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GM Maize 59122 Not Safe
-----------------------

by Prof. Joe Cummins and Dr. Mae-Wan Ho
Science in Society
Issue 34, Summer 2007

Dismissing differences detected between GM and
non-GM feed in safety tests appears to be common
practice, and is condoned by regulatory
authorities.

This report has been submitted to the European
Food Safety Authority public consultation on
behalf of ISIS. Please circulate widely.

[A fully referenced version of this article is
posted on ISIS members' website.

An electronic version of this report, or any
other ISIS report, with full references, can be
sent to you via e-mail for a donation of £3.50.
Please e-mail the title of the report to: report
at i-sis.org.uk]

Double-whammy GM maize gets positive opinion
from European Food Safety Authority

Maize 59122 is genetically modified for rootworm protection and
herbicide tolerance, and has been developed by Dow Chemical and its
associated company Pioneer Hybrid Seed Company. The variety is based on
the gene transformation event DAS-59122-7, expressing unique binary
proteins Cry34Ab1 and Cry35Ab1 derived from the soil bacterium Bacillus
thuringiensis (Bt) Herculex. DAS-59122-7, and the PAT protein
conferring resistance to the herbicide glufosinate ammonia. The
transgenes, along with control elements including promoters and
terminators, are inserted at a single locus in a maize chromosome. The
company has applied to place Maize 59122 on the market in Europe for use
as food, feed, processing, and other products, and the European Food
Safety Authority (EFSA) has put out its opinion for public comment.
Unsurprisingly, the EFSA considers maize 59122 "unlikely to have any
adverse effect on human and animal health or on the environment in the
context of its intended uses."

Simultaneously the company has applied to Canada, China, Japan and
Korea for import and environmental release, and to Mexico, Taiwan and
Australia/New Zealand for food use.

Dow Agrisciences/Pioneer Hybrid International had submitted an
application for non-regulated status for the same transgenic maize to
the United States Department of Agriculture Animal and Plant Health
Inspection Service (USDA/APHIS) in December 2003, and the transgenic
maize is currently marketed in the US as Herculex RW.

The application to Europe indicated that event 59122, created by
Agrobaterium-mediated transformation, had incorporated synthetic
approximations of three genes: Cry34Ab1 with a maize ubiquitin promoter
and intron and a terminator sequence from potato protease inhibitor II;
Cry35Ab1 with a wheat peroxidise promoter and terminator from potato
protease inhibitor II; and PAT for glufosinate tolerance with 35S CaMV
promoter and terminator. The application also claimed that the genes
were stably inserted at a single locus and there was no evidence of
instability. The application also stated that the transgenes were
incorporated correctly between the left and right borders of T-DNA, and
that 59122 maize does not contain fragments from the vector backbone.
However, the claim to stability appears to depend on a Southern blot
analysis within a single plant breeding generation.

The application claims a "very broad body of evidence" for the
safety of the transgenic proteins in food and feed. So let's look at
the evidence.

Safety assessment based on surrogate
proteins fundamentally flawed

The proteins synthesized from the artificial genes were compared with
proteins synthesized in bacteria and seemed identical (but see later).
The main safety and environmental tests were therefore done on proteins
derived from bacteria, and not from the transgenic maize.

USDA/APHIS conducted an environment assessment of maize event 59122
-- its potential impacts on non-target organisms including threatened
and endangered species -- and concluded the environmental effects
insignificant. However, the bulk of the tests were done also with
proteins isolated from bacteria, not from maize 59122. A fuller
comparison of the insecticidal proteins produced in 59122 with those in
the bacteria used in safety testing revealed that four amino acids in
the C-terminal domain were different in Cry35Ab1. But these differences
were considered negligible.

In general, the C-terminal domain of Bt toxins is involved in
structural stability, ion channel gating, binding to membrane vesicles
and determining insecticidal specificity. A study of Cry34/Cry35
insecticidal proteins from diverse Bt strains showed that Cry 35Ab1
contains a segment similar to the to a beta-trefoil domain that may be a
binding motif for galactose. Some examples of trefoil domains include
those in the toxins from Clostridium botulinum, abrin and ricin. It
seems very cavalier of the USDA to ignore amino acid sequences in a
domain known to be active in important functions, and the EFSA is doing
likewise.

Transgenic maize not substantially
equivalent to non-transgenic variety

Maize 59122 was analysed and compared with near-isogenic non-GM maize
lines to determine whether or not 59211 was substantially equivalent to
unmodified maize. The maize lines were compared for fibre and minerals,
for amino acids, fatty acids, vitamins, secondary metabolites and anti-
nutrients. One parameter, carbohydrate, was significantly lower in
59122 treated with glufosinate; and 13 of 65 (20 percent) determinants,
including forage fibre, grain amino acids and vitamins, were outside the
levels for conventional maize. The expected level for differences
solely due to chance is just over 3 out of 65 (5 percent). In spite of
these many differences, 59122 was deemed substantially equivalent to
unmodified maize.

Feeding studies inadequate

A sub-chronic study was carried out for 90 days on rats fed 59122 grain
compared with grain from a near isogenic line. For the most part the
differences between animals fed 59122 maize and non-GM maze were not
significant. Nevertheless, significant differences were detected in the
levels of mean corpuscular haemoglobin, haemoglobin concentration, red
cell width, reticulocyte count and platelet count; but these blood
values were ignored. Chickens were fed grain either from 59122 or from
a near-isogenic maize. Carcass and organ weights were measured after 42
days. For the most part, carcass and organ sizes were not different,
though the livers of female chickens fed transgenic maize were
significantly enlarged, but that, too, was ignored.

Significant differences ignored
and regulators turn a blind eye

It has now become customary for company researchers to pass over
significant differences due to the consumption of GM feed in animal
testing, and for regulators to condone such fraudulent practices, as is
clear in the recent re-analysis of Monsanto's MON 863 feeding study by
independent scientists (see "GM Maize MON 863 Toxic", SiS 34). The
significant differences between 59122 and near isogenic maize lines,
detected even when only relatively crude parameters were measured,
obviously cry out for fuller independent studies, and highlight the
inadequacy of current regulatory regimes (see "GM Food Nightmare
Unfolding in the Regulatory Sham", ISIS scientific publication, also SiS
33).

The use of proteins produced in bacteria as surrogates for
transgenic proteins in toxicity and other safety tests is not
acceptable. In addition to a thorough characterization of the
transgenic proteins and its mechanism of action in insects and mammals,
there must also be long term feeding trials with the transgenic maize
similar to those carried out for drugs and pesticides. A full safety
evaluation should further include characterizations using micro-array
technology, now available for maize, which would be a great improvement
on the kind of equivocal results used for the claim that 59122 is
'substantially equivalent' to non-GM maize and hence 'safe'.

In conclusion, maize 59122 has not passed its safety test, and
should not be given market approval.

http://www.i-sis.org.uk/GMmaize59122notSafe.php

( The Institute of Science in Society )

Guest · Posted: Fri Jun 01, 2007 3:19 pm Post subject: Re: Rain 2007

In article <135vf1g5hof8ebd@corp.supernews.com>, usenet@jftemple.co.uk
(Stephen Temple) wrote:

Tim Lamb · Guest

In message <fImdnT6txZI1nf3bRVnyigA@pipex.net>,
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Jill · Guest

greymaus wrote: