Regulation of Biotechnology: needs and burdens for developing

Countries

Julian Kinderlerer
Sheffield Institute of Biotechnological Law & Ethics,
The University of Sheffield,
Sheffield S10 2TN, United Kingdom

This paper addresses many of the issues that arise from the use of Genetic modification
techniques that allow new living modified organisms to be produced which have
characteristics that have not necessarily been found before. Genes are copied from organisms
that are unrelated to those into which they are inserted. This technology has provided a
concern from the very outset of its use, and most countries recognise that it needs some form
of regulation to ensure safety both to human health and the environment. In many cases no
need has been seen for changes to law, in others new laws have been implemented.
Introduction
The potential uses of genetic modification1 were obvious from the moment that the
techniques that enabled the transfer of genes from one organism to another unrelated
organism were first identified.
Agenda 21 was agreed in Rio de Janeiro in 1992. Countries identified modern biotechnology
as ‘an emerging knowledge intensive field’ which ‘is a set of enabling techniques for
bringing about specific man-made changes in deoxyribonucleic acid (DNA) or genetic
material in plants, animals and microbial systems leading to useful products and
technologies’2 There was a recognition that the technology has many advantages and it was
necessary to foster internationally agreed principles to be applied so as to ensure the
“environmentally sound management of biotechnology, to engender public trust and
confidence, to promote the development of sustainable applications of biotechnology and to
establish appropriate enabling mechanisms, especially within developing countries through…
a. Increasing the availability of food, feed and renewable raw materials;
b. Improving human health;
c. Enhancing protection of the environment;
d. Enhancing safety and developing international mechanisms for cooperation;
e. Establishing enabling mechanisms for the development and the environmentally
sound application of biotechnology.”3
The Convention on Biological Diversity, agreed in 19924, required parties to establish
national frameworks for ensuring that biotechnology is used safely. Article 8(g) states that
Parties shall as far as possible and as appropriate “Establish or maintain means to regulate,

1
Variously and at various times called genetic modification, genetic manipulation or genetic engineering
2
Agenda 21 (1992), preamble to Chapter 16: see http:// www.igc.org/habitat/agenda21
3
ibid
4
http://www.biodiv.org/convention/articles.asp
manage or control the risks associated with the use and release of living modified organisms5
resulting from biotechnology which are likely to have adverse environmental impacts that
could affect the conservation and sustainable use of biological diversity, taking also into
account the risks to human health”6. The wording implies that there are both environmental
and possible risks to human health involved in the use of modern biotechnology, while not
explicitly identifying the benefits that may accrue from the use of modern biotechnology.
Article 197 identifies that there are great benefits that might arise and attempts to provide the
mechanisms to allow developing countries to benefit. Article 19(3) calls on the parties to the
Convention to consider whether there is a need for a Protocol to the treaty which would inter
alia provide procedures between parties for the safe transfer, handling and use of living
modified organisms ‘that may have adverse effects on the conservation and sustainable use of
biological diversity”.
After many years of meetings and discussion in an ad-hoc open-ended Working Group set up
to consider the need for the Protocol, the Parties to the Convention adopted a text in January
2000. This “Cartagena Protocol on Biosafety”8 establishes mechanisms for Parties to the
Protocol to inform each other about what they are doing in relation to modern biotechnology,
and provides the systems needed to ensure acceptability of the products of the technology
when living modified organisms that meet the definition in the Protocol are transferred
between member states. The objective is much broader, but most of the Articles focus on
transfer between countries of living modified organisms that might have adverse effects on
the conservation and sustainable use biological diversity. Article 1 “The Objective” states:-
“In accordance with the precautionary approach contained in Principle 15 of the Rio
Declaration on Environment and Development, the objective of this Protocol is to contribute
to ensuring an adequate level of protection in the field of the safe transfer, handling and use
of living modified organisms resulting from modern biotechnology that may have adverse
effects on the conservation and sustainable use of biological diversity, taking also into
account risks to human health, and specifically focusing on transboundary movements.”
The Protocol was agreed, with many misgivings, but in an atmosphere which had changed
from that which pertained at the time the negotiations started. Europeans were no longer
accepting modern biotechnology; products had disappeared from the shops, and there was a
gloom and distrust in many countries not observed elsewhere. Few if any products derived
using modern biotechnology are available in Europe9. In North America, farmers adopted
transgenic organisms with little opposition, and products derived from them have been in the
shops for over 5 years.
