1 Overview of current Regulatory Policy

In 1998, over 40 million acres of transgenic crops were grown around the globe. As these products are traded and pass from one country to the next it is important to ensure that domestic regulator regimes are in place around the globe to ensure the safe use of these products. The regulatory systems of Canada, Argentina, and Chile are all at different stages of development. Canada has a system in place that is respected throughout the world for its ability to ensure high-quality agricultural biotechnology products that meet international human and environmental health and safety standards. Argentina is recognized as leader among Latin American countries in the regulation of biotechnology products. And finally, Chile is a well-known center of genetic diversity for a number of plant species, but with very little in the way of biosafety regulation. Together these countries represent a broad spectrum of technical experience, regulatory policy, and agricultural interests.

The regulatory systems of Canada and Argentina while developed independently are remarkably similar in structure. In developing biosafety regulations and establishing experienced regulators, Argentina should be considered to be about three years behind Canada. Chile, on the other hand, should be considered to be about where Canada was in 1988. Chilean departments have not really come together yet to address the need for a regulatory framework, the first step in regulatory development. The growing numbers of transgenic plant products in commercial use throughout the world make it crucial for all countries to have sufficient knowledge, experience and infrastructure to determine and implement assessment criteria appropriate for their environment.

The Canadian regulatory system for products of biotechnology is based on a product rather than process philosophy of regulation. The rationale for this approach is to provide for the assessment of all "novel" products introduced into Canada which may have a negative impact on human health, the environment, or the agricultural industry. As result, Canada has adopted a very broad definition of biotechnology, and focused regulations on novel traits rather than "genetic engineering":

The 6 principles which guide federal departments in the development of a regulatory framework system:

1. maintains Canada's high standards for the protection of the health of workers, the general public and the environment;
2. uses existing legislation and regulatory institutions to clarify responsibilities and avoid duplication;
3. continues to develop clear guidelines for evaluating products of biotechnology which are in harmony with national priorities and international standards;
4. provides for a sound scientific database on which to assess risk and evaluate products;
5. ensures both the development and enforcement of Canadian biotechnology regulations are open and include consultation; and
6. contributes to the prosperity and well being of Canadians by fostering a favourable climate for investment, development, innovation and adoption of sustainable Canadian biotechnology products and processes.

Point two of this framework is particularly important with respect to the authority and responsibility for biotechnology products within the federal government. Unlike countries such as Australia that have a "gene law", Canada chose to amend existing legislation and regulatory departments to accommodate these new products. The result is a number of different regulations with varying styles that have been developed based on specific product and usage requirements but ensure an equivalent level of safety from department to department. The only department to take on new responsibilities due to the introduction of biotechnology products is Environment Canada. Unlike, pharmaceuticals or plants, products such as industrial enzymes or organisms for bioremediation did not fall under traditional regulatory structures, so they are now captured under the Canadian Environmental Protection Act.

The first source of Canadian technical expertise for the assessment of a "novel" product lies within the regulatory departments. Evaluators within Federal departments take on significant technical responsibilities in the assessment process and in some cases are the only sources of technical expertise used in an approval. Not surprisingly, regulatory personnel are a vital repository of technical information on biosafety and risk assessment of biotechnology products

A second level of technical knowledge comes from other experts within the government that specialize in either risk assessment or biological research. Some evaluators use government laboratories and researchers to verify test data provided in company submissions. These in-house experts may at times be asked to provide their scientific opinion on the evaluation of certain submissions.

The third level of technical expertise comes from external experts such as academic researchers. These individuals are recognized as leading authorities on specific organisms are generally contacted on an "as needed" basis. Rather than establish a formal external advisory body to process applications, as is the case in some countries, the role of external advisors remains informal and case specific.

As indicated in principle 2 of the framework, all new products of biotechnology are regulated under existing federal legislation. There were however, a number of amendments were made to these acts to highlight the specific requirements for novel products of biotechnology. In addition, a number of guideline documents were produced to clarify what additional information may be required for a biotechnology product to comply with these regulations.

The detailed procedures for the introduction of a new biotechnology product in Canada are explained by walking through the regulatory procedures for a specific type of product, such as the regulatory steps in the Risk Assessment of Plants with Novel Traits, taken as a sample. They go from Step 1 for Contained Use of a plant within a laboratory, growth chamber, or greenhouse; to Step 2 for Confined Field Trial referring to a small test plot of plants that are grow in an open field; to Step 3 for Unconfined Release of plants that once permitted can then be grown in large quantities for variety registration trials or seed multiplication; to Step 4 for Commercialization of registered plants that have obtained permission for commercial release of the product. Food/Feed or industrial use permits are issued at this last step 4. Even after commercial approval adverse effect monitoring continues.

The Argentine regulatory system for products of biotechnology is philosophically different than the system established in Canada. Rather than focussing on novel products, Argentine regulations focus on the biosafety of products developed through the process of genetic engineering. As a result the regulatory system is based on the definition of "genetically modified organisms" in which any of the genes or other genetic material have been modified by a number of specific techniques.

