ISIS Report 24/10/06
GM Rice Contamination
How Regulators Tried to Sidestep the Law
BSE, drug trials and GM food, who are the regulators protecting? Prof.
Peter Saunders
A fully
referenced version of this article is posted on ISIS members’ website.
Details here
European regulator quick to reassure public
The European Union has legislation requiring that any GM product put on
the European market must have passed an authorisation procedure. Although
the scientific assessments used are superficial and ignore a great deal of
important evidence [1] (GM Food
Animals Coming, this
issue), but at least the law is clear. As the Commissioner for Health and
Consumer Protection Markos Kyprianou said, “There is no flexibility for unauthorised
GMOs – these cannot enter the EU food and feed chain under any circumstances.”
[2]
So when the
US Department of Agriculture (USDA) announced on 18 August that some commercially
grown long grain rice had been contaminated with small amounts of the GM rice
LLRICE601, the EU acted swiftly. The European Commission adopted emergency
measures that forbid US long grain rice entering the EU unless accompanied
by a certificate from an accredited laboratory assuring that LLRICE601 is
absent. This is necessary because the present US procedures for testing are
clearly inadequate: by mid-October, LLRICE601 had been detected in 74 separate
incidents in 15 European countries [3].
The Commission also asked the European Food
Standards Agency (EFSA) to examine the data supplied by the US and to assess whether they were sufficient to
allow a proper safety assessment to be carried out; and the EFSA duly reported
[4]:
“The available data are
not sufficient to allow the safety of LLRICE601 to be assessed in accordance
with the EFSA guidance for risk assessment. However, on the basis of the available
molecular and compositional data and on the toxicological profile of PAT proteins,
EFSA considers that the consumption of imported long grain rice containing
trace levels of LLRICE601 is not likely to pose an imminent safety concern
to humans or animals.”
UK regulator privately allowed the sale of tainted rice at first
The UK Food Standards Agency (FSA) also sought advice, but only informally
from two members of the Advisory Committee on Novel Foods and Processes (ACNFP).
They too were told that there was no imminent safety concern. As with the
EFSA, this positive advice was
based on a dossier supplied by Bayer CropScience on 25 August with about 30
pages deleted as confidential business information (CBI).
Bayer CropScience
eventually sent the full dossier, but too late to be used by the scientists
who advised either of the agencies.
But while the EU decided
to ban US long grain rice, the UK FSA told retailers in a memo later leaked
to the press that there was no need to check whether any of the rice they
were selling included some LLRICE601. It is, however, illegal to sell unauthorised
GMOs in the UK, and Friends of the Earth threatened to take
the FSA to court to make them comply with the law.
It would have made an interesting case, but the FSA backed
down. On 5 October a new item appeared on their web site. It included the
following statement [5]:
“The Agency has reconsidered
and updated its advice to retailers regarding rice contaminated with GM material
in the light of the EFSA risk assessment. The Agency had previously advised
retailers that it would not be proportionate to track down and remove all
products from sale that contain LLRICE601 because they were not thought to
pose an imminent risk to health.
“However,
the law states that no unauthorised GM material should be present in food
on sale in the UK.
Therefore the Agency is reminding food businesses of their responsibility
to ensure that food they sell complies with the law. Any rice known to be
contaminated with GM material is illegal and should be removed from sale.”
You may get
the impression from this that the FSA has modified its advice in the light
of new scientific evidence, as any responsible body should, and that’s obviously
what you’re meant to think. Not so. The EFSA risk assessment was based on
the same evidence that was available to the FSA, the expurgated dossier originally
provided by Bayer, and it reached the same conclusion.
In fact, the
public statement from the FSA on 1 September did say that food
retailers are responsible for ensuring that the food they sell does not contain
unauthorised GM material [6]. At the same time, however, the FSA was privately
advising retailers that it would not expect
them actually to stop selling
such food. It is the private advice that has changed.
The FSA is now admitting that it had previously advised
retailers not to take measures to ensure they were complying with the law.
It is also admitting that the reason
it is now advising them to check if their rice is contaminated and, if it
is, not to sell it, is simply that it is illegal to sell unauthorised GM products
in the UK. But that was just as true in August as
it was in October. Nothing has changed, except that the FSA now accepts that
regulatory bodies are not supposed to advise businesses to ignore the law
of the land.
Sounds familiar?
The reference to the EFSA risk assessment
is presumably an attempt to deflect criticism from whoever gave the original
advice, just the sort of thing you’d expect if you’ve read Richard Packer’s
book [7], which gives an Inside Story of BSE (this issue).
The EFSA risk assessment
was bad enough, as it was not made in accordance with the EU’s own guidelines,
partly because it was carried out in a hurry, but also because Bayer did not
provide the full dossier in time. The
FSA’s risk assessment was worse; it was done informally by only two scientists,
and on the basis of the same expurgated dossier that contained little information
relevant to safety. But you would not have gathered that from the great confidence
with which both the EFSA and the FSA advised the public that there was no
danger.
The power of
the vested interests that Packer mentions in his book is as much in evidence with GM as
with BSE. The UK government has always been a major supporter of GM crops. That
is not because UK consumers want them; on the
contrary, they have made clear
that they do not. The real reason is that both the chemical and pharmaceutical
industries are very powerful in the UK. The British government is worried about the prospect of what it sees
as the next generation of products being developed somewhere else. So there
has always been pressure to approve GM crops, not because we need them in
the UK but in the hope that our industries can profit from developing
them.
For exactly
the same reason, the Medical and Healthcare products Regulatory
Agency has failed in its duty to protect the participants in the TGN1412 drug
trials that went so disastrously wrong in the spring of this year [8, 9]
(Post Mortem on the TGN1412 Disaster).
The UK Consumers’
Association has just published a wide-ranging and devastating criticism of
the MHRA [10] When they put to
the MHRA the charge that it was too much in the pocket of the drug manufacturers,
the Agency replied (emphasis added): “We have a responsibility to ensure
that regulation is designed to enable rather than hinder the development of
new products that would improve health.”
Of course regulation should
not place unnecessary obstacles in the way of progress. But the primary responsibility
of regulators is to protect the public. They must never be allowed to forget that.
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