Act, the Federal Hazardous Substances Act including the toy safety legislation and the Poison Prevention Packaging Act.

We have under consideration also the question of whether it should assume at least part of the responsibility for the administration of the Radiation Control for Health and Safety Act.

Senator Moss. Is there a time set when this reorganization will be achieved? Must it await the passage of this legislation, or can it be done immediately?

Secretary RICHARDSON. We have already set up, Mr. Chairman, a Bureau of Product Safety within the FDA, which does comprehend responsibility for administration of all of these things except radiation control, so to that extent we have gone forward already.

The reason, primarily, for taking a further reorganizational step upon enactment of the legislation would be, as I said in my statement, that the enactment of this legislation would represent a substantial enlargement of the present responsibilities of the Department for the regulation of product safety, and so it seems justified at that point to take the further steps outlined in my testimony, including the creation of a new Consumer Safety Administration.

Senator Moss. In your opinion, is the structure of a regulatory agency important to the effect of the functioning of the agency, and in what ways is this structure important?

Secretary RICHARDSON. I think it is important, Mr. Chairman, to the extent that comparable functions and similar responsibilities are located together in such a way that, first, there is clear-cut accountability for their enforcement. And, second, so that there is a mutually complementary and mutually enforcing relationship among the functions to be carried out; such as, for example, field inspection and laboratory testing.

Senator Moss. What about the criticism that having the agency located within the larger department, loses some of the independence and freedom from influence?

Secretary RICHARDSON. I do not believe, Mr. Chairman, that this is a significant factor with respect to the issue of location. The Food and Drug Administration presently exercises, I fully believe, all the independent judgment and authority over its regulatory responsibilities that are exercised by any wholly independent agency.

Meanwhile, however, I think there is a gain inherent in the fact that there can be mutual cooperation and interchange in the case of an agency having responsibility primarily in the field of health with other agencies that have health responsibilities.

The Division of Biologics Standards, for example, within the National Institutes of Health has some functions comparable to the regulatory responsibilities of the FDA over drugs.

In the case of radiation hazards, for example, even though regulatory responsibility may be wholly invested in the new agency, which is an issue not finally resolved, there are nonetheless basic investigational aspects of the problem with respect to the understanding of the health implications of such hazards on which the new agency can usefully draw from the resources of the Public Health Service, and

so on.

We think that the present location of the FDA within HEW strengthens its overall capabilities, and so we believe the same would

essentially be true with respect to the new agency to be based upon the present framework subsequent to the enactment of this legislation.

Senator Moss. You proposed the establishment of three offices, one for food, drugs, and product safety. Would the staffs of these offices be approximately equal in resource commitment and manpower?

Secretary RICHARDSON. They would be fairly closely comparable, although it would take some period of development for the Office of Product Safety Regulation to reach the full size that is now represented in the area of drug regulations, for example.

May I ask Dr. Edwards to respond more fully to that question?
Senator Moss. Dr. Edwards.

Dr. EDWARDS. Yes, thank you.

Mr. Chairman, although, as the Secretary has indicated, at the moment both economic and manpower resources are not equal, we would anticipate that within a period of 3 to 5 years product safety will probably require more in the way of resources, both manpower and economic.

In our 1972 budget we have allocated some 718 positions and close to $19 million for product safety. Now when we talk about product safety, we are referring not only to the Bureau of Product Safety, but we also include the Bureau of Radiological Health. We include our field activities which are related to product safety, and of course we also include our cosmetic activities. These would all be included in the office of product safety regulation under the reorganization the Secretary has outlined.

Secretary RICHARDSON. May I add a few numbers to this, Mr. Chairman? The Commissioner has referred to a total of $19 million as the amount presently allocated in the 1972 budget for product safety.

It would be our intention upon enactment of this legislation to seek $14 million in additional funds in the first full year of its administration. The comparable totals for 1972 are $42 million for the administration of the FDA's responsibilities in the field of drugs and $45 million in the field of foods.

Senator Moss. Looking at the figures from the appropriations hearing, you have taken some funding out of food and drug and transferred it into product safety, is that correct?

Secretary RICHARDSON. I think that is true, in allocations under existing authority. The establishment of the new bureau in effect justified the relocation of some functions that had previously been classified as belonging in the field of food or drugs, as essentially product safety functions. But there was in addition an appropriations increase for the activity as a whole, and there would be, as I said a moment ago, a further $14 million increase in the first full year upon the enactment of the proposed legislation.

