eprintid: 20214
rev_number: 15
eprint_status: archive
userid: 2744
dir: disk0/00/02/02/14
datestamp: 2016-02-04 11:08:03
lastmod: 2016-03-08 12:21:58
status_changed: 2016-02-04 11:08:03
type: workingPaper
metadata_visibility: show
creators_name: Goeschl, Timo
creators_name: Heyen, Daniel
title: Precision requirements in pesticide risk assessments: Contrasting value-of-information recommendations with the regulatory practice in the EU
subjects: 330
divisions: 181000
keywords: risk assessment; pesticide; regulation; value-of-information; animal testing; uncertainty; active learning.
abstract: Pesticides, while rendering immense agricultural benefits, potentially entail risks to human health and the environment. To limit these risks, market approval of a pesticide is typically conditional on an extensive risk assessment demonstrating its safety. The associated testing procedures, often involving significant numbers of animals, however are not only costly; as has become apparent from recent discussions about the active substance glyphosate, testing is often incapable of providing definitive answers on concerns like human carcinogenicity. An important regulatory task, whether explicitly acknowledged or not, is hence to decide what level of remaining uncertainty is deemed acceptable in making the final market approval decision. Economic principles suggest a value-of-information (VoI) approach for this informational task. After presenting the basics of the VoI framework, this paper analyzes the actual regulatory practice in the EU's pesticide approval process, pointing out the defaults and substance-specific procedures that shape the precision
of the European Food Safety Authority's (EFSA) risk assessment and hence the level of knowledge under which the European Commission decides on the approval of substances. The comparison between theory and practice uncovers substantial deviations, providing valuable insights for restructuring the risk assessment guidelines.
date: 2016-02
id_scheme: DOI
id_number: 10.11588/heidok.00020214
schriftenreihe_cluster_id: sr-3
schriftenreihe_order: 0607
ppn_swb: 847219283
own_urn: urn:nbn:de:bsz:16-heidok-202143
language: eng
bibsort: GOESCHLTIMPRECISIONR201602
full_text_status: public
series: Discussion Paper Series, University of Heidelberg, Department of Economics
volume: 0607
place_of_pub: Heidelberg
pages: 20
citation:   Goeschl, Timo ; Heyen, Daniel  (2016) Precision requirements in pesticide risk assessments: Contrasting value-of-information recommendations with the regulatory practice in the EU.  [Working paper]     
document_url: https://archiv.ub.uni-heidelberg.de/volltextserver/20214/1/goeschl_heyen_2016_dp607.pdf