Download Food Safety: Transgenics and Pesticides

Food Safety: Transgenics and
Pesticides
Michael Hansen, Ph.D.
Senior Scientist
Consumers Union, US
Conselho Regional de Medicina do Estado
de São Paulo
São Paulo, Brazil
April 26, 2010
Outline
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A. US FDA Policy on Genetically Engineered
plants
B. Bt crops--potential allergenicity and
immunogenicity concerns
C. Unexpected Effects
D. Do GE crops reduce pesticide use?
E. Toxicity of glyphosate
F. Conclusion
FDA Policy on Genetically
Engineered Plants
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Introduced at press conference at an industry gathering
on May 27, 1992 by then Vice-President Dan Quayle as
a deregulatory initiative
Based on notion “that the new techniques [e.g. genetic
engineering] are extensions at the molecular level of
traditional methods and will be used to achieve the same
goals as traditional plant breeding” (57 FR 22991, May
29, 1992)
No requirement for human safety testing, only “voluntary
safety consultations”; to date, some 80 voluntary safety
consultations have been held
Key phrases in US Food and Drug
Administration safety consultation letters
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Letter for MON 810 (Bt corn), dated Sept. 26, 1996
“Monsanto submitted a summary assessment of corn containing
transformation event MON 810 on June 6, 1996”
“Based on the safety and nutritional assessment you have
conducted, it is our understanding that Monsanto has concluded
that corn products derived from this new variety are not
materially different in composition, safety, and other relevant
parameters from corn currently on the market, and that the
genetically modified corn does not raise issues that would
require premarket review or approval by FDA.”
www.cfsan.fda.gov/~acrobat2/bnfL034.pdf
These two sentences found in all 80 safety consultation letters
FDA does not require premarket safety assessment and does not state
its own opinion about the safety of the GE crop
Bt crops
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Engineered with endotoxins produced by the
soil bacterium Bacillus thuringiensis
Endotoxins are called Cry proteins and there
are many of them
Bt crops on market include corn, potato,
cotton, poplars; many are in testing phase,
including Bt rice, Bt brinjal, Bt soy
Concern over allergenicity and immunological
impacts of Cry proteins on the gut
Joint FAO/WHO Expert Consultation on
Allergenicity of Foods Derived from
Biotechnology, January, 2001
http://www.fao.org/es/ESN/food/risk_biotech_allergen_es.stm
Conclusions
2.
The Consultation emphasized that all foods derived
from biotechnology must be assessed for allergenic
potential
Joint FAO/WHO Expert Consultation on Allergenicity
of Foods Derived from Biotechnology, January, 2001
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7. The Consultation was of the opinion that an
evaluation of proteins for sequence homology
with sufficient sensitivity and specificity to detect
potential cross-reactivity is an important part of
the process for the assessment of the
allergenicity of the expressed protein.
Joint FAO/WHO Expert Consultation on Allergenicity
of Foods Derived from Biotechnology, January, 2001
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“6.1. Sequence Homology as Derived from Allergen Databases
The commonly used protein databases (PIR, SwissProt and TrEMBL)
contain the amino acid sequence of most allergens for which this
information is known. However, these databases are currently not fully upto-date. A specialized allergen database is under construction.
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Cross-reactivity between the expressed protein and a known allergen (as
can be found in the protein databases) has to be considered where there is:
1) more than 35% identity in the amino acid sequence of the expressed
protein (i.e. without the leader sequence, if any), using a window of 80
amino acids and a suitable gap penalty (using Clustal-type alignment
programs or equivalent alignment programs) or: 2) identity of 6 contiguous
amino acids.
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If any of the identity scores equals or exceeds 35%, this is considered to
indicate significant homology within the context of this assessment
approach. The use of amino acid sequence homologies to identify
prospective cross-reacting allergens in genetically-modified foods has been
discussed in more detail elsewhere (Gendel, 1998a, Gendel, 1998b).
