In recent years, many of the leading agbiotech and agrochemical companies-Monsanto, DuPont and Dow, among others - as well as a considerable number of smaller, more specialized companies, have begun developing plant-based systems for pharmaceutical and chemical production. A number of vaccine components and monoclonal antibodies have been produced by tobacco, potato and corn plants on an experimental basis, and several of these products have begun clinical trials. One company, the Texas-based ProdiGene, has been collaborating with Stauffer Seeds to produce eleven different proteins in genetically engineered plants on a commercial scale. This represents a significant new development in plant biotechnology, and one that has heretofore escaped public scrutiny.

These new "bioreactor" crops present many of the same potential environmental problems as other genetically engineered crop varieties, particularly if they are to be grown outdoors on a large scale. Most noteworthy are problems of cross-pollination, and unknown deleterious effects on insects, soil microbes and other native organisms. Further, we may soon see biologically active enzymes and pharmaceuticals, usually only found in nature in minute quantities-and usually biochemically sequestered in very specialized regions of living tissues and cells-secreted by plant tissues on a massive commercial scale. The consequences may be even more difficult to detect and measure than those associated with more familiar GM crop varieties, and could escalate to the point where those now-familiar problems would begin to pale by comparison.

This new technology also has potential public health consequences. As commercial grain distributors have proved unable to reliably sequester such a relatively well-characterized product as Aventis' Starlink corn, what steps could be reliably taken to prevent the accidental commingling of crops engineered for chemical production into the rest of the food supply? Proponents of this technology in the U.K. have already proposed ameliorating the high cost of purifying specific proteins from plants with income obtained by extracting food products such as oils, starches and flours.(3)

The Rationale: Why use plants to manufacture proteins?

Proteins make up at least 50 percent of the dry weight of living cells, and are fundamental to all aspects of cellular structure and function, from providing structural integrity, to regulating biochemical reactions, including the processes underlying the expression of genes. As our understanding of protein function has increased, many industries have found commercial uses for proteins that are known to mediate specific functions in living cells. Enzymes- proteins that catalyze chemical reactions-are used in a wide array of industrial processes, and numerous proteins that perform specialized regulatory functions are now commonly used as pharmaceuticals.

Making proteins available for use outside living cells has often proved problematic, however. Manufacturers have continually sought the most efficient and reliable ways to extract these highly specialized products from their natural sources. Many of these substances only exist in particular living tissues, and those with the most specialized biological functions can only be found in minuscule quantities, often only under very exacting biochemical conditions. The extraction of many known proteins, whether for commercial or research purposes, has proved a daunting task. Molecular biology and genetic engineering have considerably expanded the range of available means to isolate usable quantities of specific proteins.

First, the amino acid sequences of many useful proteins have been discovered, sometimes making it possible to synthesize the protein in the laboratory. Increased understanding of metabolic regulation has made it possible in some instances to induce higher rates of production of specific proteins in cultured cell lines, and methods of extraction and purification have also improved dramatically. More recently, genetic technologies such as Polymerase Chain Reaction (PCR) have made it possible to isolate the DNA sequence that codes for a particular protein, reproduce many copies of that sequence and ultimately produce considerably larger quantities of particular proteins than are found in any unaltered biological context.

E. coli bacteria, with their very well-characterized processes of gene expression and regulation, were the first living cells to be mobilized for this purpose. Human proteins such as growth hormone and insulin, and products such as recombinant bovine growth hormone (rBGH) are manufactured in this way. Companies such as Genzyme in Massachusetts and PPL Therapeutics in Edinburgh are splicing genes for proteins that act as as protease inhibitors into the embryonic cells of sheep and other livestock, and attempting to purify these proteins from milk when the animals reach maturity. Other companies are experimenting with genetically engineered chickens, hoping to extract pharmaceuticals from their egg whites.(4) But animals present significant technical, economic and ethical problems.

