Washing Vegetables, Antimicrobial Effectiveness and Food Safety Modernization Act (FSMA)

Brian Zomorodi Apio Inc. USA

October 27, 2016

VEGETABLE INNOVATION LAB 2016

Washing Vegetables, Antimicrobial Effectiveness Food Safety Modernization Act (FSMA)

• New Food Safety Regulation in US; FSMA • Produce Microbiological Contamination • Risk Based Food Safety & Preventive Controls • Produce Washing; A Friend or Foe • Wash Water Dynamics & Chlorination • Validating Effectiveness of Wash Water • Validation Options • Conclusion • Q&A

Food Safety Modernization Act (FSMA) A New US Food Safety Regulations

• Food Industry is held more accountable and liable to produce safe foods

• Raw Agricultural Commodities (RACs), are treated more like Ready-To-Eat

• Focus on Supply Chain Food Safety; Fresh produce food safety cannot be achieved without food safety of the entire Produce Supply Chain

• Risk Based Preventive Controls to eliminate or substantially minimize hazards

• Validations/Verification • Foreign Supplier Verification

1. Produce Rule Standards for the Growing, Harvesting, Packing, and Holding of Produce Affects Farm and Re-packing Operations

2. Preventive Control For Human Foods Food Safety Programs for production

Affects Processing Facilities and Re-packing Operations

3. Preventive Controls for Animals 4. Foreign Supplier Verification Programs

Imported food with same standards as US Affects Foreign Suppliers

5. Third Party Accreditation; Rules that governs auditing bodies

Affects Auditing Companies

6. Mitigation of Intentional Adulteration (Food Security)

7. Sanitary Transportation Preventing food contamination (Adulteration) during transportation Affects Distribution and Transportation Companies

FSMA at a Glance

Washing Produce All Fruits and Vegetables Come in Contact with Water

• Water & Produce

Packing House Washing Mango

Washing Salads

Sweet Corn Cantaloupe

Washing Spinach

Produce Microbiological Contamination

• Produce Contamination is very Rare • Mostly Unpredictable; It’s Sporadic & Random • Normally Affects Small Quantity of Product • Water Can Spread Contamination • Proper Wash System and Effective Antimicrobial Use

Can Prevent Cross Contamination • Antimicrobial Effectiveness Depends on Key Factors

such as Organic Load, pH, Type of Vegetable • Continuous Antimicrobial Dosing & Automated

Monitoring System are Necessary to Manage Production Variables

• Wash Water System as a Preventive Control

Risk Based Food Safety & Preventive Controls

Identify Hazards

Understand Causes &

Risks

Develop Preventive

Controls

Validate & Implement

Preventive Controls

Monitor & Verify

Effectiveness

Review and Adjust

Hazard:

Pathogen

Cause: Raw Contamination

Risk: High

Preventive Control: Preventing Cross Contamination in

Wash System Using Antimicrobial Implement:

Reliable Sanitizer injection and

Control System

Continuous Sanitizer Level

Monitoring

Review Verify and

Adjust

Wash Water Effectiveness; A Preventive Control

CCP: Free Active Chlorine Level

Validation

Washing Produce; “A Friend or Foe”

Why Do We Wash Produce? • Cosmetic Improvement • To Reduce Initial Microbial Load • To Remove Latex and Soil, Etc. • To Make it Safer…..?

Washing fresh produce; An opportunity to clean, or contaminate?

Quotes from Dr. Devon Zagory

Washing & Produce Cross Contamination

• Water is an excellent medium for dispersing and spreading Microorganisms

• Small amount of contaminated produce can contaminate large quantities of produce (many lots)

• Washing does not decontaminate produce • Once Contaminated, its Difficult to De-contaminate Contamination During Washing

– Via Products (surfaces/inside) • Via Particles (small pieces of produce)

– Via Water (Cross Contamination)

Opportunity for cross-contamination Is the highest in wash systems

Washing & Product Contamination

• Pathogens can adhere strongly to the surfaces • Some surfaces can attract and support bacteria • Internalized Contamination is possible

Damaged surface makes it difficult to dislodge pathogens

Washing Does Not Remove All Contaminants

• Produce surface is complex and hard to clean

Unwashed E. coli On lettuce

Washed E. coli 100 ppm Hypochlorite

Post Washed E. coli

Washing Does Not Remove All Contaminants

Contamination Via Water

Improper management of the wash system and antimicrobial level can lead to produce cross contamination

E. Coli in water and on Produce

Properly implemented Wash System can prevent cross contamination via water

Wash Water Dynamics & Chlorination

• Chlorine is the most widely used Sanitizer

• Wash System: a Complex Dynamic Environment

• Preventing Cross Contamination Depends on the Effective Level of Free Chlorine (FC) in the Water

• Effectiveness Depends on Multiple Variables: – Temperature, pH, Organic Load (Turbidity,

Conductivity/COD), Sanitizer Concentration, Product Water Ratio, Contact Time, Source Water Quality

– The main factor is the level of Free Active Chlorine in the system to destroy pathogens, if they are present

Free Chlorine Availability Depends on Depletion Rate of the Sanitizer in the System

Wash Water chlorination Key Points

• Properly managed wash system can prevent microbial cross contamination

• Free Chlorine level changes based on system variables

• The key is how a system maintains the FC ppm at a constant level by properly responding to variables

• At this time the best validated level that can prevent cross contamination is 10 ppm of FC

Validating Effectiveness of Wash Water; A White Paper

Wash Water Validation Group;

“VALIDATING EFFECTIVENESS OF WASH WATER TO PREVENT MICROBIAL CROSS-CONTAMINATION FOR FRESH-CUT LEAFY VEGETABLES”

A collaborative document by Produce Industry Experts and Regulatory Agencies’ Scientists

(FDA and USDA)

This is a work in progress

Wash Water Validation

• Definition; Obtaining scientific and technical evidence that a control measure, when properly applied, is capable of effectively controlling an identified hazard to produce safe and unadulterated products

Validation Options

Option 1: Cross-contamination is prevented under worst case operational condition, using product inoculated by pathogen or suitable Surrogate

– Validation by pathogen can only be performed in specialized and dedicated facilities (IFISH), not in commercial environment

– Can be used to develop critical limits for Antimicrobial levels

– Can establish Base Line Validation Model

Surrogates Microorganism and DNA Based Tracers are being developed

Validation Options

• Option 2: Validating minimum antimicrobial level is achieved under “Worst Case” operational conditions, as shown by sensors

• “Worse Case Scenario” is when the wash system during production is pushed to its limits, operating at the upper limits of all or some of its critical variables, (Simulated Model)

Produce Industry can use this option to validate their own system based on the Effective Sanitizer Level identified in the Base Line Validation Model

Validation Options

• Option 3: Minimum antimicrobial levels are maintained in each processing run, without considering worst case conditions

• Validation is based on: – Placement of sensor(s) in the lowest

concentration point in the wash system

– Demonstrating that system can maintain the minimum level at all times

This option while requires mapping of the wash system, it is more practical for processors to validate fresh produce wash lines

Conclusion Safe Fresh-cut Vegetables for Consumers

• Produce Food Safety Depends on Supply Chain Food Safety • Preventive Controls are necessary to assure produce food

safety • Washing Produce can be a Preventive Control • Washing Is not a Kill Step, the goal is to prevent Cross-

Contamination • Produce washing can be a complex system; needs to be

understood and managed • Improper Wash Systems, can cause cross contamination

and expand outbreaks • Wash Systems must be Validated for effectiveness • Validation options require further development to become

widely accepted and practical

Questions

THANK YOU