Joint FAO/WHO Expert Consultation on Allergenicity
of Foods Derived from Biotechnology, January, 2001
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Recommendations:
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1. The Consultation recommends that
the FAO/WHO 2001 decision tree be
used for determining allergenicity of
foods derived from biotechnology
Joint FAO/WHO Expert Consultation on Allergenicity
of Foods Derived from Biotechnology, January, 2001
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Recommendations:
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1. The Consultation recommends that
the FAO/WHO 2001 decision tree be
used for determining allergenicity of
foods derived from biotechnology
Kleter, G.A. and A.C.M Peijnenburg. 2002. Screening of
transgenic proteins expressed in transgenic food crops for the
presence of short amino acid sequences identical to potential, IgEbinding linear epitopes of allergens. BMC Structural Biology, 2: 8.
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www.biomedcentral.com/1472-6807/2/8
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Compare transgenic protein from GE/GM
crop with known allergen, looking for identical
stretches of at least 6 amino acids
Screen positives further with:
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Epitope database
Antigenicity prediction algorithm
Kleter, G.A. and A.C.M Peijnenburg. 2002. Screening of
transgenic proteins expressed in transgenic food crops for the
presence of short amino acid sequences identical to
potential, IgE-binding linear epitopes of allergens. BMC
Structural Biology, 2: 8.
Kleter, G.A. and A.C.M Peijnenburg. 2002. Screening of
transgenic proteins expressed in transgenic food crops for the
presence of short amino acid sequences identical to potential, IgEbinding linear epitopes of allergens. BMC Structural Biology, 2: 8.
Kleter, G.A. and A.C.M Peijnenburg. 2002. Screening of transgenic proteins
expressed in transgenic food crops for the presence of short amino acid sequences
identical to potential, IgE-binding linear epitopes of allergens. BMC Structural
Biology, 2: 8.
Kleter, G.A. and A.A.C.M Peijnenburg. 2002. Screening of
transgenic proteins expressed in transgenic food crops for the
presence of short amino acid sequences identical to potential, IgEbinding linear epitopes of allergens. BMC Structural Biology, 2: 8.
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“Only a limited number of identical stretches
shared by transgenic proteins (papaya ringspot
virus coat protein, acetolactate synthase GH50,
and glyphosate oxioreductase) and allergenic
proteins could be identified as (part of) potential
linear epitopes. . . The positive outcomes of this
approach warrant further clinical testing for
potential allergenicity.”
Gendel, S.M. 1998b. The use of amino acid sequence alignments
to assess potential allergenicity of proteins used in genetically
modified foods. Advances in Food and Nutrition Research, 42: 4461.
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“although it is clear that some amino acid residues are critical for
specific binding, some conservative substitutions may not affect
allergenicity. Therefore, it may be prudent to treat sequence
matches with a high degree of identity that occur within regions
of similarity as significant even if the identity does not extend for
eight or more amino acids. For example, the similarity between
Cry1A(b) and vitellogenin might be sufficient to warrant
additional evaluation” (Gendel, 1998b: 60).
Fares, NH & AK El-Sayed. 1998. Fine structural
changes in the ileum of mice fed on delta-endotoxintreated potatoes and transgenic potatoes. Natural
Toxins 6: 219-233.
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Bt-potatoes and Bt-toxin (Cry 1) caused
disruption, multinucleation, swelling,
increased degradation of ileal (gut) surface
cells in rats. Effect worse with Bt-toxin
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These effects demonstrate that Bt-toxin
survives digestion in functionally and
immunologically active form
Fares, NH & AK El-Sayed. 1998. Fine structural
changes in the ileum of mice fed on delta-endotoxintreated potatoes and transgenic potatoes. Natural
Toxins 6: 219-233.
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“These changes may suggest that deltaendotoxin-treated potatoes resulted in the
development of hyperplastic cells in the mice
ileum. Although mild changes are reported in the
structural configuration of the ileum of mice fed
on transgenic potatoes, nevertheless, thorough
tests of these new types of genetically
engineered crops must be made to avoid the
risks before marketing.” (Fares and Sayed, 1998:
219)
Vazquez-Padron, R.I., Moreno-Fierros, L., Neri-Bazan, L., de la
Riva, G.A. and R. Lopez-Revilla. 1999b. Bacillus thuringiensis
Cry1Ac protoxin is a potent systemic and mucosal adjuvant.
