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Carcinogenic Potencies and Establishment of a Threshold of Regulation for Food Contact Substances

  • W. Gary Flamm
  • L. Robert Lake
  • Ronald J. Lorentzen
  • Alan M. Rulis
  • Patricia S. Schwartz
  • Terry C. Troxell
Part of the Contemporary Issues in Risk Analysis book series (CIRA, volume 2)

Abstract

This chapter presents a compilation of data on carcinogenic potencies in the form of a probability distribution and describes how, in this form, the data could be used as a scientific foundation for making regulatory judgments about the potential risk from substances that migrate to food from packaging and other materials that come into contact with food. The idea of establishing a threshold of regulation based on the concept of a de minimis level of migration of potentially carcinogenic substances into food is discussed as a possible regulatory approach that could use the type of data presented. The discussion does not represent Food and Drug Administration (FDA) policy, however, and it does not address the possible use by FDA of a de minimis risk approach to determining the status of certain color additives currently being evaluated by the agency.

Keywords

Carcinogenic Risk Color Additive Food Contact Exposure Distribution Carcinogenic Potency 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. 1.
    Monsanto v. Kennedy, 613 F. 2d 947 (D.C. Cir, 1979).Google Scholar
  2. 2.
    L. S. Gold, et al., “A Carcinogenic Potency Data Base of the Standardized Results of Animal Bioassays,” Environmental Health Perspectives 58: 9–314 (December 1984).CrossRefGoogle Scholar

Copyright information

© Plenum Press, New York 1987

Authors and Affiliations

  • W. Gary Flamm
    • 1
  • L. Robert Lake
    • 1
  • Ronald J. Lorentzen
    • 1
  • Alan M. Rulis
    • 1
  • Patricia S. Schwartz
    • 1
  • Terry C. Troxell
    • 1
  1. 1.Department of Health and Human ServicesCenter for Food Safety and Applied Nutrition, Food and Drug AdministrationUSA

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