ICTSD Workshop on Biotechnology, Biosafety and Trade: Issues for ...


Dec 3, 2012 (6 years and 1 month ago)











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)


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 indu
strial 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


In order to understand and appreciate biosafety co
ncepts, 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,


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 f
uels, 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 conc
erns are more appropriately related to Modern Biotechnology or more precisely, Recombinant

Biotechnology (r
DNA) Technology. R
DNA Technology is the transfer of


from one organism,

across a species boundary, to another organism, which results in the e
xpression 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 a
pplications 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

acteria, 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.

Transgenic maize

Bt maize; for insect resistance; herbicide tolerant maize (glufosinate),

Transgenic cotton

Bt cotton for insect resistance, transgenic cotton (glufosinate), for herbicide


Transgenic Tomato for delayed ripening

Transgenic Soyabean for Herbicide
tolerance (glufosinate)

Transgenic Potato for Bt insect resistance and virus resistance

Transgenic Tobacco for Herbicide tolerance (bromoxynil) and virus resistance

Canola Oil Seed for Herbicide resistance and high lauric acid

Transgenic Carnation for incr
eased 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

eople 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

Bellevue, Switzerland 18

20 July 2001

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 produ

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.

Is Biosafety Necessary?

The need for biosafety was demonstrably shown by the development negotiation and the production of an

Cartagena Biosafety Protocol. However, the Cartagena Biosafety Protocol is more of a


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

boundary 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 o
ver the question of the consumption of

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:

Safe transfer of GMO/LMO and their products, from the country of origin
to the recipient country;

Safe handling of the GMO/LMO and their products in the country of origin and also in the transit


Safe handling and use of the GMO/LMO and their products in the recipient country;

Recipient countries must reserve the rig
ht 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

Bellevue, Switzerland 18

20 July 2001

The Biosafety Protocol, as an international instrument, must not be subordinate to oth
er international

instruments such as WTO/TRIPS;

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 biodiversit
y, taking into account risks to human animal health and the environment;

The Biosafety Protocol must prevent all releases of LMO/GMOs or products thereof into centres of

genetic diversity and centres of genetic origins;

The Biosafety Protocol must apply to

products derived from GMO/LMO;

Biosafety Protocol must apply to GMO/LMO and products thereof destined for contained use and for

commodity and pharmaceutical use;

Trade with non
partners to the Biosafety Protocol can only be permitted if it is on more

ronmentally stringent terms than those set out in the protocol.

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

Dangers And Risks

Scientific Uncertainties as a Potential Danger

Technology Sop

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 tec
hnologies 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 resear
ch. As a result, the international biosafety

protocol recognizes this danger and calls for a precautionary principle in the harnessing of the r

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


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 possi

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 ma
rker 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 o
f 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 her
bicides. In 1988, herbicides on three major crops, maize, soyabeans,


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

Bellevue, Switzerland 18

20 July 2001

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) F

Are They Safe?

In the year 2000, February 28

to 1

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:

Many consumers already eat GM
Foods without knowing they do so,

reviewed scientific article has yet appeared which reports any adverse effects on

Human and Animal Health as a conseq
uence of eating GM

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 no
t 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
er, in Harare, Zimbabwe. Maize is a staple food; we eat

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 y

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.

The Biotrade Danger


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
re 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 requi
red 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

es 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 w
as 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 en
forceable. 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 valu
e 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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ICTSD Workshop on Biotechnology, Biosafety and Trade: Issues for Developing Countries

Bellevue, Switzerland 18

20 July 2001


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


(i) Longevity of pollen from GMO
crops and pollen dispersal mechanisms



microorganisms a
nd 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.

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 no
t 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 tra
nsit 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 GMO
s/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

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 biosafe
ty protocol, there should be national biosafety

regulations, which take into account national specific needs on biosafety.

Biosafety Regulations/Guidelines

Developing countries need to put in place National Biosafety Boards, National Biosafety Focal Poi

National Biosafety Regulations and Guidelines to ensure the safe application of Biotechnology. They must

also have institutional Biosafety Committees.


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

Bellevue, Switzerland 18

20 July 2001

The areas where biosafety regulations are required are in:

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 nati
onal 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.

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. S
afe handling must be ensured during Transboundary Movement of GMOs/LMOs and their

products from export, through transit to importing countries.

Use of GMOs/LMOs and Products

Biotechnology products must be used safely by the producer, the country of origi
n 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, Inst
itutional 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.


There is a strong need for d
eveloping 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 ne
eded 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 sc
ope 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 r
egulations 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 adop
ted by

developing countries and be funded to a level of at least 1% NGDP.


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

Bellevue, Switzerland 18

20 July 2001


Erickson L. 1996, Edible Vaccines Agrifoods Research (Agricultural Research Institute of Ontaric,

Guelph) Vol. 19, No. 2 page 47.

Frost and Sullivan, 1996, Businesswire 28, May 1996.]

rg 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).

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


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.

James C., 1999

Adoption Rates for Transgenic Crops Global Review of Commercialized

Transgenic Crops ISAAA brief No 12. 1999.

Mason H. S., Ball J. M., Shi. J.J., Jiang X., Estes, M.K. and Arntzen, C.J. 1996, Expression of

rwark Virus Capsid Protein in Transgenic Tobacco and Potato and its Oral Immunogenicity in

USA, 93:5335

Mascliwane C. 1997, 40 Million Plant Genome Sequencing Targets the Best Science Nature

(London) 390 (6660) 539

Nature, 399
214, May


Rafi, Communique Feb. 1997. Human Tissue Trade.

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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