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 1

Safety Assessment of Transgenic Organisms, Volume 1

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24 July 2006
9789264095380 (PDF) ;9789264095342(print)

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These 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.  This is intended to encourage information sharing and prevent duplication of effort among countries. This book offers ready access to those consensus documents which have been published thus far. As such, it should be of value to applicants for commercial uses of transgenic crops, regulators 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) such as maize, soybean, rapeseed and cotton have been approved for commercial use in an increasing number of countries. During the period from 1996 to 2005, for example, there was more than fifty-fold increase in the area grown with transgenic crops worldwide, reaching 90 million hectares in 2005.1 Such approvals usually follow a science-based risk/safety assessment.
  • Introduction to the Biosafety Consensus Documents
    OECD’s Working Group comprises delegates from the 30 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. They include: Argentina; Russia; Slovenia; the United Nations Environment Programme (UNEP); the Secretariat of the Convention on Biological Diversity (SCBD); the United Nations Industrial Development Organisation (UNIDO); and the Business and Industry Advisory Committee to OECD (BIAC).
  • Presentation des documents de consensus sur la biotechnologie
    Le Sous-groupe comprend des délégués des 30 pays Membres de l’OCDE et de la Commission européenne. En général, 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 Russie, la Slovénie, le Programme des Nations Unies pour l’environnent (PNUE), le Secrétariat de la Convention sur la diversité biologique (SCDB), l’Organisation des Nations Unies pour le développement industriel (ONUDI) et le Comité consultatif économique et industriel auprès de l’OCDE (BIAC).
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  • Expand / Collapse Hide / Show all Abstracts Consensus documents on the biology of crops

