2001 submission to Canadian regulators

advertisement
Regulation of Genetically Modified Food: A Submission to the Canadian Biotechnology Advisory
Committee
Dennis R. McCalla, PhD, Richard M. Beames, PhD, Hugh Lehman, PhD, and Bert R. Christie, PhD.1
http://www.rsc.ca/foodbiotechnology/indexEN.html
April 17, 2001
INTRODUCTION
The CBAC has asked for responses to its Consultation Document 2001 (Regulation of Genetically
Modified Food). Although reference is made to the recent Report of the Royal Society of Canada’s Expert
Panel on Food Biotechnology in a sidebar on p. 2 of the Consultation Document, the Document itself
makes no mention of the carefully considered recommendations of the RSC Expert Panel. These
recommendations are highly relevant to the questions asked in the CBAC’s Consultation Document. We
have chosen to respond by commenting first on some aspects of the RSC Expert Panel’s Report followed
by a critique of the Consultation Document itself.
PART 1: COMMENTS ON THE REPORT OF THE ROYAL SOCIETY OF CANADA’S EXPERT
PANEL ON FOOD BIOTECHNOLOGY
We believe that the general analysis and recommendations of the RSC Expert Panel 2 are sound and that
substantial changes are needed in the current Canadian regulatory approach to genetically engineered
organisms. The remarkable parallel between the conclusions of the RSC Expert Panel and those of the
EU-U.S. Biotechnology Consultative Forum (Note 2) adds to the credibility of the Expert Panel’s views.
We trust that the work of the CBAC over the next few months will reinforce the conclusions of the RSC
Expert Panel and that Government of Canada will make the changes recommended by the Expert Panel.
Specific Comments
1.1. The Knowledge Base: The RSC Expert Panel concludes (p. 132) that the knowledge base available
for understanding transgenic organisms and their effects on health and on the environment is very limited.
Research on a variety of topics is urgently needed to build better evaluation capability (p. 186) and to
understand food safety (p. 48) and environmental impacts (p. 133).
There is little incentive for the commercial developers of GE products to engage in (or support) research
designed to reveal possible hazards of the products they are so vigorously promoting. The RSC Expert
Panel recommends (6.9 on p. 135) that, subject to rigorous peer review, funds should be made available to
scientists from all sectors (industry, government and university) for research on the environmental
impacts of GM plants. Given the need to maintain the integrity of the science, it is also important to
encourage qualified independent scientists to pursue such studies, as well as studies on food safety, in an
atmosphere totally free from potentially inhibiting commercial influence. Therefore, academic scientists
should not be required to have the support of, or partnerships with, industry to be eligible for grants. We
therefore urge that funding be made available to totally independent scientists who put forth quality
proposals, as judged by a rigorous peer review process, for studies on the impacts of GE organisms and
food. Again, it is essential that such proposals be judged on their scientific merits by "peers" who are not
in the employ of, or otherwise supported by, biotech corporations.
1.2. Scientific Integrity and the Modus Operandi of the Regulatory Agencies: Central to the proposals of
the RSC Expert Panel is a change in the philosophy of regulation and in the testing procedures on the part
of the Canadian agencies. In addition, the Panel recognizes the need for more test data on GE crops and
food as well as the need for "transparency" in the regulatory process.
Those who have done scientific research and/or testing know that there are many pitfalls and that constant
vigilance is needed to prevent bias (unconscious or not) from affecting the conclusions reached . Even
with the best will in the world, errors are made in experimental design and methodology and, from time to
time, workers make serious mistakes which go undetected and eventually result in inaccurate
publications. In addition, there is a low level of fraud. However, in spite of these lapses, science has been
largely self correcting. Peer review prior to publication, though far from perfect, is the first line of
defence. Methods, data and interpretations presented in the manuscript submitted for publication are
scrutinized by knowledgeable reviewers who may recommend acceptance of the paper, acceptance after
some modification or, if the paper is not up to the appropriate standard, outright rejection. The second and
more important line of defence against serious error is the reality that new and novel results can be
checked by other laboratories. Indeed, only when such verification has occurred are new results widely
accepted. Unrepeatable results are identified and untenable interpretations modified or rejected. This open
and competitive process also encourages a high degree of self discipline among researchers and their staff,
all of whom have a stake in ensuring that only sound work is submitted for publication.
