Validation of Commercial Baking as an Effective Step to Control/Inactivate Salmonella in Baked Products Major findings, analysis and conclusions

Description of the baking industry and baking emphasis in the United States.

Purpose and structure of importance

Description of the problem being addressed and its importance to the practice of applied food safety

Process of Consultation

Outline how the client (ABA) will be engaged and carefully define the problem

Identification of key stakeholders

Overview and feedback of findings and results

Recommended actions and dissemination of these recommendations

Plans for implementation and measurement

Major findings. The U.S. had approximately 167,600 baker positions available in 2012 and around 6% of these were self-employed (Bakery business, 2016). Although industry analysts project sustained growth in the U.S. baking industry, this growth will not be on par with other industries (Bakery business, 2016). Currently, the U.S. baking industry is a nearly $310 billion industry that has enjoyed a remarkably safe record for the production of shelf stable processed foods over the years (Channaih, 2015). Despite this impressive safety record, pathogens such as Salmonella spp. are still capable of being introduced into bakery products through a wide array of constituent ingredients, including milk products, eggs, flour, milk chocolate, coconut, peanut butter, fruit, spices and yeast flavorings (Channaih, 2015). Mitigating the Salmonella threat is a fundamental responsibility of all food manufacturers and effective strategies are required in order to prevent associated illnesses and deaths (Channaih, 2015). Moreover, a number of U.S. regulatory agencies have implemented zero tolerance guidelines for Salmonella for all ready-to-eat food products (Channaih, 2015).

Since the Salmonella pathogens can survive and even thrive in low-water activity foods and processing environments, identifying and implementing Salmonella control processes represent an important responsibility for food manufacturers today (Channaih, 2015). In addition, the introduction of Salmonella spp. into bakery products holds the potential for causing a threat to public health if products are not properly baked (Channaih, 2015). There are some proven methods for controlling the threat of Salmonella, though, including most especially kill-step validation procedures that have demonstrated efficacy in destroying the bacteria. Although the kill-step validation procedures recommended by the FDA are time-consuming, the procedures are fairly straightforward and can be accomplished by experienced microbiologists and statisticians who have access to containment and laboratory facilities as well as commonly used data analysis applications such as Excel. Moreover, the FDA also publishes good-specific kill-step validation guidelines for different types of common baked goods. Definitions of the key terms used in this study are provided below.

Validation: According to the Codex Alimentarius Commission (Codex), validation is defined as "obtaining evidence that a control measure or combination of control measures, if properly implemented, it is capable of controlling the hazard to a specified outcome. In other words, validation attempts to answer the questions: Are process parameters the right ones? Will they work? Validation is clearly distinct but often confused with verification which is also a major requirement of the Food Safety Modernization Act of 2011" (cited in Microbiological safety validation of food processes, 2013, p. 2).

Verification: The Codex defines this term as "the application of methods, procedures, tests, and other evaluations, in addition to monitoring, to determine whether a control measure is or has been operating as intended" (cited in Microbiological safety validation of food processes, 2013, p. 2).

Monitoring: The Codex defines this term as "the act of conducting a planned sequence of observations and/or measurements of control parameters to assess whether a control measure is under control" (cited in Microbiological safety validation of food processes, 2013, p. 2).

Analysis. The analysis of the U.S. baking industry that follows below included the number of commercial bakeries, their economic impact including both wages and taxes paid at the state level as well as national totals. In addition, current working conditions, wage levels and industry forecasts are also included in the analysis. Beyond the foregoing issues, this study also analyzed the paths by which Salmonella can be introduced into commercial bakery products in order to identify opportunities for improvement in storage, production and cooking methods. Finally, an analysis of the recommended steps to be used in kill-step validation for commercial bakeries is followed by a summary of these issues in the study's conclusion which are discussed below.

Conclusions. The research was consistent in underscoring the major impact of the baking industry on local, state...

