Considerations For The Use Of Animal Studies In The Risk Assessment Of Genetically Modified Plants

Transcription

1 Considerations For The Use Of Animal Studies In The Risk Assessment Of Genetically Modified Plants Laura Caneva, MSc Biotechnology Regulatory Affairs Specialist Bayer Crop Science

2 Outline 1. Safety Assessment of GM Crops 2. Use of Animal Studies in GM Crop Safety Assessments 3. Learnings from 20+ Years of Experience 4. The 3Rs Principle 5. Conclusions 2

3 1. Safety Assessment of GM Crops Standard Definition of Food Safety Food is not inherently safe Therefore, safety assessment uses the principle that: a reasonable certainty that no harm will result from intended uses under the anticipated conditions of consumption OECD, 1993 Food can be considered safe based on experience, therefore, a comparative safety assessment process relative to a conventional comparator with a History of Safe Use is used as safe as 3

4 1. Safety Assessment of GM Crops Integrated approach that was developed by international consensus over many years from the 1990 s to 2000 s (Codex, FAO/WHO, ILSI) Food/Feed Protein Crop Molecular GMO risk assessment Crop in its environment WEIGHT OF EVIDENCE APPROACH 4

5 1. Safety Assessment of GM Crops Step-wise approach Tier I studies Hazard identification Biological Function Mode of Action Molecular Characterization Comparative Assessment Agronomic Characteristics Phenotypic Characteristics Compositional Analysis 5

6 2. Use of Animal Studies in GM Crop Safety Assessments Step-wise approach Tier II studies If needed ACUTE ORAL TOXICITY Assessment of protein safety SUB-CHRONIC TOXICITY 28-day oral toxicity study 90-day feeding study Potential unintended effects NUTRITIONAL ASSESSMENT Livestock and poultry feeding studies Nutritional equivalence 6

7 2. Use of Animal Studies in GM Crop Safety Assessments Possible Outcomes of Substantial Equivalence Assessments Substantially equivalent to conventional counterpart Substantially equivalent to conventional counterpart except for introduced trait(s) Not substantially equivalent to accepted food or food component No further testing Focus assessment on trait(s) / gene product(s) Additional studies required on case by case basis to assess safety of the difference. 7

8 2. Use of Animal Studies in GM Crop Safety Assessments Animal feeding studies are most useful when a testable hypothesis is available: o The composition of the GM plant is modified substantially o Indications of possible unintended effects based on molecular/ compositional/agronomical analysis Limitations of animal feeding trials of whole foods/feeds: o Natural bulkiness of food o Intake limitations due to satiety o Need to maintain nutritionally balanced diet o Feed matrix effects can complicate data interpretation 8

9 3. Learnings from 20+ Years of Experience EU-funded projects research groups million* GMO Research GMO Safety Assessment 25 years GMO Regulatory Review Recent EU projects GRACE (2015) GMO90+ (2017) G-TwYST (2018) Conclusions Animal feeding studies are of limited value in the absence of a targeted hypothesis (EFSA", G- TwYST # ) * Devos, Y., et al., 90-day rodent feeding studies on whole GM food/feed. Science & Society, (7): p # 9

10 4. The 3Rs Principle A. Animal Studies 90-day feeding study: mandatory in EU but not in US, Canada, Australia and New Zealand Case-by-case requirement would reduce animals B. Omics methodologies Development of a targeted, sciencebased hypothesis Scientific justification for animal studies Tailoring the design of the animal feeding studies 10

11 5. Conclusions Safety assessment of GM crops follows a step-wise approach Tier I studies include molecular characterization, comparative assessment Tier II studies include animal studies (like acute toxicity or repeat-dose toxicity testing) when required 20+ years of EU-funded research concluded that animal studies e.g. 90-day feeding study are of limited value for GM crop safety assessment and should only be performed when a testable hypothesis is available a priori Omics approaches may become useful tools in the future to determine compositional changes and should be used when a targeted hypothesis is available 11

12 Thank you