FOR THE MORNING.

(LUNCH BREAK.)

DR. JOHN KVENBERG: I WOULD LIKE TO THANK YOU FOLKS FOR KINDLY GETTING BACK BY QUARTER AFTER THE HOUR. BUT IN THE INTEREST OF CONTINUING OUR TIME SCHEDULE FOR THE AFTERNOON, I WOULD ASK YOU IF YOU WOULD TAKE YOUR SEATS AND RECONVENE AS PROMISED AT QUARTER AFTER THE HOUR. AS I MENTIONED IN THE MORNING, WE ARE SLIGHTLY OUT OF ORDER BECAUSE OF THE CONFLICT FOR MR. CHUCK ORMAN, BUT I THINK WHAT HE HAS TO SAY IS QUITE VITAL TO THIS WHOLE DISCUSSION OF CITRUS JUICE AND THE SAFETY OF IT. AND HE'S GOING TO ADDRESS US THIS AFTERNOON ON THE SUBJECT OF THE GROWING, HARVESTING AND PACKING HOUSE CONTROLS AS SEEN THROUGH THE EYES OF FOLKS HERE IN CALIFORNIA.

SO IF I COULD TURN THE PODIUM OVER TO YOU NOW, MR. ORMAN?

MR. CHUCK ORMAN: THANK YOU FOR THE OPPORTUNITY TO SPEAK TODAY. I AM GLAD TO BE HERE. I SEE A LOT OF FAMILIAR FACES IN THE AUDIENCE. I WILL JUST START WITH THE CALIFORNIA ARIZONA INDUSTRY HAS PROVIDED A WHOLESOME, NUTRITIOUS AND SAFE PRODUCT FOR CONSUMERS IN AMERICA AND ACROSS THE WORLD FOR OVER A HUNDRED YEARS. TODAY I WILL ADDRESS MICROBIAL CONTAMINATION PREVENTION PRACTICES WHICH ARE AND HAVE BEEN NORMAL AND COMMERCIAL METHODS FOR HANDLING FRESH CITRUS.

I THINK IT IS RELEVANT AT THIS TIME TO STRESS THAT CITRUS IN CALIFORNIA AND ARIZONA IS GROWN FOR THE FRESH MARKET. WE HAVE THE ADVANTAGE OF A CLIMATE WHICH ALLOWS US TO PRODUCE PERFECT CITRUS; PERFECT IN APPEARANCE AND FOR EATING OUT OF HAND. THE CITRUS FRUIT ITSELF IS WELL-DEFINED TO PREVENT CONTAMINATION OF THE EDIBLE PORTION. THE RIND PROTECTS THIS PORTION FREE FROM PATHOGENS AND AT THE SAME TIME PROTECTS IT FROM MICROBES THAT ARE OF CONCERN FROM THE STANDPOINT OF HUMAN HEALTH. ADDITIONALLY, THE NATURALLY-OCCURRED HIGH ACID ENVIRONMENT WITHIN THE FRUIT LIMITS THE GROWTH AND VIABILITY OF MOST MICROORGANISMS. SINCE WE PRODUCE FRUIT FOR THE FRESH MARKET, HENCE ALL OF THE PROCESS I WILL DISCUSS TODAY HAVE BEEN DEVELOPED OVER THE YEARS TO ENSURE THAT THE FRUIT REACHES THE MARKET WITHOUT DECAYING OR DEGRADING. I WILL TRY TO FOCUS MY POINTS ON THOSE IDENTIFIED IN THE HACCP PRINCIPLES.

CITRUS IS, OF COURSE, A TREE CROP. IN OUR CASE, AND IN OUR INDUSTRY, THE SKIRTS OF THE TREES ARE USUALLY PRUNED TO PREVENT CONTACT WITH THE GROUND. THIS IS DONE TO PREVENT PHYSICAL DAMAGE TO THE BOTTOM FRUIT, TO PREVENT CERTAIN TYPES OF DECAY, SUCH AS BROWN ROT, TO PREVENT CERTAIN PESTS SUCH AS ROSE BEETLE, WHICH IS CONSIDERED A QUARANTINE PEST BY SOME OF OUR TREATING PARTNERS, AND TO PREVENT DAMAGE TO THE PEEL, SUCH AS BY PESTS SUCH AS SNAILS. WELL WATER AND MUNICIPAL WATER COMPRISES ABOUT 80 PERCENT OF THE WATER WE USE. IRRIGATION IS DONE PREDOMINANTLY BY MICRO SPRINKLER OR BY DRIP IRRIGATION; AGAIN ABOUT 70 PERCENT IS DONE THAT WAY AS OPPOSED TO POSSIBLY 30 PERCENT THEN BY IRRIGATION BY CANALS OR OTHER SOURCES. IN OUR GROWING AREAS, WATER IS A VERY EXPENSIVE COMMODITY AND METHODS UTILIZED MOST EFFECTIVELY ARE RIGOROUSLY PURSUED, TENDS VERY MUCH TOWARDS HIGHLY DIRECTED WATER APPLICATION. MANURE IS RARELY USED, AND WHEN IT IS, IT IS ONLY AFTER HAVING BEEN TESTED OR TREATED TO ENSURE THAT NO PATHOGENS SURVIVE. STATE LAW REQUIRES THAT ALL WORKERS HAVE ADEQUATE TOILET FACILITIES AND HAND-WASHING FACILITIES; AND AGAIN, BY LAW, THEY BE GIVEN MANDATORY TRAINING ON SANITARY PRACTICES. WORKERS ARE ALSO PROHIBITED FROM PICKING FRUIT UP OFF THE GROUND TO GO INTO THE FRESH BINS. SINCE WE MARKET TO THE FRESH MARKET, ALL OF OUR CITRUS IS PICKED BY HAND. WORKERS ARE ISSUED CLEAN GLOVES AND TAUGHT HOW TO PICK USING CLIPPERS, TO CLEANLY SEPARATE THE FRUIT FROM THE STEM, NOT DAMAGING THE FRUIT. HANDLING OF FRUIT PICKING IS A CRITICAL STEP IN PREVENTING DECAY IN THE MARKETPLACE. FRUIT IS PLACED IN A BOTTOM LEVEL PICKING BAG, AND WHEN THAT BAG IS FULL, IT IS INSERTED GENTLY INTO A PLASTIC FIELD BIN. THERE ARE STILL A FEW WOODEN FIELD BINS OUT THERE, BUT MOST OF THEM ARE PLASTIC BINS. THESE BINS GO TO THE PACKING HOUSE, THEY ARE WASHED, SANITIZED AND SENT OUT TO THE FIELD. THEY ARE NOT USED IN THE PACKING HOUSE AT ALL. THE BINS ARE TRANSPORTED TO THE PACKING HOUSE AND THEY ARE AUTOMATICALLY DUMPED INTO EITHER A TANK CONTAINING CHLORINE OR ONTO A CONVEYER WHERE THEY ARE SPRAYED WITH FRESH WATER CONTAINING CHLORINE. AFTER DUMPING, WASHERS WEARING GLOVES REMOVE DECAYED OR DAMAGED FRUIT BEFORE THE FRUIT CAN CONTAMINATE THE REST OF THE LINES WITH MOLD EXPORTION. AFTER DECAYED FRUIT IS ELIMINATED, THE FRUIT WILL EITHER BE IMMERSED INTO A HEAT TANK CONTAINING ONE OF SEVERAL MATERIALS USED TO SANITIZE AND CLEAN THE FRUIT, OR IT WILL BE SPRAYED WITH A SANITIZING SOLUTION AND CLEANED AND THEN PROCEED OVER A BRUSH BED WITH CONTINUOUS BRUSHING TO REMOVE ANY FIELD DIRT. IN EITHER CASE, THE FRUIT WILL THEN BE RINSED WITH POTABLE WATER, WHICH IS USUALLY HEATED. IN THE CASE OF LEMONS, THE FRUIT COATING OF STORAGE WAX, WHICH TYPICALLY CONTAINS A FUNGICIDE WILL OPEN AND THEN PLACED BY A MACHINE INTO PLASTIC BOXES PRIOR TO STORAGE. LEMONS ARE TYPICALLY STORED AT 50 TO 55 DEGREES FAHRENHEIT FOR ONE WEEK TO THREE MONTHS, DEPENDING ON COLOR AND THE MARKET. CITRUS OTHER THAN LEMONS WILL NEXT RECEIVE A COATING OF PACK WAX WITH FUNGICIDES, SUCH AS OPD. BY THE WAY, WHEN I REFER TO WAX, I ACTUALLY MEAN A COATING WHICH IS USUALLY COMPRISED OF A RESIN, SORT OF A WOOD RESIN OR OTHER COMPOUND INTENDED TO REPLACE THE NATURAL WAX THAT HAS BEEN REMOVED DURING THE WASHING AND SANITIZING AND SCRUBBING OPERATIONS. THIS COATING PRESERVES THE WATER IN THE FRUIT, DOESN'T ALLOW THE FRUIT TO DEHYDRATE ON THE WAY TO MARKETPLACE AND PROTECTS IT FROM PATHOGENS. LEMONS COMING OUT OF STORAGE ARE AUTOMATICALLY DUMPED ONTO THE CONVEYER BELT WHERE THEY RECEIVED A HEAVY RINSE OF POTABLE WATER CONTAINING CHLORINE. GRATERS THEN REMOVE ANY DECAYED OR DAMAGED FRUIT AND ALSO FRUIT WAS SUITABLE ONLY FOR JUICE PLANTS. THEN THEY GO TO WHERE A SANITIZER AND CLEANING COMPOUND IS APPLIED AND THE FRUIT IS THOROUGHLY CLEANED FOLLOWED BY A RINSE WITH POTABLE WATER, AGAIN USUALLY HEATED. THE FRUIT IS COATED WITH A PACK WAX CONTAINING ONE OR TWO FUNGICIDES AS MENTIONED EARLIER IN THE CASES OF ORANGES AND GRAPEFRUIT. WELL OVER 50 PERCENT OF THE ORANGE AND GRAPEFRUIT PACKING HOUSES NOW USE AUTOMATIC PACKING MACHINES WHICH PLACE THE FRUIT IN THE CARDBOARD SHIPPING BOX. THE SHIPPING BOXES ARE BOUGHT NEW FROM THE MANUFACTURER, AND STORED IN CLEAN LOCATION. AGAIN, THE PURPOSE IS NOT NECESSARILY TO PREVENT FROM HUMAN PATHOGENS, BUT TO PRESERVE THE BOXES SO THAT THEY LOOK GOOD IN THE MARKETPLACE AND THEY HOLD THE FRUIT WITHOUT BREAKING DOWN IN TRANSIT. LEMONS, WHICH COMPRISE ABOUT 23 PERCENT OF OUR FRESH CITRUS VOLUME, ARE ALWAYS PLACED INTO SHIPPING BOXES BY MACHINE AND THEY ARE PACKED ACCORDING TO COUNT. TYPICALLY, THE ONLY TIME THE FRUIT IS POTENTIALLY TOUCHED BY HUMANS IN THE PACKING HOUSE IS AT THE INITIAL GRATE AND AT THE FINAL GRATE. MANY PACKING HOUSES HAVE ALSO INSTALLED AUTOMATIC GRATING MACHINES WHICH ELIMINATES ANY HUMAN HANDLING, EVEN IN THE FINAL GRATE. IN ANY CASE, ANYONE TOUCHING THE FRUIT IN THE PACKING HOUSE IS REQUIRED TO WEAR GLOVES TO PREVENT ACCIDENTAL INJURY TO THE FRUIT FROM FINGERNAILS OR RINGS WHICH COULD LEAD TO DECAY. PACKING HOUSES AND STORAGE ROOMS ARE CLEANED REGULARLY. ALL OLD FRUIT IS REMOVED AND FRUIT CONTACT AND SERVICES ARE STERILIZED WITH ONE OF SEVERAL COMPOUNDS, SUCH AS ISOPROPYL ALCOHOL OR ORDINARY AMMONIA. MOST PACKING HOUSES ALSO HAVE INSPECTIONS TO DETERMINE THE QUANTITY OF MOLD SPORES IN THE PACKING HOUSE ENVIRONMENT AND TO DETERMINE THE PERCENTAGE OF THOSE MOLD SPORES WHICH MAY BE RESISTANT TO CHEMICALS USED TO PREVENT DECAY. THIS IS DONE TO PREVENT DECAY PROBLEMS IN THE MARKETPLACE; OBVIOUSLY IT HAS THE ADDED BENEFIT TO REDUCE ANY HUMAN PATHOGENS THAT MAY BE IN THE AIR. BY MONITORING ONE, YOU ARE MONITORING ALL. AFTER PACKING, THE BOXES ARE GENTLY PLACED ON PALETTES AND PLACED IN PRE-COOLING ROOMS TO REMOVE THE RESIDUAL HEAT AND BRING THE TEMP TO SHIPPING TEMPERATURES, 41 TO 45 DEGREES FAHRENHEIT. WE HAVE THE BENEFIT OF BEING ABLE TO SHIP OUR FRUIT MUCH COOLER THAN FRUIT FROM MORE TROPICAL ZONES. THE COOLER WE CAN SHIP THE FRUIT, THE LESS DECAY WE HAVE AT THE MARKETPLACE. SHIPPING VANS OR CONTAINERS ARE TO BE INSPECTED PRIOR TO LOADING TO ENSURE THAT THEY ARE RELATIVELY CLEAN. MARKETING ORGANIZATIONS HAVE RULES IN PLACE WHICH PROHIBIT THE CONTAINERS USED FOR NON-FOOD TRANSPORT USED TO TRANSPORT OUR CITRUS. TRACE-BACK SYSTEMS HAVE BEEN IN PLACE FOR YEARS. THE IDENTITY OF THE MARKETING ORGANIZATION IS REQUIRED TO BE ON THE CARTON BY LAW, AND MOST, IF NOT ALL, PACKING HOUSES MARK EACH CARTON WITH A CODE WHICH CAN BE USED TO TRACE ANY INTACT BOX IN THE MARKETPLACE BACK TO A SPECIFIC DRAWER OR A VERY SMALL HANDFUL OF DRAWERS.

I HAVE WITH ME A NUMBER OF COPIES OF THE CALIFORNIA CITRUS QUALITY COUNCIL WHITE PAPER, WHICH IS ENTITLED CALIFORNIA INDUSTRIAL MICROBIAL CONTAMINATION PREVENTION PRACTICES, WHICH COVERS MOST OF THE POINTS I HAVE MADE HERE TODAY. I KNOW THAT THAT'S A REAL FAST AND BRIEF OVERVIEW OF HOW WE DO THINGS IN CALIFORNIA, BUT I THINK I TOUCHED ON MOST OF THE ELEMENTS INVOLVING THE HACCP PROGRAMS. AND SINCE I HAVE JUST ARRIVED, I HAVE A FEELING I DIDN'T STAND FOR QUESTIONS OR --

DR. JOHN KVENBERG: WELL, THE WAY WE HAVE THIS ESTABLISHED IN THE SUBJECT AREA, IF YOU COULD ENTERTAIN ANY QUESTIONS FROM THE AUDIENCE?

MR. CHUCK ORMAN: ARE THERE ANY QUESTIONS ON WHAT I HAVE SAID OR WHAT I HAVEN'T SAID?

ROB, YOU ALWAYS HAVE QUESTIONS.

AUDIENCE MEMBER: ARE THERE ANY STUDIES DONE BY CALIFORNIA GROWERS, SINCE I AM HARRIETT ADAMS FROM THE INDUSTRY, THAT ACTUALLY GIVE INFORMATION WHEREIN VERIFICATION OF THE LOG REDUCTION IS DONE?

MR. CHUCK ORMAN: A NUMBER OF YEARS AGO WE DID A CONSIDERABLE AMOUNT OF TESTING ON FRUIT THAT WAS DESTINED FOR SQUEEZING AT THE LOCAL LEVEL OR SUPERMARKET OR WHATEVER. WE DEMONSTRATED THAT THERE WAS NO INCREASE IN PATHOGENS THROUGH THE SQUEEZING PROCESS. IN ANSWER TO YOUR SPECIFIC QUESTION, NO, WE HAVE NOT DONE ANY TO SEE WHETHER LOG-5 REDUCTION OCCURS. WE HAD AN INDUSTRY MEETING ABOUT A YEAR AGO AND WE DISCUSSED IT VERY THOROUGHLY. NONE OF US KNEW WHICH PATHOGENS WE WERE LOOKING FOR, HOW IT WOULD BE DONE, AND IT WAS JUST KIND OF LEFT SETTING THERE.

SINCE YOU BRING UP THE ISSUE, I REALLY HAVE A SERIOUS DIFFICULTY WITH THAT WHOLE LOG-5 CONCEPT. THE WAY WE DO THINGS IS A VERY CLEAN OPERATION. TO REQUIRE A RELATIVE REDUCTION, LIKE LOG-5 REDUCTION, TO ME MAKES NO SENSE WHATSOEVER. IF YOU WANT TO GIVE AN ABSOLUTE STANDARD AND SAY YOU CAN ONLY HAVE SO MANY UNITS ON A PIECE OF FRUIT OR A LITER OF JUICE, THAT MAKES A HECK OF A LOT MORE SENSE TO ME THAN REQUIRING A LOG-5. IF YOU START OFF WITH A FILTHY PIECE OF FRUIT AND YOU GET A LOG-5, YOU STILL HAVE A FILTHY PIECE OF FRUIT. IF YOU START OFF WITH A PIECE OF FRUIT THAT'S RELATIVELY CLEAN AND YOU DO A LOG-5, WHAT DOES THAT MEAN? EDITORIAL.

AUDIENCE MEMBER: I HATE TO -- I AM NOT SURE THIS COMMENT IS WORTH THE TIME IT TOOK ME TO WALK UP HERE. I DO HATE TO FOLLOW SUCH EMPASSIONED AND ACCURATE EDITORIAL; HOWEVER, THE LADY FROM JUICE TREE OFFERED A SPECIFIC QUESTION AND CHUCK GAVE AN ANSWER THAT IS ABSOLUTELY CORRECT FROM THE PERSPECTIVE OF THE CALIFORNIA CITRUS QUALITY COUNCIL, UNDERSTANDING THAT HAVE LEAD UP TO THIS POINT IN TIME. WE WOULD LIKE TO NOTE THAT THERE IS DATA THAT IS IN THE, YOU MIGHT SAY THE PRIVATE SECTOR. AS YOU HEARD FROM ME THIS MORNING, I AM A VENDOR; I SELL THESE THINGS. WE HAVE BEEN ABLE TO HAVE THE NEED LATELY TO QUALIFY SOME OF YOUR PRODUCTS, SANITIZERS, THE ONES YOU HAVE HEARD ABOUT THIS MORNING AGAINST PATHOGEN LEVELS THAT ARE REALISTIC, PARTICULARLY WITH E.COLI AND SALMONELLA. THE DATA IS SO NEW THAT I CAN'T EVEN GET YOU A PRODUCT DATA SHEET YET. BUT VERY SHORTLY, WITHIN WEEKS, I CAN CERTAINLY DO THAT. SO IF YOU WOULD LIKE TO SEND AN INQUIRY OR IF YOU WOULD LIKE US TO GET IT TO YOU SOME WAY, WE WOULD BE HAPPY TO DO SO.

MR. CHUCK ORMAN: I AM SURE.

ANY OTHER QUESTIONS THAT I CAN ADDRESS?

MR. DICK GERMOND: DICK GERMOND OF BEAUMONT JUICE. UNFORTUNATELY, I DON'T KNOW THAT MUCH ABOUT PACKING HOUSE OPERATIONS, BUT IS THERE ANY WAY THAT WHEN YOU CALL A PACKING HOUSE THAT YOU COULD -- THAT YOU CAN SEPARATE BROKEN AND VISIBLY CONTAMINATED FRUIT FROM JUST FRUIT THAT'S OTHERWISE HEALTHY SO THAT WHEN WE GET FRUIT FROM THE PACKING HOUSE, WE DON'T HAVE DAMAGED AND VISIBLY CONTAMINATED FRUIT IN THE LOADS, OR IS THAT IMPOSSIBLE TO DO?

MR. CHUCK ORMAN: NO. IN FACT, THAT IS THE WHOLE FOCUS OF THE PACKING HOUSE, TO PUT WHOLE, CLEAN FRUIT INTO CLEAN CARTONS. I AM NOT SURE WHAT YOUR EXPERIENCE IS.

MR. DICK GERMOND: JUICE ELIMINATIONS. THE USUAL THING WHERE THE PACKING HOUSE WANTS TO GET THE ROTTEN ONES IN THERE TO GET PAID FOR THEM.

MR. CHUCK ORMAN: NOW I UNDERSTAND. THANK YOU. WE TAKE NO RESPONSIBILITY FOR THAT.

YES?

MRS. GAIL TENZER: IT JUST CAME TO MY ATTENTION THE OTHER DAY FROM A PRODUCE BROKER THAT THERE IS SOMETHING CALLED JUICE-GRADE FRUIT. NOW, THE INTERESTING THING IS THAT THE FDA SAYS THAT WE ARE NOT SUPPOSED TO USE ANY CULLED FRUIT. BUT IF THE JUICE PRODUCERS ARE RECEIVING PRECISELY THE CULLED FRUIT, WHICH IS THE JUICE-GRADE, THEN WHAT?

MR. CHUCK ORMAN: I THINK YOU HAVE TO IDENTIFY WHAT THE CULLED FRUIT -- IN OUR CASE, IT IS SOLD FOR COSMETIC REASONS OR SHAPE REASONS.

MR. ROB HOLLAND: BUT NOBODY WILL BY THEM FRESH. IT IS ACTUALLY U.S.D.A. GRADED FRUIT.

MRS. GAIL TENZER: SO IF IT IS UNDER-SIZED, UGLY, POOR COLOR, BUT IT IS NOT SUPPOSED TO HAVE ANY HOLES, RIGHT?

MR. CHUCK ORMAN: NO, IT SHOULD BE INTACT, COMPLETELY EDIBLE.

CAN I ELABORATE ON ANY PART OF THAT PROCESS? I DID IT VERY QUICKLY, BUT I HOPE IT WAS CLEAR.

DR. JOHN KVENBERG: JUST FOR CLARIFICATION FOR THE RECORD, I DIDN'T CATCH THE NAME OF THE GENTLEMAN WHO SPOKE.

