talk to people from some kind of a base, governmental base, kind of promotes progress.

What we are looking for here is an institution which will energize industry to do a better quality job in the hazard reduction field and the presence of the agency, the existence of the agency, even if there was nobody in it at the beginning, is therapy. It helps. And I just do not believe that there would be a breakdown and that exploiters would move into this area to take advantage of the consumer during the startup period. It would be an absurd thing to have happen. I do not think it can.

Senator JAVITS. I am afraid I did not phrase my question correctly, or you would have answered it in a more relevant way.

What I was really asking about was the FDA. What you say about the moral regeneration of this agency and its evangelistic properties, I am not quarreling with. But I ask: If you take FDA where it is and turn it over to the new agency, are you not going to bog it down? Mr. ELKIND, No.

Senator JAVITS. Why not?

In other words, with no phaseout period; no 1 year, 2 years, 3 years, just turn it right over? And you do not like all of these inspectors, you think they are all doing the wrong thing?

Mr. ELKIND. They would not be involved in the particular program of product safety.

wouldn't they

Senator JAVITS. If FDA went over to the new agency, take everything along with it, including the inspectors?

Mr. ELKIND. Yes.

Senator JAVITS. Do you want that done?

STAFFING CHANGEOVER PERIOD

Mr. ELKIND. Well, there is a provision in the bill that was passed by the Senate Commerce Committee that civil service tenure would not apply. So, there would be a 1-year period during which the new agency could review the situation and make a determination as to whether or not they wanted to keep the current staff.

Senator JAVITS. Do you not think this would cause quite an upset in trying to run an agency which is in transition, where everybody is being reexamined as to whether he would stay in?

I am trying to seek enlightenment.

Would we be better off if we set a period of time, give them a chance to make the change in an orderly way, so that the day the new operation opens, it opens for business?

Mr. ELKIND. Senator, you are a Senator and you are familiar with the processes of government as well as being a trial lawyer. I am the trial lawyer they took out of the woodwork. I am back in the woodwork. I really do not know enough about the particular problem you are quizzing me on to pose as an authority.

Senator JAVITS. That is always the best answer.

Mr. ELKIND. But I recognize it is a specialized problem.
Senator JAVITS. Thank you very much.

Thank you, Mr. Chairman.

Senator PERCY. Thank you, Senator Javits, very much.

Mr. Elkind, I understand you have a plane to catch.
Mr. ELKIND. That is right.

Senator PERCY. I have no further questions.
Mr. ELKIND. Thank you very much, Senator.
Senator JAVITS. I would like to thank you, too.

(Brief recess.)

Senator PERCY. We will come to order, please.

Mr. Turner, you have finished your statement. Have you not?
Mr. TURNER. Yes, sir.

TESTIMONY OF JAMES F. TURNER-Resumed

Senator PERCY. You have spoken of the need to give full independence to the head of this regulatory agency and stated there would not be effective regulation as long as the head of the agency is subordinate to a Cabinet level.

Can you cite instances where the FDA Commissioner would have taken important regulatory action but was precluded from doing so by the Secretary?

Mr. TURNER. Well, I would like to begin to answer that question by picking up the last question that Senator Javits asked concerning the food inspectors, as an example.

COMMISSIONER VERSUS SECRETARY

Now, when I talk about the Commissioner versus the Secretary, I talk about the policies that they view themselves enforcing. And in my statement, I argue that the Secretary views himself as an official primarily concerned, or exclusively concerned, with health problems in this area.

A 1965 POLICY DECISION IN HEW

What occurred-the reason why the food inspectors that Mr. Elkind was talking about have not been functioning as they should and the reason, as he quoted from this report, that 40 percent of the food manufacturing firms inspected had bad sanitary conditions, can be traced directly back to the fact that in 1965 there was a policy decision made in HEW, which is a supportable policy decision, that sanitary inspections did not involve health. This was an important determination, and health and sanitation were separated.

I think it can be justified on health grounds. When the FDA, for example, recently released its statement on the number of rodent hairs that can be found in pepper or other spices they made the very strong point that they do not present any health hazard whatsoever, and I think that is a correct point. For this reason sanitation was lowered to a much lower prioritiy in the FDA's activities.

This greatly demoralized the food inspectors who were not then in a position of being able to go out and do the kind of sanitary inspections that they used to do. Then, gradually, over the 5- to 7-year period, up to now, health problems began to work their way into the sanitary area. As a matter of fact, sanitation was upgraded as a result. of some of the regorganization about a year and a half ago.

This is the example of the way in which a commissioner who is responsible for health issues exclusively can begin to have his authority eroded in areas that are not as glamorous and not as important and not as arguable in health circles as sanitary inspection.

CYCLAMATES

Another example, I think, is cyclamate. For a long period of time "cyclamate" was a subject of serious controversy within the scientific community. But there was not the kind of absolute evidence that required removal of the product from the market, that would be required to take action against it. However, in 1968, 1 year prior to the time that cyclamate finally was removed, there was a meeting in FDA. In December of 1968 it was, in the opinion of those present, decided that the substance would be regulated much more heavily than it had been up to that time.

Subsequently, that decision was reviewed by a superior in HEWwho happened to be the head of the Consumer Protection Environmental Health Service which was an intermediate agency at that time and no regulatory action was taken. The result of that, in my opinion, is that the community that relied on cyclamate, the business community as well as the consuming community was caught almost completely off guard by the decision made by the Secretary. It was the belief that the issue had been resolved, that there was not going to be regulatory action-at least, that is what everyone claimed to believe, and the action came at such a time that all of the packing of fruit for that summer had been completed.

