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severed all relationships with the firm.” The executive being discussed is Assistant General Counsel for HEW, Mr. Peter Hutt, who is sitting here at the table today.
I would judge, based on my personal observations, that we could not have a stronger endorsement for the caliber of man selected; in the half year or so that Mr. Hutt has served the agency, his counsel and dedication to the public interest has been, in my judgment, so overwhelming, and repeatedly demonstrated to us, that he has done a great service to the general public, FDA, HEW, and the Nation.
So it is a matter of who the person is, I presume, and how he is selected. And certainly Commissioner Edwards has succeeded, notwithstanding occasional barbs and arrows, in opening the deliberations of the FDA to public purview while providing expert and equitable leadership.
I do have a question on the Christmas tree tinsel. I have no questions on chocolate bars.
Secretary RICHARDSON. May I inject
CHRISTMAS TREE TINSEL
Senator PERCY. I have been bothered by the Christmas tree tinsel .because you did decide, for better or worse, to get rid of any tinsel that used a lead-based product in it. Certainly, the testimony has been very clear. In lead-based paint there is a recognized danger. As I understand it, here a decision was made and an agreement was reached with certain companies that they would not use that particular manufacturing process for making tinsel after December of 1971.
But what happens to the inventories that are left over? Are they permitted to sell those inventories for Christmas 1972?
Commissioner EDWARDS. It is my understanding, Senator Percy, that the answer to that is "No." But I will have to check on that.
Mr. Hutt. I do not have a copy of the agreement that was reached.
Commissioner EDWARDS. I can provide that certainly for the record, however.
(See exhibit 11, p. 302.)
Senator Percy. If I remember correctly—and I have not really gone over the details of it for severa months—they were able to dispose of their inventories through December 1972. I would say that is the same decision that we faced in cyclamates.
I, too, get pressured many times. I had food manufacturers and processors, companies in Illinois, pressuring me to influence you to get rid of those hundreds of thousands of cans of products that had cyclamates in them. I simply took the position that their research was faulty, that they had to take the risk, and I was not going to call you up and apply political pressure of any kind not that you would have given in-but I would not even make the call. I thought that if it was a mistake that was made and it was not in the public's interest, they should dispose of the food produced; that they ought not to dispose of it, if it were not a mistake.
You did not have the power of law behind you in this particular case, and you obtained an agreement which you felt was the best possible one. However, I can assure you, in regard to the dangerous Christmas tree tinsel, that a danger is involved.
It is my understanding that remaining inventories can be sold through December 1972. I think they should be withdrawn and held back.
Secretary RICHARDSON. Senator Percy, before you proceed, let me just enter a word of appreciation for your remarks about Mr. Hutt. I think that his service has fully deserved the characterization you just gave. I think the point is very well taken, that an individual of that caliber who may have been and undoubtedly was working conscientiously on behalf of private clients, seeking effectively to represent their interests in the legal process would, as he has, devoted both skill and energy and intelligence to the protection of the public interest in his new assignment.
PRESSURES BY INDUSTRY ON THE MANUFACTURER
Senator Percy. I feel very strongly about it, and I believe I know the kind of pressures put forward by industry groups and manufacturers. I just want to assure you that there are many of us in the Congress who will stand behind you when you make these very tough decisions. There is no wrath greater than the wrath from someone within a community who feels the community is betraying what should be its public conscience, consider, for example, the baby crib manufacturer who, when notified a child's head can be caught in slats spaced too far apart and be seriously injured, said “So what—I don't have to justify anything." That kind of response can only produce outrage. We put a housing bill through that provides for low income housing, homeownership opportunities for the low-income people for the first time in history, only to find a conspiracy between real estate brokers, developers, contractors, maybe some labor unions, and even officials of Dun & Bradstreet. A grand jury had to be convened and indictments were brought against those companies. They had better watch out and clean up their problems, because we are moving on that industry now.
