Canada's legendary regulatory rigour - or lack thereof! - which the OECD apparently wants other countries to use as a model - yields more delights. For how the current head of the Scottish wing of the UK's Food Standards Agency was involved in fast-tracking Monsanto's GM potatoes see second item below - full story at: http://members.tripod.com/~ngin/fsa.htm
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GENETICALLY MODIFIED SPUDS CLEARED: INSPECTORS HAD BLASTED `EXTREMELY POOR' FIELD TRIALS
January 23, 2001
Toronto Star
Stuart Laidlaw
http://www.thestar.com/cgi-bin/gx.cgi/AppLogic+FTContentServer?pagename=thestar/Layout/Article_Type1&c=Article&cid=980137951124&call_page=TS_Business&call_pageid=968350072197&call_pagepath=Business/News
According to this story, the Canadian government approved a new line of genetically modified potatoes despite "extremely poor'' field tests that federal inspectors feared would undermine the legitimacy of Canada's regulatory system, The Star has learned.
But, the story adds, despite objections by the Canadian Food Inspection Agency, or CFIA, the Monsanto Co. potatoes - modified to fight potato beetles without pesticides - were released on to the market without further testing under pressure from farmers and Monsanto. According to documents, released to Ottawa researcher Ken Rubin under the Access to Information Act, the numerous deficiencies cited by the federal inspectors included that parts of the test fields that were supposed to be left free of all insecticides were in fact sprayed with a powerful bug killer.
These areas - dubbed "refuges'' and planted with unmodified potatoes - are meant to slow the rate at which bugs develop resistance to the powerful toxins in the modified potatoes. But while the agency at the time called the use of insecticides "not compatible'' with the environmental controls it required for such tests, it is now considering allowing companies to routinely use insecticides on test fields, The Star has learned. The story says that in all, Monsanto had about 1,170 hectares, or 2,900 acres, of potato test sites in Ontario, Prince Edward Island, New Brunswick, Alberta and Manitoba in 1998, and wanted to expand to 10,000 acres in 1999.
But an October, 1998, audit by the CFIA's Fredericton office revealed numerous problems - including the use of Admire, an insecticide made by Bayer Corp. to control bugs such as the Colorado potato beetle. The story says that the documents show the CFIA wanted the Monsanto trials scaled back and warned that giving in to industry pressure to press ahead would "compromise the integrity'' of Canada's regulatory system. Monsanto stood by its potatoes and field trials throughout several meetings with the CFIA and letters exchanged with the agency, the documents show. It instructed farmers conducting the offending trials to keep those potatoes separate from the rest "until such time as the non-registered product attains registration status.''
Adele Pelland, Monsanto Canada's manager of public relations, was cited as telling The Star her company has since scaled back its potato research in Canada and imposed more strict controls on all its test sites to address the concerns raised in the audit, adding, "We've tightened our procedures.'' CFIA spokesperson Steve Yarrow was cited as saying the agency is satisfied that Monsanto is doing a better job of running its test sites, which are now restricted to no more than one hectare per site and five sites per province, and that the Monsanto sites, with about 1,100 hectares at dozens of sites in four provinces, proved too large for the company to ensure that procedures were being followed properly, adding, "If they become too large, they become difficult to manage."
The story says that CFIA. concerned about the quality of the environmental controls in Monsanto's test fields, asked the company for additional information to assess the potential environmental and health impacts of the new potatoes.
The company, however, refused the request, saying it believed it had already submitted enough data showing that the potatoes presented "no significant environmental, feed or food safety risk.'' In a deal brokered by potato growers, who called government officials and Monsanto to a meeting on March 2, 1999, Health Canada and the CFIA agreed to rule on approving the new potatoes within 30 days if Monsanto turned over the data. Pelland was cited as saying that Monsanto instead reformatted the data it had already submitted to address the CFIA's concerns. And the potatoes were approved in time for the April planting season a month later - adding another product to the company's line of potatoes that have been genetically modified to fight beetles. The potatoes are now marketed in Canada under the NewLeaf Y and NewLeaf Plus brand names.
