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10 Illustrative Case Study
10.4.3.3 Human Toxicity: Dietary
An acceptable daily intake (ADI) is a measure of the amount of a specific substance
in food or drinking water that can be orally ingested by everyone on a daily basis
over a lifetime without an appreciable health risk. This can be defined, e.g., for a
food additive or residue of a veterinary drug or pesticide.
Task: What is the published ADI for ASM within the EFSA conclusion?
10.4.4 Risk Characterization and Classification (Step 4)
With both some of the potential exposures and reported effects of ASM analyzed,
these can now be compared in order to characterize and classify risks that could
exist (see Sect. 6.6).
10.4.4.1 Risk to the Environment
Task: Consider the predicted environmental concentration (PEC) in the water
compartment as estimated from the small-region model assuming a worst-case
scenario that the maximum application rate of Bion ® is used, and it is all released
directly into the water compartment. Also, consider the EC 50 and NOEC values of
the three aquatic species identified during the effect assessment in the previous step.
Using an assumed assessment factor of 10 to consider the most sensitive organism
within each species, calculate the PNEC and the risk quotient for this scenario. Is
there a risk estimated to be posed in this case according to these toxicity studies at
this environmental concentration?
10.4.4.2 Risk to Humans: Occupational
Task: Consider the calculated longer-term operational exposures to ASM from
the EFSA tool and the published value of the AOEL identified during the effect
assessment in the previous step. For the two operational exposure scenarios
calculated using the tool (i.e., with and without PPE), what is the longer-term
systemic exposure in % of the AOEL? Is there a risk posed based on these values?
10.4.4.3 Risk to Humans: Dietary
Task: Compare the calculated PDI values of ASM across the different age groups
and countries to the published EFSA value of the ADI. Is there a risk posed to any
group based on these values?
10 Illustrative Case Study
10.4.3.3 Human Toxicity: Dietary
An acceptable daily intake (ADI) is a measure of the amount of a specific substance
in food or drinking water that can be orally ingested by everyone on a daily basis
over a lifetime without an appreciable health risk. This can be defined, e.g., for a
food additive or residue of a veterinary drug or pesticide.
Task: What is the published ADI for ASM within the EFSA conclusion?
10.4.4 Risk Characterization and Classification (Step 4)
With both some of the potential exposures and reported effects of ASM analyzed,
these can now be compared in order to characterize and classify risks that could
exist (see Sect. 6.6).
10.4.4.1 Risk to the Environment
Task: Consider the predicted environmental concentration (PEC) in the water
compartment as estimated from the small-region model assuming a worst-case
scenario that the maximum application rate of Bion ® is used, and it is all released
directly into the water compartment. Also, consider the EC 50 and NOEC values of
the three aquatic species identified during the effect assessment in the previous step.
Using an assumed assessment factor of 10 to consider the most sensitive organism
within each species, calculate the PNEC and the risk quotient for this scenario. Is
there a risk estimated to be posed in this case according to these toxicity studies at
this environmental concentration?
10.4.4.2 Risk to Humans: Occupational
Task: Consider the calculated longer-term operational exposures to ASM from
the EFSA tool and the published value of the AOEL identified during the effect
assessment in the previous step. For the two operational exposure scenarios
calculated using the tool (i.e., with and without PPE), what is the longer-term
systemic exposure in % of the AOEL? Is there a risk posed based on these values?
10.4.4.3 Risk to Humans: Dietary
Task: Compare the calculated PDI values of ASM across the different age groups
and countries to the published EFSA value of the ADI. Is there a risk posed to any
group based on these values?