Modern methods of travel, trade and communications have led to enormous increases in the movement of people, commodities and conveyances. Natural and national borders that once were effective barriers to the introduction and spread of unwanted organisms or material have shifted or have become more porous, as a result of political or other developments. Continental countries with land borders have always had difficulty monitoring and controlling the movement of pests across the borders, but expansion in the international movement of people and goods is causing increasing difficulties even in island nations, as the volumes of modern air and shipping traffic breach their natural defences against pest introduction.
To address these changing circumstances, and to keep pace with other international developments with regard to plants and plant products, countries and groups of countries have taken action to amend existing laws, regulations and international agreements, especially in the following three areas: (a) plant protection, including pest control and plant quarantine; (b) pesticide control; and (c) seeds and plant variety protection. This chapter will explore developments in these areas, all of which fall under the main heading of Plants.
Although the devastating effects of plant pests, including diseases and weeds, have been known throughout history, it is only recently that legal standards have been promulgated to prevent the spread of plant pests and to protect plant resources. It may be that in the past plant pests were viewed as divinely imposed and therefore beyond human control - like the recurring plagues of locusts in the Bible - but in more recent times the global community has worked to develop cooperative mechanisms to protect people, animals, plants and the environment from them. The growing importance of international trade has also been an impetus for regulatory change.
The adoption of the World Trade Organization (WTO) Agreement on Sanitary and Phytosanitary Measures (SPS Agreement) is undoubtedly the most significant international development relating to plants in the last ten years. The SPS Agreement establishes rules regarding sanitary and phytosanitary measures, guiding countries that are seeking to protect human, animal or plant life and health without impinging on international trade. The Agreement articulates a number of principles that are reflected in other later agreements and that are being incorporated into national legislation. The most important effect of the SPS Agreement is that it is binding and enforceable through the WTO dispute settlement procedure.
As a general matter, international agreements designed to address a specific global problem may adopt differing approaches to regulation. Some agreements outline desired goals and offer guidelines on courses of action; others establish precise standards to be met by parties to the agreement. Still others do not themselves establish standards, but instead recognize existing organizations as the source of present and future international standards in a particular subject area. Chapter 2 discussed the role of Codex Alimentarius (Codex) in establishing food safety standards, and Chapter 3 introduced the Office international des épizooties (OIE) as the international standard-setting organization for animal health and animal disease control. Along with Codex and the OIE, the SPS Agreement identifies the International Plant Protection Convention (IPPC) as the third source for international standard-setting, and as such the IPPC serves as the basis for the harmonization of plant protection legislation.
The IPPC is an international treaty relating to plant health. It was initially adopted by the FAO Conference in 1951 and came into force in 1952, superseding previous international plant protection agreements. It was revised in 1979 and its amendments came into force in 1991, and finally was further amended in 1997 to reflect the mandate articulated in the SPS Agreement that the IPPC would be the standard-setting organization for phytosanitary matters. The new wording of the Convention is currently awaiting acceptance by members countries, and will come into force 30 days after acceptance by two-thirds of the parties to the 1997 text.
In addition to its significant implications for international trade, the 1997 text of the IPPC embodies a number of other themes. For example, the 1997 text emphasizes cooperation and the exchange of information on plant protection. It also promotes the harmonization of phytosanitary measures and toward that end creates a procedure to develop International Standards for Phytosanitary Measures, and promotes their use. The text formalizes the IPPC Secretariat and the procedures for standard-setting, and outlines modern phytosanitary concepts, such as pest risk analysis to support phytosanitary measures, the designation of pest free areas and the phytosanitary security of export consignments after certification. Finally, the text makes provision for contracting parties to provide technical assistance to other contracting parties, especially developing countries, with the objective of facilitating implementation of the IPPC.
The 1997 text of the IPPC provides for the establishment of a Commission on Phytosanitary Measures that will serve as the IPPC's new governing body. The members of the Commission are the parties to the Convention and its functions are to review the state of plant protection in the world, provide direction to the work programme of the IPPC Secretariat and approve standards. The Commission is scheduled to meet annually, although special sessions may also be called. An Interim Commission on Phytosanitary Measures (ICPM) has been established until the new text comes into force.
The 1997 text reflects several conceptual shifts. One is changing the focus from national defensive responses to an international joint plan of action on plant protection. Another is that application of the text is not limited only to the protection of plants in agriculture and agricultural trade, but rather extends also to the protection of natural flora and the environment. In addition, the text applies both to direct and indirect damage by pests such as weeds. The IPPC has always been an important agreement for promoting trade in agricultural, horticultural and forestry products, but as governments become more concerned about the adverse impact of weeds and other invasive organisms on biodiversity and natural habitats as well as on commercial crops, the Convention is also acquiring an increasingly important role as a framework to be applied to matters of environmental protection.
The IPPC is a formal international convention, but the standards developed and adopted under its aegis are not in themselves binding. They do however become binding on WTO members, in that member states are required to base their phytosanitary measures on the international standards developed within the framework of the IPPC. Countries are not restricted to IPPC standards, however: they may establish their own standards so long as they justify any deviation from existing international standards through risk analysis. Risk analysis must also be used where countries develop their own requirements in the absence of any international standard. This practice is widespread, as there are only a limited number of standards established under the IPPC, as compared to standards established by the OIE and Codex.
The IPPC Secretariat became functional at FAO headquarters and established its standard-setting programme in 1992, the same year as the Rio Conference. The Secretariat has the responsibility for coordination of the work programme and for the global harmonization of phytosanitary measures under the IPPC. 1994 saw the first meeting of the Committee of Experts on Phytosanitary Measures, which was replaced by the Interim Standards Committee in 2000 and the Standards Committee in 2000. This is a group of phytosanitary experts from around the world that meets bi-annually to review draft standards, taking into consideration comments submitted by governments, and to comment on the suitability of documents prepared by the Secretariat.
The first international standards for phytosanitary measures (ISPMs) were approved by the FAO Conference in 1995, and since 1998 they have been approved by the ICPM. A number of ISPMs have been prepared and adopted, as shown in the following box. Many of these standards are already being used as the basis for the resolution of trade disputes between WTO members.
International Standards for Phytosanitary Measures
ISPM 1 - Principles of Plant Quarantine as Related to International Trade (1995): intended to reduce or eliminate the use of unjustifiable phytosanitary measures as barriers to trade;
ISPM 2 - Guidelines for Pest Risk Analysis (1996): describes the process of pest risk analysis to assist National Plant Protection Organizations in the preparation of phytosanitary regulations;
ISPM 3 - Code of Conduct for the Import and Release of Exotic Biological Control Agents (1996): lists the responsibilities of government authorities and of exporters and importers of biological control agents;
ISPM 4 - Requirements for the Establishment of Pest Free Areas (1996): outlines the requirements for the establishment and use of pest free areas in connection with phytosanitary certification of plants and plant products for export;
ISPM 5 - Glossary of Phytosanitary Terms (1999): lists terms and definitions relevant to phytosanitary systems worldwide and provides a harmonized internationally agreed vocabulary;
ISPM 6 - Guidelines for Surveillance (1997): describes the components of surveillance and monitoring systems for pest detection or for the provision of information for use in pest risk analysis, the establishment of pest free areas or the preparation of pest lists;
ISPM 7 - Export Certification System (1997): describes the components of a national system for the issuance of phytosanitary certificates for export;
ISPM 8 - Determination of Pest Status in an Area (1998): describes the content of a pest record, and outlines the use of pest records and other information in the determination of pest status in an area;
ISPM 9 - Guidelines for Pest Eradication Programmes (1998): describes the components of a pest eradication programme which can lead to the establishment or re-establishment of pest absence in an area;
ISPM 10 - Requirements for the Establishment of Pest Free Places of Production and Pest Free Production Sites (1999): describes these requirements, similar to pest free areas;
ISPM 11 - Pest Risk Analysis for Quarantine Pests (2001): provides details for the conduct of pest risk analysis to determine whether pests are quarantine pests;
ISPM 12 - Guidelines for Phytosanitary Certificates (2001): describes principles and guidelines for the preparation and issue of phytosanitary certificates;
ISPM 13 - Guidelines for the Notification of Non-compliance and Emergency Action (2001): describes the actions to be taken by countries regarding the notification of instances of failure of an imported consignment to comply with specified requirements;
ISPM 14 - The Use of Integrated Measures in a Systems Approach for Pest Risk Management (2002): provides for the development and evaluation of integrated measures in a systems approach as an option for pest risk management for import;
ISPM 15 - Guidelines for Regulating Wood Packaging in International Trade (2002): describes phytosanitary measures to reduce the risk of introduction and/or spread of quarantine pests associated with wood packaging material;
ISPM 16 - Regulated Non-quarantine Pests: Concept and Application (2002): describes the concept of regulated non-quarantine pests and identifies their characteristics;
ISPM 17 - Pest Reporting (2002): describes the responsibilities of and requirements for contracting parties in reporting the occurrence, outbreak and spread of pests in areas for which they are responsible.
Agricultural pests often migrate or spread across borders and can cause major losses. Damage can be catastrophic, leading to famines and sometimes triggering trade problems. Developing countries are frequently not able to react sufficiently quickly to such events, and extensive emergency operations as well as international assistance may become necessary.
Although there may be effective control methods for the particular pests and diseases, crisis management inevitably involves delays, a low efficiency/cost ratio and an inability to contain the problem before it has had a chance to spread. For all these reasons, as noted in Chapter 3, in 1994 FAO established the Emergency Prevention System for Transboundary Animal and Plant Pests and Diseases (EMPRES) in order to minimize the risk of such emergencies. Initial priority was given to two transboundary pest and disease problems: the desert locust and animal diseases.
The locust programme initially focused on the nine countries bordering the Red Sea and Gulf of Aden which have historically been a source of many outbreaks and plagues: Djibouti, Egypt, Eritrea, Ethiopia, Oman, Saudi Arabia, Somalia, Sudan and Yemen. The programme is now being extended to West Africa.
Regional Plant Protection Organizations (RPPOs) provide coordination on a regional level for the activities and objectives of the IPPC. The role of regional organizations has been expanded in the 1997 text of the IPPC to specify their cooperation with the Secretariat and the Commission. In addition to promoting the objectives of the IPPC, RPPOs disseminate information relating to the IPPC and cooperate with the ICPM and the IPPC Secretariat in developing international standards. They also develop regional standards in harmony with international ones.
