USA

The USDA issued a statement on March 28, 2019 to clarify they do not intend to regulate products that could otherwise be developed using traditional plant breeding. The USDA seeks to allow innovation when there is no risk present, and has stated that plant breeding innovation holds enormous promise for helping to protect crops against drought and diseases while increasing nutritional value and eliminating allergens. → READ USDA STATEMENT

Associated Press - 11/14/18: The era of gene-edited food is upon us
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Global Engage - 5/4/18: To Regulate Or Not To Regulate: Current Legal Status For Gene-Edited Crops
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Canada

Canadian authorities regulate the product, not the process used to make that product. In other words, the authorities regulate plants with novel traits, whether or not new plant breeding techniques were used to develop them. Plants with novel traits are defined as plants that demonstrate traits that are new to that species in Canada and that may have the potential to affect the Canadian environment.

Plants with novel traits undergo a thorough science-based pre-market safety assessment before they can be authorized for release in Canada. A science-based pre-market safety assessment is also performed before a novel product is authorized for use as food or as livestock feed. The Canadian Food Inspection Agency is responsible for environmental release and feed assessments, and Health Canada is responsible for food assessments. → READ CFIA Q&A ON NEW PLANT BREEDING TECHNIQUES

Associated Press - 11/14/18: The era of gene-edited food is upon us
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Global Engage - 5/4/18: To Regulate Or Not To Regulate: Current Legal Status For Gene-Edited Crops
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Europe

On July 25, 2018, the European Court of Justice issued a ruling indicating that organisms obtained by certain mutagenesis plant breeding techniques should, in principle, fall under the GMO Directive, with exemptions for crops that have a history of safety. → READ PRESS RELEASE

The ruling prompted calls for changes to the law from EU academia, from the EU food and feed industry and from EU Member States. It is expected that the European Commission will provide further guidance on the implications of the ECJ Ruling for EU policy relating to the cultivation and import of gene-edited crops and on gene-editing research within the EU.

The National Academy of Sciences Leopoldina, the Union of the German Academies of Sciences and Humanities, and the German Research Foundation (DFG) - 12/19: Towards a scientifically justified, differentiated regulation of genome edited plants in the EU
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europeanseed - 12/6/19: The Weight of Evidence and Science
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EURACTIV - 11/22/19: MEPs slam gene-editing court ruling as damaging for SMEs
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europeanseed - 11/18/19: The EU GMO Directive is No Longer Fit for Purpose
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EU Council - 10/23/19: Open Letter from the associations of the agricultural and food sector regarding the judgment of the European Court of Justice on new breeding methods
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COGEM - 10/10/19: Impression of the COGEM International Symposium ‘Gene edited crops; global perspectives and regulation’
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EU Parliament - 10/19: New plant-breeding techniques — Applicability of EU GMO rules
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AFBV & WGC - 9/5/19: AFBV and WGG propose targeted changes to the GMO Directive to enable and accelerate smart breeding in European agriculture
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VIB - 7/25/19: Open Statement for the use of genome editing for sustainable agriculture and food production in the EU
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EURACTIV - 5/24/19: 14 EU countries call for ‘unified approach’ to gene editing in plants
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EURACTIV - 5/21/19: Commission in search of ‘robust response’ to gene editing challenge
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FeedNavigator - 4/29/19: Ag trade ups pressure on Commission over EU court ruling on plant breeding
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EURACTIV - 3/28/19: Genome editing is going to be high on next Parliament agenda, MEP says
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EURACTIV - 3/27/19: Andriukaitis: New plant breeding techniques need new regulatory framework
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EURACTIV - 10/26/18: Scientists warn EU policymakers on ‘confusing’ gene editing court ruling
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EURACTIV - 8/6/18: Europe’s GM legislation is ‘outdated’, US says after Court ruling on gene editing
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Asia/Africa

Science - 3/29/19: New plant breeding technologies for food security
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Japan

In April 2019, Japan’s Ministry of Health, Labour and Welfare recommended that non-transgenic seed, traits and crops that comply with certain stipulations be cultivated, imported and sold in Japan.

Gain Report - 4/12/19: Japanese Health Ministry Finalizes Genome Edited Food Policy
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Science - 3/19/19: Gene-edited foods are safe, Japanese panel concludes
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GenomeWeb - 3/18/19: Japan to Issue Gene-Edited Food Rules
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Gain Report - 3/6/19: Japanese Environment Ministry Finalizes Policy for Regulating Genome Editing
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LATAM

Argentina, Brazil, Chile, Colombia and Paraguay have issued official resolutions to help determine if products of genome editing are subject to existing regulations for genetically modified organisms (GMO) or are subject only to regulations for “conventionally” developed varieties. Generally the new varieties that do not contain foreign genetic material are regulated as conventional varieties.

Australia

The Gene Technology Regulator (the Regulator) has conducted a technical review of the Gene Technology Regulations 2001 to clarify the regulatory status of organisms developed using a range of new technologies and ensure that the new technologies are regulated in a manner commensurate with the risks they pose.

The review has concluded with amendments to the Regulations being approved to provide clarity regarding regulatory capture of new technologies. The amendments will come into force on 8 October 2019. Further information about the review is available on the Regulations review page.

Nature - 4/23/19: Australian gene-editing rules adopt ‘middle ground’
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