Senator PERCY. Specifically, how would an independent agency, administering food, drug and product safety, better regulate and protect the public against long-range health dangers, than an agency within HEW?

Mr. TURNER. I would just like to change the concept of long-range to potential, because some of them are not necessarily long-range; they are intermediary-range.

YOU MUST HAVE STRONG STATISTICS TO TAKE AN ACTION

Some of the things Mr. Elkind was talking about in safety hazards are involved. The problems you have dealing with the HEW arrangement is that you must have very strong health evidence to get an action out of HEW at this point. You must have strong statistics showing that the bodies are piling up, in essence. You are not in a position to be able to project against the potential problem that may occur and then take an action, because the standard that is required in the health complex is a much higher one in terms of injury.

What we are asking for is that situations such as genetic damage, which was the issue that the FDA Commissioner and the staff looked at in December of 1968 in regards to cyclamate, that question, be looked at as a potential hazard without having to refer decisions on potential hazards to the Secretary's staff which is not as involved in a detailed way with the regulatory action. Without having to refer that decision to that level, the Commissioner would have probably acted to take

some initial regulatory step, and I think that is true in a number of areas Mr. Elkind cited when he talked about the Space Agency model, where you do analysis of the product because you suspect there may be a problem. When you begin to get evidence there is a potential problem or a long-range problem, then you begin to set warning standards saying "This may be a problem now," "It is more likely to be a problem," or "We think it is a problem," before there are injuries.

That can be done much more effectively in an agency outside HEW than inside.

Senator PERCY. I have a few procedural questions I think we can get precise answers to; so, we offer all of them, and if there is anything you want to supplement for the record, you can.

TERM OF OFFICE

In establishing a new agency, how important is it that the head of the agency have a set term of office?

Mr. TURNER. I believe it is important to make a way to have that person responsible so that he is not set for life in a job. To the extent that a set term accomplishes that, I would be for it. I would also be for some kind of method to remove a person who does not perform the job properly.

Senator PERCY. Is that important also, that each Commissioner has a set term of office?

Mr. TURNER. Yes.

Senator PERCY. Should the Commissioner be appointed by the Administrator rather than the President?

Mr. TURNER. I think that the Administrator should have an input into the appointment, perhaps a nominating procedure, but I believe the Commissioner should be appointed by a higher level.

Senator PERCY. The FDA has undergone a number of reorganizations and certainly has had one under the present Commissioner. With each reorganization there is inevitably a period of transition and confusion while the agency readjusts. How long do you think it would take before the new agency would be operating smoothly?

Mr. TURNER. I think if the agency would be moved out intact as it is now with the product safety office added as designed to be added in the bill, it would take a short time, I think, for that agency to operate. smoothly.

Senator PERCY. What do you mean by a short time?

Mr. TURNER. I do not think it would take longer than a year at the outside, and I think the food and drug activities can continue without any interruption.

READJUSTMENT PERIOD

Senator PERCY. Is there benefit to be derived from the reorganization adequate to warrant this period of readjustment of a year?

Mr. TURNER. Yes; because I think the readjustment would apply only to the product safety area which would be comparable if it were put in HEW. You have to do the same thing in the office in HEW that you would in the independent agency.

Senator PERCY. I will ask you the same question Senator Javits put to Mr. Elkind.

S. 3419 VERSUS S. 1177

Do you see any conflict between this bill and S. 1177 which would establish an independent agency to represent consumer interests before Federal agencies and courts?

Mr. TURNER. I not only do not see them as contradictory or in conflict, I see them as supplemental to each other, and, essentially so. I believe there has got to be some kind of independent input of consumer points of view rather than have it referenced back to the director of the agency.

Senator PERCY. You have spoken of the need for accountability of a person ultimately responsible for the regulatory decision. What difference does it make whether the person is a Cabinet Secretary or the head of an independent agency?

Mr. TURNER. In the case of the Cabinet Secretary at this point, we have a situation where a man who is ultimately accountable is not actually the man who makes the decisions on the line, on the routine basis. Therefore, the decisions are made when they become crisis decisions. The man who is involved intimately with those decisions ends up not being the person who makes the final decision.

The perfect example is DBS. In DBS it is delegated by HEW to the head of NIH, that he shall be authorized responsibility for vaccine regulation and yet to date the activities are run by the Director of the Division of Biologics Standards. Very unfortunate, I think, is the division of daily on-line activity and ultimate final responsibility or accountability

COORDINATION WITHIN HEW

Senator PERCY. The Secretary of HEW has admitted that in the past there has been inadequate coordination among the constituent agencies right within HEW, even when he has the ability to knock heads together and have them roll if they do not coordinate and work together. He had difficulties and has been very candid and frank in admitting it. He apparently believes the only way, however, to achieve a higher degree of coordination is to keep these interrelated agencies within the Department under a common superior and force them to work together.

If an independent agency is created, what arrangements can be made to require interaction with related agencies in HEW and elsewhere in the Government?

Mr. TURNER. Well, to take the first part of the question: It seems to me that it is inherent in the function of HEW that it will be impossible for any of these great departments to knock heads together on the lower echelon, the reason being that the individuals who are doing the actual day-to-day work do not get the attention of the persons who are making the decisions until there is a crisis.

INTERAGENCY AGREEMENTS

My suggestion for handling the problem of taking DBS and FDA and relating it to HEW, which will give functions of merit to it, will