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ISIS Press Release 13/04/04
Letter to the California Department of Food and Agriculture
April 3, 2004
Secretary of Food and Agriculture
A.G. Kawamura
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
Email: sbrown@cdfa.ca.gov
April 3, 2004
Governor Arnold Schwarzenegger
Governor's Office
State Capitol Building
Sacramento, CA 95814
Phone: 916-445-2841
Fax: 916-445-4633
governor@governor.ca.gov
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.
Yours sincerely,
Prof. Joe Cummins
Dr. Mae-Wan Ho
Institute of Science in Society http://www.i-sis.org.uk/
And
Independent Science Panel http://www.indsp.org/
December 17 2003
Prof. Joe Cummins
e-mail: jcummins@uwo.ca
Pharm Crops Near You?
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 [1]. 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 [3] 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 [4], 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 [5]. Canada completed 53 field tests of pharm
crops between 1995 and 2003 [6] while France completed 24 such field tests between
1995 and 1998 [4]. 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 [7]. Human
lactoferrin produced in plants has been described in a US patent granted in
2003 [8]. Human lysozyme incorporated in plants was patented in 1994 as a biopesticide
to protect plants against fungal and animal pests [9], 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
[12]; 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 [13].
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 [14]. Lactoferrin variants have
been associated with localized juvenile periodontitis [15]. It has been suggested
that milk lactoferrin possesses allergenic sites [6]. 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 [17]. 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 [18] while human
lysozyme is clearly not allergenic. Like lactoferrin, lysozyyme is a glycosylated
enzyme and variants of human lysozyme have been characterized [19]. 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 [22]. 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 [23].
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.
References
- Greenpeace Press Release "Crop producing human proteins found growing
in open
field test" 2001 http://www.greenpeaceusa.org/media/press_releases/01_09_06text.htm
- Wilson K. Crop producing human protein found growing in open field test.
Synthesis/Regeneration 2002 http://www.greens.org/s-r/28/28-26.html
- APHIS field test permits for bio-pharm crops. Washington State
University, 2001 Barley
http://www.colostate.edu/programs/lifesciences/TransgenicCrops/pharmpermits.html
- France, "Total number of summary notifications circulated" 2003
http://biotech.jrc.it/deliberate/FR.asp
- Freese,B. "Manufacturing drugs and chemical crops :biopharming poses new
threats to consumers, farmers, food companies and the environment" Friends
of the Earth Genetically Engineered Food Alert 2002, pp1-98.
- Canadian Food Inspection Agency, "confined field trials Canada pharmaceutical " 2003 http://www.inspection.gc.ca/english/plaveg/bio/triesse.shtml
- Lemaux P, Cho M and Buchanan B. "Production of protein in plant seeds"
2003 US Patent 6,642,437 pp 1-48.
- Legrand D, Salmon D, Spik G, Gruber V, Bournat P and Bertrand M. Recombinant
lactoferrin, methods of production from plants and use. 2003 US Patent 6,569,831
pp 1-39.
- Hain R. and Stenzel K. Use of lysozyme gene structure in plants to increase
resistance. 1994 US Patent 5,349,122 pp 1-24.
- Yang D, Guo F, Haung N and Watkins S. Expression and localization of human
lysozyme in the endosperm of transgenic rice. Planta 2003, 216, 597-603.
- Huang J, Nandi S, Wu L, Yalda1D, Bartley G, Rodriguez R., Lonnerda B and
Huang N. Expression of natural antimicrobial human lysozyme in rice grains.
Transgenic Research 2002 11, 229"39.
- Lonnerdal B. Expression of human milk protein in plants. Journal of the
American College of Nutrition 2002,, 18s-221s
- Humphrey B, Huang N and Klasing K. Rice expressing lactoferrin and lysozyme
has antibiotic like properties when fed to chicks. J. Nutr. 2002,
132, 1214-18.
- Tsokos M. and Paulsen E. Expression of pulmonary lactoferrin in sudden onset
and slow onset asthma with fatal outcome. Virchows Arch. 2002, 441,
494-99.
- Velliyagounder K, Kaplan J, Furgang D, Legarda D, Diamond G, Parkin R.
and Fine D. One of two human lactoferrin variants exhibits increased antibacterial
and transcriptional activation activities and is associated with localized
juvenile periodontitis. Infect Immun. 2003, 71, 6141-7.
- Sharma S, Kumar P, Betzel C. and Singh T. Structure and function of proteins
involved in milk allergies. J Chromatogr B Biomed Sci Appl. 2001,
756, 183-7.
- Samyn-Petit B, Wajda Dubos J, Chirat F, Coddeville B, Demaizieres G, Farrer
S, Slomianny M, Theisen M and Delannoy P. Comparative analysis of the site-specific
N-glycosylation of human lactoferrin produced in maize and tobacco plants"
2003 European Journal of Biochemistry 2003, 270, 3235-42.
- Yoshinori Y and Zhang J. Comparative studies on antigenicity and allergenicity
of native and denatured egg white proteins. J. Agric. Food Chem.
2002, 50 , 2679-83.
- Melcher R, Hillebrand A, Bahr U, Schroder B, Karas M and Hasilik A. Glycosylation-site-selective
synthesis of N-acetyl-lactosamine repeats in bis-glycosylated human lysozyme.
Biochem. J. 2000, 348, 507-15.
- Newswise "Gene flow patterns may give clues to managing promiscuous
plants" 2002 pp1-2 http://www.newswise.com/p/articles/view/?id=GENEFLOW.UAR
- Song Z, Lu B, Zhu Y and Chen J. Pollen competition between cultivated and
wild rice species. New Phyologist 2002, 153, 289-96.
- APHIS "determination of non-regulated status for glufosinate tolerant rice"
1999 pp1-25 http://www.aphis.usda.gov/brs/aphisdocs/98_32901p.pdf
- Cummins J. Liberty Link rice: Herbicide tolerant rice for the masses. 2001 pp1-4
http://www.amberwaves.org/web_articles/joecummins.html
- Ma J, Drake P and Christou P. The production of recombinant pharmaceutical
proteins in plants. Nature Reviews of Genetics 2003, 4, 794-806.
- Peterson R. and Arntzen C. On risk and plant based biopharmaceutical. Trends
in Biotechnology 2004, in press doi:10.1016/j.tibtech.2003.11.007
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