ngin - Norfolk Genetic Information Network
Date:  1 March 2001


1.    We still don't know if it's safe - Kitchener-Waterloo Record
2.    The Hill Times - Special biotechnology policy briefing

Thanks to Richard Wolfson for these pieces following on from the recent report on GMOs by the Canadian Royal Society.

Don't forget you can download this very readable report as a pdf: 775k
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We still don't know if it's safe
22 February 2001 - by Rose Simone, The Kitchener-Waterloo Record

As a Waterloo professor in the normally calm realm of philosophy and ethics, Conrad Brunk is not used to being in the eye of a storm. So when the report of a Royal Society of Canada panel on genetically modified foods that he co-chaired caused a political explosion that had Health Canada
officials scrambling, it took him by surprise.

He also faced the consternation of scientists who defend biotechnology. Prof. Doug Powell at the University of Guelph, for example, slammed the report as being of "shabby scientific quality," and said it has "huge holes in it."

The panel's job was simply to examine the system of approving newly engineered plants, fish and animals and point out where the risks are. As to whether the food that's already out there is safe, that's as muddy as ever for consumers.

Brunk, who teaches at Conrad Grebel College at the University of Waterloo, co-chaired and was selected for the 14-member panel last year because he specializes in the values and ethics that go along with assessing risks and making decisions about engineering life. But the panel also included people from across the country who are experts on all aspects of the issue from plant genetics to human allergies.

On one level, Brunk expected the Health Canada officials to "circle the wagons." But the intensity of the backlash surprised him because he didn't think the 245-page report with 53 recommendations was extreme or radical.

The panel, concluded, for example, that foods such as a breakfast cereal with genetically modified grains don't necessarily need mandatory labels if it is certain that it won't cause health problems such as allergies. It wasn't an anti-genetically modified food report, said Brunk, but Health
Canada officials "made it look like we were a lot more critical than we were."

But a longtime critics of genetically modified foods, Prof. Ann Clark of the University of Guelph, was not at all surprised at the reaction. "The response of the industry proponents was completely predictable," she said. ...

With all these concerns swirling about, the Royal Society of Canada was asked by Health Canada, Environment Canada and the Canadian Food Inspection Agency to form this panel to look at the risks to human health, animal health and the environment.

The panel sharply criticized Ottawa's regulation system, saying there is too much secrecy that prevents even getting access to results of tests done by the industries on new foods they submit to Ottawa for approval. Even the panel, loaded with scientific experts, couldn't get all of the testing data on Monsanto's Roundup Ready Canola, a strain made genetically resistant to the weed-killer, approved in 1995.

"You cannot claim a regulatory system is science-based if it is not open to peer review," Brunk said.

The panel was also concerned about a decision-making standard called "substantial equivalence." If a potato breed, for example, is created to produce a toxin to kill a certain bug, the industry might avoid some of the lengthy steps of testing if the new potato appears to be "substantially equivalent" to the non-modified potato.

But what makes a new plant substantially equivalent is not clear, and besides, it's possible for one change in a gene to cause unexpected changes in the organism, the panel said. "You are not in a position to declare that something is safe unless you have looked for the potential problems and
have evidence that it is safe," Brunk insists.

*  *  *.
The Hill Times --  Special Biotechnology Policy Briefing
By NDP MP Judy WasylyciaLeis (Special to The Hill Times)

Canada is disregarding caution in biotech race for market share. And long after they would have been sitting in museums under the Progressive Conservative government

There is no more clearly demonstrated need for openness, accountability and transparency on the part of the federal government than in the area of biotechnology. Massive technological change involving genetic engineering is permeating every aspect of our lives without citizen input,
Parliamentary scrutiny or public information.

Secrecy and silence are the watchwords of this field. We have witnessed an explosion of new products, industries and medical discoveries without any public debate or development of public policy. The federal government has let Canadians down, laying low while biotechnology gained a major foothold in the economy and essentially now claiming you can't put the genie back in
the bottle.

