FOREWORD AND ACKNOWLEDGEMENTS

While Africa is targeted as the main beneficiary or market for genetically modified foods, research conducted by CI on Biotechnology in Africa Which Choice? 2003, shows that most countries in Africa do not have existing food regulations, let alone regulations dealing with biosafety. In most countries legal frameworks and/or their capacity to regulate the biotechnology industry are limited or nonexistent. Yet at the same time, most governments are under pressure from external forces to liberalise their markets further and attract foreign investors. Acceptance of Genetically Modified (GM) crops, technology and products has even been used as a negotiating tool in bilateral and regional agreements. Public concerns on safety are based on several possibilities that could occur during experiments, handling, planting, storage, transportation, use and disposal of transgenic materials. It is in view of these developments that biosafety guidelines are needed as they afford protection to individuals, the community and the environment by minimising potential hazards associated with new applications of recombinant DNA (rDNA) and also facilitating the beneficial utilisation of modern biotechnology. To date, several protocols have been developed at various levels to deal with the issue of regulation. The Cartagena protocol on biosafety is the global treaty that reaffirms and incorporates the precautionary approach to biotechnology. The treaty promotes the controlled adoption and uptake of GM technology by members and has provisions that specifically address the safety concerns of consumers. The parties currently sit at 125 member countries among which several African and Asian countries are signatories to the treaty. Furthermore, African countries have set in motion an initiative on biosafety at the African Union and produced a document known as the The African Model Law on Safety in Biotechnology. The said document is however under threat of being undermined by parallel initiatives that are currently underway in some sub-regional blocks; which initiatives, if unchecked, will deprive Africa of any tool to guard itself against potential perverse effects inherent to any technology and genetic modification for that matter. Consumer confidence in the biotechnology process especially regulation,and pre-market testing, is vital to enable the outcome to be credible and accepted by consumers. Consumers must be involved, consulted and participate in all the processes on biotechnology and their views should be considered fully in the decisionmaking processes. However, in order to be effective in these discussions, consumers need to be knowledgeable about the issues under discussion. It is in view of the above, that CI-ROAF compiled and published this paper to make information available to its members and stakeholders at the national, regional and international levels to protect consumers. The paper was a desk review of existing literature which produced a comparative analysis of modern biosafety legislation in selected countries, with a view to assist members to identify those aspects which they consider important and to recommend best options for consumer organizations to critically understand their national frameworks and ensure that their views are heard to influence policy formulation. The production and publication of this paper was made possible by funding from the Ministry of Foreign Cooperation of the Netherlands. While the analysis and recommendations may not necessarily reflect the view of Consumers International, I would like to commend the author and editors and thank them for the contribution in producing this paper. Consumers International - ROAF would like to thank all the experts, peer reviewers, especially the International Centre for Trade and Sustainable Development (ICTSD) for their valuable inputs, comments and assistance in the editorial review of this document.

Amadou C. Kanoute Regional Director Consumers International Office for Africa Accra, Ghana

Contributors
James Mupariwa Mukaratirwa (author) Roger Lewis Mpande (editor) ICTSD (editorial review)

Peer Reviewers
Consumers International staff and members in the countries surveyed Centre for Food Safety (J. Mendelson- Legal Director)

Contents Abbreviations What Is Consumers International? What Is Consumers International Regional Office For Africa? Consumer Policy Rights of Consumers Responsibilities of Consumers Glossary Of Terms Executive Summary I. Background Current Trends In The Development of Modern Biotechnology in Agriculture And Related Regulations Ii. Application Of Modern Biotechnology In Agriculture Potential Benefits Potential Risks Socio-economic Issues Iii. General Overview Of Biotechnology Legislation In Various Regions Of The world National South Africa Australia Brazil Norway United States Of America Japan Regional European Union African Model Law On Safety In Biotechnology Third World Network: Model National Biosafety Laws International UN Guidelines For Consumer Protection The Convention On Biological Diversity The Codex Alimentarius Commission Iv. Assessment Of Key Issues On Compliance To Biosafety Principles V. Conclusion And Recommendations References Electronic References III IV IV IV IV IV V VI 1 1 2 2 3 4 4 4 4 5 5 6 7 7 8 8 9 10 10 10 12 13 15 15 17

ABBREVIATIONS
APHIS BCH CBD CI CI-ROAF CTNBio COP DNA EU EPA FAO FDA GE GM GMO ICCP IOCU IPPC LMO LMO-FFPs NBC NBF NGO NCC TNCs TWINs UN UNDP UNEP USDA WHO WFP WTO Animal and Plant Health Inspection Service Biosafety Clearing House Convention on Biological Diversity Consumers International Consumers International-Regional Office for Africa National Technical Biosafety Committee Conference of Parties Deoxyribonucleic Acid European Union Environmental Protection Agency Food and Agriculture Organization Food and Drug Administration Genetically Engineered Genetically Modified Genetically Modified Organism Intergovernmental Committee for the Cartagena Protocol on Biosafety International Organisation of Consumer Unions International Plant Protection Convention Living Modified Organism Living Modified Organisms Intended for Direct Use as Food, or for Processing National Biosafety Committee National Biosafety Framework Non-Governmental Organization National Coordinating Committee Transnational Corporations Third World International Networks United Nations United Nations Development Programme United Nations Environment Programme United States Department of Agriculture World Health Organization World Food Programme World Trade Organisation

III

WHAT IS CONSUMERS INTERNATIONAL

Consumers International (CI) supports, links and represents consumer groups and agencies all over the world. With a membership of over 250 organizations in 115 countries, CI strives to promote a fairer society by defending the rights of all consumers, especially the poor, marginalized and disadvantaged, by: ! Supporting and strengthening member organizations and the consumer movement in general. ! Campaigning at the international level for policies which respect consumer concerns. Consumers International was founded in 1960 as the International Organization of Consumers Unions (IOCU) by a group of national consumer organizations. The group recognized that they could build upon their individual strengths by working across national boundaries. The organization rapidly grew and soon became established as the voice of the international consumer movement on issues such as product and food standards, health and patients' rights, the environment and sustainable consumption, public utilities and the regulation of international trade. As an independent, non-profit organization, CI is not aligned with or supported by any political party or industry. It is funded by fees from member organizations and by grants from foundations, governments and multilateral agencies. adequate food, clothing, shelter, healthcare, education and sanitation ! The right to safety: To be protected against the marketing of goods or the provision of services that are hazardous to health and life ! The right to be informed: To be protected against dishonest or misleading advertising or labeling and to be given facts and information needed to make informed choices ! The right to choose: To ensure consumers choose products and services at competitive prices with an assurance of satisfactory quality ! The right to be heard: To express consumer interest in the making and execution of government policy ! The right to redress: To be compensated for misrepresentation, shoddy goods or unsatisfactory services ! The right to consumer education: To acquire the knowledge and skills necessary to be an informed consumer ! The right to a healthy environment: To live and work in an environment which is neither threatening nor dangerous and which permits a life of dignity and well-being

WHAT IS CONSUMERS INTERNATIONAL REGIONAL OFFICE FOR AFRICA?

Consumers International Regional Office for Africa (CI-ROAF) was officially opened in 1994 in Harare, Zimbabwe, with a sub-regional office in Dakar, Senegal, covering West and Central Africa. CI-OAF now has its base in Accra Ghana. It currently interacts with 120 independent consumer organizations in 46 countries out of 53 in Africa

Responsibilities Of Consumers
Action: The responsibility to be assertive and act to ensure fairness otherwise if consumers remain passive they are open to exploitation Social Concern: The responsibility to be aware of the impact of our consumption on other citizens, especially disadvantagedand powerless groups whether in the local, national or international community Critical Awareness: The responsibility to be more alert and questioning about the price and quality of goods and services we use Solidarity: The responsibility to organize together as consumers to develop the strength and influence to promote and protect our interest Environment: The responsibility to understand the environmental consequences of our consumption, and recognize our individual and social responsibility to conserve national resources and protect the earth for future generations

CONSUMER POLICY
Consumer policy promotes the establishment of legislation, institutions and information that help improve the quality of life and empower people to make changes in their own lives. It seeks to ensure that basic human rights are recognized, and promotes understanding of people's rights and responsibilities as consumers, as listed below:

Rights of Consumers
! The right to satisfaction of basic needs: Basic goods and services that guarantee survival i.e.