Scandinavian Journal of Immunology 49: 578-584
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“We conclude that Cry1Ac is a mucosal
and systemic adjuvant as potent as CT
[cholera toxin] which enhances mostly
serum and intestinal IgG antibody
responses” (Vazquez-Padron et al.,
1999b: pg. 578).
Cry1Ac is potent stimulator of immune
system
Cry1Ac survives digestion
Vazquez-Padron, R.I., et al. 2000b. Cry1Ac protoxin from Bacillus
thuringiensis sp. kurstaki HD73 binds to surface proteins in the
mouse small intestine. Biochemical and Biophysical Research
Communications 271, pp. 54-58
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“we demonstrated that Cry1Ac protoxin (pCry1Ac)
binds to the mucosal surface of the mouse small
intestine . . . six pCry1Ac-binding polypeptides
present in brush border membrane vesicles isolated
from the small intestine. Moreover, this protein
induced in situ temporal changes in the
electrophysiological properties of the mouse jejunum.
The data obtained indicate a possible interaction in
vivo of Cry proteins with the animal bowel which
could induce changes in the physiological status of
the intestine” (Vazquez-Padron et al., 2000b: 54).
Vazquez-Padron, R.I., et al. 2000b. Cry1Ac protoxin from Bacillus
thuringiensis sp. kurstaki HD73 binds to surface proteins in the
mouse small intestine. Biochemical and Biophysical Research
Communications 271, pp. 54-58
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“We think that previous to commercialization
of food elaborated with self-insecticide
transgenic plants it is necessary to perform
toxicological tests to demonstrate the safety
of Cry1A proteins for the mucosal tissue and
for the immunological system of animals”
(Vazquez-Padron et al., 2000b: 58).
Bernstein, et al. 1999. Immune responses in farm
workers after exposure to Bacillus thuringiensis
pesticides. Environmental Health Perspectives, 107(7):
575-582
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Scientists did study on farm workers in onion fields in
Ohio, US that were exposed to Bt sprays
“reactivity [IgE antibodies] to the Btk pro-deltaendotoxin was encountered in 2 of 123 workers
sensitized by the respiratory route . . . future
clinical assessment of this possibility is now
feasible because of the availability of reliable Bt
skin and serologic reagents developed during the
course of this investigation” (Bernstein et al.,
1999: pg. 581).
Bernstein, et al. 2003. Clinical and laboratory
investigation of allergy to genetically modified foods.
Environmental Health Perspectives, 111(8): 1114-1121.
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“Workers in agricultural and food preparation
facilities have potential inhalation exposure to
plant dusts and flours. In 1999, researchers
found that migrant health workers can become
sensitized to certain Bt spore extracts after
exposure to Bt spraying. Thus, the potential for
occupational and consumer risks needs to be
assessed.”
Impact of Bt cotton on farmers’ health (in Barwani and Dhar District of
Madhya Pradesh) –Dr. Ashish Gupta et al.
Investigation Report Oct. – Dec. 2005
www.gmwatch.org/print-archive2.asp?arcid=6265
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Surveyed 5 villages, talked to people with symptoms
and exposure to Bt cotton N = 23
All had skin symptoms, primarily itching (23),
redness (19), or eruptions (20). The symptoms
tended to occur on face (17), hands (15), feet (11)
Almost half (11) had eye symptoms—itching,
redness and/or swelling
About 40% (9) had upper respiratory tract symptoms
runny nose and/or excessive sneezing
Almost 90% had moderate (10) or severe symptoms
(10)
Impact of Bt cotton on farmers’ health (in Barwani and Dhar
District of Madhya Pradesh –Dr. Ashish Gupta et al.
