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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
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
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
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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