There are in existence nine RPPOs, one of which has been established since Rio: the Pacific Plant Protection Organization was created in 1995 upon a resolution of the South Pacific Conference, by the member countries of the Secretariat of the Pacific Commission. An agreement was signed in 1993 to establish the Near East Plant Protection Organization, although it has not yet begun to function.
In November 1997, the FAO Conference recommended that locust-affected countries reevaluate existing regional locust control structures in order to achieve an appropriate and efficient geographic coverage taking into account the effectiveness of these structures, and to establish a realistic financial provision that would assist affected member Nations to take common action. As a result of these recommendations, FAO invited countries affected by the desert locust (Algeria, Chad, Libyan Arab Jamahiriya, Mali, Mauritania, Morocco, the Niger, Senegal and Tunisia) as well as the secretariats of the two existing regional organizations, the FAO Commission for Controlling the Desert Locust in North West Africa and the Organisation commune de lutte antiacridienne et antiaviaire, to meet to develop a common strategy. Two meetings were held in Rome in the first half of 1999 and participants unanimously agreed that a new common regional cooperation body should be established within the FAO framework.
A ministerial meeting on the restructuring took place in Rome in November 1999, and confirmed that a new organization should be established. The meeting requested the Director-General of FAO to convene a Legal and Technical Consultation on a draft Agreement for the Establishment of a Desert Locust Control Commission for the Western Region. The Agreement was approved by the FAO Council in November 2000, and, thus far, five member nations have deposited their instruments of acceptance: Algeria, Chad, Mali, the Niger and Senegal.
Pesticides are chemicals used to kill pests, such as insects, fungi, weeds, nematodes, rats, mice, mites, ticks and snails. Pesticides may also kill other organisms, and most are poisonous to humans. FAO has prepared a number of guidelines for pesticides management, which are frequently used as the basis for the development of policies and practices in countries looking to initiate or improve their pesticide management schemes. The FAO pesticides management guidelines encourage responsible trading practices by assisting countries in establishing controls to regulate the quality and suitability of pesticide products as well as the safe handling and use of such products. The guidelines address such topics as registration and control of pesticides; legislation; personal protection for those working with pesticides; good labelling practices; pesticide storage and stock control; and tender procedures for the procurement of pesticides. A number of such guidelines have been issued or reissued by FAO within the last ten years.
Guidelines on Good Labelling Practice (revised) (1995): FAO first published Guidelines on Good Labelling Practice for Pesticides in 1985. They are intended for use by those involved in the pesticide industry as well by national regulatory personnel. The document provides guidance on the preparation of pesticide labels including specific recommendations for content and layout. Since 1985 there have been considerable changes in regulations and requirements, and accordingly these guidelines have been revised and updated. The new document, adopted in 1995, contains four main sections and appendices. The first section identifies the main objectives and considerations in preparing a label; the second identifies the information that must appear on a label; the third addresses writing a label with maximum clarity while taking into consideration the level of knowledge of users; and the last discusses the establishment of toxicity and hazard classifications for a product. The appendices contain examples of labels, hazard statements, agricultural practice statements and other summaries of specific and generic labels.
FAO Manual on the Submission and Evaluation of Pesticide Residues Data for the Estimation of Maximum Residue Levels in Food and Feed (1997): The FAO manual on pesticide residues data compiles information and principles which are currently used to estimate maximum residue levels (MRLs) and supervised trials of median residue levels. The aims of the FAO Manual are to:
clarify, update and consolidate the procedures used to evaluate experimental data and related information;
improve transparency in the work of the FAO panel which develops these guidelines;
define and provide guidance on the type, amount, quality and format of data submissions required for the estimation of MRLs on which the Codex MRLs are based;
facilitate the acceptance of Codex MRLs by governments and foster their use under the SPS Agreement;
serve as a source of information and instruction for all those directly involved in the activities of the FAO panel; and
assist member countries in evaluating residue data for the registration of pesticides and in developing their national evaluation systems.
Pesticide Storage and Stock Control Manual (1995) and Guidelines on the Prevention of Accumulation of Obsolete Pesticide Stocks (1995): Because pesticides are usually stored before use, FAO has developed a Pesticide Storage and Stock Control Manual to convey the importance of pesticide storage practice and stock control. Most developing countries have outdated and deteriorated stocks of pesticides that can no longer be used as prescribed on the label, and such stocks are often stored in poor conditions that pose a threat to human health and the environment. With the exception of a few newly industrialized countries, developing countries do not have adequate facilities to dispose of such stocks in a safe and environmentally sound manner. In view of the danger as well as the high costs of safe and environmentally sound disposal, the long-term solution to obsolete stocks lies in preventive measures: improved stock management and reduction of stocks.
The objective of the Guidelines on the Prevention of Accumulation of Obsolete Pesticide Stocks is to raise awareness about the mechanisms by which obsolete pesticide stocks accumulate and to enhance the formulation of policies and procedures aimed at prevention of such accumulation. The guidelines are useful for aid agencies, the pesticide industry and governments of developing countries, in particular ministries of agriculture and ministries of health.
Provisional Guidelines on Tender Procedures for the Procurement of Pesticides (1994): The guidelines on tender procedures are intended to instruct both suppliers and procurers of pesticides on the steps to be taken to ensure that pesticides obtained are of the required quality and are suitably packaged and labelled, taking into account local transport and warehousing conditions. The recommendations are relevant to all procurement agencies - government agencies, donors and private dealers - regardless of the ultimate user of the pesticides. The guidelines are designed to minimize problems commonly encountered in developing countries, such as supply of substandard and inappropriate formulations, contained in unsuitable packaging of poor quality with inadequate labelling. This can lead to leakage, degradation of contents and misuse.
Manual on the Development and Use of FAO Specifications for Plant Protection Products, 5th edition (1999): The establishment of voluntary standards to reduce risks associated with the use of pesticides is one of FAO's primary objectives in plant protection. The development of FAO specifications was a vital tool in this regard, designed to ensure that pesticides complying with the specifications are satisfactory for the purpose for which they are intended and that they do not present unexpected hazards. FAO specifications may be used (i) as part of a contract of sale so that a buyer may purchase a pesticide with some guarantee of the quality expected; and (ii) for the competent authority to check that the quality of the formulation on the market is the same as that registered. The specifications are intended to enhance confidence in the purchase and use of pesticides and, at the same time, to contribute to better pest control measures and agricultural production. The 5th edition of the Manual describes in detail a new procedure for the development of FAO specifications, under which the data requirements have been expanded dramatically. Now, specifications will apply only to products for which the technical materials have been evaluated by FAO, instead of to any notionally similar product, as under the previous procedure.
The Convention on the Prior Informed Consent Procedure (PIC) for Certain Hazardous Chemicals and Pesticides in International Trade, adopted in 1998 but not yet in force, represents an important step towards protecting the world's peoples and environment from the dangers of highly dangerous pesticides and chemicals. It will establish a first line of defence against future harm by preventing unwanted imports of dangerous chemicals, particularly in developing countries. Previously, the PIC system was grounded primarily on two non-binding instruments: the 1985 FAO Code of Conduct on the Distribution and Use of Pesticides, and the 1987 UNEP London Guidelines for the Exchange of Information on Chemicals in International Trade. In 1989, both the FAO Code and the UNEP Guidelines were amended to include specific provisions on PIC.
The PIC procedure helps participating countries learn more about the characteristics of potentially hazardous chemicals that may be shipped to them, initiates a decision-making process on the future importation of these chemicals and facilitates the communication of the importing country's decision to other countries. The Convention gives importing countries the power both to decide which chemicals they want to receive and the choice of excluding those they cannot manage safely. If trade does take place, the Convention imposes requirements for labelling and the provision of information on potential health and environmental effects.
Pesticides and chemicals are subject to PIC if their use has been entirely prohibited or severely restricted, refused approval for first-time use or withdrawn from the market because of environmental or health reasons, as a result of a final government regulatory action. The PIC procedure normally applies to any such pesticide or chemical upon notification to and listing by FAO or UNEP. It is implemented through a joint FAO/UNEP Secretariat, FAO being the lead agency for pesticides and UNEP the lead agency for other chemicals.
Persistent Organic Pollutants (POPs) are chemical substances that persist in the environment, bioaccumulate through the food web and pose a risk of adverse effects to human health and the environment. POPs are highly toxic, causing an array of adverse effects among humans and animals, notably morbidity, disease and birth defects. In addition, POPs concentrate in living organisms through bioaccumulation. Though not soluble in water, POPs are readily absorbed in fatty tissue, where concentrations can become enormously magnified. Fish, predatory birds, mammals and humans are high up the food chain and so absorb the greatest concentrations. When they travel, POPs travel with them, and thus POPs can be found in people and animals thousands of kilometres from any major POPs source. With the appearance of these substances in regions where they have never been used or produced and the consequent threats they pose to the global environment, the international community called for urgent global action to reduce and eliminate releases of such chemicals.
The POPs Convention was adopted in Stockholm in 2001. It covers a dozen POPs including pesticides, industrial chemicals and hazardous by-products of combustion: aldrin, chlordane, DDT, dieldrin, dioxins, endrin, furans, heptachlor, hexachlorobenzene, mirex, toxaphene and polychlo-rinated biphenyls (PCBs). Most of the 12 chemicals are subject to an immediate ban, except for a health-related exemption which has been granted for DDT, as it is still needed in many countries to control mosquitoes. The exception will permit governments to protect their citizens from malaria - a major killer in many tropical regions - until they are able to replace DDT with cost-effective and environmentally friendly alternatives.
In the case of PCBs, although they are no longer produced, hundreds of thousands of tonnes are still in use in electrical transformers and other equipment. Under the Convention, governments may maintain existing equipment in a way that prevents leaks until 2025, to give them time to arrange for PCB-free replacements. In addition, a number of country-specific and time-limited exemptions have been agreed for other chemicals: for example, governments agree to reduce releases of furans and dioxins, which are accidental by-products and thus more difficult to control, with the goal of their continuing minimization and, where feasible, ultimate elimination.
