Additives and Ingredients Subcommittee Food Advisory Committee

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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

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MISSION STATEMENT FOOD INGREDIENT SAFETY PROGRAM
To assure that the use of food ingredients is
safe by

• 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

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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.
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Food AdditiveSafety 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
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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

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Statutory Definitionof Food AdditiveFDC 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
  recognizedas safe.

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Food Ingredient Universe
Processing Aids Antimicrobials (meat and poultry
processing) Defoamers Ion exchange resins
Direct Food Ingredients Sweeteners
Preservatives Nutrients Fat substitutes
Texturizers (thickeners, emulsifiers, etc.)
Flavors
Food Irradiation Equipment To Process food To
Inspect food
Color Additives In food, animal feed, drugs,
cosmetics, and medical devices (i.e., sutures and
contact lenses)
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
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.
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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 Secretarys
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 . . . .
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REASONABLE CERTAINTY OF NO HARM(Legislative
History of the FDC Act)
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
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Standard of Safetyfor 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.
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General Approach for Food Safety Assessment
Goal New Food Must Be as Safe as Todays Food
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The olden daysONE FLAVOR

• Food and Color Additive Petitions
• GRAS Affirmation Petitions

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FOOD ADDITIVE PETITION REVIEWTHE SAFETY DECISION
What the safety evaluation is NOT

• It is NOT an academic inquiry or academic
  research
• It is NOT a search for complete knowledge
• 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
• It is NOT intended to enforce or limit consumer
  or producer
• choices among safe foods (e.g., Need is NOT a
  Criterion)

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FOOD ADDITIVE PETITION REVIEWTHE SAFETY DECISION

• 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

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Notification Programsthe shape of the future

• Bioengineered Foods Consultations
• GRAS Notices
• Food Contact Substance Notifications

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