EFSA will fund projects on read-across methodologies for hazard characterisation

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EFSA will fund projects on read-across methodologies for hazard characterisation

Author: Sherry Ward, AltTox

Call for proposals – GP/EFSA/AFSCO/2015/01: New approaches in identifying and characterizing microbiological and chemical hazards

Deadline: 30 April 2015

Call for proposals and related documents available here: http://www.efsa.europa.eu/en/art36grants/article36/gpefsaafsco201501.htm?utm_source=newsletter&utm_medium=email&utm_campaign=20141112&utm_content=call

Objectives:

“In particular, the action financed by the EFSA grant to be awarded following the present call for proposals shall contribute to the objective of boosting scientific cooperation between scientists and research organisations with a competence in the development and validation of new approaches in the area of microbiological and chemical hazard assessment. It is of paramount importance to coordinate efforts between the food, veterinary and human health sectors in order to obtain maximum benefits from the use of whole genome sequence (WGS) and read across methodologies for microbial and chemical food safety, respectively.”

A) Making use of molecular approaches to identify and characterise microbial foodborne pathogens, specifically using whole genome sequence (WGS) analysis…

B) Development and application of read across methodologies to the hazard assessment of chemicals in the food safety area

Details for Objective B:

“A number of modern methods have been developed and have provided new trends in identifying and characterising chemical hazards. Consequently, the current “toxicology paradigm” is evolving from an empirical testing approach to a mechanistic one (EFSA Journal 2014;12(4):3638). This evolution contributes significantly to the progression towards the reduction of animal testing 3Rs (Reduce Replace Refine). The main steps of the risk assessment will remain. However, various elements of the process are changing, particularly in relation to the development of predictive tools and of overall new risk assessment frameworks that bring a systems toxicology perspective using Integrated Testing Strategies (ITS) (Hartung et al 2013). ITS are driving the development of new tools and alternative testing methods focus on depicting chemical Mode of Action (MoA)/Adverse Outcome Pathway (AOP). Examples of such methodologies and tools under development include the use of alternative test species, high throughput screening (HTS) assays, physiologically-based toxicokinetic and toxicodynamic models (PB-TK-TD), in silico tools such as (quantitative) structure activity relationships (Q)SAR), read across methodologies and OMICs technologies. Research is developing with a fit-for purpose perspective, in order to provide methods designed and applied to target the relevant needs such as screening of chemicals or prioritisation of chemicals based on hazard criteria. In this context, case studies are required to illustrate and validate the use of these tools in practice.

In the recent EFSA report on “modern methodologies and tools for human hazard assessment of chemicals” (EFSA Journal 2014;12(4):3638), a number of recommendations on research priorities resulting from the consultation of EFSA panels and staff dealing with chemical risk assessment and other experts from international bodies (ECHA, OECD, WHO…) are laid down. The further development of read-across methodologies for use in hazard characterisation of chemicals has been identified as a key research priority, particularly to integrate (Q)SAR and physicochemical properties with TK and TD data (potency estimates, AOP) using specific chemicals as case studies for ‘proof of concept’. This methodology can also be useful to explore category-approaches for prioritisation of chemicals, especially for data-poor substances (e.g. flavourings, emerging contaminants…) using for example the recent OECD guidance document on grouping chemicals, the OECD QSAR toolbox or the ADMET-SAR tool (EFSA Journal 2014;12(4):3638, OECD, 2014). In addition, the use of alternative test species (including fish species), as a bridge between in vitro methods and mammalian tests, has also been recommended and would be appropriate in the context of read across.

In order to address these priority research areas, EFSA will fund projects focusing on the development and application of read-across methodologies for the hazard characterisation of chemicals. Projects should explore the use of physico-chemical properties (e.g. quantitative structure activity relationships), historical toxicological data from in vivo and in vitro studies using mammalian and alternative test species (e.g. fish) in read-across methodologies. The applicability of the developed read-across methodology should be demonstrated using specific case studies of relevance for food and feed safety (e.g. pesticides, contaminants, food and feed additives, flavourings, food contact materials) using weight of evidence approaches.”