After decades of resistance and regulatory delays, genetically modified (GM) wheat has reached a pivotal stage in the United States. This article analyses HB4 drought-tolerant wheat developed by Bioceres Crop Solutions, with particular attention to its approval for cultivation by the USDA in August 2024 and the subsequent commercialisation partnership announced in September 2025 with the Colorado Wheat Research Foundation.
Two major factors continue to hinder global acceptance. First, unlike GM feed crops, wheat is a direct human food staple, which heightens consumer sensitivity and fuels opposition, particularly in Asia and the European Union. Second, HB4 is engineered to tolerate glufosinate, an herbicide classified as reproductive toxic and prohibited in the EU since 2018 under Regulation (EU) No 540/2011, raising significant concerns about public health and environmental compatibility in key export markets.
While the technology seems to offer demonstrable drought tolerance, the scientific evidence, regulatory frameworks and market dynamics examined in this study suggest that large-scale commercial planting is unlikely to occur before 2029–2030.
Introduction
The development of genetically modified wheat represents one of agriculture’s most contentious and delayed biotechnology advances. Unlike other major commodity crops such as maize, soybeans, and cotton, which achieved widespread commercial adoption of GM varieties in the 1990s, wheat has remained largely unmodified despite decades of research and development (González et al., 2023). This resistance stems from multiple factors, including consumer concerns about food safety, market access considerations, and the unique position of wheat as a direct human food crop rather than primarily an animal feed ingredient.
The landscape for GM wheat began shifting significantly in 2024 when the United States Department of Agriculture – Animal and Plant Health Inspection Service (USDA-APHIS) approved HB4 drought-tolerant wheat for cultivation in the United States, marking a potential turning point for the industry (DTN, 2025). This regulatory milestone was followed by a crucial commercial development on September 23rd, 2025, when Bioceres Crop Solutions announced a strategic partnership with the Colorado Wheat Research Foundation (CWRF), establishing a clear pathway for technology commercialisation in the US market (Grainews.ca, 2025).
Background and historical context
Previous attempts at GM wheat commercialisation
The history of GM wheat commercialisation attempts provides crucial context for understanding current developments. In the early 2000s, Monsanto Company developed Roundup Ready wheat (MON 71800), engineered for glyphosate herbicide tolerance (GLP, 2025). Despite receiving FDA approval for food and feed use, the product faced significant opposition from wheat growers and international buyers who threatened boycotts.
The unexpected discovery of unauthorised GM wheat plants in Oregon fields in 2013 further complicated matters, leading to temporary export suspensions by Japan and other key markets (USDA, 2013).
These early setbacks created what researchers describe as a ‘chilling effect‘ on private research and development investments in GM wheat technology (van Henten et al., 2024). The wheat industry subsequently adopted stringent principles for biotechnology commercialisation, requiring broad market acceptance and regulatory approval in major importing countries before any GM varieties could be commercialised.
The development of HB4 technology
The HB4 wheat technology traces its origins to 2004, when Dr Raquel Chan’s research team at the Instituto de Agrobiotecnología del Litoral de la Universidad Nacional del Litoral in Argentina, in collaboration with CONICET, patented the genetic construct that would become IND-ØØ412-7 (González et al., 2023).
Bioceres Crop Solutions was established in Argentina in 2019 specifically to commercialise the HB4 trait for both wheat and soybeans (Grainews.ca, 2025).
The transgenic wheat incorporates a drought-tolerant gene derived from sunflowers and also exhibits tolerance to glufosinate, a reproductive toxic herbicide prohibited in the EU since 2018 under Regulation (EU) No 540/2011.
Recent developments: the CWRF partnership
Strategic commercialisation agreement
On September 23rd, 2025, Bioceres Crop Solutions announced a pivotal strategic collaboration with the Colorado Wheat Research Foundation (CWRF), marking a significant advancement in HB4 wheat commercialisation efforts (Grainews.ca, 2025). Under this agreement, Bioceres granted CWRF ‘exclusive, sublicensable rights‘ to the HB4 trait in the U.S. territory, positioning the foundation as the trait manager responsible for facilitating access to third-party breeding programmes and commercial channels.
This partnership represents what CWRF Executive Director Brad Erker described as ‘an important milestone‘ for the wheat industry and sets the stage for long-term innovation in this important crop (Grainews.ca, 2025). The collaboration combines Bioceres’ proprietary technology with CWRF’s established leadership in US wheat innovation, creating what the companies characterise as a ‘next generation wheat production system’.
Open licensing model and industry Access
A particularly significant aspect of the CWRF partnership is the commitment to making HB4 technology available through an open licensing model. This approach ensures that both public and private wheat breeding programmes across the United States can access the drought and glufosinate-tolerant trait, promoting widespread adoption while maintaining competitive breeding environments.
