Regulatory Aspects of Carcinogenesis and Food Additives: The Delaney Clause

Title Page......Page 4
Copyright Page......Page 5
Table of Contents......Page 6
PARTICIPANTS......Page 10
FOREWORD......Page 20
SESSION I......Page 26
INTRODUCTORY REMARKS......Page 28
CHAPTER 1. PUBLIC POLICY ISSUES IN REGULATING CARCINOGENS IN FOOD......Page 36
REMARKS......Page 51
CHAPTER\r2. THE DELANEY CLAUSE: AN EXPERIMENTAL POLICY DECISION THAT HAS BEEN MISINTERPRETED......Page 54
REMARKS......Page 59
CHAPTER\r3. THE REGULATION OF CARCINOGENS AT THE ENVIRONMENTAL PROTECTION AGENCY......Page 60
GENERAL DISCUSSION......Page 68
I. INTRODUCTION......Page 88
II. GENERALLY ACCEPTED CRITERIA—SIGNIFICANCE IN EXTRAPOLATION OF ANIMAL DATA TO MAN REFLECTING A POTENTIAL HUMAN CARCINOGENIC HAZARD......Page 89
III. PROCEDURES AND FACTORS THAT MAY CONFOUND PROPER ASSESSMENT OF CARCINOGENICITY STUDIES AND DATA......Page 92
IV. GENERAL COMMENTS ON LIMITING FACTORS......Page 105
V. SUMMARY......Page 106
REFERENCES......Page 107
CHAPTER\r5. ALTERNATIVES TO BE CONSIDERED IN BENEFIT:RISK DECISION-MAKING......Page 110
CONCEPTS OF BENEFIT:RISK......Page 111
THE QUESTION OF ABSOLUTES......Page 112
THE VARIABLE NATURE OF RISK AND OF BENEFIT......Page 113
ALTERNATIVES......Page 115
ALTERNATIVES IN EXPERIMENTAL DESIGN......Page 116
CONCLUSIONS......Page 117
REFERENCES......Page 118
REMARKS......Page 119
CHAPTER\r6. DECISION-MAKING ISSUES RELEVANT TO CANCER-INDUCING SUBSTANCES......Page 120
GENERAL DISCUSSION......Page 130
SESSION II......Page 144
CHAPTER\r7. INTRODUCTORY REMARKS (SESSION II, MORNING)......Page 146
CHAPTER\r8. THE DELANEY CLAUSE: AN IDEA WHOSE TIME HAS COME FOR A CHANGE......Page 148
CHAPTER\r9. THE PREDICTIVE VALUE OF ANIMAL TESTS FOR CARCINOGENICITY......Page 154
GENERAL DISCUSSION......Page 160
I. INTRODUCTION......Page 174
II. STATEMENT OF PURPOSE AND NEED......Page 175
III. RESULTS......Page 178
REFERENCES......Page 199
DETOXIFICATION AND ACTIVATION OF CHEMICALS BY MICROSOMAL ENZYMES......Page 200
THE ENDOPLASMIC RETICULUM, GLYCOPROTEIN SYNTHESIS, AND MALIGNANCY......Page 203
CARBENE FORMATION WITH CYTOCHROME P-450, MEMBRANE DEGRANULATION, AND PROMOTION OF CARCINOGENESIS......Page 205
SPECIES DIFFERENCES IN MICROSOMAL ENZYME ACTIVITY AND IN CARCINOGENESIS......Page 208
References......Page 211
CHAPTER\r12. CHEMICALLY INDUCED TUMORS— THEIR RELATIONSHIP TO HUMAN CANCER......Page 216
REFERENCES......Page 225
GENERAL DISCUSSION......Page 228
CHAPTER\r13. INTRODUCTORY REMARKS (SESSION II, AFTERNOON)......Page 246
CHAPTER\r14. METABOLISM AND PHOTODEGRADATION OF CHLORINATED HYDROCARBONS AND THEIR POTENTIAL IN CARCINOGENESIS......Page 250
CHAPTER\r15. EXPERIMENTAL PROCEDURES IN THE EVALUATION OF CHEMICAL CARCINOGENS......Page 266
REFERENCES......Page 276
REMARKS......Page 277
CHAPTER\r16. NEGATIVE HEALTH IMPLICATIONS OF THE DELANEY PHILOSOPHY......Page 280
GENERAL DISCUSSION......Page 288
INTRODUCTION......Page 302
METHODS......Page 304
RESULTS......Page 307
CONCLUSIONS......Page 321
REFERENCES......Page 323
GENERAL DISCUSSION......Page 324
SESSION III......Page 330
CHAPTER\r18. EXTRAPOLATING ANIMAL RISK TO HUMANS......Page 332
REFERENCES......Page 337
REMARKS......Page 339
CHAPTER\r19. ASSESSMENTS AT AN INTERNATIONAL LEVEL OF HEALTH HAZARDS TO MAN OF CHEMICALS SHOWN TO BE CARCINOGENIC IN LABORATORY ANIMALS......Page 342
REMARKS......Page 353
1. GENERAL CONSIDERATIONS......Page 356
2. ESTABLISHMENT OF COMMUNITY LEGISLATION......Page 357
3. EXAMPLES OF SPECIFIC ACTIONS......Page 359
4. CONCLUSIONS......Page 364
REMARKS......Page 366
CHAPTER 21. IMPACT OF THE DELANEY CLAUSE ON THE RESEARCH-INTENSIVE MANUFACTURER OF BIOMEDICAL PRODUCTS......Page 370
References......Page 379
CHAPTER 22. IMPACT OF THE DELANEY CLAUSE PHILOSOPHY ON THE CHEMICAL INDUSTRY......Page 380
REMARKS......Page 387
CHAPTER 23. THE DELANEY CLAUSE RELATION TO THE DEVELOPMENT OF CHEMICAL CARCINOGENESIS......Page 388
IS EVERYTHING THAT INDUCES TUMORS A CARCINOGEN?......Page 391
TRANSSPECIES EXTRAPOLATION......Page 393
THRESHOLDS......Page 394
EXTRAPOLATION TO LOW DOSES......Page 395
CONCLUSIONS......Page 396
References......Page 398
CONCLUDING DISCUSSION......Page 400
SUMMARY......Page 416
INDEX......Page 418