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THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

14 February 2003

Dear friends and colleagues,

RE: INTERNET USED TO SPREAD BIOPHARM CROPS

As controversy brews over the environmental and health impacts of ‘biopharm crops’, crop plants that are genetically engineered, especially to produce substances such as pharmaceuticals, moves are being made to broker contract deals over the Internet targeting farmers especially in the Third World to grow pharm crops.

Beth Burrows, President and Director of the Edmonds Institute, discovered a website based in Europe that seeks to enlist farmers to contract out their land, if it is in the ‘right location and conditions’ to pharmaceutical companies at up to 20 times ‘commercial’ rates for normal food crops to be used for growing biopharm crops.

Burrows adds, “The web brokers are offering what seems to be a perfect deal. Perfect, until you begin to wonder whether they’re not shifting the risk and liability burden from pharmaceutical and manufacturing companies to those much less able to address and bear the potential health, environmental, and legal burdens of (bio) pharm crops.”

The website that Burrows mentioned has proudly announced that it now have a few Indian growers. And farmers elsewhere, enticed by the potential profits to be made from such deals as advertised by the website, coupled with the lax and often non-existence of regulations on biopharm crops, are prime targets by such brokers especially as worries over the consequences of contamination by such crops increase in the industrialized world.

In the US, where about 300 open-air field trials are being conducted in secret locations across the US and about 400 biopharm products are reportedly in the pipeline, reports of cases of contamination are emerging.

Of the publicly known contamination that occurred was the discovery last November of corn genetically engineered with pharmaceuticals or chemical products that found its way into soya bean plants in the state of Nebraska. This led the U.S. Agriculture Department to quarantine 500,000 bushels of potentially contaminated soya beans, valued at US$2.7 million, to be eventually destroyed to prevent it from getting into the food system.

Following the discovery, the Department admitted that a similar incident occurred back in September in Iowa involving the contamination by corn unapproved for human consumption of neighbouring corn. As a result, the Department ordered 155 acres of Iowa corn pulled up and incinerated. (see http://www.washingtonpost.com/wp-dyn/articles/A51859-2002Nov13.html)

Voices of concern are already being heard. Ten U.S. food industry groups have urged the government to stop biopharm crops until it implements stricter regulations to prevent accidental contamination of other crops (US food groups urge halt to “bio-pharm” crops, Reuters, February 07, 2003).

Similar rumblings are also heard in Europe.

The danger of pharm crops cannot be ignored. Pharm crops are crops that are genetically modified to produce gene products that are pharmaceutically active, and that are not normally produced by the crops concerned. As Prof. Joe Cummins of the Institute of Science in Society reveals below, these plants are potentially dangerous as they can poison our entire food chain.

With best wishes,

Lim Li Lin and Chee Yoke Heong
Third World Network
121-S Jalan Utama
10450 Penang
Malaysia

Email: twnet@po.jaring.my

--------------

REF: Doc.TWN/Biosafety/2003/J

Item 1

EDMONDS INSTITUTE ALERT

Contact: Beth Burrows, 425-775-5383

Brokering Iffy Biotech to Out-of-the-Way Farmers

Opportunities on the Web: Shifting the Risks of Biopharming

Taking a “Dirty Industry” South?

Edmonds, Washington, Wednesday, February 12. The Edmonds Institute, a public interest, non-profit known for its work on biosafety, today warned about use of the Internet to find farmers in out-of-the-way places willing to grow pharm crops. “With bioengineered piglets going unapproved to market, with experimental crops contaminating 150 acres of corn and half a million bushels of soybeans, with an engineered corn unapproved for human consumption turning up all over the world, at a time when the environmental and human health problems posed by the so-called pharm crops* desperately need the clear scientific light of day, people are brokering contract pharming deals on the web, “ cautions Beth Burrows, Edmonds Institute President and Director.

