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PRESS RELEASE FROM GENETIC CONCERN



 Flawed Monsanto Data Calls Irish Sugar-beet Trials into question

Genetic Concern today expressed alarm at flaws discovered in data submitted by multi-national genetics company Monsanto to U.K. regulatory authorities. The revelation is the latest in a series of blunders associated with Monsanto’s releases of genetically modified organisms in Europe - Last week Monsanto was find £17,000 by magistrates in Lincolnshire for failing to maintain a 6 metre pollen boundary around a field trial of genetically engineered oilseed rape. Last year, a Monsanto field trial of genetically engineered sugar beet in Holland was accidentally harvested and the incident was not reported to the authorities until a week had elapsed, by which time the beet had been processed into animal feed and sugar.

"These revelations are further evidence that biotechnology companies are not behaving responsibly, considering the irreversible nature of any accident which may occur" said Quentin Gargan, spokesperson for Genetic Concern, "there should be a moratorium on the introduction of genetically engineered food and crops until the science can be independently proven to be safe, and we believe that companies with an invested interest cannot be trusted to do this" he added.

The flawed data, presented to the U.K. Advisory Committee on Releases to the Environment (ACRE) related to maize. Despite approval of the maize for planting and consumption in many parts of the world, including the U.S. and Japan, mistakes in the molecular data had not been spotted before.

According to ACRE’s minutes, the Committee found that the molecular data submitted by Monsanto did not support conclusions drawn by Monsanto who subsequently had to submit a revised version following new molecular analysis and a revised risk assessment.

The minutes expressed concern at the significant divergence between the current and previously submitted structure and "concluded that a lack of rigour in the original analysis and poor interpretation of the data had contributed to a standard well below that required and expected in applications to place products onto the market".

Genetic Concern believes it is absurd for the EPA and the Food Safety Authority in Ireland to accept data from biotechnology companies at face value.

Over 3,100 public submissions to the EPA about Monsanto’s most recent sugar beet trials complained that Monsanto had been subjected to investigations concerning misleading research presented to regulatory authorities. On that issue, in its report to the Board the EPA response simply stated that "the company advised that they are complying with the requirements under the GMO Regulations". (See copy of report to Board attached).

The findings mirror Genetic Concern’s assessment of data presented to the EPA which they claim included shoddy research. In an affidavit to the High Court relating to the 1997 sugar beet trials, geneticist Dr. Ricarda Steinbrecher complained that

…the data shown for the Southern analysis does not detail the quantity of genomic DNA used …., which commonly is provided in scientific reports. Further no positive genomic plant DNA containing the relevant gene was used ……… Altogether the molecular analysis report falls short of scientific standards.

In view of the series of blunders, Genetic Concern is calling once again on the government to immediately implement the moratorium it promised in a pre-election statement and stop all field trials of genetically engineered crops in Ireland until the technology has been proven to be absolutely safe.

ENDS

Background Information

Extract from ACRE Minutes of 13th January 1999,

Item 2.1: Application from Monsanto Europe for consent to market maize genetically modified for glyphosate tolerance Ref 97/M3/2 - Re-evaluation in the light of further information (ACRE/99/P1)

The Secretariat introduced this item, reminding ACRE Members that they had first seen the application in February 1998. The scope of the application is limited to import of grain for processing for food and feed. ACRE advised that the product posed very low risk to human health and the environment but the molecular data submitted by the applicant did not support the conclusions drawn regarding genomic organisation of the transgenes. ACRE advised the Secretariat that multiple copies of the gene cassette might be present, and the committee took this into account during its safety assessment.

Nevertheless, the ACRE Secretariat wished to resolve this issue and wrote to the applicant. In response to the request for further information, the applicant submitted a revised version of the structure of the insert following a more detailed molecular analysis together with a revised risk assessment.

The Committee studied the revised structure of the genetic material inserted into maize line GA21 (the GA21 insert). Members were very concerned at the significant divergence between the current and previously submitted structure and concluded that a lack of rigour in the original analysis of maize line GA21 and poor interpretation of the data had contributed to a standard well below that required and expected in applications to place products onto the market.

Extract from EPA Report to Board on Monsanto’s Application to Plant GE Sugar beet 1998

12 .Representations made under article 31(4): …….

Concerned that the EPA in its assessment has to rely on data provided by Monsanto, the very company that stands to profit from the trials. Monsanto has a poor reputation. They and their subsidiary companies have been subject to a number of investigations concerning misleading research presented to regulatory authorities

Response: The company have advised that they are complying with the requirements under the GMO Regulations implementing Directive 90/220/EEC