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Those that I outlined earlier all occurred in that way, as did the recent effort of the DBS to enforce efficacy standards for vaccines.


It is important to point out that FDA has economic as well as health responsibilities. Of course, the interactions between economic and health questions cannot be overlooked.

When the Department of Agriculture conducted its nutrition survey, it found large areas of poor diets. It gave three reasons for these poor diets: (1) the people did not know what they should purchase; (2) even if they knew, it was almost impossible for them to make proper choices in the marketplace because of packagaing, and (3) even if they knew what to buy and were able to get it, many of them did not have enough money to make these purchases. The FDA has extensive responsibilities in the areas of these economic problems, all of which are central to the question of whether or not the American food supply is one that is healthy.

The FDA then is involved in weighing economic and health considerations; however, there is a tendency, when a problem reaches priority level and it is drawn to the attention of the Secretary of Health, Education, and Welfare, to look only for a conclusive health answer to a problem.

S. 3419 expands consumer safety protection by including new product safety provisions. Ilowever, these are not under consideration today, but it does make available the opportunity to further expand necessary activities by drawing into the agency certain other activities of the Federal Government, mainly those involved with food regulation in the Department of Agriculture, many of which are very similiar to those carried out by the Food and Drug Administration.

It is my suggestion that the creation of this independent agency will force a review of the organization of these agencies and an evaluation of which of them should be brought into the new independent agency.


The food and drug law is the farthest reaching and oldest consumer product safety legislation in this country. Its provisions and the development of techniques to enforce them dates back to the passage of the first Pure Food Act in 1906. Its legislative history includes the 20 years of congressional debate preceding the passage of that act. Its administration already includes the Nation's embryonic efforts to develop a coordinated product safety program to go along with this food and drug regulation program. There is a built-up expertise of regulatory ability within the Food and Drug area.

The Consumer Safety Agency, independent and consolidated, will by no means be a penacea, but drawing on this expertise it can provide a focal point for consumer support.

When the food and drug law first passed in 1906, Harvey Wiley commented on the balancing of health and economic factors in the act. Ile said:

The principle that the right of the consumer is the first thing to be considered would be worth more to this country than the actual protection to health or the free lom from fraud.

Establishing an independent consumer agency would establish the principle that the right of the consumer is the first to be considered. Failure to establish such an agency would tell the American people that as consumers they are still not first in the marketplace.

Thank you very much.

Senator HARRIS. Mr. Turner, thank you very much for an excellent statement.

With your indulgence, I would like to call Mr. Elkind who is here now and has a plane to catch. You may just remain at the table.

Arnold Elkind is former Chairman of the National Commission on Product Safety.



Senator Harris. I am glad you are here. We will be glad to hear from you.

Mr. ELEIND. Thank you, Senator.

With your permission, I would like to file my statement and briefly summarize my position.

Senator HARRIS. All right. Without objection, the entire statement will be printed in the record.

(See exhibit 3, p. 116.) Mr. ELKIND. In previous testimony on consumer product safety, I have, in line with the general report of the National Commission on Product Safety, emphasized three essential desirable qualities for effective product safety legislation. These were

1. The visibility and independence of the governmental mechanism;

2. The elimination of the restraints on informational exchange bet ween the public and the agency; and

3. The need for a consumer advocate in the agency: S. 3119 meets the first of these two criteria and recognizes and makes provision for the need for consumer advocacy function, although not in-house.

The National Commission on Product Safety was well served by a special report on Federal consumer safety legislation which was in effert a study of the scope and adequacy of automobile safety, flammable fabrics, and the hazardous substance programs.

This report, under the direction of Howard Heffron, was of great assistance to the Commission in drafting our legislation.

The Senate Commerce Committee deserves credit, not abuse, for its intelligent response to the report of the National Commission on Product Safety, the administration proposal as exemplified by S. 1797, and the critique of existing consumer safety legislation found in the Heffron study.

Building on this information, S. 3419 identifies the search for safety as a unique specialized governmental function and proposes a consolidation of these safety functions in an independent agency with a broad arsenal with the kind of diverse powers shown to be necessary for effective consumer safety programs.

Going beyond the recommendations of the Commission, the proposal will enable the Government to overcome weaknesses which have affected much of the existing Federal consumer safety legislation.


Programs which would unquestionably be strengthened by S. 3419 would be those covered by the Hazardous Substances Labeling Act, the Flammable Fabric Act, Toy Safety and Child Protection Act, food inspection, and a number of other programs that have been marked with incomplete and inadequate statutory authority.

I have suggested in my prepared remarks that a number of other consumer safety programs could with reason and justification be placed under the aegis of the Consumer Safety Act, and I have referred to gas pipelines, boats, atomic energy, and all of the consumer safety activities now carried out by the Department of Agriculture, such as meat, poultry and fish inspection, control of pesticides, fungicides and rodenticides and fruits and vegetables.

Consumer safety programs involve the utilization of disciplines and capabilities which are quite distinct from public health programs generally, although there is a limited area of overlay.

The Department of Health, Education, and Welfare appears to have performed acceptably from the consumer's standpoint in its program of requiring premarket clearance of drugs so as to screen out drugs with undisclosed adverse reactions, somewhat less effectively with regard to efficacy of drugs, and in other areas of consumer protection HEW has, what appears to me to be, a totally unsatisfactorily track record in its regard for consumer interests.


