Oversight mechanisms are the primary tools that countries use to examine the merits of a GMO in the areas of biosafety, food safety or consumer protection. The oversight mechanisms that have been established around the world are generally premised on a GMOs first time use in a particular context: importation, in-country research or commerce/marketing and, sometimes, export. Legal and non-legal instruments describe the oversight process and various institutions that may be involved with implementation and oversight.
Requirements to submit to oversight are either mandatory, and typically described in legislation, or they are voluntary, and described in guidelines.
Common components of oversight mechanisms are (1) the designation or establishment of institutions to undertake the review and/or provide advice; (2) safety assessment; and (3) decision- making. In the systems examined, stakeholder participation is only a common element of mandatory oversight mechanisms promulgated by law.
The following sections describe those components of the oversight process that may contribute to maximize the benefits and avoid the risks of modern biotechnology.
The international instruments reviewed tended to address institutional issues in only the most general way. Typically when there is a particular reference to institutions it is only to require the designation or establishment of a competent national authority, in other words, an institution with decision-making authority. In some cases institutional responsibilities are enumerated.
At the international level, only the biosafety-related instruments reviewed mention competent national authorities. For example, the International Plant Protection Convention requires its contracting parties to make provision for an official national plant protection organization (art.IV(1)). A list of responsibilities is enumerated including inter alia surveillance of growing plants, wild flora and plants and products in storage or transportation, inspection of international consignments for plant pests, disinfestation or disinfection and the conduct of pest risk analyses (art.IV(2)(a), (b), (d) and (f).
The Cartagena Biosafety Protocol to the CBD requires each of its contracting parties to designate one or more competent national authorities (art.19(1)). These are to be authorized to be responsible for performing the administrative functions required by the Protocol.
The FAO Code of Conduct on Biological Control Agents lists some of the responsibilities of competent authorities in situations before and upon release including inter alia critical assessment, encouraging monitoring and ensuring corrective action where necessary (art.7.1).
In its chapter on biosafety and environmental concerns, the FAO preliminary International Code of Conduct on Plant Biotechnology suggests that governments should designate competent national authorities to review, assess, implement and monitor biosafety and other concerns such as genetic erosion and agro-ecological disruption from the introduction of biotechnological products (art.11). Multi-disciplinary and multi-interest national committee(s) on biosafety and other environmental concerns could contribute to the competent national authoritys work (art.11.1).
National instruments dealing with biosafety address institutional issues in far greater detail than international instruments. For example, the instruments examined either establish new institutions or designate existing institutions and give them new responsibilities related to GMOs.
Where existing line ministries or their agencies are tasked with regulatory oversight they do so within their traditional areas of competence. In Indonesia, for example, the category of organism determines the agency within the Ministry of Agriculture that reviews the application.
Where new national level institutions are created they may be interdisciplinary or inter-agency in nature and either have an oversight function or an advisory function to the competent authority that ultimately makes the decisions on a GMO.
Institutions with an inter-agency character will typically include representatives from other governmental agencies. For example, the ASEAN Guidelines on Risk Assessment of Agriculture-related Genetically Modified Organisms (1999) require each member country to establish a National Authority on Genetic Modification (NAGM) which consists of representatives from national agencies involved in agriculture, trade, economics, environment, health, science, technology and any other sectors that are deemed appropriate by the respective NAGMs.
In some countries, representatives may also be from the academic and scientific communities and other major stakeholder groups. Bringing an interdisciplinary and, ideally, an independent, perspective to the oversight review process could strengthen the determination of where the benefits and risks of the particular GMO lie.
For example, in France, the National Commission on the Release of the Biomolecular Products is a cross-sectoral body involved with risk assessment. It also defines the conditions of commerce and labelling of GMOs and the products that contain them (art.3(II)). The Commission is composed of scientists, parliamentary members, representatives of environmental and consumer protection groups, professionally concerned groups and representatives of employee groups. The National Commission generally undertakes risk evaluation and supplies an opinion to the minister of the relevant competent national authority reviewing the application for authorization.
Another example is in the Philippines. Executive Order 430 created a national committee on biosafety (NCBP) that is attached to the Department of Science and Technology (sect.1).
The NCBP has a multi-disciplinary membership including various scientists, a social scientist, citizens and representatives from various governmental agencies (sect.2). The NCBP has a number of functions. These include inter alia (1) identifying and evaluating potential hazards related to initiating genetic engineering experiments, the introduction of new species and GMOs and recommending risk minimization measures; (2) formulating and reviewing national biosafety policies and guidelines; (3) formulating and reviewing national policies and guidelines on risk assessment; (4) publishing the results of internal deliberations; holding public deliberations on proposed national policies, guidelines and other biosafety issues; and (5) assisting in the formulation of laws (sect.4). The Department of Science and Technology provides the NCBPs secretariat (sect.4).
The NCBP created the Philippine National Biosafety Guidelines in 1991. The NCBP must review and approve any work covered by the Guidelines. However, institutions and involved scientists have the primary responsibility to enforce biosafety rules and regulations and this is accomplished through institutional biosafety committees (see below) and biosafety officers. The NCBP has the power to impose sanctions on erring personal and institutions.
Other countries establish advisory bodies to focus on particular issue areas. Australia offers an example where a new competent national authority has been created and is advised by three newly created committees.
The Gene Technology Act establishes the Gene Technology Regulator as an administrative office within the Ministry of Health and Aged Care to administer the legislation and make decisions pursuant to it (sect.26). Among its responsibilities, the Regulator performs functions in relation to issuing GMO licences, develops draft policy principles and codes of practice and provides advice to the public, other regulatory agencies and the Australian Ministerial Council (sect.27).
The Act also establishes (1) a scientific committee (Gene Technology Technical Advisory Committee), (2) a community committee (Gene Technology Community Consultative Committee) and (3) an ethics committee (Gene Technology Ethics Committee) (part 8). The committees are interdisciplinary and share cross membership. On matters within their competence, the committees provide advice upon request to the Regulator and the Ministerial Council. Providing advice on the need for policy principles and codes of practice is a function common to all three committees.
The Ethics Committee is to provide advice on ethical issues relating to gene technology, the need for and content of codes of practice in relation to ethics and conducting dealings with GMOs and the need for a content of policy principles in relation to dealings with GMOs that should not be conducted for ethical reasons (sect.112). All committee members are subject to disclosure and conflict of interest rules.
Under the South African Genetically Modified Organisms Act, the Ministry of Agriculture oversees implementation. The Minister of Agriculture shall appoint an interagency Executive Council for GMOs composed of representatives from various governmental agencies (sect.3). The Council is to advise the Minister on all aspects concerning activities within the laws scope of application and ensure that all activities are performed according to the Act (sect.4). The Council has the power to inter alia (1) require a permit for the use of facilities to develop, produce, use or apply GMOs or to release GMOs into the environment, to submit through a registrar a risk assessment and where required an environmental impact assessment of these activities (sect.5(a)); (2) require a registrar to examine an applications conformity with the Act (sect.5(b)); and (3) approve the use of facilities or a release (sect.5(g)). The Council may also inform any other country of an accident that may have an impact on that countrys environment (sect.5(i)) and approve and publish guidelines for all GMO uses (sect.5(l)).
The Act establishes an Advisory Committee whose members are appointed by the Minister after recommendation by the Council (sect.10(1)). The Committees membership is to reflect representation from all fields of expertise involved with GMOs (sect.10(2)). The Committee is to act as the national advisory body on all matters related to genetic modification of organisms (sect.11).
Advice may include that related to GMO introductions into the environment, proposals for specific activities or projects, contained use, importation and exportation and proposed regulations and guidelines (sect.11(1)(b)). The Committee may advise upon request (or upon its own initiative) the Minister, the Council, other Ministries and bodies. It may also invite written comments from knowledgeable persons on any aspect of genetic modification of organisms (sect.11(1)(d)). Committee members are to recuse themselves when the Committee considers subjects in which they have direct or indirect interest (sect.13).
Under the Peruvian Law on the Prevention of Risks Derived from Biotechnology an Environment National Council (CONAM) is established. It functions as the competent authority for the coordination of matters in the field of conservation and sustainable exploitation of biodiversity. CONAM promotes, through the Framework of Environmental Management, coordination among the various authorities involved in the field of safety in biotechnology (art.5.1). The National Commission on Biological Diversity (CONADIB) is the advisory body for matters of safety in biotechnology. It supports CONAM in the proposal of guidelines on living modified organisms (art.5.2).
