Pesticide evaluation: Tools
PRIMo – Pesticide Residue Intake Model
In the safety assessments of EU maximum residues levels (MRLs) for pesticides, or proposals for MRLs, the chronic and acute dietary consumer exposure to pesticide residues is estimated by using a calculation model developed by EFSA (PRIMo – Pesticide Residue Intake Model). The model is based on national food consumption figures and unit weights provided by Member States and implements internationally agreed risk assessment methodologies to assess the short-term (acute) and long-term (chronic) exposure of consumers.
The calculation model was initially developed by EFSA for the risk assessment of temporary MRLs.
Since that, revised versions of the model for calculating the acute and chronic consumer exposure have been developed, the most recent one being PRIMo revision 3, which should be used for new applications as from 1 February 2018. A detailed description of the tool is available in a guidance document.
Following feedback from users, the risk assessment tool has been updated into version 3.1, including editorial modifications and corrections of input values used for the calculation of the exposure assessments. A summary of the modifications introduced is made available in a technical report
The new PRIMo model can be downloaded below:
Old version (used for applications before 1 February 2018):
FOCUS simulation models and FOCUS scenarios
FOCUS DG SANTE stands for “Forum for the co-ordination of pesticide fate models and their use”. The aim of the initiative is to harmonise the calculation of predicted environmental concentrations (PEC) of active substances of plant protection products (PPP) in the framework of the EU Directive 91/414/EEC. FOCUS brings together scientists of regulatory agencies, academia and industry.
At the link below you can obtain the currently approved versions of FOCUS simulation models and FOCUS scenarios, which are used to calculate the concentrations of plant protection products in groundwater and surface water in the EU review process.
Calculation tool annexed to the guidance document on non-dietary exposure to pesticides
The guidance on the assessment of exposure of operators, workers, residents and bystanders to pesticides sets out for the first time a harmonised methodology. It also presents a tool for calculating non-dietary exposure to pesticides for all these groups.
From the link below you can consult the guidance document and the annexed calculator tool. The tool draws on available data to help risk assessors and applicants carry out exposure assessments. Following the input of key data the calculator provides real-time estimates of non-dietary exposure under specific conditions of use for each of the four population groups.
Calculation tool annexed to the guidance on dermal absorption
The guidance on the assessment of dermal absorption assist notifiers, users of test facilities and Member State authorities on critical aspects related to the setting of dermal absorption values to be used in risk assessments of active substances in Plant Protection Products (PPPs). The guidance originally issued in 2012 was revised in 2017 on the basis of new available data on human in vitro dermal absorption for PPPs. In order to support calculations of dermal absorption from in vitro studies, a template has been provided by the German Federal Institute for Risk Assessment (BfR). The template and a practical example of its application, published with the guidance as supporting information, can be downloaded below.
Calculation tool annexed to the guidance on risk assessment of plant protection products and bees
The guidance document on risk assessment of plant protection products and bees provides guidance for applicants and authorities. It suggests a tiered risk assessment scheme with a simple and cost-effective first tier to more complex higher tier studies under field conditions. Each of the tiers has to ensure that the appropriate level of protection is achieved.
Together with the bee guidance document, EFSA has developed a tool to perform the calculations that are required for the screening step and the first tier.
MetaPath – structuring results of metabolism studies on rats, plants and livestock
Applicants submitting an application under Regulation (EC) No 1107/2009 or Regulation (EC) No 396/2005 are requested to provide data on metabolism in the areas of residues and mammalian toxicology as attachments, generated with the MetaPath composer software.
The MetaPath platform has been developed to collect, organise and analyse experimental data on metabolism or catabolism, observed biotransformation pathways and crucial supporting metadata. The results from metabolism studies on rats, plants and livestock are compiled and organised into a systematic database.
EFSA identified the MetaPath platform as a suitable tool for powerful searches and information extraction based on chemical structure, biotransformation, experimental metadata as well as for metabolic simulations and predictions. MetaPath was originally developed by the Laboratory of Mathematical Chemistry, Burgas (LMC, Bulgaria) and the US Environmental Protection Agency (EPA), and has been integrated with the OECD QSAR toolbox.
The MetaPath platform allows users to build custom databases and import and query existing databases such as EFSA’s public MetaPath database and the Regulatory Legacy database.
How to compile plants and livestock metabolism studies
All the required study information on plants and livestock metabolism studies (details on material and methods, detailed results and discussions) should be reported in Metabolism Study Summary (MSS) composers. For detailed instructions on how to complete MSS composers, please refer to the manual.
In the context of the Transparency Regulation implementation, a series of MetaPath video tutorials (Chapters 1-5, Chapters 6-10, Chapters 11-13, Chapters 14-16) and dedicated webinars on MSS composers and validation of XML file for pesticides metabolism studies have been developed.
How to compile mammalian toxicology metabolism studies
All required study information on mammalian toxicology metabolism should be reported in the Data Evaluation Record (DER) composers. Detailed instructions on how to complete DER composers and some Frequently Asked Questions are available in the DER composer manual.
In the context of the Transparency Regulation implementation, a dedicated webinar recording on DER composers for rat metabolism studies is available.
Further information on MetaPath platform is available in the Frequently Asked Questions (FAQ) Excel document published in Zenodo and regularly updated by EFSA.
Requirements to submit data on metabolism
Data on metabolism in the areas of residues and mammalian toxicology generated with the MetaPath composer software (xml files generated with the DER or the MSS composer) should be submitted as part of the IUCLID dossier (and attached to the literature reference in Endpoint study records). Detailed instructions on the compilation of IUCLID dossiers are available on the dedicated page.
For metabolism studies for which maps are already available in the EFSA database, applicants are not requested to submit the xml-files as part of their IUCLID dossier.
Prior to starting the completion of metabolism studies in the MSS composer, applicants are requested to check if the respective study has already been populated, consulting the following two lists:
- List 1) Regulatory Legacy collection of maps
- List 2) EFSA public MetaPath database of maps (the database is regularly updated. Users are therefore invited to check it regularly.)
If a metabolism study has already been populated according to the references provided in list 1 or list 2, applicants are requested not to create a new xml file. If the study is already available in either list 1 or 2, applicants are required to report the corresponding individual file number in the IUCLID dossier (in the literature reference of the relevant Endpoint study records).
For studies which are not listed and for new metabolism studies the applicants should compile and submit xml files. An overview and a detailed description of the steps to follow to report structured metabolism data in the context of EU applications is available here.
Applicants and Member States are invited to report any technical issue as well as any proposal for further improving the MetaPath platform in the existing IUCLID backlog file.