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Summary
Canada applies a risk-based regulatory approach to both GMOs and genome edited plants, that is triggered by ‘novelty’ and based on a rather complex biotechnology-related regulatory oversight consisting of no fewer than eight acts and policies, administered by eight agencies, pertaining to the different aspects of biotechnology products on the Canadian market.
The complexity of the Canadian model is afforded by the country’s effort to use existing acts and regulations rather than developing any new regulation, when new breeding methodologies had started to be increasingly used in the 1980s and 1990s.
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Summary
The US applies a regulation under existing laws to all biotechnology products, providing a network of agency jurisdictions. In 2015, however, a modernisation of the regulatory system for biotechnology products was initiated, whose main goal was to ‘[e]nsure public confidence in the regulatory system and improve transparency, predictability, coordination, and efficiency of the regulatory system’. The review resulted in two key documents:
In 2019, Honduras, Guatemala and El Salvador published a ‘resolution to establish a streamlined authorization procedure for crops developed using new breeding techniques (NBTs).’[1]
[1] Website: Human and Agriculture Gene Editing Regulations and Index – Central America: Crops/Food (accessed: 9th March 2023)
Go to the FULL PAGE of the Joint Statement of selected South American Countries
In September 2018, Argentina, Chile, Brazil, Paraguay and Uruguay issued a joint statement about the role of genome edited crops in agricultural production, and their countries’ plans to collaborate with third countries on the continuing development and trade of gene edited crops (English translation of the Spanish original).[1]
[1] Genetic Editing Techniques, Southern Agricultural Council (CAS) XXXV Regular Meeting, 20th September 2018. (accessed: 1st March 2023)
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Summary
Argentina was the first country to consider and provide clarification on whether the application of NBTs should be regulated as GMOs. The country’s regulatory framework is based on its membership of a number of international groups and committees (incl. FAO/WHO/CODEX[1], WTO/SPS[2], FAO/IPPC[3]), as well as its effort to ratify the CPB[4].
[1] Website: Food and Agriculture Organisation of the United Nations (FAO) and World Health Organisation (WHO) CODEX ALIMENTARIUS – International Food Standards (accessed: 10th March 2023)
[2] Website: World Trade Organisation (WTO) Sanitary and Phytosanitary Measures (accessed: 10th March 2023)
[3] Website: FAO International Plant Protection Convention (IPPC) (accessed: 10th March 2023)
[4] According to Argentina’s Country Profile at the Biosafety Clearing House for the CPB, Argentina signed the CPB in May 2000, but has not yet ratified it.
The corresponding Brazilian regulation defines so-called ‘Innovative Precision Improvement Techniques (TIMP), from the English term ‘Precision Breeding Innovation (PBI)’, which also encompasses the NBTs (Whelan & Lema, 2019). In 2018, the Brazilian Ministry of Science, Technology, Innovations and Communications published a Normative Resolution 16/2018, stipulating that ‘TIMP encompass a set of new methodologies and approaches that differ from the genetic engineering strategy by transgene, as it results in the absence of recombinant DNA/RNA in the final product’, and that ‘[the new technologies] may originate a product not considered as a Genetically Modified Organism (GMO) […] are considered examples of Innovative Precision Improvement Techniques (TIMP), but not limited to them.’ (Whelan & Lema, 2019). In order to determine whether a product obtained by TIMP should be considered a GMO, the Brazilian regulation creates a case-by-case assessment procedure similar to that of Argentina.
Similar to Argentina’s approach, Chile’s Ministry of Agriculture’s Agricultural and Livestock Services regulates plants modified through genome editing techniques as conventional plants, unless they contain foreign DNA.[1] The underlying decisions and required procedures have been laid out in a guidance, published in 2017, that describes exemptions from the Chilean regulation for genetically modified crops (1523/2001)[2] stating that gene-edited crops that do not contain “a new combination of genetic material” are not subjected to GMO regulations.