The Convention sets out control measures covering the production, import, export, disposal and use of POPs, according to which governments are to promote the best available technologies and practices for replacing existing POPs while preventing the development of new POPs. To carry out their commitments, countries will draw up national legislation and develop action plans. Although the control measures will apply to the initial list of 12 chemicals cited above, a POPs Review Committee will consider additional candidate chemicals for the POPs list on a regular basis, thus ensuring that the treaty remains dynamic and responsive to new scientific findings.
In 1996 FAO developed a Special Action Programme on Seeds to ensure that emerging trends in seed development are more appropriately and effectively addressed. The programme aims, among other things, to develop national seed policies, plans and programmes, to define seed security strategies and to train and organize farmers.
A great deal of attention has been paid to plant variety protection in recent years. The justification for protecting new plant varieties is to encourage plant breeders to invest the time and resources necessary to improve existing varieties. The argument is that without exclusive rights, breeders will not have sufficient incentives to develop new varieties. In addition, the grant of exclusive rights to plant breeders is intended to benefit society, as it should encourage research and development into new breeding techniques and new varieties, thereby reducing the need for government funding in these areas. An international system of protection for plant varieties expands these benefits by facilitating access to new varieties created in other states. The assumption is that once breeders are assured that their rights will be protected in other states, they will be more willing to make their new varieties available.
Two international agreements relating to plant variety protection have come into force since Rio, the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights, which became effective in 1995, and the 1991 UPOV Act (Union internationale pour la protection des obtentions végétales), which came into force in 1998. These two treaties contain comprehensive rules for their member states regarding the protection of plant varieties.
The 1991 UPOV Act requires states to protect at least fifteen plant genera or species upon becoming members of the Act, and to extend protection to all plant varieties within ten years. A variety is eligible for protection if it is novel, distinct, uniform and stable. Once protection is granted, prior authorization must be obtained from the breeder by any person seeking to use reproductive or vegetative propagating material of the variety for: (1) production or reproduction; (2) conditioning for the purpose of propagation; (3) offering for sale; (4) selling or marketing; (5) exporting; (6) importing; or (7) stocking for any of these purposes. (Art. 14)
The 1991 UPOV Act requires national treatment, meaning that whatever rights member states grant to their nationals in their own plant variety protection laws, they must also grant to nationals of other 1991 Act member states. For example, if a 1991 Act member chooses to grant more expansive exclusive rights to breeders than the exclusive rights required by the 1991 Act, it must grant those rights to breeders from all other 1991 Act member states. The Act also contains a compulsory licence provision, meaning that a member may restrict a breeder's exclusive rights only in the public interest. However, equitable remuneration must be paid to the breeder whose rights are limited.
The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) requires its member states to protect new plant varieties using patent rights, a sui generis system of protection (that is, a system of its own kind) or some combination thereof. The TRIPS Agreement is unusual in that it seeks to establish universal, minimum standards of protection across the major fields of intellectual property, including patents, copyrights, trademarks, industrial designs, integrated circuits and trade secrets. Although the TRIPS Agreement devotes only minimal attention to plant varieties, its article 27(b)(3) has done more to encourage the legal protection of plant varieties than any other international agreement.
TRIPS is part of a set of trade-related treaties on a variety of subjects going far beyond intellectual property rights. Other treaties adopted during the Uruguay Round of Multilateral Trade Negotiations covered agriculture, sanitary and phytosanitary measures, technical standards, textiles and trade in goods and services. TRIPS was only one part of a global package deal, under which developing countries agreed to provide minimum standards of effective intellectual property protection, and in exchange developed countries agreed to open their domestic markets to goods and other products manufactured by producers in the developing world. (Helfer, 2002) The TRIPS Agreement is binding on all WTO members except for the least developed countries, which have until 2006 to implement the treaty's obligations.
In the development of regional trading blocs, policymakers are increasingly drawing attention to the need to harmonize standards so as to facilitate trade. One of the first stated tasks of the newly created African Union, for example, is to assess the web of food safety, phytosanitary and animal health standards on the continent, and to make recommendations for harmonization in order to remove barriers to trade. Interest in the harmonization of standards for trade purposes has triggered the development of standards at the regional level, where regional standard-setting organizations exist. These regional standards must be consistent with the SPS Agreement and other applicable international obligations, although they may address areas not yet covered by international standards. For example, a regional organization may develop a standard for surveillance of a particular pest in the region, although that standard will be based on science and on the existing IPPC surveillance standard.
The relationship between a regional economic grouping and its relevant standard-setting organization varies. At one end of the spectrum might be the North American Free Trade Agreement and the North American Plant Protection Organization, where the standards established by the latter have direct legal effect. At the other end of the spectrum, standards established by the European Plant Protection Organization are not binding on European Union members, although they are persuasive and are most often taken on board. As noted, however, regional standards, whatever their effect, must be based on science and on what has already been agreed at the international level.
Andean Community: The Andean Community has recognized the importance of public knowledge on the phytosanitary situation of its member countries and has approved Resolution 419 of 1996, which contains a sub-regional pest and plant diseases inventory that is intended to be updated. This Resolution arose from Decision 328 of 1992, which proclaimed the necessity of surveillance against exotic pests and diseases of plants.
Caribbean Community (CARICOM): In 2001 FAO prepared a model plant quarantine law for the Caribbean region, following country consultations and a discussion of the draft law at a meeting of the Caribbean Plant Protection Commission. The Commission recommended that a more detailed discussion be carried out, and a meeting of Caribbean countries was held in August 2002 to finalize the draft. Individual countries wishing to follow the regionally agreed guidelines will have to enact a nationally tailored version of the model law to ensure that the legislation captures local circumstances and needs.
The existence of harmonized plant quarantine laws is intended to facilitate trade in agricultural products among CARICOM countries and with other trading partners. It should also facilitate compliance with the WTO, as the model law applies the concepts and terminology of the SPS Agreement and the 1997 text of the IPPC. Harmonized legislation should also provide a good foundation for incipient regional efforts to create a Caribbean Agricultural Health and Food Safety Agency, as noted in Chapter 2.
Comité de sanidad vegetal del Cono Sur (COSAVE) and the Mercado Común del Sur (MERCOSUR): COSAVE is an RPPO established in 1989 within the framework of the IPPC through an agreement among its member countries (Argentina, Brazil, Chile, Paraguay and Uruguay). Its main objective is regional plant protection. After the formation of the WTO and MERCOSUR, it started to develop regional standards to harmonize phytosanitary regulations and procedures in order to facilitate regional and international trade in agriculture products. Phytosanitary standards issued by COSAVE make possible the harmonization of plant protection methods among the member countries, while preventing phytosanitary measures being used as barriers to the regional and international trade. To accomplish this objective, NPPOs may use COSAVE's standards to establish their own phytosanitary regulations, and as technical references to solve any bilateral controversy on the application of such regulations.
The interaction between COSAVE and MERCOSUR assists in creating effective regional phytosanitary measures. COSAVE standards are horizontal, and support the vertical standards of MERCOSUR. MERCOSUR's vertical standards apply the concepts designed by COSAVE to develop normative and practical procedures related to regional and international trade. COSAVE standards are not compulsory, but the developed guidelines are incorporated into MERCOSUR's community legislation as provided in Resolutions GMC 12/93 and 59/94. COSAVE also carries out the initial phases of pest risk analysis, identifying which pests are of quarantine concern. It then develops the later phases, establishing the phytosanitary requirements for each specific product from specified origins.
COSAVE has adopted the following standards since Rio:
Guidelines for the development and adoption of regional standards in plant protection (1995), which describe the process of elaboration and adoption of COSAVE regional standards;
Principles of plant quarantine in relation to international trade (1995), which are intended to reduce or eliminate the use of unjustified phytosanitary measures as barriers to trade;
Glossary of terms related to the registration of phytosanitary products (1996), which describes the officially accepted terms concerning regulations of phytosanitary products;
Guidelines for the establishment of a system of phytosanitary certification for export (1998), which describe the elements of a national system of phytosanitary certification;
Guidelines to authorize official inspectors to issue phytosanitary certificates (2000), which outline the responsibilities of NPPOs and the basic levels of training, knowledge and authority that their officers need to have to issue phytosanitary certificates in conformity with the IPPC;
Procedures for the approval of quarantine treatments (2000), which describe procedures used by COSAVE in order to recognize quarantine treatments used by the respective NPPOs of the member states;
Labelling of phytosanitary products (2000), which prescribes the contents and form of compulsory labels for phytosanitary products.
European Union (EU): With Directive 77/93/EEC, the EU established a Community Plant Health Regime, specifying the phytosanitary conditions, procedures and formalities to which plants and plant products are subjected when introduced into or moved within the EU. In particular, this directive prohibits the introduction into member states of certain harmful organisms which were listed in an inventory. For the sake of clarity and internal consistency, the directive has been amended on a number of occasions, often substantively. Directive 95/44/EC of 1995, for example, establishes the conditions under which certain harmful organisms, plants, plant products and other objects listed in the annexes to Directive 77/93/EC could be introduced into or moved within the EU, for experimental or scientific purposes and for work on varietal selections. It was finally consolidated in Directive 2000/29/EC of 8 May 2000.
Gulf Cooperation Council (GCC): FAO assisted the Gulf Cooperation Council in the revision of a draft Plant Quarantine Law for the Gulf Region in 2001. At a meeting with legal and quarantine experts from the six Gulf countries (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and United Arab Emirates), the contents and format of the law were agreed upon. The law is intended to harmonize quarantine activities in the region and facilitate compliance with the SPS Agreement, and has since come into force.
Pacific Plant Protection Organization (PPPO): The Pacific Plant Protection Organization in 2001 agreed to guidelines for drafting biosecurity laws in the region, which have been used to draft legislation for Kiribati and Niue.
