WORLD TRADE
ORGANIZATIONG/SPS/GEN/239
14 March 2001
(01-1237)
Committee on Sanitary and Phytosanitary Measures Original:  English/
French/
Spanish
BIOSECURITY IN FOOD AND AGRICULTURE
Submission by the FAO
The following document has been submitted by the secretariat of the Codex Alimentarius
Commission for the attention of the SPS Committee.  The document will be considered at the
Sixteenth Session of the FAO Committee on Agriculture (COAG), meeting in Rome on 26-30 March 2001.
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TABLE OF CONTENTS
Pages
I. INTRO DUCTION ................................................................................................................. ...2
II. COMMON COMPONENTS ...................................................................................................3
III. INTERNATIONAL AND NATIO NAL FRAMEW ORKS ...................................................4
IV. NEED AND OPPORTUNITIES FOR COORDINATION AND
HARMONISATION.................................................................................................................5
V. ISSUES THAT COAG MA Y WISH TO CONSIDER ..........................................................7G/SPS/GEN/239
Page 2
I. INTRODUCTION
1. Biosecurity is a key requirement for achieving the goals set out in the FAO Strategic
Framework by promoting, developing and re-enfor cing policy and regulatory frameworks for food,
agriculture, fisheries and forestry. Biosecurity has direct relevance to food safety, the conservation ofthe environment (including biodiversity), and sustainability of agriculture.  Biosecurity encompasses
all policy and regulatory frameworks (including inst ruments and activities) to manage risks associated
with food and agriculture (including relevant environmental risks), including fisheries and forestry.
Biosecurity is composed of three sectors, namely food safety, plant life and health, and animal life and
health. These sectors include food production in relation to food safety, the introduction of plant pests,
animal pests and diseases, and zoonoses, the introduction and release of Genetically Modified
Organisms (GMOs) and their products, and the intr oduction and safe management of invasive alien
species and genotypes.
2. Biosecurity is of growing interest as a result of major international developments, including
globalization of the world economy, the rapid in crease in communications, transport and trade,
technological progress, and increased awareness of biological diversity and environmental issues.Members require effective, efficient, improved and updated international frameworks and standards to
support appropriate national action. Members also require national frameworks to regulate, manage
and control biosecurity for food and agriculture, including forestry and fisheries, thus permitting
practical implementation, increasing cost effectiveness, and improving consistency across sectors.
These international and national requirements address the FAO strategies B1 (internationalinstruments concerning food, agriculture, fisheries and forestry and the production, safe use and fair
exchange of agricultural, fishery and forestry goods) and B2 (national policies, legal instruments and
supporting mechanisms that respond to domestic requirements and are consistent with international
policy and regulatory framework), respectively.
3. Recent developments in biosecurity in food and agriculture include the tendency toward
integration of and cooperation across sectors. Internationally, this tendency is demonstrated in the
WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), and
the Convention on Biological Diversity (CBD ) and its Cartagena Protocol on Biosafety.
1 It is further
addressed in the FAO/WHO Codex Alimentarius, the International Plant Protection Convention
(IPPC) and the FAO Code of Conduct for Responsible Fisheries. There is also a tendency in some
countries for the integration and institutionalization of the three sectors, namely food safety, plant lifeand health, and animal life and health.
4. FAO is active in a number of areas that relate to biosecurity, including the development of
international and regional instruments, capacity , expertise, and programmes. In terms of FAO
activities:
• food safety relates to all food-related consumer health matters;
• plant life and health (including forestry) issues include phytosanitary issues, GMOs,
the introduction and safe management of invasive alien species, safeguarding genetic
resources and variability, and limiting genetic erosion. In addition, the forestry sector
gives special emphasis to introduced species and genotypes, and genetic pollution of
local provenances of forest trees; and
                                                     
1 The term biosafety is used in the Cartagena Protocol on Biosafety where it refers to the safe transfer,
handling and use of living modified organisms possessing a novel combination of genetic material obtained
through the use of modern biotechnology.G/SPS/GEN/239
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• animal life and health (including fish) issues include sanitary issues (including
zoonoses), GMOs, the introduction and safe management of invasive alien species,and the safeguarding of genetic resources and variability, and limiting genetic
erosion.
5. This paper considers the interrelationships between the food safety, and animal and plant life
and health in the context of cooperation and coordination at both the international and national levels.
It provides:
• an analysis of the common components to the three sectors and the need for their
further development;
• an analysis of the international and nationa l frameworks, and the need for a consistent
international approach to relevant in ternational regulatory frameworks, the
identification of gaps and common components in international frameworks;
• an outline of the needs and opportunities for coordination and harmonisation with
respect to national legislative frameworks, relevant infrastructure, expertise and
output;  and
• the possible role of FAO in biosecurity in food and agriculture, including forestry and
fisheries.
