ACRE Advice

Consideration of new information concerning the presence of unexpected transformation events in seed sown under consents 00/R14/8, 98/R19/18 and 00/R33/9

Advice of the Advisory Committee on Releases to the Environment under Section 124 of the Environmental Protection Act 1990

13 August 2002

On 7 August ACRE were asked for advice on information in a letter from Aventis (dated 2 August) (Adobe Acrobat format, 100kb) stating that oil seed rape seed used under consents 00/R14/8, 98/R19/18 and 00/R33/9 contained transformation events additional to those originally notified in these consents. The seed containing the additional transformation events was sown on 14 sites in spring 2002 as part of the Farm Scale Evaluations (FSE) of GM crops. In the past the same seed batch has been used in FSE sites in 1999 and 2000, and at small scale research trials at Scottish Agricultural College (SAC). A full list of sites where seed from this batch has been sown is given at Annex A.

The transformation events notified under consents 00/R14/8, 98/R19/18 and 00/R33/9 are Ms8 and Rf3, which contain:

• The bar gene encoding phosphinothricin acetyltransferase which confers resistance to the herbicide glufosinate.
• The barnase gene which confers male sterility.
• The barstar gene which inhibits the action of the barnase gene, thus restoring fertility in the hybrid line .

The additional transformation events that have been identified are Ms1, Rf1 and Rf2. These transformation events contain the same genes as Ms8 and Rf3, and also contain the nptII gene which encodes neomycin phosphotransferase which confers resistance to the antibiotics neomycin and kanamycin.

Ms1, Rf1 and Rf2 have been released previously under Part B research. Ms1 and Rf1 have a Europe-wide marketing consent issued in the UK on 28 February 1996.

Via an e-mail discussion, ACRE were asked to reconsider our risk assessment for consents 00/R14/8, 98/R19/18 and 00/R33/9 in the light of the new information, and to consider whether the plants currently growing should be harvested early, and whether the post-harvest monitoring requirements of the consents should be altered.

ACRE's advice:

ACRE was disappointed to discover that unexpected transformation events had been present in oil seed rape seed over a number of years without detection by either Aventis or the Regulatory Authorities. They noted that the material had now been rigorously tested and that the presence of genetically modified material was now fully characterised. In particular, tests have indicated the absence of genes encoding glyphosate tolerance.

In formulating its advice ACRE noted that all of the transformation events concerned have been considered thoroughly on previous occasions, and have been deemed not to pose a risk to human health or the environment. The Committee further noted that both the current and past releases were subject to conditions that prevent entry of the genetically modified material into the food or feed chains, and that the additional events were present in no more than 2.8 % of the seed.

ACRE was content that its original risk assessment of Ms1 combined with Rf1, and of Rf2 alone continue to apply. ACRE considered potential interactions between the transformation events that had not been considered as part of the original risk assessments (for example, Ms8 with Rf1), and were content that these combinations did not pose any additional hazards not considered in the original risk assessments. Finally, ACRE considered the implications of the presence of the nptII gene encoding resistance to the antibiotics neomycin and kanamycin. This gene is not considered harmful since:

1. It will only be transferred from the GM plants to bacteria at very low rates, if at all,

2. Genes encoding resistance to these antibiotics (including the nptII gene itself) are widespread in naturally occurring bacterial populations, and,

3. The antibiotics concerned are of little clinical importance.

In addition, ACRE noted that the consent conditions on these releases are such that material containing the nptII gene will not enter the food or feed chains.

As a result of these considerations, ACRE concluded that the presence of the additional transformation events did not pose any additional risks to human health or the environment.

In the light of this conclusion and the imminent harvest of the trials, ACRE advised that the currently growing plants should be harvested on a date that would minimise seed shed, and that no changes to the conditions of the consents concerning post-harvest monitoring were required.

ACRE also recommends that Aventis give urgent attention to the robustness of their quality control procedures relating to seed purity and that they provide ACRE with a full molecular characterisation of the adventitious transformation events. Further, ACRE suggests that the GM Inspectorate should review their approaches to the analysis of the purity of seed material used in releases of GM plants.

ACRE also advises that there are no new plantings of GM winter oil seed rape in the coming autumn until firm assurances regarding the composition and provenance of the seed to be used have been provided, and, if necessary, appropriate testing carried out.

Annex A

Locations where the seed batch containing Ms1, Rf1 and Rf2 has been sown: