Modern biotechnology for food and agriculture raises a wide variety of ethical questions, including in relation to the need to ensure food security for present and future generations, to conserve and sustainably use natural resources, to respect human rights, and to share the benefits of technology in an equitable manner. National legislation and international law constitute one of the ways in which such concerns are operationalized. Recent years have seen rapid technological advances and regulatory changes at the international and national levels.
The FAO Panel of Eminent Experts on Ethics in Food and Agriculture held its first session from 26-28 September 2000. The Panel addressed three issues among them biotechnology, including genetically modified organisms (GMOs) (FAO, 2001).
In its report, the Panel examined three aspects of the biotechnology issue as it relates to food and agriculture:
Risks, uncertainties, and doubts in the use of GMOs;
Potential benefits and problems faced; and
Enabling conditions to realize the potential and avoid the risks of modern biotechnologies, including GMOs.
Law is one of the enabling mechanisms through which society can realize the potential and avoid the risks of modern biotechnologies.
The purpose of this study is to indicate the extent to which international, regional and a selected group of national laws may already be assisting societies to realize modern biotechnologys potential and avoid its possible risks.
The study is comparative in nature. It reviews legal instruments at international, regional and national levels.
It should be kept in mind that biotechnology is a very broad topic. Some of the intersecting thematic areas include biosafety, food and feed safety, consumer protection, intellectual property, seed certification, bio-ethics, as well as access to genetic resources and benefit-sharing. The study does not attempt to review all of these different thematic areas. To narrow the studys scope three categories of legal instruments have been reviewed: those dealing with biosafety, food safety and consumer protection.
Biotechnological techniques can be described as conventional or modern. To narrow the studys scope further, and to parallel worldwide trends, the studys primary focus is on modern biotechnology. Modern biotechnology encompasses the techniques of recombinant DNA or genetic engineering. Therefore the studys focus is on genetically modified organisms (GMOs).
The primary research for the study was undertaken with the assistance of the FAO Legal Office. The Legal Office suggested a number of possible countries to review in different regions around the world. It provided primary and secondary source materials, including legislation and literature. These materials were then supplemented with additional Internet-based research. A selected subset of countries is referenced in the study following the FAO Member Nations by region classification.
The study is designed around a number of thematic areas that may contribute to assisting societies to realize the potential and avoid the risks of modern biotechnologies. Examples are provided to help illustrate a particular concept. To maintain the studys brevity, general descriptions of the legal instruments reviewed are found in Table I (International Instruments) and Table II (National Instruments).
Section II describes the nature of the instruments addressing biotechnology. Public participation, including access to information and labelling, is a major tool for realizing the potential and avoiding the risks of modern biotechnology. How the instruments reviewed address public participation is described in section III. Oversight mechanisms, including institutions, safety assessment, and decision-making are the primary tools countries use to examine the merits of GMOs and these are described in section IV.
Finally, section V briefly suggests some general conclusions on major gaps and trends of existing biotechnology-related legislation. This section also identifies areas for possible further work that might be addressed by supplementary or supporting mechanisms such as a future FAO Code of Conduct on Biotechnology.
The instruments reviewed for this study include those on biosafety, food safety and consumer protection.
Biosafety instruments represent the primary source of law on modern biotechnology in the world today. Biosafety instruments address the risks posed to the environment and human health when GMOs are released into the environment either for research (e.g. small scale or field-testing) or for commercial purposes. Biosafety instruments also address contained use of GMOs. This area has not been reviewed for the study.
Food safety instruments address the risks posed to humans by genetically modified foods. The general goal of these instruments is to minimize risks to humans presented by GMOs or their products used as foods themselves or as ingredients in food. Ideally the entire human food chain is examined moving from the farm to the kitchen table.
A related area that was not specifically reviewed is animal feed safety. This area is mentioned within the study in isolated instances. A new trend, exhibited by new instruments being developed in the European Union, is to make no distinctions between regulating food or feed derived from GMOs when feed could find it is way into the human food chain.
Consumer protection instruments address a range of issues primarily in that area of biotechnology related to food or feed products. The labelling of end products resulting from genetic engineering, such as food or animal feed, is the primary area addressed. In general these instruments are designed to (1) protect the consumers right to know and the right to make informed choices and (2) ensure fair trade practices to ensure that consumers are not victimized by false or misleading claims about a product.
At the international level there is no single comprehensive legal instrument that addresses all aspects of GMOs or the products of modern biotechnology. Some of the existing instruments are hard law or binding. Others are non-binding soft law type documents.
In the biosafety area there are at least fifteen instruments. The major instruments are described in Table I which supplements this study. Binding instruments include the United Nations Convention on the Law of the Sea (1982), Convention on Biological Diversity (CBD) (1992), the World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures (1994), the WTO Agreement on Technical Barriers to Trade (1994), the UN Food and Agriculture Organization (FAO) International Plant Protection Convention (IPPC) (1997), Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters (1998), the CBD Cartagena Protocol on Biosafety (2000) and the International Treaty for Plant Genetic Resources for Food and Agriculture (2001).
Non-binding codes of practice and technical guidance documents include the World Conservation Union (IUCN) Position Statement on Translocation of Living Organisms (1987), Agenda 21, Chapter16 (Environmentally Sound Management of Biotechnology) (1992), Organisation for Economic Co-operation and Development (OECD) Safety Considerations for Biotechnology (1992), the FAO preliminary draft International Code of Conduct on Plant Biotechnology as it Affects the Conservation and Utilization of Plant Genetic Resources (1992), the United Nations Industrial Development Organization (UNIDO) Voluntary Code of Conduct for the Release of Organisms into the Environment (1991), the FAO Code of Conduct on Responsible Fisheries (1995), the UNEP Technical Guidelines (1995) and the FAO Code of Conduct for the Import and Release of Exotic Biological Control Agents (1996).
In the food safety area the Codex Alimentarius is the primary collection of internationally adopted food standards (Codex, 1999). The Codex Commission is the primary forum in which the food safety aspects of GMOs are presently being addressed.
There are six relevant instruments. The Codex instruments are described in Table II which supplements this study. Of these (as of December 2002), only the Codex Guidelines for the Production, Processing, Labelling and Marketing of Organically Produced Foods (1999), which refer to GMOs, have been adopted.
Instruments still being developed include the Proposed Draft Guidelines for the Labelling of Foods Obtained Through Certain Techniques of Genetic Modification/Genetic Engineering, the Proposed Draft Principles for the Risk Analysis of Foods Derived from Modern Biotechnology, the Codex Alimentarius Proposed Revized Code of Ethics for International Trade in Food and the Proposed Draft Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant DNA Plants. In addition, in the animal feed area, the Codex Commission is developing a proposed Code of Practice on Good Animal Feeding.
Of the three primary groups of instruments, those dealing with consumer protection and modern biotechnology are the least developed at the international level. Only two instruments appear to exist at the international level. Both of these are non-binding soft law instruments.
The first instrument is the UN Guidelines on Consumer Protection (1985). The Guidelines are currently being revised within the Commission on Sustainable Development process to address sustainable consumption patterns including references to GMOs. These may be finalized at the World Conference on Sustainable Development. The second instrument is the Codex Alimentarius Proposed Revised Code of Ethics for International Trade in Food (1985).
The legal instruments from twenty-two countries and regions were reviewed for this study. Twenty of these are actually referred to in the study. As might be expected, at the national level the legal systems applying to modern biotechnology in the biosafety, food safety and consumer protection areas vary from country to country. If the countries reviewed are any indication, there does not appear to be any single law addressing all aspects of biotechnology. Instead, the primary focus is on GMOs.
Perhaps the most obvious distinction is that a country can have specific laws on GMOs or it can rely on existing non-specific laws that apply through an expanded interpretation. Australia relies on specific legislation.
For example, the Gene Technology Act (2000) consolidates the countrys treatment of GMOs and genetically modified products (GM products). All dealings with GMOs are regulated and a gene technology regulator is established. The gene technology regulator is set-up as the competent authority overseeing the laws implementation.
