Master of Science / Food Science Institute / Fadi M. Aramouni / Since the Food Safety Modernization Act (FSMA) was signed into law in 2011, the government has taken huge strides toward making the food safety system preventive rather than reactive. Specifically, the Preventive Controls for Human Food (PCHF) final rule has required collaboration from government officials, educational institutions, industry professionals, and stakeholders to assist in the rulemaking, education, and implementation of the new rule. The rulemaking process for the PCHF final rule took 4 years to finalize. The Food and Drug Administration funded a grant to the Illinois Institute of Technology’s Institute for Food Safety and Health (IIT IFSH) to help create an educational program about food safety risk-based preventive controls. Since then, the Food Safety Preventive Controls Alliance (FSPCA) has been coordinating training programs to certify food professionals as Preventive Controls Qualified Individuals (PCQI). After gathering minor statistical evidence through course evaluations for 10 FSPCA facilitated education programs, extension personnel of the Food Science Institute at Kansas State University found that the educational materials are a big help to those in industry and in regulatory agencies.

Acontecimentos terroristas na indústria de alimentos publicados ao longo de décadas levaram a que emergisse nos EUA o conceito de \"Food Defense\" (defesa alimentar), cujo objetivo é adotar medidas preventivas da contaminação intencional de produtos, onde indivíduos recorrem a agentes (biológicos, químicos, físicos ou radiológicos) com intenção de causar prejuízos às companhias, governos ou à população em geral. O reconhecimento da sua importância na indústria alimentar promoveu a difusão deste conceito pelas normas certificáveis como a FSSC 22.000 e o desenvolvimento de ferramentas como o software CARVER+Shock por parte da FDA (Food and Drug Administration). Apesar de ser uma tendência recente, vários países têm adotado práticas ou ferramentas de defesa alimentar, embora no Brasil esta adoção seja de pouca amplitude mesmo sendo um dos maiores produtores de alimentos do mundo. CARVER+Shock representa um acrônimo de sete atributos: Criticidade - Impacto sobre a saúde pública, Acessibilidade - capacidade de acesso físico, Reconhecibilidade - facilidade de identificar um alvo, Vulnerabilidade - facilidade de realizar uma contaminação, Efeito - consequências de uma contaminação e Recuperabilidade - capacidade do sistema se recuperar perante uma falha de segurança e o Shock que mistura os impactos da saúde, econômicos e psicológicos. O objetivo principal do presente estudo foi realizar uma pesquisa exploratória para aplicar e avaliar de forma prática o software para assim julgar a sua efetividade. Para tal, procedeu-se à implementação do software em duas companhias processadoras de leite, a primeira é a \"Empresa A\" de pequeno, porte localizada no Estado de São Paulo e a segunda é a \"Empresa B\" de porte médio, localizada no Estado do Paraná. No estudo foi possível concluir que o software consegue efetuar uma avaliação de vulnerabilidade detalhada considerando vários fatores que permitem análise sobre o impacto econômico, psicológico e na saúde da população depois que uma contaminação intencional ocorra. Os resultados facilitaram a construção de um plano de defesa alimentar, o qual visa proteger os produtos de contaminações intencionais para garantir um ambiente de trabalho seguro para os funcionários, fornecer um produto seguro para a população, proteger as empresas e aumentar o grau de preparação e a capacidade de resposta perante uma situação critica. / The terrorist events in the food industry, published along decades in the USA, generated the concept of \"Food Defense\", whose objective is to adopt preventive measures against the intentional contamination of products, where individuals fall back upon agents (biological, chemical, physical or radiological) with intention of causing damages to the companies, governments or to the population in general. The recognition of its importance in the food industry promoted the diffusion of this concept to the establishment of certified norms, such as FSSC 22.000, and the development of tools such as the software CARVER+Shock by the FDA (Food and Drug Administration). Being a recent tendency in several countries, it has been adopted as a practice or tool for food defense. In Brazil, this adoption is little despite of it being one of the countries with the highest food production in the world. CARVER+Shock represents an acronym of 7 attributes: Criticality - Impact on public health, Accessibility - Capacity of physical access, Recuperability - easiness of identifying an objective, Vulnerability - easiness of accomplishing a contamination, Effect - consequences of a contamination, Recognizability - capacity of the system to recover before a flaw of safety and Shock that mixes the impacts of health, economical and psychological effects. The objective of the present study was to accomplish an exploratory research to apply and evaluate the software in a practical way so as to judge its effectiveness. For such a purpose, the researcher proceeded to implement the software in two dairy companies, the first company \"A\" located in the state of São Paulo and the second company \"B\" in the state of Paraná. In the study it was possible to conclude that the software achieved to make an evaluation of detailed vulnerability considering several factors that allow analysis on the economical, psychological and health impacts on the population after an intentional contamination with success, making it possible to construct a food defense plan. This plan seeks to protect the products of intentional contaminations, to guarantee an atmosphere of safe work for the employees, it supplies a safe product, it protects the companies and it increases the preparation and the capacity to answer while facing a critical situation.