There have been many arguments that decisions on the use of these living modified
organisms must be based on science; this is made very clear in the Cartagena Protocol.
Article 15 states that “Risk assessments undertaken pursuant to this Protocol shall be carried

5
"Living modified organism" (as defined in the Cartagena Protocol) means any living organism that possesses a
novel combination of genetic material obtained through the use of modern biotechnology; The Protocol
applies to living modified organisms resulting from modern biotechnology that may have adverse effects on
the conservation and sustainable use of biological diversity, taking also into account risks to human health,
and specifically focusing on transboundary movements.
6
http://www.biodiv.org/convention/articles.asp?lg=0&a=cbd-08
7
Article 19. Handling of Biotechnology and Distribution of its Benefits,
http://www.biodiv.org/convention/articles.asp?lg=0&a=cbd-19
8
http://www.biodiv.org/biosafety/default.asp
9
The Royal Society (February 2002) Genetically Modified Plants for Food Use and human helath – an update,
Policy Document 4/02 ISBN 0 85403 576 1 paragraph 2.
out in a scientifically sound manner Article 23 of the Cartagena Protocol requires public
involvement in the decision making process and article 26 allows for specific socio-economic
issues to be taken into account in the process:
“The Parties, in reaching a decision on import under this Protocol or under its domestic
measures implementing the Protocol, may take into account, consistent with their
international obligations, socio-economic considerations arising from the impact of living
modified organisms on the conservation and sustainable use of biological diversity, especially
with regard to the value of biological diversity to indigenous and local communities.”
Responses to modern biotechnology
The European public debate resulted in rejection of modern biotechnology which in 1998 had
the effect of influencing the main distribution companies to remove these products from
European shelves. In the United States, there appeared to be little rejection, attributed by the
US government to the openness of the American system. “In 1994 approximately 7,000 acres
were planted under 593 USDA field-test authorizations, compared to 57,000 acres under
1,117 authorizations in 2001. The first biotechnology-derived crops were commercialized in
1996 and, in 2001, approximately 88 million acres were planted in the United States and 130
million acres were planted world-wide”10. Canada, Argentina and Mexico are the only other
countries in which there has been significant use of modern agricultural biotechnology,
although many other countries are starting to increase their use of living modified organisms
in agriculture. China has approved a small number of transgenic varieties of cotton and
expects to proceed to the commercial production of modified rice in the next two years.
Many developing countries are fearful of the impact of agricultural biotechnology. Zimbabwe
and Zambia, for example, have been wary of permitting food-aid which contains transgenic
maize into the country, even though many of its people are starving. This reluctance relates to
the possible disappearance of major markets if crops are ‘contaminated’ with transgenic
material.
In most circumstances the introduction of safety legislation within a country has followed a
major accident or incident. Regulation has been reactive whereas for modern biotechnology
the system of regulation has been proactive. There are no documented cases of harm resulting
directly from the use of recombinant techniques, whether in the research environment or for
commercial applications. There are many who ask whether a proactive approach to
biotechnology regulation is sensible, for it places in the public domain a concern that has
been translated into a fear of the new technology, particularly in Europe. Would most of the
innovations that have so fundamentally modified our way of life during the twentieth century
have happened had a full risk evaluation been required?
Although this paper has to consider the importance of ensuring the safe use of modified
organisms in developing countries that which is happening in Europe is significant as it has a
direct bearing on that which can be done in developing countries. In the first instance the
concerns being expressed by Greenpeace, Friends of the Earth, Christian Aid or even the
British Medical Association create a groundswell against the use of this new technology. Can
it be right to introduce these ‘untested’ technologies in developing countries when public
‘informed’ opinion is so virulently opposed to their use in Europe? When even statutory

10
Office of Science and Technology Policy (2002) - Proposed Federal Actions To Update Field Test
Requirements for Biotechnology Derived Plants and To Establish Early Food Safety Assessments for New
Proteins Produced by Such Plants; Notice, Federal Register / Vol. 67, No. 149 / Friday, August 2, 2002, p
50578 – 50580.
bodies like the Nature Conservation Organisations in Britain and France reject modern
biotechnology because of a predicted negative effect on the environment, are developing
countries to embrace them? The UNEP International Guidelines and the Cartagena Protocol
require the public to be informed and educated about biosafety, but the virulent reaction
against the technology in Europe impacts directly on any public image more easily than a
reasoned argument for the safe use of the technology. The rejection of genetically modified
foods by many European Supermarkets and food producers has impacted on production and
growing of genetically modified crops that have to be exported to one of the largest food
markets in the world. To grow rice modified so that it produces vitamin A is a wonderful
prospect for nutrition in the many countries that depend on rice as a primary food. If,
however, the produce cannot be exported as well, producers will be reluctant to grow it!
