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 and national economies and the ubiquity of baked goods in Americans’ diets. 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).
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, the U.S. federal government was faced with a world war looming on the horizons and became concerned over the malnourishment that adversely affected the American population during the Great Depression (Wonder Bread, 2012). In fact, this concern was well warranted and even represented a national security threat because at least 13% of the initial million men assessed by draft boards in 1940 were refused active duty service due to malnourishment and associated symptoms (Wonder Bread, 2012). According to the editors of The Wilson Quarterly, “It dawned on the government to spike the most ubiquitous items in American pantries with vitamins. Thiamin, niacin, iron, and eventually riboflavin became banner ingredients of enriched bread” (Wonder Bread, 2012, p. 66).
In an effort to ensure that the American public would be receptive to this enriched bread product, the U.S. Department of Agriculture partnered with researchers in the baking industry to launch was has been termed the “Manhattan Project of bread” in 1952 (Wonder Bread, 2012, p. 66). The goals of this collaborative public-private partnership were two-fold: (a) to identify American consumers preferences for white bread taste, texture and appearance, and (b) to develop manufacturing processes that could produce large quantities of bread rapidly (Wonder Bread, 2012). The findings that emerged from this research were based on exhaustive testing of 600 American families living in Rockford, Illinois (Wonder Bread, 2012). The majority of these consumers were found to prefer “extremely fluffy bread,” most likely since this quality was widely regarded as a sign of freshness (Wonder Bread, 2012). In addition, this research found that American consumers preferred bread that was than the typical product of the day (Wonder Bread, 2012).
With respect to manufacturing, researchers identified a new method for discretely fermenting yeast that significantly reduced the amount of time commercial bakeries were required to wait for bread products to respond by rising (Wonder Bread, 2012). Other innovations that facilitated the production process of bread during this period in American history included new methods for strengthening gluten strands that could withstand the more rigorous automatic production methods that were being introduced (Wonder Bread, 2012). As the editors of The Wilson Quarterly conclude, “Four years and almost one hundred thousand slices of bread later, the prototypical loaf of enriched white bread was born” (Wonder Bread, 2012, p. 66).
The “Manhattan Project of bread” succeeded beyond anyone’s expectations, and average American consumers were of the newly enriched bread product each week by 1962 which provided between 25% and 30% of their requisite caloric intake for the period (Wonder Bread, 2012). While the average consumption level has declined somewhat from this 1962 peak year, the editors of The Wilson Quarterly conclude that, “Bread remains a fundamental conduit of governmentally mandated nutrients — and[[:blank:]]a staple of American diets” (Wonder Bread, 2012, p. 66).
Today, companies competing in the American baking industry produce an enormous array of products, including fresh and frozen bread as well as cakes, pies, and doughnuts (Bakery business, 2016). In the United States, major competitors in the baking industry include Flowers Foods and Mckee Foods (Bakery business, 2016). At present, bakery products in the U.S. are produced by approximately 2,800 commercial bakeries that account for a combined annual revenue of approximately $36 billion together with around 6,000 retail bakeries that generate combined annual revenue of approximately $3.8 billion (Bakery business, 2016).
The early research by the U.S. government concerning consumer preferences for baked goods has been greatly expanded in the intervening years, and the U.S. baking industry continues to evaluate optimal recipes to satisfy changing consumer tastes (Bakery business, 2016). Demand for bakery goods is also affected by the extent to which bakeries are operated by grocery stores rather than purchasing from commercial bakeries (Bakery business, 2016). According to the U.S. Small Business Development Centers (SBDC), “Profitability for individual companies is determined by efficiency of operations. Large companies have scale advantages in procurement, production, and distribution” (Bakery business, 2016, p. 2). By contrast, smaller baking industry companies seek to gain and sustain a competitive advantage through optimal distribution processes or by providing specialty baked goods (Bakery business, 2016).
The SBDC adds that, “In the United States, the commercial side of the industry is concentrated: the 50 largest companies generate 75% of revenue. The retail side of the industry is highly fragmented: the 50 largest companies generate about 15% of revenue, and the typical company operates just one facility” (Bakery business, 2016). Although companies competing in the baking industry range from micro to major conglomerates, the general product line produced by this industry includes fresh and frozen bread and baked goods (this category includes muffins, cakes, and croissants but not cookies and crackers) (Bakery business, 2016). Besides marketing these baked good products to grocery stores and other food service companies, many commercial bakeries also market their products to the public directly (Bakery business, 2016).
Given that bread remains the “staff of life” for most American consumers, demand for these products is projected to increase at a yearly rate of approximately 0.6% over the next 5 years, reaching a total of nearly $40 billion (Bakery business, 2016). The SBDC also reports that, “Consumers are expected to continue to trend toward health eating and increase demand for items like fortified breads, gluten-free loaves and sprouted and organic sweets” (Bakery business, 2016, p. 3). As a result, the profitability of the baking industry in the United States is also projected to increase over the next 5 years due to the stabilization of constituent ingredient prices and the enhanced ability of commercial bakeries to adjust their pricing levels as prices for ingredients shift (Bakery business, 2016). There are also expectations that continued strategic alliances between major players in the industry will further enhance productivity and profitability during the next 5-year period (Bakery business, 2016).