OH, I AM ROB HOLLAND WITH INDEPENDENT NATIONAL.

MR. CHUCK ORMAN: YOU CAN IGNORE HIM, WE DO.

MR. ROB HOLLAND: I AM GOING HOME.

MR. TOM BRICKWEB: I AM TOM BRICKWEB (PHONETIC) WITH FMC, AND I HAD WORKED IN PRODUCE, THE COMMERCIAL PACKING HOUSE SIDE OF THE BUSINESS, ALSO AS ART SAID ABOUT THE VENDOR FOR THE CODING AND THAT PART NOW AT THE RETAIL SIDE. BUT CHUCK HAD MORE OF A QUESTION FOR CLARIFICATION FOR THE GROUP BECAUSE I THINK THERE WAS SOME MORE ALLUDED TO THIS MORNING ON BEHALF OF FLORIDA, AND I KNOW THAT OKAY; FLORIDA, CALIFORNIA. BUT I THINK THIS IS AN INDUSTRY ISSUE THAT WE ARE ALL WORKING FOR THIS TOGETHER, AND I THINK THE QUESTION IS THAT, IN MY EXPERIENCE ANYWAY, THAT PACKING HOUSES THROUGHOUT FLORIDA, TEXAS, ARIZONA AND CALIFORNIA ALL PRETTY MUCH FOLLOW A VERY SIMILAR PATH WHEN WE CALL A CERTIFIED OR LICENSED PACKING HOUSE IN CLEANING, GRATING, AND SO FORTH. SO SOME OF THAT WORK OUGHT TO BE TRANSFERABLE AS FAR AS LOG REDUCTION AND SO FORTH. WOULD YOU AGREE WITH THAT OR --

MR. CHUCK ORMAN: I AGREE WITH IT IN PART. I READ THOSE REPORTS; I THOUGHT THEY WERE WONDERFUL WORK. I WOULD LOVE TO SEE SOMEONE DO THAT WORK IN CALIFORNIA. THERE ARE ENOUGH DIFFERENCES IN THE WAY WE GROW, PICK AND HANDLE FRUIT BETWEEN FLORIDA AND CALIFORNIA THAT I THINK YOU CAN SEE SIGNIFICANT DIFFERENCES. THE CONCEPT IS THERE. THERE IS THESE LOG REDUCTIONS THROUGH PROCESSES, MANY OF WHICH ARE THE SAME WHETHER IT IS FLORIDA OR CALIFORNIA. FOR EXAMPLE, WASHING AND SANITIZING OPERATIONS AND WAXING OPERATIONS ARE THE SAME WHEREVER YOU DO THEM.

MR. TOM BRICKWEB: WHICH, I THINK, IS WHERE MOST OF THE SUCCESS IS BEING SHOWN AS FAR AS THE EFFECTIVENESS OF GETTING THE FRUIT CLEANED BEFORE IT GOES TO THE CONSUMER OR RETAILER.

MR. CHUCK ORMAN: IT IS JUST MORE DIRTY IN FLORIDA.

MR. TOM BRICKWEB: THAT'S NOT WHAT WE ARE HERE TO TALK ABOUT.

MR. CHUCK ORMAN: SORRY, IT'S BEEN A LONG DAY FOR ME ALREADY.

AUDIENCE MEMBER: CHUCK, QUIT WHEN YOU ARE AHEAD.

MR. CHUCK ORMAN: GOOD WORDS OF ADVICE. I DIDN'T KNOW YOU WERE IN THE AUDIENCE.

DR. JOHN KVENBERG: IF THERE ARE NO OTHER QUESTIONS, I WOULD LIKE TO THANK YOU VERY MUCH, MR. ORMAN.

MR. CHUCK ORMAN: YOU ARE WELCOME.

DR. JOHN KVENBERG: SO, THE NEXT SESSION OF TODAY'S AGENDA NOW TURNS TO THE CRITICAL POINT IN THE PROCESS WHERE EXTRACTION TECHNIQUES ARE GOING TO BE DISCUSSED, INCLUDING THE TYPE OF EXTRACTION, SHIPMENT AND PROCEDURES THAT ARE USED. AND THE TECHNICAL EXPERTS ON THIS PANEL ARE A MIX BETWEEN THE EQUIPMENT MANUFACTURERS, THE PEOPLE WHO PRODUCE THE JUICE, AND THE SCIENCE FROM FLORIDA, DR. ISMAIL WILL BE SPEAKING TO THIS FROM A RESEARCH PERSPECTIVE.

OUR FIRST SPEAKER, AND FORGIVE ME, MR. VICTOR ABULARACH. I MET YOU AND I TRIED TO RECALL THE NAME WITH FMC CORPORATION. DID I COME CLOSE?

MR. VICTOR ABULARACH: YES.

GOOD AFTERNOON. MY NAME IS VICTOR ABULARACH. I AM WITH FMC CITRUS SYSTEMS DIVISION IN RIVERSIDE. WITHIN OUR CITRUS SYSTEMS DIVISION, WE HAVE THREE MAJOR PROTOTYPES, WE HAVE FRESH FRUIT PRESERVATION, WHICH INCLUDES CHEMICAL WASHES AND FRUIT HANDLING EQUIPMENT. WE ALSO HAVE THE COMMERCIAL CITRUS JUICE EXTRACTOR AND THE SMALLER FRESH SQUEEZED EXTRACTOR USED BY RETAIL PROCESSORS. MY PRESENTATION THIS AFTERNOON WILL COVER THE FMC EXTRACTION PRINCIPLE AND WILL BE RATHER BRIEF. THE COMMERCIAL EXTRACTOR SEEN HERE IS USED BY LARGE PROCESSORS AND CAN HANDLE UP TO FOUR AND A HALF TONS OF ORANGES PER HOUR. IT HAS FIVE EXTRACTION CUPS SIDE-BY-SIDE OPERATING AT BETWEEN 60 OR 100 CYCLES PER MINUTE. PRODUCTION OF SAFE, GOOD QUALITY ORANGE JUICE REQUIRES FIRST AND FOREMOST SOUND FRUIT PROPERLY WASHED, GRATED AND SANITIZED. THE EXTRACTOR ENHANCES THE QUALITY OF THE JUICE BY SEPARATING THE ORANGE INTO ITS INDIVIDUAL COMPONENTS WITH A MINIMUM OF CONTACT BETWEEN THE OUTER SURFACE OF THE FRUIT AND JUICE WITHIN.

LET ME ILLUSTRATE, FIRST OF ALL, THE JUICING COMPONENT OF THE FMC EXTRACTOR. WE HAVE A NUMBER OF STATIONARY PARTS. WE HAVE A LOWER CUP, A LOWER CUTTER, A STRAINER TUBE AND THE JUICE MANIFOLD. THE MOVING PARTS ARE AT THE TOP. WE SEE OVER HERE -- I GUESS THE BATTERIES MUST BE A LITTLE LOW. WE SEE THE UPPER CUTTER, WHICH TRAVELS DOWNWARDS TO MAKE CONTACT WITH THE FRUIT, AND DOWN BELOW WE SEE AN ORIFICE. FRAME NO. 2 WE SEE THE FIRST STEP OF EXTRACTION. THE UPPER CUP TRAVELS DOWN, COMPRESSES THE FRUIT, AND THE CUTTER DOWN BELOW PUNCHES A HOLE IN THE FRUIT, WHICH ALLOWS THE JUICE TO ESCAPE INTO A PERFORATED TUBE OR STRAINER. AT THAT POINT, THE ORIFICE, WHICH IS CALLED AN ORIFICE SIMPLY BECAUSE THE WORD IMPLIES IT HAS A HOLE IN IT, MOVES UPWARDS, COMPRESSES THE CONTENTS OF THE STRAINER ALLOWING THE JUICE TO ESCAPE THROUGH THESE. THE JUICE FLOWS INTO THE JUICE MANIFOLD AND NOW THE EXTRACTOR, WHILE AT THE SAME TIME THE CONTENTS, THE INSIDE OF THE MEMBRANES, SEEDS AND PEEL THAT WAS ON THE FRUIT GOES, DOWN THE ORIFICE AND IS EJECTED INTO A PEEL WASTE SCREW. LET ME REITERATE THAT THE ONLY PART OF THIS THAT COMES IN CONTACT WITH JUICE IS THAT SMALL PLUG THAT IS CUT OFF THE FRUIT TO ALLOW THE JUICE TO ESCAPE. DEPENDING ON THE SIZE OF THE FRUIT OR THE SIZE OF THE CUP, THAT CUTTER MAY HAVE A DIAMETER OF ANYWHERE FROM THREE QUARTERS TO ONE INCH IN DIAMETER. AT THE END, THE EXTRACTOR NEATLY SEPARATES THE ORANGE INTO ITS OUTER PEEL, THE INNER CORE AND PULP JUICE, OR IF ONE PREFERS, PULPLESS JUICE, AND PULP AS A BYPRODUCT. THE STAINLESS STEAL SURFACE AND THE ENCLOSED JUICE HANDLING SYSTEM MAKES IT POSSIBLE FOR IT TO BE CLEANED AND BACK-FLUSHED. AND BY BACK-FLUSHING, WE MEAN INTRODUCING THE SOLUTION BACKWARDS FROM WHERE THE JUICE CAME INTO THE EXTRACTOR TO REMOVE CARBOHYDRATES, MICROBES AND OTHER ORGANISMS FROM THE EXTRACTOR. AFTER RINSING WITH POTABLE WATER, THE EXTRACTOR CAN ALSO BE SANITIZED BY THE SAME METHOD. THE JUICING COMPONENTS, SUCH AS A STRAINER TUBE, THE JUICE MANIFOLD, CAN ALSO BE CLEANED MANUALLY OR TOUCHED UP AFTER CIP FOR ADDITIONAL INSURANCE.

ANOTHER ESSENTIAL IS USED BY GIFT FRUIT SHIPPERS AND SUPERMARKET RETAILERS, OUR SMALLER VERSION OF THE EXTRACTOR, ONE HEAD EXTRACTOR, WHICH IS OUR FRESH-SQUEEZED JUICER. IT IS A COMPACT ONE STATION JUICE OPERATION WITH A BUILT-IN FRUIT HOPPER AS ILLUSTRATED, A FEEDER, A WASTE COMPARTMENT, AND A JUICE RESERVOIR. THIS SECTOR OF THE INDUSTRY ALWAYS USES PACKED FRUIT PURCHASED FROM A LICENSED PACKING HOUSE. THE FRUIT AS DR. ISMAIL SHARED WITH US EARLIER, HAS ALREADY BEEN TREATED IN SUCH A WAY AS TO ACHIEVE A 3.4 REDUCTION IN PATHOGENS, UTILIZES THE SAME METHOD OF JUICE EXTRACTION USED BY OUR COMMERCIAL MACHINE AND ITS JUICING COMPONENTS CAN BE EASILY REMOVED FOR CLEAN-UP AND SANITATION, AS YOU CAN SEE IN THIS SLIDE HERE. THIS MACHINE RUNS A LITTLE SLOWER THAN OUR COMMERCIAL EXTRACTOR. IT PROCESSES 20 FRUIT PER MINUTE.

BOTH EXTRACTORS SHARE THE INCLUDED JUICE-HANDLING SYSTEM, SANITIZED JUICE CONTACT SURFACES THAT ARE EASY TO CLEAN. BOTH EXTRACTORS PROVIDE A MINIMUM OF CONTACT BETWEEN THE SURFACE OF THE FRUIT AND THE JUICE THEY PRODUCE.

IN SUMMARY, NO DOUBT THE FMC EXTRACTOR, WHETHER IT BE COMMERCIAL-SIZE MACHINE OR A FRESH SQUEEZE EXTRACTOR, ARE THE WAY TO MAKE THIS WHOLESOME, NUTRITIOUS, GREAT-TASTING JUICE. THANK YOU.

 

(APPLAUSE.)

DR. JOHN KVENBERG: IF YOU HAVE A CURRENT AGENDA, WE ARE GOING TO REVERSE SPEAKERS AND TAKE THEM IN THE FOLLOWING ORDER: NEXT WE'LL AGAIN HEAR FROM DR. MOHAMED ISMAIL FROM FLORIDA DEPARTMENT OF CITRUS ON EXTRACTION TECHNIQUES THAT ARE UNDER STUDY IN THIS UNIT.

DR. ISMAIL?

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

I DID NOT BRING IN SLIDES FOR THIS PRESENTATION, BUT I DO HAVE A DISC THAT YOU CAN'T SEE ANYTHING FROM. BUT THIS IS TECHNOLOGY, HUH? I CAN GIVE YOU THAT AS A COPY THAT YOU CAN KEEP AND ALSO I HAVE THE PRESENTATION SUMMARIZED ON A HARD COPY AND WE CAN ALSO MAKE COPIES FOR YOU, IF YOU WISH. THE PURPOSE OF THIS PARTICULAR STUDY IS TO FIND OUT WHAT KIND OF EFFECT DOES EXTRACTION METHOD HAVE OR HAS ON THE LEVEL OF MICROBIAL DONE CONTAMINANT IN THE JUICE. CITRUS JUST BEING ACIDIC, PERHAPS THE EXTRACTION TECHNIQUE IS UNIQUE TO SOME EXTENT, DOES GIVE US AN INDICATION THAT YOU CAN ACHIEVE A CERTAIN DEGREE OF REDUCTION BY SIMPLY EXTRACTING THE JUICE. FOR THE STUDY, I WOULD LIKE TO SHOW SOME SLIDES THAT I TOOK WHILE THE WORK WAS BEING DONE JUST TO SHOW YOU THE PEOPLE THAT DID THE WORK. THE STUDY, OF COURSE, WAS DONE IN COOPERATION WITH FMC AND OUR STAFF, DR. STEVEN PAO ON THE LEFT-HAND SIDE WORKED VERY CLOSELY WITH THEM, AND IT WAS DONE IN OUR PILOT PLANT FACILITY AT THE CITRUS RESEARCH EDUCATION CENTER IN LAKELAND, FLORIDA. THIS IS JUST A PICTURE OF A FRUIT IN THE CUP, REAL FRUIT THIS TIME, AND AGAIN ANOTHER PICTURE SHOWING THE TWO COMPONENTS THAT EXTRACT THE JUICE. THIS IS THE LARGE COMMERCIAL IN-LINE EXTRACTOR, AND THIS IS A PICTURE OF THE PEEL AFTER THE JUICE HAS BEEN REMOVED. AND YOU CAN SEE THERE ARE SOME CUTS ALONG THE OUTER SURFACE OF THE FRUIT THAT COULD NOT PENETRATE INTO THE JUICE ITSELF. AND THAT IS PERHAPS THE REASON THAT WE GET THE CERTAIN DEGREE OF REDUCTION, BECAUSE NOT ALL THE SURFACE CONTAMINANTS GO INTO THE JUICE. AND THIS IS JUST SOME OF THE BAGS THAT STEVEN PAO AND OTHERS USE TO COLLECT THE SAMPLES, BECAUSE IT WAS DONE WITH E.COLI AND IT WAS DONE WITH BACILLUS. WE'LL GIVE YOU SOME INFORMATION ON THAT. AND AGAIN, SOME OF THE UTENSILS AND LAB EQUIPMENT WE USE. SO WE -- I WAS GLAD TO BE PART OF THIS STUDY. AND WHAT HAPPENED IS WE DID THE JUICE EXTRACTION USING THE INDUSTRIAL FMC CITRUS EXTRACTOR, AND ALSO WE DID A STUDY WITH -- I THINK THE SLIDES ARE THROUGH. WE MIGHT BE ABLE TO TURN IT OFF RIGHT NOW. THE OTHER ONE WAS DONE WITH THE FMC FRESH AND SQUEEZE, THE SMALL MACHINE THAT WAS SHOWN ON THE SCREEN EARLIER. THE INDUSTRIAL EXTRACTOR WAS SET UP AS A STANDARD CUP, ONE INCH CUP CUTTER, AND .025 INCH STRAINER TUBE, AND ANOTHER SETTING WAS THE ONE INCH CUP, THREE-QUARTER INCH CUP CUTTER INSTEAD OF ONE AND .025 STRAINER. A THIRD SETTING WAS WHAT THEY CALL A PREMIUM JUICE EXTRACTOR CUP, WHICH IS THREE-QUARTER INCH CUTTER, .040 INCH STRAINER TUBE, AND A FRESH AND SQUEEZE WAS SET UP WITH ONE INCH CUTTER. THERE IS ONLY ONE SET UP FOR IT, THERE IS NO VARIATION. IT WAS ONE INCH CUTTER, AND .025 INCH STRAINER TUBE. THE RESULTS WERE CALCULATED IN A SCIENTIFIC MANNER, AND THEY DO INDICATE WHEN THE FRUIT WERE INOCULATED WITH E.COLI AT A LEVEL APPROACHING 5-LOG, LIKE 100,000 ORGANISMS PERFECT SQUARE CENTIMETER, WE WERE ABLE TO ACHIEVE A REDUCTION THAT RANGES BETWEEN 1.9- AND 2.1-LOG IN THE NUMBER OF ORGANISMS THAT WERE TRANSFERRED INTO THE JUICE. AND THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN THE DIFFERENT SETTINGS, WHETHER IT WAS THREE-QUARTER INCH OR ONE INCH. BUT WE DID NOTICE A LESSER DEGREE OF MICROBIAL REDUCTION WHEN WE USED THE LACTOBACILLUS PLANETARIUM WHERE WE WERE ABLE TO ACHIEVE LEVELS RANGING BETWEEN 1.3- OR 1.8-LOG REDUCTION. THE FRUIT THAT WERE USED IN THE STUDY WERE DEFINITELY CLEAN AND WASHED AND INOCULATED IN A STANDARD MANNER WHEN DIPPING THE FRUIT IN A BROTH CONTAINING THE MICROORGANISM. ALSO LOOKED AT THE DIFFERENCE BETWEEN STANDARD AND PREMIUM SET-UP, AND WE DID NOT SEE ANY DIFFERENCE. THE PREMIUM ACHIEVED 1.6, AND THE STANDARD SET-UP ACHIEVED 1.8-LOG REDUCTION. AND THE STATISTICS INDICATED NO SIGNIFICANCE IN THIS CASE. WITH THE FRESH AND SQUEEZE MULTI-FRUIT JUICER, WE ACHIEVED 1.3-LOG REDUCTION IN CASE OF BACILLUS PLANETARIUM OR 1.7-LOG REDUCTION IN THE E.COLI. AND THE DIFFERENCE BETWEEN E.COLI AND BACILLUS, WE DON'T QUITE KNOW EXACTLY WHY, HOWEVER, WE SEEM TO FEEL THAT THERE IS A DIFFERENCE BETWEEN THE BROTH IN WHICH THE ORGANISMS WERE SUSPENDED AND HOW TENACIOUS OR HOW ADHERING THAT BROTH IS TO THE SURFACE OF THE FRUIT.

IN CONCLUSION, ABOUT 1.3- TO 2.-LOG MICROBIAL REDUCTION CAN BE EXPECTED FROM THE TESTED FRESH CITRUS JUICE EXTRACTION PROCESS. MICROBIAL REDUCTION WAS NOT SIGNIFICANTLY AFFECTED BY THE CUTTER SIZE, WHICH IN THIS CASE WAS THREE-QUARTER VERSUS ONE INCH, BY THE CUP AND STRAINER TUBE SET UP, WHICH IS THE STANDARD VERSUS PREMIUM, OR BY THE INOCULATION LEVEL. WE DID TEST INOCULATION LEVEL AND E.COLI OF FIVE- AND 4-LOG, FOUR MICROBIAL STARTING LEVEL, INITIAL LEVEL. IN CASE OF BACILLUS, WE COMPARED 5. AND 5.7 INITIAL LOG. NO DIFFERENCE. AND TEST ORGANISM MIGHT HAVE SOME EFFECT ON THE MICROBIAL REDUCTION, IN THIS CASE E.COLI VERSUS LACTOBACILLUS.

THIS CONCLUDES MY PRESENTATION.

 

(APPLAUSE.)

DR. JOHN KVENBERG: ALTHOUGH TECHNOLOGY FAILED US FOR YOUR PRESENTATION, DR. ISMAIL, WE ARE MAKING COPIES OF THE SLIDE PRESENTATION MATERIALS FOR THOSE WHO WOULD BE INTERESTED HERE. AND AT THE TIME WE HAVE A SHORT BREAK LATER ON, THEY SHOULD BE AVAILABLE TO THOSE LATER ON, THOSE SEEING THE ACTUAL DATA THAT HE WAS TALKING ABOUT THAT UNFORTUNATELY WE COULDN'T HAVE ON THE SCENE.

OUR NEXT SPEAKER IS GOING TO BE MS. JEAN KIGOZI, I THINK I HAVE SAID THAT CORRECTLY, WITH THE HANSEN JUICE COMPANY.

MS. JEAN KIGOZI: MY NAME IS JEAN KIGOZI AND I AM WITH HANSEN JUICES. I AM GOING TO FOLLOW UP FROM WHAT DR. ISMAIL WAS TALKING ABOUT. I AM GOING TO SHARE WITH YOU THE DATA THAT WE HAVE IN-HOUSE AT HANSEN'S USING THE FMC EXTRACTOR. SO THAT'S JUST A PICTURE OF OUR COMMERCIAL EXTRACTOR IN THE PLANT. NEXT SLIDE. THAT WAS JUST WHEN IT WAS RIGGED TO BE USED. THE NUMBERS UP HERE ARE THE NUMBERS IN THE FRUIT THAT'S THE BACKGROUND COUNT BEFORE THE EXTRACTION. THESE NUMBERS ARE AFTER THE EXTRACTION OF THE JUICE WAS DONE IN THE FMC.

DR. MOHAMED ISMAIL: COULD YOU READ SOME OF THESE? IT IS VERY HARD TO SEE.

AUDIENCE MEMBER: JUST GO AHEAD AND GIVE THEM THE HIGHS AND THE LOWS THAT WE WERE ABLE TO ACHIEVE.

MS. JEAN KIGOZI: THESE BACKGROUND NUMBERS ON THE COLUMN ON THE RIGHT-HAND SIDE ARE LOGARITHMS PER ORANGE, I THINK IT WAS 20 ORANGES. SO YOU WANT ME TO READ LIKE 20 ORANGES OR JUST THE AVERAGE?