This document also provides a follow-up to the 15
th Session of COAG and the 116th FAO Council,
which discussed biosafety in the context of biotechnology.
II. COMMON COMPONENTS
6. There are a number of common components for the management of the elements of
biosecurity for food and agriculture. The SPS Agreement identifies the rights of States concerning
sanitary and phytosanitary measures in relation to international trade but also provides commonobligations that discipline those rights. The FAO/WHO Codex Alimentarius and the IPPC are,
together with the Office International des Epizooties (OIE), recognised as standard setting
organizations in the SPS Agreement for food safety, plant and animal life and health, respectively.
Although FAO has relevant programmes related to bi osecurity in forestry, fisheries and animal life
and health in relation to livestock, these do not carry the same level of international recognition inrelation to international standard setting.
7. Part of the technical base of the biosecurity  elements of FAO's programme is common. Risk
analysis is the basis for the establishment of sanitary and phytosanitary measures, and makes use of
the same concepts among the various sectors. International standard-setting (including, whereappropriate, environmental considerations) uses the same methodologies. Mechanisms for the
exchange of official information need to be transparent, effective and efficient, and will largely
address the same national and international community.
8. There are common components for national capacity building (including institutional,
infrastructure, expertise and personnel capacity) and there is a need for national investment in the
sectors addressing biosecurity.
9. The common components would facilitate the reduction of unjustified obstacles to trade and
international traffic and transport, whilst safeguarding food safety, animal and plant life and health.
10. Common components in biosecurity extend beyond the mandate of FAO, particularly those
components within the mandate of OIE with respec t to animal life and health and the CBD with
respect to the protection of ecosystems, habitats or species and genotypes. In addition, otherG/SPS/GEN/239
Page 4
international organizations and international legal instruments also address components of these
common elements.
III. INTERNATIONAL AND NATIONAL FRAMEWORKS
11. The international policy and regulatory framework:
• sets out the policy and legal rules governing biosecurity in food and agriculture, and
defines the rights and obligations of governments in this subject area;
• defines the forum or fora within which inter-governmental consultations and
negotiations take place on biosecurity; and
• should promote consistency and synergy among the various fora, facilitate common
action with respect to biosecurity, and facilitate the safe growth of international trade
while ensuring adequate protection of human, animal and plant life and health, andthe environment.
12. The international policy and regulatory framework consists of legally binding instruments,
soft law and policy declarations and institutional st ructures within which the instruments, soft law and
policy declarations operate.
13. Binding international legal instruments relevant to biosecurity in food and agriculture
(including forestry and fisheries) include:
• the IPPC  as revised by the FAO Conference in 1997, and the various agreements
establishing regional plant protection organizations
2, from the point of view of
potential impacts of the movement of plant pests on plant life and health and the
environment;
• the Constitution of the European Commission for the Control of Foot and Mouth
Disease (1953) , and the Agreement for the Establishment of a Regional Animal
Production and Health Commission for Asia and the Pacific (1973)  are relevant
from the point of view of the protection of animal life and health;
• the SPS Agreement  impacts on sanitary, phytosanitary and zoosanitary measures in
international trade;
• the Biological Weapons and Toxins Convention (1972)  from the point of view of
biological warfare and disarmament;
• the Convention on Biological Diversity (1992) and its Cartagena Protocol on
Biosafety (2000) from the point of view of potential impacts of living modified
organisms on biological diversity;
• the United Nations Convention on the Law of the Sea and various agreements
establishing regional fisheries management organizations such as the Convention for
the Establishment of the Lake Victoria Fisheries Organization (1994) and
Convention on the Conservation of Antarctic Marine Living Resources (1980),
and the various regional seas agreements3 are relevant from the point of view of
protecting living marine resources from pollution and the introduction of invasive
alien species;
                                                     
2 E.g. the Plant Protection Agreement for the Asia and Pacific Region and the Agreement for the
Establishment of the Near East Plant Protection Organization.
3 E.g. the Agreement for the Protection of the Mediterranean Sea from Pollution (1974).G/SPS/GEN/239
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• the RAMSAR Convention on Wetlands  and the various regional nature
conservation agreements such as the African Convention on the Conservation of
Nature and Natural Resources (1968) and ASEAN Agreement on the
Conservation of Nature and Natural Resources (1985)  are also relevant in relation
to the introduction of invasive alien species; and
• the International Undertaking on Plant Genetic Resources is now under revision
by the FAO Commission on Genetic Res ources for Food and Agriculture, for
adoption as a legally binding instrument.
