From: Sandy Miller Hays <shays@asrr.arsusda.gov> To: roglun@fidnet.com Subject: Plant Technology Protection System Date: Friday, August 07, 1998 10:29 AM Dear Sir or Madam: Your question about the plant Technology Protection System (TPS) was forwarded to me by the staff of the National Agricultural Library. TPS has sometimes been referred to in the media as "terminator technology." In response to your request for information, here's some background for you. On March 3, 1998, a patent was granted to the Agricultural Research Service--that's the chief research agency of the U.S. Department of Agriculture--and a company called Delta and Pine Land Co. of Scott, Miss. It's my understanding that DPL is a major producer of cottonseed. The patent covered "Control of Plant Gene Expression." The technology being patented came out of cooperative research between ARS and DPL under what is known as a Cooperative Research and Development Agreement, or CRADA. CRADAs are not an unusual factor in ARS' operations; this agency has entered into approximately 800 CRADAs with private companies since the mid-1980s. The reason for a CRADA is this: ARS is in the "business" of developing new technologies to benefit the U.S. food and fiber production system...but we're not in the business of actually making or selling a specific product. So ARS will "partner," if you will, with a particular company on a project, the idea being that if a product develops out of this research, the company would get "first crack" at a marketing license. This way all the great things that are developed in federal laboratories using taxpayers' dollars actually get turned into products for consumers, rather than just languishing on a shelf in a federal lab somewhere. At any rate, the work on "control of plant gene expression" was done under a CRADA signed in 1993 between ARS and DPL. The question being tackled was a simple one: Can you put a gene into a seed and then turn that seed on and off when you want to, rather than having to wait for Nature to turn it on and off? The answer appears to be "yes." In the particular work in question, a gene was inserted (via genetic engineering) into a seed. Then, if that seed receives a certain treatment before planting, the inserted gene is "turned on." If the seed does not receive the specific pre-planting treatment, the gene remains "turned off." To be more specific about this project, the way the gene is "turned on" is by treating the transgenic seed with tetracycline before planting that seed. If the tetracycline treatment is given, the gene in the seed is turned on. That seed can be planted and will produce a plant. That plant, in turn, will produce seed--but those second-generation seed will not germinate. However, by the same token, you can take that same transgenic seed and NOT treat it with tetracycline--just plant it in the ground without the pre-planting treatment. In that case, the inserted gene will NOT get turned on; the seed will grow a plant, the plant will produce seed, those second-generation seed can be planted and will produce a plant, those plants will produce seed....and on and on and on. The key is the pre-planting treatment--in the case of our studies, tetracycline. Tetracycline was used because we deliberately chose a substance that is NOT going to be encountered "accidentally" in Nature. We do not want to turn on the inserted gene by accident. Our studies were done first in tobacco, as a model species only. (It's my understanding that tobacco is the "guinea pig" of the plant world--very easy to work with. But ARS is NOT doing--and is not INTERESTED in doing--research on tobacco. We used tobacco as a model species ONLY.) Later tests were done in cotton, although I think only greenhouse tests have been done--not field tests. The process worked in tobacco and in cotton...so far. The $64,000 question is, of course: Why would ARS want do this research? The answer is this: There is a tremendous amount of genetic diversity available to us; we're constantly learning something new about a plant gene that confers this desirable trait or that one, such as ability to withstand drought or ability to fend off insect attacks. The tools are out there for development of some terrific new plant varieties, utilizing the genetic diversity that we now know exists. But this type of research still takes a lot of time and a lot of money...and there's not that much incentive at present for a plant breeding to company to invest a lot of dollars and scientist-hours in coming up with those terrific new varieties. Why? Because as things stand now, a plant breeding company might spend years and lots of dollars developing and patenting a new variety. They finally put it on the market. Everyone rushes out to buy the seed that first year. Everyone goes home, plants the seed, grows the resultant plants, collects the seed from those plants...and never has to go back to the plant breeding company for more seed because the people are now "growing their own." This means that, for all its time and effort and investment, the plant breeding company has managed to make good sales that first year...and that's it. It was the hope of ARS that if a seed company could see a way that it could "protect" its research investment--"copyright" their new seed, if you will--those seed companies might be significantly more interested in putting for the effort to develop the new varieties that farmers really need--like crops that can live in very dry areas or survive on poor-quality water or even worse quality soil. ARS also develops new varieties of crops...but we can't do it all. We need the efforts of plant breeding companies, too, to meet farmers' needs; it was hoped this "technology protection system" would encourage them to push harder on developing new varieties. BUT---important note: New plant varieties that come out of ARS--and probably those that come out of land-grant university systems as well--will NOT contain the "technology protection system." It is ARS' mission to serve the public and the needs of our agricultural community. As a result, farmers will still continue to have a wide choice of varieties to plant, with and without TPS. Now, to get back on track: While ARS has a CRADA with DPL, and while DPL is a co-holder of the patent with ARS, DPL still has to come to ARS to negotiate a license to market this technology. This is a very important point!! Those negotiations are in the very early stages...and as those negotiations proceed, ARS will be very vigilant in protecting the public's interests. Also, it is ARS policy that technology in which it has an ownership interest will be made widely available. Therefore, this technology will be freely available for research purposes by public and private researchers, ensuring that no one seed company will monopolize the technology. I must point out that I have not heard anyone mention use of this technology in garden-type crops--only in the very large, mainstream agricultural crops, such as cotton. And what our researchers have told me is that the system basically has to be "custom-designed" each time for each individual crop; that this is not "one-size-fits-all" technology, and there's no guarantee it will even work in all crops...and if it were to work, there's no guarantee that it would be deemed appropriate for use in all crops. We're still in very early days here on what and where and how this technology can and should be used. For example, we know it works in cotton--or at least, it seemed to work in lab tests--but the earliest that anyone expects a commercial cottonseed with this technology to be on the market is the year 2004. Even if the technology does work in a specific crop, use of this technology in individual varieties will require the approval of various regulatory agencies (ARS is NOT a regulatory agency--we're strictly a research agency). Commercial production of TPS plants--as with any genetically engineered plant--would require approval by USDA's Animal and Plant Health Inspection Service, so there's an important safeguard there; they're not going to allow a crop into the environment that might "accidentally" pose a threat to another crop. So you can rest assured that significant safeguards will be put into place before this technology pops up in a neighboring field. Also, if the technology is to be used in a food crop, that food crop must conform to the rules of the U.S. Food and Drug Administration. One of the great fears concerning transgenic plants--plants that have genes other than those given to them by Nature--is that those "transgenes" will somehow "jump" into nature. With the "technology protection system," it's virtually guaranteed that that cannot happen--because while the first-generation transgenic seeds will produce a plant, the seeds that come off that plant are sterile--so they absolutely CANNOT "spread" the transgene into other plants. I think you can safely report to your gardening friends that this is not going to pose problems for their tomato crops...or their flower crops...or their watermelon crops, for a number of reasons, starting with the fact that this is likely to be limited to massive field crop varieties that will bring in enormous quantities of income to cover the extensive costs incurred by the plant breeding company...and secondly, they have agencies like the Animal and Plant Health Inspection Service whose role it is to ensure that nothing goes into a field that could endanger other crops. I'm sorry to have given you such a long-winded answer, but I wanted you to have all the details. If you feel you need additional assistance, please feel free to call me anytime at 301-344-2415 (after Aug. 21, my telephone number will change to 301-504-1636) or you can e-mail me at shays@asrr.arsusda.gov Good luck with your gardening! Sandy Miller Hays Director of Information Agricultural Research Service U.S. Department of Agriculture Greenbelt, Maryland