EFSA/2025/LVP/0002 - Support from Member States on NAMs4PestRes

Call reference: EFSA/2025/LVP/0002

Deadline to register interest: 10/02/2015

Background

In 2023 EFSA launched a project [1] to promote the use of New Approach Methods (NAMs) into the risk assessment of pesticide residues metabolites (NAMs4PestRes) through the use of the OECD QSAR toolbox, a free available in silico tool managed by ECHA, to enhance connectivity of IUCLID and MetaPath and to implement embedded in silico models. The result will be an automated and standardized workflow for the assessment of mutagenicity (bacterial gene mutation) of pesticide residue metabolites to be implemented in a software application within the OECD QSAR toolbox. The workflow will be designed by the software developer of the OECD QSAR and MetaPath.

The workflow will consider the identity and quantity of the residues to be assessed as well as the main steps of toxicological evaluation of residue metabolites based on experimental data on the residue (if available), coverage of the metabolite by the parent compound based on the ADME properties of the parent (if applicable), and QSAR, grouping and read-across.

The scheme will follow the forthcoming guidance on the residue definition. The proposed solution contributes to target and reduce the requests for experimental data by encouraging the use of alternatives to animal testing. Ultimately the proposed solution will strengthen the collaboration with ECHA and Member States.

Within this project, 3 case studies will be carried-out in 2025-2026 in order to test the automated and standardized workflow for mutagenicity assessment (bacterial gene mutation) of pesticide metabolites.

There will be 3 case studies with approximately:

i. 55 metabolites
ii. 25 metabolites
iii. 45 metabolites

The OECD QSAR toolbox offers connectivity to VEGA, Danish QSAR database, OASIS times (if installed in the same computer than the OECD QSAR toolbox). EFSA has access to OASIS, so EFSA could run for one of the case studies if the beneficiary does not have access to OASIS times.

Expert reviews will be needed for the 3 case studies. The expert review will need to consider:

a) experimental data, if available,
b) coverage by ADME data of parent, if applicable
c) QSARs prediction and the grouping and read across.

The workflow will retrieve automatically the experimental data (once uploaded in the tool by the user), it will indicate whether the metabolite is likely to be a major rat metabolite and it would indicate a grouping proposal.

For QSAR predictions, the proposal is to apply OECD QSAR assessment framework14. Given the high number of metabolites, the approach might be to apply it only for one of the case studies. This should be agreed during the kick off meeting.

• Considering that the assessment of pesticide active substances and their metabolites in Europe is done by EFSA Pesticide Peer Review Unit in close collaboration with Member States [2] , this call is restricted to Member States Organization. Moreover, this call is restricted only to Member States Organisations part of the PESTICIDE STEERING NETWORK - IUCLID SUBGROUP [3] . This is because the beneficiary must have access to EFSA IUCLID instance [4] where IUCLID pesticide dossiers and MetaPath files are available; files that will be used for data gathering in the workflow for the case studies

Objectives

The objectives of the call are:

1) to test and provide feedback on the functionality of the automated and standardized workflow for mutagenicity assessment (bacterial gene mutation) of pesticide metabolites that will be developed within the OECD QSAR toolbox.
2) To provide an experts’ review on the outcome of the case studies.

Selection criteria - technical and professional capacity:

- Requirement 1: overall at organisational level .The tenderer overall must have extensive and demonstrable experience in in the field of European Union Peer Review or National or Zonal Authorisation of plant protection products (at least 3 years).

a) Requirement 2: Ability to provide a team of experts compliant with these specific expertise requirements: At least one of the experts involved in the tasks should prove a university degree at post-graduate level (Master of Science in toxicology) and the expert must cover these areas of knowledge:

1) Toxicological assessment of pesticide active substance and metabolites under European Union Peer Review or National or Zonal Authorisation of plant protection products (at least 3 years).
2) Practical experience on applying the OECD QSAR assessment framework (e.g. by presenting it or referring to specific case studies on which it was used).
3) Practical experience on using the OECD QSAR toolbox.

b) At least one expert involved in the tasks should prove a university degree at post-graduate level (Master of Science) and the expert must cover these two areas of knowledge:

1) Residue assessment of pesticide active substance and metabolites under European Union Peer Review or National or Zonal Authorisation of plant protection products (at least 3 years).

- Practical experience on using MetaPath (e.g. by being part of the OECD MetaPath User Group)

- Requirement 3: English language capacity of each team member individually: The team of experts must have overall/each expert individually an excellent level of spoken and written standard UK English. For non-native speakers, this must be demonstrated by at least 3 years of work in an English-speaking environment etc. and /or;

- Requirement 4: overall at organisational level:

• The tenderer must have access to the EFSA IUCLID instance [5] as part as the Member States bellowing to PSN IUCLID network, for contract execution, and;
• Technical equipment compliant with these specific requirements:
• Installation of the OECD QSAR toolbox desktop (last version).
• Installation of the IUCLID Desktop (last version).
• Installation of MetaPath desktop (last version).

If you are interested in this procedure please insert it in the Funding & Tendering Portal, following this link, within the deadline, clicking on “Express Interest” and specifying the following:

• your name/organisation’s name and address (follow the instructions provided in the tool, you might be requested to register yourself and create a PIC);
• whether you participate as a physical person or an organisation/private company.