External competition has increased over the past five years and imports will continue to grow at an annualized rate of 7.1%. However, growing demand for this product outside of the country will increase exports by 9.8% per year over the next five years. (Bakery business, 2016)
A categorical breakdown of projected sales for individual bakery good products is provided in Table 1 below.
Projected sales for individual bakery good product categories
Cakes and Cupcakes
The largest households, which are those with children, are the best customers for cakes and cupcakes. Six in ten married couples with children spend more than the average household on cakes and cupcakes, with that rate increasing to almost three in four for people with school-aged children. Hispanics spend about 17% more than average on this product and Asians spend an even greater amount at 25% more. The average household spending on this product fell by more than one fifth between 2000 and 2006. The cake and cupcake sector of the baking industry then stabilized between 2006 and 2009.
The largest portion of revenue from cookies is derived from households with children. A household with a married couple and children will spend 54% more than the average household on this product within the baking industry. If the children are school-aged, the household will spend 73% more than average. Spending on cookies fell by over two tenths between 2000 and 2006, but has held steady since then.
The oldest consumers as well as married couples with school-aged children or older children at home are the best customers for the prepared desserts segment of the baking industry. Couples with school-aged children spend over a fourth more and those with adult children spend more than 54% more than the average household on this product. People aged 65 years or older spend 12 to 17% more than the average household on prepared desserts. An increase in consumer preference for the convenience of prepared desserts has led to an 18% increase in household spending from 2000 to 2009. (Bakery business, 2016)
Pies, Tarts and Turnovers
Households with children are the best customers of pies, tarts and turnovers. Those households spend 47 to 71% more than the average, while single parents spend just above the average on this product. People aged 35 to 54 spend around two fifths more than the average household and take up 47% of the market.
Coffee Cakes and Doughnuts: Households with children are the best customers for sweetrolls, coffee cakes and doughnuts and spend about 52 to 69% more than the average household on this segment of the baking industry. Household spending on sweetrolls, coffee cakes and doughnuts fells 23% between 2000 and 2009, and will continue to decline as the baby-boomer generation exits the best customer life stage.
Source: Adapted from Bakery business, 2016
In 2012, there were approximately 167,600 baker jobs in the United States and about 6% of these bakers were self-employed (Bakery business, 2016). Self-employed bakers are typically required to invest long hours in their operations and larger commercial bakeries are especially hazardous working environments. As a result, bakers in the U.S. tend to experience higher levels of illnesses and injuries compared to the national average (Bakery business, 2016). Despite these risks, industry analysts project a 6% increase in the number of bakers in the U.S. during the period from 2012 through 2022, but this increase is less than the average increase for all occupational types (Bakery business, 2016). Furthermore, additional innovations in manufacturing and production that facilitate even greater mass production methods are also expected to limit job growth in the U.S. baking industry for the foreseeable future (Bakery business, 2016).
There are other factors involved, most especially changing consumer preferences, that will inevitably have an effect on the U.S. baking industry as well. For instance, fully 50% of American consumers currently report that high fiber content in prepared cakes and pies is important to them (Zegler, 2014). In addition, just as the U.S. government determined during its “Manhattan Project of bread” research, more recent studies of consumer preferences for baked goods has confirmed increased demand (currently about 58%) for bakery good products that are fresher and higher in protein content (Zegler, 2014). Furthermore, Zegler emphasizes that, “Not only do consumers want to know what’s inside their products, they want to know how it got there and more about the company that made it. Interest in how it’s made extend into who made it, the maker’s training and the size of the batch” (2014, para. 3). Taken together, it is clear that the U.S. baking industry is faced with both significant challenges as well as opportunities in the future. Given this industry’s impact on local and national economies, the outcome will have a correspondingly significant effect on the country as a whole as discussed further below.
B. Purpose and Structure of Importance
As noted above, the economic impact of the baking industry in the United States is enormous, and this impact is relatively consistent as a percentage of per capita across the country by state as shown in Table 2 below.
Economic Impact of Baking Industry by State
Direct Wages (in thousands)
Total Wages (in thousands)
Total Output (in thousands)
All States Total
District of Columbia
Source: American Bakers Association, 2016 at http://www.americanbakers.org/industry-data/
As can be readily discerned from the figures in Table 2 above, the total output of direct impact of wages paid by the baking industry in the U.S. is nearly one-third of a billion dollars and this amount does not included the so-called “induced impact” of these earnings. The impact the induced impact that is generated through re-spending by employees of industry and supplier firms is calculated by applying an input/output model of the United States (Baking industry economic impact study, 2016). The aggregated “total” of the jobs, wages, and output figures shown in Table 2 above take into account supplier and induced impact; however, the “direct” category of jobs, wages, and output figures do not taken into account the supplier and induced impact but are rather the actual figures for the baking industry (Baking industry economic impact study, 2016).
Overall, the U.S. baking industry has an enormous impact on the American economy, generating approximately $311.0 billion in total economic output or about 2.1% of the country’s GDP (Baking industry economic impact study, 2016). According to the American Bakers Association (ABA), “Bakers, product wholesalers and retailers directly or indirectly employed approximately 1.76 million Americans in 2010” (Baking industry economic impact study, 2016). Individuals employed in the U.S. baking industry earned more than $90.2 billion in wages and benefits in 2015 and paid $38.5 billion in direct federal, state and local taxes, a figure that does not take into account state and local sales taxes that were paid on baked goods during this period (Baking industry economic impact study, 2016).