North American Plant Protection Organization (NAPPO): NAPPO has been very active in preparing and reviewing regional standards in the last ten years. Some of the most important include:
Guidelines for the Use of Irradiation as a Phytosanitary Treatment (1997), which offer guidance for the evaluation, adoption and use of irradiation as a phytosanitary treatment;
Accreditation of Laboratories for Phytosanitary Testing (1998), which outlines criteria for the accreditation of diagnostic laboratories to perform specific functions in support of phytosanitary certification;
NAPPO Glossary of Phytosanitary Terms (1999), which is intended for use within NAPPO and by the NPPOs in the NAPPO region, and which includes only those terms that are defined in NAPPO standards or other current NAPPO policy documents that do not occur in the FAO Glossary of Phytosanitary Terms;
Guidelines for Preclearance Programs (2000), which contain a framework for establishing preclearance programs between NAPPO member countries;
Accreditation of Individuals to Sign Federal Phytosanitary Certificates (2001), which describes the responsibilities of NPPOs and the base level of knowledge, skills, ability and authority appropriate for NPPO officials to sign phytosanitary certificates under the IPPC;
and a number of other standards on pest free areas, on the pest status of particular pests in the region and on the import of particular products into the NAPPO area.
Andean Community: The Andean Community issued in 1998 Decision 436 concerning the registration and control of chemical pesticides for agricultural use. It establishes requirements and harmonized procedures for the registration and control of chemical pesticides for agricultural use, to regulate their use and correct handling in order to prevent and minimize damage to health and the environment as well as to facilitate trade in the sub-region. Manufacturers, importers, exporters and whole-salers of pesticides for agricultural use are required to be registered by the competent national authority. Special permits are also required for research and scientific experiments.
COSAVE and MERCOSUR: For pesticides, a 1997 COSAVE standard establishes procedures and criteria for the harmonization and adoption of procedures and analytical methods for phytosanitary products and their residues in accredited laboratories in the region. In 2002, two standards were elaborated on pesticides: one outlines the requirements for proper labelling of phytosanitary products, including the contents and form of labels that are required for particular formulations, and the other describes and codifies the internationally accepted formulations for use in the region. An earlier standard (1995) set out the requirements that must be considered for the accreditation of bodies that will assess the efficacy of phytosanitary products.
In the area of biological control, COSAVE has adopted several standards regarding biological control agents (BCAs), the first on their import, quarantine and release (1996). Another standard elaborated basic procedures and requirements for the registration of BCAs and other biological control products (1997), and a recent standard addressed the establishment and functioning of quarantine laboratories for BCAs in the region (2000). The member states of MERCOSUR decided with Resolution 48/96 of 1996 to establish a common list of products that can freely be circulated in the common market. They also agreed on a process aimed at harmonizing national pesticides registries.
EU: Directive 99/45/EC relates to the classification, packaging and labelling of dangerous preparations. Classification is to be carried out based on the degree of hazard of the particular product, and member states are also required to follow certain packaging requirements before placing such products on the market. Directive 94/43/EC establishes uniform principles for the evaluation and authorization of plant protection products.
Directive 98/8/EC concerns the authorization and placing on the market of biocidal products; the mutual recognition of authorizations within the EU; and the establishment at EU level of a list of active substances which may be used. Member states are required to prescribe that a biocidal product may not be placed on the market and used within their territory unless it has been authorized in accordance with the directive. Products must be classified, packaged and labelled in accordance with the directive as well.
Directive 2000/80/EC of 4 December 2000 amended Annex I of Directive 91/414/EEC concerning the placing of plant protection products on the market, so as to consolidate that Annex and include a further active substance. The directive provides that after inclusion of an active substance in Annex I, member states must, within a prescribed period, grant, vary or withdraw, as appropriate, the authorizations of the plant protection products containing the active substance. In particular, plant protection products should not be authorized unless account is taken of the conditions associated with the inclusion of the active substance in Annex I and the uniform principles laid down in the directive.
European Plant Protection Organization (EPPO): EPPO issued Guidelines on Good Plant Protection Practice in 1998. The main purpose of the EPPO recommendations is to provide guidance on whether to use plant protection products and how to use them safely and effectively. EPPO also approved a standard for the efficacy evaluation of plant protection products in 1999, which describes how the risk of resistance to plant protection products can be assessed and, if appropriate, systems for risk management can be proposed.
Permanent Interstate Committee for Drought Control in the Sahel (Comité Permanent Inter-Etats de Lutte contre la Sécheresse dans le Sahel, CILSS): In 1999 CILSS revised its Common Regulation for the Registration of Pesticides. The main objective of the regulation is to combine the expertise on pesticide evaluation and management in all CILSS member states for purposes of pesticides registration. The revision was adopted by the 34th session of the CILSS Council of Ministers, held in N'Djamena, Republic of Chad, as Resolution 8/34/CM/99.
Andean Community: Decision 345 of 1993 of the Andean Community established a common regime for the protection of plant breeders' rights.
CARICOM: In 1995 FAO prepared a model Seed Law for the Caribbean, which incorporates updated definitions and concepts relating to seed certification and control, and draws on the national seed policies and plans which most countries have already considered and adopted. A number of countries have carried out discussions at the national level intended to lead to enactment of national legislation based on the model law.
EU: Directive 98/44/EC of 1998 on the Legal Protection of Biotechnological Inventions provides that biological material which is isolated from its natural environment or produced by means of a technical process may be patentable. Member states must adjust their national patent laws to take account of the provisions of this directive. For the purposes of the directive, inventions which are new, which involve an inventive step and which are susceptible of industrial application shall be patentable even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used. Plant varieties and essentially biological processes for the production of plants shall not be patentable.
Regulation EC/2100/94 on plant variety rights establishes an EU system as the sole and exclusive form of EU intellectual property rights for plant varieties. Generally the system tracks the 1991 UPOV Act, with minor differences. EU plant variety rights cover varieties of all botanical genera and species, including hybrids between genera or species. A Community Plant Variety Office is established for the implementation of this regulation.
MERCOSUR: In the seed area, MERCOSUR adopted in 2000 Resolution 1/00 which sets up criteria for the elaboration of standards for the production of certified propagating material with the aim of facilitating trade of seeds within member states. For plant varieties, the member countries of MERCOSUR signed an Agreement of Cooperation related to the Protection of Plant Breeding in 1998 (No. 2/98). The objective of the agreement is to adapt countries' plant protection legislation to the provisions of the 1978 UPOV Act. The agreement defines rules on plant variety protection regarding equal treatment (art. 1); denomination of varieties (art. 2); harmonization of technical examinations (art. 3); exchange of information (art. 4); harmonization of administrative procedures (art. 5); and cooperation (art. 6).
Organization of African Unity (OAU): The foreign ministers of the member states of the OAU issued a statement in 1999 calling for a hold on intellectual property protection for plant varieties until an Africa-wide system has been developed that grants greater recognition to the cultivation practices of indigenous communities. However, at a subsequent meeting of the Organisation Africaine de la propriété intellectuelle, patent officials from sixteen francophone African nations recommended that their countries adopt the 1991 UPOV Act.
As noted earlier, the most important influence on national legislation relating to plant protection in the last ten years has been the adoption of the SPS Agreement and the new revised text of the IPPC (1997). Many countries are amending their existing plant protection laws, or enacting new ones, to ensure that their legislation uses the new definitions from the IPPC and the Glossary of Phytosanitary Terms, and that their laws reflect the concepts and rules of the SPS Agreement.
Another recent development is the trend toward the establishment of a central national food safety authority, discussed in Chapter 2. Such central authorities often draw together food safety, animal health and phytosanitary matters under one roof, and coordinate national inspection activities in two or more of these fields. El Salvador's Ley de sanidad vegetal y animal of 1995 abrogates earlier legislation and combines the protection of plant and animal health. Under the law, Consultative Councils of Plant Health and Animal Health will draw on government representatives, producers, professional associations, academic institutions and other organizations. Peru's Servicio nacional de sanidad agraria is a decentralized government body charged under the Ley marco de sanidad agraria of 2000 with addressing all risks to the agricultural health of the country, whether zoosanitary or phytosanitary. Central food and sanitary authorities may also be established as agencies not under the auspices of any ministry, so as to ensure their independence.
National plant protection laws can follow many forms, but there are certain elements that FAO has been advising countries to include when updating phytosanitary legislation or preparing new phytosanitary laws. The following discussion centres on these elements, although it should be borne in mind that not all matters outlined here are essential in every country. The decision of what to include and what to exclude will depend on the international obligations, policy priorities, existing structures, budgetary constraints and human resources of a country at the time of enactment.
Title and preliminaries: The title and preamble outline the ambit of the plant protection law, stating its purpose and scope. The preamble has no real legal effect, but instead outlines why the law was enacted, what purpose it is intended to serve and what areas are covered by it. For example, the draft Plant Quarantine Act for Ghana is termed an Act to provide for the efficient conduct of plant quarantine in Ghana and to assist in the prevention of the importation or spread of plant pests. Similarly, a bilateral agreement between Croatia and Bulgaria on plant protection signed in 1996 aims to protect plants and plant products through the prevention of the introduction and spread of plant pests and diseases on the territory of the contracting parties.
One notable development in the years since Rio is that whereas existing plant protection legislation in many countries provides that the Minister can take action only to prevent the introduction of a plant pest, newer laws adopt the concepts of the 1997 text of the IPPC, which recognizes that even pests already established in a country may be regulated at borders if they are under official control within the country.
Definitions: All phytosanitary laws include a list of definitions of the main terms employed. Because the SPS Agreement requires countries to rely on international standards developed by the IPPC for phytosanitary matters, the definitions in recently drafted plant protection laws use the language and concepts established under the 1997 text, including the Glossary of Phytosanitary Terms. In fact, the existence of these global reference points for phytosanitary terminology has been one impetus for many countries to seek to harmonize their legislation using these terms. Countries can also introduce their own terms to meet national needs: for example, the draft plant protection legislation for Sudan introduces the term pests of national concern. This innovative concept is designed to ensure that the Act will apply to all pest control programmes, pest management activities and pests, even those of purely domestic interest.
It must be emphasized that in all legislation, no matter the subject matter, the list of definitions is not a glossary of terms in general. The definitions that are included must be only those that appear in the body of the law, and the definitions should not be overly detailed but should be designed solely for the purpose of application and interpretation of the law.
Administration: The Administration part of a modern phytosanitary law contains the enabling provisions, which are those that define the nature and the limits of the powers to be exercised under the law and also identify the persons or institutions in whom those powers are to be vested. Normally a phytosanitary law vests power in the Minister responsible for agriculture, although naturally he or she may delegate necessary powers to the National Plant Protection Organization (NPPO). The duties assigned to the NPPO in the law are usually those listed in the 1997 text of the IPPC. For example, the draft legislation for Sudan sets out in detail the mandate and responsibilities of the NPPO, and those details are based on the IPPC.
