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Thresholds as a unifying theme in regulatory toxicology
1Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, MD 20740, USA. Mitchell.Cheeseman@FDA.Gov
Food Additives and Contaminants
|October 18, 2005
Summary
The US Food and Drug Administration's (FDA) threshold of regulation aligns with toxicity testing for food contact substances. Computational toxicology, like MULTICASE, can predict carcinogens as effectively as genetic toxicity tests at low dietary levels.
Area of Science:
- Toxicology
- Food Safety
- Computational Biology
Background:
- The US Food and Drug Administration (FDA) utilizes a threshold of regulation (TOR) for assessing food contact substances.
- Current FDA recommendations involve toxicological testing and exposure estimation for these substances.
Purpose of the Study:
- To evaluate the scientific basis of the FDA's TOR in relation to its toxicological testing recommendations.
- To assess the predictive capability of genetic toxicity tests and computational toxicology for carcinogens.
Main Methods:
- Examination of the FDA's exposure-based toxicological testing framework for food contact substances.
- Analysis of genetic toxicity tests for predicting carcinogens of varying potency.
- Evaluation of the MULTICASE v. 3.1 computational toxicology program for carcinogen prediction.
Main Results:
- The FDA's TOR is presented as a logical extension of its existing toxicity testing strategy.
- Genetic toxicity tests were analyzed for their effectiveness in predicting carcinogens.
- The MULTICASE program demonstrated an ability to predict carcinogens.
Conclusions:
- The MULTICASE computational toxicology program can achieve results comparable to genetic toxicity tests.
- This equivalence is particularly noted at the lowest dietary exposure concentrations for food contact substances.