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Executive Summary


Overview

In considering the use of modern biotechnologies, in particular GMOs for food and agriculture, the FAO Panel of Eminent Experts on Ethics in Food and Agriculture noted that there were still uncertainties, risks and doubts, but recognized, as well, that there were important potential benefits. It recommended a comparative study of regulations concerning biotechnology, including GMOs, exploring the possibility and desirability of harmonizing such regulations. Such regulations balance a multitude of interests and reflect the legal traditions of the countries concerned. However, a comparison of legislation of relevance can assist in identifying major trends and gaps, and in understanding the state of the current regulatory framework around the world.

The purpose of this study is to indicate the extent to which international agreements and a small selected group of national laws may already be assisting societies to realize modern biotechnology’s potential and avoid its possible risks.

The study reviewed three categories of legal instruments at international and national levels in the areas of biosafety, food safety and consumer protection.

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 study’s 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 study can only be considered indicative because of the small sampling of national level instruments undertaken. However, when combined with a wider sampling of international instruments, a number of trends and gaps were evident in two key areas: public participation and oversight mechanisms.

Public Participation in Policy and Regulatory Decision-Making

Whether at the international or national levels, the biosafety instruments examined were generally found to be more specific on public participation than the food safety or consumer protection instruments examined. This demonstrates that the general principle of public participation is well established in the biosafety field.

However the extent to which public participation is actually facilitated or exists in a country is difficult to determine from a simple review of the country’s biotechnology related legislative instruments. For example, general references to public participation may not translate into actual participation if additional criteria are not provided on the form public participation can take. Also the best public participation provisions may not be used if the public does not have the capacity to effectively participate. Finally, the lack of specific public participation provisions in, for example, a biosafety law does not necessarily mean that the public is barred from participation. It must be kept in mind that generic laws on public participation may already exist in the country and that the necessary criteria are applicable to the policy-making and regulatory decision-making processes addressing modern biotechnology.

The general lack of references to public participation in the food safety area, at least in what could be considered the first generation of laws at the national level, was striking because it appeared to be across the board, regardless of whether a country was developed or developing. However, some countries such as the United Kingdom are beginning to open the food safety assessment process up to greater public participation and scrutiny.

While consumer protection instruments examined did not promote public participation per se, they did promote access to information to enable consumers to make informed choices and to prevent fraud.

Access to information is an important cornerstone of public participation and is one tool that could help to realize the benefits and avoid the risks of modern biotechnology.

International instruments address access to information with varying degrees of specificity. The Aarhus Convention is perhaps the standard against which to judge other instruments at international and national levels. Though its reach is limited to the region in which it applies it is an important source of principles from which international negotiators and national level lawmakers could draw.

In general, those countries with legislation that were reviewed had more references to public participation and access to information than countries relying on voluntary guidelines. Developed countries typically have legislation on biosafety. However, many of the developed countries examined do not appear to be any more progressive in terms of substance than those developing countries examined. This is despite the fact that developed countries have been working on biosafety issues far longer than developing countries, may have a better informed public and constantly urge developing countries to increase public participation and transparency within their decision-making processes.

Still it must be kept in mind again that generic public participation laws may pre-empt the need for specific references to public participation and access to information in the sectoral legislation. This may explain the situation in Canada where none of the five sectoral laws examined had explicit provisions on public participation in general and access to information in particular. In contrast, two of these laws did have explicit confidentiality provisions.

The review indicates that confidentiality provisions have proliferated at both international and national levels. There may be a need to further study confidentiality provisions to determine how countries use them and, in particular, whether the application of such provisions impedes the public’s access to relevant information on modern biotechnologies. It may be particularly important for future international and national instruments to supply principles to guide the use of confidentiality provisions by decision-makers.

The review reveals that the principle of providing information to neighbouring States is increasingly recognized at the international level. Notwithstanding this, no national level instrument examined made specific reference to access to information by other States. Bridging this gap could be foreseen as an important contribution to international cooperation and could help to avert transboundary incidents involving GMOs.

Labelling, especially in the food safety and consumer protection areas, is being increasingly addressed at international and national levels. The issue of when labels can or should be applied to products that may or may not contain GMOs is a major issue that is being tackled. In the biosafety area no international instruments specifically address labelling. The Aarhus Convention is examining the issue. Notwithstanding this lack of international action on biosafety related labelling, the review did reveal that some States and regional economic integration organizations are addressing the biosafety and labelling nexus.

The primary concern in all labelling areas is that a proliferation of standards at international, regional and national levels will create barriers to trade and ultimately confuse consumers and other end-users. Therefore there is a need to harmonize standards. For food, harmonization is taking place at the international level within the Codex Alimentarius. In the biosafety area, there does not appear to be any international process other than an examination of the issue within the Aarhus Convention. An important threshold issue to more action at the international level is determining the need for labelling GMOs and GMO-related products in the biosafety context.

With regard to public participation in policy-making, no international instruments specifically mention the need for public participation in strategic processes focussing on modern biotechnology. In addition, the countries examined do not appear to have participatory policy-making processes within which all aspects of modern biotechnology could be addressed. The most important possibility for public input appears to occur on a case-by-case basis as promoters of individual genetically modified organisms attempt to gain approval through a regulatory process.

