Food Safety Network

A Draft Technical Critique of the Royal Society of Canada's Expert Panel Report on the Future of Food Biotechnology.

07.feb.01, Shane Morris and Douglas Powell, Food Safety Network

Context

The Royal Society of Canada, in response to a request from Health Canada, the Canadian Food Inspection Agency and Environment Canada, formed an Expert Panel of 15 people to provide advice on a series of questions related to the safety of new food products being developed through the use of genetic engineering technologies.

The report was issued after nearly a year of work. It was first published on the Internet on the evening of February 4th, 2001. The report is 263 pages in length and divided into nine chapters (available at http://www.rsc.ca).

An initial reading of the report raised some concerns that some scientific material seemed to have been ignored or disregarded in the preparation of the report. An opinion column outlining initial concerns was published by Powell and Morris in the National Post on Feb. 7/01.

Invitation to comment

Below is a more detailed substantiation of specific, scientific concerns found within the Royal Society report. We invite scientists with expertise in the areas covered by the Royal Society report to submit fully referenced briefs that may be supportive, critical or provide contextual arguments, to conclusions and recommendations presented by the Royal Society expert panel.

Shane Morris will collect all responses for a 90-day period. Of course, this is an on-going and rapidly evolving scientific and public discussion, but after 90 days, responses will be collated, analyzed, and a final critique of the Royal Society report on genetically engineered foods will be published.


Chapter 1:

Chapter 1 outlines the terms of reference, the panel's interpretation of these, and procedures to carry out their work. There are sections that describe health and environmental risks, socio-economic risk, philosophical/metaphysical risks and scientific and extra-scientific issues in risk analysis.

Two points worth noting are: on page 6 in the section concerning Philosophical/Metaphysical risks the Panel's suggestion reads:

"the critical operative concept here, clearly is that of what is natural. This concept is not a scientific one but a normative one - a view of how human, animal and plant should be, or how God intends them to be."

This suggestion seems to completely ignore the public's historic initial unnatural feeling towards the technologies of aeroplane flight, IVF, AI, tinned food and even contraception.

The report then goes on in the next sentence to state:

"The fact that a member of the British Royal family can, with the support of a large number of British and EU citizens, question whether human beings have a right to play God"

This line is interesting from an ethical and historical point of view considering the British Royal family were responsible for millions of 'unnatural' deaths during the Irish Famine where their political system kept English landlords in power demanding crops (wheat, barley) for rent from Irish farmers while the potato crop rotted. Also there is no evidence that the un-elected member of British Royal family has "support of a large number of British and EU citizens'" as it is unlikely, for example, that the French and the Irish would be offering such support in "large numbers". The same member of the Royal family also supported British beef in the height of the BSE crisis but actually eating beef on the bone (which was officially banned at the time) at a press meeting in Wales (February 27, 1999; http://sparc.airtime.co.uk/bse/news15.htm).

The same "normative" influences of what is considered 'natural' or 'un-natural' as described in the Panel's report led to the denial of the Catholic Church in the early 1600's to accept the then 'unnatural' suggestion that the Earth circled the Sun and not visa versa. Scientists who at the time supported this 'un-natural' suggestion were tried, condemned and burned at the stake. Galileo was brought forward in 1633, and, there, in front of his "betters," he was, under the threat of torture and death, forced to his knees to renounce all belief in such theories, and was thereafter sentenced to imprisonment for the remainder of his days.

The second point occurs on page 7, where the panel describes the biotechnology debate which they do not accept the three kinds of disagreement namely: scientific, political and religious, ethical and
philosophical and correctly state the need for including "extra-scientific" judgments as inherent in any assessment of risk.

However, the panel fails to recognize that scientific and political disagreement can merge into what has commonly been described as the term 'biopolitics'. This term has been defined in the journal Trends in Biotechnology as the politicization of modern biotechnology issues within the political stream that can influence public policy at local, national and international levels. The concept of the political stream is derived from John Kingdon's book called Agenda, Alternatives and Public Policies (1984). This is an important concept when considering the discourse surrounding food biotechnology.


Chapter 2:

This chapter identifies the social and scientific dynamic driving the current development of food biotechnology. It also points to technological developments that are likely to bring new applications of biotechnology.

Chapter 3:

This chapter summarizes the system currently in place for the regulation of agricultural biotechnology in Canada.

Chapter 4:

This chapter claims to conduct the scientific identification of short and long-term risks that the panel found to be most important for the regulatory concern in Canada.

Part 1: Toxicant assessment

This section outlines the issues the Panel has with both the concept of "substantial equivalence" and animal feed studies. In relation to animal feed studies the Panel make no reference to numerous studies in this area (as outlined in Appendix 1)

The section also deals with an issue entitled "Resistance Factors" from which the panel concludes antibiotic resistance markers should not be used in transgenic plants for human consumption. The Panel states on page 49:

"However, in view of the availability of alternative technologies that eliminate the need to use antibiotic resistance genes as markers in transgenic plants. The Panel endorses the position already adopted by others (OCED, 2000; WHO 2000d) on this topic and recommends antibiotic resistance markers should not be used in any GM food intended for sale in Canada."

