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. 77-615-72-22 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 by protecting consumers against injury resulting from the use of foods, drugs, devices, and consumer products-as defined in the bill. Title II would transfer to the new Agency all functions of the Secretary of Health, Education, and Welfare which are presently administered through the Food and Drug Administration or through the Division of Biologics Standards of the National Institutes of Health. It would also repeal several consumer safety laws directed at certain classes of products or hazards, which would be replaced, under title III, with a single, comprehensive, product safety program capable of reaching any consumer product, as defined in the bill, presenting an unreasonable risk of injury. Among other things, title I of the bill places special emphasis on three particular matters: Maximum dissemination of information to and access to information by the public (sections 108 and 113), Comprehensive collection of information on occurrences that produce injury, which will enable the Agency to better identify products and conditions needing regulatory attention (section 109), and Comprehensive reporting to the Congress on the need for, availability of and use of resources, and on the specific activities and accomplishments of the Agency and each of its major components (section 112). MORE ON PESTICIDES Each of these tends to enhance the visibility of the Agency's mission and activities and thus the accountability for their proper conduct. On the basis of our work, we believe this is appropriate and important. For example, in our work in pesticides regulation we found that the Agricultural Research Service, which really didn't have adequate resources to do the job, had not taken action over a period of 13 years to prosecute violations of pesticide laws even where it found repeated major violations. Also, misbranded, adulterated, or unregistered products remained on the market and available to consumers for years after ARS had found them to be in violation. SANITARY CONDITIONS IN FOOD PLANTS In our recent review of sanitary conditions in the food manufacturing industry, we found that the resources available to the Food and Drug Administration in relation to its enforcement responsibilities were clearly inadequate. Also, FDA had no system for effectively accumulating and analyzing consumer complaints to assist in identifying products or facilities needing increased regulatory attention. The importance of visibility, Mr. Chairman, suggests an issue which is of concern to this subcommittee and which has been debated in the prior legislative history of this bill; that is, whether the consumer protection function can best be carried out by an agency which has independent status or by a component of an existing Department. The pros and cons of this issue have been pretty well described by other witnesses and it is largely a matter of judgment, upon which opinion can differ, as to which setting is most appropriate. We believe the important things, in whichever setting is finally settled upon, are a clear commitment by the Federal Government to consumer protection, with adequate resources devoted to the purpose, and competent and aggressive administration of the laws by the responsible officials and agencies. Although these things can undoubtedly be influenced by organizational placement, they probably depend more on public and political concern for the importance of the mission. We do believe it important that the mission be housed in an agency which is not charged with responsibilities which might conflict with or detract from its willingness to aggressively administer its consumer protection responsibilities. We have suggested this type of situation in our work concerning the enforcement of sanitation standards at meat and poultry slaughtering and processing plants by the Consumer and Marketing Service of the Department of Agriculture, which is charged both with the consumer protection function and with a responsibility to promote the marketing of agricultural products. Last month the Secretary of Agriculture renamed the Consumer and Marketing Service as the Agricultural Marketing Service, and placed certain consumer protection functions in a newly created Animal and Plant Health Inspection Service. The functions remain, however, in an executive department having a principal mission of serving the agricultural and related segments of industry. As we understand the provisions of S. 3419, they would leave undisturbed the present consumer protection functions of the Department of Agriculture and their relationship to the activities of the Food and Drug Administration relating to foods, which would be transferred to the new agency. The subcommittee may wish to consider whether these functions should also be included in the new agency, for the purposes of both enhancing independence and consolidating similar functions to permit flexibility in use of resources and elimination of overlapping activities. We note, as mentioned here this morning, that S. 1432, which would implement part of the President's proposal for reorganization of the executive branch, would place the food inspection functions of both the Department of Agriculture and FDA in the proposed Department of Human Resources. "CONSUMER PRODUCT" In a somewhat related vein, we note that products subject to safety regulations under the Federal Insecticide, Fungicide, and Rodenticide Act, now regulated by the Environmental Protection Agency, are specifically excluded from the definition of "consumer product" included in section 101 of the bill. Many of the products coming within the purview of that act are produced and marketed for use in or around households. Also, the bill would repeal the Poison Prevention Packaging Act of 1970, presently administered by the Food and Drug Administration, which was intended to serve to protect against accidental poisoning and other injury from toxic agents such as pesticides. Accordingly, the subcommittee might consider whether pesticides marketed for household use should be included within the definition of "consumer product." |