April, 2003

Electronic Forum on Biotechnology in Food and Agriculture: "Regulating GMOs in developing and
transition countries"

1. Introduction

As observers of the biotechnology debate will be very aware, the subject of genetically modified organisms (GMOs) in food and agriculture is highly controversial. Although, genetic modification is generally seen as a tool offering potential benefits to farmers and consumers in a wide range of food and agriculture areas, there is concern about the potential impacts on human health and on the environment.

The significance of the potential benefits it offers can be appreciated by considering the tremendous progress that has been made in recent years in the field of genetics and the realisation that, as the identity, location, impact and function of the majority of genes affecting traits of importance for food and agriculture are still unknown, this is only the tip of the iceberg. In the future, it will be possible to better understand the genetic mechanisms behind a whole range of key traits in the agro-industry, crop, fisheries, forestry and livestock sectors and to use this information to produce GMOs with the desired characteristics.

Human health issues have been raised because GMOs can be a direct source of food (by eating a GM plant, animal or fish) or an indirect source, where ingredients in processed foods may be GM
(e.g. soybeans are widely used in processed foods, including margarine, biscuits and sausages) or where domestic animals or fish, eaten by humans, may be raised on GM feed. Currently, GMOs
are primarily an indirect food source, as the dominant crops in commercial use are used in livestock feed and food processing and GM fish or livestock are not commercially available for food consumption.

Environmental issues have been raised because of potential consequences of gene flow from GM to non-GM individuals of the same species (a topic covered in Conference 7 of this Forum) or because GMOs may have a negative impact on unrelated species (e.g. crops genetically modified for insect resistance might harm non-target organisms, such as soil microbiota and beneficial insects).

Regulation of GMOs has therefore always been a central part of the general GMO debate i.e. what kind of regulations they should be, what exactly they should regulate, how strict they should be, how GMOs should be regulated compared to their conventionally-bred counterparts etc.. The theme is especially important because of the impacts of regulation on the trade of GM products and on the research and development climate for GMOs, in what is still a relatively new field. For example, an FAO report (document 03/7) prepared for the biennial session of FAO's Committee on Commodity Problems (March 2003) notes the current impacts on trade of crops: "the presence of GM products has affected trade, both in commercial transactions and in food aid deliveries. Segregated markets are developing for non-GM products to accommodate consumer preferences, with some countries focusing on supplying the markets for non-GM commodities and some major importers sourcing part of their products in countries known to be free of GM varieties". The issue of GMO regulation has also engaged policy-makers at the highest international level, where for example, 103 countries in 2000-2001 signed the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, an important international agreement concerning GMOs.

It is therefore appropriate to dedicate a conference of the FAO Biotechnology Forum to this theme. The outcome of the conference will also be used in preparation of The State of Food and Agriculture (SOFA) 2003, which is one of FAO's main publications, providing an annual report on current developments affecting world agriculture. SOFA 2003 will be entitled "Agricultural biotechnologies: Meeting the needs of the poor?".

In this Background Document, Section 2 provides a brief overview of the current status regarding GMOs in food and agriculture. In Section 3 the areas that might be regulated are covered while
Section 4 considers some key factors concerning regulation of GMOs. Section 5 lists some specific questions that should be addressed in the conference.

Note, this Forum hosts conferences about specific topics concerning biotechnology in food and agriculture for developing countries. As a simplification, the term "developing countries" in this context has always been intended to include the "transition" countries (i.e. the central and eastern European countries and the new independent states of the former Soviet Union), although there has been little participation from these countries in the Forum so far. To encourage their participation, the conference title for the first time specifically mentions transition countries.

2. Background and current status regarding GMOs in food and agriculture

A GMO is an organism that has been transformed by the insertion of one or more genes (called transgenes). The genes may be from a different kingdom (e.g. a bacterial gene into plant genetic
material), a different species within the same kingdom or even from the same species. For example, two genes from the daffodil Narcissus pseudonarcissus and one gene from the bacteria Erwinia
uredovora were inserted into the genetic material of rice to produce the transgenic rice variety commonly known as "Golden Rice", which produces a precursor of vitamin A.

