ICTSD Workshop on Biotechnology, Biosafety and Trade: Issues for Developing Countries

Bellevue, Switzerland 18 - 20 July 2001

Biosafety and Trade Issues for Developing Countries

Joseph M Gopo
Director, Biotechnology Research Institute (BRI)
Harare, Zimbabwe

1 What Is Biosafety?

Biosafety is the safe development of Biotechnology products and their safe application resulting from the
existence of effective mechanisms for the safeguard of human and animal health, safe agricultural
production, safe industrial production, safeguard of the natural plant and animal species, (flora and fauna)
and the environment from negative consequences from the practice and applications of biotechnology and its
products.

In order to understand and appreciate biosafety concepts, it is necessary to have some appreciation of what
biotechnology is. Biotechnology is the integration of the biological, biochemical, biophysical and
bioengineering sciences in order to enable the use of organs, cells, biomoleculars, (nucleic acids, enzymes
and proteins) and other derivatives including molecular analogues for commercial or industrial applications.
Biotechnology products have applications in agriculture, commodity production, human and animal health,
production of bulk chemicals and fuels, production of fibres and industrial polymers and plastics, waste-
water treatment, bioremediation and bioprocessing, mineral extraction, processing and recovery, molecular
farming and drug production as well as in disease diagnostics.

Biosafety concerns are more appropriately related to Modern Biotechnology or more precisely, Recombinant
Biotechnology (r-DNA) Technology. R-DNA Technology is the transfer of Genes from one organism,
across a species boundary, to another organism, which results in the expression of the transferred genes in
the new host to produce a new desired product, making the new host a transgenic organism, called a
Genetically Modified Organism (GMO) or a Living Modified Organism (LMO).

Biosafety then deals with the safe uses and applications of GMO/LMOs and their products for the safeguard
from the negative consequences on human and animal health and on the environment. A number of
Biotechnology products are already on the commodity markets. In medicine, human insulin produced in
Bacteria, growth hormone BST, pharmaceuticals, new generation drugs, active biologicals from transgenic
animals (cows, sheep, goats, rabbits etc).

In agriculture, a number of biotechnology products are already on the commodity markets.

1. Transgenic maize - Bt maize; for insect resistance; herbicide tolerant maize (glufosinate),
2. Transgenic cotton - Bt cotton for insect resistance, transgenic cotton (glufosinate), for herbicide
tolerance
3. Transgenic Tomato for delayed ripening
4. Transgenic Soyabean for Herbicide tolerance (glufosinate)
5. Transgenic Potato for Bt insect resistance and virus resistance
6. Transgenic Tobacco for Herbicide tolerance (bromoxynil) and virus resistance
7. Canola Oil Seed for Herbicide resistance and high lauric acid
8. Transgenic Carnation for increased vase life and modified flower colour.

It must be noted that crops like transgenic corn/maize, whose adoption rate by America farmers was 22% in
1998, with a total planting hectarage of 6,500,000ha (James 1998) is a major staple crop to millions of
people in Africa. Adoption rates for transgenic cotton by American farmers were also 20% with over
1,000,000 ha planted in 1998 (James 1998, 1999). These increased adoption rates by American farmers

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 ICTSD Workshop on Biotechnology, Biosafety and Trade: Issues for Developing Countries
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bring tangible benefits to them and must be consumed at the end of the day by people in the developing
countries where starving millions need food-aid. The American farmers improve the competitiveness of
these crops on the international commodity markets. The question to ask is Are these GM Foods safe for
consumption by the millions in Africa and the rest of the Third World?