The profound economic impact of the federal, state and local taxes is clearly discernible from Table 3 below.
Baking Industry Taxes
State and Local Taxes
All States Total
District of Columbia
Source: American Bakers Association, 2106
Description of the problem being addressed and its importance to the practice of applied food safety
Today, Salmonella bacteria are the most frequently reported source of foodborne illness in the United States (Claudio, 2012; USDA food safety information, 2016). The Salmonella bacteria are gram-negative pathogens which can cause diarrheal illnesses in humans who are infected by the pathogen (USDA food safety information, 2016). A representative sample of a common strain of Salmonella spp. is shown in Figure 1 below.
Figure 1. Microscopic view of a common strain of Salmonella spp.
According to the FDA’s cautions about this pathogen, “[Salmonella] are microscopic living creatures that pass from the feces of people or animals to other people or other animals. The Salmonella family includes over 2,300 serotypes of bacteria which are one-celled organisms too small to be seen without a microscope” (USDA food safety information, 2016, para. 4). Two serotypes of Salmonella, Salmonella Typhimurium and Enteritidis are the most commonly encountered bacteria in the U.S. at present and cause fully 50% of human infections (USDA food safety information, 2016).
Interestingly, some Salmonella strains do not cause animals to become sick while they can still cause sickness in humans and the reverse is also true (USDA food safety information, 2016). Compounding the problem is the fact that Salmonella does not typically change the smell, taste or appearance of food products, making its detection even more difficult (USDA food safety information, 2016). In fact, all raw foods that have an animal origin including many that are commonly used as ingredients in baked goods such as eggs, milk and other dairy products (USDA food safety information, 2016).
Although most commonly associated with raw poultry and beef processing, bakeries can also experience salmonella contamination from the constituent ingredients that are used in their baked goods and outbreaks have occurred in the past and this threat remains salient for bakeries the world over, even in highly developed nations (Claudio, 2012). In fact, as recently as 2002, there were two deaths and hundreds of illnesses caused by Salmonella poisoning in London that were caused by the same egg supplier (Harris & Wright, 2002). According to a newspaper account of the incident, “The outbreak of the rare strain of salmonella – enteritidis PT 14b – has prompted the UK Food Standards Agency to issue a warning to restaurants and catering firms” (Harris & Wright, 2002, p. 37). A follow-up report found that “more than 350 people have been taken ill in Britain in six salmonella outbreaks linked to eggs since August 2002 and two people in the North West have died. Many of the cases were traced back to bakeries which used raw eggs in icing and desserts” (Poulter, 2002, p. 23).
Despite increasingly rigorous efforts by commercial bakeries to implement and administer effective protocols against Salmonella contamination, the potential sources of entry and difficulties in ensuring that any contamination is destroyed through proper controls make it a challenging enterprise. For instance, one industry analyst emphasizes that:
At the beginning of the twenty-first century, efforts to prevent microbial contamination of the food supply continue to be held hostage to industries obstructing intervention, agencies competing for scarce resources, inspectors defending obsolete job descriptions, courts defending obsolete laws, and a Congress more anxious to protect the sources of campaign contributions than the health of the public. While many food safety problems have improved since the era of The Jungle, the solution to others continues to face formidable political opposition. (Nestle, 2010, p. 137)
These are especially significant issues for the U.S. baking industry given the potential threat represented by Salmonella contamination since it is responsible for more human deaths than any other human foodborne pathogen (Nestle, 2010). Although there have not been any high-profile, large-scale outbreaks in recent years, the harsh reality remains that approximately 1.2 million American consumers suffer from Salmonella poisoning each year (Nestle, 2010). Moreover, the Salmonella pathogen is highly resistant to conventional cleaning and sanitation methods (Nestle, 2010).
Some of the factors that can cause Salmonella contamination in the types of low-moisture food environments typical of commercial bakeries include but are not limited to the following:
Poor building and equipment design;
Poor quality ingredients;
Poor cleaning and sanitation practices;
Poor pest management practices;
Lack of validation (Channaih, 2015).
In addition, even airborne dust in a food manufacturing facilities can be a source of Salmonella contamination and the bacteria are capable of adapting to extreme conditions in their environments including pH (can survive at pH 3.8 and 9.5 (optimal 6.5 to 7.5), low-water activity, and varied temperature conditions (2-54C (optimal 35-37C) (Channaih, 2015)..When water activity (denoted as “aW”) of baked goods is reduced, there is a corresponding reduction in Salmonella growth; nevertheless, the surviving Salmonella bacteria are actually strengthened by this process and their survival rates are significantly increased (Channaih, 2015). According to one food safety expert, “The survival [of Salmonella] is affected by nutritional composition of the products: Salmonella showed highest resistance in low water activity and high fat foods. The location (internal vs. external) of Salmonella cells in a product is also critical for its long-term survival” (Channaih, 2015, p. 4). Further, Salmonella survival rates can also be affected by the manner in which products are stored and the serotype and strain of the bacteria can also have an effect on Salmonella survival levels for lengthy periods of time in low-moisture environments and food products (Chainnaih, 2015).
