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GE - Flawed Monsanto Data Calls Irish Sugar-beet Trials into question

  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