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U.S. Department of Health and Human Services

Animal & Veterinary

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Use of Risk Assessment in Regulatory Decision-Making

Les Crawford, D.V.M., Ph.D.

DR. CRAWFORD: Thank you very much. Congratulations to Steve and to Andy on the risk assessment and also on this meeting and thanks for asking me. I, among all of you here, probably are the only one that remembers when your hair did turn white, Dr. Beaulieu.

(Laughter.)

And it was one of the most astonishing moments of my life. I was sitting there being grilled by the Honorable Ted Weiss. And I was trying not to look at him because that was an unspeakable thing to have to do. So I was turning my head away. And I could see the friendly face of old Andy Beaulieu in stark terror.

(Laughter.)

And then Weiss invoked the name of Andy Beaulieu. And I turned and looked at Andy. And all of a sudden, his hair had gone from deep brown-black to white in one fell moment.

(Laughter.)

Risk assessment, the use of risk assessment in regulatory decision-making is what I am charged to discuss this morning. And I would like to begin by talking a little bit about the transition between toxicological risk assessment and microbial risk assessment and then finish by the recent adaptation by U.S. Government and also WHO to microbial risk assessment as a tool in the evaluation of antibiotic resistance and how that fits into the regulatory climate and calculus worldwide.

The first real use that we made when I was in the government of risk assessment happened in a curious way because we had showed the courage to ban DES, diethylstilbestrol, in the year 1979 when I was Senate Director. And if you think this will turn your hair white, Steve, you should have seen those days.

We were not -- we had the courage to ban it. But the cattlemen of the United States did not have the courage to stop using it. So we faced a Constitutional crisis. And one fine day, FDA/CVM had to take possession of 500,000 steer throughout the United States.

And we had people like the Under Secretary for Food Safety at USDA calling for their euthanasia. And the only way we got out of that was to do a risk assessment which showed that the cattle could be held for 63 days, their ears surgically excised or amputated depending on the situation. And we had that done to half a million head. And it was based on a risk assessment. And I suppose that is probably the first time I had ever heard of risk assessment.

And then following that, the risk assessor, who was Joe Rodericks, now is one of the principals in Environ, contracted with the National Academy of Sciences to do a series of three meetings similar to this and similar to what WHO did to develop toxicological risk assessment using the DES risk assessment as a model.

Some of you, like me, may have attended and participated in those meetings. But when we came out of there, we had both routinized risk assessment and we also had made it available as a regulatory tool and as a legal tool which we needed the latter most desperately at that time.

It remained for us to decide what the level of risk was. And so the Commissioner of FDA, Dr. Hayes at the time, ordered what he considered the four risk managers in the area locked up at the Xerox Center in Leesburg, Virginia to decide on a level of risk for a number of exercises and for FDA in general.

Those were Mark Novich who was Associate Commissioner for Medicine -- Medical Affairs, Sandy Miller, me and Tom Scarlett who was the General Counsel. And the issue was to decide whether or not we would have one in 100,000 risks, one in a million or one in a billion. And it was not possible given our dim understanding of risk assessment to decide which was best. And, of course, we were prone to use the political route.

And about 11:00 p.m. on the last night that we were to be freed the next day to go back to our jobs, we all had a different figure except for Tom Scarlett who as a lawyer was wise enough not to give his opinion. But he was finally forced into it and he did it in a way that I shall never forget. And I suppose this is the reason we have the risk assessment and risk figure that we have.

He said, "Well, I haven't said anything now in about six hours. So it is time for me to say something." And he said, "I was just sitting here thinking. We are still struggling between one in a million, one in a billion and one in 100,000." He said, "I think one in a billion is just out of the question." And he said, "I have never heard, I don't think it would be popular to use one in 100,000 because thinking about it, I have never heard a young man say to his sweetheart, 'My darling, you are one in 100,000." So we voted then for one in a million. And we went home.

(Laughter.)

Following those exercises, the next thing that happened of note was the World Health Organization under the leadership of Fritz Kafferstein who has now become something of an American put on a series of four meetings starting in 1995 and finishing in last spring, 1999, to define risk assessment for microbial concerns.

And these four reports, including the last one, are now available. And some of the same people who were out at Leesburg chaired those meetings. And I think they will be used now throughout the world, certainly in the countries that belong to the World Health Organization which is virtually all.

And many countries, particularly in this last one that I was involved in, made major investments in time and in funding in order to make sure that they had this tool done by this international organization. So the time of risk assessment as a regulatory tool is certain here.

Now, I like risk assessment. And I think that I would live a lot longer had I had it and had it been routinized and been the subject of some rigger when I first started out in my regulatory career. I think it takes the politics out of food safety to some extent. And I will give you some examples of that.

You recall in the European Union-U.S. dispute over hormones, when this came before the World Trade Organization three years ago and the ruling came down, the EU pleaded not to have to yield to the finding of the WTO which, of course, found in favor of the United States and specifically in favor of FDA/CVM. The EU appealed not to have to do that until they could do a risk assessment.

