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In the event that we in the Government Operations Committee determine that there is good reason for keeping food, drug, and consumer product safety regulation together under the rubric of the Department of Health, Education, and Welfare, instead of in an independent agency, it may be helpful based upon my study of the issue to date, to set forth certain minimal guidelines for organizing around this vital purpose and assuring virtual regulatory independence.

Most important of all, authority for regulating in the area of consumer safety would have to be elevated within the Department and vested in an Assistant Secretary or Administrator for Consumer Safety reporting directly to the Secretary. I presume that would be through the Under Secretary, of course. I can think of no higher concern, or any function more deserving of immediate attention by the secretary of this or any other department of the Federal Government, than the protection of public health and safety. Notwithstanding how we have treated this subject in the past, if we cannot now afford the highest level attention to this concern, then I can only conclude that our priorities are somehow woefully askew.

By vesting authority directly in the Assistant Secretary or Administrator for Consumer Safety, I mean that he should have final authority to establish standards to promulgate regulations, to decide when and whom to prosecute, and to enforce agency rules and orders. This would promote certainty in decisionmaking and hopefully avoid future cyclamate snafus or vacillation over phosphate detergents, which illserves the consuming public as well as affected industries.

Consideration should also be given to the other important facets of independence which are reflected in S. 3419 in order to fully insulate this peculiar safety function from foreseeable political influences and economic and other tradeoffs. These factors include a fixed term of office for the agency head, and his removal only for cause; permitting him to appoint those who will serve under him, flexibility and an absence of interference in his budget submissions and legislative recommendations.

Finally, to facilitate an ongoing exchange of information and healthrelated research within HEW, I would suggest the formation of a Health and Safety Council consisting of the Secretary, the Assistant Secretary or Administrator-for Consumer Safety, the Assistant Secretary for Health, the Directors of HSMHA and NIH, and the Commissioners of Food, Drugs, and Product Safety.

Subject to qualification and refinement upon hearing from Secretary Richardson today, I offer these points as guidelines only, with the caveat that these hearings will help us determine whether an independent agency wouldn't perhaps be the best idea after all.

There are virtues to literal independence just as there are benefits to virtual independence within HEW. Whatever the arrangement, we must avoid mere box shuffling, title changes, and pay raises which give the illusion of substance but in fact amount to straw piled upon

straw.

Thank you, Mr. Chairman.

Senator RIBICOFF. Thank you, Senator Percy.

Mr. Secretary, you may proceed.

77-615-72—12

TESTIMONY OF HON. ELLIOT L. RICHARDSON, SECRETARY OF HEALTH, EDUCATION, AND WELFARE; ACCOMPANIED BY STEPHEN KURZMAN, ASSISTANT SECRETARY FOR LEGISLATION; RODNEY H. BRADY, ASSISTANT SECRETARY FOR ADMINISTRATION AND MANAGEMENT; MERLIN K. DuVAL, M.D., ASSISTANT SECRETARY FOR HEALTH AND SCIENTIFIC AFFAIRS; CHARLES C. EDWARDS, M.D., COMMISSIONER OF FOOD AND DRUGS, FOOD AND DRUG ADMINISTRATION; ROBERT W. BERLINER, M.D., DEPUTY DIRECTOR FOR SCIENCE, OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH; AND PETER B. HUTT, ASSISTANT GENERAL COUNSEL FOR FOOD, DRUGS, AND PRODUCT SAFETY FOR OFFICE OF THE GENERAL COUNSEL

Secretary RICHARDSON. Thank you, Mr. Chairman and members. of the subcommittee.

May I begin by identifying, for the record-I need not introduce them since I know you are acquainted with them already the colleagues who accompany me here today.

On my immediate right is the Assistant Secretary for Health and Scientific Affairs, Dr. Merlin K. DuVal; on my left are the Assistant Secretary for Legislation, Stephen Kurzman; the Commissioner of Food and Drugs, Dr. Charles C. Edwards; and the Department's Assistant General Counsel for the Food, Drugs, and Product Safety, Peter B. Hutt. On my right are the Assistant Secretary for Administration and Management, Rodney H. Brady; and the Deputy Director for Science, Office of the Director of the National Institutes of Health, Dr. Robert W. Berliner.

