You have discussed at some considerable length what is wrong with S. 3419, but I was hoping we could have some positive suggestions for dealing with the problem of actually organizing to achieve an effective consumer product safety program. COMMERCE COMMITTEE ACTION The Commerce Committee has been very clear in its 17-to-1 vote turning down the administration's proposal. They considered simply a shuffling of boxes not actually solving the problem of realigning the forces of government to take into account the really new demand of the American people that we accord this function a higher priority level inside government than we have heretofore. Has the administration given any sort of consideration to a means of organizing within HEW to provide the Consumer Safety Agency with the visibility, independence and direct access to the Secretary that the function seems to demand? ORGANIZATIONAL CHANGES Mr. CARLUCCI. We have discussed, Mr. Chairman, with Secretary Richardson some organizational changes that he might make. I feel, quite frankly, it would be more appropriate for Secretary Richardson to speak to the committee rather than to have it come from the Office of Management and Budget at this point. Senator PERCY. You were present yesterday in the room, and I think that is quite good. I recognize there are certain prerogatives of the Secretary-and I participated in the reorganization of the Office of Management and Budget. We were looking to OMB also, independently, just as you quite independently arrived at decisions on appropriate budget levels and balancing of priorities, to give your expertise to this activity. We are now soliciting and seeking counsel and advice. I think I made it very clear in my opening statements, my bias. I am trying to keep my mind open, but I just do not think this committee is going to sit here and do nothing about this problem when faced on one side with an overwhelming mandate of the Commerce Committee that it just be taken out lock, stock, and barrel and independently set up. I can simply say that I could not countenance just box shuffling and then presume we are going to pretend to the American people that we have really changed something by doing that. There has got to be substance, there has to be power put in, and we have to decentralize certain of the functions and specifically say who is responsible and not have the kind of problems we have been facing now. We had a decision made by the Secretary yesterday which I think is very important, but still I would like to get the benefit of the judgment of yourself and Mr. Shultz who carry a tremendous responsibility, for how the executive branch of our Government is actually organized to better its affairs. ent there is a conflict between environmental protection and the basic mission of the Department of the Interior to engage in water resources development and in the development of the Nation's energy potential. These conflicts do not exist within HEW with regards to FDA. To the contrary, as Secretary Richardson and I both testified, we think the programs are mutually supportive. Finally, the authority of FDA is well established over a 66-year history, and it has a strong operating base and strong working relationship in HEW. The elements that went into EPA which were not well-established had only a rudimentary operating authority and were more easily separable with minimum disruption, and FDA, as I mentioned, has strong alliances and strong ties with other functions in HEW, which would make their separation more of a critical problem. POLITICAL DETERMINATIONS Senator PERCY. Yesterday, Secretary Richardson said that FDA attorneys should be able to enforce their own determinations concerning health and safety violations in the courts, that they should be able to decide whom to prosecute and when to prosecute and what evidence to adduce, free from any political consideration that might be involved in those determinations, as you know, by the Justice Department. Do you concur with the Secretary? Mr. CARLUCCI. Would you repeat that statement, please? Senator PERCY. Yes. I wanted to read so I could get exactly what I considered to be the essence of his testimony. Secretary Richardson said yesterday that FDA attorneys should be able to enforce their own determinations concerning health and safety violations in the courts; yet, they should be able to decide whom to prosecute and where to prosecute and what evidence to produce, free from any political considerations. These political considerations conceivably could be involved, for instance, if their decision in this regard could be reversed by another agency such as the Justice Department, as it now stands. Mr. CARLUCCI. I would agree attorneys should certainly be free to pursue the interests of their clients without any interference at all in the lawyer-client relationship. I think that is very important. RELATIONSHIP BETWEEN JUSTICE AND HEW The paragraph you read does raise questions as to the relationship between the Department of Justice and HEW. As you are aware, traditionally, the Department of Justice has served as the Government's lawyer and has an established relationship with the courts. So, I would like an opportunity to review that particular paragraph before commenting on it in the form of an OMB prospective. (See exhibit 20, p. 353.) Senator PERCY. Right now, Justice Department attorneys actually prosecute FDA cases and prior approval of the Justice Department is therefore needed. It would seem logical, if we really provide authority for this agency, that they should have within HEW the power to move ahead. on their own, as they might well have if they were in an independent regulatory agency. In other words, if we are going to find a way to embrace this function under the umbrella of HEW, we certainly must then take into account the very clear mandate that the agency should prosecute its own cases. Mr. CARLUCCI. Well, a case can be made along those lines. A similar case could be made, for example, in the occupational safety and health area and in a number of other areas, perhaps in the highway safety area, that one can cite. The concern we have would be that we not so fragment the handling of litigation that we cause problems in the courts or that we disrupt the kinds of relationships that already exist. I would like an opportunity to take that particular paragraph under advisement and comment on it at a later date. Senator PERCY. You certainly can. It just seems logical, considering the degree of expertise, background, and knowledge which has been built up in HEW, that they are best able to actually prosecute their own cases. For the record, in what percentage of cases recommended for prosecution by EPA has Justice refused to prosecute; and could that be furnished for the record? Mr. CARLUCCI. Yes, we will furnish that for the record. (See exhibit 21, p. 353.) Senator PERCY. In your communication with Senator Norris Cotton's Commerce Committee on March 8, you objected to provisions authorizing