[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index]
[SANET-MG] dont trust uncle sam
I think that it is wrong to presume that Bt10 is safe, it has never been
Nature 434, 807 (14 April 2005); doi:10.1038/434807a
Don't rely on Uncle Sam
European regulators should pursue their own investigation into how the
'wrong' genetically modified corn was allowed on the market for years.
Unfortunately, their US equivalents show little sign of rising to the
Given widespread unease among the European public about genetically
modified crops, you'd have expected the news that unapproved batches of
transgenic seed containing a gene for antibiotic resistance had been
shipped from the United States to Europe to have provoked a vigorous
So far, however, reactions from Brussels have been equivocal. Markos
Kyprianou, the European commissioner responsible for health and consumer
protection, started strongly, declaring that he "deplores" the
inadvertent release of unapproved seed in the European Union (EU). But
since then, his spokesman has sent mixed messages. First, he simply
expressed confidence in the ongoing US investigation into the incident;
only later did he state that the European Commission is itself
vigorously demanding more information from the company responsible about
The spokesman's second statement is appropriate; the first seems
inadequate. This incident points to fundamental problems with the
regulatory framework for agricultural biotechnology in the United
States. And the response of the agencies involved gives little
confidence that these problems are being seriously addressed.
The facts of the case are these: from 2001 until late last year, a US
subsidiary of the Swiss firm Syngenta allowed American farmers to plant
15,000 hectares of corn, or maize, that had been modified with an
unapproved version of a gene from the soil bacterium Bacillus
thuringiensis that codes for an insecticidal protein (see Nature 434,
423; 2005). Small batches of the unapproved seed were also exported to
After Nature revealed this mistake, Syngenta claimed that there was no
significant difference between the approved genetically modified corn,
called Bt11, and the corn that had been inadvertently released, called
Bt10. Only later did the company admit that Bt10 differs from Bt11 in
that it contains an additional gene that confers resistance to the
antibiotic ampicillin (see Nature 434, 548; 2005) — a difference that
most experts agree is of some significance.
Some scientists are shocked that this oversight could have been allowed
to persist for so long without detection. One might think that the US
federal government, a long-standing champion of agricultural
biotechnology, would be hopping mad about the mistake, and keen to get
the facts out to satisfy sceptics around the world that it now has the
situation firmly under control.
Think again. The US regulatory system divides responsibility between
three different agencies, which have collectively failed to respond
adequately to this incident. Under a framework introduced during the
administration of President Ronald Reagan in the 1980s, the US
Department of Agriculture (USDA), the Food and Drug Administration (FDA)
and the Environmental Protection Agency (EPA) between them share
responsibility for the approval and monitoring of genetically modified
Broadly speaking, the USDA checks to see whether a transgene should be
regarded as an agricultural 'pest'; the EPA considers the safety of
proteins that can act as pesticides, such as the bacterial toxins
expressed by Bt10 and Bt11; and the FDA is responsible for regulating
other food safety aspects of transgenic crops.
The FDA has some justification in taking a back seat in the US
investigation, noting that the toxin in Bt10, as a pesticide, falls
outside its jurisdiction, and judging — quite reasonably — that the
antibacterial-resistance gene in Bt10 does not represent a food safety
The USDA, meanwhile, sees itself primarily as a promoter of US
agriculture and related commercial interests — a self-image that has so
far been reflected in its handling of this case. Its press office could
be taking its line straight from Syngenta: "The system is working," a
departmental spokesman said late last month of a process that has taken
four years to unearth the cultivation of an unapproved crop. Using the
time-honoured technique for burying uncomfortable information, the USDA
chose to release news of its decision to fine Syngenta $375,000 for its
error on a Friday afternoon.
That leaves the onus on the EPA to investigate the matter. In theory, it
has the technical expertise and the legislative authority that it needs
to function effectively. But in practice, the EPA's efforts in
regulating transgenic crops are mostly devoted to premarketing
approvals. According to well-informed critics, the agency has few
resources to devote to the Bt10 investigation. This does little to
dispel the message of a story carried on 23 March by the satirical
website The Onion (http://www.theonion.com), which suggested that the
EPA had announced that it would henceforth be known as The Agency.
"We're not really 'environmental' anymore, and we certainly aren't
'protecting' anything," read a quote mischievously attributed to an
Given the state of the US investigation, the European Commission should
establish the relevant facts to its own satisfaction. Syngenta, after
all, is a European company — albeit one with headquarters in
Switzerland, a non-EU state not known for the transparency of its
corporate sector. The company should be forced to reveal how Bt10 got on
to the market in the first place, and why it then took four years to
discover the mistake.
So far, we've heard nothing on the former, and Syngenta has attributed
the belated discovery of its inadvertent release of Bt10 to progress in
the technology that it uses to monitor seeds. If true, this explanation
will come as news to anyone who had assumed that the
agricultural-biotechnology industry had known from the start what
transgenes it was putting into its seeds. If the discovery was simply a
matter of happenstance, we can have little confidence that similar
problems won't occur again.
Thankfully, on this occasion we're not dealing with a threat to public
health. But the incident will further undermine public confidence.
Covering up the circumstances of the current incident may in the short
term make life more comfortable for Syngenta and for the regulators who
were supposed to prevent the release of unapproved seed. But the
long-term prospects for the application of plant genetics would be
better served by firm regulation and a degree of candour that has so far
been sadly lacking in the performance of the main players in this case.
To unsubscribe from SANET-MG:
1- Visit http://lists.sare.org/archives/sanet-mg.html to unsubscribe or;
2- Send a message to <firstname.lastname@example.org> from the address subscribed to the list. Type "unsubscribe sanet-mg" in the body of the message.
Visit the SANET-MG archives at: http://lists.sare.org/archives/sanet-mg.html
For more information on grants and other resources available through the SARE program, please visit http://www.sare.org.