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2-plants: Canadian GE potato approval might "compromise the integrity" of regulation



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TITLE:  Genetically modified spuds cleared
        Inspectors had blasted 'extremely poor' field trials
SOURCE: The Star, Canada, by 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
DATE:   January 23, 2001

------------------ archive: http://www.gene.ch/genet.html ------------------


Genetically modified spuds cleared
Inspectors had blasted 'extremely poor' field trials

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 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.

Among the numerous deficiencies cited by the federal inspectors, 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.

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 beetle is the most feared bug 
in any potato farmer's field.

The documents, released to Ottawa researcher Ken Rubin under the Access to 
Information Act, 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, told 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. "We've tightened our procedures," she said in a telephone 
interview.

CFIA spokesperson Steve Yarrow said 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. 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, Yarrow said. "If they become too large, they 
become difficult to manage," he said in a telephone interview from Ottawa.

The agency, 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. Monsanto instead reformatted the data it had already 
submitted to address the CFIA's concerns, Pelland said. 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. Questions to Health Canada were referred to the CFIA.

Colorado potato beetles kill potato plants by eating the leaves. Plants in 
a badly infested field can be stripped of their leaves by the bugs, 
rendering the field virtually incapable of producing a crop. The beetle is 
able to quickly adapt to pesticides meant to keep them at bay, forcing 
farmers to be on an almost constant lookout for new products to apply to 
their fields.

==========================================================================
'Fundamental changes to the regulatory system . . . as proposed by the 
potato industry, will compromise the integrity of this program.'
- Morven McLean, Canadian Food Inspection Agency
==========================================================================

One popular product is Admire, which is often sprayed into the soil at 
planting time to help non-GM plants fight beetles as they grow. It is not 
meant for use on GM fields. Companies have been able to sell GM seed for 
about twice the price of conventional seed because farmers don't have to 
buy pesticides. In the Monsanto trials, however, Admire was used in refuge 
areas of the fields. Refuges, used commonly in GM farm plots and required 
by the CFIA in field trials, are planted with non-GM plants to slow the 
adaptation of beetles to toxins in GM crops. They are supposed to make up 
about 20 per cent of a field.

"The use of Admire in designated refuges is not compatible with the 
function of the refuge," Grant Watson of the CFIA said in a Dec. 3, 1998, 
letter to Monsanto. In documents obtained by The Star, agency staff member 
Morven McLean said 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. "The 
results of this audit clearly demonstrate that Monsanto was not able to 
manage confined trials of this size," wrote McLean, who conducted the 
audit, in a memo dated Feb. 19, 1999.

"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." Still, Yarrow at the 
CFIA said the agency is considering allowing companies, and the farmers 
contracted to conduct their trials, to routinely use insecticides in test 
fields.

That's 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.

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. "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. 
Despite the earlier warnings, however, the potatoes being tested were 
quickly approved by both the CFIA and Health Canada and were on the market 
within weeks of the March, 1999, meeting, in time for the start of the 
planting season.

The move came amid pressure from both potato farmers and Monsanto, who said 
any delay would put the Canadian industry at a competitive disadvantage to 
the United States, where Monsanto's potatoes were closer to being approved 
and could be on the market sooner. "However, this is a deficiency, not an 
advantage, of the U.S. regulatory system," McLean wrote in her February, 
1999, memo.

In the same memo, McLean warned 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. "Fundamental changes to the 
regulatory system . . . as proposed by the potato industry, will compromise 
the integrity of this program."

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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