citizen suits against the Safety Agency and its employees, holding them personally liable for improper actions or for failures to act. MANDAMUS ACTION Recognizing that the bill now before us no longer would allow suits holding employees personally liable, do you still object to the mandamus action as set forth in section 111 of S. 3419? Mr. CARLUCCI. Yes, we still have problems with section 111, because, basically, the whole intent of this section seems to us to be wrong. It encourages the consumer to think, when he has a problem with a product, that his recourse is to sue the Government. It has obvious implications for our overworked courts. There are over 200 million consumers in this country. There are hundreds of thousands of consumer products. If every redress is to go to the courts, our courts would very quickly become clogged with consumer suits. In addition, the courts really have no further power to act administratively. All they can do is encourage the Consumer Safety Administration to do what it is legislatively mandated to do in the first place, and that is to protect the consumers. So, we hink this would result in very time-consuming and expensive litigation processes with very little productive results. I think that the clear oversight responsibility exists in Congress to see that the agency functions effectively. 77-613-72- 22 The President is accountable to the public for the functioning, effective functioning, of the agency, and we think it would be wrong to try and introduce an administrative role, in effect, for the country's courts. Senator PERCY. In that report dated June 30, 1970, the General Accounting Office called for the reassessment of the Federal role in food inspection programs to be conducted by OMB. Was there any action on this recommendation? Mr. CARLUCCI. Let me ask Mr. Bingman, who accompanied me, to comment on it. I am not familiar. Mr. BINGMAN. I think we indicated that OMB would like to consider the circumstances of that report. It seemed to indicate that there should be a major reassessment of the food inspection activities throughout the Federal Government and that would represent very substantial commitment of resources to study that kind of a program. We have not undertaken that kind of study largely, I gather, because those resources were not available to us. I do not think that issue was posed. Senator PERCY. Is there any further action planned on that? I think individual efforts but not of the depth that GAO demands. Senator PERCY. Lastly, apart from your discussion of section 112 dealing with annual reports and the basic question of where the Consumer Safety function should be located, does OMB have any further comments to add on specific sections of the bill, and would you care to make any answers in writing to us? Mr. CARLUCCI. Yes, we have comments with respect to a number of other sections in the bill. I think it would be appropriate for us to submit it for the record or in writing. There are a number of administrative provisions that give us some trouble. (See exhibit 22, p. 354.) Senator PERCY. We thank you very much indeed for being with us. Again, we are sorry the delay yesterday caused you to lose a half day some place along the line. Mr. CARLUCCI. Thank you. Senator PERCY. We know you are very busy, indeed, but we appreciate the fine contribution made this morning. Mr. CARLUCCI. Thank you very much. Senator PERCY. Our next witness is Gregory J. Ahart, Director, Manpower and Welfare Division, General Accounting Office. We are happy to have you, Mr. Ahart. If you care to, introduce your colleagues. Go ahead with your testimony. TESTIMONY OF GREGORY J. AHART, DIRECTOR, MANPOWER AND WELFARE DIVISION, GENERAL ACCOUNTING OFFICE; ACCOMPANIED BY MORTON A. MYERS, DEAN K. CROWTHER, ARLAND N. BERRY, AND JOHN R. TIPTON Mr. AHART. Thank you very much, Mr. Chairman. On my immediate left is Mr. Morton Myers, Assistant Director in charge of our work at the National Institutes of Health and the Food and Drug Administration. On my right is Mr. Dean Crowther, Deputy Director of the Manpower and Welfare Division. On his right, Mr. Arland Berry, Assistant Director of the Resources in the Economic Development Division, responsible for work at the Department of Agriculture, and Mr. John Tipton, who is a supervisory auditor under Mr. Berry's direction. We are pleased to have this opportunity to comment on the proposed Consumer Safety Act of 1972 in the light of the work we have done in the area of consumer protection. Interest in consumer product safety has increased considerably in recent years, with the expansion in the number and volume of consumer products being marketed and a growing awareness and demand on the part of consumers for the right to enjoy products that are reasonably safe and of acceptable quality. There has been some expansion also in the role of the Federal Government in consumer protection, with the passage of laws and implementation of programs directed at particular classes of products or specific hazards. In light of the increased interest in the Congress and by the general public, the General Accounting Office has in recent years placed increased emphasis on evaluating the effectiveness of existing programs in protecting the consumer as intended by the authorizing legislation. Since March 1968, we have sent to the Congress or its committees and subcommittees 13 reports relating to consumer protection programs. Our work has shown the need for much improvement in the administration and management and in the use of enforcement authorities, to better assure consumers the protection intended by programs for: Regulating pesticides products, Enforcing sanitation standards at meat and poultry slaughtering and processing plants, and Enforcing sanitation standards in the food manufacturing industry. OVERLAPPING ROLES We have also reported on the somewhat overlapping roles of several Federal departments in the area of food inspection and the need to reassess these roles and their interrelationships. Work we have done at the request of this subcommittee has shown the need for improvements with respect to assuring the quality, safety, and usefulness of certain drugs and vaccines. Attached to my statement you will find-appendix A-a listing of the reports we have issued and certain digests-appendixes B-K-of the reports. Also attached for your information is a list of 18 studies relating to consumer protection programs that we currently have underway-appendix L. (See exhibit 23, p. 356.) Our on-going work includes two studies requested by this subcommittee relating to the adequacy of control over the use of investigational drugs and regulation of vaccines. In all of our work in the consumer protection area, we have been impressed by the need for the Federal Government to do a better job. This is the objective of S. 3419, the bill under consideration. Title I of the bill would create an independent Consumer Safety Agency with the responsibility to promote the public health and safety |