10.4 Product Risk Assessment
257
(b) Find the current maximum residue levels (MRL) for ASM in the EU (use the
EU pesticides database European Commission, 2019a) for each of the foods
included in Table 10.8.
(c) Carry out a simple calculation to define the predicted daily intake (PDI) [mg
kg
−1
bw d −1 ] of ASM for each of the three dietary age groups from each of the
foods in Table 10.8 for both the United Kingdom and Italy. Use the extracted
dietary intake values, and assume the MRL for each food is applied.
(d) Does the daily intake of ASM differ significantly between the various foods?
In each country, which of the three dietary groups is predicted to consume the
largest amount of ASM through this particular set of foods?
10.4.3 Effect Assessment (Step 3)
In this third step within product risk assessment, the relationship between the level
of exposure to a substance and the level of resulting effect is determined (the
dose-response relationship; see Sect. 6.5). For ASM, results from published toxicity
studies exist that can be used to help complete the effect assessment.
Many of these have been compiled within the EFSA conclusion on the peer
review of the pesticide risk assessment of ASM (EFSA, 2014a). In the tasks below,
values will be extracted from this document to represent acceptable exposure levels
for environmental health using toxicity studies on algae, daphnia, and fish species
as well as for human health considering data describing occupational and dietary
exposure.
10.4.3.1 Environmental Toxicity
A safe level of environmental exposure can be defined through the use of, e.g.,
a no observed effect concentration (NOEC) based on ecotoxicity studies and
an appropriate assessment factor to define the predicted no effect concentration
(PNEC).
Task: Review the published ecotoxicty data in the EFSA conclusion, and extract
the following toxicity values for these three aquatic organisms:
• EC 50 on biomass (EbC 50 ) for the algae species Scenedesmus subspicatus from a
72-hr static test
• NOEC for the daphnia species Daphnia magna from a 22-day semi-static test
• NOEC for the fish species Oncorhynchus mykiss from a 87-day flow-through test
10.4.3.2 Human Toxicity: Occupational
A safe level of occupational exposure during application of Bion ® can be defined
using an acceptable operator exposure level (AOEL) to ASM.
Task: What is the published AOEL for ASM within the EFSA conclusion?
257
(b) Find the current maximum residue levels (MRL) for ASM in the EU (use the
EU pesticides database European Commission, 2019a) for each of the foods
included in Table 10.8.
(c) Carry out a simple calculation to define the predicted daily intake (PDI) [mg
kg
−1
bw d −1 ] of ASM for each of the three dietary age groups from each of the
foods in Table 10.8 for both the United Kingdom and Italy. Use the extracted
dietary intake values, and assume the MRL for each food is applied.
(d) Does the daily intake of ASM differ significantly between the various foods?
In each country, which of the three dietary groups is predicted to consume the
largest amount of ASM through this particular set of foods?
10.4.3 Effect Assessment (Step 3)
In this third step within product risk assessment, the relationship between the level
of exposure to a substance and the level of resulting effect is determined (the
dose-response relationship; see Sect. 6.5). For ASM, results from published toxicity
studies exist that can be used to help complete the effect assessment.
Many of these have been compiled within the EFSA conclusion on the peer
review of the pesticide risk assessment of ASM (EFSA, 2014a). In the tasks below,
values will be extracted from this document to represent acceptable exposure levels
for environmental health using toxicity studies on algae, daphnia, and fish species
as well as for human health considering data describing occupational and dietary
exposure.
10.4.3.1 Environmental Toxicity
A safe level of environmental exposure can be defined through the use of, e.g.,
a no observed effect concentration (NOEC) based on ecotoxicity studies and
an appropriate assessment factor to define the predicted no effect concentration
(PNEC).
Task: Review the published ecotoxicty data in the EFSA conclusion, and extract
the following toxicity values for these three aquatic organisms:
• EC 50 on biomass (EbC 50 ) for the algae species Scenedesmus subspicatus from a
72-hr static test
• NOEC for the daphnia species Daphnia magna from a 22-day semi-static test
• NOEC for the fish species Oncorhynchus mykiss from a 87-day flow-through test
10.4.3.2 Human Toxicity: Occupational
A safe level of occupational exposure during application of Bion ® can be defined
using an acceptable operator exposure level (AOEL) to ASM.
Task: What is the published AOEL for ASM within the EFSA conclusion?