Food Quality Control

Objectives:

Food Customer Impact

Food QC Pathogens

Regulations

Why and How QC is Performed

Certified Reference Materials

Microbiologics Products

Increasing Customer Impact

Blue Bell – 3 deaths - ListeriaChipotle – $2 Billion and counting

Food Product Recalls

Protecting Consumers

Salmonellosis

• Tens of millions of human cases worldwide every year (WHO)

Listeriosis

• Particularly high case-fatality rate (CDC)

• 1600 illnesses and 260 deaths yearly in the US

Enterohaemoragic E. coli

• May lead to life-threatening disease especially in young children and the elderly

Campylobacter

• Especially problematic for the young, the elderly and the immunocompromised

Examples of Foods that are Tested

Meat

Produce

Grains

Spices

Beverages

Milk

Pet Food

Animal Feed

Common Food Pathogens

Pathogens Food Examples

Salmonella spp. Raw eggs, poultry, beef and pork

Campylobacter spp. Poultry and raw dairy products

Listeria monocytogenes Cheeses, raw vegetables, ice cream, and deli meats

Listeria spp. Cheeses, raw vegetables, ice cream, and deli meats

E. coli O157:H7 Raw/undercooked ground beef and sprouts

Non-O157 Shiga-Toxin E. coli (STEC) Raw/undercooked ground beef

Common Spoilage and Indicator Organisms

Organism (group) Sample Type

Aerobic plate counts (APC)Environmental samples, frozen, chilled, pre-cooked,prepared foods, and product shelf life determination

Coliforms / Generic E. coliEnvironmental samples, processing water, and equipment surfaces

Enterobacteriaceae (EB)Environmental samples, processing water, and equipment surfaces

Yeast and mold Processed foods and raw vegetables

Spores Processed and canned foods

Food QC Testing Regulations

Who Says You Need to Perform QC Testing?

The Consumer

Government & Standards

OrganizationsIndustry

ISO 11133 and WDCM

ISO 11133: Microbiology of food, animal feed and water – Preparation, production, storage and performance testing of culture media

Cites the use of reference strains represented by a WDCM number

ATCC® strains have WDCM numbers; Microbiologics catalog cross-referenced to WDCM

Food Safety Modernization Act (FSMA) became law on January 4, 2011

Seven rules have been finalized to date, addressing:

Preventive Controls for Human Food

Preventive Controls for Animal Food

Foreign Supplier Verification Program

Accredited Third-Party Certification

Produce Safety

Sanitary Transportation

Intentional Adulteration

· FSMA says:

“… facilities have a responsibility to choose testing laboratories that will produce reliable and accurate test results.” (Preventive Controls for Human Food)

Food Safety Modernization Act

FSMA says:

“For a regulatory audit, (when) sampling and analysis is conducted, the accredited third-party certification body must use a laboratory accredited in accordance with ISO/IEC 17025:2005 or another laboratory accreditation standard that provides at least a similar level of assurance in the validity and reliability of sampling methodologies, analytical methodologies, and analytical results.” (3rd Party)

· FSMA says:

Importers must “retain documentation of each sampling and testing of a food, including … the test(s) conducted (including the analytical method(s) used)… the results of the testing… and information identifying the laboratory conducting the testing...” (FSVP)

· More rules and guidance documents anticipated, including

Laboratory Accreditation for Analyses of Foods

Model Laboratory Standards

Food Safety Modernization Act

Regulations Driving CRM’s

Food Safety Modernization Act (FSMA) became law on January 4, 2011. FSMA says:

• “…facilities have a responsibility to choose testing laboratories that will produce reliable and accurate test results.” (Preventive Controls for Human Food)

• “For a regulator audit, (when) sampling and analysis is conducted, the accredited third-party certification body must use a laboratory accredited in accordance with ISO/IEC 17025:2005 or other laboratory accreditation standard that provides at leas a similar level of assurance in the validity and reliability of sampling methodologies , analytical methodologies, and analytical results.” (3rd Party)

• Importers must “retain documentation of each sampling and testing of a food, including the test(s) conducted…the results of the testing…and information identifying the laboratory conducting the testing…” (FSVP)

Organizations and Standards

Organization/ Standard

What It’s About

AOACPublishes approved methods on their website –Official Methods of Analysis

ISO 17025General requirements for the competence of testing and calibration laboratories

ISO 11133Microbiology of food and animal feeding stuffs – Guidelines on preparation and production of culture media

BAM The FDA’s Bacterial Analytical Module of food and cosmetics

No matter what regulations you face, quality control in the microbiology lab is

essential…

Why Are Controls Important?