Investigation Report Oct. – Dec. 2005
www.gmwatch.org/print-archive2.asp?arcid=6266
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Symptoms overwhelmingly on exposed parts of body (face, hand,
feet, neck, eyes and respiratory tract). Only 1 of 23 had symptoms
only on covered parts of body (14 exposed body parts only, 8 both)
Almost 80% (18) exposed in cotton field, 4 exposed at home
Almost 74% (17) directly involved in picking cotton
People that symptoms increased in severity when they continued to
work in fields and decreased when they stopped work
Symptoms started within last two years, when Bt cotton was
introduced
Impact of Bt cotton on farmers’ health (in Barwani and Dhar District
of Madhya Pradesh –Dr. Ashish Gupta et al.
Investigation Report Oct. – Dec. 2005
www.gmwatch.org/print-archive2.asp?arcid=6266
Ginning factory
Owner noted that “most of the farmers and labourers
were having skin related problems due to Bt cotton”
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Detailed interview with 6 workers in different ginning
factories found all had itching problems on exposed
parts of body (hands, legs, face), and 2 were having
eruptions on body
Workers had been in factory from 2 – 7 years, but
symptoms only began last year, with introduction of
Bt cotton
MON 863
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MON 863—Monsanto Bt maize for corn
rootworm (with Cry3Bb1)
Approved in US and in EU
Monsanto submission revealed significant
effects on organs and blood parameters (Séralini et
al. 2007. New analysis of a rat feeding study with a genetically modified maize reveals
signs of hepatorenal toxicity. Arch Environ Contam Toxicol, 52: 596-602.)
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Increased: basophils, lymphocytes and white
blood cells. Decreased reticulocytes
Decreased kidney weight
Increased blood sugar
Vendômois, JS, Roullier, F, Cellier, D and GE Séralini. 2009. A
comparison of the effects of three GM corn varieties on
mammalian health. International Journal of Biological Sciences,
5(7): 706-726.
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Study obtained Monsanto’s submission to EU for 3
GE corn varieties (NK 603, MON 810, MON 863) and
reanalyzed all the data
“Approximately 60 different biochemical parameters
were classified per organ and measured in serum
and urine after 5 and 14 weeks of feeding.”
Vendômois, JS, Roullier, F, Cellier, D and GE Séralini. 2009. A
comparison of the effects of three GM corn varieties on
mammalian health. International Journal of Biological Sciences,
5(7): 706-726.
“Our analysis clearly reveals for the 3 GMOs new side effects
linked with GM maize consumption, which were sex- and often
dose-dependent. Effects were mostly associated with the
kidney and liver, the dietary detoxifying organs, although
different between the 3 GMOs. Other effects were also noticed
in the heart, adrenal glands, spleen and haematopoietic system.
We conclude that these data highlight signs of hepatorenal
toxicity, possibly due to the new pesticides specific to each GM
corn. In addition, unintended direct and indirect metabolic
consequences of the genetic modification cannot be excluded.”
Zolla, L. et al. 2008. Proteomics as a Complementary Tool for
Identifying Unintended Side Effects Occurring in Transgenic Maize
Seeds As a Result of Genetic Modifications. Journal of Proteome
Research, 7: 1850-1861.
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Proteomics is the study of expressed proteins. This
is good way to detect unintended effects associated
with GE, particularly the disruptive effects due to the
random insertion of transgene
Superior study design: GE maize (MON810) and
near isoline grown side-by-side in growth chamber, to
control for environmental effects
Zolla, L. et al. 2008. Proteomics as a Complementary Tool for
Identifying Unintended Side Effects Occurring in Transgenic Maize
Seeds As a Result of Genetic Modifications. Journal of Proteome
Research, 7: 1850-1861.
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Results: “43 proteins resulted up- or down-regulated in transgenic
seeds with respect to their controls (T06 vs WT06), which could be
specifically related to the insertion of a single gene into a maize
genome by particle bombardment.” (pg. 1850). Of these 43 proteins,
14 were down-regulated, 13 up-regulated, 9 shut off and 7 newly
expressed.