14. Soft law instruments would include:
• Agenda 21 of UNCED (1992) ;
• the FAO International Code of Conduct on Responsible Fisheries (1995) ;
• the International Code of Conduct for Plant Germplasm Collecting and Transfer
of Germplasm (1993) ;
• the FAO Code of Conduct for the Import and Release of Exotic Biological
Control Agents (1995) ;
• the Code of Conduct on Biotechnology as it relates to Genetic Resources for
Food and Agriculture  (currently under negotiation);
• the ICES Code of Practice on the Introductions and Transfers of Marine
Organisms (1994) ;
• the IMO Guidelines for the Control and Management of Ships’ Ballast Water to
Minimize the Transfer of Harmful Organisms and Pathogens (1997) ; and
• the IUCN Guide to Designing Legal and Institutional Frameworks on Alien
Invasive Species .
15. Institutions and fora active in biosecurity for food and agriculture, in addition to FAO, would
include:
• the FAO/WHO Codex Alimentarius Commission , which sets standards for food
safety and the OIE, which sets standards for the protection of animal health, both sets
of standards being recognised, together with international standards for phytosanitary
measures set by the IPPC  (through the FAO Interim Commission for
Phytosanitary Measures - ICPM ), as reference points for international trade under
the SPS Agreement and the SPS Committee  established under that Agreement,
• the Conference of Parties and Secretariat of the CBD and its Cartagena Protocol
on Biosafety ; and
• the various commissions and other bodies established by the agreements noted above.
IV. NEED AND OPPORTUNITIES FOR COORDINATION AND HARMONISATION
16. The above description of the international policy and regulatory framework for biosecurity in
food and agriculture, necessarily incomplete and illustrative only, is indicative for the vast range and
complexity of the subject. Most instruments deal with aspects of biosecurity from distinctly sectoral
perspectives, whether this be disarmament, biological diversity, wetland protection, plant, animal or
human health, marine resources conservation and management, nature conservation or concern with
the introduction of genetically modified organisms or invasive alien species and genotypes. The WTO
SPS Agreement, which deals with sanitary, phytosani tary and zoosanitary measures together, does soG/SPS/GEN/239
Page 6
predominantly from the point of view of their im pact on trade, rather than their own intrinsic
effectiveness.
17. The international policy and regulatory framework for biosecurity in food and agriculture in
toto is thus somewhat disjointed and as yet incomplete. There is a need for a coordinated, though notnecessarily unified, approach to biosecurity, drawing on the common components. In particular, there
is a need to critically examine areas of potential overlap and perhaps areas of potential conflict, such
as the interrelationship between sanitary and phytosanitary measures on the one hand, and the control
of invasive alien species, biological diversity and the control of GMOs on the other.
18. The situation with respect to national policy and regulatory frameworks is broadly similar:
• controls and national authority for biosecurity matters tend to be scattered over a
variety of ministries, including Ministri es of Agriculture, Health, Environment,
Labour, Forestry, Fisheries, and Trade and Industry;
• there is a tendency to draw together relevant authorities and ministries, or at least to
create coordinating mechanisms; and
• in developing countries, authorities still tend to be organized along sectoral lines, due
perhaps to the relative importance of agriculture to their economies, although the
need for a coordinated approach may be particularly important, for example for smallisland countries with particularly vulnerable ecosystems.
There may be a particular need for technical assistance to developing countries in adopting
coordinated approaches to biosecurity, and the strengthening of relevant national and regional
institutions, both in the implementation of controls in their own countries and the negotiation ofrelevant instruments at the international level, in the light of the pressures on them of an incomplete
and disjunctive international framework.
19. The SPS Agreement provides for a common approach to the different sectors in biosecurity in
relation to agricultural trade, and this approach is complemented by the approach of the Cartagena
Protocol. In relation to other sectors, a common approach will allow for a more integrated approach to
basic biosecurity issues, to common components and to managing interconnected elements, while still
providing for sectorial application. The international harmonization of regulatory biosecurity
measures, including the analysis of gaps and potential overlaps within and across international
agreements, will provide the basic legal framework for a common approach to biosecurity.
20. Possible international and regional actions include the further development of a coordinated
international regulatory framework for biosecurity for food and agriculture, including forestry and
fisheries. The primary aim would be to avoid duplication and inconsistencies within the international
regulatory framework and reduce disputes among the various international and regional Organizations
and Instruments.
21. FAO's programmes related to biosecurity and programmes of other relevant International
Organizations and secretariats of International Instruments, may benefit from the further development
of common methodologies, particularly for risk-analysis, international standard-setting (including,
where appropriate, environmental-related standards), and integrated management and monitoring.
Regional and sub-regional action may be required to promote common regional or sub-regional actionand to enhance the ability of countries to participate in the development of common methodologies
and implement those.