Contrast these features of traditional scientific research with the Government’s apparent expectations for
"regulatory science". The data on which decisions are made are provided by the applicant which is
naturally eager to have its product approved. Data are then judged by regulators who work in the very
Government Departments which are engaged in the promotion of Biotechnology. (In fact, the
Consultation Document (p. 8) explicitly acknowledges that Agriculture and Agri-Food Canada, the same
Department responsible for the Canadian Food Inspection Agency, " has a clear mandate to promote
agricultural biotechnology and international trade in agricultural commodities"). There is no provision for
any independent replication of the tests. Further, the applicant may (and seemingly, generally does)
declare that the data provided are to be regarded as confidential business information so that they cannot
be made available for scrutiny by outside scientists. Thus, neither the experimental design, statistical
power or degree of replication can be judged by other scientists.
Quite aside from the difficulty in understanding why the safety data for any proprietary GE crop or food
should be regarded as confidential, this has at least two unfortunate effects. First, it prevents any input
from experts in the wider scientific community and second, it removes much of the discipline of
traditional science. In fact, the RSC Expert Panel indicated that, in the one case to which it had access, the
quality of the data submitted was scientifically inadequate for either a rational regulatory decision-making
process or for a peer reviewed publication (p. 215). Further, Stuart Laidlaw, writing in the Toronto Star
(Jan. 23, 2001) states that the Canadian Government approved a new line of genetically modified potatoes
despite "extremely poor'' field tests that federal inspectors feared would undermine the legitimacy of
Canada's regulatory system. If true, this is another serious indictment of the process and makes a mockery
of the regulators’ claims for thoroughness and integrity.
The RSC Expert Panel’s finding that the regulators show a great deal of concern for "maintaining a
relationship of trust between industry and the regulator" comes as no surprise. However, there does not
seem to be a similar degree of concern to maintain the trust of the Canadian public, including independent
scientists! Requests for information have been rebuffed and criticism of regulatory policies and actions
have been met with derision and hostility. Indeed the situation gives credence to Ursula Franklin’s
declaration that, "... in fact, we have lost the institution of government in terms of responsibility and
accountability to people. We now have nothing but a bunch of managers, who run the country to make it
safe for technology."
Full implementation of the RSC Expert Panel’s recommendations on pages 191 and 206-7 plus the earlier
detailed recommendations regarding testing would go a long way toward remedying the situation. We
believe that the regulators should not accept data which does not meet the standard set by first rate, peer
reviewed, journals. To achieve the necessary openness and transparency, the detailed scientific results on
which regulatory decisions are made must be readily available to interested parties - preferably in the
form of actual peer reviewed articles in the scientific literature. Pending the appearance of such articles,
detailed scientific reports should be published electronically on the Agency’s web-sites. Likewise, all
other relevant information which is not published should be available on the web-site. In this era of cheap
electronic communication it is not acceptable merely to make data available for perusal at the
headquarters of the agency.
The magnitude of the changes required to implement the RSC Expert Panel’s recommendations on the
regulatory system should not be underestimated. Indeed, a complete change of attitude on the part of the
regulators is needed. Such change will require inspired leadership and will not occur if the Departments
involved are allowed to retain their dual and conflicting roles as regulators and promoters of
biotechnology! One approach would be to create a Ministry whose sole job it is to assess the acceptability
of our crops and food, including those produced by genetic engineering.
Whatever new system is put in place it will serve the public interest effectively only if sufficient resources
are provided and if the staff members involved are treated as professionals by management. Indeed, the
difficulty of attracting top notch scientific talent to the regulatory agencies in the face of blandishments
from industry and academia should not be underestimated. Again, there is evidence that radical change is
needed. Health Canada has been in conflict with staff scientists. To cite a recent case, Dr. Shiv Chopra, a
Health Canada scientist, was suspended after speaking out about problems in that Ministry. On March 13,
a court cleared Dr. Chopra of all allegations of misconduct. Health Canada was ordered to rescind his
suspension, to return to him the one-weeks' pay that was deducted, and to remove from his file any
reprimands. The judge declared that Dr. Chopra was justified in speaking out about the problems of
Health Canada for the sake of the public interest. Federal legislation to protect responsible whistle
blowers from repercussions by superiors who have been compromised by undue political pressure is
badly needed.
