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Threshold of regulation

  • M. A. Cheeseman
  • E. J. Machuga
Chapter

Abstract

This chapter discusses the scientific and legal basis for establishment of a threshold of regulation for substances used in food contact material. The so-called threshold of regulation is set at a level below which exposure to a given chemical substance can be reasonably expected to result in negligible risk in the absence of specific information on the toxicity of the substance. The utility of the threshold of regulation concept in enabling regulatory decision-making has been frequently discussed in the literature (Frawley, 1967; Flamm et al., 1987; Rulis, 1989; Munro, 1990; Machuga et al., 1992). In August 1995, the United States Food and Drug Administration (FDA) established a process for applying a threshold of regulation to uses of substances in food contact materials (Food and Drug Administration, 1995). Other regulatory bodies worldwide are also currently considering the application of the concept to the regulation of food packaging and other regulatory areas. We use the FDA’s process as an established example, but the general principles of the threshold process are applicable to any regulatory process for food packaging and may have application in broader regulatory areas.

Keywords

Food Packaging Food Contact Dietary Concentration Environmental Health Perspective 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. Cheeseman, M.A. (1994) FDA’s colorants in polymers rule. American Ink Maker, 9, 81–87.Google Scholar
  2. Cramer, G.M., Ford, R.A. and Hall, R.L. (1978) Estimation of toxic hazard — a decision tree approach (and errata sheet). Food and Cosmetics Toxicology, 16, 255–276.CrossRefGoogle Scholar
  3. Flamm, W.G., Lake, L.R., Lorentzen, R.J. et al. (1987) Carcinogenic potencies and establishment of a threshold of regulation for food contact substances. In: Whipple, C. (ed.) Contemporary Issues in Risk Assessment, Vol. 2. De Minimis Risk. Plenum Press, New York, 87–92.Google Scholar
  4. Food and Drug Administration (1982) Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food. Red Book. US Food and Drug Administration, Bureau of Foods, Washington, DC.Google Scholar
  5. Food and Drug Administration (1993) Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food. Redbook II (Draft). US Food and Drug Administration Center for Food Safety and Applied Nutrition, Washington, DC.Google Scholar
  6. Food and Drug Administration (1995) Food additives: threshold of regulation of substances used in food-contact articles; Final Rule. Federal Register, 60, 36582–36596.Google Scholar
  7. Frawley, J.P. (1967) Scientific evidence and common sense as a basis for food-packaging regulation. Food and Cosmetics Toxicology, 5, 293–308.CrossRefGoogle Scholar
  8. Gaylor, D.W. and Gold, L.S. (1995) Quick estimate of the regulatory virtually safe dose based on the maximum tolerated dose in rodent bioassays. Regulatory Toxicology and Pharmacology, 22, 57–63.CrossRefGoogle Scholar
  9. Gold, L.S., Sawyer, C.B., Magaw, R. et al. (1984) A Carcinogenesis Potency Database of the standardized results of animal bioassays. Environmental Health Perspectives, 58, 9–319.CrossRefGoogle Scholar
  10. Gold, L.S., de Veciana, M., Backman, G.M. et al. (1986) Chronological supplement to the Carcinogenic Potency Database: standardized results of animal bioassays published through December 1982. Environmental Health Perspectives, 67, 161–200.CrossRefGoogle Scholar
  11. Gold, L.S., Slone, T.H., Backman, G.M. et al. (1987) Second chronological supplement to the Carcinogenic Potency Database: standardized results of animal bioassays published through December 1986 and by the National Toxicology Program through June 1987. Environmental Health Perspectives, 84, 215–286.CrossRefGoogle Scholar
  12. Gold, L.S., Slone, T.H., Backman, G.M. et al. (1990) Third chronological supplement to the Carcinogenic Potency Database: standardized results of animal bioassays published through December 1986 and by the National Toxicology Program through June 1987. Environmental Health Perspectives, 84, 215–286.CrossRefGoogle Scholar
  13. Krewski, D., Gaylor, D.W., Soms, A.P. and Szyszkowicz, M. (1993) An overview of the report ’Correlations between carcinogenic potency and the maximum tolerated dose: Implications for risk assessment’. Risk Analysis, 13, 383–398.CrossRefGoogle Scholar
  14. Machuga, E.J., Pauli, G.H. and Rulis, A.M. (1992) A threshold of regulation policy for food- contact articles. Food Control, 3(4), 180–182.CrossRefGoogle Scholar
  15. Munro, I. (1990) Safety assessment procedures for indirect food additives: an overview. Regulatory Toxicology and Pharmacology, 12, 2–12.CrossRefGoogle Scholar
  16. Munro, I.C., Ford, R.A., Kennepohl, E. and Sprenger, J.G. (1996) Correlation of structure class with no-observed-effect levels: a proposal for establishing a threshold of concern. Food Chemical Toxicology, 34, 829–867.CrossRefGoogle Scholar
  17. Rulis, A. (1989) Establishing a threshold of regulation. In: Bonin, J. and Stevenson, D. (eds) Risk Assessment in Setting National Priorities. Plenum, New York, pp. 271–278.Google Scholar
  18. World Health Organization (1967) Procedures for investigating intentional and unintentional food additives: Report of a WHO scientific group. WHO Technical Report Series No. 348. WHO, Geneva.Google Scholar
  19. World Health Organization (1978) Principles and methods for evaluating the toxicity of chemicals, Part 1 — Principes et méthodes d’évaluation de la toxicité des produits chimiques, Partie 1. Environmental Health Criteria No. 6. International Programme on Chemical Safety (IPCS). WHO, Geneva.Google Scholar
  20. World Health Organization (1987) Principles for the safety assessment of food additives and contaminants in food. Environmental Criteria 70. International Programme on Chemical Safety in Co-Operation with the Joint FAO/WHO Expert Committee on Food Additives (JECFA). WHO, Geneva.Google Scholar

Copyright information

© Chapman & Hall 1997

Authors and Affiliations

  • M. A. Cheeseman
  • E. J. Machuga

There are no affiliations available

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