The issue of Genetically Modified Organisms (GMOs) has received a lot of attention from decision-makers, scientists, industry, farmers, civil society, the general public and the media globally. The ongoing debate on GMOs has pitted scientist against scientist, farmer against farmer, environmentalist against environmentalist etc. Unfortunately this has sent mixed signals to the general public and policy makers.

When discussing issues pertaining to GMOs, it is unavoidable to mention the term biotechnology. Biotechnology can be defined in a number of ways depending on the context the term is being used. The Convention on Biological Diversity (CBD) defines biotechnology as “any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or process for specific use”.

GENETICALLY MODIFIED ORGANISMS

Genetically Modified Organisms are organisms or cells whose genetic material have been deliberately manipulated to make them capable to produce new substances or perform new functions they would not do in nature. Genetic material is material of plant, animal, microbial or other organisms containing functional units of heredity. Recombinant deoxyribonucleic acid (DNA) technology or genetic engineering is the technology used to alter the genetic material.

Genetic engineering has advanced to the stage where it now allows scientists to change the characteristics of living organisms or cells by transferring the genetic material from one organism, across species boundaries. As such, DNA technology allows the transfer of genetic material between organisms that under normal circumstances would not be able to breed in any natural or laboratory setting.

CONVENTIONAL BREEDING AND GENETIC ENGINEERING

There are significant differences between conventional breeding and genetic engineering. Conventional breeding involves crossing related species. Organisms or cells with desired characteristics are selected from the progeny for reproducing and the selection is repeated over several generations. On the other hand genetic engineering bypasses reproduction all together. It horizontally transfers genes from one organism or cell to another (as opposed to vertically, from parent to offspring). It often uses infectious agents as vectors or carriers of genes to enable genes to be transferred between distant species that would never interbred in nature.

CONCERNS ABOUT GENETICALLY MODIFIED ORGANISMS

Broadly speaking there are three major concerns about the application of GMOs. The first concern is the manner by which GMOs are produced, the nature of genetic engineering itself. The second concern is on the acquired characteristics to be expressed by GMOs. The third concern is on the consequences of releasing GMOs to the environment. Adding to these concerns is the limited experience human kind has with GMOs.

From the scientific point of view, there are questions being asked on how precise genetic engineering is. Is it comparable to traditional breeding? It is urged in certain quarters that insertions that give rise to GMOs are random and unpredictable. Should this be of concern or it should not be an issue at all?

Questions on the consequences of releasing GMOs to the environment do arise. Is the releasing of GMOs into the environment going to adversely affect the conservation of biological diversity? Do GMOs pose a risk that is peculiar to centres of genetic diversity? Should there be concern about the effects of GMOs on both human and animal health?

POTENTIAL BENEFITS OF GMOs

Proponents of genetic engineering are of the view that the technology does not pose any significant risks or even any risk at all. Some of the potential benefits often quoted are increased food production, improved human and animal health, waste treatment and management as well as microbial mineral leaching.

It has been suggested that genetic engineering can contribute to increased food production through the development of food crops and animals with desirable properties such as pest resistance, herbicide resistance, drought tolerance, salt tolerance, improved nutritional profiles and the ability to manufacture chemicals more economically.

Other cited benefits are that GMOs can contribute to improved human and animal health through the production of inexpensive pharmaceutical and veterinary products, diagnostics (in vivo and in vitro tests to detect disease and measure bodily functions), vaccines and other products to administer and deliver drugs.

POTENTIAL RISKS OF GMOs

Some public interest groups and even scientists have brought the potential risks of genetic engineering to light. At the fore are issues of conservation and sustainable use of biodiversity, food safety, fair and equitable sharing of benefit from biodiversity and intellectual property rights. Biotechnology may also have implications for the ownership of food production and distribution systems.

At the moment not much is known about GMOs to categorically predict how they will affect the environment. GMOs released to the environment could have adverse effects on the biological diversity. Ordered biological diversity is the basis of ecological stability that has already been seriously eroded, primarily as a result of industrialisation, urbanisation and over exploitative agricultural practices. The addition of novel adaptive traits to “wild-type organisms” could give some of them a competitive advantage and cause them to over-run natural communities of plants and animals, thus reducing both biological diversity and agro-biodiversity.

It is possible that genetic engineering will facilitate an even more rapid rate of loss of global agricultural and biological biodiversity. These impacts are of special concern to some developing countries, which are home to a large share of the world's biodiversity, an asset that, among other things, promises significant economic benefits.

