U.S. Food & Drug Administration
Center for Food Safety & Applied Nutrition
APPLE CIDER FOOD SAFETY
CONTROL WORKSHOP
July 15-16, 1999

CITRUS JUICE VALIDATION PRACTICES

J. PETER CHAIRES
ACTING CHAIRMAN - AMERICAN FRESH JUICE COUNCIL
ASSOCIATE VICE PRESIDENT - FLORIDA GIFT FRUIT SHIPPERS ASSOCIATION

INTRODUCTION

FGFSA
AFJC To promote the value and development of a safe fresh juice industry through education, communication and the continuous improvement of GMP's.

EFFORTS TO DATE:
1. Focused on compliance with Warning Label Regulation. Finalized on July 8, 1998.
2. Warning is quite strong - Warning: This product has not been pasteurized and therefore may contain harmful bacteria that can cause severe illness in children, the elderly and persons with weakened immune systems.
  Strong push to help producers keep label off product.
3. Display options:
  Point of Sale or on Package
4. Exemptions
  1. Product sold for consumption on this site.
  2. Juice processed in a manner to produce a 5-log reduction or whatever is equal to or greater than the final HACCP rule in the pertinent microorganism for period equal to its shelf life.
5. Effective Dates:
  1. September 8, 1998 for all juices other than citrus.
  2. Initially November 5, 1998, but extended to July 8, 1999 for citrus juice producers requesting the time and agreeing to develop a 5-log (and agree to certain parameters).
IT IS AFJC AND INDUSTRY'S HOPE THAT COMPLIANCE WITH THE WARNING LABEL RULE - WILL PROVIDE A LAUNCHING PLATFORM INTO SOLID HACCP PLANS.

WHAT HAS THE INDUSTRY (AFJC) BEEN DOING?

Practical Changes:

Division in Approaches:

LARGER SCALE:* Continuous Production * Distribution

Private labs and validation

Some - more proprietary due to intense competition.

Some use of cumulative reduction concept. Some with a beginning to end measure.

SMALLER SCALE:* Retail / Grocers * Roadside stands & shops

Forced to work cooperatively

Corporate validation concept

FCJTF -

Attempted interstate effort

Great level of cooperation

Not intended to validate existing techniques -- but rather to work within knowledge of what small plants are doing and can do.

Focus on cumulative reduction with traditional set-ups -- with additional research for enhanced results and unique situations.

Consolidation of scientific and technical expertise. Some of this was used by larger scale plants.

FORMAL CHANGES:

Improved knowledge and use of SSOP's and GMP's across country

Knowledge sharing within industry

Active land-grant and extensive programs. (Education, workshops)

Cross-commodity exchange of technology and ideas

Widespread HACCP application.

GENERAL TREATMENT PROGRAMS - CITRUS

OBJECTIVE

5 log reduction of microorganisms in fresh squeezed citrus juice

Target organisms are E. coli O517:H7 and salmonella spp.

Appropriate surrogate can be used.

Cumulative log reduction can be used.

TRADITIONAL TREATMENTS

Chemical cleaning

Mechanical cleaning

Grading / culling

FMC Extraction

External sanitizer treatment

CHEMICAL CLEANING

Various fruit cleaners have been used on the brushwasher, e.g.:

Phosphoric acid / anionic cleaner

Chlorine

Cholorine dioxide

Alkaline cleaners

Other soaps

SOME ALKALINE CLEANERS ARE PROVING VERY EFFECTIVE, SUCH AS FMC's 395 CLEANER

Foaming

2.5 - 3.0 logs ( 30 seconds p # 11.5 - 12)

No phenyls

MECHANICAL CLEANING

Brushwashing with soap / cleaner

Log reduction may need to be determined for specific application, due to variance in dwell time and concentration of cleaner

GRADING CULLING

If aggressive and diligent, does provide a log reduction

Somewhat unique to each application, though some general research is available.

EXTRACTION

Individual and corporate validation of FMC 5-head machine. FDOC research of most common smaller units.

