All course information is listed within this syllabus.

FDSC 497D: Food Defense: Prevention Planning for Food Processors (3 credits). Course prepares current and aspiring professionals to learn, recognize and apply measures to prevent intentional contamination of the food supply.

Prerequisites: FDSC 408 (Food Microbiology) and FDSC 411 (Food Quality)


Instructor for FDSC 497D

Catherine N. Cutter, Ph.D.
Professor and Food Safety Extension Specialist

433 Rodney A. Erickson Food Science Building
University Park, PA 16802

Phone: 814-865-8862
Fax: 814-863-6132
E-mail: Use Canvas Inbox

Teaching Assistant

Nelson Gaydos

434 Rodney A. Erickson Food Science Building


Course Overview

The main objective of this course is to provide students with information to assist them in recognizing and applying measures to prevent intentional contamination of the food supply. This course focuses on hazards associated with the food supply; the differences between unintentional and intentional contamination of the food supply; methods for detecting hazards; risk analyses and/or assessment; prevention of intentional contamination; crisis management, including recalls; and steps involved in the development of a food defense plan. Students will garner basic information about food safety as it relates to food defense, the role of risk analyses and risk assessment in developing a food defense plan and apply this knowledge to real-world scenarios. Students also will undergo training in crisis management in order to prepare them for an intentional contamination incident. Finally, students will work together in groups to develop and critique food defense plans.

I. Characteristics of the US food supply (1 week)

Students will be introduced to the characteristics of the food supply (numbers and types of food establishments), the laws that govern the food supply, the role and responsibilities of the regulatory agencies that oversee inspection of the establishments, other domestic agencies involved with protecting the food supply, as well as the role of international organizations and individual countries in protecting the global food supply.

II. Hazards associated with the food supply (1 week)

An introduction to the history of biological warfare and bioterrorism will be provided. Students also will learn the causes of contamination in the food supply due to biological (bacteria, viruses, fungi, toxins, prions), chemical (radiological, drugs, allergens, pesticides, etc.), and physical (metal, plastic, glass, wood, etc.) hazards. Unintentional contamination of food products can be addressed through the use of the Hazard Analysis Critical Control Point (HACCP) process used to ensure food safety. Differences between intentional and unintentional contamination will be highlighted and case studies of real-world incidents will be discussed and analyzed.

III. Epidemiological investigation methods (2 weeks)

Epidemiological investigations associated with foodborne illnesses caused by intentional or unintentional hazards require the expertise of trained scientists, the development and implementation of rapid diagnostic methods, collaboration with numerous regulatory agencies, and cooperation by the food industry. Diagnostic methods that rely on culture microbiology, molecular biology, immunology, or other emerging technologies are needed to conduct these types of epidemiological investigations. While isolation and identification of hazards used to take weeks or months to accomplish, newer technologies can provide results in a matter of hours or days. Students will understand how these advances have provided investigators with the tools needed to improve response time when faced with an outbreak of unknown etiology.

IV. Risk analysis (2 weeks)

Risk analysis is a scientifically based process that builds upon the concept of hazard analysis and introduces concepts such as hazard characterization, exposure assessment, and risk characterization. The first step in risk analysis is to identify hazards (i.e., biological, chemical, or physical agents) that can cause adverse health effects with associated foods. For hazard characterization, an evaluation of the health effects associated with hazards in the foods is determined. With biological, physical, and chemical agents, an exposure or dose-response assessment also can be performed to determine the relationship between the magnitude of exposure dose to an agent and the frequency of associated adverse health effects (response), as well as exposures from other sources. Finally, a probability of occurrence and severity of known or potential adverse health effects in a given population based on the concepts identified in hazard identification, hazard characterization, and exposure assessment are used to determine risk characterization.

Definitions and examples of risk analysis, hazard characterization, exposure assessment, and risk characterization will be introduced. Students will understand concepts of operational risk management, vulnerability assessment, and what types of risk assessment activities are performed for risk analyses and how they can be used in the event of an intentional contamination incident. Case studies and examples of risk analyses will be presented and discussed.

V. Prevention of intentional contamination (3 weeks)

Both FDA and USDA recommend (but do not mandate) that food processors develop and institute a food defense plan for their facility. Food defense plans are designed to assist food processors with steps that can be implemented to minimize the risk that foods will be intentionally contaminated. Food defense plans also are designed to increase an establishment's preparedness in the event an incident occurs or if other types of emergencies arise. Having a documented set of procedures in a food defense plan can improve an establishment's ability to respond quickly during a crisis, maintain a safe working environment for employees, provide a wholesome and quality product for consumers, and protect a company's economic viability.