Such problems call into question the sustainability of the key technological paradigms on
which much of the expansion of food production since 1960 has depended”11 “It is probably
fair to say that the most significant breakthroughs in recent years in the area of crop
biotechnologies have stemmed from research into the genetic mechanisms behind
economically important traits”12 The FAO estimate that in South Asia 191 of the potential
228 million hectares (84%) were under cultivation in 1988-89, and there is little scope for an
increase in land usage for agricultural purposes.
This response in Western Europe to the new technology cannot easily be dismissed through
assertions by scientists that there is negligible risk, or that permits to market transgenic foods
and crops (in particular) should be based solely on risk assessments that are science based. If
all the scientific information had been available and a consensus amongst scientists could be
achieved that the impact on the environment is minimal, it would be possible to argue for a
totally science based risk assessment process.
In December 1996 FAO and WHO convened a consultation on Biotechnology and Food
Safety. This consultation concluded that the food safety issues raised by modern
biotechnology are basically of the same nature as that that might arise when other methods of
modifying new plant varieties are used, including traditional methods of plant breeding. They
also concluded that the comparative method used in the OECD concept of ‘substantial
equivalence’ could be the basis for an evaluation of foods consisting of, or derived from,
genetically modified plants13 However, the same consultation meeting concluded that proper
safety assessments are needed for food produced by recombinant DNA technology. The
report of an OECD Workshop on the toxicological and nutritional testing of novel foods in
1998 suggests “Demonstration of equivalence of a new food to an existing food product with
an established history of safe use provides assurance that the new food is as safe as the
established food”14. “The workshop concluded that the demonstration of substantial
equivalence concept provides equal or increased assurance of the safety of foods derived
from genetically modified plants as compared to foods derived by conventional methods.” A
subsequent safety evaluation is then focussed on the identified differences due to the
introduction of new characteristics. This process is not, however, sufficient to evaluate the

11
P.A. Oram and Behjat Hojjatti (1995) in “Population and Food in the Early 21st century: Meeting Future
Food Demand of an Increasing Population” ed. Nurul Islam. International Food Policy Research Institute,
Washington DC p 167.
12
FAO (2000) Electronic Forum on Biotechnology in Food and Agriculture” Introduction to an online
conference running between March 20 – May 19, 2000 on http://www.fao.org/biotech/Cidoc.htm.
13
FAO (1997) Biotechnology and Food Safety, Food and Nutrition Paper 61, FAO, Rome.
14
Organisation for Economic Cooperation and Development (1998) Report of the OECD Workshop on the
toxicological and nutritional testing of novel foods, OECD, Paris.
behaviour of a new food plant in the environment, especially where the modification may
change the interaction of that plant with other organisms within the environment in
unpredictable ways. The OECD workshop (reference 22, section 5.ii) noted that the
traditional assessments of plant breeders in evaluating new varieties rarely address issues
related to the safety of crop plants and “cannot therefore be considered sufficient to establish
substantial equivalence or to ensure the safety of a new crop variety”. The assessment of
environmental risk due to a new plant variety almost always is performed on a case-by-case
assessment and based on scientific intuition supplementing the wealth of data about the
organism and the environment into which it is placed. In 2002 The European Union is
considering no further use for the ‘substantial equivalence’ concept. In February the Royal
Society15 commented on its use. They state that the amount of information needed to
establish ‘substantial equivalence’ is subjective, and the technique has therefore attracted
considerable criticism16,17. Much needs to be done to ensure that there is an agreement on
what constitutes acceptable data amongst the protagonists for and against modern
biotechnology.
