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sults in a relationship getween DBS and the manufacturer in which the latter stands virtually in fear of the Director. Since he makes unappealable decisions that inevitably involve commercial profit, this posture on the part of the manufacturers is understandable.

The American people make a substantial investment in biomedical research, but very little attention has been paid to the widening gap between the fruits of laboratory research activity and the delivery of those accomplishments to benefit the people who pay for them. That gap should be partly filled by our control authorities whose responsibility is to narrow that gap and at the same time protect an innocent public.

Thank you.

Senator HARRIS. Thank you, Dr. Hayflick.

I think you have made a devastating case against DBS and its present policies and practices on all three criticisms which you have levelled.

I think you have made it clear that you do not feel just finding a capable scientist and administrator to head the organization will be enough, that there is going to have to be institutional changes?

REQUIREMENTS OF A NEW DIRECTOR

Senator HARRIS. I wanted to ask you, though: As you have said, HEW has already announced that a new Director of DBS is to be named. Do you have any feelings about what characteristics the research committee ought to look for in such a candidate, whether it is going to be in DBS or wherever else it is to be? Would you care to comment?

Dr. HAYFLICK. The combination of qualities that one would ideally like to have in such a Director are probably humanly impossible to obtain, so one obviously must reach a compromise.

I do not think it essential that the Director be a highly regarded basic research scientist. I do not think this is a necessary requirement. I think the individual needs to have skills in the health sciences and certainly knowledge of the field, in addition to expertise as an administrator and be an effective individual in dealing with personnel and with the community of manufacturers that the department serves. Other than those broad generalizations I am afraid I cannot give you any details.

Senator HARRIS. Are there countries you are familiar with who you feel have a more effective vaccine program than ours?

Dr. HAYFLICK. I do not know that the vaccine programs are any more effective per se because these developments largely stem from the vaccine scientists, as one might refer to them. But I do believe that some of the organization of vaccine control in other countries has meritorious components, some certainly superior to those in this country.

Senator HARRIS. Could you give us examples of countries like that. and what we might learn from them.

UNITED KINGDOM

Dr. HAYFLICK. I think one of the most outstanding countries in the area of biological products control is the United Kingdom. I think

that this group is a progressive organization, that it is organized, obviously, in different ways than the Division of Biologics Standards in this country.

The Director does not wield the total power that I believe the Director of DBS does in this country. He is, in the United Kindom, answerable to a committee of specialists who command the respect of the biomedical community in the United Kingdom. This is one of the salient reasons why I make the proposal that a system of such committees might better respond to the goals of the Division of Biologics Standards as currently organized.

Senator HARRIS. Very good.

What about the question that has been raised that an agency that would be devoted primarily to regulation rather than research might not be able to attract and hold top level scientists?

Would you comment on that and, then, a related question: How is DBS doing in that regard as presently constituted?

RESEARCH ACTIVITIES

Dr. HAYFLICK. That issue is, in my judgment, largely a red herring. I think it has been raised only because historically, DBS has in fact attracted an echelon of highly qualified research scientists. And it is clear that several of these individuals-and I would probably say the Director in particular-would like to have research activities ongoing in the DBS, although they are, in my judgment, not very well organized.

I do not think that basic scientific research is an essential component of a regulatory agency. I think that what research activities might be conducted under the umbrella of the regulatory agency would best be confined to specific areas of research into tests for potency, safety, and efficacy, itself, the main charge of this particular regulatory agency.

In respect to the question of attracting qualified personnel to regulatory agencies that may not be engaged in research, I think this is an issue that addresses itself to the variety of scientific species that exist among us. Many scientists find their peculiar satisfactions in the areas of basic research, others in the area of biological development that have a direct financial goal; others, in areas of quality control, or in teaching. I think the respect that their fellow scientists have for them is not colored, or at least hopefully not colored, by the kind of scientific activities, or teaching activities, that qualified scientists perform. Consequently the issue of research capability by members of a regulatory agency is in my judgment not essential.

PERFORMANCE

Senator HARRIS. You know DBS has argued that if you transfer control authority to FDA, that DBS presently has, there would be an isolation of control activities in scientific research and that would hinder the agency's performance.

Do you think that is so?

Dr. HAYFLICK. No, I do not think that is so. I think that the current activities of FDA, where research, to the best of my knowledge, is not stressed to the extent it is in DBS, has not compromised its policing

activities. The hindrances that may have occurred are from other

sources.

Senator HARRIS. One last question. If DBS is amalgamated with FDA, how important do you think it is that the new agency be independent of HEW?

Dr. HAYFLICK. I really have no strong feeling in response to that question. I can see the identity of these agencies more logically falling under the aegis of HEW. But, on the other hand, the mechanics of successfully operating a control agency should have the highest priority, and if the mechanics are better achieved through HEW, then, sobeit.

On the other hand, I can see very meritorious argument for including it in a separate agency.

Senator HARRIS. Anything further, Dr. Hayflick?

Dr. HAYFLICK. No.

Senator HARRIS. Thank you very much.

Our last witness for the day is Mr. Rodney Leonard.

Mr. Leonard is former Administrator of the Consumer and Marketing Service of the Department of Agriculture and is presently executive director of the Community Nutrition Institute here in Washington.

Mr. Leonard, we are pleased you are here, and we would be glad to hear from you.

