Current risk assessment approaches for environmental and food and feed safety assessment

Abstract

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.

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Correspondence to Jeffrey D. Wolt.

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Wolt, J.D. Current risk assessment approaches for environmental and food and feed safety assessment. Transgenic Res 28, 111–117 (2019). https://doi.org/10.1007/s11248-019-00140-7

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Keywords

  • Genetically engineered
  • Genome edited
  • GMO
  • Novel food
  • CRISPR
  • ERA