The United States of America represents the approach taken at the opposite end of the spectrum. The United States does not have a specific law on GMOs. Instead, existing laws on agricultural pests, toxic chemicals and food, have been adapted through administrative regulations to address GMOs. The regulations have been promulgated in a loosely co-ordinated framework (Jenkins, 2001) that is overseen by existing institutions. Gaps remain. Several classes of GMOs lack specific regulations or enforceable guidelines, for example, arthropods and fish, and in those and other cases, the applicability of existing statutes is unclear and in debate among the agencies that potentially have oversight (Jenkins, 2001).
Some countries do not appear to rely on any legislation at all. Instead they have developed and applied voluntary guidelines.
For example, as of December 2002, Thailand does not have in place comprehensive laws to address biosafety. Other laws apply in part, but a set of guidelines is the primary instrument applicable. The Guidelines are considered soft law based on voluntary action. However, the Plant Quarantine Act prohibits GMO imports without a permit from the Department of Agriculture and when imports are allowed this can only be for experimental purposes. The Plant Variety Protection Act set rules for the registration of a new plant variety derived from genetic modification which can be registered as new plant variety only upon a successful result of a safety appraisal with regard to environment, health or public welfare.
The extent to which a voluntary system helps to realize the benefits while avoiding the risks of modern biotechnology is unclear. The success of voluntary systems (or mandatory systems for that matter) very much depends on the national situation of the country(ies) involved (Young, 2001). The most important aspects of a voluntary system are (1) ensuring compliance and (2) issues of accountability, including liability, when the guidelines are breached and/or damage occurs. Without assurances of accountability, such as legal enforcement, the risks of modern biotechnology could be shifted to third parties.
An example at the regional level is the Biodiversity Regional Strategy which has been recently developed by the Andean Community. The Andean Community is a sub-regional organization with international legal status composed of Bolivia, Colombia, Ecuador, Peru and Venezuela and the Andean Integration System (AIS). The Biodiversity Regional Strategy contains provisions on biosafety dealing with living modified organisms (LMOs). The need to develop a regional approach to biosafety arises from the lack of uniform regulatory mechanisms. Recognizing the validity of existing legal instruments, new ones concerning the implementation of the Regional Strategy could be established and developed by the Andean Community Secretariat through Resolutions and/or Decisions.
As might be expected, developed countries tend to have the most comprehensive and specific legal and institutional systems in all three thematic areas examined. Some developed countries, such as those in the European Union, or Australia, are developing second-generation laws.
Second generation laws tend to be more comprehensive than those that they replace. They move away from sectoral treatment that may have created gaps in the past. A more comprehensive regulatory approach may result in greater possibilities to capture biotechnologys benefits while minimising its risks. A number of characteristics may contribute to this. The most important may be the consistency of approach that comes from the use of a single competent authority entrusted with review and decision-making.
The legal and institutional systems of developing countries are best represented in the biosafety area. Within this group the systems vary in comprehensiveness.
For example, some systems address the complete spectrum of GMO uses - from research and field-testing to commercialization. Other systems may only apply to research. In some countries, a step-wise approach to developing and implementing a regulatory system may be taken.
In Egypt, for example, the regulatory programme appears to be based solely on voluntary guidelines. It will be expanded to include commercialization of GMOs when the need arises.
The extent to which a step-wise approach helps to realize the benefits and avoid the risks of modern biotechnology is unclear. However, a step-wise approach may help to strategically focus limited resources and capacity into areas most in need, such as risk assessment and risk management. While resources may always be limited, the knowledge, experience and capacity developed in a step-wise approach could be adapted and shifted to other areas needing attention as the circumstances present themselves. However, it would appear that a step-wise approach needs to be carefully tied to a suitable regulatory framework that can also be adapted as the circumstances change.
The prescriptive nature of the rules governing biosafety also varies with the country. For example, as alluded to earlier, a number of countries have adopted biosafety guidelines. The guidelines may or may not be supported by accompanying implementation legislation calling into question whether they are legally binding or simply voluntary. The aspirational tone of some of the guidelines reviewed could be problematic because their obligatory nature is left unclear.
Developing countries generally tend not to have laws that specifically address the food safety or consumer protection aspects of GMOs. That more specific instruments do not exist may be due to the lack of capacity to focus on GMOs. Another reason could be a different cultural perspective on the risks posed by GMOs, particularly with regard to food safety (Aerni, et al., 1999).
In the absence of specific laws, developing countries for example may rely on the product approvals issued by countries with more developed laws. Depending on the circumstances, this may or may not be appropriate for the particular country at issue. For example, the assessments upon which the other countrys competent authority based its decision may not be specific enough for the importing countrys own unique circumstances.
General laws on food safety and consumer protection do exist in developing countries but they may not have been developed with GMOs in mind. General laws on food safety and consumer protection could be applied to GMOs as stopgap measures as the situation arises. However, where there is a need, and the goals are to realize the potential and avoid the risks of modern biotechnology, it may be better to develop more specific legislation tailored to the countrys particular needs. This is an important point because without specific references to GMOs in the general laws it may be difficult to motivate governmental oversight agencies to act.
The instruments examined are also distinguishable according to their regulatory trigger. In other words, does the process that was used to create an end product (such as the techniques of modern biotechnology) trigger the application of a legal instrument? Or, regardless of the process used, is the trigger the potential risks posed by the end product itself?
A legal instrument is product-oriented when the risks posed by the end-product trigger review, regardless of the techniques used to produce the end product.
Notwithstanding this, a distinction is still made between non-GMOs and GMOs in product-oriented systems, whereby non-GMOs are typically not regulated. For example, most countries do not formally evaluate new seed varieties produced by traditional breeding methods for their food safety or environmental safety. This is primarily because the breeding process is premised on the familiarity with the varieties being released. Traits that might pose a threat to the environment or to human health are typically identified in the breeding process and eliminated.
Interestingly, Canada takes a different, and possibly unique, product-based approach. Canada does not distinguish between organisms and products made from recombinant DNA techniques and more traditional techniques such as plant breeding. Instead, the regulatory trigger is whether a new organism or product has a novel trait or characteristic that sets it apart from other similar, but non-modified organisms or products, regardless of the process used. This is most apparent for plants.
In Canada, plants with novel traits (PNTs) are varieties or genotypes. They are regulated because they or their characteristics are not considered to be familiar or substantially equivalent to those in a distinct, stable population of cultivated species of seed in Canada and have been intentionally selected, created or introduced through a genetic change (CFIA, 1994). Familiarity is the knowledge of the characteristics of a plant species and experience with the use of that plant species in Canada (CFIA, 1994).
Substantial equivalence is the equivalence of a novel trait within a particular plant species, as it relates to the novel plants use and safety for humans, the environment (and animals - in the case of feeds), compared to plants of the same species that are used and generally considered safe in Canada (CFIA, 1994).
One of the most useful legal tools for realizing the potential and avoiding the risks of modern biotechnology may be legally requiring public participation in the policy-making and regulatory decision-making processes. Opening decision-making processes up to the public may help to ensure that decision makers have the best information at their disposal in order to evaluate the benefits and risks that modern biotechnology could present. Public participation could also help to ensure better transparency and accountability in decision-making.
Of course a necessary pre-condition to public participation is the publics capacity to meaningfully participate (Young, 2001). The mere will to participate is not enough even where the legal regime is conducive. For example, for NGOs to act as biosafety watchdogs requires sustained efforts, financial resources and trained personnel. Other important elements include access to information (sect.3.1) and access to the judicial system (sect.220.127.116.11).
Access to accurate information related to biotechnology in general and GMOs in particular is a cornerstone of any system to realize modern biotechnologys benefits and avoid its risks. The accessible information could include permit applications, environmental and other assessment results, the results of consultations with the public, as well as information on consents and denials.
Access to information is especially important because GMO releases generally take place on a case-by-case basis. Therefore it is through the regulatory process that the public may have the most direct access to information on modern biotechnology.
A sub-area of access to information is the extent to which a permit applicant may withhold confidential information and prevent its dissemination to the public during the regulatory review and decision-making process. The possibility to withhold commercially sensitive information is found in almost all instruments examined whether international or national.
The more advanced instruments provide principles against which a request to withhold confidential information is weighed by competent decision-making authority. Many times an instrument will stipulate which pieces of information must remain part of the public record.
A second sub-area of access to information relates to that provided between States. A number of international instruments provide the basis to ensure information transfer.
Finally, product labelling can provide consumers with information. Product labelling is presented here as a third sub-area.