Product yields are often very low, production is expensive, and there is a significant risk of contamination with pathogenic viruses or prions. As the success rates for animal genetic engineering are exceedingly low, researchers are focusing on the mass production of clones of successful "bioreactor" animals. This raises difficult ethical issues that will likely become much more pronounced if this technology ever becomes commercially viable. But experimenters still prefer animal cells and bacteria for producing animal proteins, as plant cells often add unique sugar moieties (a process known as glycosylation) and other factors to newly synthesized proteins. These complicating effects render proteins significantly less usable, especially for pharmaceutical applications, as they may render proteins allergenic and otherwise alter their biological activity.(5)

Recent advances in plant genetic engineering have raised the possibility of producing pharmaceuticals and other human and animal-derived proteins in plants. Researchers, working mostly in commercial laboratories, have in recent years engineered plants to produce vaccines, tissue-specific (monoclonal) antibodies, and a wide array of animal-derived enzymes, blood factors, neurologically active agents, and other useful proteins. One company, the Texas-based ProdiGene, is collaborating with Stauffer Seeds (a spin-off of Stauffer Chemical, and formerly a division of Novartis) to produce ten specific proteins in genetically engineered field corn, including vaccines, enzymes and a new protein-based sweetener. Extracting proteins from corn kernels may alleviate problems of product storage, shipment and purification that often arise with bacterial and animal models. Other companies are using tobacco and potato plants as their experimental "bioreactors," and one Virginia-based company (CropTech) advertises this technology as the saving grace for struggling tobacco farmers.(6)

It remains to be seen whether any compelling technological or clinical advantage will be obtained from these products. However, the biotechnology industry's public relations needs are readily apparent. In the November 2000 issue of Nature Biotechnology, Julian Ma of Guy's Hospital in London writes: "Indeed it is to be hoped that the eventual market release and safety evidence from GM plant vaccines might allay many of the safety concerns surrounding GM foods."(7)

The Problems: What is wrong with this picture?

Critics of genetic engineering have raised numerous concerns about the environmental consequences of large-scale production of GM crops. An increasing number of peer reviewed studies has validated concerns about cross-pollination of related crops and wild relatives, damaging effects on non-target populations of insects and arthropods, soil contamination via the secretion of transgene products from plant roots, and alterations in the populations and behavior of soil microbes, to name just a few of the impacts.(8)

The Starlink corn scandal in the United States raises the further question of whether crops engineered to produce industrial chemicals and pharmaceuticals can be successfully isolated from the food supply. While Aventis quickly attempted to recall stocks of Starlink corn, it is clear that farmers and grain silos had already commingled this potentially allergenic corn with much larger quantities of approved varieties, as well as with non-GMO corn. There is growing evidence that the particular variety of Bt toxin that is expressed in Starlink may be allergenic to humans, but in the case of plants that contain pharmaceuticals and other animal and viral proteins, the consequences may be much more severe.

The introduction into the food supply of byproducts from these new generation GM crops may indeed prove crucial to the commercial success of this technology, as the cost of purifying proteins from plant tissues is often quite prohibitive. Glynis Giddings and colleagues, from the Institute of Biological Sciences at the University of Wales, recently reviewed the purported benefits of GM plant-derived pharmaceuticals in the journal Nature Biotechnology, and discussed ways of overcoming difficulties with extraction and purification:

Tony Laos, president of Stauffer Seeds, the company that has pioneered the commercialization of this technology, told a reporter that "The actual grain becomes a by-product in the protein production," further suggesting that such products will inevitably find their way into the food supply.(10)

The problem of soil contamination has already been documented in the case of Bt toxin.(11) In this case, biologically active quantities of the active bacterial toxin were found in soil samples for more than 9 months after the GM plant was harvested. In the next generation of GM plants, there are plans to take commercial advantage of this phenomenon, a technique that has been termed rhizosecretion:

Rhizosecretion is being touted as an economical alternative to the chemical extraction of biologically active compounds.(13) If this is indeed a viable possibility, how will contamination of agricultural soils by a widening array of GM plant varieties be adequately controlled?