That is the only thing we are trying to say. And I say it to the members of industry who are sitting in this room. The reason we get so much regulation is because there is not enough self-regulation in a free economy. We must have some regulations. The businessman comes down here and says you are just piling paperwork on us with all of this regulation, and the Federal regulators say you are the ones who have caused this by not doing the job in your own industry. I told the Japanese manufacturers in 1945 "don't try to come into this country with the junk made in Japan and put on it 'Made in U.S.A.'." Some of those manufacturers went back and repeated what I had said, and beefed up their self-regulation. I sat in on some of those meetings concerning the regulation of their own industry, and they have done the most marvelous job of upgrading the quality of Japanese products. You cannot say today it is unfair competition from abroad, when a Japanese product works better than an American product and "Made in Japan” now is proudly put on as a symbol. So business itself has to recognize that it is its own worst enemy. We are just trying to get at a very small percentage of major American businesses which undercut legitimate competitors.
I do not want to get into a speech, but I feel very strongly about the matter. I want to assure you that Senator Ribicoff, Senator Javits-and certainly there is no Senator who knows more about business and how it operates in this economy than Senator Javits—and I will stand foursquare on backing up whatever you must do and will take the brunt as much as you do.
I would like very much to get into the structure of organization, and would appreciate your detailing for us the lines of reporting from Commissioner Edwards, for example, Mr. Secretary. Through what channel and route does FDA now report to you and how far down the line is it in the structure and organization?
THREE HEALTH AGENCIES IN HEW
Secretary RICHARDSON. There are three health operating agencies in the Department of Health, Education, and Welfare. One is, of course, the Food and Drug Administration itself. The other two, the National Institutes of Health and the Health Services and Mental Health Administration.
During the period when John Gardner was Secretary, the position that had been formerly known as Special Assistant to the SecretaryHealth and Medical Affairs-was converted into the position of Assistant Secretary for Health and Scientific Affairs. It has never been entirely clear until fairly recently how the role of the Assistant Secretary of Health and Scientific Affairs related to the three health agencies. It seemed to me that it was important from my perspective that the Assistant Secretary for Health should undertake on my behalf those functions that have to do with the coordination of activities among the three agencies. So he has served in essentially a line capacity, in many day-to-day operating relationships with the heads of those three, including the Commissioner of Food and Drugs.
On the other hand, the Commissioner of Food and Drugs can and does come directly to me, with the Assistant Secretary, on issues of policy that are the kind that belong to the long-range development of staff, for example, or legislative authority, or close questions of judgment. We have, in addition, throughout the Department, a direct relationship between the Secretary and the operating agencies including the Food and Drug Administration, under which management objectives are established and monitored through direct periodic meetings of the Secretary with the agency heads.
These operational planning meetings are held roughly every 6 weeks, and here the kinds of things, as a rule administrative, that are reported to me are progress toward the completion of the review of the so-called GRAS list progress toward the instrumentation of the efficacy requirements as applied to drugs, the development of more effective techniques of making visible the inspectional functions of the Food and Drug Administration, and so on.
It is fair to say, out of these operational planning meetings, have come a good many of the judgments that are reflected in the requested budget increases.
Senator Percy. I think you know my concern in keeping the function under a Cabinet official, who is at the top level of policymaking in Government, if it is hard for the Secretary to really get direct access to some of these offices and knowledge of their operations.
We are dealing in the area of product safety. You do have a Bureau of Product Safety and yet I notice that the Director of that Bureau is not at the table with us here.
Could you describe for us the sequence of organization for the Director of the Bureau of Product Safety? The organizational structure he must go through before he does get to the Secretary?
ELEVATED STATUS OF FDA
Secretary RICHARDSON. I should reemphasize as I pointed out in the beginning of my statement, that we have since this administration took office in 1969, elevated the status both of the Food and Drug Administration and the status of product safety within the Food and Drug Administration. The Food and Drug Administration was not one of the coordinate health agencies of the Department when we came in, and product safety was not until recently a bureau of coordinate status with the food and drug bureaus. So the Director of the Bureau of Product Safety reports directly to the Commissioner on the same footing as the heads of these other two units.
