Previous Page Table of Contents Next Page


INTERNATIONAL INSTRUMENTS RELATED TO MODERN BIOTECHNOLOGY


Biotechnology Industry Organization (United States of America)

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Statement of Principles (1999)

Y

Y




Y




Y


Y


Selected Legal Annotations and Comments

The Biotechnology Industry Organization (BIO) is the primary US-based trade group representing the biotechnology industry. According to the Statement’s preamble, BIO represents biotechnology companies, academic institutions, state biotechnology centres and related organizations in the US and in other countries. BIO recognizes that biotechnology needs to be approached with an appropriate mixture of enthusiasm, caution and humility. The first principle acknowledges respect for the power of biotechnology and the intent to apply it for the benefit of humankind. The members of BIO will avoid technological applications that do not respect human rights or carry risks that outweigh potential benefits. BIO members affirm that they will “listen carefully” to those who are concerned about the implications of biotechnology and respond to their concerns (principle 2). BIO members also affirm that they help to educate the public about biotechnology, its benefits and implications (principle 3). BIO’s highest priority is health, safety and environmental protection in the use of its members’ products through science-based regulation (principle 4). It also respects animal welfare (principle 6). Principle 10 affirms that BIO’s members will develop their agricultural products to enhance the world’s food supply, andto promote sustainable agriculture with attendant environmental benefits. Finally, BIO supports the conservation of biodiversity (principle 13).

Food and Agriculture Organization of the United Nations and World Health Organization

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Codex Alimentarius














Selected Legal Annotations and Comments

The Codex Alimentarius is a collection of internationally adopted food standards presented in a uniform manner (Codex, 1999). Codex standards ensure that consumers receive products that meet internationally accepted minimum acceptable quality levels, are safe and do not present a health hazard (FAO/WHO, 1999). Standards are prescribed for individual foods and food groups. General standards have also been adopted, for example, for labelling pre-packaged foods.

In addition to specific standards, the Codex also includes “related texts”. Related texts include advisory instruments: statements of principle, codes of practice, guidelines and codes of technological practice. Some of these instruments apply to food and food products that have been derived from biotechnology (genetically modified).

The Codex Alimentarius Commission, an intergovernmental body, develops and keeps under review the Codex. The Joint FAO/WHO Food Standards Programme administers the Codex Commission.

The highest priority of the Codex Commission is to protect the health of consumers and ensure fair practices in food trade according to article 1 of the Codex Statute (Codex, 2000c). The Codex Commission, and the Codex itself, also facilitates international trade in food through the elaboration and harmonization of definitions and requirements for food. In this regard, the Codex Commission has been recognized as an international standard setting body for purposes of implementing the World Trade Organization’s Agreement on Sanitary and Phytosanitary Measures (SPS Agreement). The Codex itself is recognized as an international standard for purposes of the SPS Agreement. As part of its work, the Codex Commission also keeps under review its relationship with other international intergovernmental organizations such as the Convention on Biological Diversity, and the Cartagena Protocol on Biosafety.

Subsidiary bodies undertake the bulk of the standard setting and the development of related texts. Subsidiary bodies can include codex committees, ad hoc intergovernmental task forces, as well as working groups. Joint FAO/WHO expert consultations help to supplement the technical content of the Codex work on an as needed basis. The overall elaboration of the Codex instruments is guided by the Procedures for the Elaboration of Codex Standards and Related Texts (Codex, 2000d). The uniform procedures are outlined as a series of steps. In general, subsidiary bodies develop standards and related texts. During their development they are submitted periodically for review to the Codex Commission and to member States for comment and ultimate adoption. The instruments can be elaborated and adopted in pieces. The Codex Commission keeps all instruments under review. The instruments relevant to genetically modified foods are in various stages of development within the Codex Commission.

Notably, the Codex Commission has yet to adopt an agreed definition of “genetically engineered/modified organisms” (Codex, 1999). As of December 2002, the Codex Commission, through its subsidiary bodies, was working on a number of issues relevant to genetically modified organisms and foods either explicitly or more generally such as inter alia traceability, labelling, identification and risk assessment.

More specifically, the following subsidiary bodies are working on different aspects of genetically modified foods and food products: (1) Codex Committee on Food Labelling (Amendments to the Codex General Standard for Labelling Pre-packaged Foods: Labelling of Foods Obtained Through Certain Techniques of Genetic Modification/Genetic Engineering (step 6) (Codex, 2001b); and Proposed Draft Guidelines for the Labelling of Foods Obtained Through Certain Techniques of Genetic Modification/Genetic Engineering (step 3) (Codex, 2001b); (2) Ad hoc Intergovernmental Task Force on Foods Derived from Biotechnology (Draft Principles for the Risk Analysis of Foods Derived from Modern Biotechnology (step 8); Draft Guidelines for the Conduct of Food Safety Assessments of Foods Derived from Recombinant DNA Plants (step 8); Draft Guidelines for the Conduct of Food Safety Assessment of Foods Produced Using-Recombinant-DNA Micro-organisms (step 5) (Codex, 2001e); (3) Codex Committee on Methods of Analysis and Sampling (General co-ordinating role on the development of methods to analyse foods derived from biotechnology especially in the context of detection) (Codex, 2001f); (4) Codex Committee on Food Import and Export Inspection and Certification Systems (Examines the general concept of “traceability” and information exchange within the systems that it oversees) (Codex, 2000a); (5) Codex Committee on General Principles (Develops the concept of precaution and other aspects of risk analysis within the Codex System - see below) (Codex, 2001c); (6) Codex Committee on Pesticide Residues (Agreed to a “case by case” approach to be followed in establishing “maximum residue limits” for genetically modified crops and metabolic residues) (Codex, 2001d); and (7) the Ad hoc Intergovernmental Task Force on Good Animal Feeding (Proposed Code of Practice on Good Animal Feeding) (Codex, 2000b).

The Committee on General Principles has been working on two issue areas that are relevant to genetically modified foods and food products as applied to the Codex’s mode of operation. The first issue area deals with risk analysis in the work of Codex. Working Principles for Risk Analysis in the Framework of the Codex Alimentarius are being developed (Step 5). Work is on going. The 24th Session of the Codex Commission clarified that when there is evidence that a risk to human health exists but scientific data are insufficient or incomplete, the Codex Commission should not elaborate a standard (Codex, 2001a). Instead, it should consider elaborating a related text that should itself be supported by available scientific evidence. In addition, other Codex Committees are working on risk analysis and these will be presented to the Commission in a single consolidated document (Codex, 2001a).

The Committee on General Principles has also been working on further elaborating “other legitimate factors relevant to health protection of consumer and for the promotion of fair practices”. In general, 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). According to the General Principles, the Commission should also consider “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. Other Codex committees are feeding into this Committee’s work including those on Food Additives and Contaminants, Residues of Veterinary Residues and Drugs in Foods and Pesticide Residues.

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Codex Alimentarius Proposed Draft Guidelines for the Labelling of Foods Obtained Through Certain Techniques of Genetic Mod./Genetic Engineering


Y

Y


Y

Y


Y

Y

Y



Y

Selected Legal Annotations and Comments

Proposed Draft Guidelines for the Labelling of Foods Obtained through Certain Techniques of Genetic Modification/Genetic Engineering as well as an amendment to the General Standard for the Labelling of Pre-packaged Foods (draft Recommendations for the Labelling of Foods Obtained through Certain Techniques of GM/GE) are currently at step 3 in the Codex elaboration procedure.

Two parts of the work to amend the General Labelling Standards (work on definitions and on the declaration of allergens) have been separated from the main body of work. The work on these parts is at a more advanced stage in the Codex elaboration procedure. The Draft development of an amended set of definitions is at step 6 in the Codex procedure. The Draft Amendment to the General Standards for the Labelling of Pre-packaged Foods: Labelling of Foods Obtained Through Certain Techniques of Genetic Modification/Genetic Engineering: Declaration of Allergens was adopted by the 24th Session of the Codex Commission as a final Codex text.

Because the Draft Guidelines are still in an early stage of development they are only generally described here. Many bracketed sections remain. The Guidelines are proposed to apply to labelling of foods and food ingredients in three situations when they are: [(1) no longer equivalent/different significantly from conventional counterparts;] (2) composed of or contain GM/GE organisms or contain protein or DNA resulting from gene technology; and (3) when they are produced from but do not contain GM/GE organisms, protein or DNA from gene technology (sect.1, para. 1.1). Labelling would describe those food characteristics or properties that are different than a corresponding conventional counterpart.Labels would declare the presence of allergens resulting from the GM process (sect.3, paras. 3.1 and 3.2). Criteria would be provided for labelling the method of production (sect.3., para. 3.4). Bracketed text exists on labelling in situations where substances exist that are absent from the corresponding conventional counterpart in situations that could raise ethical concerns (sect.3, para. 3.5). Threshold levels for the presence of GM/GE organisms and the trigger for labelling are still under discussion (sect.4). In general, all label declarations for pre-packaged food shall not be described in a manner that is false, misleading or deceptive or likely to create an erroneous impression regarding the product’s character or safety (sect.6)

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Codex Alimentarius Guidelines for the Production, Processing Labelling and Marketing of Organically Produced Foods (1999)


Y

Y

Y

Y

Y


Y

Y





Selected Legal Annotations and Comments

The Codex Guidelines for the Production, Processing, Labelling and Marketing of Organically Produced Foods provide an internationally agreed approach to produce, label and make claims about organically produced foods. The general aims of the guidelines include inter alia protecting consumers against deception and fraud, to protect organic producers against misrepresentation of other agricultural products as organic and ensuring that all stages of production, preparation, storage, transport and marketing are subject to inspection and comply with the guidelines (Foreword). The Guidelines are interpreted as a first step in efforts to harmonize internationally the requirements for organic production. They are seen as a tool to help countries develop national regimes on organic production. Principles of organic production are set out at the farm, preparation, storage, transport, labelling and marketing stages. Accepted inputs are specified. Organic production claims and labelling are limited to operators certified by a certification body.