Many international instruments address the publics access to information in relation to GMOs.
The Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters (Aarhus Convention) is probably the standard against which other international and national instruments can be measured. It has recently entered into force, but Aarhus is only a regional convention. Therefore, though it may be a good example, its reach may be limited.
The Aarhus 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.
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-way to ensure 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 Conventions 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 enumerated criteria (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)). Public authorities are to establish systems to ensure an adequate flow of information on proposed and existing activities (art.(1)(b)). Public authorities also must ensure the availability of information to enable the public to take steps to mitigate harm where there is an imminent threat to human health (art.5(1)(c)).
The manner 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 to enable consumers to make informed environmental choices (art.5(8)).
The public participation provisions of the Convention on Biological Diversity are comparatively weak to those of the Aarhus Convention. The only explicit call for public participation is in the context of environmental impact assessment and this is qualified as appropriate (art.14(1)(a)). The CBD, however, is strong in the transboundary context.
The CBD has general provisions to promote notification, information exchange and consultation regarding activities under a partys jurisdiction or control which are likely to significantly affect adversely the biodiversity of other States or areas beyond the limits of national jurisdiction (art.14(1)(c)). These provisions can be interpreted to apply to GMOs.
In addition, where it does not ratify or accede to the Biosafety Protocol, a CBD party still needs to implement article 19(4). Article 19(4) creates a bilateral obligation for a contracting 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.
The Cartagena Protocol on Biosafety contains explicit provisions on access to information. Contracting parties shall 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)). Finally, each contracting party is to endeavour to inform its public about access to information through the Biosafety Clearing-house (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 the notifier prior to disclosure. The party must provide reasons on request and an opportunity for consultation and internal review of decision prior to disclosure (art.21(2)).
Each contracting party is to protect the confidential information that it receives. Each party is also 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)).
Under the Protocol, some information cannot be made confidential: (a)the notifiers 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 most significant provisions of the Biosafety Protocol focus on the evaluation and notification between parties for LMOs slated for export and subsequent import. Advance 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). For a first time import of an LMO slated for release into the environment, 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 and9).
AIA does not apply to LMOs intended for direct use as food or feed, or for processing. Instead, the contracting party that makes a final decision on an LMO 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.
In both cases, 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)).
The Protocol also addresses access to information in another transboundary context. Affected or potentially affected States are to be notified when an occurrence may lead to an unintentional transboundary movement (art.17(1)).
The WTO Agreement on Sanitary and Phytosanitary Measures (SPS Agreement) has a number of provisions on stakeholder participation - as between WTO member States. For example, a member State is entitled to an explanation from another member State when the former believes a specific sanitary or phytosanitary measure (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 (AnnexB, para. 2); and (3) providing one enquiry point responsible for answering questions (AnnexB, para. 3).
Similar provisions are made under the WTO Agreement on Technical Barriers to Trade. In addition, confidential information does not have to be disclosed (Annex B, para. 11).
The UNEP Technical Guidelines on Biosafety were adopted in 1995. They were designed and adopted as a contribution to the implementation of Agenda 21 (Chap. 16) (which incidentally makes very limited reference to public participation). 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.
The Guidelines suggest that 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. This could 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.
The Guidelines also apply to information exchange between States in a transboundary context. For example, 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 advance informed agreement in the CBD Biosafety Protocol. It is particularly intended to assist those countries without fully operational regulatory programmes.
UNIDO Voluntary Code of Conduct for the Release of Organisms into the Environment 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 focussing on release into the environment (sect.I-B). The Code is founded upon a number of general principles.
For example, national authorities, industries and researchers have the responsibility to make safety information available to the public (sect. II-C-1((e)). Furthermore, 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)). Finally, 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 FAO Code of Conduct for the Import and Release of Exotic Biological Control Agents does not specifically mention GMOs. However, because a GMO could act as a biological control agent the Code could be interpreted to apply, even though a first time import for environmental release would now be likely be covered by the Biosafety Protocol.
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.
Article 16 of the FAO preliminary draft International Code of Conduct on Plant Biotechnology as it Affects the Conservation and Utilization of Plant Genetic Resources 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 (art.16.2).
The UN Guidelines for Consumer Protection were adopted in 1985 as UN General Assembly Resolution 39/248 (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). The Guidelines are most relevant to food safety issues. They form one foundational 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 focussed on identifying the issues related to sustainable consumption that should be incorporated into consumer protection policy (UNESC, 1998).
The expert groups recommendations include various specific references to GMOs in relation to food. In addition, some of its general recommendations could be more generally 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).
The States examined have treated access to information at the national level in a number of ways. There is a great variation between instruments, whether in developed or developing countries, but some general patterns can be discerned.
Perhaps the most explicit examples pertaining to access to information come from within the EU, despite the fact that first generation EU level legislation was comparatively weak in public participation. For example, in the United Kingdom applications for GMO release into the environment must be publicly advertised pursuant to the Environmental Protection Act (sect.III(4)). The GMOs Regulation makes the applicant responsible for advertising the application for consent to release by publishing a notice in a newspaper or newspapers in the areas likely to be affected by the proposal (reg. 8(1)). The information is to include (a) the applicants name and address; (b) the general description of the organisms to be released; (c) the releases location and general purpose; and (d) the foreseen release dates (reg. 8(1)(a)-(d)). The level of detail regarding the releases location must be that which appears in the public register created pursuant to the Environmental Protection Act. In addition, the applicant must specifically notify a number of individuals that he has made the application along with the information found in the public notice. These include inter alia (a) the owner or owners of the site when different from the applicant; (b) the local authority for the area of the proposed release; (c) a number of different councils and commissions; and (g) each member of the genetic modification safety committee that the applicant has established pursuant to the UK Genetically Modified Organisms (Contained Use) Regulations of 1992 (see generally reg. 3(a)-(h)).
The Environmental Protection Act establishes a public register system. The Secretary of State is to maintain the public register. The register is to include a wide variety of information. This includes (1) notifications for release under section 108 of the Act, (2) prohibition notices, (3) applications for consent and advice given by an appointed committee, (6) consents granted and information furnished pursuant to conditions of consent and (6) convictions for offences (sect.122(1)). The register is to be open to the public, free of charge and is to afford the public facilities to obtain copies of register entries for reasonable charges (sect.122(2)). The register shall not include (1) information contrary to national security interests, (2) information that could lead to environmental damage or (3) information that is commercially confidential (without consent of the information holder (sect.123(1-3)). The register goes beyond EU requirements.
Confidential information is also explicitly addressed. The holder of commercially confidential information must apply to have the information excluded from the register (sect.123(4)) and the Secretary of State decides upon the application and informs the applicant accordingly. When it has been obtained as a result of the laws implementation, the Secretary of State shall notify third parties of information that may be commercially confidential to give them a reasonable opportunity to object to its posting in the register (sect.123(6)). The Secretary of State shall take the third partys representations into consideration before determining whether the information is commercially confidential. Information to be included in the register for notifications, consent applications and consents granted is to include (1) name and address of person; (2) GMO description; (3) location of the GMOs; (4) purposes of importation, acquisition, keeping, release or marketing; (5) results of environmental risk assessment; and any other information which the public interest requires notwithstanding its commercial confidentiality (sect.123(7)(a-e)). Confidential information can be excluded from the register for up to four years, at which time the holder needs to reapply (sect.123(8)).
The UK takes a different approach to public participation and access to information in the food safety area where a combination of sectoral and generic instruments refer to public participation. Public participation through stakeholder involvement is not explicitly provided for in the food assessment process under the Novel Foods and Novel Foods Ingredients Regulations. However, amendments to the regulation, and their subsequent interpretation by the UK Food Standards Agency and the Advisory Committee on Novel Foods and Processes (ACNFP), change this. Another influencing factor is the UK Freedom of Information Act (2000). Finally, some of the shift to greater transparency may also be due to a series of food safety crises that have struck the United Kingdom and Western Europe in recent years.
