TABLE 2.

Global approaches to regulation of agricultural applications of precision biotechnology (genome editing).

Category defining questions	Categories of products of precision breeding techniques				Null segregant
Could be obtained via “conventional cross-breeding” or via mutagenesis?	yes	yes	yes	no	yes
Nucleic acid template?	no	short	long	yes	NA
“Foreign” DNA (Synthetic or Transgenic)	no	no	no	yes	NA

Country	Policy c	Distinctions among categories may vary with country				Null segregant	Decisions for GnEd animals
Central and South America
Argentina 1	Resolution 21/2021	Not GMO	Not GMO	likely Not GMO a	GMO	Not GMO	yes
Brazil 2	Normative Resolution 16	Not GMO	likely Not GMO	likely Not GMO	GMO	Not GMO	yes
Colombia 3	Resolution No. 22991	Not GMO	Not GMO	likely Not GMO	GMO	Not GMO	yes
Uruguay 4	Decree No. 84/024	Not GMO	Not GMO	likely Not GMO	GMO	Not GMO
North America
Canada 5	Novel Foods Laws (Product based)	Method of genetic modification does not determine whether safety assessment is required; ‘novelty’ of product is regulatory trigger for pre-market assessment
United States 6 (HHS-FDA-CVM)	United States does not have “GMO” laws; the U.S. Coordinated Framework for Biotechnology Products is based upon existing U.S. laws “Intentional Genomic Alterations” (IGAs) introduced into animals via biotechnology are regulated under animal drug laws
	GFI #187 A/B (final/draft)	IGAs individually evaluated. FDA may grant “enforcement discretion” (no further review) or IGAs may go through a pre-market approval process; determinations may vary within SDN categories				Not “GMO”	yes
Asia
Indonesia	Draft proposal	Not GMO	Not GMO	likely Not GMO	GMO	Not GMO
Japan 7 , 8	MAFF- Environment	Not GMO	GMO	GMO	GMO	Not GMO	yes
	MAFF- Animal Products	Not GMO	Likely Not GMO	Likely GMO	GMO	Not GMO
	Ministry of Health, Labor and Welfare	Not GMO	Likely not GMO	Likely GMO	GMO	Not GMO
Oceania
Australia 9 (OGTR)	environmental release	Not GMO	GMO	GMO	GMO	Not GMO
Australia/NZ 10 (FSANZ - food)	Proposal P1055	Not GMO	Likely Not GMO	Likely Not GMO	GMO	Not GMO
New Zealand (EPA)	Current legislation -environmental release (Hazardous Substances and New Organisms Act, 1996)	GMO	GMO	GMO	GMO	Not GMO
	new legislation proposed	Not GMO	Risk-tiering system proposed		GMO	Not GMO
Africa and Middle East
Ghana 11		Not GMO	Not GMO	Not GMO	GMO	Not GMO
Kenya 12		Not GMO	Not GMO	Not GMO	GMO	Not GMO
Malawi		Not GMO	Not GMO	Not GMO	GMO	Not GMO
Nigeria 13		Not GMO	Not GMO	Not GMO	GMO	Not GMO
South Africa 14	GMO Act of 1997	GMO	GMO	GMO	GMO	undetermined
Europe
Norway 15	Proposed	Not GMO	expedited assessment	expedited assessment	GMO
United Kingdom 16 (DEFRA)	Implementation for animals after welfare provisions established	Not GMO	Not GMO	Not GMO	GMO	Not GMO
Plant-specific
Chile 17		Not GMO	Not GMO	likely Not GMO	GMO	Not GMO
China		4-tiered approach (classification criteria not yet clarified)
Costa Rica 18 , b	Decree No. 44244-MAG	Not GMO	Not GMO	likely Not GMO	GMO	Not GMO
Ecuador 19 , b	Ministerial Agreement No. 063	Not GMO	Not GMO	likely Not GMO	GMO	Not GMO
European Union 20	European Commission Proposal	Not GMO	Not GMO	Not GMO	GMO	Not GMO
Guatemala 21 , b	Ministerial Agreement No. 271-2019	Not GMO	Not GMO	likely Not GMO	GMO	Not GMO
Honduras 22 , b	Agreement C.D. SENASA 008-2019	Not GMO	Not GMO	likely Not GMO	GMO	Not GMO
India 23		Not GMO	Not GMO	Not GMO	GMO	Not GMO
		SDN1	SDN2	SDN2	SDN3
Israel		Not GMO	Not GMO	Not GMO	GMO	Not GMO
Paraguay 24 , b	Resolution MAG No. 842/2019	Not GMO	Not GMO	likely Not GMO	GMO	Not GMO
Philippines 25	animal regulations under consideration	Not GMO	Not GMO	Not GMO	GMO	Not GMO
Singapore 26	Singapore Food Agency (SFA) and GMAC	Not GMO (notify SFA)	Not GMO (notify SFA)	likely Not GMO (notify SFA)	GMO	Not GMO
Thailand 27 , b	Ministry of Agriculture and Cooperatives B.E. 2567	Not GMO	Not GMO	likely Not GMO	GMO	Not GMO

^a perfect allelic replacement.

