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Infant Formula: Evaluating the Safety of New Ingredients
d. Improving the Risk Assessment Process/Safety Assessment
C. Immunotoxicity Studies
1. Immunity: A Brief Review
2. Key Concepts in Immunotoxicity Testing
3. Indicators of Possible Immune Toxicity
4. Expanded Type 1 Immunotoxicity Tests
5. Type 2 Immunotoxicity Tests
6. Relevance of Primary Indicators of Immune Toxicity to Health
7. Adequacy and Reliability of Primary Indicators of Immune Toxicity
8. Recommendations for Further Immunotoxicity Testing when Primary Indicators are Positive
9. Animal Models for Immunotoxicity Tests
10. Recommended Strategy for Assessing the Immunotoxic Potential of Food Ingredients
A. Clinical Evaluation of Food Ingredients
1. General Considerations for Clinical Studies of Food Ingredients
2. Specific Considerations for Clinical Studies of Food Ingredients
3. Sequence of Clinical Studies for Food Ingredients
4. Submitting Reports of Clinical Studies on Food Ingredients
5. Appendix A—Principles of Institutional Review and Informed Consent
C. Safety of Food Ingredients Developed by Biotechnology
E. Microbially Derived Food Ingredients
F. Advances in the Development of Alternatives to Toxicity Testing
G. Heritable and Somatic Genetic Toxicity
Glossary: Acronyms and Definitions
NOTE: Food ingredients include: direct food additives, color additives used in food, Generally Recognized as Safe substances, food contact substances, and constituents or impurities of any of the above. Bolded text denotes a section that has been finalized and is found only online in the Redbook 2000 (OFAS, 2003); the other information is found only in Redbook II-Draft (OFAS, 2001).
OFAS (Office of Food Additive Safety). 2001. Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food. Redbook II-Draft. Washington, DC: OFAS, Center for Food Safety and Applied Nutrition, Food and Drug Administration.
OFAS. 2003. Redbook 2000. Toxicological Principles for the Safety of Food Ingredients. Online. Center for Food Safety and Applied Nutrition, Food and Drug Administration. Available at http://www.cfsan.fda.gov/~redbook/red-toca.html. Accessed November 19, 2003.