IV

GLOSSARY OF TERMS
Advance Informed Agreement (AIA): an arrangement which requires anyone supplying a product containing genetically modified organisms to provide full information regarding the good and the relevant GMO to the competent national biotechnology regulator, who then uses the information to consider whether to consent to the import, deliberate release, contained use, or placing on the market of the product. The supplier is required to disclose all relevant information and take full responsibility for the accuracy and completeness of the information. Applicant: any natural or legal person who has submitted or intends to submit an application in writing to the competent regulatory authority seeking approval to import, use in contained conditions, release or place on the market genetically modified organisms or products containing genetically modified organisms. Biological Diversity: the variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems. Biotechnology: any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use. Modern Biotechnology: Generally, a process that involves the manipulation of the deoxyribonucleic acid (DNA) of an organism. This can include nucleic acid techniques including direct injection of DNA into cells or organelles. Competent Authority: the authority designated or established by the national government to carry out functions specified by relevant laws. Contained Use: any operation in which GMOs or products thereof are produced, grown, stored, destroyed or used in a closed system in which physical barriers are employed, either alone or together with chemical and /or biological barriers, to effectively limit their contact with, and their impact on, the general population, biological diversity and the external environment. DNA Deoxyribonucleic Acid: a long chain of molecules that encodes genetic material in cells and controls all cellular functions in most forms of life. It is usually found as two complementary chains known as the double helix. The chain is arranged in subunits repeated many times. Genetic Engineering: the manipulation of information in the DNA of an organism in order to alter the characteristics of the organism. Genetically Modified Organism (GMO): an organism produced from genetic engineering techniques that has been modified in order to change some physical property or capability, including plants, animals, micro-organisms (viruses, bacteria, plasmids) and cell cultures. Living Modified Organism (LMO): any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology. Model Law: a document written to be used as a guide or example for countries seeking to draft legislation. Risk Assessment: the evaluation of the direct and indirect, short, medium and long term risk to the environment, biological diversity, human health, socioeconomic conditions or values arising from the contained use, release or placing on the market of a genetically modified organism or a product of a genetically modified organism. Risk Management: measures and strategies to regulate, manage and control risks identified in risk assessment procedures. Recombinant DNA (rDNA): the hybrid DNA produced by joining together pieces of DNA from different organisms in test tubes. The Protocol: the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. Traceability: the ability to trace and follow a food, feed, food-producing animal or substance intended to be or expected to be incorporated into a food or feed, through all stages of production and distribution.

EXECUTIVE SUMMARY
Realizing that current biotechnology regulatory frameworks are inadequate in many ways, this study was commissioned by the Consumers InternationalRegional Office for Africa (CI-ROAF) to critically review modern biotechnology/biosafety legislation in selected countries. The goal of CI-ROAF is to provide information to its members on biotechnology/biosafety legislation in order to protect consumers. It is hoped that an increased awareness of the risks and benefits of modern biotechnology, as well as how these challenges are addressed at national, regional and international levels, will enable consumers to make informed decisions regarding food and environmental safety, to critically understand their national biotechnology and biosafety regulations, and to ensure that their views on GMOs are heard and incorporated into regulations to make them more effective and supportive of consumer rights. The study includes a background section that gives an overview of the state of debate on biotechnology, a review of some of the arguments made on the risks and benefits of the technology, and an analysis of the legislation of South Africa, Australia, Brazil, Norway, United States of America, Japan and the European Union. In addition, the African Model Law on Safety in Biotechnology as well as the Third World Network's Model National Biosafety Law are examined as prototypes of good biosafety legislation. Three international instruments are used in this analysis, and subsequently examined in their own right: the Cartagena Protocol on Biosafety which aims to ensure an adequate level of protection in the safe transfer, handling and use of genetically modified organisms; the Codex Alimentarius Commission, which gives priority to the protection and interests of consumers in the formulation of food standards and the UN Guidelines for Consumer Protection are used in the review of national legislation to evaluate the effectiveness of biosafety regulations from a consumer perspective. Particularly pertinent are the right to safety; to a healthy environment; to be informed; to be heard; to redress; to consumer education; and to choose. In terms of the right to safety and a healthy environment, this paper examines legislation to ensure the presence of a comprehensive national system of biosafety regulation that includes a body responsible for implementation; an application process for release of GMOs that includes a risk assessment that is as independent as possible; incorporation of the precautionary principle; and a decision-making process that is in practice and theory effective in its consideration of consumer and environmental health. In addition, provisions for public information and participation are examined because they address the consumer's right to be informed, to education, and to be heard. The presence and scope of liability schemes are also examined as important for the satisfaction of the right to redress, while the presence and extent of labeling requirements for GMOs are also examined as key to guaranteeing the right to choose. An assessment of key issues, and a conclusion highlight the key lessons. Many of the countries examined have some of these provisions, but this review will show that different countries are better or worse in these fields. CI-ROAF believes that a reasonable approach to these issues should be based on the United Nations guidelines for Consumer Protection which recognize, among others, responsibility and accountability. It is on this basis that a meaningful advocacy programme for consumers can be formulated.

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BIOSAFETY LEGISLATION IN SELECTED COUNTRIES: A COMPARATIVE ANALYSIS

I. BACKGROUND
What is biotechnology? To put it simply, biotechnology is the use of biological processes or organisms for the production of materials and services. One of the many branches of biotechnology concerns the genetic manipulation of seeds grown for agriculture. The results of this manipulation are given names such as genetically engineered foods, genetically modified organisms or transgenic products. It is important from the onset to understand the distinction between biotechnology and genetic engineering. Biotechnology is any application of biological science that uses biological systems and living organisms to make or modify products or processes, while genetic engineering is more specifically an advanced form of biotechnology that involves the transfer of genes within and between species. This ability to create a new living organism has raised concerns regarding food security, safety, ethics, consumer choice and environmental impact. Although genetically modified crops may have certain benefits, consumers worldwide are concerned that the technology might present new risks to the environment and to their health. Genetic engineering involves, for example, the insertion of a foreign gene into a plant and while this can mean that the plant now has a useful characteristic -- such as being resistant to an insect or disease -- the claims made that such changes bring only benefits are unfounded. Combining genes from widely different types of organisms would not occur in nature and it has proven difficult so far to predict the impacts of this on the environment and human health. It is on the basis of these concerns that an internationally binding Biosafety Protocol to regulate the safety of international trade in GMOs was adopted under the auspices of the UN Convention on Biological Diversity on 29th January 2000. The objective of the 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 trans-boundary movements. Recognizing the potential negative impacts of GMOs on consumers and the environment, consumer organizations worldwide have assumed an active role of making consumers aware of the need for appropriate and consumer friendly policies and biosafety regulations. As part of its mandate, Consumers International, (CI) has taken great interest in the GMO and biosafety debate and and as a result the Regional Office for Africa conducted a study on the status of biotechnology and biosafety in various countries of the world. The study indicate that despite the fact that modern biotechnology presents some potential risks to human beings and the environment, a number of countries have no legal frameworks to regulate the technology. In an attempt to enable consumers to understand biosafety issues and the status of regulations, this study by CI-ROAF (Regional Office for Africa) uses a comparative analysis of biosafety legislation in selected countries of the world to reveal what components are necessary to ensure biosafety. The results of the findings, which form the contents of this report, are expected to be used at the national, regional and international level to: ! Strengthen the capacity of consumer organizations to understand the salient features surrounding the application of the technology; ! Influence national, regional and international biotechnology/ biosafety policy and regulatory formulation processes; ! Conduct public campaigns and consumer education in order to raise awareness of the potential risks and risk management strategies; ! Enhance the capacity of consumer organizations and other relevant institutions to represent the consumer movement on the GMO and biosafety debate.

Current Trends in the Development of Modern Biotechnology in Agriculture and Related Regulations
The need to address world hunger and ensure food security has long been at the forefront of the international agenda and advocates of biotechnology have since the creation of the technology presented it as a way to address world hunger. At the 2002 World Food Summit, following several decades of unmet goals on eliminating hunger, food insecurity and malnutrition, the Food and Agriculture Organization (FAO) formally and controversially endorsed biotechnology as a way to address hunger after goals to eradicate hunger and malnutrition were not met. Using this emphasis on the need to address hunger, GM foods have spread worldwide both as a result of potential benefits and also because of questionable claims of significantly increased crop yields that could decrease hunger. The following figures from the ISAAA Annual Global Review of Commercialized Biotech/GM crops 2004 are illustrative of the increase in plantings of GM crops: ! It is estimated that the global area under GM crops increased from 1.7 million hectares in 1996 to 81.0 million hectares in 2004. About 80 per cent of the crops are planted in two countries the United States and Argentina. Together with

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BIOSAFETY LEGISLATION IN SELECTED COUNTRIES: A COMPARATIVE ANALYSIS

! ! ! ! !

Canada and Brazil, they account for 91 per cent of GM crop acreage; Two countries account for much of the remaining 9 per cent of GM acreage China, with 3.7 million hectares of GM cotton, and Paraguay with 1.2 million hectares of cotton. Six countries therefore account for almost all GM production; Ownership of GM crop technology is mostly concentrated in the hands of one company, Monsanto. In 2001, the products of Monsanto accounted for 91 per cent of the total area sown to GM crops in 2001. Most GM crops- 72 per cent in 2004- are bred for herbicide tolerance. Other traits are insect resistance (19 per cent) and combined herbicide tolerance and insect resistance (9 per cent). These three traits account for virtually 100 per cent of commercially grown GM crops; GM crops are grown by 8.25 million farmers in seventeen countries, up from 5 million farmers and thirteen countries in 2001; GM soy was planted on 48.4 million hectares (60 percent of global area); GM corn was planted on 19.3 million hectares (23 percent); GM cotton was planted on 9.0 million hectares( 11 percent); and GM canola was planted on 4.3 million hectares (6 percent).