[1] Website: Human and Agriculture Gene Editing: Regulations and Index – Chile: Crops / Food (accessed: 10th March 2023)
[2] Website: Chilean Applicability of Resolution No. 1523 / 2001 in propagation material developed by new plant breeding techniques (accessed: 10th March 2023)
Genome edited crops and food stuff are regulated as conventional plants, unless they contain foreign DNA; a resolution passed in 2019 outlines requirements for approval of crops developed using gene editing and other NBTs and stipulates that the National Commission on Agricultural and Forestry Biosafety reviewed dossiers on the relevant new crops or food on a case-by-case basis, in order to determine, if they are exempted from GMO regulation.
Uruguay has no specific regulatory provisions for genome edited crops or food stuff; three different genome edited products are currently known to be under development: herbicide-resistant soy-beans, soybeans with reduced lectins, and mandarins and tomatoes with higher lycopene content.[1]
It is noteworthy that the Uruguayan regulation of GMOs differs from that of its neighbours in that it is triggered by the application of a process (utilising recombinant DNA) (Alejandra & Gardini, 2013).
[1] Website: Human and Agriculture Gene Editing Regulations and Index – Uruguay: Crops/Food (accessed: 1st March 2023)
Since a referendum in 2008, Ecuador’s constitution prohibits the cultivation of GMOs in the country, but permits their import, as long as they are labelled, supported by the President and approved by the National Assembly (Gatica-Arias, 2020).[1] In May 2019, the Regulation of the Organic Code of the Environment was published, establishing a regulatory approach to GMOs, and detailing that ‘organisms resulting from genetic improvement which are not harboring recombinant or foreign DNA in the resulting genome are excluded from risk assessment’ (article 230a) (Gatica-Arias, 2020).
[1] Website: Human and Agriculture Gene Editing Regulations and Index – Ecuador: Crops/Food (accessed: 1st March 2023)
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In February 2018, the Colombian Agricultural Institute (ICA) notified the World Trade Organization (WTO) of a ‘Draft Colombian Agricultural Institute (ICA) Resolution establishing the procedure applicable to a cultivar where innovative plant breeding techniques deriving from modern biotechnology have been used at some stage of the plant-breeding process, and the end product does not contain foreign genetic material. [1],[2]
The resolution foresees a case-by-case consultation process, under which an applicant submits a dossier to the ICA, and the ‘ICA shall carry out an assessment of the information received within a period no longer than sixty (60) working days, determining whether the new crop contains any foreign genetic material inserted in its genome due to the use of modern biotechnology techniques. For a genetic change to be considered as foreign genetic material, it shall be analyzed whether a stable and joint exogenous insertion has been produced in one (1) or more genes or DNA sequences forming part of a specific genetic construction.’ (Whelan & Lema, 2019).
[1] Website: Human and Agriculture Gene Editing: Regulations and Index – Colombia: Crops / Food (accessed: 1st March 2023)
[2] Website: WTO, G/SPS/N/COL/282, 26 February 2018, Committee on Sanitary and Phytosanitary Measures, Notification (accessed: 1st March 2023)
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Summary
Argentina was the first country to consider and provide clarification on whether the application of NBTs should be regulated as GMOs. The country’s regulatory framework is based on its membership of a number of international groups and committees (incl. FAO/WHO/CODEX[1], WTO/SPS[2], FAO/IPPC[3]), as well as its effort to ratify the CPB[4].
[1] Website: Food and Agriculture Organisation of the United Nations (FAO) and World Health Organisation (WHO) CODEX ALIMENTARIUS – International Food Standards (accessed: 10th March 2023)
[2] Website: World Trade Organisation (WTO) Sanitary and Phytosanitary Measures (accessed: 10th March 2023)
[3] Website: FAO International Plant Protection Convention (IPPC) (accessed: 10th March 2023)
[4] According to Argentina’s Country Profile at the Biosafety Clearing House for the CPB, Argentina signed the CPB in May 2000, but has not yet ratified it.