The Guidelines are interesting because they focus on a product whose character, and the claims made about it, are dependent on the production process used to create it. This distinguishes organic produce from other products in international trade where production process distinctions are not and should not be emphasized to ensure non-discriminatory trade practices. In short, the focus is on regulating the process rather than the final product per se (Foreword).

The Guidelines apply to products that carry or are intended to carry descriptive labelling referring to organic production (sect.1.1). Products include (a) unprocessed plants and plant products, livestock and livestock products and (b) processed products for human consumption derived from (a). The Guidelines declare, “all materials and/or products produced from genetically engineered/modified organisms (GE/GMO) are not compatible with the principles of organic production (either the growing or manufacturing or processing) and therefore are not accepted under these guidelines” (sect.1.5). Therefore, the Guidelines take a process rather than a product based approach with regard to genetic manipulation. In a footnote to the definition of GE/GMOs, the Guidelines note that the Codex Commission has yet to agree a definition. Therefore, a provisional definition is provided. GE/GMOs “are produced through techniques in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination” (sect.2.2).

Criteria are listed as to when labelling and claims for a product may refer to organic production, including the need for ingredients of agricultural origin to meet certain specifications (sect.3.3). Derogations are allowed when ingredients of agricultural origin do not satisfy the enumerated specifications (sect.3.4). A five-percent threshold (total ingredients) is set. From the earlier statements in the Guidelines against GE/GMOs it appears a zero threshold is implicitly set for ingredients of GE/GMO origin. In addition, transition periods are specified during which time farms can or cannot make organic claims about the agricultural products that they produce while they move to organic production methods.

In addition to maintaining strict organic agricultural practices, the authenticity of a product claimed as organic is maintained by establishing strict handling, storage, transportation, processing and packaging requirements. In other words, authenticity must be maintained throughout the “organic food or supply chain” to the final consumer. For example, organic products must not be co-mingled with non-organic products; bulk stores should be separate from conventional product stores (Annex1). When in international trade, imports are dependent on the issuance of a certificate of inspection by the exporting country. The certificate is to demonstrate that the lot meets the minimum standards of the Guidelines (sect.7). After import, authenticity through the supply chain must be maintained.

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Codex Alimentarius Proposed Draft Principles for the Risk Analysis of Foods Derived from Modern Biotechnology


Y


Y[2]


Y




Y

Y

Y


Selected Legal Annotations and Comments

The Codex Ad hoc Intergovernmental Task Force on Foods Derived from Biotechnology is developing the Proposed Draft Principles for the Risk Analysis of Foods Derived from Modern Biotechnology (Codex, 2001e). In March 2002, the third Session of the Task Force reached final agreement on the principles and forwarded them to the 25th Session of the Codex Alimentarius Commission for final adoption (July 2003).

The introduction to the principles acknowledges that risk analysis approaches to assess chemical hazards for substances such as pesticide residues, contaminants, food additives and processing aids were not specifically designed to address whole foods (para. 2). These techniques are focused on discrete hazards that may be present in foods. A risk analysis approach can be applied to foods, but must be modified when applied to whole foods because of their complexity.

The Draft Principles supplement the general Codex Working Principles on Risk Analysis that are being developed by the Codex Committee on General Principles. The Draft Principles are to provide a framework for risk analysis on the safety and nutritional aspects of foods derived from modern biotechnology (sect.2, para. 7). The Draft Principles do not address the environmental, ethical, moral and socio-economic aspects of research, development, production and marketing of foods derived from modern biotechnology (sect.2, para. 8).

The definition of modern biotechnology is taken from the Cartagena Biosafety Protocol (under the Convention on Biological Diversity). Principles include inter alia those on risk assessment, risk management and risk communication (including advice and stakeholder participation).

The risk assessment principles clarify that risk assessment includes a safety assessment designed to identify whether a hazard, nutritional or other safety concern is present and, if so, to gather information on its nature and severity (sect.3, para. 10). The principles reflect the concept of substantial equivalence whereby the safety assessment should include, but should not be substituted for, a comparison between the food derived from modern biotechnology and its conventional counterpart (sect.3, para. 11). The comparison should determine similarities and differences between the two. A safety assessment should (1) account for intended and unintended effects; (2) identify new or altered hazards; and (3) identify changes relevant to human health in key nutrients (sect.3, para.11). Safety assessment should take place on a case-by-case basis (sect.3, para. 12).

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. Different risk management measures can meet the same objective. Risk managers are to account for the uncertainties identified in the risk assessment and manage the uncertainties (sect.3, para. 18). Risk management measures could include food labelling, conditions on marketing approvals, post marketing monitoring and development of methods to detect or identify foods derived from modern biotechnology (sect.3, para. 19). Traceability may also be a risk management measure but is still under consideration.

The risk communication principles are premised on the ideal that effective communication is essential in all phases of risk assessment and management (sect.3, para. 22). It 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).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Codex Alimentarius Proposed Draft Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant DNA Plants


Y




Y


Y

Y

Y




Selected Legal Annotations and Comments

The Codex Ad hoc Intergovernmental Task Force on Foods Derived from Biotechnology is developing the proposed Draft Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (Codex, 2001e). In March 2002, the third Session of the Task Force reached final agreement on the guideline and forwarded them to the 25th Session of the Codex Alimentarius Commission for final adoption (July 2003).

The Draft Guideline is designed to support the Proposed Draft Principles for the Risk Analysis of Foods Derived from Modern Biotechnology. The Guideline describes the recommended approach for making a safety assessment of foods derived from r-DNA plants where a conventional counterpart exists. “‘Conventional counterpart’ means a related plant variety, its components and/or products for which there is experience of establishing safety based on a common use as food” (sect.2, para. 7). The Draft Guideline reflects the concept of substantial equivalence (see below). The techniques described in the Draft Guideline may in theory be applied to foods derived from plants that have been altered by techniques other than modern biotechnology (sect.1, para. 6).

The Draft Guideline provides an introduction and rationale for food safety assessment, drawing distinctions between it and toxicological risk assessment for individual compounds that rely on animal studies. The “goal of the assessment is a conclusion as to whether the new food is as safe as and no less nutritious than the conventional counterpart against which it is compared” (sect.5, para. 57). The discussion is based on a treatment of the concept of substantial equivalence undertaken by the Joint FAO/WHO Expert Consultation on Foods Derived from Biotechnology. The Expert Consultation noted that a more focused approach, substantial equivalence, is needed to judge the safety of foods derived from all plants taking into account both intended and unintended changes in the plant or foods derived from it (WHO, 2000). The Draft Guideline 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 Draft Guideline outlines a stepwise procedure for conducting safety assessments.

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Codex Alimentarius Proposed Revised Code of Ethics for International Trade in Food


Y

Y



Y


Y

Y




Y

Selected Legal Annotations and Comments

The Codex Alimentarius Proposed Revised Code of Ethics for International Trade in Food builds on the original Code adopted by the Codex Commission in 1985. The Codex Committee on General Principles is revising the Code. As of December 2002the elaboration procedure is at step 3. The scope of application of the Revised Code remains to be determined but it will apply at least to governments. In addition, the relationship of the Code with WTO Agreements such as SPS and TBT and the implications for national implementation remain to be determined.

The Code establishes standards of ethical conduct food in international trade. The Code makes only one reference to foods derived from biotechnology, though its general provisions can be interpreted to apply to these foods. The Code is premised on a number of general principles including inter alia consumer protection, food safety and fair trade practices (art.4, para. 4.1). It takes into account various Codex Standards and related texts as well. The Code specifies that no food should be in international trade which “has in it or on it any substance in any amount which renders food poisonous, harmful or otherwise injurious to health unless the food is subject to further processing so as to address those risks” (art.4, para. 4.2(a)), and is “labelled or presented in a manner that is false, misleading or deceptive or that may adversely affect the safety of the food” (art.4, para 4.2(d)). It calls for the establishment of national food standards based on risk analysis (art.5, para. 5.1) and adequate labelling of pre-packaged and bulk foods (art.5, para. 5.3). Food additives and pesticide residue limits should follow codex standards and principles (art.5, paras. 5.4 and 5.5). Foods derived from biotechnology are also to take into consideration Codex standards and related texts (art.5, para.5.9). Implementation measures are suggested for exports and imports (art.6, paras. 6.1 and 6.3). Finally, provisions are suggested for exceptional circumstances - such as famines or other emergencies - where application of the Code may not be fully possible or desirable (art.8). In these situations, due regard is still be given to food safety and those principles enumerated as may be applicable in such circumstances.

