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Kill-Step Validation of the Baking Process to comply with FSMA rule Kantha Channaiah, PhD Director of Microbiology AIB International

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Kill-Step Validation of the Baking Process to

comply with FSMA rule

Kantha Channaiah, PhDDirector of Microbiology

AIB International

Introduction

FDA’s FSMA validation requirement

Baking Kill-Step validation (KSV) research

Foundational KSV research: Hamburger buns

Baking Process Kill-Step Calculators

Additional KSV research

Benefits of KSV research

Outline

Introduction

In the United States:

2,800 commercial bakeries

6,000 retail bakeries

Market value = $30 billion

Safe production record

compared to the rest of the

food industry

Yet, there were 4,200 illnesses

related to bakery products from

1998 to 2007

Bakery Products: Food Safety Challenges?

Salmonella spp. in bakery ingredients and products

could create a public health risk if the product is

improperly baked

Salmonella can survive in adverse conditions

Pathogens such as Salmonella spp. can be introduced

into bakery products through a wide range of

ingredients:

‒ Egg

‒ Milk products

‒ Flour

‒ Milk chocolate

‒ Coconut

– Peanut butter

– Fruit

– Spices

– Yeast flavorings

The need….

Most bakery products undergo

a putative kill step at the point

of production, such as baking

or cooking

However, these lacks scientific

proof or validation

FDA-FSMA regulatory

requirement requires

validation and verification of

kill-step

Key FSMA validation requirements

FDA-FSMA (117.160) regulatory

requirement requires validation and

verification of kill-step

The three key FSMA requirements are:

1. Validation of preventive controls

2. Provide scientific evidence

3. Keep documents/records accessible for FDA inspection

Kill-step validation research to help the baking industries

AIB International has partnered with industry stakeholders &

various state universities to develop kill-step validation (KSV)

procedures for various bakery products.

Main objectives:

Develop KSV procedures for bakery products

Publish KSV research findings for the benefit of bakery

industry’s food safety needs

Develop Baking Process Kill-Step Calculators

Provide on-site support and training for the US baking

industry to comply the FDA-FSMA’s (117.160) validation and

verification requirement

Baking Process Kill-Step Validation Research

Collaborators

FTRAC: Food Technical and Regulatory Affairs Committee

The ABA - FTRAC

Validation of baking as a kill step in controlling

Salmonella in hamburger buns

Foundational Research Project:

1. Validate the baking process as a kill step in reducing Salmonella spp. during hamburger bun manufacturing

2. Validate the baking step’s effectiveness in reducing S. cerevisiae and E. faecium to determine appropriateness of utilizing non-pathogenic surrogate for industry validation and process verification purposes

3. Determine the heat resistance viz, D-value, and z-value of Salmonella spp., S. cerevisiae and E. faecium in hamburger bun dough

Research objectives

Baking temperatures: 425 ºF (218 °C)

Time: 9, 11, 13, and 13 + 30 minute cooling phase

Initial microbial (Salmonella or Enterococuus)

concentration of ~6/ 7 log was maintained in the flour and

dough

After both proofing and baking, the bacterial

concentration was determined to confirm a minimum of 5

log kill

Surviving Salmonella or Enterococcus were enumerated

using selective & injury-recovery media

The experiment was replicated three times

Bun baking temperature and sampling

Materials and methods

Salmonella serovars: Salmonella enterica serovar Typhimurium

(ATCC 14028) Salmonella enterica serovar Newport

(ATCC 6962) Salmonella enterica serovar Senftenberg

(ATCC 43845)

Enterococcus: Enterococcus faecium (ATCC 8459)

Yeast: Saccharomyces cerevisiae

(Fleischmann’s compressed yeast)

Microorganisms used in this research

Salmonella spp. Enterococcus spp.

Hamburger bun kill-step validation research

1 43

6

2

5 7 8

Enumerated on selective media; xylose lysine desoxycholate agar, m-Enterococcus agar and potato dextrose agar.