Acontecimentos terroristas na indústria de alimentos publicados ao longo de décadas levaram a que emergisse nos EUA o conceito de \"Food Defense\" (defesa alimentar), cujo objetivo é adotar medidas preventivas da contaminação intencional de produtos, onde indivíduos recorrem a agentes (biológicos, químicos, físicos ou radiológicos) com intenção de causar prejuízos às companhias, governos ou à população em geral. O reconhecimento da sua importância na indústria alimentar promoveu a difusão deste conceito pelas normas certificáveis como a FSSC 22.000 e o desenvolvimento de ferramentas como o software CARVER+Shock por parte da FDA (Food and Drug Administration). Apesar de ser uma tendência recente, vários países têm adotado práticas ou ferramentas de defesa alimentar, embora no Brasil esta adoção seja de pouca amplitude mesmo sendo um dos maiores produtores de alimentos do mundo. CARVER+Shock representa um acrônimo de sete atributos: Criticidade - Impacto sobre a saúde pública, Acessibilidade - capacidade de acesso físico, Reconhecibilidade - facilidade de identificar um alvo, Vulnerabilidade - facilidade de realizar uma contaminação, Efeito - consequências de uma contaminação e Recuperabilidade - capacidade do sistema se recuperar perante uma falha de segurança e o Shock que mistura os impactos da saúde, econômicos e psicológicos. O objetivo principal do presente estudo foi realizar uma pesquisa exploratória para aplicar e avaliar de forma prática o software para assim julgar a sua efetividade. Para tal, procedeu-se à implementação do software em duas companhias processadoras de leite, a primeira é a \"Empresa A\" de pequeno, porte localizada no Estado de São Paulo e a segunda é a \"Empresa B\" de porte médio, localizada no Estado do Paraná. No estudo foi possível concluir que o software consegue efetuar uma avaliação de vulnerabilidade detalhada considerando vários fatores que permitem análise sobre o impacto econômico, psicológico e na saúde da população depois que uma contaminação intencional ocorra. Os resultados facilitaram a construção de um plano de defesa alimentar, o qual visa proteger os produtos de contaminações intencionais para garantir um ambiente de trabalho seguro para os funcionários, fornecer um produto seguro para a população, proteger as empresas e aumentar o grau de preparação e a capacidade de resposta perante uma situação critica. / The terrorist events in the food industry, published along decades in the USA, generated the concept of \"Food Defense\", whose objective is to adopt preventive measures against the intentional contamination of products, where individuals fall back upon agents (biological, chemical, physical or radiological) with intention of causing damages to the companies, governments or to the population in general. The recognition of its importance in the food industry promoted the diffusion of this concept to the establishment of certified norms, such as FSSC 22.000, and the development of tools such as the software CARVER+Shock by the FDA (Food and Drug Administration). Being a recent tendency in several countries, it has been adopted as a practice or tool for food defense. In Brazil, this adoption is little despite of it being one of the countries with the highest food production in the world. CARVER+Shock represents an acronym of 7 attributes: Criticality - Impact on public health, Accessibility - Capacity of physical access, Recuperability - easiness of identifying an objective, Vulnerability - easiness of accomplishing a contamination, Effect - consequences of a contamination, Recognizability - capacity of the system to recover before a flaw of safety and Shock that mixes the impacts of health, economical and psychological effects. The objective of the present study was to accomplish an exploratory research to apply and evaluate the software in a practical way so as to judge its effectiveness. For such a purpose, the researcher proceeded to implement the software in two dairy companies, the first company \"A\" located in the state of São Paulo and the second company \"B\" in the state of Paraná. In the study it was possible to conclude that the software achieved to make an evaluation of detailed vulnerability considering several factors that allow analysis on the economical, psychological and health impacts on the population after an intentional contamination with success, making it possible to construct a food defense plan. This plan seeks to protect the products of intentional contaminations, to guarantee an atmosphere of safe work for the employees, it supplies a safe product, it protects the companies and it increases the preparation and the capacity to answer while facing a critical situation.