I appreciate, Mr. Chairman and members of the subcommittee, the opportunity to appear before you today to present the administration's views on titles I and II, the executive reorganization provisions of S. 3419, the Consumer Safety Act of 1972.

With respect to your determination, Mr. Chairman, and that of Senator Percy, to assure that strong and definitive actions be taken to assure the protection of the consumer, it should, I think, be noted and underscored that the most significant provisions of the legislation before you that would accomplish this are those of title III. It should be, I think, emphasized, that there is no significant difference between the views of the administration and the provisions of title III in S. 3419.

These are the truly significant operative provisions insofar as the increase in the effectiveness of consumer protection is concerned, irrespective of the organizational issues that have to do with the question of where these powers should lie.

Indeed, I think one might well say that all of the other issues are. essentially those of reshuffling boxes on the organizational chart.

The question, really, of how effectively the consumer is protected is a question of what powers are vested in some agency, in some officials, and the degree to which these regulatory provisions are adequately comprehensive to do the job. And it is, as I say, significant

in my view that as to those issues there is no disagreement among the proponents of legislation on this subject.

So we turn to what are essentially organizational issues and where the boxes belong within the executive branch.

S. 3419 would wrench FDA out of HEW, and so, therefore, before turning to the implications of this step, I believe it would be helpful to review briefly some of the actions which we have taken within HEW to improve FDA's performance and role in protecting the public health, a record which is the most dramatic in FDA's 66-year history.

STRENGTHENING OF CONSUMER PROTECTION SINCE 1969

The Food and Drug Administration has since its establishment in 1906 been the principal Federal agency charged with the protection of consumer health and safety. However, in 1969, when this administration took office, FDA was essentially a subagency within what was then known as the Consumer Protection and Environmental Health Service of HEW.

High priority was assigned to reexamining FDA's mission and organization and, as a result of that review, major changes were made during the first 2 years of the administration to upgrade FDA. First, FDA was elevated to full agency status within HEW, along with the National Institutes of Health and the Health Services and Mental Health Administration. Second, within FDA the product safety function was elevated to bureau status, placing it for the first time on a par with foods and drugs. And, third, related enforcement activities of the Bureau of Radiological Health, as well as a number of other departmental product safety functions formerly located elsewhere in the Consumer Protection and Environmental Health Service, were transferred to FDA.

BUDGET EXPANSION

In addition to reorganizing FDA, we have vastly increased its budget. In fiscal year 1970, the budget for FDA was $76.3 million. For fiscal year 1973, the Administration has requested $187.8 million, assuming enactment of the pending expansions of product safety and other authorities, which represents an increase of 148 percent over the past 4 fiscal years. The increase requested by the President between fiscal years 1972 and 1973 is 70 percent, the largest in FDA's history. With its improved organization and enhanced resources, FDA is now making the progress toward effective health and safety protection that the American consumer demands and deserves. As evidence of its greatly accelerated activity, Mr. Chairman, I would like to insert in the record at this point an enumeration of the consumer protection actions which FDA has taken in the first 4 months of this year. Senator RIBICOFF. Without objection, so ordered.

Secretary RICHARDSON. Thank you, Mr. Chairman. It is, I believe, an impressive list.

(The list follows:)

January 4.-Announced a massive, unprecedented program to review the efficacy of more than 100,000 over-the-counter drugs.

January 6.-Proposed a four-point program to ensure consumer safety in the use of drugs and cosmetics containing antibacterial chemicals.

January 31.-In a move to preserve the benefits of antibiotics for man, took new action to restrict their use for food animals.

February 15, March 9, and March 20.-Ordered child-resistant safety closures for use on aspirin products, certain furniture polishes containing petroleum distillates, lye products, and oven and drain cleaners.

March 10.-Ordered a phasing-out of lead from household paints.

March 10.-Acted to eliminate cross-contamination of animal feeds containing DES (diethylstilbestrol), the growth-promoting chemical.

March 17.-Proposed regulations to limit human exposure to PCB, a toxic commercial chemical, through our food supply.

March 24.-Published a proposal to ensure separation in function between the attorneys representing the Government at public hearings and the officials charged with decision-making authority, and to require that communications between these officials and affected parties in the private sector be made matters of public record.

March 30.-Proposed criteria for labeling packaged food with information from which consumers can determine nutritional values.

