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BP-393E
AGRICULTURAL
BIOTECHNOLOGY -
OPPORTUNITIES AND CHALLENGES
Prepared by:
Sonya Dakers
Science and Technology Division
November 1994
Revised June 1996
TABLE
OF CONTENTS
AGRICULTURAL
BIOTECHNOLOGY AT THE CROSSROADS
CURRENT
AND NEXT GENERATION AGRICULTURAL
BIOTECHNOLOGY
PRODUCTS
A.
Introduction
B.
Animals
C.
Plants
PUBLIC
PERCEPTIONS OF THE BENEFITS AND RISKS
REGULATION
AND RISK ASSESSMENT
TYING
IT ALL TOGETHER
AGRICULTURAL
BIOTECHNOLOGY -
OPPORTUNITIES AND CHALLENGES
AGRICULTURAL
BIOTECHNOLOGY AT THE CROSSROADS
Ten years ago, the word
biotechnology was used to signify a variety of activities and uses. A
consensus has gradually developed whereby biotechnology is defined as
a set of technologies, methods or tools but not a monolithic entity. Agriculture
and Agri-Food Canada's formal definition sees biotechnology as "the
applied use of living organisms, or their parts, to produce new products."
Many traditional food-making processes depend on living organisms: yeast,
a fungus, is used to make bread rise; bacteria are used to "age"
cheese and make sour cream. Some medicines, such as antibiotics, are manufactured
from substances produced from other organisms, such as bacteria and fungi.
Today, scientists are refining these biotechnology methods so that the
results are controlled and specific.(1)
Ten years ago, it was even
questioned whether agricultural biotechnology would be part of the agri-food
system. Today, when we are on the verge of having an impressive portfolio
of available products, the emphasis has shifted to the benefits and risks
of these biotechnology applications.(2)
It is still not clear what
forces drive the biotechnology agenda. From the point of view of the public
this is an important issue; unless there is public input into this agenda,
technology will have free rein to develop in response to the profit motive
rather than for solving particular food or health problems.
Public concerns often centre
on efficacy and health and environmental safety, but another criterion
is now being debated - the socio-economic effect of the product or technology.
Given that biotechnologies are often the tools used to achieve particular
socio-economic goals, the public is increasingly exercising its right
to shape the developments of technology to reflect these goals. This places
an onus on scientists, regulators, and policy-makers to understand and
evaluate not only biotechnology's implications for human safety, animal
safety and environmental risk but also its socio-economic impacts. This
criterion was applied in the decision-making for the European Common Market's
ban on growth hormones in food products and the Canadian government's
delay of the use of rbST (recombinant bovine somatotropin) in this country.
Questions about the government's
ability to protect public health and safety and promote technologies that
respond to socio-economic concerns have placed control processes squarely
at the centre of discussion. How can we establish regulatory regimes capable
of differentiating between synthetic products that imitate their natural
counterparts so closely that they pose no threat and products requiring
special scrutiny before approval? How can these regulatory procedures
be designed to assess adequately the benefits and risks of new agricultural
biotechnology products?(3)
The paper discusses the
agricultural biotechnology products now on the horizon, considers their
potential benefits and risks for the public, reviews the regulatory role
and comments on biotechnology's implications for agriculture.
CURRENT
AND NEXT GENERATION AGRICULTURAL
BIOTECHNOLOGY
PRODUCTS
A.
Introduction
Most scientists working
in agriculture tend to view advances in biotechnology as being on the
continuum of the ongoing process of refining and perfecting agricultural
practices.(4) Evidence of
this continuum abounds in Canada. Milk production per cow, for instance,
has doubled in the last 40 years so that we are producing more milk with
half the cows. The same kind of efficiencies are evident in the swine,
beef and poultry industries.(5)
Technology has played an
active role in these improvements in genetics, nutrition, disease prevention
and pest control. Some of the technologies commercialized before 1980
and now taken for granted include selective breeding, vaccination, veterinary
diagnostics and therapeutics, artificial insemination, and crossbreeding.
Embryo transfer and regulation of reproductive cycles came into general
use about 1980.(6)
While there are many promising
applications of biotechnology in agriculture, biotechnology is neither
a panacea for all ills nor a replacement for established tools. It merely
provides an additional approach.(7)
Changing animal nutrition, selective breeding, administering hormones
or (eventually) gene transfer, for instance, all offer different means
of producing leaner meats. The best route may be a combination of techniques,
including those using biotechnology. Similarly, new plants can be produced
through selective breeding and cell culture as well as by genetic engineering
techniques for extending the range of new traits that may be introduced
into a plant from other species.