There should be provision for periodic in-depth review (perhaps every three years) of the Agency to
ensure that the quality of its work is appropriate and that new regulatory challenges are being met.
Perhaps a Parliamentary panel advised by a group of independent scientists and consumers would be
appropriate.
1.3. Special GE-plants for the Production of Nutraceuticals, Vaccines, Enzymes, and Industrial
Chemicals: The RSC Expert Panel describes briefly the prospects for the introduction of GE plants
modified to produce a variety of products (p. 21). Some of these will be engineered to have enhanced
nutritional value. Others will produce vaccines and various pharmaceuticals and still others will produce
enzymes or industrial chemicals. If open pollinated food crops are used, there is every possibility that the
pollen from the GE plants will transfer the engineered genes to non-GE crops which are destined for
human consumption. Spillage of seed or dispersion of seed by the wind will likewise cause
contamination. Also, given the demonstrated contamination of the human food supply with Starlink corn,
a variety approved for livestock feed but not for human consumption, it is reasonable to expect that such
special GE products will inevitably enter the food chain directly through error. While the RSC Expert
Panel did recommend that approvals should be given for GM products with human food counterparts only
if they are themselves acceptable for human consumption, it really did not grapple with the problem posed
by the developments it described in the introductory chapter. It seems to us that there are a number of
important issues that require regulation.
1.3.1. In the case of plants engineered to produce pharmaceuticals, enzymes, industrial chemicals and the
like, food crop plants should not be used unless it can be established beyond all doubt that these products
are safe (as might be the case of a plant producing a chemical which is already consumed at comparable
levels by humans). The reason: there is a very high probability that the human food supply will become
contaminated. Only species that are not consumed by humans or by livestock should be permitted for the
production of these substances.
1.3.2. The situation with vaccines and nutraceuticals is more complex. With the former, the object may be
to produce food which contains an "oral"vaccine for direst administration to humans and domestic
animals. If so, crop plants will be used. Existing Food and Drug regulations will presumably deal with
both the efficacy and safety of vaccine-bearing foods for their intended recipients. Ideally, food derived
from such varieties would be consumed only by those in need of the vaccine However, given the near
inevitability of the introduction of these materials into the general food supply, much wider exposure to
some level of the vaccine seems inevitable. The inadvertent administration of a vaccine, or a variety of
different vaccines, to large numbers of people including the very young, the elderly and the sick as well as
to livestock and wildlife, needs wide discussion and very careful consideration.
With nutraceuticals there are even larger issues. These products will be engineered to confer a supposed
advantage such as a higher level of some essential nutritional factor, oils having more desirable fatty acid
composition and so on. We can be sure that the proponents of these products will promote them
vigorously with strong claims for their efficacy. There are at least two problems to consider. The first is
the matter of the pollution of other food through inadvertent contamination of the corresponding non-GE
food as was discussed above. Such plants should be grown in strict quarantine until their safety, both for
human health and the environment has been established.
The second issue has to do with the need for some responsible body to examine and certify the claims that
will be made for the benefits of these products. Otherwise, one can anticipate a plethora of exaggerated
and misleading claims (genetically modified snake oil?). The CBAC should recommend that a rigorous
process to approve the claims that are being made for nutraceuticals be put in place by Health Canada.
Again, the studies supporting the efficacy of these products should be made public as a matter of course.
1.4 Labelling: The RSC Expert Panel has accepted the notion that voluntary labelling of products derived
from GE organisms should suffice. In this its conclusions differ from those of the EU-U.S. Biotechnology
Consultative Forum which stated (p. 15), " The consultative forum considers it of importance that
consumers are informed truthfully and adequately about genetically modified food products. Labelling of
genetically modified food products is an important tool in providing customers with relevant
information." We believe that the Forum has it right - it is a simple matter of consumer justice that
individuals can determine if the food products they are considering contain material from GE organisms.
Having said that, it should be emphasised that the Expert Panel’s recommendation to develop a scheme of
voluntary labelling for GE products (pp. 220-228) is predicated on the assumption that recommendations
regarding testing and management of risks presented elsewhere in the Report are fully (emphases in the
original) implemented. The Report is silent on the issue of what sort of labelling should be required if the
response to these other recommendations is unsatisfactory.
In our view, unless the public can be assured through more stringent testing requirements plus public
disclosure of the results, that truly meaningful steps have been taken to test products derived from GM
organisms, strict mandatory labelling should be required. This is a matter of simple consumer justice:
people should know when they are being presented with inadequately tested food derived from new and
unproven technology. The CBAC must deal with this issue in a very forthright way so that the
Government cannot, on the one hand, fail to accept the recommendations regarding the need for better
testing while at the same time accepting the recommendation to implement only voluntary labelling.
1.5 Other Crops: While at this stage of its work, the CBAC is concentrating on GE food, there are rapidly
developing issues involving other plant crops that need immediate attention. Three of the world's largest
paper and lumber producers have formed a joint venture, called ArborGen, that hopes to be the first group
to commercialize genetically modified trees. GE tree species having increased growth rates, herbicide and
insect resistance and reduced levels of lignin are being developed. ArborGen expects to seek approval
from the U.S. Department of Agriculture and other regulatory bodies for mass planting by 2005.
The Canadian Forest Service describes itself as the largest Canadian organization involved in forest
biotechnology. It reports success in introducing novel genes into several species of conifers and is
working on the creation of pest and herbicide tolerant varieties. It is also working on genes for flower
sterility. Such GE tree crops raise a number of very serious questions In particular, the issue of gene flow
from GE tree crops into their wild counterparts needs very careful examination. Gene flow takes place
most extensively in situations in which GE crops are open pollinated and have wild relatives in the same
location - something that will occur with most proposed GE tree crops. Unless these varieties are
effectively segregated from their wild counterparts, flow of the engineered genes into wild trees is
inevitable. The effect of such genes on the wild species and ultimately on the ecosystem is totally
unknown. Prudence dictates that GE tree varieties should not be allowed where there is the slightest
chance of contamination of their wild counterparts. It has been proposed that sterility genes be used to
prevent or limit gene flow but this untested technology has serious limits. As well, introduction of sterility
genes may have profound effects on forest species and ecology. Given the imminence and importance of
these issues, we trust that the CBAC will soon turn its attention to this matter if it has not already done so.
PART 2: COMMENTS ON THE CBAC CONSULTATION DOCUMENT.
While the CBAC has worked hard to try to present itself as operating in an unbiassed and open manner,
the Consultation Document contains seriously misleading statements that force us to question the
objectivity of the whole consultation effort regarding the regulation of GM crops and foods.
2.1. Biassed Wording in the Consultation Document:
2.1.1 The process of genetic engineering: On page 2 it is stated that,"This 'genetic engineering' is more
precise than randomly creating mutations because the basis for the change is understood at both the DNA
and protein level". This partial truth represents a wilfully misleading statement. While it is true that the
DNA construct that is introduced into the recipient plants is generally well characterized, the actual events
that lead to incorporation of the construct into the genome and its subsequent expression constitute a
"black box". At present it is impossible to control the site of integration or the number of copies of the
construct that become incorporated. Each transformation event is unique so that the genetically modified
"daughter" plants will all be distinct from one other. Pages 18-19 and 183-185 of the RSC Report discuss
this issue. More detail can be found in the report commissioned by Greenpeace Netherlands, and prepared
by Amsterdam Plant Research International B.V., Wageningen, August 2000. The situation is further
confounded by gene silencing and by the fact that the insertion of the new genes may affect the expression
of other genes through disruption or through pleiotropic effects.
The statement on p. 19 that GE organisms can be produced using "genetic material - sometimes from
closely related species or from species that are distantly related or even essentially unrelated" (emphasis
added) reveals a bias towards minimizing the revolutionary nature of genetic engineering. The fact is that
with these techniques DNA from several totally unrelated organisms can be combined and introduced into
a plant (e.g. the Bt gene from insects, a promoter from cauliflower mosaic virus, an antibiotic resistance
marker from bacteria, as well as start and stop sequences, something that is totally impossible in either
nature or conventional plant breeding.
