International updates on coexistence – April to June 2006

Global

  • In June, chemical and biotechnology company DuPont announced plans with oil giant BP and British Sugar to use GM in efforts to manufacture biobutanol as an alternative fuel. The project will develop a GM microorganism to improve the yield when converting feedstocks such as corn, sugar beets, sugar cane, wheat and cassava into biobutanol. Butanol can be blended with petroleum at a higher concentration than ethanol and used without the need to retrofit vehicles.

Europe

  • In April, Poland’s upper house of parliament passed a bill banning the use of 16 varieties of GM maize seeds and 700 non-GM varieties of maize throughout the country. This measure has been authorised by the EC, because the varieties of maize are not suitable for cultivation in Poland. Poland previously had a ban on the sale of GM food and the cultivation of all GM crops; however, Poland dropped this ban prior to joining the EU in May 2004.
  • Ireland’s Department of Agriculture and Food has produced a report that examines the issues surrounding the coexistence of GM and non-GM crops, and explains proposals for a national strategy and best practices to ensure coexistence between different agricultural production systems can occur. The measures take into account the characteristics of the crop and the farming systems in Ireland.
  • A recent study in Germany examined short distance outcrossing (or cross-pollination) of transgenic oilseed rape (canola) over a three year period. It aimed to determine the effects of distance and wind direction on the frequency and direction of pollination in plots with different ratios of transgenic plants (100%, 1.0% and 0.1%). Surrounding plots within a distance of 3-11 metres were tested for the presence of the transgene, which conferred resistance towards a broad-range herbicide. All surrounding plots had levels of the transgene well below the EU food labelling threshold of 0.9%. Wind was found to have no significant influence on gene flow; the authors explained the random and undirected flow they found by insect activity.
  • A coexistence meeting titled “Freedom of Choice” was held by the EC from 4-6 April 2006 in Vienna. The presentations and discussions focused on the political and societal aspects of coexistence, with a particular attention to regulatory, technical and economic approaches to coexistence as well as consumer attitudes and market responses. Participants at the conference were delegates invited from primarily EU Member States and stakeholder organisations operating at EU level. Three workshops were held in parallel:
    • regional and national approaches to coexistence in the EU: regulatory frameworks for technical segregation rules, liability and compensation mechanisms;
    • segregation in farming and throughout the food chain – technical and economic aspects; and
    • consumer attitude and market responses to GM organisms, viewpoint of the stakeholders.
  • On 22 May 2006 the EU Agriculture Council, (comprised mostly of the Agriculture Ministers from the EU countries) recommended that:
    • the EC to come forward, as soon as possible, with EU-wide thresholds for seeds that would allow the mandatory GM food labelling threshold (0.9%) to be respected. The Ministers stated that the level of these thresholds should allow freedom of choice throughout the whole food production chain, and it should not create a disproportionate burden for any group of operators. To date, however, the EC has not yet adopted thresholds; and
    • the EC develop more “in-depth” technical guidelines on specific crops that can be adapted by the Member States to meet their own individual needs (such as share of different crops in cultivation, crop rotations, field sizes, climatic conditions, etc.).
  • The Dutch Ministry of Agriculture, Nature and Food Quality asked the Wageningen University to develop a genetically modified (GM) potato with resistance to late blight (Phytophthora infestans). Six field trials with the GM maize hybrid Mon810 will be conducted this year to establish the size of buffer zones for coexistence purposes. 9.9 million Euro from the Government’s Economic Structural Fund (FES) is being used to fund this project.
  • The world’s first medicine derived from a genetically engineered animal has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use. The European Medicines Agency initially rejected ATryn, a recombinant form of a human anti-clotting agent made from the milk of transgenic goats. The use recommended for approval is for people with a rare inherited disease who are undergoing surgery. The approval was a reversal of an earlier decision and was made on the basis of re-examination of the previous opinion as well as a review of responses to specific questions posed by the Committee to an independent expert panel composed of internationally recognised experts in blood and blood disorders. The drug is currently undergoing US FDA phase III clinical trials.
  • Transgenic Bt-toxin producing potatoes of the “Elizabeth” variety have been produced in Russia and registered for human consumption. Russia does not officially grow any GM crops commercially at present and this potato variety has not yet been approved for commercial production, but has been designed to grow in Russian conditions.

Asia

  • India has approved new rules for the importation of GM organisms. The key requirements are:
    • imported GM materials must be labelled as GM;
    • importation of GM food for manufacture, release or field trials will be permitted only with the approval of the Genetic Engineering Approval Committee of the Ministry of Environment and Forests; and
    • importation of GM materials for research must be approved by the Review Committee for Genetic Modification within the Department of Biotechnology.

Australasia

  • Food Standards Australia New Zealand (FSANZ) is currently assessing an application from Monsanto Australia Limited to amend the Australia New Zealand Food Standards Code (the Code) to approve food derived from a GM high lysine corn, corn line LY038.
  • Australia released a report in April detailing its review of the Gene Technology Act 2000, five years after it entered into force. Two issues discussed in the review were:
    • the scope of the Act, which currently focuses on the health and safety of people and the environment - it was decided that the scope of the Act should remain the same, and not consider economic, marketing and trade, cultural and social impacts of GM organisms when making decisions about the development and use of GM organisms under the Act; and
    • whether assessments by the Gene Technology Regulator should consider the benefits as well as the risks of GM organisms - the review panel concluded that the risk assessment process prescribed by the Act should not be modified to a risk-benefit assessment.

North America

  • A report was released in June describing a trend that emerged in the US in 2005 with sixteen state bills being introduced to preempt or disallow existing local and county regulations restricting the use of GM seeds and crops. The US state bills were prompted by concerns of some legislators that local regulations limiting or prohibiting the use of GM for agricultural purposes could be inconsistent with state-wide policies and regulations.
  • The US Food and Drug Administration (FDA) issued guidance for industry on 20th June on early food safety evaluation of new non-pesticidal plant proteins that could inadvertently enter the food supply. Procedures for submitting an early food safety evaluation of such proteins to the FDA are described, but the recommendations are voluntary.
  • The Center for Food Safety (a not-for-profit interest group) filed a lawsuit against the US FDA in June seeking to force the US government to conduct mandatory pre-market safety reviews of genetically engineered foods and require labelling of such foods once they are approved. Officials will monitor the progress of this lawsuit.

Central America

  • Cuban scientists have developed the first monoclonal antibody from transgenic plants for use as a human vaccine against hepatitis B. The antibody, CB-Hep.1, is produced in what the researchers describe as a non-commercial version of the ancestral tobacco plant. The antibody was approved by Cuba's medication quality control agency, part of the public health ministry, in April 2006. Previously, antibodies used for therapeutic vaccines have been obtained from fermentation of mammalian mouse cells – a time consuming and costly method that generates very small quantities.

South America

  • Chile’s House of Representatives has approved legislation requiring that all food products with transgenic content of 1% or more be labelled, saying either “This product contains genetically modified organisms” or “This product contains (name of genetically modified organism).”

Contact for Enquiries

Dr Sharon Adamson
Manager, Innovation Policy
Ministry of Agriculture and Forestry
PO Box 2526
Wellington
NEW ZEALAND

Phone: +64 4 894 0618
Fax: +64 4 4 894 0741
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