ACRE Advice

ACRE's response to concerns raised in written representations and submissions associated with the CHARDON LL public hearing and to statements made at ACRE's open hearing relating to the safety assessment of T25 GM maize conducted under Directive 90/220/EEC

Index:

• Introduction
• ACRE's Overall Advice on Concerns Raised During the CHARDON LL Public Hearing and During ACRE's Open Hearing
  • Background to the transgenic trait
  • Environmental Issues
  • Animal Feed Safety Issues
• Further information

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Introduction

The Advisory Committee on Releases to the Environment (ACRE) is a statutory, independent science and technical committee that advises ministers on the risks to human health and the environment from the deliberate release to the environment of genetically modified organisms (GMOs). Further information about ACRE, its remit and membership, its range of expertise and declarations of members interests, agendas, minutes, and publications are available on the ACRE website ¹.

CHARDON LL ² is a GM maize variety containing the T25 transformation event that confers tolerance to the herbicide glufosinate ammonium. The T25 / CHARDON LL GM maize lines were developed by AgrEvo (who subsequently became Aventis Cropscience and more recently became Bayer Cropscience).

In 1995, AgrEvo applied through the French authorities for approval under EU Directive 90/220 to place GM maize carrying the T25 transformation event on the European market for import as grain, cultivation and use as animal feed. In June 1995 France circulated the dossier to other member states with the recommendation that T25 maize be given approval. After due consideration, in 1998 European Union member states approved the marketing of T25 maize. As part of this process ACRE considered the French opinion and dossier supporting the application and gave its advice to the UK government in June 1996. ACRE agreed with the assessment of the French competent authority that T25 maize poses no greater risk to human health and the environment than non-GM commercial maize varieties.

CHARDON LL, a genetically modified (GM) fodder maize variety developed with tolerance to the herbicide glufosinate ammonium, has been proposed for addition to the National List ³. Under the 1982 National List of Varieties Regulations, parties affected by the proposed decision to "list" a variety could make written representations to and/or request a hearing before a person appointed by ministers. Many of the representations received are critical of the marketing approval given for T25 maize by the European Community in 1998 ⁴. Further written submissions were presented for consideration when the hearing was resumed after an adjournment ⁵. ACRE has considered all the relevant scientific concerns raised in written representations and submissions to the CHARDON LL hearing. In excess of fifteen box files of written material was submitted and ACRE has considered all the relevant scientific concerns expressed within it.

In addition, ACRE called an open hearing on February 20^th, 2002 in which the Committee invited witnesses and independent experts to speak on scientific issues addressing four key areas associated with the risk assessment of T25 maize:

(i) Transgene stability and the risks from horizontal gene transfer

(ii) Environmental risk assessment and monitoring

(iii) Compositional equivalence

(iv) Feed safety assessment including the chicken feeding study

Witnesses included those for and against the marketing of T25 maize. The Committee's aim was to ensure that they had an accurate overview of both sides of the argument as well as having considered the relevant scientific issues. As animal feed studies were discussed, members of the Advisory Committee on Animal Feedingstuffs (ACAF) augmented ACRE at the hearing.

This paper gives ACRE's advice on the concerns expressed at ACRE's hearing as well those raised in the written representations and submissions associated with the CHARDON LL hearing - it is not intended to provide a comprehensive summary of ACRE's safety assessment.

Reconsidering risk assessments in the light of new information is an important part of ACRE's remit. To this end, ACRE has continued to issue advice concerning T25 maize following it's original assessment ⁶. One of the features of the GM regulatory regime in Europe is that consents are not fixed and any new evidence that indicates that the product is causing harm will result in the consent being altered or withdrawn.

In the remainder of this document, points raised in written representations and submissions for the CHARDON LL public hearing and during ACRE's open hearing are in bold italicised text; these are followed by a response from ACRE.

1 www.defra.gov.uk/environment/acre/index.htm

2 CHARDON LL is a variety of maize containing the transformation event T25 that is approved under Directive 90/220/EEC. Transformation events are regulated under the GMO regulations; the seed legislation operates at the "variety" level.

3 Before any new plant variety (GM or conventional) can be placed on the market it has to be listed on the National List of approved varieties. To be "listed" the variety has to pass minimum agronomic standards. The legislation that underpins this process and serves to protect farmers from buying sub-standard seed (the National List Regulations) is quite separate from the GMO safety legislation.

4 Bad Science, Bad Decisions. Friends of the Earth briefing paper, www.foe.co.uk and official proceedings of the CHARDON LL public hearing, www.defra.gov.uk/planth/pvs/CHARDON/index.htm

5 The CHARDON LL Hearing was adjourned in November 2000 to allow the European Commission time to clarify the lawfulness of distinctness, uniformity and stability tests carried out by the French that comprised part of the proposal to add CHARDON LL to the National List.

6 Advice issued by ACRE in connection with T25 maize:

• Advice on notification for consent to market GM maize with tolerance to glufosinate ammonium herbicide, 20 June 1996.
  Advice for the secretary of State 23 June 1998. Genetically modified maize in national list trials adjacent to an organic farm in Devon. Available on ACRE's website: http://defra.gov.uk/environment/acre/pubs.htm
  Advice for The Secretary of State 25 March 1999. A Report on The Dispersal of Maize Pollen Compiled by the National Pollen Research Unit and Commissioned by The Soil Association