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    • Section 1 - 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 (variety, etc.), i.e. familiarity with the crop plant. The intent of the biology consensus document 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.
    • Section 2 - Soybean (GLYCINE MAX (L.) MARR.)
      Cultivated soybean, Glycine max (L.) Merr., is a diploidized tetraploid (2n=40), in the family Leguminosae, the subfamily Papilionoideae, the tribe Phaseoleae, the genus Glycine Willd. and the subgenus Soja (Moench). It is an erect, bushy herbaceous annual that can reach a height of 1.5 metres. Three types of growth habit can be found amongst soybean cultivars: determinate, semi-determinate and indeterminate (Bernard and Weiss, 1973). Determinate growth is characterised by the cessation of vegetative activity of the terminal bud when it becomes an inflorescence at both axillary and terminal racemes. Determinate genotypes are primarily grown in the southern United States (Maturity Groups V to X). Indeterminate genotypes continue vegetative activity throughout the flowering period and are grown primarily in central and northern regions of North America (Maturity Groups 000 to IV). Semi-determinate types have indeterminate stems that terminate vegetative growth abruptly after the flowering period. None of the soybean varieties are frost tolerant, and they do not survive freezing winter conditions.
    • Section 3 - Maize (ZEA MAYS SUBSP. MAYS)
      Maize, or corn, is a member of the Maydeae tribe of the grass family, Poaceae. It is a robust monoecious annual plant, which requires the help of man to disperse its seeds for propagation and survival. Corn is the most efficient plant for capturing the energy of the sun and converting it into food, it has a great plasticity adapting to extreme and different conditions of humidity, sunlight, altitude, and temperature. It can only be crossed experimentally with the genus Tripsacum, however member species of its own genus (teosinte) easily hybridise with it under natural conditions.
    • Section 4 - Oilseed Rape (BRASSICA NAPUS L.)
      This consensus document addresses the biology of the species Brassica napus L. Included are general descriptions of this species as a crop plant, its origin as a species, its reproductive biology, its centres of origin, and its general ecology. The ecology of this species is not described in relation to specific geographic regions. Special emphasis has been placed on detailing potential hybridisation between B. napus and its close relatives, although this discussion is limited to hybridisation events which do not require intervention through means such as embryo rescue (i.e. these events could possibly occur in nature, and could result in fertile offspring).
    • Section 5 - Rice (ORYZA SATIVA L.)
      Rice is grown worldwide and is a staple food for about a half of the world’s population. It is a nutritious grain crop which contains carbohydrates, proteins, lipids, minerals, etc. Rice straw is an important animal feed in many countries
      This consensus document addresses the biology of the potato (Solanum tuberosum subsp. tuberosum). It contains general information on the taxonomy, morphology, and centre of diversity of the species which can be of importance during a risk assessment (for example, information on reproductive biology, the possibility of crosses, and ecology). In regard to intra- and interspecific crosses, emphasis has been given to the conditions which make a cross possible rather than listing all successful crosses. Such a list would be very long and subject to frequent changes. Only hybridisation events not requiring human intervention are considered.
    • Section 7 - Bread Wheat (TRITICUM AESTIVUM)
      Triticum aestivum, bread wheat, belongs to the order Poales (Glumiflorae), family Poaceae (Gramineae), tribe Triticeae, genus Triticum. The tribe Triticeae consists of 18 genera which are divided into two sub-groups, the Triticinae and the Hordeinae. The major genera in the sub-group Triticinae are Triticum, Aegilops, Secale, Agropyron and Haynaldia (Odenbach 1985, Zeller 1985, Körber-Grohne 1988).
    • Section 8 - Sugar Beet (BETA VULGARIS L.)
      Sugar beet (Beta vulgaris L. ssp. vulgaris var. altissima) belongs to the family Chenopodiaceae and the genus. B. vulgaris comprises several cultivated forms of B. vulgaris subsp. vulgaris. Cultivars include leaf beet (var. cicla) and beetroot (root beet USA). The genus Beta is divided into four sections shown in Table 1.14 below (Ford-Lloyd and Williams, 1975; Campbell, 1976; Tranzschel, 1927 and Ulbrich, 1934)...
    • Section 9 - Sunflower (HELIANTHUS ANNUUS L.)
      The sunflower belongs to the genus Helianthus in the Composite family (Asterales order), which includes species with very diverse morphologies (herbs, shrubs, lianas, etc.). The genus Helianthus belongs to the Heliantheae tribe. This includes approximately 50 species originating in North and Central America.
    • Section 10 - Papaya (CARICA PAPAYA)
      Papaya, Carica papaya L., is an almost herbaceous (succulently soft-wooded), typically unbranched small tree in the family Caricaceae. Europeans first encountered papaya in the Western Hemisphere tropics by at least the early 1500s (Sauer, 1966), and various interests were soon disseminating it widely (Ferrão, 1992). Papaya is now cultivated worldwide in tropical and subtropical climates mainly for its melon-like fruit.
    • Section 11 - Oyster Mushroom (PLEUROTUS SPP.)
      Oyster mushroom is regarded as one of the commercially important edible mushrooms throughout the world. It consists of a number of different species including Pleurotus ostreatus, Pleurotus sajor-caju, Pleurotus cystidiosus, Pleurotus cornucopiae, Pleurotus pulmonarius, Pleurotus tuber-regium, Pleurotus citrinopileatus and Pleurotus flabellatus. They thrive on most of all hardwoods, wood by-products such as sawdust, paper, pulp sludge, all the cereal straws, corn and corn cobs, coffee residues such as coffee grounds, hulls, stalks, and leaves, banana fronds, and waste cotton often enclosed by plastic bags and bottles. The oyster mushroom is the second most important mushroom in production in the world, accounting for 25% of total world production of cultivated mushrooms. Oyster mushroom is grown worldwide, and China is the major producer. P. ostreatus was first cultivated in the USA in 1900 and several other species of the oyster mushroom such as Pleurotus sajor-caju were initially cultivated in India after the late of 1940s. The oyster mushroom has been regarded as one of the most profitable cash crops in Korea, accounting for 65% of total domestic mushroom production.
    • Section 12 - Capsicum Annuum Complex
      Capsicum annuum L. is a dicotyledonous flowering plant commonly grown worldwide, with many general names in English, such as hot pepper, chili, chilli or chile pepper, and as well sweet pepper and bell pepper. Sometimes the plant is just called pepper, which however is often reserved for the earlier known Asian Piper nigrum (black pepper, white pepper) in the family Piperaceae. The pre- Columbian, indigenous Nahua (Aztec) Amerindian name for the plant was transcribed as chilli or chili, and the usual name in Spanish is chile, which results in the plurals of chillies, chilies, and chiles (Bosland 1996). Other broad names for C. annuum relate more to particular varieties or strains, culinary uses, and ripeness, such as jalapeño, Cayenne, pimento (pimiento), paprika, red, and green peppers. Furthermore, four other less commonly cultivated Capsicum species are also considered chile peppers, and two of these species are similar and closely related to C. annuum.
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