Call for new scientific information/data related to the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products

Deadline
10 December 2018

Background

The EFSA guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products, and the associated calculator, were published in October 2014. It was taken note by the Standing Committee with specific implementing provisions (SANTE-10832-2015), lastly modified on 24 January 2017.

Scenarios for which exposure estimates are not satisfactory (e.g. unrealistic or overestimated) and recommendations for further research that would reduce the existing uncertainties were already identified in the guidance itself. Further, since the date of publication of the guidance, new scientific data/reports became available which merit consideration as they contribute to fill the gaps identified.

On the basis of these considerations, on 29th November 2017 EFSA has been requested by the European Commission to update the above mentioned guidance as well as the associated calculator. In order to gather all available relevant data for this activity, an open call for data is considered necessary at the beginning of the process.

Overall objective

The purpose of this open call for data is to offer interested parties and/or stakeholders the opportunity to submit documented information and data (published, unpublished or newly generated) relevant for an update of the EFSA Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products, and the associated calculator.

Deadline for submission of data and disclosure of contact details

Interested parties and stakeholders should provide by 10/12/2018 the information described below.

To assist our planning and assessment of new information, if you intend to supply information after 30/09/2018 please email brief details of the information with confirmation that it will be sent by the 10/12. If the 10/12 deadline is impracticable please explain why and propose a new deadline for the specific information. Depending on all replies received we will confirm by email the latest we can receive the specific information referred to.

Information sought

EFSA kindly invites all interested parties, such as national competent authorities in the area of pesticides, interested organizations, research institutions, industry and other interested parties (etc.) to submit relevant data and comments, expected to lead to more accurate non-dietary exposure scenarios and calculations, or as starting point for refinement of risk assessments. The aim of this call is to fulfill the following data needs (non-exhaustive list):

  1. Representative uses and formulations not covered by the current guidance, but still of relevance at EU level:
    1. Amateur use (or non-professional use)
    2. Seed treatment
    3. Post-harvest treatment (e.g. fogging, dusting, waxing)
    4. Indoor applications[1] (e.g. spraying permanently or non-permanently protected crops, fumigation, application on conveyor belts)
    5. Bare soil applications
    6. Single plant treatment (e.g. dripping, drenching, spot applications, paintbrush applications)
    7. Hand-held application (e.g. application on high/low crops, mixing/loading or application using knapsacks, pouring)
    8. Application of dustable powders
    9. Aerial applications (e.g. by drone)
    10. Any other uses
  2. Possible refinement of the proposed default values:
    1. Average air concentrations
    2. Hectares treated per day
    3. Exposure durations
    4. Dermal absorption values during re-entry, i.e. when in contact with dry residues of pesticides
  3. Additional risk mitigation measures:
    1. Further developments in the use of protective equipment (at individual or collective level) with validated protection factors
    2. Technical equipment or packaging (e.g. water soluble packages, closed transfer systems, closed cabins, drift reducing technology)
    3. New drift values and buffer zones.
  4. New data on parameters related to re-entry of workers and residents/bystanders (existing and new scenarios):
    1. Further crop groupings (compared to the existing ones in the guidance) based on the crop morphology, structure and size
    2. New foliar residues data (dislodgeable and/or transferable), also relevant for residents/bystanders (turf/ground deposits)
    3. Data supporting crop-to-crop extrapolation possibilities
    4. New data on transfer coefficients related to exposure via contact with contaminated surfaces (leaves/turf/ground)
    5. New exposure data/activities for workers (e.g. for existing or new scenarios)
    6. Further considerations of multiple applications.

The information may include the followings:

  • literature data, including grey literature and any other data from research activities relevant for the non-dietary exposure assessment (for operators, workers, residents and/or bystanders) resulting from the applications of plant protection products in EU
  • original study reports from field exposure studies with plant protection products, which were not considered during the development of the EFSA calculator
  • national evaluations and/or monitoring data relevant for the non-dietary exposure assessment (including risk mitigation measures applied at national level) of operators, workers, residents and/or bystanders, and not yet considered during the development of the EFSA calculator
  • feedback on experience on use of the current calculator with suggestion for amendment to improve accuracy of assessments.
 

Process for data submission

In order to allow subsequent processing of the data in a harmonized way, the provider is requested to download and fill in the below excel template for each data set, study or comment provided and submit it together with the relevant data.

Opex_opencall_TEMPLATE

When submitting, the provider is also asked to confirm that it holds all the necessary rights to grant EFSA permission to use and, where appropriate, to disclose the submitted information, data, document, paper or study for the purposes defined in the present call (see above § Background and Overall objective; and below) and that the terms and conditions asserted by any copyright holder(s) are fully satisfied. In case the provider does not enjoy the necessary rights for these data or studies, the contact details of the respective owner(s) of data and/or of the relevant copyright holder(s) should also be provided, so that EFSA may seek their approval directly.

EFSA is interested to receive the numerical data in Excel format together with the original study reports. In case the data (e.g. paper, report etc.) are publicly available, it may be sufficient to provide EFSA with the information needed to retrieve these data (e.g. the relevant reference / web link to the concerned document etc.).

For transparency reasons, a listing of the submitted information, including the summary information, as reported in the submitted overview table (Opex_opencall_TEMPLATE), will be made publicly available at a later stage. The complete datasets and the studies received by EFSA during the open call will be evaluated in view of their possible use for the revision/amendment of the guidance, and associated calculator. Some assessment criteria for experimental field studies can be found in the External Scientific Report on the Review of the published exposure data to pesticides for residents and bystanders, and for environmental risk assessment: Final report (EFSA, 2017); and in the report of Joint development of a new Greenhouse Agricultural Operator Exposure Model for hand-held application (C. Groβkopf et al, 2015). It is desirable to receive all information and data needed for an assessment against such criteria.

Interested parties are invited to contact EFSA for further clarifications, if required.

Confidentiality

The provider is requested to specify clearly any information that should remain confidential (i.e. not to be disclosed to the public) and submit appropriate verifiable justification for this claim pursuant to Article 63 of Regulation (EC) No 1107/2009. EFSA notes that data not granted public availability might not be further taken into account for the revision of the EFSA guidance.

Interested parties are invited to submit the information (‘Opex_opencall_TEMPLATE’ filled in and original reports, with Excel tables) electronically to EFSA, preferably via email, or alternatively on a physical medium (e.g. CD, memory stick, etc.). All available information should be submitted by 10 December 2018 at the latest.

The provider is also requested to clearly indicate the contact details (name of contact person, name of company, email address) of the person responsible for the data submission.

Contact details

It is recommended that submissions are sent electronically to the following email address:

Opex.Opencall [at] efsa.europa.eu

For further clarifications please also contact this mailbox.

Alternatively, submissions on a physical medium (e.g. CD, DVD, memory stick, etc.) may be sent to the following address:

Pesticides Unit
European Food Safety Authority
Via Carlo Magno 1/a
43126 Parma
Italy


[1] It is noted that EFSA is requested by European Commission to take into account the report Joint development of a new Greenhouse Agricultural Operator Exposure Model for hand-held application (C. Groβkopf, 2013) for the update of the calculator.

Published
18 June 2018