Abstract
This paper presents the activities and publications of Organisation for Economic Co-operation and Developments (OECD’s) Working Group on Harmonisation of Regulatory Oversight in Biotechnology and the Task Force for the Safety of Novel Foods and Feeds. The main outputs of the work are the Series of “consensus documents” of the respective groups. These documents compile information which is intended to be used by those involved in the business of risk/safety assessment. These documents are one means of ensuring the transportability of data amongst authorities. An increasing trend in both the Working Group and Task Force is to consider crop species which are relevant to tropical regions and therefore to countries that are not necessarily members of the OECD. For example, the Working Group has recently published a consensus document on bananas and plantains while the Task Force has published a document on cassava. This trend towards crops of greater interest in the tropics is likely to continue into the future.
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All the documents mentioned in the text can be found in chronological order and downloaded from the OECD Biotrack public web site, www.oecd.org/biotrack
It comprises those related to the environmental safety activities of the Working Group that can be found at: http://www.oecd.org/env/chemicalsafetyandbiosafety/biosafety-biotrack/consensusdocumentsfortheworkonharmonisationofregulatoryoversightinbiotechnology.htm and those related to the food and feed safety activities of the Task Force at: http://www.oecd.org/env/chemicalsafetyandbiosafety/biosafety-biotrack/consensusdocumentsfortheworkonthesafetyofnovelfoodsandfeeds.htm
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The opinions expressed and arguments employed herein are those of the authors and do not necessarily reflect the official views of the OECD or of the governments of its member countries.
Appendix: Consensus documents published (Or Being Prepared) on environmental safety assessment and Novel Food/Feed Safety assessment
Appendix: Consensus documents published (Or Being Prepared) on environmental safety assessment and Novel Food/Feed Safety assessment
Document numbers refer to the OECD Series on Harmonisation of Regulatory Oversight in Biotechnology and the OECD Series on the Safety of Novel Foods and Feeds, available at www.oecd.org/biotrack
Organisms | BIOSAFETY/Biology of (organism) | FOOD/FEED SAFETY Compositional considerations of CROPS/MUSHROOMS/FRUITS | Notes |
|---|---|---|---|
CROP PLANTS | |||
Alfalfa & other Temperate Forage Legumes | No. 13 (2005)8 | 8 Chinese translation in progress | |
Barley (Hordeum vulgare L.) | No. 12 (2004) | ||
Cassava (Manihot esculenta) | Under preparation | No. 18 (2009) | |
Cowpea (Vigna unguiculata) | Under preparation | ||
Cotton (Gossypium spp.) | No. 45 (2008) Gossypium spp.6 | No. 11 (2004)—with 2009 corr. G. hirsutum. & G. barbadense 6 | 6 Chinese version available (Food 2004 doc updated by Secretariat with 2009 correction) |
Common Bean (Phaseolus vulgaris) | Under preparation | ||
Grain Sorghum (Sorghum bicolor) | Under preparation | No. 19 (2010) | |
Maize (Zea mays) | No. 27 (2003)2; 6 | No. 6 (2002)6 | 2 Japanese available 6 Chinese available |
Oilseed Rape, incl. Canola (Brassica spp.) | No. 7 (1997)1; 6 (Brassica napus) Cancelled, replaced by No. 54 Brassica spp. (2012) | No. 1 Low Er. Acid Rapeseed (2001)6 Cancelled, replaced by No. 24 Revised Low Erucic Acid Rapeseed (Canola) (2011) | 1 Russian available 6 Chinese available |
Peppers (Capsicum annuum Complex: Chili P., Hot P. and Sweet P.) | No. 36 (2006) | ||
Potato (Solanum tuberosum subsp. tuberosum) | No. 8 (1997)1; 8 | No. 4 (2002)8 | 1 Russian available 8 Chinese translation in progress |
Rice (Oryza sativa) | No. 14 (1999)2; 6 | No. 10 (2004, with 2009 correction)2;6 under revision | 2 Japanese available 6 Chinese available |
Soybean (Glycine max) | No. 15 (2000)1; 5; 6 | No. 2 (2001)6 Cancelled, replaced by No. 25 Revised Soybean (2012) | 1 Russian available 5 Japanese available 6 Chinese available |
Squashes, Pumpkins, Zucchinis and Gourds (Cucurbita L.) | No. 53 (2012) | Under preparation | |
Sugar Beet (Beta vulgaris) | No. 18 (2001) | No. 3 (2002) | |
Sugarcane (Saccharum spp. hybrids) | Under preparation | No. 23 (2011) | |
Sunflower (Helianthus annuus) | No. 31 (2004) | No. 16 (2007) | |
Sweet Potato (Ipomoea batatas) | No. 20 (2010) | ||
Tomato (Lycopersicon esculentum) | Under preparation | No. 17 (2008) | |
Wheat (Bread Wheat) (Triticum aestivum) | No. 9 (1999)6 | No. 7 (2003)6 | 6 Chinese available |
MUSHROOMS | |||
Cultivated Mushroom (Agaricus Bisporus) | No. 15 (2007) | ||
Oyster Mushroom (Pleurotus spp.) | No. 34 (2005) | Under preparation | |
FRUITS (PLANTS & TREES) | |||
Apple | Under preparation | ||
Bananas and Plantains (Musa sp.) | No. 48 (2009) | ||
Citrus sp. | (on hold) | ||
