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

A Review of Risk Matrices Used in Acute Hospitals in England.

In healthcare, patient safety has received substantial attention and, in turn, a number of approaches to managing safety have been adopted from other high-risk industries. One of these has been risk assessment, predominantly through the use of risk matrices. However, while other industries have criticized the design and use of these risk matrices, the applicability of such criticism has not been investigated formally in healthcare. This study examines risk matrices as used in acute hospitals in England and the guidance provided for their use. It investigates the applicability of criticisms of risk matrices from outside healthcare through a document analysis of the risk assessment policies, procedures, and strategies used in English hospitals. The findings reveal that there is a large variety of risk matrices used, where the design of some might increase the chance of risk misprioritization. Additionally, findings show that hospitals may provide insufficient guidance on how to use risk matrices as well as what to do in response to the existing criticisms of risk matrices. Consequently, this is likely to lead to variation in the quality of risk assessment and in the subsequent deployment of resources to manage the assessed risk. Finally, the article outlines ways in which hospitals could use risk matrices more effectively

Scientific Opinion on the re-evaluation of Quinoline Yellow (E 104) as a food additive:Question No EFSA-Q-2008-223

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of Quinoline Yellow (E 104). Quinoline Yellow has been previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1975, 1978 and 1984, and the EU Scientific Committee for Food (SCF) in 1984. Both committees established an Acceptable Daily Intake (ADI) of 0-10 mg/kg body weight (bw). Studies not evaluated by JECFA and the SCF included a chronic toxicity and carcinogenicity study with a reproductive toxicity phase in rats and a study on behaviour in children by McCann et al. from 2007. The latter study concluded that exposure to a mixture of colours including Quinoline Yellow resulted in increased hyperactivity in 8- to 9-years old children. The Panel concurs with the conclusion from a previous EFSA opinion on the McCann et al. study that the findings of the study cannot be used as a basis for altering the ADI. The Panel notes that Quinoline Yellow was negative in in vitro genotoxicity as well as in long term carcinogenicity studies. The Panel concludes that the currently available database on semi-chronic, reproductive, developmental and long-term toxicity of Quinoline Yellow, including a study in rats not apparently taken into consideration by JECFA or the SCF, provides a rationale for re-definition of the ADI. Using the NOAEL of 50 mg/kg bw/day provided by the chronic toxicity and carcinogenicity study with a reproductive toxicity phase carried out in rats and applying an uncertainty factor of 100 to this NOAEL, the Panel establishes an ADI of 0.5 mg/kg bw/day. The Panel notes that at the maximum levels of use of Quinoline Yellow, refined intake estimates are generally well over the ADI of 0.5 mg/kg bw/day

Ascertainment of childhood vaccination histories in northern Malawi

OBJECTIVE: To assess factors related to recorded vaccine uptake, which may confound the evaluation of vaccine impact.METHODS: Analysis of documented vaccination histories of children under 5 years and demographic and socio-economic characteristics collected by a demographic surveillance system in Karonga District, Malawi. Associations between deviations from the standard vaccination schedule and characteristics that are likely to be associated with increased mortality were determined by multivariate logistic regression.RESULTS: Approximately 78% of children aged 6-23 months had a vaccination document, declining to <50% by 5 years of age. Living closer to an under-5 clinic, having a better educated father, and both parents being alive were associated with having a vaccination document. For a small percentage of children, vaccination records were incomplete and/or faulty. Vaccination uptake was high overall, but delayed among children living further from the nearest under-5 clinic or from poorer socio-economic backgrounds. Approximately 9% of children had received their last dose of DPT with or after measles vaccine. These children were from relatively less educated parents, and were more likely to have been born outside the health services.CONCLUSIONS: Though overall coverage in this community was high and variation in coverage according to child or parental characteristics small, there was strong evidence of more timely coverage among children from better socio-economic conditions and among those who lived closer to health facilities. These factors are likely to be strong confounders in the association of vaccinations with mortality, and may offer an alternative explanation for the non-specific mortality impact of vaccines described by other studies

The development of national injury prevention policy in the Australian health sector: and the unmet challenges of participation and implementation

For the last 20 years injury prevention policy in Australia has been hampered by poor consultation practices, limited stakeholder involvement, inadequate allocation of resources, poor implementation, and an absence of performance measures. This paper describes the development of injury prevention policy in Australia from its beginnings in 1981 to the current day and considers what measures should be undertaken to create an effective platform for the reduction of the burden of injury in Australia. The National Injury Prevention and Safety Promotion Plan 2004–2014, released in 2005, needs to be supported by a whole of government commitment to the reduction of injury. The Council of Australian Governments would be an ideal forum to monitor progress, supported by a cross-government Ministerial Council