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EXHIBITS—Continued No. 4. Statenent of Dr. Leonard Hayflick, professor, Stanford University
School of Medicine, Stanford, Calif. 5. Statement by Rodney E. Leonard, Executive Director, Community
Nutrition Institute... 6. Statement of Judy Jackson, Public Interest Research Group, and a
section-by-section research analysis of S. 3419 submitted for the
record. 7. Table setting forth budget authority for certain Federal regulatory
agencies, submitted for the record by Secretary Richardson 8. “Responsibility and Responsiveness, the HEW potential for the
seventies, submitted for the record by Secretary Richardson.
in Food for Human use That Presents No Health Hazard, Depart-
tration, 21 CFR part 128-
Education, and Welfare, March 29, 1972, and the material subse
quently submitted for the record.. 11. Lead Christmas tinsel agreement supplied for the record by HEW at
the request of Senator Percy 12. Letter and questions from Senator Javits to Secretary Richardson,
May 3, 1972, and the response subsequently submitted for the
record, June 2, 1972. 13. Statement of Secretary Richardson on the transfer of DBS to FDA. 14. Assistance provided to the Food and Drug Administration by the
National Bureau of Standards, 1970–72.. 15. Exchange of correspondence between HEW and the Department of
Commerce relevant to the possibility of NBS assisting the Consumer
Safety Agency in testing and establishing standards for products... 16. Resources for FDA by program category--1972 and 197317. Material submitted for the record on the Ash Council report by OMB
at the request of Senator Percy.. 18. Response as to whether OMB would support Secretary Richardson
in striking the balance in the authority to be given to the Assistant
Secretary, if it is created within HEW 19. Food and Drug Administration budget history submitted for the record
by OMB.. 20. OMB comments on statement of Secretary Richardson regarding
conduct of litigation by FDA attorneys. 21. OMB response to question from Senator Percy regarding what per
centage of cases recommended for prosecution by FDA has Justice
refused to prosecute. 22. Further OMB comments on administrative provisions of S. 3419.. 23. GAO reports relating to consumer product safety issued since March
1968.. 24. Statement of Peter Isacson, associate professor of social and preventive
medicine, project director of the Vaccine Evaluation Unit, State
University of New York, Buffalo, N.Y. 25. Statement by George P. Shultz, Director, Office of Management and
budget--26. Statement of the National Consumers League, submitted by Alice
Shabecoff, executive director, May 3, 1972. 27. Statement of Communications and Industrial Electronics Division
of Electronic Industries Association submitted by Richard E. Horner. 28. Statement of George P. Lamb, general counsel, on behalf of the
Association of Home Appliance Manufacturers.29. Statement of the Parts Division, Solid State Products Division,
Tube Division of the Electronic Industries Association.... 30. Statement by J. Garrott Allen, M.D., professor of surgery, Stanford
University Medical Center, Stanford, Calif., May 8, 1972.
Martin Goldfield, M.D., and Federico Colosimo, B.A., from the
Laboratories, Inc., to Robert J. Wager, Esq., general counsel of
Research, dated April 20, 1972.
tion of America, to Senator Fred R. Harris, dated April 21, 1972. 34. Letter from Antonie T. Knoppers of Merk & Co., Inc., to Senator
Abraham A. Ribicoff, dated April 26, 197235. Letter from Leonard Hayflick, Ph. D., of Stanford University, to
Antonie T. Knoppers, M.D., of Merck & Co., Inc., dated May 2, 1972. 36. Letter from Wilbur J. Cohen, dean, University of Michigan, to Senator
Gaylord Nelson, dated April 29, 1972. 37. Letter from Stanley A. Plotkin, associate professor of pediatrics,
University of Pennsylvania, to Senator Ribicoff, dated May 1, 197238. Letter from C. Henry Kempe, M.D., professor and chairman, Depart
ment of Pediatrics, University of Colorado Medical Center, to
Senator Ribicoff, dated May 3, 1972.. 39. Letter from Walter S. Lewis, Jr., of Gas Manufacturer Association, to
Senator Ribicoff, dated May 3, 1972----40. Letter from Hilton Davis, of Chamber of Commerce of the United
States, to Senator Ribicoff dated May 10, 1972, and accompanying
statement submitted for the record. 41. Press release by Senator Ribicoff dated March 30, 1972, and the text of
speech regarding effectiveness of vaccines. -
ment Research, Committee on Government Operations, U.S.