^b no GM, animal regulations in place; based on the definition of an “LMO”.

SDN: Site-Directed Nuclease.

GMO: genetically modified organism; “GMO” and “Not GMO” indicate whether an organism in each category would be included in a country’s rDNA/GMO, regulations.

(NB: not all countries use the term “GMO” or have GMO, laws. Quotes are used to indicate these instances and whether products would be subject to biotechnology regulations).

^c FAS GAIN: https://gain.fas.usda.gov/#/(updated annually) Details on country policies available in the USDA GAIN system and in the weblinks below.

Weblinks to Country Policies.

¹Argentina: https://www.argentina.gob.ar/agricultura/alimentos-y-bioeconomia/nuevas-tecnicas-de-mejoramiento-nbt; https://www.argentina.gob.ar/normativa/nacional/resoluci%C3%B3n-21-2021-346839

²Brazil: https://ctnbio.mctic.gov.br/en/resolucoes-normativas/-/asset_publisher/OgW431Rs9dQ6/content/resolucao-normativa-n%C2%BA-16-de-15-de-janeiro-de-2018

³Colombia: https://www.anla.gov.co/eureka/normatividad/resoluciones/2960-resolucion-no-22991-del-11-de-noviembre-de-2022

⁴Uruguay: https://www.impo.com.uy/bases/decretos/84-2024

⁵Canada: https://www.canada.ca/en/health-canada/services/food-nutrition/genetically-modified-foods-other-novel-foods.html; https://inspection.canada.ca/en/plant-varieties/plants-novel-traits/gene-editing-techniques

⁶United States: https://www.fda.gov/animal-veterinary/biotechnology-products-cvm-animals-and-animal-food/intentional-genomic-alterations-igas-animals

⁷Japan (MAFF): https://www.maff.go.jp/j/syouan/nouan/carta/tetuduki/nbt.html

⁸Japan (MHLW): https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/bio/genomed/index_00012.html

⁹Australia (OGTR): https://www.ogtr.gov.au/resources/publications/overview-status-organisms-modified-using-gene-editing-and-other-new-technologies; https://www.genetechnology.gov.au/reviews-and-consultations/past/2017-third-review

¹⁰Australia/NZ (FSANZ): https://www.foodstandards.gov.au/food-standards-code/proposals/p1055-definitions-for-gene-technology-and-new-breeding-techniques

¹¹Ghana: https://bch.cbd.int/en/database/LAW/BCH-%20LAW-GH-265861-1

¹²Kenya: https://www.biosafetykenya.go.ke/images/GENOME-EDITING-GUIDELINES-FINAL-VERSION-25th-Feb-2022-03.pdf

¹³Nigeria: https://nbma.gov.ng/wp-content/uploads/2022/03/NATIONAL-GENE-EDITING-GUIDELINE.pdf

¹⁴South Africa: https://old.dalrrd.gov.za/doc/Minister%20final%20decision%20on%20AGBIZ%20appeal.pdf

¹⁵Norway: https://www.bioteknologiradet.no/filarkiv/2019/01/Proposal-for-relaxation-of-GMO-regulations-with-annexes.pdf.

¹⁶United Kingdom: https://www.legislation.gov.uk/ukpga/2023/6/contents/enacted

¹⁷Chile: https://www.sag.gob.cl/ambitos-de-accion/aplicabilidad-de-resolucion-ndeg-15232001-en-material-de-propagacion-desarrollado-por-nuevas-tecnicas-de-fitomejoramiento

¹⁸Costa Rica: https://www.imprentanacional.go.cr/pub/2023/11/10/ALCA222_10_11_2023.pdf

¹⁹Ecuador: https://www.fao.org/faolex/results/details/es/c/LEX-FAOC223895/

²⁰European Union: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13119-Legislation-for-plants-produced-by-certain-new-genomic-techniques_en

²¹Guatemala: https://visar.maga.gob.gt/visar/2019/20/AM271-2019.pdf

²²Honduras: https://senasa.gob.hn/web/wp-content/uploads/2022/02/ACUERDO-CD-SENASA-008-2019-GACETA-35047.pdf

²³India: https://dbtindia.gov.in/sites/default/files/SOPs%20on%20Genome%20Edited%20Plants.pdf

²⁴Paraguay: https://conbio.mag.gov.py/media/ckfinder/files/RES.N842%2010%20DE%20JULIO%20DE%202019%20NBT.pdf

²⁵Philippines: https://www.da.gov.ph/wp-content/uploads/2022/06/mc08_s2022_Revised.pdf

²⁶Singapore: https://www.sfa.gov.sg/docs/default-source/food-information/guidance-on-regulatory-framework-for-genome-edited-crops-for-use-as-food-and-feed-(2024-08).pdf; https://www.gmac.sg/guidelines/?tab=singapore-guidelines-on-the-release-of-agriculture-related-gmos#tab_section

²⁷Thailand: https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=Regulation%20on%20Plants%20Developed%20Using%20Genome%20Editing%20Technology%20_Bangkok_Thailand_TH2024-0052.pdf