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6-Regulation: Regulating GMOs in developing and transition countries



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TITLE:  Regulating GMOs in developing and transition countries
SOURCE: FAO ELECTRONIC FORUM ON BIOTECHNOLOGY IN FOOD AND AGRICULTURE
        http://www.fao.org/biotech/C9doc.htm
DATE:   April 2003

------------------ archive: http://www.gene.ch/genet.html ------------------


"Regulating GMOs in developing and transition countries"
Background document to Conference 9: 28 April - 25 May, 2003
[check web page for links]

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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