The 1999 amendment to the UK Novel Foods Regulations increased the transparency of ACNFPs proceedings such that any information submitted to it under the European Commission Regulation257/97 is discloseable to anyone who requests it. This is subject to three exceptions: (1) the information is not required by the EC Novel Foods Regulation; (2) ACNFP agrees with the information holder that the information is confidential because it would harm competitive position; or (3) the ACNFP agrees that the information is confidential because disclosure would harm intellectual property rights (UK Food Standards Agency). Other aspects of stakeholder involvement such as public participation in decision-making are not clarified, although another UK law that has not been reviewed as part of this study, such as the UK Freedom of Information Act, could provide for this.
In contrast, European Union Regulation 258/97/EC (Concerning Novel Foods and Novel Food Ingredients) does not appear to have any requirements for public participation at the Community level, other than co-ordination between the Member States. In addition, there are no requirements for public participation at the national level.
The situation may improve slightly with the adoption of the proposed EU Regulation on Genetically Modified Food and Feed. An application process would be established by the proposed regulation (art.6). The application would be sent to the proposed European Food Authority. Along with a variety of other information, including a study demonstrating compliance with the authorization criteria in article 4(1), the application must include inter alia a dossier summary (art.6(3)(l)). The Authority would make the applicants dossier summary available to the public (art.7(3)(c)). Favourable opinions by the Authority are to be made available to the public after deletion of confidential information (art.7(7)).
The European Commission will prepare a draft decision. The authorized food is entered into the proposed Community Register of Genetically Modified Food and Feed and made available to the public (art.30).
Confidentiality provisions are similar to those in Directive 2001/18/EC. However, it is clarified that the Commission, Authority and the Member States are obliged to keep confidential all information identified as confidential except for information which must be made public if circumstances so require, in order to protect human health, animal health or the environment (art.31(5)).
The European Union is a little more progressive in its new directive on the Deliberate Release of GMOs into the Environment (2001/18/EC) with regard to access to information. Directive 2001/18 promotes transparency by emphasising the necessity of public consultation, either by the European Commission or the Member States (preamble para. 10).
In Part B (first release), article 9 applies to public information and consultation with respect to environmental releases. Member States are to make information available to the public on all GMO releases into the environment (art.9(2)). In addition, the Commission is to make available to the public the information contained in the system of information exchange between the Commission and the Member States competent authorities (art.9(2), which includes summaries of the notifications received by the competent authorities, observations and a list of GMOs released within the Member States territories (art.11).
Part C (marketing and commercialzation) of the Directive places the responsibility on the European Commission to inform the public of the application and its receipt. The Commission has the responsibility to make available to the public a dossier summary provided with the applicants notification (art.24(1)). This is to happen immediately upon the notifications receipt. In addition, the assessment reports for GMOs attaining written consent, and the opinions of any Scientific Committees consulted, must also be made public (art.24(2)), but it is unclear who is to do this.
Part C also creates Member State requirements with regard to access to information. For example, the Member States competent authority issues the written consent that allows the notifier (i.e. the applicant) to go ahead with marketing or commercialization (art.15(3) and art.19). Member States are to take all necessary measures to ensure that the written consent, and decisions by a committee created to address Member State objections to a notification (art.18) are made accessible to the public (art.19(4)). In addition, the Member State is to take emergency measures, including providing public information, when the GMO or the product presents a severe risk after consent has been granted (art.23(1)).
The release of information to the public in all cases is subject to the confidentiality provisions of article 25. The Commission and competent national authorities shall not divulge to third parties confidential information notified or exchanged under the Directive (art.25(1)). The notifier may indicate that information whose disclosure might harm his competitive position and which should be treated as confidential (art.25(2)). He must provide verifiable justification. The competent national authority consults with the notifier and decides which information shall be kept confidential (art.25(4)). Information that cannot be kept confidential includes inter alia a general description of the GMO, monitoring methods and plans, emergency responses and environmental risk assessment (art.25(4)).
Finally, the Commission is to establish registers on genetic modification that shall include a part which is accessible to the public (art.31(2)). Member States are also to create public registers with release site locations for Part B GMO releases (art.31(3)(a)). They are to also create registers for GMOs grown under Part C whose locations shall also be publicly available (art.31(3)(b)).
The African Union has issued draft model legislation on biosafety that includes provisions on access to information. When an application is received, the information included is to be made available to the public and other governmental agencies by the competent authority (CA) (art.5(1)). The information provided is subject to confidentiality restrictions for business purposes, after the applicant makes a claim for confidentiality to the CA (art.11(1)). Information that cannot be kept confidential includes (1) a description of the GMO or the product; (2) methods and plans for monitoring and emergency plans (3) evaluation of foreseeable effects (pathogenic or ecological) (art.5(2)(a)-(c)). The CA may make the confidential information available if it decides that it is in the public interest to do so (art.12(3)). The public may make comments within a period specified by the CA (art.5(2)). Where the CA arranges for a public consultation it is to be announced in the media with national coverage for a given period of time (art.5(3)). The CA is to make available to the public information on consents and denials as well as the risk assessment for the GMO or product of a GMO at issue (art.5(5)).
Another example of a draft law on GMOs is the one issued in Tunisia on the contained use, deliberate release and commercialization of GMOs. Public information requirements are reflected in article 7. A dossier containing all the information concerning the utilization of GMOs in public or private laboratories is to be made available to the public. The dossier is to contain, with the exception of information protected by trade and industrial secrets and by the law, general information on: (1) the activities of laboratories and the purposes of research; (2) GMOs to be used; (3) containment measures; (4) emergency plans in case of accidents, which have to be approved by the Biosafety National Commission; (5) traceability of GMOs; (6) consumers information on the presence of GMOs in certain products; (7) a summary on the opinion of the Biosafety National Commission; and (8) the address of the Biosafety National Commission for any comment the public may wish to send. The right for any person to have information on the possible impact on the environment, biodiversity and human health which may be caused by a deliberate release of GMOs is also recognized. Notwithstanding this, access to information is subject to confidentiality provisions.
Similarly, access to information is addressed in a certain number of laws in the Latin American countries analyzed. According to Law No. 27104 on the prevention of risks derived from biotechnology issued in Peru, anyone wanting to introduce into the national territory LMOs to be used for research, production, manipulation, transfer, conservation, commercialization, contained use and release, must submit a formal application to the competent authority. The application is to include all the information necessary for carrying out a risk assessment. When the application is received, an informative summary is published at the national level. The information contained in the application is subject to confidentiality restrictions that are actionable by the claimant to avoid unfair use. Information that cannot be kept confidential includes: the name of the applicant, the objectives of the activities to be realized, where these will be realized, methods and plans of monitoring, emergency plans and risk assessment reports. Confidentiality restrictions cannot be authorized when the application concerns activities which may cause damage to human health, the environment and biodiversity.
In Costa Rica, Law 7788 on Biodiversity regulates the import, export, trials, and release into the environment, commercialization and use of GMOs. A permit is required prior to carrying out these activities. Anyone realizing activities of genetic manipulation is to be registered with the Technical Bureau of the National Technical Commission on Biosafety. The Technical Bureau is to organize and update a register of rights to access to genetic and biochemical elements. The Director of the Technical Bureau will also act as Director of the Register and is responsible for the safe-keeping and authenticity of the registered information. Such information will be public except for that protected by industrial secrets. If public disclosure is due to biosafety reasons trade secrets can not be invoked as a reason to maintain confidentiality.
Decree No. 190 on Biological Safety issued in Cuba includes provisions on the development of an information policy. Representatives of the State Central Administration, as well as researchers involved in this field, upon consultation with the Ministry of Science, Technology and Environment, are responsible for developing a policy on public information that is to be mainly addressed to people directly or indirectly involved with the release. The policy is to be developed in collaboration with the National Health System, political organizations and mass media (art.9).
Under the Mexican Law on Sustainable Rural Development the Federal Government is to establish mechanisms and instruments for biosafety related to the production, import, handling, propagation, release, consumption, use and general development of such organisms, their products and sub-products, providing sufficient information to the consumers (art.97).
In Brazil, pursuant to Law No. 8974 any organization using genetic engineering techniques and methods shall create an Internal Biosafety Commission/CIBio (art.9). A CIBio will be responsible for, inter alia, providing to employees and to the community information on possible effects caused by activities related to GMOs, including information related to health, safety and to procedures to be followed in the event of accidents.