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Codex Alimentarius Proposed Draft Code of Practice on Good Animal Feeding


Y

Y

Y

Y

Y




Y




Selected Legal Annotations and Comments

The Ad hoc Intergovernmental Codex Task Force on Animal Feeding is developing a new Animal Feeding Code of Practice. As of December 2002, the elaboration procedure is at step 3. Though the Code is at a very early stage of development its general provisions are potentially relevant to the use of genetically modified or engineered materials in animal feeds.

The purpose of the Code is to establish a feed safety system that covers the whole “‘feed chain’ from farm to table” (sect.1). This will eliminate potential risks to human health, animal health and the environment. It will apply to the production and use of all materials of animal, plant and marine origin used in animal feed at all levels, whether produced industrially or on the farm (sect.2). The Code’s objectives will be to encourage adherence to Good Animal Feeding Practice (GAFP) at the farm level and Good Manufacturing Practice (GMP) during procurement, handling, storage, processing and distribution of animal feedstuffs. This is to ensure food safety for humans. It only applies to animal welfare issues to the extent that issues of animal health arise.

In addition to other substantive requirements, labelling of feedstuffs is to be clear and informative to allow the farmer to handle and use the feed correctly (sect.4.2). It is also to ensure the traceability (‘product tracing’ as alternatively defined in the June 2002 meeting of the Ad Hoc Intergovernmental Task Force on Animal Feeding) 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 Code calls for the establishment of official regulatory programmes to ensure foods of animal origin produced for human consumption are safe and wholesome (sect.4.4) with inspection systems designed around objective risk assessment. Feeding stuffs generally should be marketed when wholesome, unadulterated and of merchantable quality. They should not be dangerous to human or animal health and should not be marketed in a misleading manner (sect. 4.5.3). Undesirable substances such as pesticides should be minimized (sect. 4.5.4). The Code assigns ultimate responsibility to the producer or manufacturer of feeds to ensure the safety and wholesomeness of feed (sect. 5).

Food and Agriculture Organization of the United Nations

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

International Treaty on Plant Genetic Resources for Food and Agriculture (2001)

Y









Y


Y


Selected Legal Annotations and Comments

The FAO International Treaty on Plant Genetic Resources for Food and Agriculture was adopted by the FAO Conference in 2001 and opened for signature. The Treaty’s objectives are the conservation and sustainable use of plant genetic resources for food and agriculture (PGRFA) and the fair and equitable sharing of the benefits arising out of their use (art.1.1). It applies to all PGRFA (art.3).

The treaty’s application to modern biotechnologies, such as genetically modified organisms, is not direct. In fact, the term “modern biotechnologies” is only referred to once and this is in the preamble’s 6th recital. This paragraph acknowledges that PGRFA are indispensable as raw material for crop genetic improvement including that through modern biotechnologies.

The conservation provisions of the Treaty are found in Article 4 (Conservation, Exploration, Collection, Characterization, Evaluation and Documentation of PGRFA). Each contracting party is to promote an integrated approach to exploration, conservation and sustainable use of PGRFA (art.5.1). Cooperation should be promoted to develop and transfer appropriate technologies leading to an efficient and sustainable system of ex situ conservation (art.5.1(e)). This could include the use of modern biotechnologies. Finally, contracting parties are “to take steps to minimize or, if possible, eliminate threats to PGRFA” (art.5.2). Though there are potentially many threats to PGRFA, this provision could be interpreted to apply to the threats posed by modern biotechnology such as GMOs especially in centres of origin or diversity. Flowing from this would be the need to undertake safety assessments prior to release.

Stakeholder participation might also be envisioned. This is foreshadowed in article 9 dealing with Farmers’ Rights. National governments have the responsibility for realizing Farmers’ Rights (art.9.2). The right to participate in decision-making at the national level on matters related to the conservation and sustainable use of PGRFA is among the measures to protect and promote Farmers’ Rights (art.9.2(c)). This could be interpreted to include the right of farmers to participate in biosafety decision-making processes and to have access to information.

The Treaty creates a Multilateral System of Access and Benefit-sharing (MLS) in article 10. Access is to be facilitated to PGRFA that are part of the MLS. Access to those PGRFA that are included in the MLS is provided “solely for the purpose of utilization and conservation for research, breeding and training for food and agriculture” (art.12.3(a)). These uses are not to include those for the purpose of chemical, pharmaceutical and/or other non-food/feed industrial uses.

The benefit sharing provisions of the Treaty will not be elaborated upon here. However, it should be noted that benefits might include the sharing of modern biotechnologies that use or incorporate PGRFA.

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

International Plant Protection Convention (1997)

Y





Y

Y

Y

Y

Y


Y

Y

Selected Legal Annotations and Comments

The FAO International Plant Protection was originally adopted in 1951. It has been subsequently revised with the latest revision adopted in 1997 (described here). The IPPC regulates plant pests. It also regulates “any organism, object or material capable of harbouring pests or spreading pests that affect plants or plant products” (art.I(4)). The purpose of regulation is to prevent “the spread and introduction of these pests and promoting measures for their control” (ICPM, 2001a). IPPC provides a framework to develop and apply harmonized phytosanitary measures through the elaboration of international standards, the creation or management of national plant protection organizations. A “phytosanitary measure” is “any legislation, regulation or official procedure...to prevent the introduction and/or spread of pests” (art.II(1)).

“Pests” are “any species or biotype of plant, animal or pathogenic agent injurious to plants or plant products” (art.II(1)) (including fungi) (ICPM, 2001b). Therefore, the IPPC’s scope of application is broad enough to include genetically modified organisms, or living modified organisms/products of modern biotechnology that may directly or indirectly damage plants. Damage to plants is not necessarily limited to cultivated plants. The IPPC can be interpreted to apply to all plants - whether cultivated or wild - though in actual operation many contracting parties have limited its application to the former.

The IPPC creates a Commission on Phytosanitary Measures (art.XI(1)). Until the 1997 revision enters into force, the Commission meets as the Interim Commission on Phytosanitary Measures (ICPM). The Commission is tasked with inter alia establishing and keeping under review the arrangements to develop and adopt international standards on phytosanitary measures (ISPMs) (art.XI(2)(b)). ISPMs are “the standards, guidelines and recommendations recognized as the basis for phytosanitary measures applied by Members of the World Trade Organization under the Agreement on the Application of Sanitary and Phytosanitary Measures” (ICPM, 2001a). The development and application of ISPMs contributes to minimising phytosanitary measures as barriers to international trade.

A suite of ISPMs has been developed under the IPPC. Perhaps the most relevant are the Guidelines for Pest Risk Analysis. The PRA Guidelines describe the three stages of PRA: (1) initiating the process for analysing risk presented by a pest; (2) assessing the pest risk and (3) managing the pest risk (IPPC, 1996b). As described in the Guidelines, initiating the process begins with identifying the pests or pathways for which the PRA is needed. A pest risk assessment then determines whether the pest identified is a quarantine pest. A quarantine pest is characterized in terms of the likelihood of entry, establishment, spread and economic importance. Pest risk management involves developing, evaluating, comparing and selecting options for reducing risk.

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 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 to justify their continued application (art.VII (6)).

In general, import requirements must comply with minimum stakeholder related requirements (as between IPPC parties). Some of these include publication and transmission of import requirements and the availability of a rationale (art.VII(2)).

At its second session, the ICPM established the Exploratory Open-ended Working Group on Phytosanitary Aspects of GMOs, Biosafety and Invasive Species to review among other things the relationship between IPPC and the plant pest concerns that may be presented by LMOs/products of modern biotechnology. The Working Group noted that the IPPC was relevant to and adequate for managing the plant pest risks posed by LMOs/products of modern biotechnology (ICPM, 2000). Based on the Working Group’s recommendation, the ICPM at its third session decided to create an Open-ended Expert Working Group for the Development of a Detailed Standard Specification on the Plant Pest Risks Associated with LMOs/Products of Modern Biotechnology (ICPM, 2001a).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce / Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Code of Conduct for the Import and Release of Exotic Biological Control Agents (1996)

Y







Y

Y

Y


Y


Selected Legal Annotations and Comments

Another IPPC instrument that may be relevant to GMOs used in or having an effect on plant protection is the Code of Conduct for the Import and Release of Exotic Biological Control Agents. The Code’s Outline notes that the Code could be applied to the handling and release into the environment of strains of organisms created artificially by genetic engineering techniques (IPPC, 1996a). In general, the code applies to exotic biological control agents (1) imported for research; (2) imported and released for biocontrol; and (3) imported and released for use as biological pesticides. The Code aims to facilitate safe import, export and release of exotic biological control agents by introducing internationally acceptable procedures for public and private entities (art.1.1). It provides standards that inter alia encourage responsible and generally accepted trade practices (art.1.1). The Code promotes the assessment of risks to the environment and human and animal health prior to import (at first import: identification of potential hazards, the risks posed and proposed mitigating procedures) (art.4.3) and prior to release (where not already to in an import permit) (art.7.1.1). Responsibilities for authorities are also described for situations before and upon release including inter alia encouraging monitoring (art.7.1.3) and ensuring corrective action when problems arise (art.7.1.4). Curiously, an importer is only to make information publicly available relating to safety and environmental impact after import and release (art.8.1.2). A “free and frank” exchange of information, not subject to commercial confidentiality, is to be maintained. 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).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce / Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Code of Conduct for Responsible Fisheries (1995)

Y









Y


Y

Y

Selected Legal Annotations and Comments

The FAO Code of Conduct is a voluntary set of principles and standards applicable to the conservation, management and development of all fisheries (preface and article 1.3). Some of its provisions reflect existing international law. It is global in scope and applies to all governments, fisheries organizations, non-governmental organizations and the private sector (art.1.2).