“Interestingly, a newly expressed spot (SSP 6711) corresponding to 50
kDa gamma zein, a well-known allergenic protein, has been detected.
Moreover, as a major concern, a number of seed storage proteins
(such as globulins and vicilin-like embryo storage proteins) exhibited
truncated forms having molecular masses significantly lower than the
native ones.” (pg. 1855)
Finamore, A et al. 2008. Intestinal and Peripheral Immune
Response to MON810 Maize Ingestion in Weaning and Old Mice.
Journal of Agricultural and Food Chemistry
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Well designed study: MON810 and near isoline grown simultaneously in
neighboring fields in Landriano, Italy, to control for environmental effects
“This study evaluated the gut and peripheral immune response to
genetically modified (GM) maize in mice in vulnerable conditions. Weaning
and old mice were fed a diet containing MON810 or its parental control
maize . . . for 30 and 90 days. . . As compared to control maize, MON810
maize induced alterations in the percentage of T and B cells and of CD4+,
CD8+, γδT, and RT subpopulations of weaning and old mice fed for 30 or 90
days, respectively, at the gut and peripheral sites. An increase of serum IL6, IL-13, IL-12p70, and MIP-1 [cytokines involved in allergenic and
inflammatory response] after MON810 feeding was also found. These
results suggest the importance of the gut and peripheral immune response
to GM crop ingestion as well as the age of the consumer in the GMO safety
evaluation.”
Velirimov et al. 2008. Biological effects of transgenic
maize NK603xMON810 fed in long term reproduction
studies in mice.
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Very carefully designed Austrian long-term feeding study. The non-GE
maize control was a near isogenic line. Both control and GE maize
were grown in adjacent fields in Canada in the same year (2005, 2007),
to control for environmental effects. Large sample sizes were used to
detect more subtle adverse effects.
Major result: statistically significant adverse reproductive effects shown
in the reproductive assessment by continuous breeding (RACB) study.
RACB is a feeding study whereby a pair of mice are fed GM maize for
140 days, during which time the female is bred so that she delivers 4
litters. RACB puts mice under stress making it easier to detect adverse
effects.
Velirimov et al. 2008. Biological effects of transgenic
maize NK603xMON810 fed in long term reproduction
studies in mice.
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“From 24 pairs assigned to the ISO and GM group, all females of the
ISO group (100%) delivered 4 litters. In the GM group the number of
deliveries declined with time. In the 4th litter only 20 deliveries occurred
(p=0.055). The average number of pups born was always lower in the
GM group but not significant before the 3rd delivery. There were
significantly fewer pups born in the GM group in the 3rd (p= 0.011) and
4th (p=0.010) delivery and weaned in the 4th litter (p=0.025).
Regarding all deliveries per group more pups were born in the ISO than
in the GM group (1035 versus 844). Furthermore females of the GM
group always had smaller litters (n < 8) as compared to females of the
ISO group.”
Benbrook, C. 2004. Genetically engineered crops and
pesticide use in the United States: The first nine years.
At: http://www.biotech-info.net/Full_version_first_nine.pdf
Benbrook, C. 2004. Genetically engineered crops and
pesticide use in the United States: The first nine years.
At: http://www.biotech-info.net/Full_version_first_nine.pdf
Benbrook, C. 2009. Genetically engineered
crops and pesticide use in the United States:
The first thirteen years.
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During first 9 years, pesticide use on genetically
engineered crops was increased by a total of 122
million pounds.
Update on the Benbrook’s 2004 paper: “Bt corn and
cotton has reduced insecticide use by 56 million
pounds, but herbicide tolerant crops have increased
pesticide use by 383 million pounds, for an overall
327 million pounds increase over the 13 years.”
So, for 1996-2004, 122 million pounds more pesticide
was used on GE compared to non-GE crops. For
2005-2008, an additional 205 million extra pounds
were applied.
Wang, S., Just, D.R. and P. Pinstrup-Andersen. Tarnishing Silver
Bullets: Bt technology adoption, bounded rationality and the outbreak
of secondary pest infestations in China.