22. FAO's programmes related to biosecurity should, in cooperation with other relevant
international organizations and secretariats of international agreements, cooperate in the establishmentG/SPS/GEN/239
Page 7
and operation of an official biosecurity information exchange system which will draw, in a
coordinated manner, on official information available from member countries, information from
relevant FAO programmes, and from other relevant international organizations and agreements.
23. FAO's programmes related to biosecurity should, in cooperation with other relevant
international organizations and secretariats of international agreements, cooperate in the creation of
awareness and in capacity building across sectors at the national level, to ensure an optimal use of
resources at both international and national level. FAO will assist in implementing the CBD
Cartagena Protocol in its' sphere of competency, and will harmonise its work with this Protocol.
24. Optimisation of coordination and management among relevant international organizations and
secretariats of international agreements, may reduce costs in the Harmonization  of measures, and
make optimal use of international capacities. A FAO Priority Area for Interdisciplinary Action
(PAIA) addresses the need for an Organization- wide programme that optimises coordination among
the various sectorial activities and allows for a join t response to the needs of member governments. It
also allows for a joint point of reference for cooperation and coordination among international
organizations and secretariats of international agreements.
25. Regional and national actions include:
• the coordination and cooperation among the relevant authorities and ministries in
relation to national policy and action and participation in the definition of common
international actions;
• harmonisation and integration of national legislation;
• modernisation and harmonisation of regulations, with the aim to rationalise sanitary,
phytosanitary and zoosanitary measures, while protecting human health and theenvironment;
• establishment, rationalisation and optimisation of national capacity with the aim of
avoiding duplication, inconsistency and disputes among the relevant nationalagencies;
• make optimal use of regional resources and capacities; and
• cooperate in the exchange of relevant official information among states.
V. ISSUES THAT COAG MAY WISH TO CONSIDER
26. The Committee on Agriculture may wish to consider recommending to the 31
st FAO
Conference through the 120th FAO Council to endor se a common integrated approach to biosecurity
through:
• through further development in FAO's programmes relating to biosecurity and in
association with programmes of other relevant international organizations andsecretariats of international agreements of common methodologies, particularly for
risk-analysis, and further international standard-setting (including, where appropriate,
relevant environmental standards);
• in cooperation with programmes of other relevant international organizations and
secretariats of international agreements the development of  integrated management
and monitoring methodologies;
• seeking the cooperation of international agencies and secretariats of international
agreements to further the development of a coordinated international regulatory
framework for biosecurity for food and agriculture, taking into account agriculturalG/SPS/GEN/239
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sustainability, trade issues, food security, and environmental protection and
conservation;
• in cooperation with other relevant international organizations and secretariats,
establishing and implementing of a biosecurity information system which will drawon official information available from member countries, information from relevant
FAO programmes and from relevant international organizations and secretariats tointernational agreements; and
• FAO's programmes relating to biosecurity and in cooperation with other relevant
international Organizations and Secretariats of International Agreements, cooperating
in the creation of awareness and in capacity building across sectors.
27. The Committee on Agriculture may consider recommending through the 120th Council that
the 31
st Conference encourages Members to:
• coordinate among the relevant national authorities and ministries to adopt common
national actions and participate in common international actions, including theestablishment of international standards;
• modernise, harmonise and integrate national biosecurity legislation and regulations,
with the aim to rationalise sanitary and phytosanitary measures, while protectinghuman health and the environment;
• establish, rationalise and optimise national capacity;
• make optimal use of regional resources and capacities; and
• cooperate in the exchange of relevant official information among states.
28. The Committee on Agriculture may consider recommending through the 120th Council that
the 31
st Conference encourages Members who are in a position to do so, to provide technical
assistance to developing countries and to countries with economies in transition, to enable such
countries to establish, rationalise and optimise national capacity for biosecurity.
29. The Committee on Agriculture may also wish to consider recommending that the FAO
Secretariat, subject to extra-budgetary funding, sees to:
• the Convening of a Consultation on Biosecurity in Food and Agriculture, including
Forestry and Fisheries, for the second half of 2001 with the aim to create overall
awareness of the new concepts and opportunities in relation to biosecurity;
• the immediate development of an international information exchange mechanism to
enable members to identify relevant official biosecurity information for internationaltrade and transport;
• the development of manuals and guidelines for the application of risk analysis
principles to food safety, covering the entire food chain,
• the convening of a series of regional awareness and training sessions on all aspects of
biosecurity related to food and agriculture; and
• the provision of technical assistance, on request, to developing countries and
countries with economies in transition, in the establishment and development of
relevant policies, legislation and regulations and institutions.
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