Food Safety Assessment of Foods Derived From RecombinantDNA Plants

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Food Safety Assessment of Foods Derived From
Recombinant-DNA Plants

• Codex Alimentarius Commission

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Codex Alimentarius Commission

• fundamentals
• intergovernmental body 167 members
• reports to FAO and WHO
• objectives
• protecting the health of consumers
• ensuring fair practices in the food trade
• publishing standards for food quality and safety

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Codex standards at work

• used as a basis of national regulation
• reference point for the WTO
• Agreement on the Application of Sanitary and
  Phytosanitary Measures (SPS)
• Agreement on Technical Barriers to Trade (TBT)

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Participation

• national delegations (delegates, alternates,
  advisors)
• UN and other agencies
• international NGOs
• industry, producers, civil society, scientific
  organizations

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Foods derived from biotechnology

• work in progress
• labelling
• specifications for enzymes
• principles for risk analysis
• guidelines on risk assessment
• methods of analysis and detection

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Codex intergovernmental task force on foods from
biotechnology

• established 1999
• host government - Japan
• meetings in 2000, 2001, 2002
• ad hoc working group on drafts
• ad hoc working group on methods
• open to all members and international NGOs

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Task Force consensus achieved

• principles for the risk analysis of foods derived
  from modern biotechnology
• guideline for the conduct of safety assessment of
  foods derived from recombinant-DNA plants
• list of validated methods for analysis

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Final Process after achieving consensus in the
Task Force

• Adoption by the Codex Alimentarius Commission
  (June 30-July 7, 2003) is expected.
• Principles for the risk analysis of foods derived
  from modern biotechnology
• Guideline for the conduct of safety assessment of
  foods derived from recombinant-DNA plants

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Task Force work underway

• Guideline for the conduct of food safety
  assessment of foods produced using
  recombinant-DNA microorganisms

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Scientific Inputs to the Codex Task Force

• Joint FAO/WHO Expert Consultation on Foods
  derived from Biotechnology
• Safety Aspects of Genetically Modified Foods of
  Plant Origin (29 May- 2 June 2000 )
• Evaluation of Allergenicity of Genetically
  Modified Foods (22-25 January 2001)
• Safety Assessment of Foods derived from
  Genetically Modified Microorganisms
  (24-28 September 2001)

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PRINCIPLES FOR THE RISK ANALYSIS OF FOODS DERIVED
FROM MODERN BIOTECHNOLOGY

• Main Themes

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Risk analysis

• included
• food safety
• nutritional aspects
• excluded
• environmental, and ethical, moral and
  socio-economic aspects of research, development,
  production and marketing

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Risk assessment

• whole food or component relative to an
  appropriate conventional counterpart taking into
  account
• intended and unintended effects
• new or altered hazards
• changes relevant to human health
• changes in key nutrients

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Pre-market assessment

• structured and integrated
• case-by-case basis
• science of a quality and quantity to withstand
  scientific peer review

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Risk management

• measures proportional to the risk
• other factors taken into account
• uncertainties taken into account
• measures may include
• labelling
• conditions for marketing approvals
• post-market monitoring

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Post-market monitoring

• case-by-case basis to
• verify conclusions of the safety assessment
• monitor changes in nutrient intake levels to
  determine their human health impact.

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Tools to facilitate the risk management

• Tools to facilitate the implementation and
  enforcement of risk management measures
• analytical methods
• reference materials
• tracing of products

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Risk communication

• at all stages of the safety assessment and risk
  management process with all interested parties
• government, industry, academia, media and
  consumers
• fully documented
• consultative

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Consistency

• consistent approach safety and nutritional risks
• acceptable level of risk should be consistent
  with that for similar foods
• consistency of data requirements, assessment
  frameworks, communication and consultation
  mechanisms

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Capacity building

• Essential for developing countries to
• assess and manage and communicate risks
• enforce rules
• interpret assessments of other bodies

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Review process

• ensure consistency with new scientific knowledge
  and other information relevant to risk analysis
• risk management measures to be adapted if
  necessary

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FOOD SAFETY ASSESSMENT OF FOODS DERIVED FROM
RECOMBINANT-DNA PLANTS

• Highlights

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Framework of Safety Assessment

• Description of the recombinant-DNA plant
• Description of the host plant and its use as food
• Description of the donor organism(s)
• Description of the genetic modification(s)
• Characterization of the genetic modification(s)
• Safety Assessment

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Safety assessment

• expressed substances (non-nucleic acid
  substances)
• compositional analyses of key components
• evaluation of metabolites
• effect of food processing
• nutritional modification

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Allergenicity

• Assessed in all cases when protein is present
• Multifactorial approach using various criteria in
  combination
• Evaluation for gluten-sensitive enteropathy if
  the introduction is from wheat, etc.

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Nutritional modifications

• Intentional nutritional changes must be assessed
  taking into account
• requirements of specific population groups
• bioavailability and stability with time,
  processing and storage
• geographical and cultural variation in food
  consumption patterns

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Antibiotic resistance marker genes

• alternative, safe technologies recommended
• if risks to human health suggested, marker genes
  should not be present in food
• genes that encode resistance to clinically used
  antibiotics should not be present

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Guideline for the conduct of safety assessment of
foods derived from recombinant-DNA plants already
used

• by some member countries as a basis for safety
  assessment.