In relation to the Asian region, public access to information is not addressed in the ASEAN Guidelines on Risk Assessment of Agriculture-related Genetically Modified Organisms (1999). Public access to information requirements were not identified in the instruments reviewed in Indonesia, Philippines and Thailand.
The Indonesian Ministerial Decree on the Provisions on Biosafety of Genetically Engineered Agricultural Biotechnology Products (1997) does not appear to have any provisions for public participation, though another law may apply. The successful applicant has a number of rights and obligations.
For example, commercial confidentiality is available to the applicant over the genetically engineered agricultural biotechnology product, but it appears to be limited to situations where the approval has been issued (art.40(1)). Confidentiality is extended to the application by the agency reviewing the application (art.40(2)). No criteria are provided in either case for reviewing claims to confidentiality.
The labelling of GMOs or products derived from GMOs is a sub-area of the access to information theme. Labelling is being considered, and in some cases is already being used, in the biosafety and food safety areas in order to provide consumers with information on the GMO or GMO-derived product that they are either considering to purchase or are already using. Consumers may be farmers, mass caterers or individuals (either wittingly or unwittingly).
One aspect of labelling is premised on the principle that the consumer has a right to know what he or she is purchasing and subsequently using. This principle has its origins in consumer protection. With the information that labels provide, consumers may make better, more informed choices about the products that they are thinking of buying. Furthermore, when products are properly labelled consumers can exercise their right to choose products that meet their particular economic, health, religious, ethical, moral or other needs. For these reasons, labels can become a market-based mechanism that can contribute to the marketplaces acceptance of a product or the technology upon which the product is based.
A second aspect of labelling, related to the right to know, is protecting the consumer from false, misleading or deceptive practices. This is another consumer protection principle. Labelling may be able to ensure that the claims made about a product are indeed true and that the consumer really gets what is being advertised.
Finally, a third aspect of labelling is premised on consumer education. Consumer safety and environmental protection can be promoted when labels supply the appropriate information to consumers.
For example, a labels information may warn the consumer of product attributes that could endanger his or her health or threaten the environment if the product is used in a certain way. In this way, labels can be viewed as a risk management tool (see sect. 18.104.22.168 below).
When labels can or should be applied to products that may or not contain GMOs is a major issue that is being addressed at international and national levels. Labelling has been most prevalently used in relation to food derived from GMOs and food that producers would like to claim is GMO free. In the first instance, there is a trend worldwide to label food products that are clearly derived from GMOs.
In the second instance, some food producers would like to distinguish their products from those that are genetically modified. But, because de minimis or adventitious amounts of genetically modified ingredients may appear in otherwise normal materials, the issue then becomes what percentage of the modified materials can be allowed while enabling producers to still make the GMO free claim? In other words, what percentage of GMO products triggers labelling? This issues resolution not only has market implications. It could also have an impact on food safety and the consumers right to know, especially in relation to foods that may contain ingredients that have religious or ethical implications.
At the international level, no general rules on labelling are in place. The rules for GMOs and food are being developed within the Codex Alimentarius. In the biosafety area, the Cartagena Protocol on Biosafety to the CBD sets out in article 18 the obligations of Parties concerning the identification of living modified organisms (LMOs). Article 18 provides different obligations for LMOs intended for direct use as food or feed or for processing (LMO-FFPs) (subpara.(a)), LMOs destined for contained use (subpara.(b)), and LMOs intended for intentional introduction into the environment (subpara.(c)).
Perhaps sometime in the future the Aarhus Convention will play a large role in the biosafety arena as a task force has been examining the issue of labelling with regard to GMOs (UNECE, 2001). In the former two cases, when the products are in international trade, the World Trade Organizations Agreement on Technical Barriers to Trade will ensure that labelling is applied according to the principles of necessity and proportionality so as not to create a trade barrier.
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 to prevent deceptive practices. This can be at levels it considers appropriate provided the TBT Agreements 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 WTO 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. The TBT is premised on a number of trade-related principles.
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.
At the international level, the Codex Alimentarius Commission dominates the food safety and labelling area. The Commission is attempting to develop harmonized world wide labelling practices related to foods derived from modern biotechnology in order to minimize the effects that food labelling could have on international trade.
Notably, the Codex Commission has yet to adopt an agreed definition of genetically engineered/modified organisms (Codex, 1999). However a number of subsidiary bodies are working on different aspects of genetically modified foods and food products.
In the food labelling area, the Codex Committee on Food Labelling is working to amend the Codex General Standard for Labelling Pre-packaged Foods: Labelling of Foods Obtained through Certain Techniques of Genetic Modification/Genetic Engineering (definitions, step 6). As part of the standards amendment process, it is also working on Proposed Draft Guidelines for the Labelling of Foods Obtained through Certain Techniques of Genetic Modification/Genetic Engineering (step 3). The Proposed Draft Guidelines are still in an early stage of development. Consequently, they are only generally described here. Many bracketed sections remain as of December 2002.
The Guidelines are proposed to apply to labelling of foods and food ingredients in three situations. These would be when they are: (1) no longer equivalent/different significantly from conventional counterparts; (2) no longer equivalent/different significantly from conventional counterparts; (3) 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 (sects.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 products character or safety (sect.6).
In 1999, the Codex Commission adopted Guidelines for the Production, Processing, Labelling and Marketing of Organically Produced Food. The Guidelines 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. Organic production claims and labelling are limited to operators certified by a certification body.
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 that all materials and/or products produced from genetically engineered/modified organisms (GE/GMO) are not compatible with the principles of organic production (growing, manufacturing or processing) and therefore are not accepted under these guidelines (sect. 1.5). Therefore, the Guidelines take a process based, rather than a product based, approach 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.
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. 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 of the feeding stuffs. Presently, the Code specifically states that Genetically modified organisms (GMO products) should be labelled.
The extent to which national measures are taking their cue from the Codexs work on food labelling and modern biotechnology is unclear because the majority of the Codexs work is still in the development phase. However, a number of the countries reviewed for this study have taken steps on food labelling issues and these can be categorized as either voluntary or mandatory.
For example, in Canada, food-labelling responsibilities are split between the Canadian Food Inspection Agency (CFIA) and Health Canada. CFIA handles general food labelling policies and regulations not related to health and safety such as misrepresentation and fraud along with basic food labelling requirements (CBAC, 2001). Health Canadas responsibilities relate to health and safety issues related to, for example, allergenicity.
The Food and Drug Act sets out the general requirements for food labelling in Canada. No person can label, package, treat, process, sell or advertise any food in a false, misleading, or deceptive manner or that is likely to create an erroneous impression regarding the foods character, value, quantity, composition, merit or safety (sect.4). According to the CFIA Guide to Food Labelling and Advertising (CFIA, 1996), since 1993, there have been three major consultations on foods derived from genetic modification. Guidelines have been developed.
Mandatory labelling is required if there is a health or safety change or a signification change in nutrition or composition. In addition, any labelling must be understandable, truthful and not misleading. Finally, voluntary positive labelling (e.g. does contain products from biotechnology) and negative labelling (e.g. does not contain products from biotechnology) is permitted provided it is truthful and not misleading (CFIA, 1996).
There are no federal obligations to indicate that a food is a product of gene technology (Canadian General Standards Board, 2001). Because of the lack of federal regulations on this specific aspect of food labelling, an initiative is under way to create a voluntary national standard for labelling of foods derived from biotechnology. The Canadian General Standards Board oversees the standards development process.
A first draft standard has been circulated in 2001 for public comment. The standard would apply to voluntary labelling and advertising of food in order to distinguish whether or not the food is a product of gene technology or contains or does not contain ingredients that are products of gene technology (sect.1.1). It would not apply to the labelling of foods produced using processing aids, veterinary biologics or livestock feeds that are products of gene technology (sect.1.2).
Distinctions are made between claims for single ingredient and multi-ingredient food (sect.4). In general, it is proposed that claims that a single ingredient food is a product of gene technology can only be made for that food when it is obtained from sources of which more than 5 percent are products of gene technology (sect.5.2). Similarly, a 5 percent threshold is proposed for multi-ingredient foods claimed to be produced from gene technology (sect.5.3). Conversely, a threshold of less than 5percent is proposed for single and multi-ingredient foods claimed not to be a product of gene technology (sect. 6).