DR. MOHAMED ISMAIL: AVERAGE WOULD BE FINE.

MS. JEAN KIGOZI: AVERAGE WAS 7.53, SO THESE WERE THE NUMBERS AFTER THE JUICE WAS EXTRACTED. THE MEAN OF THE AVERAGES FOR THIS NUMBER WAS 5.31. THE ORGANISM STEVE HUNTER IS GOING TO TALK ABOUT. SO THIS IS JUST A GRAPH SHOWING BEFORE AND AFTER. WE GOT A MEAN LOGARITHM OF 2. SO, IN ADDITION TO THE STEPS THAT STEVE HUNTER WAS TALKING ABOUT EARLIER, THE WASHING, THE GRATING, OR THE SANITIZING, WE EVALUATE IN THE EXTRACTION FOR THE TOTAL OF ALL THE PROCESS WE GOT IN EXCESS OF 5-LOG REDUCTION.

 

(APPLAUSE.)

DR. JOHN KVENBERG: THANK YOU. THE HISTORY ORGANISM WILL BE DISCUSSED WHEN WE GET THE VALIDATION, INTO THE TECHNIQUES SECTION, I HOPE. IT IS IN YOUR HANDS. WE HAVE TALKED LARGELY ABOUT ONE EXTRACTION PROCEDURE UP TO THIS POINT IN TIME BY ONE PIECE OF EQUIPMENT, BUT THERE ARE OTHER EXTRACTION PROCEDURES OUT THERE AND ADDITIONAL WORK WE ARE AWARE OF AT THIS POINT THAT I AM SURE WILL BE FOLLOWED.

OUR NEXT SPEAKER IS MR. JIM BECK, AND HE IS PRESIDENT OF JUICE TREE COMPANY THAT HAS A UNIT THAT EXTRACTS JUICE, AND I BELIEVE IS LARGELY AIMED AT THE RETAIL MARKET FOR EXTRACTION OF JUICE AT THAT LEVEL, MAYBE SMALL.

WELCOME, MR. BECK.

MR. JAMES BECK: AGAIN, MY NAME IS JIM BECK. I AM WITH JUICE TREE COMPANY. WE HAVE BEEN MANUFACTURING SMALL COMMERCIAL JUICE MACHINES FOR THE PAST 30 YEARS. I HAVE TO APOLOGIZE, I HAVE NO SLIDES FOR ANYBODY TO LOOK AT, BUT I DID BRING SOME PAMPHLETS IN THE BACK. IF YOU WANT TO, YOU WILL SEE WHAT OUR MACHINES LOOK LIKE. IF I HAD TO PICK ONE UP, YOU MIGHT RECOGNIZE THIS ONE FROM A SUPERMARKET. IT IS A TYPICAL SMALL, COMMERCIAL MACHINE. WE TAKE 40-POUND BOXES OF ORANGES, LOAD THEM IN THE TOP HOPPER, TREAT THEM ONE AT A TIME AT 14 ORANGES A MINUTE. WE HAVE A STAINLESS STEEL HEAD, THREE KNIVES THAT CUT CIRCULAR HOLES IN THE ORANGE DURING THE SQUEEZING PROCESS. THE ORANGE IS EXTRACTED OUT THROUGH THE KNIFE BLADES THROUGH SLOTS WHICH HOLD MOST OF THE PULP AND ALL OF THE SEEDS IN THE ORANGE AND THEN WE PRESS BACK IN THE EXPOSED PART OF THE ORANGE. IT DROPS INTO A REMOVAL CONTAINER IN THE BOTTOM. WE HAVE ALSO BEEN RUNNING SOME TESTS ON OUR MACHINE, AND ASSUMING WE CAN GET A 2.- OR 2-LOG REDUCTION FROM A PACKING HOUSE, WE HAVE RUN SOME TESTS UP IN CHICAGO AT SULKIN LABS (PHONETIC) AND YOU CAN SEE A REPORT IN THIS PAMPHLET THAT SHOWS OUR MACHINE CREATED A 3.6 REDUCTION AFTER THE ORANGES WERE SQUEEZED. AT PRESENT TIME, WE HAVE APPROXIMATELY 30 THOUSAND OF THESE MACHINES AROUND THE UNITED STATES, NOT ALL OURS. THESE ARE THREE MAJOR MANUFACTURERS. THE THING THAT WE WOULD LIKE TO ACCOMPLISH TODAY IS TO FIND A WAY TO HANDLE THEM. IT IS VERY HARD FOR A SMALL MARKET TO BE INFORMED ABOUT ALL THESE FDA REGULATIONS AND EVERYTHING THAT'S GOING ON. THEY NEVER GET THE INFORMATION THAT'S SUPPOSED TO BE SENT TO THEM. SO I THINK SOMEHOW IF WE CAN CREATE ANOTHER CATEGORY FOR FRESH-SQUEEZED ORANGE JUICE MACHINES, WE MIGHT BE ABLE TO PUT THE MANUFACTURERS IN CHARGE OF CREATING THE REDUCTION REQUIRED AND NOT THE INDEPENDENT SUPERMARKET.

I THINK THAT'S ABOUT ALL I HAVE. THANK YOU.

 

(APPLAUSE.)

DR. JOHN KVENBERG: IF THERE ARE QUESTIONS ABOUT THE EXTRACTION STUDIES NOW THIS MOMENT? ARE THERE ANY QUESTIONS ABOUT THE EXTRACTION TECHNIQUES?

MR. SILVERSTEIN: MY QUESTION IS: WHAT KIND OF WORK HAS BEEN DONE TO IDENTIFY THE PATTERN OF CONTAMINATION, FOR INSTANCE, ON AN ORANGE RATHER THAN OTHER ALL IMMERSION? BECAUSE WE HAVE THEM ON A TREE, AND IT DOESN'T STAND THAT IT IS GOING TO BE A UNIFORM COATING. WE HAVE CLUMPS. HAS THERE BEEN ANY WORK DONE ON IDENTIFYING WHERE THOSE CLUMPS ARE AND ACTIVITIES TO THE CLUMPS?

DR. MOHAMED ISMAIL: I DON'T THINK WE HAVE THAT WORK DONE AS FAR AS THE DISTRIBUTION OF MICROBIAL CONTAMINATION. THE ONLY THING WE CAN DIFINITIVELY SAY IS THAT THERE IS DEFINITELY MORE ORGANISMS THAT WOULD BE HIDDEN IN THE BUTTON AREA AND ALSO IN THE NAVAL AREA OF NAVAL ORANGES, AND THESE WOULD PROBABLY BE MORE DIFFICULT TO ELIMINATE. AND THAT'S ONE REASON MORE WORK IS REALLY NEEDED, AND I BELIEVE THE U.S. GOVERNMENT IS MAKING AVAILABLE SOME FUNDS NOW TO UNIVERSITIES AROUND THE COUNTRY TO PERHAPS STUDY IN DETAIL SOME OF THESE ISSUES AND SOME OF THESE QUESTIONS AND GIVE US THE ANSWER THAT WE HOPE TO GET.

DR. JOHN KVENBERG: THANK YOU. I AM REFERRING TO RESEARCH DOLLARS THIS YEAR ASSOCIATED WITH COOPERATIVE RESEARCH FUNDS GOING ON NOW. THANK YOU FOR THAT COMMENT.

YES, ADDITIONAL COMMENTS?

MR. PETER JAYERS (PHONETIC): PETER JAYERS. IS IT REASONABLE TO ASSUME THAT INDIVIDUAL PRODUCERS, WHEN THEY ARE PUTTING TOGETHER THEIR ACID PLANS AND THEIR 5-LOG REDUCTION PLANS, TO TAKE ADVANTAGE OF THE RESEARCH THAT'S BEEN DONE BY THE EQUIPMENT PRODUCERS, AS WE HEARD TODAY, AS FAR AS REFERENCING THEIR RESEARCH AND INCLUDING THAT IN THAT CUMMULATIVE 5?

DR. JOHN KVENBERG: I THINK THE ANSWER TO THAT QUESTION KIND OF LIES WITH THE FOLKS WHO ARE AT THIS MEETING AND IN A DIALOGUE WITH US AND THE FEDERAL GOVERNMENT AND THE STATE ASSOCIATIONS AND THEIR PARTNERS. CLEARLY, WHEN WE GET TO THE QUESTION OF NEXT STEP, WHAT CONSTITUTES CUMMULATIVE 5-LOG REDUCTION IS HEAVY ON MY MIND OF EXACTLY HOW WE CAN PUT THIS TOGETHER. YOUR QUESTION IS WELL TAKEN BECAUSE AT THIS POINT IN TIME I THINK IN ORDER TO PUT THINGS TOGETHER THAT WE HAVE SPOKEN ABOUT TODAY OBVIOUSLY NEEDS TO BE EVALUATED, DISCUSSED AND DECIDED ON. BUT I AM EXCITED ABOUT WHAT I AM HEARING WITH RELATION TO WHAT WE ARE HEARING AT THIS POINT.

ARE THERE ANY OTHER COMMENTS WITH REGARD TO EXTRACTION TECHNIQUES? IF NOT, WE CAN MOVE BEYOND THAT, I THINK, TO AN AREA WHERE PEOPLE ARE QUITE VITALLY INTERESTED IN. HOW DO YOU PUT THIS ALL TOGETHER RELATIVE TO THE CHALLENGE THAT'S PUT FORTH ON VALIDATING THE 5-LOG SYSTEM THAT'S PUT TOGETHER? AND IN THAT REGARD, IT'S BEST TO HEAR FROM THE TECHNO EXPERTS WHO HAVE WALKED THIS WALK.

OUR FIRST DISCUSSION IS -- WELL, IT IS GOING TO BE IN TWO PARTS, AND THE WAY FOLKS HAVE APPROACHED US IS THROUGH SIMULATING THE PRACTICES IN A PLAN THROUGH LABORATORY OR PILOT PLANT SIMULATION WITH ACTUAL PATHOGENS AND BY USING WHAT'S BEEN TERMED SURROGATE ORGANISMS TO TRACK WHAT'S ACTUALLY GOING ON IN THE PLANT. IN THIS SECTION, OUR FIRST DISCUSSION IS MR. DAVE SPERRY, AND HE IS ASSOCIATED WITH CALIFORNIA DAY FRESH. HE WILL BE TALKING TO US ABOUT PATHOGENS IN LABORATORY STUDIES.

DAVE?

MR. DAVE SPERRY (PHONETIC): THANK YOU VERY MUCH.

AT CALIFORNIA DAY FRESH, WE ARE PROUD TO HAVE THE OPPORTUNITY TO TALK TO YOU TODAY. CALIFORNIA DAY FRESH, FOR THOSE OF WHO DON'T KNOW IT, WE ARE BASED HERE IN GLENDORA, CALIFORNIA, AND WE MANUFACTURE AND DISTRIBUTE FRESH JUICE THROUGHOUT THE WESTERN STATES, AND ABOUT 30 PERCENT OF OUR VOLUME IS CITRUS. SO THIS IS OBVIOUSLY OF GREAT ATTENTION TO US TODAY. I AM REALLY HERE TO SPEAK ON BEHALF OF OUR CALIFORNIA DAY FRESH PATHOGENS AND VALIDATION STUDIES AND I REALLY WANT TO BEGIN BY SAYING THAT YOU NEED TO APPROACH THE REDUCTION OF MICROORGANISMS AND FOOD SAFETY WITH A SYSTEM PERSPECTIVE. THIS INCLUDES EVERY STEP IN THE MANUFACTURING PROCESS FROM SELECTING VENDORS AND GROWERS TO THE RECEIPT AND PRODUCTION AT YOUR FACILITY THROUGH THE DISTRIBUTION AND SALES TO THE FINAL CONSUMER. YOU WANT TO MAKE SURE THAT ALL YOUR PREREQUISITE PROGRAMS ARE IN PLACE. THESE PROGRAMS ESTABLISH THE BASE FOR YOUR COMPLETE FOOD SYSTEM PROGRAM. YOU NEED TO INCLUDE YOUR PREREQUISITE PROGRAM, SUCH PLANS AS VENDOR APPROVAL PROCESS, SELECTING GROWERS AND SUPPLIERS BASED ON FULL CREDENTIALS THAT YOU SEED. SELECT A PRODUCER THAT WILL PROVIDE YOU WITH SOUND RAW MATERIALS. YOU MUST HAVE SOUND FRUIT TO PRODUCE SAFE FRUIT. THAT'S A COMMON DENOMINATOR IN MOST OF TODAY. MAKE SURE YOU HAVE FULL UNDERSTANDING OF WHAT YOUR PRODUCT REQUIREMENTS ARE SO THEY CAN MAKE SURE THAT THEY ARE COMPLYING WITH THEM. CREATE SPECIFICATIONS THAT OUTLINE PHYSICAL, MICROBIOLOGICAL AND CHEMICAL CHARACTERISTICS. OUTLINE ANY GROWING CONDITIONS THAT REQUIRES SUCH ASSIMILATION THAT FRUIT MUST BE TREE-PICKED WITH ZERO TOLERANCE FOR GROUND FRUIT AND GROUND FRUIT MUST NOT COME FROM GROVE TREES THAT ARE ADJACENT TO LIVESTOCK AREAS. IF YOU NEED TO, SPECIFY WHAT TYPES OF FERTILIZERS CAN OR CANNOT BE USED FOR YOUR PRODUCT. AND THEN CREATE PRODUCT GUARANTEES THAT STATE ANY OTHER REQUIREMENTS THAT MUST BE MET IN ORDER TO SUPPLY YOUR COMPANY WITH FRUIT. THIS MUST INCLUDE REGULATORY COMPLIANCE ITEMS, PESTICIDES AND CHEMICAL USE. HAVE YOUR DOCUMENTATION SIGNED BY THE SUPPLIER SO THEY KNOW AND UNDERSTAND THE ELEMENTS THAT THEY ARE RESPONSIBLE FOR. AND WE ALSO HAVE THIS WRITE-IN CANDIDATE HERE, WE HAVE A C OF A SORT OF ANALYSIS WHICH IS DOCUMENT EACH LOAD THAT EACH LOAD DOES COMPLY WITH YOUR SPECIFICATIONS. AND, OF COURSE, GOOD MANUFACTURING PROCESSES, INCLUDING HOUSEKEEPING, REFUSE REMOVAL, HAND WASHING AND EMPLOYEE HYGIENE, AND, OF COURSE, OPERATING PROCEDURES. CREATE, MONITOR, AND PROPERLY DOCUMENT SANITATION PROCESSES. ALL CHEMICALS MUST BE MONITORED AS TO PROPER USE OR CONCENTRATIONS AND DWELL TIMES. WASHING, CLEANING AND SANITIZING OF THE PRODUCTION FACILITY AND SERVICES SHOULD BE MAINTAINED A REGULAR SCHEDULE. AND, OF COURSE, ANOTHER WRITE-IN CANDIDATE HERE IS HACCP. WE HAVE PROUD TO IMPLEMENT A COMPLETE HACCP PROGRAM AT CALIFORNIA DAY FRESH.

SO LET'S MOVE ON TO THE VALIDATION STUDY ITSELF. THE FIRST STEP IN THE PROCESS FOR US WAS YOU NEED TO CHOOSE YOUR ORGANISM. I DON'T WANT -- FIRST OF ALL, I DON'T WANT TO CHOOSE YOUR WEAPONS, BUT IT IS A LITTLE BIT KIND OF THE SAME THING, SO YOU NEED TO CHOOSE YOUR ORGANISM. CHOOSE THE ORGANISM YOU CONSIDER TO BE THE PERTINENT MICROORGANISM THAT MIGHT BE OF HEALTH SIGNIFICANCE THAT IS LIKELY TO OCCUR IN OUR PRODUCT. YOU NEED TO CHOOSE -- YOU CAN CHOOSE WITH TWO SUCH OPTIONS, FIRST OF ALL SURROGATE MICROORGANISM, WHICH WE ARE GOING TO HAVE A COUPLE OF SPEAKERS ON NEXT WHICH MUST BE SIMILAR TO A RELEVANT PATHOGEN IN A NUMBER OF WAYS, INCLUDING GROWTH AND SURVIVAL RATES, OR YOU CAN SELECT AN ACTUAL PATHOGEN. AT CALIFORNIA DAY FRESH WE CHOSE SALMONELLA AS THE PATHOGEN CONTROLLED IS THE OUTBREAK OF THE MAY, 1995 THEME PARK AND UNPASTEURIZED ORANGE JUICE. IT WAS ESTIMATED THAT BETWEEN 630 AND 6300 CASES COULD HAVE RESULTED FROM THIS OUTBREAK. WE ACTUALLY USED TWO STRAINS THAT WERE ISOLATED FROM PATIENTS. INDUSTRY ADVISORS AND RESEARCHERS INDICATED SALMONELLA, WHATEVER ORGANISMS, IF IT IS A PATHOGEN, YOU NEED TO RUN THE STUDY IN AN APPROVED LABORATORY FACILITY. IF YOU SELECT A SURROGATE, YOU CAN, OF COURSE, RUN IT IN YOUR PLANT. SO THE SECOND STEP, IF YOU DECIDE TO SELECT THE ACTUAL PATHOGEN, YOU NEED TO SELECT A REPUTABLE LABORATORY. MAKE SURE YOUR LABORATORY HAS -- MAKE SURE YOUR COMPANY MAINTAINS AN ACTIVE ROLE IN THE STUDY TO ASSURE THAT YOU SIMULATE YOUR ACTUAL PROCESS. THE THIRD STEP IS TO SIMULATE THE EXACT CONDITIONS OF THE PLANT WHICH WOULD INCLUDE BELTS AND CONVEYORS, DWELL TIMES, CONCENTRATIONS, CHEMICALS, CULLING PROCESS, BRUSHING, WASHING AND SANITIZING. YOU MAY WANT TO RUN MORE THAN ONE TEST SCENARIO. IT WILL BE VERY SIMILAR, TIMELY AND COSTLY, IF YOU DON'T ACHIEVE THE 5-LOG REDUCTION AND YOU HAVE TO GO BACK AND RE-TEST. WE RAN TWO STUDIES THAT RESULTED IN AN ACTUAL LINE MODIFICATION. THESE EXTENSIVE ENHANCEMENTS WERE COMPLETED IN TIME TO COMPLY WITH THE NOVEMBER 5TH DEADLINE. THE FOURTH STEP IS TO DEVELOP THE TESTING PROTOCOL, WHICH MATERIALS ARE NEEDED, FORECASTING TIME NEEDED TO MEET REQUIRES DEADLINES, COST, INOCULATION TECHNIQUES, INOCULUM EXTRACTION PROCESS, WASHING AND SANITIZING PROCESS. AND THEN LAST STEP FIVE IS TO PERFORM THE ACTUAL STUDY. WE SELECTED REPRESENTATIVE ORANGES FROM VARIOUS SUPPLIERS. WE TRIED OUR BEST TO SIMULATE OUR TRUE PROCESSING CONDITIONS. IN CERTAIN CASES, ACTUAL EQUIPMENT WAS TOO LARGE OR HEAVY, SO PILOT-SIZED EQUIPMENT WAS USED. DEPENDING ON YOUR SYSTEM, THESE ARE PRESENTED OR FOR BRUSHING OR SMALLER ITEMS THEY CAN, OF COURSE, BE PURCHASED. WHILE SIMULATING OUR CITRUS LINE, WE DECIDED TO PULL SAMPLES AT VARIOUS LOCATIONS THROUGHOUT THE PROCESS IN ORDER TO BETTER UNDERSTAND WHERE WE WERE ACHIEVING OUR REDUCTIONS, RE-INOCULATED WITH GREATER THAN 5-LOGS TO COMPENSATE FOR ANY LOSSES DUE TO DRYING OR FOR OTHER CIRCUMSTANCES. WE SUGGEST SHOOTING FOR A 10 TO THE 8TH INOCULATION. WE USE THE SAME CHEMICALS AND CONCENTRATIONS THAT ARE MONITORED IN OUR PLANT OR ADMINISTERED THESE AT THE SAME LOCATIONS AND DWELLING TIMES. THE BEST WAY TO DETERMINE DWELLING SOMETIMES IS TO USE A STOPWATCH AND TIME OUR PLANTS' LINE, MAKE SURE THAT OUR CHEMICALS COME FROM A REPUTABLE SUPPLIER, AND THEY MEET ALL AGENCY REGULATIONS, SUCH AS EPA AND FDA. WE SORT THE FRUIT. BASED ON OUR PRODUCT, WE SELECTED FINISHED JUICE FROM ORANGES THAT WERE INOCULATED ON THE PEEL WITH SALMONELLA. JUICE WAS COLLECTED IN ACTUAL NAKED JUICE TYPE BOTTLES AND HELD FOR A PERIOD OF DAYS ACCORDING TO SHELF-LIFE. THE FINAL JUICE MUST ACHIEVE A 5-LOG REDUCTION THROUGH THE SHELF-LIFE PERIOD WHILE UNDERGOING MODERATE ABUSE CONDITIONS. THEREFORE, WE TESTED OUR JUICE AT FOUR DIFFERENT POINTS; NUMBER ONE, POINTS ALONG THE CITRUS LINE; TWO, FINISH JUICE DIRECTLY OFF THE LINE; THREE, FINISHED JUICE HELD FOR SHELF-LIFE AT REFRIGERATED TEMPERATURES; AND FINISHED JUICE HELD FOR SHELF LIFE AT ABUSED TEMPERATURES.

IN CONCLUSION, WE DID IT. IT CAN BE DONE IN SEVERAL WAYS, AND WE AND FELLOW INDUSTRY MANUFACTURERS HAVE

A KEY ITEM TO REMEMBER IS EACH STUDY WILL BE DIFFERENT BECAUSE EACH MANUFACTURING PROCESS IS DIFFERENT.

IN CONCLUSION, I WOULD ALSO LIKE TO SAY THAT IT IS IMPORTANT, AS A FEW OF MY FELLOW INDUSTRY MEMBERS MENTIONED THIS MORNING, MARC ISAACS SAID WE WORK CLOSER TOGETHER TO HELP SUPPORT THIS INDUSTRY, AND ALSO WE ARE JUSTIFIABLY PROUD OF OUR RESULTS. THIS WAS A TOTAL CALIFORNIA DAY FRESH TEAM EFFORT AND TRANSPIRED OVER SEVERAL MONTHS AND REPRESENTED SIGNIFICANT INVESTMENT IN BOTH TIME AND CAPITAL. WE ALSO SOLICITED INPUT FROM SEVERAL AGENCY EXPERTS AND AGENCIES IN ORDER TO COMPLETE THE PROJECT ON TIME. THANKS.

