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Mini-Review 84-37E
THEREGULATION OFGENETICENGINEERING
ThomasCurrenScienceandTechnologyDivision
26 October1984
Libraryof ParliamentaryParliament ResearchBibliothèqueduParlement ranc
CANADA
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THE REGULATION OF GENETIC ENGINEERING
Modern biotechnology, or genetic engineering, has expanded
rapidly over the past decade and promises to make important contributions to
basic biological research, medicine, agriculture and industry. Various
industries are preparing to use genetically-engineered microorganisms in
large-scale production processes and agricultural scientists have applied to
use novel organisms in a number of field trials in Canada and the United
States. If these latter applications are approved, they would be the first
instances of the deliberate release into the open environment of
genetically-engineered microorganisms developed using recombinant DNA
technology. Questions have been raised about the wisdom of allowing such
releases, the types of risks involved and the adequacy of Canadian
legislative structures to regulate such uses.
GENETICS AND RECOMBINANTDNA TECHNOLOGY
Biotechnology in various forms has been used by humans for
centuries and possibly, as in the fermentation of wine and beer, for
millennia. Also, the genetic alteration of animals, plants and
microorganisms - that is, the deliberate changing of their inherited
characteristics through selective breeding - has been an important part of
agriculture for several hundred years. Over the last 20 years, however,
scientists have developed radical new techniques for manipulating the
inherited characteristics of living organisms. These techniques are so
dramatically different from traditional methods that the significance of
their development has been compared to that associated with nuclear power.
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All living organisms are composed of aggregations of cells.
As the basic unit of organised life, the cell contains, among other things,
the genetic material that determines the characteristics of the organism. A
single hereditary unit is a “gene”; a large number of genes make up a
thread—like component in a cell called a “chromosome”. In higher organisms
such as plants and animals, pairs of chromosomes are located in a specific
part of the cell called the ~nucleus”.
Genes are composed of a chemical called deoxyribonucleic acid
or DNA. Detailed examination of the molecular structure of DNA revealed the
nature of the “genetic code”, the biochemical basis of heredity. Once the
genetic code was understood, it became possible to “read” an entire gene,
almost in the manner of reading a page of typescript.
Applied genetics, the deliberate manipulation of an
organism’s hereditary make-up, consists of two groups of technologies.
“Classical genetics” utilizes natural mating processes to produce superior
types of animals and plants to satisfy man’s needs. “Molecular genetics”
involves the manipulation of the genetic material itself. With recombinant
DNA (rDNA) technology, specific genes can be taken from one species and
recombined with those of another species in a “host organism”. The new life
form thus created owes its existence, not to natural evolution, but to man’s
creative intervention. The most common application of rDNA uses bacteria as
hosts for genes from other organisms.
In 1979, for example, the human gene for insulin was inserted
into a bacterium which then was able to produce insulin in a nutrient broth.
Insulin has traditionally been obtained from the pancreases of slaughtered
cattle and pigs. Now, human insulin is available for those diabetes
patients who have problems tolerating animal insulin.(1) Many other
chemical products are candidates for production by rDNA technology,
including human and animal growth hormones, interferons, vaccines, and
industrial enzymes.
Genetically-engineered microorganisms are also being designed
for use in the open environment. This application of rDNA technology has
(1) Human insulin is marketed under the trade name “Huniilin” by the EliLilly Company.
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this situation: existing legislation can be amended, or new legislation can
be created to deal with the perceived risks associated with the new
technol ogy.
The federal Environmental Contaminants Act(s) is designed
“to protect human health and the environment from substances that
contaminate the environment”. “Substance” in the act is defined as
inanimate matter, thus excluding living organisms. It has been suggested
that the act could be made applicable to genetic engineering by classifying
recombinant DNA molecules as chemical agents. However, there are other
deficiencies in the act which make it unsuitable for the regulation of novel
organisms, including the lack of a requirement for an environmental impact
assessment (EIA) prior to release into the open environment.
The Pest Control Products Act(4), in addition to
regulating traditional pesticides, applies to biological pesticides such as
viruses and bacteria, and to biochemical products used to control the growth
processes of plants and insects. Pesticides undergo an evaluation process,
including assessment of environmental impact, before the products are
registered for sale and use. The legislation is administered by Agriculture
Canada acting upon advice received from the departments of Health and
Welfare, Environment, and Fisheries and Oceans. Thus, the PCP Act does
provide for a review process for those novel organisms that fall under the
act’s definitions of “pest control products”. The “ice-minus” bacterium is
currently going through this review procedure to determine its suitability
for field testing under Canadian conditions.
The Seeds Act(5) regulates the sale of seeds in Canada.
The act designates the Canadian Seed Growers Association as the agency
responsible for prescribing standards for agricultural crops. Presumably, a
genetically-engineered crop would fit into the established regulatory system
since the legislation is indifferent to the method by which new varieties
are produced. The legislation does not, however, include broader
environmental concerns within its regulatory ambit.
(3) S.C. 1974-75, c.72, as amended.
(4) R.S.C. 1970, c.P-10, as amended.
(5) R.S.C. 1970, c.S-7, as amended.
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The CELRF has proposed the development of new federal
legislation to regulate the release of new life forms into the open
environment and the creation of a “National Biotechnology Commission” (NBC)
as the regulatory agency.(6) The foundation envisions a small
administrative “core” of commissioners appointed by the Governor in Council
who would report to a specific cabinet minister. The Commission would also
have a staff of technical experts. Central to the concept of the NBC is
public participation through the use of multi-disciplinary ad hoc technical
panels to evaluate release proposals as well as a period of public comment
prior to any final decision being taken on a release.
An alternative regulatory policy envisions amendments to the
Environmental Contaminants Act “to include biological agents used in
production plant settings and in the environment”.(7) This would give
clear authority to Environment Canada and Health and Welfare Canada to
regulate new life forms. An “interagency review panel” would assess the
release of novel organisms into the open environment and make recommend-
ations to Environment Canada and the appropriate provincial authorities.
Thus, there are several approaches which can be made toward
the effective regulation of genetically-engineered organisms destined for
release into the open environment. Whichever route is chosen, there appear
to be two essential guiding principles. First, it is preferable to develop
comprehensive regulations earlier rather than later, before releases of
novel organisms take place. Second, an environmental impact assessement
with appropriate input from the general public as well as technical experts
should precede any intentional release into the open environment.
(6) Valiante and Muldoon, 1984, p. 32-47.
(7) Sheldon Krimsky, Regulatory Policies on Biotechnology in Canada, AManuscript Report Prepared for the Science Council of Canada, Ottawa,October 1984, p. 38-39.