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Toxicological TestingThe CFSAN “Redbook”Minimum Toxicity TestsShort-term tests for genetic toxicityMetabolism & pharmacokineticstudiesShort-term tox tests with rodentsSubchronic tox tests with rodentsSubchronic tox tests with nonrodentsReproduction study w/ teratologyphaseOne-Yr tox tests with non-rodentsCarcinogenicity study with rodentsChronic tox/ carcinogenicity studywith rodentsConcern LevelsI II IIIX X XXX XX XXX XXXX
The “Toxicological” Safety Assessment Model(Based on the Review of Toxicological Data)• Requires defining population exposureto the additive, “Estimated DailyIntake” (or EDI), and• Comparing that to an “AcceptableDaily Intake” (ADI) from toxicologicalstudies
Page 5 and 6: A Core Statute for Food IngredientS
Page 7 and 8: House of Representatives, Report No
Page 9 and 10: REASONABLE CERTAINTY OF NO HARMLegi
Page 11 and 12: Reasonable Certainty ofNo HarmWhat
Page 13: Traditional Safety Evaluation(Petit
Page 17 and 18: The “Circle” ofReasonable Certa
Page 19 and 20: “Olestra”a macronutrient substi
Page 21 and 22: Olestra: Molecular Structure
Page 28 and 29: Beyond “Toxicity” Studies• Fo
Page 30 and 31: Beyond “Toxicity” StudiesIn fac
Page 32 and 33: Summary of Olestra Data Review• I
Page 34 and 35: Summary of Olestra Data ReviewDrug
Page 36 and 37: Studies to Assess Nutritional Effec
Page 38 and 39: Summary of Olestra Data Review8-Wk
Page 40 and 41: Summary of Olestra Data ReviewStudi
Page 42 and 43: Carotenoids• Serum levels are aff
Page 44 and 45: GI Effects• After review by FDA o
Page 46 and 47: FDA’s s Safety Review: Summary•
Page 48 and 49: Labeling of FoodsContaining Olestra
Page 50 and 51: A More Complex “Circle” ofReaso
Page 52 and 53: “Generally Recognized as Safe”(
Page 54 and 55: GRAS Criteria: Comparing a GRASSubs
Page 56 and 57: 3 Types of Responseto a GRAS Notice
Page 58 and 59: Other Examples of “Bioactive”Fo
Page 60 and 61: Nutritional Risk Assessment?• For
Page 62 and 63: Nutritional Risk Assessment• An u
Page 64 and 65:
A Still More Complex “Circle” o
Page 66 and 67:
Relative Food-Related Concerns(A Po
Page 68:
The End!Thank You!
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