Verification provisions are established. No claim is permitted if it cannot be verified (sect. 7.1). The person making the claim is responsible for providing the data necessary to verify the claim (sect.7.2.2). Provisions on confidential information are proposed. The claimant must have in place a verification system (sect. 7.3). In addition, the claimant must have a plan that includes a detailed description of sources of food/ingredients and a description of the management system used to maintain integrity of the food/ingredient (sect. 7.3.2). The standard is equivocal on testing and detection methods (sect. 7.4).
Of the instruments reviewed, Indonesia had one of the most explicit in relation to religious claims and food. The Indonesian Food Act makes specific reference to genetic engineering in article 13. Persons who produce food or use foodstuffs, food additives or other auxiliary material in the production activity or process of food derived from genetic engineering must have the food examined before it is circulated (art.13(1)).
The government is to set requirements and principles for research, development and use of the genetic engineering method in the food production activity or process (art.13(2)). It will also lay down requirements to test food derived from the genetic engineering process.
These provisions build on the more general provisions on contaminated food. A person is prohibited from circulating (1) food containing materials which are toxic, dangerous or which may harm or endanger human health or life, and (2) food containing materials prohibited from use in food production or processes (art.21(a) and (c)).
Pre-packaged food to be traded, either produced within Indonesia or imported, must have a label (art.30(1)). Among other things, the label shall contain information on halal (allowable for Muslim consumption; relatedly but not required for listing is haram (forbidden)) (art.30(2)(e)). The government may determine other information to be included in or withheld from the label (art.30(3)). Persons are prohibited from providing untrue or misleading information through the label (art.33). A person making a claim about a foods acceptability to the requirements of a religion or belief through a label or advertisement is responsible for the correctness of the statement based on the religion or belief (art.34(1)).
Indonesias Food Labels and Advertising Regulations have provisions related to labelling products derived from biotechnology. Primary source materials were not available for analysis.
As of December 2002, Thailand does not appear to have food safety laws in place for genetically modified foods. However, a regulation was drafted by the Food and Drug Administration (FDA) for mandatory labelling of genetically modified food (Greenpeace, 2001). No texts were available for review.
The present situation within the European Union on labelling and foods derived from GMOs is a little complex because there are a number of instruments addressing various aspects of the issue. The EU Novel Foods Regulation (258/97/EC) applies to the placing on the market for the first time of novel foods or novel food ingredients (i.e. foods that have not hitherto been used for human consumption to a significant degree) (art.1(1) and (2)). This includes inter alia (1) foods and food ingredients containing or consisting of GMOs and (2) foods and food ingredients produced from, but not containing, GMOs (art.1(2)(a) and (b)).
Labelling requirements in addition to other Community labelling requirements can be specified for foodstuffs to ensure that the final consumer is informed. Among these, additional labelling is required when (1) any characteristic or food property no longer renders a novel food or food ingredient equivalent to an existing counterpart (based on scientific assessment and accounting for natural variations); (2) the presence of material not present in the existing counterpart and which may have human health implications for certain population sectors; (3) the presence of material not found in existing counterparts that gives rise to ethical concerns; and (4) the presence of GMOs (art.8(1)). Where an existing equivalent counterpart does not exist appropriate provisions are to be adopted to ensure that consumers are adequately informed of the nature of the food or food ingredient (art.8(2)).
Regulation 1139/98/EC (Labelling of Certain Foodstuffs Produced from GMOs), as amended, supplements Regulation 258/97/EC (Novel Foods). Regulation 1139/98 covers food and food ingredients which are delivered as such to the final consumer or mass caterers (e.g. restaurants) and are produced in whole or in part from GM soya beans (Decision 96/281/EC) and GM maize (Decision 97/98/EC). These foodstuffs are subject to labelling requirements in addition to those in Directive 79/112/EEC.
The labelling requirements do not apply when the protein or DNA resulting from the genetic modification is not present in the food ingredients individually considered or the food when it comprises a single ingredient (art.2(2)(a)). In addition, labelling is not required where the foodstuff contains GM soya beans and/or GM maize and any other material placed on the market pursuant to Regulation 258/97 (Novel Foods and Food Ingredients) derived from GMOs in a proportion no higher than 1 percent of the food ingredients (art.2(2)(b)). In other words, de minimis amounts of genetically modified materials up to 1 percent do not trigger additional labelling requirements. Operators must be in position to supply evidence to satisfy competent authorities that they have taken appropriate steps to avoid GMOs as a source.
Additional labelling requirements vary with the form the food product takes. For example, where the food consists of more than one ingredient, the words produced from genetically modified soya or produced from genetically modified maize are to appear in the list of ingredients in brackets immediately after the ingredient concerned or in a prominently displayed footnote (art.3(a)).
Regulation 50/2000 (Labelling of Foodstuffs and Food Ingredients Containing Genetically Modified Additives and Flavourings) fills in a gap created by Regulation 258/97 (Novel Foods and Food Ingredients) because it does not apply to GM additives and flavourings. Regulation 50/2000 applies to additives and flavourings used in foodstuffs that are, contain or are produced from GMOs (art.(2)).
Labelling requirements, in addition to other Community labelling requirements, are to be specified for additives and flavourings to ensure that the final consumers and mass caterers are informed. Among these, additional labelling is required when (a) any characteristic or food property no longer renders a novel food or food ingredient equivalent to an existing counterpart (based on scientific assessment and accounting for natural variations); (b) material that is present is not present in the existing counterpart and which may have human health implications for certain population sectors; (c) the presence of material not found in existing counterparts gives rise to ethical concerns; or (d) GMOs are the present (art.2(a-d)).
Additives or flavourings are not equivalent if scientific assessment demonstrates that the characteristics assessed are different to traditional additives or flavourings taking into consideration accepted limits for natural variation (art.3).
Additives or flavourings with protein or DNA resulting from genetic modification are not considered equivalent. The labelling requirements vary with the form of the flavouring or additive and may include wording such as produced from genetically modified... (where a characteristic or food property is not equivalent to existing additives or flavourings) (art.4(1)) or genetically modified (where an additive or flavouring is or contains an organism modified by GM techniques (art.4(2)).
The proposed regulation of the European Parliament and the European Council on Genetically Modified Food and Feed flows from various proposals made in the Commission White Paper on Food Safety (COM (1999) 719 Final, 21 January 2000) and the adoption of Directive 2001/18/EC. It will consolidate existing Community level legislation and procedures on these issues and close gaps such as feed produced from GMOs and the evaluation of genetic modifications in additives and flavourings.
The proposed regulation is premised on three fundamental objectives: (1) to ensure a high level of consumer and animal health and life protection; (2) to facilitate the consumers and in the case of feed, the end users right to know to enable an informed choice; and (3) to ensure that the consumer or end user is not misled (CEC, 2001).
The proposed regulation would fit within a larger framework of food law that is being proposed for a regulation at the Community level in the aftermath of European food crises involving BSE and dioxin contaminated feed (see EC proposed regulation COM (2000) 716 Final - 2000/0286(COD)). The proposed legal framework would lay down general principles and requirements of food law, establish an independent European Food Authority and provide procedures for food safety. It will include a proposed regulation on traceability and labelling of GMOs and traceability of food and feed products produced from GMOs.
The proposed regulation would cover genetically modified food, livestock feed and additives and flavourings regardless of whether DNA or protein resulting from the genetic modification can be detected (CEC, 2001). In other words, it will apply to products produced from a GMO, rather than products produced with a GMO (CEC, 2001).
All products subject to the authorization under the proposed regulation would also be subject to mandatory labelling (CEC, 2001). Under the proposal, labelling requirements will apply to foods delivered as such to the final consumers or mass caterers which (1) consist or contain GMOs or (2) are produced from or contain ingredients produced from GMOs (art.13(1)). Labelling requirements will not apply to foods with material that contains, consists of or is produced from GMOs in a proportion no higher than the thresholds to be established provided the presence is adventitious or technically unavoidable (art.13(2)). This leaves open the possibility that labelling requirements may apply to a threshold of adventitious materials different than that set for authorization (one percent). As with the procedures for GMO food authorization, the operator must be in a position to supply evidence to satisfy the competent authorities that they have taken steps to avoid the presence.
