Novel Food and Feed Safety

ISSN :
2304-9502 (online)
ISSN :
2304-9499 (print)
DOI :
10.1787/23049502
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This series represents a compilation of the science-based Consensus Documents developed by the OECD Task Force for the Safety of Novel Foods and Feeds since 2001. They contain information for use during the regulatory assessment of food/feed products of modern biotechnology, i.e. issued from transgenic crops. Relevant information includes compositional considerations (nutrients, anti-nutrients, toxicants, allergens), use of the plant species as food/feed, and other elements. These documents should be of value to applicants for commercial uses of novel foods and feeds, to regulators and risk assessors in national authorities for their comparative approach, as well as the wider scientific community. More information on this OECD work is found at BioTrack Online (http://www.oecd.org/biotrack).

 

 
Safety Assessment of Transgenic Organisms, Volume 3

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Safety Assessment of Transgenic Organisms, Volume 3

OECD Consensus Documents You do not have access to this content

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Author(s):
OECD
Publication Date :
09 Nov 2010
Pages :
324
ISBN :
9789264095434 (PDF) ; 9789264095427 (print)
DOI :
10.1787/9789264095434-en

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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.
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    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.
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    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, avec notamment le Brésil, le Cameroun, la Chine, l’Estonie, l’Inde, les Philippines et l’Afrique du Sud.
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    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 trees

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      Section 1 - Western white pine (Pinus monticola)
      The largest genus in the family Pinaceae, Pinus L., which consists of about 110 pine species, occurs naturally through much of the Northern Hemisphere, from the far north to the cooler montane tropics (Peterson, 1980; Richardson, 1998). Two subgenera are usually recognised: hard pines (generally with much resin, wood close-grained, leaf fascicle sheath persistent, two fibrovascular bundles per needle — the diploxylon pines); and soft, or white pines (generally little resin, wood coarse-grained, sheath sheds early, one fibrovascular bundle in a needle — the haploxylon pines). These subgenera are called respectively subgenus Pinus and subgenus Strobus (Little and Critchfield, 1969; Price et al., 1998; Gernandt et al., 2005). Occasionally, one to about half the species (20 spp.) in subgenus Strobus have been classified instead in a variable subgenus Ducampopinus.
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      Section 2 - Jack pine (Pinus banksiana)
      The largest genus in the family Pinaceae, Pinus L., which consists of about 110 pine species, occurs naturally through much of the Northern Hemisphere, from the far north to the cooler montane tropics (Peterson, 1980; Richardson, 1998). Two subgenera are usually recognised: hard pines (generally with much resin, wood close-grained, sheath of a leaf fascicle persistent, two fibrovascular bundles per needle — the diploxylon pines); and soft, or white pines (generally little resin, wood coarse-grained, sheath sheds early, one fibrovascular bundle in a needle — the haploxylon pines). These subgenera are called respectively subg. Pinus and subg. Strobus (Little and Critchfield, 1969; Price et al., 1998). Occasionally, one to about half the species (20 spp.) in subg. Strobus are classified instead in a variable subg. Ducampopinus.
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      Section 3 - Native north american larches: subalpine larch (Larix lyallii), western larch (L. occidentalis), and tamarack (L. laricina)
      Each of the three North American larch species is usually discussed separately in each section and subsection of this Consensus Document in the following order: subalpine larch (Larix lyallii), western larch (Larix occidentalis), and tamarack (Larix laricina).
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      Section 4 - Douglas-Fir (Pseudotsuga menziesii)
      Pseudotsuga menziesii (Mirbel) Franco is generally called Douglas-fir (so spelled to maintain its distinction from true firs, the genus Abies). Pseudotsuga Carrière is in the kingdom Plantae, division Pinophyta (traditionally Coniferophyta), class Pinopsida, order Pinales (conifers), and family Pinaceae. The genus Pseudotsuga is most closely related to Larix (larches), as indicated in particular by cone morphology and nuclear, mitochondrial and chloroplast DNA phylogenies (Silen 1978; Wang et al. 2000); both genera also have non-saccate pollen (Owens et al. 1981, 1994). Based on a molecular clock analysis, Larix and Pseudotsuga are estimated to have diverged more than 65 million years ago in the Late Cretaceous to Paleocene (Wang et al. 2000). The earliest known fossil of Pseudotsuga dates from 32 Mya in the Early Oligocene (Schorn and Thompson 1998).
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      Section 5 - Lodgepole pine (Pinus contorta)
      The following text applies principally to lodgepole pine (Pinus contorta Dougl. ex. Loud.) in the most important part of its range; namely central and southern British Columbia, western Alberta, eastern Washington, eastern Oregon, Idaho, Montana, Wyoming, northern Colorado, and northern Utah. It also discusses use of lodgepole pine as an exotic.
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      Section 6 - Black spruce (Picea mariana)
      Black spruce [Picea mariana (Mill.) B.S.P.], known by many alternate common names including bog spruce, swamp spruce, Canadian spruce, eastern spruce, and shortleaf black spruce (Viereck and Johnston, 1990; Alden, 1997), is one of the most common and important boreal species native to North America, especially in eastern Canada. Black spruce is one of about 40 species in the genus Picea of the family Pinaceae, all of which are found in cooler portions of the northern hemisphere (Farrar, 1995). Ten spruce species are native to North America (Weng and Jackson, 2000). There is no consensus among taxonomists regarding subdivision of the genus, but Picea is often described as having three sections (Eupicea, also known as Picea or Morinda; Castica; and Omorika), with black spruce generally placed among the Eupicea (Dallimore and Jackson, 1948; Alden, 1987). Mikkola (1969) suggested dividing the genus into only two sections, Abies and Omorika. Fowler (1983) recommended adopting Mikkola’s classification, but splitting the section Omorika into two subsections, Omorikoides and Glaucoides, and placing black spruce into the former subsection based upon species crossability. Other examples of taxonomic classification have also been proposed for the genus (e.g., see Weng and Jackson, 2000).
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  • Expand / Collapse Hide / Show all Abstracts Consensus document on safety information on traits