Active research into genetic modification of living organisms has been ongoing since the 1980's. However, large-scale production of GMOs in agriculture has only become a reality in the past few
years, with the commercial planting of GM crops. Here, we will briefly look at the current status of GMOs in the crop, forestry, animal, fisheries and agro-industry sectors. GMOs are currently commercially available in two sectors - crop and agro-industry.

a) GM crops

Estimates indicate that the global area planted with transgenic crops increased from 2 to 59 million hectares from 1996 to 2002 respectively (ISAAA, 2002). Each year, four countries (the United States, Argentina, Canada and China) and four crops (soybean, maize, cotton and canola) have dominated the transgenic acreage statistics. For example, in 2002, the four countries were responsible for 66, 23, 6 and 4% respectively of the global transgenic acreage, with the four crops covering 62, 21, 12 and 5% respectively of the transgenic area planted. Of the 59 million hectares planted with transgenic crops in 2002, 75% contained crops modified for herbicide tolerance, 17% were modified for insect resistance while 8% were modified for both traits.

b) GM forest trees

There is no reported commercial-scale production of GM forest trees. However, there is much active research in the area of genetic modification of trees and a large number of laboratory and field trials, involving a range of tree species, has taken place since the 1980's. The traits of interest for GM forest research include herbicide tolerance and pest resistance (as for crops), but also other features, such as delayed flowering (so that trees can be harvested before they pollinate) or lowered amounts of lignin (to reduce the costs and environmental pollution associated with paper-making). Breeding trees for drought, flooding or salt tolerance may find useful applications in environmental rehabilitation, and soil and water restoration. A study commissioned by FAO to review the global status and trends regarding genetic modification of forest trees is currently under way.

c) GM animals

Although transgenic animals (especially mice) are used routinely for research purposes, no GM animals are commercially produced for food purposes. Regulatory approval for GM food animals (excluding fish, that are covered below) has only been sought in a single case, for a GM pig in Australia containing a growth hormone transgene allowing the animals to produce meat more efficiently, which never made it to the market. The kinds of transgenes currently being studied for potential use in commercial populations include the growth hormone gene (to increase growth rates), the phytase gene from bacteria (to reduce phosphorous emissions from pigs) or keratin genes (to improve the properties of wool in sheep).

d) GM fish

There is much research and commercial interest in the production of GM fish. The trait of major interest is increased growth rate, although disease resistance and improved environmental tolerance
are also being researched. Transgenic fish from about 20 species, including carp, catfish, salmon and tilapia, have been produced for experimental purposes. Two transgenic fish species are awaiting regulatory approval for food purposes - a GM salmon in the United States and a GM tilapia in Cuba. The GM salmon is the AquAdvantage Atlantic salmon which contains the Chinook salmon growth hormone gene together with a promoter from the ocean pout's antifreeze protein gene, allowing the salmon to continue to grow well in winter when, in non-GM salmon, growth would slow down. The GM tilapia is a hybrid containing a modified tilapia growth hormone gene to improve growth and conversion
efficiency.

e) GM micro-organisms

The genetic modification of micro-organisms offers considerable prospects for the food industry in the production of food additives (amino acids, peptides, flavours, organic acids, polysaccharides
and vitamins) and processing aids (enzymes, micro-organisms). Genetic modification of micro-organisms is already applied for the purpose of increasing efficiency and reducing cost in the
production of a number of food additives (artificial sweeteners, amino acids). GM yeasts are applied for flavour development in brewery applications. Recombinant enzymes which are the products of GM micro-organisms are also widely applied in the food industry in the areas of baking, brewing, and in dairy and fruit juice processing. For example, GM chymosin, a crucial enzyme for cheese-making, was first approved in 1990 in the United States and is currently used in several counties. Current applications of genetic modification in the agro-industry sector are taking place primarily in developed countries.

3. Areas for regulation

Regulations governing GMOs can potentially act at a number of key stages:

a) Research and development (R&D)

Development of GM individuals or a GM variety can be a long process. It begins in the laboratory, where the GMOs are produced and where presence of the transgene is confirmed etc., and proceeds to field testing of the organisms produced to ensure they have the desired characteristics. Regulations here may cover the conditions under which laboratory experiments take place; exchange of GM material between laboratories and conditions for testing GMOs in greenhouses, other contained facilities or in the field.

b) Seeking approval for commercialisation

After the R&D stage, there may be interest in bringing the GM product to the market. Regulations here may cover assessment of the potential human health and environmental risks, to be carried out prior to eventual approval.

c) Commercial release

If approval is granted, the next stage is the commercial release of the GMOs. Regulations here may cover aspects such as how and where GMOs may be released (e.g. minimum distance of GM crops
from organic agriculture or non-GM fields; need for GM-free refuges) and, if used for food, the kind of labelling needed, if any; whether post-commercialisation monitoring of the impacts of GMOs is necessary or what kinds of sanctions should be imposed following eventual violation of the regulations.

d) Imports of GM material or food

Applications may be made to import GMOs or their genetic material (semen, seeds etc.) for release in the environment. Similar GM varieties may or may not already be approved in the importing country. Regulations here may cover the kind of information required for approval e.g. whether information on potential environmental impacts from the exporting country is sufficient or whether new tests are required in the importing country.