Such a simplistic statement without context could lead the public and pressure groups to conclude that because many GM foodstuffs commercially available contain such antibiotic genes they are hence dangerous. The Panel also cited an OECD Chairman's report they claim endorses such a position; however the OECD paper quoted by the panel makes no reference to a ban of antibiotic resistance marker genes whatsoever. Further, the Canadian report ignores both a French report (April 2000) and a Belgian (December, 1999) report on the issue of antibiotic resistance genes.

The Belgian report states:

"The fact that the feed or food has a transgenic origin, implicating or not the insertion of transcriptionnaly-functional antibiotic resistance gene should not mathematically modify significantly the global probability of gene transfer from natural bacteria."

The French Report instead of opting to ban antibiotic resistance genes out right suggests:

"However, applying a precautionary principle, the integration in the genome of a transgenic plant of an antibiotic resistance gene should be avoided if the antibiotic is of major interest in human and animal therapeutics. On the other hand the maintenance in the genome of a transgenic plant of an antibiotic resistance gene which is of no interest to human and animal medicine does not present a health or environmental risk. The resistance gene (nptII) meets these criteria. Therefore, it can be used in plant transgenesis."

Part 2:

This section dealing with threats to human health from allergens in GM foods is a well written and well-referenced section and puts the risks into perspective while making some worthwhile recommendations

Part 3:

Nutritional Issues are dealt with here but there is no mention of nutraceutical or functional foods, which are important issues in the future of food biotechnology. Such an omission denies the public a chance to engage in a true risk-benefit analysis of the potential of food biotechnology while reading the report.


Chapter 5:

This chapter considers the use of biotechnology in animal production systems. It is divided in two parts, the first deals with GM animals as a whole the second part deals with GM feeds, feed additives and metabolic modifiers administered to food-producing animals.


Chapter 6: Environmental Risks

Part 1

The Panels report says:

"The relationship of animals and plants with the microorganisms that surround them or grow within them are the result of millions of years of natural selection."

This may be true in many cases but in the last 100 years there have been dramatic increases and changes in such relationships.

In the section entitled, Direct effects of GMOs on Soil Microflora, the panel's concerns in this section could also be applied to non-GM hybrids.

The sections entitled 'Lateral Gene Transfer' and 'Transfer of antibiotic resistance genes' are missing several key studies. For example a major paper of importance presented at the WHO seminar in Rome Italy in Sept. 2000 and prior to that at the 6th International Symposium on The Biosafety Of Genetically Modified Organisms, July 2000 in Saskatoon Canada (this conference was well advertised since early 2000) by Smalla, K. entitled, Horizontal transfer of antibiotic resistance genes from transgenic plants to bacteria - are there new data to fuel the debate? This paper concludes:
"Given the fact that antibiotic resistance genes, often located on mobile genetic elements, are already widespread in the bacterial populations and that Horizontal gene flow (AKA lateral gene flow) events from transgenic plants to bacteria are supposed to occur at extremely low frequencies and have not yet been detected under field conditions, it is unlikely that antibiotic resistance genes used as markers in transgenic crops will contribute significantly to the spread of antibiotic resistance in bacterial populations." Apart from missing this important paper that was presented to the WHO and also here in Canada, the Panel deems it fit to use a 1993 paper by the same author.


Part 2: GM Plants

Environmental Plant - Could GM plants become invasive?
There is great concern highlighted in this section over the risk of GM plants becoming invasive. However again there are numerous papers missing on the subject which the Panel were either completely unaware of or did not feel it fit to consider research that has been ongoing over the last ten years that has been published this week. This ten-year UK survey of four types of genetically modified (GM) crop has found that they do not survive well in the wild and are no more likely to invade other habitats than their unmodified counterparts. The study outlined should help allay fears that GM plants will be super-weeds, either in their own right or by breeding with unmodified plants.

Part 3: Environmental Impact: An Entomological perspective
(Pages. 139 ­ 149)
The Panel completely fails to mention the US EPA's report on Bt and the Monarch in the latest issue of Biotechnology International (also at http://www.epa.gov) and also a brief reported on in the current Monarch Butterfly issues of the journal Trends in Biotechnology Vol. 19, No. 2 Feb. 2001 page 41

Shelton and Roush (1999) responded to the papers cited by the Panel in which pollen from Bt-transgenic corn was fed to Monarch butterflies (Losey, et al., 1999). The Losey et al. Paper has attracted considerable coverage in the popular press, but has also garnered widespread rebuttals and criticisms in the scientific press (Beringer, 1999; Fumento, 1999; Hodgson, 1999). Shelton and Roush (1999) also state that a previous and more relevant and realistic field study (Hansen and Obrycki, 1999) has been largely overlooked, whereby the authors examined Bt-corn pollen deposition on milkweed plants within, and adjacent to, field corn and then assayed the leaves with first instar larvae. Pollen levels were highest within the field (where Monarchs are scarce), but even there Monarch mortality was only 16 per cent (again not highlighted by the panel).