Norway maintains one of the most restrictive regulation on the cultivation and import of GMO food and feed; while the use of GMO soy as salmon feed is allowed, the industry avoids it, due to fear of a public backlash (Heggdal, 2016). In December 2018, the Norwegian Biotechnology Advisory Board published ‘A forward-looking regulatory framework for GMO’, recommending a tiered approach for regulatory assessment under the Gene Technology Act of 1993 (The Norwegian Biotechnology Advisory Board, 2018; Government of Norway, 1993).[1] The proposed tiers differentiate the following levels of changes to the genome and their corresponding assessment:
[1] Website: Human and Agriculture Gene Editing Regulations and Index – Norway: Crops/Food (accessed: 9th March 2023)
With the exception of the support of the ‘International Statement on Agricultural Applications of Precision Biotechnology’ [1] to the World Trade Organization (WTO) Committee in November 2018 by the Secretariat of the Economic Community of West African States (see the relevant section at the end of this country analysis), little is known about policies pertaining to genome editing in African countries. Schmidt et al. reports that South Africa currently treats genome edited plants as GMOs, but that a discussion about a policy amendment was ongoing, while in Kenya, the National Biosafety Authority was in the process of drafting guidelines for the regulation of genome editing technologies (Schmidt, Belisle, & Frommer, 2020).
The African Union (AU) announced that it was looking at the possibility of harmonising biosafety regulations to ensure more effective handling of biotechnology application in its 55 member states, with a specific view to ‘enhance regulatory framework by engaging themselves in addressing the issues of emerging technologies.’ (Alliance for Science, 2019).[2]
[1] WTO, G/SPS/GEN/1658/Rev3, 1st November 2018, Committee on Sanitary and Phytosanitary Measures, International Statement on Agricultural Applications of Precision Biotechnology (accessed: 1st March 2023)
[2] Website: Human and Agriculture Gene Editing Regulations and Index – Africa: Crops/Food (accessed: 10th March 2023)
In November 2019, Nigeria published an Amendment to its 2015 National Biosafety Management Agency Act (Nigerian National Biosafety Management Agency, (Amendment) Act, 2019; Nigerian National Biosafety Management Agency, 2015). As a result of the amendment, the legislation now provides that ‘[a] person shall not carry out gene drive, gene editing and synthetic biology except with the approval of the Agency,’ and adds ‘”gene editing” means a type of genetic engineering in which DNA is inserted, deleted, modified or replaced in the genome of a living organism’ (Nigerian National Biosafety Management Agency, (Amendment) Act, 2019). National Guidelines on Gene Editing (2020) have also been published, which make it clear that ‘if the gene editing process or the gene edited product does not lead to or have a new combination of genetic material (e.g. does not use a transgene/uses a transgene which is removed in the final product), a non-GM regulatory classification is applied…. If on the other hand, the gene editing process requires the use of recombinant DNA sequences or the gene edited product has a new combination of genetic material (e.g. uses a transgene which remains in the final product)’ the final product will fall under GM regulation (National Guidelines for the Regulation of Gene Editing, Federal Republic of Nigeria, 2020).
Senegal reported that it was ‘reviewing and revising its new biosafety law which may include language for an expedited approval process for certain genetically engineered (GE) products.’ (Osinski & Sylla, 2020)[1]
[1] Website: Human and Agriculture Gene Editing Regulations and Index – Africa: Crops/Food (accessed: 10th March 2023)
In South Africa, all non-human modifications to genomes are governed by the 1997 “GMO” Act (USDA Foreign Agricultural Service, 2019). An expert report on the regulatory implications of new breeding techniques, commissioned by the Government’s Department of Science and Technology, and authored by the Academy of Science of South Africa, noted ‘that new techniques may be more accurate and precise and may thus need a lower/different level of regulatory scrutiny.’ The Department of Science and Technology may investigate the need for possible regulatory amendments (USDA Foreign Agricultural Service, 2019).[1]
[1] Website: Human and Agriculture Gene Editing Regulations and Index – Africa: Crops/Food (accessed: 10th March 2023)
In Israel, GMOs are regulated by the ‘Seed Act (Genetically Modified Plants and Organisms) – 2005’, which defines (USDA Foreign Agricultural Service, 2020):
Genetically Modified Organism – An organism, including a microorganism, virus, viroid, and any single-celled or multi-celled entity, that has undergone a modification by genetic engineering and is involved with plants in any way during its lifecycle.
In March 2017, the Israeli National Committee for Transgenic Plants (NCTP) published a decision that the cultivation of genome editing plants would not be subject to the country’s GMO regulation, if no foreign DNA sequences were incorporated into the plant genome (Floral Daily, 2017).