In Mexico, pursuant to the Official Standard NOM-056-FITO-1995, the General Directorate for Plant Health is the responsible authority which issues the certificates for genetically manipulated products to be released into the environment (Annex 3). Certificates can only be issued upon a favourable opinion from the National Agricultural Biosafety Committee. The General Directorate submits the application to the Committee for review. A copy of the application and of the Committees opinion is sent to the relevant governmental office and, in the case of exports, to the pertinent governmental authority of the country in which the GMOs will be released. The governmental office and/or the government of the country shall have a maximum of 30 calendar days to send comments to the head of the General Directorate for Plant Health (3.2.2).
Under the Mexican Law on Sustainable Rural Development the Federal Government is to establish a National System of Health and Food and Agricultural Quality. The Secretariat of Agriculture, Livestock, Rural Development, Fishery and Food will coordinate the activities of the National System (art.92). An Inter-Secretariat Commission, with the participation of the Mexican Council, will propose to the Secretariat of External Relations, the adhesion to treaties and international instruments considered necessary in the field of genetically modified organisms. It may also promote agreements to harmonize phytosanitary requirements (art.95).
In Tunisia, a Biosafety National Commission, inter alia, (1) provides technical opinions on any application for import, contained use, deliberate release and commercialization of GMOs; (2) verifies and analyzes documents prepared for risk analysis; (3) supervizes the risk analysis for the release and commercialization of GMOs; (4) sets limits for the presence of GMOs in food products, seeds and plants; establishes and updates the list of GMOs to be regularly controlled; (5) prepares a list of experts in the field of GMOs; (6) sets up the conditions and modalities for transport of GMOs within the national territory; (7) controls any GMOs imported or locally produced; and (8) gives advice on establishing national policy and assisting the competent organizations in establishing biotechnology regulations in the field of biotechnology and the competent institutions in implementing such regulations (art.9).
Some instruments also require all institutions that work with GMOs to create institutional biosafety committees (IBC). IBCs are typically given the ultimate responsibility to ensure the safety of any GMO-related work within the institution.
When used effectively, IBCs could have a particularly important role in maximising the benefits and minimising the risks of GMOs. This is because projects could be screened early on at the level of the researcher or institution before government oversight is more formally applied.
The Philippines experience is particularly interesting because of the breadth of responsibilities that IBCs are given and the interaction that occurs with the National Committee on Biosafety. In the Philippines, all institutions engaged in genetic engineering are to create institutional biosafety committees (sect.B). IBCs have the responsibility to evaluate and monitor the biosafety aspects of their institutions biological research. IBCs need to have the collective expertise to supervise and assess planned field releases. The Guidelines outline additional expertise to be represented on IBCs (sect.B, para 1.1). IBCs may have consultants on call that are knowledgeable in a variety of issues, including standards of professional conduct and practice and community attitudes (sect.B, para. 1.2).
Among its functions an IBC is to review work conducted or sponsored by the institution and recommend research proposals (sect.B, para. 2.1). Reviews are to include holding discussions on the comparative ecological, economic and social impacts of alternative approaches to attain the purposes of the genetic engineering product or services (sect.B., para. 2.1.3). An IBC should also formulate and adopt emergency plans and notify the National Committee on Biosafety about significant problems (sect.B, paras. 2.4 and 2.5).
Procedurally, IBCs review proposals made by the principal investigator (sect.C, paras. 1.1 and 1.3). The IBC assesses the project and sends the proposal and its evaluation to the NCBP for its assessment (sect.C, para. 1.3).
A cornerstone of all oversight systems examined - whether voluntary or mandatory - is to assess the GMO for safety. Biosafety regimes attempt to identify the risks posed by the GMO to the environment and human health. Food safety regimes attempt to identify the risks posed by the GMO to human health.
Safety assessment generally consists of (1) hazards identification, (2) risk assessment and (3) risk management (UNEP, 1995). Only risk assessment and risk management are discussed here.
The underlying principle of risk assessment is to prevent harm by identifying the probability that particular hazards will occur. Because case-by-case risk assessment is quite burdensome other principles such as familiarity and substantial equivalence have evolved with which certain assumptions can be made about the GMO under scrutiny in order to facilitate the review.
The principle of familiarity is used primarily in the biosafety area to determine the level of oversight applied to a particular GMO. It is premised on knowledge and experience with the host and recipient organisms. This then can be used to extrapolate the potential risks of the modified organism.
The UNEP Biosafety Guidelines note that familiarity does not imply that an organism is safe, while unfamiliarity does not imply that an organism is necessarily unsafe (para. 19). Unfamiliarity means however that an organism should be assessed on a case-by-case basis. With experience and knowledge, a risk assessment may apply to a group of organisms for characteristics functionally equivalent on a physiological level. The development of generic risk assessment approaches or exemptions in one country does not necessarily mean that other countries will apply similar approaches. Monitoring can provide knowledge and experience on the use of organisms with novel traits (para. 24).
The principle of substantial equivalence is used primarily in the food safety area where, because of the complex nature of food and the inadequacy of traditional risk assessment techniques, there is a need for a targeted approach. Substantial equivalence is primarily applied to foods derived from genetically modified plants and it attempts to take into account both intended and unintended changes in the plant or foods derived from it (WHO, 2000).
The Codex Proposed Draft Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant DNA Plants points out that substantial equivalence is not a safety assessment per se. Rather, it is a way to structure food safety assessments relative to a conventional counterpart (sect.3, para. 12). Substantial equivalence is used to identify similarities and differences between the new food and the conventional counterpart acknowledging that, for the foreseeable future, foods derived from modern biotechnology will not be used as conventional counterparts. The safety assessment then assesses the safety of identified differences, taking into consideration unintended effects due to genetic modification (sect.3, para. 16). Risk managers subsequently judge this and design risk management measures as appropriate.
The proper application of familiarity and substantial equivalence, in particular the assumptions upon which both principles are founded and applied, is an outstanding issue that may determine the extent to which the risks of GMOs can be accurately identified and subsequently minimized or eliminated. In particular, some uses of substantial equivalence are becoming increasingly criticized.
For example, the Royal Society of Canada Panel on the Future of Food Biotechnology rejected the use of substantial equivalence as a decision threshold to exempt new [genetically modified] products from rigorous safety assessments on the basis of superficial similarities because such a regulatory approach is not a precautionary assignment of the burden of proof (Royal Society of Canada, 2001). The Royal Society went on the say that [w]hen substantial equivalence is invoked as an unambiguous safety standard (and not as a decision threshold for risk assessment), it stipulates a reasonably conservative standard of safety consistent with a precautionary approach to the regulation of risks associated with [genetically modified] foods.
Similarly, the European Union has recognized the problems with applying substantial equivalence. Consequently, the proposed new Novel Foods and Feed Regulation would eliminate the simplified notification procedure provided in the current Novel Foods Regulation (97/258/EC) for GM foods which are substantially equivalent to existing foods. According to the explanatory memo accompanying the proposal, the substantial equivalent concept has been controversial in the Community. It has been recognized internationally only as a key step in the safety process of GM foods, but not a safety assessment in itself, as it has been used as a regulatory shortcut.
International law has imparted additional principles to guide the risk assessment process. For example, the concept of science-based risk assessment is referred to in international instruments. The reference to science may be an attempt to ensure that an assessment is objective in order to minimize arbitrary assessment approaches.
The UNIDO Voluntary Code of Conduct states that risk assessment should be based on sound scientific principles involving the participation of experts from appropriate disciplines (sect.II-C-1(h)). International trade law also appears to be a source of the guiding principle that risk assessment should be science based.
The WTO Agreement on the Application of Sanitary and Phytosanitary Measures applies to all sanitary and phytosanitary measures which may directly or indirectly affect international trade (art.1). The SPS agreement does not explicitly mention GMOs. However, when GMOs are in international trade, and may pose a threat to human, animal or plant life or health in an importing country, the SPS Agreement would apply to national sanitary or phytosanitary measures (SPMs) designed to address the threats prior to import.
WTO member States must ensure that sanitary and phytosanitary measures are based on an assessment of risks to human, animal or plant life or health (art.5(1)). Risk assessment techniques developed by relevant international organizations must be taken into account. Risks are to be assessed taking into account a number of enumerated factors including available scientific evidence (art.5(2)).
In the food safety and trade area, the Codex Statements of Principle Concerning the Role of Science in the Codex Decision-making Process and the Extent to Which Other Factors Are Taken Into Account states that Codex instruments are to be based on the principle of sound scientific analysis and evidence (Codex, 1995).