 

(APPLAUSE.)

DR. JOHN KVENBERG: THANK YOU, MR. SPERRY.

TURNING THE PAGE FROM PATHOGEN STUDIES AND A PARTICIPATING-IN STUDY, WE ARE NOW GOING TO HEAR FROM THE TECHNICAL EXPERTISE OF THE FOLKS THAT WORK WITH TRANSLATING THROUGH THE USE OF SURROGATE-TYPE ORGANISMS IN ACTUAL PLANT STUDIES AND WHAT THOSE FINDINGS WERE. OUR NEXT SPEAKER WAS ONE THAT WAS WITH US EARLIER THIS MORNING, MR. STEVE HUNTER, AGAIN, FROM FJC.

MR. STEVE HUNTER: THANK YOU. I AM GOING TO TRY IT ONCE AGAIN WITH THE SLIDES. AS HE JUST MENTIONED, OUR VALIDATION WAS DOING AN IN-PLANT STUDY AND WE HAD SELECTED A SURROGATE AND WE HAD FOUND -- WE FELT LIKE THE SURROGATE SELECTION PROCESS IDENTIFIES THE LOWER LIMITS OF THE REDUCTION; AND BY THAT I MEAN THE PATHOGENS ARE NOT AS HEARTY AS MOST OTHER ORGANISMS. WE ARE LUCKY IN A WAY THAT PATHOGENS ARE VERY VULNERABLE, OTHERWISE WE WOULDN'T BE HERE IF THEY WERE AS HEARTY AS SOME OF THE SURROGATE ORGANISMS THAT WE HAD CHOSEN. WITH DOING AN IN-PLANT VALIDATION, DEPENDENT UPON THE IN-PLANT VARIABILITY LOWER LIMITS OF REDUCTION, BY THIS I MEAN THAT WHEN WE DID THE VALIDATION STUDIES AT BOTH OF OUR PLANTS IN FLORIDA AND IN CALIFORNIA, WE DID IT AT THE END OF THE DAY AFTER THE LINE HAD BEEN RUN. AND SO WHEN WE LOOKED AT THE BRUSH WASHERS AND THE SANITIZING STEP THE EQUIPMENT, IT WAS FROM A FULL DAY'S WORTH OF PRODUCTION, DIFFERING FROM SOMETIMES IN LAB STUDY YOU WOULDN'T HAVE THOSE REAL LIFE CONDITIONS THE DEFINITION OF SURROGATE. AND WE TALKED ABOUT IT EARLIER, A NON-PATHOGENIC, AND THE CASE OF THE SURROGATE WE WANTED TO USE A SURROGATE THAT BEHAVED SIMPLY TO THE PERTINENT MICROORGANISM UNDER THE CONDITIONS BEING EXAMINED. SO WHEN IT CAME TIME TO DECIDE ON A PERTINENT MICROORGANISM FOR ORANGE JUICE, WE CHOSE SALMONELLA BECAUSE OF THE PRIOR HISTORY, THE THING FROM DISNEY. ALSO, THERE IS SOME ENVIRONMENTAL CONDITIONS, TOO. THE WAY THE FRUIT WAS PICKED, CONTAMINATION WOULD PROBABLY BE FROM A FECAL SOURCE, AND CITRUS GROWING CONDITIONS, IT WOULD PROBABLY BE FROM A BIRD OR AN AMPHIBIAN, RATHER THAN A MAMMAL. AND SO WE CHOSE SALMONELLA AS BEING THE PERTINENT MICROORGANISM.

NOW, IN ORDER TO QUALIFY THE SURROGATE, IT HAD TO COMPARE THE SAME AS THE INOCULUM. COULD YOU GROW UP THE SURROGATE TO THE SAME LEVEL THAT YOU COULD GROW UP THE PATHOGEN? ONCE YOU INOCULATED THE FRUIT, WOULD THE SURROGATE STAY ON THE FRUIT IN THE SAME FASHION AS THE PATHOGEN DID? WOULD THEY REACT TO BRUSH WASHING THE SAME WAY? WOULD THEY RESPOND TO THE SANITIZER IN THE SAME WAY? AND WOULD THEY APPEAR ON THE SURFACE THE SAME WAY IN THE EXTRACTION PROCESS? IN OUR STUDY, YOU CAN SEE THE EFFECT OF SALMONELLA. YOU CAN PRETTY MUCH SEE ON THE INOCULATING THAT WE WERE ABLE TO GROW THEM UP TO ABOUT THE SAME LEVEL, BOTH OF THEM ARE A 10 TO THE 8TH. RETENTION ON A FRUIT AFTER THEY HAD BEEN DIPPED INTO THE INOCULUM AND ALLOWED TO DRY AND THE CONCENTRATION WAS MEASURED ON THE SURFACE. SEE, THERE AGAIN THEY ARE VERY COMPARABLE. AND AFTER BRUSH WASHING, THE SAME THING OCCURS. AGAIN, THEY ARE VERY -- AND IF YOU DREW A LINE, IF YOU WERE TO MAKE A SLOPE BETWEEN THESE HERE AND THESE DOWN HERE, YOU WOULD FIND THE SLOPES ARE COMPARABLE OF THOSE LINES. SO NOW I AM SORT OF AFRAID WHICH WAY THIS ONE'S GOING TO SHOW UP. THIS STEP WE COMPARED THE PATHOGEN TO THE SURROGATE SURROUNDING THE ACTION WITH THE SANITIZER. AND BOTH OF THE ORGANISMS SURVIVED ABOUT THE SAME. YOU CAN SEE THE LACTOBACILLUS AND THE SALMONELLA SURVIVING ABOUT THE SAME. AND THEN, UPON TREATMENT WITH THE SANITIZER, THEY PRETTY MUCH FOLLOWED THE SAME PATTERN. THE WHOLE TIME WE WERE DOING OUR STUDY YOU WILL NOTICE THAT ON A LOT OF THESE WE HAVE SOME STATISTICAL INFORMATION AND WE WERE MOVING OUT THAT THEY TRULY WERE A MATCHED STATISTICALLY.

OKAY. HERE ARE SOME THINGS I WANTED TO MENTION SURROUNDING OUR STUDY AS FAR AS THE VALIDATION STUDIES GO. THERE IS A COUPLE OF TECHNIQUES THAT ARE USED FOR DETERMINING THE MICRO LOADING LEVEL ON THE SURFACE OF THE FRUIT. WE CHOSE TO USE THE SWAB TECHNIQUE VERSUS EXTRACTION. WE FELT LIKE THE SWAB TECHNIQUE MORE DUPLICATED THE PROCESS OF CONTAMINATION. OUR IDEA OF CONTAMINATION IS A BIRD WOULD FLY OVER, THERE IS THE ORANGE, THERE WOULD BE SOMETHING DROPPED ON THE ORANGE, IT GETS SOME WATER, IT GETS ROLLED AROUND AND SPREAD ON THE SURFACE OF THE FRUIT, AND SO WE THOUGHT THAT THE SWAB TECHNIQUE WAS BETTER VERSUS THE EXTRACTION TECHNIQUE WHERE YOU WOULD TAKE THE ORANGE AND PUT IT IN A BAG AND SHAKE IT IN A SOLUTION. SO WE HAD CHOSEN THAT TECHNIQUE.

ONE OF THE OTHER THINGS THAT WE FOUND IN OUR STUDY, AND IT HAS ALREADY BEEN MENTIONED, TOO, IS THAT I REALLY NEED TO BE STARTING OUT WITH RELATIVELY HIGH LEVELS OF ORGANISMS ON THE SURFACE OF THE FRUIT. AND WE FOUND WHEN DOING OUR STATISTICAL STUDIES, THAT OUR MOST STATISTICALLY-CORRECT NUMBERS CAME OUT WHEN WE STARTED OUT WITH AN INOCULUM OF ABOUT 10 TO THE 8TH. IT'S ALREADY BEEN MENTIONED HERE. IN THE VALIDATION STUDY, YOU NEED TO START OUT WITH A DESIGN. WRITE UP THE DESIGN BEFORE YOU START THE STUDY, AND THAT WAS MENTIONED EARLIER. YOU REPEAT THE STUDY UNTIL YOU GET TO STATISTICAL VALIDITY. I MEAN, WHEN WE DID OUR STUDY IN FLORIDA, FOR INSTANCE, WE GOT A VERY SMALL 95 PERCENT CONFIDENCE INTERVAL, AND SO WE SAID OKAY, WE KNOW THAT OUR LOG REDUCTION WAS 5.92 AND THE 95 PERCENT CONFIDENCE INTERVAL WAS BETWEEN 5.44 AND 6.34. THE OTHER THING IS, IT'S ALREADY BEEN MENTIONED BEFORE, ABOUT THE SEQUENTIAL ANALYSIS OF STEPS. AND THIS MEANS TAKING EACH STEP AT A TIME, ANALYZING THE LOG REDUCTION IN THAT STEP. THIS PRETTY MUCH GOES ALONG WITH THE CLASSICAL APPROACH TO ANALYZING INDEPENDENT SAFEGUARDS. EACH ONE OF THESE STEPS ARE, IN ITSELF, AN INDEPENDENT SAFEGUARD; THE BRUSH WASHING STEP, THE SANITIZING STEP, THE SELECTION OF FRUIT STEP, WHERE YOU ARE DOING THE EXTRACTION STEP. ANOTHER THING ABOUT THAT GOES BACK TO THE INOCULUM AND THE 10 TO THE 8TH FROM STUDIES WE HAVE SEEN OTHER PEOPLE TRY AND SOME OF OUR PRELIMINARY WORK WHERE YOU TAKE THE FRUIT ALL THE WAY THROUGH THE SYSTEM, THEY WERE FINDING THAT THEY WOULD GET REAL GOOD STATISTICAL NUMBERS RIGHT AT THE START WHEN YOU WERE TAKING IT RIGHT THROUGH THE FIRST COUPLE OF STEPS, BUT WHEN YOU GOT DOWN TO ONLY HAVING 10 TO THE 4TH INOCULUM ON THE FRUIT, THAT NEXT STEP YOU WERE GETTING REALLY ERRATIC NUMBERS, WEREN'T REALLY STATISTICALLY DIFFERENT.

THAT'S IT. THANK YOU.

 

(APPLAUSE.)

DR. JOHN KVENBERG: THANK YOU.

NEXT WE ARE GOING TO HAVE MR. DICK GERMOND FROM BEAUMONT JUICE, ALSO TALKING ABOUT EXPERIENCES WITH THE SURROGATES HERE IN BEAUMONT JUICE IN CALIFORNIA.

MR. DICK GERMOND: GOOD TO SEE EVERYBODY HERE. EVERYTIME I COME TO ONE OF THESE MEETINGS AND I GO BACK, I GO BACK WITH SO MANY IDEAS MY BOSS HATES TO SEE ME COME BACK. BUT I CAN TELL RIGHT NOW THAT THIS MEETING IS NOT GOING TO BE ANY DIFFERENT. I JUST NEED TO FIGURE THIS OUT HERE.

AS EVERYONE KNOWS, ROME WASN'T BUILT IN A DAY, BUT WE HAVE ABOUT SEVEN MONTHS LEFT, EIGHT MONTHS LEFT. ANYWAY, THAT'S FROM THE SISTINE CHAPEL. THE CHARACTER IS THE JUDGMENT, SO YOU CAN SEE HIS FACE. IF YOU FEEL UNFAIRLY JUDGED AND ARE STILL FIGHTING THIS AND CONTEMPLATING RUIN, DON'T WORRY, THERE ARE JUST ARE A FEW STEPS YOU TAKE TO GET TO A VERY NICE VIEW OF LIFE.

ALL RIGHT. I WANT TO THANK A COUPLE OF PEOPLE, ESPECIALLY ABC RESEARCH. THEY CONDUCTED SCIENTIFIC AND TECHNICAL STUDIES. DR. SCHNEIDER COULDN'T BE HERE. PATRICIA BAXTER, WHO IS THE LABORATORY DIRECTOR, IS HERE. IN CASE I GET IN TROUBLE, I WILL BE POINTING AT HER. ALSO, WE CHOSE PROTOCOL THAT FRESH JUICE AND HANSEN JUICE, WE HAVE HAD A VERY INERJISTIC RELATIONSHIP OVER THE LAST FOUR OR FIVE YEARS. STEVE'S BEEN VERY HELPFUL TO ME. HAVING COME FROM THE WORLD OF DENTISTRY ABOUT FIVE YEARS AGO, I DIDN'T KNOW THE DIFFERENCE BETWEEN A VALENCIA AND ANY OTHER TYPE OF ORANGE. I HAVE LEARNED A LOT. WE CHOSE A TWO-FOLD PURPOSE TO THE STUDY, WE WANTED TO, SINCE WE WERE GOING TO LOOK AT A SANITIZER, ONE THAT COMPARED TO, SO WE WANTED TO COMPARE THOSE TWO SANITIZERS AT THE SAME TIME THAT WE DID OUR VALIDATION STUDIES. THE TWO SANITIZERS WE CHOSE WAS THE FREE CHLORINE, SODIUM HYPOCHLORIDE AT 12.5 PERCENT THAT WAS DILUTED IN WATER, AND, OF COURSE, A MIXTURE OF THE FREE CHLORINE IN A PRODUCT CALLED CD85, WHICH IS A CHLORINE POTENTIATOR. AND IT BASICALLY ENHANCES AND EXTENDS THE RANGE OF PH AND THE AMBIENT TEMPERATURE THE CHLORINE WORKS IN. I WILL TALK A LITTLE BIT ABOUT THAT LATER. DURING THE COURSE OF THE STUDY, WE USE A STANDARD ISOMETRIC DURING THE BEGINNING OF EACH PHASE OF RUNNING THE ORANGES THROUGH THE PROCESS BOTH THROUGH THE POURING AND THE MIXTURE. THE CD85 WAS USED AND MONITORED USING AN OROPEEN SENSOR AND IT WAS VERY STABLE. AGAIN, WE RECOGNIZE FIVE STEPS THAT ARE INTEGRAL TO REDUCING MICROBIAL LOAD. THE ONES THAT ARE ITALICIZED ARE THE ONES WE CHOSE TO LOOK AT BECAUSE THE OTHER PARTS BASICALLY GET RID OF THE FRUIT THAT'S OBVIOUSLY CONTAMINATED OR BROKEN. WE WANTED TO LOOK AT WHAT HAPPENS TO THE FRUIT IN THE MICROBIAL LOAD AS IT GOES THROUGH THE PROCESS. SO WE ARE ACTUALLY GOING TO GO THROUGH THOSE THREE STEPS. I ALMOST FEEL LIKE I GOT MY BLOOMERS SHOWING BECAUSE I AM SHOWING A LOT OF DATA ABOUT MY PLANT, BUT THAT'S WHAT WE ARE HERE FOR, I GUESS.

WE HAVE 113 FEET OF SANITIZED FRUIT CONVEYANCE. I HAVE ONE OF THESE FANCY POINTERS HERE. THIS PART OF THE CONVEYANCE HERE IS VARIABLE SPEED, AND WHAT WE DID IS FOR ALL THE TESTING, THIS WAS AT THE FASTEST SPEED. BASICALLY THE SANITATION STARTS HERE, THESE ARE BIRD'S-EYE VIEWS, THIS IS OUR ZERO TOLERANCE OR OUR INSIDE GRATE TABLE, MORE OF THESE AND A BRUSH WASHER AND THEN OUR POTABLE RINSE. BASICALLY WE GET FROM A MINIMUM OF TWO MINUTES, JUST A LITTLE UNDER TWO MINUTES TO JUST A LITTLE UNDER FOUR MINUTES OF SANITIZER CONTACT TIME THROUGHOUT THAT WHOLE CONVEYANCE. WE SANITIZE THE BELT WHEN WE START, SANITIZE THE BELT AT THE END OF THE EXTRACTION LINE. SOME THINGS THAT WE THINK ARE REALLY NEAT ABOUT THE WAY WE DID IT. WE DON'T START OUT WITH A GRATING. WE UNLOAD THE TRUCKS HERE IN THIS AREA AND THEN WE HIT IT WITH A SANITIZER RIGHT AWAY TO BEGIN PERMEATING AND LOOSENING UP ANY SURFACE CONTAMINATION OF THE FRUIT. THEN IT GOES OVER A SEPARATED ROLLER ASSEMBLY TO GET RID OF A LOT OF LEAVES AND TWIGS AND DEBRIS. THEN OUR GRATERS CAN GET TO IT A LOT EASIER. THIS SECTION IS OUR SANITIZING SECTION FROM HERE TO HERE, TOTAL OF 74 SECONDS OF SANITIZER CONTACT RIGHT HERE, AND THAT'S A MINIMUM. AGAIN ALL OUR TESTING WAS DONE AT OUR FASTEST SPEED, WHICH COULD GIVE US OUR WORST CASE SCENARIO. OUR BRUSH WASHER, BRUSHING AND SANITIZING COMES HERE AT THIS SECTION. THIS IS AN ENCLOSED BRUSH WASHER AND THIS IS ENCLOSED. BY CLOSING THEM, BOTH THIS AND THE BRUSH WASHER WE WERE ABLE TO CREATE A LOT MORE SOAKING ACTION, AND FROM THE SANITIZER WE WEREN'T LOSING THE MIST. AND OUR LAST GRATE AREA. AND AGAIN, ALL THIS RIGHT HERE IS PART OF OUR BRUSHING SECTION. THIS HERE IS A TUMBLING BRUSHER, IT IS ACTUALLY, I BELIEVE, A POTATO WASH BRUSH. AND SO WE GET A LOT OF TUMBLING, A LOT OF MECHANICAL ACTION JUST BEFORE THE SANITIZERS RINSE AND IT GOES TO THE EXTRACTOR. I AM GOING TO SKIP OVER THIS; YOU CAN'T SEE IT ANYWAY. IT JUST TALKS ABOUT HOW LONG EACH SECTION IS, HOW MANY SECONDS IT EITHER GOT SPRAYED OR IS IN CONTACT WITH SANITIZERS. WE HAVE AN OLD PLANT, BUT WE THINK THAT WE HAVE MADE A LOT OF CAPITAL IMPROVEMENTS IN THE PLANT WHERE IT WAS NECESSARY. THE FAMILY, SINCE TAKING IT OVER ABOUT FIVE YEARS AGO, HAS MADE SOME TREMENDOUS CAPITAL IMPROVEMENTS IN EQUIPMENT. AND THEY HAVE ALSO SPENT AN AWFUL LOT OF MONEY ON TRAINING RESOURCES; SEVERAL OF US HAVE BEEN THROUGH HACCP TRAINING AND OTHER TRAINING. SO NOW WE ARE AT THE STAGE WHERE WE ARE TRYING TO INCORPORATE EVERYTHING. WHAT YOU ARE LOOKING AT HERE IS BASICALLY OUR UNLOAD SECTION RIGHT HERE. SANITIZING STARTS RIGHT THERE, GOES OVER THE SEPARATED ROLLER ASSEMBLY WHERE WE GET RID OF A LOT OF DEBRIS, AND THEN IT GOES INTO OUR GRATING SECTION. THIS IS JUST A CLOSER VIEW OF THAT. THIS IS OUR GRATE SECTION. THEN YOU COME TO OUR -- THIS IS THE END OF WHAT WE CONSIDER OUR SANITIZING AREA. THIS IS WHERE WE END THE 74 SECONDS. THAT'S THE MINIMUM AMOUNT OF SPEED AND WE GO INTO OUR BRUSH WASHING SECTION, ENCLOSED BRUSH WASHER, ENCLOSED ELEVATOR, THEN OUR INSIDE GRATE TABLE. THROUGH OUR PLANT YOU WILL SEE THESE LITTLE SIGNS; THESE ARE BASICALLY EITHER CRITICAL CONTROL POINTS OR JUST CONTROL POINTS THAT WE HAVE ESTABLISHED AS PART OF OUR HACCP PLAN. ANYWAY, THIS IS THE ENCLOSED BRUSH WASHER. IT REALLY DOES CREATE A CLOUD OF MIST IN THERE WHEN THIS IS RUNNING. AND THE SAME WITH THE ELEVATOR. WE JUST GET SO MUCH -- WE THINK WE GET SO MUCH MORE ACTION IN THERE, SO MUCH MORE SANITIZER CONTACT. IT HAS REALLY DONE A LOT FOR US, I THINK. THIS IS OUR ZERO TOLERANCE IN THE LAST INSIDE GRATE AREA BEFORE THE TUMBLING BRUSHES AND THE EXTRACTION AREA. THAT'S LOOKING AT THE BRUSH TUMBLER FROM THE OTHER END. THIS IS JUST COMING INTO OUR TRANSITION AREA WHERE IT GETS RINSED WITH WATER. THIS IS THE BACK TO THE EXTRACTORS, FRONT OF THE EXTRACTORS. THAT'S WHAT THE LINE LOOKS LIKE. SO WE ACTUALLY LOOKED AT THE THREE AREAS OF FRUIT SANITIZING, FRUIT WASHINGS, BRUSHING AND EXTRACTION.

WE HAVE ALREADY GONE OVER PRETTY MUCH THE TEST METHOD. BASICALLY WHAT THEY DO IS THEY DREW AN EQUATORIAL LINE AROUND THE ORANGE WHICH WAS INOCULATED, AND THEN WE INSERTED THE ORANGES AT THE BEGINNING OF EACH STAGE AND PULLED OUT AT THE END, AND THEN THEY WERE SWABBED, PUT IN A BUFFER VORTEX, AND LATER COUNTED. I AM JUST GOING TO GO REAL QUICK THROUGH THE THREE STEPS.

