Harmonisation of Regulatory Oversight in Biotechnology Safety Assessment of Transgenic Organisms in the Environment, Volume 5..

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I.1. BACTERIA: PATHOGENICITY FACTORS – 27

Chapter 1. Bacteria: Pathogenicity factors


This chapter provides guidance on topics and issues relevant to the risk/safety assessment
of commercial environmental applications involving genetically engineered
micro-organisms, especially bacteria. It explores the important aspects in bacteria for
causing adverse human health effects, and how this knowledge can be used in biosafety
regulatory assessment. It contains information on bacterial pathogenicity (general
considerations, factors and determinants, genetics and molecular biology), and also
elements on assessing potential for bacteria-mediated adverse human health effects.


The chapter was prepared by the OECD Working Group on the Harmonisation
of Regulatory Oversight in Biotechnology, Sub-working Group on Micro-organisms,
with the Netherlands and Canada having served as lead countries. It was initially
issued in September 2011.
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