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Summary
In January 2020, the Indian government published Draft Document on Genome Edited Organisms: Regulatory Framework and Guidelines for Risk Assessment, in order to seek comment on the proposed policy pertaining to genome editing through a public consultation exercise.[1] Issued by the Department of Biotechnology, of the Ministry of Science and Technology, the document is based on the biosafety regulatory framework established under ‘Manufacture, use, import, export and storage of hazardous microorganisms/ genetically engineered organisms or cells, Rules 1989 (Rules 1989) under Environment (Protection) Act (EPA), 1986’, and clarifies up front that ‘[t]he definition of gene technology under Rules 1989 covers genome editing, process and product.’ In this course, the draft explicitly applies to both genome-edited plants, animals, and human cells in one sweep of the proposed biosafety rules.
[1] Government of India (January 2020): Draft Document on Genome Edited Organisms: Regulatory Framework and Guidelines for Risk Assessment (accessed: 7th March 2023)
In April 2019, Russia announced a large funding programme, under which 30 new varieties of genome edited crops and animals would be created (i.e. 10 by 2020 and another 20 by 2027). The programme furthermore suggested that some genome edited products would be exempt from a law passed in 2016 that prohibits the cultivation of genetically modified organisms in Russia, except for research purposes (Dobrovidova, 2019).[1]
[1] Website: Human and Agriculture Gene Editing Regulations and Index – Russia: Crops/Food (accessed: 10th March 2023)
No Chinese policy pertaining to genome edited plants is known, although the country is by far the biggest generator of publications and patents for genome editing applications in agriculture (Schmidt et al., 2020; Cohen & Desai, 2019).[1]
[1] Website: Human and Agriculture Gene Editing Regulations and Index – China: Crops/Food (accessed: 10th March 2023)
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Summary
Concluding a five-year review process, the Japanese Ministry of the Environment (MOE) published a decision regarding the regulation of genome edited plants in February 2019, that ‘some genome-edited organisms should be considered as LMOs while others are not subject to the Cartagena Act.’ (Tsuda et al., 2019)
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Summary
Australia’s response to genome edited plants and their products builds on regulatory frameworks created for GMOs. All dealings with GMOs and the sale of GM food must be authorised, the form of authorisation corresponding with potential risks. In summary, recent amendments clarify that organisms and products produced using SDN1 are not regulated as GMOs although they may be regulated by other agencies such as that for food or therapeutic products. Similarly, the food regulator has determined that food from plants with no new DNA present in their genome, even if the genome has been changed, are not regulated under the current GM standard (FSANZ webpage ‘Foods Derived using new breeding techniques – review’ (April 2020)). Additional modernisation of these two regulatory frameworks is underway to ensure that regulation remains proportionate to potential risk.
More specifically, the question whether GMO and/or food regulations apply to genome edited plants and their products is determined by the use of ‘gene technology’, although the meaning of gene technology differs between GMO regulation and food regulation.
Using a stringent process-driven regulatory framework,[1] New Zealand currently regulates all genome edited plants as GMOs that are subject to an approval process by the Environmental Protection Authority (EPA).[2] New Zealand regulations are triggered by the use of a GMO, defined as ‘any organism in which any of the genes or other genetic material have been modified by in vitro techniques’ unless expressly excluded. The definition of GMO was amended in 2016 to clarify that while plants created using chemical and radiation mutagenesis techniques in use before 29 July 1998 or using conventional plant breeding techniques (such as selective breeding, selection and propagation of somaclonal variants, and cell fusion) are not GMOs, plants resulting from other newer techniques including genome editing are GMOs. As discussed above in relation to Australia, New Zealand shares a bi-national food regulatory agency with Australia meaning that food from plants with no new DNA present in their genome, even if the genome has been changed, is not considered to be GM food but food from plants whose genome does contain new DNA is regulated and requires pre-approval.
[1] Hazardous Substances and New Organisms Act 1996 and Hazardous Substances and New Organisms (Organisms Not Genetically Modified) Regulations 1998.
[2] Website: New Zealand Environmental Protection Authority (NZ EPA) (accessed: 15th March 2023)
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