1. Additives and Ingredients Subcommittee Food Advisory Committee The Office of Food Additive Safety George Pauli Associate Director for Science and Policy Office of Food Additive Safety August 26, 2003

2. MISSION STATEMENT FOOD INGREDIENT SAFETY PROGRAM  Evaluating new applications efficiently & effectively  Expediting applications that mitigate food hazards  Meeting high performance standards with strong science and modern infrastructure  Directing resources to issues of greater public health importance while anticipating future trends  Maintaining data to monitor safety over time  Conducting research that supports the FDA regulatory agenda To assure that the use of food ingredients is safe by:

4. Food Safety Decision Framework U.S. law provides different approaches for different segments or components of the food supply; i.e., whole foods, generally recognized as safe food ingredients, food additives, color additives, food contact substances, dietary ingredients in dietary supplements, contaminants, etc.

5. Food Additive Safety Decision Framework “…the steps (i.e., scientific basis) by means of which the agency deduces (under the applicable statutory construct) whether a particular use of a food additive is safe.” > Statutory standards > Scientific principles

6. Food, Drug, and Cosmetic Act (as amended, ‘58, ‘60, ‘94, ‘97) Defines “food additive,” w/ GRAS exemption Requires premarket approval of new uses of food additives Establishes the standard of review Establishes the standard of safety Establishes formal rulemaking procedures – Petition or Agency Initiative ------------since FDAMA of 1997:------------------ Defines “food contact substance” (FCS) Establishes a premarket notification program for FCSs

7. Statutory Definition of “Food Additive” FD&C Act Section 201(s) “The term ‘food additive’ means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food… …if such substance is not generally recognized…as safe….” …if such substance is not generally recognized…as safe….”

8. Direct Food Ingredients Sweeteners; Preservatives; Nutrients; Fat substitutes; Texturizers (thickeners, emulsifiers, etc.); Flavors Color Additives In food, animal feed, drugs, cosmetics, and medical devices (i.e., sutures and contact lenses) “GRAS” Ingredient uses Enzymes; Fibers; Proteins; Lipids; Sugars; MSG; Antimicrobials; Phytosterols/stanols; Flavors; Infant formula ingredients Foods/Ingredients produced using modern biotechnology Plants w/ herbicide resistance or insect resistence; delayed ripening, etc. Processing Aids Antimicrobials (meat and poultry processing); Defoamers; Ion exchange resins; Food Packaging / Food Contact Substances. Coatings (paper, metal, etc.); New/recycled plastics including both polymers and monomers; Paper; Adhesives; Ingredients in pkgs. (i.e., colorants; antimicrobials; antioxidants, etc.); Packaging materials for use during food irradiation; Food packaging “formulations” Food Irradiation Equipment To Process food To Inspect food Food “Ingredient” Universe

9. House of Representatives, Report No. 2284, “Food Additives Amendment of 1958” Committee on Interstate & Foreign Commerce, 85th Congress, 2nd Session, July 28, 1958 “The committee feels that the Secretary’s findings of fact and orders should not be based on isolated evidence in the record, which evidence in and of itself may be considered substantial without taking account of the contradictory evidence of equal or even greater substance....”

10. “The concept of safety used in this legislation involves the question of whether a substance is hazardous to the health of man or animal. Safety requires proof of a reasonable certainty that no harm will result from the proposed use of an additive.” “It does not -- and cannot -- require proof beyond any possible doubt that no harm will result under any conceivable circumstance.” H.R. Report No. 2284, 85th Congress 1958 REASONABLE CERTAINTY OF NO HARM ( Legislative History of the FD&C Act)

11. Standard of Safety for New Food Additives The petitioner has the burden to demonstrate a “reasonable certainty of no harm” from the intended use of the additive This requires that the FDA assess whether it has received adequately documented answers to appropriate questions of probative value.

12. General Approach for Food Safety Assessment Goal: “New” Food Must Be as Safe as “Today’s” Food

13. The “olden days:” “ONE FLAVOR”  Food and Color Additive Petitions  GRAS Affirmation Petitions

14. FOOD ADDITIVE PETITION REVIEW THE SAFETY DECISION It is NOT an academic inquiry or academic research It is NOT an academic inquiry or academic research It is NOT a search for “complete knowledge” It is NOT a search for “complete knowledge” It is NOT intended to ensure, nor is it possible to ensure It is NOT intended to ensure, nor is it possible to ensure safety with absolute certainty: (“Reasonable Certainty of No Harm” rather than “Certainty of No Theoretical Possibility of Harm”) Does NOT weigh risks and benefits Does NOT weigh risks and benefits It is NOT intended to enforce or limit consumer or producer It is NOT intended to enforce or limit consumer or producer choices among safe foods (e.g., Need is NOT a Criterion) choices among safe foods (e.g., Need is NOT a Criterion) What the safety evaluation is NOT:

15. It DOES, in fact, ensure safety It IS a consensus decision, made under uncertainty, that provides a fair evaluation of all the data of record … - That must protect the public health - That is made in the absence of complete knowledge - That will withstand scientific, procedural, and legal challenge from all sides - Where the residual uncertainty is not out-of-line with what has been previously tolerated in the context of all previous similar safety decisions FOOD ADDITIVE PETITION REVIEW THE SAFETY DECISION

16. Notification Programs… the shape of the future  Bioengineered Foods Consultations  GRAS Notices  Food Contact Substance Notifications

17. “Threshold“ Indirect Low-Exposure FCSs Higher-Exposure FCSs “Direct” Additives Macro-Ingredients (Including Macronutrient Substitutes and some GRAS ingredients) Tox- and Nutrition-based Review Whole Foods Including bioengineered foods or infant formula ingredient uses Traditional Tox- Based Review A “Food Ingredient Spectrum”