With traditional plant breeding, genes from the same or closely related species are introduced into a plant
by pollination and then letting the natural processes of fertilization and genetic recombination do the rest.
This results in a tidy, functional and stable arrangement of genes on the chromosomes. Thus, while the
starting material for conventional breeding is more complex, the processes which incorporate the desired
gene into new varieties are natural and precise - the product of millions of year of evolution. This
distinction lies at the core of the controversy over genetic engineering. By failing to acknowledge this, the
Consultation Document reveals a serious bias on the part of its authors.
This section of the Consultation Document also leaves the impression that conventional breeding is solely
based on "mutation breeding" or mutagensis. This is incorrect - much of the new genetic material for
improvement of domestic plants has come from genes that exist naturally in other lines of the same plant,
in their wild ancestors or in other relatives that are sufficiently closely related that they can be crossed. As
has been pointed out by Stoskopf et al., mutation breeding is a supplement to conventional hybridization
methods, and is used only in special circumstances - primarily in self-pollinated and vegetatively
propagated plants.
Also, since the existence of induced mutations was not recognized until the work of Muller in 1927,
mutagensis breeding cannot have been used "since the beginning of the 1900s"!
What is one to make of this? At best it shows a careless approach to the writing of the Consultation
Document; alternatively it can justifiably be taken to represent a deliberate attempt to minimise the
differences between conventional plant breeding and GE with the hope of making the latter seem less
radical. In neither case does it enhance the credibility of the CBAC.
2.1.2 The description of the regulatory process: The account of the development of procedures for the
regulation of GE foods and crops on p. 3 of the Consultation Document states,"These principles were
formulated to ensure (emphases added) that the practical benefits of biotechnology products were
balanced with the need to protect the environment, human health and safety". This whole section is
written in a way that implies that the efficacy of the approvals system is accepted by the CBAC. However,
given the weaknesses of the current regulatory system as explained in the Report of the RSC Expert
Panel, it is clear that risks of harm to people and livestock and to the environment from GE plants have
not been given their proper weight in decisions to permit the introduction of GM-crops. The assertion in
the Consultation Document that, "...there are opportunities for improving the efficiency, effectiveness and
public understanding of the system" is wishy-washy to say the least.
2.2 Ethics of the insidious approach to the introduction of GE food: With all the apparent emphasis of the
CBAC on ethical considerations, the Consultation Document completely misses the most relevant ethical
question of all, namely, was it ethical to introduce the products of an unproven technology like GE plants
without prior public discussion of their acceptability or any indication to the public as to which specific
items are products of the technology? The rationalization often used is that GE products are deemed to be
"substantially equivalent" to their non-Ge counterparts. However, this concept is vague and, as a series of
recent reports, including the RSC Expert Panel Report (p. 177 and following), makes clear, this is an
assumption, not an experimentally verified fact.
In our opinion, the introduction of GE crops and foods without genuine public disclosure and informed
discussion was clearly unethical in that it deprived citizens of any choice in the matter of accepting or
rejecting the products of agricultural biotechnology. The situation is particularly repugnant in that the
benefits of the initial GE crops accrued to the multinational corporations and perhaps to some growers but
(unlike the products of medical biotechnology) did not directly benefit the consumers who were the ones
at risk for any untoward health effects. A parallel situation would be a decision to fluoridate a
community’s water supply without telling the populace, something that would clearly be unacceptable
even if evidence supports the safety and efficacy of the measure. Alternatively, the surreptitious
introduction of GE foods, could be likened to a physician using treatment procedures without the
knowledge or consent of the patient.
Similarly, GE crops have impacted growers of conventional crops such as canola, corn and soy because
their non GE varieties have become contaminated with pollen or seeds from GE crops with the result that
major world markets have been closed to them. Again, this occurred without any real and informed
discussion within the farming community of the possible problems that GE crops would pose.
Also, completely missing from the Consultation Document is any recognition of the issue of liability. As
has been demonstrated by the widespread contamination of the western Canadian canola crop and by the
Starlink corn debacle in the U.S., it is quite unclear who is liable in the event of problems. Transgenic
agriculture necessarily externalizes costs and risks involuntarily and unavoidably in the form of both
genetic pollution and post-harvest mixing. Because these effects are inevitable, it is unconscionable to
penalize those whose livelihoods have been compromised by unavoidable contamination.
