China Developed ADI Formation Rules for Pesticide

China established guideline for ADI (acceptable daily intake) calculation of pesticide to set technical basis for MRL establishment and risk assessment to human.

 

The Chinese Ministry of Agricultural has published the Announcement No. 1825, “Guideline for Developing ADI of Pesticide”. The guideline is aimed at setting technical basis for MRL establishment and risk assessment to human.
 
Generally, the ADI (acceptable daily intake) of a pesticide substance can be obtained by dividing the NOAEFL (no-observed –adverse-effect level)or BMDL(benchmark dose level confidence limit) by the UF(uncertainty factor,). Different toxicity data obtained from different animals and human species shall employ different UFs in ADIs calculating, and the different UFs adopted in ADI deduction are in the table below.
 

Uncertainty circumstance

factor

Extrapolation from experimental animal to  general population, including:

Toxic kinetics difference

Toxic dynamic difference

10(total)

    4

2.5

Extrapolation from general population to susceptible population, including:

Toxic kinetics difference

Toxic dynamic difference

 

10(total)

3.16

3.16

Extrapolation from LOAEL to NOAEL

10

Deduction from sub-chronic experiment data to chronic data

10

Severe toxicity detected

10

Incomplete data collections

10

The guideline also provides some special circumstances for ADI developing: In cases of limited toxicity data or data collecting periods for ADI renewal, provisional ADIs shall be established; if the ais in one category are identical in toxic mechanism, target and effect, or the ais are similar in chemical structure, one ADI can be set for the whole category; if it is sufficiently indicated that the ai is risk-free of long-term exposures, ADI formation can be exempted.
 

Reference Link

MoA’s Announcement No.1825

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