International law also provides a basis for the consideration of socio-economic factors in risk assessment. The FAO preliminary draft International Code of Conduct on Plant Biotechnology appears to be the most comprehensive in this regard.
For example, one of the draft Codes eight objectives is to help assess and minimize possibly adverse socio-economic effects of biotechnology in agriculture and the food industry on farming communities and developing countries economies (art.1.6). From this flows one of the key provisions of the draft Code: promoting the transfer and development of appropriate biotechnologies applied to PGRs (art.5.1). Appropriate biotechnologies include those which contribute to sustainable development (art.3). Criteria for identifying appropriate biotechnologies are provided and include those that are: (1) technically feasible; (2) bring tangible benefits to users; (3) are environmentally safe; and (4) socio-economically and culturally acceptable (art.3).
Additionally, the draft Code emphasizes preventing and mitigating possible negative effects of agro- and food biotechnologies. To this end, the draft Code first emphasizes foreseeing and preventing possible negative socio-economic effects of agro- and food biotechnologies (art.8.1). Governments and international organizations should, as part of their technology assessment procedures, monitor and assess the socio-economic impacts of biotechnologies.
Under the WTO SPS Agreement Member States can also take relevant economic factors into account when assessing the risk, and establishing risk management measures (i.e. establishing the appropriate level of protection as manifested by a sanitary or phytosanitary measure). Economic measures include (1) the potential damage to production or lost sales; (2) costs of control or eradication; and (3) relative cost effectiveness of alternative approaches to limit risks (art.5(3)). It is unclear whether this is an exhaustive list.
The Guidelines for Plant Risk Analysis promulgated under the FAO Plant Protection Convention emphasize that the potential economic importance of the pest is a key determinant in the assessment process. It is in this determination that potential environmental damage is assessed along with other criteria such as perceived social costs (sect.2.2.3). If the pest has sufficient economic importance and introduction potential (i.e. there is sufficient risk) then phytosanitary measures are justified - in other words pest risk management should be considered. The Guidelines highlight which options could be taken and suggest the efficacy and impact of the options should be evaluated (sects.3.1 and 3.2).
The Biosafety Protocol, which has yet to enter into force, appears to establish the most comprehensive collection of criteria with which a risk assessment is to comply. While acknowledging that a risk assessment must be undertaken in a scientifically sound manner, the assessment must also take account of recognized risk assessment techniques (art.15(1)).
Risk assessment should be based on existing scientific evidence in order to identify and evaluate the possible adverse effects of GMOs on the conservation of biodiversity, taking into account risks to human health (art.15(1)). Annex III adds that the risk assessment must be undertaken in a manner that is transparent and on a case by case basis. The lack of scientific knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk or an acceptable risk (Annex III).
Like the Biosafety Protocol, the FAO preliminary draft International Code of Conduct on Plant Biotechnology acknowledges the need to conduct risk assessment for deliberate releases on a scientifically sound basis (art.13.3). What the draft code adds is the principle that countries should ensure that there is a full review and risk assessment by both the proposer and the competent authority (art.13.1). Review and risk assessment should be undertaken on case-by-case basis (art.13.5).
The draft Code also adds that risk assessment should proceed on a step-by-step basis. The step-by-step approach involves evaluating each step of the deliberate release (i.e. laboratory, small scale release, and adequate tests prior to marketing the novel product) (art.13.6). Containment measures may be reduced gradually in each step, but only if the tests conducted in the previous step justify it. The details and depth of information required for the authorization is to be proportional to the estimated degree of risk.
Risk communication is one final principle related to risk assessment that may soon be introduced more into international instruments. Risk communication is an area related to public participation and access to information. Within the food safety area, the risk communication principles found in the Codex Proposed Draft Principles for Risk Analysis of Foods Derived from Modern Biotechnology are premised on the belief that effective communication is essential in all phases of risk assessment and management (sect.3, para. 22).
Risk communication is to be an interactive process involving all interested parties. Processes should be transparent, fully documented and open to public scrutiny while respecting legitimate concerns for confidential commercial information. Safety assessment reports and other aspects of the decision-making process should be available to the public (sect.3, para. 23). Responsive consultation processes should be created (sect.3, para. 24).
The extent to which the principles reflected in international instruments are actually applied at the national level is unclear from a simple review of the instruments examined. While all instruments reviewed require safety assessment and typically refer to risk assessment few details are provided within the instruments themselves to guide the risk assessment process.
In some cases, the identification of risks is undertaken through classification according to the different levels of threat to human health and ecological environment. For example, Chinas Safety Administration Regulation on Genetic Engineering (1993) sets out four safety classes. Different responsibilities for undertaking the safety evaluation are associated with each class. Similarly, the French Decree No. 98-18 (1998) defines four risk levels in order to classify GMOs.
The most explicit references relate to substantial equivalence and familiarity, which provide a basis for oversight. The principle of case-by-case review is the next most referred to principle. The OAU draft Model Legislation on Safety in Biotechnology explicitly refers to an assessment of risks to the environment, biodiversity and health, including socio-economic conditions (art.8(2)).
In Costa Rica, the Plant Protection Law contains provisions on risk assessment. Risk assessment is to be carried out considering: (1) scientific evidence; (2) adequate processes and methods of production; (3) adequate methods of inspection; (4) the presence of pests; (5) the existence of area free of pests; (6) pertinent ecological and environmental conditions and (7) quarantine systems (art.45). In such risk assessment explicit reference is made to the consideration of economic factors, such as the possible damage for lost production or sale in case of entry; propagation of diseases; the costs for the control or eradication within the national territory and the relation cost-efficacy of others possible methods to eliminate risks. The Peruvian Law on the Prevention of Risks Derived from Biotechnology provides criteria for risk assessment procedures to be carried out on a case-by-case basis (art.13).
Who actually undertakes the risk assessment depends on the country and may have a bearing on realizing modern biotechnologys potential and avoid its possible risks. For example, in Canada the risk assessment is undertaken by the proponent and reviewed by the regulatory agency. Similarly, in China the risk assessment is completed by the institutions carrying out genetic engineering work and subsequently re-examined by relevant administrative departments at different levels. In contrast, the Australian Office of the Gene Regulator undertakes the risk assessment based upon information supplied by the proponent. In Cuba process of risk assessment concerning areas for release of GMOs is to be followed by owners and/or whoever is responsible for such areas. The Ministry of Science, Technology and Environment has supervisory functions. In the food safety area, the Australian New Zealand Food Authority assesses, approves and lists foods produced from gene technology that may be imported into the two countries. In the plant protection area, it is responsibility of Costa Rican State Phytosanitary Service to make sure that phytosanitary measures are based on an adequate assessment of the risks to human health and to the protection of plants.
It is difficult to ascertain which approach - assessment by the proponent or assessment by the regulator - will be more effective in minimising the risks presented by a GMO, especially in developing countries. Both approaches assume that an oversight agency either has the capacity, in the first instance, to critically review the risk assessment presented to it or, in the second instance, has the capacity to actually undertake the risk assessment itself.
The underlying principle of risk management is to identify and take steps to eliminate or minimize to an acceptable level risks identified in the risk assessment. Risk management is typically practised at the level of the regulatory decision maker who must process risk assessment data along with other factors that may be required to then determine whether approval should granted or denied.
The decision maker must determine what is an acceptable risk for society in relation to other possible benefits and costs. This is an inherently political decision (CEC, 2000).
Risk management strategies vary with circumstances and can embrace a number of techniques ranging from an outright ban to softer approaches that might include educating users of the proper application of an end product. In particular, post-approval monitoring, labelling and traceability can be used within risk management strategies and are described below.
A cornerstone of risk management practice, at least in toxicity studies related to human health, has been to build in a safety factor to ensure that risks are truly minimized, if not eliminated. The evolution of this practice to a wider number of applications such as GMOs may be reflected in part now by the precautionary principle, which should be applied by decision makers where there is scientific uncertainty. The recognition of the need for a precautionary approach is greatest at the international level.
In the biosafety area, the Cartagena Protocol on Biosafety is, at the moment, the foremost international instrument referring to a precautionary approach. In its preamble, the protocol reaffirms the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development (4th recital). The precautionary approach is also referred to in article1 (Objective). Under the Protocol, decisions of the contracting party importing a GMO destined for first-time release into the environment (and where necessary for GMOs intended for direct use as food or feed, or for processing) must be according to a risk assessment (art.10). However, lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of potential adverse effects shall not prevent the contracting party of import from taking a decision, as appropriate, in order to avoid or minimize potential adverse effects (arts. 10(6)).