Despite its demonstrated track record of success in mitigating Salmonella outbreaks due to baked goods contamination in the past, the U.S. baking industry still faces some significant challenges in this area. Bakery goods can have pathogens, including Salmonella spp., introduced through a wide array of constituent ingredients such as egg, milk products, flour, milk chocolate, coconut, peanut butter, fruit, spices and yeast flavorings (Channaih, 2015). If commercial bakery products are improperly cooked, the presence of Salmonella spp. can represent a public health threat (Channaih, 2015)
At present, the FDA’s overarching concerns with respect to Salmonella in baked goods include the following:
1. Salmonella cannot grow in low moisture foods and environments but, it can survive;
2. Survival can occur for long periods of time;
3. Longer shelf life of low moisture foods;
4. Increased heat resistance at low moisture conditions;
5. Low numbers of Salmonella can cause illness; and,
6. If low-moisture ingredients or foods are rehydrated during manufacturing or preparation, then bacteria grows fast thus increasing the health risk to consumers (Chainnaih, 2015)
Mitigating the threat represented by foodborne pathogens such as Salmonella is an integral responsibility for all food manufacturers which is needed to prevent illness and even deaths (Channaih, 2015). Various U.S. regulatory agencies have implemented zero toelerance guidelines for Salmonella in all prepared, ready-to-eat food products (Channaih, 2015). Because Salmonella bacteria are capable of living in low-water activity foods and processing environments, identifying and implementing Salmonella control processes is therefore a vital responsibility of food manufacturers (Channaih, 2015).
Controlling Salmonella in low moisture foods and environments
There are some steps that commercial bakeries can take to help control Salmonella in low-moisture foods and environments, including the following:
Consider points of entry for microorganism;
Understand the factors that influence the survival of Salmonella in low-moisture food and environments;
Building and equipment design;
Effective implementation of preventive controls, prerequisite programs; GMPs, HACCP;
Inspection and auditing;
Effective corrective action; and, Process validation or kill-step validation (Channaih, 2015).
Possible entry points of Salmonella
Commercial bakeries should also be vigilant concerning the numerous possible entry points of Salmonella, including the following:
Contact materials/surfaces; and, Pests (Channaih, 2015).
Control strategies: Raw materials/ingredients
There are also some straightforward strategies that commercial bakeries can use to control the introduction of Salmonella into baked goods, including the following:
In most cases ingredients are the primary source of contamination;
Ingredients are increasingly being tested by food processors and customers;
In most cases positive finished product tests have led to positive ingredient tests and recalls;
Ask for certificates of analysis and conduct testing where necessary
Control strategies: Pest management
As noted above, one of the possible entry points for Salmonella is pests (including birds, rodents and insects) which can be especially problematic in mitigating. Some of the proven control strategies for pests including the following:
Effective good manufacturing practices (GMPs);
Building and equipment design;
Production and process controls;
Sanitation and cleaning practices;
Storage and distribution;
Environmental monitoring program (EMP); and, Microorganisms are generally introduced into the food processing environment through raw materials, pests, air, water, and employees (Channaih, 2015).
To the extent that contamination levels are allowed to increase unchecked or inadequate sanitation procedures are used will likely be the extent to which Salmonella can become established and cause foodborne illnesses (Channaih, 2015). In this regard, Channaih (2015) advises that, “A substantial amount of foodborne illness outbreaks results from poor environmental controls and/or hygiene practices. Hence, it is critical to maintain and monitor the hygienic environment in the food processing facility” (p. 4).
Implementing an Effective Pathogen Environmental Monitoring Program
A useful strategy for mitigating the risk of Salmonella contamination of food manufacturing facilities is the implementation of a pathogen environmental monitoring (PEM) program. An effective PEM program can help mitigate the risk of Salmonella spp. contamination in the production as well as post-production environments when included as an integral element of a food production facility’s hazard analysis and critical control points (HACCP) plan (Preventing Salmonella recontamination: Pathogen environmental monitoring program guidance document, 2015). An effective PEM program will measure the overall effectiveness of the following:
The PEM can be use to verify that cleaning and sanitizing procedures are (a) keeping indicator organisms and any organisms of particular concern in check and (b) assess the risks posed by pathogen of concern (Preventing Salmonella recontamination, 2015). It is important to note, though, that even the most rigorous PEM program is insufficient to ensure food safety. In this regard, Channaih (2015) emphasizes the environmental monitoring programs are “not designed to validate the effectiveness of cleaning and sanitizing methods, but is more focused on validating cleaning and sanitizing frequencies, and all the programs of the Good Manufacturing Practices (21 CFR)” (Channaih, 2015, p. 5)
As food safety management moves toward risk-based food management, food manufacturers will need to provide scientific evidence that their foods comply with current safety standards (Channaih, 2015). A preemptive scientific evaluation providing documentary evidence that a particular process is capable of consistently delivering a product, meeting its pre-determined specifications based on a collection of scientific evidence that is often expressed as “log reduction” (Channaih, 2015).
An FDA rule, 117.150(a)(2)) that became effective September 17, 2015 requires that the validation of preventive controls for pathogens such as Salmonella include information concerning data collecting and evaluating and in those cases where this information is not available or is deemed scientifically inadequate, requires the conduct of studies to evaluate to the extent to which properly implemented preventive controls will mitigate the threat of contamination (Channaih, 2015). According to the FDA’s most recent guidance, the amendments to the FDA regulations covering Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food introduced two important changes:
1. The FDA is modernizing the long-standing current good manufacturing practice requirements; and,
2. The FDA is adding requirements for domestic and foreign facilities that are subject to our regulation for Registration of Food Facilities to establish and implement hazard analysis and risk-based preventive controls for human food (Current Good Manufacturing Practice, hazard analysis, and risk-based preventive controls for human food, 2015).