It is shocking to learn from GAO that 40 percent of the food processing is carried out in an unsanitary manner and that 24 percent is seriously unsanitary, and even worse is the thuoght that food processing can be carried out by plants without any registration or notification to the FDA, so that even the inventory of manufacturers may or may not be complete.


Another example of a recent episode where it is obvious that this agency suffocated itself, came to light last month with the disclosure of an internal conflict between lawyers in HEW that resulted in the distribution of 60 million doses of ineffective and potentially hazardous flu vaccine.

In 1964, a conflict arose as to whether or not power existed to control the menace of a substandard vaccine. It was no until 1971 that the general counsel for HEW finally made the determination that HEW did, indeed, have the necessary power.

Meanwhile, many of us suffered needless side effects of the innoculation—fever, rash, cramps, diarrhea, without receiving any benefit of insulation from influenza. The benefits went to the pharmaceutical manufacturers.


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Now, I have related other instances of bureaucratic inefficiency which would paralyze a consumer safety agency and which seems to be standard operating procedure in HEW, such as: the 11 weeks which passed between the formulation of the regulations for safety closures and their clearance to the Federal Register by HEW officialdom; the j-month delay between finding a competent specialist and engineer for the Bureau of Product Safety and his clearance for employment; and such as the inordinate delays in the simple procurement problems concerning essential devices for the technical people in the Bureau of Product Safety.

Now, considering that the bureaucratic malfunctions are occurring at a time when HEW is fighting for this program and when the Bureau of Product Safety is under the scrutiny of the Congress and the public, it seems to me futile to anticipate a satisfactory consumer safety program in this governmental conglomerate, after the heat is off.

Safety issues, Senator, are quite impersonal until after one is involved in an accident. The classical unrepresented man in our society is, indeed, the potential accident victim. For this reason, in the quest for funding in a governmental conglomerate, safety people are probably going to come off with the short end of the stick which would lead to inadequate personnel, inadequate equipment, and a feeble regulatory effort.

Within a superagency are the mechanisms for restraint in efficiency, negativism and worse. With the participatory features of S. 3419 in an independent agency, the Consumer Safety Agency could, unlike any existing Government effort, become quite populist and open in its procedures and decisions.

Of course, any agency could be ruined by the appointment of the wrong people, but the environment in Washington has been radically changed from the environment which permitted the decay of consumer services and consumer orientation in previous independent agencies.

In other words, I do not think that the history of other independent agencies is a valid measuring method for determining what the future might be of this independent agency, because the environment has changed. I do not think it could happen now.


The National Commission on Product Safety was able to operate quite effectively within days after it was funded. In fact, we had our first hearings 10 days after we were funded and made an important mark for household product safety despite its short term of life, which was 21,2 years, and its limited powers which were really only the power to study and have hearings.

Many of the good reactions of industry were engendered only by concern regarding the kind of legislation that the Commission could recommend and the openness—the openness of our work. I find it unbelievable that Secretary Richardson would predict that the passage of this legislation would create a vacuum or a diminution in industry effort to reduce hazards.


All existing orders and regulations promulgated under repealed statutes would be retained and administered by the Commissioner of Product Safety in accordance with the language of the legislation.

While a function of HEW would be dismantled by this legislation, I would urge that the net result is not a fragmentation of Federal activities; instead, it is really a consolidation of significant governmental functions that simply cannot thrive in the competitive atmosphere of diversified departments.

Now, in the President's message on reorganization, March 25, 1971, he said—and I think it is quite appropriate to the problem that we have here, and I agree with what he said here:


We sometimes seem to have forgotten that Government is not in business to deal with subjects on a chart but to achieve real objectives for real human beings. These objectives will never be fully achieved unless we change our old ways of thinking. It is not enough merely to reshuffle departments for the sake of reshuffling them; we must rebuild the executive branch according to a new understanding of how Government can best be organized to perform effectively. The key to that new understanding is the concept that the Executive Branch of the Government should be organized around basic goals. Instead of grouping activities by narrow subjects or by limited constituencies, we should organize them around the great purposes of Government in modern society.

For only when a department is set up to achieve a given set of purposesand here we are not talking about a department, we are talking about an independent agency—a given set of purposes, can we effectively hold that department accountable for achieving them. Only when the responsibility for realizing basic objectives is clearly focused in a specific governmental unit can we reasonably hold that those objectives will be realized. When Government is organized by goals, then we can fairly expect that it will pay more attention to results and less attention to procedures. Then, the success of Government will at least be clearly linked to the things that happen in society, rather than the things that happen in Government.

Of course, that message proposes the organization into four departments that this committee is familiar with. But, as you look through those departments, Senator, you will find that safety can fit in with each one of those, not only with Human Resources but can fit in withi each one of them. Therefore, since this is a particular goal--and I believe the mechanisms are unique-it serves and should function and will function best in an independent environment.


I would like to add that from the emphasis that I have put on the need for obtaining adequate budgetary requirements, I do not wish to imply that the Government would be spending more money for its safety function in an independent agency than it would be spending on sa fety in the aggregate if it is divided up as at present. On the contrary, I would expect an independent Consumer Safety Agency to operate more economically. The difference is that the giant agency approach would attempt to cover every aspect and every product with surveys and analyses and ultimately with standards, and this could cost the taxpayers billions of dollars with slight reward, whereas a visible Consumer Safety Agency on the other hand would find it necessary to focus attention to those categories of products which conceptually and/or statistically require attention. With a lower

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