While many companies that are active in this field suggest that these specialized GM crops will be contained in greenhouses, or hand-harvested before pollination, it is clear that for many products, successful implementation of this technology will require very large-scale outdoor plots. For example Carole Cramer of Virginia Polytechnic Institute, the founder of CropTech, told a reporter from Farm Progress that for some proteins, thousands or even hundreds of thousands of acres, planted at densities (in the case of transgenic tobacco) of 50,000 to 100,000 plants per acre, would be needed to supply the current market for these products.(14) Indeed it has been suggested that plant cell cultures will continue to be more cost effective for producing smaller batches of more specialized proteins,(15) raising the question of whether whole plants may only be useful for larger-scale production.

Concerns about the public health and environmental consequences of these crops are exacerbated by their wide range of very high-level biological activities. Products being actively researched for plant-based production include blood coagulants, proteases and protease inhibitors, growth promoters, neurologically active proteins, and enzymes that modify the structure and function of other biologically important compounds, as well as monoclonal antibodies and viral surface proteins potentially useful for vaccination. Large scale releases of antibodies and viral antigens may trigger unexpected allergic or autoimmune reactions in some people. Further, the purported benefits of plant-produced vaccines are cast in doubt by the well-documented phenomenon of oral tolerance: a concerted loss in vaccine efficacy that often follows the administration of antigens through a mucous membrane.(16) Substances such as cholera toxin are often used as cofactors (adjuvants) to increase the effectiveness of oral vaccines.(17) Contamination of pharmaceuticals with pesticide residues has also been identified as a significant problem for manufacturers.(18)

The active collaboration between ProdiGene and Stauffer Seeds has already brought several products of this technology to market, and their products serve to highlight the potential hazards of plants engineered to produce commercial proteins. Stauffer is actively contracting with farmers to grow corn containing the genes for three or four enzymes, three vaccines, a protein-based sweetener, a proprietary "Therapeutic Agent," and two other biologically active chemicals.(19) Three of their products, avidin, beta-glucuronidase and aprotinin (a protease inhibitor commonly used by surgeons), have been produced in sufficient quantities to be sold through a commercial supplier, the St. Louis based Sigma Chemical Company.(20) Avidin is a protein that occurs naturally in raw egg whites. While Sigma markets it for use in medical diagnostic kits, it is also used as an insect growth inhibitor and is being investigated as a next-generation biopesticide.(21) Avidin binds to biotin, an important B-vitamin, and prevents its absorption across the intestinal mucosa.(22) It causes a type of vitamin B deficiency in some people who consume raw egg whites.(23)

There are contradictory reports as to whether beta-glucuronidase from plant "bioreactors" is still being marketed by Stauffer, but it appears to have been available in this form for a number of years. This enzyme reverses a biochemical reaction that helps render irritant molecules soluble. This added solubility helps to facilitate the detoxification and elimination of compounds as diverse as hormones, antibiotics and opiates. In the presence of this enzyme, potential toxins are freed from the molecular complex that enables their proper excretion. One can only speculate on the consequences of elevated levels of such compounds being released into the open environment.

Stauffer's professed goal is to maximize production of these and other compounds via both foreign and domestic production of transgenic corn, allowing for three growing cycles per year. According to their web site, production is currently taking place in South America, the South Pacific, and the Caribbean, as well as within the continental U.S.(24) As South America is a center of biodiversity for maize, the potential for severe disruptions of indigenous wild relatives may be quite severe; Stauffer and their allies have yet to announce any biosafety studies intended to better understand the consequences.

Companies and Products - A Brief Summary

Below is a partial listing of key companies currently involved in this technology and some of their products:

ProdiGene/StaufferSeeds (www.prodigene.com, www.staufferseeds.com)

Avidin, Aprotinin, Beta-glucuronidase, Trypsin, "Enzyme No. 1" (identity is labeled 'confidential'), Laccase, TGEV (Transmissible Gastroenteritis Virus vaccine for swine), Hepatitis B Vaccine (human), LtB (human E. coli vaccine), "Therapeutic Product No. 1" (also labeled 'confidential'), Brazzein (a protein sweetener of West African origin). Preferred crop: field corn.