In addition, the FDA is also in the process of changing its regulation for the Registration of Food Facilities in an effort to make it clearer which foreign and domestic food production facilities are required to perform hazard analyses and updating its existing good manufacturing practices (Current Good Manufacturing Practice, hazard analysis, and risk-based preventive controls for human food, 2015). Pursuant to these changes, affected commercial bakeries will be required to conduct controlled scientific studies to determine whether a preventive control measure is sufficient for mitigating the pathogen threat (Channaih, 2015). According to Channaih (2015), “Scientific validation is the only way to confirm that a particular process is consistently delivering a desired lethal effect (heat in this case) to ensure the destruction of pathogenic microorganisms; often expressed as ‘log reduction’” (p. 5).
Benefits of Kill-Step Validation for Commercial Bakeries
The kill-step validation process is described by Channaih (2015) as “a preemptive scientific evaluation that provides documentary evidence that a particular process (e.g., cooking, frying, chemical treatment, extrusion, etc.) is capable of consistently delivering a product that meets predetermined specifications” (p. 5). In sum, the kill-step validation process includes evaluation steps that gather the evidence needed to ensure the effectiveness of the Salmonella mitigation strategies that are in place Chainnaih, 2014). Regardless of the source of pathogen contamination, some of the demonstrated benefits of validating kill-steps for Salmonella in the baking industry include the following:
Helps achieve maximum food safety and protect consumers;
Helps meet the safety standards (e.g., five log reduction of pathogenic E. coli/Salmonella) set by regulatory agencies;
Helps determine effective treatment;
Saves food industry millions of dollars by avoiding recalls and other legal penalties due to foodborne illness outbreaks;
Helps to retain consumer confidence; and, Supports business success (Kill-step validation for food safety, 2016, para. 3).
Guaranteeing food safety, though, still represents a complex and challenging enterprise. While the majority of food products currently in use today are required to be subjected to a kill-step during their production, 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). There are several resources that are needed to develop an effective validation study, including a comprehensive design, a statistician and an experienced microbiologist as well as an appropriate containment and laboratory facilities (Channaih, 2015).
Kill-step validation analyses that involve pathogens such as Salmonella should be performed by experienced microbiologists who must follow established laboratory safety guidelines and standard operating procedures throughout the evaluation (Channaih, 2014). According to the leading industry expert on kill-step validation studies, “A kill-step validation study involving a pathogen (e.g., E. coli O157:H7) should be conducted in certified BSL 2 or 3 laboratories depending on the type of pathogen. However, it is important to accurately reproduce the process (similar to industry) in the laboratory to achieve desired specifications (e.g., five log reduction of pathogenic E. coli/Salmonella)” (Channaih, 2014, p. 2). Commercial bakeries can use surrogate non-pathogenic organism if they are approved by the FDA to confirm a kill step in their facilities, but it is vitally important to take into account that even surrogate organisms can result in manufacturing plant contamination if appropriate precautions are not taken (Channaih, 2014).
According to a white paper published by the National Food Lab (2013), optimal surrogates must possess the following characteristics:
Resistance is quantitatively correlated to target (destruction kinetics — D and z values)
Correlation to target is valid through range of treatment
Correlation to target allows for practical use in terms of surrogate concentration needed for work
Can be prepared as a stable suspension
Each crop is calibrated prior to use
Possess distinct metabolic or morphological characteristic(s) (Microbiological safety validation of food processes, 2013, p. 9).
The Food Safety Modernization Act of 2011 (“the Act”) now requires food producers to conduct hazard analyses of their products in order to determine if there are microbial hazards associated with specific food product present. In addition, the Act also requires the food producers to implement preventive control measures that have proven efficacy in mitigating the risks that are identified through the hazard analysis (Microbiological safety validation of food processes, 2013). The National Food Lab also reports that, “A critical component in assessing the efficacy of a microbial control measure is a scientifically sound validation process. Following validation of the microbial control measure, verification and monitoring procedures must be implemented to assure that the control measure as implemented is operating as intended” (p. 2).
In recent years, a number of significant improvements have been made to food production, handling, and distribution, but keeping food products safe from pathogen contamination remains an ongoing problem. As a result, it is vitally important to develop, implement and administer and effective scientific validation process to ensure pathogens are actually being destroyed through cooking or other preventive measures. Although every commercial bakery is unique in some way, they all share this common need. The effectiveness of a kill-step validity study, though, also requires the following: (a) industry-specific GMPs, (b) an effective and timely hazard analysis and critical control points program, (c) a sanitation program, (d) effective employee hygiene practices, (e) a comprehensive pest control program, and (f) good hygiene post-process handling procedures (Channaih, 2015). Following the establishment of pathogen controls, it is also important to conduct process validation to ensure they are performing as required (Channaih, 2015).
Process of Consultation
The client, ABA, is well situated to promote industry-wide kill-step validation measures and this objective is highly congruent with the organization’s stated mission which is “To be the leading voice for the baking industry” as well as its corresponding vision statement that states: “To grow and enhance the baking industry through public policy advocacy, education and networking opportunities” (About us, 2016, para. 4). The process of consultation for this client is described below.