To date there is no consensus on the impact of genetic engineering on hunger. Its opponents argue that genetic engineering will do nothing to address the underlying structural causes of hunger, which are political and social, but would instead do much to exacerbate them. They argue that the problem needs political solutions rather than technical fixes and approaches to research that see the farm as a complex ecological system. Crop yields are only a small part of the solution. Enough food is produced worldwide now, but 800 million people are hungry. This indicates that production levels are not the real problem (Hungry Corporations 2003).On the other hand, some argue that genetic engineering, while clearly not a catch-all solution to end hunger, can when properly regulated and harnessed for the interests of development and consumers be beneficial to society. Whatever the arguments are on the topic,it is critical that biotechnology be regulated to ensure biosafety in terms of human health, the environment, and long-term sustainability. In order for this to happen it is important that consumers have some basic understanding of the political, environmental, social and human health benefits and risks of modern biotechnology.

II. APPLICATION OF MODERN BIOTECHNOLOGY TO AGRICULTURE: RISKS AND BENEFITS

The application of modern biotechnology to food and agriculture is the central source of debate regarding biotechnology, with a variety of potential benefits and risks claimed as weighing the scales in favour or against its usage. Whilst biotechnology may have its advantages, it also carries with it a number of significant disadvantages.

Figures from ISAAA should be treated with caution. It is partly funded by GM companies and does not reveal its sources. According to the Network of Concerned Farmers,there are serious question marks over the accuracy of ISAAA claims. Many claims are made purely on producer estimates and some have been shown to be contrary to the findings of properly-controlled scientific studies. Despite the impression of growth given by these numbers, resistance to GM adoption has been witnessed around the world, particularly in Europe and Africa. This is in reaction to health and environmental concerns and against claims made that GM crops can end hunger. A classical example of this resistance was demonstrated by a group of 24 delegates from 18 African countries in 1998 during the FAO 5th Extraordinary Session of the Commission on Genetic Resources, 8 - 12 June 1998 They told the meeting: "We strongly object that the image of the poor and hungry from our countries is being used by giant multinational corporations to push a technology that is neither known to be safe, environmentally friendly, nor economically beneficial to us. We do not believe that such companies or gene technologies will help our farmers to produce the food that is needed in the 21st century. On the contrary we think it will destroy the diversity, the local knowledge and the sustainable agricultural systems that our farmers have developed for millennia and that it will undermine our capacity to feed ourselves."

Potential benefits
The proponents of biotechnology argue that developments in this field can lead to many economic, environmental, and agricultural benefits. According to Conway, 2000, when applied correctly, modern biotechnology "will be essential if yield ceilings are to be raised, excessive pesticide reduced, the nutrient value of basic foods increased, and farmers on less favored lands provided with varieties better able to tolerate drought, salinity and lack of soil nutrient". Among potential benefits cited are (Flavell, 1999, IFST, 2000): ! Improved agricultural performance; ! Ability to grow in inhospitable environment; ! Improved nutrient composition and profile (proteins, amino acids, starch, fats, beta carotene);

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BIOSAFETY LEGISLATION IN SELECTED COUNTRIES: A COMPARATIVE ANALYSIS

! ! ! !

Bacterial and fungal disease resistance; Insect resistance; Virus resistance; Delayed over-ripening of fruits and vegetables;

essential to ensure that farmers and consumers are able to choose between GM and non- GM food. Health The World Health Organization (WHO, 2002) identifies three important safety issues: ! Allergenicity: Food, whether developed by conventional means or through biotechnology, is a potential source of allergens. It is feared that genes will be transferred from one food, such as a peanut, into another, such as wheat, and people with an allergy to peanuts will eat the wheat and have an allergic reaction because of the presence of the peanut gene. As a matter of principle, the transfer of genes from commonly allergenic foods is discouraged unless it can be demonstrated that the protein product of the transferred gene is not allergenic. Traditionally developed foods are not usually tested for allergens. The problems of allergenicity, and the lack of government attention to the problem, were demonstrated in the Starlink case. Scientists are not certain whether Starlink, a GM maize crop, causes allergies in humans; however, there is proof that the unique protein (Cry9C) has the potential to trigger allergic reactions, especially in children. Although numerous health complaints believed to be associated with Starlink were reported to the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), follow-up studies necessary to determine the connection between the episodes of illness and Starlink were never pursued by the two government agencies (see Comments to Docket Control Number PF-678 and OPP-00678). The US Environment Protection Agency has nonetheless said that (Cry9C) has a likelihood of being an allergen. A strategy to address allergenicity of biotechnology products has been formulated by FAO and WHO (FAO/WHO, 2001) including a method to test the allergenicity of GM products. ! Gene transfer: There are concerns that genes could be transferred from GM foods to bacteria in the human stomachs because of fears that the transferred genetic material could adversely affect human health. For example, most GMOs are created by not only inserting the gene of interest, but also a gene that makes the GMO resistant to antibiotics. There are concerns that bacteria in human stomachs could absorb these "antibiotic resistant genes", and in this way become resistant to antibiotics which could no longer be used to treat infections. There is general

Many experts around the world believe that modern biotechnology applied together with adequate policies, infrastructure and traditional methods can help poor farmers around the world by developing crop varieties that harbor needed properties. While modern biotechnology is not a silver bullet or a catch-all answer to the problems of poor farmers, they argue, it is a partial solution to their problems, and they should not be denied access to it (Pinstrup-Andersen and Cohen, 2000).

Potential risks
Environmental The United Nations Development Programme describes the potential negative effects of GMOs on the environment (UNDP, 2001) as follows: ! Transformed organisms could displace and even make extinct existing similar plant species because their new, improved characteristics make them more likely to survive. This could c h a n g e the ecosystem by reducing the diversity of species, which in turn could have unknown consequences. Such a reduction in biological diversity could impact on the availability of materials for medicines, for example, or could mean that food security is threatened because of the absence of a "back-up species" for humans to use as breeding material or to use if the newly dominant GM species falls prey to a pest. This is particularly important in centers of origin, which are places where a crop (i.e. Mexico for corn) originated in which a rich diversity of similar varieties can be found; ! The flow of genes between plants could transfer the new genes from the GM species into related species, leading, for example, to super weeds that people do not want to grow but that have acquired resistance to insects or pesticides because of the genes they have acquired from the GM plant; ! The new gene could have unintended harmful effects on non-target species. For example, a gene intended for pest control against one pest could unintentionally adversely affect other insects, plants or animals; ! Genes from GM crops can also be passed to organic crops. This can threaten the survival of organic producers whose market claim is based on GM-free, natural crops. The need to ensure "co-existence,"that is, the possibility of protecting/ensuring non-GM production, is

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BIOSAFETY LEGISLATION IN SELECTED COUNTRIES: A COMPARATIVE ANALYSIS

agreement that transfer of antibiotic resistant genes from plant to human gut micro flora is unlikely to occur (FAO/WHO, 1996, 2000) but the potential of gene transfer cannot be completely ruled out. As a result, safety assessment of GMOs should also consider information on the role of antibiotics. ! Out crossing: As described above, the movement of genes from GM plants into conventional crops or related species in the wild, as well as the mixing of crops derived from conventional seed with those grown using GM crops, may have an indirect and unintended effect on food safety and food security. It may be found after the fact that a GMO has adverse effects on human health, for example. The precautionary principle recognizes that "lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation" where "there are threats of serious or irreversible damage" and is used by countries concerned that some problems, though not fully explained by science, can none-the-less have the potential to do damage. It is sometimes used for biotechnology given how hard it would be to deal with a widespread health or environmental problem after the fact. Overall, the use of risk assessment and, where appropriate, post-market monitoring, is necessary to evaluate the safety of GM foods (WHO, 2002).

ensuring that this information gets through to educate the public in an unbiased way. Ensuring consumer choice and awareness of the issues surrounding GMOs, is a central part of any evaluation of biotechnology from a consumer perspective.

III. GENERAL OVERVIEW OF BIOTECHNOLOGY LEGISLATION

An overview of biotechnology legislation around the world reveals that most countries are moving towards the regulation of genetically engineered foods. However, some are lagging behind, partly due to reluctance to adopt such laws because vested interests like biotechnology companies resist such regulations. A good example is the United States of America. Others are taking their time because they are not yet familiar with the technology and lack the capacity to develop a regulatory framework. Nonetheless, the point cannot be overemphasized that for the purposes of sustainable development, human health and long-term sustainability of the ecosystem there is need for protection through adequate regulations.

