Global LLP Initiative (GLI) Communiqué on Approaches to Reduce Asynchronous Authorizations in Food and Feed Derived From Recombinant DNA (rDNA) PlantsFootnote 1
- The objective of this communiqué is to offer a broad range of potential approaches for governments, technology developers and other stakeholders to consider to minimize occurrences of asynchronous authorizations of food and feed derived from recombinant DNA (rDNA) plants.
- The number and complexity of rDNA plants being developed, cultivated, and traded worldwide is increasing annually. However, the timing of authorizations differs across countries.
- For the purposes of this communiqué, an asynchronous authorization is a situation where there is a regulatory authorization of a rDNA plant intended for food and feed use in the country of origin and no corresponding authorization in a country of import.
- Asynchronous authorizations can delay commercialization of new rDNA plants as well as create the potential for trade disruptions arising from the low-level presence (LLP) of unauthorized rDNA plants in food and feed shipments.Footnote 2
- We re-affirm our position that reducing asynchronous authorizations is the most effective way of reducing trade disruptions due to LLPFootnote 2, and further note that the need for practical approaches for managing LLP incidents will persist as long as situations of asynchronous authorizations exist.
- GLI member countries are committed to exploring practical approaches to reduce asynchrony in authorizations in the context of food and feed safety, recognizing that due to national laws, not all approaches to reducing asynchronous authorizations may be feasible or applicable for an individual country.
- Asynchronous authorizations result predominantly from differences between countries in regulatory and legal requirements for the assessment and authorization of rDNA plants for food and feed.
- The approaches belowFootnote 3 may be considered by governments, technology developers, and other stakeholders as practical means to help reduce occurrences of asynchronous authorizations, recognizing that individual countries need to devise measures consistent with their domestic legal requirements, and acknowledging that regulatory approaches to rDNA plants should provide transparent and predictable timeframes for decision making, be science-based, be no more trade restrictive than necessary to fulfill legitimate objectives, and be consistent with relevant international obligations.
Potential approaches for reducing asynchronous authorizations
- Develop sufficient capacities, to the extent resources and national priorities allow, in regulatory processes to enable food and feed safety reviews to be completed and decisions made in a timely manner.
- Review regulatory procedures to identify redundant or scientifically unjustified data requirements for possible change or elimination, including for stacked products.
- Ensure that re-registration requirements and/or time-bound reviews for food and feed derived from recombinant DNA (rDNA) plants are not an impediment to the continued marketing of these crops.
- Strive towards procedural efficiencies in regulatory systems as appropriate, for example by: allowing year-round submissions, simultaneous review of new products under evaluation in other countries, simplified dossier reviews and authorization procedures (where such steps can be taken without compromising the rigor of the analyses), and avoidance of duplication in review processes, including overlap among agencies.
Governmental Bilateral and Regional Efforts:
- Establish information exchange mechanisms on regulatory review processes for food and feed derived from rDNA plants, including encouraging standardization of data and information requirements for applications.
- Consider, as appropriate, recognition of data sets generated in another country during the review processes, including allowance of transportability of data to the extent possible.
- Consider permitting imports of a rDNA plant which is authorized by a competent authority of a country, or countries, that uses science-based food (and, where available, feed) safety assessments that are consistent with international guidelines.
- Encourage and support joint reviews and authorizations for food and/or feed derived from rDNA plants, where such endeavors are feasible and would increase efficiency and reduce asynchrony.
- Coordinate outreach to other countries emphasizing the importance of transparent application procedures and decision making timeframes.
- Undertake regional cooperation in performing food and/or feed safety evaluations, where feasible/appropriate.
Governmental Efforts in International/Multilateral Fora:
- Increase communications regarding new authorizations so as to improve information exchange.
- Explore means by which countries that do not have regulatory systems for food and/or feed from rDNA plants at present could establish clear and efficient procedures enabling authorization of products intended for food and feed.
- Encourage establishment of criteria for consideration of another country's evaluations or authorizations, where appropriate.
- Explore common processes for risk analysis and assessments, where feasible, to improve the timeliness of decision-making.
- Encourage development of an internationally-standardized dossier format for food and feed derived from rDNA plants, where possible.
- Promote use of web-based global information databases, such as the FAO GM Foods Platform, including by ensuring that timely updates of authorizations are made publicly accessible.
- Encourage recognition of the work done multilaterally on safety assessments, particularly that of the Codex Alimentarius Commission and the OECD Task Force for the Safety of Novel Foods and Feeds, and the use of these results in respective country safety assessment processes for food and feed derived from rDNA plants.
Governments and Technology Developers:
- Enable simultaneous submissions of product applications to multiple countries.
- Ensure completeness of an application package at the time of submission, as well as provide for regulator-developer dialogue during the review process, as additional questions arise.
- Support regional regulator-developer consultative mechanisms that improve understanding of data requirements.
- Encourage stakeholders to access information about the status of reviews/authorizations in importing and exporting countries.
- Plan product launches and stewardship efforts so that the likely timing of authorizations would reduce asynchronous authorizations.
- Submit applications to as many markets as possible and as resources allow, including for products intended for domestic use only that may be inadvertently commingled with exported crops.
- Tailor applications to meet multiple country requirements to avoid delays in completing assessments; strive to make relevant data readily accessible.
- Provide technical and/or other assistance, as appropriate, to governments.
- Strive to work with other stakeholders to share information about product launches and facilitate industry-wide stewardship efforts and coordination.
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