The most promising areas of transgenic plants is the area of Molecular Farming, which is used to produce
High Value products using transgene plants such as Tomato, Potato, Tobacco and Banana to produce
recombinant vaccines, special chemicals, pharmaceuticals, enzymes, autoinimune antigens, new generation
antibiotics. These new products are cheap, orally administered, low risk in disease transmission and have
improved patient compliance. The production and assembly of Hepatitis B virus-surface antigen (Hbs Ag) in
tobacco by Palmer in 1988 is a good example. The plant genome initiative has received more than US$40
million to investigate the genomes of economically significant plants for molecular farming (Macliwan, 1997
Erickson 1996, Mason et al 1996, Haq et al 1998, Wayt.Gibbs, 1997). The geopolitical resource distribution
shows that 83% of these economic plants come from the south. When these transgenic plants are exploited,
“Will it be for the Safety and equitable benefit for the South or for profit for the North?”

There is need for the international community to consider biosafety issues in order to put in place biosafety
protocols that govern and regulate the science of biotechnology, the laboratory practice in biotechnology, the
production and marketing of biotechnology products. The GMOs/LMOs and products thereof, which are on
the international commodity markets need to be strictly evaluated for safety before they are consumed or
sued for food aid and pharmaceuticals. It is necessary to have biosafety protocols it national, regional and
international levels.

2 Is Biosafety Necessary?

The need for biosafety was demonstrably shown by the development negotiation and the production of an
international Cartagena Biosafety Protocol. However, the Cartagena Biosafety Protocol is more of a
Biotrade Protocol. The developed countries pushed for the Biotrade Protocol rather than a more effective
Biosafety Protocol because they have already, on the international commodity markets, transgenic crops for
economic benefits, such as; Bt maize, Bt cotton, Bt potato, Herbicide tolerant soyabean, herbicide tolerant
cotton, maize and others. The current Biosafety Protocol is more centred on the issues of facilitated
transboundary movement of GMOs and does not address the more important issues of safety. The Cartagena
Biosafety Protocol does not place enough emphasis on the potential negative consequences on human and
animal health and on the environment.
The necessity for Biosafety is however, supported by the acceptance of the precautionary principle in
adoption and application of the new Biotechnology and its products, by the cartagena biosafety protocol.
Biosafety is very necessary because of the growing public concern over the question of the consumption of
GM-Foods since February 1999. The public rejection of GM-Foods is based on a range of concerns about
the potential adverse impacts of GM-Foods on human health, the environment, biological diversity, ethics
and impacts on indigenous and local communities. As a consequent, in Europe, retailers, supermarkets
suppliers and farmers are now trying to meet consumer demands for organic or non GM-Foods. Consumers
of the world demand safe applications of the products of the new Biotechnology (GMOs/LMOs and products
thereof), which are on the international commodity markets to meet Biosafety conditions at country level and
international level, which involve:

1. Safe transfer of GMO/LMO and their products, from the country of origin to the recipient country;
2. Safe handling of the GMO/LMO and their products in the country of origin and also in the transit
countries;
3. Safe handling and use of the GMO/LMO and their products in the recipient country;
4. Recipient countries must reserve the right under the Biosafety Protocol to require labelling,
traceability of GMO/LMO and their products to ensure safety. They must also require liability and
redress in the event of adverse effects;

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 ICTSD Workshop on Biotechnology, Biosafety and Trade: Issues for Developing Countries
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5. The Biosafety Protocol, as an international instrument, must not be subordinate to other international
instruments such as WTO/TRIPS;
6. The Biosafety Protocol must provide measures to ban and/or phase out at the global level, any
GMO/LMO and products thereof, that may have adverse impacts on the conservation and sustainable
use of biodiversity, taking into account risks to human animal health and the environment;
7. The Biosafety Protocol must prevent all releases of LMO/GMOs or products thereof into centres of
genetic diversity and centres of genetic origins;
8. The Biosafety Protocol must apply to products derived from GMO/LMO;
9. Biosafety Protocol must apply to GMO/LMO and products thereof destined for contained use and for
commodity and pharmaceutical use;
10. Trade with non-partners to the Biosafety Protocol can only be permitted if it is on more
environmentally stringent terms than those set out in the protocol.

All the above ten (10) principles require the existence of an international enforceable Biosafety Protocol.