In many countries, the initial screening of plant products in the possession of ship and airline passengers is done by officers of the Customs Department rather than the Ministry responsible for agriculture. Accordingly, recent phytosanitary laws may state that although the Ministry responsible for agriculture has the ultimate authority for all plant protection inspection activities (because it is the Ministry with the relevant expertise in plant health matters), the Minister may nonetheless call upon officers of other ministries to assist with implementation of the Act. Where the delegation clause is restricted only to government officials, however, this may conflict with a recent trend in many countries for NPPOs to out-source some of their inspection and other activities to contracted parties. A restrictive delegation clause would have to be amended if an NPPO intended to privatize certain government functions.
Because plant protection intersects with other government departments, quasi-governmental agencies and the private sector, it is important that the law make provision for coordination. Most modern phytosanitary laws establish a mechanism for consultation and joint decisionmaking such as a Plant Protection Board, which has as its essential mandate the provision of advice to the Minister responsible for agriculture on all matters related to plant protection in the country. The specific membership will vary from country to country but, in general, all the relevant governmental bodies and stakeholders should be represented, to ensure that all parties interested in and affected by plant protection issues in the country will be able to give their inputs. This also fosters transparency in decisionmaking. Due to the technical complexity of many matters the Board will be called on to address, for example in carrying out pest risk analysis, it must have representation from scientific experts or must be able to constitute technical committees to draw upon their expertise.
Finally, an important administrative provision that may be included in newer phytosanitary laws, which does not often appear in older laws, establishes a Phytosanitary Emergency Fund which can be used when the Minister declares a phytosanitary emergency. The Board generally has the task of developing the applicable criteria for when an emergency should be declared, which triggers activation of the Fund. Alternatively, the law may not specifically create a Fund, but may simply provide that the Minister has a right to go to Cabinet for funds to be appropriated from consolidated revenue in the case of a phytosanitary emergency.
Imports: There are two main regulatory approaches to imports of plants, plant products and other regulated articles (such as biological control agents). Some countries will evaluate all imports in order to assess the risk of allowing the item into the country; others will establish a priori a list of commodities and relevant conditions imposed, based on already demonstrated risk. An example of the first category is a Croatian ordinance of 1998 which establishes phytosanitary measures for the import of seed potatoes, requiring the importer to provide a certificate of import and other information before permission to import will be granted. An example of the second category is the 1995 Malian Decree on plant protection, which contains a list of prohibited articles, and imposes restrictions and conditions on the import of other plants and plant products.
An important provision generally empowers the Minister to prohibit the entry of any plant, plant product or other regulated article in order to protect plant resources or the environment. This permits the Minister, for example, to prohibit the entry of alien plant species which might cause harm to local flora, and also living modified organisms (LMOs) for the same reason. As will be discussed below, all such prohibitions must be scientifically based or they risk violating the concepts of the SPS Agreement and the IPPC.
It should also be borne in mind in relation to LMOs that here they are being regulated only for the purposes of protecting the plant resources or the environment of the country. Governments that have other concerns in relation to LMOs, such as public health and the economy, may wish to address LMOs comprehensively in other legislation. Norway, for example, enacted a Decree Relative to Impact Assessment Pursuant to the Genetic Engineering Act in 1993, which makes provision for the assessment of risk to the environment and public health upon the release of genetically modified organisms.
Scientific justification: Perhaps the most important change in phytosanitary regulation in the years since Rio is that requirements for the import of plants, plant products and other regulated articles should have a scientific basis. All decisions on imports that are not based on international standards must be based on pest risk analysis. In practice, an importer will apply for an import permit, stating the type of commodity, its source and its end use. The authority then evaluates the application based on an assessment of the risk (using pest risk analysis), and if the risk is acceptable, or can be properly managed, the import permit will be issued. Original phytosanitary certificates from the country of origin may be required. For example, under the Ley de protección fitosanitaria (1997) of Costa Rica, the State Phytosanitary Service is responsible for issuing phytosanitary certificates in conformity with operative norms as well as norms established by the Ministry of Agriculture (art. 59).
The most effective way to comply with the principle of transparency expressed in the SPS Agreement is to collect all scientifically justified requirements that the Minister develops in regard to the importation of certain plants, plant products and other regulated articles into a document entitled Commodities and their Import Requirements. This could be issued as a schedule to the primary law (so that it can be amended easily), or it could be kept more informally as an official document retained by the NPPO and made available on demand to potential trading partners.
Costs of treatment: Different treatments or levels of control will be imposed based on the assessed risk. Treatment costs or costs of removal and destruction almost always fall on the importer, even in older phytosanitary laws. However, many modern laws also address the issue of how to calculate those costs. While it is relatively easy to bill the importer for the treatment imposed where it is a private company that has carried it out, where it is the Ministry itself that does the work, costing is more difficult. Newer phytosanitary laws may develop a formula to calculate costs, thus avoiding the necessity in each case of having to calculate fuel prices, hours of overtime for inspection and so forth, in order to bill the importer. Draft plant protection legislation in the Bahamas, for example, establishes such a costing formula.
Ports of entry: The import permit, if granted, will state that a particular article may be imported for a particular purpose at a particular port of entry. Because there may be a number of sea ports and airports where citizens and visitors may try to bring in plants and plant products but where the NPPO does not have a presence, phytosanitary laws generally provide that plants, plant products and regulated articles may only be imported at official ports listed in a schedule to the law. The law will also provide that it is an offence to bring plants and plant products into the country except at these prescribed ports.
Containment and eradication of pests: In order for the Ministry responsible for agriculture to be able to take action in regard to pests in the country, it must know when pests have appeared. Phytosanitary laws generally impose a duty on land owners to inform the NPPO where the existence of a regulated pest is suspected. Similarly, postal workers and customs officers have a duty to inform the NPPO upon the arrival of plants, plant products or other regulated articles.
The powers accorded to the Minister responsible for agriculture to declare an area infested, to restrict or prohibit the movement of plants, plant products and people into and out of the area, to regulate when planting and replanting may take place, to modify or remove the restrictions and to declare the area no longer infested (i.e., lift the quarantine), have not changed much in recent years. Even the oldest colonial-era legislation usually has such provisions. However, newer laws make clear that where a land owner does not carry out the ordered treatment, the Ministry may do so, but it is the land owner who pays. Albania's 1993 Law on Plant Protection Service, for example, provides that where there is a risk from the spread of a pest, the producer must take control measures; if he or she does not, the necessary action is taken by the Plant Protection Service but with the cost borne by the producer.
In some cases, the Minister retains discretion to waive the requirement of payment for reasons of poverty, or for expediency. This ensures that treatment and/or destruction will not be delayed in cases where the owner does not have the financial wherewithal to carry it out, or cannot be found, or where there are larger national issues at stake. Albania's law establishes an exception to the requirement that the costs be borne by the farmer, for those pests specially indicated by the Ministry of Food and Agriculture.
Compensation: Whether to permit compensation for the destruction of plants or plant products is a policy decision, to be decided by each government before enactment of a phytosanitary law. There are strong arguments in favour of a compensation policy. For one thing, farmers will be more likely to draw the attention of the NPPO to the presence of a pest if they know that the government will assist in any associated losses, and this could limit the spread of the pest. Similarly, where there is compensation, farmers may be more likely to agree to the destruction of healthy plants, and to the creation of a buffer zone, both of which can assist in hindering the spread of a disease. Hungary's new Plant Protection Act of 2000 specifically provides for indemnification in the case of damage caused by quarantine measures.
Nonetheless, the law should make clear that compensation may be payable only in limited circumstances, and should define them. Canada is unusual in having enacted a law specifically addressing compensation for farmers whose agricultural products are found to be contaminated with pesticide residues where the farmer properly used the product. However, the law states that compensation is only payable where the loss suffered is not due to any fault of the farmer. Furthermore, compensation is only payable when the farmer takes prescribed steps with regard to minimizing the loss, and to pursuing legal action against other parties. (Pesticide Residue Compensation Act, updated to 2000)
Pest free areas: Under the 1997 text of the IPPC, where the NPPO takes certain steps to eradicate a pest from an area, imposes certain phytosanitary measures to keep the area free of the pest and institutes a monitoring system to verify that the area remains free of the pest, it can declare the area pest free. Newer phytosanitary laws, such as the draft plant protection law for the Bahamas, include a provision permitting the Minister to make such a declaration.
Once the NPPO implements the proper surveillance and monitoring activities in relation to a particular pest in a particular area and achieves the required results, the Minister may add the area to a schedule which lists pest-free areas in the country. Of course it is then up to the importing countries to make their own assessment of the actual implementation of the phytosanitary measures and monitoring system by the exporting country, and to decide accordingly whether to accept that the area is in fact pest free.
Exports: Plant protection laws generally make clear that exporters are responsible for applying for the appropriate documentation from the Ministry responsible for agriculture in order to meet the importing countries' requirements. Cuba's Plant Health Regulations (Decree-Law of 1994), for example, establish that certificates and permits may be required by the Ministry of Agriculture for the import and export of agricultural or forestry products. Whereas older laws were based on quality assurance, current export regulations are generally based on importing countries' requirements.
Enforcement: All phytosanitary laws outline some of the enforcement powers of inspectors, for example that they may enter premises and stop and search persons and vehicles where they suspect that a violation of the law is taking place. Also, at any time that an inspector feels that a home owner, a traveller or an importer is not being cooperative, he or she may call upon a representative of the forces of public order, such as a police officer, to assist in enforcing the law. In order to prevent the introduction or spread of pests, inspectors must have the power to take immediate action, including treating and destroying infected goods. For instance, the Lithuanian Phytosanitary Law of 1999 grants to officers of the State Plant Protection Service the power to take specific decisions during the control of plants, plant products and other objects at import.