Given the enormity of these activities, identifying opportunities to improve the safety of commercial baked goods represents a timely and valuable enterprise. Although the majority of food products that are used today are required to be subjected to a kill-step at the production points, there remains a lack of scientific evidence to confirm their efficacy. Consequently, there is a compelling need for an industry-wide scientific-validation procedure that can help ensure food safety (Channaih, 2015).
Introduction

Today, the American baking industry generates more than $102 billion in economic activity each year and employs more than 706,000 workers who are highly skilled (Baking industry economic impact study, 2016). This economic impact is just the tip of the commercial bakery iceberg, though, because the production generated by these commercial bakeries uses constituent ingredients that are purchased from other vendors, creating a multiplier effect that further increases this economic impact (Baking industry economic impact study, 2016). According to the American Bakers Association, "Thus, economic activity started by the baking industry generates output (and jobs) in hundreds of other industries, often in sectors and states far removed from the original economic activity" (Baking industry economic impact study, 2016, p. 2). At present, this aggregated economic impact is estimated at nearly $310 billion a year (Baking industry economic impact study, 2016).

This study provides a review of the relevant literature concerning the American baking industry to include an analysis of this economic impact as well as the potential for the introduction of Salmonella into commercial bakery products to disrupt this industry. Although the U.S. baking industry has experienced an enviable safety record with respect to Salmonella, outbreaks of Salmonellosis have occurred in the past and continue to adversely affect bakery operations in the U.S. and abroad. In response, government agencies including the U.S. Food and Drug Administration, have developed standardized, step-by-step protocols for handling and monitoring commercial bakery products that ensure the destruction of any Salmonella contamination that might slip through quality assurance protections.

Moreover, specific step-by-step protocols for kill-step validation have been formulated for the most commonly manufactured commercial bakery goods that provide a valuable framework in which to ensure the food safety of these products. To gain some new insights concerning the importance of these kill-step validation procedures to the contemporary multi-billion dollar baking industry, a brief description of the baking industry in the United States is provided below.

Description of the baking industry in United States

The baking industry in the United States is older than the country itself, and a number of flour mills in the American colonies operated bakeries (Albion & Williamson, 1944). Many of the baked goods that were produced by these early bakeries, though, especially bread products, bore little resemblance to their modern, enriched counterparts. For instance, Albion and Williamson (1944) report that, "A considerable part of their exports being bread, probably mainly a 'hardtack' that would not deteriorate on long sea voyages" (p. 447). Over time, the American baking industry became more specialized, with one sector focusing on the production of pastries, cakes, pies and breads while a second sector produced biscuits and crackers (Albion & Williamson, 1944).

The biscuits and cracker sector of the American baking industry was the first to introduce large-scale factory production, due in large part to the fact that its products were not as perishable as pastries and breads and were able to be distributed over larger geographic regions (Albion & Williamson, 1944). At the fin de siecle, American bakeries competing in the biscuits and crackers sector began to form strategic alliances and large corporations became commonplace (Albion & Williamson, 1944). For instance, Albion and Williamson note that, "In 1898 the National Biscuit Company [NBC] was formed by the merger of four large companies. The new company, it was claimed, would control the cracker and biscuit trade from the Atlantic to the Rockies, operating 139 plants and about 90% of the total capacity of the industry" (p. 447).

Indeed, NBC was good for its word and by applying improved packaging methods and innovative marketing strategies, the company grew its market share throughout the country rapidly to the point where by 1900, it was using more than two million barrels of flour each year and had plans to make its production even more efficient by milling its own flour (Albion & Williamson, 1944). As noted above, the other baking industry sector that emerged during this period in early American history specialized in more perishable baked goods such as breads, pies, cakes and pastries (Albion & Williamson, 1944). Additional improvements in manufacturing and processing that were implemented during World War I helped this sector to develop commercial bakery products, most especially breads with preservatives that enjoyed widespread popularity (Albion & Williamson, 1944).

By 1940, though,…