In the food safety area, it appears the Codex Commission is embracing a precautionary approach, even if the term is not explicitly referred to in the Codex itself. For example, the Codex Proposed Draft Principles for the Risk Analysis of Foods Derived from Modern Biotechnology state that risk managers are to account for the uncertainties identified in the risk assessment and manage the uncertainties (sect.3, para. 18).
In the area of trade, the WTO SPS Agreement provides some flexibility for member States to provisionally adopt sanitary and phytosanitary measures (SPMs) when scientific evidence for the measures is insufficient (art.5(7)). Provisional SPMs can be adopted on the basis of available pertinent information derived from a variety of sources. However, member States must subsequently seek additional information to more objectively assess the risk and to review the SPM within a reasonable period of time.
Article 5(7) has been commonly referred to as evidence that the SPS Agreement reflects a precautionary approach (Charnowitz, 2000), even without specifically saying so. Even so, the ultimate burden to justify an SPS measure is placed on the importing country - even in the face of uncertainty (Jenkins, 2001). Indeed, this could be interpreted as contrary to a precautionary approach where such a burden would normally be placed on the exporter (Jenkins, 2001).
While risk assessment is itself a contribution to a precautionary approach, the explicit or implicit reference to precaution as a decision-making principle has found its way only into a handful of regional and national instruments that were examined. For example, the precautionary principle is reflected in article 6(7) of the OAU Model Legislation on Safety in Biotechnology: where threats of serious damage exist, lack of scientific evidence should not be used as a basis for not taking preventative measures. The same principle is reflected in other developing countries legislation.
For example, in the Mexican Law on Sustainable Rural Development the precautionary principle provisions apply in case of presumption of risks or adverse effects deriving from the use of GMOs when no scientific adequate evidence is available (art.97). In Peru, the principle is reflected in art.10 of the Law on the Prevention of Risks Derived from Biotechnology. Analysis of the negative impacts to human health, the environment and biodiversity, which may be caused by the release of LMOs, is to be carried out. The State can refuse authorization for the use and release of LMOs where threat of serious damage exists, and only if such denial has technical justification and does not constitute a technical barrier or restriction on trade.
In the finalization process of the Andean Community Biodiversity Regional Strategy, a series of principles have been identified in the context of the Biosafety Strategy. One of those is the precautionary principle.
Within the European Union, the precautionary principle is to be considered in the implementation of Directive 2001/18/EC (Deliberate Release of GMOs into the Environment) (preamble, 8th recital). An earlier Communication from the Commission on the precautionary principle seeks to harmonize the interpretation of the precautionary principle within the European Union (CEC, 2000). The Communication provides guiding principles for applying the precautionary principle.
In Australia, the Gene Technology Act refers to the concepts embodying the precautionary principle. The objectives of the Act are to be achieved through a regulatory framework premised inter alia on the precautionary principle: where there are threats of serious or irreversible environmental damage, a lack of full scientific certainty should not be used as a reason for postponing cost-effective measures to prevent environmental degradation (sect.4(aa)). The term precautionary principle is not used in the Act and it is unclear whether this is a policy principle for purposes of the Act. This is an important point because, according to the law, the Gene Technology Regulator must not issue a license if it would be inconsistent with a policy principle in force (sect.57).
As is the case with risk assessment, additional principles have been recognized by the international community that provide a framework for the application of risk management, especially as it relates to international trade.
The need for risk management measures to be necessary and where implemented, proportional to the risks identified are two principles that share the widest recognition at the international level. Calls for necessity and proportionality are common to both biosafety and food safety instruments.
Another common principle is the need for risk management measures to be scientifically or technically justified. This qualifier attempts to inject objectivity into the decision-making process in order to limit arbitrary decisions.
Three principles are closely related to trade-related issues. The principle of non-discrimination means that comparable situations should not be treated differently (CEC, 2001). In a trade context, GMOs from one country should not be treated differently than their domestic counterparts. The principles of taking the least trade restrictive measures and measures that afford the minimum impediment to trade require the decision maker to consider the impacts of the risk management measures on trade.
In the biosafety area, the FAO Plant Protection Convention has the most comprehensive collection of principles affecting risk management. The IPPC provides that phytosanitary measures can be taken for quarantine pests and regulated non-quarantine pests, but not non-regulated pests (art.VI).
Phytosanitary measures must meet minimum requirements: they must be non-discriminatory. They must be necessitated by phytosanitary considerations and be proportional. They must be technically justified. They must represent the least trade restrictive measures available. Finally, they must result in the minimum impediment to the international movement of people, commodities and conveyances (arts VI(1) and VII(2)(g)). Emergency measures are justified but must be evaluated as soon as possible after their application to justify their continued application (art.VII(6)).
The IPPC principles parallel those found in the WTO SPS Agreement. Each WTO member State has the right to take sanitary and phytosanitary measures (SPMs) necessary to protect human, animal, plant life or health, provided these measures are not inconsistent with the SPS Agreement (art.2(1)). A member States SPMs: (1) must only be applied to the extent necessary; (2) be based on scientific principles; and (3) must not be maintained without sufficient scientific evidence (art.2(2)). SPMs must also not arbitrarily or unjustifiably discriminate between member States and SPMs cannot be applied in manner that would constitute a disguised restriction on international trade (art.2(3)).
Member States are directed to base their SPMs on international standards, guidelines and recommendations, where they exist in order to harmonize SPMs as widely as possible (art.3(1)). However, a member State can introduce an SPM resulting in a higher level of protection than that offered by an international standard, guideline or recommendation (art.3(3)). This is conditioned on the existence of one of two things: (1) scientific justification or (2) if the State deems the SPM to be appropriate (art.3(3)). This last point is subject to the further conditions in article 5. Nonetheless, all measures that differ from international standards must be consistent with the SPS Agreement. Other factors to take into consideration when establishing the appropriate level of protection (1) should include minimising negative trade effects (art.5(4)); (2) avoiding arbitrary or unjustifiable distinctions in the levels it considers appropriate in different situations (if they result in discrimination or a disguised restriction in international trade) (art.5(5)); and (3) ensuring SPMs are not more trade-restrictive than required for an appropriate level of protection (art.5(6)).
The CBD Biosafety Protocol specifies general risk management measures and criteria. Any measures based on risk assessment should be proportionate to the risks identified (i.e. to the extent necessary to prevent adverse effects within the Party of import) (art.16(2)). Measures to minimize the likelihood of unintentional transboundary movement of LMOs are to be taken (art.16(3)).
The UNEP Technical Guidelines on Biosafety reflect the principle that risk management should be proportional to the level of risk and the scale of the operation (paras. 30 and 31). Risk management measures should be taken until risks have been minimized to acceptable levels. If risk cannot be minimized either the intended operation should not proceed, or a risk/benefit analysis could be used to determine whether the higher level of risk is acceptable (para. 30).
The UNIDO Voluntary Code of Conduct for the Release of Organisms into the Environment states that safety precautions and monitoring procedures should be proportional to the level of assessed risk (sect.I-C-1(d)).
The provisions of the FAO preliminary draft International Code of Conduct on Plant Biotechnology reflect a number of risk management principles already elaborated upon earlier. For example, when it is approved, the release must be conducted and implemented...to minimize the possible negative effects and the dispersal of transgenic plants, parts of plants, pollen, and organisms which affect plant genetic resources (art.14.1).
Interestingly, the draft Code suggests applying the step-by-step principle to risk management (art.14.2). The various aspects of the release should match the potential risks. In other words, any scale-ups should be evaluated and authorized on the basis of results of experiments conducted in the previous steps (art.14.2).
Governments and competent authorities should inform the competent authority of countries that could be affected by negative and unexpected consequences of a deliberate release (art.14.4). Finally, Governments should also consider establishing technical and financial assistance to farming communities and countries to mitigate adverse socio-economic effects from biotechnological developments (art.8.4).
In the food safety area, the Codex Proposed Draft Principles for the Risk Analysis of Foods Derived from Modern Biotechnology state that risk management measures are to be proportional to the risk. These should take into account where relevant other legitimate measures (sect.3, para. 16) according to general decisions of the Codex Commission and the Codex Working Principles on Risk Analysis.
