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- Sandin, Per, et al.
(author)
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Technology Neutrality in European Regulation of GMOs
- 2022
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In: Ethics, Policy & Environment. - : Informa UK Limited. - 2155-0085 .- 2155-0093. ; 1
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Journal article (peer-reviewed)abstract
- Objections to the current EU regulatory system on genetically modified organisms (GMOs) in terms of high cost and lack of consistency, speed and scientific underpinning have prompted proposals for a more technology-neutral system. We sketch the conceptual background of the notion of ‘technology neutrality’ and propose a refined definition of the term. The proposed definition implies that technology neutrality of a regulatory system is a gradual and multidimensional feature. We use the definition to analyze two regulatory reform proposals: One proposal from the Netherlands for improving the exemption mechanism for GMOs under Directive 2001/18/EC, and one from the Norwegian Biotechnology Advisory Board, outlining a new stratified risk assessment procedure. While both proposals offer some degree of improved technology neutrality in some dimensions compared to current EU regulation, in some extents and dimensions, they do not. We conclude that proposals for more technology-neutral regulation of GMOs need, first, to make explicit to what extent and in what dimensions the proposal improves neutrality and, second, to present arguments supporting that these specific improvements constitute desirable policy change against the background of objections to current policy.
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| 2. |
- Wittgren, Hans B, et al.
(author)
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An actor game on implementation of environmental quality standards for nitrogen in a Swedish agricultural catchment
- 2005
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In: Ambio. - : Royal Swedish Academy of Sciences. - 0044-7447 .- 1654-7209. ; 34:3, s. 237-247
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Journal article (peer-reviewed)abstract
- Despite political efforts, diffuse pollution from agriculture continues to be the single largest source of nitrogen (N) emissions into the aquatic environment in many countries and regions. This fact, and the recent enactment of a new Swedish environmental code, led to the design of a study targeted at the evaluation of new N pollution abatement strategies. An actor game was chosen as the key component of the study, with a focus on four major goals: to test the implementability of legally binding environmental quality standards for nitrate concentration in groundwater and N transport to the sea, to find sets of agriculturally feasible and cost-effective measures to decrease N loads, to investigate the possibilities for collective action through negotiated and institutionalized actor cooperation, and to investigate the role of mathematical modeling in environmental N management. Characteristics from the agriculturally dominated catchment of Genevadsan (224 km(2)) on the southwest coast of Sweden served as the playing field for the actor game. The most noteworthy result from the study was that it appeared to be possible to meet ambitious environmental N standards with less economically drastic measures than anticipated by most of the participants. The actor game was shown to be a good method for learning about the new Swedish environmental code and its application and for gaining deeper insight into the issues of N management. In addition, the actor game functioned as an arena for gaining a more thorough understanding of the views of different stakeholders.
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| 3. |
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| 4. |
- Nielsen, Maria, et al.
(author)
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Nanomaterials in the European chemicals legislation-methodological challenges for registration and environmental safety assessment
- 2021
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In: Environmental Science: Nano. - : Royal Society of Chemistry. - 2051-8153 .- 2051-8161. ; 8:3, s. 731-747
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Journal article (peer-reviewed)abstract
- In the European Union the Annexes of its chemical legislation (REACH) were revised and now clarify the technical data requirements for nanomaterials (NMs). These new provisions, effective from January 1, 2020, introduce requirements for manufacturers, importers and downstream users regarding registration and safety assessment of NMs. This study aims to assess the availability and suitability of methods needed to comply with the new regulatory provisions on NMs for physico-chemical characterisation and environmental fate and effects. The scientific literature and relevant test guideline frameworks were reviewed to identify applicable methods. These were subsequently evaluated and categorised as either: 'internationally accepted test guideline or standard (TGS)', 'internationally accepted test guideline or standard under development (TGSUD)', 'established as standard methods in scientific literature (SCI)', 'other methods and/or more research needed (O)' or 'no method (N)'. We find that 80% of the information requirements and a bit more than 40% of the waiving criteria in the new REACH Annexes are supported by methods that are available as TGS, TGSUD or SCI. Most of the relevant methods in the scientific literature are included in recent OECD guidance documents or ECHA guidance. We recommend that a targeted effort is made to develop protocols and guidelines for methods to determine NM adsorption/desorption, degradation, exposure scenarios and ability to cross biological membranes. Here methods to fulfil the information requirements and waiving criteria are currently lacking. Furthermore, we recommend that increasing attention is directed towards regulatory reliability and relevance of the information that is submitted by the registrants.
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