food safety - university of...

University of

Maryland

Food and Drug Administration

2134 Patapsco Bldg.

University of Maryland

College Park, Maryland 20742-6730

Tel: 301.405.8382 Fax: 301.405.8390 jifsan.umd.edu

Food Safety Risk Analysis Training Program

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What is JIFSAN?

The Joint Institute for Food Safety and Applied Nutrition (JIFSAN) was established between the United States Food and Drug Administration (FDA) and the University of Maryland (UM) in April 1996. The Institute is a jointly administered, multidisciplinary research, education and outreach program.

The Institute is the foundation of public and private partnerships that provides the scientific basis for ensuring a safe, wholesome food supply as well as provide the infrastructure for contributions to national food safety programs and international food standards.

The Institute fosters the missions of FDA and the University through the creation of partnerships to increase the quantity and quality of research, which will provide the basis for sound public health policy. It promotes food safety and human nutrition and animal health and production through an integrated academic and regulatory science program. This includes multidisciplinary research, outreach and educational programs, and policy studies. The participation of FDA scientists in JIFSAN collaborative research programs related to FDA’s mission and the consultative arrangements with other scientists associated with FDA, the Institute, and the University ensures the critical science-based foundation needed to establish sound food safety policy. In addition, opportunities exist for collaborative projects with other Federal and state agencies, private industry, consumer and trade groups, and international organizations with mutual interests.

JIFSAN’s mission is to advance sound strategies to improve public health, food safety, and applied nutrition using risk analysis principles through cooperative research, education, and outreach programs.

Upcoming Classes

For more information, course dates and package pricing please visit risk.jifsan.umd.edu/registration.

CORE PROGRAM

Overview of Risk Analysis

This is a one day course that focuses on the basic principles of risk assessment, risk management, and risk communication. The course serves as an introduction for new members of the risk analysis community as well as those highly specialized individuals who possess a desire to broaden their perspective views of risk analysis.

This short overview concentrates on giving participants an international perspective on food safety. It will also serve as a contextual primer for anyone interested in or involved with a broad range of risk analysis activities, regardless of application.

The course provides an introduction to the terminology, concepts, tools and techniques used in food safety risk analysis and acquaints students with the predominant risk analysis models. Overview also gives students a summary of the tasks and issues associated with risk management and risk communication while introducing some of the tools of risk assessment. This course is currently taught by Dr. Charles Yoe.

The course will cover a variety of topics including: By the end of the session you should be able to:

• Risk is everywhere

• Why do risk analysis

• A risk analysis model

• Risk analysis tasks intuitively defined

• Formal definitions

• Alternatives to risk analysis

• Internet resources

• Describe the reasons for doing a risk analysis

• Describe the elements of consensus risk models

• Discuss the intuitive definitions of the three risk analysis tasks

• List the tasks in the risk manager's role in risk assessment

• Explain the role of questions in a risk assessment

• Describe five uses of risk assessment models

• Describe a risk management model

• Identify five decision criteria used in risk management

• Explain the significance of the divergence between risk and the perception of risk

• Identify several factors about a hazard that influence the perception of risk

• Describe some of the lessons learned from past risk communication experiences

Risk Management

Risk management in the context of food safety 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 are often plagued by uncertainty. This course teaches the basics that risk managers need to make informed decisions. It is designed not just for decision makers but also for all those who will work with decision makers.

This course is currently taught by Dr. Charles Yoe.


• Simple decision rules • Multiple objective decisions • Multi-criteria decision support model • Trade-offs • Marginal principle • Sources of management alternatives • Coordination and cooperation • Purpose of a risk assessment • Benchmarking RM practices • Characteristics of good and poor teams

• 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 questions statement • Identify elements of a risk profile • Distinguish concepts of uncertainty and

variability and their importance in decision making

• Identify several key properties of a 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

Qualitative Risk Assessment

Qualitative Risk Assessment course teaches students the skills needed to predict the likelihood of

harm resulting from exposure to chemical, microbial and physical agents in the diet. Our course introduces the range of risk assessment approaches across a wide spectrum of food safety hazards, providing hands-on experience with both qualitative techniques.

This course is currently taught by Dr. Charles Yoe.


• Historical development • Tolerable risk • International food safety • Communication with decision makers • Formal definitions • Screening and ranking tools • Generic processes • Probabilistic scenario analysis • Bayesian methods • Red book paradigm • Monte Carlo analysis • Food additives • Microbial risks • Food security • Biotechnology • Food contaminants • Dealing with variability and uncertainty • Hazard identification • Dose-response • Risk characterization • Common probability distributions

• 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 definition

• 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

• List and define the steps of the red book paradigm

• Identify at least three kinds of uncertainty that can be present in a risk assessment

• Discuss the significance of uncertainty and variability to the risk assessor

• Discuss the significance of uncertainty and variability to the risk manager

• Discuss the role of probability in quantitative risk assessment

• Identify several of the more frequently used probability distributions in 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

Risk Communication

Risk Communication is the interactive exchange of information and opinions about hazards and risks, risk-related factors and risk perception. This 3 course presents the basics of risk communication related to food safety.