THE FRUIT SANITIZING STEP. ONE OF THE THINGS YOU WILL ALSO SEE IS FRUIT IS INSPECTED, IT IS SANITIZED, DEBRIS IS REMOVED, AND THEN WE ACTUALLY HAVE A GRATING STEP IN OUR SANITIZING STEP THAT WE LOOKED AT OUR PLANT. THE FRUIT INSPECTION AT THE BEGINNING WHERE THE UNLOAD IS, THAT'S REALLY THE SECOND INSPECTION POINT IN OUR PLANT. THE FIRST ONE IS OUTSIDE THE SCALE. HOWEVER, ONE OF THE ISSUES THAT WE HAVE, WE REJECT FRUIT AT THE SCALE WHEN IT FIRST COMES IN, BUT WITH PACKING HOUSE FRUIT OCCASIONALLY IT WILL COME IN OR YOU WON'T KNOW WHAT IT REALLY LOOKS LIKE UNTIL YOU START UNLOADING IT. AND SO WE ALSO WILL REJECT FRUIT AT THAT POINT. SO JUST BECAUSE IT GOT INTO THE PLANT DOESN'T MEAN IT IS GOING TO GO THROUGH. SANITIZING STARTS IMMEDIATELY TO INCREASE THE CONTACT TIME. WE REMOVE ALL THE DEBRIS, LEAVES, TWIGS, REMOVE A MAJOR PORTION OF THE VISIBLY-DAMAGED, CONTAMINATED FRUIT. SO THIS HERE IS JUST A BLOW-UP OF THIS SECTION RIGHT HERE. INSERT THE INOCULATED ORANGES AT THIS POINT AND THEY WERE PICKED OUT HERE AND LATER TABULATED, COUNTED AND TABULATED. FRUIT WASHING, BRUSHING STEP I THINK WE HAVE ALREADY -- I THINK I ALREADY WENT THROUGH THIS PRETTY MUCH. AS I WAS TALKING ABOUT -- THE SANITIZER CONTACT TIME ON THIS SECTION IS A MINIMUM OF 58.5 SECONDS WITH 51 SECONDS OF SPRAY. SO WE ARE GETTING A LOT OF SPRAYING CONTACT TIME AT THE PLANT. THIS IS THE SECTION WHERE WE INSERT THE INOCULATED ORANGES HERE, THE SURROGATE, AND THEY WERE PULLED OUT HERE AT THE END JUST PRIOR TO THE RINSE.

THE PINPOINT JUICE EXTRACTION TECHNIQUE JEAN HAS ALREADY GONE OVER, WHEN YOU GET TO THE BOTTOM LINE HERE, WHICH I KNOW EVERYBODY IS INTERESTED IN. HERE ARE THE RESULTS THAT WE GOT. FRUIT SANITIZING, 2.68 WITH THE CHLORINE, 2.3 WITH THE CHLORINE AND THE CONVEYOR BELT 85. NOTICE HERE THIS IS 6.03 HERE.

NOW, IN ALL FAIRNESS, I HAVE TO EXPLAIN WHAT HAPPENED. WE WERE VERY DISAPPOINTED WITH THESE RESULTS THAT WE GOT HERE. FRANKLY, AND I TRULY AND I THINK EVERYBODY IN THE COMPANY BELIEVES THAT WE SHOULD HAVE GOTTEN A LOT MORE. WE DECIDED TO COMPARE A STUDY THREE DAYS BEFORE WE RAN A TEST. I ASKED VONAGRA TO COME DOWN AND WE WERE TOLD THE DAY BEFORE THAT THEY DON'T KNOW IF THEY HAD ENOUGH MIXING TIME AND WE CHOSE TO RUN IT ANYWAY. WE DIDN'T -- ABOUT A YEAR AGO, WE RAN A TEST AT DFL LABS IN MODESTO USING E.COLI 0157, MANY LARGER REDUCTIONS ARE A COMBINATION MIXTURE IN THE LAB IN THE IN VITRO STUDY THAT WAS DONE THERE. AND WE REALLY TRULY BELIEVE THAT THE PROBLEM WAS THAT THERE WAS INADEQUATE MIXING BEFORE IT WAS INJECTED. AND WE AREN'T DONE WITH THIS YET. AND THIS IS REALLY JUST A SNAPSHOT IN TIME OF WHAT'S GOING ON HERE. WE ARE LOOKING AT VONAGRA FOR SOME OTHER ADVANTAGES TO THEIR SYSTEM THAT WILL TAKE CARE OF SOME ISSUES RELATED TO MONITORING AND DOCUMENTATION OF THE HACCP PROGRAM. SO NOT ONLY -- WE LOOK TO THEM FOR THE CHEMICAL HELP, BUT ALSO SOME OTHER THINGS. I WANTED TO PUT THAT PLUG IN BECAUSE THIS WAS REALLY NOT FAIR TO THEM.

I HOPE YOU HAVE A PIECE FULL TRIP HOME AND A NICE NIGHT.

 

(APPLAUSE.)

DR. JOHN KVENBERG: THANK YOU VERY MUCH.

WE HAVE ANOTHER SPEAKER IN ADDITION TO THE PROGRAM WHICH WAS MY FAULT. ODWALLA ALSO HAS INFORMATION ON THEIR VALIDATION TECHNIQUES THAT THEY WOULD LIKE TO SHARE AND DISCUSS WITH US TODAY. AND LINDA FRELKA, WHO SPOKE TO US THIS MORNING, WILL AGAIN RETURN TO THE PODIUM TO SPEAK ABOUT HER EXPERIENCES WITH ODWALLA.

MS. LINDA FRELKA: I AM BACK, AND AGAIN I AM THE LAST SPEAKER BEFORE BREAK. THERE IS SOMETHING GOING ON HERE.

I DIDN'T GET A CHANCE TO TELL YOU A LITTLE BIT ABOUT VALIDATION STUDIES THAT WE HAVE DONE AT ODWALLA. THE FIRST STUDY THAT WE ACTUALLY PERFORMED WAS IN JULY OF 1997 AT SILICONE LABS, IN-LAB, SO TO SPEAK, TYPE OF STUDY. AND WE THOUGHT THAT STUDY WAS JUST GREAT AND WE THOUGHT WELL, WE'LL REST ON OUR MORALS ON THAT. BUT WE THOUGHT WELL, I THINK WE SHOULD DO AN IN-HOUSE STUDY, TOO. AND HAVING TALKED TO OTHER PEOPLE IN THE INDUSTRY, WE DECIDED THAT'S A GOOD WAY TO GO. IT IS CRITICAL TO KNOW HOW YOUR SYSTEM IS GOING TO REACT WITH A PATHOGEN AND HOW IT IS GOING TO REACT WITH CIRCUIT ORGANISMS. A CIRCUIT ORGANISM WAS CHOSEN. SALMONELLA WE DIDN'T CHOSE, ALTHOUGH IT DID SURVIVE IN THE DISNEY OUTBREAK. WE WANTED SOMETHING THAT WOULD MORE SIMULATE IN OUR PROFESSION. E.COLI 0157 WOULD BE MUCH MORE ACID TOLERANT THAN SALMONELLA WOULD BE. THAT'S WHERE OUR THOUGHTS WERE. WE ALSO CHOSE LACTO ACIDOPHILUS BECAUSE IT IS A COMMERCIALLY-AVAILABLE CULTURE. THE STRAIN WAS ALSO INSTRUCTED BY RESISTANCE, WHICH WE THOUGHT WOULD BE AIDING US IN OUR IDENTIFYING WITH THE ORGANISM. THE WHOLE REASON BEHIND DOING A VALIDATION STUDY WAS NOT SIMPLY TO SATISFY THE FDA REQUIREMENT THAT CAME OUT WITH THE NEW RULE BECAUSE WE HAD ALREADY DONE THAT A YEAR AGO. THE REASON TO PERFORM THE VALIDATION STUDY WAS TO PROVE THAT THE CRITICAL CONTRACT TO HACCP PLAN WERE BEING DONE CORRECTLY, PROVE TO OURSELVES AND OUR CONSUMERS. THE COMPANY HACCP, A 100 CCP OR ONE CCP, BUT IF THEY HAVEN'T PROVEN THE PLAN CORRECT, THE PLAN'S WORTHLESS. THE SAME GOES WITH HAVING HACCP PLAN VERIFIED. THE PLAN CAN BE WRITTEN ON THE SHELF, BUT IF IT IS NOT BEING FOLLOWED, AGAIN IT IS WORTHLESS. ODWALLA HAD A THIRD PARTY COMING TO THE PLANT TO PERFORM AN AUDIT TO VERIFY THAT THE PLAN IS BEING DOCUMENTED CORRECTLY. THIS PROCESS IS PERFORMED ON AN ANNUAL BASIS. THE FIRST ITEM OF BUSINESS IN A EVALUATION STUDY IS OBVIOUSLY THE DEVELOPING EXPERIMENTAL PROTOCOL, WHICH WE HAVE HEARD TODAY. ODWALLA WORKED WITH SILICONE LABS IN CARSON, CALIFORNIA, WHO IS REPRESENTED HERE TODAY. A LOT OF THANKS TO THEM. AND ALSO DR. MICHELSON AND DR. DOUG ARCHER, WHO IS AT THE UNIVERSITY OF FLORIDA. THERE ARE SOME ITEMS THAT WE WANT INFORMATION ON WHICH EXACTLY IS WHERE VALIDATIONS ARE DONE TO GET INFORMATION. ONE WE WANTED VALIDATION THAT CCPS ARE IDENTIFIED DURING OUR HACCP ANALYSIS WERE CORRECT. ITEMS INVOLVED IN THESE CCPS HAD TO BE AT THE CRITICAL LIMIT. AND I AM NOT SURE WHERE THE OTHER PLANS SET THEIR CRITICAL LIMITS, BUT AS I TALK ABOUT IT, YOU KNOW ONE OF MY CRITICAL LIMITS WITH ONE PART PER FREE UNIT OF CHLORINE. SO WE HAD TO 1.1 PH. IT IS NOT FAIR TO RUN A VALIDATION STUDY AT 200 PARTS PER MILLION FREE CHLORINE WHEN YOUR CRITICAL LIMIT IS ONE. SECOND, WE HAD TO QUANTIFY THE LAB REDUCTION ON EACH WAS RINSE AND SANITIZING RINSE IN THE PROCESS. AND LASTLY, WE WANTED TO QUANTIFY THE LAB REDUCTION FOR FRESH SQUEEZED ORANGE JUICE. FOURTH POINT, WHICH I DON'T HAVE HERE AND I WON'T GO OVER REALLY, WE ALSO WANTED TO VALIDATE IN OUR OWN MINDS WHETHER OR NOT WE NEEDED A FRUIT AND VEGETABLE WASH CHEMICAL THAT WE APPLIED TO THE BRUSH SCRUBBER AND WE DID THAT ALSO, SO IT'S A GOOD OPPORTUNITY. WE ACTUALLY PERFORMED TWO STUDIES WITH THIS ACIDOPHILUS CULTURE, OR THE FIRST STUDY ACTUALLY PROMPTED A NEED FOR MORE DATA. WHAT'S REALLY SPECIFIC ABOUT USING THIS CULTURE, IT IS SOMETHING THAT YOU SPECIFICALLY GO TO A HEALTH FOOD STORE AND PURCHASE IF YOU WANT TO. NOW WE NOW HAVE THIS FANTASTIC BASELINE OF INFORMATION THAT WHENEVER WE MAKE A CHANGE TO THE PROCESS, WE CAN GO BACK AND DO THE STUDY ON OUR OWN, ALTHOUGH IT WAS THERE AND CREDENTIALED IT THERE THE FIRST AND SECOND TIME WE DID IT. ANY TIME WE WANTED TO CHECK A CHANGE IN THE PROCESSOR, HEY WE WANT TO CHECK ANOTHER CHEMICAL SANITIZER, AND WE'LL BE ABLE TO SIMPLY GO BACK AND DO THAT BY OURSELVES AND VALIDATE OUR PROCESS CONSTANTLY.

FIRST ONE I WANT TO TALK A LITTLE BIT ABOUT THE INOCULATING TECHNIQUES THAT WE WERE USING. WE USED A LOT OF DIFFERENT TYPES OF INOCULATIONS THAT COULD BE USED. EACH OF OUR TWO STUDIES CALLED FOR ABOUT 300 INOCULATED ORANGES. AND WE DECIDED THAT WE REALLY DIDN'T WANT TO DO A DIPPING BECAUSE WE THOUGHT THERE WOULD BE POOLING AS THE ORANGE SAT. WE ALSO FELT LIKE WE WERE USING DIFFERENT SIZED ORANGES, ALTHOUGH SIZES IN CALIFORNIA ARE FAIRLY CONSISTENT. WE DIDN'T WANT TO HAVE BIG ORANGES BE FULLY INOCULATED WITH THE SIZE OF THE ORANGE BECAUSE WE TOOK OUR COUNTS ON A PER-ORANGE BASIS. WE DIDN'T GO BACK AND LOOK AT CENTIMETERS SQUARE OR HOW BIG THE ORANGE WAS, SO WE ARE LOOKING AT PER-ORANGES. SO WE THOUGHT IF WE HAD BIG ORANGES, WE WOULD HAVE MORE INOCULATION; IF WE HAD LITTLE ORANGES, WE WOULD HAVE LESS INOCULUM. SO WHAT WE DEVELOPED WITH SILICON WAS A SPRAY BOTTLE TO DELIVER .8 TO .9 MILLILITERS OF INOCULUM PER SPRAY. THE FIRST INOCULATE THE 10 TO THE 5TH, WHICH WE HEARD FROM THE LAST FEW STUDIES, 10 TO THE 5TH IS NOT HIGH ENOUGH TO FIGURE OUT WHAT THE HECK IS GOING ON. THE SECOND STUDY WENT TO 10 TO THE 7TH. WE DECIDED WHERE SHOULD WE SPRAY THE ORANGE, WELL, WE THOUGHT WE WERE GOING TO GO WITH THE STEM END. EVERY SINGLE ORANGE WAS SPRAYED ON THE STEM END BECAUSE THIS IS THE MOST CHALLENGING PORTION OF THE ORANGE. DR. POWELL AT DEPARTMENT OF CITRUS IN FLORIDA HAS SHOWN THROUGH HIS STUDY, WHICH IS AVAILABLE HERE, THAT THE WATER THAT THE STEM END RETAINS MORE ORGANISMS THAN ANY OTHER PART OF THE ORANGE. SO WE CHALLENGED THIS SYSTEM AS MUCH AS WE COULD. WE ALSO IDENTIFIED ALL OF OUR INOCULATED ORANGES WITH SPRAY PAINTING THE BASE OF THE ORANGE. WE OPTED NOT TO USE A MARKER OR PEN BECAUSE WHEN WE TESTED IN THE PROCESS, IT SCRUBBED IT OFF, WHICH WAS GOOD. BUT WE ENDED UP HAVING TO SPRAY PAINT 100 ORANGES. ALSO QUANTITY OF ORANGES. SINCE A WHILE WE REALLY WANTED TO CONTROL THE SYSTEM, WE DECIDED WE WANTED TO PUT 100 ORANGES INTO EACH WASHING AND SCRUBBING AND RINSING STEP, PUT THEM IN AND TAKE THEM OU TO SEE THE EFFECT. IN SOME CASES, WHEN WE WERE GOING FOR JUICE COLLECTION, WE USED 500 POUNDS OF ORANGES. THE TYPE OF FRUIT WE USED WAS CALIFORNIA VALENCIAS, EACH PICKED THAT NIGHT OR BEFORE. THEY WERE NOT PRE-WASHED OR CLEANED IN ANY WAY AND ONLY WHOLESOME FRUIT WAS UTILIZED. THE FIRST EXPERIMENT IS REALLY CUMMULATIVE DATA. WE IDENTIFIED SEVEN DIFFERENT SAMPLING POINTS FROM RINSING AND SANITIZING. I WON'T BOTHER WITH YOU ALL THOSE DETAILS, BUT WE ALSO SAMPLED THE RIND THAT WAS LEFTOVER ON THE EXTRACTOR AFTER WE EXTRACTED THESE ORANGES, AND ALSO THE JUICE, THE RESULTANT JUICE. EACH SAMPLE POINT WE PUT IN 10 PIECES OF INOCULATED ORANGES WITH 90 PIECES OF UNINOCULATED ORANGES. SO WE HAVE A 10 PERCENT INOCULATION LEVEL THAT WE ARE CHECKING. WE ENDED UP TAKING FOUR PIECES OF TAGGED FRUIT IMMEDIATELY AFTER THE WASH, OR WHICHEVER RINSE OR SANITIZING STEP, BROKE THEM INTO TWO SETS, MADE TWO SETS OF TWO AS SAMPLES IN THE FIRST EXPERIMENT. THIS IS ALSO DONE AT THE EXTRACTOR; WE TOOK SAMPLES OF THE RIND AND SAMPLES OF THE JUICE. THE DATA THAT I AM GOING TO SHOW YOU IS EXPRESSED IN PER MILLILITER FROM THE 10 MILLILITER RINSE PER ORANGE. AND YOU HAVE A HARD TIME WITH TALKING ABOUT MILLILITERS AND JUICE OF INOCULUM THAN IF YOU MULTIPLIED BY 10, YOU ARE TALKING ABOUT CFUS PER ORANGE. SO HERE IS THIS DATA. A, B, C, THOSE ARE JUST WASHING, RINSING, SCRUBBING STEPS THAT EVERYBODY HAS TALKED ABOUT. FAIRLY SIMPLE. YOU ALREADY KNOW IT IS 10 PERCENT INOCULUM. SO WHAT WE DID WAS WE HAD OUR STEP A IS INOCULATED FRUIT, SO THAT'S WHAT WE STARTED WITH. NOT AS HIGH AS WE HAD HOPED TO START WITH AT 4.65-LOG COUNT. PUT IT INTO STEP B. WE PUT THAT FRUIT INTO STEP B AND HERE IS OUR REDUCTION ALL ALONG THE DIFFERENT STEPS THAT WE ENDED UP HAVING. IF WE ADD THOSE UP, WE HAVE A CUMMULATIVE LOG REDUCTION OF 11.09. THAT'S THE RESULTANT OF WASHING, RINSING, SCRUBBING STEPS. OKAY. THEN WE COME TO THE JUICE. WE GOT SOME REALLY CONFUSING DATA. THE TOP PORTION IS JUICE FROM 100 PERCENT INOCULATED ORANGES. WE HAD RUN THIS BIN OF 500 POUNDS OF ORANGES, OF WHICH 50 OF THEM WERE INOCULATED OR RIGHT BEFORE IT WENT TO EXTRACTION, WE PULLED OUT ALL THE OTHER INOCULATED FRUIT BECAUSE WE DIDN'T WANT TO DILUTE WHATEVER WAS LEFT THERE. THAT'S WHAT OUR THOUGHT WAS. SO ALL WERE WASHED, RINSED AND SANITIZED. AND WHAT WE ENDED UP COMING UP WITH WAS A 4.3-LOG COUNT. UH-OH. WHAT IS THAT? WELL, WHAT WE COME TO FIND OUT IS THAT HERE WE WERE THINKING THIS STREPTOMYCIN RESISTANT -- SO LIKE JUST LIKE FRESH JUICE, THEY DIDN'T WASH OR CLEAN THEIR SYSTEM BEFORE THEY RAN THEIR TEST. OUR PRODUCTION LINED RUN FOR 16 HOURS AND THEN SAT FOR FOUR MORE HOURS BEFORE WE DID THE TEST. AND THEN THE BOTTOM NUMBER WAS WHEN WE HAD TAKEN THE SAME TYPE OF PROCESS FROM THE EARLIER SLIDE, 10 PERCENT INOCULATED FRUIT DIRECTLY INTO THE FOS, WE WENT FROM 4.3 TO 3.15. SO THIS PROMPTED US TO GO BACK AND SEE WHAT WAS GOING ON AND DO THE STUDY AGAIN FROM THE JUICE PORTION. THAT LEADS US TO OUR SECOND EXPERIMENT. THERE WERE A FEW THINGS WE NEEDED TO CHANGE. FIRST, WE NEEDED TO INCREASE OUR INOCULATION LEVELS BECAUSE IF WE TRULY WANTED TO SEE A 5-LOG REDUCTION IN THE JUICE, WE DIDN'T START AT LEAST THIS LOG, SO WE BOOSTED THAT UP. WE ALSO MADE A CHECK FOR FRUIT FOR ANY NATURALLY OCCURRING ORGANISMS THAT WERE STREPTOMYCIN-RESISTANT, AND ALSO NEEDED TO CONFIRM THE TARGET ORGANISM. ADDITIONALLY, WITH THIS SET OF DATA, WE DECIDED TO INCREASE OUR SAMPLING SIZE. WE SAW DIFFERENCES IN THE INDIVIDUAL DATA POINTS THAT TWO SETS OF TWO THAT LEAD US TO THINK A LITTLE MORE DATA HERE. SO WE WENT WITH FIVE SETS OF TWO FOR ALL THE ORANGES AND FIVE SETS OF SAMPLES OF JUICE. WE DID JUICE FROM 100 PERCENT INOCULATED ORANGES DIRECTLY INTO THAT EXTRACTOR. YOU SEE HERE, STEP A, WE STARTED AT LOG POINT OF 7.47, SO WE ACCOMPLISHED BOOSTING UP THAT INITIAL LOG COUNT, SO OUR FRUIT STARTED AT 7.47. THIS IS FOR 10 PERCENT INOCULATED ORANGES, AND WE RAN THEM THROUGH THE ENTIRE SYSTEM. AND THIS WENT THROUGH THE ENTIRE SYSTEM, WE SAMPLED THEM ALONG THE PROCESS THIS TIME, AND THEN ALSO LOOKED AT THE RESULTANT JUICE FROM BEING WASHED AND SCRUBBED AND SANITIZED. SO WE ENDED UP WITH 6.4 OVERALL TOTAL LOG REDUCTION, AND WE COUPLED THAT WITH OUR OTHER RESULTS ON THE LOG REDUCTION. WE FEEL GOOD ABOUT THAT. WE SAMPLED THE RIND THAT WAS LEFT ON THE EXTRACTOR DURING THE EXTRACTION PROCESS, AND IT CAME OUT AT LESS THAN ONE ALSO. WE ALSO DECIDED THAT WE REALLY WANTED TO LOOK AT JUICE-TO-JUICE, LET'S JUST COMPARE JUICE-TO-JUICE. IF WE TOOK THIS HORRIBLY INOCULATED GROUP OF ORANGES, 100 OF THEM, OR WE THREW THEM IN THE EXTRACTOR WITH 100 PERCENT OF EVERY SINGLE ORANGE WENT THROUGH THERE HAD A BIRD COME BY, WHAT WOULD HAPPEN? AND HERE IS WHAT WE ENDED UP, WHICH SURPRISED US AT THE LOW NUMBER THAT WE ACTUALLY GOT. WE CAME WITH AN AVERAGE LOG COUNT OF 3.27 COMPARED TO OUR INOCULUM OF OVER 7. SO THE JUICE THAT WAS RESULTANT OF ALL OF THOSE ORGANISM WAS 1,000 ORGANISMS. SO WE DID THE SAME THING, WE TOOK 100 ORANGES THAT WERE INOCULATED AND RAN THEM THROUGH THE ENTIRE SYSTEM TO COMPARE THAT JUICE AND WE CAME OUT WITH A LESS THAN 1-LOG, NON-DETECTIBLE LACTOBACILLUS ACIDOPHILUS STRAIN. ONE STUDY ALWAYS LEADS TO ANOTHER STUDY, I ALWAYS THINK.

