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U.S. Department of Health and Human Services

Animal & Veterinary

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The Importance of Risk Communication in the Development of Science-Based Regulatory Requirements

Doug Powell, Ph.D.

DR. POWELL: Always fun going after Lester. AV person? There we go. It keeps moving. There we go. Okay. I am going to make my comments brief and talk about the role of risk communication. You are going to hear a lot about risk assessment over the next two days. And Lester certainly gave a good overview.

I want you to keep in mind though the risk assessment works best when your expectations are not too high. And the reason why is other industries have gone through this where if we can just get the science better, we will have a resolution to these difficult public policy questions. And they are disappointed.


This is the model. I know FDA uses this in some of their other regulatory areas. It is from a 1997 Presidential Commission on Risk Management. And basically what it says is -- you know, in the past, it was assessment and then management and then communication, a very linear separation.

This is more than just circles. It is not just because it is the '90s and we are all holistic and draw circles. It actually is a very powerful model that says to integrate all three of those things. And what it really says is you need really good science, but you also need really good communications. And the reason why is because there is so much uncertainty in a risk assessment that you can't just rely on the numbers.


For consumers, they often view these things as stigma or stigmata. And the risk assessment isn't actually that important. Consumers might not know all the details of bovine spongeiform encephalopathy and new variant Creutzfeld-Jacob disease. But if I say British beef, there is generally a yuck factor. That is a stigmata. That is a short-cut that consumers use.

And for a regulatory agency, they have to be aware of that and keep that in mind. And the characteristics apply quite nicely to the use of antimicrobials in animal agriculture. There is a hazard. There is a potential for risk, a standard of what is right and natural. You know, why are we doing this is somehow violated or overturned. Impacts are perceived inequitably. Lots of scientific uncertainty. This is normal for any risk scenario.

The bottom line is the management and the hazard is brought into question. And that is critically important and that is why you have meetings like this, is so that you have a clear and transparent management of hazard.

For example, think of the dioxin in Belgium crisis that happened earlier this year. We just reviewed about 300 stories. I mean, it gripped Europe for a couple of weeks. People were talking about, "Oh, my God, we can't even get food on the table." Grocery stores were empty.

And out of those 300 stories, we found one, one that talked about the actual risk to human health and safety in terms of consuming the stuff. The other 299 were all about how the hazard was managed and the fact that the Belgium government knew for six weeks and didn't bother telling anybody and directly led to their electoral defeat.

So management of the hazard is critical in terms of -- because what happens is something is stigmatized. Things go off the rails. And it is very difficult to have a meaningful discussion using all the great science of risk assessment.


So we need good surveillance systems. And I would argue that you generally have that. They can be improved. Good communication. A credible, open and responsive regulatory system. That varies from agency. It varies by country. Demonstrable efforts to reduce levels of uncertainty in risk and evidence that actions match words.


Surveillance, I am not going to go through this. You basically have a good system through FoodNet, PulseNet and NARMS. You are getting some of that basic data which can feed into the risk assessment that needs to be improved.


Risk communication has been around for at least ten years if not more. This is the long definition from the National Research Council. The short definition is any conversation about risk which is usually with your spouse.


This is the history of risk communication. And there are some powerful lessons in here as you embark on risk assessment for antimicrobials. Baruch Fishoff pulled this together a few years ago. In the early days, it was thought all we have to do is get the numbers right, make the risk assessment better. We will get better numbers. We will have answers. The nuclear industry went through this.

It doesn't work that way. It's like you are one in 100,000. People only remember the one. All we have to do is tell them the numbers. You know, if we educate the public, then clearly we will be able to understand this better and we will resolve conflict. Say what we mean by the numbers. This is risk analogies, you know.

These numbers, one in a billion or one in a million. People can't get their minds about it. So we have to use analogies like, you know, well, it is like a marble in a beach full of marbles the size of the United States or, you know, analogies like that. And that tends just to make people mad because what you are doing is trivializing concern.

Show them they have accepted similar risks in the past. Well, you know, you drove here so what are you worried about this for? How many times have you heard that one? You know, these guys have figured it out to get rid of this about 15 years ago. But we still hear it all the time.

Show them that is a good deal. Can you buy people off? Actually, you can sometimes in citing hazardous waste facilities. They always promise, you know, a lot of jobs and there is usually one part-time that ends up getting employed.

