Examples of Approaches on Cooperation, Collaboration, and the Streamlining of Product Approvals for Plant Agricultural Biotechnology Produced Using Recombinant DNA Techniques
Paraguay's Path Toward the Simplification of Procedures in the Approval of GE Crops
Paraguay has taken a unique approach to help mitigate or resolve the issue of asynchronous approvals which can lead to LLP situations. As part of this new approach, Paraguay considers and approves commercial release for GMOs that have been granted commercial release in other countries. This creates a streamlined approval procedure for commercial release within a set of conditions. These include: the level of experience of the country's regulatory system, whether assessments are carried out for food and feed safety according to CODEX guidelines, familiarity with scientific, technical, and food safety aspects, and other parameters specific to Paraguay's agricultural and environmental conditions.
Paraguay's Path Toward the Simplification of Procedures in the Approval of GE Crops
Mercosur Resolution on LLP and the Importance of Intra-Regional Cooperation
Mercosur takes a regional approach to LLP amongst members (Argentina, Brazil, Paraguay, and Uruguay). When a new event is approved in one of the countries that adopted the Resolution on LLP, the country issues a notification and shares its National Biosafety Commission's risk assessment with the Mercosur Commission for Ag-Biotechnology (CBA). The CBA analyzes any potential LLP issues that may arise within the region and utilizes the risk assessment as an input for their report. The mechanism requires the event developer to have already submitted the event for authorization in the other Mercosur countries. The CBA report may include recommendations for managing a potential LLP situation, which may involve an event approval, or a threshold, amongst other recommended actions. Once prepared, the report is sent to a subgroup to inform Mercosur authorities. Even in cases where the CBA report may not provide specific recommended actions, it does generate a forum to share regulatory information, recognizes the risk assessment of other countries as an input to solve a potential LLP situation, and helps to transition potential LLP towards compliance in a timely manner.
Mecanismo para disminuir la ocurrencia de presencia en bajos niveles (PBN) de organismos genéticamente modificados (OGM) entre los estados partes (in Spanish and Portuguese only)
USDA Plant Biotechnology Regulations and the Use of Familiarity to Revise its Regulatory Approach
The United States Department of Agriculture (USDA) is one of three agencies responsible for regulating plants that are the product of biotechnology in the United States. Since 2020, the USDA has implemented a new approach (found at 7CFR Part 340) for regulating plants produced using genetic engineering that may pose a plant pest risk. The new approach takes into account the last three decades of experience and advances in science and technology to provide regulatory relief for certain plants developed using genetic engineering that do not qualify for defined exemptions from the regulation because they could have been produced through conventional plant breeding. Plants that are not eligible for exemption are evaluated to determine whether they pose a plausible increased plant pest risk relative to an appropriate comparator and thus fall within the scope of the regulation. This evaluation for plant pest risk is not based upon the event, but on the plant, the new trait, and the mechanism of action (PTMOA) of the new trait within the plant through which the introduced genetic material determines the new trait. If the plant is determined unlikely to present an increased plant pest risk, it is not regulated under 7CFR Part 340. Future products with the same PTMOA from different events will be exempt. This regulation establishes a clear, consistent, and risk-based regulatory framework for products developed using genetic engineering that provides regulatory relief and better focuses regulatory resources on potential areas of risk. This focused approach may be useful for efficiently addressing environmental evaluations that are required as part of a food safety decision in some jurisdictions.
Animal and Plant Health Inspection Service: Help and Site Map
Canada-Australia-New Zealand Joint Safety Assessment Initiative
Canada, Australia, and New Zealand developed an initiative to explore ways in which they could collaborate on the pre-market food safety assessment of biotech products (i.e., GM foods). In this case, there was already a solid foundation for collaboration between the agencies responsible for food safety assessment of agricultural biotechnology, namely Health Canada (HC) and Food Standards Australia New Zealand (FSANZ). The two agencies previously collaborated on work related to the safety of GM foods in international fora (e.g., Codex Alimentarius Commission, OECD), and there was an existing agreement for information sharing on GM foods. The two agencies also have similar approaches to the safety assessment of GM foods, and industry stakeholders showed strong support and willingness to participate in this initiative. While there were differences in the agencies' operating procedures, a process was established to ensure these differences would not impede the collaboration; there would be no changes to each country's legislative framework, both agencies would be flexible, and each agency would continue to make its own independent regulatory and risk management decisions following its own post-assessment timeframes. For this collaborative assessment to work, there were also requirements on the applicant's part: that they are seeking a GM food approval from both agencies, that they agree to full information exchange between both agencies, that they satisfy the data requirements for both agencies, and that the application was for a GM food that both agencies regulate under their pre-market regulatory framework. The development of this initiative occurred in five stages, spanning from 2013 to 2019. They are the following:
- Stage 1: Comparing both countries regulatory approaches
Triggers, timelines, data requirements, amongst other factors
- Stage 2: Benchmarking exercise to compare the safety assessment processes and build trust
This was done by comparing two previously completed safety assessments.
- Stage 3: Formulating an approach for collaboration
The right model in this case was "Safety Assessment Sharing".
- Stage 4: Trust Building
Concurrent safety assessment of simple and nutritionally complex applications
- Stage 5: Administrative, legal, and communication considerations
Developing details for the process of safety assessment sharing, communication/guidance documents, and liaising with senior executives and relevant Government ministers for all countries involved.
The initiative's first pilot was completed in April 2021, and it is currently looking for candidates for its second pilot. Following the completion of the second pilot, stakeholder guidance will be developed.
Overall, this collaborative effort made it possible to share expertise between the two agencies, benefit from time and cost savings, provide a test case for potential collaboration that other countries can learn from if a similar arrangement interests them, and ultimately improve synchronisation of GM food approval to facilitate trade.
For more information about this initiative, please visit the Health Canada and Food Standards Australia New Zealand working together on GM food safety webpage.
Recent Free Trade AgreementsA number of recent trade agreements include provisions on agricultural biotechnology with the aim of increasing transparency and predictability surrounding product assessments and approvals; measures aimed at the prevention and management of LLP; and, the establishment of cooperative mechanisms for continued cooperation and dialogue. This includes the United States-Mexico-Canada Agreement (USMCA), specifically Chapter 3, Section B: Agricultural Biotechnology. The Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) also includes provisions for agricultural biotechnology under Article 2.27: Trade of Products of Modern Biotechnology of the agreement.
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