To protect property owners, importers and travellers, inspectors are required to follow certain procedures where they treat or destroy objects seized under the law. In addition, where the actions are taken with respect to imported goods, the Minister should inform the exporting country's NPPO. This stems from the duty imposed on NPPOs under the 1997 text of the IPPC to notify trading partners not only of the requirements for import, but also of any incidents of non-compliance. Too often the exporting country's NPPO does not know what problems may have befallen its goods when they arrive overseas.
Appeals: Although the law generally does not provide for any liability of the government or its officers for official actions taken, importers and land owners generally have the right to appeal against decisions by inspectors to destroy, dispose of or treat plants, plant products or other regulated articles. The details of the appeals procedure are set out in regulations.
Offences and penalties: The Act should list all the acts and omissions that constitute an offence under the law, including selling items knowingly imported into the country contrary to the law, preventing an inspector from carrying out his or her duties under the law and falsely filling out documents required under the law. Responsibility for enforcement of the law may be assigned to the courts, to the Minister, to the head of the plant protection service or to the inspectors themselves. For example, under the Lithuanian Phytosanitary Law, action may be taken by officers of the State Plant Protection Service in accordance with the procedure established by the laws of the Republic of Lithuania. (Art. 14) In addition, a trend in modern phytosanitary legislation is to state explicitly that inspectors who abuse their power or improperly share information acquired in the course of their duties have violated the law.
One new provision often appears, stating that it is not simply the plants, plant products and packaging that may be seized where an offence has been committed, but also anything used in the commission of an offence. Draft plant protection legislation in the Bahamas, Ghana and Namibia includes such a provision. This would permit, for example, the government to seize vehicles used to transport illegally imported plants, plant products and regulated articles. The inclusion of this provision (to be applied at the discretion of the court in appropriate cases) is intended to make the penalties under the law a greater deterrent.
The penalties should be set at a level that is sufficiently high to deter and to punish. It is expected that a judge imposing the fine will link the punishment to the nature of the offence, and to its magnitude. Usually such a judge may impose a prison sentence, or both a fine and imprisonment.
New legislation often adopts creative ways of avoiding the effects of inflation which in some countries makes penalties derisory only a few years after enactment. The new draft standards bill in Ghana, for example, provides that any person who commits an offence under the law is liable, upon summary conviction, to a fine expressed in penalty units. One penalty unit is equivalent to one-third of the prevailing national daily minimum wage multiplied by 30. The penalty unit concept thus provides for automatic increases in the levels of fines in line with inflation. Some countries have considered other alternate strategies to calculate fines, including by multiplying by a certain factor the monthly salary of a civil servant at a certain grade; basing the fine on a percentage value of an offending shipment; or enacting a separate law multiplying all existing fines in all existing legislation by a certain figure (such as 1 000).
Fixed penalties: Another development in recent phytosanitary laws is the institution of a system of on-the-spot fines (fixed penalties) which can be paid in lieu of a regular court appearance, much in the same way that traffic fines are paid in many countries. The draft CARICOM legislation includes this procedure. Spot fines are intended to be used in the case of arriving airline passengers or pleasure yacht owners who do not declare that they have plants, plant products or other regulated articles in their possession. The advantage of a fixed penalty scheme is that offenders are subject to enforceable and immediate punishment without having to enter into the court system, which would otherwise be onerous and might have negative effects on tourism. On the other hand, in some countries a spot fine system can open up possibilities for corruption, and thus each country has to ensure that the fixed penalty scheme is an appropriate feature in its own context.
Regulations: All laws grant power to the Minister to issue regulations to carry out the purposes of the law. The provision usually states that this power is unrestricted, but recent laws tend to list in detail the areas in which the Minister may act, so as to avoid any future challenge to regulations issued. For example, the draft plant protection law for Namibia lists no less than 15 subject matters that the Minister may address through regulations, in addition to granting broad power to take all necessary action to further the objectives of the law.
Naturally the power to issue regulations includes the power to establish the format for application forms, permits, certificates and other documents that will be issued under the law. An annex to Portugal's Decree-Law No. 14 of 1999 contains model forms that are to be used in the implementation of the law, which concerns the production, circulation, import and export of plants or plant products; and Decree-Law No. 91/98 contains model import permit application forms. In many countries such documentation is now available and may even be submitted electronically, a trend that can be expected to increase in the future.
Although as described above there have been significant international developments in the pesticides arena, these have not had a great deal of effect on the structure of national legislation regarding pesticides. Accordingly, the following broad outlines of the contents of modern pesticides laws can be described as follows.
Title and preliminaries: Whereas common law countries generally separate their legislation on plant quarantine from legislation regulating pesticides, civil law countries tend to combine them. For example, Namibia is considering adoption of a law on plant quarantine, as well as a separate law on pesticides to replace the 1947 South African legislation which regulated pesticides, farm feeds, fertilizers and stock remedies in one Act. By contrast, Chad adopted a Plant Protection Law No. 14/PR/95 which addresses the registration of pesticides and more generally the protection of plants and plant products, and the Niger did the same in its Plant Protection Ordinance of 1996. Hungary also adopted a law in 2000 which addresses the practice and management of plant protection as well as the marketing and use of pesticides. (Act XXXV on Plant Protection)
Definitions: The definitions in modern pesticides laws are generally drawn from the Convention on the Prior Informed Consent (PIC) Procedure for Certain Hazardous Chemicals and Pesticides in International Trade. Malta's Pesticides Control Act of 2001, for example, contains updated definitions including active ingredient and residue.
Administration: The most important administrative elements of a pesticides law are the appointment of a Registrar of Pesticides (who keeps a Register of Pesticides containing enumerated information), and the establishment of a Pesticides Board. The Austrian Federal Act on Plant Protection Products (1997), for example, establishes a Plant Protection Register at the Federal Office for Agricultural Research, which at the beginning of each year issues the list of registered pesticides.
An observed trend in recent years is that pesticides boards have become more cross-sectoral, with representation not only from the Ministry of Agriculture but also the Ministry of Health and the Ministry of Trade, among others. The Plant Protection Ordinance of the Niger creates a broad-based National Committee on Phytopharmaceutical Products, to advise the Minister of Agriculture on the registration and use of pesticides. Burkina Faso's Law No. 006/98/AN also establishes a National Pesticides Control Commission. The Namibian draft pesticides legislation establishes a Pesticides Board consisting of representatives of a variety of ministries, to evaluate applications for registration of pesticides, license premises which manufacture pesticides and persons who apply pesticides for profit, manage the Development Fund established under the Act, propose and prepare regulations to be made under the Act and generally to advise the Minister on all issues relating to pesticides in Namibia. Industry is generally not represented on pesticides boards, as the regulated should not act in the role of regulators.
Pesticides laws generally provide that the Minister can appoint or designate inspectors to enforce the law. Inspectors should be given the power to inspect locales where pesticides are manufactured, imported, packed, repacked, labelled, stored, sold, distributed or advertised, and also to search land, premises, aircraft, vessels or vehicles without a warrant if they suspect that the law is being violated. Great Britain's Pesticides Act 1998 (Cap. 26) amends the Food and Environment Protection Act, among other things to provide for the enforcement of controls on pesticides by local authorities. Like inspectors under most modern plant quarantine laws, they may request the assistance of customs officers or police officers in these tasks.
Registration of Pesticides: The basic rule behind modern pesticides laws is that in order to be lawfully imported, manufactured, packed, repacked, labelled, stored, sold, distributed, applied, possessed or used in a country, a pesticide must be registered under the law. Canada's Pest Control Products Act of 2000 makes it a violation to sell or import into Canada any product that has not been registered, that does not conform to prescribed standards or that is not packaged or labelled as required. Pesticides laws often list the permissible pesticides in a regulation or schedule to the main act, or to the contrary, list banned pesticides. Singapore recently adopted a law on the registration of pesticides (Control of Plants Rules No. S606 of 2001), which sets out the pesticide products that may be used in the cultivation of plants in Singapore. Pesticide products are listed in a table that includes information such as the pesticide registration number, ingredients and intended use. Portugal, by contrast, issued Decree No. 238 in 2001 to include 13 more active substances within the Annex of its Decree-Law on Pesticide Trade which lists banned substances.
Depending on the policy decisions of the government, exemptions from the registration requirements may be made for certain kinds of pesticides, such as those used in paint, those manufactured solely for export and others. The Netherlands amended its Pesticides Act 1962 in 2001 so as to permit the entry of certain pesticides considered indispensable. The amending Act sets forth the criteria to be applied in determining whether the pesticide may be admitted, including whether it is urgently needed; whether no valid alternative is available, taking into account public health and the environment; and whether certain requirements of novelty, resistance and cost-effectiveness are met. (Act No. 68 of 2001)
Requirements for registration may also be waived for pesticides imported for purposes of scientific research and evaluation, so long as the importer seeks a permit under the law. And finally, registration may not be required where the authority specifically exempts certain pesticides, which it might do, for example, as to a pesticide whose registration has been cancelled but where stocks of that pesticide already in the country need to be used up.
Applications for registration must be made according to the details in the law and its regulations. One recent trend is for the law to specify that the Board must treat information supplied in connection with an application as proprietary information of the applicant, for a period of time specified in the law (for example ten or 15 years, or some other time period). The draft pesticides law for Namibia, for example, establishes such a requirement. Registrations are valid for the period of time specified. The Moroccan Law on the Use of Pesticides in Agriculture of 1997 is typical, providing that registrations are valid for ten years.
Where the Board refuses an application (for reasons enumerated in the law), it must notify the applicant of the reasons for that refusal. This permits the applicant to make an appeal as outlined in the section of the law dealing with appeals. Usually the law permits applicants whose applications were refused for incompleteness of information to supplement them within a specific time.
Registration may be granted unconditionally, or in some jurisdictions, for limited purposes; or it may be denied. The Pesticides Control and Management Act of Ghana (1996), for example, grants or denies registration depending on the classification of the pesticide as: (i) for general use; (ii) for restricted use; (iii) suspended; or (iv) banned.
It is important to note that a comprehensive law will make clear that any time the applicant intends to change the formulation, trade name, pesticide active ingredient or concentration of the pesticide, or where someone other than the original applicant intends to manufacture, import, pack, repack or label that pesticide, a new application must be submitted. Normally, the less significant changes must simply be notified in writing to the Pesticides Board. The Board may cancel a registration for enumerated reasons, but must give the applicant notice and the opportunity to submit a written justification as to why the cancellation should not go forward.
