Regulatory Futures in Retrospect

In our 1998 volume ‘The Politics of Chemical Risk: Scenarios for a regulatory Future’ we envisioned four ideal typical scenarios for the future of European chemicals policies. The scenarios focused on the nature of expertise (seen either as a universal or a localised phenomenon) and the organisation of the boundary between science and policy (as either diverging or converging). The four scenarios were titled International Experts, European Risk Consultation, European Coordination of Assessment, and Europe as a Translator. For all four scenarios, we hypothesized internal dynamics and articulated dilemmas related to the development of the sciences contributing to chemical assessment, the relation between the EU and member states and the role of the public. In this contribution, we look back on our four scenarios fifteen years later, to see which ones have materialized and to explore whether the dilemmas we saw have indeed surfaced. We conclude that the International Experts scenario by and large has materialized and explore some of the underlying tensions and dynamics in this development

EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA); Scientific Opinion on principles for deriving and applying Dietary Reference Values

This Opinion of the EFSA Panel on Dietetic products, Nutrition, and Allergies (NDA) deals with the general principles for development and application of Dietary Reference Values (DRVs). These quantitative reference values for nutrient intakes for healthy individuals and populations are based on health criteria. Derived from DRVs, nutrients goals and recommendations take into account other criteria such as food composition or dietary habits, and may be used for assessment and planning of diets. It is proposed to derive the following DRVs: 1) Population Reference Intakes (PRI), 2) Average Requirement (AR), 3) Lower Threshold Intake (LTI), 4) Adequate Intake (AI), 5) Reference Intake ranges for macronutrients (RI). Nutrient requirements differ with age, sex and physiological condition. The Panel proposes to define the age ranges used for each nutrient on a case-by-case basis depending on the available data. For the age group < 6 months requirements are considered to be equal to the supply from breast- milk, except in those cases where this does not apply. Separate reference values will be established for pregnant and lactating women. Interpolation or extrapolation between population groups will be used in instances where no data are available for defined age and sex groups

An exploratory qualitative assessment of factors influencing childhood vaccine providers' intention to recommend immunization in the Netherlands

<p>Abstract</p> <p>Background</p> <p>Under the Dutch national immunization program (NIP), childhood vaccination is not mandatory, but its recommendation by childhood vaccine providers (CVP) is important for maintaining high vaccination coverage. We therefore examined factors related to providers' intentions to recommend vaccinations to parents of young children.</p> <p>Methods</p> <p>We conducted four focus group discussions with nurses and physicians who provide vaccines to children 0-4 years old in diverse regions of the Netherlands. Three groups represented CVPs at child welfare centers (CWCs) serving the general population, with the fourth representing anthroposophical CWCs. Elements of the Theory of Planned Behaviour (TPB) were used to design the groups; thematic analysis was used to structure and analyze the dataset.</p> <p>Results</p> <p>Four main themes emerged, including 1) perceived responsibility: to promote vaccines and discuss pros and cons with parents (although this was usually not done if parents readily accepted the vaccination); 2) attitudes toward the NIP: mainly positive, but doubts as to NIP plans to vaccinate against diseases with a low perceived burden; 3) organizational factors: limited time and information can hamper discussions with parents; 4) relationship with parents: crucial and based mainly on communication to establish trust. Compared to CVPs at standard CWCs, the anthroposophical CWCs spent more time communicating and were more willing to adapt the NIP to individual cases.</p> <p>Conclusions</p> <p>Our qualitative assessment provides an overview of beliefs associated with providers' intention to recommend vaccinations. They were motivated to support the NIP, but their intentions to recommend vaccinations were affected by the perceived relevance of the vaccines, practical issues like limited time and by certain types of resistant parents. These results will inform future studies to test the magnitude and relative impact of these factors.</p

Personal genome testing: Test characteristics to clarify the discourse on ethical, legal and societal issues

Background: As genetics technology proceeds, practices of genetic testing have become more heterogeneous: many different types of tests are finding their way to the public in different settings and for a variety of purposes. This diversification is relevant to the discourse on ethical, legal and societal issues (ELSI) surrounding genetic testing, which must evolve to encompass these differences. One important development is the rise of personal genome testing on the basis of genetic profiling: the testing of multiple genetic variants simultaneously for the prediction of common multifactorial diseases. Currently, an increasing number of companies are offering personal genome tests directly to consumers and are spurring ELSI-discussions, which stand in need of clarification. This paper presents a systematic approach to the ELSI-evaluation of personal genome testing for multifactorial diseases along the lines of its test characteristics. Discussion: This paper addresses four test characteristics of personal genome testing: its being a non-targeted type of testing, its high analytical validity, low clinical validity and problematic clinical utility. These characteristics raise their own specific ELSI, for example: non-targeted genetic profiling poses serious problems for information provision and informed consent. Questions about the quantity and quality of the necessary information, as well as about moral responsibilities with regard to the provision of information are therefore becoming central themes within ELSI-discussions of personal genome testing. Further, the current low level of clinical validity of genetic profiles raises questions concerning societal risks and regulatory requirements, whereas simultaneously it causes traditional ELSI-issues of clinical genetics, such as psychological and health risks, discrimination, and stigmatization, to lose part of their relevance. Also, classic notions of clinical utility are challenged by the newer notion of 'personal utility.' Summary: Consideration of test characteristics is essential to any valuable discourse on the ELSI of personal genome testing for multifactorial diseases. Four key characteristics of the test - targeted/non-targeted testing, analytical validity, clinical validity and clinical utility - together determine the applicability and the relevance of ELSI to specific tests. The paper identifies and discusses four areas of interest for the ELSI-debate on personal genome testing: informational problems, risks, regulatory issues, and the notion of personal utility

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013 . Scientific O pinion on Dietary Reference Values for molybdenum

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) derived Dietary Reference Values (DRVs) for molybdenum. Molybdenum is efficiently and rapidly absorbed at a wide range of intakes, and the body is able to maintain homeostasis through the regulation of excretion via the urine. Molybdenum deficiency in otherwise healthy humans has not been observed and there are no biomarkers of molybdenum status. Various metabolic balance studies have been performed to establish molybdenum requirements. However, only one balance study, which was performed with a constant diet and under controlled conditions in adult men, was considered to be of sufficient duration. In this small study, balance was reported to be near zero when molybdenum intakes were 22 µg/day. Biochemical changes or symptoms suggestive of molybdenum deficiency were not observed, and it is possible that humans may be able to achieve molybdenum balance at even lower intakes. Data on molybdenum intakes and health outcomes were unavailable for the setting of DRVs for molybdenum. As the evidence required to derive an Average Requirement and a Population Reference Intake was considered insufficient, an Adequate Intake (AI) is proposed. Observed molybdenum intakes from mixed diets in Europe were taken into consideration in setting this value. An AI of 65 µg/day is proposed for adults; a figure that is based on molybdenum intakes at the lower end of the wide range of observed intakes. It is suggested that the adult AI also applies to pregnant and lactating women. An AI is also proposed for infants from seven months and for children based on extrapolation from the adult AI using isometric scaling and the reference body weights of the respective age groups