Burrows is referring to “biopharming”, the genetic engineering of organisms, such as crop plants, to produce substances they don’t ordinarily produce, such as pharmaceuticals and industrial chemicals. Because of the danger of contamination of our food and feed supplies, “pharming” was the subject of a recent call for comment by the US Food and Drug Administration.

“The web middlemen tells companies to ‘contact us if you see anyone (on our website list of growers) who might be in the right place to safely contract grow your crop for you’,” notes Burrows, “and then they tempt farmers with the thought that, “(w)e would expect in order to get exactly the right location and conditions, Pharmaceutical Companies to lease land at up to 20 times ‘commercial’ rates for normal food crops.”

Burrows adds, “The web brokers are offering what seems to be a perfect deal. Perfect, until you begin to wonder whether they’re not shifting the risk and liability burden from pharmaceutical and manufacturing companies to those much less able to address and bear the potential health, environmental, and legal burdens of pharm crops.”

Burrows points to Molecularfarming.com, a website that came to her notice via Indusfarming, an electronic digest that originates in India and focuses on the problems of agrarian peoples in the South Asia and Indus basin region. Late January, an article in Indusfarming heralded “Molecular farming. Contract growing opportunity”.

The article announced a “global project, based in Europe,” that aimed to “enable the future SAFE production of Biopharmaceuticals, Biodegradeable plastics, New Fibers and New Polymers in transgenic, NON-FOOD USE, genetically engineered molecular crops.” The article acknowledged that “there will be cross-contamination and Environmental risks” but foresaw a “huge future industry” for contract farmers able to grow “molecular crops” in greenhouses or in “’isolated’, ‘non-native’, ‘away from related food crop’” places. The article announced a “free to join Global Database of future potential growers, with the idea of introducing Biopharmaceutical companies with crops to grow to contract growers and farmers in safe locations.”

Mentioning that they already “have a few Indian growers”, the article called attention to the project’s website <http://www.molecularfarming.com and enjoined the reader to “explore the potential for you.”

Burrows points out that, “This is an inducement to exactly the kind of ‘pharming’ that FDA and all the rest of us are concerned about,* and doing it in out of the way places doesn’t guarantee the safety of anything. “ Devinder Sharma, award-winning journalist and food system analyst based in New Delhi, saw the same article Burrows did, and commented:

“This is shocking indeed...This is part of the global design to translocate the dirty industry to the Third World. First, it was the translocation of toxic and hazardous waste recycling to developing countries (mainly South Asia and Africa). . .Then came the translocation of the flower industry, one of the dirtiest farming systems...to India, Kenya and Colombia...Now, it is the turn of bio-pharma crops. Even in the United States, there is tremendous problems with bio-pharma crops. So what do you do? Translocate this dirty industry to countries of South Asia.”

According to the website - Molecularfarming.com - its “worldwide molecular farming database” was started in February, 2002. Since then, “potential growers” for “pharm” crops have been found in Canada, Ireland, Australia, Argentina, a dozen states of the USA, Scotland, England, Zimbabwe, New Zealand, India, Pakistan, Korea, Greece, Turkey, Panama, Romania, Nigeria, and South Africa. The website owners also “have leads to a farmer’s group in the Baltic Sea Islands” and” a contact for 147,000 acres in Guinea (in West Africa).”

Not surprised by the website, Sharma notes, “I am sure we will have a number of ‘farmers’ waiting on line to encash this opportunity.”

Burrows admits that the website “offers an attractive package” but, she notes, “If you read it carefully, you see many, many safety problems. At best, they are talking about hoped-for solutions. They talk ‘protection’ but it’s mostly talk about protection from gene flow in the field. That is not the only problem, not even the only environmental problem, posed by pharm crops.”

In its recent draft Guidance for Industry regarding Drugs, Biologicas and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals, the US Food and Drug Administration (FDA) advised industry to “consider the potential environmental impact of all aspects of the manufacturing process, including but not limited to transport of seeds and plants, growing, harvesting, processing, purifying, packaging, storage, and disposal.”

