Regulatory Aspects of Carcinogenesis and Food Additives: The Delaney Clause

Regulatory Aspects of Carcinogenesis and Food Additives: The Delaney Clause is composed of papers and discussions presented in the seventh meeting of the International Academy of Environmental Safety regarding the philosophy of the Delaney Clause. The Delaney Clause became a part of the Food and Drug Law in 1958. It states in part "that no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found after tests which are appropriate for evaluation of safety of food additives to induce cancer in man or animal. This book covers the different views of the meeting's participants on the interpretation of the Delaney Clause. It presents list of points that should be considered in making decisions with respect to safety. Many other factors that should be taken into consideration are also discussed in this reference.

Participants ixForewordSession I Public Policy Issues in Regulating Carcinogens in Food The Delaney Clause: An Experimental Policy Decision That Has Been Misinterpreted The Regulation of Carcinogens at The Environmental Protection Agency By Appropriate Methods: The Delaney Clause Alternatives to Be Considered in Benefit: Risk Decision-Making Decision-Making Issues Relevant to Cancer-Inducing SubstancesSession II The Delaney Clause: An Idea Whose Time Has Come for a Change The Predictive Value of Animal Tests for Carcinogenicity The Design Criteria and Application of Dose-Response Relationships to Interpretation of Carcinogenesis Bioassay The Role of the Endoplasmic Reticulum in Carcinogenesis Chemically Induced Tumors: Their Relationship to Human Cancer Metabolism and Photodegradation of Chlorinated Hydrocarbons and Their Potential in Carcinogenesis Experimental Procedures in the Evaluation of Chemical Carcinogens Negative Health Implications of the Delaney Philosophy The Use Of Nonhuman Primates for Chemical Carcinogenesis StudiesSession III Extrapolating Animal Risk to Humans Assessments at an International Level of Health Hazards to Man of Chemicals Shown to Be Carcinogenic in Laboratory Animals The Establishment of European Community Legislation for Toxic Substances Impact of the Delaney Clause on the Research-Intensive Manufacturer of Biomedical Products Impact of the Delaney Clause Philosophy on the Chemical Industry The Delaney Clause: Relation to the Development of Chemical CarcinogenesisConcluding Discussion Summary Index