Currently, most GMOs, especially crops are proprietary and are owned almost exclusively by the private sector in industrialised countries. Many developing countries are concerned that companies from industrialised countries are patenting genetic material sourced from developing countries without sharing the benefits as required by the objectives of the CBD.

Genetic engineering may change the nature, structure and ownership of food production systems. While genetic engineering is often promoted by transnational corporations as an answer to the world’s food problems, real food security problems are caused not by food shortages, but by inequity, poverty and the concentration of food production. Genetic engineering is likely to further consolidate concentration and control of food production systems by a few large firms.

By increasing the herbicide resistance of crops, genetic engineering may boost the use of chemicals to kill weeds but harm the environment. In the same vein the use of pest resistant crops developed through genetic engineering may harm non-target organisms. While these GMOs are promoted as a way to increase crop yields, the results are at least currently, inconclusive. Finally, GMOs may also reduce crop diversity by promoting monocultures. In addition, new technologies such as ‘terminator technology’, which renders a crop’s seeds sterile, could lead to serious consequences as such as food insecurity.

Genetic modification may change the toxicity, allergenicity or nutritional value of food, and alter antibiotic resistance, with serious implications for human and animal life and health. The safety of GMO food and feed has not been ascertained while the testing of GMO products is complex and expensive. This would leave consumers at the mercy of producers of GMOs. Developing countries may not have the required capacity for determining the safety of GMO products.

THE PRINCIPLE OF SUBSTANTIAL EQUIVALENCE

The concept of substantial equivalence is widely used as the basis of determining the safety of products of genetically modified organisms. Substantial equivalence is by nature not a safety assessment process but an analytical tool in assessing the safety of new foods in relation to existing foods.

The term substantially equivalent implies that two foods are equivalent in all characteristics that are of importance to the consumer-safety, nutrition, flavour, and texture. However, in actual practice the investigator compares only selected characteristics of the genetically engineered food to those of its non-genetically engineered counterpart. The argument supporting this practice is that since most of the characteristics of a particular genetically engineered food are similar to those of its non-genetically engineered counterpart, it must be the case that the genetically engineered food is substantially equivalent to its non-genetically engineered counterpart with respect to all characteristics relevant to the consumer.

THE PRECAUTIONARY PRINCIPLE

Among the major outcome of the United Nations Conference on Environment and Development (also known as the Earth Summit) held in Rio de Janeiro, Brazil, in June 1992, was the adoption of the Agenda 21, Rio Declaration on Environment and Development (Rio Declaration) and the Convention on Biological Diversity (CBD). Chapter 16 of Agenda 21 is “Environmental Sound Management of Biotechnology” while the “Precautionary Principle” is the Principle 15 of the Rio Declaration.

Chapter 16 of Agenda 21 recognises that biotechnology cannot solve all the fundamental problems of environment and development. However, it could contribute to the sustainable development through increased food and feed production, health care and environmental protection. The chapter also recognises that maximal benefits from modern biotechnology can only be realised if it is developed and applied judiciously. It advocates for safety in biotechnology development, applications, exchange and transfer through international agreements based on risk assessment and management principles.

Principle 15 of the Rio Declaration states that “[i">n order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation”. This is referred to as the “Precautionary Principle”.

THE CONVENTION ON BIOLOGICAL DIVERSITY

The aims of the Convention on Biological Diversity are: the Conservation of biological diversity, sustainable use of its components and fair and equitable sharing of benefits arising from the use of genetic resources. Parties of the convention "affirm sovereign rights over the biological resources found within their countries, while accepting responsibility for conserving biological diversity and using biological resources in a sustainable manner". There is no mention of genetically modified organisms in CBD. It, however, refers to them as living modified organisms (LMOs).

Article 19 paragraph 4 of the Convention provides for Parties to "consider the need for and modalities of a protocol, including advance informed agreement (AIA) in particular, to ensure the safe transfer, handling and use of living modified organisms derived from modern biotechnology that may have an adverse effect on biological diversity and its components". This article was the basis of the negotiations that led to the adoption of the Cartagena Protocol on Biosafety.

Article 8 (g) of the Convention states that: “Each Contracting Party shall, as far as possible and as appropriate establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from modern biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking into account the risks to human health”. This article requires Parties to the CBD to have national biosafety frameworks.

