Harmonisation of Regulatory Oversight in Biotechnology

2311-4622 (online)
2414-6854 (print)
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This series represents a compilation of the science-based consensus documents developed by the OECD Working Group on the Harmonisation of Regulatory Oversight in Biotechnology since 1995. They contain information for use during the regulatory assessment of organisms produced from modern biotechnology - transgenic crops, trees, animals and micro-organisms - intended for release in the environment. Information relevant to environmental risk assessment (biosafety) includes biology, centres of origin, reproduction, genetics, interaction with other organisms and other elements. Knowledge of the traits introduced in the organisms, and their biotechnological developments, is also critical. These documents should be of value to applicants for commercial uses of transgenic organisms, to regulators and risk assessors in national authorities in charge of granting approvals to their environmental release, as well as to the wider scientific community. More information on this OECD work can be found at BioTrack Online (http://www.oecd.org/biotrack).

Safety Assessment of Transgenic Organisms, Volume 4

Safety Assessment of Transgenic Organisms, Volume 4

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09 Nov 2010
9789264096158 (PDF) ;9789264096141(print)

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The books on "Safety Assessment of Transgenic Organisms" constitute a compilation of the OECD Biosafety Consensus Documents. When published, Volume 1 and 2 contained the documents issued before 2006; Volume 3 and 4 are a continuation of the compilation up to 2010.

The OECD Biosafety Consensus Documents identify elements of scientific information used in the environmental safety and risk assessment of transgenic organisms which are common to OECD member countries and some non members associated with the work. This is intended to encourage information sharing, promote harmonised practices, and prevent duplication of effort among countries.

These books offer ready access to those consensus documents which have been issued on the website thus far. As such, it should be of value to applicants for commercial uses of transgenic organisms (crops, trees, microorganisms), to regulators and risk assessors in national authorities, as well as the wider scientific community.

More information on the OECD's work related to the biosafety of transgenic organisms is found at BioTrack Online (http://www.oecd.org/biotrack).

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  • Foreword
    Genetically engineered crops (also known as transgenic crops) have been approved for commercial release in an increasing number of countries, for planting or for use as commodities. Genetically engineered varieties of over a dozen different plant species have received regulatory approval in several OECD and non-OECD countries from all regions of the world, the large majority of plantings being for soybean, maize, cotton and rapeseed (canola), as outlined in The Bioeconomy to 2030: Designing a Policy Agenda (OECD, 2009). During the period from 1996 to 2009, for example, there was an almost eighty-fold increase in the area grown with transgenic crops worldwide, reaching 134 million hectares in 2009, as mentioned in Global Status of Commercialized Biotech/GM Crops (James, 2009). Such approvals usually follow a science-based risk/safety assessment.
  • Introduction to the biosafety consensus documents
    The OECD’s Working Group on Harmonisation of Regulatory Oversight in Biotechnology (the Working Group) comprises delegates from the 33 member countries of OECD and the European Commission. Typically, delegates are from those government ministries and agencies, which have responsibility for the environmental risk/safety assessment of products of modern biotechnology. The Working Group also includes a number of observer delegations and invited experts who participate in its work, such as Argentina; the Russian Federation; the United Nations Environment Programme (UNEP) and; the Secretariat of the Convention on Biological Diversity (SCBD); the Food and Agriculture Organization of the United Nations (FAO), the United Nations Industrial Development Organisation (UNIDO); and the Business and Industry Advisory Committee to the OECD (BIAC). In recent years, with the increasing use of biotech products in many regions of the world together with the development of activities relating to tropical and subtropical species, there has been increased participation of non-member economies including Brazil, Cameroon, China, Estonia, India, the Philippines and South Africa.
  • Présentation des documents de consensus sur la sécurité biologique
    Le Sous-groupe de l’OCDE sur l’harmonisation de la surveillance réglementaire en biotechnologie (le Sous-groupe) comprend des délégués des 33 pays Membres de l’OCDE et de la Commission européenne. Généralement, les délégués sont des fonctionnaires des ministères et organismes gouvernementaux chargés de l’évaluation des risques pour l’environnement et de la sécurité des produits issus de la biotechnologie moderne. Le Sous-groupe comprend aussi plusieurs délégations et experts invités qui participent à ses travaux en qualité d’observateurs, notamment l’Argentine, la Fédération de Russie, le Programme des Nations Unies pour l’environnent (PNUE), le Secrétariat de la Convention sur la diversité biologique (SCDB), les Organisation des Nations Unies pour l’alimentation et l’agriculture (FAO) et pour le développement industriel (ONUDI) et le Comité consultatif économique et industriel auprès de l’OCDE (BIAC). Ces dernières années, du fait de l’utilisation croissante des produits issus de biotechnologie dans plusieurs régions du monde et le développement d’activités portant sur les espèces tropicales et sub-tropicales, la participation au Sous-groupe des économies non membres s’est intensifiée,
  • Points to consider for consensus documents on the biology of cultivated plants
    Most environmental risk/safety assessments of transformed (genetically modified or engineered) plants are based upon a broad body of knowledge and experience with the untransformed species based on familiarity with the crop plant. The intent of the biology consensus documents is to describe portions of this body of knowledge directly relevant to risk/safety assessment in a format readily accessible to regulators. The document is not an environmental risk/safety assessment of the species. Rather, the consensus document provides an overview of pertinent biological information on the untransformed species to help define the baseline and scope (the comparator against which transformed organisms will be compared), in the risk/safety assessment of the transformed organism. Consensus documents are not detailed crop handbooks or manuals of agricultural or silvicultural practice or economic botany, but rather focus on the biological information and data that may be clearly relevant to the assessment of newly transformed plants.
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  • Expand / Collapse Hide / Show all Abstracts Consensus documents on the biology of crops