The story says that questions to Health Canada were referred to the CFIA. The story explains that companies have been able to sell GM seed for about twice the price of conventional seed because farmers don't have to buy pesticides, but in the Monsanto trials, Admire was used in refuge areas of the fields. Grant Watson of the CFIA was quoted as saying in a Dec. 3, 1998, letter to Monsanto that, "The use of Admire in designated refuges is not compatible with the function of the refuge." The story says that in documents obtained by The Star, agency staff member Morven McLean was quoted as saying that the "confined trials'' by Monsanto were so poorly handled that the company should not be allowed to expand its tests to a planned 10,000 acres, or 12 per cent of Canada's total potato acreage. McLean, who conducted the audit, in a memo dated Feb. 19, 1999., was quoted as writing that, "The results of this audit clearly demonstrate that Monsanto was not able to manage confined trials of this size. The production of 10,000 acres of transgenic potatoes, as proposed by the seed-potato industry, would put the CFIA, the minister and the industry at risk as such large-scale production cannot be grown under adequate conditions of confinement and the environmental, food and feed safety of these transgenic potatoes has yet to be determined.''
Yarrow at the CFIA was cited as saying the agency is considering allowing companies, and the farmers contracted to conduct their trials, to routinely use insecticides in test fields because Monsanto told the agency its tests showed that Admire was not able to kill all the bugs in the refuge area, leaving behind enough bugs for the refuge to continue fulfilling its function.
The story says that Yarrow, while admitting that it would seem "counter-intuitive'' to spray bug killer in a field meant to test potatoes that have been genetically modified to resist bugs, said the need to maintain an insecticide-free zone must be balanced against the farmer's need to ensure that his entire field is commercially viable, adding that, "From the grower's point of view, they don't like the idea of growing 20 per cent of their potatoes vulnerable to the beetle.''
He said agency staff have been working with seed companies, including Monsanto, and farmers for four months to come up with new guidelines for future field trials, including allowing insecticides in refuge areas. In a Feb. 1999 memo. McLean was cited as writing that the reputation of Canada's regulatory system - which, she wrote, the Organization for Economic Co-operation and Development had urged others to copy - could be damaged by approving the potatoes as quickly as the industry wanted, adding, "Fundamental changes to the regulatory system . . . as proposed by the potato industry, will compromise the integrity of this program.''
The story also says that McLean's audit raised several other concerns, including: Improper training of farmers involved in the trials, and on whose land the trials were being conducted. The company had not done enough to ensure that the farmers were conducting the trials properly and was not able to prove it had ever visited any of the test sites to make sure the trials were done properly. The refuges in some of the fields were below the 20 per cent required under the terms and conditions for CFIA approval of the confined trials. Buffer zones, the space left between the test plots and the farmers' commercial fields, were likewise too small.
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Government fast-tracked Monsanto's GM potatoes
Private deal struck quietly to speed up regulatory system
Pauline Tam
Ottawa Citizen
Tuesday, Nov 30 1999, P. A1
Biotech giant Monsanto Company struck a private deal with senior federal food regulators that resulted in the swift approval of two new kinds of genetically modified potatoes, according to an internal Health Canada document obtained by the Citizen.
The undated memo, addressed to a senior aide for Health Minister Allan Rock, outlines a deal brokered in March that paved the way for Monsanto to begin selling its new potato seeds less than two months later.
Until the deal was negotiated, the potatoes had been held up in the regulatory system because Monsanto refused to provide key scientific information to regulators assessing the products' health and environmental effects, the memo shows.
"Monsanto objected to these requests believing that their data adequately supports their conclusions that these products present 'no significant environmental, feed or food safety risk.' "
The seeds, marketed by the NatureMark unit of Monsanto and sold under the brand names New Leaf Y and New Leaf Plus, are genetically engineered to repel two separate potato viruses.
They are also designed to resist the Colorado Potato Beetle, a common pest.
While the seeds have been approved for sale, they do not yet exist in large enough quantities for commercial farming.
Details of the deal and how it was made point to evidence of high-level industry interference in a regulatory process that the government has defended as impartial and rigorous, said Michele Brill-Edwards, a former Health Canada drug regulator and critic of the system.
"What you're seeing is a high-level example of a very dirty game that practically nobody knows about. These kinds of meetings go on all the time and it's almost never captured because people are careful not to let this kind of thing be known."
She added it is highly unusual for briefing notes of such meetings to be prepared for top ministerial aides.
The memo was written by George Paterson, former director general of Health Canada's Food Directorate, and addressed to John Dossetor, a senior policy advisor to Mr. Rock.