The view has been expressed that the surreptitious introduction of GE crops and foods was a deliberate
act designed to contaminate the food chain irretrievably with GE products before the public became aware
of what was being done and thus preempt public involvement in decision making. Whether or not this is
true, the history of the industry and its regulation does leave open this interpretation.
The Consultation Document makes reference to the concern of "others" that, as a result of mandatory
labelling of GE foods, people may be "denied" beneficial products because of consumer rejection. We
read this as saying that the consumer may choose not to buy something if he/she knows what is in it. It is
remarkable that persons and corporations that otherwise vehemently champion free market principles
should suggest that basic information needed for consumers to make informed choices should be withheld
because sales might be affected if people knew what they were getting!
2.3. Communications: It has been our experience that "poor communications" are often invoked as a
means of deflecting attention from more fundamental problems. Thus, while Health Canada and the CFIA
could undoubtedly improve the way they communicate with the public, this is not the basic problem. As
noted above, the Agencies’ whole approach to their tasks needs to be reformed along the lines suggested
by the RSC Expert Panel. Simply explaining in a more elaborate way what is being done now will not
help to instill public confidence and will be a waste of resources.
2.4. "Unknown Unknowns": The Consultation Document reads as if all of the information needed to reach
scientifically valid conclusions regarding the risks and benefits of GE crops and foods is attainable.
However, given the complexities of cellular processes on the one hand and of the ecosystem on the other,
coupled with our profound ignorance of both these areas, no such firm conclusions are possible. There
are, to use Thomas Homer-Dixon’s term, "unknown unknowns". Further, there are some serious Catch-22
situations involved. For example, it is impossible to judge with certainty how a GE crop will behave in
the wider environment by means of confined experiments, yet once the crop is released into the
environment for study there could be irreversible effects. While there are those who argue that the
likelihood of grim, irreparable environmental effects is very small, it is also recognized that the impact of
such events, should they occur, could be very damaging. Future basic science discoveries will help to
narrow the range of our ignorance but complete predictability will never be achieved. Meanwhile, there is
the unresolved question of liability in the event of harm.
Past experience with the deleterious side effects of technological developments3 (Note 3) should be
sufficient to induce a state of humility and to sensitize us to the inevitability of serious unanticipated
problems. However, it is clear that many of the corporate and technological elite reject this view. Perhaps
this is only to be expected since those who are pioneering a new technology are dazzled by the exciting
intellectual adventure in which they are caught up and in which they may have a substantial direct or
indirect financial stake. For scientists and regulators to reject a precautionary approach and to assume that
they are now so much better informed than their predecessors as to be infallible, is arrogance. For the
public to accept such nonsense is folly!
CONCLUDING REMARKS
We recognize that the remit of the CBAC is to make recommendations on biotechnology. There is,
however, need for a balanced approach to the solution of the problems confronting agriculture and the
food industry. It is by no means clear that biotechnology will provide the best solutions. This was
recognized by the RSC Expert Panel who point out (p. 29) the need for a much broader research agenda
which would look at systems and methods of sustainable agriculture so that society will be able to make
informed choices between alternate approaches to food production. This seems to us to be a wise
recommendation - one that any prudent civilization would embrace. Yet, in the developed countries both
governments and business are putting a disproportionate share of research resources into the development
of agricultural biotechnology to the detriment of other approaches. Is it rational for society to devote an
increasing proportion of its scarce scientific resources (including academic researchers) to biotechnology
or would some of them be better applied elsewhere? We believe that support for research on a variety of
non-proprietary agricultural topics should receive increased public support. Industry will continue to fund
potentially lucrative areas such as biotechnology but progress in other equally important areas is
completely dependent on public funding.
-------------------------------------------------------------------------------NOTES
1. The authors:
Dennis R. McCalla, PhD (biochemistry and genetics) 1961 from the California Institute of Technology;
Faculty Member, McMaster University 1961 to 1989. Dean Faculty of Science, 1967 to 1975, Vice
President Health Sciences, 1982 to 1989. Over 90 peer reviewed publications in biochemistry and genetic
toxicology. Served on NSERC and NCI grants panels. Chairman of the Ontario Council on Occupational
Health and Occupational Safety, 1984 to 1989.
