Cambridge, United Kingdom
May 23, 2005
Monsanto's information
about its MON 863 maize, which was sent to the
Independent on Sunday
many weeks ago, is available here.
The full "rat study" has not been released
because it contains confidential business information which
could be of commercial use to our competitors and exploited by
others for commercial advantage, if made available. This is why
EU regulations contain data confidentiality provisions for
commercially sensitive information. Equally, under these
regulations, certain data may NOT be treated as confidential
information, but this does not extend to technical reports
containing research results.
So, the full study has been used by the
competent regulatory authorities and EFSA, whose report from
last year is available at
http://www.monsanto.co.uk/search/display.phtml?uid=8322.
All the relevant safety information from that
study is included in the summary which is also available on the
American Monsanto web site at
http://www.monsanto.com/monsanto/content/sci_tech/prod_safety/ratstudy.pdf
These two documents help to explain why those
best qualified to assess the safety of these products have been
satisfied.
BACKGROUND
Information on MON 863, the EU regulatory process and the
relevant information regarding the rat feeding study and expert
conclusions.
Response to Pusztai Report - reinforces the methodology and
quality of the rat study.
In conclusion, five independent experts have
reviewed the data and confirmed that MON 863 maize does not
adversely affect the health of rats.
The overwhelming opinion of expert authorities
is that MON 863 is safe for human and animal consumption.
-
Monsanto has met all regulatory data
requirements in the European Union and responded to all
supplemental requests for information from regulatory
authorities.
-
Monsanto contracted the 90-Day Rat Feeding
Study, as required by European regulatory authorities, and
subsequently updated the submission to fulfill the new
2001/18/EC requirements.
-
All qualified experts concluded that the
observed small numerical decrease in rat kidney weights is
not biologically meaningful, and the weights are well within
the normal range of kidney weights for control animals.
-
In the case of the MON 863 rat study, there
were no corresponding microscopic findings in the relevant
organ systems, and all MON 863 blood chemistry and organ
weight values fell within the "normal range of historical
control values" for rats. Thus, the experts concluded that
there were no effects on the functioning of kidneys in rats
fed a diet of MON863 corn.
Copyright 2005
Monsanto UK
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