KANSAS CITY, MISSOURI, US — Despite the promise brought by US Department of Agriculture approval of Bioceres Crop Solutions’ HB4 drought-resistant wheat technology, industry stakeholders remain in a wait-and-see mode on the platform’s potential to yield the US market’s first genetically modified wheat product.

Expectations are positive but tempered, not just by the time required to develop, field-test and commercialize HB4 wheat but also possible resistance to a bioengineered core food product by a range of players, from growers, millers and food manufacturers to global and domestic trading partners, regulators and consumers.

“US Wheat has been and continues to be supportive of developing innovative technologies, including GMO wheat, that are helpful to producers and bring benefits throughout the supply chain,” said Peter Laudeman, director of trade policy at US Wheat Associates (USW). “For HB4 specifically, one thing we’ve been trying to make sure folks understand is that the regulatory approval is a big step, but that’s a distinct step from commercialization.

“Bioceres has been clear that they’re intending to move forward with the commercial track, but that’s still probably a minimum of three to five years down the road. And we’re supportive of that. We look forward to continuing to engage with the company. But in terms of timeframes, this isn’t going to be growing in a wheat field near you tomorrow. There’s just a little bit of time and process that needs to take place to get to that commercial step.”

According to Rosario, Argentina-based Bioceres, the HB4 technology — using a modified sunflower gene to enhance drought tolerance — has been shown to raise wheat yields by an average of 20% in water-limited conditions. That adaptation also favors double-cropping systems, where water management is pivotal. In addition, Bioceres said, HB4 data have shown no drag on wheat yield in high-yield conditions, meaning a crop with that trait would be productive in areas with occasional drought as well.

“US Wheat has been and continues to be supportive of developing innovative technologies, including GMO wheat, that are helpful to producers and bring benefits throughout the supply chain.” - Peter Laudeman, director of trade policy at US Wheat Associates 

The technology also has exhibited environmental benefits. Bioceres said that, under no-till practices, HB4 soy-wheat rotations result in an estimated 1,650 kgs of carbon fixed into the soil per hectare per year, versus positive emissions from conventional soy monoculture.

“With the deregulation of HB4 (wheat) for consumption here in the US, the National Association of Wheat Growers and US Wheat Associates both put out statements praising this decision to move forward and really hoping that this opens the gates for the wheat industry to continue to look at management practices so that we can continue to be competitive,” said Chandler Goule, chief executive officer of the National Association of Wheat Growers (NAWG).

“When you look at the wheat industry, the last 20 years we have continued to lose acreage every year,” he said. “A lot of that has to do with the margins that wheat has. But the other part is that corn and soy have been able to take advantage of gene technology, and they’ve been doing it since the ’80s. Twenty-five years ago, we did not have 72-day corn growing on the Canadian border, and now we do. So, as we continue to move forward, the wheat industry being able to embrace and use some of this innovation and technology that other commodities have had at their fingertips for decades is critical so that we can continue to be competitive.”

The USDA’s Animal and Plant Health Inspection Service approved the Bioceres HB4 drought-tolerant trait in wheat on Aug. 27, opening the door for cultivation in the United States. That came after US Food and Drug Administration clearance in June 2022, when the agency said it had “no further questions at this time about the safety, nutrition and regulatory compliance of human food” from HB4 wheat.

“Kansas Wheat is excited about the USDA announcement and innovations in the future for the adoption of technologies that can solve problems for crop production efficiencies, human health and nutrition, and value-added opportunities for the US wheat industry,” said Justin Gilpin, CEO of Kansas Wheat. “Wheat is front and center for food and national security. It is important that the US has the genetic tools available to ensure its long-term future and value.”

 HB4 wheat activity

HB4 wheat’s USDA approval will enable Bioceres to “move forward with nonregulated field activities for product development and commercialization,” CEO Federico Trucco said in September.

“We are already collaborating with some participants — in particular, with the Colorado Wheat Research Foundation, with whom we are developing seven materials targeting the hard red wheat footprint, both winter and spring,” he said during an earnings call. “We are also looking forward to on-board other state organizations that are active in bringing genetics for the Midwest to have a more broad approach to the HB4 opportunity for the US. Now this will not materialize for one year to the next; it will take time.”

