JAMES S. BENSON - ANIMAL HEALTH INSTITUTE
JAMES S. BENSON
ACTING COMMISSIONER OF FOOD AND DRUGS
ANIMAL HEALTH INSTITUTE
50th ANNUAL MEETING
MAY 2l, 1990
I appreciate that gracious introduction and the opportunity to be with you today. I regret I was unable to be here last year, but, I'm glad Dr. Guest was able to fill in, and that you have invited me back for this historic meeting that marks your fifty years of commitment to animal health.
I've been Acting Commissioner for six months now, and in the Commissioner's Office for two years. So, you might say I'm still on the steep side of the learning curve. And most of the learning is through crises and dealing with issues like BST and drug residues in milk.
There are lots of important subjects for us to address today as we consider animal health issues for the 1990's, and our joint responsibilities in assuring the safety of the nation's food supply.
Food safety is -- and will continue to be -- a main theme for FDA, and our constant goal.
This is a time of intense activity for FDA. There are lots of regulatory issues, which is not unusual. There is increased interest in our activities by the Secretary of Health and Human Services. We have been shocked by the generic drugs irregularities and have been the subject of considerable amount of oversight. Secretary Sullivan has recently set up a Blue Ribbon panel to examine the Agency's strengths and weaknesses, resources and obligations, performance and priorities. We're going to be scrutinized under a magnifying glass, which is healthy. We welcome this opportunity for thorough analysis and stock-taking.
The timing of this meeting is good, because I can give you a fresh report on the opening session of the advisory panel, which met last Thursday and Friday. During the meeting, senior FDA staff, including Gerry Guest, provided an overview of our activities. Many of the topics we discussed bear directly on animal health issues for the 1990's. Gerry, for instance, talked about biotechnology products and generics.
In my mind, there are two major FDA themes for the Blue Ribbon group: the gap between public expectations and what we can deliver, and our credibility. The level of expectations from FDA keeps going up all the time. People are more health conscious than ever, and they look to the Agency to guarantee not only the safety of their food and cosmetics, but also the safety and efficacy of their drugs, and medical devices.
Our job keeps getting bigger and bigger. We're getting new drug applications in unprecedented numbers -- twice to three times as many as we used to get a decade ago. Imports have tripled since 1972. Congress has passed 23 new laws in the last l7 years whose implementation is wholly or partly our responsibility. On top of all this, there is a growing pressure from consumer organizations and the general public for greater scrutiny of foods for traces of pesticides and other potentially harmful chemicals. We are expected to handle this ever-growing workload by everyone -- Congress, industry, the ordinary citizen.
Yet when you look at our budgets over the past ten years, you will see that after subtracting the special increases for the AIDS epidemic, the amounts we've received have remained flat. The pressure on our available resources has become so serious that we have recently initiated a comprehensive needs assessment that will look at the projected Agency work load until 1997 and estimate the FDA needs to handle it.
We're looking for the most cost-effective ways of fulfilling our various regulatory tasks, from sampling imported produce for pesticides to testing the performance of medical devices and checking the safety and efficacy of drugs. The bottom line is that we have to align our mission with public expectations. If we don't, the FDA will lose assets in one area where depletion cannot be tolerated -- namely, credibility.
Credibility, as I see it, is one of the biggest challenges we're facing now and will face in the years ahead. In the 1950's and 1960's, it was possible to submit a food sample to a battery of state-of-the-art tests and proclaim it free of pesticides and other harmful chemicals. At that time, we could identify traces of pesticides at the level of one part per l00 million.
By now, scientific measurements have become so refined that we can look for carcinogens at the level of one part per trillion -- and we find them. They are there, far below concentrations which pose a risk to human health, but they exist.
The results make headlines -- about Alar in apples, about traces of chemicals in milk, about pesticides in imported vegetables stopped by FDA investigators at the border. Frequent headlines of this sort breed distrust that you see reflected in the campaign against milk from experimental herds injected with BST.
What we've also learned in the last few years is that simply pronouncing a food "safe" is not enough. The public remains skeptical. State legislatures, food processors, and supermarket chains respond more to public perceptions than to our scientific evidence.
I am not sure of the solution. One obvious part of the answer to our credibility gap is that we always have to be very careful to tell the public the truth. We have to speak openly about the size of the risk, if there is a risk involved, and we have to do a better job than we have done in the past of educating the public.
Our public should know what we really mean when we talk about a "negligible" risk posed by traces of pesticides in our food. It should also have an idea about the contribution which these pesticides make to our standard of living. Only then will consumers be in a position to arrive at their own conclusions about food safety.
A better informed, more sophisticated public perception of food hazards would enable us at the FDA to use our resources where they would do the most good, not where they allay the greatest misconceptions and fears.
