The Environmental Protection Agency (EPA) has today given consent to BASF Plant Science GmbH, Ludwigshafen, Germany, to carry out field trials on genetically modified (GM) potato lines with improved resistance to late potato blight. The consent is subject to ten conditions.

This consent is for field trials only and should not be confused with the placing of GM products on the market, which requires a separate consent and approval process at EU level.  Potatoes (GM or non-GM) harvested from the field trials will not be used for food or feed purposes.

The trials can be modified, suspended or terminated by the EPA at any time if new information comes to light.

The approval for field trials follows a detailed examination and assessment of the BASF notification and extensive consultations with all appropriate state agencies and government departments including the National Advisory Committee on Genetically Modified Organisms (GMOs) and the GMO Sub-Committee under the Food Safety Authority of Ireland (FSAI).  A total of 96 representations were received from interested parties and these were fully assessed as part of the licensing process.

The field trials will be carried out at one location at Arodstown, Summerhill, Co Meath and the trial site will not exceed 1 hectare in size. The duration of the experiment is for five years from 2006 to 2010 (inclusive), with post trial monitoring continuing until 2014.

Under the EPA consent the trials will be subject to strict conditions with regular monitoring and reporting to the Agency. The trial sites will also be checked for compliance with the licence conditions on a regular basis by the EPA’s expert agronomists.

The company will also be required to fund independent post planting environmental studies to look at the following aspects:

• Measurement of indicators of biodiversity that might be affected by the trial;
• Potential pollen flow to adjacent crops;
• The potential for the GM tubers to persist both inside and outside the field trial area.

The details of this monitoring must be fully agreed by EPA in advance of planting.

The company will also be required to submit monthly reports to the EPA for monitoring purposes. Information about the trials including the results of monitoring will be available to the public at the EPA Headquarters in Wexford and on the EPA website at www.epa.ie/Licensing/GMOLicensing/DeliberateReleaseofGMOs/ProposedFieldTrialwithGMPotatoes/.

BACKGROUND

What are GMO’s?

GMOs are defined as organisms (bacteria, viruses, fungi, plant and animal cells, plants and animals) that are capable of replication or of transferring genetic material in which the genetic material has been altered in a way that does not occur naturally by mating or natural recombination. GMO technology is often called ‘modern biotechnology’ or ‘gene technology’, ‘recombinant DNA technology’ or ‘genetic engineering’. It allows selected individual genes to be transferred from one organism into another, also between non-related species.

In 1996, the first GM seeds were planted for commercial use in the US. In 2005, 8.5 million farmers from 21 countries grew GM crops on approx. 90 million hectares worldwide. The most commonly grown GM crops were GM soybean, GM maize, GM cotton and rapeseed.

Why is late blight a focus for study?

Late blight is a very common disease in potatoes grown in Ireland.  Many plant pathologists consider it to be the most dangerous plant disease in the world because of how rapidly it can spread when conditions are warm and moist, causing devastating losses. Owing to its flexibility, it has been able to survive every management strategy used thus far and has responded with new, adapted forms. According to data published by scientists at Teagasc, Oakpark, annual losses due to this fungus in Ireland have been estimated at €10.2 m per annum and this potato disease requires regular application of fungicides at high rates and short intervals throughout the growing season in order to control crop losses caused by the fungus.

When was the licence application received by EPA?

A notification for a licence for GMO potato field trials was received by the EPA on the 13^th January 2006 from BASF Plant Science GmbH, Carl-Bosch-Str. 38 D-67056 Ludwigshafen, Germany. 

The EPA had until 12^th April 2006, to make a decision, however, the period for consideration of the notification was extended on five (5) occasions as the EPA sought further clarification on questions raised by both itself and its reviewers. The EPA received the final portion of the requested information on 22^nd March 2006, which extended the deadline to 13^th May 2006.

Who did EPA consult as part of its licence assessment process?

The EPA’s extensive consultation process included: the National Advisory Committee on Genetically Modified Organisms (GMOs), the GMO Sub-Committee under the Food Safety Authority of Ireland (FSAI), Teagasc, Department of Agriculture & Food, Department of Health and Children, Department of the Environment Heritage and Local Government and the Health and Safety Authority  as well as consideration of the comments and concerns expressed in the 96 representations received from interested parties.

In what ways have the GM potato lines been modified?

The GM potato lines contain two genes (called R-genes) (and other important regulatory DNA inserts) inserted into three (3) potato breeding lines using GMO technology. The two R-genes are derived from a wild potato species (Solanum bulbocastanum) from Mexico that confers improved resistance against the potato blight fungus, which causes late blight in potatoes. The GM potato lines also contain a herbicide marker gene from another plant species (thale crest, (Arabidopsis thaliana), an edible weed plant from the mustard family) called the ahas gene which is present for purposes of GMO selection during the tissue culture stage of the process. It does not confer herbicide tolerance to plants.  In any case, the herbicide has not been approved for use in Ireland and thus cannot be used in Irish Agriculture.

Why is a field trial important?

The deliberate release of GMOs into the environment for field trial purposes in Ireland and in other EU Member States are mainly carried out for the purposes of study, research, demonstration and development of novel varieties. The behaviour of the GMO in an open environment and its interactions with other organisms and the environment are important aspects to be studied at the field trial stage. In fact, the EU Directive on the deliberate release of GMOs foresees that the field trial stage is a necessary step in the development of new products derived from, or containing GMOs.

Are field trials taking place elsewhere?

BASF also sent notifications to Germany, Netherlands and Sweden seeking permission to carry out field trials on these GM potato lines in these countries. The GM potato lines carrying one of the R-genes were released in the field in Sweden in 2005. During these trials no unforeseen effects as compared to conventional potato varieties were observed according to the Swedish Competent Authority.

What happens next if the trials are positive?

If the results of the experimental release are positive, the company may decide to place the GMO on the market, i.e. make it available to farmers for cultivation purposes.

However, it is important to point out that the placing on the market of a GMO cannot proceed without the prior approval under the provisions of Part C of Directive 2001/18/EC on the deliberate release into the environment or under Regulation (EC) No 1829/2003 on food and feed. If approval is granted under the comitology procedure at EU level, then the GMO may then be placed on the market in the EU for purposes of cultivation, importation, or transformation into different products for food and feed use.