| 2. |
- Mie, Axel, 1974-, et al.
(författare)
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Non-disclosure of developmental neurotoxicity studies obstructs the safety assessment of pesticides in the European Union
- 2023
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Ingår i: Environmental Health. - 1476-069X. ; 22
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Tidskriftsartikel (refereegranskat)abstract
- Background In the European Union (EU), the safety assessment of plant protection products relies to a large extent on toxicity studies commissioned by the companies producing them. By law, all performed studies must be included in the dossier submitted to authorities when applying for approval or renewal of the active substance.Methods For one type of toxicity, i.e. developmental neurotoxicity (DNT), we evaluated if studies submitted to the U.S. Environmental Protection Agency (EPA) had also been disclosed to EU authorities.Results We identified 35 DNT studies submitted to the U.S. EPA and with the corresponding EU dossiers available. Of these, 9 DNT studies (26%) were not disclosed by the pesticide company to EU authorities. For 7 of these studies, we have identified an actual or potential regulatory impact.Conclusions We conclude that (1) non-disclosure of DNT studies to EU authorities, in spite of clear legal requirements, seems to be a recurring phenomenon, (2) the non-disclosure may introduce a bias in the regulatory risk assessment, and (3) without full access to all performed toxicity studies, there can be no reliable safety evaluation of pesticides by EU authorities. We suggest that EU authorities should cross-check their data sets with their counterparts in other jurisdictions. In addition, applications for pesticide approval should be cross-checked against lists of studies performed at test facilities operating under Good Laboratory Practice (GLP), to ensure that all studies have been submitted to authorities. Furthermore, rules should be amended so that future studies should be commissioned by authorities rather than companies. This ensures the authorities’ knowledge of existing studies and prevents the economic interest of the company from influencing the design, performance, reporting and dissemination of studies. The rules or practices should also be revised to ensure that non-disclosure of toxicity studies carries a significant legal risk for pesticide companies.
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| 3. |
- Bohman, Brita
(författare)
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Regulatory control of adaptive fisheries : Reflections on the implementation of the landing obligation in the EU common fisheries policy
- 2019
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Ingår i: Marine Policy. - : Elsevier BV. - 0308-597X .- 1872-9460. ; 110
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Tidskriftsartikel (refereegranskat)abstract
- The most recently revised CFP Regulation, adopted in 2013, includes a number of significant changes with the aim to make fisheries more in tune with concept of the ecosystem approach and to avoid unsustainable exploitation of marine biological resources, including fish, as a natural resource. As part of that the CFP Regulation introduced the landing obligation, an obligation to land all catches as opposed to previous praxis where fisheries have been relying on a system of discarding fish and other marine biological resources in order to optimize their catch. One aim with the landing obligation is to push for new adaptive fishing methods and in a way to implement an ecosystem approach since the fishing strategies are meant to be adjusted to ecosystem factors. To be effective, the system for controlling implementation must be adjusted to take different aspects of the ecosystem approach into account. The paper presents some reflections on the required balance between adaptive approaches connected to the ecosystem approach and the strictness established by principles of rule of law in relation to the so called EU CFP landing obligation. It is concluded that the best way to create a control system adjusted to these factors seems to be by giving more influence to the industry itself. Involving those concerned at all levels, and thus applying all aspects of the regulatory governance under an ecosystem approach, would create an effective adaptive system where the rule of law is also safe-guarded.
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