Foundational activities at the international level underlie current risk and safety assessment approaches for genetically engineered/modified organisms (GEOs/GMOs). Early risk assessment considerations beginning with the OECD 'Blue Book' established risk/safety assessment as the characterization of the organism and its environmental release; establishment and persistence in the environment; and human and ecological effects, analyzed in principle through existing methods. Important in this context was recognition that GEOs/GMOs as a class did not represent new risks relative to products of traditional plant breeding and that any incremental risk would need to be established on a stepwise case-by-case comparative basis with existing crops and derived-foods as the baseline. Accordingly, concepts of familiarity and substantial equivalence were advanced by OECD and WHO as ways to establish a risk analysis baseline for determining whether and to what extent risk/safety assessment was needed. Regulatory implementations of this paradigm have skewed to increasingly complex portfolios of studies rather than adhering to analysis which is formulated to fit the risk/safety questions relevant to a given case. Plants produced through genome editing technology will benefit from risk analysis that implements sound problem formulation to guide the need for and nature of risk/safety assessments.

中文翻译：

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当前用于环境，食品和饲料安全评估的风险评估方法。

国际一级的基础活动是目前针对基因工程/修饰生物（GEO / GMO）的风险和安全性评估方法的基础。从经合组织《蓝皮书》开始的早期风险评估考虑将风险/安全评估确定为生物体及其环境释放的特征；在环境中建立和持久化；以及人类和生态影响，原则上通过现有方法进行分析。在这种情况下，重要的是要认识到，相对于传统植物育种产品，GEOS / GMOs并不代表新的风险，任何增量风险都需要与现有作物及其衍生产品进行逐案逐案比较的基础上确定。 -以食物为基准。因此，经合组织和世界卫生组织提出了熟悉和实质等效的概念，作为建立风险分析基准的方法，以确定是否需要以及在何种程度上需要进行风险/安全评估。该范例的监管实施偏向于越来越复杂的研究组合，而不是坚持为适应与给定案例相关的风险/安全性问题而制定的分析。通过基因组编辑技术生产的植物将受益于风险分析，该风险分析可实施合理的问题表述，以指导风险/安全评估的需求和性质。该范例的监管实施偏向于越来越复杂的研究组合，而不是坚持为适应与给定案例相关的风险/安全性问题而制定的分析。通过基因组编辑技术生产的植物将受益于风险分析，该风险分析可实施合理的问题表述，以指导风险/安全评估的需求和性质。该范例的监管实施偏向于越来越复杂的研究组合，而不是坚持为适应与给定案例相关的风险/安全性问题而制定的分析。通过基因组编辑技术生产的植物将受益于风险分析，该风险分析可实施合理的问题表述，以指导风险/安全评估的需求和性质。