While the more lucrative
therapeutic or diagnostic applications of biotechnology led in sales in
1995, the agri-food sector contributed $1 billion of the total $3.2 billion
spent on biotechnology products in Canada that year.(8)
B.
Animals
Biotechnology applications
to animals fall into four major categories: reproductive technologies,
animal health care products, growth hormones and transgenic animals.
With respect to reproduction,
biotechnology is able to refine procedures carried out by selective breeding
for generations. Thus, traits from genetically superior female animals
can be propagated using embryo transfer techniques and sperm can be separated
to permit sex determination. In addition, bovine embryos can be stored
in liquid nitrogen to allow more flexibility in their use, importation
and exportation and certain laboratory techniques permit the embryos to
be split into multiple identical copies.(9)
The application of biotechnology
to animal health care products is similar to the application of the results
of R and D to health products for humans, and often these products are
developed by the same firms. Monoclonal antibodies have been developed
into new diagnostic products for animal diseases like those used in tests
for human disease. New, safer animal vaccines, including genetically engineered
vaccines for such diseases as scours and rabies, have also been developed.
Recombinant bovine growth
hormone or bovine somatotropin was approved by the U.S. Food and Drug
Administration in 1994 as a stimulant to milk production. As one of the
products of agricultural biotechnology most evident to the consumer and
the producer, it has met with a mixed reaction. Concerns about its possible
effects on animal and human welfare and on an industry already experiencing
surpluses have led to moratoria on its use in the European Community,
Canada, and various U.S. states such as Wisconsin, Minnesota and Vermont.
Use of animal growth hormones
is also being studied as a way to produce leaner meats. Selective breeding
has already resulted in leaner hogs and beef but the administration of
genetically engineered growth hormones can have this effect and can also
speed growth and improve feed efficiency.(10)
As an alternative to farmers'
use of growth hormones to treat animals, it is thought that growth hormone
genes could be transferred directly into the genomes of animals. The ability
to transfer sections of genetic code into the genome of an animal - thereby
creating a new genetic resource for a species - is termed transgenic technology.(11)
For this to come about, more knowledge about gene function as it relates
to production traits in farm animals is required. This is an expensive
technology involving species with long generation intervals(12)
and food from transgenic livestock is not expected before the end of the
century.
C.
Plants
Modification of crop plants
to improve their suitability for cultivation has gone on for at least
10,000 years.(13) Early
farmers produced better crops by saving the seeds of desirable plants.
During the past century, plant breeding has become more rigorous as a
result of cross-breeding within a species and crossing sexually incompatible
species of the same family. Now genetic engineering offers techniques
for taking a gene from one species of plant and inserting it into a different
species, something that would not occur naturally or through traditional
breeding programs. Genetic engineering offers a means of endowing plants
with new traits, thus expanding their repertoire of characteristics for
withstanding insects, viruses, spoilage and herbicides.
Genetic engineers may also
be able to fashion healthier foods from inserting into crops genes for
proteins with superior nutritional properties. Plants could also be tailored
to produce specific chemicals such as starches, industrial oils, enzymes
and even pharmaceuticals. Preliminary trials on such innovations are underway.(14)
There are some technical
problems with the transgenic science since genetic engineers can at present
modify traits expressed by no more than three to five genes. Furthermore,
some crops do not respond to current gene-transfer methods, and isolating
useful genes for insertion is sometimes difficult.
There is no doubt that biotechnology
offers tremendous potential for increasing food production if these technical
problems can be overcome. It is estimated that food production will have
to increase threefold during the next 40 years to meet the needs of an
estimated nine billion people. Biotechnological breakthroughs could provide
breathing space to deal with upcoming serious demographic problems and
problems of environmental degradation and distribution of wealth.
According to the literature,
the hundreds of field tests of engineered plants being conducted in the
U.S. and Europe confirm their safety and potential commercial viability
and the new crops should be available to farmers in the mid-1990s.(15)
Nevertheless, in 1989 and 1990 groups in the Netherlands and Germany protested
against such tests.
