[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index]
[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
********************************************************
To unsubscribe from SANET-MG:
1- Visit http://lists.sare.org/archives/sanet-mg.html to unsubscribe or;
2- Send a message to <listserv@sare.org> from the address subscribed to the list. Type "unsubscribe sanet-mg" in the body of the message.
Visit the SANET-MG archives at: http://lists.sare.org/archives/sanet-mg.html.
Questions? Visit http://www.sare.org/about/sanetFAQ.htm.
For more information on grants and other resources available through the SARE program, please visit http://www.sare.org.