The HB4 wheat technology
Mechanism of action
HB4 wheat contains two key genetic modifications: the HaHB4 gene from sunflower, which confers drought tolerance, and the bar gene from Streptomyces hygroscopicus, which provides glufosinate herbicide resistance (Zonneveld et al., 2019). The bar gene encodes the enzyme phosphinothricin N-acetyltransferase (PAT), which inactivates glufosinate (phosphinothricin) by acetylating it, thereby allowing the wheat plants to survive herbicide applications for weed control while non-GM weeds are eliminated.
The HaHB4 protein functions as a transcription factor belonging to the homeodomain-leucine zipper family, regulating the expression of hundreds of genes involved in stress response and delaying plant senescence under drought conditions. The drought tolerance mechanism operates by enabling plants to maintain biomass accumulation during water stress periods whilst waiting for normal water availability to return (ISAAA, 2019).
Field performance data
Extensive field testing conducted across 37 diverse environments over nine years in Argentina demonstrated significant performance benefits for HB4 wheat (Journal of Experimental Botany, 2019). The transgenic line showed a 6% overall yield advantage (P<0.001) compared to non-modified controls, with this benefit increasing to 16% under stress conditions.
Water use efficiency improvements of 9.4% (P<0.02) were also documented, attributed to an 8% improvement in grain number per square metre. These results suggest that HB4 technology may successfully address the historical challenge of developing drought tolerance without compromising yield potential under normal growing conditions.
Regulatory approval and commercialisation pathway
United States regulatory status
The regulatory pathway for HB4 wheat in the United States involved multiple agencies and phases. The Food and Drug Administration (FDA) completed its voluntary consultation process in June 2022, concluding that products derived from HB4 wheat are as safe for human and animal consumption as conventional wheat varieties (World Grain, 2024). This safety assessment encompassed detailed compositional analyses demonstrating nutritional equivalence between GM and conventional wheat.
The USDA-APHIS approval announced in August 2024 represented the final major regulatory hurdle for cultivation approval (USDA, 2024). The agency determined that HB4 wheat poses no greater plant pest risk than conventional varieties, thereby exempting it from stringent regulations under 7 CFR part 340.
International regulatory landscape
HB4 wheat has received cultivation approval in Argentina, Brazil, and Paraguay, with these countries currently permitting commercial production (Grainews.ca, 2025). Additionally, food and feed import approvals have been granted by Australia, New Zealand, South Africa, Nigeria, Thailand, Indonesia, Colombia, and Chile (World Grain, 2025). However, critical markets for US wheat exports have not yet provided approval, creating significant commercialisation challenges.
Notably absent from the approved markets is the European Union, which maintains strict regulations on genetically modified foods, providing European Food Safety Authority (EFSA) approval processes (CBI, 2025). The EU’s regulatory framework requires comprehensive safety assessments for GM products, and HB4 wheat has not received approval for either cultivation or food/feed use.
Other major importers, including Mexico, the Philippines, Japan, and South Korea, have similarly not yet authorised HB4 wheat imports. This regulatory gap presents substantial commercialisation challenges, given that these markets collectively represent significant portions of US wheat export volume, emphasising the industry’s cautious approach to GM wheat commercialisation without broad international market acceptance.
Market acceptance and export concerns
Industry principles and market requirements
The wheat industry’s approach to the commercialisation of GM technology is governed by the ‘Wheat Industry Principles for Biotechnology Commercialisation‘, jointly developed by the National Association of Wheat Growers (NAWG, US) and US Wheat Associates (USW) in 2008. These principles require regulatory approval in major importing countries representing at least 5% of the average US wheat export volume before commercialisation can proceed (USW, 2025).
This conservative approach reflects lessons learned from previous GM crop introductions and recognises wheat’s unique position as a food grain consumed directly by humans. The industry’s commitment to these principles demonstrates awareness that premature commercialisation could jeopardise valuable export relationships built over decades.
Commercialisation timeline and challenges
Despite regulatory approval and the CWRF partnership, Peter Laudeman, Director of Trade Policy with US Wheat Associates, emphasises that ‘cultivation approval is different from commercialisation’, with American farmers unlikely to plant GM wheat until 2029, 2030, or later (Grainews.ca, 2025).
The extended timeline reflects the complexity of commercialising GM wheat, with Laudeman noting that ‘this process is likely to take three to five years or more’ (Grainews.ca, 2025). The critical bottleneck remains export market approvals.
Regional considerations and farmer perspectives
Different wheat-growing regions in the United States exhibit varying levels of enthusiasm for GM wheat adoption. Midwest hard red winter wheat states show particular interest in drought-tolerant technology, given their exposure to periodic drought stress (Capital Press, 2025). Conversely, Pacific Northwest soft white wheat producers express greater caution, recognising that their primary export markets in Asia may be more resistant to GM wheat acceptance.
A survey conducted by the Washington Grain Commission revealed mixed farmer sentiment, with producers seeking clear evidence of both performance benefits and market acceptance before committing to GM varieties (Capital Press, 2025). This cautious approach reflects farmers’ sophisticated understanding of global market dynamics and the potential consequences of market disruption.
