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The SAFEFOODS framework proposes an integrated five-step procedure for the risk analysis. The five steps are: framing, risk assessment, evaluation, risk management, and review. The framework is designed to address both risks and benefits. The SAFEFOODS approach introduces a 20-member Interface Committee, headed by a risk manager, to run the procedure. First third of the members is risk managers, second third is independent scientific experts and the last third is stakeholders with economic interests and with consumer interests. The role of the different steps in the procedure and the role of each category of Committee Members during the process are described. The proposal suggests a strict separation of responsibilities between managerial members on one side and scientific members and stakeholder members on the other side. This division of responsibilities in the committee opens up new possibilities for transparency, openness and participation without violation of the delegation-of-power rule. For the communication with the interested parties and the public at large during the process it is foreseen to create an Internet Forum, and use press conferences, press releases and interviews. Overall the SAFEFOODS proposal shall be seen as an invitation for rethinking the current risk assessment/risk management system in EU.

Presentatie tijdens de Safe Foods Meeting over een nieuwe geïntegreerde risico-analyse

The Common European Framework of Reference (CEFR) is intended as a reference document for language education including assessment. This article describes a project that investigated whether the CEFR can help test developers construct reading and listening tests based on CEFR levels. If the CEFR scales together with the detailed description of language use contained in the CEFR are not sufficient to guide test development at these various levels, then what is needed to develop such an instrument? The project methodology involved gathering expert judgments on the usability of the CEFR for test construction, identifying what might be missing from the CEFR, developing a frame for analysis of tests and specifications, and examining a range of existing test specifications and guidelines to item writers and sample test tasks for different languages at the 6 levels of the CEFR. Outcomes included a critical review of the CEFR, a set of compilations of CEFR scales and of test specifications at the different CEFR levels, and a series of frameworks or classification systems, which led to a Web-mounted instrument known as the Dutch CEFR Grid. Interanalyst agreement in using the Grid for analyzing test tasks was quite promising, but the Grids need to be improved by training and discussion before decisions on test task levels are made. The article concludes, however, that identifying separate CEFR levels is at least as much an empirical matter as it is a question of test content, either determined by test specifications or identified by any content classification system or grid.

This paper provides guidance on how to assess the safety of foods derived from genetically modified crops (GM crops); it summarises conclusions and recommendations of Working Group 1 of the ENTRANSFOOD project. The paper provides an approach for adapting the test strategy to the characteristics of the modified crop and the introduced trait, and assessing potential unintended effects from the genetic modification. The proposed approach to safetyassessment starts with the comparison of the new GM crop with a traditional counterpart that is generally accepted as safe based on a history of human food use (the concept of substantial equivalence). This case-focused approach ensures that foods derived from GM crops that have passed this extensive test-regime are as safe and nutritious as currently consumed plant-derived foods. The approach is suitable for current and future GM crops with more complex modifications. First, the paper reviews test methods developed for the risk assessment of chemicals, including food additives and pesticides, discussing which of these methods are suitable for the assessment of recombinant proteins and whole foods. Second, the paper presents a systematic approach to combine test methods for the safetyassessment of foods derived from a specific GM crop. Third, the paper provides an overview on developments in this area that may prove of use in the safetyassessment of GM crops, and recommendations for research priorities. It is concluded that the combination of existing test methods provides a sound test-regime to assess the safety of GM crops. Advances in our understanding of molecular biology, biochemistry, and nutrition may in future allow further improvement of test methods that will over time render the safetyassessment of foods even more effective and informative.

This paper provides guidance on how to assess the safety of foods derived from genetically modified crops (GM crops); it summarises conclusions and recommendations of Working Group I of the ENTRANSFOOD project. The paper provides an approach for adapting the test strategy to the characteristics of the modified crop and the introduced trait, and assessing potential unintended effects from the genetic modification. The proposed approach to safety assessment starts with the comparison of the new GM crop with a traditional counterpart that is generally accepted as safe based on a history of human food use (the concept of substantial equivalence). This case-focused approach ensures that foods derived from GM crops that have passed this extensive test-regime are as safe and nutritious as currently consumed plant-derived foods. The approach is suitable for current and future GM crops with more complex modifications. First, the paper reviews test methods developed for the risk assessment of chemicals, including food additives and pesticides, discussing which of these methods are suitable for the assessment of recombinant proteins and whole foods. Second, the paper presents a systematic approach to combine test methods for the safety assessment of foods derived from a specific GM crop. Third, the paper provides an overview on developments in this area that may prove of use in the safety assess-merit of GM crops, and recommendations for research priorities. It is concluded that the combination of existing test methods provides a sound test-regime to assess the safety of GM crops. Advances in our understanding of molecular biology, biochemistry, and nutrition may in future allow further improvement of test methods that will over time render the safety assessment of foods even more effective and informative.

Item does not contain fulltext, BACKGROUND: Cutaneous melanomas are aggressive tumors with an unpredictable biologic behavior. It has been suggested that women who present with melanoma during pregnancy have a worse prognosis due to more aggressive behavior of the melanoma. The objective of the current study was to evaluate the long-term effect of pregnancy on disease progression in women with Stage I-II melanoma. METHODS: From 1965 to 2001, 46 pregnant women were treated for a Stage I-II melanoma at the University Medical Center Groningen. These patients were compared with an age-matched and gender-matched control group (nonpregnant) of 368 women with Stage I-II melanoma. The patients were staged according to the 2002 American Joint Committee on Cancer TNM classification system for melanoma. The 10-year disease-free survival (DFS) and 10-year overall survival (OS) rates were calculated using logistic regression analysis. RESULTS: The median age of patients in the pregnant group was 30 years (range, 18-46 years), and the median age of patients in the nonpregnant group was 36 years (range, 17-45 years). The median follow-up was 109 months (range, 1-356 months). Pregnant patients presented more often with thicker melanomas (median, 2.0 mm vs. 1.7 mm; not statistically significant). No differences with regard to tumor location, histologic subtype, tumor ulceration, or vascular invasion were detected between the pregnant group and the nonpregnant group. There was no statistical difference in the 10-year DFS and 10-year OS rates between the two groups. The 10-year DFS rates for patients in the pregnant and nonpregnant groups, respectively, were 88% versus 86% for patients with Stage I melanoma and 67% versus 73% for patients with Stage II melanoma. The 10-year OS rates for patients in the pregnant and nonpregnant groups, respectively, were 94% versus 90% for patients with Stage I melanoma and 82% versus 81% for patients with Stage II melanoma. CONCLUSIONS: Pregnancy does not appear to have an adverse