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310 312

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.
9. “Notice of Proposed Rulemaking on Natural or Unavoidable Defects

in Food for Human use That Presents No Health Hazard, Depart-
ment of Health, Education, and Welfare-Food and Drug Adminis-

tration, 21 CFR part 128-
10. Request for information from Senator Percy to Secretary of Health,

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.
31. “Some Features of the Blood-Service Complex in New Jersey" by

Martin Goldfield, M.D., and Federico Colosimo, B.A., from the
Division of Laboratories and Epidemiology, New Jersey State
Department of Health..





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32. Letter from E. B. Mayo, Jr., of the American Council of Independent

Laboratories, Inc., to Robert J. Wager, Esq., general counsel of
Subcommittee on Executive Reorganization and Government

Research, dated April 20, 1972.
33. Letter from Erma Angevine, executive director of Consumer Federa-

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. -
42. Report to the Subcommittee on Executive Reorganization and Govern-

ment Research, Committee on Government Operations, U.S.
Senate, entitled “Problems Involving the Effectiveness of Vaccines”

by the Comptroller General of the United States
43. Memorandum from J. E. Smadal, M.D., Chief, LVR, DBS, to J.A.

Morris, Ph. D., chief, SRV, LVR, dated September 18, 1962-
44. Memorandum from Division of Public Health Grants and Services,

Office of the General Counsel-HEW to Dr. Roderick Murray,
Director, Division of Biologics Standards, dated February 28, 1969,

and accompanying material submitted for the record..
45. Memorandum from Director, Division of Biologics Standards, to

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..
58. Memorandum to Dr. Robert Q. Marston, Director, National Institutes

of Health, from James S. Turner and Dr. J. Anthony Morris regard-
ing the scientific mismanagement at DBS, May 10, 1972.



















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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-
Human Drugs Which Are Biological Products, Federal Register,

February 25, 1972
63. “Vaccines," reprinted from Ramparts.
64. “GAO Report on Tuberculosis Drug," from the Congressional Record,

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.


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817 820







Statement by Senator Ribicoff..
Letter from Senator Ribicoff to William D. Ruckelshaus, Administrator,

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.
Letter from George W. Koch, president, Grocery Manufacturers of

America, Inc., to Senator Ribicoff, October 7, 1971.
Comments of the Environmental Mutagen Society submitted for the

record at the request of Senator Ribicoff.









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.


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.



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.)

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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

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