It would appear that non-technical,
rather than technical, issues may delay commercialization of some technologies,
even if they are approved by regulatory agencies.(16)
Such issues are likely to be financial constraints and lack of public
acceptance as a result of concerns about food safety and ethics, the environmental
impact, and lack of understanding of the new technology. Thus, the next
section of this paper looks at public perceptions of the benefits and
risks of biotechnology.
PUBLIC
PERCEPTIONS OF THE BENEFITS AND RISKS
The ability to improve plants,
animals, and microorganisms in ways described above could mean dramatic
improvements in the quantity and efficiency of food production and processing
and the extension of uses of raw agricultural commodities. Consumers could
benefit from reduced prices and safer and more nutritional foods. The
new technologies also have the potential to change the very nature of
food itself and to expand the range of possible food products. Consumers
will show whether they find biotechnological food products acceptable
by whether or not they buy them.(17)
Certain aspects of biotechnology
raise questions regarding the ethics of tampering with the genetic material
of animals and ultimately the balance of nature. Instances where the public
has been assured that scientific breakthroughs - especially in the health
sector - are safe, only to be told down the road of emerging health problems,
have made the public cynical about the information provided by developers
of innovative products on which even government in its regulatory role
has to depend for information. The promotional material these companies
provide is not as likely to address the likelihood of long-term safety
or environmental problems.
Consumer surveys(18)
conducted between 1992 and 1995 show that consumers have more faith in
information provided by third party experts, such as national health and
nutritional organizations, for weighing the pros and cons of biotechnology.
Generally speaking, consumers see nothing wrong in using biotechnology
to alter plants but feel it is morally wrong to use it to change animals.
Consumers have indicated they want to be informed through labelling about
foods that have been altered, and favour such foods that provide tangible
health benefits (for instance less fat). In Canada, most consumers are
reported to have a high degree of confidence in the federal government
to regulate and assess these products for health and safety.
While a product is undergoing
development, however, there is no mechanism in Canada or the U.S. for
involving the public in the process. The U.S. approval process of recombinant
bovine somatotropin (rbST) is a case in point. By the time field tests
were approved, there was considerable public controversy about the efficacy
of this drug which was designed to be given to cows to improve their milk
production. The approval agency, the Food and Drug Administration, had
to take the unusual steps of orchestrating a public hearing process and
gaining the permission of the applicant companies to release the results
of safety studies to the public domain.
Likewise, in Canada there
is no public review process to allow discussion of upcoming biotechnology
decisions before they are approved. Nevertheless, Canada delayed the use
of rbST for more than one year whereas the U.S. approved it in February
1994. Agriculture and Agri-Food Canada now publishes "decision documents"
on its website on the Internet, "InforAgBiotech," explaining
the regulatory decisions it has made in relation to novel plants. The
site is intended to make the department’s regulatory system more
widely understood. The department also publishes regulatory guidelines
as they are approved. As well as the decision documents for products that
have been approved, the website includes information on regulations, guidelines,
consultation documents, and lists of field trials. This certainly represents
the beginning of a dialogue between the regulator and the public.
Another concern relates
to the ownership of these technologies, many of which are in the commercial
hands of multinationals that transcend geographic boundaries and hold
limited national allegiance.(19)
The patenting of plants and animals by these corporations has the potential
to threaten genetic diversity, particularly in the Third World. In theory,
the genetic engineering of plants can provide the latest technology to
farmers in a very traditional package, the seed, to which even the most
impoverished nations could have access without the need for high-technology
supplies. In practice, however, biotechnology can make the seeds too expensive
for poor farmers. Moreover, natural crops may be replaced by synthetic
equivalents; for example, in Madagascar, 100,000 farmers are dependent
on the vanilla crop, which is to be replaced by a cheaper bio-synthetic
product. In such ways, those who provide the indigenous resource placed
under patent end up unable to benefit from the technology.(20)
Another example closer to
home arises out of the development of herbicide-resistant crops. Should
these become increasingly concentrated in a few hands, as appears to be
a trend, it must be asked whether farmers will be better off. Whose interests
are being served by the promotion of such products?
It is important for everybody,
including biotechnology developers, to make the public feel comfortable
with biotechnology. Indeed, public acceptance and support has been identified
as a key component in creating a viable competitive environment for biotechnology
in Canada. Greater public participation would enable the biotechnology
agenda to reflect more accurately a society's diversity of values, interests
and priorities and encourage consideration of environmental and social
concerns. An acceptable biotechnology agenda must include participatory
decision-making to ensure that applications of biotechnology serve the
public good, as well as an accessible and consistent regulatory system
to safeguard the quality of resulting food products.