UNEP introduced a set of guidelines in 1995 that aimed to provide a baseline for the
introduction of regulation or guidelines for countries to ensure the safe use of products
resulting from biotechnology. The guidelines called for national biosafety frameworks to be
introduced that would allow for governments to establish processes for identifying the uses to
which biotechnology was being put within their borders and to develop the appropriate
national mechanisms for dealing with any use to which the technology could be put. The
guidelines provided protocols for identifying hazards and minimising harm to both human
health and the environment due to the use of modern biotechnology. The guidelines provided
that “Risk assessment and risk management can be based in part on knowledge of and
experience (i.e. familiarity) with an organism, the intended application and the potential
receiving environment.” The process of risk assessment was recognised as varying from a
short process of assurance of safety to an extensive review, depending on the extent of
familiarity.
The requirement to provide capacity building for developing countries in both biotechnology
and in biosafety has been echoed in the Cartagena Protocol to the Convention on Biological
Diversity. Article 11, which primarily deals with the procedures in relation to the movement
of living modified organisms intended for direct use as food or feed, identifies a need for
financial and technical assistance and capacity building. The procedures identify a need for a
risk assessment, for which capacity building will be extremely important. Article 22 deals
directly with capacity building, and expects the parties to the protocol “to cooperate in the
development and or strengthening of human resources and institutional capacities in
biosafety, including biotechnology to the extent that it is required for biosafety”. The training
that is envisaged in the Protocol includes scientific and technical capacity and the use of risk
assessment and risk management in order to ensure the safe use of living modified organisms.
Article 23 identifies the need to promote and facilitate public awareness, education and
participation in relation to all uses of living modified organisms and requires that the public
be consulted in the decision making process regarding LMOs.

15
The Royal Society (February 2002) Genetically Modified Plants for Food Use and human health – an update,
Policy Document 4/02 ISBN 0 85403 576 1
16
Royal Society of Canada (2001). Elements of Precaution: Recommendations of the regulation of food
biotechnology in Canada. Royal Society of Canada: Ottawa
17
Millstone E P, Brunner E J & Mayer S (1999). Beyond ‘substantial equivalence’. Nature 401, 525–26
Developing countries look at that which is happening elsewhere with bewilderment and
concern. It is clear that Europe does not want the technology, and that North America does.
Leaving aside the need to sell products in Europe – which is a major purchaser of agricultural
produce, the rejection raises the problem of dumping in these countries and governments are
concerned at a possible backlash if the products are to be sold within their borders. Most
countries have no legal framework to handle modern biotechnology as required by the
Protocol.
Legal frameworks do not necessarily need new laws; there may well be legal systems in place
that address the many issues that these countries will have to attempt to consider.
The technology appears to be designed for developed countries for it could be used to solve
many of their problems. However, it is expensive to do, and the companies involved in the
production of new crops using modern biotechnology have (obviously) aimed them at those
who can pay for them. Most agriculture in developed countries is commercial, where farmers
grow those crops, which sell well. In developing countries there are (essentially) two forms of
agriculture. Firstly, commercial or industrial farms where crops are grown as in developed
countries, often for export and the same needs and wants are there. The crop and the varieties
designed by the biotechnology companies may solve their problems as well. There is a
second form of agriculture, where crops are grown in traditional ways and often the crops
(and varieties) are different from those grown commercially. These crops could benefit
enormously from modern technology, whether modern biotechnology or not. Reduction in
virus infection and in pests could dramatically increase their yields, but the large seed
organisations may be uninterested as the profits are elsewhere.
Countries want to increase the efficiency of both of these forms of agriculture of these forms
of agriculture. In theory, the first is easy if the money is there or if foreign companies can be
induced to invest in farms in these countries. There remain problems if seed variety listing
and biosafety legislation require that new varieties are tested for fitness and safety before
introduction. The second is more difficult to solve, as it requires a technology infrastructure
to design and insert new genes conferring desired characteristics into local crops or varieties
and then to perform the rigorous testing necessary to ensure safety in the environment and as
a food. Companies are often willing to provide ‘gene cassettes’ – set of genes and signal
sequences that confer desired characteristics – but the science and legal structures necessary
to use these are needed.
It is relatively simple for countries to set up a legal framework; it is a much longer process to
provide the scientific infrastructure to produce new and effective food varieties.
The challenge to developing countries is not clear. Their needs are to produce a greater
quantity and higher quality of food for their populace and to increase production from
agriculture to provide for export markets. They also have to protect the health of their people
from imports of inappropriate food and feed and to attempt to protect their environment from
the introduction of alien species or new varieties of organisms that could have adverse effects
on the environment. It seems that living modified organisms are subject to far stronger
regulation than other ‘alien’ organisms. The use of these new varieties may increase food
availability if they are the right varieties for the conditions in the countries and they may
increase exports and therefore foreign earnings if countries are willing to accept exports of
these varieties.
