April 3, 2004
Secretary of Food and Agriculture
California Department of Food and Agriculture
Division of Plant Health and Pest Prevention Services
1220 N Street, Room A-316
Sacramento, California 95814
attn:Stephen Brown, Special Assistant
April 3, 2004
Governor Arnold Schwarzenegger
State Capitol Building
Sacramento, CA 95814
Re: Biopharmaceutical rice in California
Dear Secretary Kawamura:
Greg Massa, an organic rice producer from California reported, "Well, they did it. The California Rice Commission let down their growers, ignored public comment, and approved Ventria Biosciences' protocol for the introduction of genetically modified, pharmaceutical rice to California." And, "The worst part is that they approved this protocol with a special "emergency" petition, so that the California Secretary of Agriculture has only 10 days to decide on the issue, rather than the standard 4 months. This was to allow Ventria to plant the rice this year. This "emergency" may completely eliminate the public's ability to comment on the decision."
There is a very disturbing side to the above development. Normally, commercial production is preceded by USDA/APHIS approving a petition to deregulate the crop in question. There does not appear to be any recorded decision to deregulate the crop published at this time, and a retroactive deregulation would not normally be considered legal. Along with the USDA/APHIS's deregulation, FDA must provide review and support for the commercial production and marketing, but no FDA action has been made public up to now. Finally, human lysozyme has been patented as a plant incorporated protectant, and thus the rice should have been evaluated by EPA as well as FDA and USDA/APHIS. None of these evaluations, which normally take years, have been made available to the public as normally required. Therefore, the rush to authorize spring planting this year seems to say that US federal law will be ignored, or else that federal bureaucrats have promised a quick, perfunctory evaluation, which is illegal, to say the least.
Biopharmaceutical rice modified with human genes for the proteins lactoferrin and lysozyme is presented as if the product were as safe as mother's milk. But the modified rice does not contain the native human genes and proteins. Instead, it contains synthetic copies of the native genes that are modified for high level production in plants. This involves changes in codons and amino acids as well as in the sugar molecules added to the final protein. The products are essentially untested for potential allergenicity and toxicity to humans, livestock and wild life. At any rate, prudence dictates that food crops modified with pharmaceutical products should be grown only in isolated and controlled greenhouses.
We are enclosing a special report on the hazards of the transgenic rice and other pharm crops for your attention.
In conclusion, once released, the modified rice cannot be recalled, and its polluting effects may persist for generations to come.
December 17 2003
Prof. Joe Cummins
In 2002, Greenpeace disclosed the location of a site in Northern California where rice plants modified with the human genes lactoferrin and lysozyme were being tested . Lactoferrin acts against bacterial pathogens by preventing them from taking up iron needed for their growth, while lysozyme breaks down the cell wall material of the bacterial pathogens. The biopharmaceutical rice-crop was being tested by a California biotechnology company, Applied Phytologics [1,2].
The Greenpeace disclosure created an avalanche of concern from the public and from both conventional and organic rice farmers fearing that contamination of their crops would lead to economic disaster.
Washington State University field-tested barley altered with human genes for lactoferrin, lysozyme, antitrypsin and antithrombin  without any comment from the public even though this posed an obvious threat to both conventional and organic beer production and animal feed, not to mention the hazards to health.
Maize modified with human lactoferrin was field-tested by Biochem SA company and by Meristem Therapeutics company in France , again with no comment from the public even though such tests threaten both conventional and organic maize production in Europe.
Most of the field-testing of genetically modified (GM) biopharmaceutical crops appears to have been carried out in the United States (US), France and Canada. US completed 315 such tests between 1991 and 2002, including GM maize, rice, soya and Tobacco Mosaic Virus .The majority of tests were done in Nebraska, Hawaii, Wisconsin and Puerto Rico . Canada completed 53 field tests of pharm crops between 1995 and 2003  while France completed 24 such field tests between 1995 and 1998 . In the US and Canada, field trials of pharm crops are veiled in secrecy under the "confidential business information (CBI)" designation, which hides the details of the gene-constructs as well as the exact locations of the field tests. Thus, people living near the field trials have no means of relating any illness or discomfort experienced from exposure to polluted plant debris or pollen, or to contaminated ground or surface water escaping from the test sites.
