Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(10):3874
doi
10.2903/j.efsa.2014.3874
Acknowledgements

EFSA wishes to thank the members of the Working Group on the operator, worker, resident and bystander exposure assessment: Claudia Grosskopf (as of September 2013), Paul Y Hamey, Kyriaki Machera, Sabine Martin, Walter Steurbaut for the preparatory work on this scientific output, the hearing expert: Georgina Downs, and EFSA staff: Lena Elisabeth Jacobi (until October 2012), Jane Richardson, Istvan Sebestyen (until May 2012), Hans Steinkellner (until April 2014) and Manuela Tiramani for the support provided to this scientific output.

Type
Guidance of EFSA
On request from
European Commission
Question Number
EFSA-Q-2011-01062
Approved
17 October 2014
Published
23 October 2014
Last Updated
24 April 2015. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Regulation (EC) No 1107/2009 ensures that the residues of plant protection products (PPPs), consequent to application consistent with good plant protection practice and having regard to realistic conditions of use, shall not have any harmful effects on human health. In 2010, the EFSA Panel on Plant Protection Products and their Residues (PPR) prepared a Scientific Opinion on “Preparation of a Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Residents and Bystanders”, which highlighted some inconsistencies between the approaches adopted by regulatory authorities. Therefore, the PPR Panel proposed a number of changes to those practices in use (e.g. routine risk assessment for individual PPPs should continue to use deterministic methods, and a tiered approach to exposure assessment remains appropriate; there is a need to introduce an acute risk assessment for operators, workers and bystanders where PPPs are acutely toxic; for acute risk assessments, exposure estimates should normally be based on 95th percentiles of relevant datasets, whereas, for longer term risk assessments, the starting point should be a 75th percentile). To prepare a Guidance Document, an ad hoc working group was established to revise all available data and procedures to perform the operator, worker, resident and bystander risk assessment. In addition to the data reported in the PPR opinion, further data were made available to the working group which were analysed and considered. The opinion also identifies those scenarios for which exposure estimates are least satisfactory, and makes recommendations for further research that would reduce current uncertainties. An exposure calculation spreadsheet, reflecting the Guidance content, is annexed to this Guidance Document, to support stakeholders in performing the assessment of exposure and risk.

Summary

Based on the “Scientific Opinion on Preparation of a Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Residents and bystanders” prepared by the EFSA PPR Panel in 2010 and on the subsequent public consultation, EFSA was asked to proceed with the preparation of a Guidance Document on the topic, in accordance with Article 31 of Regulation (EC) No 178/2002.

The Guidance is designed to assist risk assessors and notifiers/applicants when quantifying potential non-dietary, systemic exposures as part of regulatory risk assessment for plant protection products (PPPs). It is based on an initial draft that was presented as part of the EFSA PPR Panel opinion (EFSA PPR Panel, 2010), followed by further developments and then revision after public consultation held in 2014 (EFSA Technical Report “Outcome of the Public Consultation on the draft EFSA Guidance Document on the Assessment of Exposure for Operators, Workers, Residents and Bystanders in Risk Assessment for Plant Protection Products”).

Risk assessments must be carried out for all scenarios of exposure of operators, workers, residents and bystanders that can be expected to occur as a consequence of the proposed uses of a PPP. Most exposure scenarios will fall into a category for which a standardised first tier exposure assessment can be applied as described in the Guidance. For scenarios that are not covered by these standardised methods, the risk assessor will need to follow an ad hoc approach that is judged to be the most appropriate. An ad hoc, higher tier, exposure assessment may also be used for exposure scenarios that are covered by a standardised first tier method. However, this should be done only if there are good grounds for concluding that the ad hoc method will provide a more reliable and realistic estimate of exposures arising from the proposed good plant protection practice than the standard method. The Guidance also identifies those scenarios for which exposure estimates are least satisfactory, and makes recommendations for further research that would reduce current uncertainties. An exposure calculation spreadsheet, reflecting the Guidance content, is annexed to this Guidance Document, to support stakeholders in performing the assessment of exposure and risk.

The Guidance should hereafter be reviewed periodically, as and when relevant new data become available, and, if appropriate, should be amended or revised.

Keywords
exposure, operator, worker, bystander, resident, plant protection products, estimation, guidance, calculator
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