It would appear to make
sense for the developers of biotechnology to prepare the public for innovations
by providing good information before they have made a significant investment
in research and development. It would then be possible to gauge the reaction
of the public to potential biotechnological products.
The public sector has historically
played a role in conducting fundamental research relating to the biotechnology
industry and should continue to do so, since companies may be unwilling
to take on more high-risk research at this time of major spending reductions.
If this does not continue, government will not be able to evaluate the
efficacy of new technologies. This would be especially true where research
related to the risk assessment of new organisms, monitoring their dispersal,
or studying gene transfer or other areas where biosafety information might
be incomplete. Unlike Canada, the U.S. Department of Agriculture has designated
a specific percentage (1%) of its biotechnology research funding for risk
assessment work.(21) This
type of research is one means of addressing public concerns since it leads
to better methods of controlling and monitoring new products of biotechnology.
The next section of this
paper looks at how government here carries on regulatory functions to
ensure that benefits and risks are adequately assessed and communicated
to the public. A strong regulatory framework provides assurance that the
products of biotechnology meet acceptable standards for the protection
of human health and the environment and sends a signal of confidence to
the domestic and international market.(22)
REGULATION
AND RISK ASSESSMENT
Federal activity in biotechnology
began in 1980 when a private sector task force was commissioned to advise
the government on this new science. In its report, the task force recommended
establishing a national strategy that would encourage a strong and competitive
Canadian industry.
In response, the federal
government in 1983 established the National Biotechnology Strategy Program;
initially, it was to run for five years, but it was extended and will
now end in 1997. The program consisted of an industry-government National
Biotechnology Advisory Committee (NBAC) to advise the Minister of Industry
on new policy requirements; multi-disciplinary centres of excellence to
encourage technology transfer; seven sectoral networks to promote scientific
cooperation in priority research areas; and an Interdepartmental Committee
on Biotechnology (ICB) to coordinate federal biotechnology policy.
In 1987, the NBAC published
eight key criteria intended "to develop a regulatory system able
to determine whether the commercial benefits from the substantial investments
made to date would be reaped in Canada."(23)
The regulatory task was to: engender public confidence; make economic
sense; allow industry planning for development and commercialization;
be compatible with international approaches; be flexible and accommodate
new approaches; clarify jurisdictional approaches; and draw on independent
scientific advice.
Departments having regulatory
responsibilities, such as Agriculture and Agri-Food Canada, began to draft
regulatory proposals under their specific mandates. Together, as part
of the Interdepartmental Subgroup on Safety and Regulations, in 1988 they
drafted Bio-tech Regulations: A User's Guide. That same year, the
departments of Agriculture, Environment, Health, Labour and Fisheries
were directed by Cabinet to develop a plan of action for a coordinated
regulatory system for the products of biotechnology. In 1990, the Green
Plan set a five-year framework for implementation. It also called for
national standards and codes of practice for protecting the environment
and human health following accidental or deliberate release of products.
The Green Plan also called for notification of new biotechnology products
prior to release or introduction.(24)
The basic principles of
The Federal Framework for Regulating Biotechnology Products were
announced on 11 January 1993. They included using existing legislation
and regulatory institutions to clarify responsibilities and avoid duplication;
developing guidelines for evaluating products of biotechnology that uphold
domestic health and environmental safety standards; using risk-based assessments
and supporting a consultative regulatory process.(25)
In 1993, the ICB proposed
that the departments adopt a series of definitions to ensure consistency
with respect to references to biotechnology in all federal documents and
communications. They included definitions for "product" versus
"process" regulation, risk-based assessment and a single-window
approach and adopted the Canadian Environmental Protection Act's
definition of biotechnology as: "...the application of science and
engineering in the direct or indirect use of living organisms or parts
or products of living organisms in their natural or modified form"
(CEPA, Section 3(1)).(26)
In agriculture, this definition
includes genetic engineering and novel technologies of molecular biology
such as tissue culture, recombinant DNA and mutagenesis. Agriculture and
Agri-Food Canada, as agreed in the federal framework for biotechnology,
regulates on a "commodity," or "product," basis. The
department regulates new products of biotechnology in the same way as
traditional products under various agricultural statutes and commodity
areas, based on the requirement that they be safe and efficacious regardless
of how they were developed.(27)
On 11 January 1995, regulations under these Acts were amended to
clarify that they covered biotechnology products.