This course is currently taught by Dr. Bill Hallman.


• Defining risk • Defining risk communication • Differences between risk communication and

crisis communication • Persuasion as a risk communication goal • Audience basics • Risk perceptions • Involvement • Anxiety • We are all risk communicators • Defining credibility • Expertise • Communicating trust • The practical aspects of messages • Message maps • Message choices • Some basics about journalists • The media interview • Interview checklist

• Understand the goals of risk communication

• Differentiate between proactive and reactive risk communication

• Recognize communication competence and communicator credibility

• Understand how to communicate expertise and trustworthiness

• Know how to consider audience attributes • Understand 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

• Know how to prepare for an interview

QUANTITATIVE COURSES

Quantitative Risk Assessment

Quantitative Risk Assessment teaches participants the basics of building and understanding quantitative risk assessment models and provides participants with the opportunity to develop, scrutinize and present Monte Carlo simulation models.

This course is currently taught by Greg Paoli.


• Introduction to modeling • Deterministic modeling • Probabilistic modeling • Expressing variability and uncertainty using

probability distributions • Introduction to Monte Carlo Simulation • A brief demonstration of other modeling

environments • More Insight into Commonly-Used Distributions • Choosing and Justifying Distributions • Understanding Monte Carlo Simulation • Advanced Concepts in Simulation • Model Building Exercises

• 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 • Build basic probabilistic models using Excel and

@RISK • Understand some pros and cons of other model-

building environments • Understand simulation principles and techniques • Understand Stochastic processes • Understand Scenario and Sensitivity analysis • Know how to use data when building a model • Know how to present risk assessments and their

results

Introductory/Intermediate Quantitative Risk Assessment

Introduction to Quantitative Risk Assessment is a “refresher” course on basic modeling techniques. This refresher course provides the basic principles of risk assessment and where it fits into the risk analysis process. Practical probability and statistics theory, stochastic processes and risk modeling principles are the focus of the course, which provides the participants with hands-on skills to effectively use a risk modeling software environment.

This one week 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. This course will also introduce participants to 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. We 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. They will also experience some techniques and challenges to expect in presenting their results to various audiences. Participants will learn both why and how to include variability and uncertainty in models. This requires a review of basic probability theory and the concept of Monte Carlo simulation. They will then apply these concepts by describe model variables using probability distributions and generating probabilistic risk estimates (using @RISK) as an add-in to Microsoft Excel). This course is currently taught by Dr. Francisco Zagmutt and Dr. Clare Narrod.

JIFSAN is proud to partner with EpiX Analytics to offer Introductory/Intermediate Quantitative Risk Assessment.


• Introduction to risk analysis in food safety • Statistical foundations for quantitative risk

assessment • Introduction to risk modeling • Fundamental stochastic processes • Determining distributions from data /

distribution fitting

• Understand the usefulness of risk analysis in food safety

• Understand risk analysis frameworks in food safety

• Understand the importance of risk communication and risk management in risk analysis

• Understand the pros and cons of different risk assessment approaches (qualitative, deterministic, probabilistic)

• Gain a strong foundation in basic probability theory and probability distributions

• Be able to build basic probabilistic models using Excel and @RISK

• Understand some pros and cons of other model-building environments

• Understand simulation principles and techniques • Understand stochastic processes • Know how to present risk assessments and their

results

Advanced Quantitative Risk Assessment Participants in this course will get practical, hands-on experience in developing and working with quantitative risk assessment models. The course will emphasize modeling methods and how to use them for solving real-world risk analysis problems.

The course begins with an optional 5-day refresher course on basic modeling techniques. Students opting not to take this course will be requested to take a self-assessment test to ensure they feel comfortable with the advanced material that will be covered. This

refresher course provides the basic principles of risk assessment and where it fits into the risk analysis process. Practical probability and statistics theory, stochastic processes and risk modeling principles are the focus of the course, which provides the participants with hands-on skills to effectively use a risk modeling software environment.

The advanced course will allow participants to further develop their risk analysis skills, and will provide participants with in-depth knowledge of the modeling techniques required for risk assessments of internationally accepted standard. Advanced modeling methods are reviewed during the week, while maintaining the focus on producing models that risk managers can understand. Strengths and weaknesses of mechanistic vs. empirical models are discussed, and the importance of parsimony in model building is emphasized. Participants will learn how to choose between potentially conflicting sources of evidence or modeling approaches. Existing risk models will be reviewed critically, and participants are encouraged to discuss modeling problems they are currently faced with. The course will also introduce participants to effective ways to communicate results to different audience including risk managers or the general public. This course is currently taught by Dr. Francisco Zagmutt and Dr. Clare Narrod.

JIFSAN is proud to partner with EpiX Analytics to offer Advanced Quantitative Risk Assessment.