In 1991 the Secretary of Agriculture, Livestock and Fisheries created the Comisión Nacional Asesora de Biotecnología Agropecuaria (CONABIA) (The National Advisory Committee on Agricultural Biosafety) as a mechanism for consultation and technical support on the design and management of regulations concerning the biosafety of the introduction and environmental release of transgenic material. The CONABIA is made up of representatives of both public and private sectors engaged in agricultural biotechnology. The Department of Agricultural Production under the National Department of Agriculture and Forestry Production and Economics from the Undersecretariat of Agriculture, Livestock and Forest Production acts as secretariat to the CONABIA.

While the philosophy underlying the Argentine regulations for assessments of GMOs is fundamentally different than Canadian regulations, the product approval procedures for GMOs in Argentina are remarkably similar to the Canadian "Regulatory steps in the Risk Assessment of Plants with Novel Traits". The main differences in the two systems are:

• Argentina exerts regulatory oversight on products for contained use (same data required for contained or confined trial) where Canada does not exert oversight until Confined use is requested.
• Canada asks for more detailed information in the field trial applications
• Unconfined release requirements in both counties are remarkable similar. (Note: Unconfined status in Argentina is called flexibilization)

Apart from these differences the systems are remarkably similar. The same types of approvals (environmental assessment, feeds, human health, and variety registration) are required in both countries and are based on very similar information requirements. CONABIA provides the biosafety element for each of the approvals. The specific regulations involved in the approval process are outline in the full document.

The Chilean regulatory system for products of biotechnology is still in its infancy. The regulatory system for field trials is operating under sanitary and phyto-sanitary regulations for importation of plant material. Thus, the law requires field trials of imported transgenic products only. There's no system in place for the regulation of transgenic products developed domestically and no system for approval of products for commercial use. This means that there are no commercial approved transgenic products available to the Chilean consumer. A few plant products have received approval for large scale growing, but are restricted to multiplication of seed and re-export for use elsewhere; none of these products are available to Chilean consumers.

In November 1993 the "Advisory Committee on the Release of Transgenic Organisms (CALT)" was created to provide technical support to the Agricultural and Livestock Service (SAG) with regard to the introduction and environmental release of transgenic material. The CALT members are specialists appointed by the Minister of Agriculture as permanent officials representing the Ministry of Agriculture, Ministry of Health, agricultural research centres and Universities. The Advisory board does not have any private sector representation. The Department of Plant Protection under the National Agricultural and Livestock Service (SAG) acts as secretariat to the CALT.

The procedures for control of agricultural products in Chile are somewhat different than those in Canada. Chilean regulators are very focused on preserving the unique indigenous species found in the distinct ecosystem zones that divide the country. The primary role of the Agricultural and Livestock Service (SAG) is the protection of the zones through quarantine procedures. As a result, the regulatory system is very focused on the threat of invasive foreign species. The regulations under which Chile is currently regulating GMOs are limited in their authority to products of import. Transgenic plants produced at INIA, a government research facility, have been voluntarily submitted to CALT for review. Chilean regulators seem to be taking "a wait and see approach" before developing domestic regulations hoping to benefit from international initiatives such as the UN Biosafety Protocol. Identification of Key Human Resources and Authorities

As with any information system, the key to success is always the people that use the system. In the case of a biosafety information system, users of the system are the regulatory authorities of the various government departments involved in regulation of biotechnology products. Whether through specific designation in their job description or through an evolution of their duties, each regulatory group in all of the countries studied tend to have one or two people that deal with biotechnology products on behalf of the group. Thus, the full document provides a breakdown of the different regulatory departments and the key biotechnology contacts within those departments in Canada, Argentina and Chile, including organization charts.

In analyzing the information management capacity of the various government departments it is important to keep in mind that the volumes and urgency of information dictate system requirements. The key to developing an appropriate system for each situation is to thoroughly understand the current information needs and hopefully anticipate near-term and long-term information requirements.

As the volumes of information required to process and track the development of biotechnology products increase, a greater need is placed on information management systems rather than on traditional paper files. In this regard, Canada is at a significant advantage relative to many other countries, in that we have an advanced and well-used telecommunications and computer infrastructure. Tools such as high-speed Internet connections are readily available and used almost universally throughout both government and businesses. Canadians also enjoy the benefit of seamless integration into the U.S. network.

Countries such as Argentina and Chile have relatively modern computer systems often networked through LANs. External linkages and tend to be slow due to limited bandwidth for telecommunications connections such as to the Internet. For example, a Latin American research Institute of 300 people would typically share a 64 KBPS connection, where a Canadian office of 12 people sharing that same bandwidth would likely be considering an upgrade. As well, Latin American countries tend not to have developed a sufficient number of domestic network nodes and as a result Internet service providers (ISPs) often have only a single high-speed connection to the Internet through a provider in the United States. This means that a message being sent across the street in Chile to a computer that is using a different ISP must be routed through the United States. Similarly, when that single connection fails, those users are isolated from the rest of the Internet until repairs are made.

