Brian Strouts, AIB International
Brian Strouts, vice-president, baking and food technical services for AIB.

For grain-based foods, it long has been assumed that the baking process confers a “kill step,” eliminating microbial activity and helping keep baked foods safe.

Now, as new regulations under the Food Safety Modernization Act (FSMA) take effect, the baking industry must scientifically validate this assumption.

A major research initiative by AIB International, with collaboration from the American Bakers Association, has been unveiled to help bakers comply with the new regulations.

Details of the program were shared by Andre Biane, AIB International’s president and chief executive officer, and Brian Strouts, vice-president, baking and food technical services, in a recent interview with Milling & Baking News.

“All of us in baking know that by running the product through the oven, and raising the internal temperature of baked foods to 200 degrees Fahrenheit, all micro activity is killed,” Mr. Biane said. “But there was no public data available to validate this from a scientific perspective.”

AIB International worked with the A.B.A. and Kansas State University to create this foundational research, beginning with a single study using hamburger buns.

The purpose of the research is straightforward — validate that the process involved in baking a standard hamburger bun delivers the desired lethality of pathogenic microorganisms.

Using temperature probes already adopted industrywide for calibrating ovens and quality checks, the study involved collecting time and oven/product temperature data.

Next, test dough was inoculated with Salmonella. Because this research requires working with live Salmonella, doing the study in an actual baking plant or even at AIB International, would have been risky. This part of the research was conducted at a level 2 biosafety lab at Kansas State University under strictly controlled conditions.

Mr. Biane said the results confirmed the long held belief that the baking process acts as a kill step.

“The study did confirm that microbes are killed,” he said.

The initial paper, “Validation of baking as a kill step for Salmonella in hamburger bun manufacturing,” was written by Lakshmikantha (Kantha) Channaiah, AIB International’s director of microbiology; Randy Phebus, professor from K.S.U.; Harshavardhan Thippareddi, professor from University of Georgia-Athens; and others.

Because FSMA regulations require scientific proof of a “kill step” for each product category and manufacturing line, additional research is now under way for other products that are significantly different from hamburger buns in terms of variables like moisture content, pH, water activity, etc.

Products included in the next round of research include whole wheat multigrain bread, muffins and cookies.

“The initiative was started as a function of FSMA requirements,” Mr. Biane said. “If the industry had taken this upon themselves, each and every company would spend between $250,000 and $300,000 to generate the data needed to support these four product categories. With the work we’ve done for hamburger buns and are doing for the basic muffin, whole wheat bread and cookies, one can easily calculate dollars and cents in cost avoidance to the industry.”

The largest companies may have the internal resources to conduct these kinds of tests.

“But think about all the medium and smaller companies,” Mr. Biane said. “For them, undertaking this work would be very, very expensive.”

Compounding the potential cost of compliance is the wide variety of baked foods produced by the typical baking company and uncertainty over how the Food and Drug Administration may interpret its own regulations.

“If at any time any aspect of a formula changes — ingredients, temperature, cooking time — it could mandate a new validation,” Mr. Strouts said. “To run this real time would be untenable. Instead, it should be very simple to verify and comply with FSMA regulations.”

AIB International will continue to study products that represent “the more challenging compositions” in terms of demonstrating microbial lethality during baking.

“Pathogens will live or die in different time/temperature profiles, depending on whether I’m dealing with a simple product like a hamburger bun versus a more complicated product like a fruit and nut bread,” Mr. Strouts said. “The findings may be used across multiple categories.”

Out of this research AIB International and its partners created both a measurement protocol and a Baking Process Kills Step Calculator, a tool into which bakers may enter their own data to determine whether their baking process is a valid kill step. Additional information may be found at

“If I’m baking a hot dog bun, I can leverage this research,” Mr. Strouts said. “Then by running the probes and collecting data, I can drop my findings into the calculator, run the calculation and verify that my operation is performing a kill step.”

Mr. Strouts said the program AIB International has put together represents a simple solution for bakers, adding though that the process of developing this new protocol was far from simple.

“We’ve been looking at this for some time,” he said. “It’s important to keep in mind that we basically started from zero. There are zero public research studies that look at answering this question — kill step validation for baked foods. As we extend the research into multiple categories, we’ll further validate the lethality of the baking process.

 “We worked with the FTRAC (Food Technical Regulatory Affairs Committee) of the A.B.A. to hone our approach for this foundational research. We needed their input from a scientific standpoint and also so that our solution would be practical for the industry.”

All told, about three years have elapsed since AIB International was first approached by the baking industry to validate the kill step.

In addition to the A.B.A. and K.S.U., AIB International has partnered with the University of Nebraska – Lincoln, to bring in considerable pathogen testing experience in the meat, nuts and related industries.

This endeavor fits well into AIB International’s mission, which includes conducting industry applicable research, Mr. Biane said. The research findings will be published in the public domain.

“This research will be beneficial not just to the U.S. but also worldwide,” he said. “Companies that import baked foods into the United States also will need to comply with FSMA.

“Second, with the protocol in the public domain, if people want additional assistance running the tests, we are here to help the industry work through their challenges.”

The research initiative has been financed through one of AIB International’s endowment funds, a research fund specifically designated for public research. The A.B.A. has agreed to help fund the public relations and marketing activities needed to create awareness and direct bakers to AIB International for assistance, if needed, Mr. Biane said.

Going forward, AIB International will work with stakeholders to further assist bakers with compliance efforts. This work will include research into other product categories, to be shared publicly, and the development of similar calculators for other product types. AIB International also will offer proprietary research for specific products and clients, generating confidential information for that particular company. Mr. Strouts said multiple companies could participate jointly as well.

“What we would envision is that as we perform the research on these categories, we would go back to F.D.A. and get them to acknowledge that this research would represent all types that would fall under the umbrella of one category like all wheat breads under the whole wheat bread umbrella,” Mr. Biane said. “If we researched 12 categories that would cover 2,500 different products in the market, and everyone will have access to the foundational research without duplicating the research investment.”

Mr. Biane said the approach AIB  International has taken toward its research was shared with the F.D.A. in a July meeting in Washington with industry stakeholders. The response was encouraging, he said.

Mr. Biane and Mr. Strouts expressed the view that the baking industry will find more value in the exercise than simply demonstrating that pathogens die during the baking process.

“Both of us come from the industry, and as much as people will look at this as the result of a regulation, I think it will help bakeries become more efficient,” Mr. Biane said. “It will force them to do more rigorous quality check of their ovens. Further productivity and product quality consistency could result.”

Mr. Strouts continued, “They’ll say, ‘I never realized I had a cold spot in my oven.’ They’ll bring in engineers, find they optimize energy input and improve product quality at the other end.”

As bakers look to use these tools in their compliance efforts, AIB International said it is ready to assist at whatever level of engagement bakers may seek. While many bakers use temperature probes and related equipment for quality assurance, the same equipment used for kill step validation, other bakers may not.

“If you are a small or medium baker and don’t have the resources, to purchase data loggers, an $8,000 investment, we have multiple sets in house,” Mr. Strouts said. “We could bring in equipment and help them generate the necessary data from their ovens.”

Mr. Strouts said AIB International also was willing to help train bakers to gather and interpret the data so that they will be able to do the verification work themselves. MBN






There are zero public research studies that look at answering this question — kill step validation for baked foods.

- Brian Strouts, AIB International


As much as people will look at this as the result of a regulation, I think it will help bakeries become more efficient.

- Andre Biane, AIB International