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Forever in food genes

Health Canada says GM foods safe; recommends more studies, transparency

With a U.S. company cloning human embryos, the ethical debate over genetically modified foods seems somewhat trivial, yet you would have expected a little more fanfare when Health Canada released their report on GM foods.

It’s always suspicious when the government releases a major document like this on a Friday afternoon, after the principals involved in the study have left for the weekend. But then supporters of GM foods have never been popular.

Back in February, the Royal Society Expert Scientific Panel released a Report on the Future of Food Biotechnology, asking the government to approve GM foods.

"Under the Food and Drugs Act, health Canada conducts a thorough safety assessment of each new product before it can be sold in Canada. The Canadian Food Inspection Agency (CFIA) also has responsibility for the regulation of products derived from biotechnology including plants, animal feeds and animal feed ingredients, fertilizers and veterinary biologics."

The Royal Society also recommended that "Environment Canada and Health Canada conduct risk assessment of new substances including biotechnology products, to determine if there are adverse effects to the environment or human health, prior to their import into or manufacture in Canada."

For example, rather than view a GM tomato as just another tomato, the Royal Society recommends treating it as a different species that requires a separate approval process.

Health Canada, however, rejected the Royal Society’s recommendation in their Nov. 23 report, forgettably titled "Action Plan of the Government of Canada in Response to the Royal Society of Canada Expert Panel Report – Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada"

According to Health Canada, "substantial equivalence" is an acceptable safety standard when comparing one food to another. In other words, if it walks, talks, and swims like a duck then it’s still mostly a duck – even though it may have been genetically modified to lay eggs like a chicken.

This may seem like an extreme and ridiculous example, but keep in mind that one controversial GM product on the market is a tomato that has been modified with genes from an Atlantic flounder in order to make it more resistant to the cold.

Before a GM food is allowed to go to market, scientists will examine the genetic processes that were used to create that food, but will compare the end product, or novel food, with its unmodified counterpart.

The Royal Society also asked Health Canada to look into the science used to develop, monitor and enforce actions against GM products, and to see if any new policies, guidelines or regulations are required to protect human health, animal health and environmental health.

The aim of the Health Canada study wasn’t to determine the safety of GM foods in development or whether labelling of GM foods is necessary for the public to make their own ethical and scietific choices – other government commissions are looking into that, including the Canadian General Standards Board. Rather, the aim was to look at the bureaucracy in place and the tools that we have available to monitor GM foods in Canada to determine if they are safe, or proficient enough to recognize problems with GM products in the future.

According to the report, "…current products on the market consist mostly of plants with simple genetic modifications, typically one or two traits. We recognize the dramatic potential for increased complexity of these products in the future."

The recommendations within the report are divided into seven sections, including Substantial Equivalence, Use of Precaution, Transparency and Increasing Public Confidence, Potential Human Health Impacts, Environmental Safety and GM Plants, GM Animals and GM Feeds, and Other Recommendation.

Under "Substantial Equivalence," the report recommends that this process be used in the assessment of biotechnology products "by comparing the novel food to its unmodified counterpart which has a history of safe use. The value of substantial equivalence in food safety has been clearly and effectively demonstrated in its application to the regulation of novel foods in Canada."

It’s the food safety equivalent of "innocent until proven guilty" – if a regular tomato doesn’t have the potential to cause health problems, and a stick of celery doesn’t have the potential to cause health problems, then a tomato genetically modified using celery, or another type of tomato, will probably be just as safe.

While this may seem like a cop-out, it will only make the approval process easier for simple genetic alterations. Radical genetic modifications, such as the combination of plant and animal genes, will have a harder time proving their safety using this model.

Under "Use of Precaution," the Health Canada report says that the burden of proof should fall on the companies and agencies using food biotechnology, rather than the government. It also states that where human, animal or environmental safety is perceived to be an issue, the onus should be on the biotechnology user to prove that a product is safe, rather than on the government to prove that it isn’t.

This is a significant clause, and mirrors proposed federal laws that would place the onus of safety and research on chemical manufacturers to prove their products are safe for people and the environment before they can be used. Although that legislation will likely never see the light of day because, in a sense, it’s already too late and approvals for controversial chemicals have already been given, GM foods are a relatively new field, and both the government and the scientific communities are starting with a clean slate.