Magnetische Formgedächtnislegierungen (MSM-Legierungen) weisen im Vergleich zu anderen Festkörperwandlern und konventionellen elektromagnetischen Wandlerprinzipien unikale Kopplungseigenschaften auf. Dies motiviert ihre Anwendung in kompakten und schnellschaltenden Antrieben. Aufgrund der Kompliziertheit ihres Kopplungsverhaltens ist jedoch ein modellbasierter Entwurf unumgänglich. Die vorliegende Arbeit widmet sich der Beschreibung einer Unterklasse von MSM-Antrieben mit eisenbehafteten Magnetkreisen und engen Luftspalten durch eine Kombination von Messung und Modell. Ziel ist dabei die Beantwortung anwendungsrelevanter Fragestellungen im Antriebsentwurf. Die Grundlage dafür bildet die heuristische Definition eines auf verallgemeinerten Kirchhoffschen Netzwerken (Netzwerkmodellen) basierenden Ersatzmodells des MSM-Elements samt umgebendem Luftspalt. Die das Verhalten des Ersatzmodells beschreibenden magnetischen Größen werden durch ein neuartiges und im Rahmen der Arbeit entwickeltes Messverfahren ermittelt. Ein Prüfstand setzt dieses Messverfahren um und ermöglicht eine simultane magnetische und magnetomechanische Charakterisierung von MSM-Elementen unter Kraft- oder Wegvorgabe. Eine empirische Validierung der gemessenen Zusammenhänge, auch anhand thermodynamischer Gesichtspunkte, weist die Plausibilität der das Ersatzmodell beschreibenden Zusammenhänge nach. Diese Ergebnisse motivieren die Entwicklung eines Netzwerkmodells, das die hysteresebehaftete magnetomechanische Kopplung innerhalb des Ersatzmodells thermodynamisch korrekt berücksichtigt. Mithilfe des Modells gelingt es, das experimentell bestimmte integrale magnetomechanische Verhalten des MSM-Elements samt umgebendem Luftspalt in wesentlichen Aspekten vorherzusagen. / Magnetic shape memory (MSM) alloys are considered promising active materials for compact electromagnetic drives due to their strong magneto-mechanical coupling. However, the latter is associated with a strong nonlinearity and a distinct hysteresis making a model-based design indispensable. The present work describes the behavior of a subclass of MSM drives with iron-core and small air gaps by means of a combination of model and experiment. Heuristically, an equivalent lumped-element model considering the MSM element and the surrounding air gap is proposed. An associated novel magnetic measurement procedure determines the quantities describing the behavior of this equivalent model. A test setup implements the measurement procedure and allows for a simultaneous magnetic and magneto-mechanical characterization either under constant load or under constant displacement. An empiric validation, also with regard to thermodynamic aspects, indicates the plausibility of the collected data describing the simplified equivalent model. These results motivate the development of a novel lumped-element model considering the hysteretic magneto-mechanical coupling of the equivalent model in a thermodynamically consistent way. Its validation by means of various magneto-mechanical experiments shows that the model is able to predict the essential magnetic and magneto-mechanical behavior of the MSM element and the surrounding air gap with sufficient accuracy, making it appropriate for system design.

This thesis examined the efficacy of various sampling and detection methods used for environmental monitoring of Listeria species on wooden surfaces used for cheese aging. Government agencies including the Food and Drug Administration (FDA) and United States Department of Agriculture (USDA) recommend enrichment methods coupled with use of environmental sponges and swabs. Our study compared efficacy of sponge swabs manufactured by 3M™ and World Bioproducts. There is a lack of research validating the best performing swab type and enrichment method combination that is sensitive when used on rough, porous surfaces. The sensitivity of these environmental sampling tools and methods are critical considerations to effectively monitor the presence of Listeria species on wooden boards used during aging of artisan cheese. Seasoned spruce wooden shelves, cut into 100cm2 replicates, were spot inoculated with varying concentrations of Listeria species inocula, the Listeria species strains consisted of two L. monocytogenes strains and a Green Florescence Protein (GFP) expressing strain of L. innocua. The inoculated wooden surface was swabbed with three environmental sampling sponge/swab formats (World Bioproducts© EZ ReachTM environmental swabs (WBEZ) with HiCap (WBHC) and Dey-Engley (WBDE) neutralizing broths; and 3MTM environmental swabs (3MTM) with Dey-Engley neutralizing broth). Enumeration methods were used to determine the low target limits of detection. Once the low target concentrations were identified, five enrichment methods consisting of 3MTM Listeria Environmental Plate, FDA, Dual Enrichment, modified USDA, and modified FDA were challenged against low concentrations of Listeria species inocula (0.01 cfu/cm2, 0.1 cfu/cm2, 1 cfu/cm2) and the three environmental sponge swab formats. Performance of the swab formats was assessed by collection of naturally contaminated environmental samples (n=405) from dairy farm environments, swabbing where wooden surfaces existed, and analyzed using the most effective enrichment methods found from previous experiments. Lastly, the wooden surfaces and sponge swabs were observed under a Florescent Microscope using GFP L. innocua to visually determine how each sponge material of the 3M™ and World Bioproducts recovered the inocula. When wood surfaces were inoculated at high concentration levels of Listeria spp., all swab formats performed equally for detecting Listeria. Success of positive recovery at low concentrations was variable, where enrichment methods and swabs were not dependent on each other. The swab format that worked best for detecting low levels of Listeria species was the WBDE sponge swab. The WBDE swab also performed the best in dairy farm environmental sampling. The m-USDA enrichment method was found to be most effective in recovery and repair of low and potentially injured Listeria spp. Wooden surfaces are rough and porous and should be taken into consideration when creating an environmental sampling plan for these food contact surfaces. All swabs and methods performed with only slight variation, but the variation could be significant when monitoring wooden shelves with low level contamination of Listeria species. Artisan cheesemakers who use wooden shelves during the aging of their cheese, should ensure use of the most sensitive detection methods.

