Validation and verification are essential activities for an effective food safety system such as a Hazard Analysis and Critical Control Points (HACCP) plan or a Preventive Controls for Human or Animal Food as per Food Safety Modernization Act (FSMA) rule. Validation is a subset of verification, which is an ongoing process designed to provide evidence that the Food Safety Plan is being properly implemented and operating as intended and verification is only possible when validation parameters are known. Validation and verification have important ramification vis-à-vis FSMA Preventive Controls regulations. The main objective of this chapter is to address the principles of validation and verification in the context of contemporary food safety management systems and FSMA regulations.

The global regulatory landscape relating to food and food preservation technology is exceedingly complex. Successfully navigating this nuanced dominion with the view to commercializing novel preservation methods can be an especially daunting challenge. The regulations for many countries pertaining to the uptake of novel technologies are based on the “precautionary principle.” Other countries, including the United States, are increasingly demanding a complete assessment of risk before novel processing and preservation methods can be utilized in the production of foods intended for human consumption. Also, to be considered in this complicated morass or rules and laws are the public health implications, posed by those nations where legislation and regulations relative to novel technologies are mute or simply nonexistent. This chapter provides an overview of emerging regulatory trends and legislative developments, globally, that are likely to impact the procedures and protocols that are demanded for obtaining the necessary approvals for allowing the commercial uptake and use of high hydrostatic pressure thermal processing (HPTP) as an accepted preservation technique for use in the production of human food.

Great disparities exist globally with regard to regulations and standards governing the control of substances allowed for addition, directly or indirectly, to human food. A number of countries have adopted strict criteria for both defining and classifying the many and various types of substances that are permitted for inclusion in foods and food ingredients. Likewise, there are nations that have promulgated legislation regulating the precise manner in which the various classes of approved substances might be added to human food. By contrast, the food additive standards and regulations of other nations that participate in the global trade in food and food ingredients are far less refined and robust. In general, substances found in human food can be assigned one of the six following classifications: (1) Residues, (2) Unavoidable Contaminants, (3) Prohibited Substances, (4) Supplements, (5) Food Additives, and (6) and Cosmetic Additives. Included in these various classifications are color and flavor agents, as well as pesticide residues, vitamins, veterinary compounds, and environmental contaminants (Schultz, 1981) (see Fig. 14.1). This chapter explores both the opportunities and impediments to harmonization of the definitions, permissible usage, and labeling of the substances permitted for inclusion in the production of foods that are intended for human consumptions. This survey of international regulations is focused on Food Additives, Processing Aids, Color Additives, and Banned Substances.

Process validation plays a key role in accelerating commercialization of new processing technologies in the production of safe foods. In this chapter, general concept and definitions, structure, key components and approaches to process validation will be identified and discussed. This includes physical, microbiological safety, quality and equipment validation with elements of cleaning, calibration and analytical parts, and validation of facilities. The general guidelines for each key component of the validation process will be given. The basic outline of objectives and critical procedures of process and equipment validation aimed for food processors, technology developers, equipment manufacturers, regulatory inspectors, and extension specialists during the commercialization of new technologies is given. The importance and steps of the scale-up process are also discussed in the chapter.

The working population growth have created greater consumer demand for ready-to-eat (RTE) foods. Pasteurization is one of the most common preservation methods for commercial production of low-acid RTE cold-chain products. Proper selection of a pasteurization method plays an important role not only in ensuring microbial safety but also in maintaining food quality during storage. Better retention of flavor, color, appearance, and nutritional value of RTE products is one of the reasons for the food industry to adopt novel technologies such as high-pressure processing (HPP) as a substitute or complementary technology for thermal pasteurization. HPP has been used industrially for the pasteurization of high-acid RTE products. Yet, this method is not commonly used for pasteurization of low-acid RTE food products, due primarily to the need of additional heating to thermally inactivate spores, coupled with relatively long treatment times resulting in high processing costs. Practical Application: Food companies would like to adopt novel technologies such as HPP instead of using conventional thermal processes, yet there is a lack of information on spoilage and the shelf-life of pasteurized low-acid RTE foods (by different novel pasteurization methods including HPP) in cold storage. This article provides an overview of the microbial concerns and related regulatory guidelines for the pasteurization of low-acid RTE foods and summarizes the effects of HPP in terms of microbiology (both pathogens and spoilage microorganisms), quality, and shelf-life on low-acid RTE foods. This review also includes the most recent research articles regarding a comparison between HPP pasteurization and thermal pasteurization treatments and the limitations of HPP for low-acid chilled RTE foods.

This chapter discusses the capacity building for harmonizing and achieving food safety. In the process of assigning cause to food safety failures the epidemiologists and regulatory officials are beginning to acknowledge that insufficiency in both scientific and regulatory capabilities is the major contributing factor. Lacking capacity frequently translates into an inability to provide the surveillance mechanisms necessary for ensuring the safety of foodstuffs bound for international commerce. Achieving and sustaining capacity is difficult, even for wealthy, technology-rich nations. Food safety has been defined as "the biological, chemical, or physical status of a food that will permit its consumption without incurring excessive risk of injury, morbidity, or mortality." The inequality in food safety capacity, scientific and regulatory, among various supply chain contributors places the global trade in food at risk. Building the scientific capability and regulatory framework corresponding with food safety capacity is an expensive proposition.

