Abstract
The increasingly widespread use of genome editing brought with it a fierce debate about the most adequate regulation of this latest innovation in modern biotechnology and the products resulting from it. In almost all cases, this debate has become a repetition or continuation of the deliberations concerning genetically modified organisms (GMOs) of the 1990s and early 2000s.
This chapter aims to untangle the historically influenced and often biased arguments of the debates by addressing the complex question of the correct interpretation of relevant underlying law and its applicability. In doing so, the chapter considers 25 countries and regions that have published results or ongoing investigations and discussions pertaining to the governance of genome editing in their jurisdictions: 16 have published policies or signed statements that exempt gene edited plants from GMO-regulations, as long as no foreign DNA or transgene remained in the final product. Such exemptions are based on the widely supported acceptance that the products of the underlying genome editing processes resemble those of “conventional breeding” techniques. These policies and statements often refer to the important role that modern precision biotechnologies, of which genome editing is one, play in addressing some of the world’s overarching challenges, such as the loss of biodiversity, pest and disease control, and climate change; they are furthermore shown to exhibit an adherence to the four universal principles of good regulation: (a) proportionality, (b) non-discrimination, (c) predictability, and (d) enforceability. And while it is the right of jurisdictions to develop their own regulations independent from that of their neighbors, it is specifically the principle of “enforceability” that may become the ultimate litmus test of those regulations that do not grant exemptions from GMO-regulations.
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Notes
- 1.
Terminologies, such as “product-based” or “process-based,” that are often utilized during the analyses and discussions of regulatory frameworks/arrangements, are much less accurate then the reference to a “trigger,” and may even mean different things in different contexts.
- 2.
Website: Cartagena Protocol on Biosafety (accessed: 10th March 2021).
- 3.
According to Food and Agriculture Organization of the United Nations (FAO), the “so-called Cartagena Protocol on Biosafety to the 1992 Convention on Biological Diversity (2000) (Secretariat of the Convention on Biological Diversity, 2000 [2]) […] does not refer to genetically modified organisms but rather, for reasons that are not explicit, to “living modified organisms” but it is clear that the two terms should be regarded as synonymous.”
- 4.
Russia announced a large funding programme, under which 30 new varieties of genome edited crops and animals would be created, but very little is known about the underlying policies.
- 5.
Website: Biology Fortified (accessed: 29th April 2021).
- 6.
Website: New (Plant) Breeding Techniques (accessed: 10th March 2021).
- 7.
NBTs include: cisgenesis, intragenesis (technologies using transformation with genetic material restricted to the species’ own gene-pool), emerging techniques to induce controlled mutagenesis or insertion (ODM, Zinc Finger Nuclease technologies 1–3), other applications such as grafting on GM rootstocks or reverse breeding, and the three different site-directed nuclease (SDN) types of genome editing: SND1, SDN2, and SDN3 [6].
- 8.
In fact, the inability to retrospectively differentiate between a naturally occurring mutation and one that may have been induced through SDN1 genome-editing techniques presents a major discussion point vis-à-vis the basic “enforceability”-principle of good regulation; this will be discussed in more detail below (cf. section Considerations of adequate Regulation and Governance of Genome Editing), together with the other principles of “proportionality,” “non-discrimination,” and “predictability.”
- 9.
Website: Food and Agriculture Organization of the United Nations (FAO) and World Health Organization (WHO) CODEX ALIMENTARIUS – International Food Standards (accessed: 10th March 2021).
- 10.
Website: World Trade Organization (WTO) Sanitary and Phytosanitary Measures (accessed: 10th March 2021).
- 11.
Website: FAO International Plant Protection Convention (IPPC) (accessed: 10th March 2021).
- 12.
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.
- 13.
Genetic Editing Techniques, Southern Agricultural Council (CAS) XXXV Regular Meeting, 20th September 2018 (accessed: 1st March 2021).
- 14.
Website: Human and Agriculture Gene Editing: Regulations and Index – Chile: Crops / Food (accessed: 10th March 2021).
- 15.
Website: Chilean Applicability of Resolution No. 1523 / 2001 in propagation material developed by new plant breeding techniques (accessed: 10th March 2021).
- 16.
Website: Human and Agriculture Gene Editing Regulations and Index – Uruguay: Crops/Food (accessed: 1st March 2021).
- 17.
Website: Human and Agriculture Gene Editing Regulations and Index – Ecuador: Crops/Food (accessed: 1st March 2021).
- 18.
Website: Human and Agriculture Gene Editing: Regulations and Index – Colombia: Crops / Food (accessed: 1st March 2021).
- 19.
Website: WTO, G/SPS/N/COL/282, 26 February 2018, Committee on Sanitary and Phytosanitary Measures, Notification (accessed: 1st March 2021).
- 20.
Website: Human and Agriculture Gene Editing Regulations and Index – Central America: Crops/Food (accessed: 9th March 2021).
- 21.
Website: USDA APHIS “Am I regulated” (AIR) process (accessed: 10th March 2021).
- 22.
Website: Determining the Regulatory Status of a Food Ingredient (accessed: 29th April 2021).
- 23.
Website: Q&A on FDA Regulation of Intentional Genomic Alterations in Animals (accessed: 29th April 2021).
- 24.
Website: Human and Agriculture Gene Editing Regulations and Index – Norway: Crops/Food (accessed: 9th March 2021).
- 25.
Website: European Union: GMO Legislation (accessed: 20th March 2021).
- 26.
Government of India (January 2020): Draft Document on Genome Edited Organisms: Regulatory Framework and Guidelines for Risk Assessment (accessed: 7th March 2021).
- 27.
Website: Human and Agriculture Gene Editing Regulations and Index – Russia: Crops/Food (accessed: 10th March 2021).
- 28.
Website: Human and Agriculture Gene Editing Regulations and Index – China: Crops/Food (accessed: 10th March 2021).
- 29.
Website: Human and Agriculture Gene Editing Regulations and Index – Japan: Crops/Food (accessed: 10th March 2021).
- 30.
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 2021).
- 31.
Website: Human and Agriculture Gene Editing Regulations and Index – Africa: Crops/Food (accessed: 10th March 2021).
- 32.
That framework comprises the Gene Technology Act 2000 (GT Act) and its accompanying regulations (Gene Technology Regulations 2001) as well as an inter-governmental between the Australian Federal, State and Territory governments. Website: Office of the Gene Technology Regulator (accessed: 15th March 2021).
- 33.
Website: Food Standards Australia New Zealand: Proposal P1055 – Definitions for gene technology and new breeding techniques (accessed: 15th March 2021).
- 34.
Hazardous Substances and New Organisms Act 1996 and Hazardous Substances and New Organisms (Organisms Not Genetically Modified) Regulations 1998.
- 35.
Website: New Zealand Environmental Protection Authority (NZ EPA) (accessed: 15th March 2021).
- 36.
Website: Secretariat of the Economic Community of West African States (accessed: 15th March 2021).
- 37.
Website: Human and Agriculture Gene Editing Regulations and Index – Paraguay: Crops/Food (accessed: 1st March 2021).
- 38.
Website: GMO regulations clarified (accessed: 1st March 2021).
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Friedrichs, S., Ludlow, K., Kearns, P. (2022). Regulatory and Policy Considerations Around Genome Editing in Agriculture. In: Verma, P.J., Sumer, H., Liu, J. (eds) Applications of Genome Modulation and Editing. Methods in Molecular Biology, vol 2495. Humana, New York, NY. https://doi.org/10.1007/978-1-0716-2301-5_17
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