Processes for regulating genetically modified and gene edited plants

Figures & data

Figure 1. Status of UPOV membership as of September 2022. Green – members of UPOV (78)(covering 97 States); Red – initiating states (19) and organisations (1); and Orange – States (23) and organisations (1) in contact with the UPOV Office.⁶¹.

Table 1. Recent attitudes towards consumption of food generated from genetically modified and gene edited crops.

Representative population	Question asked	Survey result	Reference
China	Consumer opinions towards allowing gene-edited and transgenic technologies	Transgenic plants − 36% agree; 34% neutral; 31% disagree Gene edited plants − 45% agree; 36% neutral; 20% disagree	^Citation84
	Awareness, knowledge, and opinion on GM food.	11.9%, 41.4%, and 46.7% had a positive, neutral, or negative view on GM food, respectively.	^Citation85
France and USA	Willingness to purchase a cisgenic apple with reduced browning	Boycott purchase: France − 42% USA − 19%	^Citation86
Italy (young consumers)	GM foods are safe	24% agree; 39% indifferent; 37% disagree	^Citation87
	GM foods are unnatural products	57% agree; 26% indifferent; 17% disagree
	GM experimentation should be more controlled	78% agree; 17% indifferent; 5% disagree
New Zealand	Support for gene edited food production in NZ	32% positive support, 47% neutral and 21% against	^Citation88
	Should governments regulate NBTs	55% strongly agree, 35% agree, 9% neutral	^Citation89
	Support for GM food if they contain less pesticide and better nutrition	25% support; 47% neutral; 28% against	^Citation90
Sweden	Attitude toward GM and plant breeding	GM: Males - positive 26%; negative 31% Females – positive 9%; negative 36% Plant breeding: Males - positive 46%; negative 6% Females – positive 27%; negative 10%	^Citation91
UK and Poland	Support for GM foods	19.8% positive; 52.5% neutral; 27.7% negative	^Citation92
USA – university students	Willingness to pay more for non-GM foods	70% unwilling; 22% willing	^Citation93

Table 2. Number of GM plant events authorised for (a) commercial cultivation and (b) for food and/or feed use - since 1992 per jurisdiction Source^4,174.

Application	USA	Canada	Australia	Japan	NZ	EU	Norway	Switzerland
Cultivation	184^a	144	56	145b	0	10^c	11d	0^e
Food/feed	370	293	142	375	142^f	226	11	4

a - Stacked events of registered single events are not included in the US list.

b - No commercial cultivation despite approval; Japan has approved a lot of commercial GMOs for cultivation.

c - Commercial cultivation with one event only in some regions of the Union (Spain and Portugal).

d - Only cultivation of blue carnation for decoration purposes allowed.

e - Moratorium for commercial cultivation in place since 2005.

f – Only approved for use as food (not feed).

Table 3. Categorization of 30 countries by the regulatory system used (product versus process) and the amount of commercially cultivated GM crops. (Adapted from¹⁵⁹).

Level of GM cultivation	Regulatory system
	Product-based	Process-based
Greater than 0.1 million ha	8 – USA, Argentina, Canada, Uruguay, Philippines, Mexico, Colombia, Sudan	9 – Brazil, India, China, Pakistan, South Africa, Bolivia, Australia, Burkina Faso, Spain
Less than 0.1 million ha	6 – Honduras, Costa Rica, Bangladesh, Japan, South Korea, Russa	7 – Portugal, Slovakia, Romania, European Union, UK, New Zealand

Table 4. Difference between discounted aggregate consumer and producer surplus (US$ billion) over 40 years for four scenarios of adoption of a gene edited solution providing resistance against an emerging plant disease, Fusarium oxysporum f.Sp. cubense Tropical race 4 compared with no adoption of a solution under moderate disease incidence (adapted from.²⁴⁸

	Scenario
	1. Immediate adoption	2. Late adoption	3. Late-modest adoption	4. Exporter delay
Consumer surplus change	+13.5	+7.8	+3.1	+1.4
Producer surplus change	+23.7	+13.9	+5.4	+2.1
World total change	+422	+244	+85	+44

Table 5. New Breeding Technologies (NBT) legislation for growing GM crops and forages for 56 countries plus the European Union. Refer also to^{32, 34, 159, 227, 264, 288, 289,158, 180, 228, 290, 291} and²⁹² for further detail.