The GM rice pharm-crop, like other crops that produce pharmaceuticals in seed, has a gene construct that includes the human genes for the biopharmaceutical protein driven by a seed-specific promoter, and the protein is expressed with a fusion polypeptide (the signal peptide) that causes the fusion protein to accumulate in a cell compartment such as a vacuole or seed endosperm . Human lactoferrin produced in plants has been described in a US patent granted in 2003 . Human lysozyme incorporated in plants was patented in 1994 as a biopesticide to protect plants against fungal and animal pests , and its localization to the endosperm of transgenic rice has been reported more recently[10,11].
Expression of human milk proteins in plants was discussed by nutrition experts who said such products should be tested in rats and then in human volunteers ; but they have totally ignored the problem of inadvertent exposure to the products by consuming crops contaminated by the product resulting from the inevitable, "accidental"spread of pollen or seed. Chickens were fed GM rice with human lysozyme and lactoferrin, and the rice was reported to have antibiotic-like properties .
Lactoferrin participates in the regulation of immune functions and controls pathogens by binding iron required for bacterial growth. Lactoferrin has been implicated in asthma with fatal consequences . Lactoferrin variants have been associated with localized juvenile periodontitis . It has been suggested that milk lactoferrin possesses allergenic sites . Lactoferrin is a protein modified by glycosylation, a modification that contributes to enzyme activity and to allergenicity of the protein. Human lactoferrin was found to be glycosylated differently from the human transgene protein produced in tobacco . The different patterns of glycosylation observed in human and the tobacco transgene product should not be considered insignificant until full studies of allergenicity of the transgenic protein are completed.
Chicken egg lysozyme is a well- known potent food allergen  while human
lysozyme is clearly not allergenic. Like lactoferrin, lysozyyme is a glycosylated enzyme and variants of human lysozyme have been characterized . The glycosylation patterns of the transgenic enzyme produced in plants appear to have been neglected even though that pattern will influence allergenicity of the product. Clearly, both transgenic lactoferrin and transgenic lysozyme are potentially hazardous to human health, and such concerns should be made clear to those exposed at or near the field-test sites.
Transgenic rice crops may spread pollen or seed to adjacent fields thus contaminating those crops. Rice is known to be somewhat self fertilizing, but clearly capable of spreading both pollen and seeds to nearby fields. Studies on gene flow between commercial rice and weedy red rice [20, 21] suggest that transgenes may spread to non-transgenic rice. Once established, the transgenes may be difficult if not impossible to eliminate. Organic and conventional rice producers have a legitimate concern over the secrecy surrounding the field testing of the transgenic rice.
Transgenic glufosinate resistant rice (Liberty Link) was de-regulated in the US during 1999, the Animal Plant Food Inspection Service (APHIS) of US Department of Agriculture (USDA) thought that the transgenic rice would not pollinate weedy red rice, and even if it did, the weed could be eliminated using herbicides other than glufosinate . I have outlined the concerns over the threat of transgenic rice to organic and conventional producers and the probable instability of transgenic rice due to somaclonal variability some years ago .
Recently, recombinant biopharmaceutical production in transgenic crops has been actively promoted, in spite of incidents of contamination of food production uncovered during field tests of such crops [24,25]. Production of the biopharmaceutical crops in confined greenhouses was deemed un-economic even though such production provides the barest essentials for isolating the pharm crops from contaminating our food crops as well as the atmosphere and groundwater.
Transgenic crops producing human milk proteins are promoted because "mother's" milk is presumed safe for all, but the transgenic "mother's milk" proteins are far from identical to the real thing. Furthermore, the transgenic milk-protein crops will soon be followed by anticoagulants, human growth hormone, antibodies and a range of other biopharmaceutical products all potentially significantly different from the original products. The biopharmaceutical dam may soon burst leaving the human population with an array of hidden non-prescribed medications in their food, plus a host of side-effects to boot.
Article first published 13/04/04
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