by the Comptroller General of the United States
Morris, Ph. D., chief, SRV, LVR, dated September 18, 1962-
Office of the General Counsel-HEW to Dr. Roderick Murray,
and accompanying material submitted for the record..
Director, Office of Legislative Analysis, dated July 30, 1969, and
accompanying material submitted for the record.. 46. Meinorandum from Edward J. Rourke, Assistant General Counsel, to
Dr. Luther L. Terry, Surgeon General, dated February 21, 1963.-47. Memorandum from Director, Division of Biologics Standards, to
Director, Office of Legislative Analysis, OD, dated November 19,
1969.. 48. Vemorandum from Head, Immunoserology Unit, LVR, to Director,
DBS, through: Chief, LVR, dated July 12, 1968. 49. National Institutes of Health report on review of managerial and
personnel conditions in the Division of Biologics Standards. 50. "Division of Biologics Standards: In the Matter of J. Anthony Morris,”
reprinted from Science, February 25, 1972_ 51. "Division of Biologics Standards: Scientific Management Questioned,”
reprinted from Science, March 3, 1972. 52. “DBS: Officials Confused Over Powers,” reprinted from Science,
March 10, 1972..53. “Division of Biologics Standards: The Boat That Never Rocked,"
reprinted from Science, March 17, 1972. 54 "DBS: Agency Contravenes Its Own Regulations,” reprinted from
Science, April 7, 1972. 55. "Vaccine Safety," from the Congressional Record, October 15, 1971.. 36. "Vaccine Regulation,” from the Congressional Record, December 8,
1971, the documents supplied by HEW, and Morris-Turner analysis. 57. Comments on Morris and Turner “rebuttal” to ad hoc committee
report on DBS scientific management..
of Health, from James S. Turner and Dr. J. Anthony Morris regard-
EXHIBITS—Continued No. 59. Letter to Dr. Robert Q. Marston, Director, National Institutes of
Health, from Mr. James S. Turner. 60. Department of Health, Education, and Welfare-Public Health
Service Bacterial Vaccines and Bacterial Antigenes, Federal
Register, March 15, 1972 61. Department of Health, Education, and Welfare-Public Health
Service-- Biological Products, Federal Register, February 24, 1972. 62. “Redelegation of Authority Tó Administer Certain Provisions of the
Federal Food, Drug, and Cosmetic Act,” Office of the Secretary-
February 25, 1972
October 20, 1971..-. 65. Letters to Senator Abraham A. Ribicoff and Senator McClellan from
Ernest B. Howard, M.D., May 4, 1972, and May 19, 1972. 66. Letter to Senator Abraham Ribicoff from Aaron Locker, May 8, 1972. 67. Letter to Senator Abraham Ribicoff from Henry W. Gadsden, Merck &
Co., Inc., May 10, 1972.68. Letter to Senator John L. McClellan from John W. Barnum, Office
of the Secretary of Transportation, May 18, 1972. 69. Letter to Senator Abraham Ribicoff from John A. Schnittker,
Schnittker Associates, May 22, 1972.. 70. Statement of the Outdoor Power Equipment Institute, Inc. 71. Statement of Rev. Robert H. Thomas, deputy guardian, U.S. Churches
of Scientology, Los Angeles, Calif.. 72. Statement of the National Association of Manufacturers.
Statement by Senator Ribicoff..