When they are mentioned in the international or national instruments examined, risk management measures have rarely been elaborated upon. This may be because risk assessment is typically undertaken on a case-by-case basis, and therefore risk management measures need to be prescribed on a case-by-case basis as well. Notwithstanding this, three measures are typically mentioned: (1) post-approval monitoring and other responsibilities; (2) labelling; and (3) traceability.
Post-approval monitoring is a mechanism to ensure compliance after a permit is issued, to gather general information and to identify unexpected consequences resulting from an approval. Post-approval monitoring therefore may be an important way to minimize the risks of modern biotechnology.
After receiving consent, the authorization holder may be required to comply with certain conditions related to the release or marketing of a GMO that contribute to risk management. Monitoring may be one such condition. Another may be for the authorization holder to notify authorities when a problem occurs and to take corrective action.
Monitoring may also take place in a strategic manner. This would take place for all releases within a country over a period of time.
The FAO preliminary draft International Code of Conduct on Plant Biotechnology addresses both strategic and post-approval monitoring. For example, governments and international organizations should monitor and assess socio-impacts of biotechnologies as a part of their technology assessment programmes (art.8.2). Technology assessment procedures should include monitoring and long-term assessment of environmental impact (art.8.2). Finally, a proposer must ensure adequate and proportional monitoring of the actual effects that the organisms had on the environment as part of technology assessment procedures; suggestions are made as to what information should be recorded (art.14.3).
A number of international instruments in the biosafety and food safety areas only refer to post-approval monitoring in a very general way. These instruments include the Codex Proposed Draft Principles for the Risk Analysis of Foods Derived from Modern Biotechnology (risk management measures could include post-marketing monitoring (sect.3, para. 19)), the Pest Risk Analysis Guidelines of the Plant Protection Convention (the effectiveness of phytosanitary measures should be monitored and risk management options should be reviewed if necessary (sect.3.3)), the Convention on Biological Diversity (identify processes and categories of activities which have or are likely to have significant adverse impacts on biodiversity and monitor their effects (art.7 (c)) and the UNIDO Voluntary Code of Conduct for the Release of Organisms into the Environment (researchers/proposers have the general responsibility to notify unexpected or adverse public health or environmental impacts to the appropriate national authorities (sect.II-C-3(e))).
The FAO Biological Control Agents Code of Conduct is more explicit with regard to other post-approval responsibilities. For example, the importer should ensure that the persons involved in distributing their biological control agents are trained adequately so that they can provide users with advice on efficient use (para. 8.1.1). Information related to safety and environmental impact of the biological control agents should be made publicly available and a free and frank exchange of information, not subject to commercial confidentiality, is to be maintained (para. 8.1.2). Finally, the importer has the responsibility to notify authorities when a problem occurs and to voluntarily take corrective action when requested (art.8.1.4).
At the national level, post-approval monitoring and the responsibilities of the holder of authorization were not explicitly evident in most instruments reviewed. This is not to say that they do not exist. Rather, they may be buried in the more general requirement for risk management or permit compliance. The exceptions are described here.
In Indonesia, pursuant to the Ministerial Decree on the Provisions on Biosafety of Genetically Engineered Agricultural Biotechnology Products, the person holding the approval is obliged to submit a periodic report every six months or any time there is an event of biosafety harm (art.43). The oversight agency appears to be responsible for monitoring use (art.44(2)).
The Official Mexican Standard NOM-056-FITO requires the issuance of a plant certificate for the release into the environment and/or import of GMOs. If the certificate is granted, the Secretariat of Agriculture, Livestock and Rural Development appoints officers to inspect and to monitor the transgenic product released. They are also to receive a periodical update.
In Brazil, pursuant to Law No. 8974, any organization using genetic engineering techniques and methods is to create an Internal Biosafety Commission/CIBio. A CIBio is responsible for, inter alia, (1) establishing prevention and monitoring programmes; (2) maintaining progress reports for each activity or project involving GMOs; (3) notifying the National Biosafety Commission (CTNBio), the Public Health Authority and employees organizations of the results of risk assessment as well as of any accident that may be caused by the dissemination of biological agents; and (4) investigating accidents and pests possibly related to GMOs.
A Biosafety National Commission is to be created under the Tunisian draft Law on the Contained Use, Deliberate Release and Commercialization of GMOs. The Commission is tasked with, inter alia, monitoring any GMO imported or locally produced.
Monitoring is referred to in the European Unions new directive on biosafety and the proposed regulation on food safety. In the biosafety area, the 20th preambular recital of EU Directive 2001/18/EC notes that monitoring should be undertaken after release. In addition, Part C (Placing on the Market as or in Products) states that when the competent national authority provides its consent in writing it may stipulate conditions that are to include monitoring and the public release of subsequent results to ensure transparency (art.20(4)).
In the food safety area under the proposed EU regulation on genetically modified foods, all authorization holders will have supervisory obligations to undertake post-market monitoring and report to the European Food Authority (art.10(1)). The Authority will be informed of new scientific or technical information that may influence the foods safety evaluation and will be informed of any prohibition or restriction imposed by the competent authority of a third country in which the food is placed on the market (art.10(3)).
In the United Kingdom, every consent issued for importation, acquisition, keeping, releasing or marketing of GMOs comes with specific and implied conditions. The specific conditions will vary with the circumstances. The implied conditions generally include (1) keeping informed of any risks of environmental damage from the permitted activity, (2) notifying the Secretary of State of any new information regarding the risks of environmental damage being so caused and the effects of any releases especially those when it appears the risks are more serious than apparent when the consent was first granted and (3) using best available techniques, not entailing excessive costs, to prevent environmental damage as a result of the activity (sect. 112 of the 1990 Environmental Protection Act as amended by regulation 9 under the GMO Deliberate Release Regulations of 1992).
Labelling has a dual role as a mechanism to provide access to information and as a means to manage risks. Labelling as an informational tool has been described earlier in section 3.2 (Access to information).
As a risk management tool, the information that labels can provide to end-users can refer to a GMO or GMO products food toxicity or environmental safety. Consequently, with this information, the end user can take appropriate steps to minimize or avoid the risks specified for example by following the instructions on the label. Labelling and associated documentation may also provide important information to intermediate handlers of GMOs, for instance when they are in transit through the postal system. In the biosafety context, this latter role is being further examined under the Biosafety Protocol pursuant to article 18(2) in cooperation with other fora.
Traceability - the ability to track a GMO - is an emerging issue within the biosafety and food safety areas. The concept behind traceability is to create a system to ensure that information is available on the origin of a genetically modified product as it moves from its point of manufacture or production to the end user. The system established would enable authorities to trace the organism back to those responsible for the import and export, as well as those responsible for the GMOs original development.
Traceability could be applied in instances where illegal export, import or release is suspected. It could also be applied where environmental damage has occurred from intentional and unintentional releases. Finally, it may be applied to situations where unforeseen food toxicity is identified.
A unique identifier assigned to approved GMOs would facilitate tracing. Methods to detect or identify GMO based products would need to be developed perhaps using molecular techniques.
In the instruments reviewed, provisions on traceability are usually associated with those on labelling. But it should be kept in mind that labelling is likely to be only one tool in a comprehensive traceability system. International and national level food safety and biosafety instruments reference traceability.
At the international level, the Codex Committee on Food Import and Export Inspection and Certification Systems is examining the general concept of traceability within the systems that it oversees (Codex, 2000a). Traceability as a risk management measure is still under consideration by the Codex Ad hoc Intergovernmental Task Force on Foods Derived from Biotechnology (Codex, 2001e).
The Codex Proposed Draft Code of Practice on Good Animal Feeding links labelling to traceability. Labelling of feedstuffs is to be clear and informative for proper handling and use (sect.4.2). It is also to ensure the traceability of the feeding stuffs. Presently, the Code specifically states Genetically modified organisms (GMO products) should be labelled. Traceability of raw materials, minerals, vitamins and feed additives in feedstuffs is to be ensured by proper labelling and record keeping (sect.4.3). Records are to be maintained to allow tracing in emergency situations.
The Biosafety Protocol does not specifically mention traceability. However, in the context of labelling the Meeting of Parties is to decide within two years of entry into force on detailed requirements especially on identity and unique identification (art.18(2)(a)).
At the national level, the OAU Model Legislation makes a general reference to the need for the identity of any GMO product to specify the relevant traits and characteristics in sufficient detail for the purposes of traceability (art.11(2)).