Numerous factors can lead to inaccurate results…

Unacceptable media

Instrument or equipment malfunction

Defective reagents

Technician error

Interfering components in the food may mask the presence of pathogens

1. Presence/absence (qualitative) tests for detecting pathogens such as Salmonella, Campylobacter, and Listeria monocytogenes

2. Enumerated (quantitative) tests for determining the number of targeted organisms in a food sample

How is Food QC Testing Performed?

Presence/Absence

(Qualitative) Testing

QC for Presence/Absence Testing

QC organisms are used to ensure that the test method is able to detect pathogens, if present

• Example: KWIK-STIK and LYFO DISK

QC can be used to verify that the test method is not only able to detect pathogens, but detect pathogens that are present at very low levels.

• Epower or EZ-FPC

Presence/Absence Test – 2 Steps

1. Enrichment Step - used to increase low levels of pathogens (that would not otherwise be detected)

• Measure food sample into suitable enrichment broth

• Incubate appropriately to allow bacteria to multiply to detectable levels

2. Detection Step – used to screen the enrichment sample for presence of the pathogen

• Detection steps range from traditional (culture) methods to molecular methods (PCR)

• Some culture methods may take several days, while PCR may only take hours

Enumerated

(Quantitative) Testing

Types of Enumerated (Quantitative) Testing

Bacterial and spore enumeration on samples such as:

• Milk, juice

• Carcass swabs and rinses

• Bread

• Canned goods

Indicator and food spoilage organism enumeration on samples such as:

• Carcass swabs and rinses

• Processing water

• Environmental samples

Quantitative Tests

Range from traditional to rapid

No enrichment step required (the number of bacteria cells that are in the product at that time are counted). Examples of methods:

• Pour Plate/Spread plate

• Film-Based Media (Petrifilm)

• Autoplate® Spiral Plating System

Example of Film-Based Test for E. coli

1. Prepare the food product as required

2. Inoculate Petrifilm with 1.0 ml food sample or food rinse

3. Incubate appropriately

4. Enumerate CFUs

Petrifilm™ test for E.coli

Why Perform QC in a Food Lab?

1. Positive and negative controls of each test batch

2. New batches of media

3. Determine if test method is in control (SPC)

4. Validation of new test methods, instrumentation, test kits and verification of first-time test performance

5. Proficiency: test the competency of the laboratory technicians and test methods

Media Testing

Instrumentation

Lab Techs

1. QC of Each Test Batch

Positive and Negative Controls

Verify that:

• Media and reagents are performing satisfactorily

• Equipment is functioning properly

• Analyst is performing test properly

• Components in sample do not interfere with testing system

Example Requirements

The USDA FSIS Establishment Guidance for the Selection of a Commercial or Private Microbiological Testing Laboratory; March 2012 states:

“The testing laboratory should have routine control with each batch of samples.”

ISO 17025: General requirements for the competence of testing and calibration laboratories states:

“The laboratory shall have quality control procedures for monitoring the validity of tests.”

2. QC of New Batches of Media

Media is tested for productivity, selectivity, and specificity.

ISO 11133 has strict requirements for media made in-house

• Enumerated tests on agar uses 80-120 CFU (outside range 50-150 CFU)

• Enrichment broth uses less than 100 CFU

ISO 11133: Culture Media Guidelines

Who follows it?

• Europe

• Some countries in South America and Asia

• Manufacturers of media

• Labs that prepare their own media for quantitative testing must test all lots

4. Validation and Verification of New Test Methods

Validate all methods, instrumentation, test kits, and lab techs

Requires testing with numerous target and non-targeted strains

Verification

• New test kits

Food Matrix Extensions

Known QC strains produce known reactions

What is Certified Reference Material (CRM)?

Manufacturer must be certified to ISO Guide 34, and product names must be listed on a scope document

Must come with a certificate providing traceability and uncertainty.

