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APPROVAL: New risks to the environment? Confusion surrounds BVLnotification in Germany

------------------------------- GENET-news -------------------------------
TITLE:  New risks to the environment? Confusion surrounds BVL notification
SOURCE: GMO Safety, Germany
DATE:   14.05.2007

Sale of MON810 maize restricted
New risks to the environment? Confusion surrounds BVL notification

The sale of seed of the genetically modified maize variety MON810 is
prohibited in Germany with immediate effect until such time as the
producer, Monsanto, submits an up-to-date monitoring plan. This does not
however affect maize already planted in this year's cropping period. The
official explanation for this decision is causing confusion: It states
that new findings indicate that the cultivation of MON810 maize could
harm the environment. While anti-genetic engineering associations called
on agriculture minister Seehofer to ban MON810 maize immediately,
scientists were puzzled by the sudden U-turn in the safety assessment.

On 27 April 2007 the Federal Office of Consumer Protection and Food
Safety (BVL) sent a formal notification to agro-biotech company
Monsanto. In it, the BVL, the authority responsible for genetic
engineering in Germany, orders an immediate sales ban on seed from
genetically modified MON810 maize. Sales may resume only when the
company submits a suitable monitoring plan for monitoring undesirable
effects on the environment and identifying them in good time. The
notification lists nine points for checking, including what happens to
the Bt toxin produced by MON810 maize in the soil, impacts on non-target
organisms and long-term effects on biodiversity.

MON810 maize has been authorised in the EU since 1998 and is the only GM
plant currently grown commercially in Germany and many other EU
countries. At the beginning of February 2007, farmers - particularly
those in the eastern German states - had registered a total cultivation
area of 3700 hectares in the site register, although some of these were
later withdrawn.

At the time the BVL sent the notification with the sales ban, most
farmers had already sown their MON810 seed. "Seed already delivered to
farmers or sown is not affected by this ruling," the BVL clarified in a
press release. And there are no plans to restrict use of the harvest for
food and feed. This means that the ruling will not make any difference
to farmers planting fields with MON810 maize this year. Cultivation is
still permitted with no restrictions, Monsanto explained. The company
also claimed it was already carrying out a monitoring programme "that
fully complies with the future requirements."

"New and additional scientific findings"

What triggered heated public discussion was the explanation given for
the measures. In its explanatory statement, the BVL cited "new and
additional scientific findings" that "provide justified grounds for
assuming that the cultivation of MON810 represents a danger to the
environment." A large number of scientific studies are listed to justify
this claim.

The response was immediate.
- On the one hand, organisations against genetic engineering, and
organic farming associations called on agriculture minister Seehofer to
draw the conclusions from the BVL explanation and ban the cultivation of
MON810 immediately.
- On the other hand, scientists in particular were puzzled that the
authority responsible in Germany is now assuming that there is a change
in the environmental safety assessment of MON810.

As recently as the end of 2006, the expert panel of the European Food
Safety Authority (EFSA ) looked in a detailed statement at the national
MON810 ban in Greece, which is based largely on the same scientific
sources as the explanatory statement for the sales ban in Germany. The
EFSA experts examined all the current scientific data on MON810 and the
Bt toxin produced in the plant and found no indications to justify
revising the cultivation authorisation for MON810.

What is most surprising though is that for many years the German
government has been promoting a biological safety research programme.
Numerous projects and field trials spanning several years have
investigated, among other things, potential environmental effects of Bt
maize - mostly MON810. However, the results, which have since been
published in scientific journals, have not been taken into account in
the BVL explanation.

This mentions two areas in which "new and additional information" give
grounds for a re-evaluation of the environmental risks posed by MON810:
"risks for the soil" and "risks for non-target organisms ", i.e. all
organisms apart from the targeted pest that come into contact with Bt
maize directly or indirectly.

Predatory insects: Ingest Bt toxin with their prey, but no clear
indications of risk

According to the explanation of the BVL notification, it is only more
recent research that has shown "that Bt toxin reaches higher links of
the food chain and to what extent." By "higher links" they mean e.g.
predatory insects that ingest Bt toxin indirectly with their prey. An
evaluation of numerous laboratory investigations (Lövei & Arpaia 2005)
showed that negative effects were measured in 41 per cent of the
parameters investigated for predatory insects, including lifespan,
development time and breeding rate.

- However, on closer inspection, it appears that the majority of the 44
studies evaluated were not dealing with Bt toxin but with other proteins
used to combat pests, such as protease inhibitors and lectins (insect
resistance ). Many of the studies did not investigate the Bt toxin used
in MON810 (Cry1Ab), but looked instead at other variants - and not just
in Bt maize, but also in insect-resistant potatoes, cotton and rice.

- Many studies do in fact show that Bt toxin ends up in organisms in the
higher levels of the food chain. But there appear to be hardly any clear
scientific findings that demonstrate a harmful effect of the Bt toxin.
Another review (Romeis et al. 2006), which is also mentioned in the BVL
explanatory statement, comes to the conclusion that negative effects of
the Bt toxin on predatory insects are observed only when the prey in
question is fed with Bt toxin and is sensitive to it. Only in cases
where the prey is obviously weakened by the Bt toxin does this have a
negative effect on their predators, as is to be expected. There is much
to suggest that Bt toxin does not in general have any direct toxic
effect on the predatory insects.

- As part of the BMBF-funded biological safety research programme,
numerous field studies have been conducted to investigate potential
effects on non-target organisms. The elaborate experiment design meant
that it was possible to make statistically reliable statements. In
total, around a million organisms were collected, identified and
assessed. The few Bt effects that were detected were slight and much
smaller than the effects of conventional insecticide treatments.

Butterflies: Only a few trials with MON810 maize

The Bt toxin produced in MON810 is found to have "clearly harmful
effects on caterpillars", according to the BVL explanation. However,
almost all the studies used to support this statement relate to Bt176, a
different insect-resistant maize. However, this variety has not been
sold for a long time now, since it has an unnecessarily high Bt
concentration in its pollen, 150-250 times higher than that found in MON810.

Only one of the studies listed (Diveley et al. 2004) actually relates to
MON810. It looks at potential negative effects on the Monarch butterfly,
a popular butterfly in North America. And in fact, it was found that one-
quarter fewer butterflies reach the larval stage if they are exposed to
the Bt toxin in high doses. Although negative effects were observed in
individual caterpillars, the effects on the Monarch population as a
whole are limited. No more than 2.4 per cent of the Monarch population
in the American corn belt was thought to be affected. In view of natural
fluctuations, e.g. as a result of climate change, the study authors felt
that the effects of MON810 cultivation were negligible. In Germany
comparable research carried out over three consecutive years found no
harmful effects even on the most sensitive species of butterfly.

Bt toxin in the soil: persistence, but no accumulation

The effect and persistence of Bt toxin in the soil is "currently
unclear," so the BVL claims in its notification, but "holds considerable
potential for ecological consequences." Bt toxin can enter the soil
through plant remains or secretions in the root area.

The behaviour of Bt toxins from plants is, however, basically no
different from that of conventional Bt preparations that are used as
biological pesticides. Regardless of the form of application, the active
Bt substance can be detected in the soil for several months. After the
cultivation of Bt plants, traces of Bt toxin can persist in the soil in
plant remains for a whole growing season - this too was shown by a BMBF-
funded biosafety research project. But the concentrations are so small
that no harmful effects can be detected on soil life. This means that
there are no indications that the Bt toxin could accumulate in the soil
and so reach toxicologically relevant concentrations.

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