title: Development of a standard documentation protocol for communicating exposure models.
abstract: An important step in building a computational model is its documentation; a comprehensive and structured documentation can improve the model applicability and transparency in science/research and for regulatory purposes. This is particularly crucial and challenging for environmental and/or human exposure models that aim to establish quantitative relationships between personal exposure levels and their determinants. Exposure models simulate the transport and fate of a contaminant from the source to the receptor and may involve a large set of entities (e.g. all the media the contaminants may pass though). Such complex models are difficult to be described in a comprehensive, unambiguous and accessible way. Bad communication of assumptions, theory, structure and/or parameterization can lead to lack of confidence by the user and it may be source of errors. The goal of this paper is to propose a standard documentation protocol (SDP) for exposure models, i.e. a generic format and a standard structure by which all exposure models could be documented. For this purpose, a CEN (European Committee for Standardisation) workshop was set up with objective to agree on minimum requirements for the amount and type of information to be provided on exposure models documentation along with guidelines for the structure and presentation of the information. The resulting CEN workshop agreement (CWA) was expected to facilitate a more rigorous formulation of exposure models description and the understanding by users. This paper intends to describe the process followed for defining the SDP, the standardisation approach, as well as the main components of the SDP resulting from a wide consultation of interested stakeholders. The main outcome is a CEN CWA which establishes terms and definitions for exposure models and their elements, specifies minimum requirements for the amount and type of information to be documented, and proposes a structure for communicating the documentation to different users.
authors.affiliation: Electricité de France (EDF) R&D, National Hydraulic and Environment Laboratory, 6 quai Watier, 78400 Chatou, France. Electronic address: philippe.ciffroy@edf.fr.
authors.forename: P
authors.initials: P
authors.lastname: Ciffroy
authors.affiliation: Austrian Standards Institute, Heinestr. 38, 1060 Vienna, Austria.
authors.forename: A
authors.initials: A
authors.lastname: Altenpohl
authors.affiliation: AIEFORIA srl, via Gramsci 22, 43036 Fidenza (PR), Italy.
authors.forename: G
authors.initials: G
authors.lastname: Fait
authors.affiliation: TNO, PO Box 360, 3700AJ Zeist, The Netherlands.
authors.forename: W
authors.initials: W
authors.lastname: Fransman
authors.affiliation: Institute for Health and Consumer Protection, European Commission, Joint Research Centre, Ispra, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Paini
authors.affiliation: Institute for Health and Consumer Protection, European Commission, Joint Research Centre, Ispra, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Radovnikovic
authors.affiliation: IRSN, Institut de Radioprotection et de Sûreté Nucléaire (IRSN), PRP-ENV, SERIS, LM2E, Cadarache, France.
authors.forename: M
authors.initials: M
authors.lastname: Simon-Cornu
authors.affiliation: Istituto di Chimica Agraria ed Ambientale, Università Cattolica del Sacro Cuore, via Emilia Parmense 84, 29122 Piacenza, Italy.
authors.forename: N
authors.initials: N
authors.lastname: Suciu
authors.affiliation: Arche cvba, Liefkensstraat 35d, 9032 Gent (Wondelgem), Belgium.
authors.forename: F
authors.initials: F
authors.lastname: Verdonck
mesh_terms: D004282:Documentation / Q000592:standards*; D004781:Environmental Exposure; D004784:Environmental Monitoring / Q000379:methods*; D006801:Humans; D008962:Models, Theoretical; D018570:Risk Assessment / Q000379:methods*
keywords: Documentation; Exposure model; Multimedia models; PBPK models; Standardisation