A. How the client (ABA) will be engaged and carefully define the problem
The process of consultation represents a highly significant resource for helping organizations better manage their operations in a competitive marketplace (Isaac, 2016). For instance, according to one consultation expert, “Organizations exist to create value for stakeholders and consultation is a process by which the management of the organization aims to better understand the needs, wants and expectations of stakeholders, so that value can be created” (Isaac, 2016, para. 2).
It is important to keep in mind, however, that the consultation process requires ongoing communications between consultant and client using both formal and informal channels (Isaac, 2016). Such formal and informal communication channels can include the following:
Open meetings (e.g., stakeholders are invited to come to an open meeting or a series of meetings);
Surveys (e.g., stakeholders are invited to complete a paper-and-pencil or online survey);
Focus groups (e.g., a select cross-section of stakeholders, small in number, are invited to attend a meeting or series of meetings);
Invitation to send a written response (e.g., stakeholders are invited to submit comments in writing on a proposal or plan);
Informal meetings (e.g., organization management might mingle with people at an event a canvass certain ideas and see what response they get) (Isaac, 2016, para. 3).
The purpose of consultation is three-fold:
1. To invite stakeholders to provide advice to the management of the organization about their needs, wants and expectations. In other words, tell the organization what value it wants and how it can provide this value.
2. To invite stakeholders to comment on plans that have been created by organization management to provide this value requested by stakeholders.
3. To quell any criticism that organization management have not taken account of, or are not listening to the needs of stakeholders in developing strategic and operational plans (Isaac, 2016).
B. Identification of key stakeholders (VP level, Technical level, Operational level..etc.)
The client’s key stakeholders for a kill-step validation program initiative are set forth in Table 4 below.
Key ABA stakeholders
ABS Staff Liaison, ABA Senior Vice President, Government Relations and Public Affairs
Food Technical Issues
Marketing & Communications Coordinator
Assistant Director of Executive Office & Strategic Initiatives
Board of Directors
Director, Membership & Marketing, IBIE Registration Manager, Bulletin (Publications)
What’s New (Communications)
Source: ABA staff (2016) at http://www.americanbakers.org/staff/
C. Describe your sources of information and data
The peer-reviewed and scholarly texts used for this study were drawn from university and public libraries, organizational Web sites such as the ABA and the ABA’s Economic Impact Study which provides an estimate concerning the economic contributions of the U.S. baking industry to the national economy in 2010. According to the ABA, “This data study used standard econometric models first developed by the U.S. Forest Service, and now maintained by the Minnesota IMPLAN Group. Data came from industry sources, government publications and Dun and Bradstreet, Inc.” (American Bakers Association economic impact study, 2016, p. 2).
The ABA’s Economic Impact Study estimates the number of jobs in the baking industry, wages and taxes paid at the state and federal levels and defines the baking industry as being “those firms involved in the production, importation/wholesaling, and retailing of baked goods including breads, cakes, pastries, cookies, crackers and tortillas. Preprepared dough manufacturers are also included in the definition on the industry” (American Bakers Association economic impact study, 2016, p. 2). In addition, this study used on-point guidelines provided by a leading industry expert, the director of microbiology for AIB International, K. Channaih.
D. Collection, summary and analysis of data
Following the collection of the above-described data, it was reviewed following the guidelines advocated by Noblit and Hare (1988) which they term “reciprocal translation” wherein the analysis of one set of data serves to inform the next to provide researchers with fresh insights and new findings that might otherwise go unnoticed.
E. Overview and Feedback of Findings and Results
On the one hand, the bad news was that pathogenic microorganisms such as Salmonella remain a major public health issue by virtue of their ability to contaminate food products even in low-water environments (Channaih, 2015). Indeed, according to the director of microbiology for AIB International, “Each year, foodborne illness outbreaks affect millions of people and kill thousands. Tainted food has cost the food industry billions of dollars in recalls, lost sales and legal expenses. Additionally, these outbreaks undermine consumer confidence in affected products, and diminish market demand” (2015, p. 2).
On the other hand, though, the good news is that there are evidence-based strategies available for mitigating this public health threat that can be used by commercial bakeries in the United States, including most especially kill-step validation that can confirm the effectiveness of preventive protocols and the adequacy of baking times in destroying any pathogens that find their way into their food products.
The U.S. baking industry has a multi-billion dollar impact on the American economy in the form of wages and taxes paid at the state and federal levels, and the industry has enjoyed a remarkable track record of success in mitigating Salmonella contaminations (Channaih, 2015). This track record of success is all the more noteworthy because pathogens such as Salmonella spp. can be introduced into bakery products through a wide range of constituent ingredients including eggs, milk products, flour, milk chocolate, coconut, peanut butter, fruit, spices and yeast flavorings (Channaih, 2015). Because Salmonella spp. is the most prevalent source of foodborne illnesses, bakery products that contain these bacteria could cause a public health threat if bakery products are improperly baked and handled (Channaih, 2015)
G. Outline recommended actions and dissemination of these recommendations
It is recommended that the ABA develop evidence-based kill-step validation procedures including a relevant environmental monitoring program that can be disseminated to the more than 700 baking facilities and baking company suppliers it represents before the U.S. Congress (About us, 2016). In addition, the USDA Food Safety and Inspection Service recommends that (a) commercial bakeries closely monitor staff health conditions and absences that could represent early signs food contamination and (b) request that transporters be able to verify the location of a load at any time during shipment (Gips, 2009).
