The use of mechanisms and modes of toxic action in integrated testing strategies: the report and recommendations of a workshop held as part of the European Union OSIRIS Integrated Project

This report on The Potential of Mode of Action (MoA) Information Derived from Non-testing and Screening Methodologies to Support Informed Hazard Assessment, resulted from a workshop organised within OSIRIS (Optimised Strategies for Risk Assessment of Industrial Chemicals through Integration of Non-test and Test Information), a project partly funded by the EU Commission within the Sixth Framework Programme. The workshop was held in Liverpool, UK, on 30 October 2008, with 35 attendees. The goal of the OSIRIS project is to develop integrated testing strategies (ITS) fit for use in the REACH system, that would enable a significant increase in the use of non-testing information for regulatory decision making, and thus minimise the need for animal testing. One way to improve the evaluation of chemicals may be through categorisation by way of mechanisms or modes of toxic action. Defining such groups can enhance read-across possibilities and priority settings for certain toxic modes or chemical structures responsible for these toxic modes. Overall, this may result in a reduction of in vivo testing on organisms, through combining available data on mode of action and a focus on the potentially most-toxic groups. In this report, the possibilities of a mechanistic approach to assist in and guide ITS are explored, and the differences between human health and environmental areas are summarised.

Risk assessment for the design of a risk-based surveillance programme for fish farms in Switzerland (in accordance with Council Directive 2006/88/EC of the European Union).

Swiss aquaculture farms were assessed according to their risk of acquiring or spreading viral haemorrhagic septicaemia (VHS) and infectious haematopoietic necrosis (IHN). Risk factors for the introduction and spread of VHS and IHN were defined and assessed using published data and expert opinions. Among the 357 aquaculture farms identified in Switzerland, 49.3% were categorised as high risk, 49.0% as medium risk and 1.7% as low risk. According to the new Directive 2006/88/EC for aquaculture of the European Union, the frequency of farm inspections must be derived from their risk levels. A sensitivity analysis showed that water supply and fish movements were highly influential on the output of the risk assessment regarding the introduction of VHS and IHN. Fish movements were also highly influential on the risk assessment output regarding the spread of these diseases.

Analysis of the prospects for updating the trade pillar of the European Union-Chile Association Agreement

The perception of the present state of trade relations with Chile is obscured by a lack of adequate understanding of its legal framework as well as of the policy behind it. This study attempts to clarify the present state of and future prospects for trade between the EU and Chile through an examination of previous agreements and the EU’s new approach to trade liberalisation. The authors agree with the large consensus existing on both the EU and Chilean sides regarding the efficacy of the Association Agreement, but note that any extension of an agreement with Chile should capture the spirit of older EU agreements rather than simply following the ‘NAFTA route’. The study also includes a comparative analysis between the EU-Chile agreement and current trade agreements being negotiated by the EU and Chile with third countries.

Analysis of the upcoming Modernisation of the Trade Pillar of the European Union-Mexico Global Agreement

Study for the EU Parliament co-authored by Rodrigo Polanco: The 1997 Global Agreement between the EC and its Member States and Mexico, together with the set of decisions taken in its framework, has been effective, and thus modifications of the agreement are mainly motivated by changes in the global landscape since it was first enacted. Therefore, broad considerations on how the European Union (EU) trade policy is shaped are extremely relevant for the upcoming negotiations with Mexico. In this context, the needs and expectations, both from the EU and Mexico, regarding any further agreements are examined, focusing in particular on areas beyond trade in goods and services such as procurement, investment, and regulatory cooperation. It is argued that the 'old' Association Agreements should be taken as models for any modifications, given their emphasis on EU-specific issues and their ability to accommodate the needs of Mexico in any deepened agreement.