Is that essentially right, Mr. Commissioner?

Dr. EDWARDS. That is correct, Mr. Secretary.

In addition to that, we have reprogramed some money in our 1972 budget in the food field for our grants program. We have reallocated that to our product safety operation.

Senator Moss. Well, would you supply the figures showing for the record the extent to which the reprograming varies from the budget request that was submitted to the Appropriations Committee for HEW?

Secretary RICHARDSON. We will be glad to do that, Mr. Chairman.2 Senator Moss. Thank you.

I was concerned about this question of independence and I think we can look to the Auto Safety Act for guidance. The National Highway Safety Bureau which was authorized to set auto standards, was placed in the Highway Administration. The Safety Bureau was supposed to be coequal to the Bureau of Public Roads, but because the Bureau of Public Roads was more firmly established, the Safety Bureau suffered. As you know, it was finally removed from the Highway Administration and upgraded to the National Highway Traffic Safety Administration. Would this "infancy" problem plague the product safety bureau that you proposed?

Secretary RICHARDSON. I don't think so, Mr. Chairman. It seems to me on the face of it that there is a clear distinction in the two situations. Whatever the merits of what may have been done with respect to highway safety, it is clear that the Bureau of Public Roads is not primarly charged with auto safety as such. Whereas each of the other proposed offices in the new Consumer Safety Administration is already concerned with consumer protection, these responsibilities apply to foods and drugs as opposed to other consumer products generally. So we think that there would be mutual reenforcement, a synergistic impact, in effect, a total greater than the sum of the parts, through combining these responsibilities as distinguished from separating them. Senator Moss. In this proposed Consumer Safety Administration, will the administrator set the product safety standards or will the Secretary?

Secretary RICHARDSON. As a practical matter, the Secretary would delegate this responsibility to the head of the Consumer Safety Administration.

Senator Moss. But would the standards have to be sent up to the Secretary in order to be approved, or would the administrator have final authority?

Secretary RICHARDSON. I think that in this case, the final authority should be delegated to the administrator of the proposed agency. Senator Moss. Will he have a fixed term of appointment, or will he serve at the pleasure of the Secretary?

Secretary RICHARDSON. He will be appointed by the President and serve at the pleasure of the President.

Senator Moss. Not with a definite fixed term of years?
Secretary RICHARDSON. That is correct.

Senator Moss. And will the administrator be able to deal directly with the OMB or must he go through the Secretary's office?

Secretary RICHARDSON. He will go through the Secretary like other constituent agencies of HEW.

Senator Moss. Would the Consumer Safety Administration be located in the Department of Human Resources under the President's reorganization plan?

Secretary RICHARDSON. My earlier testimony was that the Consumer Safety Administration will be established as soon as product safety legislation, along the lines now that are the subject of this hearing, is enacted. It would not await the creation of the Department of Human Resources, although it is fair to say that the creation of the proposed new Department is a step in the same general direction. As you know,

* See p. 900.

66-631 0-71-pt. 1- -8

Mr. Chairman, the proposed new Department would embrace some of the regulatory authority over foods, for example, which is now vested in the Department of Agriculture, thus strengthening in effect the range of responsibility of the Consumer Safety Administration.

The Department of Human Resources would also absorb that part of the responsibility for the Flammable Fabrics Act now administered by the Department of Commerce, so that that would also enlarge the role and make more comprehensive and complete the consumer protection function of the CSA.

Senator Moss. This Consumer Safety Administration would parallel quite readily the EPA in terms of function of operation. Is that true? Secretary RICHARDSON. It would do so, Mr. Chairman, with, of course, the distinction that the EPA is concerned with consumer products only insofar as their composition or use affects the external environment as distinguished from safety of individual consumers under conditions of ordinary use of products at home.

There is, as my statement pointed out earlier, in connection with some products like detergents, for example, an area of potential overlap, and this is the kind of thing that has to be worked out between the agencies in order to prevent waste, and in order to reduce confusion on the part of the public and the regulated industry.

I see no way, however, given the public interest in the existence and operation of an EPA and an agency charged with consumer safety, of avoiding entirely some such areas of potential duplication. And the only way of resolving them, it seems to me, are, as often in Government, dependent upon good communication and cooperation.

