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[SANET-MG] APHIS EA Field Test Release of Safflower Modified with Genes for Human Proinsulin co,,emts due by 23 july 2007



Comments on the APHIS EA are due by 23 July 2007. Washington State seems to be providing a haven for testing and production of crops geneticaly modified with pharmaceutical proteins and GM crops for human consumption. The crops being tested include forest trees, apples, berries, forage crops , lawn grass and safflower. The field tests were done by University of Washington,Washington State University, Oregon State University, Purdue University . Michigan State University, USDA/ARS and Boyce Thompson Institute. Companies testing included Monsanto, Pioneer, Scotts, Dry Creek, Forage Genetics International,Okanagan Biotechnology Inc , SemBioSys of Calgary, Alberta and a sneaky outfit designated CBI. For the most part, the tests went ahead without EA. The tests have directly threatened threatened species and have gone ahead with vitually no awareness from the residents of the state. APHIS seems to take the position that the tests are more important than threatened species I urge everyone to make some coment to APHIS about the current tests.

26 June 2007
Prof. Joe Cummins
University of Western Ontario ,London, Ontario ,Canada and
The Institute of Science in Society, London UK
Comments on the Environmental Assessment of Field Test Release of Safflower Modified with Genes for Human Proinsulin in Washington State USDA-APHIS conducted an Environmental Assessment (EA) In response to permit application (06-363-103r), received from SemBioSys, Inc. for a field-test to produce human proinsulin (line 4438-5A) in genetically engineered safflower (Carthamus tinctorius). The genetically engineered (GE) safflower (Carthamus tinctorius) was developed to express an oleosin-human proinsulin protein exclusively within its seed. A field site (<1 acre) will be located on private property in Lincoln County, WA. The experimental plot will be bordered on all sides by a 50 ft fallow strip. The exact location of the field test was withheld from the public. http://www.regulations.gov/fdmspublic/component/main SemBioSys Genetics, Inc.; Availability of an Environmental Assessment for a Field Release of Safflower Genetically Engineered To Produce Human Proinsulin APHIS-2007-0023 Comments Due by 07/23/2007 (1). Proinsulin is the prohormone precursor to insulin made in the beta cell of the islets of Langerhans. It is synthesized in the endoplasmic reticulum, where it is folded and its disulfide bonds are oxidized. It is then transported to the Golgi apparatus where it is packaged into secretory vesicles, where it is processed by a series of proteases to form mature insulin. Mature insulin has 39 less amino acids; 4 are removed altogether, and the remaining 35 form the C-peptide. The C-peptide is abstracted from the center of the proinsulin sequence; the two other ends (the B chain and A chain) remain connected by disulfide bond (2,3). The patent application US2005/0039235 A1 Methods for the production of insulin in plants describes the genetic modifications that allow high level production of human insulin in plants noting that the human DNA sequence was altered for optimum production in plants and the C-peptide was shortened in length (4). The APHIS EA report notes that the human proinsulin has two amino acids removed for stability in plants plus eleven C terminal amino acids added to added to ensure retention to the plant endoplasmic reticulum of the plant seed cell. The proinsulin sequence was fused to n Arabidopsis oleosin gene to be excusively expressed in seeds. Expressio of the fused gene was controlled by the phaseolin promoter and terminator sequences from common bean, The bean promoter drives exclusively seed specific transcription of the pro insulin approximation. A selectable marker is driven by a parsley ubiquitin promoter and terminator sequences. The selectable marker was deemed confidential business information (CHI) even though even though it is the most commonly used selectable marker in plants and had been used in many previous field trials (1) Animal feeding tests evaluating the toxicity of the gene and its proteins were not included with the EA. The area picked to do the recombinant safflower field test releases is called sagebrush steppe. The area is dry and the vegetation is dominated by sage brush. Animal residents include the sage grouse, sage sparrows, loggerhead shrikes, and even the once ubiquitous black-tailed hare or "jackrabbit" . According to the USAD-APHIS draft environment assessment (1) the threatened species in the test area include bald eagle, pygmy rabbit, Columbian white tailed deer and grey wolf. The plant species include Spalding’s catch fly and Ladies’ tresses. Pygmy rabbits are the most threatened specie , the Columbia pygmy rabbit feeds mainly on sagebrush, Their number may be as low as 30 or less. Breeding the rabbits in captivity have had limited success (5,6) . The pygmy rabbit is likely to feed on the recombinant safflower seeds with potentially detrimental (even fatal) consequences. The APHIS EA maintains that there will be no ingested toxicity from ingesting seeds from the GM safflower , from contact with debris from the GM safflower or from breathing dust from the debris of the GM safflower (1). Even if that claim were true (there is evidence ,ignored by APHIS, that shows the ingested pro insulin from transgenic safflower is active after oral ingestion) the disruption of the habitat of threatened species such as the pygmy rabbit by human activities and transportation is likely to drive the treasured animals to extinction. APHIS displayed a cavalier disregard for the treasured species and appears to have ignored studies that did not support their conclusions. There is a t least one report showing transgenic pro insulin can effectively reduce blood glucose in rats. A bracken fungus , Ganoderma lucium , modified with a gene for human pro insulin reduced blood glucose when fed to diabetic rats (7). Presumably the modified fungus cell wall and endoplasmic reticulum prevent rapid degradation