Codex Science-based Approach Codex Science-based Approach to the Safety of Foods Derived to the Safety of Foods Derived from Modern Biotechnologyfrom Modern Biotechnology

James H. Maryanski, Ph.D.James H. Maryanski, Ph.D.

Food and Drug AdministrationFood and Drug AdministrationCenter for Food Safety and Applied NutritionCenter for Food Safety and Applied Nutrition

Department of Health & Human ServicesDepartment of Health & Human Services

Codex Alimentarius Commission

• Established in 1962 by the United Nations’ World Health Organization and the Food and Agriculture Organization

• Codex is a collection of internationally adopted food standards that protect consumers’ health and ensure fair practices in the food trade

Ad Hoc Intergovernmental Task Force: Foods Derived from Modern

Biotechnology

• Established by CAC

• 4 years – 1999-2003

• Host - Japan, MHLW

• Meetings March 2000, 2001, 2002, & 2003

Task Force Terms of Reference

•“Consideration of the Elaboration of Standards, Guidelines, or Other Principles for Foods Derived from Biotechnology”

New Codex Guidelines

• Principles for Risk Analysis

• Guideline for Safety Assessment of Foods Derived from rDNA Plants

• Guideline for Safety Assessment of Foods Produced Using rDNA Microorganisms

• Source: www.codexalimentarius.net

Codex Principles for Risk Analysis

• Risk Assessment– Safety Assessment (Hazard identification)

• Risk Management

• Risk Communication

Safety Assessment

• Within the Risk Assessment Framework

• Substantial Equivalence:– Comparison: New Food v. Counterpart– Identify Differences –Evaluate safety– Intended & Unintended Effects Considered

• If Hazard Identified, Risk to Health Assessed

Definitions• Modern Biotechnology (Cartegena

Biosafety Protocol) – in vitro nucleic acid techniques, including rDNA…

• Recombinant-DNA Plant - changed through in vitro nucleic acid techniques (rDNA) & direct injection of cells

• Conventional Counterpart – related organism/component…safety based on common use as food.

Food Safety Assessment

• Description of rDNA plant• Description of the host plant & use as

food• Description of the donor organism(s)• Description of the genetic modification• Characterization of the genetic

modification• Safety assessment……

Safety Assessment, cont’d

• Expressed substances (non-nucleic acid)Annex- Possible allergenicity

• Compositional analyses (key components)

• Evaluation of metabolites

• Food processing

• Nutritional modification

• Other considerations (e.g. marker genes)

Description of the Genetic Modification

• The transformation process/host plant– Specific method (Agrobacterium-mediated)– Source, identity, function of DNA– Intermediate hosts

• The DNA to be introduced• All genetic components (genes, markers,

regulatory sequences, etc.)• Size, identity; location/orientation; function

Characterization of the Genetic Modification/DNA Insertion

• Number of sites & organization; copy number & sequence data of insert & surrounding region, sufficient to identify expressed substances, or analysis of transcripts or expression products that may be present in food.

• Open reading frames & insertions with contiguous plant DNA (fusion proteins)

Characterization of the Genetic Modification/ Expressed

Substances• Gene products, including un-translated

RNA• Function & phenotype• Level & site of expression; level of

metabolites in food• Amount of target gene product, if

function is to alter endogenous mRNA or protein

Genetic Modification Additional Information

• Arrangement of genetic material• Whether modifications to protein

sequence affect post-translation/function• Intended effect & heritable stability• Expression in appropriate tissues & any

evidence that host plant is affected• Identity & expression of any fusion

protein

Goals of Safety Assessment

• Food will not cause harm based on its intended use

• New food is as safe as its conventional counterpart

• Account for dietary impact of any nutritional changes

• Risk managers can determine if any special measures are needed