When the Cartagena Protocol comes into force, countries will, in general, have to have in
place legal and administrative systems to ensure that they are able to deal with both exports
and imports of living modified organisms. If a scientific infrastructure to produce new
varieties adapted for their environment is not in place, the development of the capacity will
take much longer.
Adverse Effects on the Environment and on Human Health
There are a number of steps that need to be taken to ensure that any adverse impacts on the
environment or on human health are minimised. The trigger for beginning the process is
usually but not exclusively the technique by which the organism has been made. If an
organism is novel, but not made through the use of ‘modern biotechnology’ it may not trigger
the whole risk process.
Once the process has been triggered, a risk assessment needs to be implemented. Risk
assessment and risk management are addressed in the Protocol in Articles 15 and 16 and the
Annexes. Article 15 explains that where risk assessment is required it should be carried out in
a scientifically sound manner. Information identified in the Annexes to the protocol
(particularly Annex III) is used to identify and evaluate the possible adverse effects of LMOs
on the conservation and sustainable use of biological diversity (and any risk to human
health). The Protocol is clear that risk assessment should be based on recognised techniques.
What is most important is that the risk assessment process is based on science.
Science does not have all the answers, and the Protocol requires that a ‘precautionary
approach’ be taken where complete information is not available. There is disagreement at a
scientific level about the manner in which an inserted gene is likely to modify characteristics
of the organism or its impact on the environment. This results in an incomplete scientific
evaluation of the risks because there is an insufficiency of data, or they are incomplete,
inconclusive or imprecise, and it may be that it is not possible to determine with sufficient
certainty what the risks actually are18. The risk assessment will be incomplete, and the risk
management that follows must allow decisions as to mechanisms for minimisation of risks.
This is usually interpreted as requiring that each new living modified organism is considered
case-by-case; that a stepwise approach be taken to allow impacts on the environment to be
assessed – first in a greenhouse or equivalent, then a limited release, possibly a further
limited semi-contained release and finally approval may be given for commercial release.
Monitoring to ensure that assumptions made during the risk assessment are borne out in the
environment is also part of the precautionary approach.
The risk assessment may indicate changes that need to be made to the organism or to the
manner in which it is handled in the environment. If these changes are implemented, the
assessed risk will change; hence the approach to risk assessment is iterative.
Assessment of risk is an important first step in any attempt to minimise harm to the
environment, and risk management provides the tools to ensure that any risk identified during
the assessment process is minimised. The two are not completely separate processes, and it is
necessary to iterate between risk assessment and management to achieve the desired goal –
minimisation of any risk to an acceptable level.19 Although the Protocol has as a primary
focus the transboundary movement of living modified organisms that may have an adverse
effect on biodiversity conservation and its sustainable use, these provisions cannot be
implemented without considering the adverse impact of the use or handling of these
organisms in general.

18
Communication for the European Commission on the Precautionary Principle, February 2000, Com 2000 (1).
19
Framework for Environmental Risk Management (1997) The Presidential /Congressional Commission on
Risk Assessment and Risk Management, Final Report, Volume 1, United States of America.
Although risk assessment is science-based in many countries the decision as to whether to
permit or not to permit use under specified conditions may be separated from the assessment
process. Often it is a minister responsible to a parliament that makes the decision which
might be based on considerations other than science. It is the transboundary movement of
living modified organisms that the Protocol focuses on. It does not provide a comprehensive
system for the management of living modified organism at the national or international level.
However, the risk assessment (and risk management) procedures require consideration of the
adverse impact on conservation and sustainable use of biological diversity in any
environment into which the organism is placed. Risk assessment must not only concern itself
solely with transfer between Parties to the Protocol, but to the introduction of a new organism
into an environment, and the risks posed during the transfer and handling of the living
modified organisms.
Risk
Risk may be defined as the likelihood that an organism introduced into the environment may
cause harm to that environment and can be seen as comprised of two factors,
a. the consequence of a particular event
b. the likelihood of the event occurring
Risk arises from exposure and hazard. There is no risk, regardless of how hazardous a
particular organism may be, if there is no exposure. Hazard may be regarded as the potential
to cause harmful effects20.
