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.