Government fast-tracked Monsanto's GM potatoes
Private deal struck quietly to speed up regulatory system

Pauline Tam / Ottawa Citizen 30nonv99

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.

Mr. Dossetor did not respond to requests from the Citizen for comment. While it's unclear who requested the memo or whether Mr. Dossetor received it, a Health Canada spokeswoman said there are occasions when ministers' aides are briefed on meetings between regulators and biotech companies.

"This just informs them of what happened at that meeting and it's for their information," said Lynn Lesage.

The revelations come at a time when consumer sensitivity about genetically modified foods is high, and the credibility of the country's food-safety system is being called into question.

This week, New Brunswick-based McCain Foods announced it would stop buying genetically altered potatoes from Canadian farmers in response to consumer fears about such products.

The move comes just weeks after 200 scientists from Health Canada's Health Protection Branch signed a petition that, among other things, raised alarm at the acute shortage of scientists for evaluations and risk assessments of genetically modified foods. Public-health critics also attacked the regulatory system for relying on data supplied by industry rather than original research.

According to the memo, released under the Access to Information Act to Ottawa-based researcher Ken Rubin, the deal was made after two high-level meetings in February and March.

The meetings were attended by Ron Doering, president of the Canadian Food Inspection Agency (CFIA), officials from Agriculture and Agrifood Canada, deputy ministers from New Brunswick and Prince Edward Island, and groups representing potato growers from four provinces. On the second occasion, representatives from Monsanto were also present.

The resulting deal set deadlines over a six-week period during which Monsanto agreed to provide regulators with the missing information. The data were needed to complete a routine government assessment of the potatoes' impact on human health and the environment.

In exchange for Monsanto's co-operation, Health Canada and the CFIA "agreed to a 30-day turnaround for reviewing the information provided" on the potatoes.

Jane Shapiro, spokeswoman for Monsanto Canada, declined to comment on the reasons the company withheld data from regulators.

The meetings were arranged at the request of potato growers from Prince Edward Island, New Brunswick, Alberta and Manitoba. The growers were worried that as a result of Monsanto's incomplete submissions to the government, the company's new potatoes would not be approved in time for spring planting, which would put them at a competitive disadvantage with U.S. farmers.

Patton MacDonald, executive director of the New Brunswick Potato Agency and one of those present at the meetings, said he first heard the potatoes were held up in the regulatory system at a seed-industry conference last December. By early 1999, when federal regulators still hadn't approved the products, he decided to mobilize the support of farmers' groups and senior provincial mandarins, he said.

The second meeting, which included a half-dozen senior executives from Monsanto's Canadian and international divisions, was called to find ways to ensure the regulators got the information they needed so the product could be approved quickly, said Mr. MacDonald.

"They (Monsanto) brought their heavy artillery and we were glad about that, because we thought we would get the answers."

But the resulting deal did not mean Monsanto's potatoes received rubber-stamp approval, said Grant Watson, the CFIA's national manager of the variety section, who attended the meetings.

"It was not a case of, 'Well, you give us something and we'll review it and sign it off.' No, it doesn't work that way. There are critical things that need to be met, and as long as the data answered all our questions, then we're prepared to look at time and make the decision within 30 days."

But the memo also shows the deal was not arrived at easily, because Monsanto refused to sign an agreement allowing all parties to talk openly about its confidential business information. The company eventually agreed to a verbal waiver.

Dr. Brill-Edwards said such tactics point to deliberate efforts by Monsanto to prevent damaging information about its products from reaching the potato growers. "It's like a courtroom where you don't want the evidence against you to get out."

According to the memo, government inspections on past "confined field trials" conducted by Monsanto showed the company performed poorly. As a result, the CFIA was concerned that Monsanto would "not be able to adequately manage a larger scale 'field trial.' "