New varieties of plants
and forestry trees, including plants with novel traits, are regulated
under the Seeds Act. This includes "transgenic plants,"
new crop varieties that are created using "genetic engineering"
or recombinant-DNA technology, as well as plants with novel traits developed
using older technologies, including mutagenesis and traditional cross-breeding.
The introduced genes may confer such traits as improved protein content,
tolerance to a herbicide, resistance to frost damage, or resistance to
insects. Assessments of plants with new traits are conducted regardless
of the breeding method or process used to develop them. Approvals for
field testing and commercialization take place only after thorough environmental
assessments have been performed.
While Agriculture and Agri-Food
Canada is responsible for the agronomic and ecological safety assessments
of crops, in the case of food crops, Health Canada is the department with
primary responsibility for matters of food safety. To cite an example,
Health Canada conducted an assessment of the New Leaf potato -
genetically modified to protect against Colorado potato beetle infestation
- to determine the safety of the product and its acceptability for food
use.
Feeds are regulated under
the Feeds Act. A feed is defined as "any substance or mixture
of substances manufactured, sold or represented for use for consumption
by livestock, for providing the nutritional requirements of livestock,
or for the purpose of preventing or correcting nutritional disorders of
livestock." In addition to traditional types of feeds, there are
also "biofeeds," which may include microbial products (both
living and non-living), plants with novel traits (see above), and a variety
of fermentation products such as enzymes, biomass proteins, amino acids,
vitamins and flavouring agents. Assessments focus on toxicity to livestock,
anti-nutritional and allergenicity effects, and human safety.
Veterinary biologics are
regulated under the Health of Animals Act. This category includes
a variety of products, including animal vaccines, toxins, bacterins,(28)
toxoids,(29) antisera, and
diagnostic kits used for the diagnosis, treatment, mitigation or prevention
of infectious diseases of animals. The majority approved so far have been
diagnostic kits, such as those used to detect animal diseases. Other products
regulated under the Health of Animals Act include animal pathogens,
animal products and by-products, and transgenic animals with disease-resistance
claims.
Fertilizers are regulated
under the Fertilizers Act. These products are developed to supply
plants with nutrients, and can include microorganisms. Microbial fertilizers
have been used as alternatives to chemical-based products for many years,
particularly as seed coatings. For example, seed coating microorganisms
produce fertilizer naturally. The safety assessment focuses on identifying
the organism and its behaviour in the environment in terms of any adverse
health effects.
Importation of plants, microorganisms
and animals is controlled by import permits under the Health of Animals
and Plant Protection Acts. Import permit reviews examine the potential
of a new imported plant, animal or microorganism for having adverse effects
on human safety, animal safety and ecological impact.
Finally, the Canadian
Agricultural Products Act provides authority for the safety and integrity
of agri-food products through standards and mechanisms such as certification
and inspection.(30)
This means that new agricultural
products, like conventionally derived products, are regulated according
to product characteristics. The criteria of "familiarity" and
"substantial equivalence" are used to determine whether risk
should be assessed; risk assessments estimate the hazard to human beings
or the environment; and safety and performance standards are applied.
This procedure applies to imports, field research, and the pre- and commercialization
stages of a product.(31)
In developing guidelines
in the various commodity areas outlined above, the department has held
consultations and workshops to receive input on the acceptability of its
approaches to biotechnology. A number of issues have arisen, one of which
concerns the criteria for determining which products need to undergo risk
assessment. There has also been a realization that "familiarity"
depends on the existence of a broad body of information, including information
on the safety of any product considered to be a substantial equivalent
to the new product of biotechnology. In the proposed model, the degree
to which a product/use is "familiar" and "substantially
equivalent" to an accepted one will determine which new products
require an assessment of potential risk. The risk assessment process itself,
which is not new, identifies potential hazard, and determines exposure
and risk.
For the proposed model to
function usefully, the knowledge bases used in determining both "familiarity"
and "substantial equivalence" must be capable of evolving. How
this works can be seen in the case of canola, originally assessed for
the safety of oil and feed meal products. The broad experience we have
had since then with canola cannot be considered sufficient to deem a new
canola variety (for instance, developed through recombinant DNA to produce
a specialty vegetable oil) "substantially equivalent" though
we do have sufficient "familiarity."(32)
Some of the other issues
arising in the context of the new policy are: the impact of regulation
on competitiveness, its transparency, its flexibility, its credibility,
the need for monitoring its effectiveness, and the need for public participation
in the process.