The Agricultural Biotechnology Stewardship Working Group (ABSWG) -- funded 17 studies to quantify the risk of Bt-corn to Monarchs (Weiss, 1999; Currie, 1999). The research was conducted during the summer of 1999 at universities in corn-producing regions of North America (BIO, 1999). Data presented at the meeting indicated that not all strains of Bt-corn are equally toxic (Brower and Zalucki, 1999); some varieties of Bt-corn may, in a theoretical or laboratory setting, harm the butterfly, while other types may not (Currie, 1999). Furthermore, it was suggested that the amount of pollen migrating to milkweeds was "likely to be dangerous to only those monarchs feeding on milkweeds within or close to the edges of the cornfields" (Brower and Zalucki, 1999). Although researchers have much to learn about the ecological consequences of Bt-corn on Monarchs, the findings of the meeting were, according to media accounts and discussions with some participants, generally positive.

Stuart Weiss, a Stanford University expert in ecological modeling, was quoted as saying, "the worst-case scenario of this toxic cloud of pollen saturating the corn belt is clearly not the case." Dr. Mark Sears, chair of the department of environmental biology at the University of Guelph and chair of the Ontario Corn Borer Coalition, reported that virtually all pollen grains land within 10 yards from the field, 90 per cent of which travel less than five yards (Weiss, 1999). Sears postulated that the risk of the hazard to Monarch larvae is minimal, especially after discovering that at least 500 grains of pollen per square centimeter of milkweed leaf was necessary to sicken caterpillars. After three days of accumulation during pollination season, Sears found this concentration was barely attained on nearby milkweed leaves.

Iowa State University's John Pleasants found that wind direction, rainfall and other factors significantly affect pollen concentrations on milkweed. Pleasants found that "88 per cent of milkweed within one meter of a corn field would fall below the level where they could hurt the caterpillars and 100 per cent of the milkweed just two meters from a Bt field would be monarch-safe" (Kendall, 1999). Such findings on pollen dispersion are especially significant when coupled with planting preferences. Powell, et al. (1999) found that planting the borders of a corn field to non-Bt corn was the second most prevalent implementation of Bt-refugia guidelines among 400 Ontario corn producers who planted Bt-corn in 1999, and the most common practice among those with more than 100 acres of corn.

Overall this section is relatively one sided and fails to highlight much of the relevant research


Chapter 7:

Substantial Equivalence as a regulatory concept.

The Panel in this section quotes from various international reports such as Codex (March 2000) where they cite the sentence: While recognizing that the concept of substantial equivalence was being used in safety assessment, several delegations and observer organizations stressed the need for further review of the concept and its applicability to safety assessment. They also cite on page 179 a direct reference to a WHO 1995 report on the topic.

However the panel fails to cite the conclusions of one of the most recent international reports on the this issue, the WHO June 2000 report of a joint FAO/WHO Expert Consultation on Foods Derived from Biotechnology (which they earlier use as a reference in Chapter 4). This particular expert group
concluded:

"The Consultation was of the view that there were presently no alternative strategies that would provide a better assurance of safety for genetically modified foods than the appropriate use of the concept of substantial equivalence. Nevertheless, it was agreed that some aspects of the steps in safety assessment process could be refined to keep abreast of developments in genetic modification technology. The concept of substantial equivalence was developed as a practical approach to safety assessment of genetically modified foods. It should be seen as a key step in the safety assessment process although it is not a safety assessment in itself; it does not characterize hazard, rather it is used to structure the safety assessment of a genetically modified food relative to a conventional counterpart. The Consultation concluded that the application of the concept of substantial equivalence contributes to a robust safety assessment framework. The Consultation was satisfied with the approach used to assess the safety of the genetically modified foods that have been approved for commercial use."

It is clear the concept of substantial equivalence can be improved (like all regulations) but the unbalanced approach by the Panel to this issue could lead many to wrongly believe that the Canadian regulatory system to date had put the public at risk.

The use of some references without an alternative view been presented adds to the seemingly one-sided approach by the Panel to this topic (e.g. page 179 "the failure to define substantial equivalence was clearly emphasized by Millstone et al (1999)" {this Millstone (1999) paper was co-authored by Sue Mayer who is the founding member of the anti-GM food group GeneWatch U.K. and from 1990 to 1995 she was Director of Science at Greenpeace UK where she was involved in developing anti-GMO policy}

A summary document and a comprehensive discussion of issues raised and related to substantial equivalence can be found at: http://www.plant.uoguelph.ca/safefood/gmo/se-response.htm





APPENDIX 1:

ANIMAL FEEDING STUDY REFERENCES: as at 14/12/2000


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