THE FIRST INTERVENTION

The first intervention into regulation of the food protection laws. came in 1907, just 2 months after the law went into effect, 2 months. At that time, the decision of Food and Drug Administrator Harvey W. Wiley to seize dried fruits treated with sulfur was reversed by his superior, the Secretary of Agriculture. The Secretary argued that the action endangered a "$15 million industry*** in growing and drying fruits." He said to the industry: "We have not learned * * in Washington to guide your business without destroying it. We will learn better by-and-by, but *** just go on as you used to go on and I will not take any action to seize your goods."

A committee of Congress reviewed the case and condemned the action, setting out a guiding principle that is of great use today. "The standard of purity of food," the committee stated, "will never be determined with absolute finality. The standard will represent at any given moment the sum of our national knowledge on this subject * * * but Congress, in enacting this law, did not provide that its provisions. shall remain in abeyance until we shall have completed any given course of scientific research ***. The Secretary stands on safe grounds in asserting that 'We will know better by-and-by,' but the law is in force today."

This is a standard which should be applied today and, unfortunately, often is not.

SAME PROBLEMS STILL FACING FDA

Sixty-three years later, former Commissioner of FDA, Dr. Herbert Ley, found the same problems facing him. He said, "The thing that bugs me is that the people think the FDA is protecting them. It isn't. What the FDA is doing and what the public thinks it is doing are as different as night and day."

He went on to say, "The real solution is to isolate the FDA functions from political pressures; to give the agency the national leadership and support that will allow any Commissioner to act responsibly and solely in the public interest."

The only way to achieve the kind of clear-cut responsibility, the kind of accountability that Harvey Wiley and Herbert Ley, more than half a century apart, deemed essential to the protection of the public interest is to create a Consumer Product Safety Agency, independent of any department of the Federal Government.

Concerning coordination, Secretary Richardson has argued that the fact that HEW has a number of programs related to the product safety would suggest that his Department could in fact coordinate these activities more effectively than an independent agency. However, the situation of the Division of Biologics Standards, a regulatory agency within HEW, makes clear that the presence of such an agency inside such a department does not insure effective coordination of the resources related to its mission.

In fact, DBS's situation suggests the opposite. The presence of DBS within HEW actually appears to have inhibited its ability to make use of the health facilities of the Department.

I think this is a crucial point for independence.

DIVISION OF BIOLOGICS STANDARDS

The Secretary's own comments on the DBS suggests just how submerged and uncoordinated the policies of that agency have become. The Secretary commented:

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.

At the time that statement was made, the DBS was a relatively obscure Federal agency which no one had looked at for more than 15 years. As a result, the Secretary did not say that his office was involved with the Director of DBS in a several-year controversy over that agency's failure to invoke the efficacy provisions of the food and drug law in the vaccine field. He did not point out that another institute at NIH, the National Institute of Allergies and Infectious Diseases, had established a vaccine committee without DBS representation, because of a feeling of isolation from the DBS programs. He did not point out that one scientist, asked to comment officially on DBS cancer programs, suggested that the agency was far out of touch with the work of the other health institutes.

Being in HEW did not help DBS to take advantage of the FDA regulatory experiences. For years, FDA officials, and at least one committee of Congress, tried to get the DBS to cooperate with the FDA in enforcement of the drug laws. The DBS refused. The reason for this refusal is revealing. The Director argued that if he worked too closely with the FDA it might occur to some people to combine the two agencies.

The consolidation and coordination of programs is the reason that Secretary Richardson wishes all the consumer protection activities to remain in HEW. Yet to the DBS leadership, the very threat of consolidation led to strong resistance against coordination.

Also, this led to some serious health problems, in my opinion.

S. 3419 WOULD HELP OVERCOME

I believe that S. 3419, which combines DBS and FDA, would overcome this kind of bureaucratic lethargy and improve protection of the public.

It is also important to point out that the departments have a set of priorities and operate on these priorities-which often are counter to the regulatory priorities of the regulatory agencies within them. Now, Secretary Richardson, because he is head of a health Department, believes that health regulation is of exclusive importance. The Secretary tends not to take regulatory action unless a major health crisis is called to his attention.

I believe this is a structural problem. The Secretary has only 24 hours in a day, and he is presented with with a series of problems emanating not only from Education and Welfare activities but from a wide range of health activities of which the FDA is only one. It is only when a problem is brought to a high priority level through its crises nature that the Secretary begins to look at it and begins to intervene in it.

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

ECONOMIC AND HEALTH RESPONSIBILITY

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. However, 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.

HISTORY OF PRODUCT SAFETY LEGISLATION

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. He 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 freedom 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.

TESTIMONY OF ARNOLD ELKIND, CHAIRMAN, NATIONAL
COMMISSION ON PRODUCT SAFETY

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

Mr. ELKIND. 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 between the public and the agency; and

3. The need for a consumer advocate in the agency.

S. 3419 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 effect 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 STRENGTHENED BY S. 3419

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.

UNSANITARY FOOD PROCESSING

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.

HAZARDOUS FLU VACCINE

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 not 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.