CropTech (www.croptech.com)

Human lysosomal proteins (glucocerebrosidase, iduronidase), human serum albumin, urokinase, sIGA/G (secretory monoclonal antibody hybrid), bacterial enterotoxins, hepatitis B virus surface antigen, Norwalk virus capsid protein, human insulin, glycoproteins. Preferred crop: tobacco. Several clinical trials are in progress. Solicits contracts with pharmaceutical companies for small-scale (non-field) production. Developing techniques to make plant-derived pharmaceuticals more compatible with human cells.(25) EPIcyte (San Diego, CA.)

Partnered with Dow Chemical to develop and produce monoclonal antibodies in plants. Five antibody products in development, using technology licensed from Scripps Research Institute. Working to develop plant-produced topical microbicides against HIV and herpes and a topical contraceptive. Goal is to produce 10,000 kg annually of plant-derived monoclonals.(26) In an independent effort, Dow is also working on a corn-derived "natural" plastic.(27)

Integrated Protein Technologies (Monsanto subsidiary, www.iptbio.com)

This subsidiary of Monsanto seeks to contract with various clients to produce commercial quantities of proteins in corn, tobacco and soybean plants. Promise capability of producing several metric tons of any appropriate protein within three years. Eight current projects focus on monoclonal antibody production, including a collaboration with Bristol-Myers Squibb; also industrial enzymes, pharmaceutical proteins and vaccines.(28) Uses purification technology from ProMetic BioSciences, via a collaborative agreement. Monsanto's DeKalb division is also working on corn that produces poultry interferon as a possible antiviral,(29) and the parent company has been involved in efforts to produce a polymer plastic called Biopol from wheat sugar.(30) Monsanto's Agracetus division (Middleton, WI) is also involved in this technology.

Planet Biotechnology (Mountain View, CA.)

Seeking to commericalize technique developed at Guy's Hospital Dental School in London to use plant-produced secretory antibodies to prevent tooth decay. Antibodies against Streptococcus mutans are produced in tobacco and corn, and clinical trials suggest a potential for medium-term protection against dental caries.(31) Developing antibody-based therapeutics for "infectious diseases and toxic conditions affecting oral, respiratory, gastrointestinal, genital and urinary mucosal surfaces and the skin."(32) Therapies for intestinal pathogens including hepatitis virus, Helicobacter pylori, enterotoxigenic E. coli, and cholera.

Meristem Therapeutics (www.meristem-therapeutics.com)

An independent spin-off from the French seed giant Limagrain, with US headquarters in San Francisco. Primarily engaged in contract production, with products including human hemoglobin, lactoferrin, laboratory techniques for controlling glycosylation. Tobacco is their primary vehicle.

Large Scale Biology Corp. (Rockville, MD., www.lsbc.com)

Enzymes, cytokines, human and veterinary prototype vaccines, produced in tobacco plants. Developing a patient-specific non-Hodgkins lymphoma vaccine. Collaboration with Dow in functional genomics; company VP for genomics is a former Monsanto plant molecular biologist.

Other significant players include Protein Technologies, Inc. (a division of DuPont), Cornell University's Boyce Thompson Institute for Plant Research, SemBioSys (Calgary, Canada), Battelle Laboratories (Columbus, Ohio and Richland, Washington), and Applied Phytologics (Sacramento, California).

Notes:

1. Union of Concerned Scientists, "Foods on the Market: Genetically engineered crops allowed in the US food supply," revised June 2001, at www.ucsusa.org

2. For a critical analysis of biopolymer production from an industry insider, see T. U. Gerngross, "Can biotechnology move us toward a sustainable society?" Nature Biotechnology, Vol. 17, June 1999, pp. 541-3.

3. For a critical analysis of biopolymer production from an industry insider, see T. U. Gerngross, "Can biotechnology move us toward a sustainable society?" Nature Biotechnology, Vol. 17, June 1999, pp. 541-3.

4. "Biopharma technologies converge downstream," Chemical and Engineering News, July 31, 2000, p. 18; also "Genetic engineering is producing designer eggs that can fit into new niche markets and bring in bigger profit margins," Feedstuffs Vol. 71, No. 3, January 18, 1999, p. 18.