1. Characterization – Verification of Identity

2. Homogeneity – Variability of values from one pellet to another

3. Transport – Variability of values before and after transport

4. Stability – Variability of values over shelf-life

• Certified Value

• Expanded Uncertainty

• Standard Deviation

Role of CRM in Food QC Testing and ISO 17025

For Testing Laboratories, Section 5.6.3.2 of ISO 17025:2005 states

“Reference materials shall, where possible, be traceable to SI units of measurement, or to certified reference materials”

Examples CRM use in testing:

Method Validation

Method Verification

Method monitoring or process control

Microbiologics QC Food Products

Products for Presence/Absence (Qualitative) Testing

KWIK-STIK

KWIK-STIK Plus

LYFO DISK

Lab-Elite CRM

UV-BioTAG

Epower

New Product – UV-BioTAG (Qualitative)

UV-BioTAG cultures fluoresce under ultra-violet light to visibly distinguish these QC strains from other contaminates.

• Available in four strains in both vial and swab format

• UV-BioTAG strains are genetically modified microorganisms

• Note: We are working on getting the required approvals for importing these products into the EU due to GMO restrictions.

Products for Enumerated (Quantitative) Testing

Epower

Epower CRM

Product Highlight: STECs

Shiga-toxin producing E.coli is banned by the USDA/FSIS in non-intact beef

Microbiologics offers the STECs in a prepared format sourced from the CDC and ATCC®

Prevalent in beef around the world

Found in vegetables (2011 sprouts in Germany O104:H4)FoodQualityNews.com

Microbiologics is the only accredited supplier to offer STEC controls in ready-to-use format

Be compliant with USDA/FSIS regulations

Reduce Risk

Easy-to-use

Saves time, labor and money

Water: Life’s Link

Objectives:

Water Market Overview

Water Testing

Microbiologics Product Overview

Our Most Precious Resource

Water costs are on the rise

1 in 7 people have no access to safe drinking water

Ground water depletion

Drought

Increased food demands

Why Test Water?

People contaminate water (within the first 15 minutes of bathing, the average person sheds 6,000,000 colony forming units (CFU) of S. aureus)

Farm animals contaminate water

Around 700,000 children die every year from diarrhea caused by unsafe water and poor sanitation

CDC http://www.cdc.gov/healthywater/hygiene/fast_facts.html

http://www1.agric.gov.ab.ca/$department/deptdocs.nsf/all/agdex927

Child Health Epidemiology Reference Group (CHERG), 2012 and Unicef Child Mortality Report, 2012

http://www.wateraid.org/what-we-do/the-crisis/statistics

Laboratories Can Prevent Illness

Laboratories can help keep people healthy by detecting and reporting bacterial contamination in water samples

Accurate and timely results are important

Quality control helps ensure accurate results

CRM, ISO 17025 and Standard Methods

Many laboratories are ISO 17025 accredited, and will need Certified Reference Materials

Standard Methods, 9020 QC Lab Guidelines, section 9.2 states, “Positive and negative control cultures –Use certified reference cultures.”

What are Labs Testing For?

Indicator organisms

– They are found in animal and human waste

– They are a warning sign that pathogens may be present

Legionella

Common Water Pathogens

Vibrio

Legionella

Salmonella

Shigella

Vibrio

Giardia

Cryptosporidium

E.coli O157:H7

Indicator Organisms

Coliforms

– Gram negative, non-spore forming

E. coli (not O157:H7 or STEC)

– Specific to animals and humans

Enterococci

– Found in animal & human waste

– Can survive in salt water

Clostridium perfringens

– Ubiquitous in fecal matter

– Seen in water and wastewater

– Spores resistant to wastewater treatment

Pseudomonas

Common Testing Methods

Most common methods:

– Membrane filtration method

– Enzyme substrate method

– MPN/Fermentation Broth Method

• Multiple tubes are used to estimate the coliform and/or E. coli concentration in a water sample

– Heterotrophic Plate Method

• Estimates the number of viable bacteria in a water sample

Microbiologics Solutions

KWIK-STIK

LYFO DISK

Lab-Elite CRM

Epower, Epower CRM

Growth Promotion Test Products