Canadians are paying the price for this passive complicity with industry. Supermarkets were allowed to begin stocking genetically engineered foods before consumers even knew they existed. GMOs are cropping up on the grocery shelves without any ability on the part of consumers to opt out of this involuntary genetic experiment.

Concerns or questions are dismissed with patronizing suggestions of 'we know what's best for you' or unfounded altruistic sentiments about solving the world's hunger problem. The problem
doesn't stop with genetically modified foods. Seven years after the Royal Commission on Reproductive Technologies issued its report; there is no law on the books never mind a bill before Parliament. The result is that biotech products are being used to treat infertility, to effect
sterilization and to promote eugenics. Ideas such as sex selection, cloning, rentawomb contracts and trading in human eggs are being advanced without any public consensus about acceptable ethical constraints.

Similarly, unbeknownst to most people, Canada is fast becoming a world centre for xenotransplantation, an area where the threat of crossspecies viral transfers and secondary immunological impacts are real. We know that CreutzfeldJacob (Mad Cow) Disease has crossed from cattle to humans. It is now accepted that AIDS originated in other primate species. Yet we are disregarding caution in the race for market share.

Canadians have in effect become laboratory guineapigs. The federal government continues to be dismissive of public concerns and spiteful to scientists who suggest caution. It cannot continue such uncritical support of the biotech industry in the face of growing evidence to the contrary.

The recent report by the Royal Society of Canada is the latest study raising concerns about the safety of genetically modified foods and suggesting that the government approved practice of substantial equivalence is scientifically unjustifiable.

We're talking about playing with the building blocks of life with little knowledge of the consequences of our actions. We're talking about a technology that makes use of microorganisms, human, animal and plant cells, or parts of them, to produce new products. We're talking about a government that is embracing this new technology without adequately addressing the potential risks. The bottom line is we need a comprehensive public policy, an ethical framework grounded in Canadian values, and a regulatory system based on the precautionary principle.

But is it too late? It is true that this call for a public policy is a little like trying to shut the barn door after the horses have left. However, given the potential health and ecological problems, it can never
be too late to act. There is no excuse for not slowing down the train and putting the brakes on new

Towards a public policy on biotechnology:

1.     Provide full public disclosure of all geneticallyengineered products;  publicly acknowledge
        the unknowns associated with biotechnology; and require labelling of genetically modified

2.    Establish an independent research capacity to develop a sound scientific basis to predict
       the full consequences of biotechnology, and ensure full openness and freedom of access to
       research and research results.

3.    Implement a rigorous testing program subject to peerreviewed science to ensure the safety
       of all GMO foodstuffs taking into account potential health, social and environmental concerns,
       and provide regular reporting to the public of work being done in the public and private
       sectors including new rDNA crop development, genetic testing, artificial insemination,
       transplants and use of organs and tissues from animals.

4.    Sign the BioDiversity Protocol, support a moratorium on terminator technology, prohibit
       patents on life forms and protect farmers from corporate copyright control.

5.    Immediately introducing longoverdue reproductive technologies legislation and involve
       parliament in the development of public policy on biotechnology.

6.    Develop through public consultation an ethical framework for new technological possibilities
       based on respect for human worth, the rights of the individual and the needs of the whole

7.    Ensure a highlyregulated system based on the precautionary principle with food safety clearly
       separated from product promotion and with the public interest taking precedence over the
       needs of industry.

NDP MP Judy WasylyciaLeis is her party's health critic and represents the federal riding of Winnipeg North Centre, Man. Her email address is

*  *  *
Standards should be set to require full testing of GMOs
Sound science, in fact, should determine the safety of novel foods and the protection of the Canadian public.

by Tory Senator Mira Spivak (Special to The Hill Times)

Sound science, we are told, is the very foundation of decisions to bring geneticallyengineered foods to market. Government regulators and industry officials have assured us that science underlies their conviction that genetically engineered foods are safe to eat and genetically engineered crops
do not harm the environment.  Some scientists from Canada and the U.K. for years have challenged the claim.