In order to reduce the incidence of Salmonella in chickens and eggs, the ABA should recommend that dairy producers use lactic acid derived from whey for their chicken’s food (Hunter, 2003). At a cost of only about one cent for each five birds, this treatment is considered a highly cost-effective intervention that can reduce Salmonella at its (Hunter, 2003). In addition, according to one industry analyst, the American Baking Association should also encourage the U.S. Congress to provide the mandate, authority, and funding necessary to achieve the following outcomes:
A single agency accountable for providing consistent and coordinated oversight of food safety, from farm to table;
Revision of the 1906 safety inspection laws to permit oversight of microbial pathogens;
Institution of Pathogen Reduction: HACCP, with performance standards verified by pathogen testing, at every step of food production;
A national food safety plan that sets priorities, adopts strategies, ensures accountability, and monitors progress;
Recall authority, access to records, and penalties for lapses in safety procedures;
Uniform food safety standards for states, consistent with federal policies;
Standards for imported foods equivalent to those for domestic foods;
Food safety to take precedence over commercial considerations in trade disputes;
Universal food safety education for commercial food handlers;
A national system for monitoring cases and outbreaks of food-borne disease and their causes; and, Research methods to control microbial contamination and illness and prevention strategies (Nestle, 2010, p. 137).
H. Plans for implementation and measurement
Implementing and measuring the effectiveness of a kill-step validation program is a multi-step process. Current best practices for kill-step validation require at least three tests be conducted, and it is recommended that these tests be performed on different days of the week using different batches of ingredients so take into account possible differences that occur between production runs (Channaih, 2014). Log reduction is determined by comparing treated and untreated samples (those samples that are not exposed to thermal or chemical treatment) (Channaih, 2014).
Some other guidelines from the director of microbiology at AIB International for performing kill-step validation studies are set forth in Table 4 below.
Guidelines for performing kill-step validation studies
Selection of a surrogate or a pathogenic bacterium
The first step in a kill-step validation study is to select the right surrogate or bacterial pathogen. If commercial bakery facilities elect to use a surrogate, they should choose a surrogate bacterium that has characteristics similar to the pathogen of interest, in this case Salmonella. A surrogate of equal or greater resistance compared to the pathogen of concern can be used, provided a scientifically reliable correlation has been established for comparison. It is more practical and convenient to choose a surrogate of equal or greater resistance compared to a pathogen of concern (e.g., Salmonella) for validation studies, due to ease of enumeration, and for determining the proper treatment options to achieve food safety. The microbiologist working with you on the project can help identify the appropriate surrogates. If commercial bakery facilities elect to use a combination of two or more pathogenic or surrogate strains together, then antagonistic effects needs to be tested for before using.
A kill-step validation experiment should be designed and tested for “worst-case conditions” such as lowest oven temperature, fastest belt speed, lowest zone temperature, coldest spot possible, shortest time exposed, maximum load per batch, lowest concentration (e.g., during chemical inhibition), lowest and highest relative humidity, lowest moisture content, highest fat content, etc.
Time/temperature relationship and microbial kinetics
Time and temperature values are critical for achieving desired log kill (e.g., five log reduction). The temperature and time should be recorded throughout the entire run using calibrated thermocouples and should be reviewed for consistency across the runs. The effective use of mathematical modeling is very important in a process validation. Determining microbial kinetics such as D-value, Z-value and TDT (Thermal Death Time) is very important to knowing the thermal resistance of a bacterium in a particular food product. Microbial kinetics will help determine the shortest as well as proper treatment options. D and Z. values will allow adjustment of the time and temperature, thus optimizing the process.
Source: Channaih, 2014, p. 4
Some of the specific benefits of kill-step validation for the baking industry include the following:
Pathogen free bakery products assuring greatest safety possible;
Protects consumers, builds confidence and increases demand;
Helps in determining an effective treatment;
Demonstrate compliance with the FDA-FSMA act;
Can save bakery industries millions of dollars by avoiding recalls and other legal penalties due to foodborne illness outbreaks;
It is the responsibility of the food manufacturer to make the finished product safe;
Salmonella can survive low moisture conditions, and may grow if the facility is unable to control the introduction of water;
It is important to understand the factors that influence the survival of Salmonella in low-moisture food and environments; and, Effective implementation of preventive controls, GMPs, HACCP plan, and process validation or kill-step validation is vital to prevent, and to control Salmonella getting into the finished products (Channaih, 2015).
Some representative kill-step validation processes for common bakery goods are provided in Table 5 below; these same steps apply, with minor variation, to other bakery goods such as nut and whole wheat muffins as well as crispy and soft cookies.
Procedure for Recording Temperature Profiles in a Commercial Oven — Hamburger Bun
Step 1: Format the Data Logging Device
Prepare the data logging device for use by setting to record temperatures at a frequency of every 15 seconds or adjust the time interval as per the baking time.
Select either F or C for recording temperatures; the final calculator is equipped to convert between these values.
Refer to the device’s quick start manual for detailed instructions on preparing the specific logging device.
Step 2: Placement of Data Logger
Select a pan of buns that has just completed the proofing cycle and is ready to enter the oven and travel in the cool zone.
Hold the pan for placement of the data logger.
Place the data logger directly on top of the buns in the last row and center column of the pan.
Stretch the six thermocouple wires to the row of buns that is farthest from the data logger, concentrating the probes toward the center lane of the pan.