Looking at the molecularfarming website, Burrows worries that, “Aside from the risks that may be engendered by handling these crops, what about the risks from transporting these crops or accidents while processing these crops? Whose is the liability for the child in an out of the way place that picks and eats one of these strange new crops? And who is going to be sure that the farmer in out-of-the-way places are told all they need to know about pharm crops and their problems and how to handle them. Who is going to help those out-of-the-way farmers obey whatever relevant laws may exist in their own counties? I find it noteworthy that one of the key questions the website asks farmers is, ‘Has your property public liability insurance?’”

Molecularfarming.com does offers its readers translations into Spanish, Portuguese, French, German, Italian, Chinese, Korean, and Japanese but it admits that the translations are “not exact”. Burrows wants to know, “Exactly what things aren’t exactly well-explained, and what about the farmers who speak Hindi, or Parsi, or Arabic or Swahili? Who will explain to them the implications of the deal they are being offered? The unknowing farmers who find this website may not be so much bridging the digital divide as walking a digital plank. “

Devinder Sharma warns further, “It is time the civil society wakes up to these ecological dangers. We cannot allow the West to clean up its house and even its backyard and turn us into a rubbish bin.”

################## end #################

Contact: The Edmonds Institute, 20319-92nd Avenue West, Edmonds, Washington 98020, USA, phone: 1-425-775-5383,email: beb@igc.org, website:

<http://www.edmonds-institute.org

The Edmonds Institute is a public interest, non-profit concerned with issues related to environment and technology. Known for its work on biosafety and biodiversity, it was incorporated in 1995 and is a 501©(3) organization under the rules of the Internal Revenue Service.

Contact: Beth Burrows - 425-775-5383

Other persons to contact on issues raised in this press release:

Dr. Devinder Sharma, agricultural expert and journalist - (in India) 91 (11) 5250494, email: <dsharma@ndf.vsnl.net.in

Dr. Norman Ellstrand, University of California Riverside - professor of genetics and expert in gene flow - 909-787-4194

Dr. Michael Hansen, Consumers Union Policy Institute research and policy analyst - 914-378-2452

·        E.g.,February 6, 2003, following submission of formal comments to USFDA, a representative of the US Grocery Manufacturers of America warned, “To minimize the possible risks, a clear system of regulatory enforcement and liability needs to be in place for the development, testing and eventual commercialization of PMPs [plant made pharmaceuticals] - just as we require strict regulations for conventional drugs made in brick and mortar facilities. Until then, no permits for new field trials or for commercialization should be issued by USDA because there is no room for trial and error.”

Item 2

Pharming Cytokines in Transgenic Crops

By Prof. Joe Cummins, Institute of Science in Society, PO Box 32097, London NW1 0XR, UK.

Cytokines are small proteins secreted by one animal cell to alter the behavior of itself or another cell. Cytokines send signals to the cell by binding to specific ‘receptors’ on the cell-surface. The biological effects depend on the cytokine and the cell. Typically, these molecules affect cell activation, division, apoptosis  (programmed cell death), or movement. Cytokines produced by leucocytes and acting mainly on other white blood cells are called interleukins. Cytokines that have chemo-attractant activity are called chemokines. Those that cause differentiation and proliferation of stem cells are called colony-stimulating factors. Those that interfere with viral replication are called interferons.  Interferons protect cells by inducing intracellular production of molecules that interfere with virus replication, and increase recognition of virally infected cells by cytotoxic (cell-killing) T lymphocytes. Interferons also have anti-proliferative effects on some cancer cells.

Cytokines provide useful treatments of infections, and of cancer symptoms and diseases affecting the immune system [1]. Their clinical deployment has been limited by the cost of producing the drug proteins, and recombinant cytokines have allowed them to be used more widely.

In recent years, animal and human genes have been incorporated into crop plants in order to produce vaccines, antibodies, plasma proteins, cytokines and other therapeutics [2], with little thought given to the consequences of the pharmaceuticals genes spreading to food crops or the genes and gene products polluting surface water, groundwater and the air. The first (of possibly many) such disasters has already been uncovered [3, 4].