Then we went into -- in the early '90s, we went into what I call the happy talk phase of risk communication. And that is if we just treat people nice, we can get rid of conflict and come to some solution. We make them partners. And, you know, Clinton was certainly a man of the time. Remember, when he was elected originally in '92, he was the empathetic President. He was apparently a little too empathetic. He felt a little too much pain.


And now we've gone past that. Canadians export Canadians and hockey players. I am trying to uphold that standard.


And the bottom line is all of the above, we need all of that. It is not enough just to talk nice to people. You've got to have the data to make it meaningful.


Now, with antimicrobials, this is generally the state of public discussion. You get stories like this. I am not going to go into it.


The New York Times, oh, look, fluoroquinones and chicken. That was last -- two years ago.


Certainly, there has been a dramatic increase in media coverage over the last couple of years of antimicrobials, in particular, the agricultural use of antimicrobials leading of course to a huge increase in antibacterial products out there, both for microbial food safety concerns and other concerns which do nothing but accelerate development of antimicrobial resistance. However, they are all out there.


FDA has entered into the fray. It has gotten a lot of public coverage since last January on a proposal to manage antimicrobial resistance. And I think there is good recognition that these things are not direct anymore, that there are environmental impacts and that really we aren't talking about the environment.

It is not just a matter of plants are over here and animals are over here and humans are here. There is -- while there are different arenas, there certainly is a lot of cross-fertilization. And I mean that literally with manure.


One of the solutions then in the absence, while the risk assessments are going on, while you are improving your science, it is important also to demonstrate the management of that risk. And we have judicious use principles or prudent use guidelines. I think the Americans are on the judicious use. And a lot of the species have these things.

But what is important then is, you know, it is not just a matter of talking nice to people. You have to have data where people are actually doing it, evidence that actions match words. So in order to do that, I am going to talk about tomatoes.

And you may be wondering what's that got to do with it. Well, actually a lot of antibiotics are used on field tomatoes to control bacterial diseases. And this is another one of the environmental loads. And I think there is a growing recognition of that.


When you work with producer groups in order to implement these things, and we do this sort of stuff, we always find it useful to go out and survey them. You know, people always talk about surveying consumers to get their perceptions. We are also interested in perceptions of producers because if they are actually going to implement something to reduce and manage risk, they've got to own it.

And we've done this three times now with three different groups. And we asked people the same question we ask consumers which is an unprompted what is the greatest threat in the food supply today. And the producers always say imports. And it doesn't matter what country we ask, they all say imports.

And this is expected from a risk perception viewpoint because individuals are impervious to risk. In the United States, you know, there are surveys done every year: Is drugs a big problem for society? Absolutely. Is drugs a problem in your family? Uh-uh. Well, where is it all coming from then? Well, it is out there. It is someone else. So you need a mind-set change to demonstrate that it is their problem and they have to own it.


And this is a greenhouse tomato facility which is not important. What is important is this sort of stuff. You can develop judicious use guidelines and produce manuals. And we all have the QA programs which feed into those. But manuals aren't enough because you don't have any evidence anyone has actually read it, let alone done anything about it.


As this cartoon says, it has, "Our annual ISO 9000 audit is next week. We can pass the audit if we put all of our nonconforming documents in the trunks of our cars and then torch the cars." Doesn't that defeat the purpose of a voluntary audit?


But one of the things we did with this particular producer group that I think is instructive for implementing prudent use guidelines and communicating with producers and others who have responsibility to manage this risk is we can document changes. For instance, when we ask them, "What are the greatest threats to the food you eat?", in 1998, after imports it was pesticides. By 1999, just after a couple of rounds of meeting and after throwing the manual out, storage and handling and microorganisms were all of a sudden on the list.


More importantly, we asked them about particular programs they had implemented. And this is for microbial hazards. And in '98, they had barely heard of it. They were talking about reduce pesticides and biological control. By one year later, we are all of a sudden able to show that the number one thing is they have improved their cleanliness. They are starting to think about keeping the place clean. What a concept. But for fresh produce, this is something that is relatively new.

Hand washing and washroom facilities, not even on the list in '98, are suddenly coming in quite high. So we are able to demonstrate that there is at least an awareness. But, you know, people can lie on surveys.


So you go an additional step. And that is we have a student actually collecting data full-time on end product and on water quality and doing pathogen testing. And that is the data which supports the claims that they are making.


So as you move forward on implementing, whether it is judicious use principles for initial management because Lester and his group can be doing risk assessments for the next 20 years and they will always be getting better. That is not to slag risk assessments. The alternative I think is astrology. And what Lester said is correct.