NATIONAL SOUTH AFRICA

Any development, use, production or application of genetically modified organisms in South Africa is regulated by the Genetically Modified Organisms Act, 1997 Act No. 15 (the Act), which establishes an Executive Council for Genetically Modified Organisms. The Executive Council, along with its registrar, is responsible for the implementation of the Act and specifically with governing and making decisions relating to the application procedure for anyone looking to develop, produce, use or application of genetically modified organisms in South Africa. There is also an advisory committee that acts as the national advisory body on all matters concerning or related to the genetic modification of organisms; neither this body nor the Executive Council has any representation from consumers. The Act does not make any explicit references to the precautionary approach. There are also no provisions that provide for public information and participation in the decision-making process. The Act specifically says that users are liable for damage caused by the use or release of a GMO. Although the original Act made no reference to labeling

Socio-economic issues
Corporate control by multinationals is increased over seed and agro-chemical markets at the expense of poor farmers. The products of biotechnology, such as GM seeds, are often protected under patent and monopoly production as the proprietary technology of the corporation who manufactured them. This means that farmers who have planted these seeds can-not replant the seeds from the harvested crop in order to grow the next season's crop. Some have argued that this is a violation of the right to save seeds, while corporations argue that charging a fee for the use of the seed is necessary for them to be able to pay for their research and development costs. Another concern is that GM crops are introduced faster than the development of the regulatory capacity in developing countries. The truth about biotechnology must be shared with consumers without propaganda so that they can make well-informed decisions about whether to purchase GM products. Many of the countries reviewed below incorporate information disclosure provisions into their legislation, but in practice do not invest enough energy in

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BIOSAFETY LEGISLATION IN SELECTED COUNTRIES: A COMPARATIVE ANALYSIS

of products containing GMOs, on 16 January 2004 the government adopted "Regulations Governing The Labelling Of Foodstuffs Obtained Through Certain Techniques Of Genetic Modification". Foods containing GMOs require labeling if their composition, nutritional value, mode of storage or cooking method is significantly different from conventional food; if they contain genes from foods that are known to cause allergies; or if they contain genes from animals or humans. As a result of concerns that have been raised in South Africa about the high number of GMOs that have been approved, in April 2005 the South African Minister of Environmental Affairs said that the ministry would "establish and staff a new Bio-Safety Directorate to coordinate and support our work in implementing the Cartagena Protocol on Bio-safety" in June 2005.

However, there is no reference to the Precautionary Principle in the Act. Nonetheless, it provides a clear public consultation procedure in section 22, which says that policy principles are to be developed through input from the committees described above, along with "such environmental, consumer and other groups as the Ministerial Council considers appropriate." As regards liability, section 38 of the Act says that an offence is an aggravated offence if the commission of the offence causes significant damage, or is likely to cause significant damage, to the health and safety of people or the environment, given that the person who c o m m i t t e d the offence intended the damage or was reckless. Offences under the Act include dealing in GMOs without license or disobeying the conditions of the license. Although there is a provision that allows the Registrar to require GM creators to carry insurance, this has not been used. Food containing GMOs must be labeled according to Standard A18/1.5.2 - Food Produced Using Gene Technology adopted in July 2002 as part of the Australia New Zealand Food Standards Code. The standard is administered by Foods Standards Australia New Zealand, an intergovernmental standard-setting body, and requires all foods containing GMOs to be labeled as such unless such GMOs are present accidentally and represent less than 1 percent of the total weight of the product. Exempted from labeling are foods derived from GMOs where the GM material is no longer detectable, most processing aids and food additives, flavours present in a concentration less than or equal to 0.1 percent, and restaurant food. Australia has relatively comprehensive national legislation and has grown GM cotton for several years. However, in practice, several Australian states including South Australia, Victoria, Western Australia and New South Wales, have banned the commercial release of certain GMOs.

AUSTRALIA
Genetically modified foods in Australia are governed by the Gene Technology Act 2000: Act No. 169, under which the research, manufacture, production, commercial release and import of GMOs is prohibited unless such activity is licensed by the Gene Technology Regulator, an exempt measure as specified by the Regulator, or has been previously approved. The act was reviewed in June 2005 and the consultation closed on 15 July 2005 where responses are now being considered. According to the Act, the competent national authority is the Gene Technology Regulator who has overall responsibility to make decisions regarding issuing licenses, developing codes of conduct, providing information to the public, and generating advice to the Gene Technology Ministerial Council as broad oversight of the implementation of the regulatory system. The Regulator must also prepare a risk assessment for each application for release of GMOs under section 51 of the Act that takes into account risks posed by the release including any risks to the health and safety of people or risks to the environment. The Regulator is supported by three subsidiary bodies set up by the Act: the Gene Technology Technical Advisory Committee (GTTAC), the Gene Technology Ethics Committee (GTEC), and the Gene Technology Community Consultative Committee GTCCC). The Gene Technology Community Consultative Committee is comprised of persons from, among others, consumer groups, health personnel and environmental and industry groups. Its function is the provision of advice on the request of the Regulator or the Ministerial Council on matters of general concern in relation to GMOs and policy principles. The Gene Technology Ethics Committee has the function of providing advice on ethical issues relating to gene technology, the need for, and of, codes of practice and content of policy principles in relation to dealings with GMOs that should be conducted for ethical reasons.

BRAZIL
Activities that involve GMOs are regulated by Brazilian Law 11.105 which was passed on 24 March 2005 and grants authority over GMOs to a National Technical Biosafety Commission (CTNBio) made up of representatives of several federal ministries, independent scientists, and experts in the fields of consumer rights, health, environment, biotechnology, farms, and work health. CTNBio has the binding authority to make decisions on import, export, environmental release and all other GMO activities by issuing its technical opinion on a case-by-case basis regarding the biosafety of GMOs; authorizing the import of GMOs and their by-products for research; deciding if a GMO has to undergo a risk assessment prior to release or not; identifying activities

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which have the potential to damage the environment; and publicize the details of its activities in an "Biosafety Information System" (SIB) public bulletin. Its decisions regarding the biosafety of GMOs are binding on all other administrative entities. However, when it rules in favor of a GM product, the actual authorization of particular products and implementation of the decision is carried out by registration and inspection agencies in each of the federal Ministries. Should CTNBio determine that a GM product has the potential to degrade the environment, but nevertheless authorizes it, the Ministry of Environment is given the authority to inspect and register particular products. In addition, the National Biosafety Council (CNBS) is established by the law to provide higher advisory assistance to the President of the Republic in formulating and implementing the National Biosafety Policy, establishing principles and guidelines, and considering "the socio-economic convenience and opportunities and national interest" entailed in commercial authorization of GMOs. The Brazilian biosafety law has a strong scientific and technocratic approach to approval of GMOs for release, with some saying that CTNBio is dominated by probiotechnology scientists and industry. They also argue that the law makes no reference to the precautionary principle. However, as a result of the representation of a variety of positions, several recent decisions have seen CTNBio's members split on decisions, with the representatives from the Ministry of science and scientific experts squared off against representatives from the Ministry of Environment and others. The law has clear provisions for public participation, including allowances for representatives from the public sector and from civil society entities to be exceptionally invited to attend meetings of the CNBS and CTNBio (although without voting rights beyond the consumer representative in CTNBio); provisions requiring CTNBio to make public its proceedings; a provision requiring any institution using GM techniques to set up a Biosafety Internal Commission (CIBio) to keep workers and members of the community informed about health, safety, accidents, and risks assessments resulting from the technology; and the establishment of the SIB as a central information-sharing entity. The law does provide for an extensive liability scheme, saying in article 20 that "those who are accountable for environmental damages and third parties shall hold joint and several liability and shall pay compensation or full recovery, regardless of culpability." Article 40 states that all food for human or animal consumption that contains or is produced with GMOs must show this information on their label, in accordance with relevant regulations. Brazilian Decree No 4.680, published in April 2003, requires labeling for all foods or food ingredients containing more than one percent of GMO ingredients. The decree also mandates the labeling

of animal products from animals fed with GM grains.

NORWAY
The Norwegian law which relates to the production and use of GMOs is the Gene Technology Act No. 38 of 2 April 1993. The Act, which is supplemented by The Act relating to the Application of Biotechnology to Medicine No. 56 of August 1994, states that deliberate release of GMOs may only occur subject to approval by the King. In practice, the Ministry of Environment evaluates and accepts applications for release of GMOs. The European Food Safety Guidelines are taken into account in making decisions whether to accept a GMO, but the guidelines in Section 10 of the Gene Technology Act are the main source of guidance for all decisions relating to living GMOs. Section 10 is unique from all other biotechnology regulations in saying that a product may only be approved "when there is no risk of detrimental effects on health or the environment," although in practice a very small amount of risk can be tolerated. The section also says that decisions shall place "significant emphasis" on "whether the deliberate release represents a benefit to the community and a contribution to sustainable development". This requirement along with other provisions of the Act, including requirements to take safety precautions to prevent adverse effects on health and the environment, and measures to limit the detrimental effects of the unintentional release of GMOs, mean that while the Act does not specifically make reference to the precautionary principle, the actual approval process does follow a precautionary approach. Under the Act, Norway can refuse approval of GMOs that have been approved by the EU. According to Section 12 of the Act, the following information will always remain in the public domain, thus enhancing public information: (a) (b) (c) the description of the genetically modified organism, the user's name and address, the purpose of the use and the location of use; methods and plans for monitoring and emergency response; assessments of the foreseeable consequences.