It has been suggested that recombinant cytokines might provide a safe replacement for antibiotics. Chicken interferon gamma has been proposed as a vaccine adjuvant and growth promoter for chickens [5]. The worldwide production of chickens for meat and eggs is staggering, so the recombinant interferon treatment could spread far and wide in short time. To provide for efficient delivery of the cytokine, adenovirus vectors have been proposed to deliver the cytokine genes to the chicken [6]. The adenovirus has posed significant problems in human gene therapy and is known to cause severe immune reactions including death [7]. The adenovirus may impact the immune system of the treated chicken and also be carried into eggs, offal and meat. Interferon gamma structural gene has a high degree of homology (sequence similarity) to human interferon gamma [8] and a comparison of cytokines in different species shows 6 with 60% or greater homology to the avian gene and tend to cross react immunologically with the protein [9].

As a further complication, the cytokine transcript RNA is subject to alternative splicing to produce different proteins depending on the cellular environment in which the gene is expressed [10]. This will complicate safety assessment considerably.

Chicken interferon has been produced using baculovirus vector in cultured insect cells [11] and in transgenic plants both as a source of the cytokine and as a means of controlling plant disease.

Human interferon alpha has been produced in potato [12] and potatoes expressing interferon alpha were found to resist phytopthora [13]. A ribonuclease gene forming a part of the human interferon alpha virus defense was used to transform potato, the transgenic potato ‘defended’ against virus infection by forming necrotic spots followed by the death of the infected plants 20 days later [14], a rather extreme and impractical form of defense.

However, production of human interferon in crops may provide therapeutic agents for a number of human diseases. Oral ingestion of recombinant human interferon has been reported in over fifty publications involving different disease treatments, such as the prevention of rejection of allograft islet transplants [15]. Cytokine treatments are known to induce sickness and central nervous system toxicity [16,17]. Recombinant human interferon alpha was reported to cause dementia [18], neurotoxicity [19] and mood and cognitive side effects [20].

It is clear that crops expressing interferons would have disastrous consequences as the interferon genes spread and contaminate food crops, and poison our entire food chain. Incorporating them into chickens may well produce demented as well as poisonous chickens.

Other cytokines have begun to be produced in crop plants. Interleukin-10 a powerful immune suppressant used to control graft rejection was produced in open field trials of modified tobacco [21]. I already warned of the potential for ground and surface water to become polluted, and the danger that the transgene product, or the transgene itself could turn a relatively harmless virus into a killer [22]. The human granculocyte-macrophage colony stimulating factor fused with seed glutelin protein was used to create an easy system for oral delivery of the cytokine [23]. Such modified seeds may be widely dispersed by birds and by wind to contaminate food crops or to propagate the modified crop.

Interleukin-2 and interleukin-4 were produced in modified tobacco cells in suspension culture, the cytokines were excreted into the suspension medium allowing for easy recovery and purification [24]. This contained production method should avoid most of the risks of open production in plants in the field [25].

In conclusion, cytokines are proving valuable agents for treating disease, but like vaccines and other drugs, their production should be confined to contained facilities, and field releases of any kind should not be allowed.

1.. Parkin J and Cohen B. An overview of the immune system. Lancet 2001, 357,1777-89.

2.. Fischer R and Emans N. Molecular farming of pharmaceutical proteins. Transgenic Res 2000, 9,279-99.

3.. Ho M. Pharmageddon. SiS 17, 2003, http://www.i-sis.org.uk/full/PharmageddonFull.php

4.. Cummins J. Risk of edible transgenic vaccines. SiS 17, 2003, http://www.i-sis.org.uk/full/PharmageddonFull.php

5.. Lowenthal J, Lambrecht B, van den Berg T, Andrew M, Strom D and Bean A. Avian cytokines-the natural approach to therapeutics. Developmental and Comparative Immunology 2000, 24,355-65.