Dr. Edwards, would you like to supplement that? Commissioner EDWARDS. No; I think that is correct, Mr. Secretary. We have five operating bureaus, Senator, in our organization. These five operating bureaus all report to the Deputy Commissioner and myself.
Senator PERCY. I understand that new regulations detailing FDA compliance with the Freedom of Information Act are to be issued next week. To what extent do such regulations, and a multitude of other FDA rules, regulations, and summary orders receive review beyond the Commissioner himself?
Commissioner EDWARDS. Would you repeat your question, Senator?
FREEDOM OF INFORMATION ACT
Senator PERCY. I understand that comprehensive new regulations detailing FDA compliance with the Freedom of Information Act
be issued next week. To what extent do such regulations, and the multitude of other FDA rules, regulations, and summary orders receive review bevond the Commissioner himself?
Commissioner EDWARDS. Senator, if I might, I would like to bave Mr. Hutt, the Department's Assistant General Counsel for Food, Drugs, and Product Safety, address himself to that question.
Mr. Hutt. Those regulations have been sent to the Federal Register's Office this morning. They will be on display at the Federal Register Thursday and published Friday. Those particular regulations, because they had implications beyond simply the Food and Drug Administration, were discussed with the Department of Justice, because they are the coordinating committee that deals with the Freedom of Information matters. They were also sent forward to the Secretary's office for his review and they were, at the same time, furnished to other of my colleagues in the Office of General Counsel for comment.
Senator Percy. Would you feel that there is adequate review beyond the Commissioner of such regulations?
Mr. Hutt. Certainly, on this example, there is no question but that there has been widespread discussion and review, both within the Department and outside. Obviously, this varies depending upon the type of regulation. I believe the Secretary mentioned the enormous number of regulations that we have published in the Federal Register just in the past 4 months. The degree of review, both within and outside, would depend upon the nature of the regulation itself.
Senator PERCY. For instance, would such regulations reach the Secretary's Office -
Mr. Hutt. Not every one; no, sir. The authority to issue regulations has been delegated through Federal Register pronouncement to the Commissioner, and he therefore has that authority.
Senator PERCY. Has this authority been delegated by the Secretary or would it be well to have such delegation embodied right in legislation, so it is clearly understood that the Commissioner has that authority and the full responsibility?
Mr. Hutt. Well, it has been delegated by the Secretary under these circumstances, and I believe it has worked very well.
Commissioner EDWARDS. Certainly, from my point of view.
Senator Percy. Let me just say we may not have a Secretary in some other administration that would do that. He might decide it is too politically sensitive to delegate. He has pressure he has to respond to, so he withdraws that authority and takes it back to his office. These decisions then become more political than they are now. This particular Secretary has said there are going to be no politics involved; it is going to be delegated and done at that level.
Would it be well to put this into law, then?
Secretary RICHARDSON. Perhaps, Senator Percy, I ought to respond to that part of the question. I think it would be a good thing to put it into law, subject only to some possible effort in the language to leave open the opportunity for review in the Office of the Secretary for regulations that have administrative or policy implications broader than the Consumer Safety Agency itself, as was the case of the freedom of information regulation.
Senator PERCY. So you feel that general authority to assure independence would be a desirable thing?
Secretary RICHARDSON. Yes. As a matter of fact, one of the very first things I did in coming to the Department, was to meet with Commissioner Edwards and seek to establish a general understanding as to those matters of regulatory authority which should be exercised exclusively by him and not be subject to second guessing from me or
And to identify on the other thing, freedom of information is as good an example as any, which, because we have broader policy implications should be brought to my attention.
Senator Percy. I indicated in my opening statement that it is my feeling that vesting authority directly in the Assistant Secretary or the Administrator for Consumer Safety, whichever is set up, he really