Fwd: Letter to the California Department of Food and Agriculture

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13 Apr 2004 21:48:35 -0000

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Letter to the California Department of Food and Agriculture

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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

 

April 3, 2004 Governor Arnold Schwarzenegger Governor's

Office State Capitol Building Sacramento, CA 95814 Phone:

916-445-2841 Fax: 916-445-4633 governor

 

 

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

 

 

 

 

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

 

**********

 

 

 

1. Greenpeace Press Release " Crop producing human proteins

found growing in open field test " 2001

http://www.greenpeaceusa.org/media/press_releases/01_09_06te

xt.htm

 

 

2. 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

 

 

3. APHIS field test permits for bio-pharm crops. Washington

State University, 2001 Barley

http://www.colostate.edu/programs/lifesciences/TransgenicCro

ps/pharmpermits.html

 

 

4. France, " Total number of summary notifications

circulated " 2003 http://biotech.jrc.it/deliberate/FR.asp

 

 

5. 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.

 

 

6. Canadian Food Inspection Agency, " confined field trials

Canada pharmaceutical " 2003

http://www.inspection.gc.ca/english/plaveg/bio/triesse.shtml

 

 

7. Lemaux P, Cho M and Buchanan B. " Production of protein in

plant seeds " 2003 US Patent 6,642,437 pp 1-48.

 

 

8. 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.

 

 

9. Hain R. and Stenzel K. Use of lysozyme gene structure in

plants to increase resistance. 1994 US Patent 5,349,122 pp

1-24.

 

 

10. 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.

 

 

11. 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.

 

 

12. Lonnerdal B. Expression of human milk protein in plants.

Journal of the American College of Nutrition 2002,, 18s-221s

 

 

13. 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.

 

 

14. 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.

 

 

15. 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.

 

 

16. 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.

 

 

17. 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.

 

 

18. 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.

 

 

19. 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.

 

 

20. Newswise " Gene flow patterns may give clues to managing

promiscuous plants " 2002 pp1-2

http://www.newswise.com/p/articles/view/?id=GENEFLOW.UAR

 

 

21. Song Z, Lu B, Zhu Y and Chen J. Pollen competition

between cultivated and wild rice species. New Phyologist

2002, 153, 289-96.

 

 

22. APHIS " determination of non-regulated status for

glufosinate tolerant rice "

 

 

23. 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

 

 

24. Ma J, Drake P and Christou P. The production of

recombinant pharmaceutical proteins in plants. Nature

Reviews of Genetics 2003, 4, 794-806.

 

 

25. 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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