By placing the responsibility for proving the safety of novel foods on the companies themselves, Health Canada believes those companies will act more diligently and conduct more conservative assessments of products – after all, they’ll be liable if their claims aren’t true.

It also gives more power to the government and scientists to question research: "…products are not approved until all questions or concerns regarding the safety of the product are addressed by the proponent. During the course of an assessment, regulators may determine that additional testing is required."

Under "Transparency and Increasing Public Confidence," Health Canada recommends updating and increasing the data on GM foods that is available to the public.

"We will publish information on the regulatory process with increasing detail. We will add detail to the descriptions of our review process… As well, we will develop new fact sheets related to such issues as substantial equivalence and use of precaution. We will review information provided on specific products to ensure that we are publishing the most information currently permitted under Canadian laws and regulations. Further, we commit to discussions with industry to encourage the publication of further information."

If the current laws don’t permit regulatory bodies to publish information they see as key, the report recommends changing the legislation to allow for the highest degree of transparency possible without giving away a company’s proprietary information.

Since one of the key public objections to GM foods is the lack of study and information available to consumers, Health Canada believes that more information could be a positive for companies who produce GM foods and the public, which is wary of GM products.

Some of the GM issues that most concern the public, and the government’s response to those issues, will also see the light of day. For example, when concern arose from the use of a GM antibiotic marker gene that increased the resistance of produce to diseases, the government assessed the potential health risk. Although they found the gene to be safe, they recommended a "suitable" alternative that resulted in the cessation of the use of antibiotic-resistance markers.

Other public concerns, such as the potential for allergic reactions to products with novel proteins, have already been addressed in the approval phase – with no knowledge of the approval process, or the fact that novel products that have the potential to cause allergic reactions are not approved, the public routinely lists allergens as one of their main objections to GM products.

Health Canada also recommends post-market surveillance of products to identify any negative or positive effects related to GM products.

Under "Potential Human Health Impacts," Health Canada recommends complete toxicological testing, including teratology tests if a novel, non-protein constituent is present, or when a protein or other component is present at levels that are outside the currently accepted range.

Health Canada also recommends mandatory labelling of all GM products where there is a concern regarding allergies.

"Under Environmental Safety and GM-Plants," Health Canada recommends that Environment Canada and the Canadian Food Inspection Agency establish an assessment process to determine whether GM crops or organisms can have a negative effect on the surrounding environment.

Through cross-pollination and the release of seeds and spores, GM products have been found far away from growing sites, with properties that make them more resistant to disease, cold and pests. There is concern that these plants may affect the food chain from the bottom up by changing the genetic structures of other organisms within the chain, or by interrupting the natural cycle.

Studying how GM products relate to the natural environment is a new field, and a baseline set of criteria still has to be created to determine what, if any, effects can occur, and how they will impact nature. Although a GM wheat can be approved for consumption, if there is the potential for the wheat to impact nature, that should also be taken into account during the approval process.

Under "GM-Animals (including Fish) and GM-Feeds," the Health Canada report recommends prudence, and essentially holding off until the public can be consulted on the issue. It’s one thing to eat a GM tomato, for example, but the public might not be so inclined to eat a GM salmon or chicken.

Since we are already experimenting with transgenic species, Health Canada believes more care should be taken to isolate the animals until studies on safety can be completed.

For example, an experiment with GM Atlantic salmon has already been conducted in B.C., whereby salmon were created using white flounder DNA. The result is a fish that grows six times faster and twice as large, yet only eats three-quarters of the food of a normal farmed Atlantic salmon. While this may appeal to salmon farmers, some of the fish have already escaped and may be mixing with natural populations with unknown consequences.

Other experiments are underway with striped bass infused with insect genes, and carp infused with human growth genes. At least 20 fish species are being used in tests.

Under "Other Recommendations," Health Canada emphasizes the need for regulatory bodies to work together at every stage of the approval process, and recommends the appointment of a GM safety officer who would act as an impartial go-between for the CFIA and Canada’s biotech industry.

Health Canada also recommends more study of the long-term effects on human, animal and environmental health.

Although the Health Canada report will disappoint some anti-GM forces, it concentrates more on health issues and science than ethical issues. The result is a document that illustrates how we can make GM foods safe, but never questions whether we should produce GM foods at all.

The complete 31-page Health Canada report is available at