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      Section 1 - Safety information on transgenic plants expressing Bacillus thuringiensis - Derived insect control protein
      This section summarises the information available on the source of Bacillus thuringiensis ..-endotoxin genes, the structure and properties of the toxins they encode, unique mechanisms of action, use in plants, toxicity and exposure data, and assessment methods. Some information on Bacillus thuringiensis, the bacterial source of these traits, is included as background and where relevant to the risk assessment of the ..-endotoxins in plants, however this section does not attempt to address the vast amount of information available on the micro-organism. In addition to the scientific literature, which grew substantially over the last few years, this section also contains data submitted by registration applicants for the US-registered plant pesticide products (called plant-incorporated protectants in US pesticide regulations). These studies are required to be performed according to good laboratory practices regulations (US Code of Federal Regulations 40 CFR 160) and have been peer reviewed by USEPA scientists for acceptability for use in an environmental assessment. In the US, data from these studies may be released to the public and are available from the companies on request by other regulatory bodies. Some of these data were submitted for products that are no longer registered; however, the data are still valid to illustrate ..-endotoxin properties. Where it is necessary to illustrate assessments unique to these toxin genes, plant expression data are discussed. However, the intent of this section is not to address gene transfer or other issues unique to specific plants that have been transformed to express these toxins. Such information is outside the scope of this section. It is intended that this section should be used in conjunction with specific plant species biology consensus documents when a biosafety assessment is made of plants with Bacillus thuringiensis ..-endotoxin-mediated insect protection. It was also agreed that this section would not address the issue of insect resistance management, designed to prevent or delay the onset of resistance to specific ..-endotoxins in insects exposed to these transgenic crops.
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  • Expand / Collapse Hide / Show all Abstracts Documents to facilitate harmonised safety assessments

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      Section 1 - OECD guidance for the designation of a unique identifier for transgenic plants
      This guidance for a unique identifier for transgenic plants was developed by OECD’s Working Group on Harmonisation of Regulatory Oversight in Biotechnology. The purpose is for use as a "key" to unlock or access information in OECD’s database of products of modern biotechnology which have been approved for commercial application, as well as interoperable systems.
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      Section 2 - Molecular characterisation of plants derived from modern biotechnology
      The Working Group on the Harmonisation of Regulatory Oversight in Biotechnology and the Task Force for the Safety of Novel Foods and Feeds are implementing closely-related programmes of work at the OECD. Both of them develop science-based consensus documents, which are mutually acceptable among member countries. These consensus documents contain information for use during the regulatory assessment of products derived from modern biotechnology.
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