Applications may also be made to import "GM food", food from GMOs (e.g. GM fish) or food that contains ingredients from GMOs (e.g. chocolate containing GM soybean). Regulations may cover the  kind of information required for approval e.g. whether new food safety data is needed or whether data from the exporting country may be used.

Phillips, in a 2003 IFPRI publication, points out that the GM crops currently commercialised are extensively traded internationally and that the countries growing them are also major exporters of these crops. For example, in 2000, a total of 168 countries imported maize, with 85% of the trade coming from the main countries growing GM maize. Although many developing countries may not be
actively involved in developing their own GM products, they may nevertheless wish to introduce regulations to cover the import of GM material or food.

4. Some key factors concerning regulation of GMOs

a) The majority of developing countries currently do not have a regulatory system for GMOs in place

Whereas European and North American countries have been at the forefront in developing regulatory systems for GMOs (see e.g. Nap et al., The Plant Journal (2003), 33, 1-18), the majority of developing countries currently lack them, although many are now being established. Nap et al. (2003), as well as Phillips (2003, see above), point out that there are significant differences between the kinds of regulatory systems already in place in developed countries. Some countries have taken a cautious approach regarding regulation with the result that only few GMOs have been commercially released. Others instead have approved most of the new GM products for production and consumption. As a clear example of divergences in existing systems, Philips points out that some countries have adopted, or are developing, provisions requiring mandatory labelling of products derived from GMOs,
whereas others have opted for voluntary labelling systems.

b) Key elements in developing a regulatory framework

Development of a regulatory framework may be a costly, time-consuming process involving extensive consultation and effort. For example, the web-based "Decision Support Toolbox for Biosafety Implementation", developed by ISNAR and FAO in consultation with UNEP/GEF, describes four key elements to be considered when developing a regulatory framework. The first concerns the legislative framework, including whether to use voluntary guidelines or legally binding regulations and whether to
modify existing legal instruments or introduce new ones. The second concerns the criteria making a product subject to regulatory assessment e.g. whether the determining factor should be that the organism is produced by genetic modification (as in almost all current GMO regulatory frameworks) or, as in Canada, that the organism contains novel traits, irrespective of whether genetic modification or traditional plant breeding methods were used to introduce the novel traits. The third element concerns
transparency and public involvement in the decision making processes e.g. whether there should be public participation in the development of the regulatory framework and whether the public should be informed about products being evaluated and whether any supporting data should be made public.

The fourth element is potentially quite contentious and concerns approaches to risk assessment and risk management. This includes how to assess the risk from GMOs, how to decide when the human
health and environmental risks posed by the GMOs are too great (e.g. should they first be compared with potential risks from their conventionally-bred counterparts) and whether the regulatory framework should weigh up the potential benefits, as well as the risks, of GMOs. It also includes decisions on whether economic issues and market potential, social impacts or ethical concerns should be considered in the risk assessment and management. In this context, it is important to note that the Cartagena Protocol on Biosafety (see below), while asserting that assessments are to be undertaken in a scientific manner based on recognised risk assessment techniques, also recognises the right of importing countries to take into account socio-economic considerations, such as the value of biological diversity to its indigenous and local communities, in reaching a decision on import of GMOs.

c) International instruments

A number of existing international agreements have direct relevance to GMOs and they can be of assistance to developing countries in establishing appropriate regulatory structures that deal with potential concerns while, at the same time, promoting harmonisation of national regulations at the international level. In a recent study commissioned by FAO, Glowka reviewed the legal instruments available in this area. He showed that at the international level there is no single comprehensive legal
instrument that addresses all aspects of GMOs or its products and that in the biosafety area (i.e. addressing the risks posed to the environment and human health when GMOs are released in the environment (for research or commercial purposes)), there are at least 15 international instruments. Seven of these are legally binding, namely the UN Convention on the Law of the Sea (1982), the Convention on Biological Diversity (1992), the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (1995), the WTO Agreement on Technical Barriers to Trade (1994), the
International Plant Protection Convention (1997), the Aarhus Convention (1998) and the Cartagena Protocol on Biosafety (2000).