Critical analysis and industry perspectives
Scientific evidence and performance claims
The scientific evidence supporting HB4 wheat’s drought tolerance appears substantial, notwithstanding some conflicting reports (Canal Abierto, 2022), with peer-reviewed studies indicating consistent yield advantages under stress conditions (González et al., 2020; 2023). However, critical analysis reveals several important considerations:
- Environmental specificity. Performance benefits vary significantly across environments, with the greatest advantages observed under severe drought stress. Benefits under normal growing conditions, whilst statistically significant, are more modest;
- Genetic background effects. Field testing has primarily occurred in Argentine wheat varieties, with limited data available for US wheat genetics. Performance in adapted US varieties remains to be demonstrated through extensive field trials;
- End-use quality. Questions remain regarding the impact of drought tolerance on wheat quality parameters, particularly protein content and functionality, which are critical for end-use applications.
Economic and market dynamics
The economic implications of GM wheat adoption extend beyond farm-level considerations to encompass broader market dynamics. Proponents argue that improved drought tolerance could stabilise global wheat supplies and enhance food security, particularly as climate change intensifies weather variability (NAMA, 2024). Critics contend that uniform adoption of drought-tolerant varieties could disrupt traditional market balance and potentially depress prices through increased production stability.
The segregation and identity preservation requirements for GM wheat present additional economic challenges. Unlike feed grains, wheat marketing systems must accommodate diverse end-user preferences, requiring sophisticated segregation capabilities that add costs throughout the supply chain.
Consumer acceptance and public Perception
Consumer acceptance of GM wheat remains a significant uncertainty. Survey data from Brazil suggests that approximately 70% of consumers express no concerns regarding GM wheat, indicating potential market acceptance (World Grain, 2022).
However, consumer attitudes vary significantly across regions and demographic groups, with some markets, notably the European Union, maintaining strong preferences for non-GM products.
The direct consumption of wheat in bread, pasta, and other food products creates heightened consumer awareness compared to GM feed crops.
Civil society opposition and environmental concerns
Environmental organisations and civil society groups have expressed significant opposition to GM wheat commercialisation, particularly regarding HB4 technology. In Argentina and Paraguay, civil society organisations have called for the complete suspension of HB4 wheat cultivation, citing concerns about the technology’s environmental impact and increased herbicide use (GMWatch, 2025).
These groups argue that the use of glufosinate ammonium, which they claim is ‘up to 14 times more toxic than glyphosate’, has increased substantially in regions where HB4 crops are cultivated.
Environmental advocacy groups have raised broader concerns about GM wheat adoption, including potential impacts on biodiversity, herbicide resistance development, and corporate concentration in the seed industry. Some organisations have petitioned international human rights bodies, arguing that GM wheat commercialisation violates rights to life, health, adequate food, and food sovereignty.
International implications and Canadian concerns
The advancement of GM wheat commercialisation in the United States has significant implications for other major wheat-exporting countries, particularly Canada. As the world’s third-largest wheat exporter after Russia and the European Union, Canada faces complex decisions regarding GM wheat adoption. Krista Zuzak, Director of Crop Protection and Production at Cereals Canada, emphasises that ‘market access is a critical factor for any of those new technologies and especially in Canada. We do have such a high export volume for wheat production that it’s something we’re carefully watching’ (Grainews.ca, 2025).
This cautious approach reflects the interconnected nature of global wheat markets and the potential for GM wheat adoption in one country to affect market dynamics for all exporters. Canada’s position highlights the broader challenge facing the wheat industry: balancing technological advancement with market preservation.
Future outlook and implications
Broader implications for agricultural biotechnology
The HB4 wheat approval illustrates the technical potential of GM wheat and may inform future development of traits such as disease resistance, enhanced nutrition, or improved processing characteristics. However, persistent resistance in Europe and Asia underscores a central limitation: even scientifically advanced varieties risk failing commercially if they cannot gain consumer acceptance.
Wheat’s status as a direct human food staple amplifies public scrutiny compared with feed crops, making acceptance particularly difficult. This case highlights that the trajectory of agricultural biotechnology depends not only on innovation but also on alignment with global market realities and consumer perceptions.
Interim conclusions
The approval of HB4 drought-tolerant wheat and its US commercialisation pathway mark a technological milestone, but global market barriers remain formidable. European consumers’ entrenched scepticism, strict regulations, and Asia’s cautious stance toward GM foods make widespread acceptance highly unlikely.
The glufosinate tolerance trait exacerbates health and environmental concerns, further alienating key export markets. Premature planting could jeopardise billions in US wheat exports, isolating American growers and limiting HB4’s commercial impact despite its technological promise.
Dario Dongo
Cover art copyright © 2025 Dario Dongo (AI-assisted creation)
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Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
