The target audience is new members of the risk analysis community. It provides a generic overview of risk analysis. It serves as a contextual primer for anyone interested in or involved with a broad range of risk analysis activities, regardless of application.

Prerequisites: None

Overview of Topics

• The Language of Risk Analysis
• Introduction to the World Trade Organization
• Overview of U.S. food safety legal system and the role of risk analysis
• Risk Assessment Toolbox
• Setting up a Risk Assessment
• Introduction to Food Safety Risk Management
• Risk Management Principles
• Introduction to Risk Communication

Learning Objectives:

• Understand the language of risk analysis, its basic concepts, science-based risk analysis activities, and why risk analysis is done.
• Understand the major international agreements impacting agriculture and food trade (Sanitary and Phytosanitary Agreement, Technical Barriers to Trade, and the Trade Facilitation agreement) and how risk analysis tools are used to facilitate trade.
• Understand how a country incorporates these international requirements into their own regulatory requirements to facilitate market access while also protecting the safety of human and agricultural health using the U.S. as an example.
• Understand several of the risk analysis tools available that can be used to aid countries in evaluating risks based on the assessment goals, objectives, and available data.
• Know the risk assessment framework, the steps that go into setting up a risk assessment, and how a risk manager would manage the process so that the commissioned analysis answers the questions they are asking.
• Understand how risk management approaches to controlling food safety risk have evolved over the years and how the risk analysis approach differs from the previous approaches.
• Understand various tools used to manage risk.
• Understand the basic purpose of risk communication.

This course meets a requirement of the JIFSAN Core Certificate in Food Safety Risk Analysis

Risk Management is the process of weighing policy alternatives to control risks as effectively as possible. Success in risk management means arriving at practical and useful solutions to problems that can be plagued by uncertainty and variability. Risk managers are the decision makers and begin and end all risk analysis activities, they are responsible for the risk analysis process.

The role of risk managers in food safety risk analysis is vital to safeguarding public health, ensuring compliance with regulations, and maintaining the integrity of the food supply chain. Their efforts contribute to preventing foodborne illnesses, minimizing economic losses, and fostering consumer confidence in the safety of food products.

This 2-day in classroom course will be of interest to those who work with and support risk managers as well as risk managers.

Prerequisite:While not required, it is recommended that this course be taken after you have completed the Introduction to Risk Analysis and the Regulatory Process. That course provides contextual information about risk analysis that is not repeated here.

Overview of Topics

• Identification of Risks: Risk managers are tasked with identifying potential hazards and risks within the food supply chain.
• Risk Assessment: Once risks are identified, risk managers direct the assessment of their severity and likelihood of occurrence.
• Regulatory Compliance: Risk managers ensure that food safety practices comply with local, national, and international regulations.
• Crisis Management: In the event of a food safety incident, risk managers play a crucial role in crisis management. They are responsible for coordination response efforts, implementing emergency measures, and ensuring that corrective actions are taken promptly to protect public health.
• Data Analysis: Risk managers rely on data and analytics to make informed decisions.
• Supply Chain Management: Understanding the complexities of the food supply chain is essential for risk managers. They need to assess risks at each stage of production and distribution, working with suppliers and stakeholders to implement measures that enhance food safety.
• Continuous Improvement: The food industry is dynamic, with new challenges emerging regularly. Risk managers are responsible for continuous improvement in food safety protocols.

Learning Objectives

• Paradigms and How We Think About Things
• Risk Management Frameworks and Models
• Getting the Question Right
• Making Sense of Numbers
• Risk Management Options
• Interactions Between Assessors and Managers

By the end of the session, you should be able to

• Describe the risk manager’s role in risk analysis
• Describe two principle risk management models
• Discuss decision making under uncertainty
• Write a problems and opportunities statement
• Write an objectives and constraints statement
• Write a question statement
• Identify elements of a risk profile
• Distinguish concepts of uncertainly and variability and their importance in decision making
• Identify several key properties of good risk characterization
• Use brainstorming for option formulation
• Distinguish the evaluation, comparison and selection steps
• Discuss the economist’s view of making choices
• Distinguish between the monitoring, evaluation, and modification steps
• Define food safety management objectives
• List several techniques for engaging stakeholders
• Define the team process for risk analysis

This course meets a requirement of the JIFSAN Core Certificate in Food Safety Risk Analysis

The Qualitative Risk Assessments course focuses on the skills needed to predict the likelihood of harm resulting from exposure to chemical, microbial and physical agents in the diet.
Our 2-day in classroom course introduces the range of risk assessment approaches across a wide spectrum of food safety hazards, providing hands-on experience with both qualitative and quantitative techniques.