The food labelling requirements vary with the form of the product and are not to prejudice other Community labelling requirements (art.14(1)). Generally, the words genetically modified or produced from genetically modified [name of organism] but not containing a [GMO] must appear (art.14(1)(a)-(c)). Food without pre-packaging must have similar wording displayed on or in connection with the foods display (art.14(1)(d)). The labelling must also mention any characteristic or property when (1) the food is not equivalent to its conventional counterpart (i.e. with regard to composition, nutritional value or nutritional effects, intended use, or implications for the health of certain sectors of the public) or (2) where the food gives rise to ethical or religious concerns (art.14(2)(a) and (b)). Where a food does not have a conventional counterpart the label is to include information about the foods nature and the characteristics (art.14(3)).
In contrast to the GM food labelling requirements, which only speak in terms of label content, article 27 proscribes a person from marketing GM feed without including a clearly visible, legible and indelible label, either on an accompanying document or on the packaging, container or on a label attached thereto (art.27(3)). For genetically modified feed the name shall be genetically modified [name of feed]; for feed produced from GMOs: produced from genetically modified [name of the feed from which the feed is produced] but not containing a [GMO]; for feed containing or consisting of GMOs the unique identifier assigned to the GMO shall accompany the name of the feed (art.27(3)(a) and (b)). As with the GM food labelling requirements, any characteristic not equivalent to its conventional counterpart needs to be also clearly indicated, including a characteristic or property that may give rise to ethical or religious concerns (art.27(3)(c) and (d)).
The Australia New Zealand Food Authority (ANZFA) develops and maintains a joint Australian New Zealand Food Standards Code pursuant to the Australia New Zealand Food Authority Act (1991). The Australian States and Territories and the government of New Zealand enforce the code and police food standards set according to it. The food standards have the force of law and must be read in conjunction with national and sub-national food legislation in the respective countries.
Standard 1.5.2 applies to food produced using gene technology (whether derived or developed from an organism that has been modified by gene technology - sect.1). It does not apply to additives and processing aids derived from gene technologies, whose safety and pre-market approval, are regulated by a different standard. In general, Standard 1.5.2 prohibits the sale and use of foods produced from gene technology or classes of such foods, unless they have been assessed, approved and listed by ANZFA.
The Standard also applies to the labelling of food produced using gene technology. Genetically modified foods (i.e. food that is, or contains as an ingredient, including an additive or a processing aid, a food produced using gene technology which contains novel DNA and/or novel protein(s) or has altered characteristics - sect.4) must be labelled with an appropriate statement (genetically modified) in conjunction with the name of the food or ingredient or processing aid (sect.5). Exemptions may apply. For example, highly refined foods where the processing removes the novel DNA or novel protein (sect. 4(1)(c)). In addition, a threshold is set whereby genetically modified food unintentionally present in a food, ingredient or processing aid in a quantity no more than 10g/kg (1percent) does not trigger the labelling requirement (sect. 4(1)(f)). Additional labelling requirements may be needed in situations where a genetic modification raises significant ethical, cultural and religious concerns regarding the origin of the genetic material used in the genetic modification (sect.7(e)).
At the international level, the Cartagena Biosafety Protocol to the CBD does not address labelling in a clearly specified consumer protection sense. Instead, article 18(2) is about the identification of LMOs in documentation accompanying their transboundary movement. Therefore the labelling envisioned in this instance is primarily for the information of transport operators and customs people (Damena, 2001) as a means to manage risks during transport (see sect. 22.214.171.124). Notwithstanding this, it is important to note that article 11 refers to LMOs intended for direct use as food or feed, or processing. As these labelling provisions cover also such LMOs, they may be interpreted as indirectly protecting consumers.
According to the Protocol, each contracting party must take the necessary measures such that LMOs subject to intentional transboundary movement within the Protocols 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 Protocols requirements applicable to the exporter (art.18(2)(a-c)).
The Protocols 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)).
Of the biosafety legislation reviewed at the regional and national level, only those in the African Union, Mexico, Tunisia and the European Union have provisions related to labelling.
The OAU Draft Model Legislation on Safety in Biotechnology applies to the import, contained use, release or placement on the market of any GMO or products from GMOs (art.2). Any GMO or product of a GMO is to be clearly identified and labelled as such (art.11(1)). Identification is to specify the relevant traits and characteristics in sufficient detail for purposes of traceability. In addition, any product of a GMO is to be clearly labelled and packaged using words that will be specified in a subsequent annex to the model law that is unavailable. The CA may require additional information in particular whether the product may cause reactions, allergies or other risks (art.11(2)).
The Official Mexican Standard NOM-056-FITO-1995 establishes the phytosanitary requirements for interstate movement, import and conduct of field trials with regard to GMOs. Transgenic products must be identified and labelled as such when released, moved and/or imported. Labels must be visible on the container or package and have, inter alia, information on: (1) the general nature and quantity of the content; (2) on the country and/or place where the product was collected, developed, manufactured, cultivated or reproduced; (3) on the name and address of the carrier and sender and (4) on the number of the plant health certificate for release and/or import.
In Tunisia, pursuant to the draft Law Concerning the Import and Transfer of GMOs, any product imported into or transiting through the national territory is to be packed in a safe manner. Labels specifying the presence of GMOs are to be visible on the package. Informative notification facilitating control procedures is to accompany the package.
Within the European Union, Directive 2001/18/EC will act as a reference for GMOs as or in products authorized by other Community legislation inter alia with regards to environmental risk assessment, risk management, labelling, monitoring and public information (preamble para. 27). In general, GMOs, whether individually or in combinations, intended for placing on the market as or in products must have been subjected to satisfactory field testing in the research and development stage in ecosystems that could be affected by their use (preamble para. 25). The general procedures for notification of and consent by the competent national authorities are similar to those for release into the environment (Part B).
Notification is sent to the competent national authority of the Member State in which the product will be marketed for the first time. Notifications are to include a technical dossier including a full environmental risk assessment and, for products, precise information for use and proposed labelling and packaging (preamble para. 33; arts. 13(2)(f) and (g)). The proposed labelling must include the words this product contains genetically modified organisms clearly displayed either on a label or in accompanying documentation (preamble para. 40; art. 13(2)).
Member States are to ensure that labelling and packaging of GMOs placed on the market as or in products comply with the conditions of consent (art.21(1)). Where adventitious or technically unavoidable traces of authorized GMOs cannot be excluded, minimum thresholds may be established below which the products require no labelling (art.21(2)). Thresholds will be product specific and will be established through the EC committee procedure laid down in article 30(2).
Participation in policy and decision-making on modern biotechnology is another example of how the public can help to realize the benefits and avoid the risks of modern biotechnology. Public input can provide policy and decision makers with valuable information and perspectives that may not be accessible otherwise.
The publics access to information supports its participation in policy and decision-making. However, without explicit provisions providing for public participation in the policy and decision-making process information cannot be used to the fullest potential.
Policy-making is a strategic exercise that attempts to create a framework within which regulatory and other decisions can be made. Policymaking includes developing law. Provisions for public participation in governmental policymaking, especially with regard to law making, may generically exist in a number of countries.
At the international level, no international instruments specifically mention the need for public participation in the strategic processes focussing on all aspects of modern biotechnology.
Instead, there are only more general calls for stakeholder participation in those strategic processes involved with biodiversity conservation, environmental protection and sustainable development. The Aarhus Convention explicitly mentions the need for 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). The FAO preliminary draft International Code of Conduct on Plant Biotechnology provides another more comprehensive example.
According to the draft Code, 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).
At the national level, no country examined appears to have established a participatory policy-making process to address the benefits and risks of modern biotechnology in toto, and early-on, as the technology emerged over the last twenty years. And thus far, none of the laws reviewed appears to require the establishment of a publicly accessible process within which the merits of modern biotechnology could be discussed as a single issue.
This does not mean that generic laws on public participation in policy-making do not exist, only that the laws examined do not specifically provide for such processes with regard to biotechnology. Certainly some countries do promote and consider public comments on all proposed environmental regulations regardless of the thematic area being addressed or allow the public to participate in strategic environmental planning exercises. Some governments may also have the power to convene special commissions to examine particular topics. However, it seems apparent from the countries reviewed that, assuming the public can participate in governmental decision-making, the most important possibility for public input tends to occur on a case by case basis as promoters of individual genetically modified end-products seek regulatory approval.