Environmental Protection Agency, May 1971, and response submitted
for the record.. Letter from Senator Ribicoff to Clifford M. Hardin, Secretary, Depart
ment of Agriculture, May 1971, and response submitted for the record.. Letter from Senator Ribicoff to Charles C. Edwards, M.D., Commissioner
of Food and Drugs, May 1971, and response submitted for the record.. Letter from James S. Turner to Senator Ribicoff, January 11, 1971, and
material submitted for the record.. Letter from Philip Handler, President, National Academy of Sciences, to
Senator Ribicoff, September 28, 1971, and material submitted for the
record.. Letter from Erma Angevine, executive director, Consumer Federation of
America, to Senator Ribicoff, September 24, 1971, and material sub
mitted for the record.
America, Inc., to Senator Ribicoff, October 7, 1971.
record at the request of Senator Ribicoff.
CONSUMER SAFETY ACT OF 1972
THURSDAY, APRIL 20, 1972
AND GOVERNMENT RESEARCH,
Washington, D.C. The subcommittee met, pursuant to notice, at 10 a.m., in room 3302, New Senate Office Building, Senator Fred R. Harris (acting chairman of the subcommittee) presiding.
Present: Senators Harris, 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; and Pamela J. Gell, chief clerk. Dennison Young, Jr., legislative counsel to Senator Javits, was also present.
Senator HARRIS. The hearing will come to order.
OPENING STATEMENT OF SENATOR HARRIS
This morning we begin hearings on titles I and II of S. 3419, which was reported favorably by the Commerce Committee on March 24.
The bill would create 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.
THREE KEY FINDINGS
This legislation is the result of a 2-year study by the Product Safety Commission, which recommended the establishment of such on agency. Its recommendation was based on three key findings:
1. Every year 20 million Americans are injured in the home as a result of accidents involving consumer products. Of these, 110,000 are permanently disabled and 30,000 are killed.
2. The Federal role in product safety is fragmented, narrow, and weak.
3. Industry regulation and State laws cannot provide an enforceable, uniform standard for product safety.
Our hearings will focus on the organization and plan of operation for the proposed new agency. The most basic question before us is whether FDA and DBS should be removed from HEW and established as a separate agency in the executive branch. But beyond this, we want to know whether all product safety activities in the Federal Government should be combined in one agency and, if so, what additional transfers should be made.
We will also closely examine the proposed administrative structure of the new agency. What problems would be created by the division of responsibility between the administration and the three commissioners! How will the independence of the agency be affected by the different conditions under which the administration and commissioners serve? Are four separate legal staffs necessary? These are some of the questions for which we will be seeking answers.
Our first witness today is Mr. James Turner, author of "The Chemical Feast."
Mr. Turner, we are pleased you are here.
May I announce that we will have a brief recess at 11 o'clock because of a press conference in which I and others are involved. It will not last more than 30 minutes. We will take up again at 11:30 and at that time go directly on through the witness list planned for today until we finish.
Senator Percy, the ranking minority member of the committee, also has an opening statement.
(See exhibit 1, p. 44, for the text of S. 3419.)
Senator PERCY. Thank you very much, indeed, Mr. Chairman.
S. 3419 would create a new, independent agency within the Federal structure with undiluted responsibility for preventing consumers from being exposed to unsafe foods, drugs, devices, and other consumer products commonly found around the home. The measure would also consolidate within the new Agency various consumer product safety activities now being handled by a number of Government entities by transferring to an independent Consumer Safety Agency the present food, drug, cosmetic, vaccine, and product safety activities of HEW and other product safety functions of the Commerce Department and the FTC.
S. 3419 would also repeal various existing consumer safety laws directed at particular products or specific hazards and replace them with a single omnibus product safety law capable of reaching any consumer product in the marketplace presenting an unreasonable risk of injury.
Although our discussion of S. 3419, reported out of the Commerce Committee on March 24 by a vote of 17 to 1, will concentrate primarily on organizational issues, I want to reaffirm the underlying reasons why the Congress is and should be addressing itself to a regulatory plan of this nature.
The American consumer has a right to safe products for use in his home. The safety of a product begins in its design before it reaches