The Documented Health Risks

Genetically Engineered
of Food
By Jeffrey M. Smith,
Executive Director, Institute for Responsible
Technology
Author
Seeds of Deception & Genetic
Roulette
Hawaiian
papaya
virus resistant
Zucchini
crookneck
squash
virus resistant
Minor Food
US GM crops
Soy 91%
Corn 73%
Cotton 87%
Canola 80% (Canada)
 How do we avoid
 GMOs?
Buy organic
 Buy products that are labeled non-
GMO
 Buy products listed on a
Non-GMO Shopping Guide
 Avoid at-risk ingredients
See
www. responsibletechnology.o
Rate
yourself
1-100, How vigilant were
you to avoid GM food
when eating out?

1-100, How vigilant were

you this week to avoid
bringing GM food home?
Rate yourself
1-100, How active you
have been in educating

people on this issue?

 cells
nucleus

chromosome
DNA
gene

A A C T C G T
Basepairs: A-T & C-G (nucleotides)
T T G A G C A
How does
Genetic Engineering
work?
1. Isolate a gene with a
desired trait*

4. Change the gene so it will

work in plants*

7. Prepare plant cells or tissue

9. Transform plant cells using a gene gun

*or bacteria
Steps infection
that contain scientific method*
uncertainties and risk potential
 Gene construct
often CaMV (virus)
Regulatory
sequence: on/off
switch e.g. Bt toxin gene
from soil
bacterium
Coding sequence of a
gene

Regulatory e.g.
sequence: from
Termination
Plasmid signal
backbone DNA, pea
 Identify cells with
incorporated genes
Test for markers
Add antibiotic
Only
transformed
cells survive
Grow transformed
GM cells
via cloning (tissue
culture)
Antibiotic Resistant
Genes
“IT WOULD BE A SERIOUS
HEALTH HAZARD TO
INTRODUCE A GENE THAT
CODES FOR ANTIBIOTIC
RESISTANCE INTO THE
NORMAL FLORA OF THE
GENERAL POPULATION.”

Director, Division of Anti-infective Drug

Agency scientists warned
of:
Allergens

Toxins

New diseases
 GM plants could “contain
unexpected high concentrations
of plant toxicants.”

 “The possibility of unexpected,

accidental changes in
genetically engineered plants
justifies a limited traditional
toxicological study.”

FDA Toxicology
Group
1. “Increased levels of known
naturally occurring toxins”,
2. “Appearance of new, not previously
identified” toxins,
3. Increased tendency to gather
“toxic substances from the
environment” such as “pesticides
or heavy metals”, and
4. “Undesirable alterations in the
levels
They of nutrients.”
recommended testing every GM
food “before it enters the
marketplace.”
Division of Food Chemistry and
Technology
 “Residues of plant
constituents or toxicants
in meat and milk
products may pose
human food safety
concerns.”
Gerald Guest, Director, FDA’s
Center for Veterinary Medicine (CVM)
 FDA declares GMOs no
different
“The agency is not aware of any
information showing that foods
derived by these new methods differ
from other foods in any meaningful
or uniformofway.”
“Statement Policy”
May 29, 1992

Food and Drug Administration

 Secret FDA
documents
confirmed that
the facts
contradicted
the statement
 What was said within
FDA
“The processes of genetic
engineering and traditional
breeding are different, and
according to the technical
experts in the agency, they lead
to different risks.”

Linda Kahl, FDA compliance

officer
By “trying to force an
ultimate conclusion that
there is no difference
between foods modified by
genetic engineering and
foods modified by traditional
breeding practices,” the
agency was “trying to fit a
square peg into a round
hole.”
“Animal feeds derived from
genetically modified plants
present unique animal and food
safety concerns.”

“I would urge you to eliminate

statements that suggest that
the lack of information can be
used as evidence for no
regulatory concern.”

Gerald Guest, Director, FDA’s

Center for Veterinary Medicine (CVM)
“There is a profound difference between the types of
unexpected effects from traditional breeding and
genetic engineering,”

“There is no certainty that [breeders] will be able to

pick up effects that might not be obvious.”

“This is the industry’s pet idea, namely that there

are no unintended effects that will raise the FDA’s
level of concern. But time and time again, there is no
data to back up their contention.”