Category	Type of differentiation	Country or region	Reference
Explicitly includes all NBT crops in existing GM legislation	None	European Union	^Citation7, Citation32, Citation227, Citation266–273
	None	New Zealand	^Citation34, Citation178, Citation180, Citation227, Citation274, Citation275
GM legislation allows some NBT crops to be considered as non-GM	Final products with no transgene do not fall under the Regulatory Framework for GMOs	Argentina	^Citation5, Citation43
	Introduced RNA that blocks gene expression (RNAi) and gene editing, without introduced templates to guide genome repair (SDN1 gene edits), would not be regulated as GMOs	Australia	^Citation34, Citation178, Citation180, Citation276, Citation277
	Does not regulate plant products if no foreign DNA present (SDN1 gene edits)	Brazil	^Citation5, Citation180, Citation254
	Established a science-based regulatory system that is flexible and capable of responding to new innovative products and technologies	Canada	^Citation103,Citation227
	Plants mutated by CRISPR that do not contain any foreign DNA sequences are exempted	Chile	^Citation5, ^Citation394, ^Citation180, ^Citation5
	Plants mutated by CRISPR that do not contain any foreign DNA sequences are exempted	Colombia	^Citation394, ^Citation180
	Does not regulate plant products if no foreign DNA present (SDN1 gene edits)	Ecuador	^Citation5, Citation158, Citation180
	Authorization procedures for applications related tothe use of new genetic improvement techniques for applications related to the use of new genetic improvement techniques	Honduras	^Citation5, Citation180
	SDN-1 and SDN-2 gene edits free from exogenous DNA exempt from biosafety regulation	India	^Citation34, Citation180, Citation227, Citation278
	Does not regulate plant products if no foreign DNA present (SDN1 gene edits)	Israel	^Citation394, ^Citation394
	Does not regulate SDN-1 andSDN-2 edited plants. SDN-2 edited plants.	Japan	^Citation34, Citation178, Citation227, Citation279
	Insertion of 19 base pairs or less if DNA not regarded as GMO	Philippines	^Citation34, Citation178, Citation180
	Plants mutated by CRISPR that do not contain any foreign DNA sequences are exempted	Sweden	^Citation203, Citation280
	‘Precision bred’ plants now not regulated as GM	UK	^Citation394, ^Citation225
	Will not regulate, plants that could otherwise have been developed through traditional breeding techniques (namely SDN-1 and SDN-2 gene edits); but EPA will require information on safety	USA	^Citation160, Citation181, Citation185, Citation227, Citation281, Citation282
Moving toward a decision on how NBT crops are regulated	GMO definition encompasses genome editing. Discussion is ongoing.	Bangladesh	^Citation394, ^Citation180
	Safety evaluation of gene edited crops not subject to the same regulations as GMOs; but registration, seed production evaluation, seed business evaluation and processing regulated as GMOs	China	^Citation34, Citation180, Citation186
	Regional biosafety law for the Economic Community of West African States (ECOWAS) community is under revision Economic Community of West African States (ECOWAS) community is under revision	Ghana	^Citation180
	Discussion is ongoing	Indonesia	^Citation394, ^Citation34, Citation180
	Likely case-by-case: If no foreign DNA, then not regulated as GMO	Kenya	^Citation394, ^Citation178, Citation180
	Likely case-by-case: If no foreign DNA, then not regulated as GMO	Nigeria	^Citation394, ^Citation178, Citation180
	Proposal: If no foreign DNA,then not regulated as GMO then not regulated as GMO	Norway	^Citation394,
	Likely case-by-case: If no foreign DNA. then not regulated as GMO	Paraguay	^Citation5; ^Citation394,^Citation180
	Gene edits with no foreign gene only require safety evaluation	Pakistan	^Citation34, Citation180
	Under consideration	South Africa	^Citation178, Citation180
	Not regulated as GMO if no foreign DNA introduced or retained in final product	South Korea	^Citation34, Citation283
	Discussion is ongoing	Switzerland	^Citation158, Citation180
	Discussion ongoing	Taiwan	^Citation34
	Draft regulations: Minimumassessment for SDN-1 products whereas SDN-3 products are assessed rigorously assessment for SDN-1 products whereas SDN-3 products are assessed rigorously	Thailand	^Citation34
	Discussion is ongoing	UK	^Citation394,
	Likely case-by-case: If no foreign DNA. then not regulated as GMO	Uruguay	^Citation5; ^Citation394, ^Citation180
No specific gene editing regulations		Belize, Bolivia, Costa Rica, Dominican Republic, Egypt, Ethiopia, Guatemala, Malawi, Mexico, Peru, Russia, Sudan, Trinidad and Tobago, Uganda, Ukraine, Venezuela	^Citation5, Citation158, Citation180, Citation284
No specific GM regulations		Bhutan, Cambodia, East Timor, Laos, Myanmar, Nepal, North Korea, Papua New Guinea, Sri Lanka	^Citation34

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