TITLE II SECTION 201 Section 201 (c) according to the Committee Report at page 24 provides for transfer of all FDA and Division of Biological Standards personnel to the new Agency. Such transfers are to be without reduction in classification or compensation for one year, and the Administrator is given express authority to assign personnel during that period to carry out the functions of the Agency most effectively. Subsection (d) requires the Civil Service Commission to establish criteria, in consultation with the Administrator, when preparing competitive examinations for positions in the Agency. The above provisions appear to strike a workable compromise between protecting employee job rights, and ensuring that the Administrator retains the power to staff the new agency in such a way as to enhance consumer protection. The Committee, however, should carefully consider whether additional provisions may be necessary in order to ensure that the FDA and DBS officials who have failed to protect the public health and safety in the past are not put into positions where they can strangle the new agency in its infancy. CONSUMER SAFETY ACT OF 1972 TUESDAY, MAY 2, 1972 U.S. SENATE, SUBCOMMITTEE ON EXECUTIVE REORGANIZATION AND GOVERNMENT RESEARCH, Washington, D.C. The subcommittee met, pursuant to recess, at 10:05 a.m., in room 3302, New Senate Office Building, Senator Abraham Ribicoff (chairman of the subcommittee) presiding. Present: Senators Ribicoff, Javits, and Percy. Also present: Robert Wager, staff director and general counsel; Mark E. Greenwold, assistant general counsel; Gerry Simons, special counsel; Stuart M. Statler, minority counsel; Pamela J. Gell, chief clerk. Dennison Young, Jr., legislative counsel to Senator Javits, was also present. Senator RIBICOFF. The committee will be in order. Our first witness today will be Secretary Richardson. Before the Secretary testifies, I have a short statement. OPENING REMARKS OF SENATOR RIBICOFF This morning, we continue our hearings on titles I and II of S. 3419, which would establish an independent Consumer Safety Agency, composed of the Food and Drug Administration and the Division of Biologics Standards in the Department of Health, Education, and Welfare. The new agency would also absorb the regulatory authority under 10 separate safety and efficacy laws. Our hearings on April 20 and 21 focused on two basic issues: (1) Whether all product safety regulation should be combined in an independent agency; and (2) whether the internal structure of the proposed Consumer Safety Agency is efficient. There is much debate about these issues. But there is no debate about the need for major reforms in the Federal role in product safety regulation. The report of the National Commission on Product Safety 2 years ago made a convincing case for broad Federal safety regulation of consumer products. Since that time, the work of this subcommittee has documented other deficiencies in many fields of Federal product safety regulation: (1) In June 1970 and November 1971, I released GAO reports showing weak enforcement of the meat and poultry inspection laws. (2) In October 1971, I released a GAO report on the failure of FDA regulation tuberculosis control drug Isoniazid. (3) In March 1972, I released a GAO study of vaccine regulation revealing that over a period of 3 years, the DBS approved the release of millions of doses of subpotent influenza vaccine. These reports and others show that the time for talk is past. Now Congress must act. And the action we take must be strong and effective. Reshuffling the boxes on the organization chart is not enough. This morning, we want to hear what constructive action the Nixon administration will take to prevent the 110,000 disabling injuries and 30,000 deaths which occur each year from products. Senator Percy? OPENING REMARKS OF SENATOR PERCY Senator PERCY, Mr. Chairman, thank you very much indeed. I join with you in welcoming the Secretary and his very able colleagues. One of the disadvantages of being the opening witness is that you have to hear our statements. I think the advantage is, that by our making statements, we indicate perhaps our prejudices, our questions, and give you, then, a chance to respond. Our purpose in examining S. 3419 is to move away from what I would consider to be the folly of Federal regulation in the area of consumer products. To date, and largely the fault of Congress itself, such regulation consists of piecemeal pablum which provides little more than a morsel of protection for the American consumer. My own fooling, as an industrialist for 25 years and a public official for 6, is that the public presumes a great deal more regulation is accorded to products than actually is the case. The Senate Commerce Committee has identified the problem. It has certified that Federal safety regulation is hampered by indecent statutory authority, miniscule budgets, timid investigative power, mado uste and a fitting sanctions, and misdirected priorities. Title 168 $419.contains that committee's substantive response, which I hoeve so be both wise and well-conceived. The as son before us today is how best to house the related funcveg, and consumer product safety regulation. One as con Cwe accept a straw house for protection, we'll have to after year. And if we accept a scarecrow to oversee the I have to prop it up so often that it will hardly be worth ti ce Committee proposes an alternative to the house of Hoit 2 straw by offering an independent Consumer teadest by an Administrator with a full panoply of re advised "ty of the latter, there can be no disagreeo acconvyish our purpose, we need build a new eatose bandation may be more symbolic than asdons. Cleary the history of such agencies wave Coermission, the Folers Power CommisMicrne Commission, among others, attests "Independent regulatory agency" is iminate for all time tion. which 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. ou may proceed. |