Risk Assessment Strategies:
The risk assessment strategies adopted by all the international and national systems are very
similar, and are predominantly based on familiarity with the wild-type, unmodified, organism
and the likely impact due to the changed characteristics of the organism. Article 15 of the
Protocol requires that ‘risk assessment techniques’ already used must be taken into account.
It is assumed in all systems that have been put into place that a risk assessment will start from
a consideration of the wild type organisms from which the living modified organism has been
derived, and that variations in the behaviour of the modified organism are those that require
specific attention. For example, if the non-modified precursor of an LMO, its seeds or pollen
do not survive a harsh winter, a crucial test when considering the likelihood of the new
variety becoming a weed would be whether the modification results in an increased
likelihood of survival during a harsh winter. Information about the behaviour of donor (those
from which the inserted genes have been derived) and host organisms (those into which genes
are inserted) form the baseline for assessing hazards and therefore risks. If an organism or
part of an organism is used in the transfer of genes from donor to host, its behaviour within
the environment must also form part of the information upon which the risk assessment is
based. An example is the use of a plasmid21 derived from a plant pest, Agrobacterium
tumefaciens. The plasmid is one of the main vectors used in transferring to a plant cell, yet its
normal host is a plant pest. The regulatory system in some countries is triggered by its use
simply because it is derived from a pest, even though the plasmid actually used does not
contain the genes that would assist the bacterium. A trigger is simply a mechanism for
starting the risk assessment process

20
Ibid, page 1.
21
A plasmid is a piece of DNA that is capable of autonomous replication in a prokaryote or eukaryote cell. It is
commonly dispensable to the cell and can be transferred between cells.
Where a living modified organism that could pose risks is exported, it is the clear duty of the
country of export, or where so designated, the exporter to provide a risk assessment to the
authorities in the country of import. The Party of import receives a notification from the Party
of export (or the exporter if so required by the Party of export) identifying that which it is
intended to move across a boundary (Article 8). The information that must accompany the
notification is detailed in Annex I (as a minimum). If a living modified organism is to be
exported from one country to another, it will have been produced somewhere, possibly in the
country of export, and may have been subjected to a full risk assessment for contained use
and/or for release if released into the environment. Therefore, the exporter or party of export
must provide a previous and existing risk assessment report consistent with Annex III (Annex
I(k)). This provision applies to any further risk assessment to take account the environmental
conditions that apply within the country to which the living modified organism is to be
imported. The importing country could perform this assessment, or the exporter may be
required to perform the risk assessment, and the cost of risk assessment could be borne by the
notifier if required by the Party of import.
In some countries government, on the basis of information provided by the applicant,
performs a risk assessment. In deciding on risk, the authorities have the responsibility to
review the information provided and request further information or clarification in order to
arrive at a satisfactory risk assessment. In other countries the authority responsible for
decisions acts as an auditor of the risk assessment provided by the applicant. The applicant
must provide a dossier containing all the information used in arriving at the risk assessment
(and management); the authorities review the data and the assessment and again may ask for
further information or clarification in order to decide on the validity of the risk assessment.
This provision permits a government to request of an exporter a full risk assessment that it
may then consider or audit, and if necessary, require further work to assure that the
assessment applies to any possible risks to the environment as defined in the Protocol that
may not have been considered in a risk assessment undertaken in another country or by the
exporter in attempting to meet the requirements of the importing government.
The mechanism for handling either risk assessment or audit of risk assessment in
Government varies between countries as well. In some the process occurs totally within the
responsible government departments, with civil servants performing the risk assessment or
audit; in other jurisdictions Governments appoint independent committees of experts who
advise it on the risk assessment. The EU and US Biotechnology Consultative Forum, when
reporting in December 2000 stressed that it was less important as to ‘who’ is involved in the
decision making process than that the ‘function be specifically delineated and competently
executed’. They recommended that “The individuals charged with risk assessment should be
well qualified to make decisions in the area under review, be individuals of the highest
integrity, and meet stringent requirements for public disclosure of actual and potential
conflicts of interest”22.