Prequisite:While not required, it is recommended that this course be taken after you have completed the Introduction to Risk Analysis and the Regulatory Process and the Risk Management course. Those two courses provide contextual information about risk analysis that is not repeated here.

Overview of Topics

• Scientific Evaluation: Risk assessors rely on scientific principles and methodologies to evaluate potential hazards in the food supply chain.
• Qualitative Analysis: Risk assessors use both quantitative and qualitative methods to assess risks. Learn specific qualitative methods for assessing risk including food additive safety assessment, chemical risk assessment, microbiological risk assessment as well as several generic tools.
• Hazard Identification: Risk assessors are responsible for identifying all potential hazards associated with a particular food product or process. This includes biological, chemical, and physical hazards that may pose a threat to human health, if not properly managed.
• Exposure Assessment: Understanding how consumers are exposed to hazards is a critical aspect of risk assessment. Assessors determine how much of a hazardous substance may be present in food and how much of it is likely to be consumed by individuals. This involves considering factors such as consumption patterns and serving sizes.
• Toxicological Assessment: For chemical hazards, risk assessors conduct toxicological assessments to understand the adverse health effects associated with exposure to specific substances. This information is crucial for establishing safe exposure limits and guidelines.
• Uncertainty Analysis: Risk assessors acknowledge and quantify uncertainties associated with their assessments. This involves identifying data gaps, limitations in the available information, and variability in assumptions.

Learning Objectives

• Fundamental reasons for risk analysis
• Key developments in the role of risk assessment in international food safety
• Demonstrate familiarity with the wide range of formal definitions of risk assessment
• Differentiate variability and uncertainty in risk assessment
• Significance of uncertainty and variability to the Risk Assessor and Risk Manager
• Discuss the role of probability in quantitative risk assessment
• Identify several of the more frequently used probability distributions in risk assessment
• Understanding the differences between chemical and microbial risk assessment

By the end of the session, you should be able to

• Describe the fundamental reasons for doing risk analysis
• Identify key developments in the role of risk assessment in international food safety
• Define what screening and ranking tools are
• Rank a list of pathogens
• Demonstrate familiarity with the wide range of formal definitions of risk assessment and list the steps of the codex risk assessment definitions
• Build a simple event tree
• Differentiate variability and uncertainty in risk assessment
• List and discuss the steps in the basic approach to food safety assessment
• Identify at least three kinds of uncertainty than can be present in a risk assessment
• Discuss the significance of uncertainty and variability to the risk manager
• Discuss the role of probability in quantitative risk assessment
• Describe the differences between chemical and microbial risk assessment
• Identify aspects of bioterrorist risk assessment that distinguishes it from other risk assessments
• Outline the conduct of a whole food risk assessment

This course meets a requirement of the JIFSAN Core Certificate in Food Safety Risk Analysis

Prerequisite: While not required, it is recommended that this course be taken after you have completed our Introduction to Risk Analysis and the Regulatory Process and Risk Management course. Those two courses provide contextual information about risk analysis that is not repeated here.

