What Syngentas Product Safety Department does

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What Syngentas Product Safety Department does
1, Human safety assessment
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In order to establish dietary exposure, we need
to know
1. the fate of a chemical in basic foods 2. the
quantities of parent and its breakdown products
in these foods
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Studies conducted to estimate dietary residue
level
Metabolism Primary crop Crop rotation Livestock
- ruminant and poultry Elevated temperature
hydrolysis
Residues Magnitude of Residue Rotational
Crop Livestock Feeding Study Processing
Residue in food (mg/kg)
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Assessing Mammalian Toxicity
are performed to characterize the hazard
1. A wide range of toxicological studies
3. The threshold values are then compared with
the estimated exposure levels to assess risks
An example where NOEL 10 mg/kg
2. The data obtained is inspected to
determine the following threshold values

• 1. No Observed Effect Level (NOEL) the highest
  level of continual exposure to a chemical which
  causes no significant adverse effect
• 2. Acceptable Daily Intake (ADI) the daily dose
  that will cause no adverse effects over a
  lifetime
• ADI NOEL / 100
• Assume that the most sensitive animal is 10 times
  less sensitive than the typical human
  (Interspecies)
• Assume that some humans are 10 times more
  sensitive than the typical human (Intraspecies)
• 3. Acute Reference Dose (ARfD) the dose that
  will cause no adverse effects after one dose
• 4. Acceptable Operator Exposure Level (AOEL)
  the daily dose that will cause no adverse effects
  in those applying the compound

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Risk Meter
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What Syngentas Product Safety Department does
2, Environmental safety assessment
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Assessing Environmental Fate and Exposure

• Laboratory Studies
• Fate Processes
• Field Studies
• Actual residue
• Movement
• Simulation Modelling
• Prediction
• Sensitivity

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Establish Environmental Exposure Level

• Simulation Modelling
• The data from lab and field studies are used to
  establish the Predicted Environmental
  Concentrations (PECs) of chemicals and their
  metabolites using specific models.
• Soil, Water, Air

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Ecological Hazard

• Non-target populations may be exposed to
  pesticides via soil, water and/or food
• Need to evaluate and demonstrate safety to
  non-target populations using predicted exposures

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Ecological Effects

• Evaluate safety to wildlife
• Data requirements toxicity to
• Mammals
• Birds
• Honeybees
• Non-target arthropods (beneficials)
• Earthworms other soil organisms
• Non-target plants
• Fish
• Aquatic invertebrates
• Algae
• Aquatic plants

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Ecological Effects

• Test Indicator Species
• Measure Endpoints
• Standardised methods (eg OECD)
• Mortality
• Reproduction/growth/development
• Progressive Testing
• Laboratory Studies
• Semi-field Studies
• Field studies
• Risk assessment
• Effects vs exposure
• Apply safety factors
• Unacceptable/acceptable risk
• Higher tier assessment if necessary