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

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FDA Technical Scientific Workshop On

How Citrus Juice Firms Can Achieve 5-
Log Pathogen Reduction -- November 19,
1998
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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
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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.
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.
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.)
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.
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.
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.
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.
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.
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.
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
More in Hazard Analysis Critical Control Point (HACCP)

(/7993/20170406024335/https://www.fda.gov/Food/GuidanceRegulation/HACCP/default.htm)
HACCP Principles & Application Guidelines

Dairy Grade A Voluntary HACCP

Juice HACCP (/7993/20170406024335/https://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006803.htm)
Retail & Food Service HACCP

Seafood HACCP (/7993/20170406024335/https://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006764.htm)

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

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6/16/23, 10:15 PM Hazard Analysis Critical Control Point (HACCP) > FDA Technical Scientific Workshop On How Citrus

Citrus Juice Firms Can Achie…

FDA Technical Scientific Workshop On

CITRUS SCIENTIFIC WORKSHOP

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

I AM JUST GOING TO MAKE A COUPLE OF INTRODUCTORY REMARKS TO KIND OF ORIENT YOU TO

MR. RICHARD BALDWIN: THANK YOU, ELAINE.

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

MR. WHITING: THANK YOU, JOHN.

DR. KVENBERG: THANK YOU, DICK.

SO WITH THAT, JIM?

MR. JAMES WADDELL: THANK YOU, JOHN.

SURVIVING AND PRESENTING PROBLEMS. IN ADDITION, THE DEMOGRAPHICS OR POPULATION IS

STEVE? THANK YOU.

DR. JOHN KVENBERG: THANK YOU, STEVE.

(A VIDEO IS PLAYED, BUT NOT TRANSCRIBED.)

(END OF THE VIDEO.)

AT OUR FARM WE HAVE FORMED PARTNERSHIPS WITH PACKERS AND PROCESSORS,

ANOTHER IMPORTANT THING IS I THINK A PLAN IS ONLY SITE-SPECIFIC; IT IS FARM-BY-FARM. YOU

SO THANK YOU VERY MUCH. I APPRECIATE YOUR TIME.

MR. MARC ISSACS: THANK YOU, JOHN.

SO WITHOUT FURTHER ADO, JOHN?

DR. JOHN KVENBERG: THANK YOU, MARC.

MR. STEVE HUNTER: THANK YOU, JOHN.

SEE YOU IN 15 MINUTES.

IF YOU WILL COME TO THE MICROPHONE, PLEASE?

DR. JOHN KVENBERG: THANK YOU VERY MUCH.

CONTAMINATES. AND I THINK IT WAS IN MILWAUKEE WE HAD A PROBLEM WITH CRYPTOCRITIUM

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

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

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

MR. MARK DAWSON: CLOSE ENOUGH.

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.

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

LADIES AND GENTLEMEN, A WEEK AGO WE PARTICIPATED IN A SIMILAR TECHNICAL SESSION IN

THE FLORIDA DEPARTMENT OF CITRUS IS AN AGENCY OF THE STATE OF FLORIDA. IT IS

IN CONCLUSION, SURFACE MICROBIAL POPULATION CAN BE MINIMIZED BY HOT WATER

THANK YOU VERY MUCH.

MR. MARC ISAACS: THANKS AGAIN, JOHN.

I APPRECIATE THE OPPORTUNITY TO SHARE SUN ORCHARD PROCESS TO ENSURE PRODUCT

DR. JOHN KVENBERG: THANK YOU, MARC.

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

DR. JOHN KVENBERG: THANK YOU.

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

DR. JOHN KVENBERG: THANK YOU.

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

DR. JOHN KVENBERG: THANK YOU.

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

ROB, YOU ALWAYS HAVE QUESTIONS.

MR. CHUCK ORMAN: I AM SURE.

ANY OTHER QUESTIONS THAT I CAN ADDRESS?

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

OH, I AM ROB HOLLAND WITH INDEPENDENT NATIONAL.

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

MR. ROB HOLLAND: I AM GOING HOME.

A CERTIFIED OR LICENSED PACKING HOUSE IN CLEANING, GRATING, AND SO FORTH. SO SOME OF

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

AUDIENCE MEMBER: CHUCK, QUIT WHEN YOU ARE AHEAD.

MR. CHUCK ORMAN: YOU ARE WELCOME.

MR. VICTOR ABULARACH: YES.

IN SUMMARY, NO DOUBT THE FMC EXTRACTOR, WHETHER IT BE COMMERCIAL-SIZE MACHINE OR A

IN WITNESS HEREOF, I HAVE SUBSCRIBED MY NAME THIS _ DAY OF ___________________,