Bioceres Crop Solutions receives green light for cultivation of drought tolerant HB4 wheat in the United States
Rosario, Argentina (August 28, 2024) - Bioceres Crop Solutions Corp. (NASDAQ: BIOX) announced that the United States Department of Agriculture (USDA) has favorably concluded its Regulatory Status Review (RSR) for HB4 wheat technology. The announcement can be found here: https://www.aphis.usda.gov/biotech-regulatory-status/regulatory-status-review-table .
The USDA, through the Animal and Plant Health Inspection Service (APHIS), reviewed HB4 wheat and concluded that it does not pose an increased plant pest risk relative to comparator wheat plants. As such, it is not subject to regulations under the 7 CFR part 340 for organisms modified or produced through genetic engineering.
The determination clears the U.S. market for production of HB4 wheat and complements the FDA’s previously obtained favorable review for food and feed use. The United States is the fourth largest wheat producer in the world ― the largest in the Americas ― and is the fourth country in the world to greenlight production of HB4 wheat, following Argentina, Brazil and Paraguay.
Australia, New Zealand, South Africa, Nigeria, Thailand, Indonesia, Colombia, and Chile have all approved the technology for food and feed use. In Australia, an important wheat producing geography that is increasingly prone to water deficits, the company has recently received a license to undertake field trials to gather the necessary data for an eventual production application as well.
The company will provide further details on its HB4 wheat platform during its upcoming Earnings Call, to be held on Tuesday, September 10 at 8:30 a.m. EST.
About Bioceres Crop Solutions Corp.
Bioceres Crop Solutions Corp. (NASDAQ: BIOX) is a leader in the development and commercialization of productivity solutions designed to regenerate agricultural ecosystems while making crops more resilient to climate change. To do this, Bioceres’ solutions create economic incentives for farmers and other stakeholders to adopt environmentally friendlier production practices. The Company has a unique biotech platform with high-impact, patented technologies for seeds and microbial ag-inputs, as well as next generation crop nutrition and protection solutions. Through its HB4 program, the Company is bringing digital solutions to support growers’ decisions and provide end-to-end traceability for production outputs. For more information, visit here.
NAWG Statement on Deregulation of HB4 Wheat
Washington, D.C. (August 27, 2024) – The U.S. Department of Agriculture (USDA) announced that it would deregulate the HB4 drought-tolerant trait from Bioceres Crop Solutions. The National Association of Wheat Growers (NAWG) is thankful for the USDA's decision to provide a robust, science-based process that affords a pathway for the cultivation of the HB4 trait in the United States, which has the potential to benefit both farmers and consumers. Access to drought-tolerant wheat like HB4 could help with global supply challenges and further enhance the sustainability of wheat by using less water and other inputs.
“As a wheat grower who has experienced drought firsthand, it is exciting to see a regulatory pathway where drought-tolerant wheat might be available to producers in the future,” said Oklahoma wheat farmer and NAWG President Keeff Felty. “Over the past few years, wheat producers across the major wheat producing regions have had to grapple with intense drought, and continued innovations like HB4 can be a tool that helps growers protect and stabilize their yields.”
NAWG and U.S. Wheat Associates have developed and maintain their joint “Wheat Industry Principles for Biotechnology Commercialization,” which outlines how transgenic wheat traits should be commercialized to best meet the U.S. wheat industries’ needs. While USDA’s deregulation of the trait provides a pathway for the cultivation of HB4, additional steps are needed before the trait’s benefits can be realized and commercialized in the United States. NAWG will continue to engage with Bioceres on its plans for commercialization in the United States and as they seek regulatory approval for our major export markets.
“As a past Chairman of the NAWG/U.S. Wheat Joint Wheat Breeding Innovation Committee, I traveled to Argentina with other U.S. wheat industry leaders in the fall of 2023 to see HB4 in the field and have a productive dialogue with Bioceres,” said Kansas wheat farmer and NAWG Board Member Kyler Millershaski. “The HB4 trait has tremendous potential – particularly for growers in Kansas who, in 2023 had the smallest crop since 1966 because of drought. We are fortunate to have a robust regulatory process in place by which these – and future – new traits can be brought to market for the benefit of both wheat growers and consumers.”
In addition to the U.S. Food and Drug Administration acknowledging they have no further questions regarding the safety of the HB4 trait in 2022, Bioceres has received regulatory approval for food and feed use in Nigeria, Brazil, Colombia, Indonesia, and South Africa, and has applied for approval in several other countries. Farmers are currently growing wheat with the HB4 trait in Argentina and Brazil. Bioceres also plans field trials in Australia with the intent to gain regulatory approval for cultivation there.
About NAWG
NAWG is the primary policy representative in Washington D.C. for wheat growers, working to ensure a better future for America’s growers, the industry and the general public. NAWG works with a team of 20 state wheat grower organizations to benefit the wheat industry at the national level. From their offices on Capitol Hill, NAWG’s staff members are in constant contact with state association representatives, NAWG grower leaders, Members of Congress, Congressional staff members, Administration officials and the public.
U.S. Wheat Associates Statement on USDA Approval of Drought-Tolerant Wheat Trait
Arlington, VA (August 27, 2024) - U.S. Wheat Associates (USW) commends the U.S. Department of Agriculture (USDA) for its thorough, science-based process resulting in the deregulation of the HB4® drought-tolerant trait from Bioceres Crop Solutions announced on August 27, 2024. The farmer leaders of USW are confident that the HB4® trait has the potential to deliver significant producer and consumer benefits.