Senator Moss. One reason I asked the question is that the President has not chosen to consolidate the EPA into any one of the four departments, and since there is a similarity between the two, I wondered why the Consumer Safety Administration should be consolidated? Secretary RICHARDSON. Well, I am not sure that I am really a competent witness on this question, Mr. Chairman, but I think that the answer on its face is that the EPA is in a sense poised between a number of other departments. It has responsibilities that would be of direct concern in relationship to the Department of Natural Resources, to the proposed Department of Urban Affairs and Economic Affairs, as well as to Human Resources, and so it would be hard to know which of the departments you assigned it to.

I take it it was essentially this kind of reasoning that led to its being created as a separate agency in the first place.

Senator Moss. I have some more questions, but Senator Prouty has to leave, and I want to give him an opportunity to ask any questions he may have at this point before he has to depart.

Senator Prouty.

Senator PROUTY. Thank you, Mr. Chairman.

First, I ask unanimous consent to have a brief statement inserted in the hearing record.

Senator Moss. That will be done.

(The statement follows:)

STATEMENT OF HON. WINSTON PROUTY, U.S. SENATOR FROM VERMONT

Mr. Chairman, today we are beginning hearings on proposed legislation which is as important to the health and well-being of the American people as any legislation before Congress. I am confident that before the end of the year the President will be able to sign into law a comprehensive Product Safety Act.

This Committee, with the leadership of Senator Magnuson and Senator Cotton, has already laid the complex and careful groundwork for developing a workable law. Four years ago I was pleased to support a bill cosponsored by the Chairman and Senator Cotton which set up the National Commission on Product Safety.

Senator Cotton will not be back from New Hampshire until lated today so he is not able to be here this morning. All of us know of his interest in product safety. A year ago June when the Commission presented its final report to this Committee, Chairman Magnuson perhaps best described Senator Cotton's contribution in this area when he stated:

"As the life of the Commission draws to a close. I think it appropriate to point out its work would not have been possible without the uncommon, unwaivering support given by the senior Republican member of this Committee, Senator Cotton."

I believe I can speak for Senator Cotton and all other Republicans on the Committee when I say that all of us will do all that we can to assure prompt enactment of an omnibus product safety bill. In our modern affluent society we have literally millions of household products. Those products make life easier and are the marvel of the world. Unfortunately, each year they also result in 20 million injuries and 30,000 deaths. The same modern technology which permits the development and design of the thousands of useful household products must be focused on the goal of making those products the safest in the world. During the life of the National Commission on Product Safety we on this Committee responded with urgency in passing the Child Protection and Toy Safety Act of 1969. Based on preliminary findings of the Commission we moved with haste to insure standards for toys which too often became products of sadness rather than joy. Today the same urgency and priority should be given to the omnibus legislation before us.

S. 983, which embodies the recommendations of the National Commission on Product Safety, and S. 1797, which embodies the Administration's recommendations for product safety legislation, are both strong omnibus product safety bills. Their differences are more in form than in substance and I am confident that these hearings will serve to narrow those differences so that our Committee can report a bill to the Senate for consideration early this Fall.

Senator PROUTY. I would like to ask a few questions at this point. Senator Moss. You may.

Senator PROUTY. I believe I can speak for Senator Cotton and all other Republicans on the committee when I say that all of us will do all we can to assure prompt enactment of an omnibus product safety bill.

I regret that I was unable to be here for your statement, and if any of the questions which I pose have been answered in your statement, please so indicate.

Mr. Secretary, your expertise extends beyond HEW to many other areas. Relying for a minute on your State Department experience, I would like to hear your reasons for the proposed treatment of imported products. Why should we place the responsibility on the importers rather than directly on the foreign manufacturer?

Secretary RICHARDSON. The reason, Senator Prouty, essentially is that the importer by definition is responsible for bringing the product into the country, where we can easily get our hands on it. Whereas, the attempt to apply in an extra-territorial manner the force of our own regulations as to things that may or may not be brought into the United States would be exceedingly difficult to administer.

Senator PROUTY. In other words, you don't think it is good diplomacy for us to undergo this procedure with a foreign country? With respect to exports, should exports meet the same safety standards as products manufactured for domestic consumption?