The Cartagena Protocol on Biosafety, which seeks to protect biological diversity from the potential risks posed by living modified organisms (LMOs, i.e. living GMOs), specifically focusing on transboundary movements, is due to enter in force after it has been ratified by 50 countries (as of 4 April 2003, just five countries were lacking). It has provided an important stimulus to the development of national GMO regulatory frameworks in developing countries. In June 2001, a three year $ US 38 million UNEP/GEF project was launched to help participating countries to set up their national frameworks for the management of LMOs, allowing them to meet the requirements of the Protocol. As of 15 March 2003, there were 33, 35, 17 and 28 countries from the Africa, Asia-Pacific, Central and Eastern Europe and Latin America and the Caribbean regions respectively participating in the project.

The Joint FAO/WHO Codex Alimentarius Commission is the principal forum in which the food safety aspects of GMOs are addressed. A number of Codex Committees deal with matters related to GM
foods. In 1999, the Commission established the ad hoc Intergovernmental Task Force on Foods Derived from Biotechnology to consider the health and nutritional implications of GM foods. The Commission is developing a series of guidelines covering areas such as the labelling of GM foods or food safety assessment of foods derived from GM plants.

d) Biosecurity

The development and enforcement of a regulatory framework for GMOs may need to be co-ordinated within cross-sectorial national approaches to the management of biological risks associated with food and agriculture and the development of national institutions for these purposes. This concept is referred to as Biosecurity by FAO (see document COAG/2003/9). It covers food safety, plant life and health, animal life and health and the environment, including the introduction and release of GMOs and their products. National regulatory and export certification systems are being challenged by large increases in the volume of food and agricultural products being traded internationally, by the expanding variety of imported products and by the growing number of countries from which these imports originate. Increased travel is also creating more pathways to spread pests, diseases and other hazards that are moving faster and further than ever before, both between and within countries. Investments  (infrastructure and human resources) in regulatory frameworks are high, with high recurrent costs. Improved co-ordination is therefore being sought among national bodies responsible for enforcing sanitary, phytosanitary and zoosanitary measures to better protect human, animal and plant life and health. Models for rationalising relevant regulatory functions among sectors are appearing in a number of countries. For example, in Belize, food safety, animal and plant quarantine and environmental issues are dealt with by a single authority.

e) GMOs are very heterogeneous

When considering the kinds of GMO regulatory systems that might be appropriate for developing countries, it is important to consider that GMOs for food and agriculture are a very heterogeneous
group, covering crops, fish, forest trees, livestock and micro-organisms, and thus they may present a range of different challenges. The potential environmental risks from GM forest trees that may live 100 years and grow to large heights differ, for example, from the release of a GM yeast to make bread. In
addition, within each of these five sectors, GMOs may vary considerably, requiring different kinds of regulations. For example:

• Some species (e.g. cotton or forest trees) are not grown for food, so food safety regulations are not strictly an issue. [Although, it should be kept in mind that some material, e.g. pollen/honey derived from GM trees, may still enter the food chain].
• The same species may be modified for very different traits e.g. an agricultural crop or animal may be modified to produce human pharmaceuticals (e.g. tomatoes producing vaccines against the Norwalk virus or sheep producing proteins for treatment of cystic fibrosis). "Pharmed" products under development include vaccines, antibodies and industrial proteins and, in the crop sector, involve banana, maize, potato and tomato plants. Special regulations covering potential gene flow to their conventional counterparts may be necessary.
• Regulations may vary depending on whether the GM species is produced for export or domestic use. For example, a 2002 ISNAR study by Burachik and Traynor on Argentina's GMO regulations highlights this point: "the Argentine economy depends strongly on exports of primary agricultural commodities; consequently, maintaining and protecting markets is a major economic concern. For this reason, GMO commercialization is subject to a strict marketability requirement. GMOs intended for export are approved if and when they are accepted in Argentina's export market, primarily European countries. Otherwise, GMO varieties are not approved for commercialization. When exports are not a significant
  factor (e.g., in the case of cotton), commercial release can be approved irrespective of the regulatory status elsewhere, since there are no 'sensitive' markets for the product".

f) Balancing costs and benefits of regulation

The goals of GMO regulatory frameworks are to ensure safe release and use of these products. While developing the frameworks, policy makers have to consider the play off between the need to minimise risk and to promote technology development. Strict regulatory frameworks will act to minimise the potential risks associated with GMOs but they may also act as a barrier to investments in GMO research and to the development of potentially useful GM products. If the costs (in terms of finances, time and human resources) of complying with the regulations are substantial they will obviously act as a disincentive for parties with limited resources.

