Pesticide Registration Toolkit

Introduction

The general protection goal is to protect biodiversity and ecosystems. The focus is on the protection and maintenance of populations taking into account both soil function and organisms (invertebrates, micro-organisms) important for proper soil function and nutrient cycle conservation.

The major route of exposure is direct exposure at time of application. Other routes of exposure include treated substrate for growing crops disposed on land and plant material, treated with pesticide prior to planting.

The acute and chronic risks to soil organisms are generally assessed using a tiered approach. An initial (screening) level risk assessment assumes a worst-case scenario and identifies those pesticides and associated uses that do not pose a risk to soil organisms. When acceptable risk cannot be determined at the initial (screening ) level then more refined higher tier risk assessments are undertaken and/or risk mitigation measures applied.

What this page contains

This table summarises the principles applied during the risk assessment to determine whether the environmental risks in relation to soil ( earthworms, other soil macro-organisms and soil micro-organism) are acceptable. The focus is on the screening level assessment. The screening level assessment identifies those pesticides and uses where no further testing or analysis is required. Where available, links to documents that describe the more complex higher tier assessment in more detail are provided.

Summary analysis

As for surface water and aquatic species, the reader needs to be aware that a key issue for environmental risk assessment in relation to soil and soil organisms is the limitations inherent in extrapolation from a limited number of test species to a comparatively large number of potential species at risk. Some regulatory frameworks more precisely describe the setting of specific protection goals for soil organism (for example, earthworms), while others rely on the problem formulation component of the risk assessment to identify the specific protection goal and suitable indicator species.

 

 

Australia

Aspect

Description

Links to risk assessment guidelines, manuals and science policy documents

Hazard assessment and end-point selection

The following endpoints are derived from the hazard assessment:

  • Macro-organisms
    • for acute toxicity the relevant LC50
    • for chronic toxicity the relevant NOEC

 

  • Micro-organisms
    • for chronic toxicity the relevant NOEC

Setting of toxicological reference values and the use of assessment factors

The RAC is calculated for acute and chronic exposure scenarios using the following assessment factors:

  • Macro-organisms
    • for the LC50 (acute toxicity) an assessment factor of 10 is applied
    • for the NOEC (chronic toxicity) an assessment factor of 1 is applied

 

  • Micro-organisms
    • for the NOEC (chronic toxicity) an assessment factor of 1 is applied

Exposure assessment

The exposure assessment involves the calculation of the PEC. The screening level risk assessment assumes the works-case scenario of a direct overspray of soil without interception.

If it is necessary to refine the assessment for any particular taxonomic group or process, crop interception is considered.

If necessary further assessment using higher tier studies ( eg community/population studies or field studies) may be conducted.

Risk assessment and acceptability criteria

The risk assessment compares the PEC to the RAC to arrive at a risk quotient: RQ= PEC/RAC

Risks are considered to be acceptable where the RQ<=1.

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Canada

Aspect

Description

Links to risk assessment guidelines, manuals and science policy documents

Hazard assessment and end-point selection

Canada does not require data on soil micro-organisms.

Data on earthworms is required and assessed.

The following end-points are derived from the hazard assessment:

  • Earthworms
    • for acute toxicity the LC50
    • for chronic toxicity the NOEC

Setting of toxicological reference values and the use of assessment factors

  • Earthworms:
    • for the LC50 (acute toxicity) an assessment factor of 2 is applied
    • for the NOEC (chronic toxicity) an assessment factor of 1 is applied

Exposure assessment

The EEC is calculated based on a direct application (soil depth 15cm and soil density of 1.5g/cm3).

Where the pesticides is used multiple times in one season, the (cumulative) EEC is calculated by adjusting the sum of the applications for dissipation between applications using a soil DT50 and the application interval.

Risk assessment and acceptability criteria

The risk to earthworms is determined by dividing the EEC in soil by the toxicological reference value to calculate a RQ. The LOC is 1.

Risks are considered to be acceptable where the RQ<=1

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China

Aspect

Description

Links to risk assessment guidelines, manuals and science policy documents

Hazard assessment and end-point selection

n.a.

Setting of toxicological reference values and the use of assessment factors

The PNEC based on endpoints and an uncertainty factor is calculated.