ST: S. enterica serovar Typhimurium, SN: S. enterica serovar Newport, SS: S. enterica serovar Senftenberg,

EF: Enterococcus faecium, SC: Saccharomyces cerevisiae. DL: Detection Limit

Figure 1. Survival population of Salmonella serovars, Enterococcus faecium and

Saccharomyces cerevisiae, in hamburger buns during baking at 218°C (using

selective media)

Results

DL

Enumerated on brain heart infusion agar overlayed with xylose lysine desoxycholate agar and brain heart infusion (BHI)

ager with m-E agar overlay, ST: S. enterica serovar Typhimurium, SN: S. enterica serovar Newport,

SS: S. enterica serovar Senftenberg, EF: Enterococcus faecium, SC: Saccharomyces cerevisiae. DL: Detection Limit

Figure 2. Survival population of Salmonella serovars, Enterococcus faecium

and Saccharomyces cerevisiae, in hamburger buns during baking at 218°C

(using injury recover media)

DL

Salmonella spp. E. faecium

BHI/XLDa XLDb BHI/mEAc mEAd

Temperature (°C)

55 28.64 ± 5.19 21.30 ± 2.61 133.33 ± 0 87.21 ± 4.74

58 7.61 ± 0.61 7.53 ± 0.61 55.67 ± 9.0 45.33 ± 6.79

61 3.14 ± 0.32 2.29 ± 0.21 14.72 ± 4.11 6.14 ± 0.47

z-value 6.68 ± 0.94 6.22 ± 0.32 6.25 ± 0.80 5.20 ± 0.05

Salmonella cocktail: S. enterica serovar Typhimurium (ATCC 14028); S. enterica serovar Newport (ATCC 6962); S. enterica serovar

Senftenberg (ATCC 43845).a Injury-recovery media, Brain Heart Infusion (BHI) agar with Xylose Lysine Desoxycholate (XLD) agar overlay; b Selective

medium, XLD agar; c Injury-recovery media, BHI agar with m-Enterococcus (mE) agar overlay; d Selective medium, mE agar

Table 1. D-values (min) and z-values (°C) of a 3-strain Salmonella spp.

cocktail, and Enterococcus faecium ATCC 8459 in hamburger bun dough

Microbial kinetics study

Media: Potato dextrose agar supplemented with 100 ppm of chloramphenicol

Note: The temperature for yeast studies were decreased due to the fact that

Saccharomyces is completely dead at 61 °C instantaneously.

Temperature Bun dough

52 18.73 ± 0.72

55 5.67 ± 1.51

58 1.03 ± 0.21

z-value 4.74 ± 0.34

Table 2. D-values (min) and z-value (°C) of Saccharomyces cerevisiae in

hamburger bun dough

Figure 3. Mean internal temperature profile of hamburger buns during baking

at 218°C oven temperature for 13 min followed by 30 min of cooling

First scientific research demonstrating validation and thermal resistance of Salmonella, E. faecium and yeast in a bakery product

Research published in the

Journal of Food Protection

Journal of Food Protection, 79: 544-552 (2016)

Highlights from the FDA MeetingJuly 20, 2015 and June 10, 2016

The FDA had positive comments on

AIB’s intent to design kill-step validation (KSV) procedure, and KSV calculators for various bakery products

Provide on-site support, and

Training for the US baking industry

Bakery products selected for the KSV-Gen 2 and

3 are appropriate

Interaction with the FDA will continue during

next generation bakery product validation studies

Additional bakery product validation research

There are > 2,000 bakery products in the market.

Bacteria respond/behaves differently at varying moisture

levels, pH, fat content, etc.

Salmonella has shown the highest resistance in low

water activity and high fat foods.

Additional research is needed for baked goods with varied

moisture contents, pH, water activities (aw), etc.

Publish the next generation baking validation research

findings, thus providing documentary evidence for the

benefit of bakery industry’s food safety needs.

