Policy masquerading as science: an examination of non-state actor involvement in European risk assessment policy for genetically modified animals

In 2013, at the request of the European Commission, the European Food Safety Authority (EFSA) announced a new risk assessment policy: Guidance on the environmental risks of genetically modified (GM) animals (‘Guidance’). This policy specifies the issues to be addressed in future risk assessments for GM animals. EFSA is the European Commission's scientific arm, responsible for food-related risk assessment. EFSA relies heavily on independent experts and consults non-state actors. Employing expert interviews and documentary analysis, the article explores non-state actor involvement in a traditionally expert domain through a case study. Analysis of EFSA's consultation demonstrates the inability of non-state actors to influence policy. The article argues that despite international legal obligations to develop risk assessment policy, the European Commission failed to recognize the Guidance as policy. When policy masquerades as science, unjustified restrictions are placed on non-state actor involvement and value judgements are cloaked from public scrutiny

The impact of natural and anthropogenic Dissolved Organic Carbon (DOC), and pH on the toxicity of triclosan to the crustacean Gammarus pulex (L.).

Regulatory ecotoxicology testing rarely accounts for the influence of natural water chemistry on the bioavailability and toxicity of a chemical. Therefore, this study identifies whether key omissions in relation to Dissolved Organic Carbon (DOC) and pH have an impact on measured effect concentrations (EC). Laboratory ecotoxicology tests were undertaken for the widely used antimicrobial compound triclosan, using adult Gammarus pulex (L.), a wild-type amphipod using synthetic fresh water, humic acid solutions and wastewater treatment works effluent. The toxicity of triclosan was tested at two different pHs of 7.3 and 8.4, with and without the addition of DOC and 24 and 48hour EC values with calculated 95% confidence intervals calculated. Toxicity tests undertaken at a pH above triclosan's pKa and in the presents of humic acid and effluent, containing 11 and 16mgL(-1) mean DOC concentrations respectively, resulted in significantly decreased triclosan toxicity. This was most likely a result of varying triclosan speciation and complexation due to triclosan's pKa and high hydrophobicity controlling its bioavailability. The mean 48hour EC50 values varied between 0.75±0.45 and 1.93±0.12mgL(-1) depending on conditions. These results suggest that standard ecotoxicology tests can cause inaccurate estimations of triclosan's bioavailability and subsequent toxicity in natural aquatic environments. These results highlight the need for further consideration regarding the role that water chemistry has on the toxicity of organic contaminants and how ambient environmental conditions are incorporated into the standard setting and consenting processes in the future

Cross-Sector Review of Drivers and Available 3Rs Approaches for Acute Systemic Toxicity Testing

Acute systemic toxicity studies are carried out in many sectors in which synthetic chemicals are manufactured or used and are among the most criticized of all toxicology tests on both scientific and ethical grounds. A review of the drivers for acute toxicity testing within the pharmaceutical industry led to a paradigm shift whereby in vivo acute toxicity data are no longer routinely required in advance of human clinical trials. Based on this experience, the following review was undertaken to identify (1) regulatory and scientific drivers for acute toxicity testing in other industrial sectors, (2) activities aimed at replacing, reducing, or refining the use of animals, and (3) recommendations for future work in this area