Fda cfsan s science based approach to the safety of foods derived from modern biotechnology
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FDA/CFSAN’s Science-based Approach to the Safety of Foods Derived from Modern Biotechnology. Thomas A. Cebula, Ph.D. Director, Office of Applied Research and Safety Assessment Center for Food Safety and Applied Nutrition. The Process.

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Fda cfsan s science based approach to the safety of foods derived from modern biotechnology

FDA/CFSAN’s Science-based Approach to the Safety of Foods Derived from Modern Biotechnology

Thomas A. Cebula, Ph.D.

Director, Office of Applied Research

and Safety Assessment

Center for Food Safety and Applied Nutrition


The process
The Process Derived from Modern Biotechnology

  • Requests notification when industry plans to market a product derived by bioengineered plants

  • Encourages that industry consult with us and provide necessary documentation to ensure ‘reasonable certainty of no harm’

    • Opportunity to discuss plans for future cultivars


The process1
The Process Derived from Modern Biotechnology

  • Specific tests are not specified

Intent: To focus on the characteristics of the food product


Scientific evaluation
Scientific Evaluation Derived from Modern Biotechnology

  • Food Safety

  • Strengths/Limitations


Scientific evaluation1
Scientific Evaluation Derived from Modern Biotechnology

  • Food Safety

  • Approach is multidisciplinary

    • Agronomic and quality characteristics

    • Characteristics of new substances

    • Chemical and nutritional analysis

    • Genetic analysis

  • A bioengineered variety is evaluated relative to its traditional counterpart


Scientific evaluation2
Scientific Evaluation Derived from Modern Biotechnology

  • Food Safety

  • Identity and source of introduced genetic materials

  • Genetic stability

  • Intended changes to the composition of the food


Scientific evaluation3
Scientific Evaluation Derived from Modern Biotechnology

  • Food Safety

  • Allergenicity

  • Toxins

  • Nutrient Levels

  • Antibiotic Resistance


Food safety assessment
Food Safety Assessment Derived from Modern Biotechnology

  • 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 cont d
Safety Assessment, cont’d Derived from Modern Biotechnology

  • Expressed substances (non-nucleic acid)

  • Compositional analyses (key components)

  • Evaluation of metabolites

  • Food processing

  • Nutritional modification

  • Other considerations (e.g. marker genes)


Description of the genetic modification
Description of the Genetic Modification Derived from Modern Biotechnology

  • 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
Characterization of the Genetic Modification/DNA Insertion Derived from Modern Biotechnology

  • 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
Characterization of the Genetic Modification/ Derived from Modern BiotechnologyExpressed 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
Genetic Modification Derived from Modern BiotechnologyAdditional 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


Fda cfsan s science based approach to the safety of foods derived from modern biotechnology

Scientific Evaluation Derived from Modern Biotechnology

  • Scientific

  • Strengths/Limitations

As only one or a few genes are being incorporated into the plants, there is a limited number of manipulations.

As we move forward, traditional breeding will likely be used to transfer a desired rDNA modification into desired plant varieties.


Evaluating bioengineered plants
Evaluating Bioengineered Plants Derived from Modern Biotechnology

What tests are necessary?

Are there tests that should be required?


Fda cfsan s science based approach to the safety of foods derived from modern biotechnology

Evaluating Derived from Modern BiotechnologyBioengineered Plants

What tests are necessary?

Are there tests that should be required?

RR vs rr: 62 of 636 protein spots on a 2-D gel are qualitatively different. R-locus affects sugar content, lipid content, storage protein composition, and shape and size of starch granules.


Fda cfsan s science based approach to the safety of foods derived from modern biotechnology

Evaluating Bioengineered Plants Derived from Modern Biotechnology

What tests are necessary?

Are there tests that should be required?

Afila (af) mutants which replace leaflets with tendrils, and the tendril-less (tl) mutant which replaces tendrils with leaflets. Both tl/tl and af/af lines have the identical 686 protein profiles.

--Gottlieb & de Vienne, Genetics, 119:705-710 (1988)


Fda cfsan s science based approach to the safety of foods derived from modern biotechnology

Evaluating Bioengineered Plants Derived from Modern Biotechnology

Pleiotropy is virtually universal, i.e., essentially all gene substitutions have multiple phenotypic consequences when the phenotype is examined in sufficient detail.


Can pattern recognition work

Can Pattern Recognition Work? Derived from Modern Biotechnology