These are not issues that
are easily resolved equitably. To compete, Canada needs a well-defined
and predictable regulatory framework on which to make business and investment
decisions. At the same time, to gain credibility in the public’s
eyes, the regulatory framework also needs to be sensitive to issues of
public acceptability. This is a delicate balance to maintain.
On the international scene,
Canada's approach falls midway between stringent biotechnology-specific
regulation and no regulation. The U.S. is following a similar route and
is also relying on the existing legislation under which it has already
approved many new products. The USDA (U.S. Department of Agriculture)
and EPA (Environmental Protection Agency) have already established procedures
for reviewing field tests of modified plants and micro-organisms.(33)
The EU (European Union) has taken a more stringent approach; it has enacted
directives that are specific to biotechnology-derived products and is
considering adding socio-economic assessments of new products.
TYING
IT ALL TOGETHER
Despite their potential
for improving and expanding global food supplies, developments in food
biotechnology are emerging in a climate of public uncertainty. The controversial
reaction to the use of synthetic bST illustrates the limited public understanding
of products of biotechnology and their benefits and risks.
Some see technological innovation
in agriculture as ever-evolving, with biotechnology merely the latest
chapter. For them, biotechnology has the potential to increase crop yields,
renew the vigour of plant and animal genetics, encourage species conservation
(by making genes from native plant species more available and valuable),
encourage biodiversity, reduce the need for farm chemicals, and help increase
Third World affluence, thereby slowing population growth.(34)
For others, biotechnology
requires special vigilance and treatment that is qualitatively different.
They do not believe that the ultimate direction of biotechnology is necessarily
toward a more humane, egalitarian, socially just, and ecologically sound
agriculture, despite the opportunities for increasing crop diversity,
yields, and Third World affluence. They see the opposite: huge amounts
of resources are at present being spent on developing herbicide-resistant
varieties of crops of which we already have large surpluses and on increasing
milk productivity when milk is currently over-produced. Moreover, Third
World farmers are not always benefiting from supplying the life forms/seeds
placed under patent and said to encourage bio-diversity. These observers
see economic considerations as the driving force behind biotechnological
developments carried on without any consideration of broad ethical and
environmental concerns.
Between these two quite
divergent viewpoints are others. Parliamentary hearings held during 1996
revealed wide differences of opinion on the notification and regulation
of biotechnology products, particularly those that are created by recombinant-DNA
technology.
The environmental community
favours an approach more like the EC’s, with regulation under new
legislation specifically drafted for biotechnology or consolidated under
the Canada Environmental Protection Act (CEPA). Currently, CEPA
regulates only those biotechnological products not regulated under other
federal statutes, leaving primary responsibility to line departments having
the traditional expertise and experience in relation to specific classes
of products.(35) In its
present form, CEPA does nevertheless give Environment Canada the legislative
authority to set minimum standards for notice and assessment of all
products of biotechnology, both living and inanimate [section 26(3)(a)].
In conformity with its 1993
Federal Framework for Regulating Biotechnology Products, the government
proposes using CEPA as a "safety net" for those areas not covered
by other federal Acts.(36)
The government did agree to create a new Part of CEPA to deal specifically
with living products of biotechnology not covered by other Acts that would
require notification of data and product assessment for long-term human
and environmental effects. The proposed safety net approach, however,
would confine Environment Canada’s standards for notice and assessment
to new products not covered by existing legislation. CEPA would no longer
be the basis for setting minimum standards.
An open public discussion
of biotechnology's role in agriculture is still needed, based on balanced
and credible information. The capacity of biotechnology to be a useful
tool in dealing with major problems such as the environment, hunger and
population growth must be part of the public debate. Any health, safety,
ethical, economic or other concerns of the public must be openly addressed
in both regulatory and educational forums.
In Canada, there is a certain
reliance on the government's ability to protect the public's health and
safety; however, mechanisms whereby the public can indicate concerns or
pose questions must be provided if the government is to maintain this
credibility. Because consumers are concerned about the content of the
food they buy, labelling genetically engineered foods will be important,
as will knowledge about the effect of long-term exposure to them. The
future of genetically engineered foods will depend on consumers' confidence
in them and their benefits.