Overview of Topics

Principles of Risk Communication, Knowing your Audience, The Messenger and Risk Communication, Message Development, Channel Choices, Dealing with the Media

• Defining Risk Communication
• Risk Communication and Crisis Communication: What is the difference?
• Persuasion: How we use persuasion as a risk communication goal
• Audience: The basics of knowing who you are addressing
• Risk Perceptions: How people perceive risks serves is the basis of their attitude and behavior
• Involvement
• Anxiety
• We all are Risk Communicators
• Defining Credibility
• Expertise
• Communicating Trust
• The Practical Aspects of Messages
• Message Maps
• Message Choices
• Basics about Journalists

Learning Objectives

• Understanding the goals of risk communication
• Differentiating between proactive and reactive risk communication
• Recognizing communication competence and communicator credibility
• Understanding how to communicate expertise and trustworthiness
• Recognizing the importance of nonverbal communication in communicating credibility
• Understanding the phases of message design and the research that corresponds with each phase
• Understanding the practical aspects of message design such as message timing and message organization

By the end of the session, you should be able to

• Distinguish among the common goals of risk communication, their respective assumptions, and why this matters
• Understand the relationship between emotion and risk perception
• Recognize the major contextual factors that influence perceived risk
• Appreciate the importance of “market segmentation” and of understanding the needs of your audiences
• Describe the characteristics of a good risk communicator
• Differentiate between proactive and reactive risk communication
• Understanding how to communicate expertise and trustworthiness
• Recognizing the importance of nonverbal communication in communicating credibility
• Understanding the phases of message design and the research that corresponds with each phase
• Understand the practical aspects of message design such as message timing and message organization

This course meets a requirement of the JIFSAN Core Certificate in Food Safety Risk Analysis

This is paired with the Introduction of FDA iRisk® and the combined courses are held over one week. The course will cover basic modeling concepts, including both deterministic and probabilistic modeling approaches. Participants will be taught how to build risk assessment models using Excel with one of the more commonly-used commercial software packages (@RISK). This course will provide participants with a strong foundation in stochastic processes, probabilistic risk assessment and Monte Carlo simulation. Participants will gain a deeper understanding of the principles and mechanics of Monte Carlo simulation, build models using these principles, and learn how to analyze probabilistic models in a risk assessment context. The course will also discuss how to use data and expert opinion when building models. Participants can expect to gain hands-on experience in building and analyzing computer-based probabilistic models and experience some techniques and challenges to expect in presenting their results to various audiences. Learning by example, participants will be given exercises involving elements of real world risk assessments that are being used in current policy and risk management.

Prerequisite: None

It is strongly recommended that this course be taken after you have completed the Risk Management and Qualitative Risk Assessment course. These courses provide contextual information about risk analysis that is not repeated here. Participants should also have basic knowledge of probability and statistics and intermediate level skills in using Microsoft Excel 2003.

Resources

Excel: There are web-based resources that provide introductory Excel 2003 training. Many such courses are available - some at no cost - like the one found at www.videoprofessor.com.
Basic Statistics: The quantitative methods course does not require in-depth knowledge of statistics, but an understanding of basic terminology is necessary. There are web-based resources that provide information about basic theory in probability and statistics. Some examples include http://www.robertniles.com/stats and http://www.statsoft.com/textbook.

Overview of Topics

Going beyond terminology, Introduction to modeling, Deterministic modeling, Probability, Monte Carlo simulations, Triangular, Pert and Beta distribution and Bayes’ Theorem
Learning Objectives

• Understand why models are useful
• Understand important tradeoffs in the design of models
• Understand the differences between deterministic and stochastic models
• Gain a strong foundation in basic probability theory and probability distributions
• Be able to build basic probabilistic models using Excel and @RISK
• Simulation principles and techniques
• Stochastic processes
• Scenario and Sensitivity analysis

This course is paired with Quantitative Risk Assessment and held over one week.  As part of the course we will provide attendees a guided, hands-on opportunity to explore the tool and develop food-safety risk scenarios. The course is conducted in a computer teaching laboratory.

Prerequisite:
It is strongly recommended that this course be taken after you have completed the Risk Management and Qualitative Risk Assessment course. These courses provide contextual information about risk analysis that is not repeated here.  Participants should also have basic knowledge of probability and statistics and intermediate level skills in using Microsoft Excel 2003.