I JUST WANT TO TALK A LITTLE BIT MORE ABOUT FURTHER VALIDATION AND VERIFICATION. WE TALKED ABOUT TWO DIFFERENT THINGS THERE, SOME OF THE THINGS THAT ODWALLA IS DOING THAT MAKES SURE THAT WE PROVIDE SAFE JUICE TO OUR CUSTOMERS. FIRST, GENERAL E.COLI POLICY. WE DECIDED WE DIDN'T NECESSARILY WANT TO TEST EVERY SINGLE BATCH FOR SALMONELLA OR EVERY SINGLE BATCH FOR 0157. IN THE FRESH JUICE WORLD, THAT'S A VERY LONG TIME SPAN, AND WE HAD DONE THAT FOR OVER A YEAR AND WE HAD RESULTS FROM THAT. SO WHAT WE DECIDED TO USE FOR OUR INDICATOR ORGANISM WAS GENERAL E.COLI. GENERAL E.COLI SHOULDN'T BE THERE, SHOULDN'T BE IN FRESH ORANGE JUICE OR ON FRESH ORANGES. IT IS AN INTESTINAL TRACT ORGANISM. IT DOESN'T HURT ANYONE, BUT IT SHOULDN'T BE THERE. WE DO A DIRECT CLAIM TECHNIQUE THAT THE UNIVERSITY OF FLORIDA RECOMMENDED TO US WHICH ALLOWS TO GET TWO CFUS, NOT LOG 2, WHICH IS 100. 2. OUR POLICY IS IN PLACE THAT IF THE JUICE IS LESS THAN TWO CFUS, WE RELEASE IT. IF THE JUICE HAS TWO TO 10 CFUS, IT IS SLATED FOR PASTEURIZATION. IF JUICE IS OVER EIGHT CPUS, IT IS DUMPED DOWN THE DRAIN. JUICE IS NOT -- WE HOLD ALL OF OUR ORANGE JUICE, TANGERINE, LEMON, LIME, ANY FRESH CITRUS JUICE THAT WE MAKE FOR AT LEAST 24 HOURS BEFORE WE SHIP IT. TESTING FOR SALMONELLA WAS PERFORMED FOR OVER ONE YEAR. BASED ON 525 NEGATIVE RESULTS WITH NO POSITIVE RESULT, WE DETERMINED IT WAS NO LONGER NECESSARY. TESTING FOR E.COLI 0157:H7 FOR 17 MONTHS ON EVERY SINGLE TANK OF ORANGE JUICE, BASED ON OVER 450 NEGATIVE RESULTS WHERE NO POSITIVE TESTING, HAS BEEN REDUCED TO ONE TANK PER WEEK BECAUSE WE STILL BELIEVE THAT 0157 WOULD BE A THREAT THAT WOULD BE THE MOST DANGEROUS AT THIS POINT SINCE IT IS SUCH A LOW INOCULATION LEVEL THAT CAN HURT PEOPLE. WE ALSO GO OVER ENVIRONMENTAL SWABS WITH A VENGEANCE. WE SWAB 50 CITES PER WEEK DURING OUR PRODUCTION TIME AND 25 DURING AND 25 AFTER SANITATION. IN PARTICULAR, WE FOCUS ON OUR ULTRA CLEAN ROOM, WHICH IS CRITICAL TO MAINTAINING A SUITABLE ENVIRONMENT. THE ULTRA CLEAN ROOM HAS HEPA-FILTERED AIR AND HAS NO FORKLIFT TRAFFIC. CLEAN ROOMS ENSURE THAT THE CLEAN ROOM IS KEPT CLEAN. THESE ARE JUST A FEW SAMPLES OF WHAT ODWALLA IS DOING TO PROVIDE THE CONSUMER AS SAFE A JUICE AS POSSIBLE.

I APPRECIATE THE OPPORTUNITY TO SHARE THESE WITH YOU, AND IF THERE ARE ANY QUESTIONS, I WOULD PROBABLY BE WILLING TO DISCUSS THEM. THANK YOU.

 

(APPLAUSE.)

DR. JOHN KVENBERG: OKAY. THIS IS THE POINT IN THE PROGRAM WHERE I COME BACK UP AND SAY IT IS TIME FOR QUESTIONS AND COMMENTS FROM THE AUDIENCE. AND THIS IS YOUR OPPORTUNITY TO DISCUSS OR ASK QUESTIONS OR MAKE OTHER COMMENTS RELATIVE TO WHAT YOU HAVE JUST HEARD ON THE VALIDATION TECHNIQUES FROM THE PEOPLE THAT HAVE DONE THIS WORK.

MR. STEVEN WILLIAMSON: MY SAME STEVEN IS WILLIAMSON FROM ODWALLA. JUST REFLECTING ON WHAT LINDA SHARED WITH YOU, THIS IS OBVIOUSLY TWO YEARS OF PAINFUL AND EXPENSIVE WORK, BUT I WANT TO GO BACK TO MY OPENING STATEMENTS OF THIS MORNING, WHICH IS I REALLY THINK THE FRESH JUICE INDUSTRY IS AT A CRITICAL JUNCTURE, EVEN THOSE THESE REGULATIONS ARE EIGHT MONTHS OFF IN THE FDA'S MIND. IN THE CONSUMERS MIND, THEY ARE IN A STATE OF CONFUSION, AND WHEN YOU ARE IN A STATE OF CONFUSION, I THINK THIS ALL IMPACTS YOUR SALES. SO MY GOAL, AS I SAID EARLIER, AND I TALKED TO MARC ABOUT IT, IS TO TRY TO GET TO A POINT AS QUICKLY AS POSSIBLE BEFORE THE EIGHT MONTHS. AND I HAD SEEN JUST THIS MORNING NETWORKS THAT IS GOING ON BETWEEN STEVE HUNTER AND LINDA AND OTHER PEOPLE IN THIS ROOM DOING THIS KIND OF THING THAT'S VALUABLE. THERE ARE A LOT OF LESSONS, WE HAVE A LOT OF LESSONS REALLY INCREDIBLY VALUABLE. THE ULTIMATE IS TO SHARE WHAT YOU HAVE LEARNED IN LACTOBACILLUS WE HAVE LEARNED HERE. AND MY POINT IS WE ARE NOT THAT FAR AWAY FROM BEING ABLE TO COME UP WITH SOME BASIC OPERATING PRINCIPLES THAT SHOULD DELIVER SAFE JUICE WELL AHEAD OF THE GOVERNMENT. WE DON'T NEED EIGHT MONTHS TO DO THAT. AND THE POINTS THAT I PUT OUT EARLIER, I REALLY WANTED TO SUGGEST AN OPEN DIALOGUE ON ABOUT WHAT WE CAN DO. MAYBE THEY ARE NOT THE RIGHT FIVE POINTS, BUT I THINK THEY HAVE BEEN HELPFUL FOR US AND WE HAVE THINGS WE HAVE LEARNED THAT WE ARE SHARING. AND IF WE CAN COME TOGETHER WITH SOME BASIC PRINCIPLES ON HOW WE OPERATE, WE DON'T HAVE THIS PROBLEM WITH CONSUMERS BEING WORRIED. AND AGAIN, I THINK WE HAVE A FAIRLY GOOD NETWORK AROUND THE COUNTRY AND WE GET REALLY IMMEDIATE FEEDBACK FROM OUR OVER 160 ODD SALESPEOPLE OUT IN THE MARKETS AND 5,000 ACCOUNTS. THERE IS A LOT OF UNCERTAINTY ABOUT WHAT FRESH JUICE IS TODAY AND IT IS SOMETHING WE SHOULD NIP IN THE BUD TO MOVE TO MINIMUM-PROCESSED JUICE.

DR. JOHN KVENBERG: ADDITIONAL COMMENTS?

AUDIENCE MEMBER: THIS IS ACTUALLY DIRECTED TO THE FDA. WE PROVIDE TECHNICAL SERVICES AND VALIDATION AND AUDITING FOR THE AGRICULTURE, AND JUST ONE OF THE COMMENTS THAT WAS EARLIER MADE, THERE IS A LOT OF DATA ALREADY COMPILED BY THE PUBLIC AND THE PRIVATE SECTOR FOR VALIDATION, AND WHAT WE FIND OUT IS THAT TO THE SMALL PRODUCERS, THE SMALL JUICERS, THIS BECOMES ECONOMIC BARRIER FOR THEM TO DO BUSINESS. THE LARGE BUYERS ARE ACTUALLY ASKING FOR EVALUATION FROM THEIR VENDORS FOR THE JUICE COMPANIES, WHICH NOW ACTUALLY HAMPERS THE SMALL JUICE COMPANIES TO DO BUSINESS WITH THE LARGE BUYERS BECAUSE, AS YOU WELL KNOW, THESE VALIDATION PROCESSES ARE EXTREMELY EXPENSIVE TO PRODUCE. I WAS CURIOUS WHETHER THE FDA WOULD CONSIDER STANDARD OPERATING PROCEDURES OR SOME SORT OF A PROCESS CERTIFICATION, BECAUSE WE KNOW THAT SEVERAL SANITIZERS AND SEVERAL -- WILL PRODUCE 5-LOG REDUCTION ALREADY. IS THIS IN PROCESS WITH THE FDA?

DR. JOHN KVENBERG: WELL, I WILL ATTEMPT TO ANSWER THE QUESTION, BUT I GUESS, AS I SAID AT THE ONSET OF THE MEETING A LOT -- THE CONTROL THAT'S PUT FORTH BY THE PERFORMANCE STANDARD THAT'S BACK IN THE INDUSTRY, WE ARE TOTALLY AWARE OF THE SPECIFIC UNIQUE PROBLEMS OF SMALL BUSINESS AND FEEL IT IS NECESSARY FOR THE AGENCY TO JOIN WITH THE INDUSTRY TO BE PART OF THE SOLUTION. I NEED -- I THINK THAT THE KICK-OFF OF THIS TECHNICAL WORKSHOP IS A BEGINNING BECAUSE, AS I SAID BEFORE, AND WHEN WE GET TO THE -- WE ARE COMING UP SHORTLY ON A BREAK AND I WOULD LIKE TO ASK FOLKS TO STICK AROUND THROUGH THE AFTERNOON COFFEE BREAK, WHICH WILL BE BRIEF, TO COME UP WITH DISCUSSIONS AND RECOMMENDATIONS THAT WE CAN TAKE BACK FOR NEXT STEPS. I WILL GET INTO A BRIEF SUMMARY OF WHAT I HAVE HEARD AFTER THIS COMMENT PERIOD ON QUESTIONS ON VALIDATIONS, AND HOPEFULLY MORE FULLY GET AT THE QUESTION YOU ARE POSING ABOUT SMALL BUSINESS BEFORE WE LEAVE TODAY.

OTHER COMMENTS?

AUDIENCE MEMBER: THIS IS AN INTERESTING COMMENT, MAYBE A LITTLE BIT EARLIER SOMETHING TO DO WITH VALIDATION. A VERY REPUTABLE STRAWBERRY GROWER IN NORTH AMERICA THOUGHT THEY WERE GETTING CERTAIN PRODUCTS FROM THEIR GROWERS, AND WHEN THEY DID AN AUDIT, WHAT THEY DID WAS -- WHAT I WOULD LIKE TO GIVE TO YOU TO TAKE BACK TO YOUR REGULATION IS NOT THAT I WANT REGULATION, BUT SOMETHING TO REALLY THINK ABOUT IS THAT IT IS WORKER-ORIENTED, NOT FOOD-SAFETY-ORIENTED. TOILETS. EVERYBODY HAS TO USE IT. THERE IS A HUGE HOLE RIGHT IN THE MIDDLE, BUT THE LAW SAYS YOU DON'T HAVE TO USE IT. IT JUST HAS TO BE THERE. NOW, THAT'S A MASSIVE GAPING MINE FIELD. ALSO, THE WATER, IF YOU LOOK AT THE TECHNICAL ABILITY TO WASH YOUR HANDS AT A TOILET, WATER IS NOT THERE. FIVE GALLONS, 10 GALLONS? IN MY EXPERIENCE 25, 30 GALLONS A DAY. THE SOAPS DON'T WORK. THE TOWELS AREN'T THERE. SOME VERY BASIC STUFF. THESE ARE PREVENTIVE ISSUES THAT I WOULD LIKE TO HAVE SOMEBODY TAKE SERIOUSLY BECAUSE IF YOU DON'T HAVE TO BRING IN ALL THE GARBAGE TO THE NEXT STEP, THE NEXT STEP IS GOING TO WORK A LOT BETTER. SUPER GOOD JOB IN DOING THIS EVALUATION. GOOD JOB OF PREVENTING THIS STUFF FROM GETTING IN THERE. I THINK IT WILL BE VERY IMPORTANT.

DR. JOHN KVENBERG: THANK YOU.

MS. LINDA CHARIS (PHONETIC): LINDA CHARIS WITH UC DAVIS. I WOULD LIKE THE FDA TO COMMENT ON THE DEFINITION OF THE WORD CUMMULATIVE, BECAUSE I THINK WE HAVE SEEN A LOT OF INTERPRETATIONS OF IT TODAY. AND THERE IS A DIFFERENCE BETWEEN CUMMULATIVE BEING ANALYSIS OF WHAT HAPPENS PLUS WHAT HAPPENS WITH THE DIFFERENT EXPERIMENT WITH HEATING PLUS WHAT HAPPENS WITH THE BRUSHING VERSUS LOOKING AT WHAT HAPPENS WITH BRUSHING, CLEANING AND WASHING. SO I WAS WONDERING IF YOU WOULD COMMENT ON THAT. OR THE THIRD WAY TO LOOK AT IT IS WHAT HAPPENS BETWEEN DOING NOTHING AND WE GET FROM THAT, AS WE SAW IN SOME OF THE EXPERIMENTS, AND DOING A BUNCH OF STEPS, AND I AM LOOKING AT THE JUICE.

DR. JOHN KVENBERG: CERTAINLY. I DO HAVE A SECTION IN THE PROGRAM, AND I WILL CUT TO THE CHASE ON IT NOW, IF YOU WOULD LIKE ME TO, BECAUSE IT IS NOT GOING TO BE THAT LONG. I, LIKE MANY PEOPLE IN THIS ROOM, ARE IN THE PROCESS OF LISTENING. INDUSTRY IS TO BE APPLAUDED FOR THE PEOPLE THAT HAVE COME UP AND SHARED AND MADE EXPENDITURES TO THE WORK THAT THEY HAVE DONE. THE QUESTION OF HOW YOU GO INTO AN ISSUE OF ACHIEVING A 5-LOG REDUCTION STRATEGY AND A FRESH PRODUCT IS PIONEERING GROUND. WHAT WE ARE DOING HERE AND WHAT THE INDUSTRY IS COME FORTH AND DONE IS MEET A CHALLENGE RELATIVE TO NEW GROUND. I CAN'T ANSWER FROM THE PODIUM TODAY THE QUESTION OF WHAT CONSTITUTES THE AGENCY'S POSITION ON EXACTLY THE HOW TO DO IT MANUAL ON THE CUMMULATIVE 5-LOG STRATEGY, BUT I DO HOPE THAT YOU WILL DISCUSS SOMEWHAT BEFORE WE LEAVE FOR THE DAY OR AFTER A BRIEF BREAK IS TO GET TOGETHER AND GIVE US SOME RECOMMENDATIONS ON THE NEXT STEPS. WE DID THIS IN FLORIDA AND IT WORKED QUITE WELL. THIS IS AN OPPORTUNITY FOR FOLKS TO ACTUALLY CAUCUS AWAY FROM THE MICROPHONE AND AWAY FROM THE TRANSCRIBER, WHO HAS BEEN WORKING VERY HARD ALL DAY TO CAPTURE THESE THOUGHTS, TO WHERE YOU CAN BE ALONE FOR A DISCUSSION ON YOUR PARTS OF THOUGHTS AND RECOMMENDATIONS, WHAT YOU'VE HEARD AND WHERE YOU THINK WE SHOULD BE GOING. FROM MY STANDPOINT, I THINK THIS PROGRAM THAT WAS PRESENTED TODAY THROUGH THE EFFORTS OF THE PEOPLE, NOT MYSELF, BUT THROUGH THE EFFORTS OF THE PEOPLE THAT DID THE PRESENTING TODAY, REALLY DID PRESENT QUITE A PROFILE OF THE INDUSTRY AND THE WORK THAT HAS BEEN DONE TO ACHIEVE THE 5-LOG STANDARDS AND THE PREREQUISITE AND UNDERLYING PROGRAMS THAT NEED TO BE DONE PRE-HARVEST THROUGHOUT THE SYSTEM OF PROCESSING JUICE PRODUCTS. ALL THAT WAS EXCELLENT WORK. AND I GUESS THE QUESTION THAT YOU HAVE POSED RELATIVE TO WHAT WE ARE GOING TO DO TO DISCUSS CUMMULATIVE LOG STRATEGY IS YET TO BE DETERMINED. FROM MY PERSPECTIVE, WHAT I HAVE HEARD TODAY IS SEVERAL FOLD: FIRST, WHEN IT COMES TO THE FRUIT ITSELF, I UNDERSTAND THAT THERE IS BASICALLY THREE KINDS OF FRUIT THAT'S BEING PRODUCED FOR FRESH JUICE SUPPLY, STUFF THAT COMES OFF OF THE TREES THAT IS MOVED DIRECTLY TO THE PROCESSING PLANT. FRUIT THAT HAS COME THROUGH THE PACKING HOUSE SORTING OPERATIONS THAT IS CALLED DEFECTS, BUT IT IS WAXED AND IT IS MOVED THROUGH JUICE PROCESSING. AND THIRDLY, PACKING JUICE THAT GOES TO THE RETAIL MARKET. AND I ASSUME THAT THAT JUICE IS DEEMED FREE OF OTHER DEFECTS AND IS BEING JUICED AT THE RETAIL STORE. I FURTHER SURMISE FROM TODAY'S DISCUSSIONS AND THE ONES THAT WERE IN FLORIDA AS WELL THAT THERE IS AN INCREASING KNOWLEDGE OF THE EFFICACY OF THE PHYSICAL REMOVAL OF THE PROCESSES THAT IS POSSIBLE IN A PROCESSING ENVIRONMENT. YOU HAVE HEARD, AS I HAVE, THE STEPS AND WHAT THEY COUNTED RELATIVE TO REDUCTION OF MICROBIAL LOAD THROUGH THE VARIOUS PROCESSES, AND IT SEEMS TO ME TO BE QUITE SIMILAR NO MATTER WHAT PLANT YOU ARE IN THAT THE PROCESSING DESIGN AND FRESH JUICE PROCESSING SEEMS QUITE SIMILAR. WE HAVE HEARD FROM FOLKS THAT HAVE EXPERIENCE WITH CHEMICAL SANITIZERS AND WITH NON-CHEMICAL SYSTEMS, SO THERE IS A FLEXIBILITY IN APPROACH AND COMBINATIONS OF APPROACHES THAT THE PROCESSOR CAN USE. WE HAVE HEARD ABOUT EXTRACTION TECHNIQUES AND GETTING INTO THE LEVEL OF WHAT IS BEING DONE THROUGH THAT PART OF THE PROCESS. AND YOU HAVE HEARD ABOUT PEOPLE'S APPROACHES DIRECT MANAGEMENT THROUGH LABORATORY STUDIES OF PATHOGEN AND THROUGH THE UTILIZATION OF SURROGATES, BOTH SINGLE BY PROCESS STEP AND WHAT THE CUMMULATIVE NUMBERS MEAN. AND I THINK I HAVE ALSO HEARD THAT A LOT OF PEOPLE WOULD LIKE TO HAVE SOME STANDARDIZATION FOR THE WORK THAT'S ALREADY BEEN DONE. SO I WOULD LEAVE IT AT THAT.

IF THERE ARE NO ADDITIONAL COMMENTS AT THIS TIME ON VALIDATION STUDIES, I HAVE SOMETHING LIKE 20 MINUTES AFTER THE HOUR OF 3:00. I WOULD PROPOSE -- WELL, I WOULD CALL A 20-MINUTE BREAK AT THIS MOMENT IN TIME WHERE FOLKS CAN GET UP AND HAVE A CUP OF COFFEE. BUT USE THE TIME IF YOU WOULD IN AN INFORMAL BASIS AMONG YOURSELVES TO DISCUSS WHAT YOU HAVE HEARD TODAY AND PLEASE BE PREPARED TO COME BACK AT LET'S CALL IT 20 MINUTES UNTIL 4:00 O'CLOCK AND WE'LL BE ABLE TO ADJOURN EARLY, I HOPE. WHAT I WOULD REALLY LIKE TO HEAR AT THAT POINT AT THE CLOSE OF THE DAY IS YOUR THOUGHTS ON TODAY'S MEETING AND WHAT YOU PERCEIVE WOULD BE APPROPRIATE NEXT STEPS FOR THE INDUSTRY AND FOR THE GOVERNMENT TO MOVE AHEAD DURING THIS PERIOD. OKAY? WHY DON'T WE JUST TAKE A BREAK THEN AND SEE YOU IN 20 MINUTES.

(BREAK.)

DR. JOHN KVENBERG: THIS IS WHERE WE GET TO ASK QUESTIONS. OKAY. I AM GOING TO GO AHEAD AND NOW THROW THE FLOOR OPEN. IF YOU WILL PLEASE TAKE YOUR SEATS, WE'LL GET BACK TO THE CLOSE OF THE MEETING. THANK YOU.