• Refresher of introductory risk analysis material • The principles of food safety modeling • Exposure assessment • Dose-response modeling • Modeling uncertainty • Classical statistics • Bayesian statistics • Bootstrap techniques • Selecting data for a risk assessment • Determining distributions from data /

distribution fitting • Model design & validation • Risk communication

• Develop an understanding of advanced concepts and methods used in food safety risk analysis

• Develop skills in framing food safety risk analysis problems and designing relevant and robust risk assessment models

• Conduct quantitative risk assessments using appropriate methodologies

• Critically evaluate risk assessments • Interpret results of risk assessments, and

appropriately communicate them to technical and lay audiences

ADDITIONAL COURSES Introduction to Risk Communication

Risk communication is the interactive exchange of information and opinions about hazards and risks, risk-related factors and risk perception. This one-day course presents the basic principles of risk communication. Although it is focused in food safety applications, other areas in public health and crisis management can benefit from the basic concepts presented in this course.

This course is currently taught by Dr. Bill Hallman.

The course will cover a variety of topics including: By the end of the session you should be able to: • Establishing Your Goals • The goals of risk communication • Important assumptions • Knowing your Audience • What Influences how people perceive risk • How people take in and make use of risk

information • What people want to know in situations

involving risks • Why science communication alone doesn't

resolve risk controversies • Effectively segmenting your audience • The Messenger and Risk Communication • The characteristics of effective risk

communicators • How non-verbal messages influence how

people understand risk information • Message Development • Listening to your audiences • Choosing the right messages • Organizing your messages • Getting your messages across • Evaluating your efforts

• 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

• Comprehend the importance of mental models in how people perceive and respond to risk

• Recognize the limitations of the "Educational Deficit" model of risk communication

• Understand the ways that people take in and communicate risk information

• Appreciate the importance of “market segmentation” and of understanding the needs of your audiences

• Understand the practical aspects of message design, timing and organization

• Describe the characteristics of a good risk communicator

• Recognize the importance of nonverbal communication

Global Food Law and Regulation

Currently for many countries like the US, the demand for agricultural and seasonal food products is beyond their own production capacity. In response there has been an increased dependence on imported high value agriculture. At the same time, food safety has received heightened attention. The overall objective of this course is to expose participants (public and private sector) to food

safety regulations affecting the production and importation/exportation of food. This course is currently taught by Dr. Clare Narrod and Dr. Robert Buchanan.


• The US legal system as it relates to food law • Concepts and principles of food/public health

policy and law • The rule making process • US Federal agencies and their involvement in

food safety • Key US food protection laws/regulations • Food Safety Modernization Act (FSMA) • Meat, poultry, and egg product inspection • Product labeling • The role of the European Food Safety Authority

(EFSA) in the regulatory process • The role of the World Trade Organization • Codex Alimentarius Commission and other

intergovernmental organizations involved in food safety

• The role of private standards in food safety • Concepts in civil liability law

• Describe how the US government is responsible for protecting national food safety

• Understand food safety policy concepts and principles

• Describe the steps in the rule making process • Understand the involvement of regulatory (FDA,

EPA, etc.), trade (FAS, etc.), and research (CDC, etc.) agencies in food safety

• Understand the components of FSMA and the status of its key regulations

• Compare how EFSA, FDA/FSIS, and Codex/FAO/WHO operate

• Understand the WTO Agreement and the impact of “Sanitary and Phytosanitary” (SPS) and “Technical Barriers to Trade” (TBT) Agreements

• Describe the 8-step Codex procedure • Understand the Global Food Safety Initiative

Epidemiology for Risk Analysis

This two day course provides a general overview of epidemiologic principles, methods, and approaches as they relate to food safety and risk assessment. There will be case studies focused on foodborne outbreak investigation and epidemiologic study design needed for food safety

research hypotheses. The target audience is food safety professionals wanting to understand the different roles and synergies of epidemiology and risk assessment in regulatory decision making.


• Patterns of disease (person-place and time and host-agent-environment)

• Populations and populations at risk • Incidence vs prevalence • Measurements in epidemiology • Surveillance versus monitoring • Study designs (case-control, clinical trial, etc.) • Data quality and sources of bias • Knowledge translation

• Understand basic epidemiologic principles • Interpret incidence odds ratios • Interpret attributable risk fractions • Describe the advantages and limitations of

different study designs • Describe different sources of bias and how to

control them • Understand how to ask the right questions, get

the right answers, and how to get the right answer to the right people in the right format at the right time

Safety/Risk Assessment of Chemicals in Food

This two day course provides a general overview of foodborne chemicals, how they are regulated, dietary consumption and human exposure in foods, and how chemical safety and chemical risk assessments are conducted and by state, federal and international organizations (USFDA, USDA, USEPA, CDC, California, EFSA, and WHO).


• Chemical contaminants • Food additives • Pesticides • Veterinary drugs • Assessing dietary consumption and exposure of

chemicals in food • Safety/Risk Assessment Paradigm

• Describe different foodborne chemical hazards • Understand the difference between safety

assessments and risk assessments and how to conduct these assessments

• Understand the types of data and information needed and used to conduct safety and risk assessment for foodborne chemical hazards

• Understand regulatory and international guidance for the conduct of chemical safety and risk assessments

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