An EPA decision regarding Pioneer Hi-Bred’s Optimum AcreMax is due soon (see #msg-42728428). This could be a serious short-term headache for Monsanto if the approval allows Pioneer to reduce the refuge requirement. The reason being that Pioneer might not be capacity constrained during the 2-3 year interval it will take to ramp-up SmartStax. Consequently, during this interval, Pioneer would have the refuge advantage....
AcreMax is designed to eliminate the need for a separate refuge by combining genetically modified corn seed with non-modified seed in the same bag. Pioneer has asked that the historical 20% refuge requirement be reduced for the refuge-in-a-bag formulation. A reduction to 5% is possible, but not probable; the scientific panel that reviewed this request for the EPA last spring recommended a 20% seed blend.
The basic issue in front of the EPA, as I see it, is balancing human behavior against scientfic rationale. The mixed seed approach is not as effective in preventing the development of insect resistance as is the separate refuge approach. However, separate refuges depend upon customer compliance. Dew has pointed to evidence that lack of compliance is beginning to become a problem (see #msg-43301160). If the seeds are pre-mixed by the company, then compliance is assured.
Monsanto is proposing a strategy for SmartStax compliance assurance similar to that offered by Optimum AcreMax with a scheduled submission to the EPA in December. At the 11/11/09 Biennial Investor Event, Robert Fraley, Monsanto’s Chief Technology Officer, made the following comments:
The last project I just wanted to highlight is the decision we’ve made to advance the refuge-in-a-bag to the next phase of our commercial development. So again at the Whistle Stop I spent a lot of time focusing on refuge-in-a-bag. Quick summary, we have been working on the refuge-in-a-bag technology for about 10 years both from a science perspective of bringing the multiple genes together that enables us to get the regulatory approval for refuge reduction to the manufacturing scheme on how do you mix and blend seeds appropriately so that you have exactly the right ratios in the manufacturing side and bring that science and production together. I have mentioned that we had over a 100 trials out this year. We have been able to harvest those trials, look at the data, based on that data we’ve now made the decision to move forward with the regulatory submissions.
So the news today is we are going to go forward, we will make that submission to the EPA by the end of this year and they typically will go through their normal 18 to 24-month review process to gain the final approval.
A couple of things I would highlight from our field results this year. First of all, it really confirmed one of the things we talked about this summer that in order to have refuge-in-a-bag work the refuge component needs to be at that 5% level; levels higher than 5%, there is too much of a yield penalty. So we think the key is it’s enabled by that SmartStax level of refuge reduction to be a successful product and we think that the technology has a huge opportunity for providing growers with a convenient product. The highlight of this slide is that 90% of the farmers recognize the benefit of a reduced refuge product in terms of convenience of planting and convenience of refuge management, and that’s key.
CURRENT biotechnology refuge requirements dictate that farmers plant 20% conventional or herbicide-tolerant crops. DuPont company Pioneer Hi-Bred is petitioning the Environmental Protection Agency to substantially reduce the refuge area, which would deliver more productivity and higher yields and simplify refuge compliance. At the end of February, Pioneer formally submitted papers to EPA for the industry’s first “in the bag” seed refuge system, Optimum AcreMax, to address corn rootworm protection. A single-bag option would contain a high percentage of a Pioneer-brand hybrid with Herculex XTRA (corn rootworm/ corn borer/Liberty Link) insect protection and a low percentage of a Pioneer hybrid with the Herculex I (corn borer/ Liberty Link) trait. This approach would reduce the need to plant a separate rootworm refuge and increase the number of acres planted with below-ground pest protection. All of the seeds will be glyphosate and glufosinate tolerant and treated with an insecticidal seed treatment that protects the seed from secondary below-ground insect pests. Bill Belzer, Pioneer senior marketing manager-corn, explained that the Herculex trait technology family of traits (developed by Dow AgroSciences and marketed through Pioneer) offers unique solutions. Particularly in fending off corn rootworm, an insect that requires protection on at least one-third of all corn acres, the Herculex rootworm trait is unique in how corn rootworm larvae react. Larvae nibble on roots with the Herculex CRW protection, but they don’t like the taste, so they leave the roots alone. Because the larvae don’t actually eat the treated roots, they’re unlikely to gain resistance, the main reason for refuge areas, Belzer said. Integrating non-rootwormprotected seed in the bag increases durability by allowing suspectible plants in the field that actually promote rootworm health and prevents them from forming resistant colonies,
Belzer said. Pioneer is working with EPA to offer a choice for farmers in their refuge requirements. The first option allows for farmers to plant the required corn borer refuge in a different field, as far as a half-mile away. Belzer said this would give farmers the option to continue planting the field without having to clean out the planter to plant the refuge with the conventional or herbicide- tolerant variety. The other option requires farmers to plant 80% of the field to AcreMax 1 and the 20% balance of it to Herculex RW to provide the corn borer refuge area. This gives the field 100% corn rootworm protection without giving up any acres. Belzer said this option is ideal for the heaviest zones of rootworm infestations.
EPA plans to do a scientific review of the process over the next three months, and Belzer said Pioneer expects to hear back on the specific percentage of the bag mix by the end of the spring. The number is dependent on what EPA finds in its studies, but Belzer said Pioneer’s data indicate that it will be “substantially less than the current 20%.” This year, Pioneer will also begin conducting 25 large onfarm plot tests to demonstrate how the system works in real field situations. Pending EPA approval, the new system will give producers flexibility in how to manage their farms and be the most productive. “We believe from our data and science that this is a unique way to do things and matches the strength of a trait in a way to help farmers with productivity,” he said. Pioneer plans to launch the first phase of the system, Optimum AcreMax 1 insect protection, in 2009, pending regulatory approval. In addition, because all of the traits are already approved, it will not require any additional approval for overseas customers. Beginning as soon as 2011, Pioneer plans to introduce the next generation of its integrated insect protection program, Optimum AcreMax 2 insect protection. Optimum AcreMax 2 will combine the YieldGard corn borer gene with Herculex XTRA, providing two modes of action for above-ground pests. This addition will extend the integrated refuge strategy to include corn borer and allow growers to meet all of their refuge requirements with a single product. Pending EPA approval, this approach will result in a lowlevel refuge integrated into the product mix to increase yields, simplify compliance, extend the durability of the traits and completely eliminate the need for a separate block or strip refuge. Two years ago, Pioneer started doing scientific work to back its EPA submission. Any competitors that want to introduce similar products would have to do the same, Belzer said, explaining that Pioneer will have the lead in offering the first reduced corn rootworm solution.
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