5. P. M. Doran, "Foreign protein production in plant tissue cultures," Current Opinion in Biotechnology, Vol. 11, 2000, pp. 199-204.

6. W. Harr, "Transgenic tobacco: Producing human protein from tobacco could open new markets for growers," Farm Progress, November 1998, available at www.croptech.com/transgenic%20tobacco%20FP%2011%2098.htm

7. J. K-C. Ma, "Genes, greens and vaccines," Nature Biotechnology, November 2000, p. 1142

8. For a comprehensive review of these effects and their scientific documentation, see Ricarda Steinbrecher, "Ecological Consequences of Genetic Engineering," in Brian Tokar, ed., Redesigning Life? The Worldwide Challenge to Genetic Engineering, London: Zed Books, 2001, pp. 75-102.

9. G. Giddings, et al., 2000, op. cit.

10. S. Vacek, "Hybrids of Ag Companies Create New Grain Paradigm," at
    www.sarahvacek.com/media/Amvalue-added.htm

11. D. Saxena, et al., "Insecticidal toxin in root exudates from Bt corn," Nature, Vol. 402, 1999, p. 480.

12. E. E. Hood and J. M. Jilka, "Plant-based production of xenogenic proteins," ProdiGene, Inc., 1999, at www.prodigene.com/publications/99-10-01_plant_based_2.html

13. "Alternative Agriculture: Molecular Approaches to Produce Recombinant Proteins and to Isolate Novel Compounds," June 8, 1999.

14. W. Harr, 1998, op. cit.

15. P. M. Doran, 2000, op. cit.

16. J.K-C. Ma, 2000, op. cit.; H. S. Mason and C. J. Arntzen, "Transgenic plants as vaccine production systems," CropTech 2000; also Joe Cummins, "Edible Vaccines," Third World Resurgence, No. 127/128, March/April 2001, pp. 36-37.

17. J. K-C. Ma, ibid.

18. Utah State University Biotechnology Center, "Biotechnology in the News: Plants as Factories," March 3, 1999, at www.usu.edu/~biotech/extnews/extnew25.html

19. StaufferSeeds Product Descriptions, at www.staufferseeds.com/0404prod.htm

20. "Sigma Chemical Co. and ProdiGene Inc. Launch First Protein Products from Transgenic Plants," ProdiGene, Inc. press release, June 10, 1997, at www.prodigene.com/news_releases/97-06-10_Sigma.html; J. Olson, "Rural Pharmaceutical Grower Inc.," Farm Industry News, Mid-March 2000, at www.staufferseeds.com/0702rural.htm; see also E. E. Hood, et al., "Molecular farming of industrial proteins from transgenic maize," in F. Shahidi, et al., eds., Chemicals via Higher Plant Bioengineering, New York: Plenum Publishers, 1999, pp. 127-147.

21. L. McGraw, "Avidin: An Egg-Citing Insecticidal Protein in Corn," Agricultural Research, August 2000, at www.ars.usda.gov/

22. "Avidin: Chicken Egg White," in Calzyme Laboratories catalog, at
    www.calzyme.com/catalog/avidin.html; "Avidin," in Worthington Biochemicals catalog, at www.worthington-biochem.com/manual/A/AV.html

23. "Glucuronidase, Beta," in Worthington Biochemicals catalog, at
    www.worthington-biochem.com/priceList/G/GlucuronidaseB.html; Norbert Hoffmann, "The Ubiquitous Co-Enzyme UDPGlucuronic Acid," at www.kombu.de/glucuron.htm

24. "Glucuronidase, Beta," in Worthington Biochemicals catalog, at
    www.worthington-biochem.com/priceList/G/GlucuronidaseB.html; Norbert Hoffmann, "The Ubiquitous Co-Enzyme UDPGlucuronic Acid," at www.kombu.de/glucuron.htm

25. C. Cramer, "Plant Biotechnology and Molecular 'Pharming'," Virginia Technical University, 1998, at www.biotech.vt.edu/outreach/biotech-times/5_98/pharming.html

26. C. Potera, "Harvesting Secretory Monoclonal Antibodies from Plants," American Society for Microbiology, 1999.

27. "A New Crop of Transgenic Plant Technologies: Agbiotech Firms Adopt Collaborative Strategies for Success," Genetic Engineering News, Vol. 20, No. 4, February 15, 2000.