  • For earthworms:
    • The uncertainty factor is 10 for acute and study
    • The uncertainty factor is 5 for chronic study
    • For soil microorganisms nitrogen transformation test, the uncertainty factor is 1.

Exposure assessment

• "PECsoil_SFO_30Y"(an Excel spreadsheet) is used as a 1st tier exposure model.

China-PEARL model can be used as a higher tier exposure model

Risk assessment and acceptability criteria

n.a.

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EU

Aspect

Description

Links to risk assessment guidelines, manuals and science policy documents

Hazard assessment and end-point selection

The following end-points are derived from the hazard assessment:

  • Macro-organisms
    • sublethal effects EC10 or EC20 and NOEC

 

  • Micro-organisms
    • nitrogen transformation - percentage effect in a test at maximum predicted concentration in soil relative to the control and in a test at a multiple of the maximum predicted concentration (worst case) relative to the control

Setting of toxicological reference values and the use of assessment factors

n.a.

Exposure assessment

The exposure assessment involves the evaluation of fate and behaviour of the pesticide and transformation products in soil and the calculation of PECs.

Initial PEC values after single or multiple applications and PEC plateau values are calculated according to FOCUS.  The choice of the relevant PEC to be used for risk assessment depends on characteristics of the substance (eg persistence in soil) and intended uses.

Tier 1 assessment is based on the assumption that crop interceptions does not occur. If acceptability criteria are not met higher tier assessments are required.

Detailed guidance for the tiered approach for exposure assessment of soil organisms in three regulatory zones and EU member states is provided in
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2017.4982

Software tools are available for higher tier assessments including Persistence in Soil Analytical Model (PERSAM) and Pesticide Emission at regional and local scales (PEARL) and Pesticide Leaching Model (PELMO)

Risk assessment and acceptability criteria

For earthworms and soil macro-organism risk is characterised using a TER. For soil micro-organisms the magnitude of effect is assessed.

In accordance with Commission Regulation (EU) 546/2011 no authorisation can be granted:

  • where there is the possibility of earthworms being expose, if the acute toxicity/exposure ratio for earthworks is less than 10 or the long-term toxicity/exposure ration is less than 5
  • where there is a possibility of non-target soil micro-organisms being exposed if the nitrogen or carbon mineralisation processes in laboratory studies are affected by more than 25% after 100 days

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USA

Aspect

Description

Links to risk assessment guidelines, manuals and science policy documents

The US does not routinely require data on terrestrial soil organisms.
Earthworm data is only conditionally required, as necessary.

Hazard assessment and end-point selection

n.a.

Setting of toxicological reference values and the use of assessment factors

n.a.

Exposure assessment

n.a.

Risk assessment and acceptability criteria

n.a.

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Can the legislative criteria be applied in other countries?

In some countries risks to soil (earthworms, other soil macro-organisms and soil micro-organisms)  is only considered on a case-by-case basis. Some countries only assess data in relation to earthworms while other countries or regions will conduct a comprehensive risks assessment of soil (macro- and micro-organisms). Country or regional policy should determine whether, and what, they will include soil organisms as an environmental protection goal.

Where environmental risks in relation to soil are assessed, the criteria for assessing the risks are not consistent across regulatory frameworks Thus hazard assessment and end-point selection for soil organisms vary across regulatory frameworks. Some, but not all regulatory frameworks, set toxicological reference values for soil organisms.

The exposure assessment involves estimating concentrations of the pesticide in soil based on the user of scenarios, however different regulatory frameworks use different scenarios which will impact the outcome of the assessment.

Screening level assessments based on laboratory studies using standard test organisms and soils may be suitable for application in other countries. For higher tier risk assessments is important that the regulator understands the scope and limitations of models they intend to use. Higher tier risk assessment methods and models used are generally are based on local cropping situations, ecosystems, soil characteristics and weather. Country/region specific models based on site-specific, local cropping situations, ecosystems, soil characteristics and weather may not readily be applied in other countries.

Some regulatory frameworks use  a risk quotient approach comparing the estimated environmental exposure to the toxicological reference value to determine whether risks are acceptable. Other regulatory frameworks use a toxicity to exposure ratio and compare these to trigger values (levels of concern) set out in legislation. Country or regional policy should determine whether to use a risk quotient approach or a toxicity to exposure ratio approach and what trigger values (levels of concern), if any, to apply