Academic Journal
Repercussions of politicized regulation exemplified by compulsory new TC1507-maize 90-day rat feeding study
| العنوان: | Repercussions of politicized regulation exemplified by compulsory new TC1507-maize 90-day rat feeding study |
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| المؤلفون: | Roper, Jason, Carlson, Anne, Podevin, Nancy, Wang, Yiwei, Mathesius, Carey, Herman, Rod |
| المصدر: | Journal of Regulatory Science; Vol. 10 No. 1 (2022); 1-30 ; 2377-3537 |
| بيانات النشر: | Office of the Texas State Chemist |
| سنة النشر: | 2023 |
| المجموعة: | Journal of Regulatory Science (Texas Digital Library - TDL E-Journals) |
| مصطلحات موضوعية: | TC1507, DAS-Ø15Ø7-1, 90-day rat feeding study, regulation, prescriptive, GMO, EFSA, • The European Food Safety Authority (EFSA) oversees the safety assessment of GM crops, • EFSA concluded that 90-day rat feeding studies are generally not required to assess safety, • Despite this, the European Regulators require rat feeding studies for all new GM events, • EFSA now requires prescriptive rat studies to support single component events in stacks, • An approved product, TC1507 maize, was again found safe to rats in compulsory repeat study, • This retroactively applied requirement for an approved product is grossly unjustified |
| الوصف: | Politicized and prescriptive regulation of genetically modified (GM) crops has unintended adverse effects, including misdirected resources and reduced benefits. In the case of animal testing, this suboptimal use of resources includes the needless sacrifice of animals. Whole-food animal feeding studies are generally of negligible value in the risk assessment of GM crops, a position that was affirmed by the European Food Safety Authority (EFSA). Contrary to EFSA’s 2011 position, in 2013, the European Commission directed that 90-day rat studies be conducted for new GM events. As no EFSA guidance was available for hypothesis-free 90-day rat feeding studies, EFSA interpreted this as a mandate to develop a prescriptive study design. Recently, EFSA has retroactively required 90-day rat studies be completed under new study guidelines for previously approved component single events as part of the approval of breeding stacks. Having been unable to secure a derogation (exemption) from EFSA, a new compulsory 90-day rat study was conducted with TC1507 maize to support a breeding-stack submission. As previously shown, TC1507 maize does not adversely affect rats. This politically driven additional animal testing is risk disproportionate, at odds with European and international standards for animal welfare, and provides no scientific value to the safety assessment for GM breeding stacks. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| Relation: | https://regsci-ojs-tamu.tdl.org/regsci/article/view/192/285; https://regsci-ojs-tamu.tdl.org/regsci/article/view/192/300; https://regsci-ojs-tamu.tdl.org/regsci/article/view/192 |
| DOI: | 10.21423/JRS-V10A192 |
| الاتاحة: | https://regsci-ojs-tamu.tdl.org/regsci/article/view/192 https://doi.org/10.21423/JRS-V10A192 |
| Rights: | Copyright (c) 2022 Jason Roper, Anne B. Carlson, Nancy Podevin, Yiwei Wang, Carey A. Mathesius, Rod A. Herman ; https://creativecommons.org/licenses/by-nc/4.0 |
| رقم الانضمام: | edsbas.C6BACC49 |
| قاعدة البيانات: | BASE |
| DOI: | 10.21423/JRS-V10A192 |
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