The Code’s general provisions generally apply to release and use of GMOs without specifically mentioning these types of organisms. For example, 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). Furthermore, the precautionary approach is to be applied to the conservation, management and development of living aquatic resources (art.6.5). Finally, decision-making should be transparent and stakeholder participation should be facilitated (art.6.13).

The Code’s aquaculture provisions are most directly applicable to GMOs because GMOs will likely be released in the context of aquaculture operations. Of the different obligations, two stand out. First, States should ensure that the livelihoods of local communities, and their access to fishing grounds, are not negatively affected by aquaculture developments (art.9.1.4). This could be applied in situations where, for example, a genetically altered fish displaces wild species. Second, States in general should conserve genetic diversity and maintain the integrity of aquatic communities and ecosystems through management. Specifically, States are to minimize the harmful effects of introducing “genetically altered stocks” used in aquaculture, including culture-based fisheries, into waters (art.9.3.1).

This is especially important where there is significant potential for these stocks to spread into the waters of other States (art.9.3.1).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce / Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

International Code of Conduct on Plant Biotechnology as it Affects the Conservation and Utilization of Plant Genetic Resources (1992) (preliminary draft)

Y





Y

Y

Y

Y

Y

Y

Y

Y

Selected Legal Annotations and Comments

The FAO Commission on Plant Genetic Resources originally accepted in 1992 the preliminary draft of the FAO International Code of Conduct on Plant Biotechnology as it Affects the Conservation and Utilization of Plant Genetic Resources. Further work on the Code was postponed owing to other work priorities within the Commission, namely the renegotiation of the International Undertaking on Plant Genetic Resources. With the adoption of the International Treaty on Plant Genetic Resources for Food and Agriculture, and the earlier adoption of the CBD Biosafety Protocol, the renamed Commission on Genetic Resources for Food and Agriculture (CGRFA) has turned its attention back to the draft Code. The CGRFA, in its 9th meeting in October 2002, discussed the document ‘The Status of the draft Code of Conduct’. That document was based on the responses of FAO member countries and a large number of stakeholders to a survey carried out by the Secretariat of the CGRFA on the need for, and the possible updating of, the 1993 preliminary draft Code. It was noted within the CGRFA that the 1993 preliminary draft Code had already accomplished much, as a far-sighted source of inspiration in the development of the Cartagena Biosafety Protocol and the International Treaty on Plant Genetic Resources for Food and Agriculture.

The draft Code is a holistic document that goes beyond mere biosafety issues to address a wide range of issues involving plant genetic resources (PGRs) and biotechnology. It attempts to address technical, economic, social, ecological, ethical and legal developments on biotechnology as it relates to biotechnology and PGRs.

It lists eight objectives. Three of these are perhaps the most relevant to this study. The first objective is providing “recommendations for the safe, responsible and equitable use of biotechnologies for agriculture and food by researchers and commercial users in the public”, private governmental sectors (art.1.2). Another relevant objective 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). A third relevant objective is ensuring that “the environmental impact of innovations in biotechnology in agriculture and food industry (sp.) is (sp.) fully assessed and measures are taken to minimize and mitigate them (art.1.7).

The draft Code applies to new (or modern) biotechnologies “as they affect the conservation and utilization of plant genetic resources” (art.2). As a result the draft Code applies to all plant biotechnologies. It also applies to all other biotechnologies if they affect or are likely to affect the conservation and utilization of PGRs. This includes whether or not the plants or other organisms have been modified using the new biotechnologies.

The draft Code is voluntary in nature (art.4.1). It is addressed primarily to governments. It also addresses international organizations, researchers and research institutions, the agro- and biotechnology industries, the seed trade, trade associations, local communities, farmers and public sector groups (art.4.3).

One of the key provisions of the draft Code is 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).

Governmental action at the national level should be framed through policies and programmes in agriculture and food biotechnologies (art.6). In particular, governments should establish committees for appropriate biotechnology or similar fora. Their membership should be multi-disciplinary and represent “related interests that can assess the needs for and likely benefits and other impacts of relevant biotechnologies and their influence on the productivity and sustainability of prevailing agricultural systems” (art.6.1).

The draft Code also addresses 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. Governments and international organizations should also act to foresee and prevent possible negative long-term environmental effects of biotechnologies (art.8.2). Genetic erosion and the narrowing of the genetic basis of cultivated crops are emphasized. This is to be accomplished through adequate monitoring and long-term assessment of environmental impact as part of normal procedures for technology assessment. 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).

Article 9 addresses access to PGRs and related biotechnologies; intellectual property rights and compensation for informal innovators. These provisions are not elaborated upon here.

The FAO World Information and Early Warning System on Plant Genetic Resources (PGR/WIS) will be the focal point for the exchange of information related to the draft Code’s implementation (art.10.1). By disseminating information, the PGR/WIS will support the development of appropriate biotechnologies for the sustainable use of PGRs and biodiversity (art.10.2). One way it will do this is by promoting research to define more precisely criteria and indicators on biotechnology’s contribution “to sustainability in agriculture and use of plant genetic resources...such criteria should include both scientific (i.e. protection and development of biodiversity) and socio-economic aspects (i.e. whether innovations fit local farming systems)” (art.10.2.1). In addition, the PGR/WIS will inter alia assess possible future developments and highlight possible adverse effects, identify crops and farming communities at risk and notify governments of the eventual risks for crops, farming communities, and human and animal health (art.10.3).

The draft Code’s most extensive chapter addresses biosafety and other environmental concerns. Article 11 focuses on environmental risks from the application of plant biotechnologies. 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). The creation of a multi-disciplinary and multi-interest “national committee on biosafety and other environmental concerns” is suggested (art.11.1). The elaboration of specific new laws and regulations is also suggested while ensuring that existing legislation has “adequate mechanisms for guaranteeing biosafety is also an option (arts. 11.2 and 11.3). A mechanism is also suggested to control and monitor deliberate releases, and to ensure the enforcement of biosafety laws and regulations (art.11.5).

International co-operation is urged in consideration that plants and other organisms (whether modified by genetic engineering or not) could adversely affect PGRs on other countries (art.12.1).

The draft Code proposes together in article 13 risk assessment and authorization procedures for biotechnological applications to PGRs and the deliberate release of transgenic organisms that could adversely affect PGRs. Countries should ensure that there is a “full review and risk assessment by both the proposer and the competent authority” (art.13.1). The review should precede authorization by the national authority (art.13.2). The review and risk assessment should be “conducted on a scientifically sound basis and consider possible negative consequences for human and animal health and the environment (including agro-ecosystems, possible PGRs erosion and biodiversity) (art.13.3). The draft Code also suggests a number of bits of information that a proposer should include in any request for authorization (art.13.4).

Case by case review is suggested to consider risks associated with each deliberate release (art.13.5). Risk assessment should also proceed on a step-by-step basis - 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 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. The authorization from the competent national authority should also include liability provisions for “eventual environmental damages due to the deliberate release of a transgenic organism” (art.13.9).

Article 14 of the draft Code also suggests various risk management and monitoring steps that should be taken. 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). The proposer must ensure adequate and proportional monitoring of the actual effects that the organisms had on the environment and suggestions are made as to what information should be recorded (art.14.3). 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).

Governments and competent authorities should ensure adequate containment during transport. (art.15.1). Import of transgenic organisms intended for release that could affect PGRs should be prohibited without the importing country’s advanced informed agreement/prior informed consent (art.15.2). AIA/PIC should take place independently of risk assessment and authorization for release in the exporting country. It should be subject to inter alia (1) a preliminary risk assessment by the competent authority of the exporting country; (2) a notification from the competent authority of the exporting country along with all information to properly assess the risk and (3) the full authorization of the importing country’s competent national authority (arts. 15.2.1, 15.2.2 and 15.2.4). In addition, a preliminary risk assessment should be proportional to the expected degree of risk (art.15.2.3). A government that does not authorize handling or release of a transgenic plant or other organism should notify among others the Commission on Plant Genetic Resources (art.15.3). A transgenic plant, or micro-organism that could adversely affect PGRs, that has not been authorized because of its pathogenic effects on human health, animals or plants (independently of the environment), could be exported only following a specific request from the importing country’s competent authority (art.15.4). Unauthorized exports should be notified to the Commission on Plant Genetic Resources (art.15.5). A database of actions taken by member governments will be developed under the PGR/WIS so the information can be provided to national competent national authorities and international organizations (art.15.6).