SO THIS IS THE POINT I LIKE BEST BECAUSE THIS IS YOUR CHANCE TO TALK BACK AND GIVE US FEEDBACK. AND I AM ASKING QUESTIONS AT THIS POINT IN TIME AFTER THE DISCUSSIONS RELATIVE TO THE NEXT STEPS GIVEN THE LAYOUT OF WHAT YOU HAVE HEARD TODAY AND THE PROCESS THAT WE'VE GOTTEN IN PLACE WITH THE 5-LOG REDUCTION AS IT APPLIES TO CITRUS PRODUCTS RUNNING BETWEEN NOW AND JULY. SO LET ME THROW THE MICROPHONE OPEN AND PLEASE IDENTIFY YOURSELF AS YOU STEP FORWARD AND GIVE US YOUR THOUGHTS, PLEASE, ABOUT THE NEXT STEPS.

MR. MIKE HILLIARD: MIKE HILLIARD WITH WAL-MART. EVERYBODY IS OUT GOING TO BE DOING VALIDATIONS. HOW IS THAT INFORMATION GOING TO BE DISSEMINATED TO THE STATE AGENCIES? OBVIOUSLY THERE IS A MULTITUDE OF STATE AGENCIES OUT THERE THAT THEY ARE GOING TO BE WALKING INTO THE VARIOUS PROCESSING UNITS. HOW ARE THEY GOING TO KNOW WHO IS APPROVED, WHO IS NOT APPROVED, WHO IS VALIDATED, WHO IS NOT?

DR. JOHN KVENBERG: OKAY. I AM NOT GOING TO ANSWER THAT QUESTION, BUT I AM GOING TO MAKE A STATEMENT BACK TO YOU RELATIVE TO WHAT YOU POSED. I THINK THE OPPORTUNITY YOU WOULD PERHAPS AGREE THAT THERE NEEDS TO BE A LINE OF COMMUNICATION THAT OPENS UP INFORMATION THAT'S PASSED ON. NOW, FROM FDA STANDPOINT VALIDATION OPERATIONS THAT ARE GOING ON, I THINK SOMEONE MENTIONED EARLIER THIS MORNING THAT WE ARE GOING TO ASSUME THAT PEOPLE THAT HAVE SIGNED INTO THE PROGRAM ARE GOING TO BE DILIGENTLY WORKING ON THE PROCESS OR HAVE THEM IN PLACE BY NOW. THESE STEPS OR WHAT WE ARE GOING TO DO ABOUT JUICES.

WOULD YOU LIKE TO ADDRESS IT?

AUDIENCE MEMBER: I HAVE SOME INFORMATION. THE STATES HAVE ACTUALLY RAISED THAT QUESTION TO US: HOW ARE WE GOING TO INFORM THEM, IF NOT ON EVERYTHING, AT LEAST ON THOSE FIRMS THAT HAVE REGISTERED, HAVE SIGNED AN AGREEMENT AND HAVE OBTAINED ADDITIONAL TIME? THAT IS THOSE FIRMS DO NOT HAVE TO HAVE A WARNING LABEL REQUIREMENT UNTIL NEXT JULY. WE HAVE DECIDED THAT WE'LL MAINTAIN A LIST, WE'LL COMPILE A LIST OF THE FIRMS THAT HAVE SIGNED ON AT EACH OF THE DISTRICTS, AND WE'LL HAVE THE DISTRICT SUBMIT A LIST TO HEADQUARTERS, COMPILE A LIST AND MAKE THAT AVAILABLE, PROBABLY ON THE WEB. THE SPECIFICS HAVEN'T BEEN WORKED OUT, BUT THAT'S OUR APPROACH ON THAT. BUT ONE OF THE THINGS THAT YOU NEED TO KNOW THAT -- IT DOES CAUSE A PROBLEM FOR ALL OF US, BUT THE WAY THE LAW WORKS IS THAT ON MOST OF YOUR REQUIREMENTS AS WELL AS THIS ONE, THIS IS NOT UNIQUE, IS THAT THE LAW IS THERE, THE REGULATIONS ARE THERE, AND FOOD MANUFACTURERS ARE REQUIRED TO COMPLY WITH THEM. AND SOMETIMES FDA PROVIDES GUIDANCE ON THAT AND SOMETIMES WE DON'T. THE WAY IT WORKS IS IT IS THE MANUFACTURER'S RESPONSIBILITY TO FIND OUT WHAT HAS TO BE DONE OR THEN TO DO IT, AND THEN FDA'S CLASSICAL ROLE IS TO INSPECT, FIND OUT WHAT YOU HAVE DONE WRONG, AND TELL YOU. THAT'S THE WAY IT HAS WORKED CLASSICALLY. THE EXISTENCE OF THIS WORKSHOP IS A DEVIATION FROM THAT TO BEGIN WITH, TO WORK OUT, TO HELP THE INDUSTRY FIGURE OUT WHAT THEY ARE SUPPOSED TO DO AND HOW THEY ARE GOING TO COME INTO COMPLIANCE WITH THE REQUIREMENTS. WE DON'T HAVE ALL THE ANSWERS. WE DON'T HAVE ALL THE GUIDANCE THAT YOU ARE LOOKING FOR. WE DON'T HAVE ALL OF THAT. WHAT WE ARE HERE TRYING TO DO IS TO HELP YOU TO LEARN WHAT INFORMATION IS AVAILABLE AND SO THAT YOU CAN ADAPT FOR YOURSELVES WHAT YOU ARE GOING TO NEED TO DO AND DECIDE WHAT YOU ARE GOING TO NEED TO DO. TO THE EXTENT THAT WE CAN, WE'LL BE DOING SOME OF IT. WE'LL BE ASSISTING YOU AND THIS LIST OF THOSE PEOPLE WHO ARE ON, WHO HAVE SIGNED AGREEMENTS AND WHO HAVE TIME UNTIL JULY, WE'LL PROVIDE THAT TO -- THAT WILL BE AVAILABLE TO ALL THE DISTRICTS AND TO ALL THE STATES. IT IS ON THE WEB, THEN IT IS GOING TO BE PUBLIC. BUT WE'LL NOT HAVE A LIST -- WE DO NOT APPROVE YOUR VALIDATED 5-LOG SYSTEM. WE DO NOT HAVE A LIST OF COMPLYING FIRMS. WE'LL NOT HAVE THAT LIST. THAT'S NOT SOMETHING WE HAVE YET LEARNED HOW TO DO. IT IS JUST NOT THE WAY THINGS WORK IN THE FOOD REGULATORY BUSINESS. I AM NOT SURE HOW WE ARE GOING TO DEAL WITH THAT. IF ANYONE HAS A GOOD IDEA HOW WE ARE GOING TO DEAL WITH THAT, I DON'T KNOW, I WOULD LIKE SOME IDEAS.

THE OTHER THING YOU MAY WANT TO KNOW IS THAT THERE IS AN ENFORCEMENT ASSIGNMENT THAT HAS BEEN ISSUED TO THE FIELD, AND THAT ENFORCEMENT ASSIGNMENT WAS RECENTLY -- WELL, IT ISSUED LATE SEPTEMBER BECAUSE, OF COURSE, THE REQUIREMENTS KICKED IN FOR APPLE JUICE IN SEPTEMBER. REQUIREMENTS DIDN'T KICK IN FOR CITRUS JUICE UNTIL NOVEMBER, BUT THEY KICKED IN FOR APPLE JUICE IN NOVEMBER, SO THERE WAS AN ENFORCEMENT ASSIGNMENT, AN ASSIGNMENT FOR RELEVANT DISTRICTS TO DO SOME INSPECTIONS. THAT ASSIGNMENT HAS BEEN AMENDED TO INCLUDE THE AGREEMENTS AND THE ADDITIONAL TIME AND TO DESCRIBE THE DIFFERENT STATUS OF THE FIRMS THAT ARE ON THAT ASSIGNMENT AGREEMENT. SO THERE WILL BE SOME ENFORCEMENT FROM THE FEDS AND I EXPECT THERE WILL BE SOME ENFORCEMENT FROM THE STATES. I DON'T KNOW HOW MUCH THAT WILL BE BECAUSE THAT WILL VARY FROM ONE STATE TO ANOTHER, AND IT WILL VARY WITH THE PARTNERSHIPS THAT THE DISTRICTS HAVE.

DR. JOHN KVENBERG: CAN I HAVE OTHER COMMENTS, PLEASE?

MR. DICK GERMOND: I HAVE A QUESTION. DICK GERMOND FROM BEAUMONT JUICE AGAIN. IF I HAVE THIS RIGHT, YOU ARE GOING TO HAVE A LIST OF COMPANIES THAT ARE GOING TO COMPLY, BUT YOU ARE NOT GOING TO HAVE A LIST OF PEOPLE THAT HAVE ALREADY COMPLIED; IS THAT CORRECT?

AUDIENCE MEMBER: THAT'S CORRECT, BUT I WOULD DESCRIBE IT A LITTLE DIFFERENTLY. WE ARE GOING TO HAVE A LIST OF THOSE PEOPLE WHO HAVE BEEN ALLOWED ADDITIONAL TIME TO COMPLY, WHO WOULD BE REQUIRED TO COMPLY TODAY EXCEPT THAT THEY HAVE AN AGREEMENT. THE ENFORCEMENT FOLKS NEED TO KNOW THAT BECAUSE THEY CAN WALK INTO THE PLANT AND EXPECT YOU TO HAVE A WARNING LABEL AND YOU SAY YOU DON'T HAVE TO HAVE A WARNING LABEL, YOU HAVE AN AGREEMENT OR THEY WON'T -- WHEN THEY WALK INTO THE PLANT, THEY KNOW YOU HAVE AN AGREEMENT BECAUSE YOU ARE ON THE LIST. BUT THAT'S THE ONLY LIST WE'LL HAVE IS THE ONES WITH AN AGREEMENT.

MR. MARC ISSACS: MARC ISAACS WITH SUN ORCHARD AND THE FLORIDA JUICE COUNCIL. I THINK THAT FIRST OF ALL, HAVING PARTICIPATED IN BOTH OF THE WORKSHOPS, I JUST WANT TO COMMEND EVERYONE. I THINK TODAY WAS AN EXCELLENT DIALOGUE, A GREAT DEAL OF SHARING OF INFORMATION, I THINK A GREAT DEAL MORE THAN WHAT WE HAVE SEEN IN THE PAST.

AND I THINK, JOHN, YOUR QUESTION IS WHAT IS THE NEXT STEP? FROM THE STANDPOINT OF INDUSTRY, I THINK A LOT OF US, I KNOW A NUMBER OF US IN THE INDUSTRY HAVE SPENT A LOT OF DOLLARS, A LOT OF TIME AND RESOURCES TO COME UP WITH ALTERNATIVES THAT MAKE A GREAT DEAL OF SENSE AND PROVIDE A SAFER PRODUCT. I THINK WHAT I WOULD LIKE TO SUGGEST, BECAUSE I REALIZE THAT I KNOW YOU ALL HAVE LIMITED RESOURCES AND A NUMBER OF OTHER ISSUES NEED TO BE ADDRESSED, BUT COULD INDUSTRY PROVIDE YOU WITH A PLATFORM AS TO WHAT IS THE APPROPRIATE SURROGATES, THE TARGETED MICROORGANISM, WHAT IS THE INTERPRETATION OF A REASONABLE 5-LOG REDUCTION? LAY OUT A PLAN SO THAT PEOPLE THAT AREN'T THERE TODAY HAVE A FAIRLY CLEAR PATH AS TO WHAT THEY HAVE TO DO AND THEN WE ARE FEELING MORE COMFORTABLE WITH THE PEOPLE THAT HAVE COMPLIED. WE KNOW THAT THE ONES THAT HAVE IT ARE DOING WHAT THEY NEED TO BRING THEIR OPERATION INTO COMPLIANCE, BECAUSE FRANKLY, WE ARE AT A POINT WHERE I THINK WE HAVE DONE EVERYTHING WE CAN DO AND WE NEED SOME FEEDBACK. AND IF WE CAN MAKE IT AS EASY AS POSSIBLE AND LAY OUT THE STEPS IN THE PROCESS THAT WE WOULD AGREE ON IT, AND THAT INCLUDE CONSUMER EDUCATION OR CATEGORIES FOR CONSUMER EDUCATION, I THINK THAT THAT WOULD ENABLE ALL OF US TO MAKE OUR JOB A LOT EASIER. WE WOULD FEEL MUCH MORE COMFORTABLE PRODUCING A SAFE PRODUCT, THAT EVERYONE WAS PRODUCING A SAFER PRODUCT, AND THAT WE CAN GET ON AND TRY AND MAKE A LIVING AND RUN OUR BUSINESS.

DR. JOHN KVENBERG: THANK YOU. I THINK FROM THE STANDPOINT OF WHERE WE STAND ON THE ISSUE IS OUR DOOR IS OPEN FOR COOPERATION AND DEVELOPMENT. TO REHASH WHAT WAS SAID EARLIER TODAY, IN EXTENSION ON THIS RULE, WHICH IS A PRIMARY FUNCTION OF THE MEETING, WE SAID IN THE ANNOUNCEMENT OF THOSE MEETINGS THAT IT WAS OUR INTENTION TO REOPEN THE COMMENT PERIOD ON THE DRAFT HACCP RULE. THAT WAS THE QUESTION OF WHETHER THERE ARE GOING TO BE QUESTIONS POSED RELATIVE TO THE 5-LOG ISSUE. THAT WAS ANNOUNCED IN THE FEDERAL REGISTER DOCUMENT. NOW, THAT DEALS WITH THE REGULATION STANDPOINT. OUR EXPERIENCE THAT DEALS WITH THE AREA WHERE I AM IN THE HACCP-BASED PRODUCTION IS THERE IS A LOT OF MATERIALS AT WORK IN INTERACTION OUTSIDE FORMAL RULE MAKING AND RULES THAT DEAL WITH HOW YOU COME UP WITH GUIDANCE FOR THE INDUSTRY, HOW YOU PUT TOGETHER GOOD GUIDANCE PROCEDURES AND HOW YOU GET TOGETHER. I THINK THERE IS ROOM FOR THE INDUSTRY, FOOD AND DRUG ADMINISTRATION, AND STATE AGENCIES TO JOIN IN A DIALOGUE TO MOVE AHEAD. AND I GATHERED FROM THE FLORIDA MEETING THERE WAS A SENSE OF URGENCY TO THIS. AND SO AS THE NEXT STEP, WHAT I THINK IF THERE IS A DESIRE TO CONTINUE THIS AND MOVE IT TOGETHER, WE SHOULD STEP FORWARD AND ACCOMPLISH THAT. THERE ARE THINGS OUTSIDE OF RULE-MAKING WHERE WE COOPERATE, SUCH AS THE ISSUE OF PUTTING FORTH CHALLENGE STUDIES, SURROGATE ORGANISMS, RECOMMENDED GOOD MANUFACTURING PRACTICE TYPE GUIDANCE, STUFF LIKE THAT. THAT IS CERTAINLY WITHIN THE BOUNDS OF WHAT WE ARE TALKING ABOUT HERE TODAY.

ADDITIONAL COMMENTS? YES.

MR. STEVE WILLIAMSON: I JUST WANT TO ADD, I SHOULD LOOK THIS WAY BECAUSE I THINK IN THE ROOM WE HAVE AN AMAZING COLLECTION, BEST RETAILER IN THE WHOLE WIDE WORLD, THERE HE IS, WAL-MART. AND I THINK THEY HAVE DONE MORE THAN ANYONE ELSE, IF YOU LOOK AT IT. I THINK THEY ARE GOING TO OWN AMERICA SOON. AMAZING ORGANIZATION. SO THERE, I THINK WE SHOULD JUST REMEMBER WHAT HE SAID. HE STOOD UP AND HE WAS CONFUSED. THAT'S THE MESSAGE YOU HAVE TO HEAR. THERE IS THE BEST RETAILER IN THE ENTIRE WORLD STANDING UP, CONFUSED, AND YOU CAN WALK OUT OF HERE AND CONTINUE WITH THE CONFUSION OR YOU CAN JUMP TO A POINT WHERE YOU CAN TAKE THE BEST RETAILER AND GET THEM TO A LEVEL. IT IS NOT ABOUT JOHN UP THERE. JOHN IS FACILITATING, BUT AS WE ALL KNOW, THE FDA DOES NOT BLESS. THEY PUT RULES OUT. AND HE NEEDS TO GET A SENSE OF COMFORT. AND IT GOES BACK TO WHAT MARC WAS SAYING ABOUT A NUMBER OF POINTS TO COME TOGETHER AND CREATE OUR OWN OPERATING SYSTEM THAT THE GOVERNMENT MAY HELP US GET TO. BUT REALLY IMPORTANTLY DELIVER COMFORT TO WAL-MART. GO BACK TO THE FIVE POINTS THAT I TALKED ABOUT THIS MORNING. I THROW THOSE OUT AND SAY GRAB THEM, LOOK AT THEM, CHANGE THEM. BUT LET'S GET TO AN AGREEMENT WHERE WE ARE GOING. THIS IS THE FIVE POINTS, SPENT APPROXIMATELY $1,000,000 SHARING THEM WITH YOU, PLACE THEM TOGETHER PEOPLE LIKE WAL-MART, THE BEST CONSUMER IN THE WORLD, IS GOING TO MAKE THE LEVEL OF COMFORT, AND THE GOVERNMENT STANDS IN THAT THERE WAS A SLIDE THIS MORNING OF FOUR GREAT CONSUMERS AND I THINK MARC DID THEM, FOUR BOXES, AND THEN THERE WAS THE LOWER BOX THAT WAS THE GOVERNMENT. AND THAT'S THE MODEL HERE. THEY ARE HERE TO SUPPORT, BUT WHAT IT REALLY COMES DOWN TO IS THE RELATIONSHIP OF WAL-MART TO CALIFORNIA DAY FRESH RIGHT BACK THERE, A GREAT COMPETITOR, OR MARC ISAACS, ANOTHER GREAT COMPETITOR, BEAUMONT. THEY ARE ALL COMPETITORS TO SOME DEGREE. BUT WHAT IT COMES DOWN TO IS WE CAN OPERATE WITH A COMMON STANDARD. WALMART WOULD BE MUCH HIGHER, AND THAT WILL GIVE US SOME HELP. BUT WHAT IT REALLY COMES DOWN TO IS YOU, YOU AND YOU AND I AND WE ALL GET TOGETHER AND TALK THE SAME LANGUAGE, FEELING COMFORTABLE. AND I GO BACK TO MY FIVE POINTS, THE WAY WE SHOULD OPERATE OR, IF NOT, CHANGE THEM. I WILL LIVE WITH THEM, BUT I WANT TO GET INTO A COMMON LANGUAGE THAT IS THE SAME THING THAT CALIFORNIA DAY FRESH SPEAKS ABOUT BEAUMONT OR MARC AT SUN ORCHARD OR WHOEVER ELSE IS HERE AND TAKE THESE THINGS, RIP THEM APART, AND TELL YOU WHAT'S WRONG WITH STANDARD OPERATING. SO I CAN COME UP TO MICHAEL AND SAY, "MICHAEL, THIS JUICE IS SAFE, YOU SHOULD BUY IT." LET ME GIVE YOU MY CARD.

DR. JOHN KVENBERG: THANK YOU. LET ME SEE IF WE HAVE SOME ADDITIONAL COMMENTS.

AUDIENCE MEMBER: I THINK PICKING UP ON THE SPIRIT OF ENTHUSIASM OF TEAM WORK AND WORKING TOGETHER, I THINK ONE OF THE NEEDS FROM THE SIDE OF THE SMALL BUSINESS AND RETAILER AGAIN WAS MENTIONED A COUPLE TIMES TODAY WAS THAT THE DIFFERENT FOUR STATES THAT GROW CITRUS -- THERE ARE FOUR, RIGHT, JACK? AND YOU KNOW, IF THEY COULD ALL WORK TOGETHER, BECAUSE AGAIN WAL-MART OR ANY OF THE OTHER NATIONAL-TYPE RETAILERS, THEY CAN'T HAVE FOUR DIFFERENT SETS OF DOCUMENTS ABOUT THE FRUIT OR THE PROCESS AND SO FORTH. I THINK ONE OF THE OUTCOMES OR ANY MEMBERS OF FLORIDA ARE ANXIOUS TO DO THAT, AND CALIFORNIA AS WELL. BUT TO TRY TO COME UP WITH SOME COMMON PROCEDURE. I MEAN WE ARE DOING IT, WE HAVE BEEN DOING IT FOR YEARS, GETTING CLEAN FRUIT AND MAKING FRESH JUICE AT RETAIL. IT IS LIKE HAVING A DOCUMENTED PROCEDURE SO THAT PEOPLE AND OPERATORS CAN DO THAT, BUT THAT IT IS UNIFORM ACROSS THE BACKING. I THINK WE CAN DO THAT AS AN INDUSTRY AND GIVE THAT TO YOU AS A REFERENCE PIECE.

DR. JOHN KVENBERG: THANK YOU.

AUDIENCE MEMBER: HE TOUCHED ON ONE OF THE POINTS OF FOOD PRODUCTION, NOT JUST PRODUCTION. AND THE GREATER PERCENTAGES OF JUICE IS PRODUCED EITHER IN THE HOME OR IN THE LOCAL STORE. AND I DON'T THINK ANYBODY HAS ADDRESSED THE LIABILITY OF THOSE PEOPLE IF THEY LABEL, AND THEY ARE NOT ASKING FOR AN EXTENSION, THEY ARE NOT TRYING TO DO ANYTHING THAT GET AWAY FROM THIS LABEL THAT IS DANGEROUS OR POTENTIALLY DANGEROUS. WHAT HAPPENS IF SOMEBODY GETS SICK? IS THERE A LOCAL GUIDELINE? IS THERE A FEDERAL GUIDELINE? IS THERE ANYTHING THAT'S GOING TO COME OUT THAT WILL ASSIGN LIABILITIES OR INSURANCE POLICY THAT COVERS THAT KIND OF STUFF OR IS THAT JUST AN AREA THAT IS LEFT ALONE BECAUSE WE ARE DEALING WITH THE ORGANIZED PART OF THE INDUSTRY?

DR. JOHN KVENBERG: BETTY, YOU ARE YOU ARE SHAKING YOUR HEAD NOW.

