FAOWHO Expert Consultations Foods derived from Biotechnology

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FAO/WHOExpert ConsultationsFoods derived from
Biotechnology

• Jørgen Schlundt, DVM, PhD
• Coordinator, Food Safety Programme
• World Health Organization

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Biotechnology is it safe?

• Biotech products should not be evaluated en
  bloque - they are not inherently safe or
  inherently unsafe
• Each product should be evaluated in its own
  right, case by case
• New products with nutritional implications means
  that assessments need to look at both safety and
  benefit

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FAO and WHO Expert ConsultationsBiotechnology

• A number of Consultations throughout the 90ies
• New line of Consultations from 2000 interacting
• with the Codex task force, focusing on
• Plants
• Allergenicity
• Microorganisms
• Animals
• etc.

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Expert ConsultationsExpert Selection

• - All parties informed through Circular letter
  and other media
• - Experts evaluated by Panel with external
  participation
• - Qualified experts placed on a Roster on the web
• - Experts selected from Roster according to
  published criteria, ensuring broad scientific
  base and geographical coverage
• - Experts participate in own right and declare
  interest

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Food and Agriculture Organizationof the United
Nations
World Health Organization
Safety aspects of genetically modified foods of
plant origin Report of a Joint FAO/WHO Expert
Consultation on Foods Derived from Biotechnology
World Health Organization, Headquarters Geneva,
Switzerland 29 May - 2 June 2000
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Evaluation of the Concept of Substantial
Equivalence

• - S.E. is not an endpoint but a starting point of
  the safety assessment
• - Compositional analysis should not be the sole
  basis for determining safety
• - Equivalence difficult with new products
• -----------
• - A safety assessment of GM foods with
  conventional foods as initial reference

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Unintended Effects

• Predictable effects
• based on metabolic connections or information on
  insertion site
• Unexpected effects
• Statistically significant differences should be
  assessed for their biological significance

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Some Recommendations of the Consultation

• Pursue research and standardisation of animal
  studies with whole foods
• Profiling techniques to detect unintended effects
  to be further developed and validated
• Nutrient levels of plants should be monitored and
  effect on nutritional status should be assessed.
• Integration of nutritional and safety assessment

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Food and Agriculture Organizationof the United
Nations
World Health Organization

• Evaluation of Allergenicity of
• Genetically Modified Foods
• Report of a Joint FAO/WHO Expert Consultation on
  Allergenicity of Foods
• Derived from Biotechnology
• 22 - 25 January 2001, Rome, Italy

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Adverse Reactions to Food
Toxic
Non toxic
Immune mediated Food allergy
Non immune mediated Food intolerance
Food allergies 1-2 total, infants 5-8
Coeliac disease 0.3 - 0.03
Ortolani and Vighi, 1995
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FAO/WHO 2001 Decision Tree
Assessment of the Allergenic Potential of Foods
Derived from Biotechnology FAO-WHO 2001
Source of Gene Allergenic
Yes
No
Sequece Homology
Sequence Homology
No
No
Yes
Yes
Specific Serum Screen
Targeted Serum Screen
No
No
Yes
Pepsin Resistance Animal Models
Yes
Likely Allergenic
/ /- -/- High Low Probability of
Allergenicity
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Food and Agriculture Organizationof the United
Nations
World Health Organization

• Evaluation of Foods derived from
• recombinant-DNA microorganisms
• NEXT CONSULTATION
• 23 - 27 September 2001, Geneva, Schwitzerland

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The future of safety/risk assessment of GM foods

• Potential benefits on new GM foods, especially in
  developing countries, will not be achieved
  without a holistic view on the evaluation of such
  foods.
• New issues relative to a holistic view of GM
  foods suggest coordinating evaluation of safety,
  nutrition, environmental, socioeconomic and other
  factors

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Biotechnology Analysis
socioeconomic
nutrition
Scientific Assessment
Problem Management
ethical
safety
policy
efficacy
Communication
Interactive exchange of information and
opinions
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The transparency of safety/risk assessment of GM
foods

• - The acceptability of GM foods should not be
  confused with the safety of such foods.
• - Acceptability will in many cases be linked to a
  clear understanding of the assessment process
• - The potential of ordinary consumers to
  understand safety assessment should not be
  underestimated.
• - The consumers right to be concerned and to be
  continually informed should be acknowledged

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