by Laurie Goodwin, Director Regulatory Affairs and Advocacy, Plant Biotechnology and John McMurdy PhD, Director of Emerging Markets and Development Partnerships, CropLife International, Belgium

Access to innovation is a bedrock of the grain supply chain. Unfortunately, delays in global regulatory systems, asynchronous approvals of genetically modified (GM) crops, and inflexible low-level presence (LLP) policies contribute to farmers not being able to grow some biotech-improved grain varieties. CropLife International, a global federation representing the plant science industry, works to advocate for regulatory frameworks that enable innovation for farmers and support sustainable agriculture.

The basis of CropLife International's work in regularity harmonisation is to enable sound, predictable, science-based regulations that allow farmers to grow food in a more sustainable way. Delays in these processes can impact the global economy and food supply while predictable and timely regulations bring innovation to the marketplace and benefit exporting and importing countries alike.

One of the key hurdles to a globally streamlined regulatory system for GM crops are duplicative safety assessments with differing data requirements. Although submitting more data and undertaking more studies does not increase the level of product safety for consumers or the environment, many regulatory authorities still require submission of studies and data that are unnecessary for a risk-based safety assessment. CropLife International leverages the broad experience and familiarity we now have with GM technology and crops to encourage regulatory streamlining because, more than 25 years after the successful commercialisation of genetically modified (GM) crops, regulatory hurdles are still limiting farmer access to improved seed varieties.

CropLife International also recognises that industry has an important role to play. When product developers submit aligned and harmonised data for safety assessments, it is easier for regulators to share science. To encourage further regulatory cooperation, CropLife International is working on a project to suggest the studies and information which, based the available science and experience, should be submitted for a true science-based risk assessment for GM crops. The goal of the project is to continue to encourage greater regulatory dialogue and cooperation between jurisdictions at the international level to better enable access to improved GM seed varieties.

Another area of advocacy for CropLife International is supporting the use of different regulatory models as a pathway for regulatory streamlining and reduction of duplicative safety assessments. There are already several successful regulatory models in place around the world that allow for the maximisation of resources while reducing or eliminating duplicate work, and in no way compromises sovereignty or health and safety.

While the main goal is always predictable and timely import approvals for GM crops, there is also value in application of workable Low-Level Presence (LLP) policies that facilitate trade of improved grain when import approvals are not granted in a timely fashion. LLP is defined as the presence of a small amount of biotech grain that has been approved in the country of export, but not the country of import, within a larger commodity shipment. CropLife International and other value chain stakeholders work with governments to promote implementation of functional LLP policies through the Global Alliance for Ag Biotechnology Trade (GAABT).

Application of non-zero LLP thresholds for products not yet approved for importation (but which have already been approved by countries of export following international norms) can reduce the risk of trade disruption while also allowing farmers to access new biotech products during periods of regulatory asynchrony. CropLife International and GAABT's work emphasises that, because of the scale of global grain movements and farmer's needing access to better grain, zero, levels are not possible. Further, the coalition reiterates that the occurrence of LLP is not a safety concern, given the fact that food safety approvals have already been granted, and is rather a marketing and compliance consideration.

Through partnerships and open collaboration with other organisations in the grain trade, CropLife International continues to work toward enabling access to improved grain varieties by making positive changes to the regulatory system to enable plant science innovation to be a major contributor to sustainable agriculture and food systems around the world.

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