3 Dangers And Risks

3.1 Scientific Uncertainties as a Potential Danger

Technology Sophistication

Modern biotechnology is comparatively a very new science and is still full of many, scientific uncertainties.
There are many areas of potential dangers and risks. Recombinant DNA Technologies, as a modern science
has produced sophisticated technologies that require analysis and action in terms of assessing the scientific
uncertainties. There is need to assess the current state of the scientific understanding of the science of
genetic modification and evaluate current trends in scientific research. As a result, the international biosafety
protocol recognizes this danger and calls for a precautionary principle in the harnessing of the r-DNA
technology. The sophisticated technology is not accessible to developing countries due to lack of indigenous
industrial support base, lack of venture capital investment, lack of capital for investment in human resources
and infrastructured. The technology faces the danger of being a Western Technology for monopolistic use
by the multinationals for profit centred motives.

Horizontal Transfer of Transgenes

Scientific research has not clearly demonstrated and provided good scientific data to show that the potential
of horizontal transfers of transgenes from GMO/LMO and their products such as GM-Foods, is not possible.
The potential cumulative effects of such transgenes pause a real danger in future when human and animal
health are threatened with high concentrations of foreign genes through genetic transposition.

Antibiotic Resistance Genes

The use of antibiotic marker genes in gene cloning pauses a great potential in the spread of high levels of
resistance to multiple antibiotics in human and animal health. Most vector (plasmid, cosmid), mediated
transformations uses constracts that contain antibiotic genes as marker genes. If these constracts are used to
develop GMO/LMO whose products are GM-Foods, this pauses a danger of increased resistance to multiple
antibiotics. Recombinant DNA technology must develop new cloning methods, which do not use marker
genes. Use of biolistics, shooting clean genes is one new methods that will lessen these dangers.

Herbicide Resistance

The increase in agricultural surface treated with herbicides has been dramatic. In 1956, only 11% of acreage
planted to maize were treated with herbicides. In 1988, herbicides on three major crops, maize, soyabeans,

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and cotton had increased to 95%. It has been estimated that only 1% of the herbicide applied, reaches the
target pest. This means that more than 99% of herbicides applied contaminates the land, air, water, humans,
animals and other wildlife habitat. It has also been estimated that about 31% of the herbicides course
oncognic risks, in fresh foods and that 12% of pesticides residues are found even in processed foods
(Golburg et al, 1990).

Genetically Modified (GM) Foods – Are They Safe?

In the year 2000, February 28th to 1st March, 400 scientists met at the Edinburg International Conference
Centre for a constructive dialogue on the Safety of GM-Foods, with the emphasis on The Underlying Science
and the Impact of GM-Foods on Human Health. The main conclusion of the conference was:

(i) Many consumers already eat GM-Foods without knowing they do so,
(ii) No-peer-reviewed scientific article has yet appeared which reports any adverse effects on
Human and Animal Health as a consequence of eating GM-Foods,
(iii) The concept and practice of assessment of risk, including a consistent international approach
to the use of the concept of Substantial Equivalence and to a form of the Precautionary
Approach should be used. These conclusions do not answer the main question whether or
not the consumption of GM-Foods is safe for human and animal health.

The question must still be asked: “Are GM-Foods safe for human and animal consumption?” Consider the
case of Kundai my little 6 year old-granddaughter, in Harare, Zimbabwe. Maize is a staple food; we eat
maize-meal three times per day. If she ate Bt-maize meal until she is 60 years old, this would mean
60x365x3 = 65 7000 intakes of Bt-products . Can we today say with some degree of certainty that 60 years
later, Bt maize meal will be safe for her Kundai? It must be accepted that no scientific answer can be
provided with any degree of certainty. Consumer scare is used in such cases. Scientists must work hard to
provide the answers.