Section 21 says that where a GMO has entered the environment accidentally or deliberately, after which the use is shown to involve a greater risk to health or the environment than foreseen when the use was approved, the responsible person must take reasonable measures to prevent or limit damage and inconvenience. According to section 23, the person responsible for an activity pursuant to the Act is liable for damages regardless of any fault on his part when the activity causes damage, inconvenience or loss by deliberate release or emission of GMOs into the environment. Current Norwegian regulations require that products must be labeled whenever more than 2 percent of any ingredient is derived from biotechnology, which is more

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stringent than the EU. However, new rules that streamline its labeling practices to be the same as or more similar to EU practices are currently coming into force. The Norwegian Act has been hailed for being a progressive piece of legislation in relation to protecting consumers' interests insofar as it deals quite decisively with principles of protection of consumers, consumer redress, promotion and protection of consumer interests, and participation of consumers in decision-making processes.

authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to regulate the distribution, sale, use and testing of plants and microbes producing pesticidal substances. Under the Federal Food, Drug and Cosmetic Act (FFDCA) the EPA sets tolerance limits for substances used as pesticides on and in food and feed, or establishes an exemption from the requirement of a tolerance. The EPA also establishes tolerances for residues of herbicides used on novel herbicide-tolerant crops. The FDA regulates foods and feed derived from new plant varieties under the authority of the Federal Food, Drug and Cosmetic Act. The FDA states that many of the food crops currently being developed using biotechnology do not contain substances that are significantly different from those already in the diet (are "substantially equivalent") and thus do not require premarket approval. As such, the FDA pre-market approval process is wholly voluntary for food crops derived from biotechnology unless it has been shown that they are not "substantially equivalent" to conventional crops. There is no mandatory pre-market safety review. GM crops do not ever have to be "approved" by the FDA: instead, companies are invited if they wish, to put forth only data from their own safety tests and to withhold primary data and the results of those tests from consumer review. This review process where the FDA looks only at a summary of the safety tests done by the company producing the GM product without looking at the primary data itself -is cursory and lacks analytical methods that would enable the agency to conduct routine sampling and testing of GM foods, and does not require these methods of the technology provider who is responsible for performing any risk assessment it chooses to do as part of the nonmandatory process. The FDA does not have the authority to examine food industry records that document whether GM ingredients are used in products and they do not usually conduct postmarket oversight. They have not developed a policy to address the presence of GM ingredients products and have no regulations concerning public participation in decision-making, public information on GM releases, liability, labeling or traceability practices.

UNITED STATES OF AMERICA

The United States does not have a mandatory approval process for GMOs and regulates them under the presumption that food crops that use biotechnology are "substantially equivalent" to conventional foods unless shown otherwise. As such, biotechnology products are not treated differently within the US regulatory system. The agencies primarily responsible for policing biotechnology in the United States are the US Department of Agriculture (USDA), Environment Protection Agency (EPA), and the Food and Drug Administration (FDA). Products are regulated according to their intended use, with some products being regulated under more than one agency. The USDA is responsible for regulating plant pests, plants and veterinary biologics; the EPA regulates microbial/plant pesticides, new uses of existing pesticides and novel micro-organisms, and the FDA regulates food, feed, food additives, veterinary drugs, human drugs and medical devices. The Animal and Plant Health Inspection Service (APHIS) within the USDA is responsible for protecting US agriculture from pests and diseases. Under the authority of the Federal Plant Pest Act, APHIS regulations provide procedures for obtaining a permit or for providing notification, prior to "introducing" a regulated genetically altered plant pest in the United States. The regulated articles are considered to be organisms and products altered or produced through genetic engineering that are plant pests or reasonably believed to be plant pests. In practice, due to budgetary constraints, biotechnology oversight is a low priority for APHIS and as a result, the financial and personnel resources required to test and monitor GM crops efficiently are not available. Through powers conferred by the Toxic Substances Control Act (TSCA), the EPA's Biotechnology Program regulates micro-organisms intended for commercial use that contain or express new combinations of traits. This includes "intergeneric micro-organisms" formed by deliberate combinations of generic material from different taxonomic genera. In addition, the BioPesticides and Pollution Prevention Division of the Office of Pesticide Programs (OPP) of the EPA uses the

JAPAN
All use, import and export of living modified organisms in Japan is governed by the Law Concerning the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms (Law No. 97 of 2003). Under the law, which explicitly sets out to implement the Cartagena Protocol, anyone interested in making use of or importing LMOs must submit an application to the Ministry of the Environment that includes the name and address of the applicant, the name, type and intended method of use of the LMO, a Biological Diversity Risk Assessment

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Report, and a document detailing measures for efficiently preventing adverse effect on biological diversity taken by a person who wishes to obtain approval. The Ministry is to consult with experts in considering the application and, given "society's high concern for Adverse Effects on Biological Diversity caused by the Use of LMOs," is to publicly announce the proposed new LMO release and afterwards "take opinions and information submitted in response to the proposal into consideration". A separate regulatory scheme is created for LMOs intended for contained use that details the containment measures necessary and steps to take in case of accidental release. In addition, it specifies a rigorous testing procedure by independent bodies to ensure that imports of LMOs do not adversely affect biological diversity. While not explicitly recognizing the precautionary principle, the law nevertheless tells the minister to only approve the LMO if "no adverse effect that could pose an unacceptable risk that impairs the preservation of species" could arise, thus incorporating the concept of acceptable risk into calculations. Public information is provided through public announcements at each stage of the regulatory process and consultation specifically stressed as a component of the process in Article 35, although in practice little of this information reaches the public. Although the Law does not explicitly state that the importers or creators of LMOs are liable for any damages that result from their usage, it does set out a system of fines for a variety of offenses under the act, including inaccurate reporting of threats to biological diversity and illegal importation of LMOs. Under the Labelling Standard for Genetically Modified Foods and the Specifications and Standards for Foods, Food Additives and Other Related Products administered by the Ministry of Health and Welfare (MHLW), agricultural products and foods listed in the standard with more than 5 percent GM content must be labeled, except for foods derived from but no longer containing GMOs, and processed food where the GM ingredient is not a main ingredient.

the environment of genetically modified organisms, is the overarching law and covers both the experimental release of GMOs into the environment and the placing on the market of GMOs. The directive includes principles for environmental risk assessment (see below); mandatory post-market monitoring requirements, including on long-term effects associated with the interaction with other GMOs and the environment; mandatory information to the public; a requirement for Member States to ensure labeling and traceability at all stages of the placing on the market, a Community system on traceability which is provided for by Regulation 1830/2003 on traceability (see below); information to allow the identification and detection of GMOs to facilitate post-market inspection and control; first approvals for the release of GMOs to be limited to a maximum of ten years; the consultation of the Scientific Committee(s)/European Food Safety Authority (EFSA) to be obligatory; an obligation to consult the European Parliament on decisions to authorise the release of GMOs and the possibility for the Council of Ministers to adopt or reject a Commission proposal for authorisation of a GMO by qualified majority. The Directive specifies that action by the community relating to the environment should be based on the principle that preventive action should be taken. The precautionary principle has thus been taken into account. Part B deals with the deliberate release of GMOs for any other purpose than for placing on the market while Part C deals with the placing on the market of GMOs as or in products. Key principles included are the need to consult the public during the preparation of measures and to inform them of the measures taken during the implementation of the Directive; respect of the Cartagena Protocol; a detailed description of the methodology to be used in the environmental risk assessment procedure (included in Annex II to the Directive); ensuring that systematic research on the potential risks involved in the deliberate release or the placing on the market of GMOs is conducted; to ensure traceability at all stages of the placing on the market of GMOs as or in products authorized under the Directive. In practice, the procedure for placing a product consisting of or containing a GMO is rather lengthy. It is implemented using Regulation 1829/2003 on GM food and feed, which specifies an approval process that not only grants authorization for the deliberate release of GMOs into the environment as per the Directive 2001/18/EC process above, but can also authorize the release of the GMO into food and feed. Under this procedure, a thorough "notification" applying for approval of a GMO, which must include a full evaluation of the environmental and health risks, is submitted to a Member state of the EU. This state submits the application directly to the European Food Safety Authority, which within six months informs the European Commission and the public of its opinion.

REGIONAL
Issues of biosafety and transboundary movement of GMOs have to be regulated beyond national boundaries. It is therefore critical to have harmonized regulations that will allow compliance and implementation of the biosafety measures.