Licences: Under most pesticides laws, only those persons who are in possession of a valid licence are permitted to manufacture, pack, repack, label, sell, store or distribute a pesticide. The Plant Protection Ordinance of the Niger provides that a licence, issued by the Minister, is necessary for the import, production, preparation and conditioning of phyto-pharmaceutical products. Similarly, Nicaragua's Ley básica para la regulación y control de plaguicidas, sustancias tóxicas, peligrosas y otras similares of 1998 applies to all activities carried out in relation to pesticides, including import, export, distribution, storage and trade. Some laws also provide that anyone intending to apply pesticides for profit must apply for a Pest Control Operator's Licence. The for profit ensures that farmers applying pesticides on their own land do not fall within this rule.
Applications for licences must be submitted in the form specified in the law, and will be approved or denied by the Board for listed reasons. Portugal's Decree No. 341 of 1998, for example, establishes principles to be applied in evaluating and authorizing the use of pesticides, with particular attention to environmental effects. Normally, just as with Registration, applicants submitting incomplete applications are permitted to supplement them with the missing information, and licences are valid for a certain period of time from the date of issue. The Pesticides Board usually has the power to revoke a licence, giving the applicant an opportunity, as with cancellation of registration, to submit written arguments against that revocation. Aggrieved applicants may generally file appeals in accordance with procedures established in subsidiary regulations.
Use of pesticides: Requirements regarding the use of pesticides might provide that employers whose employees work with pesticides must follow certain procedures. Additionally, the law generally provides that pesticides must be disposed of in a manner which does not harm human or animal health or the environment. Albania's 1993 Law on Plant Protection Service, for instance, provides that expired or ineffective pesticides and their packaging must be disposed of in appropriate places, according to procedures set by the Ministries of health and agriculture.
Presentation of pesticides: Pesticides laws generally provide that containers for pesticides must meet specified standards, and must have an approved label attached. The labelling requirements will normally apply to the external container (where a container has an inner bag), and must apply to the smallest unit that can be sold separately. Larger containers of pesticides containing several smaller containers must also display a label, where consumers are likely to see that larger container. Interestingly, one observed trend in recent years is to require the use of pictograms, acknowledging the illiteracy of some users. It is intended that regulations prepared under the draft pesticides legislation in Fiji will include such a provision.
Normally, the law will make it an offence to advertise an unregistered pesticide or to advertise any pesticide in a false or misleading manner. Austria's new federal Act No. 105 of 2000 includes provisions regarding the appropriate advertising of pesticides.
Analysis: Generally, the law will give the Minister the power to appoint persons to be analysts under the law. Analysts are required to follow certain procedures for taking and marking samples, and may be required to issue a certificate of analysis.
Offences and penalties: One important provision in most modern pesticides laws specifies that it is an offence to reveal information to another person, where that information was acquired while carrying out duties under the law. Draft pesticides legislation in Fiji and Namibia contains such a prohibition. This is in acknowledgement of the fact that pesticides manufacturers may have confidential information regarding the method of manufacture, and an inspector who gains access to such information during an inspection must not share it. Other offences might include giving false information on applications or altering any document issued under the law, interfering with an inspector or manufacturing or doing other prohibited activities without a proper licence. Ghana's Pesticides Control and Management Act of 1996 contains such a comprehensive list of offences.
The penalties should be commensurate with the crime; often outdated penalties are one impetus for countries wishing to update their pesticides legislation, since the fines may be derisory if the laws have been on the books for a long time. The suggestions for innovative penalty provisions in plant protection laws, discussed above in section 3.2.1., apply equally to pesticides laws.
Little legislation purely on seeds has been enacted in the last ten years, as many countries have instead been focused on the development of national seed policies and plans. In the Caribbean, in particular, many countries have conducted national workshops and public meetings to develop and agree upon their national seed policies, which will guide the development of national legislation tailored to national needs. Another reason for the lack of legislative activity in relation to seeds is that countries have been focused on plant variety protection, as will be discussed below. Although a number of countries have enacted combined legislation on seeds and plant varieties, the two are discussed separately here. The trends in plant variety protection will be discussed in section (b), whereas the next section outlines the main provisions generally found in seed laws.
(a) Seed Legislation
Preliminary provisions: Seed laws generally contain preliminary provisions consisting of the short title, the scope of the law and the definitions of terms. Cameroon's Law on Seed Activity of 2001, for example, aims to protect the seed sector against unfair competition and to protect plant breeders' rights.
The law may come into force on the date the Minister selects, and different parts of the law can become effective on different dates. This can assist a Minister in gradually introducing agencies and structures, rather than activating them all at once.
The definitions will include such matters as what is certified seed (i.e., of which progeny), and how it has to have been handled in order to qualify as certified seed. Some countries have certified I and certified II seed, which refers to the particular generations and genetic purity of the seed. In some countries certified II seed applies not only to the progeny of certified I seed but also to the progeny of certified II seed, but this will depend on the dilution of genetic purity. Cameroon has three varieties: basic seed, certified seed, and standard seed, with only the first two subject to certification by the Seed Administration. Tunisia's Law No. 99-42 on seeds, plants and plant varieties uses the same three categories.
Administration: Like plant protection laws and pesticides laws, seed laws normally establish a National Seed Committee to serve as an advisory body to the Minister of Agriculture on all matters relating to seeds, seed certification and variety release. Peru's General Seed Law of 2000, for instance, establishes a National Seed Commission as a consultative organ of the Ministry of Agriculture; similarly, Nicaragua's National Seed Council is charged with the study, analysis and development of government seed policy (Ley de producción y comercio de semillas of 1998).
The membership of the Committee depends on the circumstances in the country: where there is a particularly strong industry such as rice or cocoa, the Committee may require more input and therefore a wider variety of actors on the Committee. The Philippines' National Seed Industry Council includes representatives from government, the agricultural university, research institutes, farmers' organizations and the seed industry (Act No. 7308 of 1992).
The seed law should next establish a seed quality control and certification agency, a seed multiplication unit and a cadre of seed inspectors. Nigeria's National Agricultural Seeds Decree of 1992, for example, establishes a National Seed Service Unit which is responsible for the certification and quality control of seeds. Current seed laws ensure that the seed multiplication unit is independent from the certification agency, to avoid any conflict of interest that would arise if the same organ that is multiplying the seed were also certifying it.
The need for a seed multiplication unit may be felt only in countries with emerging seed programmes; in others, seed multiplication activities may have already been assumed by the private sector either because of a lack of financing from the government or because the programme is so advanced that activities are more efficiently carried out by the private sector as a business. Nonetheless, even in those countries with an established seed programme, the government should set up a seed multiplication unit to multiply seeds and planting materials for crops the private sector does not consider viable.
The seed law will have to outline the duties of seed inspectors, including taking seed samples and sending them to a designated laboratory. Where inspectors suspect an offence in violation of the law is being or has been committed, they may enter premises, by invitation or by force, and seize seed, documents or other items believed to have been used in violation of the law. The model Seed Law for the CARICOM region includes such powers for inspectors.
Certified seed: The seed law will have to establish criteria for certifying seed. In determining whether seed should be certified, the law may impose certain requirements, for example directing the certification agency to consider whether the seed is of known derivation, has been produced on designated land and has been sown, cultivated, produced, inspected and tested in the appropriate manner. Nigeria's National Agricultural Seeds Decree of 1992, for example, outlines the genetic identity of certified seed (sec. 14).
Certified seed producers: Under a seed law, individuals or companies may apply for registration as certified seed producers if they wish to produce certified seed. Trade in other seed is generally not regulated. The 2000 Seed Law of China, for instance, establishes that any unit or individual must apply for a licence to produce commodity seed. In deciding on applications for registration, the certification agency must use specified criteria, and may impose conditions on the registration and cancel the registration if there are unacceptable changes in the applicant's situation. The agency usually keeps a register of certified seed producers, listing particulars of the application, any conditions and other required information. Argentina's Resolution No. 42/00 of 2000, updating rules for the registration and certification of seeds, provides that all persons interested in producing certified seed must be registered in the National Register for Trade and Certification. Similarly, Bolivia's Resolution No. 41 of 2001 provides that every person intending to produce seeds needs to be registered in the National Register of Seed Producers.
Imported seed: Normally, any person wishing to import seed into the country must apply to be a licensed seed importer, and he or she will be listed in the register of licensed seed importers to be kept by the certification agency. In China, the Seed Law sets out in Chapter VIII that companies involved in the seed import-export business shall obtain an international trade licence according to the Law of Foreign Trade. Under the Seed Law of Paraguay (2000), all natural and legal persons, whether public or private, interested in importing seeds shall be registered in the National Register of Seed Traders. No one may import certified seed into the country unless he or she is registered as a licensed seed importer, the seed conforms to the certification standards and the details of the origin and variety of the seed, among other information, accompanies the seed upon its importation.
Given the developments in the international trading system, it is advisable for the law to give the Minister the power to recognize seed certified in foreign countries as certified seed under the law. This will facilitate import, so that country A can stipulate that any seed certified in country B will be designated certified seed, without the need for the testing and other requirements of the relevant provisions of the law.
Seed inspectors: One unique provision in modern seed laws permits a person whose stock of seed has been found defective not only to remove the defect, if possible, but also to choose instead to use the seed for food or feed (except where the seed has been treated with hazardous chemicals) if he or she does not wish to remove the defect. This gives more choice to the farmer rather than giving blanket authority to the certification agency to order the farmer to destroy the seed.
Offences: The law will of course have to define specific violations, such as selling certified seed or seed marked with certified or a related word unless such seed is in fact certified; obstructing a seed inspector's exercise of his or her powers under the law; tampering with samples taken by a seed inspector; altering certificates, registers or other documents with intent to deceive; improperly using information obtained in the course of employment or appointment under the law; and allowing one's employees to violate the provisions of the law. The 2000 Seeds Act of Canada, for example, provides that every person who, or whose employee or agent, contravenes any provision of this Act or any regulation made thereunder is guilty of an offence punishable on summary conviction (sec. 9).