But don't put it up on a pedestal because it will get knocked down. It is a useful tool to provide incremental, yet significant improvements in understanding. There are a lot of data gaps at this point that need to be filled to improve that understanding. But we can't wait because you can be -- you can always do a better risk assessment. And that is the point.

In the meantime, you have to demonstrate that you are aware of the risk and are taking actions to reduce risk. And while you are doing that, you need good risk communication. And what we have shown is that, you know, you have a scientific perception of risk. You have a public perception of risk.

And I am not going to go through that today. But in between is the activity of good risk communication, entering into public discussions about levels of risk. And there is a very high level of awareness on this issue from both the medical side and an agricultural side.


So as you enter into that, just some general lessons that we have learned from previous case studies and some even involving the Center for Veterinary Medicine around BST for example. A risk communication vacuum if allowed to develop is why things end up on the front page. It is exactly what happened in Europe over genetically engineered foods which is another fun topic.

Regulators and industry and academics and producers, everyone is responsible to communicate effectively about risk. And if you are responsible, do it early and often because you won't like the results if you wait. There is always more to a risk issue than what science says. And I think we are going to spend the rest of the meeting talking about what science says.

But just keep in the back of your mind that when you leave here, there will always be something additional that is not necessarily about science. Even though FDA does not have a legal mandate to assess that and that's proper, just in terms of communication, you have to be aware of that.

Educating the public is generally a non-starter. Most people do not want to be educated or they would all be here. Most people want to go shopping, not do homework. They want to go to their grocery store and have a level of confidence so that they can focus on handling the screaming kids, not whether this thing has some sort of problem.

And it is incumbent on the regulatory agencies to generate that level of trust and credibility, that level of confidence in consumers.

I think everyone has agreed that the no risk thing is out the door. You don't hear it very often, at least not in the United States. Risk messages should directly address the contest of opinion. And that is because there are issues that aren't to do with science, yet they are what is going to be out there. For example, Belgium, dioxin. What was it about? The management of the hazard.

We have to address those issues and communicating well because you want to say it is safe has good spin-off benefits for risk management because it may mean you have to change what you do.


Finally, to use a hockey analogy since we talked about hockey, since we export all our great players here including Wayne Gretzky -- these are my four girls. I had to -- I came in late last night because I coach hockey and had to stay for that because, you know, you've got to have priorities, although Scott and I missed our regular hockey game which to Canadians is somewhat tragic. And I am not sure if I've recovered yet.

You know, the NHL is really upset because Wayne Gretzky quit. You know Wayne Gretzky, right, you Americans? I've just got to check.


I know we exported him, but, you know, maybe -- the point is Gretzky was a great player, but he also was a great communicator. Now, if you watch him -- I grew up with him. He lives around the corner, or his parents do in Branford. And if you look at him on TV, he looks pretty goofy. I mean, he is about as unsmooth as it gets, scrawny and he is not too good looking and, you know, I'm not either. Maybe it is a Branford water thing. I don't know.

But the point is he went out of his way to talk to the folks who paid the bills. And that was the fans. The guy never turned down an interview even though he looked goofy. And the reason why people believed him and listened to him is when you score 1,000 goals, that is pretty good data. So get your good data and then go out and talk about it. Thank you.


DR. BEAULIEU: There may be time for one quick question if there is one?

DR. POWELL: I thought we were all going to be quiet.

(Away from microphone.)

MS. : Well, this is just a general comment. Perhaps there is some insight in the room for us it would help if the ---.

DR. POWELL: Sorry. I wish you had told me earlier. You have to get out and communicate about these things.


(Away from microphone.)

MS. : Well, it will be ---.

DR. BEAULIEU: Thank you, Doug. Our next speaker will be Dr. Al Sheldon. Dr. Sheldon has advance degrees in microbiology and genetics. He is a team leader in microbiology in the Office of Drug Evaluation IV in our Center for Drug Evaluation and Research.

He has had 27 years in drug regulatory affairs, experience in drug regulatory affairs including clinical microbiology, quality control associated with drug manufacture, manufacturing and control of both bulk and finished dosage forms.

And let's see if we can't reorganize ourselves a little. I am not quite sure what cords I am running over here. Nothing seems to have unplugged itself yet. Does that help some? Okay.

I think I failed to mention that Dr. Sheldon is going to be talking to us this morning about antibiotic breakpoints, methods for determining those and their use in the medical community.