Author: Mary Lou McDonald November, 2013
(Mary Lou is an Ontario lawyer and one of the founding members of NoMore GMOs.)
In our last issue I wrote on a myth that many Canadians believe, including Kevin O’Leary: that our government is doing its job when it comes to genetically modified (GM) foods. We learned it isn’t so: GM laws do not require testing, the indirect and environmental effects of GM foods aren’t examined, and the companies are the only ones submitting evidence.
Now for a NEW hum-dinger: the principle of “Substantial Equivalence”. This principle is used in the safety assessment of Health Canada on GM foods.[i] If a GM [food] is “substantially equivalent” to its conventional counterpart that is considered safe, then the GM food is considered safe and no testing of the GM food is required. The rationale is set out in the original OECD 1993 statement: “If a new food or food component is found to be substantially equivalent to an existing food or food component, it can be treated in the same manner with respect to safety”.
Literature is full of criticism of the phrase “substantial equivalence”, including that published by the OECD itself[ii] and from the Royal Society of Canada.[iii] The concept may be useful for genetic modifications brought about by conventional breeding, because it is “usually possible to recombine genes within a species in many ways and create broadly similar, non-hazardous, phenotypic outcomes”.[iv] However genetic engineering actually forces the insertion of genes and crosses over species boundaries. This is completely different from conventional breeding and represents an entirely new and unpredictable process of creation. There is nothing “equivalent” about it at all.
The problem is that the phrase itself is ‘slippery’ and open to misinterpretation. Our regulators in Canada are applying the principle of “substantial equivalence” such that all GM foods are considered “substantially equivalent” to their conventional counterparts and thus are not subject to testing or safety assessments. How are they doing this? Here are the steps:
· STEP ONE: CONFUSE THE MEANING OF “SUBSTANTIAL”
The slippery problems arise because there are at least two meanings for the word “substantial”:
“large in amount, size or number” ; and
“consisting of or relating to a substance”.[v]
With the first meaning, a GM food just has to be equivalent to a large degree to its conventional counterpart for the GM food to be presumed safe and not subject to testing/ safety assessment. There just has to be a large degree of overlap and then the differences are ignored. With the second meaning, a GM food has to be equivalent in substance to its conventional counterpart before no testing is required.
The Canadian regulators use the first meaning (i.e. equivalent to a large degree) and consider that any differences between the GM food and the counterpart are not relevant if they fall within the range of variation in the counterpart.
The concern with this approach is that the differences between GM foods and their conventional counterparts are not examined or subject to assessment at all. It does not make sense to conclude that because a difference falls with a certain range, i.e. is statistically quantifiable, that the quality of the difference is not of concern. The quality of the differences between GM foods and conventional counterparts are of concern because genetic engineering causes changes that are not predictable in the modified cell, creates mutations in the host plant’s genome and causes changes to the native genes that are not well understood. [vi]
· STEP TWO: NARROW THE SCOPE OF “EQUIVALENCE”
However, even when the other meaning of “substantial” is employed, that is: “relating to a substance”, the regulations are drafted such that testing is avoided. This is done through the term “equivalent”.
There are two ways in which the law on GM foods interprets “equivalence” narrowly. First, it narrows the meaning to just equivalence in terms of how a substance is composed in space, not in terms of how it behaves over time. It is a snapshot of finite components over a finite interval. Second, it only provides for examination of a particular set of these components: those that are relevant to the consumption of food by humans. Components that relate to the impact on animals, other plants or the environment are not examined despite the fact that animal products (meat, eggs, dairy) may subsequently be consumed by humans.
To be specific, Health Canada only examines factors relevant to composition and the safe consumption of human food. The “Guidelines for the Safety Assessment of Novel Foods” (2006) (the “Guidelines”)[vii] require examination of factors that relate to food consumption such as dietary exposure and considerations relating to nutrition, toxicology, allergenicity and chemical contamination in foods. They are clear that “[T]he Food and Drugs Act and Regulations do not currently provide for the assessment of the environmental impact or for assessment of certain indirect human health aspects that the manufacture or import of a regulated product, such as a novel food, may have.”
The problem again, therefore, is that information is missed when only the static components are examined and when the only relevant standard is the safe consumption as food directly by humans. The impact of GM foods on animals (and the animal products consumed by humans) and the impact on the environment, are not part of the analysis.
· WHAT SHOULD REGULATORS BE DOING?