FDA and USDA have provided tools (ALERT, CARVER+Shock Analysis, and a Food Defense Checklist) that the food industry can use to develop and implement a food defense plan. These tools are meant to provide establishments with: 1) a step-by-step assessment of their personnel, facilities, and operations in order to better understand vulnerabilities that could lead to an intentional contamination incident; 2) ways to identify cost-effective preventive actions that can be taken to minimize those vulnerabilities; and 3) implementation of a food defense plan with resources, contacts, and other management responsibilities. Students will be introduced to the various tools and work through different food defense scenarios and/or case studies representative of food production, processing, distribution, and warehouse storage.

VI. Crisis management and emergency preparedness (2 weeks)

On any given day, the food industry is subject to food-related crises, such as an outbreak or recall associated with unintentional contamination by biological, chemical, or physical hazards. Unintentional foodborne outbreaks and recalls cannot only create consumer distrust and confusion, but also regulatory issues and other concerns for the food industry. While the food industry has not been subjected to many intentional food contamination incidents, there is a need for food industry professionals to prepare for such an event. Students will understand the steps involved in a crisis and/or recall, including the role of the federal, state, and local regulatory agencies, consumers, as well as, food industry responsibilities. Development of a crisis management team, a comprehensive recall plan, recall management strategies, and execution of mock recalls will be introduced and explored. Additionally, students will learn how to prepare for crises and how to communicate with the media following an intentional contamination incident. Finally, emergency preparedness and response plans will be introduced and discussed as they relate to intentional contamination and the food industry.

VII. Development of a food defense plan - group activity (2 weeks)
Critique of food defense plans (1 week)

For this portion of the course, student(s) will work in groups to develop a model food defense plan and presentation. An example plan will be provided to provide guidance to the students. Students will pick a food product/process they are familiar with (but not already presented-ex. ham or milk), work together to develop a plan, and present it to the class. Plans should address important components of food defense (ex. vulnerability assessments), recalls, emergency preparedness and response measures, as well as identify 3 points in the process that appear vulnerable to intentional contamination and adequately address cost-effective strategies for mitigating issues and/or sites. A recall plan, along with press release(s) and/or a script for a video to address an intentional contamination incident also will be evaluated. Finally, plans should include an emergency preparedness and response plan with resources, contacts, and other management responsibilities identified and assigned. Students are required to critique presentations as a group, via a standardized form that is shared with the instructor.

VIII. Final Exam (last week)

Students will take a final exam which will test their knowledge of concepts gained over the semester.

Description of the Course

This course will not only provide participants with knowledge of the domestic and international food industry, but it also provides tools for food industry and homeland security professionals to develop food defense programs to protect the food supply from terroristic activities leading to intentional contamination.

The course will introduce and apply: examples where intentional contamination has been used in the food industry; biological, chemical and physical hazards of primary concern in the food industry; methods for detecting hazards in the food supply; systems employed to monitor foodborne illness in the general public; management practices employed in food production to deal with recalls and other crises; vulnerabilities and mitigation procedures unique to food production; as well as, agencies, resources, and tools needed to protect, prepare, and respond to intentional contamination incidents.

Course Objectives

  • Identify the issues and challenges of protecting the food supply from intentional contamination.
  • Identify and utilize the knowledge and skills necessary to contribute to a food industry organization's effort in food defense.
  • Identify and utilize tools to assess, understand, and prepare appropriate responses and plans to mitigate and reduce the vulnerabilities and risks of an intentional contamination incident to a food processing establishment.
  • Explain the processes by which an organization can identify threats, implement recall strategies, and prepare for emergencies and/or crises.

Course Schedule

For due dates, refer to the Course Summary on the Syllabus page in Canvas.

Grading Policy

Grading Criteria
Requirement Cumulative Point Value Weight
Class Participation* --- 10%
Quizzes (7)** --- 25%
Case Studies (5) --- 30%
Food Defense Plan and Presentation (Group) --- 20%
Final Exam (Open Book/Note) --- 15%
TOTAL: --- 100%

*Class participation will be calculated using a peer evaluation form at the end of the semester.

**The lowest quiz score will be dropped.

Grading Scheme
Letter Grade Percentage
A 100% – 90%
B < 90% – 80%
C < 80% – 70%
D < 70% – 60%
F < 60%

Please refer to the University Grading Policy for Undergraduate Courses for additional information.

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