Now, some steps in this direction have already been taken. Following the Alar episode a little over a year ago, the White House set up a task force to look at depth at the problems of food safety. Cooper Evans, the Agriculture Adviser of President Bush, very knowledgeably took up the issue of revision of the pesticide legislation, including the Delaney Amendment which set up the now-unattainable standard of "zero risk" of carcinogens in food additives. At the same time, the President's plan made realistic food safety a national priority, as we are the FDA -- and our friends at the Environmental Protection Agency and the U.S. Department of Agriculture -- have believed it should be.
Just how widespread is the concern about safe food and drugs is reflected in the unprecedented number of bills that have been dropped into the hopper during the current session of Congress. So far, we have counted:
- l0 seafood safety bills
- 8 garbage backhauling bills
- 4 pesticide bills
- l ban on BST
- l ban on L-tryptophan
plus 8 states considering their own legislation on some of these issues.
I should add that despite their variety, most of the proposals agree in one important aspect: they set the standard of negligible risk at about one in a million over a lifetime exposure.
Our scientists tell us this is an attainable ratio and a standard which can be enforced, as well as a very high assurance of safety.
But legislative action alone will not get the job done. I feel that we must do much more than simply pass a pesticide bill.
We must act to reassure, as well as to assure the public that the food supply is safe. We at the FDA will continue working with the Department of Agriculture to monitor food for pesticide residues. The problem of Salmonella enteritidis in eggs must be addressed. The danger of foodborne diseases has to be dealt with more adequately.
Last but not least, we'll have to continue cooperating with the European Community, Canada, and our other trading partners to harmonize our regulations and improve the safety of food in international commerce. This is one of our major issues.
Let me turn to some specifics. There are many important issues concerning animal health and food safety of concern to all of us. I want to talk about three: drug residues in milk, BST, and generic animal drugs.
Let me begin with drug residues in milk.
In public perception, milk is right up there with motherhood and apple pie. People, above all, want a safe milk supply. We, along with you, must assure that! We can accomplish this with the cooperation of the milk producers, the veterinary community, and AHI.
As you know, our probe into residues in milk which we conducted earlier this year caused some controversy.
What happened was that when we finished the first phase of the testing, we said that we had found no sulfamethazine but that we would continue looking for it. We then found 2-3 parts per billion of sulfamethazine -- amounts well below the established level of concern of l0 parts per billion.
The criticism that followed our second announcement was an important lesson. It showed that facts need to be clearly presented -- and clearly understood -- the first time.
We believe that the trace amounts of residues in milk found to date pose no health concern. But we need to be more careful in our communications; if we're not, we pay a penalty in a highly valuable area, which is our credibility.
Milk, perhaps more than any other food, must remain safe and pure. We all have a role to play in this regard. An excellent example of how producers and veterinarians can cooperate in safeguarding milk is the quality assurance guidelines for drugs used on dairy farms which were prepared by the American Veterinarian Medical Association and the National Milk Producers Federation. This program is expected to begin in the fall. We need more joint ventures of this kind. It is the type of industry responsibility that Senator Kennedy is pushing for in his pesticide bill.
Now, allow me to proceed to another issue that has challenged our communications stills and raised questions about our credibility: BST.
As I mentioned before, BST is an excellent example of a credibility issue. What happened was that we handled the review of BST entirely in the scientific framework, just like any other drug application. What did not get enough attention was the fact that the use of BST has economic and social implications for dairy farming, and that the future of small dairy farms is of considerable concern to a segment of the public, both here and in Europe. As a result, our position on BST was widely criticized, and many consumers ended up not trusting FDA.
We believe that BST is safe. To prove our point, we have taken such unprecedented steps as submitting an article about the drug to Science magazine where it should appear this summer, and asking the National Institute of Health to evaluate the human safety data on milk produced by cows injected with BST.
All this to establish our credibility, an attribute that's easy to undermine, but hard to build.
And now on to my final topic -- generics.
The law covering generic animal drugs becomes effective January l, 199l. We've done a lot to get ready for the new task: we've increased our resources, tried to establish a policy and procedures, and communicated with the industry and others.
Hopefully we've learned something from problems of the human generics trouble.
Among other things, we will set up a new data tracking system that enables us to track a document down to the individual reviewer and to establish whether the application is being reviewed according to the priority of its receipt.
We also have hired ten of the l6 additional reviewers we'll need to handle the new generics workload, and we're looking for more manpower to enforce compliance with our regulations. You have to expect us to be tougher in the field, although we still want to cooperate. However, we also believe that industry must establish its own ethics. We can't do it all.
In closing, let me return to our two main themes for the future:
expectations and credibility.
I'm optimistic about the future of FDA. The Roper Polls show that in spite of our communications problems we still enjoy the consumer support rate of 74% -- the best among American regulatory agencies.
Another good news is an improvement in our budgetary climate. Our resources are on the upswing.
We have learned our lesson about the importance of communication, and we are going to make the FDA and its works better known and more easily understood.
But I must emphasize that we're in this together. Risk communications present a problem for you no less than for us, and it is your interest to help us deal with it.
Thank you for your attention.