6.. Johnsao M, Pooley C and Lowenthal J. Delivery of avian cytokines by adenovirus vectors. Developmental and Comparative Immunology  2000, 24,343-54.

7.. Ho M and Cummins J. Failures of gene therapy. SiS 16, 2002.

8.. Kaiser P, Wain H, and Rothwell L. Structure of the chicken gamma interferon gene and comparison to mammalian homologues. Gene 1998, 207, 25-32.

9.. Scheerlink J. Functional and structural comparisons of cytokines in different species. Veterinary  Immunology and Immunopathology 1999, 72, 39-44.

10.. Atamas S. Alternate splice variants of cytokines. Life Sciences 1997, 61,1105-12.

11.. Takehara K, Kamikawa M, Ohnuki N, Nagata A, Yamaguchi D, Yokomozo Y and Nakamura M.  High level expression of C-terminal truncated recombinant chicken interferon gamma in Baculovirus vector system. Avian Pathology 2002, 64,95-100.

12.. Ohya T, Matsumura T, Ohashi K, Onuma M, and Sugimoto C.  Expression of two subtypes of human INF alpha in transgenic potato. J.Interferon and Cytokine Res 2001, 21,595-602.

13.. Ozeretskovskaia O, Vasiukova N, Chalenko G, Gerasimova N, Grishanina A, Khromova L, Iakovleva G, Varlamov V, Skriabin K “Induced phytopthera resistance in transgenic potato tubers.  Prinkl Biokhim Microbiol 2002, 38,552-5.

14.. Ogawa T, Hori T, Ishida I. Virus induced cell death in plants expressing the mammalian 2’,5’ oligoadenlyate system. Nature Biotech 1996,14,1538-9.

15.. Brod S, Katz S, Phan T and Stepkowski S. Ingested interferon alpha prevents allograft islet transplant rejection. Transplantation 2000, 69,2162-66.

16.. Dantzera R. Cytokine-induced sickness behaviour: Mechanisms and implications. Annals of the NY Acad of Sci 2001, 933,222-34.

17.. Bocci V. Central nervous system toxicity of interferons and other cytokines. J. Biol. Regul. Homeost Agents 1998,2,107-18.

18.. Moulinier A.  Recombinant interferon alpha induced chorea and subcortical dementia. Neurology (Correspondence) 2002, 59,18-21.

19.. Caracenti A, Gangeri L, Martini C, Belli F, Brunelli C, Baldini M, Mascheroni L, Lenisa L and Cascinetti N. Neurotoxicity of interferon alpha in melanoma therapy. Cancer 1998, 83, 482-9.

20.. Valentine A, Meyers C, Kling MA, Richelson E, and Hauser P. Mood and congnative side effects of interferon alpha. Semin Oncol 1998, 25 (suppl 1) 39-47.

21.. Menassa R, Nguyen V, Jevnikar A, and Brindle J. A self contained system for the production of plant recombinant intereukin-10. Molecular Breeding 2001,8, 177-85.

22.. Cummins J. Poison pharm crops near you. SiS 16, 2002,  Isis Report 2002 http://www.i-sis.org.uk/DeadlyPharm.php

23.. Magnuson N, Linzmaier P, Reeves R, An G, HayGlass K, and Lee J. Secretion of biologically active human interleukin-2 and interleukin-4 from genetically modified tobacco cells in suspension culture. Protein Expression and Purification 1998, 13, 45-52

24.. Sardana R, Alli Z, Dudani A, Tackaberry E, Panahi M, Naraanan M, Ganz P and Altosaar I. Biological activity of human granulocyte macrophage colony stimulating factor is maintained in fusion with seed glutelin peptide. Transgenic Res 2002,11,521-31.

25.. First suggested by Ho MW and Steinbrecher RA. Fatal flaws in food safety assessment: critique of the joint FAO/WHO biotechnology and food safety report. Environmental & Nutritional Interactions 1998, 2, 51-84.

 


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