THE CARTAGENA PROTOCOL ON BIOSAFETY

The Cartagena Protocol on Biosafety was negotiated under the auspices of the CBD and was adopted in September 2000 and came into force in September 2003. It is a legally binding international instrument that mandates Parties to establish national biosafety regulatory frameworks.

The objective of the Protocol is stated in Article 1, “To contribute to ensuring an adequate level of protection in the fields 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 sets out guidelines in the use of LMOs, with specific focus on transboundary movements of LMOs. It features a set of procedures including one for LMOs that are to be intentionally introduced into the environment called the Advance Informed Agreement (AIA) procedure, and one for LMOs intended for use directly as food or feed or processing. In addition, Parties to the Protocol must ensure that LMOs are handled, packaged and transported under conditions of safety. Furthermore, the shipment of LMOs subject to transboundary movement must be accompanied by appropriate documentation specifying, among other things, identity of LMOs and contact point for further information. These procedures and requirements are designed to provide importing Parties with the necessary information needed for making informed decisions about whether or not to accept LMO imports and for handling them in a safe manner.

Decisions to import LMOs must be based on sound risk assessments. The Protocol sets out principles and methodologies on how to conduct a risk assessment. In case of insufficient relevant scientific information and knowledge, the Party of import may evoke the precautionary principle when deciding whether to import. Parties may also take into account, consistent with their international obligations, socio-economic consideration in the decision making process. In addition, Parties must also adopt measures for managing any risks identified by risk assessment, and they must take necessary steps in the event of the accidental release of LMOs.

To facilitate its implementation, the Protocol established a Biosafety Clearing House for Parties to exchange information, and contains a number of important provisions, including capacity-building, a financial mechanism, compliance procedures, and requirements for public awareness and participation.

BIOSAFETY

The term biosafety describes a set of measures used for assessing; monitoring, and managing risks associated with GMOs and the policies and procedures adapted to that end. In order to address these concerns, “biosafety” has emerged as critical to the deployment of modern agricultural biotechnology.

There is a universal recognition and acknowledgement that for nations to benefit from the promise of modern biotechnology, its research, development, application and commercialisation must be done in a manner that minimises or avoids adverse effects to human and animal health as well as to the environment.

NATIONAL BIOSAFETY FRAMEWORK

The concern about the possible adverse effects of GMOs implies countries to establish National Biosafety Framework (NBFs). National biosafety frameworks are a system of legal, technical and administrative mechanisms that are established to address safety in the research, development, use and marketing of GMOs. National Biosafety Regulatory Frameworks are usually country-specific due to the different historical backgrounds and legal systems.

The development of NBFs are based on national aspirations and should take into account a country’s legal system and existing administrative structures, which are responsible for specific relevant areas.

Although national biosafety frameworks vary from country to country, they have common features:

i. Government policy on biosafety, which is usually part of broader policies such as policies on biotechnology in general, or sectorial policies on agricultural production, health care or environmental protection;
ii. Regulatory regime for biosafety, which often is a combination of enabling legislation, implementing regulations and complementing guidelines;
iii. Systems to handle notifications or requests for authorisations for certain activities, such as releases into the environment. Such systems typically include administrative functions, risk assessment, decision making and public participation;
iv. Systems for follow up such as enforcement and monitoring for environmental effects. Enforcement typically focuses on compliance with the regulatory regime, whereas monitoring is a term that usually refers to evaluating actual impacts on the environment and human health; and
v. Approaches for public information and public participation e.g. informing and involving stakeholders in the development and implementation of the National biosafety framework as well as international exchange of information.

DECISION MAKING

The introduction of GMOs into a country must be based on a case-by-case basis taking into consideration the results of cost-benefit analysis. There is need to develop and strengthen the technical expertise and institutional capacity to implement NBFs, this includes the following:

i. The competence to determine, implement, monitor and regulate conditions of containment appropriate for specific GMOs and specific environments in the country;
ii. Information management – keep updating and make available to users databases on GMOs;
iii. The technical capacity to evaluate the socio-economic impacts of GMOs;
iv. The legal and technical capacity to effectively criminalize the unauthorised transboundary movement of GMOs; and
v. The institutional, technical, scientific, legal and administrative capacity to undertake biosafety risk assessment and risk management.

* Mwananyanda Mbikusita Lewanika is Founder and Chief Executive Officer of the STEM Education Centre. He represented Zambia in the negotiations of the Cartagena Protocol

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