This dissertation examined recently issued regulatory standards using cheese and produce as model systems. FDA's 2015 Domestic and Imported Cheese and Cheese Products Compliance Program Guidelines (CPG) E. coli standards on cheese safety, and the extent to which these standards affect domestic and imported cheese commerce, was assessed. Results from FDA's Domestic and Imported Cheese Compliance Program for samples collected between January 1, 2004 and December 31, 2006 were analyzed. Of 3,007 cheese samples tested for non-toxigenic E. coli, 76% (2,300) of samples exceeded 10/g, FDA's target for regulatory activity. In cheese samples containing E. coli levels of 10/g and 100/g, there was no statistically significant association with presence of Listeria monocytogenes. However, associations between Staphylococcus aureus levels of 10,000 CFU/g and presence of Salmonella and L. monocytogenes were statistically significant, indicating that EU regulations targeting S. aureus as the pathogen of concern may be more appropriate than E. coli for cheese safety assessment. Compost amended soils in the Northeastern U.S. were assessed for the presence and survival of E. coli and Listeria spp. against FDA Food Safety Modernization Act (FSMA) requirements. Manure and poultry litter-based biological soil amendments of animal origin (BSAAO) must achieve pathogen reduction to reduce risk of pathogen contamination on the harvested produce. Two trials of replicated field plots of loamy (L) or sandy (S) soils were tilled and un-amended (NC) or amended with dairy compost (DC), poultry litter compost (PL), or poultry pellets (PP). Colony count and most probable number (MPN) methods were used to determine persistence of E. coli in these plots over 104 days post-inoculation. Detection of indigenous Listeria spp. were also examined in all plots. Higher E. coli populations were observed in PL and PP amended soils when compared to DC and NC plots. E. coli was detected at low levels on radish crops, where PL treatments encouraged greater levels of survival and growth than DC or NC. Study results verify that a 120 day interval following BSAAO application should be sufficient to ensure food safety of edible crops subsequently planted on these soils. The sensitivity of environmental monitoring methods and collection formats were evaluated to identify optimal procedures for detection of Listeria spp. on product contact surfaces within artisan cheese production environments. Four environmental surfaces (dairy brick, stainless steel, plastic, and wood; n=405/surface type) were inoculated with L. innocua, L.m. ATTC® 19115 and L.m. 1042, at high (106-107/cm2) and low (0.1-1/cm2) target concentrations. Inoculated surfaces were swabbed with World Bioproducts© EZ ReachTM and 3MTM environmental swabs (3MTM). Five enrichment and enumeration methods were used to compare sensitivity of recovery between environmental swabs. All swab formats performed equally on all environmental surfaces at high target concentrations. At low concentrations, PetrifilmTM and WBEZ swabs recovered Listeria spp. from 87.5% of plastic, stainless steel, and dairy brick surfaces, but only 62.7% of wooden surfaces; recovering 14.8%, 77%, and 96.3% of cells from initial inoculations of 0.01, 0.1, and 1/cm2, respectively . Our data demonstrate that results may be discrepant due to variation in the porosity of environmental surfaces and should be taken into consideration when implementing environmental sampling plans. Results from this thesis can be used to inform regulatory policy and help to achieve improved food safety.