EFSA: Data collection on exposure assessment scenarios for operator exposed to pesticides

EFSA issued in October 2014 a Guidance Document on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products (EFSA Journal 2014;12(10):3874). In this Guidance, new approaches are proposed to be used to calculate the exposure to PPPs. In addition, a way to assess resident exposure has been proposed according to the new requirements in the legislation. However, even though considering the most up to date available data for the assessment of non-dietary exposure to pesticides, many uncertainties still remain due to the complexity of this type of assessment and the scarcity of data. Therefore, it will be helpful for EFSA and the Member States to have available a comprehensive database of the non-dietary exposure assessments performed so far at EU level for the substances peer reviewed by EFSA, including all the key parameters, in order to: 1) identify critical issues not covered by the Guidance (e.g. use scenarios), 2) test the Guidance, and 3) identify the need of further research.

A compilation of a comprehensive MS Excel database with technical data from non-dietary exposure assessments performed at EU level for operators of PPPs was thus performed. The database as compiled contains information for 179 substances. The scientific report and the Excel database were published by EFSA on 24 July 2015.]

In the current project the work was focused on operator exposure assessments. However, due to the nature and structure of the database, the database can be easily adapted and expanded to also include worker and resident/bystander exposure assessments.

With regard to possible data gaps and needs for future research, the scientific report gives an overview of intended used labelled as ‘unusual’ with regard to their application method and/or application equipment for which NO exposure assessment was made based on one or more of the exposure models. Future research could focus on gathering exposure data/studies for these methods and or new model developments. The most frequent listed ‘unusual’ application methods concern seed treatment, soil injection/incorporation, gassing and fumigation.

Lynxee consulting’s team can adapt and develop exposure models for your intended uses not covered by standard models.

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France: comparative assessment (Order and Guidance document)

An order and a guidance document on comparative assessment (Article 50) have just been published in France.  Since 01 August 2015, for PPP containing a substance candidate for substitution (CfS) (list of candidates for substitution), information on comparative assessment must be submitted in dRR Part A of the application if France is the zRMS and in a National addendum to Part A if France is not the zRMS.

The comparative assessment is carried out in several steps. For each step, the applicant shall give detailed information as defined by the French Ministry of Agriculture’s Order.

  • Preliminary step: For PPPs containing CfS but where it is necessary to acquire experience first through using that product in practice, the comparative assessment will not be implemented. The authorisation will be granted once for a period not exceeding five years. For instance:

    • new PPPs containing a new active substance approved under Regulation (EC) No 1107/2009 and a candidate for substitution,

    • a new active substance/use combination,

    • a significant advance enabling exposure to be reduced (e.g. formulation type),

    • a new combination of active substances having real agricultural advantages or enabling the authorised doses to be lowered.

For applications not falling within the framework mentioned above, a comparative assessment shall be carried out for every use in the application.

  • Step 1: Taking into account minor uses, resistance management, regulated pest control measures

    • Minor uses:  potential consequences of substitution for the major uses on the minor uses of the product;

    • Resistance management: number of modes of action available for a use and/or role of the candidate substance in the resistance management strategy;

    • Regulated pest control measures: information if the PPP is a significant component of the strategy for controlling a regulated quarantine pest or a pest subject to mandatory control measures.

  • Step 2: Comparison with other available solutions

    • Identification of other available solutions for the specified use (non-chemical prevention or control methods and other authorised PPP);

    • Practical and economic disadvantages of other available solutions;

    • Efficacy of other available solutions.

  • Step 3: Comparison of risks to Human or animal Health or the environment

    • first, criteria that led to the status of candidate for substitution;

    • if necessary, complete risk profiles and risk management measures.

The comparative assessment will conclude for each specified use if substitution is considered or not. Substitution will be considered if there is a non-chemical prevention or control method or an authorised PPP, identified at the end of step 3, that is significantly safer for human or animal health or the environment.

French Order (23/07/2015): Arrêté_20150731.pdf

Anses Guidance document (31/07/2015, English): DAMM-DocumentGuide EvaluationPPPv1EN.pdf

 

Lynxee consulting’s team is very much involved in comparative assessment and can prepare this assessment for you.

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