Notwithstanding this the review found that some countries are indeed taking a new approach. They are creating broad-based stakeholder processes on certain aspects of modern biotechnology such as the release of GMOs. These processes help the government to gauge public opinion, generate dialogue, gather useful information and develop awareness within their populations on modern biotechnology. New Zealand is a particularly good example.

Because of the dearth of specific references to public participation in policy-making at the international level specific to modern biotechnology, it may be useful for future international instruments, such as the forthcoming FAO Code of Conduct on Biotechnology, to unambiguously refer to the desirability of creating such processes.

Public participation in decision-making is a more familiar concept at international and national levels than public participation in policy-making. Still only four international instruments reviewed address the issue, the standard again being the Aarhus Convention. Examples of varying specificity do exist at the national level specific to GMOs.

Some important considerations include the mechanism through which the public is notified (e.g. public notice) and can provide inputs (in writing or via a public hearing) and the time period within which the comments must be received. However, it is really not enough simply to give the public an opportunity to participate and provide information. Most importantly the competent authority must take those views into consideration. In the best case, the competent authority may also be required to justify why a particular viewpoint was accepted or not. Work on future international or national level instruments should keep this in mind.

Oversight Mechanisms

The oversight process may contribute to maximize the benefits and avoid the risks of modern biotechnology. Three mechanisms were examined: institutions; safety assessment; and decision-making.

Oversight and advisory institutions are the most obvious oversight components addressed at international and national levels. The generality with which institutional issues have been treated at international level does not seem to have impeded the establishment of institutional oversight nationally. All countries examined have some form of institutional oversight in place.

What does vary between countries is whether bodies have been created to provide advice to competent authorities tasked with decision-making responsibilities. A multidisciplinary and/or multi-stakeholder advisory body could have an important role to play in assisting a competent authority in its examination of the merits of GMOs and, consequently, maximizing the benefits and minimizing the risks of modern biotechnology. With the exception of the FAO preliminary draft International Code of Conduct on Plant Biotechnology, no international instrument reviewed refers to the desirability of creating advisory bodies. Future instruments could include provisions on advisory bodies.

Another potentially important institutional consideration is creating institutional biosafety committees (IBCs). These can be given the ultimate responsibility within an institution working with GMOs to ensure the safety of any GMO-related work before and after regulatory oversight. In fact, IBCs appear to be widely referenced in legislation and voluntary guidelines promulgated at the national level. It is unclear whether the concept of IBCs originated with an existing international instrument. Those reviewed for the study did not mention them. Nonetheless negotiators and lawmakers may wish to consider the concept for future instruments.

Safety assessment (e.g. hazards identification, risk assessment and risk management), the second oversight mechanism, is referred to in all national oversight systems examined. It is also referenced in all international instruments examined dealing with biosafety and food safety.

While the need for risk assessment is undisputed, one concept in particular is coming under greater scrutiny, namely “substantial equivalence” in the food safety area. The concept is intended to identify similarities and differences between new food and conventional counterparts in order to focus the safety assessment procedure on identified differences. Future negotiators of international instruments that may refer to substantial equivalence may wish to provide guidance on its proper application so that the concept does not simply become a decision threshold to exempt genetically modified products from rigorous safety assessments.

Greater attention is also being given to factors other than environmental protection and human health in the oversight process. For example, an emerging trend is the consideration of socio-economic considerations. Governments may need assistance, particularly capacity building and technical guidance, in assessing socio-economic impacts.

Finally, risk communication is a new area of risk assessment that emphasizes effective communication in all aspects of risk assessment and risk management. Negotiators and lawmakers may wish to consider it in their work in order to better integrate the public’s access to information and participation in the safety assessment process.

In the risk management area the precautionary approach is being referenced more frequently in post-Rio international instruments. The extent to which the precautionary approach is actually practised at the national level is unknown. However, the small collection of second-generation biosafety and food safety laws that were reviewed do tend to refer to it explicitly. Guidance for applying a precautionary approach to modern biotechnology may need to be promulgated at the international level to ensure consistent application worldwide.

Post-approval monitoring is a risk management technique referred to in a number of international instruments reviewed. It was not explicitly mentioned in the majority of national level instruments reviewed, but this may be a function of its application in permit conditions. Post-approval monitoring will be important to minimizing the risks of modern biotechnology and should be addressed specifically in sectoral instruments at the national level.

Traceability is an emerging risk management tool within the biosafety and food safety areas. It could be useful where illegal export, import or release is suspected, where environmental damage has occurred or where unforeseen food toxicity is identified. It is just being referred to at international and national levels and, where technically feasible, may be useful for negotiators and lawmakers to consider as they create new legal instruments.

Decision-making is the third common component of any oversight mechanism. One important aspect of decision-making consists of the extent to which considerations other than environment and human health are used by decision-maker to reach a decision concerning a GMO. Based on the instruments reviewed it appears that a trend may be emerging to the extent that other factors, such as socio-economic and ethical considerations, are beginning to be considered. A more holistic approach to decision-making may result in a more accurate consideration of costs and benefits in the regulatory decision-making process. Negotiators and lawmakers may wish to consider this broader approach in their work.

A second important aspect of decision-making is mechanisms to ensure greater accountability in the decision-making process. Greater accountability can be supported by criteria for decision-making, publicly available rationales to the decisions taken and the possibility for judicial or administrative review of decisions. Each of these areas is underrepresented in international instruments and only a handful of the national level instruments reviewed refer to all of them. Therefore, negotiators and lawmakers may wish to consider these points in their work.


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