Under a materials transfer and intellectual property agreement (MTA), the Colorado Wheat Research Foundation (CWRF) shared germplasm with Bioceres in October 2022, said Brad Erker, executive director for the CWRF, Colorado Association of Wheat Growers (CAWG) and Colorado Wheat Administrative Committee (CWAC).

“The MTA allows Bioceres to introgress the HB4 trait into CWRF germplasm, and to evaluate the commercial value of new varieties through testing, but does not allow any commercialization of varieties containing CWRF germplasm in combination with the trait,” Erker said.

Currently, no HB4 wheat is being bred or grown in the United States, and the CWRF doesn’t expect any commercial plantings to take place for several years, said Erker.

“We are in the middle of a multi-year process to breed the trait into adapted Colorado varieties — being done by Bioceres — so there are several more years before that will be completed,” he said. “All of the varieties sent to them, seven different ones, are hard red winter varieties owned by CWRF. There’s no testing occurring yet because the variety development isn’t far enough along for that yet.”

The CWRF owns a range of wheat varieties adapted to the US High Plains and Central Plains, and Colorado regularly experiences drought as abiotic stress because of its location in a 12- to 15-inch annual precipitation zone that is “highly variable” year to year, Erker said.

“Colorado wheat growers have historically demonstrated a willingness to adopt new technologies that enhance their productivity and sustainability,” he said.

The USDA employed a “thorough, science-based process” in deregulating the HB4 drought-tolerant trait for wheat, Erker said, adding that “Colorado wheat growers wish to position ourselves and the US wheat industry for validation of the HB4 trait in-country and US wheat industry acceptance of GMO wheat.”

At the same time, he noted, “Our goal is to ensure our growers have access to technologies, and that our customers have access to reliable supplies of the type of wheat they want to buy.”

 Market challenges

USW and NAWG have issued joint statements on the wheat industry’s position and principles for biotechnology use and commercialization. High on the list: Nations representing major US wheat export markets — i.e. accounting for at least 5% of normal US wheat export volume — must provide regulatory clearance for a GM trait before it can be commercialized in the United States. That will apply to HB4 wheat, USW’s Laudeman said.

“We export 50% of the wheat that we grow in the United States; our export customers are very, very important to us,” Laudeman said. “One of the key steps in bringing a commercial product forward — that US Wheat enshrines in a document called our ‘Principles for Biotechnology Commercialization’ — basically says that, before we support a commercial launch of a product in the United States, you need to seek export market approvals in all of our key export markets. So if you’re growing this wheat in the United States and it could end up in a trade channel going to one of our overseas customers, that country should have the opportunity to review and do a regulatory assessment of that product in a reasonable and effective, science-based timeframe.”

Jane DeMarchi, president of the North American Millers’ Association (NAMA), said “a lot of tough research work still needs to go on” with the HB4 wheat platform “to get that trait into varieties that can be grown successfully in the US.”

Along with field-testing of HB4 wheat varieties to “make sure they’re effective,” the global approval process will take up a chunk of the timeline for the technology to advance in the United States, she noted.

“US wheat growers have made it very clear that they want to see the biotech traits approved in their major exporting markets,” DeMarchi said. “In markets like Japan and Korea, it takes some time to work through that regulatory process. And then the millers will need to conduct their own evaluations to make sure the varieties meet their quality standards and that there’s no decrease in the quality of wheat. So there are lots of questions to be answered. That being said, the recent droughts were historically bad, and I think we need to take a close look at any type of research or technology that tries to address drought.”

Beyond performance in drought conditions, millers will expect HB4 wheat to yield flour of the same quality they get from the current wheat varieties they use.

“From a NAMA perspective, we don’t want to see anything that will change the functional characteristics of the grain compared to conventional varieties,” DeMarchi said. “That goes across any biotech trait, corn or wheat. We want to make sure the functional characteristics are the same, as well as the nutritional characteristics.”