The costs of regulation of modern biotechnology are high, both to a government ( that assures
that possible adverse effects of living modified organisms on the conservation and sustainable
use of biological diversity, taking also into account risks to human health, are minimised) and
to the applicant (for permission to use or release the organism). Governments vary as to their
approach to recovering the costs of the procedures. In some no charge is made for the
regulatory processes within government, in others the full costs (insofar as they can be

22
The EU-U.S. Biotechnology Consultative Forum Final Report (December 2000)
http://europa.eu.int/comm./external_relations/us/biotech/report.pdf
determined) are recovered from those proposing to use, handle or move living modified
organisms. Article 15 of the Cartagena Protocol enables a Party, if it so wishes, to charge
exporters the full cost of the regulatory system needed to assess the proposal put to them.
Risk Management
Risk management, which includes the system by which decisions are made is considered to
be separate from risk assessment. “Risk management is the process of identifying, evaluating,
selecting, and implementing actions to reduce risk to human health and to ecosystems. The
goal of risk management is scientifically sound, cost-effective, integrated actions that reduce
or prevent risks while taking into account social, cultural, ethical, political, and legal
considerations”23. The management of risk includes the need to consider the risk assessment
by considering the nature and magnitude of all identified risks and identifying procedures that
eliminate or reduce these risks. There is a need to ensure that risk management decisions
take into account the many different views of those affected by the introduction into the
environment of LMOs that meet the definitions in the Protocol, so as to ensure that differing
“technical assessments, public values, knowledge, and perceptions are considered”.24
Risk management is based on “a careful analysis of the weight of scientific evidence that
supports conclusions about a problem’s potential risks to human health and the environment.”
The techniques used need to be feasible, insofar as is possible to prevent rather than simply
control risk, are sensitive to political, legal, social and cultural issues and can be implemented
with stakeholder support.25
Most risk management procedures that have been imposed have not sought to prevent risk,
but rather to minimise any danger. Prevention is difficult to attain, as risk can never be zero.
Many of the living modified organisms grown within the borders of a Party to the Protocol
will have been produced, and possibly grown commercially in other countries which may
have very different eco-systems and indigenous organisms. Although these new organisms
may have been subject to risk assessment and risk management procedures in all the
countries where they are already used, (particularly in the country of manufacture and first
use) these risk assessments may not be adequate to protect the environment and biological
diversity and ensure the sustainable use of biological diversity in a new and different
environment.
A great deal has been said about the need for predictability in decision making. If the risk
assessment procedure is clearly defined and followed the science-based advice on adverse
impacts may be different in different countries, but is defensible. If the decision making
process is open, with clear guidelines the system is mostly predictable. In some countries the
decision making process is made by officials without reference to ministers following an
agreed protocol. In other countries a system has been set up where the decision making
process is open and transparent and not accountable to political whim. In Australia, for
example, the regulator is responsible to the Parliament rather than to ministers; In the United
States Government has delegated its powers to agencies with clear guidelines on the decision
making process. In other countries the decision is made by ministers taking account many
factors including non-science-based information.

23
Framework for Environmental Risk Management (1997) The Presidential /Congressional Commission on
Risk Assessment and Risk Management, Final Report, Volume 1, United States of America. Page 1.
24
Ibid, page 10.
25
Ibid, pages 4.
All the above indicates that the processes that need to be instituted to ensure that any living
modified organisms are used safely are complex. A country needs
1. A system for receiving notifications about the intended introduction of a living
modified organism. That system must provide for informing the applicant of the
receipt of the dossier of information. This system may be the same for applications
received from applicants working on the modification of organisms within the country
or for those from applicants wishing to import products into the country.
2. The systems set up may be different for different uses – if a product is to be used only
for food and feed, and for which there is no intention to grow the organism, the
procedure may be very different from those instituted with organisms that are
intended to be released into the environment.
3. The administrative system must then examine the dossier submitted by an applicant to
ensure completeness – is all the necessary information provided?
4. Either the Government performs a risk assessment based on information in the
dossier, or the Government audits the risk assessment provided by the applicant. In
either event, it must set up a system of scientific oversight of the dossiers received. If
information is absent a system for requesting further information from applicants must
be put into place.
5. There is an obligation to set up systems to allow public and stakeholder comment to
be considered.
6. A system for evaluating the risk assessment and/or the audit report and any public
comments must be instituted. Changes to the design of the ‘release’ or marketing
programme may have to be requested.
7. The decision making process, including the manner in which the decision is
communicated to the applicant and to the general public must be implemented
All of this must be in place before the first decision is made….