Additives and Ingredients Additives and Ingredients Subcommittee Subcommittee

Food Advisory CommitteeFood Advisory Committee

The Office of Food Additive SafetyThe Office of Food Additive Safety

George PauliGeorge Pauli

Associate Director for Science and PolicyAssociate Director for Science and Policy

Office of Food Additive SafetyOffice of Food Additive Safety

August 26, 2003August 26, 2003

MISSION STATEMENT MISSION STATEMENT FOOD INGREDIENT SAFETY PROGRAMFOOD INGREDIENT SAFETY PROGRAM

Evaluating new applications efficiently & effectivelyEvaluating new applications efficiently & effectively Expediting applications that mitigate food hazardsExpediting applications that mitigate food hazards Meeting high performance standards with strong Meeting high performance standards with strong

science and modern infrastructurescience and modern infrastructure Directing resources to issues of greater public health Directing resources to issues of greater public health

importance while anticipating future trendsimportance while anticipating future trends Maintaining data to monitor safety over timeMaintaining data to monitor safety over time Conducting research that supports the FDA regulatory Conducting research that supports the FDA regulatory

agendaagenda

To assure that the use of food ingredients is safe by:

Food Safety Decision FrameworkFood 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.

Food AdditiveFood AdditiveSafety Decision FrameworkSafety 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

Food, Drug, and Cosmetic ActFood, Drug, and Cosmetic Act (as amended, ‘58, ‘60, ‘94, ‘97) (as amended, ‘58, ‘60, ‘94, ‘97)Food, Drug, and Cosmetic ActFood, Drug, and Cosmetic Act

(as amended, ‘58, ‘60, ‘94, ‘97) (as amended, ‘58, ‘60, ‘94, ‘97)

Defines “food additiveDefines “food additive,” ,” w/ GRAS exemptionw/ GRAS exemption

Requires Requires premarket approvalpremarket approval of new uses of food of new uses of food additivesadditives

Establishes the Establishes the standard of reviewstandard of review

Establishes the Establishes the standard of safetystandard of safety

Establishes formal rulemaking proceduresEstablishes formal rulemaking procedures– Petition or Agency InitiativePetition or Agency Initiative

------------since FDAMA of 1997:------------------------------since FDAMA of 1997:------------------Defines “food contact substance” (FCS)Defines “food contact substance” (FCS)

Establishes a premarket notification program for FCSsEstablishes a premarket notification program for FCSs

Statutory DefinitionStatutory Definitionof “Food Additive”of “Food Additive”

FD&C Act Section 201(s)FD&C Act Section 201(s)

““The term ‘food additive’ means any substance The term ‘food additive’ means any substance the intended use of which results or may the intended use of which results or may reasonably be expected to result, directly or reasonably be expected to result, directly or indirectly, in its becoming a component or indirectly, in its becoming a component or otherwise affecting the characteristics of any otherwise affecting the characteristics of any food…food…

… …if such substance is not generally if such substance is not generally recognized…as saferecognized…as safe….”….”

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 biotechnologyPlants 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” UniverseFood “Ingredient” Universe

House of Representatives, Report No. House of Representatives, Report No. 2284, “Food Additives Amendment of 1958”2284, “Food Additives Amendment of 1958”

House of Representatives, Report No. House of Representatives, Report No. 2284, “Food Additives Amendment of 1958”2284, “Food Additives Amendment of 1958”

Committee on Interstate & Foreign Committee on Interstate & Foreign Commerce, 85th Congress, 2nd Session, July Commerce, 85th Congress, 2nd Session, July

28, 195828, 1958

Committee on Interstate & Foreign Committee on Interstate & Foreign Commerce, 85th Congress, 2nd Session, July Commerce, 85th Congress, 2nd Session, July

28, 195828, 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 . . . .”

“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 REASONABLE CERTAINTY OF NO HARMHARM

((Legislative History of the FD&C Act)Legislative History of the FD&C Act)

Standard of SafetyStandard of Safetyfor New Food Additivesfor New Food Additives

Standard of SafetyStandard of Safetyfor New Food Additivesfor 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.

General Approach for Food Safety Assessment

Goal: “New” Food Must Be as Safe as “Today’s” Food

The “olden days:”The “olden days:”“ONE FLAVOR”“ONE FLAVOR”

Food and Color Additive Food and Color Additive PetitionsPetitions

GRAS Affirmation GRAS Affirmation PetitionsPetitions

FOOD ADDITIVE PETITION REVIEWFOOD ADDITIVE PETITION REVIEWTHE SAFETY DECISIONTHE SAFETY DECISION

It is NOT an academic inquiry or academic researchIt 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: safety with absolute certainty: (“Reasonable Certainty of No (“Reasonable Certainty of No Harm” Harm” rather than “rather than “Certainty of No Theoretical Possibility ofCertainty of No Theoretical Possibility ofHarmHarm”)”)

Does NOT weigh risks and benefitsDoes NOT weigh risks and benefits

It is NOT intended to enforce or limit consumer or producerIt 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:

• 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 REVIEWFOOD ADDITIVE PETITION REVIEWTHE SAFETY DECISIONTHE SAFETY DECISION

Notification Programs…Notification Programs…the shape of the futurethe shape of the future

Bioengineered Foods ConsultationsBioengineered Foods Consultations

GRAS NoticesGRAS Notices

Food Contact Substance NotificationsFood Contact Substance Notifications

“Threshold“Indirect

Low-Exposure FCSs

Higher-ExposureFCSs

“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”A “Food Ingredient Spectrum”A “Food Ingredient Spectrum”A “Food Ingredient Spectrum”