Within the regulatory agencies studied, Internet access is often restricted to only a few machines within each organization. Often people are required to log onto specific workstation in order to check their e-mail [often not routed through the LAN to the computer on their desk]. As a result, communications via Internet do not tend to have the same immediate response rate as is generally found here in Canada. The basic hardware and software tools are available to ensure effective information management with the regulatory groups of both Argentina and Chile. What are lacking are applications designed to specifically handle these products.

The full document provides a deep insight of the availability, accessibility and extension of the biosafety information systems and data bases that are in place in Canada, Argentina and Chile, including the specific information services and websites, when available.

The experience of Canadian regulators in the development of regulations, assessment of products, and management of information, can greatly assist Southern Cone regulators in increasing their capacity to deal with these new products. Based on interactions with the regulatory departments discussed in this document, a number of recommendations are made vis-à-vis a long term collaboration between Canada and Argentina and Chile. Some of them are shown below:

Last year CONABIA, the national advisory body, reviewed 78 applications for field trials. This is up almost one hundred percent from the year before. As a result, SAGPyA was forced to increase their staff and start preliminary screening of applications in-house. It is clear that this trend will continue over the next few years and SAGPyA will be expected to rely more and more on decisions from their regulators rather than CONABIA. During site visits, the SAGPyA staff displayed good technical knowledge and experience could handle greater responsibility in the approval process. These staff members will benefit greatly from interactions with Canadian regulators in seeing how large volumes information are handle. It is expected that over the next few years the role of CONABIA will be forced to change as the demands on committee members increases and experience with the products and in-house expertise grows. It may eventually be decided that certain types of approvals or combinations of organisms and transformation could be handled competently by SAGPyA staff rather than requiring a decision from CONABIA.

The role for Canadians in the evolution of the Chilean regulatory system is twofold. Primarily, the Chileans need to establish the policy and regulatory framework for the assessment of these products. In addition, access to technical expertise is required.

The technical needs of the Chileans are very different from those of the Argentines. In fact, the need for an expanded technical advisory body is significant. The lack of in-house experts should be augmented, at least in the short-term, by a greater use of the advisory body (CALT). This group should be expanded to include individuals with industrial expertise and formalized procedures for review of applications should be established. The Chileans may benefit greatly from interactions with the Argentine regulators to discuss their development and use of CONABIA and how they dealt with issues such as representation and confidential business information. If possible, the Chilean visits to Canada should be coordinated to coincide with those of their Argentine counterparts.

The key to successful technology, knowledge or resource transfer is based on "information pull" rather than "push". If Canada is to have a significant impact on the way countries such as Argentina and Chile regulate products of biotechnology, there must exist the right attitude and desire for collaboration. Partners must first recognize that there is a need for what Canada can offer to them, and second engage champions to integrate this knowledge into domestic regulatory systems. In the case of Argentina, both of these requirements have been satisfied. The case of Chile, the attitude towards products of biotechnology is one of suspicion. To date, commercial products of biotechnology have not focused on priority areas for the Chilean agricultural industry or consumers and thus they are seen as being forced on them by foreign multinationals. Domestic development of products of biotechnology has already begun and once this is recognized, attitudes will likely change.

Insofar as policy development is concerned, there is value in providing models for countries such as Chile to use as reference. But ultimately, policy and regulatory development is a domestic issue. It is hoped to that through discussion of the Canadian and Argentine models and particularly in sharing how and why these models have been developed to their current form, a better understanding of the regulatory process will be achieved in all three countries and open the doors to regulatory harmonization.

With regard to technical cooperation, both Chile and Argentina have advisory bodies designed to augment the technical knowledge of their regulators. It is expected that these advisory bodies will continue to play a vital role in the regulatory process for the next several years, particularly with regard to their understanding of unique domestic situations that cannot be provided from Canada. However, as regulators gain more experience with these products and conduct more of the assessments in-house, networks of personal contacts will become more important. It is recommended that an electronic network [email list serve] be established to connect regulators brought together through this technology transfer initiative. In addition, an effort should be made to develop a formal database of experts in the areas of biotechnology products and risk assessment for the benefit of both Canadian regulators and those in Latin America. This database should be made available to as many regulators as possible, and include experts from all over the world.

Finally, an effort should be made to link information dissemination about product approvals and field trials with current OECD / UNEP initiatives such as BioTrack and the Global Environment Facility Biosafety Enabling Pilot Project. At this time, information about product approvals is still not available in any sort of regularly updated clearinghouse mechanism. However, should these international organizations decided to establish and/or maintain a global database or internet based search system, Canada, Argentina and Chile should be prepared to participate and possibly prototype such an initiative.

5. Relevant International Initiatives

Since biotechnology products are being rapidly adopted around the world there is an increasing need to ensure consistent safety standards are put in place to protect human health and the environment from any potential adverse effects of these products. To date, there are only three international organizations (OECD, UNIDO, and UNEP) that have, or plan to, invest significant resources into biosafety information systems. Recent pressures due to increasing global trade in these products and the UN Biosafety protocol negotiations have encouraged cooperation between these organizations. Thus, the document provides profiles and references of a number of biosafety information programs and services put in place by OECD (e.g. BioTrack), UNIDO (e.g. BINAS) and UNEP (e.g. Biosafety Protocol, GEF).