Under EU Directive 2001/18/EC (Deliberate Release of GMOs into the Environment), a system will be designed to assign a unique identifier to GMOs (preamble para. 41). In all stages of placing on the market, traceability of the GMO as or in products is to be ensured by the Member State (preamble para. 42, art.4(6)). This will take account of international developments. Monitoring plans are required to trace and identify any direct or indirect, immediate, delayed or unforeseen effects on human health or the environment of GMOs as or in products after their placement on the market (preamble para. 43).
A system will be designed to assign a unique identifier for GMOs (preamble para. 41). In all stages of placing on the market, traceability of the GMO as or in products is to be ensured by the Member State (preamble para. 42, art.4(6)). This will take account of international developments. Monitoring plans are required to trace and identify any direct or indirect, immediate, delayed or unforeseen effects on human health or the environment of GMOs as or in products after their placement on the market (preamble para. 43).
The proposed EU Regulation on Genetically Modified Food and Feed will be part of the suite of GMO-related instruments that will include a proposed regulation on traceability and labelling of GMOs and traceability of food and feed products produced from GMOs. Unique codes or identifiers will be developed under the traceability and labelling regulations. The proposed GM Food regulation will facilitate these future instruments by requiring in the application process for a novel food or feed a method to detect and identify the transformation event in the food and/or foods produced (arts.6(3)(i) and 19(3)(i)).
In France under the Decree 95-487 (Applications for Genetically Modified Animals), authorization cannot be made if the GM animal and its descendants cannot be traced (art.22). Animals must be kept under surveillance for diseases and behaviour.
The Tunisian draft Law on the Contained Use, Deliberate Release and Commercialization of GMOs refers explicitly to traceability. A dossier containing all the information concerning the utilization of GMOs in public or private laboratories has to be made available to the public. The dossier is to include, with the exception of information protected by trade and industrial secrets, general information on traceability of GMOs.
Decision-making is the third common component of any oversight system related to GMOs.
The primary role of the oversight body is to review applications on GMOs and decide whether or not to approve them. There are two aspects of decision-making that may contribute to realizing the benefits and minimising the risks of modern biotechnology: (1) decision-making considerations other than environment and human health and (2) mechanisms to ensure greater accountability in decision- making.
Judging from the instruments reviewed it appears that oversight decisions related to GMOs primarily are made on the risks posed to the environment and human health. There are some exceptions to this in the sanitary and phytosanitary areas with regard to safety assessment. For example, both the WTO SPS Agreement and the FAO Plant Protection Convention allow socio-economic factors to be considered in risk assessment and risk management measures.
But for the most part, decision makers apparently have not begun to more widely factor other considerations into their decision-making outside of the traditional realm of environmentally oriented safety assessment. Other considerations may include socio-economic, cultural, religious or ethical implications of commercialization. Consumer protection issues may also be applicable.
This said, a trend might be emerging whereby decision makers are beginning or will begin to consider other factors in addition to environment and human health. Other considerations could be addressed in broader assessments, such as socio-economic impact analysis or cost/benefit analysis.
At the international level, with the exception of the Biosafety Protocol, there are more soft law instruments than hard law instruments that refer to other considerations.
In the food safety area, the Codex Alimentarius Commission has been working to further elaborate other legitimate factors relevant for the health protection of consumers and for the promotion of fair practices in food trade (Codex, 2001c). According to the Codex Statements of Principle Concerning the Role of Science in the Codex Decision-making Process and the Extent to Which Other Factors Are Taken Into Account, the Commission .....will have regard, where appropriate, to other legitimate factors... as it develops and adopts food standards.
The Codex Alimentarius Commission has adopted Criteria for the Consideration of the Other Factors Referred to in the Second Statement of Principle as a final Codex text (Codex, 2001c). Other Codex committees are feeding into the Commissions work including those on Food Additives and Contaminants, Residues of Veterinary Residues and Drugs in Foods and Pesticide Residues.
During the Biosafety Protocol negotiations, there was a debate on the extent to which socio-economic considerations should be considered in the risk assessment. The adopted version of the Protocol states that contracting parties reaching import decisions under the Protocol or under domestic legal measures implementing the Protocol may account for socio-economic considerations arising from the impact of LMOs on biodiversity conservation and sustainable use (especially with regard to value of biodiversity to indigenous and local communities) (art.26(1)). In other words, decision-making may only account for the socio-economics related to potential biodiversity loss and not more generally.
Furthermore, it is implied that socio-economics should not be addressed in identification of hazards and assessment of risk. Instead, it appears socio-economic considerations may be considered as an additional decision-making criterion.
The FAO Code of Conduct on Responsible Fisheries specifically applies to genetically altered stocks used in aquaculture. Its more general provisions do not specifically refer to GMOs but they could be interpreted to apply. The Code suggests that conservation and management decisions should be based on the best scientific evidence, taking into account traditional knowledge, as well as environmental, economic and social factors (art.6.4).
Agenda 21 addresses environmentally sound management of biotechnology in Chapter 16. Agenda 21 sets out a five point programme: (a) increasing the availability of food, feed and renewable raw materials; (b) improving human health; (c) enhancing environmental protection; (d) enhancing safety and developing international mechanisms for co-operation; and (e) establishing enabling mechanisms to develop and apply biotechnology in an environmentally sound manner.
The development of appropriate safety procedures, taking into account programme area D, is common to all programme areas. Programme area D suggests that ethical considerations should be taken into account.
In programme area A, governments are called on to improve plant and animal breeding and micro-organisms both through traditional and modern biotechnologies. This should be undertaken taking into account the needs of farmers, the modifications socio-economic, cultural and environmental impacts. Furthermore, work should proceed to promote sustainable social and economic development while paying particular attention to how the use of biotechnology will impact on the maintenance of environmental integrity (para. 16.4).
The basis for action in programme area E stresses the need for strengthened endogenous capacities in developing countries in order to facilitate accelerated development and application of biotechnology (para. 16.37). Mention is made of the needs for socio-economic assessment and safety assessment. The basis for action also recognizes that biotechnological research and its application could have significant positive and negative socio-economic and cultural impacts and that these should be identified early in the development phase to appropriately manage them (para. 16.38).
The UNEP Technical Guidelines on Biosafety acknowledge the importance of assessing socio-economic and other impacts of new biotechnologies. Unfortunately, the Guidelines do not address these issues.
Finally, the FAO preliminary draft International Code of Conduct on Plant Biotechnology should also be noted. If finalized and adopted the draft Code could help to influence a broadening of the considerations upon which decisions are made because it focuses on a triad of issues: the safe, responsible and equitable use of biotechnologies for food and agriculture. Socio-economic impacts are particularly emphasized.
At the national level, there are also emerging examples of decision-making taking other considerations into account. The Indonesian Ministerial Decree on the Provisions on Biosafety of Genetically Engineered Agricultural Biotechnology Products regulates and supervises the use of genetically engineered agricultural biotechnology products (GEABP) (art.2(1)) to ensure the safety and health of humans, biosafety and the environment related to the use of GEABPs (art.2(2)). It applies to (1) transgenic animals and fish and materials originating from them, (2) transgenic plants and their parts and (3) transgenic micro-organisms (art.4).
The use of GEABPs must meet general and category-specific requirements (arts. 10-33) enumerated in the decree. For example, in general, both domestic and foreign GEABPs must pay attention to and take into consideration religious, ethical, socio-cultural and aesthetic norms (art.9(1)). The Decree leaves unclear how this is actually ensured.
In Costa Rica, pursuant to the Plant Protection Law, in the risk analysis carried out to protect plants and to identify measures to achieve an adequate level of phytosanitary protection, the State Phytosanitary Service is to take also into consideration economic factors, such as the possible damage for lost of production or sale in case of entry and propagation of pests; the costs for the control or eradication within the national territory; the relation cost-efficacy of others possible methods to eliminate risks. In determining the adequate level of phytosanitary protection, the Service will have to consider the objective to reduce to the minimum the negative effects on the commerce and will not constitute a restriction to it.
The Biodiversity Regional Strategy for the Andean Tropic Countries contains provisions on biosafety. Reference is made to security measures that are to be designed to minimize the LMO-related risks for sustainability of the environment, biological diversity, human health and the socio-economic structure.
European Union Directive 2001/18/EC (Deliberate Release of GMOs into the Environment) states that Member States may consider ethical aspects when GMOs are released into the environment or placed on the market (preamble para. 9). Furthermore, at its own initiative, or upon request of the European Parliament, the Council of Ministers or a Member State, the European Commission may consult any committee it has created to obtain advice on the ethical implications of biotechnology, such as the European Group on Ethics in Science and New Technologies (art.29(1)). This is without prejudice to the competence of Member States on ethical issues. The consultation is to be based upon openness, transparency and accessibility to the public (art.29(2)). Results shall be publicly available.