Dick Beames, Ph.D. McGill University (nutrition), 1965. 1954-1968, Husbandry Officer, Queensland
Department of Primary Industries. 1968-1996, Faculty member, Department of Animal Science, UBC.
Past President, Canadian Society of Animal Science (1976); 1976-1989, member CUSO Canada-Cuba
team to improve pig production in Cuba; Over 60 peer-reviewed papers in scientific journals and three
book chapters on animal nutrition and food evaluation and analysis.
Hugh S Lehman, Ph.D. (Philosophy), Harvard University, 1963. Facultymember, University of Guelph,
Guelph, Ontario, 1969-1996. Author of Rationality and Ethics in Agriculture, (University of Idaho
Press,1995). Co-editor of: The Pesticide Question: Environment, Economics and Ethics, (Chapman and
Hall, 1993) and The Journal of Agricultural and Environmental Ethics, (Kluwer Academic Publishers),
1988 - 1998.
Bert Christie, PhD, 1959, Iowa State University ( Plant Breeding, Genetics and Biometrics). Faculty
member, 1959-1989 Faculty of Crop Science Department, University of Guelph: 1989-1998 Research
Scientist, Agriculture and AgriFood Canada, Charlottetown, PEI. Author or co-author of over 90
scientific papers in peer reviewed journals; Editor or co-editor of 3 text books; developed 10 cultivars of
forage crops. Past President, Canadian Society of Agronomy, Honorary Life Member, Canadian Seed
Growers' Association, Agcellence Award, Agriculture and AgriFood Canada.
2. The EU-U.S. Biotechnology Consultative Forum: This 20-member group including scientists, business
executives, farmers, environmentalists and ethicists (including Norman Borlaug, Nobel Prize winner and
"father of the green revolution"), was established in May 2000 by President Clinton and President Prodi
of the European Commission to,"provide a consensus report reflecting their views and assessments of the
benefits and risks" [of biotechnology]. In mid December of last year, the group issued its final report. This
report is comprehensive, candid, and balanced. Its opening paragraph sets the tone for the remainder of
the report: "Modern biotechnology holds the promise of dramatic and useful advances in some of the
areas of greatest challenge for humankind during the 21st century. Like all new technologies, it also holds
risks, both known and unforeseen. In the absence of broadly acceptable and open consultation processes,
discussion about the issues has become polarized." The Report then presents a detailed analysis of the
benefits, risks and uncertainties that are involved with plant biotechnology. The response of the U.S.
Government is worth noting. The U.S. Mission to the EU put out a "Fact Sheet" over the imprimatur of
the "Office of the Spokesman, Department of State that seriously distorts the findings of the EU-U.S.
Report by extracting, out of context, virtually all of the comments that support biotechnology without
mentioning the Report’s statements that are critical of biotechnology, the substantiative recommendations
for more rigorous evaluation of GE products or the serious questions the report asks about the current
practices and applications of agricultural biotechnology. Apparently the U.S. Government is not willing to
respond positively to thoughtful suggestions made by knowledgeable outside experts. A similar situation
seems to exist in Canada since Canadian regulatory agencies responded to the RSC Expert Panel’s Report
with a press conference at which conclusions of the Report regarding the adequacy of testing were
attacked and the work of the Panel denigrated.
3. Unfortunate "Side Effects" of New Technologies: For people of a certain age, the debate over GE crops
and foods evokes memories of the chemical industry in the decades following World War II. It is worth
examining some of the events for the lessons they provide.
In 1940 Paul Müller, working for the Geigy chemical company in Switzerland discovered that DDT,
which had been synthesized in the 1890's, was a powerful insecticide. His discovery was made known to
both the Allied and Axis Powers and was widely and successfully used by the military of both factions
against insects and insect borne disease such as malaria and typhus. Müller received the Nobel prize in
1948 for his discovery. When the compound was made available to civilians, it was used with complete
abandon. Wide areas (and their populations) were repeatedly fogged with DDT aerosols to control
mosquitos. Other, nastier, organochlorine pesticides like dieldrin, aldrin and heptachlor were added to the
arsenal and were embraced by farmers, gardeners and householders. A cartoon from the period shows a
garden centre customer saying," I want a spray that kills everything but isn’t dangerous"!