Now a panel of experts from the Royal Society of Canada has added its weight to the allegations that science has been compromised.

At the heart of the matter is the notion of substantial equivalence that regulators use in safety assessments of these novel foods. Introduced in 1993 by the Organization for Economic Cooperation and Development, substantial equivalence soon found its way into Canadian guidelines for safety assessments of tomatoes, corn, canola and other food crops.

In practical terms, it means that a geneticallyengineered potato, for example, is judged safe if its composition is substantially equivalent to a potato produced without biotechnology. No longterm tests are required for toxins or its potential to spark an allergic reaction.

Sixteen months ago, British scientist Erik Millstone exposed the myth of substantial equivalence in the journal Nature, suggesting that it gave biotechnology companies a means to have it both ways. Their products could be judged sufficiently different to be patented. At the same time, they
could be judged sufficiently similar to other foods to avoid the range of tests required
before food additives, pesticides or drugs are allowed on the market.

By sidestepping those tests the biotechnology industry also avoided approximately $25million (U.S.) per product in research and delays of five years in reaching the marketplace, he estimated. In Mr. Millstone's opinion, substantial equivalence is 'the stuff of farce, designed to expedite product approval with little or no regard for safety.'

The recent assessment by the Royal Society expert panel is more polite, but equally damning.
 The panel found that the regulatory use of substantial equivalence is 'scientifically unjustifiable when used to exempt new products from full scientific scrutiny.' It recommended that 'rigorous scientific assessment' replace the unscientific notion in all future assessments of genetically modified foods.

Among its several recommendations to restore public confidence in the regulatory regime, the panel suggested that an independent panel of experts review all tests on new genetically modified foods and report their findings publicly.

As instructive and timely as the Royal Society report is, it does not explain how we arrived at the current situation.

One explanation is offered up in a recent New York Times article that reveals how the biotechnology food industry, led by Monsanto, abandoned its cautious, sciencebased approach of the 1980s in favour of a strategy to erase regulatory barriers.

In the 1980s, Monsanto executives were confident of their food products' overall safety, according to the Times story, 'Biotechnology Food: From the Lab to a Debacle.' Those former executives, however, recognized others' concerns about unintended toxins, allergens and environmental effects. They were willing to proceed cautiously.

In the 1990s, the company changed direction. Quick market access for geneticallyengineered food was the chief goal of Robert Shapiro, who then headed Monsanto. The company used its highlevel influence with governments to push for a favourable regulatory regime. In 1992, the U.S. government announced its policy that would allow quick approval for biotech foods. Canada soon followed suit.

By 1996, there was evidence that a genetically engineered crop could have an unintended, dangerous effect when Pioneer Hybrid created soybeans containing a gene from Brazil nuts. Tests showed that the soybeans could set off a strong, potential deadly, allergic reaction in people sensitive to the nuts.

The discovery luckily came in time for the company to cancel its plans to put the soybeans on the market. Government regulation of genetically engineered food, however, has not been modified. Eric Millstone revealed how other soybeans received the substantially equivalent seal of approval. The soybeans were genetically engineered to resist a pesticide. The soybeans that arrived on the market in processed foods, however, were different from those that were tested and approved. The tested beans had not been sprayed with the pesticide that changes their chemical composition.

Other scientists have pointed out that substantial equivalence does not mean equivalence to the unengineered plant or animal. Comparison can be made with any and all varieties in the species, have the worst characteristics of all of them, and still be considered substantially equivalent.