EUROPEAN UNION
The European Union has comprehensive legislation governing genetically modified foods and crops in its territories. Directive 2001/18/EC of the European Council and the Parliament, on the deliberate release into

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Within three months of receiving the opinion of EFSA, the Commission drafts a proposal for granting or refusing authorisation. The Commission may diverge from EFSA's opinion, but it must then justify its position. The Commission's proposal must be approved through qualified majority by the Member States within the Standing Committee on the Food Chain and Animal Health, composed of representatives of the Member States. If the Committee gives a favourable opinion, the Commission adopts the Decision. If not, or in the event of rejection of the Commission's proposal by qualified majority of the Committee, the draft Decision is submitted to the Council of Ministers for adoption or rejection by qualified majority. If the Council does not act within three months or does not obtain a qualified majority for the adoption or rejection of the Commission's proposal, the Commission automatically adopts the decision. The Labelling and Traceability Regulation (Regulation 1830/2003) covers all GMOs that have received EU authorisation for their placing on the market. Traceability of GMOs is practiced so that if accidents and harmful effects are caused by a product, the GMO at fault can be identified. The traceability requirement says that the producer of a product consisting of or containing GMOs must transmit to the recipient of the product notification in writing that the product contains GMOs and, if applicable, which ingredients contain GMOs. The same regulation says that all pre-packaged products consisting of or containing GMOs must be labeled as this product contains genetically modified organisms," and Regulation 1829/2003 lays down specific labeling requirements including the exception of products with unavoidable GM content of less than 0.9 percent. From the above outline it is clear that the EU has sought to streamline and specify its areas of concern insofar as the impact of GMOs is concerned. This specificity assists in the assessment and monitoring of the use of GMOs based on a precautionary approach.

regulations to serve as a model law, designed to protect Africa's biodiversity, environment and the health of its people from the risks posed by GMOs. The document was finalized in May 2001 and was endorsed by the 74th Ordinary Session of the OCAU Council of Ministers in Zambia in July 2001. The Council urged its member states to use the Model Law to draft their own national legislation, but to this date it has not been explicitly used by any state in the drafting of legislation. The African Model Law on Safety in Biotechnology recognizes that while biotechnology might hold much promise for the improvement of human well-being it equally has potentially adverse effects on the environment, biological diversity and human health. It therefore recognizes the precautionary principle as a means of regulating any undertaking for the import, contained use, release or placing on the market of genetically modified organisms and products of genetically modified organisms. It adopts many of the provisions of the Cartagena Protocol, but in many cases goes further. For example, the Advance Informed Agreement procedure is applied to all imports of GMOs, including those intended for contained use, food aid, or those in transit, products of GMOs, along with any for direct use as food or feed or for processing, unlike the Cartagena procedures. It outlines in detail an application process to be applied equally to all types of GMOs that includes an assessment report on risks that may be posed by the GMO or GMO product on the environment, biological diversity or human health, including the consequences of unintentional release. While it is notable that the Model Law calls for a more extensive risk assessment, it lacks a requirement of an independent risk assessment. It is doubtful that the applicant who is seeking to be granted permission to carry out a genetic engineering activity will produce an adverse risk assessment for the proposed work. The law provides that where a risk assessment proves that risks cannot be avoided, the Competent Authority shall refuse approval for carrying of any GM activity; and that in the event of such refusal to approve, any patent or application for a patent on the GMO or GMO product shall be revoked or rejected. The Model Law also suggests that countries create a competent authority to make decisions on GM imports; establish a National Biosafety Committee (NBC) comprised of governmental representatives, nongovernmental organizations and the private sector to make policy recommendations and suggest guidelines on biosafety issues, and create a biosafety clearinghouse for public information. It also requires that the public be engaged in the decision-making process by way of a notice and comment procedure and public consultations at the discretion of the competent authority. It requires that the information furnished by the applicant be made available to the public, with provisions for making some information confidential left to the discretion of the competent national authority.

MODEL LAWS
A number of different organizations have created model laws to assist countries that are considering creating national biosafety legislation, often to comply with the Cartagena Protocol. While not legally binding, they do serve as good examples that countries could consider when drafting legislation.

THE AFRICAN MODEL LAW ON SAFETY IN BIOTECHNOLOGY

The Organisation of African Unity (OAU: now the African Union) in 1999 decided to convene a group of biosafety experts to draft a framework of biosafety

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A person who carries out a genetic modification activity is strictly liable for any harm caused by such a GMO under Article 14(1) of the model law. The capacity to sue has been extended to any person, group of persons, or any private or State organization. These may bring a claim or seek redress for the breach or threatened breach of any provision relating to damage to the environment, biological diversity, to human health or to socioeconomic conditions. The Model Law also calls in Article 11 for the labeling of all GMOs and products of GMOs for the purposes of traceability.

The liability provisions impose strict liability for any damage caused by the introduction of a GMO or product thereof. Liability attaches to any person or entity responsible for the harm. Liability also attaches to officers of a corporation unless they can show that they did all that was possible to prevent the activity in relation to the GMO or product thereof. In addition, all GMOs must be identified and labeled such that they can be traced.

INTERNATIONAL THIRD WORLD NETWORK: MODEL NATIONAL BIOSAFETY LAW

In response to concerns that the Third World was in danger of becoming the dumping ground for GMOs and as a result of the movement by consumers, manufacturers and retailers in the North in rejecting these GMOs and their products was gaining momentum, the Third World Network (TWN) drew up the Model National Biosafety Law. The purpose of this Model Law was to provide a framework for developing countries to craft laws to protect themselves from the widely acknowledged serious potential risks presented by genetic modification. The Model National Biosafety Law is very similar to the African Model Law on Safety in Biotechnology. An application has to be made by anyone interested in importing or releasing GMOs. The application must include an assessment of the impacts and risks posed by the GMO or product thereof to human and animal health, the environment and biological diversity. This report is evaluated by the competent authority and/or the panel of experts that it may set up to assist it to carry out this task. The panel is drawn from experts chosen from a wide range of disciplines. The evaluation is comprehensive, on a case-by-case basis, and is intended to deal with all the potential risks to the environment, biological diversity and animal and human health. At the conclusion of the evaluation of the applicant's report, the competent authority may, if it so decides, carry out, or caused to be carried out, a further assessment of the impacts and risks. The competent authority must prepare a report of its decision and the grounds of its decision, setting out the matters that it considered in its evaluation. No authorization may be given unless there is firm evidence that there are no risks posed to the environment, biological diversity and human and animal health, and risk management measures may be specified by the competent national authority. Furthermore, the public is to be kept informed and must be given adequate notice of any application. It should also be provided with all information supplied by the applicant to the national competent authority, including the risk assessment report, and its feedback must be solicited. There are three key international instruments that are relevant to the issues of biosafety regulations, which can be used by consumers in their advocacy work: (a) (b) (c) The UN guidelines for consumer protection The Convention on Biological Diversity and its Cartagena Protocol on Biosafety Codex Alimentarius Principles and Guidelines on Food Derived from Biotechnology

UN GUIDELINES FOR CONSUMER PROTECTION

On 16 April 1985 the United Nations General Assembly adopted A/Res 39/248, which stipulated certain guidelines for consumer protection. The United Nations Guidelines are based on seven objectives, namely: (a) (b) (c) (d) To assist countries in achieving or maintaining adequate protection for their population as consumers; To facilitate production and distribution patterns responsive to the needs and desires of consumers; To encourage high levels of ethical conduct for those engaged in the production and distribution of goods and services to consumers; To assist countries in curbing abusive business practices by all enterprises at the national and international level which adversely affect consumers; To facilitate the development of independent consumer groups; To foster international co-operation in the field of consumer protection; To encourage development of market conditions which provide consumers with greater choice at lower prices.

(e) (f) (g)

The guidelines are important as a basis to develop international standards to protect consumers especially those from the developing countries. Thus GMO-related legislation of the various jurisdictions should be measured against the outlined guidelines or principles.