Major Bakery Products Category

Pan Bread

White wheat

Whole wheat multigrain

bread

Sweet breads

Large pan formats

Hearth/Artisan

Dinner rolls

Par baked

Dense breads

Bagels

Chemical Leaven

Products

Plain muffin

Nut muffins

Crispcookies

Softcookies

Crackers

Snack cakes

Laminated Dough Products

Croissants, puff pastries

Filled products

Cinnamon rolls

Biscuits

Complex Multicomponent Products

Prebaked pies

Fruit cake

Yeast raiseddonuts

Cake

Flat Bread

Tortillas

Pizza

Naan bread

Peta bread

AIB’s KSV 2 & 3rd Generation Research

KSV Gen 2

KSV Gen 3

Baking Process Kill-Step Calculator

Translation of research to commercial application

Baking Process Kill-Step Calculator

Objective:

To provide bakery manufacturers with a science-based validation tool that can be used to demonstrate the

effectiveness of a baking process to destroy Salmonella spp. in a variety of bakery products

Baking Process Kill-Step Calculator (BPKC)

How Does It Works?

Baking Process Kill-Step Calculator

T-ref: Reference Temperature

D, Z and T-ref are obtained

from AIB’s KSV study

Temp data obtained from

data logger

Baking process lethality for Salmonella

in log values

How it Works?

D-Value: This indicates time in minutes at a constant temperature, that is necessary to destroy 90% or 1 log of the

organism present at a given reference temperature.

z-Value: This is the temperature increase required to reduce the thermal death time by a factor of 10.

BPKC: How It Works?

Download the calculator to your computer from AIB's website http://www.aibonline.org/aibOnline/develop-your-product-solutions/baking-process-kill-step-calculators.aspx

Format the temperature profile (time-temperature data)so that the time is in intervals of 15 seconds and thetemperature is in °F or °C

Once programmed, the temperature data logger is placedin the cold spot of an oven, the probes are inserted into thegeometric center of the to-be baked products (e.g., dough)

Let the data logger continue to travel through the coolestoven zone, and retrieve after the baking cycle is complete

The process is repeated five times

Download the temperatureprofile (time-temperature data) from the data logger to an Excel sheet

Select 20 data points fromthe probe that takes the longest time to reach 170°F (77°C) to plug into the Kill-Step calculator to calculate total process lethality

BPKC: How It Works? Cont.

Output Cont.

Determines F - value and cumulative F - value

Automatically determines the total process lethality

(e.g. 5 log) for Salmonella

Generates three graphs: Product internal temperature,

F - value/min and cumulative log reductions

If the desired log reduction is achieved for the baking process, the process lethality report generated can be used as a supporting documentation for FSMA validation and verification process

Baking Process Kill-step Calculator: Output in terms of Salmonella log reductions

AIBI has released “Baking Process Lethality Calculators” for

Hamburger buns,

100% whole wheat multi-grain pan bread

Basic round top cake muffins

Crisp cookies

Soft cookies

These Kill Step calculators can be downloaded from AIBI’s

website for free and comes with complete instructions and

procedures

We strongly believe that the baking process Kill-Step

calculators will enable bakeries of all sizes to meet

requirements of the FDA FSMA without investing in costly

and time-consuming microbial challenge studies

Baking Process Kill-step Calculator:

Benefits of Kill-Step Validation Research

Pathogen free bakery products assuring maximum safety

Protects consumers, builds confidence

Demonstrates FSMA compliance

Can save bakery industries millions of dollars by avoiding

repetition and duplication of KSV research

Acknowledgements

The experimental baking laboratory, AIB International,

Manhattan, KS

Food Safety and Defense Laboratory (FSDL), Kansas State

University, Manhattan, KS

The American Bakers Association (ABA), and the ABA- Food

Technical and Regulatory Affairs Committee (FTRAC),

Washington, D.C

Prof. Harshavardhan Thippareddi, University of Georgia-

Athens, Atlanta, GA

Prof. George Milliken, emeritus professor of statistics, Kansas

State University, Manhattan, KS

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References

Thank you

Questions?