During evolution humans have adapted to the sources of energy and nutrients available in nature and learned, by trial and error, which food can be eaten safely and which can be stored for the future and still be safe to eat. Microbes have contributed to this process by converting uneaten food back to soil on which plants can grow again. They have also fermented foods such that they remain edible or become more palatable. Because food is needed at all times, it was discovered that foods could be preserved by drying them in the sun, the addition of salt or the use of fire to dry and smoke simultaneously. Food safety incidents are most frequently caused by food vendors or by people cooking at home. A lack of understanding of the causes of spoilage is at the root of these incidents. While many people exaggerate the risk of chemicals, without understanding that toxicity is a matter of substance and dose, they ignore microbiological risks that should be a primary concern since it is these which cause the vast majority of food safety incidents. Education, at all levels along the food chain, is important, but particularly for those involved in food preparation. Regulations and informed food inspectors may help to reduce the number of (sometimes deadly) food-safety incidents. These regulations, however, should not lead to needless destruction of food and should, therefore, be based on good science and be consistent globally.

This chapters discusses the efforts by the US Army food industry academic consortium research to develop validation protocols and demonstrate efficacy of a pressure-assisted thermal sterilization process (PATS) for the production of a commercially sterile ambient stable, low-acid mashed potato product. Studies include qualification of the equipment, product, and package and process performance. Under the specified conditions of the validation study, it was concluded that the PATS process is capable of eliminating six log(10) of heat-and pressure-resistant C. botulinum spores/145 g from the deliberately contaminated packs of mashed potatoes. Subsequently the consortium submitted a filing of a mashed potato product treated by PATS with FDA. FDA issued a letter of no objection to the consortium by 2009.

Trade in food and food ingredients among the nations of the world is rapidly expanding and, with this expansion, new supply chain partners, from globally disparate geographic regions, are being enrolled. Food and food ingredients are progressively sourced more from lesser developed nations. Food safety incidents in the USA and Canada show a high unfavorable correlation between illness outbreaks and imported foods. In the USA, for example, foodborne disease outbreaks caused by imported food appeared to rise in 2009 and 2010, and nearly half of the outbreaks, associated with imported food, implicated foods imported from areas which previously had not been associated with outbreaks. Projecting supply chains into new geographical regions raises serious questions about the capacity of the new supply chain partners to provide the requisite regulatory framework and sufficiently robust public health measures for ensuring the safety of the foods and foodstuffs offered for international trade. The laws, regulation and legislation among the many nations participating in the global food trade are, at best, inconsistent. These inconsistencies frequently give rise to trade disputes and cause large quantities of food to be at risk of destruction on the often dubious pretext that they are not safe. Food safety is often viewed through a political or normative lens. Often as not, this lens has been wrought absent scientific precision. Harmonization of food safety legislation around sound scientific principles, as advocated by the US Food Safety Modernization Act (FSMA), would ultimately promote trade and likely provide for incremental improvement in public health. Among the priority roles of most national governments are the advancement of commerce and trade, preservation of public health and ensuring domestic tranquility. Achieving these priorities is fundamental to creating and preserving the wealth of nations. Countries such as the Netherlands, Canada, Germany, Japan and the USA, for example, have very stable governments, are leaders in trade and commerce and enjoy high standards of public health. It is not by accident or coincidence that these nations are also among the world's wealthiest. Attainment of national priorities, especially those related to promoting trade in foodstuffs and also in preserving public health (food safety), would benefit greatly from international efforts in harmonizing food safety regulations and legislation.

As existing technologies are refined and novel microbial inactivation technologies are developed, there is a growing need for a metric that can be used to judge equivalent levels of hazard control stringency to ensure food safety of commercially sterile foods. A food safety objective (FSO) is an output-oriented metric that designates the maximum level of a hazard (e.g., the pathogenic microorganism or toxin) tolerated in a food at the end of the food supply chain at the moment of consumption without specifying by which measures the hazard level is controlled. Using a risk-based approach, when the total outcome of controlling initial levels (H(0)), reducing levels (ΣR), and preventing an increase in levels (ΣI) is less than or equal to the target FSO, the product is considered safe. A cross-disciplinary international consortium of specialists from industry, academia, and government was organized with the objective of developing a document to illustrate the FSO approach for controlling Clostridium botulinum toxin in commercially sterile foods. This article outlines the general principles of an FSO risk management framework for controlling C. botulinum growth and toxin production in commercially sterile foods. Topics include historical approaches to establishing commercial sterility; a perspective on the establishment of an appropriate target FSO; a discussion of control of initial levels, reduction of levels, and prevention of an increase in levels of the hazard; and deterministic and stochastic examples that illustrate the impact that various control measure combinations have on the safety of well-established commercially sterile products and the ways in which variability all levels of control can heavily influence estimates in the FSO risk management framework. This risk-based framework should encourage development of innovative technologies that result in microbial safety levels equivalent to those achieved with traditional processing methods.

This chapter discusses the global harmonization initiative (GHI). GHI anticipates that while developing global consensus on the science of food regulations and legislation will help narrow regulatory differences, it may also help focus food safety research on areas, where supportive scientific evidence is currently lacking. Elimination of regulatory discrepancies will reduce and hopefully in time prevent the undue destruction of food. Furthermore, it will make it more attractive for the private sector to invest in food safety research and development, consequently strengthening the competitiveness of each nation's food industry and of the industries supplying the food sector. Harmonizing global regulations will aid in the uptake and application of new technologies as well as encourage the food industry to invest in new tools to enhance the safety, availability, and quality of the food supply for consumers worldwide. While global harmonization of food safety regulations is a definite challenge to the twenty-first century, it has now become an overriding necessity in an era of rapid globalization.

It is generally assumed around the world that food is safe. Food must be safe, for its intended use for human consumption, but food safety and regulatory measures should not unnecessarily hamper the availability of human food or hamper the introduction of novel processing methods aimed at retaining the natural healthy properties of food.

While the globalisation of world trade has created new pathways to economic growth for many nations, the trend toward a “one-world economy” has also exposed critical differences in international laws and regulations that are designed to protect the world’s citizens. These differences may result in the needless destruction of healthy food and hamper the introduction of new technologies designed to make food healthier and safer.