MS. ELIZABETH CAMPBELL: ONLY IF THE FDA IS NOT GOING TO ASSIGN A LIABILITY ANYMORE --

AUDIENCE MEMBER: I AM SAYING ARE THEY GOING TO ABSOLVE PEOPLE OF LIABILITY BECAUSE THERE IS A LABEL THERE THAT SAYS IT IS POTENTIALLY DANGEROUS?

MS. ELIZABETH CAMPBELL: CLEARLY, NO ONE IS GOING TO ABSOLVE PEOPLE OF LIABILITY BECAUSE THERE IS A LABEL THERE. IN FACT, I THINK WE ARE ALREADY IN WRITING AS SAYING THAT THE FACT THAT A LABEL IS ON A PRODUCT THAT WARNS THE PERSON NOT TO DRINK IT -- IF THAT PRODUCT THAT BEARS THE LABEL MAKES SOMEONE ILL, IT IS THE FIRM THAT IS RESPONSIBLE THAT, THERE IS NOT A REMOVAL OF RESPONSIBILITY TO PRODUCE A CLEAN PRODUCT EVEN THOUGH THE LABEL IS THERE.

AUDIENCE MEMBER: DOES THAT ONLY INVOLVE STATE OR LOCAL?

MS. ELIZABETH CAMPBELL: YOU NEED TO STAND UP OR IDENTIFY YOURSELF.

DR. JOHN KVENBERG: WE ARE NOT IN QUESTION MODE HERE. I AM LOOKING FOR COMMENTS.

AUDIENCE MEMBER: THE FIRM IS A JUICE BAR OR A WAL-MART THAT IS SQUEEZING SOME OF THEIR OWN JUICE, THAT'S WHAT I WAS REFERRING TO. ARE THEY LIABLE IF THEY HAVE --

MS. ELIZABETH CAMPBELL: ARE YOU ASKING IF THEY ARE LIABLE UNDER THE REGULATION?

AUDIENCE MEMBER: THEY DON'T NEED A WARNING LABEL IF THEY MAKE IT IN THEIR OWN PLACE. THEY DON'T NEED THE WARNING LABEL. THEY DON'T EVEN NEED A WARNING LABEL.

AUDIENCE MEMBER: I THINK IT IS A GOOD ANSWER.

AUDIENCE MEMBER: THAT IS A GREAT PART OF THE JUICE BUSINESS. I REPRESENT PRIMARILY SMALL ROADSIDE PRODUCERS, SMALL QUANTITIES OF FRESH-SQUEEZED CITRUS JUICE IN FLORIDA. ONE OF THE THINGS WE HEARD IN THE FLORIDA MEETING, AND YOU ASK THE QUESTION WHERE DO WE GO FROM HERE. THE WORK CALLS IT A NON-CONTINUOUS PRODUCER. THEY PRODUCE ON A PART-TIME BASIS OR FOR VERY LIMITED PRODUCTION TO SERVE THEIR NEEDS, SOMETIMES MOST OF THE TIME IN A LOCAL REGIONAL MARKET. WE DISCUSSED IT AT THE FLORIDA MEETING THAT THERE IS A GREAT DEAL OF INTEREST IN CONTINUING IMMEDIATELY ON THE CREATION OF MORE OR LESS A PROCEDURE MANUAL THAT TAKES IN SOME OF THE EXPERIMENTATION THAT'S DONE, DATA THAT'S BEEN PRESENTED AND SHARED BY A LOT OF THE PIONEERS IN OUR INDUSTRY, MANY OF WHOM ARE HERE TODAY. BUT THE SMALL PRODUCER THAT WE HEARD BEFORE REALLY CANNOT AFFORD TO GO OUT AND PULL IN PRIVATE LABORATORY STUDIES ON THEIR OWN, REALLY RIDE ON THE SHOULDERS OF SOME OF THE PIONEERING RESEARCH THAT WE HEARD TODAY BY LOOKING AT EACH INDIVIDUAL STEP IN THEIR PROCESS, VALIDATING AND DOCUMENTING HOW THAT CAN BE DONE EFFECTIVELY, WHAT KIND OF LOGARITHMIC PRODUCTION EACH OF THOSE STEPS CAN PRODUCE. AND THEN THEY WILL BE ABLE TO BE RESPONSIBLE FOR REPLICATING THOSE INDIVIDUAL PROCESSES IN THEIR OWN PLANT TO ACHIEVE THE 5-LOG REDUCTION. ULTIMATELY THE HACCP RULE COMES FORWARD TO BUILD THAT INTO THEIR HACCP PLAN. AND I KNOW THE FLORIDA INDUSTRY VERY WELL. BUT I DON'T KNOW THE WEST COAST PRODUCERS. SO WE DID SHARE THAT WE WANT TO WORK VERY CLOSELY WITH THE FDA IN PUTTING TOGETHER THIS TYPE OF PROCEDURAL MANUAL THAT WILL ADDRESS THESE ISSUES. BUT I WANT TO TALK TO TEXAS, ARIZONA OR CALIFORNIA, THAT IS EITHER NON-CONTINUOUS PRODUCTION FACILITY OR REPRESENTS THEM OR KNOWS OF THEM, THAT WOULD LIKE TO PARTICIPATE IN THAT MOVE, I WOULD BE VERY PLEASED TO TALK WITH YOU.

DR. JOHN KVENBERG: THANK YOU.

ANY OTHER COMMENTS? ANY COMMENTS AT ALL?

MR. JOHN BARKLEY: MY NAME IS JOHN BARKLEY AND I WORK FOR VALLEY FOODS, INC. MY QUESTION HAS TO DO WITH -- FIRST OF ALL, I WOULD LIKE TO SAY THIS WAS A REAL EYE-OPENER FOR US BECAUSE WE ARE KIND OF A SMALL COMPANY. WE DON'T OPERATE CONTINUOUSLY, JUST OVER THE SUMMER. I CAN SEE SOME PEOPLE HAVE DONE THEIR HOMEWORK. BUT WHAT MY QUESTION IS, ASSUMING THAT WE DO OUR HOMEWORK AND WE ACHIEVE THE 5-LOG REDUCTION, WE SELL OUR PRODUCT TO SOMEBODY ELSE AND HE PACKAGES IT. WHAT HAPPENS BEYOND THERE? OBVIOUSLY HE CAN'T DO A 5-LOG REDUCTION ON THE JUICE SHORT OF PASTEURIZING IT, SO WHAT IS HIS RESPONSIBILITY OTHER THAN WHAT OUR RESPONSIBILITY IS?

MS. ELIZABETH CAMPBELL: THE REQUIREMENT IS THAT THE JUICE HAVE RECEIVED, AND I WILL CALL IT A KILL STEP. WE KNOW IT CAN BE MORE THAN ONE STEP, THAT THE JUICE RECEIVE A 5-LOG KILL. THE REQUIREMENT DOES NOT SAY WHERE THAT 5-LOG KILL OCCURS. ONCE IT HAS OCCURRED, IT NEED NOT BE DONE AGAIN. NOW, THIS IS THE ASSUMPTION, AND EVERYTHING WE HAVE DONE TODAY ASSUMES WE ARE IN A SANITARY OPERATION AND NOBODY IS INTRODUCING NEW BUGS INTO THIS, BECAUSE WE ARE TALKING ABOUT THE BUGS THAT COME IN WITH THE FRUIT. WE ARE NOT TALKING ABOUT BUGS THAT GET ON THE FRUIT FROM AN UNSANITARY PLANT. SO WE ARE TALKING ABOUT SANITARY OPERATIONS HERE. AND AS LONG AS YOU ARE SELLING A JUICE THAT HAS HAD A 5-LOG KILL IN ONE STEP OR MORE TO SOMEONE ELSE, THEN THAT SOMEONE ELSE GETS THE BENEFIT OF THAT. THAT PRODUCT, ONCE IT HAS HAD THE KILL, DOES NOT HAVE TO HAVE THE WARNING STATEMENT DOWN THE ROAD.

AUDIENCE MEMBER: I JUST HAD A QUESTION, A COUPLE OF THEM. ONE IS THE AGREEMENT, THE SECOND PART OF IT IS REALLY CLEAR. I THINK WE ALL UNDERSTAND HACCP, SOP, GOPS, BUT THE FIRST PART OF IT, IN TERMS OF THE 5-LOG KILL, AND EVEN WITH THE JUICE THAT YOU MIGHT PURCHASE, BUT ALSO IF YOU ARE TALKING ABOUT A PACKING HOUSE AND YOU BUY FRUIT FROM A PACKING HOUSE AND YOU DON'T BUY IT FROM THE FIELD, IS THAT CONSIDERED A 3.4-LOG KILL BASED ON THE DOCUMENTATION THAT WAS PROVIDED HERE TODAY OR DO YOU HAVE TO JUSTIFY THAT BY GOING INTO A PACKING HOUSE AND MAKING SURE THAT THAT FOOD IS COMING FROM A PACKING HOUSE THAT HAS QUALIFIED OR IS -- IT IS JUST NOT REAL CLEAR. AND I GUESS TODAY I HAVE GOTTEN A LOT OF INFORMATION, BUT I STILL HAVE A LOT OF QUESTIONS, TOO.

DR. JOHN KVENBERG: WELL, AS WAS STATED TODAY, WE ARE IN A FORMING PROCESS HERE. THE IDEA IS TO MOVE AHEAD. THIS IS A MOVING TARGET, OBVIOUSLY. A LOT HAS BEEN THROWN AT US, AT THE FOOD AND DRUG ADMINISTRATION, AS WELL AS HAS BEEN THROWN AT YOU. AND WE ARE QUITE ANXIOUS I THINK TO COME TO A RAPID INTERPRETATION OF WHERE THE DATA LEADS. YOU HAVE HEARD FROM INDUSTRY AND FROM STATE OF FLORIDA DEPARTMENT OF CITRUS AND THE KINDS OF WORK THEY HAVE DONE. THEY HAVE DONE -- WE'LL DO WHAT WE CAN, INCLUDING RESEARCH, AND WOULD BE QUITE WILLING TO WORK COOPERATIVELY WITH THE INDUSTRY ITSELF TO COME UP WITH GUIDANCE. SO THIS IS JUST THE BEGINNING OF THE DIALOGUE TODAY. I WISH I COULD GIVE YOU ALL THE ANSWERS TO MAKE JUICE WITH, BUT WHAT WE HAVE PROVIDED IS THE INDUSTRY, THE CITRUS INDUSTRY STEPPED FORWARD AND SAYS WE THINK WE CAN. WE LISTENED, WE RESPONDED, AND WE ARE HERE. SO THAT'S ABOUT AS FAR AS I CAN TAKE IT TODAY.

YES?

MR. DAN COOK: DAN COOK. I WORK FOR RALPHS GROCERY COMPANY. AND BASED ON THE INFORMATION I HEARD TODAY, WHAT I WOULD LIKE TO SEE IS THE FLORIDA, ARIZONA, CALIFORNIA GROUPS GET TOGETHER WITH THE FDA ASSIMILATING THIS INFORMATION, PROVIDE US WITH A MINIMUM STANDARD THAT HAS BEEN USED WITH THE DATA THAT SAYS IF WE ACHIEVED A 5-LOG REDUCTION, THIS IS THE AMOUNT OF MICROBES YOU WILL HAVE IN YOUR PRODUCT. THAT WAY WE'LL HAVE A TARGET. IF WE DON'T HAVE A TARGET, IT MAKES IT VERY DIFFICULT TO SAY WE HAVE ACHIEVED THAT. IN MY SMALL OPERATION OR WE DON'T RUN CONTINUOUSLY, WE HAVE HACCP PRINCIPLES IN PLACE THAT WE JUST TRANSFERRED OVER FROM OUR DAIRY OPERATION. SO IF I AM GOING TO SAY HEY, AM I GOING TO LOOK AT MY OPERATION AND SAY NOW THAT I HAVE THIS STANDARD, SHOULD I BE TRYING TO RECEIVE 5-LOG FROM THIS POINT OR FROM THE POINT WHEN I RECEIVE MY BINS INTO MY COOLER OR WHAT POINT? I SEE A LOT OF DIFFERENT STARTING POINTS TO WHERE WE ARE SAYING I HAVE A LOT OF POINT OF REDUCTION HERE, I HAVE A POINT OF REDUCTION HERE, I HAVE A POINT OF REDUCTION AT DIFFERENT VARIOUS LEVELS. BUT AS WAS STATED BY THIS GENTLEMAN, WHERE DO YOU START? WELL, I WOULD LIKE TO KNOW WHERE I SHOULD FINISH. IT WOULD MAKE IT A LOT EASIER FOR US.

DR. JOHN KVENBERG: THANK YOU.

MRS. GAIL TENZER: I DON'T KNOW, MAYBE I CAN HELP WITH SOME OF THE EXPERIENCE THAT WE HAVE HAD IN FOLLOWING FRUIT FROM THE FARM ALL THE WAY THROUGH. AND SOME OF IT -- SOME OF THE KNOWLEDGE I HAVE MAY NOT NECESSARILY BE FROM THE FRUIT ITSELF, BUT FROM WHAT GOES ON WITH PACKAGING FERTILIZERS. IN THE FIRST PLACE, IF YOU ARE TALKING ABOUT THE SOLID FRUIT COMING TO YOU PRE-WASHED, BUT YOU ARE GOING TO PROCESS IT, IN LIGHT OF WHAT GOES ON IN THE TRUCKING INDUSTRY AND ALL OF THAT, I DON'T THINK IF I WERE A PROCESSOR THAT I WOULD TRUST THAT THAT WENT THROUGH THE ADEQUATE KILL STEP OVER THERE AND HAS NOT BEEN RECONTAMINATED SOMEHOW. SO I BELIEVE IF I WERE THE PROCESSOR RECEIVING FRUIT FROM SOMEBODY, EVEN THOUGH I WENT THROUGH ALL OF THE SCREENING AND EVERYTHING, I WOULD STILL GO AHEAD AND DO MY KILL STEPS AT MY PROCESSING PLANT. THE OTHER QUESTION WAS, I THINK, IF YOU WERE YOUR GETTING JUICE THAT SUPPOSEDLY WENT THROUGH A KILL STEP SOMEWHERE ELSE AND NOW YOU ARE JUST THROUGH PACKAGING IT, WHEN YOU ARE DEALING WITH FERTILIZERS, FOR EXAMPLE, CALIFORNIA DEPARTMENT OF FOOD AND AGRICULTURE SAYS THAT THE ONE THAT FINALLY DOES THE PACKAGING, HE'S THE ONE THAT HAS TO DO THE REPORTING AND STUFF LIKE THAT. AND IT BRINGS TO MIND WHAT HAPPENS WITH THE STRAWBERRIES AND THE HEPATITIS A. IN FACT, IT MAY VERY WELL HAVE BEEN, SINCE NOBODY EVER IDENTIFIED WHAT THE SOURCE WAS, THAT WHEN THEY WERE RE-PACKAGED, I THINK IN MICHIGAN OR SOMEPLACE LIKE THAT, THAT MAYBE THERE WAS SOME CONTAMINATION IN THE PACKAGING IN THE CONTAINERS. SO AGAIN, I WOULD SAY IF YOU WANT TO FEEL SAFE ABOUT YOUR PRODUCT AND YOU ARE ULTIMATELY PACKAGING IT AND YOU ARE PUTTING YOUR NAME ON IT, I WOULD MAKE SURE THAT I AM IN CONTROL OF THOSE KILL STEPS AND NOT RELY SO MUCH ON WHAT'S COMING TO ME FROM OTHER SOURCES. I WOULD WORRY ABOUT WHO TOUCHED IT, WHAT THE TRUCKS CARRIED BEFOREHAND, AND ALL KINDS OF VARIABLES THAT CAN COME INTO PLAY ON THAT FRUIT.

DR. JOHN KVENBERG: DO YOU HAVE ANY ADDITIONAL COMMENTS?

DR. MOHAMED ISMAIL: MOHAMED ISMAIL, FLORIDA DEPARTMENT OF CITRUS. I WOULD LIKE TO TAKE THIS OPPORTUNITY TO THANK THE FOOD AND DRUG ADMINISTRATION FOR TAKING THE LEAD IN ORGANIZING THE TWO WORKSHOPS. AND I WOULD ALSO LIKE TO FOLLOW-UP ON THE GENTLEMAN FROM ODWALLA THAT TALKED ABOUT CONSUMER CONFUSION AND THE NEED FOR US TO DISPEL THAT CONFUSION BY ASKING FOOD AND DRUG ADMINISTRATION TO ISSUE SOME TYPE OF AN EDUCATION OR UNDERTAKE AN EDUCATIONAL PROGRAM, A FACT SHEET, TELLING THE CONSUMER, TELLING THE RETAILERS WHAT HAS BEEN DONE SO FAR IN THIS INDUSTRY.

DR. JOHN KVENBERG: THANK YOU.

ANY ADDITIONAL COMMENTS THIS AFTERNOON? YES. AND PLEASE REMEMBER, FOLKS, TO IDENTIFY YOURSELVES.

DR. ABE TENZER: WE HAVE INITIATED A SEPARATE SANITATION ASSURANCES PROGRAM WHEREBY WE ARE TESTING THE PRODUCT AT VARIOUS LOCATIONS, NAMELY THE WAREHOUSE WHERE THEY GROW PRODUCE, GROWN PRODUCE HAS BEEN STORED, AND IT DOESN'T NECESSARILY APPLY TO JUICES. BUT MAYBE WE SHOULD APPLY IT TO JUICES. AND THEN FROM THE GROWERS WAREHOUSE WE FOLLOW IT ALL THE WAY UP TO THE DISTRIBUTOR WAREHOUSE AND THEN ALL THE WAY UP TO THE STORE BY TESTING AND VERIFYING THAT WE DON'T HAVE E.COLI OR SALMONELLA AND THINGS OF THIS NATURE. BUT THIS IS AN INTERACTIVE PROGRAM THAT ASSURES THAT PEOPLE, THE CONSUMER ON ONE END AND THE STORE ON THE OTHER END, THAT THEIR PRODUCT HAS BEEN TESTED AT VARIOUS PHASES OR STAGES. BUT MOST IMPORTANTLY, THAT THE LAST STAGE WHERE THE CONSUMER IS SPEAKING UP. AND THIS PROGRAM -- WE HAVE OUR OWN SEAL LIKE "SAFETY-WASHED" AND SEAL THINGS LIKE THAT AND WE IDENTIFY THE GOODS SO THAT THE CONSUMER KNOWS THAT THE STORE HAS DONE SOMETHING TO PROTECT HIM. AND THIS IDEA I THINK IS GOING TO CATCH ON MORE AND MORE. WE HAVE -- EVERY YEAR WE HAVE MORE AND MORE PEOPLE WHO ARE LOOKING INTO THE PROGRAM AND WHO WOULD LIKE TO SUBSCRIBE TO IT. THAT'S IT.

DR. JOHN KVENBERG: THANK YOU.

ANYBODY ELSE HAVE ANY OTHER COMMENTS?

AUDIENCE MEMBER: MY NAME IS (INAUDIBLE) FROM ORANGE COAST FOODS, AND WE ARE A DISTRIBUTOR FOR SQUEEZING EQUIPMENT FOR THE JUICE INDUSTRY. AND IT SEEMS TO ME LIKE THE NEXT STEP IN OUR PART OF THE INDUSTRY IS TO FILL A COUPLE OF GAPS THAT EXIST. AND THE GAPS, IN LISTENING TO EVERYTHING, ALL THE DISCUSSIONS THAT HAVE GONE ON HERE TODAY, IN OUR INDUSTRY SEEM TO BE BETWEEN THE RETAILER, WHO HAS THE EQUIPMENT SQUEEZING THE JUICE, THE SUPPLIER OF THE FRUIT OR THE PACKING HOUSE THAT'S INVOLVED IN DISTRIBUTING THE FRUIT TO THAT RETAILER, AND MANUFACTURER. SO I THINK THE NEXT STEP IN OUR INDUSTRY IS FINDING SOME WAY TO BRIDGE THAT GAP BETWEEN THOSE THREE PLACES.

DR. JOHN KVENBERG: ANYBODY ELSE? OKAY. WE ARE TALKED OUT, I THINK.

I HOPE -- YOU MAY BE WALKING AWAY FROM THIS AFTERNOON WITH MORE QUESTIONS THAN ANSWERS, BUT I THINK THAT IF ANYTHING TODAY PROVIDED SOME DEGREE OF AWARENESS, AND I AM ENCOURAGED BECAUSE OF THE DISCUSSION AND INTEREST THAT THERE WILL BE AN OPPORTUNITY TO INTERACT WITH THE INDUSTRY, WITH THE STATES, WITH THE FOOD AND DRUG ADMINISTRATION IN THE AREA OF CITRUS RELATIVE TO THE PERFORMANCE STANDARD. AND OUR DOOR IS OPEN AND WE WOULD LIKE TO CONTINUE THE DIALOGUE WITH THE FOLKS OVER THIS PERIOD AND BEYOND TO CONTINUE TO PROVIDE GOOD PUBLIC HEALTH IN THE AREA OF CITRUS JUICE.

I WANT TO THANK ANYBODY THAT PRESENTED TODAY, AND I WANT TO THANK THE AUDIENCE ITSELF. LET'S GIVE YOURSELVES A BIG HAND TODAY.

 

(APPLAUSE.)

(THE WORKSHOP ENDED AT 4:20 P.M.)


REPORTER'S CERTIFICATION

I, JULIE A. BEARMAN, A CERTIFIED SHORTHAND REPORTER, IN AND FOR THE STATE OF CALIFORNIA, DO HEREBY CERTIFY:

THAT THE FOREGOING PROCEEDING WERE THEN TAKEN BEFORE ME AT THE TIME AND PLACE HEREIN SET FORTH; THAT THE TESTIMONY AND PROCEEDINGS WERE REPORTED STENOGRAPHICALLY BY ME AND LATER TRANSCRIBED INTO TYPEWRITING UNDER MY DIRECTION; THAT THE FOREGOING IS A TRUE RECORD OF THE PROCEEDINGS TAKEN AT THAT TIME.

IN WITNESS HEREOF, I HAVE SUBSCRIBED MY NAME THIS _____ DAY OF _______________________, 1998.

___________________________________________

JULIE A. BEARMAN, CSR NO. 7585