The Royal Society of Canada in 2001 discussed the principle of “substantial equivalence”.[viii] It recommended an approach that interprets “substantial” with the second meaning set out above and that looks at a substance’s impact on the environment and at its observed behaviour over time (part of its “phenotype”[ix]):
“This interpretation requires a scientific finding that the new food does not differ from its existing counterpart in any way other than the presence of the single new gene and its predicted phenotypic change. In every other way, phenotypically and in terms of its impact on health and the environment, it will have been demonstrated to be identical to the existing food. Once this finding is made, the food can then be considered (i.e. “treated as”) safe, in as much as the existing food is already considered safe, with the caveat that the phenotypic expression of the added novel gene(s) must also be demonstrated to have no negative health or safety impacts. In this interpretation, the concept of “substantial equivalence” functions as a scientific finding or conclusion that in turn becomes the justification for an assumption of safety. In effect, “substantial equivalence” is invoked as a standard of safety.” (p. 182)
Regulators are starting to move toward this more comprehensive approach. Strategies that look at the genome (hereditary information) in greater detail are being suggested. For example, the Food and Agriculture Organization of the United Nations in 2008 developed a framework for the assessment of foods derived from recombinant-DNA plants, based on internationally accepted principles and guidance.[x] It recognized that changes may not be reflected in known compounds that are preselected for substantial equivalence because of unintended changes occurring at that RNA transcript, protein or metabolic levels. It recommended the use of genomic strategies using biometric tools to effectively analyze the changes occurring at these levels. (p.9) Strategies relating to examination of the GM substances’ “phenotypic expression” (how they behave) are also required.
Based on the above, the recommended approach to “substantial equivalence” is that regulators examine whether a genetically modified substance behaves in identical fashion to its conventional counterpart phenotypically[xi]and in terms of its impact on health and the environment. Such an examination requires techniques beyond just compositional analysis. If such techniques reveal differences, then the differences are to be examined to determine their impact on health and the environment.
· WHAT ARE OUR REGULATORS DOING? THE ALFALFA GREEN LIGHT
Health Canada does not set out in public documentation its understanding of “substantial equivalence”. But it is evident from the recent alfalfa file that Health Canada is employing the “slippery” version of the phrase. It looked at similar components between the GM substance and the conventional substance with respect to human consumption, viewed the two as “mostly” equivalent, and as a consequence did not require any safety testing. Here are the details:
· The GM substance in issue is Genuity® Roundup Ready® Alfalfa, an alfalfa strain that tolerates Roundup® agricultural herbicide. The Health Canada’s Novel Food Information report is only three pages long and provided brief summaries of the analysis. In the comparison to the conventional counterpart, the comparative examination was only of the composition and nutritional quality of the strain. [xii]
· With respect to product information, an explanation of the additional gene was provided, then a list of traits of the GM alfalfa was set out and the finding was stated that the traits “were within the normal range of these traits currently displayed by commercial alfalfa varieties”. In other words, by virtue of the traits being within the range, they are considered “mostly” like the traits of the conventional variety.
· With respect to [human] dietary exposure, the issue was discounted, because “alfalfa is used primarily as an animal feed, with only minor uses as a human food or dietary supplement. Monsanto does not intend to introduce Roundup Ready alfalfa into the food supply, either as compressed leaf material or as sprouts. Roundup Ready alfalfa will be sold solely to producers of forage for use as animal feed.” This shows that examination is relevant only with respect to food consumed directly by humans, not indirectly by consumption of animal products. The effect of the substance on animals is not examined.
· With respect to nutrition, it was stated that “[t]he analysis of nutrients from Roundup Ready alfalfa events J101 and J163 and control and conventional alfalfa did not reveal any significant differences in the levels of protein, fat, ash, moisture, fibre, carbohydrates, amino acids, minerals, vitamins and anti-nutrients. In each case the level of each respective component was comparable to the control and within the reported range for conventional alfalfa. The consumption of products from alfalfa events J101 and J163 will have no significant impact on the nutritional quality of the Canadian food supply”. Again, the analysis is that the GM component was “within the reported range” for conventional alfalfa, i.e. “mostly” equivalent.
The predictable conclusion was: “Health Canada is of the opinion that alfalfa lines J101 and J103 are as safe and nutritious as current commercial alfalfa varieties”. No testing required. REALLY??
[iii] Expert Scientific Panel of the Royal Society of Canada (2001): Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada https://www.uoguelph.ca/foodsafetynetwork/sites/uoguelph.ca.foodsafetynetwork/files/GMreportENRCS2001.pdf
[iv] Expert Scientific Panel of the Royal Society of Canada (2001): Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada (pp. 177-178)
[vi]Institute for Responsible Technology: State of the Science on the Health Risks of GM Foods v.1.24.13 http://www.responsibletechnology.org/media/docs/state_science_gmo.docx
[vii][vii]http://www.hc-sc.gc.ca/fn-an/legislation/guide-ld/nf-an/guidelines-lignesdirectrices-eng.php#a4
[viii] Expert Scientific Panel of the Royal Society of Canada (2001): Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada https://www.uoguelph.ca/foodsafetynetwork/sites/uoguelph.ca.foodsafetynetwork/files/GMreportENRCS2001.pdf
[ix] “Phenotype” means “all the observable characteristics of an organism, such as shape, size, colour, and behaviour, that result from the interaction of its genotype (total genetic inheritance) with the environment” http://www.britannica.com/EBchecked/topic/455632/phenotype
[x] Food and Agriculture Organization of the United Nations, Rome (2008): GM Food Safety Assessment Tools for Trainers
[xi] the manifest characteristics of an organism collectively, including anatomical and psychological traits, that result from both its heredity and its environment http://www.yourdictionary.com/phenotypically
[xii] Health Canada: Glyphosate Tolerant Alfalfa Events J101 and J163 http://www.hc-sc.gc.ca/fn-an/gmf-agm/appro/nf-an115decdoc-eng.php