Conservative 1.1 - 1.9 logs

EXTERNAL TREATMENTS

Phosphoric Acid / Anionic cleaner / sanitation

Chlorine

Chlorine dioxide

Peroxyacetic acid

Iodophor

Ozone

Note: Actual sanitizers are more effective at preventing cross contamination

SMALL SCALE PRODUCERS (Cumulative)

(Must have minimally addressed)

Fruit purchasing and / or harvesting standards

Fruit grading

Fruit cleaning (brush wash, rinse)

Surface treatment

Chemical: chlorine, SOPP (sodium orthophenylphanate), acid cleaner, alkaline cleaner)

Heat (pasteurize the peel only)

Sanitary storage - if short term - hold prior to extraction

Extraction

Research conducted on most widely used equipment

In some instances -- juice treatment (thermal, UV treatment).

Example of log reduction scenario - from FCJTF:
Brush washing, SOPP soaping, rinsing	3.5.log +/- .4
High alkaline wax application, with heat dry. (Also tested alkaline cleans.)	1.1 log
Extraction with FMC or Juice Tree technology	1.0 log (conservative)
	5.6 log
Options: Other Sanitizers, heat. Ex. Hot water immersion: 176° = 1 minute 158° = 2 minute	5 log
Hot water spray or steam 190°F - 200°F, 30 - 60 seconds	5 log reduction
Note: Surface thermal treatments are highly effective - but must be integrated into a program of solid GMP's, SSOP's and/or HACCP - to maintain effectiveness and minimize or remove a chance of contamination.

LARGE SCALE - FRESH PLANT EXAMPLES
1. Albritton Fruit Company
  Use a combination of traditional methods
  - Chemical washing or brushwasher (FMC fruit clearn 395 for 30 seconds)
  - Fruit surface acic anionic sanitizer
  - Aggressive culling
  - FMC 5-head extractor
  Achieved and independently verified >5 log.
2. The Fresh Juice Company
3. Steam Applications: (such as Sun Orchard)
INFO SHARED AT PUBLIC MEETINGS - AVAILABLE ON NET
In plant testing for surrogates
Outside testing - process duplication in labs or university settings - pilot processes
FDA surrogate research.
Chemical applications and use of ORP technology
RESEARCH STILL NEEDED:
- Sanitizer research should include -- all fruit types -- Cleaning and grading of raw fruit most important to preventative measure -- Most effective for each fruit type.
- The sanitizers effect on fruit and equipment, residue in product and overall safety.
- Sanitizer usage including effective concentrations, duration of exposure and temperature.
- Based on the use of certain types of sanitizers, what will be the subsequent type of frequency of tests for the pathogenic bacteria?
- Based on results on this research, what corrective action, criteria and procedures need to be implemented?
- Research the microbiological environment surrounding the growing and cultivation of each type of raw fruit and vegetable used to make fresh unpasteurized juice. This review would need to be specific and address existing assumptions which have proven to be inaccurate (such as: pH and acid levels) and what conditions impact the survival, growth or destruction of the Salmonella and E. coli 0157:H7 bacteria.
- Develop further extensive research on the ecology of Salmonella and E. coli 0157:H7 in the field and in the processing plant.
- Develop scientific performance information on the acceptable levels of coliform, mold, yeast, and E. coli. Take new test methods into consideration.
- Develop, validate, and implement improved detection methods for rapid testing of low levels of Salmonella and E. coli 0157:H7.
- Provide prevention techniques for long term control, reduction, and elimination of E. coli and Salmonella by developing new methods to prevent initial colonization, new methods to reduce or eliminate contaminates before harvest, new disinfection methods, surface decontamination, alternative disinfection methods and biofilm control.
- Explore the practicality of package sensors that will allow the industry to alert consumers of inappropriately stored or contaminated product.
- Public meeting for FDA and USDA to share information generated to date.
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CITRUS JUICE VALIDATION PRACTICES

J. PETER CHAIRES ACTING CHAIRMAN - AMERICAN FRESH JUICE COUNCIL ASSOCIATE VICE PRESIDENT - FLORIDA GIFT FRUIT SHIPPERS ASSOCIATION

J. PETER CHAIRES
ACTING CHAIRMAN - AMERICAN FRESH JUICE COUNCIL
ASSOCIATE VICE PRESIDENT - FLORIDA GIFT FRUIT SHIPPERS ASSOCIATION