28. Utah State University Biotechnology Center, 1999, op. cit.

29. J. Olson, "Seed companies improve the nutritional value of feed corn," Farm Industry News, April 1999, at www.staufferseeds.com/0704feed.htm

30. op. cit. 24.

31. "Planet Biotechnology Begins U.S. Clinical Trial for Treatment Against Cause of Tooth Decay," PR Newswire, November 3, 1998

32. "Planet Biotechnology Inc., "Published Study Shows Positive Results for Vaccine Against Cause of Tooth Decay," Press release, April 28, 1998, at www8.techmall.com/techdocs/TS980428-8.html

The Edmonds Institute
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Edmonds, Washington 98020 USA
email: beb@igc.org
website: http://www.edmonds-institute.org

Concerns Over Pharmaceutical Traits In Grains And Oilseeds

Dirk E. Maier, Agricultural & Biological Engineering
Grain Quality
Purdue University
Fact Sheet #47
July 2, 2002

An April 10 Reuters press release (www.reuters.com) indicates that a biotechnology company, ProdiGene =AE , College Station, TX (www.prodigene.com), through a grant from the National Institutes of Health (NIH), has produced a transgenic corn variety that contains a protein found on the surface of HIV, the virus that causes AIDS. The company's intent is to utilize such corn in the future as an oral delivery system for an AIDS vaccine, through corn-based products such as breakfast cereals. This transgenic corn variety apparently has been grown on enough acres already to produce sufficient quantities of grain to begin animal studies during the summer of 2002, to determine whether ingestion of this corn elicits an immune response.

Five other transgenic corn hybrids from Prodigene =AE have been released commercially via Stauffer Seeds =AE , Omaha, NE (www.StaufferSeeds .com), and have been grown by a select group of farmers on a few hundred acres primarily in the western Corn Belt, much of it in western Iowa and on irrigated acres in Nebraska. These hybrids contain: Aprotinin - a protease inhibitor that is used in medical applications to control blood loss during surgery and in non-medical applications as a cell culture reagent.

Avidin - a protein that binds with biotin to make useful products for the medical and biochemical diagnostics industry and has application in protein purification.

Laccase - an industrial enzyme used for adhesives in the manufacturing of medium density fiberboard (MDF) as well as in the detergent industry as an environmentally friendly "bio-bleach."

Brazzein - a low calorie, intense natural sweetener 2000 times sweeter than sucrose.

Trypsin - a protease enzyme that has many uses including as an intermediate in pharmaceutical manufacturing and in the leather tanning and detergent industries.

Additional protein-based drugs and industrial compounds produced from genetically modified (GM) field crops are currently under development by several companies and are expected to be ready for commercial release approval within a few years.

Examples include:

A topically-applied antibody from Epicyte Pharmaceutical Inc., San Diego, CA (www.epicyte .com), that prevents the transmission of herpes simplex virus (HSV) 1 and 2, topical contraceptive microbicides and preventives for pulmonary infection due to Respiratory Syncytial Virus (RSV) and Clostridium difficile-associated diarrhea.

Antibodies for therapeutic blood products from Monsanto's Integrated Protein Technologies, St. Louis, MO (www.iptbio.com).

Prodigene's oral vaccine products including hepatitis-B vaccine, Lt-B vaccine to treat E. coli in humans, TGEV vaccine to treat the transmissible gastroenteritis virus that kills thousands of piglets every year, and additional confidential animal vaccines and human health products under development with such partners as Eli Lilly and Avant Immunotherapeutics. Various seed companies that are partnering with biotechnology firms are already recruiting farmers, and in some instances crop acres have been acquired by foreign biotechnolgy companies such as Meristem Therapeutics Inc., Clermont-Ferrand, France (www.meristem-therapeutics.com), for experimental testing on private farmland throughout the midwestern Corn Belt.

