When news broke late Friday about Bayer's unapproved GM rice contaminating the US food supply, Agriculture Secretary Mike Johanns released a statement saying that the Food and Drugs Administration (FDA) and the US Department of Agriculture (USDA) had concluded there are "no human health, food safety, or environmental concerns associated with this GE rice." http://www.usda.gov/wps/portal/usdahome?contentidonly=true&contentid=2006/08/0307.xml

They had reached this conclusion, he claimed, after they reviewed "the available scientific data." But the key word here is "available".

As Bill Freese of Friends of the Earth (USA) points out, they don't do any independent tests of their own so any "available data" would typically come entirely from Bayer: "USDA and FDA are relying completely on Bayer's assessment. This is what they do even for formal approvals, of course, but here it's even worse because public interest groups and independent scientists haven't had a chance to look at whatever info Bayer may have shared with FDA-USDA."

Below Dr Doug Gurian-Sherman - a former US Environmental Protection Agency (EPA) biotech specialist and now a Senior Scientist with the Center for Food Safety - explains how there are a number of reasons for serious concern raised by this latest contamination incident, quite apart from Johanns' reliance on the industry's testing and data on safety.

Dr Gurian-Sherman notes, in particular, that no one has any idea of the real extent to which surrounding crops or the US food supply are being contaminated by experimental genes from field trials. This is because no testing occurs to assess this despite the huge number of trials taking place across the US.

As he notes, "There are roughly 1000 field permits or notifications approved by USDA every year, often with several test sites per approval, for many crops and many genes." Some of these trials, of course, even involve the production of industrial and pharmaceutical products in food crops.

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[This is in an author-edited version of a response forwarded to the GM Free Africa list]

In response to your question, USDA typically does no independant safety testing (just as with the other US regulatory agencies). In the press conference with USDA and FDA officials, and in a subsequent conference call, there was only discussion of company-performed testing data.

In the conference call, a question was asked about compositional analysis of the unapproved rice "event" LL601, because every separate transformation event can have different unintended effects (which is why all regulatory agencies regulate by tranformation event). The question was asked because in the press conference, the agencies repeatedly talked about the safety of the GE protein - which is in addition to the safety issues of the rest of the GMO plant. FDA's response was that the company had submitted data on the plant composition, but then decided not to pursue this transformant. It was not clear whether all of the data was submitted on LL601 as with the two events that were approved.

It is unclear why Bayer dropped this event, and only pursued the other two. It is possible that there was some red flag concerning unintended safety effects, but it could also have been that there were unintended effects regarding agronomic properties (like yield or grain quality) that have nothing to do with safety, or the efficacy of the transgene - or something else entirely.

Most revealing was that this shows up years after the last (as far as we know) field trial. And the fact that detectable levels are showing up from contamination from field trials is also, frankly, fairly shocking. Field trials are only carried out for a few years, and even the large ones are much smaller than the commercial acreage of the crop. This suggests that the most likely explanation is that experimental seed with the LL601 trait was mixed with supposedly non-GE seed, and may have been planted, unwittingly, all along (cross pollination from mostly self-pollinating rice, from one or more field trials, is unlikely to have caused levels of contamination that would have been detected - although that can't be ruled out yet). When (if) USDA presents more data on levels of contamination and how widespread it is, that should become more clear. In the conference call, we requested assurances of transparency, and that the company should not be able to call any of this confidential business information - which would allow them to withhold the information from the public. Anything short of thorough testing to determine how widespread this contamination is, how it occurred, and the levels of contamination, would compromise the agencies even more.

Although the safety of the particular gene is always the first thing people think about, I think this misses (even detracts from) the bigger question, which was also missed by all of the journalists covering this so far - what about contamination from all of the other field trials? There are roughly 1000 field permits or notifications approved by USDA every year, often with several test sites per approval, for many crops and many genes.

For the many very small field trials (an acre or less) conducted by non-commercial researchers, the risk is probably very low for getting into the food supply (although we need to remember the incident at University of California at Davis, where undetected GMO tomato seeds were distributed to researchers around the world). But companies that produce GE and non-GE seed may have a much higher possibility of mix-ups. The current example is reinforced, in that context, by the Bt10 incident not long ago. This is especially troubling if it occurs with breeder's seed or foundation seed - which are amplified to produce certified seed sold to farmers - because the level of contamination could be higher than would occur at a later stage of seed production.

There is almost never any actual testing of surrounding crops or the food supply to see if they are contaminated by experimental genes from field trials (it took some persistent to get USDA to admit this during the phone conference). Although this gene (for glufosinate herbicide resistance) happens to be one that has gone through the regulatory process, many others have not, and have had little or no safety testing. Since no one is looking, we don't know how many of these might be in our food.

Doug

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