4 The Biotrade Danger

4.1 Human Tissue Trade

Developed countries are practicing human tissue trade, exemplified by the US American Type Culture
Collector (ATCC), and the European Collection of Animal Cell Culture (ECACC). They has developed the
International Tissue-Culture Industry. Human tissue, cells, genes and their components are critical for
investigations in search for treatments of genetic disease disorders. Also current studies in cases of genetic
diversity between individuals and among human populations are required to solve future disease problems.
There is danger in the trade in human tissue genes and for the developing countries of Africa, Asia and Latin
America. The human tissue trade industry has developed international human tissue exchange routes from
centres of origins in developing countries to process centres in the Developed Country Laboratories (Rafi,
1997). The market for human tissues and their products is enormous. It is estimated that the worldwide
market for cell-lines, and tissue culture in 1996 was US$427.6 billion and is further expected to be US$914.1
billion by the year 2002 (Rafi 1997, Frost and Sallivan 1996). The countries of origin where these tissues are
sourced, do not benefit without proper biosafety protocols that are internationally enforceable. Are these
tissues used for the safety and benefit of the people from developing countries or are they used for the sale
profit motives by the multinationals in the First-World? Practice safe, biotechnology research to enable them
to produce value added products for the competitive international commodity markets they also need to
adopt and understand the technology to enable them to use the technology safety.

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4.2 Danger to the Environment

A number of studies on the impact of the products of r-NA technology (GMO/LMOs and products thereof),
have been conducted. In agricultural biotechnology, further studies need to be carried out to assess the
following:

(i) Longevity of pollen from GMO-crops and pollen dispersal mechanisms (wind, soil
microorganisms and insects),
(ii) Harmful impacts on non-target species. The Monarch Butterfly in North America was shown
to be at risk of increased mortality from feeding off the pollen from Genetically Modified
Maize (Bt maize) dispersed by wind or insects. (Nature 399-214, 20 May 1999). Other
examples may be cited.

5 How To Ensure Safe Use Of Biotechnology

The safe use of Biotechnology must be ensured, especially in developing countries where the GMO/LMOs
and their products are used sometimes without choice. One of the sure ways to ensure the safe use of
biotechnology is make certain that the international community must have an international enforceable
biosafety protocol which addresses all the important issues pertaining to the safe practice of biotechnology
and the safe use of the products of biotechnology. The current cartagena biosafety protocol does not cover
comprehensively all he necessary concerns of the developing countries. The protocol dwells on the question
of Transboundary Movement of GMOs/LMOs. It does not place enough emphasis on the Use of
Biotechnology products (GMOs/LMOs and products thereof). The scope of the protocol must not only
emphasise safe transboundary movement from export to recipient countries but must also emphasis safe
movement through transit countries, safe handling and use of GMOs/LMOs and products thereof by the
export, and import countries. The protocol must also address the issue of labelling of GMOs/LMOs and
products thereof to give the consumer the right to choice. The consumer has the right to informed choice to
the consumption of any product. The importer must have the right to prior informed consent to enable them
to make the decision to import or not to import all products. The right to prior informed consent must
include all GMOs/LMOs and the products thereof whether they are commodities; pharmaceuticals or
whether they are intended for contained use or not. It is expected that the bulk of commodities, which shall
be donated for food aid such as maize for drought relief, shall be GM-Maize. The starving millions from
developing countries who must get food aid still deserve the right to chose; to eat Bt maize or not. The
internationally enforceable biosafety protocol must allow for liability and redress in the event of the imported
GMOs/LMOs and products thereof causing unintended harm to human/animal health and to the
environment. The existence of such a biosafety protocol will promote the safe use of biotechnology. In
addition to the existence of the Cartagena international biosafety protocol, there should be national biosafety
regulations, which take into account national specific needs on biosafety.

6 Biosafety Regulations/Guidelines

Developing countries need to put in place National Biosafety Boards, National Biosafety Focal Points,
National Biosafety Regulations and Guidelines to ensure the safe application of Biotechnology. They must
also have institutional Biosafety Committees.