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T H E C A R TA G E N A P R O TO C O L O N BIOSAFETY TO THE CONVENTION ON BIOLOGICAL DIVERSITY

The Convention on Biological Diversity (CBD) has as its objectives the conservation and sustainable use of biological diversity and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, and by appropriate funding. The Cartagena Protocol on Biosafety to the CBD was adopted by the Conference of the Parties to the CBD on 29 January 2000 and currently sits at 125 member countries. It covers both LMOs for intentional introduction into the environment and, in a separate scheme, for use as food, feed or processing. It does not cover LMOs in transit, for pharmaceutical use, for contained use, or for food aid. It establishes a legally binding advance informed agreement (AIA) procedure for ensuring that countries are provided with the information necessary to make informed decisions before agreeing to the import of LMOs for intentional introduction into their environment. The Protocol contains reference to the precautionary approach and reaffirms the precaution language in Principle 15 of the Rio Declaration on Environment and Development. The Protocol also establishes a Biosafety Clearing-House to facilitate the exchange of information on living modified organisms and to assist countries in the implementation of the Protocol. The first time an LMO is to be exported into the territory of a party to the Protocol for intentional introduction into the environment, the party looking to export must follow the AIA procedure. Under this procedure, the exporting party must first as specified in Article 8 provide written notification (which includes a full set of information specified in Appendix II to the Protocol) to the importing government that it is interested in exporting a new LMO into the importing country. The importing country government must then acknowledge receipt of the notification as per article 9. A competent body within the importing country must then make a decision according to Article 10, using risk assessment procedures described in Article 15. Article 10 contains explicit support for the precautionary approach, saying that "lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of the LMO on the conservation and sustainable use of biological diversity in the party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision" to avoid such adverse impacts. The Protocol also sets up a separate procedure for LM

intended for direct use as food or feed, or for processing, in Article 11. Under this provision, any party making a final decision regarding domestic use of LMOs including placing on the market must within 15 days notify other parties of the Convention of this fact through the Biosafety Clearing House. The Clearing House is an electronic forum established under Article 20 to facilitate the exchange of scientific, environmental and legal information on biosafety. The other key provisions are: (a) Article 18 : Handling Transport, Packaging and Identification Transboundary movements of LMOs for intentional introduction into the environment must identify the organisms as LMOs. The objective of this article is to make sure that the LMOs are handled and moved safely to avoid adverse effects on biodiversity and human health. (b) Article 22: Capacity Building This article provides that The Parties shall cooperate in the development and/or strengthening of human resources and institutional capacities on biosafety including biotechnology to the extent that it is required for biosafety, for the purpose of the effective implementation of this Protocol, in developing country Parties, in island developing states among them, and in Parties with economies in transition, including through existing global, regional, sub-regional and national institutions and organizations and, as appropriate, through facilitating private sector involvement. Governments recognize the limited capabilities of many developing countries (especially) and countries in transition to cope with the nature and scale of known and potential risks associated with GMOs. So cooperation is indispensable as capacity building is a priority. Many such countries currently lack adequate human, technical or financial resources to implement the Protocol fully and undertake risk assessment and risk management of LMOs or to monitor LMOs once released in the environment. (c) Article 23: Public Awareness and Participation This is an important article for consumers. Parties are obliged to promote and facilitate public awareness, education and participation concerning the safe transfer, handling and use of LMOs by, inter alia, providing access to information on LMOs that may be imported. (d) Article 26: Socio-economic Considerations In making import decisions, parties can take into account socio-economic considerations arising from the import of LMOs on the conservation and sustainable use of biodiversity, especially with regard to the value of biological diversity to indigenous and local communities.

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(e) Article 27: Liability and Redress This is one of the critical articles in the Protocol as it addresses issues of prime importance to the consumers, that of liability and redress. The liability scheme is still under negotiations and is as yet incomplete. This is not satisfactory considering that work on GMOs is already being carried out in various countries of the world. This means that damage may be caused for the next four plus years without clearly stipulated laws pertaining to liability and redress. (f) Article 34: Compliance The compliance regime for the Protocol is not yet finalized. It will provide procedures and mechanisms to promote compliance and address non-compliance. Strengths and Weaknesses of the Protocol The Biosafety Protocol in itself is very important in that it establishes an internationally binding framework of minimum standards. Its major strength is the reaffirmation and operationalization of the Precautionary Principle in the decision-making procedures in the Protocol. This allows countries, in the absence of scientific certainty, to use caution and restrict the import of GMOs on account of potential adverse effects. Some of the key weaknesses in the Protocol are: ! Specific provisions on liability and redress are not yet in place. Meanwhile, Parties are already trading in GMOs and the area cropped is increasing astronomically by the year. ! Exclusion from the protocol of GMOs that are destined for contained use and GMOs in transit. ! Information submitted to a Party of Import, as required by the Protocol, can be claimed to be confidential by the exporter. Thus the public's right to know is restricted.

Three documents relating to biotechnology have been adopted by the Commission in 2003. These are: ! Principles for the risk analysis of foods derived from modern biotechnology; ! Guideline for the conduct of food safety assessment of foods derived from recombinantDNA plants; and ! Guideline for the conduct of food safety assessment of foods produced using recombinant-DNA microorganisms. These documents were the result of extensive negotiations within the Codex Intergovernmental Task Force on Foods Derived From Biotechnology between 2000 and 2002. The principles for risk analysis describe "the tracing of products" and labeling as risk management tools without including an explicit reference to traceability (a system for tracing all foods and food components from their origin to the point of final consumption). During negotiations on the principles, the US strongly resisted including full traceability and labeling provisions that were proposed by the EU, describing them as "not workable" and unnecessarily trade restrictive. Though the principles do not explicitly recognise the precautionary principle, they do require authorities to take into account uncertainties identified in safety assessments and allow them to implement appropriate risk management measures. The Principles also state that an examination of substantial equivalence, that is, a comparison of the GM product to its conventional counterpart, should only be the beginning of any risk analysis. Furthermore, the standards say that "in the foreseeable future, foods derived from modern biotechnology will not be used as conventional counterparts". The Guidelines for the conduct of food safety assessment of foods derived using GM plants and GM microorganisms are quite similar in their description of the necessity to test not only the GMO itself, but also the food in which it is embedded, for safety. The inclusion of safety assessment requirements for foods produced with GM micro-organisms, including a relatively weak annex setting out standards for the assessment of possible allergic reactions, are key parts of these documents from a consumer perspective. In addition, the Committee on General Principles in 2003 adopted Working Principles for Risk Analysis for Application in the Framework of the Codex Alimentarius Commission and is currently negotiating similar principles to apply outside the activities of the Commission. Furthermore, the Codex Committee on Food Labelling is currently considering Draft Recommendations for the Labelling of Foods obtained through Certain Techniques of Genetic Modification / Genetic Engineering.

THE CODEX ALIMENTARIUS COMMISSION

The Codex Alimentarius Commission is the joint WHO/FAO international body charged with the development of food standards. Its standards are recognised by the World Trade Organisation as being consistent with the WTO Agreement on Sanitary and Phytosanitary Standards (SPS Agreement). Since its inception in 1961, this body has drawn world attention to the field of food quality and safety. The Commission has encouraged food-related scientific and technological research as well as discussion. It has given top priority to the protection and interests of consumers in the formulation of food standards and related activities.

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BIOSAFETY LEGISLATION IN SELECTED COUNTRIES: A COMPARATIVE ANALYSIS

IV. ASSESSMENT OF KEY ISSUES ON COMPLIANCE TO BIOSAFETY PRINCIPLES

By way of summary, the following are the key issues based on the UN Guidelines on Consumer Protection that were assessed during the comparative analysis study on biosafety legislation. 1. Consumer Protection from Hazards to Health and Safety In this area governments are encouraged to formulate or promote mechanisms that are likely to enhance consumer protection by certifying the safety and quality of GMO products. This includes a binding, transparent advance informed agreement procedure for both imports and domestic release of GMOs, effective and independent risk assessment, procedures to ensure environmental effects are taken into account, and an implementation scheme that insures that these regulations are carried out in practice. 2. Precautionary Principle The well-being of present and future generations is a consumer right that can be protected by respect for the precautionary principle where there are potentially hazardous environmental impacts. It is recommended that GMOs only be introduced using a precautionary approach. 3. Access to Adequate Public Information One of the areas essential to consumer protection is access to information. On biosafety issues it is important that consumers are informed about proposed new introductions of GMOs, that as much information as possible that is submitted as part of biosafety applications is made public and, through labeling, that consumers are informed when a product does contain GMOs. This also can ensure that the GMO can be traced back to production, a process that could be essential should health problems arise. 4. Consumer Education Adequate provisions should exist to educate consumers on the various issues related to GMO products. This includes possible risks to consumers (economic, social and health). Of critical importance is the risk associated with the introduction of GMO products to the environment. While difficult to quantify and evaluate from the legislation reviewed in this paper, it is nonetheless essential that the public understand the presumptions that the legislation is built upon and the concerns it attempts to address. 5. Public Participation The introduction of GMO products in a country has major political, economic, social and health implications. There is a need therefore for transparency in decisions related to GMO development and introduction. Public participation is therefore a key factor in consumer protection. 6. Consumer Redress The issue of consumer redress is fundamental in the protection of consumer interests. It is therefore important that mechanisms are put in place to allow for fair process of redress. In cases where these mechanisms are not in, less liability might be imposed on farmers and other users. 7. Provision of Choice Consumers should be given the tools to make their own choices about whether to consume and support GMOs. Mandatory labeling of GM or foods containing GM ingredients is a necessary requirement for the exercise of this choice and also enables the tracing of GMOs from their production to final consumption, a process that many argue is an essential safeguard should something go wrong with a GM product. Overleaf is a table that summarizes the status of compliance with biosafety principles in various regions. Please note that the status table is reflective of the situation prevailing as at May 2005. The matrix can be used as a monitoring tool for consumer protection in the area of biosafety mechanisms.