TESTIMONY OF RODNEY E. LEONARD, FORMER ADMINISTRATOR OF THE CONSUMER AND MARKETING SERVICE OF THE DEPARTMENT OF AGRICULTURE AND PRESENTLY THE EXECUTIVE DIRECTOR OF THE COMMUNITY NUTRITION INSTITUTE IN WASHINGTON, D.C.

Mr. LEONARD. Thank you, Mr. Chairman.

In order to conserve time, I would like to just have my statement inserted in the record.

Senator HARRIS. Without objection, that will be done. (See exhibit 5, p. 127.)

THREE MAJOR POINTS

Mr. LEONARD. We are talking about three major points.

One is the question of the institutional structure for a consumer agency. The problem is not so much whether it is S. 1171 or S. 3419 as it is that we do not get bogged down in conflict over jurisdiction. We are trying to create an institutional basis for dealing with all of these problems.

The second major problem, it seems to me, is how you provide an advocacy function within that framework.

Thus far, it has been rather difficult to find any kind of in-house advocacy procedures which remain able to perform over any extended period of time.

The Department of Agriculture, for example, had a consumer advocate in 1937 and 1938 under Secretary Wallace and the advocate re

mained as long as Secretary Wallace was willing to take the criticism and guff, and the pressures internally. He finally had to end it.

So, in the files of the Department there is a beautiful history of internal advocacy that did not succeed.

The third point is that even with S. 3419, you are considering legislation which I think will be inadequate if it only does what the legislation now proposes. The problem is simply that you are not going far enough. The Consumer Safety Agency will not be able to deal effectively with food and drug problems as we face them today, or even as we face them in the next decade, unless you transfer to the agency the power and the authority that is now in the Department of Agriculture for poultry and meat inspection, as well as quite a number of other functions including the Consumer Marketing Service which would provide grading programs for food products that control price setting on milk and various other activities such as authority to intervene on transportation rate cases.

TRANSFERS

Food and nutrition service ought to be transferred, because that provides the mechanism by which food services and nutritional services begin to be delivered to both families and children.

It ought to include the Commodity Analysis Branch and other market analysis functions of the Economic Research Service.

It ought to include the Agricultural Research Service activities relating to consumer and food economics, the regional utilization laboratories, human nutrition, and in pesticides.

In addition to those transfers, the legislation ought to require or specify additional functions similar to those that now exist in the Department of Agriculture:

There ought to be a statistical reporting service, to collect, and to disseminate, after analysis, significant information on consumer programs, problems, actions, and activities.

There ought to be an extention service to provide useful and worthwhile information within an education program.

CONSUMER LIBRARY NEEDED

There ought to be a consumer library to collect, catalog, and make available all information on consumers and their programs, not only in this country but throughout the world.

What I am saying is that until we put together a structure which matches in complexity the Department of Agriculture, a structure which has solved better than anything else in the world the problems of producing food but which is yet unable to really resolve the problems of feeding people-until you put together a complex of that capacity, you are really kind of kidding yourselves that you are going to put together a useful consumer agency. In food the problem we deal with today is not production. We solved that pretty well. In food and agriculture, the problem is to insure the distribution and delivery of food. And it cannot be done by an agency which has limited policy authority or limited operational tools.

It obviously is not going to be done by the Department of Agriculture. The Department of Agriculture faces too many problems. There

is a filtering process that insures that even if there are efforts made within those agency functions to serve consumer interests, the filters pretty much remove that before any specific action can be taken.

The filters work in quite obvious ways. Positions in these agencies are filled, both those that relate to policy functions as well as those that relate to the top-level administrative posts; through a process where the industry and farm interests vitally affected by these programs pass on those appointments. Once you get those people in those positions, there is very little pressure for them to respond to consumer needs or consumer problems.

In fact, the only time you do get a response is when the problem becomes so obviously bad it cannot be avoided.

I do not think that what I am proposing is necessarily going to be very easy. Agricultural interests, while they only reflect about 4 percent of the total population, nonetheless are very strong politically. Recent events in the last few months have indicated they want to keep all of these functions together. They know very well that it is important to keep them as hostages for trading purposes in agricultural legislation and agricultural appropriations.

But, if we are to have meaningful consumer legislation which creates an institutional basis for considering consumer problems, that either we will have to transfer these functions or else create new functions to the same kind of governmental services as are available in the USDA. Senator HARRIS. Thank you very much, Mr. Leonard.

I was particularly taken with your comments about the agricultural filter, as you called it. Do you think it is less likely-and I take it you do-that that same filter would not exist if you moved the functions over to another and separate agency outside the Department?

Do you imagine they would find their way over there, too? And if that is true, is there some way we could guard against it?

Mr. LEONARD. I think so. In the period I was in the Department, we began making an effort to shift more emphasis onto consumer programs. We were not as successful as we would like to have been, but I found that if you were able to give the staff very clear directions as to what you wanted to do and why you were doing it, and you backed them up on it, then they very quickly were able to pick up and follow those policy directions.

I think there is a lot of deadwood in the civil service, and that needs to be cleared out. But that is a continuing process, and regardless of where you put assignments in agencies, you will have to continue doing that. There are, however, some very intelligent people in civil service, and they are very quick to sense policy directions.

MEAT AND POULTRY INSPECTION

When the Department very recently transferred meat and poultry inspection out of consumer-marketing and put it in the animal health division, it became very obvious to inspectors that, whatever consumer functions they once may have performed, those were now being downgraded. The reaction of the inspectors in the field and of staff people here in Washington has been to reflect great demoralization in this agency. But they also know if they are going to survive for 25 or 30

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