To some extent, the scientific
community bears the burden of demonstrating to the public that biotechnology
products are both desirable and safe. Most people have very strong emotional,
cultural, and religious feelings about food. Some believe that tinkering
with animal or plant genes violates the integrity of the species. It would
behove the developers of biotechnology to be judicious in their selection
of the early genetically engineered foods that come to market in order
to ensure that the benefits outweigh the risks. The experience with rbST
shows that a public dissatisfied with the efficacy of a product will strive
to make itself heard and, lacking any other forum, will turn to the media
to make its point. This is not necessarily the best mechanism for public
debate of biotechnology and its benefits and risks.(37)
(1)
Agriculture Canada, Biotechnology in Agriculture, Science for Better
Living, c. 1993, p. 1.
(2)
National Agricultural Biotechnology Council, Report 3, Agricultural
Biotechnology at the Crossroads, NABC, Ithaca, N.Y., 1991, p. 18
[hereafter NABC 3].
(3)
Institute for Science in Society Conference, "Food Biotechnology:
A New Paradigm for Food, the Farm and the Public," Bio/Technology,
Vol. 11, December 1993, p. 1584.
(4)
NABC 3 (1991), p. 98.
(5)
Senate of Canada, Proceedings of the Standing Senate Committee on Agriculture
and Forestry, Issue No. 4, 22 September 1994, p. 30-31.
(6)
NABC 3 (1991), p. 99.
(7)
United States, Congress, Office of Technology Assessment, Biotechnology
in a Global Economy, Congress of the United States, Washington, D.C.,
1991, p. 100.
(8)
Industry Canada, Biotechnology in Canada, a presentation to the
House of Commons Standing Committee on Environment and Sustainable Development,
16 May 1996, p. 4.
(9)
U.S. Congress (1991), p. 100.
(10)
Ibid., p. 102.
(11)
NABC 3 (1991), p. 38.
(12)
Ibid., p. 104.
(13)
Charles S. Gasser and Robert T. Fraley, "Transgenic Crops,"
Scientific American, June 1992, p. 62.
(14)
Ibid., p. 69.
(15)
Ibid.
(16)
National Agricultural Biotechnology Council, Report 5, Agricultural
Biotechnology: A Public Conversation about Risk, NABC, Ithaca, N.Y.,
1993, p. 73.
(17)
Ibid., p. 74.
(18)
D’Arce McMillan, "Consumers Seen As Unfazed by Biotechnology,"
The Western Producer, 20 June 1996, p. 5.
(19)
NABC 3 (1991), p. 163.
(20)
Sonya Dakers, Biotechnology and the Public Good: NABC 6 Conference
Report, Mini-Review MR-127E, Research Branch, Library of Parliament,
Ottawa, 28 June 1994, p. 2.
(21)
NABC 3 (1991), p. 141.
(22)
Agriculture Canada, Workshop on Food Biotechnology, Proceedings,
Ottawa, 29 March 1993, p. 4.
(23)
Ibid., p. 4.
(24)
Agriculture and Agri-Food Canada, Workshop on Regulating Agricultural
Products of Biotechnology, Proceedings, Ottawa, 8-10 November
1993, p. 4.
(25)
Ibid.
(26)
Ibid., p. 6.
(27)
The following description of the agricultural legislation is taken from
Thomas Curran, Briefing Notes on Biotechnology, 12 June 1996, p.
4-6 and Agriculture and Agri-Food Canada, Biotechnology Presentation to
the House of Commons Standing Committee on Environment and Sustainable
Development, 16 May 1996, p. 3-4.
(28)
A "bacterin" is a suspension of killed or attenuated bacteria
for use as an antigen.
(29)
A "toxoid" is a toxin of a pathogenic organism treated so as
to destroy its toxicity but still leave it capable of inducing the formation
of antibodies on injection.
(30)
Agriculture Canada, Workshop (1993), p. 6.
(31)
Ibid., p. 6-7.
(32)
Ibid., p. 12.
(33)
U.S. Congress (1991), p. 196.
(34)
Bio/Technology (1993), p. 1585-88.
(35)
Canada, Parliament, House of Commons Standing Committee on Environment
and Sustainable Development, It’s About Our Health: Towards Pollution
Prevention, June 1995, p. 123.
(36)
Environment Canada, Environmental Protection Legislation Designed fort
the Future - A Renewed CEPA, Minister of Supply and Services, Ottawa,
1995, p. 51.
(37)
Ibid., p. 1588.
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