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The areas where biosafety regulations are required are in:

6.1 Safe Biotechnology Research

Safe research which leads to the production of GMOs/LMOs needs to be regulated at institutional levels.
Biosafety regulations are needed at National level to ensure that Safe Biotechnology research is conducted at
all research institutions. Biotechnology research must be conducted at national levels in safe laboratory
environments. The research laboratories must be registered as levels 1,2,3 and above to ensure that safe
research at national level, for the production of biotechnology products (GMOs/LMOs and products thereof),
is conducted.

6.2 Safe Handling of GMOs/LMOs and Products

Biosafety regulations at national level must ensure that all GMOs/LMOs and products thereof must be
handled safely. There must be regulations and guidelines for the safe handling of he products of
biotechnology. Safe handling must be ensured during Transboundary Movement of GMOs/LMOs and their
products from export, through transit to importing countries.

6.3 Use of GMOs/LMOs and Products

Biotechnology products must be used safely by the producer, the country of origin and the importer.
Enforceable biosafety regulations must be put in place by National Biosafety Boards, which are based and
supported and are in line with the international biosafety protocol. Care must be taken to ensure that there is
safe transboundary movement on the GMOs/LMOs and products thereof. The safety in transboundary
movement must also include transit countries. All the above safety regulations must be at international
levels and at national levels. There must be National Biosafety Boards, Institutional Biosafety Committees
and also some regional as well as international biosafety networks to assist developing countries in capacity
building for both human resource capacity and infrastructural capacity.

7 Conclusions

There is a strong need for developing countries of Africa, Asia and Latin America to have a clear
understanding and practice of the science of Biotechnology. Developed countries should assist developing
countries to deal with scientific uncertainties and build capacity where it is needed most, such as human
resource development infrastructural development, industrial development and investment in venture capital.

The cartagena biosafety protocol which is internationally enforceable, should address issues of labelling, the
enlarged scope of the protocol to include safe transboundary movement, safe handling in transit countries,
safe use and safe applications of biotechnology products. Enforceable international biosafety protocol is
necessary. There is also need for national biosafety regulations and guidelines, National Biosafety Focal
Points, National Biosafety Boards and Institutional Biosafety Protocol Commitment. Biotechnology holds
the potential promise for industrial development but also potential harm. The technology must be adopted by
developing countries and be funded to a level of at least 1% NGDP.

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8 References

1. Erickson L. 1996, Edible Vaccines Agrifoods Research (Agricultural Research Institute of Ontaric,
Guelph) Vol. 19, No. 2 page 47.
2. Frost and Sullivan, 1996, Businesswire 28, May 1996.]
3. Golburg R., Rissler J., Shand, H., Hassebrook, C., 1990, Biotechnology’s Bitten Harvest: Herbicide
– Tolerant Crops and the Threat to Sustainable Agriculture. A Report of the Biotechnology Working
Group (USA).
4. Haq T A., Mason H S., Clements J D., and Aintzen C J, 1998, Oral Immunization with a
Recombinant Bacterial Antigen Produced in Transgenic Plants. Science (Washington, DC), 268-
714-716.
5. James C, 1998 – Benefits of Bt-cotton in USA: 1996-1998 in ISAAA Brief-Global Review of
Commercialised Transgenic Crops, ISAAA brief No. 8, Ithaca N.Y.
6. James C., 1999 – Adoption Rates for Transgenic Crops Global Review of Commercialized
Transgenic Crops ISAAA brief No 12. 1999.
7. Mason H. S., Ball J. M., Shi. J.J., Jiang X., Estes, M.K. and Arntzen, C.J. 1996, Expression of
Norwark Virus Capsid Protein in Transgenic Tobacco and Potato and its Oral Immunogenicity in
Mice-PNAS-USA, 93:5335-5340.
8. Mascliwane C. 1997, 40 Million Plant Genome Sequencing Targets the Best Science Nature
(London) 390 (6660) 539-540.
9. Nature, 399-214, May 1999.
10. Rafi, Communique Feb. 1997. Human Tissue Trade.
11. Wayt, Gibbs, W 1997, Plantbodies: Human Antibodies Produced by Field Crops entre Clinical
Trials Scientific American (N.Y). Vol. 277. No5 pg 23.

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