The complete document is available at:
http://www.agcom.purdue.edu/AgCom/Pubs/GQ/GQ-47.pdf

GM Corn Set To Stop Man Spreading His Seed

Robin McKie, science editor
The Observer
September 9, 2001

Scientists have created the ultimate GM crop: contraceptive corn. Waiving fields of maize may one day save the world from overpopulation. The pregnancy prevention plants are the handiwork of the San Diego biotechnology company Epicyte, where researchers have discovered a rare class of human antibodies that attack sperm.

By isolating the genes that regulate the manufacture of these antibodies, and by putting them in corn plants, the company has created tiny horticultural factories that make contraceptives.

'We have a hothouse filled with corn plants that make anti-sperm antibodies,' said Epicyte president Mitch Hein.

'We have also created corn plants that make antibodies against the herpes virus, so we should be able to make a plant-based jelly that not only prevents pregnancy but also blocks the spread of sexual disease.'

Contraceptive corn is based on research on the rare condition, immune infertility, in which a woman makes antibodies that attack sperm.

'Essentially, the antibodies are attracted to surface receptors on the sperm,' said Hein. 'They latch on and make each sperm so heavy it cannot move forward. It just shakes about as if it was doing the lambada.'

Normally, biologists use bacteria to grow human proteins. However, Epicyte decided to use corn because plants have cellular structures that are much more like those of humans, making them easier to manipulate.

The company, which says it will not grow the maize near other crops, says it plans to launch clinical trials of the corn in a few months.

Pharm Rice Found In Open Field Test

For Immediate Release
September 6, 2001, 5:25 PM
Contact:  Greenpeace USA
Greenpeace Media Department: (202) 319-2461

SUTTER COUNTY, CALIFORNIA - September 6 - Holding a large banner reading, "This Rice is a Drug, Stop Genetically Engineered Food," Greenpeace activists today for the first time exposed the location of a crop that is genetically engineered to produce human proteins for drug production. While other engineered crops are intended for human food, this pharmaceutical rice produces the human proteins lactoferrin and lysozyme meant for use in drugs. Wearing biohazard suits and marking the field with giant syringes, the protesters warned that open-air field trials of genetically engineered (GE) pharmaceutical crops pose unacceptable risks to the food supply and the environment.

"Finding animal feed in our corn was bad enough, but now we may have to worry about unknown drugs in our rice," said Jeanne Merrill, a Greenpeace genetic engineering campaigner. "This corporate food pollution has to stop before all our food is genetically contaminated."

Greenpeace has delivered a letter to the California Department of Food and Agriculture (CDFA) calling on it to remove the pharmaceutical rice and revoke all permits for field testing of drug-producing crops. Both the California Rice Commission and the Farmers' Rice Cooperative have recently adopted policies to segregate GE and non-GE rice. Industry insiders doubt that purity can be assured given the many potential points for contamination along the path from airplane seeding of fields to the final milling process. A pharmaceutical crop that cross-pollinates or otherwise pollutes the food supply would expose Americans to unknown drugs in their food.

Last year, StarLink corn, a genetically engineered corn variety not approved for human consumption, contaminated over 300 supermarket products, resulting in mass food recalls. The contamination was caused by cross-pollination and mixing of GE and non-GE corn in the food stream.

Applied Phytologics (AP), the biotech corporation responsible for the field trial, is developing gene-altered rice to produce a variety of different proteins for drug production. Lactoferrin and lysozyme, both human proteins, are two known compounds growing in the rice. However, according to permit application documents, AP is testing up to a dozen other GE pharm rice varieties in the same location. In Hawaii, the company has recently conducted field tests of gene-altered wheat and barley producing other human proteins.

While the industry is already conducting open-air trials of pharmaceutical rice, wheat, corn, and barley, few regulations to protect public health and the environment are in place. Additionally, no long-term studies have been done to assess the potential environmental damage these plants could cause. The USDA, which claims authority over field trials of GE crops, has virtually no requirements specific to pharmaceutical crops. State agencies like the CDFA also have failed to establish any regulations governing these risky plants.

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