KF26 G6443 1972 COMMITTEE ON GOVERNMENT OPERATIONS JOHN L. MCCLELLAN, Arkansas, Chairman SUBCOMMITTEE ON EXECUTIVE REORGANIZATION AND GOVERNMENT RESEARCH FRED R. HARRIS, Oklahoma LEE METCALF, Montana HUBERT H. HUMPHREY, Minnesota JACOB K. JAVITS, New York CHARLES McC. MATHIAS, JR., Maryland ROBERT WAGER, Staff Director and General Counsel STUART M. STATLER, Minority Counsel (n) Page James F. Turner, author of "The Chemical Feast". Arnold Elkind, former Chairman, National Commission on Product Dr. Leonard Hayflick, professor, Stanford University School of Medicine, Rodney E. Leonard, former Administrator of the Consumer and Marketing Service of the Department of Agriculture and presently the Executive Director of the Community Nutrition Institute in Washington, D.C..... J. Edward Day, Esq., Sidley & Austin Law Firm, special counsel for Consumer Electronics Group, Electronic Industries Association__ C. Joseph Stetler, president, Pharmacutical Manufacturers Association; accompanied by Bruce J. Brennan, general counsel and vice president, Pharmaceutical Manufacturers Association___ Judy Jackson, Public Interest Research Group, Washington, D.C............. Elliot L. Richardson, Secretary, Health, Education, and Welfare; ac- companied by Stephen Kurzman, Assistant Secretary for Legislation; Rodney H. Brady, Assistant Secretary for Administration and Manage- ment; 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, NIH; and Peter B. Hutt, Assistant General Counsel for Food, Drugs and Product Safety, Gregory J. Ahart, Director, Manpower and Welfare Division, General Accounting office; accompanied by Morton A. Myers, Dean K. Crowther, Dr. Peter Isacson, assistant professor of Social and Preventive Medicine, project director of the Vaccine Evaluation Unit, State University of New 1. Text of S. 3419, a bill to protect consumers against unreasonable risk of injury from hazardous products, and for other purposes, cited as 2. Statement of James S. Turner, Esq.. 112 3. Statement of Arnold B. Elkind, Chairman, Commission on Product 116 No. EXHIBITS-Continued 4. Statement of Dr. Leorard 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 10. Request for information from Senator Percy to Secretary of Health, 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.. 15. Exchange of correspondence between HEW and the Department of 18. Response as to whether OMB would support Secretary Richardson 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 percentage of cases recommended for prosecution by FDA has Justice refused to prosecute_ Page 119 127 160 202 203 237 244 302 303 308 309 310 312 351 352 352 353 353 22. Further OMB comments on administrative provisions of S. 3419... 23. GAO reports relating to consumer product safety issued since March 1968.. 354 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.. 356 374 25. Statement by George P. Shultz, Director, Office of Management and budget... 378 26. Statement of the National Consumers League, submitted by Alice Shabecoff, executive director, May 3, 1972_. 380 27. Statement of Communications and Industrial Electronics Division 381 383 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, 388 390 404 No. EXHIBITS-Continued 32. Letter from E. B. Mayo, Jr., of the American Council of Independent 33. Letter from Erma Angevine, executive director of Consumer Federa- 35. Letter from Leonard Hayflick, Ph. D., of Stanford University, to Antonie T. Knoppers, M.D., of Merck & Co., Inc., dated May 2, 197236. 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, 1972 38. Letter from C. Henry Kempe, M.D., professor and chairman, Department 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--- Page 414 415 416 417 418 419 421 421 40. Letter from Hilton Davis, of Chamber of Commerce of the United 41. Press release by Senator Ribicoff dated March 30, 1972, and the text of 43. Memorandum from J. E. Smadal, M.D., Chief, LVR, DBS, to J.A. 46. Memorandum from Edward J. Rourke, Assistant General Counsel, to 424 429 436 473 474 479 482 483 48. Memorandum from Head, Immunoserology Unit, LVR, to Director, DBS, through: Chief, LVR, dated July 12, 1968. 485 49. National Institutes of Health report on review of managerial and 486 491 51. "Division of Biologics Standards: Scientific Management Questioned," reprinted from Science, March 3, 1972. 498 52. "DBS: Officials Confused Over Powers," reprinted from Science, March 10, 1972_... 503 53. "Division of Biologics Standards: The Boat That Never Rocked," reprinted from Science, March 17, 1972 504 54 "DBS: Agency Contravenes Its Own Regulations," reprinted from Science, April 7, 1972__ 55. "Vaccine Safety," from the Congressional Record, October 15, 1971__ 56. "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 regarding the scientific mismanagement at DBS, May 10, 1972__ EXHIBITS-Continued 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 61. Department of Health, Education, and Welfare-Public Health Service Biological Products, Federal Register, February 24, 1972_ 62. "Redelegation of Authority To Administer Certain Provisions of the Federal Food, Drug, and Cosmetic Act," Office of the Secretary- Human Drugs Which Are Biological Products, Federal Register, 63. "Vaccines," reprinted from Ramparts- 64. "GAO Report on Tuberculosis Drug," from the Congressional Record, 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.. 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 & Letter from Senator Ribicoff to William D. Ruckelshaus, Administrator, Environmental Protection Agency, May 1971, and response submitted 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 Handier, President, National Academy of Sciences, to Senator Ribicoff, September 28, 1971, and material submitted for the Letter from Erma Angevine, executive director, Consumer Federation of America, to Senator Ribicoff, September 24, 1971, and material sub- |