RESOURCES

Excel: There are web-based resources that provide introductory Excel 2003 training. Many such courses are available - some at no cost - like the one found at www.videoprofessor.com.
Basic Statistics: The quantitative methods course does not require in-depth knowledge of statistics, but an understanding of basic terminology is necessary. There are web-based resources that provide information about basic theory in probability and statistics. Some examples include http://www.robertniles.com/stats and http://www.statsoft.com/textbook.

Overview of Topics

Introduction to FDA-iRISK®, Building scenarios in FDA-iRISK®, Guided walk through of working in FDA-iRISK®

Learning Objectives

• Understand usefulness of models and the important tradeoffs in the design of models
• Understand the differences between deterministic and stochastic models
• Gain a strong foundation in basic probability theory and probability distributions
• Be able to build basic probabilistic models using Excel and @RISK
• Case studies: Microbial hazard and Chronic chemical hazard
• Simulation principles and techniques
• Scenario and Sensitivity analysis

Many countries in the world have experienced an exponential increase in the number of food establishments that produce and market food under their jurisdiction. Authorities, however, have experienced a significant decrease in the resources (monetary and personnel) to carry out inspection and surveillance activities. This situation requires countries to optimize and focus their resources to food products and establishments that represent the highest public health risk. This is also true for the private industry where they need to focus their monitoring and verification activities to the hazards, providers and food products that pose the highest risk. This requires the use of risk ranking tools so countries can identify their food safety priorities (biological and chemical) and develop accordingly a risk-based inspection and surveillance. This can also serve as the identification of national food safety issues that will require a risk assessment.

Intended Audience

This course is mainly intended for risk managers at the Ministries of Health and Agriculture in charge of food safety and also quality control and food safety managers from the food industry.

Overview of Topics

WHO Foodborne disease burden online tool, Multi-criteria decision analysis, Decision trees and decision matrices for biological and chemical hazards, Risk ranger and iRisk

Learning Objectives

• Become familiar with risk ranking tools (decision trees, decision matrices, multi-variate decision analysis, online software)
• Develop their own risk ranking tools for a specific situation
• Build a risk-based inspection and surveillance system

Over the last couple of decades the demand for seasonal food year round has dramatically increased outstripping the US’s capacity to meet its own production. In the last ten years, imports to the US have expanded three- fold. The US is having increased dependence on imported foods traveling longer distances than ever for which the production is scattered around the world. At the same time there has been increased demand for safe food due to rising household incomes, technological improvements in measuring contaminants, and the increased media and consumer attention on the risks of food borne illness. In response, many food retailers and food service firms, particularly in developed countries, have adopted private protocols relating to residues, microbial pathogens, field and pack house operation, and traceability. Historically governments have responded with voluntary and occasional mandatory food safety programs yet with extensive changes in demand and increase reliance of products coming from abroad many countries like the US, Canada, EU are revamping their food safety approaches and laws to ensure the food is safe whether produced domestically or abroad.

Intended Audience :

The course is designed for public and private sector stakeholders involved in ensuring products meet domestic and other countries food safety requirements.

Overview of Topics

• Concepts and principles of food/public health policy and law
• US Federal agencies and their involvement in food safety
• The role of the EU European Food Safety Authority (EFSA) in the regulatory process
• Canadian Federal Agencies and their involvement in food safety
• Australian/New Zealand Agencies and their involvement in food safety
• Japanese Agencies and their involvement in food safety

Learning Objectives

• Understand the role of the World Trade Organization
• Discuss the Codex Alimentarius Commission and other intergovernmental organizations involved in food safety
• Understand the role of private standards in food safety
• Understand important concepts in civil liability law

Intended Audience

The course is designed for public and private sector stakeholders involved in ensuring products meet domestic and other countries food safety requirements.

Overview of Topics

Chemical contaminants, Food additives, Pesticides, Veterinary drugs, Safety/Risk Assessment Paradigm

Learning Objectives

• Knowledge of foodborne chemical hazards
• Assessing dietary consumption and exposure of chemicals in food
• Understanding the difference between safety assessments and risk assessments and how to conduct these assessments
• Overview of the types of data and information needed and used to conduct safety and risk assessment for foodborne chemical hazards
• Insight regarding regulatory and international guidance for the conduct of chemical safety and risk assessments