(b) Plant Variety Protection Legislation
Recently, in various parts of the world, many countries have enacted legislation on plant variety protection. Austria (1993), Chile (1994), Hungary (1996), India (2001), Lithuania (1996), Paraguay (1994), Tunisia (1999), Ukraine (1993), the United States (1994) and Uruguay (1997) are only some of the countries that have chosen to regulate plant varieties since the Rio Conference. This flurry of activity may be due to the fact that many countries are facing mandatory obligations under the WTO TRIPS Agreement (see section 2.3.2.): as noted, article 27.3(b) of TRIPS requires state parties to provide protection for plant varieties either by patents or by an effective sui generis system or by any combination thereof. Most of the TRIPS obligations became binding on developed nations in 1996, whereas for developing countries and countries in transition to market economies the TRIPS requirements became obligatory in 2000. Least developed nations are not required to implement the treaty's substantive obligations until 2006.
Unlike earlier intellectual property rights agreements, TRIPS not only specifies the minimum substantive requirements for various forms of intellectual property, but also requires its members to adopt effective provisions within their national laws to permit those whose intellectual property rights are being infringed to enforce them. (Art. 41.1) A country's choice of how to protect plant varieties, however, will depend on the universe of its international obligations, specifically, how much discretion it has depending on whether it is a member only of one of the UPOV Acts, a member of TRIPS and one of the UPOV Acts, a member of TRIPS alone or not a member of any of these agreements.
Members of the 1991 or 1978 UPOV Act only: Only two states are not members of the WTO but are members of one of the UPOV Acts - the Russian Federation and Ukraine. These countries must comply with the numerous requirements of the UPOV Act to which they are a party. Ukraine, which is a member of the 1978 Act, does not have to protect all plant varieties, although the Russian Federation, as a member of the 1991 Act, does. On the other hand, as a member of the 1978 Act, Ukraine may impose certain reciprocity requirements on those varieties that it does protect. For both countries, their national treatment obligations are limited to those states that are members of the same UPOV Act.
Members of TRIPS and the 1978 UPOV Act: Twenty-nine countries are members of TRIPS and the 1978 UPOV Act. Countries in this category must comply with all of the 1978 Act requirements. They must also meet the four main TRIPS requirements when they legislate on plant varieties: first, the law must apply to all plant varieties (i.e., all species and all botanical genera); second, it must grant to plant breeders the exclusive right to control particular acts with respect to the protected varieties, or at least the right to compensation when third parties engage in certain acts; third, the law must provide national treatment and most favoured nation treatment to breeders from other WTO member states; and finally, it must implement procedures that enable breeders to enforce the rights granted to them under the law.
Members of TRIPS and the 1991 UPOV Act: Because the 1991 UPOV Act grants more protection for plant breeders' rights than does the 1978 Act, countries that are members of TRIPS and the 1991 Act have less discretion than members of TRIPS and the 1978 Act in choosing how to protect plant varieties. Twenty-one nations fall in this category. These states must comply with TRIPS, and, naturally, with all of the other provisions of the 1991 Act. In particular, these states must adopt all of the exclusive rights contained in article 14 of the 1991 Act regarding breeders' rights, i.e., the breeder's prior authorization must be obtained for the use of reproductive or vegetative propagating material of the protected variety for the purpose of: (1) production or reproduction, (2) conditioning for the purpose of propagation, (3) offering for sale, (4) selling or marketing, (5) exporting, (6) importing and (7) stocking for any of these purposes.
Japan is one of the countries that has enacted a law and regulations relating to plant varieties modelled on the 1991 Act. The Seeds and Seedlings Law, enacted in 1998, aims to promote the breeding of plant varieties and the distribution of seeds in Japan by providing a system for the registration and protection of plant varieties. The Law contains provisions related to the labelling of designated seeds and seedlings. The Seeds and Seedlings Law Enforcement Regulations of 1998 outline the application procedure for variety registration and list the particulars to be contained in an application, including the seed or strain of the variety.
TRIPS members only: States that are parties to the TRIPS Agreement but not members of either UPOV Act enjoy a great deal of discretion. At present this category contains approximately 94 of the 144 member states of the WTO. As members of TRIPS, these countries are required to comply with the four core obligations of article 27.3(b), but how they choose to comply is a matter of choice. States are free to model their national laws protecting plant varieties on the 1978 UPOV Act, the 1991 UPOV Act, the patent provisions of TRIPS or some combination of the above. Each of these approaches achieves, in different ways, the principal policy goal of an intellectual property rights system: creating adequate incentives for plant breeders to develop and market new varieties. The approach chosen will depend on the needs of that nation's agricultural industry and farming sectors, its desire to encourage foreign investment relating to plant breeding and biotechnology and its international trade objectives.
Although TRIPS only states have wide discretion in how to implement the Agreement's core obligations, most countries that have adopted plant variety protection laws have followed one of the two UPOV Acts. Examples of countries that have followed the UPOV model are Dominica, which enacted a Protection of New Varieties of Plants Act in 1999, and Belize, whose Protection of New Plant Varieties Act of 2000 is nearly identical to it. The Act provides for the grant and protection of breeders' rights, establishing a Register of Plant Breeders' Rights which will be maintained by the Registrar of Companies and Intellectual Property. The Act establishes criteria for the grant of a right (novelty, distinctness, homogeneity and stability); outlines the scope of the right; states the requirements of eligibility to apply; and includes provisions on the termination, invalidation and forfeiture of rights.
India's Protection of Plant Varieties and Farmers' Rights Act of 2001 is a notable counter-example to the trend of following the UPOV model. The Act protects breeders' rights while also recognizing farmers' rights by allowing farmers to register the varieties they cultivate. It also contains benefit-sharing provisions that allow individuals and communities to claim compensation for their contributions to plant genetic diversity. Finally, the Act requires inventors to disclose the source and geographical origin of biological material used in their inventions. Other proposed laws that deviate from the UPOV model include bills in Bangladesh, Nicaragua, Thailand and Zambia.
The most notable trend, however, is the large number of TRIPS members that have not enacted any plant variety protection laws despite the 2000 deadline for developing nations to enact such laws. According to a May 2000 study, 80 percent of African countries, 80 percent of countries in the Asia-Pacific region and 56 percent of Latin American and Caribbean states which should have implemented TRIPS article 27.3(b) by 2000 had not done so. This reluctance can be attributed to the controversial nature of article 27.3(b) (Helfer, 2002), and to the fact that the article was scheduled to be reviewed in 1999 but was not. The pace of implementation is unlikely to increase until WTO members resolve issues regarding the scope of plant variety protection during the Doha Round of trade negotiations that commenced in November 2001.
Not members of TRIPS or either UPOV Act: Countries that are not members of either TRIPS or a UPOV Act have no obligation to protect plant varieties or plant breeders' rights. However, they may find that intellectual property issues arise if, for example, they must implement obligations under other treaties to which they may be parties, such as regional or bilateral agreements. In addition, the actions of other countries are likely to have effects even on countries that are not members of TRIPS or UPOV. The globalization of trade makes it increasingly more difficult for countries to chart an independent course, and thus countries that are not yet members of TRIPS may wish to consider which choices they intend to make.
Since Rio, there have been some major international advances regarding plants. First, there are new international instruments concerning matters that previously were not covered by universal international law. For example, the 2001 Convention on Persistent Organic Pollutants can be seen as a response to the calls made in Agenda 21 to regulate harmful pollutants. Second, there was further development of existing instruments, such as the voluntary PIC procedure under the FAO Code of Conduct on the Distribution and Use of Pesticides and the UNEP Guidelines for the Exchange of Information on Chemicals in International Trade, which became the PIC Convention in 1998.
The WTO SPS Agreement identified the International Plant Protection Convention as the source of internationally agreed standards on phytosanitary measures, and the new revised text of the IPPC adopted a number of new and innovative concepts and structures. The influence of the SPS Agreement will continue to be far-reaching, as numerous countries seek to update their legislation to incorporate the concepts and language of that Agreement and the 1997 text of the IPPC.
At the regional level, economic blocs and standard-setting organizations developed a variety of standards based on international norms and adapted to regional needs. A number of meetings were held and draft model legislation prepared to assist in meeting the harmonization goals of the SPS Agreement. In the coming years, countries will be tailoring their national legislation to regional models to take account of their priorities, resources, legal systems and policy goals.
In the area of plant variety protection, a number of countries have begun to take steps to conform with the WTO TRIPS Agreement, which requires states to implement some form of protection for plant varieties. Interest in plant variety protection, plant breeders' rights and intellectual property rights in general can be expected to increase in the coming years, as countries take note of their international obligations not only under the WTO, but also under the Convention on Biological Diversity and the new International Treaty on Plant Genetic Resources for Food and Agriculture. Guidance from FAO and other international organizations will continue to be useful in providing information and comparative assessments of potential national choices.
Comité Permanent Inter-Etats de Lutte Contre la Sécheresse dans le Sahel. Convention for the Registration of Pesticides (www.cilss.org).
Comunidad Andina. Normativa Andina (www.comunidadandina.org).
Comité de Sanidad Vegetal del Cono Sur (www.cosave.org.py).
European Plant Protection Organization (www.eppo.org).
GRAIN. 2000. For a Full Review of TRIPs 27.3(b), An Update on Where Developing Countries Stand with the Push to Patent Life at WTO (www.grain.org/publications/tripsfeb00-en-p.htm).
Helfer, L. 2002. Intellectual Property Rights in Plant Varieties: An Overview with Options for National Governments, FAO Legal Paper Online No. 31 (www.fao.org/Legal).
IPPC Secretariat (www.fao.org).
Leskien, D. & Flinter, M. 1997. Intellectual Property Rights and Plant Genetic Resources: Options for a sui generis System In Issues in Genetic Resources No. 6. IPGRI, Rome.
Mercosur. Secretaria Andina del Mercosur, www.mercosur.org
North American Plant Protection Organization (www.nappo.org).
UNEP. 2001. Persistent Organic Pollutants (www.chem.unep.ch/pops).
UNEP/FAO. 1998. Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (www.pic.int).
UPOV (Union internationale pour la protection des obtentions végétales) (www.upov.int).
Vapnek, J. 1995. Model Seed Legislation for the Caribbean Region. FAO, Rome.
Vapnek, J. 2001. Strengthening Phytosanitary Capabilities (CARICOM). FAO, Rome.