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U.S. Department of Health and Human Services

Animal & Veterinary

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What is Risk Assessment, Risk Management and Risk Communication

Wes Long, Ph.D.

DR. LONG: I want to thank the Center for Veterinary Medicine, Steve and Andy and Sharon for inviting me to give you a little bit of a primer on risk assessment, risk management and risk communication. I think it is to CVM's credit that they thought it was worth their time in a very busy agenda for today to allow a little bit of time to make sure we all have a common basis and understanding for this area of risk assessment and how it fits into risk analysis.

(Slide.)

I think that -- well, I know that there is potential for a great deal of confusion when you start to talk about risk assessment. I spent the last three days at the Society for Risk Analysis Annual Conference in Atlanta. And these are 2,500 risk analysis professionals. And even they can't agree on what is the difference between risk assessment and risk management. So you are not alone if you have trouble with this, these different concepts and sorting them out.

You are going to have a lot of information coming at you over the next two days, a lot of science, a lot of sort of hard core science. You are going to have some risk assessment modeling that you may find difficult to understand. There will be discussions of legal statute. There will be opinions. There will be discussions of standards.

And I think it is important that as CVM is actually here to learn what you think, that it is useful to provide you with the tools to effectively communicate with CVM your opinions and your needs and your perspectives.

(Slide.)

So we are going to start off with a little test. I hope everybody got a good night sleep. No, not really. If we just look at the title of the meeting, Workshop on Risk Assessment and Establishment of Thresholds, actually right here in the title, some of you may know and maybe most of you know that actually risk assessment is risk assessment. Establishment of thresholds is risk management.

So already -- now, risk assessment, of course, is a tool for the risk management aspect of establishing thresholds.

(Slide.)

Let me explain. First of all, I will show this slide. And if a Power Point slide could get tattered, this would be my tattered slide. Risk analysis actually is composed of three components that are interrelated: risk management, risk communication and risk assessment.

(Slide.)

All right. Well, what is risk assessment? One way to describe what risk assessment is is that it is a tool to predict the likelihood of the occurrence of an adverse event.

(Slide.)

Now, if this is a little bit too complicated and we want to back up a step, then we can think of risk assessment as looking at what can go wrong, how likely hazard is likely to occur and what are the consequences if it does happen.

(Slide.)

Again, while risk assessment is a tool to predict the occurrence -- the likelihood of occurrence of an adverse event, it is also a science-based technique for organizing our information and separating what we know from what we don't know, and then taking this information and presenting it to our risk managers as well as to fellow risk assessors and fellow scientists for their critique and analysis.

So this presentation of relevant scientific facts needs to be structured to clearly tell what we know, what are the data sources we used, what information did we rely on. It needs to characterize how well we know what we say i it is that we are knowing. And it needs to be transparent to reveal any biases that the risk assessor might have and also to really pull out the simplifying assumptions because it is often necessary with data gaps to make simplifications and assumptions that may affect the analysis.

(Slide.)

All right. Well, but that is not enough. Risk assessment really has to try its darnedest to answer the question. Whose question? It is the risk manager's question. And without a good communication between the risk assessor and the risk manager, then the risk assessment can end up coming up with something that really does not address the needs of the risk manager to make the decision that the risk manager needs to make. What happened here?

(Slide.)

Okay. So what are the questions that this risk assessment is trying to answer, like Dr. Sundlof said? What is the extent of the risk to human health from resistant food-borne pathogens associated with the use of antimicrobials in food-producing animals? That was the question put to the risk assessors.

(Slide.)

What questions does this risk assessment not answer or not attempt to answer? It is not going to tell you what the level of risk that expresses a quantitative definition of acceptable risk is.

(Slide.)

And if that is too much gobblety-goop, it is not going to tell you what the appropriate level of public health protection is.

(Slide.)

The risk manager -- those are all considerations for risk management. And there are a number of considerations that risk managers have to consider when they go to make a decision. And certainly the science is critical as Dr. Sundlof noted. FDA is a science-based organization and we try our darnedest to base our decisions on the science.

(Slide.)

But there are other factors, as well. There are public values. There is an expectation from the public about the safety of the food supply and the degree of protection that is necessary. And there is a relationship between those expectations and the perceptions of the public of where we stand at this point in assuring that sort of safety. Public values also include stakeholders from producers, farmers, manufacturers, as well.

(Slide.)

There are economic factors that have to be considered. And if there is a result in rule-making down the road, that rule-making will include an economic assessment that will look at the costs and benefits of any alternatives, as well as looking at the competing benefits of different technologies and the cost of those technologies, as well.

(Slide.)

Statute, I think you will hear more today about how statute describes FDA's authority to act, but it also places some limitations on what those actions can be that FDA can take.

(Slide.)

And finally, there are always going to be political factors. And here when I say political factors, I am not talking about Congress putting the thumb screws on Dr. Sundlof based on his decision. But rather about the political priorities and how this fits into the broader range of concerns of the Center and the Agency and the needs of the Congress and White House.

(Slide.)

Okay. Briefly I am going to mention risk communication. I have already mentioned the risk communication between risk managers and risk assessors. This is in framing the question and monitoring. While you try to maintain a functional separation between the risk assessors and the risk managers, they have to communicate with each other.

(Slide.)

There is communication between the risk assessors and the scientific community. And I hope that we are going to hear some of that communication today as this greater scientific community evaluates the risk assessors' use of the available science.

(Slide.)

There is communication between the risk managers and the stakeholders. And all of you here today are stakeholders in one way or another.

(Slide.)

And finally, and sort of in a separate category is the risk managers communicating their decision, the final outcome of this meeting and the rest of the meetings when FDA does get to the rule-making stage. How do we get the message out?

(Slide.)

Okay. So to summarize, risk analysis is composed of three components: risk assessment, risk management and risk communication. Risk assessment is the technical work. Risk management is the decision-making. And risk communication is the way we get risk management and risk assessment to work together in conjunction with stakeholders.

(Slide.)

Okay. So what is CVM hoping to get from this workshop? I think in terms of your input today, we are spending most of our time critiquing the assessment, understanding risk assessment principals. And so the questions are is the risk assessment understandable, does it have utility, is it a fair presentation of the available data and information.

And speaking as a risk assessor, risk assessors always want to make their risk assessments better. And one of the best ways that they can make those assessments better is to have more and better data. So certainly if you are knowledgeable about data that is available that wasn't utilized that perhaps should be utilized, I am sure the risk assessors in the audience would be thrilled to have that information.

(Slide.)

Okay. So today -- I say tomorrow on the slide. But today and tomorrow, the risk managers are going to be listening. They want to know what you think about the risk assessment. As they evaluate the assessment, they want to know your evaluation of the assessment, as well, to incorporate it into their decision-making process.

And they are also going to be looking for your opinions on risk standards and the role on how this risk assessment fits into developing and setting those standards and thresholds. So I hope you all can use this information a little bit to help direct your questions and your comments today. Thank you.

DR. BEAULIEU: Any questions for Wes?

(Applause.)

DR. BEAULIEU: Sorry. My question was premature. Any questions for Wes? Thank you, Dr. Long. Our next speaker this morning will be Dr. Lester Crawford. Les has a D.V.M. and a Ph.D. from some places down south. He is currently the Director of the Center for Food and Nutrition Policy at Georgetown University.

In former lives, he was an administrator of FSIS/USDA and an Executive Vice President of the National Food Processors Association. And he was an Associate Dean at the University of Georgia and also something I am having -- oh, yes, he was former Director of the Center for Veterinary Medicine.

(Laughter.)

Les is going to talk to us this morning about the use of risk assessment in regulatory decision-making.