It may be useful to have on-going dialogues with stakeholders as a country develops and adapts its policies on modern biotechnology. Such dialogues could gauge public opinion and build awareness within and outside the government. The dialogues could be part of a stand-alone policymaking process on modern biotechnology or they could be incorporated into existing environmental policy-making processes such as those on sustainable development, the environment or biodiversity conservation.
The sole reliance on case by case review may be ebbing and giving way as some countries face their first commercial GMO releases, begin to develop second generation laws or as their public becomes more interested and knowledgeable in or concerned about modern biotechnologies. Possibilities are emerging for broader based stakeholder processes to provide inputs into policy-making processes. In this regard, independent commissions or councils can be used to facilitate dialogue within a country. Perhaps the best examples of this are from New Zealand.
New Zealand has established two bodies within the last few years. Within their mandates each is to inform the government on public opinion and to supplement the internal policy-making process on modern biotechnology.
In May 1999, the New Zealand Government set up the Independent Biotechnology Advisory Council (IBAC) to help New Zealanders explore and consider issues in biotechnology (IBAC, 2000). IBAC does not have legislative or regulatory responsibility (IBAC). It reports directly to the Minister of Research, Science and Technology in order to provide independent advice to the New Zealand Government on the environmental, economic, ethical, social and health aspects of biotechnology.
IBACs main role is described as stimulating dialogue and enhancing public understanding about biotechnology (IBAC). IBAC has looked at a range of issues including biotechnology applied in the agricultural, food, medical and environmental contexts. Among other things, IBAC found:
A need for balanced, factual and accessible information on biotechnology within New Zealand; and
General support for IBACs role of facilitating dialogue and providing advice on biotechnology (IBAC, 2000).
The IBAC was originally commissioned for two years. A monitoring and evaluation process is to determine how to proceed after this period is completed.
The New Zealand Royal Commission on Genetic Modification was created in 2000 by the government through a warrant (specialized law). Its mandate was to (1) research and report on the strategic options available to New Zealand on genetic modification, GMOs and products and (2) any changes considered desirable to the current legislative, regulatory, policy or institutional arrangements for addressing genetic modification, GMOs and products in New Zealand (RCGM, 2000). Some of the relevant matters that the Royal Commission could investigate and receive representations on included (1) the risk of and benefits to be derived from the use or avoidance of genetic modification, GMOs or products and (2) the key strategic issues drawing on ethical, cultural, environmental, social and economic risks and benefits (RCGM, 2000).
Because of the treaty obligations the New Zealand government holds, the Royal Commission also consulted with New Zealands aboriginal peoples, the Maori. The warrant directs the Commission to consult and engage with Maori in a manner that specifically provides for their needs.
Among its conclusions, the Royal Commission noted that New Zealands regulatory system is appropriate. However, because the values held by Maori add special emphasis to the ethical and cultural objections many people have on biotechnology, it was clear that existing regulatory bodies were not best equipped to address these types of issues (RCGM, 2001). Therefore, the Royal Commission recommended setting up a specialist body on bioethics in which matters could be debated.
Also, the Commission emphasized the need for a strong overall biotechnology strategy to guide New Zealand in the use of all new biotechnologies in the field. Finally, it recommended that a single, independent institution, such as a Parliamentary Commissioner on Biotechnology, undertake the general auditing of biotechnological applications (RCGM, 2001).
Public participation and decision-making is more clearly addressed by international and national instruments than in the policy-making area.
At the international level five instruments refer to public participation in decision-making. Under the Aarhus Convention 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 (arts.6(2)(a), (d) and (e)). The procedures should include reasonable time frames (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)).
It is important to note that public participation in decision-making is strengthened by the provisions of article 9, according to which the substantive and procedural legality of any decision, act or omission taken under Article 6 can be challenged by members of the public concerned through a review procedure before a court and or another impartial body (art.9(2)).
Under the CBD, the only reference to public participation is in the context of environmental impact assessment for activities that adversely affect biodiversity (art.14(1)(a)).
The Cartagena Protocol on Biosafety to the CBD contains provisions on public participation in decision-making. The Parties shall in accordance with their respective laws and regulations, consult the public in the decision-making process regarding LMOs and shall make the results of such decisions available to the public, while respecting confidential information (art.23). The qualification (in accordance with their respective laws and regulation) builds-in an enormous amount of discretion for governments and does not require changes to a status quo that may be inadequate at present.
Under the recently adopted FAO International Treaty on Plant Genetic Resources for Food and Agriculture (2001), contracting parties are to take steps to minimize or, if possible, eliminate threats to PGRFA (art.5.2). Public participation in decision-making could be envisioned to flow from this and 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 FAO preliminary draft Code of Conduct on Plant Biotechnology does not specifically mention public participation in decision-making. However, article 16 (Public Information) suggests 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).
Despite the scarcity of international instruments addressing public participation in decision-making, national level instruments do address the issue in varying degrees of specificity.
The Australian Gene Technology Act demonstrates how access to information and public participation go hand in hand. When an intentional release is involved, and the Regulator is satisfied that it may pose significant risks to human health and safety or the environment, he must publish a notice on the application in the Official Gazette, a national newspaper and on the Regulators website (v. 49). Criteria are provided for the public notice including inviting submissions on whether the license should be issued along with a closing date for submissions (sect.49, para. 3). Once an assessment and plan are completed, the Regulator must again notify the public that they are available for comment (sect.52, para. 2). The Regulator may also hold public hearings (sect.53).
Persons may request copies of the application and the risk assessment or risk management plan (sect.54, para. 1). However, confidential commercial information so declared by the Regulator is not to be shared (sect. 54, para. 2).
The applicant must apply to the Regulator for a declaration of confidential commercial information (sect.184). Criteria are provided to guide the Regulators decision-making (sect.185). The Regulator may refuse a declaration when the public interest in disclosure outweighs the prejudice disclosure would cause to the information holder (sect.185, para. 2). The Regulator must refuse a declaration of confidential information if the information relates to one or more locations at which GMO field trials would occur, unless the Regulator is satisfied that significant damage to human health and safety, the environment or property would likely occur if the locations were disclosed (sect.185, para. 2(a)). The Regulator must make publicly available a statement of reasons for making the declaration (sect.185, para. 3(a)).
In any licensing decision - whether for release or otherwise - the Regulator cannot issue a license without being satisfied that risks posed by the dealings proposed to be authorized by the license can be managed to protect human health and safety and the environment (sect.56). Guidelines are provided to guide the Regulators decision-making process. For example, the Regulator must be inter alia guided by submissions received from the public (sect.56, para. 2).
Other instruments do not go into as much detail as the Australian Gene Technology Act but nonetheless are interesting to describe here. Under the OAU draft model legislation the public may make comments within a period specified by the competent authority (art.5(2)). Where the CA arranges for a public consultation it is to be announced in the media with national coverage for a given period of time (art.5(3)). The CA is to take the publics views and concerns into consideration when it is making or reviewing its decisions (art.5(4)).
In relation to first releases, Part B of European Union Directive 2001/18/EC requires the Member States to consult with the public, including groups. They are to create arrangements for consultation, including reasonable time periods for the public to express an opinion (art.9(1)). On the other hand, Part C allows the public to make comments to the Commission within 30 days on the public summary provided by the notifier to the Member States competent authority pursuant to article 13(2)(h) and forwarded to the Commission (art.24(1)). The public can also only provide comments on the assessment reports (art.14(3)(a)) which comprise the competent authoritys assessment of the notification and which is also forwarded to the Commission (art.24(1)). While the distinction between opinions and comments is not clarified, it could be that opinions are actually taken into greater consideration by the Commission and the Member States than comments.
Of the four Asian countries reviewed only the Indonesian Food Act (1996), which addresses genetically modified food in a handful of specific articles, has public participation provisions. The Act provides the community with the opportunity to participate in realizing the protection of any natural person consuming food (art.51). The community may submit problems, inputs and/or the solution for matters in the field of food in the framework of improving and upgrading the food system (art.52). It is unclear how participation is to be realized. The extent to which this means the public can participate in regulatory decision-making is also unclear. No criteria are provided on the extent to which governmental decision makers must consider the comments and other inputs that are provided.
Of the remaining developing countries analyzed, none specifically addresses the issue.