Staff Publications

Staff Publications

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    'Staff publications' is the digital repository of Wageningen University & Research

    'Staff publications' contains references to publications authored by Wageningen University staff from 1976 onward.

    Publications authored by the staff of the Research Institutes are available from 1995 onwards.

    Full text documents are added when available. The database is updated daily and currently holds about 240,000 items, of which 72,000 in open access.

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Record number 548108
Title Equivalence limit scaled differences for untargeted safety assessments : Comparative analyses to guard against unintended effects on the environment or human health of genetically modified maize
Author(s) Voet, Hilko van der; Goedhart, Paul W.; García-Ruiz, Esteban; Escorial, Concepción; Tulinská, Jana
Source Food and Chemical Toxicology 125 (2019). - ISSN 0278-6915 - p. 540 - 548.
DOI https://doi.org/10.1016/j.fct.2019.02.007
Department(s) Biometris
Publication type Refereed Article in a scientific journal
Publication year 2019
Keyword(s) Arthropods - Equivalence test - Rat feeding study - Risk assessment - Standardised effect size - Unintended effects
Abstract

Safety assessments guard against unintended effects for human health and the environment. When new products are compared with accepted reference products by broad arrays of measurements, statistical analyses are usually summarised by significance tests or confidence intervals per endpoint. The traditional approach is to test for statistical significance of differences. However, absence or presence of significant differences is not a statement about safety. Equivalence limits are essential for safety assessment. We propose graphs to present the results of equivalence tests over the array of endpoints. It is argued that plots of the equivalence limit scaled difference (ELSD) are preferable over plots of the standardised effect size (SES) used previously for similar assessments. The ELSD method can be used either with externally specified equivalence limits or with equivalence limits estimated from (historical) data. The method is illustrated with two examples: first, environmental safety of MON810 Bt maize was assessed using field trial count data of arthropods; second, human safety of herbicide tolerant NK603 maize was assessed using haematological, biochemical and organ weight data from a 90-day rat feeding study. All assessed endpoints were classified in EFSA equivalence categories I or II, implying full equivalence or equivalence more likely than not.

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