In 1962 Rachael Carson published Silent Spring, the first detailed account of the hazards of these
compounds. The chemical industry circled its wagons, claiming that if DDT and other organochlorine
pesticides were banned, there would be mass starvation as the insects took over! Carson was attacked
unmercifully and shamelessly by spokesmen for industry who denigrated her credentials, dismissed her as
one who wrote for the public rather than for scientists and as a woman who "kept cats and loved birds".
Ezra Taft Benson, a former US Secretary of Agriculture, even went so far as to wonder "why a spinster
with no children was so concerned with genetics"! Yet we all know the outcome: basically, Carson was
right. DDT and its relatives accumulate in animal tissues and move up the food chain so that top predators
carried large burdens of the compound. As a consequence, the eggs of species such as eagles, ospreys,
peregrine falcons and brown pelicans failed to calcify properly, resulting in a marked decrease in
hatching. By 1970 there were also reports that preparations of these chlorinated hydrocarbons caused
cancer in test animals. By the end of the 1970's, developed countries had either banned these compounds
or restricted their use to a few applications for which there were no alternatives. Tissue levels in wildlife
and humans have now decreased and the threatened species are recovering.
There are at least two important lessons here: first chlorinated insecticides acted in the environment in a
way that was not anticipated, and second, the economic interests that profited from them, aided by some
academic and government scientists , conducted a campaign of vilification and misinformation in what
turned out to be a vain attempt to suppress knowledge of the hazards. This kind of behavior is by no
means an isolated incident.
Unexpected effects seem to be the rule rather than the exception when new technology is introduced.
Consider the chlorofluorocarbons (CFC’s) which replaced toxic sulfur dioxide and ammonia as
refrigerants and were also used as propellants in aerosol cans. By the 1970's it had become apparent that
enough of these compounds had entered the atmosphere to destroy part of the ozone layer which shields
the earth from the UV component of sunlight. This is undoubtedly contributing to the increased incidence
of human skin cancers and, if severe enough, could even endanger the production of marine algae, an
important source of food for many other creatures. Even though CFC’s are being phased out, they are
slow to decompose and seasonal thinning of the ozone layer will continue for many years as material now
in use continues to escape.
Thalidomide was approved for use in the treatment of nausea of pregnancy in several countries. Although
no birth defects were detected when this compound was tested on rats and mice it proved to cause severe
limb deformities in humans. Thalidomide was not approved for use in the US - thanks to Frances Kelsey,
an astute FDA official who remained unconvinced of the adequacy of the safety data provided.
Margarine, produced by hydrogenation of vegetable oils was vigorously promoted as being healthier than
butter. Decades later we are told that partially hydrogenated margarine may be as harmful, or even more
harmful, than butter because of the trans fatty acids formed during the process.
British regulatory authorities allowed meat meal produced from offal containing animal brains and other
nervous system tissues to be used as an ingredient in feed, apparently assuming it would safe because the
high temperature used in the rendering process would inactivate the infectious agent and also because
they assumed that the agent would not cross the species barrier to humans. As we now know, both these
assumptions were wrong. Prions transmitted to cattle spread "mad cow disease" which in turn caused an
outbreak of Creutzfeldt -Jakob disease in humans.
Even where there are no complications due to ecosystems and physiology, new technologies cause
problems. Every computer and every line of code is the result of human ingenuity. Yet, even in this
situation the so called Y2K problem was allowed to develop, apparently through a combination of
misplaced frugality and sloth. In Canada alone, twenty billion dollars were spent to correct the problem.
Jan. 1, 2000 is long gone. The Y2K "bug" did not cause serious problems anywhere in the world. Whether
we were saved from a serious situation by the heroic efforts of the computer industry or simply conned
into spending billions to up-grade computer systems unnecessarily, the conclusion is clear, the experts are
fallible!
The take home lesson from all of this is that powerful new technologies will inevitably have unanticipated
negative side effects. As systems increase in complexity, more subtle and potentially more serious
problems are to be expected. Some of these will be impossible to rectify.
Download