Article 16 addresses public information. Article 16.1 provides that the public should be informed about possible risks to the environment and health. In addition, governments and competent authorities should “apply transparent procedures in risk assessment, giving access to all the information that could be of public interest” (art.16.1). Governments and public authorities should inform and consult the public, particularly local and farming communities that could be affected, about specific deliberate releases (art.16.2). Governments should also organize adequate public education and information on plant biotechnologies (art.16.3).

Governments should inform the Commission on positive results and any negative effects, both environmental and socio-economic, from the applications of new biotechnologies (art.17.2). Finally, non-observance of the rules and regulations of a host country regarding the safe, responsible and equitable use of agro- and food biotechnologies should be provided to the Commission with copies to the transgressor (art.17.3).

The Code is to be reviewed and updated periodically to take into account technical, economic, social, ecological, ethical and legal developments (art.18.1).

Organization for Economic Co-operation and Development

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce / Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Safety Considerations for Biotechnology (1992)

Y









Y




Selected Legal Annotations and Comments

The 1992 OECD Safety Considerations follow earlier OECD work in 1986 that set out the first safety guidelines for biotechnology applications to industry, to agriculture and to the environment (OECD, 1992). The 1986 Recombinant-DNA Safety Considerations provided guidance to be used in assessing field research involving GMOs. The 1992 Safety Considerations address two issues: biotechnological industrial production (good industrial large-scale practice of fermentation-derived biotechnology products) and, for field experiments, “Good Developmental Principles” (GDP). GDPs are proposed to contribute to “design...safe small scale field research with plants and micro-organisms with newly introduced traits” (OECD, 1992). Only the second aspect is described here.

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).

GDPs are premised on three working assumptions. First, that “certain general scientific principles related to the organism, the research site and experimental conditions have varied relative importance in determining whether an experiment is of low or negligible risk” (OECD, 1992). Second, is that an experiment’s risk can be determined “by evaluating the relevant factors and their interaction under conditions of the experiment...” (OECD, 1992). Third and finally, “the interaction of these factors is easier to address in small-scale field experiments...because of their limited scope, which permits closer monitoring, generally easier assessment and analysis and the possibility of more effective containment measures” when something unforeseen happens (OECD, 1992).

Three “key” safety factors are described. The first is the characteristics of the organism. It is acknowledged that some organisms may have characteristics that present low or negligible risk under a broad range of conditions. Organisms with known adverse effects may still be able to be used when the experimental design allows the reduction of the likelihood of adverse effects through mitigation and/or confinement to a restricted research site. The first key safety factor recognizes higher plants can be more readily mitigated and confined than micro-organisms.

The characteristics of the research site are the second key safety factor. The research site is to be “chosen both to design field trials of low or negligible risk and to meet the objectives of the research” (OECD, 1992).

The experimental conditions are the third key safety factor. Careful experimental design is a precondition to “acceptable and environmentally sound field research” (OECD, 1992). Some of the many considerations provided in the document include: (1) choosing an appropriate site in relation to the proximity of significant biota that could be affected; (2) characterising the site; (3) developing suitable safety and handling procedures for application and contingency plans; (4) keeping introduced organisms to the lowest practicable level appropriate for the experiment; (5) limiting dispersal; (6) adequate monitoring and preparedness to apply control or mitigation measures to avoid unintended adverse environmental effects; and (7) appropriate training for all involved personnel.

The Safety Considerations also provide guidance on the application of GDP to plants and micro-organisms, as well as scientific considerations for small-scale research with plants and micro-organisms.

United Nations Commission on Economic Co-operation in Europe

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce / Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters (1998)

Y


Y


Y







Y


Selected Legal Annotations and Comments

The Aarhus Convention has not yet entered into force. The Convention specifically mentions GMOs in the context of decision-making (art.6(11)), but its broader or more general provisions could be interpreted to apply to GMOs as well. When the Convention was first adopted, the signatories requested that the first meeting of contracting parties develop further the application of the Convention with respect to GMOs. The first meeting of signatories established the Task Force on Genetically Modified Organisms (UNECE, 2000). The Task Force met twice in 2000. At its first meeting the Task Force generally agreed that article 6(11) of the Convention “left it unclear to what extent and in what situations the provisions of article 6 should be applied to decision-making on GMOs” (UNECE, 2000). At its second meeting, the Task Force sought to identify possible procedural options to clarify the Convention’s application to GMOs (e.g. developing an annex or a set of guidelines); to clarify the definition of “deliberate release”; and to review the means, including labelling, of providing information on products containing GMOs, products derived from GMOs and products obtained by using GMOs (UNECE, 2001). A new Intergovernmental Working Group was established in October 2002 by the meeting of the parties. Of particular relevance in the agenda of the Intergovernmental Working Group are the Guidelines on Access to Information, Public Participation and Access to Justice with respect to Genetically Modified Organisms. Up to December 2002 the Guidelines are in an advanced but unedited version.

The Convention is premised upon the principle that every person of present and future generations has the right “to live in an environment adequate to his or her health and well-being” (art.1). One aspect of ensuring this is for governments to “guarantee the rights of access to information, public participation in decision-making and access to justice in environmental matters” pursuant to the Convention’s provisions (art.1). The 20th recital in the preamble recognizes “the concern of the public about the deliberate release of genetically modified organisms into the environment and the need for increased transparency and greater public participation in decision-making in this field”.

Environmental information is defined to include any information in any media on inter alia (1) the state of elements of the environment, including GMOs and (2) factors affecting or likely to affect the elements of the environment, cost benefit and other economic analysis and assumptions upon which environmental decision-making is based. A person may access environmental information without an interest having to be stated (art.4(1)(a)). The information should be made available as soon as possible (art.4(2)). Requests for access may be refused according to criteria enumerated (art.4(3)). In addition, access to environmental information may be refused for reasons of commercial confidentiality (art.4(4)(d)), but the grounds for refusal are to be interpreted restrictively, taking into account the public interest served by disclosure (art.4(4)). There is an affirmative obligation on public authorities to possess and update environmental information relevant to their functions (art.5(1)((a)). They must establish systems to ensure an adequate flow of information on proposed and existing activities; (art.(1)(b) and the availability of information enabling the public to take steps to mitigate harm where there is an imminent threat to human health (art.5(1)(c)). The way in which public authorities make information available to the public is to be transparent and environmental information is to be effectively available (art.5(2)). The progressive availability to the public of easily accessible electronic sources of information is required, including environmental legislation (art.5(3)(b)). Operators undertaking activities with a significant environmental impact are to be encouraged to regularly inform the public of the environmental impact of their activities and products (art.5(6)). Parties are also to develop mechanisms to ensure that sufficient product information is available to the public that enables consumers to make informed environmental choices (art.5(8)).

Public participation in decision-making is to take place for activities enumerated in Annex I (art.6). However, the provisions of article 6 are specifically to be extended “to decisions on whether to permit the deliberate release of GMOs into the environment (art.6 (11)). For example, the public is to be informed early on in the decision-making process of inter alia the proposed activity, the technical details of the decision-making process itself and whether a national or transboundary environmental impact assessment is necessary (art.6(2)(a), (d) and (e)). The procedures should include reasonable timeframes (art.6(3)). Prospective applicants are encouraged to meet early with stakeholders before applying for a permit (art.6(5)). Competent national authorities are to give the public access to all information relevant to the decision-making, subject to certain exceptions (art.6(6)). Procedures are to allow the public to submit any comments, information, analyses or opinions considered relevant to the proposed activity (art.6(7)). Each contracting party is also to ensure in the decision that due account is taken of the outcome of public participation (art.6(8)). When a decision is taken the public is to be promptly informed; 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)). Whenever a decision is reconsidered after the fact, the same procedures for the original decision as specified in the Convention are to be followed (art.6(10)). The Convention also includes provisions on public participation in strategic processes such as planning and programming (art.7), as well as in law making and the promulgation of regulations (art.8).

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)). The public is to have access to administrative or judicial procedures to challenge acts or omissions by private persons and public authorities (art.9(3)). Finally, adequate and effective remedies, including injunctive relief, are to be provided as well (art.9(4)).

United Nations Commission on Sustainable Development

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce / Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Agenda 21, Chapter 16, Environmentally Sound Management of Biotechnology (1992)

Y





Y

Y


Y

Y


Y

Y

Selected Legal Annotations and Comments

Agenda 21 addresses the environmentally sound management of biotechnology in chapter 16. The programme is to help foster the application of internationally agreed principles to ensure environmentally sound management; “to engender public trust and confidence”; to promote development of sustainable biotechnological applications; and establish appropriate enabling mechanisms (para. 16.1). 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. Only programme areas A, C, D and E are summarized here. The development of appropriate safety procedures taking into account programme area D, while “taking account of ethical considerations” is common to all programme areas.