Paper presented at American Ag. Econ. Assoc. annual meeting, Long Beach,
CA, 22-26 July, 2006
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Household survey of 481 farmers, 20 villages, 5 provinces:
Hebei, Shandong, Henan, Anhui, Hubei
Results for 2004:
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Average expenditure on pesticides was same ( US$101/ha)
between Bt and non-BT farmers
Bt farmers spend 46% less on bollworm pesticide, but spend 40%
more on pesticides for secondary pest(s), compared to non-Bt
farmers
Main secondary pest – mirids
GM cotton seeds cost 3 times more than non-Bt cotton, so Bt
farmers make less money than non-Bt farmers
Results markedly different from data from 1999, 2000, 2001
Wang, S., Just, D.R. and P. Pinstrup-Andersen. Tarnishing Silver
Bullets: Bt technology adoption, bounded rationality and the outbreak
of secondary pest infestations in China.
Paper presented at American Ag. Econ. Assoc. annual meeting, Long Beach,
CA, 22-26 July, 2006
Wang, S., Just, D.R. and P. Pinstrup-Andersen. Tarnishing Silver
Bullets: Bt technology adoption, bounded rationality and the outbreak of
secondary pest infestations in China.
Paper presented at American Ag. Econ. Assoc. annual meeting,
Long Beach, CA, 22-26 July, 2006
Wang, S., Just, D.R. and P. Pinstrup-Andersen. Tarnishing Silver
Bullets: Bt technology adoption, bounded rationality and the outbreak
of secondary pest infestations in China.
Paper presented at American Ag. Econ. Assoc. annual meeting, Long Beach,
CA, 22-26 July, 2006
Do GE crops reduce pesticide use?
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“farmers have rotated RR crops, usually
soya and maize, to the point that the
weeds themselves are now Roundup
resistant, which has resulted in much
higher applications of Roundup along
with a host of other chemicals.” Nathalie
Moll, EuropaBio. In “GM crops: Biotech agriculture—Time to
take GM seriously”, Ethical Corporation, February 7, 2008 At:
www.ethicalcorp.com/content.asp?ContentID=5684
Richard, S. et al. 2005. Differential effects of glyphosate and
Roundup on human placental cells and aromatase. Environmental
Health Perspectives, 113(6): 716-720.
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Exposure of male farmers in Ontario, Canada to glyphosate-based
herbicides was associated with increase in miscarriage and premature
birth in farm families (Savitz et al. 1997. Male pesticide exposure and pregnancy outcome. Am
J Epidemiology, 146: 1025-1036.) this study tried to look at possible mechanisms.
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Design: incubated human placental JEG3 cells with various
concentrations of Roundup (up to 2%) or equivalent concentrations of
glyphosate. Cell viability was measured after 18, 24, and 48 hours.
Aromatase (which regulates estrogen synthesis) levels were measured
after 1 hour and 18 hours.
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Results: 2% Roundup and an equivalent concentration of glyphosate
killed 90% of the JEG3 cells after 18 hours incubation. Median lethal
dose for Roundup (0.7%) was approximately 1.8 times lower than for
glyphosate. Viability of cells exposed to glyphosate was considerably
reduced when just 0.1% Roundup was added.
Richard, S. et al. 2005. Differential effects of glyphosate and
Roundup on human placental cells and aromatase. Environmental
Health Perspectives, 113(6): 716-720. Cont’d
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Results: After 1 hour incubation with Roundup, aromatase activity
increased by 40%. After 18 hours, synthesis was inhibited, with a
median inhibiting concentration (IC50) of 0.04%, perhaps reflecting an
effect on aromatase gene expression. No effect was seen with
glyphosate alone.
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In sum, study showed that effect of Roundup on cell viability increased
with time and was obtained with concentrations of Roundup 10 times
lower than those recommended for agricultural use. Roundup also
disrupted aromatase activity at concentrations 100 times lower than
those used in agriculture.
Eriksson, S., Hardell, L et al. 2008. Pesticide exposure as risk
factor for non-Hodgkin lymphoma including histopathological
subgroup analysis. Int. J. of Cancer, 123: 1657-1663.