Papaya (Carica papaya) | No. 33 (2005)8 | No. 21 (2010) | 8 Chinese translation in progress |
Stone Fruits (Prunus sp.) | No. 24 (2002)1 | 1 Russian available | |
FOREST TREES | |||
Black Spruce (Picea mariana) | No 49 (2010) | ||
Douglas Fir (Pseudotsuga menziesii) | No 43 (2008) | ||
Eastern White Pine (Pinus Strobus) | No.22 (2002) | ||
Eucalyptus (Eucalyptus spp.) | Under preparation | ||
European White Birch (Betula pendula) | No. 28 (2003) | ||
Jack Pine (Pinus banksiana) | No. 40 (2006) | ||
Lodgepole Pine (Pinus contorta) | No. 44 (2008) | ||
Native North American Larches: Sub-alpine Larch (Larix Lyalli), Western L. (L. occidentalis) and Tamarack (L. laricina) | No. 41 (2007) | ||
Norway Spruce (Picea abies) | No. 12 (1999) | ||
Poplars (Populus sp.) | No. 16 (2000)1; 8 | 1 Russian available 8 Chinese translation in progress | |
Sitka Spruce (Picea Sitchensis) | No. 21 (2002) | ||
Western White Pine (Pinus monticola) | No. 38 (2008)3 | 3 Revising the 2006 issue | |
White Spruce (Picea glauca) | No. 13 (1999) | ||
ANIMALS | |||
Atlantic Salmon (Salmo salar) | Under preparation | ||
Aedes aegypti (Mosquito) | Under preparation | ||
MICROORGANISMS | Information used in Environmental Applications Involving: | ||
Acidithiobacillus | No. 37 (2006) | ||
Acinobacter | No. 46 (2008) | ||
Bacteria—Taxonomy in Risk Assessment | No. 29 (2003) | ||
“”—Methods for Detection when introduced into the Environment | No. 30 (2004) | ||
“”—Pathogenicity Factors/Potential Adverse Health Effect | No 52 (2011) | ||
“”—Horizontal gene transfer between bacteria | No 50 (2010) | ||
Baculoviruses | No. 20 (2002) | ||
Fusarium | Under preparation | ||
Pseudomonas | No. 6 (1997) | ||
TRAITS | Biosafety/Information. on genes and enzymes that confer… to plants | ||
Insect Control through Bacillus Thuringiensis (Bt)-Derived Protein | No. 42 (2007)6; 7 | 6 Chinese available 7 Japanese translation in progress | |
Tolerance to Glyphosate Herbicide | No. 10 (1999)5; 8 | 5 Japanese available 8 Chinese translation in progress | |
Tolerance to Phosphinothricin (Glufosinate-Ammonium) Herbicide “considered as Module I” | No. 11 (1999)5; 8 | 5 Japanese available 8 Chinese translation in progress | |
Tolerance to Phosphinothricin Glufosinate-Ammonium) Herbicide—Module II—Herbicide Biochemistry, Metabolism & Residues in Plants | No. 25 (2002)5 | 5 Japanese available | |
Virus Resistance through Coat Protein Gene-Mediated Protection | No. 5 (1996)8 | 8 Chinese translation in progress | |
GENERAL DOCUMENTS ON ENVIRONMENTAL SAFETY WORK | |||
Guidance for Designation of Unique Identifier for Transgenic Plants– Revised 2006 | WG No. 23 (2006)4; 5 | 4 Russian available 5 Japanese available | |
Unique Identifier for Transgenic Micro-organisms | (on hold)—ENV/JM/BIO(2009)9/REV2 archived for future reference | ||
Guide for Preparation of Biology Consensus Documents | No. 47 (2008) | ||
Introduction to the Biosafety Consensus Documents | No. 32 (2005)5 | 5 Japanese available | |
Points to Consider for Consensus Documents on the Biology of Cultivated Plants | No. 35 (2006)5 Under revision | 5 Japanese available | |
Low Level Presence in Seeds and Commodities in the Context of Environmental Safety | No. 55 (2013) | ||
Environmental Considerations for Risk/Safety Assessment for Release of Transgenic Plants | Under preparation | ||
Molecular Characterisation of Plants Derived from Modern Biotechnology (Working Group and Task Force Joint Project) | No 51 Working Group = No 22 Task Force (2010)8 | 8 Chinese translation in progress | |
GENERAL DOCUMENTS ON FOOD & FEED SAFETY WORK | |||
Considerations for the Safety Assessment of Animal Feedstuffs derived from GM plants | No. 9 (2003)2 | 2 Japanese available | |
Introduction to the Food & Feed Safety Consensus Documents | No. 14 (2006) | ||
Instruction for Authors drafting Food & Feed Safety Consensus Documents | ENV/JM/FOOD(2006)3/REV4 available for future updates and reference Under preparation |
TOTAL | WORKING GROUP 47 Cons. documents published + 10 under preparation + 2 on hold | TASK FORCE 24 Cons. documents published Incl. 2 of them cancelled/superseded by new version + 1 internal doc for authors’ reference + 4 under preparation | Translations of WG and TF Consensus documents into Japanese : 11 docs available, 1 expected Russian : 6 docs available Chinese : 11 docs available, 13 expected |
Other publications under translation (May 2013):
Recombinant DNA Safety Considerations (OECD, 1986): Chinese translation in progress
Safety Considerations for Biotechnology (OECD, 1992): Chinese translation in progress
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Kearns, P., Dagallier, B. & Suwabe, K. The risk/safety assessment of transgenic crops: the transportability of data. Transgenic Res 23, 1015–1023 (2014). https://doi.org/10.1007/s11248-013-9766-8
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DOI: https://doi.org/10.1007/s11248-013-9766-8