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Status of Compliance with UN Guidelines on Consumer Protection in the Context of Biosafety Principles
Australia Brazil Norway United States of Japan America Not adequate Low Low Low Low Low Not adequate Not adequate Not adequate Adequate Adequate Adequate Not adequate Not adequate Present Present Low Low Low Not adequate Adequate Not Adequate Not adequate European Union Adequate High High Low High High Adequate Adequate Adequate Adequate

United Nations Guidelines on Consumer Protection & the South Biosafety Protocol Principles Africa Not adequate Adequate Present Present High High High Adequate Present Present Low Low Low Not adequate Adequate Adequate Adequate

1. Consumer protection from hazards to health and safety Not adequate Adequate Present Present Low Low Low Not adequate Not adequate Not adequate Adequate Not adequate Adequate Not adequate Not adequate Low Present Present Low High

(a) (b) (c) (d)

risk assessment risk management strict liability duty to prevent or limit damage

2. Precautionary principle

3. Access to adequate public information and education

(a) (b)

publication of applications public feedback

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4. Participation in decision-making (public participation) Not adequate Absent Absent Not adequate Absent Absent Present Adequate Present Absent Present Not adequate Absent Absent Absent Present Not adequate Not adequate Absent Absent Absent Absent Present Present Not adequate Absent Absent Present

5. Consumer redress (a) insurance cover (b) class action

6. Provision of Choice (a) labeling

Key:

Adequate Inadequate Present Absent High Low

Mechanism to support Consumer protection are in place Mechanisms to support consumer protection not in place Instrument to support consumer protection available Instrument to support consumer protection absent Strategies to support consumers high Strategies to support consumers low

BIOSAFETY LEGISLATION IN SELECTED COUNTRIES: A COMPARATIVE ANALYSIS

V. CONCLUSION AND RECOMMENDATIONS

This report presents the challenges posed by modern biotechnology and the need for effective regulatory frameworks particularly in developing countries. It has clearly shown that of all the countries reviewed, only the USA has not made an effort to protect consumers from adverse effects. The other countries have recognized the said benefits and potential risks posed by biotechnology and have, to differing extents, implemented legislation and regulations that attempt to strike a balance between ensuring the development of biotechnology and safeguarding the interests of consumers and the environment. It is clear that in any such question, the consumer rights to safety, information, education, redress, choice, to be heard and to a healthy environment must be predominant. While areas such as Norway and the European Union have put in place rigorous and consumer friendly biosafety frameworks that have resulted in relatively few approvals of GM products, Australia and Japan, and particularly the former, have very extensive regulatory frameworks that have nonetheless resulted in relatively more approvals of GM products. The European Union lays down a framework for traceability and labeling of GMOs, as well as traceability of food and feed products produced from GMOs, at all stages of their placing on the market, while most other countries reviewed have some sort of labeling standard. However, the provisions for mandatory independent risk assessment, traceability, use of the precautionary principle and liability schemes are still in their infancy in many countries, as can be seen in the status table on the earlier page. Furthermore, many countries have not successfully implemented provisions that attempt to recognise consumers' right to information, to be heard, and to be educated. While many provisions have been put on paper it is necessary that the governments, as well as consumer organizations around the world, educate the public about biotechnology issues and ensure that their voices are heard in the regulatory process. Norway, Australia and the EU should be hailed, in particular, for having crafted legislation that accommodates the interests and rights of consumers through a rigorous application process and a better-thanaverage public participation, education and information practices. The importance of such legislation cannot be overemphasized. Other countries that have enacted biosafety legislation that has a mild approach to addressing consumer interests include Brazil and the US. These countries have biosafety frameworks that attempt to address the needs of consumers, but fall short when it comes to issues of consumer redress, effective risk assessments, insurance cover, labeling and traceability. The German law on coexistence includes a compensation scheme, which compensates conventional and organic farmers if cross contamination through GMOs causes damage. Critics of the tough regulatory frameworks like those imposed by Norway, Australia and the European Union would argue that these rigid biosafety frameworks may interfere with free trade. However, one should not lose sight of the fact that free trade should not be interpreted to mean uncushioned hazards to the environment and human health. In order to achieve the recommendations outlined, it is important that stakeholders from all spheres of influence build alliances to establish effective legislation by lobbying and establishing consumer advocacy programmes at national, regional and

REFERENCES AND RELATED PUBLICATIONS

European Union MEMO/05/104. EU, Brussels, Belgium. FAO/WHO 1991. Strategies for Assessing the Safety of Food Produced by Biotechnology. Report of a joint FAO/WHO Consultation. World Health Organization, Geneva, Switzerland. FAO/WHO 1996. Biotechnology and Food Safety. Report of a joint FAO/WHO Consultation. FAO Food and Nutrition Paper 61. Food and Agriculture Organization of the United Nations, Rome, Italy. FAO/WHO 2000. Safety Aspects of Genetically Modified Foods of Plant Origin. Report of a joint FAO/WHO Expert Consultation on Foods Derived from Biotechnology. Geneva,

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Consumers International Africa office: Fact Sheets on Biotechnology and Biosafety 2004/5 Consumers International Africa office: Biotechnology in Africa: Which choice? 2003 Consumers International: World Consumer Rights Day 2005 Fact Sheet 1 Convention on Biological Diversity, UNEP Conway G., 2000. Food for All in the 21st Century, Environment, vol. 42, 1. January/February. Eggers B. and Mackenzie R. The Cartagena Protocol on Biosafety, 2000. Journal of International Economic Law, 525-543. European Commission, 2005. Questions and Answers on the Regulation of GMOs in the

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Switzerland. Food and Agriculture Organization of the United Nations, Rome. FAO/WHO 2001. Evaluation of Allergenicity of Genetically Modified Foods. Report of a joint FAO/WHO Expert Consultation on Foods Derived from Biotechnology, Geneva, Switzerland. Food and Agriculture Organization of the United Nations, Rome, Italy. Flavell R., 1999. Biotechnology and Food and Nutrition Needs, International Food Policy Research Institute (IFPRI), 2020 Focus 2 (Biotechnology for Developing Country Agriculture: Problems and Opportunities), Brief 2 of 10. The Cartagena Protocol on Biological Diversity to the Convention on Biological Diversity, UNEP Guidelines for Consumer Protection, UN, New York, 1986. James C., 2002. Global Status of Commercialized Transgenic Crops: 2002, ISAAAA Briefs N 27. Kok E.J. and Kuiper H.A., 2003. Comparative safety assessment for biotech crops. Trends Biotechnology. 21, 439-444. La Vina A.G.M., 2003. Genetically Modified Organisms and the Cartagena Protocol on Biosafety: What is the Stake for the C o m m u n i t i e s ? Wo r k i n g P a p e r N 4 : Globalization, Environment and Communities of the Ford Foundation. Madden D., 1995. Food Biotechnology: An Introduction, International Institute of Life Sciences ILSI. ILSI Europe. Concise Monograph Series. Mackenzie et al. 2003. An Explanatory Guide to the Cartagena Protocol on Biosafety, published by IUCN and FIELD in cooperation with WRI. IUCN Environmental Policy Paper and Law Paper N 46. Mayet, Mariam, 2003. Why Africa Should Adopt the African Model Law on Safety in Biotechnology. African Centre for Biosafety. 2494th EU Council Meting on Agriculture and Fisheries, Brussels, 17-18 March 2003 The Norwegian Act Relating to the Production and use of Genetically Modified Organisms (Gene Technology Act) Act No.38 of 2 April 1993 The Norwegian Act Relating to the Application of Biotechnology in Medicine, Act No. 56 of 5 August 1994

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Intellectual Property Rights in Biotechnology: Emerging Issues, Dr Patricia Kameri-Mbote Biosafety CTNBio, Ministry of Science and Technology-MCT Executive Secretary, National Technical Biosafety Committee CTNBio, Brazil CEP African Model Law on Safety in Biotechnology, OAU Pinstrup-Andersen P. and Cohan M.J. 2000. Modern Biotechnology and Poor Farmers in Developing Countries. Submitted to the New York Biotechnology Association News Letter. The South African Genetically Modified Organisms Act, 1997, No. 15 of 1997 The South African Genetically Modified Organisms Regulations The Australian Gene Technology Act 2000, No.169, 2000 The Australian Gene Technology Regulations 2001, Statutory Rules 2001 No. 106 Guidelines for Application of Recombinant DNA Organisms in Agriculture, Forestry, Fisheries, the Food Industry and Other Related Industries (Translated from Japanese), Ministry Of Agriculture, Forestry and Fisheries Government of Japan, April, 1992 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the Deliberate Release into the Environment of Genetically Modified Organisms Corporate Control of the Food Chain: the GM Link, CI USDA Economic Research Service, Concentration and Technology in Agricultural Input Industries, Agriculture Information Bulletin No.763, March 2001 UNDP 2001. Human Development Report 2001. Making New Technologies Work for Human Development. UNEP-GEF, 2003. Project on Development of National Biosafety Frameworks. WHO 2002. 20 Questions on Genetically Modified (GM) Foods. World Health Organization Food Safety Programme.

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