Programme area “A” puts into perspective the need not just to increase food supply through biotechnology, but also to improve food distribution and putting agriculture on a more sustainable footing (para. 16.2). It highlights that productivity gains have benefited only industrialized countries where biotechnology has been concentrated and that this imbalance needs to be rectified. Of the proposed activities in this programme area, those related to management may be most important in the context of this study. For example, governments are called on to improve plant and animal breeding and micro-organisms both through traditional and modern biotechnologies. But this should be undertaken taking into account the needs of farmers, the modifications’ socio-economic, cultural and environmental impacts; the need 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 primary aim programme area “C” is to prevent, halt and reverse environmental degradation through the appropriate use of biotechnology in conjunction with the use of other technologies (para.16.22). Some of the management-related activities that governments are foreseen to undertake include inter alia: (a) developing applications to minimize the use of unsustainable synthetic chemical inputs; (b) increasing the availability of planting materials particularly indigenous varieties, for afforestation and reforestation and to improve sustainable yields from forests; (c) developing applications to increase the availability of stress-tolerant planting materials for land rehabilitation and soil conservation; (d) promoting the use of integrated pest management based on judicious use of bio-control agents; (e) promoting the use of bio-fertilisers within national fertiliser programmes (para.16.23).

The basis for action on programme area “D” includes many of the concepts reflected in the literature, fora and instruments reviewed thus far in these summary tables. These include: the need for internationally agreed principles on risk assessment and management; the need for adequate and transparent safety and border-control procedures to build confidence in biotechnology and lay the foundation for the community at large to accept potential risks and benefits of biotechnology; the primary consideration of the organism in safety assessment; the application of the principle of familiarity in a “flexible framework” considering national requirements, and logical progression within “a step-by-step and case-by-case approach”; the evolution to a more comprehensive approach based on the experiences of the first period leading to streamlining and categorising; complementary consideration of risk assessment and risk management; classification into contained use and release into the environment (para. 16.29). The aim of the programme area is “to ensure safety of biotechnology development, application, exchange and transfer through international agreement on principles to be applied on risk assessment and management, with particular reference to health and environment considerations, including the widest possible public participation and taking into account ethical considerations” (para. 16.30). The activities proposed were to be built upon planned or existing activities (para. 16.31). Among the management-related activities, governments should: (a) make existing safety procedures widely available and adapt them to local needs; (b) further develop existing safety procedures; (c) compile a framework of internationally agreed principles as a basis for guidelines on biosafety; and (d) exchange information on safety procedures and assist in emergency situations (para. 16.32).

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. Mention is also made of the need for “national mechanisms to allow for informed comment by the public with regard to biotechnology research and application”. 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). One of the programme area objectives is to raise public awareness on the beneficial aspects of and risks related to biotechnology (para. 16.39(a)(iii)).

United Nations Environment Programme

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce / Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Convention on Biological Diversity (1992)

Y





Y


Y

Y

Y


Y


Selected Legal Annotations and Comments

The CBD addresses biosafety in two articles: Article 8(g) and Article 19(3) and (4). Article 8(g) requires each contracting party to domestically regulate or manage the risks associated with the use and release of living modified organisms (LMOs) resulting from biotechnology likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity. Risks to human health are also to be taken into account but it is unclear in what context. For example, should risks to human health be considered in the purest sense or only in the context of biodiversity conservation and sustainable use? No further details are given. Other principles reflected in the CBD preamble and other CBD articles could be interpreted to apply to the use and release of LMOs. The principles of prevention and precaution, reflected in the CBD’s preamble, are examples of the former case.

In the latter case, contracting parties are to introduce appropriate procedures to require impact assessment of proposed projects likely to have significant adverse effects on biodiversity (art.14(1)(a)). The objective is to avoid or minimize such effects. “Where appropriate” public participation in the procedures is to be allowed. Other relevant obligations include those on reciprocity, notification, exchange of information with other States and international organizations where activities in one party may adversely affect the biodiversity of another party or an area beyond the limits of any national jurisdiction (art.14(1)(c and d)). Parties are to create emergency response arrangements at national level and joint contingency plans with other States (art.14(1)(e)). Finally, there is a general obligation for parties to transfer environmentally sound technology (including biotechnology) relevant to the conservation and sustainable use of biodiversity (art.16(1)).

Domestic measures may benefit from international measures. The Biosafety Protocol, the need for which the CBD COP was required to consider under Article 19(3), now provides the basis for international measures related to the trade in LMOs. Prior to the Biosafety Protocol (see below), there was no global legally binding instrument to address the transfer, safe handling and use of LMOs resulting from modern biotechnology in the context of adverse effects on the environment that could subsequently adversely effect biodiversity.

Whether it ratifies or accedes to the Protocol or not, a CBD party must still fulfil its obligations to implement CBD Article 8(g). In addition, where it does not ratify or accede to the protocol, a CBD party still needs to implement CBD Article 19(4).

CBD Article 19(4) creates a bilateral obligation for a CBD party to provide information on an LMO prior to providing it to another CBD party. This information includes (1) any available information on the regulatory measures taken by the exporting CBD Party and (2) any available information on the “potential adverse impact” of a particular LMO.

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce / Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Cartagena Protocol on Biosafety to the Convention on Biological Diversity (2000)

Y



Y

Y

Y

Y

Y

Y

Y


Y

Y

Selected Legal Annotations and Comments

The Biosafety Protocol was adopted in 2000. It has yet to enter into force. Along with the adoption of the Biosafety Protocol, the CBD COP Extraordinary Meeting established the Open-ended Ad Hoc Intergovernmental Committee for the Cartagena Protocol on Biosafety (ICCP). The ICCP has the mandate to prepare for the first meeting of the Protocol Parties.

The ICCP’s first three meetings took place in 2000, 2001 and, recently, in April 2002. At the latest meeting, ICCP conducted a survey among States that suggests the possible entry into force of the Protocol in early 2003.

The objective of the Protocol is to contribute to ensuring adequate levels of protection in the field of safe transfer, handling and use of LMOs (from modern biotechnology) that may have adverse effects on the conservation and sustainable use of biodiversity (accounting for human health risks) (art.1). The Protocol specifically applies to transboundary movement, transit, handling and use of LMOs that may have adverse effects on biodiversity conservation and sustainable use (accounting for risks to human health) (art.4). The Protocol applies only to the movement of LMOs between contracting parties. There is only one exception to the scope of the Protocol. It does not apply to the transboundary movement of LMOs that are pharmaceuticals for human use that are addressed by other relevant international agreements or organizations (art.5) (Sendashonga, 2001).

In general, each party (1) is to take the necessary and appropriate legal, administrative and other measures to implement the protocol’s obligations; and (2) is to ensure the development, handling, transport, use transfer and release of LMOs is undertaken in a manner that prevents or reduces risks to biodiversity (accounting for human health risks) (art.2(1 and 2). Each party can take more protective action to conserve and sustainably use biodiversity, provided action is consistent with the Protocol (art.2(4)).

The most significant provisions of the Biosafety Protocol focus on the evaluation and notification between parties for LMOs slated for export and subsequent import. Advanced informed agreement (AIA), in other words, notification and subsequent approval of a first-time import (an intentional transboundary movement), applies to LMOs that are intended for intentional introduction into the environment where they may have adverse effects on the conservation and sustainable use of biodiversity (arts.7-10 and 12). The Protocol sets up a notification procedure between the exporting contracting party (or an exporter that is a legal or natural person) and an importing contracting party (arts.8 and 9). Criteria are provided for decision-making on importation (art.10). Most notably, decisions of the contracting party of import must be according to a risk assessment.

It is important not to confuse the exceptions to AIA procedure with exceptions to the Protocol’s scope of application (Damena, 2001; Sendashonga, 2001). In the case of the latter, there is only one exception: pharmaceuticals intended for human use that are already addressed by another international instrument or organization). In the case of the former there are four categories of exceptions: (1) LMOs in transit (art.6(1)); (2) LMOs for contained use (art.6(2)); (3) LMOs identified in a decision of the Conference of Parties/Meeting of Parties as not likely to have adverse effects on biodiversity conservation and sustainable use (art.7(4)); and (4) LMOs intended for direct use as food, feed or for processing (art.11).

For LMOs intended for direct use as food or feed, or for processing, the contracting party that makes a final decision for domestic use must notify the Biosafety Clearing-house created under the Protocol when the LMO could find its way into international trade (art.11). The notification, at minimum, must contain information required under Annex II. The exemption for AIA does not apply to decisions on field trials. Even though AIA does not apply, a contracting party may still take an import decision under its domestic regulatory framework, provided this is consistent with the Protocol (art.11(4)). 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 (art.10(6)).

When it lacks a domestic regulatory framework, a developing country contracting party, or a party with a transition economy, can declare through the Biosafety Clearinghouse that its decision on the first import of an LMO for direct use as food, feed or for processing will be pursuant to a risk assessment (art.11(6)). 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 (art.11(8)).

