EXTRTACTS: 'SmartStax' contains 6 of the Bt insecticidal toxins and will mean greater human exposure to toxins that may be allergenic.

Industry has always assured Canadians that GE foods are safe because the regulatory system has approved them. But the federal government cannot make the claim that stacked trait GE foods are safe because they have not evaluated their safety -- Health Canada has not even officially approved them.

This outcome is not a design flaw in our regulatory system but is an illustration of the limitations that were deliberately designed into the system.
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Why did Monsanto's latest GE foods get a free pass into Canada?
By Lucy Sharratt
Rabble, September 10 2009
http://rabble.ca/news/2009/09/why-did-monsantos-latest-ge-foods-get-free-pass-canada

Health Canada has begun permitting genetically engineered (GE, also called genetically modified or GM) foods onto the market without any health safety assessment. Our government has never adequately examined the safety of GE foods and crops but has now dropped the pretence altogether.

After almost 15 years of approving the varieties of GE soy, canola and corn that we now eat, Health Canada has stopped bothering with the formalities. This complete lack of safety evaluation is not an oversight or loophole in the regulation of GE crops and foods however. Rather, it is the deliberate extension of a regulatory system that relies on corporate data and was designed to support the industry.

On July 15, Monsanto and Dow AgroSciences announced that they had received approval to introduce their new eight-trait GE corn 'SmartStax' into Canada and the U.S. But Health Canada did not assess 'SmartStax' for human health safety and didn’t even authorize it. The Canadian Food Inspection Agency (CFIA) officially approved the environmental release of 'SmartStax' but didn’t conduct an environmental risk assessment. Furthermore, the CFIA actually substantially weakened a critical environmental stewardship rule just for the introduction of ‘SmartStax’ -- without publishing a justification.

Canada’s approval of ‘SmartStax’ corn without health safety evaluation contradicts an international guidelines that our government helped to negotiate. “Stacking” multiple GE traits together is accomplished by crossing GE plants and the UN Codex food safety guideline explicitly states that conventional breeding of GE plants can give rise to unintended effects and that safety assessments should therefore be conducted. Canada is wilfully ignoring this guideline because following it would require fundamental change.

Canada excluded ‘SmartStax’ from safety assessment because the eight GE traits stacked together in the GE corn were previously approved individually in other GE foods. As far as Canadian regulators are concerned, if single GE traits have already been approved in separate crops, there’s no need to evaluate the safety of new stacked-trait crops. Canadian regulations, such as they are, merely limit safety assessments to so-called “novel traits”, which includes GE traits. Even the combination of eight traits in the case of ‘SmartStax’ did not warrant examination.

For Health Canada, GE foods are not regulated as the products of genetic engineering but are regulated as “Novel Foods”, identified by their “Novel Traits”. Health Canada does not classify ‘SmartStax’ as a “Novel Food” because its traits are not novel, having been approved earlier in separate foods. If the traits are not novel, the regulations are not triggered.

The category of “Novel Foods” and “Plants with Novel Traits” is unique to Canada and includes non-GE foods and crops, like products of conventional plant breeding and mutagenesis. It was created to regulate GE foods and crops without naming or singling out the technology of genetic engineering. By constructing an approval process that is limited to evaluating the “novelty” of traits rather than identifying risk questions raised by the process of genetic engineering, the government is supporting quicker GE product approvals.

In authorizing release of 'SmartStax' without approval from Health Canada, the CFIA has also ignored a safeguard it established in the wake of the first major GE food recall. In response to the contamination of our food system with 'Starlink' corn which was approved for animal feed but not for humans, the federal government decided to only approve GE crops for growing if they were also approved for human consumption. This was designed to protect public health, the food industry, and farmers from contamination by unapproved GE foods.

'Starlink' corn was not approved for human consumption because the insecticidal toxins in Bt (insect resistant) crops show similarities to proteins that cause food allergies. 'SmartStax' contains 6 of the Bt insecticidal toxins and will mean greater human exposure to toxins that may be allergenic. In a statement released only to the media, Health Canada said that there is no need to examine 'SmartStax' for unintended effects because, "If there was a change, the company would have to provide the necessary information to Health Canada."

Without mandatory labeling of GE foods or post-market monitoring of the population, Health Canada is not tracking any possible health impacts. This is helpful to Health Canada if they are going to continue allowing GE foods on the market without requesting and assessing safety data.

The scandal of ‘SmartStax’ extends further than health questions, however, as the CFIA not only failed to assess the environmental risks of this GE corn but also significantly reduced one of its only environmental stewardship requirements for ‘SmartStax’. Without providing a rationale, the CFIA reduced the required size of refuge areas to 5 from 20 per cent. These refuge areas are a percentage of a Bt crop area that is planted with non-Bt crops as a strategy to slow insect resistance. By giving insects somewhere to go, some insects remain susceptible to the Bt toxins. Bt (Bacillus thuringiensis) is a naturally occurring soil borne organism that can be used topically by organic farmers to control pests. The genes from Bt have been genetically engineered into corn to make the plant act as a pesticide, and are speeding the development of insect resistance because the GE plants express the Bt toxin in every cell, all the time.

The reduction of the refuge area means that Monsanto can sell 15 per cent more ‘SmartStax’ seeds to farmers. This is a tremendous coup for Monsanto and Dow which between them own eight patents in the one seed and will charge up to 45 per cent more for ‘SmartStax.’ ‘SmartStax’ will quickly replace other GE corn on the market and will rapidly enter the food chain as livestock feed and processed food ingredients (not to mention being turned into ethanol for fuel).

Industry has always assured Canadians that GE foods are safe because the regulatory system has approved them. But the federal government cannot make the claim that stacked trait GE foods are safe because they have not evaluated their safety -- Health Canada has not even officially approved them.

This outcome is not a design flaw in our regulatory system but is an illustration of the limitations that were deliberately designed into the system. The regulation of GE crops and foods in Canada is constructed to be flawed in order to permit the predictable and speedy approval of GE products. The system fails from the perspective of public health and environmental protection but works perfectly well for Monsanto and other huge biotech seed companies.

Unless the government is content to entirely abandon its claim to protect public health and the environment in relation to GE foods and crops, the CFIA must withdraw authorization for ‘SmartStax’ pending environmental and human health safety risk assessments. But to do so should trigger deep structural change.

There has never been a democratic debate over the introduction of GE crops and foods in Canada, there is no mandatory labeling of GE ingredients and, despite 58 recommendations for change from a Royal Society of Canada Panel in 2001, there has never been an attempt to reform our regulatory system. With ‘SmartStax,’ Canadians are faced with the urgent need for this reform.

Lucy Sharratt is Coordinator of the Canadian Biotechnology Action Network.