of pro insulin allowing the transgenic organism to be used to deliver insulin to the diabetic animal (7). Cholera toxin pro insulin fusion proteins were produced in lettuce and tobacco plants. When powdered transgenic plant preparations were fed to diabetic mice oral tolerance to insulin was produced leading to prevention of autoimmune degradation of insulin producing beta cells (8). Human insulin produce in Arabidopsis seeds was activated to an active form by exposure to the common digestive enzyme trypsin (9). The APHIS ER (1) presumes that human pro insulin will be degraded too rapidly to be active when it is ingested by animals but the reports above show that is not entirely the case, furthermore functional peptides were found to enhance intestinal absorption of insulin (10). Seed debris may produce dust containing human pro insulin and it is worth noting that inhaled insulin is an available option for human therapy (11). The APHIS EA (1) dismissed the possibility that inhaled debris and dust from the transgenic safflower could be active but they did not provide experimental evidence to support that conclusion. The APHIS EA (1) implied that wild animals would not be affected by human insulin. It is worth mentioning that experimental rabbits were among the animals first study in the discovery of insulin and they are currently used in experiments on insulin action (12). Furthermore , Furthermore, birds (13) and snakes (14) also respond to human insulin, it is probably safe to say that all of the threatened species from humans to rabbits, birds and snakes are potentially victims of careless release of food crops modified with gens for human insulin. The APHIS EA (1) noted that the GM safflower field plot would be surrounded by grain crops to provide a “free lunch” for birds and mammals that was more attractive than safflower seed. The idea that birds and predators would be discouraged from consuming GM safflower by a “free lunch” is a terrible one! Wild migratory birds , and other wild birds and animals will be attracted to the “free lunch” threatening the endangered species whose survival depends on solitude. Furthermore, the crowd of animals converging on the hand out will soon consume the GM safflower seeds as leftovers. The EA suggested that a fallow strip surrounding the test site would discourage the threatened animals from exposing themselves to predators such as raptors , however, rabbits mainly browse at night and view the fallow strip as no barrier to browsing. The field plot design is a disaster in the making. Eastern Washington State is rapidly being transformed into a haven for the production of crops modified with pharmaceutical biochemicals. Along with previous safflower field test releases large plantings of humanized barley are being tested. The exact locations of such tests are not disclosed and residents neighbouring the tests are unaware of release of organisms that may affect their health. The impact of such developments on treasured threatened species is treated disrespectfully by APHIS and there is little doubt that APHIS has written off such irreplaceable treasures. The APHIS EA reads like a uncritical public relations document for a company rather than an independent critical evaluation of a company proposal. The people of Washington State may or may not agree to the sacrifice of treasured species but the public should not be mislead and disregarded in the way that APHIS has dealt with the GM crop releases . A truly independent agency is needed to oversee field test release of GM pharmaceutical crops.
References
1. USDA-APHIS Environmental Assessment In response to permit application (06-363-103r), received from SemBioSys, Inc. for a field-test to produce human proinsulin (line 4438-5A) in genetically engineered safflower (Carthamus tinctorius) seeds U.S. Department of Agriculture Animal and Plant Health Inspection Service Biotechnology Regulatory Services 06_363103r 06/22/2007 http://www.regulations.gov/fdmspublic/component/main
2. Wikipedia Proinsulin 2007 http://en.wikipedia.org/wiki/Proinsulin
3. Davidson, H. Proinsulin processing Cell Biochemistry and Biophysics 2004 Supplement, 143-57 4. Molony,M,Boothe,J,Keone,R,Nykiforuk,C and Van Rooijen Method for production of insulin in plants 2005 US Patent 2005/0039235A1
5. .Washington Department of Fish and Wildlife Pygmy Rabbit 1995
6. Hays, D. Washington Department of Fish and Wildlife Washington Pygmy
Rabbit 2003 Recovery Plan Update addendum to 1995 above
7. Ni T, Hu Y, Sun L, Chen X, Zhong J, Ma H and Lin Z. Oral route of mini-proinsulin-expressing Ganoderma lucidum decreases blood glucose level in streptozocin-induced diabetic rats. Int J Mol Med. 2007 Jul;20(1):45-51. 8. Ruhlman T, Ahangari R, Devine A, Samsam M and Daniell H. Expression of cholera toxin B-proinsulin fusion protein in lettuce and tobacco chloroplasts--oral administration protects against development of insulitis in non-obese diabetic mice. Plant Biotechnol J. 2007 Jul;5(4):495-510 9. Nykiforuk CL, Boothe JG, Murray EW, Keon RG, Goren HJ, Markley NA and Moloney MM. Transgenic expression and recovery of biologically active recombinant human insulin from Arabidopsis thaliana seeds. Plant Biotechnol J. 2006 Jan;4(1):77-85. 10. Morishita M, Kamei N, Ehara J, Isowa K and Takayama K. A novel approach using functional peptides for efficient intestinal absorption of insulin.
J Control Release. 2007 Apr 2;118(2):177-84.
11. Guevara CA. Inhaled insulin for diabetes mellitus. N Engl J Med. 2007 May 17;356(20):2106-7 12. Barillas R, Friehs I, Cao-Danh H, Martinez JF, del Nido PJ. Inhibition of glycogen synthase kinase-3beta improves tolerance to ischemia in hypertrophied hearts. Ann Thorac Surg. 2007 Jul;84(1):126-33. 13. Remage-Healey L and Romero LM. Corticosterone and insulin interact to regulate glucose and triglyceride levels during stress in a bird. Am J Physiol Regul Integr Comp Physiol. 2001 Sep;281(3):R994-1003. 14. Sidorkiewicz E and Skoczylas R. Effect of insulin on the blood sugar level in the grass snake (Natrix natrix L.). Comp Biochem Physiol A. 1974 Jul 1;48(3):457-64

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