“From a NAMA perspective, we don’t want to see anything that will change the functional characteristics of the grain compared to conventional varieties.” - Jane DeMarchi, president of NAMA

The USW-NAWG biotech principles also call for an “accurate, economical and timely trait detection test” from the trait developer before commercialization, plus “the ability of non-transgenic wheat to meet commercially recognized thresholds for the low-level presences of transgenic traits” in domestic and international markets. Wheat customers, too, must be able to “make purchases on the basis of specific traits,” their position statement said.

“The question mark remains in the marketplace,” Wheat Foods Council president Tim O’Connor said of HB4 wheat’s US prospects. “The infrastructure in the industry is going to have to be established to segregate this seed and all of the commercial wheat that’s produced from it. They’re going to have to be able to guarantee customers whatever they want.

“Those customers are going to have to have certainty that they’re getting exactly what they demand and are paying for. And I think that’s a challenge in the US grain handling industry being met by other grain classes. While most corn and soybean production are genetically modified crops, there certainly is a marketplace for those that are not, and there are buyers demanding them who need to be guaranteed they’re not getting them.”

Practices to identify and separate HB4 wheat will need to “flow all through the chain,” O’Connor said.

“There will be buyers up and down the chain who will not be concerned — it would be viewed to them as wheat — and there will be buyers who will want to know that they are not getting a genetically modified (product),” he said. “The industry is going to have to make certain that the wheat that goes to the miller, the flour that goes from the miller to the baker, and the goods from the baker that go to the next step in the chain are going to have to be handled in a way that sensitive buyers can be satisfied.”

Bioceres’ Trucco said the company already has “an effective way” to identify HB4 presence in wheat shipments via developments in Argentina with optic devices, which are “available at all points of delivery and carry almost negligible costs for HB4 detection.”

“And that will be partnered with outreach and educational programs so we can have all elements in place at the time of launch and hopefully take advantage of this opportunity in the medium term,” he said in the call. “In the short term, I think that the approval in the US also serves as a validation in our domestic market in Argentina and Brazil, where we’re currently scaling HB4 wheat. The process is always comforting to see the stamp of US regulators and the additional acceptance in other geographies as a way to mitigate some of the fears that existed early on in terms of the commercial implications around GMO wheat.”

Both DeMarchi and Gilpin said they want more details about Bioceres’ US stewardship strategy for HB4 wheat.

“Another area that we will be talking about with Bioceres is what are their plans for stewardship, both for field trials and then also once it’s commercialized to make sure that you maintain separation between conventional non-BE varieties and any of the HB4 wheat,” DeMarchi said.

“They have indicated that they have strong identity preservation systems that they’re using, but we have not reviewed those ourselves,” she added.

Gilpin said he hopes Bioceres takes a “broad approach” in working with public and private breeding companies by allowing access to the HB4 wheat trait for introgression and evaluation, though “the initial stewardship and segregation growing pains for non-GM wheat demand on companies” could be challenging.

“Other crops have already gone through this process that the US wheat industry will be able to use as blueprints for success,” he said.

 Ongoing process

The wheat commissions of Idaho, Oregon and Washington — representing Pacific Northwest wheat (PNW) producers — said USDA deregulation of HB4 wheat “provides a pathway to future commercialization of the HB4 trait in wheat in the United States” but noted that “the scientific process is lengthy,” making US commercial cultivation or availability unlikely for at least three to five years.

“The PNW wheat industry supports and encourages new technologies that increase producer profitability and will help feed the growing world population,” PNW said in a statement after the USDA announced its HB4 wheat approval. “At the same time, we remain committed to providing our customers with the quality and reliability they have come to expect from PNW wheat.

“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.”

The balance between sustainability benefits and bioengineering concerns stands as the key marketplace “unknown” for HB4 wheat, said O’Connor.

“HB4 probably will be a bit more sustainable from a production standpoint,” he said. “The yield per acre against a set of input costs and/or environmental scoring might be more positive because it’s able to perform better in the situation of extreme drought conditions. But then the offset might be, ‘Well, is there enough demand for it that it will come through the marketplace as a winner, or will there be minimal demand for it?’ Yes, you can grow it successfully, but is it going to sit in a bin looking for a buyer?”