Concentration models tiers

In addition to the possibility for users to work with their own choices for all settings, MCRA implements four tiers from two documents:

  • The optimistic and pessimistic basic assessments from the EFSA 2012 Guidance on the Use of Probabilistic Methodology for Modelling Dietary Exposure to Pesticide Residues [EFSA, 2012].

  • Tier 1 and 2 from the European Commission working document SANTE-2015-10216 rev. 7 (2018) on risk management aspects related to the assessment of cumulative exposure [EC, 2018].

Overview

Table 38 Tier overview for module Concentration models.
Name EFSA 2012 Optimistic EFSA 2012 Pessimistic - Acute EFSA 2012 Pessimistic - Chronic EC 2018 Tier 1 EC 2018 Tier 2

Default concentration model

Empirical

NonDetectSpikeLogNormal

NonDetectSpikeLogNormal

Empirical

Empirical

Include MRL fallback model

false

true

true

false

false

Restrict LOR imputation to authorised uses

false

false

false

false

Non-detects replacement

ReplaceByZero

ReplaceByLOR

ReplaceByLOR

ReplaceByLOR

ReplaceByLOR

Factor f (f x LOR)

1

1

0.5

0.5

MRL Factor (f x MRL)

1

1

Sample based

true

true

true

true

true

Imputation of missing values

false

true

true

true

true

Correlate imputed values with sample potency

false

true

true

true

false

Use occurrence frequencies for imputation

true

true

Parametric uncertainty

false

true

false

false

false

The sections below describe the settings specified by each tier in detail.

EFSA 2012 Optimistic

Use the optimistic model settings according to the EFSA Guidance 2012. Non-detects and missing values are replaced by zero.

Table 39 Tier definition for EFSA 2012 Optimistic.
Name Setting

Default concentration model

Empirical

Include MRL fallback model

false

Non-detects replacement

ReplaceByZero

Sample based

true

Imputation of missing values

false

Correlate imputed values with sample potency

false

Parametric uncertainty

false

EFSA 2012 Pessimistic - Acute

Concentration model settings for acute pessimistic dietary exposure assessments according to the EFSA Guidance 2012. A non-detect spike lognormal model is fitted to the positive residue values and non-detects are replaced by the LOR. When the number of positives is smaller than 2, the maximum residue limit (if available) is used instead. Missing values are imputed.

Table 40 Tier definition for EFSA 2012 Pessimistic - Acute.
Name Setting

Default concentration model

NonDetectSpikeLogNormal

Include MRL fallback model

true

Restrict LOR imputation to authorised uses

false

Non-detects replacement

ReplaceByLOR

Factor f (f x LOR)

1

MRL Factor (f x MRL)

1

Sample based

true

Imputation of missing values

true

Correlate imputed values with sample potency

true

Parametric uncertainty

true

EFSA 2012 Pessimistic - Chronic

Concentration model settings for acute pessimistic dietary exposure assessments according to the EFSA Guidance 2012. A non-detect spike lognormal model is fitted to the positive residue values and non-detects are replaced by the LOR. When the number of positives is smaller than 2, the maximum residue limit (if available) is used instead. Missing values are imputed.

Table 41 Tier definition for EFSA 2012 Pessimistic - Chronic.
Name Setting

Default concentration model

NonDetectSpikeLogNormal

Include MRL fallback model

true

Restrict LOR imputation to authorised uses

false

Non-detects replacement

ReplaceByLOR

Factor f (f x LOR)

1

MRL Factor (f x MRL)

1

Sample based

true

Imputation of missing values

true

Correlate imputed values with sample potency

true

Parametric uncertainty

false

EC 2018 Tier 1

Table 42 Tier definition for EC 2018 Tier 1.
Name Setting

Default concentration model

Empirical

Include MRL fallback model

false

Restrict LOR imputation to authorised uses

false

Non-detects replacement

ReplaceByLOR

Factor f (f x LOR)

0.5

Sample based

true

Imputation of missing values

true

Correlate imputed values with sample potency

true

Use occurrence frequencies for imputation

true

Parametric uncertainty

false

Input tiers

Table 43 Input tiers for EC 2018 Tier 1.
Module Input tier
Occurrence patterns EC 2018 Tier 1
Concentrations EC 2018 Tier 1

EC 2018 Tier 2

Table 44 Tier definition for EC 2018 Tier 2.
Name Setting

Default concentration model

Empirical

Include MRL fallback model

false

Restrict LOR imputation to authorised uses

false

Non-detects replacement

ReplaceByLOR

Factor f (f x LOR)

0.5

Sample based

true

Imputation of missing values

true

Correlate imputed values with sample potency

false

Use occurrence frequencies for imputation

true

Parametric uncertainty

false

Input tiers

Table 45 Input tiers for EC 2018 Tier 2.
Module Input tier
Occurrence patterns EC 2018 Tier 2
Concentrations EC 2018 Tier 2

EFSA 2012 Pessimistic

Note

This tier is deprecated and has been replaced by separate acute/chronic tiers.

Concentration model settings for pessimistic dietary exposure assessments according to the EFSA Guidance 2012. A non-detect spike lognormal model is fitted to the positive residue values and non-detects are replaced by the LOR. When the number of positives is smaller than 2, the maximum residue limit (if available) is used instead. Missing values are imputed.

Table 46 Tier definition for EFSA 2012 Pessimistic.
Name Setting

Default concentration model

NonDetectSpikeLogNormal

Include MRL fallback model

true

Restrict LOR imputation to authorised uses

false

Non-detects replacement

ReplaceByLOR

Factor f (f x LOR)

1

MRL Factor (f x MRL)

1

Sample based

true

Imputation of missing values

true

Correlate imputed values with sample potency

true

Parametric uncertainty

true