As mentioned in previous Forum conferences (e.g. Background Document to Conference 8), the agricultural biotechnology field is currently dominated by developed countries and by the private
sector in these countries, with the result that the research and the biotechnology products being developed or released are directed primarily to farmers in the developed (and not developing) countries and of richer (and not poor) farmers that can afford the products. Establishment of strict regulatory regimes in developing countries may therefore exacerbate this situation as they have fewer available resources. This is expressed dramatically by Nap et al. (2003, see earlier) i.e. "the cost of meeting regulatory requirements is currently a significant negative impact on the release of GM crops compared to the release of cultivars from traditional breeding. Excessive regulatory reviews will frustrate and curtail research and application to such an extent that only a few large multinational companies can afford to make progress. In this manner, over-regulation will help to promote a situation that is a concern of many: corporate control of agriculture. This trend is already clearly apparent and may result in the creation of a single (or a few) companies dominating world food production and
increasing world dependence". On the other hand, relaxed regulations, allowing rapid and easy approval of GMOs, may not effectively protect citizens and the environment from potential risks. Policy makers have therefore to carefully balance these costs and benefits.

Costs and benefits have also be weighed up when considering the monitoring and enforcement aspects of GMO regulations. Strict measures, involving frequent, long-term and careful checks and inspections of GMOs, strain the limited resources of developing countries. Relaxed measures may, on the other hand, encourage parties to flout the rules.

5. Some topics to be considered in this conference

This conference considers the subject of regulating GMOs, for food and agriculture, in developing countries (including transition countries). More specifically, some items we would like to see discussed here are:

• How strict should the framework be in developing countries i.e. how should policy makers balance the need to guard against potential environmental and health risks with the need to economise on resources to monitor\enforce the regulations and the wish to promote development of appropriate products for their own country?
• GM varieties may be exported world-wide. How appropriate is it to use environmental and food safety data from one country when seeking approval for commercialisation in a second country? Is the sector involved (agro-industry, crop, fisheries, forestry or livestock) important in this context?
• Developing countries are facing increasing challenges in regulating to better protect human, animal and plant life and health. Given this situation, and given the limited resources (financial and personnel) available, what priority should they give to the development of regulatory frameworks for GMOs?
• A regulatory framework can be quite detailed and cover a number of different areas (see Section 3). For developing countries with limited resources wishing to establish a GMO regulatory framework, what are the key areas that should first be prioritised?
• How useful is the Biosecurity concept, involving a cross-sectorial national approach to the management of biological risks associated with food and agriculture (see Section 4.d), for developing countries wishing to establish or enforce a GMO regulatory framework?
• Monitoring of the development, import, release and use of GMOs to ensure compliance with the laws or guidelines can be expensive for developing countries with limited finances and qualified human resources. How can monitoring be carried out efficiently in this situation?
• When addressing risk analysis and risk management in the regulatory framework, should a) the risks associated with GMOs be compared with those from their conventionally-bred counterparts? b) economic, social and ethical factors be included, in addition to potential human health and environmental impacts?
• Different issues are raised by the application of genetic modification in the agro-industry, crop, forestry, animal or fisheries sectors. Are different sets of regulations required for each sector?

NB: When submitting messages (which should not exceed 600 words), participants are requested to ensure that their messages address some of the above elements. Before sending a message,
members of the Forum are requested to have a look at the Rules of the Forum and the Guidelines for Participation in the E-mail Conferences. These were provided when joining the Forum, and they can also be found on the Forum website. One important rule is that participants are assumed to be speaking in their personal capacity, unless they explicitly state that their contribution represents the views of their organisation.

Abbreviations: FAO = Food and Agriculture Organization of the United Nations;
GEF = Global Environment Facility;
GM = Genetically modified;
GMOs = Genetically modified organisms;
IFPRI = International Food Policy Research Institute;
ISAAA = International Service for the Acquisition of Agri-biotech Applications;
ISNAR = International Service for National Agricultural Research;
R&D = Research and development;
UN = United Nations;
UNEP = United Nations Environment Programme;
WHO = World Health Organization;
WTO = World Trade Organization

FAO, April 2003.

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