NEW SEED AND GENE PROTECTION METHODS: MONSANTO'S POSITION

The recent issuance of the patent "Control of Plant Gene Expression" adds a new dimension to the overall public dialogue on biotechnology. The patent was issued to Delta & Pine Land Company ("D&PL") of Scott, Mississippi, and the United States Department of Agriculture. Various points of view have already been expressed regarding the technology, and each needs careful consideration before this new technology is put to use in our agricultural systems.

 Some people have responded with apprehension to news of this new technology. Among the concerns are farmers' rights, the development of new varieties, and global biological diversity. Critics have been quick to rename the patent, "terminator gene." In our view, this is misleading and a more accurate shorthand is "Gene Protector" ("GP" for short). Indeed, seed and gene-protection methods are desirable developments in biotechnology for all farmers. Thus, early criticism of the method appears to be based on a simple misunderstanding of the patent and its effect.

Although Monsanto was not involved in developing the patent, assuming Monsanto's planned acquisition of D&PL is completed within the next 12 months, Monsanto will assume the ownership interests of D&PL in the patent. As a result, several research institutes, NGOs, and the press recently have asked Monsanto for our position on the patent. This statement responds to those requests. It clarifies what the patent is, how it could be used, and what its effects would and would not be, and sets forth our position on the principles underlying the patent.

The new technology covered by the patent is complex and not ready for commercial use. The patent describes a new, theoretical technique that would, in essence, prevent the germination of seeds from genetically improved plants. Thus, seeds harvested at the end of a growing season could not be saved and re-planted the following year. The procedure described in the patent remains theoretical and has not yet been tested in practice; it may be five to seven years before it is ready for submission for any regulatory approval. In the meantime, many lab tests and field trials must be performed to test the method's viability, reliability, and safety. Once these tests are completed, the technology will only be put into commercial use after it undergoes the full review and approval of the appropriate governmental authorities.

The harvest of seeds from plants with gene protection (GP) will not germinate if planted. The idea is one seed, one plant. This approach is the same as that required for the use of hybrid seeds -- farmers that want to use GP seeds every year must buy GP seeds every year. Farmers will only continue to buy GP seeds each year if they obtain more value and economic benefit than the costs associated with the repurchase of GP seed.

Farmers who do not want to buy GP seeds may choose not to do so. These farmers can continue to use and, where appropriate, save non-GP seeds.  

The cross-pollination of plants within species occurs naturally. Plants of some species easily cross-pollinate plants of that same species. Plants of other species, such as cotton, do not cross-pollinate easily, if at all. The proper use of the GP method has the potential to eliminate the risk that a biotech-improved seed that has cross-pollinated with non-biotech-improved seeds can propagate. Thus, the GP method protects both GP and non-GP seeds.

In the event of a successful cross-pollination between a biotech-improved plant with GP and a traditional plant, the seed produced by the out-crossed plant would be sterile. The environmental impact of such a cross-pollination would therefore be extremely limited and temporary - one generation of the individual seeds cross-pollinated.  

The only seeds that are prevented from germination by the GP method are seeds produced by GP plants. This GP method will in no way prevent other seeds from germinating. Depending on their preferences and needs, farmers and growers can choose from a wider range of seeds, including traditional seeds, biotech seeds, and biotech seeds improved with the GP method.  

Developers of transgenic seed may have one more method of controlling involuntary outcrossing, protecting crop integrity and preserving global biodiversity. Some people will oppose the introduction of this technology on the theory that it represents a departure from some traditional farming practices.

WHAT IS MONSANTO'S POSITION ON GP TECHNOLOGY?

Monsanto is a firm believer in the benefits of biotechnology, both for the environment and for everyone who eats foods grown from biotech-improved seeds. We are committed to getting new plant varieties into the hands of those farmers who choose to use and benefit from modern biotechnology. Small-holder farmers can benefit as much from it as large-holder farmers. Agricultural biotechnology offers an expansion of farmer choices and options to reduce inputs, improve yields, and lower farm production costs without requiring extra machinery. It does not constrain the use of traditional farming practices, including saved seed, or the use of many other improved agricultural techniques.

Seed-protection methods (of which the GP method is one) are a key part of our overall commitment to the careful management of agricultural biotechnology. An effective and socially acceptable seed-protection method will meet the diverse interests of all concerned, including:

• provision of consistently high-quality seed;
• development of the best varieties of seeds as they are improved year after year;
• maintenance of the desirable characteristics of those varieties or strains that are grown for more than one year;
• minimization of outcrossing with related plant species;
• compliance with resistance-management programs and ensuring the viability of refuge acres; and
• protection of the inventor's/patent holder's commercial rights and research and development investment.

Thus, although it would be premature to comment on the D&PL technology before it has been thoroughly tested, Monsanto welcomes the development and responsible use of seed-protection methods in general and is in full agreement with the principles that underlie the GP technology.

An important point to remember is that choice in this area continues to belong to the farmer -- not the seed companies. Seed companies introduce new hybrid varieties to provide farmers with more choices that address special needs. A farmer who does not want the value that hybrid seed delivers has remained free to choose from other seed and agricultural practices. Monsanto anticipates that the result of seed-protection methods will be the development of more choices for farmers interested in transgenic seeds and continuation of the traditional options currently available.

The safety and environmental acceptability of seed-protection methods will be addressed by numerous laws and rules refined by governments around the world. Monsanto believes regulation of genetically-improved and seed-protected agriculture is necessary. Government's role is to create clear rules of responsible practice that all parties can understand, follow and abide. Monsanto abides by all national and local laws and rules that apply to our biotechnology research and to

our efforts to bring our products to market. In countries that currently lack sound regulations to address biotechnology and, in particular, seed-protection methods, we will continue to advocate the development of strong regulations consistent with international standards. We do not bring products to market before comprehensive tests are completed to assess safety and efficacy; there is a regulatory system in place to review and approve our products for the intended use within a country; and all regulatory approvals, as appropriate, are granted by the local governmental agencies. Further, Monsanto has been and shall continue to be a supporter of post-approval monitoring programs on the safety of its products.

 Moreover, particularly with seed-protection methods, farmers can feel comfortable that they will not use seeds improved by biotechnology unless they choose to do so. Monsanto has a strong history and commitment to product stewardship, which means that we pro-actively make efforts to ensure that our seed products are used appropriately by our customers, the farmers.

We are committed to getting new plant varieties into the hands of those farmers who choose to use and benefit from the technology. We also support clear labelling of foods improved by biotechnology, particularly when these foods have improved nutritional or other characteristics that consumers value, such as improved taste or durability. Seed-Protection Methods have the potential to add to food confidence in Europe, by helping to increase the reliability of food labelling schemes, which is in everybody's best interests. Monsanto reiterates its position of responsiveness to European labelling requirements. We recognize European consumers and food retailers want trustworthy, empirically verifiable labelling to help them select what they eat. We are cooperating accordingly and in line with evolving regulations.    In sum, we believe that seed and gene-protection methods are an important improvement in biotech farming, not only for biotech farmers but also for traditional farmers. We support the principle underlying the D&PL patent and look forward to seeing safe and practical seed-protection methods at work in the farms of the future. We also believe that these methods merit inclusion in the public dialogue currently underway about the larger issues surrounding the integration of biotechnology into global agricultural practices.