The Commission will also submit a report to the European Parliament every three years to report on the experience of Member States. The upcoming report for 2003 will include an assessment of inter alia the socio-economic implications of deliberate GMO releases and subsequent marketing (art.31(7)(d)). Finally, the Commission will report annually to the Council and the Parliament on ethical issues (art.31(8)), including proposals to amend the Directive.
If adopted, the proposed EU Regulation on Genetically Modified Food and Feed would require the applicant to submit as part of the application either a reasoned statement that the food does not give raise to ethical or religious concerns or a proposed labelling scheme to address these concerns (art.6(3)(g)). In addition, the references in the proposed regulation to other legitimate factors indicate that the Commission, as decision maker, may in making its decision rely on other factors in addition to the scientific risk assessment undertaken by the European Food Authority and provided for in the Authoritys written opinion. The draft decision produced by the Commission is to take account of Community law and other legitimate factors relevant to the matter under consideration (art.8(1)).
Requirements that GMOs not damage the environment or adversely affect human health are features typical of many of the instruments reviewed. For example, GMOs cannot usually be introduced into the environment without a risk assessment and risk management plan.
However, many of the instruments reviewed do not provide criteria to guide decision makers in their decisions. Without greater specification and additional guidance, decision makers may have too much discretion to decide in favour of an application. Too much discretion could lead to poor, even arbitrary decision-making. This in turn could impede efforts to realize the potential and avoid the risks of modern biotechnologies such as GMOs.
Decision-making criteria in addition to environmental and human health criteria do not appear to be incorporated into the international instruments reviewed at all. However, in article 3 the FAO preliminary draft International Code of Conduct on Plant Biotechnology indirectly provides some criteria in its definition of appropriate biotechnology. For example, appropriate biotechnologies include those which contribute to sustainable development (art.3). Criteria for identifying appropriate biotechnologies are provided. These include those that are: (1) technically feasible; (2) bring tangible benefits to users; (3) are environmentally safe; and (4) are socio-economically and culturally acceptable (art.3).
At the national level, some countries have provided their decision makers with more guidance that consequently limits their discretion.
In the African Union, under the OAU Draft Model National Legislation on Safety in Biotechnology, approval cannot be issued unless the CA considers and duly determines that the GMO or product of GMOs poses no risks to the environment, biological diversity or health (art.6(6)). In addition, no approval is to be given unless the activity will: (a) benefit the country; (b) contribute to sustainable development; (c) not have adverse socio-economic effects and (d) accord with ethical values and concerns of communities and not undermine traditional knowledge and technologies (art.6(8)).
Resolution 76/200 on Biological Safety for the Facilities where Biological Agents and their Products, Organisms and Fragments with Genetic Information are Used regulates in Cuba the granting of authorizations in the field of biosafety. The authorization of safety in biodiversity is necessary to: (1) construct, restructure, start up and closure of laboratories which use micro-organisms, their products and GMOs; (2) research, production and field trials of such organisms; (3) release into the environment; (4) import and export; and (5) transfer of dangerous waste (art.3). The authority responsible for granting such authorization will proceed with an analysis of the documents presented by the applicant and with a risk analysis for each activity mentioned in the application.
Decision-making in the Philippines is guided by a single overarching principle that applies to approvals. The Biosafety Guidelines provide that [g]enetic manipulation of organisms should be allowed only if the ultimate objective is for the welfare of humanity and the natural environment and only if it has been clearly demonstrated that there is no existing or foreseeable alternative approaches to servicing the welfare of humanity and the natural environment (sect.C, para 1.4).
Finally, in any Australian licensing decision - whether for release or otherwise - the Regulator cannot issue a license without being satisfied that risks posed by the dealings proposed to be authorized by the license can be managed to protect human health and safety and the environment (sect.56). Additional guidelines are provided to guide the Regulators decision-making process.
For example, the Regulator must be guided by the risk assessment and management plan, submissions received from the public and any policy guidelines in force related to risks and ways to manage them (sect.56, para. 2). However, the Regulator must also not issue a license if it would be inconsistent with a policy principle in force or if the applicant is not suitable to hold a license (sect.57).
The publics access to information and participation in policy and decision-making are important tools to ensure accountability. The public availability of the rationale for a decision is a complementary requirement. A rationale could accompany any decision whether an approval or a denial. Few of the international and national level instruments reviewed provide for a publicly available rationale.
At the international level only two instruments were found to require a publicly available rationale. As between parties of the FAO Plant Protection Convention, the imposition of phytosanitary measures should be supported by an available rationale (art.VII(2)).
Under the Aarhus Convention when a decision is taken the public is to be promptly informed. In addition, a text of the decision and the reasons and considerations upon which the decision is based are also to be made publicly available (art.6(9)).
At the national level, in Indonesia only denials are to be accompanied by a rationale under the Ministerial Decree on the Provisions on Biosafety of Genetically Modified Agricultural Biotechnology Products (art.39(3)).
In the Philippines, the Biosafety Guidelines state that the national committee on biosafety has the responsibility to publish the results of its internal deliberations (sect.4). It is unclear whether this includes a rationale for its decisions.
In the food safety area the United Kingdom provides an interesting example that contributes to greater public accountability. The UK Food Standards Agency is to prepare and publish a statement of general objectives that it intends to pursue and the general practices that it intends to adopt to carry out its functions (sect.22(1)). The statement is to include as one of the Agencys objectives securing the records of its decisions, and the information upon which they are based, are kept and made available to enable the public to make informed judgments about the manner in which the Agency carries out its functions (sect.22(2)(c)).
Perhaps the ultimate tool to ensure accountability in decision-making is public access to judicial or administrative review. Judicial or administrative review provisions may be found in the instrument itself or they may be part of more general instruments dealing with civil procedure or administrative procedures. Therefore the absence of these procedures in GMO-related instruments may not mean that the procedures are denied in other more generally applicable laws.
Of the international instruments reviewed for the study only the Aarhus Convention addresses judicial or administrative review of decisions. Contracting parties are to provide access to a review procedure to those people who consider that their requests for information (under article 4) have been ignored, wrongfully refused or otherwise not dealt with (art.9(1)). In addition, a review procedure is to be provided before inter alia a court of law to people with sufficient interest or an impairment of right in order to challenge the substantive and procedural legality of any decision, act or omission (subject to article 6) (art.9(2)).
At the national level, of the instruments reviewed, only the Philippines provided access to administrative review. The Philippine Biosafety Guidelines note that a decision to deny a permit can be appealed (procedures and guidelines on the introduction, movement and field releases of regulated materials, sect.1, para. 1.1.6).
The study can only be considered indicative because of the small sampling of national level instruments undertaken. However, when combined with the wider sampling of international instruments a number of trends and gaps were evident in two key areas: public participation and oversight mechanisms. These are described below.
Whether at the international or national levels, the biosafety instruments examined were generally found to be more specific on public participation than the food safety or consumer protection instruments examined. This demonstrates that the general principle of public participation is well established in the biosafety field.
However the extent to which public participation is actually facilitated or exists in a country is difficult to determine from a simple review of the countrys biotechnology related legislative instruments. For example, general references to public participation may not translate into actual participation if additional criteria are not provided on the form public participation can take. Also the best public participation provisions may not be used if the public does not have the capacity to effectively participate. Finally, the lack of specific public participation provisions in, for example, a biosafety law does not necessarily mean that the public is barred from participation. It must be kept in mind that generic laws on public participation may already exist in the country and that the necessary criteria are applicable to the policy-making and regulatory decision-making processes addressing modern biotechnology.
The general lack of references to public participation in the food safety area, at least in what could be considered the first generation of laws at the national level, was striking because it appeared to be across the board, regardless of whether a country was developed or developing. However, some countries such as the United Kingdom are beginning to open the food safety assessment process up to greater public participation and scrutiny.
While consumer protection instruments examined did not promote public participation per se, they did promote access to information to enable consumers to make informed choices and to prevent fraud.
Access to information is an important cornerstone of public participation and is one tool that could help to realize the benefits and avoid the risks of modern biotechnology.
International instruments address access to information with varying degrees of specificity. The Aarhus Convention is perhaps the standard against which to judge other instruments at international and national levels. Though its reach is limited to the region in which it applies it is an important source of principles from which international negotiators and national level lawmakers could draw.