Risk assessment and risk management are key requirements in both situations covered by the Protocol. In both cases, the risk assessment must be consistent with criteria enumerated in an annex (art.15). For example, the risk assessment must be undertaken in a manner, which is scientifically sound and transparent and on a case-by-case basis (Annex III). 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). The criteria reflect the principle of substantial equivalence though the term is not specifically used. For example, risks posed by an LMO or products thereof (of LMO origin with detectable novel combinations of replicable genetic material obtained through use of modern biotechnology) should be considered in the context of risks posed by the non-modified recipients or parental organisms in the likely receiving environment (Annex III). While risk assessment is to be carried out by competent national decision-making authorities, the exporter may be required to undertake the assessment (art.15(2)). The importing party may require the notifier to pay for the risk assessment (art.15(3)).

The 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)). Affected or potentially affected States are to be notified when an occurrence may lead to an unintentional transboundary movement (art.17(1)).

During the Protocol negotiations, there was a debate on the extent to which socio-economic considerations should be considered in 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. The parties are encouraged to co-operate on research and information exchange on any socio-economic impacts of LMOs, especially on indigenous and local communities (art.26(2)).

The Protocol contains explicit public participation provisions. Contracting parties shall: (a) promote and facilitate public awareness, education and participation concerning safe transfer, handling and use of LMOs in relation to biodiversity conservation and sustainable use (taking into consideration risks to human health) (art.23(1)(a)). The contracting parties are to endeavour to ensure public awareness and education encompasses access to information on LMOs identified by the Protocol that may be imported (art.23(1)(b)). In addition, the Parties shall consult the public in the decision-making process regarding LMOs and shall make decisions available to public (in accordance with respective laws), but respecting confidential information (art.23(2)). Finally, each Party is to endeavour to inform its public about access to information on Biosafety Clearinghouse (art.23(3)).

Confidential information is explicitly addressed in the Protocol. For example, the contracting party of import is to permit the notifier to identify information submitted under Protocol procedures or required by the contracting party of import for AIA to be treated as confidential (art.21(1)). The notifier must justify this upon request. The party of import is to consult the notifier if the information identified does not qualify for confidential treatment and inform notifier prior to disclosure; the party must provide reasons on request and opportunity for consultation and internal review of decision prior to disclosure (art.21(2)). Each contracting party is to protect confidential information that it receives; each Party is to ensure that it has procedures to protect confidentiality and shall protect this information no less favourably than confidential information for domestically produced LMOs (national treatment) (art.21(3)). The party of import is not to use the confidential information for commercial purposes except with written consent of the notifier (art.21(4)). When the notifier withdraws or the notification is withdrawn, the contracting party must respect the confidentiality of commercial and industrial information (R&D included) and information where there is disagreement as to confidentiality (art.21(5)). Some information cannot be made confidential: (a) the notifier’s name and address; (b) the general description of the LMO; (c) a summary of the risk assessment; and (d) methods and plans for emergency response (art.21(6)).

The Protocol also contains provisions on LMO handling, packaging and transportation. For example, each contracting party must take the necessary measures such that LMOs subject to intentional transboundary movement within the Protocol’s scope are handled, packaged and transported under safety conditions (considering relevant international rules) in order to avoid adverse effects on biodiversity conservation and sustainable use (accounting for risks to human health) (art.18(1)). In particular, each contracting Party is to take measures to require documentation that:

(a) clearly identifies LMOs intended for direct use as food or feed, or processing with the words “may contain” LMOs and “not intended for intentional introduction into the environment” and contact point; the COP/MOP is to decide within two years of entry into force on detailed requirements especially on identity and unique identification;

(b) clearly identifies LMOs destined for contained use and specifies any requirements for safe, handling, storage, transport and use; contact point; and consignee; and

(c) clearly identifies LMOs intended for intentional introduction into the environment of the party of import; specifies identification and traits/characteristics, requirements for safe, handling, storage, transport and use; contact point; name/address of importer/exporter; and a declaration that the movement conforms to the Protocol’s requirements applicable to exporter (art.18(2)(a-c)).

The meeting of parties is to consider the need for modalities to develop standards on identification, handling, packaging and transport practices in consultation with other relevant bodies (art.18(3)).

A process to address liability and redress for damage resulting from LMO transboundary movements is to be set up by the first meeting of the Protocol parties (art.27). This is to take due account of ongoing processes and with the anticipated completion of the process within 4 years.

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce / Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

UNEP Technical Guidelines on Biosafety (1995)

Y





Y


Y

Y

Y


Y


Selected Legal Annotations and Comments

The UNEP Guidelines were adopted in 1995. They were designed and adopted as a contribution to the implementation of Agenda 21 (Chap. 16). They provide the possibility for States to voluntarily develop mechanisms for evaluating the biosafety of “organisms with novel traits” and to identify, assess and manage the risks associated with the use of biotechnology. “Organisms with novel traits” are those organisms whose genetic make-up is unlikely to develop naturally (para. 21). The Guidelines acknowledge the importance of assessing socio-economic and other impacts of new biotechnologies but do not address these issues.

The Guidelines draw from common elements and principles of regional and international instruments and national regulations and guidelines. They focus on human health and environmental safety for all applications of biotechnology, whether research, development or commercialization. Safety assessment is premised on (1) hazard identification; (2) risk assessment; and (3) risk management (para. 18). Risk assessment and risk management can be based in part on knowledge and experience with an organism (familiarity) with the proviso 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 exemption 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 user of the organism has the primary responsibility for the safe use or transfer of organisms with novel traits once adequate risk management strategies have been devised. The introduction of organisms with novel traits into centres of origin must be particularly considered in risk assessment and management. Annex 3 provides additional considerations for risk assessment. Annex 5 provides additional considerations for risk management.

The Guidelines 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).

Risk assessment and management needs to be undertaken within an institutional framework (para.33). Multidisciplinary scientific expertise may be drawn upon (para. 36). The oversight authorities are responsible for encouraging public participation, through access to information on which decisions are based, while respecting confidential business information. Annex 7 highlights examples of how the public may be involved. Examples include inter alia, establishing a register of information on organisms with novel traits, giving interested groups the opportunity to comment, publishing a newsletter, encouraging proponents to inform local people and encouraging dialogue between the public and companies and academic institutions.

Where transboundary impacts could occur, the potentially affected country should be notified of the intended use and should be given the opportunity to determine whether risk management measures will protect its interests (para. 42). The potentially affected country should be informed immediately when adverse effects could affect it.

The Guidelines also provide a framework to exchange information related to transboundary transfer or organisms with novel traits (para. 44). The framework is premised on a user in an exporting country providing information to a user or focal point in the importing country, prior to transfer. This is much like the concept of “advanced informed agreement” in the CBD Biosafety Protocol. It is particularly intended to assist those countries without fully operational regulatory programmes.

United Nations General Assembly

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

United Nations Convention on the Law of the Sea (1982)

Y













Selected Legal Annotations and Comments

UNCLOS entered into force in 1994. Article 196 (Use of technologies or introduction of alien or new species) applies to biotechnological applications involving marine and coastal areas. It says “States shall take all measures necessary to prevent, reduce and control ... the intentional or accidental introduction of species, alien or new, to a particular part of the marine environment, which may cause significant and harmful changes thereto”. Although not specific, UNCLOS’s provisions can be interpreted to support, for example, assessment of GMOs prior to their release into the marine environment.

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

UN Guidelines for Consumer Protection (1985)

Y

Y

Y


Y

Y




Y


Y


Selected Legal Annotations and Comments

The UN Guidelines for Consumer Protection were adopted in 1985 as UN General Assembly Resolution 39/248 of 9 April 1985. The guidelines were incepted as “a comprehensive policy framework outlining what governments can do to promote consumer protection in such areas as safety, economic interests of consumers, quality and distribution of goods and services, consumer education and information and redress” (UNESC, 1998). They form one cornerstone group of principles underpinning the Codex Alimentarius. The UN Commission on Sustainable Development (CSD) established an international work programme on changing consumption and production patterns in 1995. In 1995, the CSD recommended expanding the consumer protection guidelines to include guidelines on sustainable consumption patterns (UNESC, 1998). The UN Economic and Social Council requested the Secretary General to work on this through the creation of an interregional expert group meeting (UNESC, 1998). The expert group, which met in 1998, made specific recommendations for submission to Council through the Commission on Sustainable development at its sixth session (UNESC, 1998).

The expert group focused on identifying the issues related to sustainable consumption that should be incorporated into consumer protection policy (UNESC, 1998). It noted that sustainable consumption addresses the demand side of production processes, focusing on consumer choices of goods and services such as food, shelter, clothing, mobility and leisure in order to fulfil basic needs and improve the quality of life (UNESC, 1998). Its recommendations include various specific references to GMOs in relation to food. In addition, some of its general recommendations could be applied to GMOs. For example, governments should encourage all concerned to participate in the free flow of accurate information on all aspects of consumer products (sect.B, para. 12). Government policymaking should be conducted in consultation with business, consumer and environmental organizations and other concerned groups (sect.FF, para. FF2). The design development and use of products and services should take into consideration their full life cycle (sect.FF, para. FF5).

In the food area, it was recommended to encourage governments to introduce controls on genetically engineered foods and crop varieties based on long-term risk assessment to ensure they are safe for people and the environment and are compatible with sustainable agriculture (sect.G, para. 39b). Furthermore, government controls should encompass the production process and the final product in an “open and transparent fashion”. Products should be labelled taking consumer concerns into account (sect.G, para. 39b).

