PMID- 32625567
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230525
IS  - 1831-4732 (Electronic)
IS  - 1831-4732 (Linking)
VI  - 15
IP  - 7
DP  - 2017 Jul
TI  - Pilot study on uncertainty analysis in EFSA Reasoned Opinions on the modification 
      of pesticide maximum residue levels.
PG  - e04906
LID - 10.2903/j.efsa.2017.4906 [doi]
LID - e04906
AB  - Applicability of the EFSA Scientific Committee revised draft Guidance on 
      uncertainty in EFSA scientific assessment is tested in the context of an EFSA 
      Reasoned Opinion on the modification of pesticide maximum residue levels (MRLs). 
      EFSA purchased services for the preparation of a non-regulatory Evaluation Report 
      with example non-standard uncertainties related to a fictitious application for 
      the modification of MRLs. The Evaluation Report was assessed by EFSA in the 
      format of a Reasoned Opinion and case-specific examples of non-standard 
      uncertainty in the acute and chronic dietary risk assessments were analysed. 
      Methods were selected from the general framework outlined in the Scientific 
      Committee draft Guidance in order to apply a relatively simple strategy that 
      could be considered for use in a regulatory context. The individual non-standard 
      uncertainties were assessed by sensitivity analysis with iterative 
      back-calculation of the parameter values that would lead to exceedance of the 
      toxicological reference value (exceedance limit calculation), and quantified by 
      subjective probability estimation. Non-standard uncertainties affecting the 
      chronic risk assessment were quantified by subjective upper bound probability 
      percentile estimation and the combined estimated non-standard uncertainty 
      calculated by probability bounds analysis. Probability bounds analysis provides a 
      relatively simple approach for calculating the probability related to a 
      combination of uncertainties. The draft Guidance was found to provide a 
      comprehensive range of methods for uncertainty analysis. However, 
      process-specific guidelines and practical procedures may need to be developed in 
      order to implement the uncertainty assessment framework in routine pesticide risk 
      assessments. The uncertainty assessment is intended to provide additional 
      information on how certain the conclusions of the risk assessment are and thereby 
      support the risk-based decision-making process by enabling risk managers to take 
      account of uncertainty. The outcome of the pilot study will inform the EFSA 
      Scientific Committee Working Group on how to further tailor the draft Guidance on 
      uncertainty for the needs of the EFSA panels and units.
CI  - (c) 2017 European Food Safety Authority. EFSA Journal published by John Wiley and 
      Sons Ltd on behalf of European Food Safety Authority.
CN  - European Food Safety Authority (EFSA)
FAU - Pedersen, Ragnor
AU  - Pedersen R
LA  - eng
PT  - Journal Article
DEP - 20170727
PL  - United States
TA  - EFSA J
JT  - EFSA journal. European Food Safety Authority
JID - 101642076
PMC - PMC7009859
OTO - NOTNLM
OT  - MRL
OT  - consumer risk assessment
OT  - pesticide
OT  - scientific assessment
OT  - uncertainty
EDAT- 2017/07/27 00:00
MHDA- 2017/07/27 00:01
PMCR- 2017/07/27
CRDT- 2020/07/07 06:00
PHST- 2020/07/07 06:00 [entrez]
PHST- 2017/07/27 00:00 [pubmed]
PHST- 2017/07/27 00:01 [medline]
PHST- 2017/07/27 00:00 [pmc-release]
AID - EFS24906 [pii]
AID - 10.2903/j.efsa.2017.4906 [doi]
PST - epublish
SO  - EFSA J. 2017 Jul 27;15(7):e04906. doi: 10.2903/j.efsa.2017.4906. eCollection 2017 
      Jul.