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    • Section 1 - Cotton (Gossypium spp.)
      Generally cotton refers to four species of the genus Gossypium L. apparently domesticated independently in four separate regions, in both the Old World and the New World (Sauer, 1993; Brubaker et al., 1999c). The word is derived from the Arabic "quotn", "kutum" or "gutum" and refers to the crop that produces spinnable fibres on the seed coat (Lee, 1984; Smith, 1995). Gossypium (cotton) comprises approximately 50 species worldwide in the arid to semi-arid tropics and subtropics (Fryxell, 1992; Wendel and Cronn, 2003) (Appendix 1). The cultivated species are grouped according to their level of ploidy...
    • Section 2 - Bananas and plantains (Musa spp.)
      Edible bananas and plantains belong primarily to Musa section Musa (traditionally Eumusa). Within this section, the originally Asian species Musa acuminata and Musa balbisiana have provided the sources for domestication and development of the great majority of edible fruit. Dessert and cooking bananas and plantains are major foods worldwide, cultivated in over 130 countries throughout tropical regions and in some subtropical regions, in Asia, Africa, Latin America and the Caribbean, and the Pacific. Global production is difficult to determine because the plants are so often grown locally in small plots (e.g. household gardens) and consumed locally. The reported area cultivated worldwide in 2006 was 4.2 million hectares of bananas and 5.4 Mha of plantains, with a world production of 70.8 millon metric tonnes of bananas and 34.0 Mmt of plantains (FAO, 2008). The international trade, which involves just a few varieties of fruit, accounts for 15% of production. In addition to the edible species, Musa textilis (abacá, Manila hemp) is important for fibre production, and there are several ornamental species (Häkkinen, 2007).
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    • Section 1 - Information used in the assessment of environmental applications of Acinetobacter
      This document represents a snapshot of current information that may be relevant to risk assessments of micro-organisms in the genus Acinetobacter. This document presents information in the scientific literature and other publicly-available literature about the known characteristics of Acinetobacter species encountered in various environments (including clinical settings) and with diverse potential applications (environmental, industrial, agricultural, and medical).
    • Foreword to the guidance documents relating to micro-organisms
      The OECD’s Working Group on Harmonisation of Regulatory Oversight in Biotechnology decided at its first session, in June 1995, to focus its work on the development of consensus documents which are mutually acceptable among Member countries. These consensus documents contain information for use during the regulatory assessment of a particular product.
    • Section 2 - Guidance document on the use of taxonomy in risk assessment of micro-organisms: Bacteria
      For risk assessments of micro-organisms used in biotechnology there is, in a general sense, a significant amount of commonality in methods that are used. Regardless of the organism employed or the uses of the organism that are evaluated, certain basic issues always need to be addressed during the course of an assessment. This document addresses one of the basic elements: the use of microbial taxonomy in assigning or confirming the identity of a subject micro-organism. Since the methods of taxonomy and the rules for naming organisms are different for prokaryotes than for eukaryotes or viruses, this document will be limited in scope to the use of taxonomy in the assessment of Eubacteria and Archea (simplified as "bacteria").
    • Section 3 - Guidance document on methods for detection of micro-organisms introduced into the environment: Bacteria
      The aim of this Guidance Document is to provide information on the "state-of-the-art" detection methods available for micro-organisms released into the environment. The document is meant to offer guidance to regulators and applicants on how to interpret and evaluate data from scientific studies. It is therefore not an exhaustive list of all detection methods presently available, but a document that discusses the merits and pitfalls of a number of the most current, frequently used methods. However, this can also be helpful for similar discussions on alternative, or newly developed methods.
    • Section 4 - Guidance document on horizontal gene transfer between bacteria
      Horizontal gene transfer (HGT) 1 refers to the stable transfer of genetic material from one organism to another without reproduction. The significance of horizontal gene transfer was first recognised when evidence was found for ‘infectious heredity’ of multiple antibiotic resistance to pathogens (Watanabe, 1963). The assumed importance of HGT has changed several times (Doolittle et al., 2003) but there is general agreement now that HGT is a major, if not the dominant, force in bacterial evolution. Massive gene exchanges in completely sequenced genomes were discovered by deviant composition, anomalous phylogenetic distribution, great similarity of genes from distantly related species, and incongruent phylogenetic trees (Ochman et al., 2000; Koonin et al., 2001; Jain et al., 2002; Doolittle et al., 2003; Kurland et al., 2003; Philippe and Douady, 2003). There is also much evidence now for HGT by mobile genetic elements (MGEs) being an ongoing process that plays a primary role in the ecological adaptation of prokaryotes. Well documented is the example of the dissemination of antibiotic resistance genes by HGT that allowed bacterial populations to rapidly adapt to a strong selective pressure by agronomically and medically used antibiotics (Tschäpe, 1994; Witte, 1998; Mazel and Davies, 1999). MGEs shape bacterial genomes, promote intra-species variability and distribute genes between distantly related bacterial genera.
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