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U.S. Department of Health and Human Services

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    1993 Draft Redbook II

    Toxicological Principles for the Safety Assessment of
    Direct Food Additives and Color Additives Used in Food
    Redbook II
    Draft Guidance

    This draft guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if such an approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach contact the FDA staff responsible for implementing this guidance (Office of Food Additive Safety, 301-436-1200 (Updated phone: 240-402-1200)).

    Draft Redbook II was distributed in 1993 by the Office of Premarket Approval. Effective June 18, 2001 the Office of Premarket Approval is now the Office of Food Additive Safety. Based on comments, experience, and other information, FDA staff has revised and issued several sections of the draft as final guidance in Redbook 2000. Those sections of the 1993 Draft Redbook II not yet available in Redbook 2000 are being placed here for your reference.

    Table of Contents

    Chapter I. Introduction

    Section has been updated and finalized and can be found in Redbook 2000

    Chapter II. Agency Review of Toxicology Information in Petitions for Direct Food Additives and Color Additives Used in Food

    (available in PDF, 257KB)

    1. Introduction
    2. Expediting Review of Toxicology Information
    3. Evaluating Toxicology Information
      1. Introduction
      2. No-Observed-Effect Level (NOEL)
      3. Safety Factors
      4. Acceptable Daily Intake (ADI)
      5. Carcinogenic Risk Assessment

    Chapter III. Recommended Toxicity Studies

    Section has been updated and finalized and can be found in Redbook 2000

    Chapter IV. Guidelines for Toxicity Tests

    1. Introduction
      Section has been updated and finalized and can be found in Redbook 2000
    2. General Recommendations for Toxicity Studies
      1. General Guidelines for Toxicity Studies
        Section has been updated and finalized and can be found in Redbook 2000
      2. Summary Guidelines for Reporting the Results of Toxicity Studies
        Section has been updated and finalized and can be found in Redbook 2000
      3. Pathology Considerations in Toxicity Studies
        Section has been updated and finalized and can be found in Redbook 2000
      4. Statistical Considerations in Toxicity Studies
        Section has been updated and finalized and can be found in Redbook 2000
      5. Diets for Toxicity Studies (available in PDF)
    3. Guidelines for Recommended Toxicity Studies
      1. Short-Term Tests for Genetic Toxicity
        Section has been updated and finalized and can be found in Redbook 2000
      2. Acute Oral Toxicity Tests (available in PDF)
      3. Short-Term Toxicity Tests with Rodents and Non-Rodents
        Section has been updated and finalized and can be found in Redbook 2000
      4. Subchronic Toxicity Tests with Rodents and Non-rodents
        Section has been updated and finalized and can be found in Redbook 2000
      5. Chronic Toxicity Studies
        1. Chronic Toxicity Studies with Rodents
          Section has been updated and finalized and can be found in Redbook 2000
        2. One-Year Toxicity Tests with Non-Rodents
          Section has been updated and finalized and can be found in Redbook 2000
      6. Carcinogenicity Studies with Rodents
        Section has been updated and finalized and can be found in Redbook 2000
      7. Combined Chronic Toxicity/Carcinogenicity Studies with Rodents
        Section has been updated and finalized and can be found in Redbook 2000
      8. In Utero Exposure Phase for Addition to Carcinogenicity Studies with Reporting
        Section has been updated and finalized and can be found in Redbook 2000
      9. Reproduction and Developmental Toxicity Studies
        Section has been updated and finalized and can be found in Redbook 2000

    Chapter V. Additional Recommended Studies

    1. Introduction (available in PDF)
    2. Metabolism and Pharmacokinetic Studies (available in PDF)
    3. Neurotoxicity Studies
      Section has been updated and finalized and moved to Redbook 2000 Chapter IVC10
    4. Immunotoxicity Studies (available in PDF)

    Chapter VI. Human Studies

    1. Clinical Evaluation of Foods and Food Additives (available in PDF)
    2. Epidemiology Studies
      Section has been updated and finalized and can be found in Redbook 2000

    Chapter VII. Emerging Issues in Safety Assessment of Food Additives and Color Additives Used in Food

    1. Introduction (available in PDF)
    2. Macro-Additives (available in PDF)
    3. Safety of Foods and Food Additives Developed by Biotechnology (available in PDF, 428Kb)
    4. Enzymes (available in PDF)
    5. Microbially Derived Food Ingredients (available in PDF)
    6. Advances in the Development of Alternatives to Whole Animal (Vertebrate) Testing (available in PDF)
    7. Heritable and Somatic Genetic Toxicity (available in PDF)

    Chapter VIII. Glossary: Acronyms and Definitions

    Section has been updated and finalized and can be found in Redbook 2000

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