The Royal Society panel recommends that the notion of substantial equivalence should be abandoned. Standards should be set that require full, longterm testing of genetically engineered foods before any new products enter the market. Sound science, in fact, should determine the safety of novel foods and the protection of the Canadian public

*  *  *
Royal Society's biotech report a vindication of common sense - This governmental overindulgence of corporate secrecy can be a threat to public trust in regulatory system

by Liberal MP Karen Kraft Sloan (Special to The Hill Times)

Last year in this space I noted that the 'debate' around GM foods looked more like a schoolyard spat, and that the government was not engaging the public in any meaningful discussion of GM foods, especially problematic given the enormous taxpayer investment in this industry.

I regret to say that since then little has changed. On the subject of public involvement, the government plans consultations in the spring, but they will be limited to the topic of 'the patenting of higher life forms.' Another series of consultations on GM foods is scheduled for later this
year, but it's unclear when and what that entails.

What has changed, however, is that some persistent concerns about biotechnology raised for many years by scientists, academics, public interest groups, and ordinary citizens have recently been vindicated. Last week's report of the Royal Society of Canada Expert Panel on the Future of
Food Biotechnology identified numerous areas for improvement in the science and regulatory processes around GM food, but most notably has lent credence to some very commonsense concerns.

A few examples will suffice.

Many have argued for years that the principal regulatory authority for GM foods, the Canadian Food Inspection Agency (CFIA), is in a conflict of interest in that it both regulates and promotes biotechnology. Despite the CFIA's insistence that a) they do not promote biotech, and therefore b)
they are not in a position of conflict, the expert panel disagreed with them on both counts.

Many have argued for years that there is an uncomfortably close alliance between corporate biotech interests and university research in this area. The expert panel concurred, calling for more fullyindependent research.

Many have argued for years that too much of the information relating to the approvals process for GM products is classified as 'confidential business information' (CBI). The data often are not available for peer review, and are not permitted to be released to public scrutiny, even under access to information laws. This governmental overindulgence of corporate secrecy can
be a threat to public trust in the regulatory system. The expert panel agreed.

One needn't be trained in science to sniff out these problems, which is precisely why they resonate with the public, contributing to their suspicion of GM foods.

What is most noteworthy about the expert panel report is what it didn't investigate. Its terms of reference excluded, for example, social, ethical, and religious issues pertaining to the GM food debate. In other words, on the science and the regulatory processes alone, the panel found plenty to be concerned about. Had the terms of reference been broader, the report may
well have been even more unflattering.

Proponents of biotech have responded to most criticisms over the years by doing their best to restrict the debate to scientific issues alone. And within that limited context, they often dismiss critics by accusing them of relying on 'unsound science.' This from an industry that often relies on
science that is not peer reviewed, and is often performed by scientists with vested financial interests in the outcome.

The response to the report from the government and industry has been lukewarm. A senior Health Canada official insisted that the Panel didn't understand how her department worked.

And some industry critics dismissed the report as being biased and scientifically unsound. The cynic  in me thinks that if the Royal Society of Canada is scientifically unsound, then the definition of 'sound science' has clearly become 'science we agree with.'

This kind of denunciation simply erodes public trust even further. Instead of criticizing the report, government and industry should consider it a starting point for meaningful public engagement.

I receive many letters and telephone calls from constituents concerned about biotech issues. Some would like to see the total abandonment of the industry. Most people, however, would simply like the government to slow down and remove the evident problems in the regulatory system. 'Stop
promoting and regulating the industry under the same agency.' 'Stop buying memberships in the lobby group that represents the industry.' 'Stop excluding the public from decisionmaking processes, and worse, don't ask the public for their views well after decisions have been made.' These are the kinds of comments I receive.

Such issues are not just 'bad optics.' These are problems that are contributing to the failure of GM food products in the court of public opinion, and hence the marketplace. The same common sense that spotted them years ago suggests that they can and should be solved quickly.

Liberal MP Karen Kraft Sloan represents the federal riding of York North, Ont., and has been a member of the House of Commons Standing Committee on Environment and Sustainable Development since 1993.

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