Although USDA’s ruling clears the regulatory pathway for cultivation of HB4® wheat in the United States, there are several additional steps needed before those benefits are realized and HB4® is grown commercially in the United States. These include the need to conduct closed-system field trials prior to commercialization. USW will continue monitoring Bioceres’ commercialization plans to ensure careful stewardship and alignment with the “Wheat Industry Principles for Biotechnology Commercialization” developed jointly with the National Association of Wheat Growers (NAWG).
“Wherever wheat is grown in the world, drought takes its toll on yields and quality, so an innovation like HB4 holds a lot of interest for growers like me,” said USW Past Chairman and Okarche, Okla., wheat grower Michael Peters. “With global demand for wheat hitting new records almost every year, there is concern about variable production. A drought-tolerant trait offers more stable, sustainable production. At the same time, it is important that customers who have specific purchase preferences understand the industry supports their ability to purchase the type of wheat they want. That remains our policy after more than 16 years.”
In line with the principles for commercialization, USW and NAWG support for HB4® and any transgenic wheat commercialization is linked to the technology company receiving regulatory approval in major importing countries that represent at least five percent of average U.S. wheat export volume.
In addition to the U.S. Food and Drug Administration accepting the safety of the HB4® trait in 2022, Bioceres has received regulatory approval for food and feed use in Nigeria, Brazil, Colombia, Indonesia, and South Africa, and has applied for approval in several other countries. Farmers are currently growing wheat with the HB4® trait in Argentina and Brazil. Bioceres also plans field trials in Australia with the intent to gain regulatory approval for cultivation there.
“Our organization has established a productive dialogue with Bioceres, and we appreciate that the company understands the importance of our joint wheat industry principles,” said USW Director of Trade Policy Peter Laudeman. “I have travelled with growers to Argentina to see HB4 wheat in the field and they were impressed by its performance. We believe the trait represents good science with positive potential to improve food security in a more sustainable way.”
Laudeman noted that beyond the announcement of the competed regulatory review, it will still take years for Bioceres to complete the additional steps needed to successfully commercialize wheat with the HB4® trait in the United States.
“There is still a lot of ground to cover with this technology and our organization will stay actively engaged in the process on behalf of our farmers and overseas customers,” Laudeman said, “We appreciate the commitment that Bioceres is making to working with its wheat industry partners to ensure robust stewardship of this technology prior to commercial release.”
More information about Bioceres, HB4®, and U.S. wheat organization positions on transgenic wheat commercialization is available at:
- Wheat Industry Principles for Biotechnology Commercialization
- Wheat Industry Biotechnology Position Statement
- Joint Statement on FDA’s Drought Tolerant HB4 Wheat Safety Conclusion
- Bioceres Crop Solutions Announces Brazil’s Regulatory Approval of Drought Tolerant HB4® Wheat for Commercialization and Cultivation
- USW Discusses HB4 Wheat with Bioceres
- Genetically Modified Wheat Could Provide Drought Relief
PNW wheat commissions statement on APHIS approval of genetically modified wheat trait
(August 27, 2024) - The U.S. Department of Agriculture (USDA)’s Animal and Plant Health Inspection Service (APHIS) announced its decision to deregulate the drought-tolerate HB4® trait in wheat.
The wheat commissions of Idaho, Oregon, and Washington, representing Pacific Northwest (PNW) wheat producers, provided the following statement to address some of the questions that may arise from this announcement, especially from our valued customers around the world:
“The PNW wheat industry supports and encourages new technologies that increase producer profitability and will help feed the growing world population. At the same time, we remain committed to providing our customers with the quality and reliability they have come to expect from PNW wheat.
“It is important to understand that the APHIS approval process is different than commercialization. This announcement provides a pathway to future commercialization of the HB4® trait in wheat in the United States, however the scientific process is lengthy, and it is unlikely that the trait will be commercially grown or available for at least three to five years. We can still confidently say that no genetically modified (GM) wheat is currently being cultivated commercially in the United States.
“The PNW wheat industry has always been a global leader in wheat quality by focusing on the high standards for end-use characteristics driven by our export customers. PNW wheat breeding has been acutely focused on, and responsive to, the needs of our export markets. The region will continue to provide a reliable supply of high-quality grains and wheat foods that customers know and expect.”
From the U.S. Wheat Associates
“The farmer leaders of USW are confident that the HB4® trait has the potential to deliver significant producer and consumer benefits.,” wrote the U.S. Wheat Associates (USW) in a statement released earlier today. USW is the export market organization for the U.S. wheat industry. USW believes in using a science-based approach for wheat breeding technologies while meeting the specific needs of importing customers.
“Our organization has established a productive dialogue with Bioceres, and we appreciate that the company understands the importance of our joint wheat industry principles,” said USW Director of Trade Policy Peter Laudeman. “I have traveled with growers to Argentina to see HB4 wheat in the field and they were impressed by its performance. We believe the trait represents good science with positive potential to improve food security in a more sustainable way.”
U.S. Wheat Associates is supportive of science-based regulatory approval for biotechnology wheat products in the United States in line with its joint Wheat Industry Principles for Biotechnology Commercialization with the National Association of Wheat Growers.
Read the full statement from USW here.
More about HB4® wheat
HB4® wheat is a transgenic wheat trait owned and sold by the Argentine company, Bioceres Crop Solutions. The trait incorporates drought tolerance transferred through a sunflower gene. According to results reported by the company in the drought conditions experienced by Argentina in 2022, HB4® wheat demonstrated up to a 43% yield improvement in targeted environments.
Bioceres Crop Solutions applied to the USDA in September 2022 for cultivation approval. USDA’s APHIS approved the import of HB4® grain for food and feed use in 2022. Prior to today’s APHIS announcement, transgenic traits in wheat were not approved for cultivation within the U.S.
According to USW, there is no known HB4® wheat present in the United States in any capacity at this time.
The regulatory status review from APHIS can be found online here.