And they assumed it would take 15 months to the day to do the risk assessment. And they proceeded then to hire some risk assessors for the first time, and also were painfully at a loss to explain the fact that they had never done a risk assessment before on this subject which meant that they didn't know whether they were safe or not safe because they had never thought about it.

But the power of that as a political and regulatory and public health tool was I think forever enshrined in the world as a result of that. If a risk assessment was so important to the decision process in something that is probably one of the major regulatory disputes of all time historically, if that was the case, then we have risk assessment as a tool that is enshrined then forever.

And then a little later, they decided to evaluate feed-additive antibiotics. And in the pressure of the moment in having forgotten their commitment to risk assessment, they took action against several antibiotics without benefit of clergy or of a risk assessment.

I think probably they will now have to go back at some point in history and do that. So the lesson to me is clear. And also, the concept of the risk manager.

I have been involved since the WHO meeting last spring in a number of seminars and meeting with various governments -- we are doing this with Brazil next month -- and trying to the ministers -- never have I met one that was qualified in regulatory affairs or in medicine or science -- explain to them that the role of risk manager is what they really are and what is a risk manager and how do you react and what is risk assessment, and isn't it great that you are the risk manager for this country and you are going to have more fun with less trauma than you ever thought you would because of that.

And it is working. It is working around the world. And it links in a fundamentally important way and mathematically even the risk assessors with the risk managers. And the public is all the enriched buy because it is a transparent affair. It is not something that sneaks up on them.

And it really is what the world is demanding, for example, in the battle in Seattle on biotechnology. That is really what they want. And I am not sure they would be willing to live up to the outcome. But that is what they want.

And the other thing I would say is that risk assessment is becoming the international language of food safety. Food safety, you are either going to have a risk assessment mentality and a risk assessment that is enshrined in government or you are going to have a situation where you have a learned oligarchy making decisions for the people.

And I have been somewhat part of that and I thought it was great. But the public doesn't think that's too great. And the first time I ever heard how hateful it was was when we were trying to sell the general agreement on tariffs and trades in the sanitary and phyto-sanitary amendments to that.

I appeared around a lot of different places telling them how great this was going to be. And I had that unhappy assignment. And what people would say, "Well, what CODACS really is a bunch of little gnomes meeting in Rome and in Geneva every two years. And they decide all these horrible things for the world. We don't want any more of that. It is not transparent."

And up until that time, I had always thought transparent applied to a window pane. But I knew then what it meant and I knew that risk assessment was probably the way we would get out of that. And we actually wound up having to pledge to go in that direction.

In the United States, as all of you know, there is pending in Congress a bill called the Regulatory Improvement Act of 1999 which would make risk assessment law and would require it for all regulations that have to do with public health and virtually any other thing. Whether or not the bill passes this year is academic.

It was introduced last year. I think it will continue. And I think it will eventually pass. And it would require the Office of Management and Budget not to lick their fore finger and hold it up to the wind, but to actually evaluate what these regulations are going to do for the public, or do to them. And I think that is great.

And then the next thing is we had a meeting at Georgetown last month. And the World Trade Organization representative talked about the fact that they are now incorporating the requirement for risk assessment in all of the issues and disputes that they take on. And that is now a matter of legality with them.

And he modeled -- he said he modeled their amendments after the Regulatory Improvement Act of 1999. So it is passed worldwide and it is still pending in the U.S. like some other things have throughout history.

So -- and then, of course, CODACS has further more enshrined it. The EU has. And I think we are seeing history being made. And I would mention several models that I think are -- in closing, Dr. Beaulieu -- that I think are going to define this for us.

The Georgetown model that Steve Anderson will present a little later on we had a great deal of fun with. And we also learned. Some of the lessons we learned were difficult. But we are now ready to do them and we are starting another one which Steve will also mention.

The FDA model which I got the same time all the rest of you did certainly plows new ground. It is a document of historical significance. The model in Canada by Anna Lamberding. There was work done in the United States by Bob Buchanon and others which we will hear some more about today.

It is just actually like a textbook to me. I think if you want to learn about how you use it in regulatory decision-making, you need to get that first and foremost. And then the Listeria monocytogenes, which is being broadly trashed around the world even as we speak, but nonetheless will be a good risk assessment model and I think will probably plow even better and newer ground than the SE model did.

So we now have -- we have had the philosophy. We developed the science thanks to WHO. And now we have what is needed in order to make this a discipline and a very strong discipline in regulatory decision-making. And that is some actual models to look at, teach from and learn from.

So with that, Dr. Beaulieu, I will conclude my remarks. Thank you.

(Applause.)

DR. BEAULIEU: Maybe time for one quick question for Les if there is one. Okay. Thank you, Les. Our next speaker is Dr. Doug Powell. Dr. Powell has a Ph.D. in food science from the University of Guelph. He is currently an Assistant Professor in the Department of Plant Agriculture at that university.

He is co-author of a text -- or maybe not a text, but a book on Mad Cows and Mother's Milk which is a series of case studies involving risk assessment, management and risk communication. And he is here today to talk to us about the importance of risk communication in the development of science-based regulatory requirements. Dr. Powell.