In general, those countries with legislation that were reviewed had more references to public participation and access to information than countries relying on voluntary guidelines. Developed countries typically have legislation on biosafety. But surprisingly, many of the developed countries examined do not appear to be any more progressive in terms of substance than those developing countries examined. This is despite the fact that developed countries have been working on biosafety issues far longer than developing countries, may have a better informed public and constantly urge developing countries to increase public participation and transparency within their decision-making processes.
Still it must be kept in mind again that generic public participation laws may pre-empt the need for specific references to public participation and access to information in the sectoral legislation. This may explain the situation in Canada where none of the five sectoral laws examined had explicit provisions on public participation in general and access to information in particular. In contrast, two of these laws did have explicit confidentiality provisions.
The review indicates that confidentiality provisions have proliferated at both international and national levels. There may be a need to further study confidentiality provisions to determine how countries use them and, in particular, whether the application of such provisions impedes the publics access to relevant information on modern biotechnologies. It may be particularly important for future international and national instruments to supply principles to guide the use of confidentiality provisions by decision-makers.
The review reveals that the principle of providing information to neighbouring States is increasingly recognized at the international level. Notwithstanding this, no national level instrument examined made specific reference to access to information by other States. Bridging this gap could be foreseen as an important contribution to international co-operation and could help to avert transboundary incidents involving GMOs.
Labelling, especially in the food safety and consumer protection areas, is being increasingly addressed at international and national levels. The issue of when labels can or should be applied to products that may or may not contain GMOs is a major issue that is being tackled. In contrast, in the biosafety area no international instruments address labelling, though the Aarhus Convention is examining the issue. Notwithstanding this lack of international action on biosafety related labelling, the review did reveal that some States and regional economic integration organizations are addressing the biosafety and labelling nexus.
The primary concern in all labelling areas is that a proliferation of standards at international, regional and national levels will create barriers to trade and ultimately confuse consumers and other end-users. Therefore there is a need to harmonize standards. For food, harmonization is taking place at the international level within the Codex Alimentarius. In the biosafety area, there does not appear to be any international process other than an examination of the issue within the Aarhus Convention. An important threshold issue to more action at the international level is determining the need for labelling GMOs and GMO-related products in the biosafety context.
With regard to public participation in policy-making, no international instruments specifically mention the need for public participation in strategic processes focussing on modern biotechnology. In addition, the countries examined do not appear to have participatory policy-making processes within which all aspects of modern biotechnology could be addressed. The most important possibility for public input appears to occur on a case-by-case basis as promoters of individual genetically modified organisms attempt to gain approval through a regulatory process.
Notwithstanding this the review found that some countries are indeed taking a new approach. They are creating broad-based stakeholder processes on certain aspects of modern biotechnology such as the release of GMOs. These processes help the government to gauge public opinion, generate dialogue, gather useful information and develop awareness within their populations on modern biotechnology. New Zealand is a particularly good example.
Because of the dearth of specific references to public participation in policy-making at the international level specific to modern biotechnology, it may be useful for future international instruments, such as the forthcoming FAO Code of Conduct on Biotechnology, to unambiguously refer to the desirability of creating such processes.
Public participation in decision-making is a more familiar concept at international and national levels than public participation in policy-making. Still only four international instruments reviewed address the issue, the standard again being the Aarhus Convention. Examples of varying specificity do exist at the national level specific to GMOs.
Some important considerations include the mechanism through which the public is notified (e.g. public notice) and can provide inputs (in writing or via a public hearing) and the time period within which the comments must be received. However, it is really not enough simply to give the public an opportunity to participate and provide information. Most importantly the competent authority must take those views into consideration. In the best case, the competent authority may also be required to justify why a particular viewpoint was accepted or not. Work on future international or national level instruments should keep this in mind.
The oversight process may contribute to maximize the benefits and avoid the risks of modern biotechnology. Three mechanisms were examined: (1) institutions; (2) safety assessment; and (3) decision-making.
Oversight and advisory institutions are the most obvious oversight components addressed at international and national levels. The generality with which institutional issues have been treated at international level does not seem to have impeded the establishment of institutional oversight nationally. All countries examined have some form of institutional oversight in place.
What does vary between countries is whether bodies have been created to provide advice to competent authorities tasked with decision-making responsibilities. A multidisciplinary and/or multi-stakeholder advisory body could have an important role to play in assisting a competent authority in its examination of the merits of GMOs and, consequently, maximising the benefits and minimising the risks of modern biotechnology. With the exception of the FAO preliminary draft International Code of Conduct on Plant Biotechnology, no international instrument reviewed refers to the desirability of creating advisory bodies. Future instruments could include provisions on advisory bodies.
Another potentially important institutional consideration is creating institutional biosafety committees. These can be given the ultimate responsibility within an institution working with GMOs to ensure the safety of any GMO-related work before and after regulatory oversight. In fact, IBCs appear to be widely referenced in voluntary guidelines promulgated at the national level. It is unclear whether the concept of IBCs originated with an existing international instrument. Those reviewed for the study did not mention them. Nonetheless negotiators and lawmakers may wish to consider the concept for future instruments.
Safety assessment (e.g. hazards identification, risk assessment and risk management), the second oversight mechanism, is referred to in all national oversight systems examined. It is also referenced in all international instruments examined dealing with biosafety and food safety.
While the need for risk assessment is undisputed, one concept in particular is coming under greater scrutiny. The application of the substantial equivalence concept in the food safety area is the primary example in this regard. Future negotiators of international instruments that may refer to substantial equivalence may wish to provide guidance on its proper application so that the concept does not simply become a decision threshold to exempt genetically modified products from rigorous safety assessments.
Greater attention is also being given to factors other than environmental protection and human health in the oversight process. For example, an emerging trend is the consideration of socio-economic considerations. Governments may need assistance, particularly capacity building and technical guidance, in assessing socio-economic impacts.
Finally, risk communication is a new area of risk assessment that emphasizes effective communication in all aspects of risk assessment and risk management. Negotiators and lawmakers may wish to consider it in their work in order to better integrate the publics access to information and participation in the safety assessment process.
In the risk management area the precautionary approach is being referenced more frequently in post-Rio international instruments. The extent to which the precautionary approach is actually practiced at the national level is unknown. However, the small collection of second-generation biosafety and food safety laws that were reviewed do tend to refer to it explicitly. Guidance for applying a precautionary approach to modern biotechnology may need to be promulgated at the international level to ensure consistent application worldwide.
Post-approval monitoring is a risk management technique referred to in a number of international instruments reviewed. It was not explicitly mentioned in the majority of national level instruments reviewed, but this may be a function of its application in permit conditions. Post-approval monitoring will be important to minimising the risks of modern biotechnology and should be addressed specifically in sectoral instruments at the national level.
Traceability is an emerging risk management tool within the biosafety and food safety areas. It could be useful where illegal export, import or release is suspected, where environmental damage has occurred or where unforeseen food toxicity is identified. It is just being referred to at international and national levels and, where technically feasible, may be useful for negotiators and lawmakers to consider as they create new legal instruments.
Decision-making is the third common component of any oversight mechanism. One important aspect of decision-making consists of the extent to which considerations other than environment and human health are used by decision-maker to reach a decision concerning a GMO. Based on the instruments reviewed it appears that a trend may be emerging to the extent that other factors, such as socio-economic and ethical considerations, are beginning to be considered. A more holistic approach to decision-making may result in a more accurate consideration of costs and benefits in the regulatory decision-making process. Negotiators and lawmakers may wish to consider this broader approach in their work.
A second important aspect of decision-making is mechanisms to ensure greater accountability in the decision-making process. Greater accountability can be supported by criteria for decision-making, publicly available rationales to the decisions taken and the possibility for judicial or administrative review of decisions. Each of these areas is underrepresented in international instruments and only a handful of the national level instruments reviewed refer to all of them. Therefore, negotiators and lawmakers may wish to consider these points in their work.
 Another aspect of risk
management is practised at the level of the researcher. At the researcher level,
especially where mandatory oversight by a governmental agency may not exist,
well-designed risk management practices may be particularly important. The 1992
OECD Safety Considerations for Biotechnology are an example of guidance designed
to promote safer small-scale research involving field trials. The Safety
Considerations are intended to apply to the second stage of the continuum of
research on GMOs - small-scale basic and initial applied research involving
genetically modified plant and micro-organisms and how to ensure the
environmental safety of this work. The GDPs provide guidance to researchers
on selecting organisms, choosing the research site and designing
appropriate experimental conditions (OECD, 1992).|