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Design: Population based case-control study. 910 NHL cases (male
and female age 18-74 years, living in Sweden, from December 1, 1999,
to April 30, 2002) and 1016 controls.
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Results: Exposure to phenoxyacetic acids yielded odds ration (OR)
2.04 (95% confidence interval [CI 1.18-2.51]). Exposure to glyphosate
gave OR of 2.02, 95% CI 1.10-3.71 and with >10 years latency period
OR was 2.26, 95% CI 1.16-4.40.
Previous study involving pooled analysis of 2 Swedish case-control
studies showed OR for glyphosate of 3.04 (95% CI 1.08-8.52). (Hardell, L.,
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Eriksson, M and M. Nordstrom. 2002. Exposure to pesticides as risk factor for non-Hodgkin’s lymphoma
and hairy cell leukemia: pooled analysis of two Swedish case-control studies. Leukemia Lympoma, 10431049)
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Conclusion: “our study confirmed an association between exposure to
phenoxyacetic acids and NHL and the association with glyphosate was
considerably strengthened.”
Conclusion
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1. US FDA does not require preapproval safety assessments
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2. The endotoxins in Bt crops raise issues of allergenicity and
immunogenicity
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3. Feeding studies have found unexpected adverse effects
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4. Between 1995-2009, GE crops in US have increased use of
herbicides, particularly glyphosate, by 383 million pounds
and decreased insecticide use by 56 million pounds
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5. Roundup appears to be an endocrine disruptor and has been
linked to increased risk of Non-Hodgkin’s lymphoma
Codex Alimentarius
Principles for the Risk Analysis of Foods Derived
from Modern Biotechnology (CAC/GL 44 2003)
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“18. Risk managers should take into account the
uncertainties identified in the risk assessment and
implement appropriate measures to mange these
uncertainties
19. Risk management measures may include, as
appropriate, food labelling, conditions for market
approval and post-market monitoring”
(paras 18, 19 CAG/GL 44-2003)
Codex Alimentarius
Guideline for Conduct of Food Safety Assessment of
Foods Derived from Modern Biotechnology (CAC/GL 45
2003)
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“Unintended effects due to genetic modification may be
subdivided into two groups: those that are “predictable” and
those that are “unexpected” . . . A variety of data and information
are necessary to assess unintended effects because no
individual test can detect all possible unintended effects or
identify, with certainty, those relevant to human health. These
data and information which considered in total, provide
assurance that the food is unlikely to have an adverse effect on
human health” italics added (paras 16 and 17, CAG/GL 452003)
Codex Alimentarius
Guideline for Conduct of Food Safety
Assessment of Foods Derived from Modern
Biotechnology (CAC/GL 45 2003)
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“Molecular biological and biochemical
techniques (that) can also be used to
analyse potential changes at the level of
gene transcription and message
translation that could lead to unintended
effects” (para 16, CAG/GL 45-2003)
Unintended Effects
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Belgian scientists looked at molecular characterization of
6 transgenic crops: 3 Bt maizes; herbicide tolerant maize
(LibertyLink maize); glyphosate tolerant soybeans, and a
canola engineered for male sterility
In all but canola, structure of transgenic inserts differed
between a company’s initial submission and subsequent
studies. Differences involved rearranged inserts, partial
copies of genes inserted, multiple copies of transgenes
inserted, scrambling of DNA near the border of the
transgenic inserts, etc., instability and/or more likely to
result in unintended effects.
Scientists recommend that further analysis “should be
done to determine the presence of chimaeric open
reading frames in the border integration sequences”, e.g.
are any unexpected proteins being produced?
Codex Alimentarius
Annex on the Assessment of Possible Allergencity of the
Guideline for the Conduct of Food Safety Assessment of
Foods Derived from Recombinant-DNA Plants

“2. At present, there is no definitive test
that can be relied upon to predict allergic
response in humans to a newly expressed
protein” (para 2, Annex, CAG/GL 452003)