Begin by inserting probe 1 in the bun in the farthest left column and working through, probe-by-probe, until reaching the bun column farthest right.
For pans containing fewer than 6 columns, place any additional probes in the buns closest to the center line of the pan.
When inserting the probes, pierce through the sidewall of the bun, being careful to insert the tip of the probe as close to the geometric center of the bun as possible
Once the probes have been set, follow your data logger device’s specific procedures to start recording and close the box lid.
Let the pan continue to travel through the coolest oven zone and retrieve after the baking cycle is complete.
Follow the device instructions for removing probes and ending recording.
Download the recorded data to a computer and prepare the data logger for another run.
Export the data from each run into Excel format and save for later use. For quick reference, save each run under a new tab in the same Excel worksheet.
Repeat this process until data from a total of five product runs has been recorded
Step 3: Data Compilation and Oven Validation
Using the Excel files from the five completed runs, determine which probes took the longest amount of time to reach 170F (77C) for each run.
Converting the Excel data into graphical format allows for easier selection of the coolest probes.
In Excel, highlight the entire data series for all six probes, select the Insert tab and click on Insert Line Chart icon. A graph will display next to the data columns on the worksheet. The lowest line represents the coolest sensor (time along x-axis, temperature along y-axis).
Copy and paste the column of data for the coolest sensor across all five runs into the appropriate Baking Process Kill Step Calculator tab.
Appendix A: Identifying the Coolest Oven Zone
Using a data logger, setup a test run following the protocol outlined in Step 2 of the Procedure for Recording Temperature Profiles in a Commercial Oven.
Rather than running five replicates, run three replicates for each position in the oven.
Example 1: If there are four lanes of pans, then three replicates will be run at each of the lanes.
Example 2: In a revolving oven on Shelf 1 with six pan positions, run three replicates at each of the six pan positions.
The cool zone would be the position that requires the longest time to reach an internal bun temperature of 170F (77C).
Temperature data from the selected probes must all fall within a range of +/- 10% of the time to reach 170F. (i.e. if the average time to 170F is 9 minutes then the range that all temperatures must be in is +/- 0.9 min. or 8.1-9.9 minutes). If temperatures do not fall within this range corrective action should be taken to modify the baking profile until data falls within this range
Source: Adapted from AIB International (2016) baking process kill step calculators at https://www.aibonline.org/aibOnline/develop-your-product-solutions/baking-process-kill-step-calculators.aspx
Beyond the foregoing specific steps, other initiatives that are needed in order to reduce Salmonellosis in commercial bakeries include a for ensuring food safety (USDA food safety information, 2016). According to the U.S. Department of Agriculture (USDA), “Farmers, industry, food inspectors, retailers, food service workers, and consumers are each critical links in the food safety chain” (USDA food safety information, 2016, para. 2).
Auditing a kill-step validation study
Auditing a kill-step validation study involves the analysis of the following values and factors:
D. value. The time required at a certain temperature to kill 90% of specific bacterial populations or reduce the bacterial load by one log under specified conditions.
Z. value. The change in the temperature, in degrees Fahrenheit (F) or Celsius (C), required to reduce the specific bacterial load by a factor of 10 or by one log.
Thermal Death Time (TDT). The shortest time needed to kill all bacteria or microorganisms in a product at a specific temperature and under defined conditions.
Kill-step validated processes should be audited yearly or as directed by a HACCP reassessment by a qualified microbiologist or an expert to ensure that a particular process is consistently delivering a desired effect. Further, for any major change in the process parameters or ingredients, or for a new pathogen, a process should be validated after a thorough literature review (Channaih, 2014, p. 5).
Preparing the validation report
Finally, following the completion of a kill-step validation study, a validation report should be prepared that contains all relevant data and data analysis that can be furnished to regulatory authorities or customers upon request (Channaih, 2014). According to the director of microbiology at AIB International, “The validation report should include sections such as introduction, contact information, background information, general information of the produce, parameters studied, details of equipment (type and make) used, validation methodology, TDT, Z-value, D-value, microbial strains used in this study, results, date of experiment, detailed discussion, significance, etc.” (Channaih, 2014, p. 5).
Complex problems typically require complex solutions, and this is certainly the case with mitigating the threat of foodborne illnesses in the United States today. With a multi-billion dollar economic impact and provider of a mainstay of the American diet, the U.S. baking industry is vitally important to the nation’s best interests. The research was consistent in showing the despite the challenges and complexity of the problem of microscopic pathogens such as Salmonella spp., the American baking industry has achieved a solid track record of success in mitigating this serious threat to the public health. Nevertheless, the research was also consistent in emphasizing that Salmonella is the leading source of foodborne illness and the pathogen is not expected to go away anytime soon. Indeed, even if Salmonella spp. was extinct, other microscopic pathogens such as Clostridium botulinum also represent significant threats and the baking industry must remain vigilant and proactive in mitigating these threats. While the kill-step validation process is complex, time-consuming and must be performed by experienced microbiologists and statisticians with appropriate containment and laboratory facilities, this is the only proven method that can provide evidence that mitigation strategies are working as they are intended. Finally, a number of recommendations emerged from the review of the relevant literature and industry-specific resources, including the need for the American Bakers Association to develop and disseminate evidence-based kill-step validation strategies for the more than 700 baking facilities and baking company suppliers it represents before the U.S. Congress.
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