United Nations Industrial Development Organization

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Voluntary Code of Conduct for the Release of Organisms into the Environment (1991)

Y









Y

Y

Y


Selected Legal Annotations and Comments

The UNIDO Code of Conduct provides general principles governing standards of practice for all parties involved with the introduction of organisms or their products/metabolites into the environment (sect.II-A-1(a)). It covers GMOs in all stages of research, development and disposal while focusing on release into the environment (sect.I-B).

The Code is founded upon a number of general principles. For example, regulatory oversight and risk assessment should be focused on the characteristics of the resulting product rather than the molecular or cellular techniques used to produce it (sect.II-C-1(a)). Furthermore, safety precautions and monitoring procedures should be proportional to the level of assessed risk (sect.I-C-1(d)). Furthermore, national authorities, industries and researchers have the responsibility to make safety information available to the public (sect.II-C-1((e)) and unexpected or adverse public health or environmental impacts related to the GMO should be reported to appropriate authorities at national and international levels (sect.II-C-1(f)). Risk assessment should be based on “sound scientific principles” involving the participation of experts from appropriate disciplines (sect.II-C-1(h)). Systems to review proposed applications should remain flexible and adaptable in relation to the latest scientific information (sect.II-C-1(j)). Information on anticipated consequences, which may be transboundary in nature, needs to be provided to those countries that may be affected (sect.II-C-1(l)).

The actions and responsibilities of governments are enumerated. These include inter alia (1) assuring the independence of the assessment process, (2) the use of multi-disciplinary scientific competence and using case by case evaluation as the rule unless sufficient experience and (3) an adequate body of knowledge is gathered to allow classifications and general experience on GMO behaviour (sect.II-C-2(a, c and d)). Maximum disclosure of information necessary for risk assessment may be balanced by respect for confidential business information (sect.C-2-(h)). The local community should be informed of a planned introduction prior to release and appropriate educational materials should be provided (sect.II-C-2(i)). In addition, public access to information upon which decisions regarding use or release of organisms should be ensured (sect.II-C-2(j)).

Researchers/proposers have the general responsibility of evaluating risks at appropriate research and development stages (sect.II-C-3-(b)). Approvals should be secured prior to the conduct of any activity involving release (sect.II-C-3(d)) and unexpected or adverse public health or environmental impacts should be notified to the appropriate national authorities (sect.II-C-3(e)). Finally, the proposer should notify and suggest alternative review mechanisms where a regulatory procedure within a country is not yet in place (sect.II-C-3(g)).

World Conservation Union

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

IUCN Position Statement on Translocation of Living Organisms (1987)

Y









Y


Y


Selected Legal Annotations and Comments

The Statement sets out IUCN’s position on translocation of living organisms covering introductions, re-introductions and re-stocking. The instrument was not drafted with genetically modified organisms in mind, however, some of the principles it embodies may be applicable to GMOs. The Statement establishes the general principle that alien species should only be considered if clear and well-defined benefits to man or natural communities could be foreseen. In addition, an alien species should only be considered if no suitable native species is available. Principles are also provided for assessment based on analysis of risk, especially to biodiversity. Special principles are provided for aquatic introductions, in particular that no introduction should be made for which a control does not exist. Principles are also provide for extensive introduction after experimental assessment introductions, including making all the results of all phases of introduction available to the public, while the person or organization introducing the species, not the public, should bear the cost of control where problems arise. Specific references are made to biological control and “micro-organisms genetically altered by man” when they will be introduced into areas where they have not previously existed. In both cases, the same procedures and care should be used that are enumerated for other species introductions.

World Trade Organization (WTO)

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Agreement on the Application of Sanitary and Phytosanitary Measures (1994)

Y

Y



Y

Y

Y

Y

Y

Y


Y

Y

Selected Legal Annotations and Comments

The WTO oversees the implementation of the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement). The SPS Agreement 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. One of the primary goals of the SPS Agreement is to encourage the harmonization of SPMs on the basis of international standards, guidelines and recommendations promulgated by international organizations. Consequently, the work of the Codex Alimentarius Commission, the International Office of Epizootics and the International Plant Protection Convention on GMOs is relevant to the SPS Agreement’s implementation. In fact, an SPM measure conforming to an international standard promulgated by one of these international organizations is “deemed to be necessary” to protect human, animal or plant life or health and “presumed to be consistent” with the SPS Agreement and the GATT 1994 Agreement (art.3(2)).

In general, the SPS provides a multi-lateral framework of rules to guide development, adoption and enforcement of sanitary and phytosanitary measures to minimize their negative impacts on trade (preamble, para. 4). Each member State has the right to take 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 State’s 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 (see below). Nonetheless, all measures that differ from international standards must be consistent with the SPS Agreement.

In general, member States must ensure that SPMs 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)). 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 manifested by an SPM). 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. Other factors to take into consideration when establishing the appropriate level of protection (1) “should” include “minimizing 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 SPS Agreement provides some flexibility for member States to provisionally adopt 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.

The SPS Agreement has a number of provisions on stakeholder participation - as between member States. For example, a member State is entitled to an explanation from another member State when the former believes a specific SPM is or could constrain its exports (art.5(8)). This only applies when the SPM is not based on an international standard, guideline or recommendation. Furthermore, members are to notify changes in their SPM according to an annex to the SPS Agreement (art.7). These procedures include (1) publishing a notice to interested member States; (2) notifying member States through the SPS Secretariat; (3) providing copies of the proposed SPM to members on request; and (4) allowing reasonable time for members to make comments, discuss the comments upon request and take the comments and discussion results into account (Annex B, para. 5(a-d)). Some of these steps can be omitted in emergencies (Annex B, para. 6). Other means to ensure transparency are also provided. These include (1) prompt publication of new regulations (Annex B, para. 1); (2) allowing reasonable time for other members to adapt their systems to the new requirements (Annex B, para. 2); and (3) providing one “enquiry point” responsible for answering questions (Annex B, para. 3). Confidential information does not have to be disclosed (Annex B, para. 11).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Agreement on Technical Barriers to Trade (1994)

Y


Y


Y

Y


Y

Y



Y


Selected Legal Annotations and Comments

The WTO oversees the implementation of the Agreement on Technical Barriers to Trade (TBT Agreement). The TBT Agreement is relevant to biotechnology products because it generally applies to technical regulations and standards, including packaging, marking and labelling requirements. It also applies to conformity assessment procedures. The TBT Agreement recognizes that “no country should be prevented from taking measures necessary” to ensure the quality of its exports; to protect human, animal or plant life or health, of the environment; or prevent deceptive practices. This at levels it considers appropriate provided the TBT Agreement’s conditions are met (preamble, para. 6).

The TBT Agreement applies to all products (art.1.3). It does not apply to sanitary and phytosanitary measures (art.1.5). Therefore, the SPS Agreement would apply where a biotechnological product may be a risk to human, plant or animal health. The TBT Agreement would apply where, for example, a product is merely labelled as containing GMOs. In general, imported products are to be accorded national treatment (art.2.1). Technical regulations should not create unnecessary obstacles to international trade and should not be more trade-restrictive than necessary to fulfil a “legitimate objective, taking account of the risks of non-fulfilment” (art.2.2). Legitimate objectives include inter alia preventing deceptive trade practices, protecting human health or safety, animal or plant life or health, or the environment. Relevant elements are suggested for assessing the risks. Interestingly, developing country member States may adopt technical regulations, standards or conformity assessment procedures aimed at preserving “indigenous technology” and production methods compatible with their development needs. They are, therefore, not expected to use international standards as the basis to develop technical regulations or standards, which are not appropriate to their development, financial, and trade needs (art.12.4). The meaning of “indigenous technology” is ambiguous.

When member States require technical regulations they are to be based on international standards to the extent that this would be effective (art.2.4). Whenever a technical regulation is based on an international standard, and is to be applied to one of the legitimate objectives listed, it is “rebuttably” presumed not to create an unnecessary barrier to trade (art.2.5). Where an international standard does not exist, or the technical content of a proposed technical regulation is not in accordance with the technical content of an existing international standard, and the technical regulation may have a significant effect on trade, the TBT Agreement requires the member State to engage in stakeholder participation type-activities with other member States (art.2.9). These are similar to those enumerated for the SPS Agreement described above (e.g. written justification; notice; notification through the secretariat; making copies available; reasonable time for comments) (arts. 2.5 and 2.9). And like the SPS Agreement, some of these steps are omittable in emergency situations (art.2.10).

A Code of Good Practice for the Preparation, Adoption and Application of Standards is annexed to the TBT Agreement. This is to guide a member State’s development of standards. Standardizing bodies must not act contrary or inconsistent with the Code (art.4.1). The application of standards by member States is premised on the same principles of international trade as for technical regulations: national treatment and non-discrimination; avoiding unnecessary obstacles to trade and proportionality (i.e. no more strict than necessary) (art.5.1). Likewise, the preference is highlighted for deriving national standards from international standards, guidelines and recommendations (art.5.4)


[2] As of December 2002, text addressing traceability in the draft Principles is still under consideration.

Previous Page Top of Page Next Page