April 5.-Acted to close a loophole which has permitted diversion of illegal fireworks to consumer channels.

April 6.-Established a unique form of licensing for methadone to prevent misuse of this anti-heroin addiction drug.

April 7.-Announced a recommendation to make bicycles safer and called in manufacturers to seek corrections.

April 10.-Announced regulations for the voluntary registration of cosmetic manufacturers and the filing of product formulations.

April 13.-Proposed child safety packaging standards for charcoal starter and cigarette lighter fluids.

Secretary RICHARDSON. In addition to these actions, during the same brief period FDA issued 83 Federal Register notices implementing the continuing prescription drug efficacy study, 79 food additive notices, 62 new animal drug notices, and 83 other notices related to aspects of consumer safety.

Finally, the administration has also proposed substantial new consumer safety legislation to expand and improve FDA's regulatory authority still further, including S. 1797, the product safety bill which was the basis for title III of the bill now before this subcommittee, and bills expanding regulatory authority in the areas of medical devices (S. 3028), fish inspection (S. 700), drug listing (H.R. 9936), and food ingredient labeling (H.R. 14641).

PROGRESS IN FDA'S 66-YEAR HISTORY

In sum, Mr. Chairman, the regulatory actions taken by FDA touch the lives of virtually every citizen and wide segments of industry, and each of the actions is subject to public controversy between those who argue the FDA has acted prematurely or too aggressively and those who argue that it has not gone far enough or fast enough. Within this difficult frame of reference, FDA has compiled a record in the past 30 months that can be favorably compared with any other regulatory agency in the Federal Government. It is no exaggeration to say, as I have, that this has been the most dramatic period of progress in FDA's 66-year history.

NEED FOR IMPROVED LEGISLATIVE AUTHORITY

But we cannot-and do not intend to-rest on the progress FDA has already made, substantial as it has been. We are proposing still further steps to insure the future safety and health of the Nation's

consumers. As I have stated, we have proposed S. 1797, the Consumer Product Safety Act of 1971, which would replace with a single, comprehensive regulatory system the patchwork of existing laws covering many, but not all, the potentially danerous products used in and

around the home.

The need for such gap-filling and unifying legislation was very effectively demonstrated by the National Commission on Product Safety, an independent Commission established by the Congress. An interim report of the Commission, developed in cooperation with FDA, led to the enactment of the Child Protection and Toy Safety Act of 1969. The Commission's final report, issued in July 1970, noted that the law continued to leave unregulated, in regard to their mechanical, electrical, and thermal hazards, consumer products used by adults. Its report cited departmental statistics indicating that up to 20 million injuries a year may be traceable in whole or in part to such product hazards as untempered glass doors, unshielded rotary mowers, and defective power tools and small appliances. Accordingly, the Commission recommended comprehensive Federal legislation authorizing the setting of safety standards for all household products and the banning of unsafe products from the marketplace, and establishing a permanent independent commission to enforce these product-regulation authorities.

After studying its final report, the administration agreed with the Product Safety Commission that additional household product regulatory authority is very much needed. But we also concluded that this authority should be vested, not in a newly created independent commission regulating only household products, but in the Department of Health, Education, and Welfare, which has the primary responsibility in the executive branch for protecting the public health, and therefore, through FDA, is already administering those consumer health and safety protection laws having the greatest breadth. These include, as you know, the Federal Food, Drug, and Cosmetic Act, the radiation control for health and safety program, and the Federal Hazardous Substances Act. Enactment of the President's reorganization proposals, by transferring these as well as other product safety programs to a new Department of Human Resources, would further consolidate consumer protection responsibility in a single Federal entity. Centralizing these responsibilities in this way would, we concluded, give Federal consumer protection efforts a single direction, a more rational ordering of regulatory priorities than is now possible, as well as coordinated, and therefore enhanced, enforcement.

NEW RESPONSIBILITIES FOR FDA

Along with our product safety bill, S. 1797, the administration also committed itself to strengthening the organizational structure for product safety within our Department so that it could exercise more effectively the new responsibilities that our product safety proposal would give to us. When I testified in favor of S. 1797 before the Senate Commerce Committee, I transmitted a letter to the chairman from President Nixon announcing the intention to improve our consumer protection activities further, once the bill was enacted, by establishing within HEW a Consumer Safety Adminstration with a reorganized

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