FDA microbiologist Louis Pribyl

“What has happened to the scientific
elements of this document? Without a
sound scientific base to rest on, this
becomes a broad, general, ‘What do I
have to do to avoid trouble’-type
document. . . . It will look like and probably
be just a political document. . . . It reads
very pro-industry, especially in the area of
unintended effects.”
FDA microbiologist Louis Pribyl
Who overruled
the scientists?
Michael Taylor
• In charge of FDA policy
• Former Monsanto
attorney
• Later Monsanto vice
president
‘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. . . . as you
are aware, it is Monsanto’s responsibility to
ensure that foods marketed by the firm are
safe...’”
First GM
Crop

FlavrSav
Tomato
r
Rats refused
to eat the Yuk!
tomato
 After 28 days
•7 of 20 rats developed stomach lesion

•Another
Industry study
7 of 40 died within 2 weeks
First possible
cause of
problems
The process of
creating a GM
crop creates
unpredicted
changes in DNA
and plant
composition
Unexpected
changes
in the DNA
•Mutations (2-4% of
DNA)
•Deletion of genes
•Permanently on or off
•Altered gene
expression
(up to 5%)
Disruption of gene
networks
July 1, 2007, New York Times:
 The presumption that genes operate
independently has been institutionalized. . . . It is
the economic and regulatory foundation on which
the entire biotechnology industry is built.
 Evidence of a networked genome shatters the
scientific basis for virtually every official risk
assessment of today’s commercial biotech
products.
 Yet to date, every attempt to challenge safety
claims for biotech products has been categorically
dismissed, or derided as unscientific.
DNA changes can alter:

•RNA
•Proteins
•Natural compounds
 UK attempts to create
long-term safety studies
Dr. Arpad
Pusztai
GM potatoes
damaged rats
(10 or 110
days)
Rats developed
• Potentially pre-
cancerous cell growth
in the digestive tract
• Smaller brains, livers
and testicles
• Partial atrophy of the
liver, and
• Immune system
damage
Lancet, 1999 & others
Intestinal Wall

Non-GM GM
Stomach lining

Non-GM GM
A second cause of problem
The protein
produced
by the inserted
gene
may be harmful
 Two primary
traits
• Herbicide tolerance (73%)
– Roundup Ready
– Liberty Link
• Pesticide production (18%)
– Bt toxin
• Crops with both traits (8%)
Bt-toxin
Industry
claims Bt:
• Has a history of
safe use
• Is destroyed during
digestion
• Is not active in
mammals
 In reality
•People react to Bt spray
•Bt survives digestion
•Mice react to Bt-toxin
Bt in crops
Thousands of times more
concentrated than the spray

Designed to be more toxic

Has properties of a
known allergen
Bt cotton
Hundreds of
laborers in India
reported allergic
reactions to Bt
cotton
 Upper Eyes Skin Overal
respirator l
y

Bt sneezing water itching fever

Spray runny nose y burning
asthma red inflammatio some
n in
red, swelling hospita
l
Bt sneezing water itching fever
cotto runny nose y burning
n red eruptions some
red, swelling in
hospita
l
Bt cotton
Thousands of
sheep died after
grazing on
Bt cotton plants
“The Andhra Pradesh
government has advised
farmers not to allow animals to
graze on Bt cotton fields after
four institutes reported the
presence of toxins in them.”
The Hindustan Times, 17 June 2007
Bt corn, reports…

12 cows
died on
German
a
farm
Bt corn, reports…
Farmer
s say
pigs
and
cows
becam
e
sterile
Bt corn, reports…

Inhaled
pollen
may have
 Upper Eyes Skin Overall
respirator
y

Bt sneezing watery Itching, fever

Spray runny red burning some in
nose inflammation, hospital
asthma red, swelling

Bt sneezing swelling fever

corn asthma some in
polle coughs hospital
n nose
bleeds

Other symptoms: headache, stomach ache, dizziness,

diarrhea, vomiting, weakness, numbness.
9 horses, 4 water buffalos, and 37 chickens died after eating
the corn.
5 unexplained human deaths.
Rats ate Bt corn (90
days)
Indicators for
Liver and kidney
toxicity
Blood pressure
problems,
allergies, infections
or disease, higher
blood sugar and
Monsanto anemia
study
 Third reason for
The proteinproblems
may be different than
intended
The transgene sequence may:
Mutate
or
Rearrange
truncate
Be read

differently
Produce
multiple

proteins
 The protein
may:

Be folded differently

Have different molecules
Mice had
an
immune
response
toAgricultural
GM
pea
Food Chemistry,
2005
protein
Fourth possible problem

More herbicide residues

in herbicide tolerant
Chickens fed
Liberty Link
Industry study

corn died at
twice
the rate
 Fifth
possible Gene
problem transfer to
gut
bacteria
or
 Transfer •Bacterial
of sequences are
transgen easier to
transfer to
es to gut bacteria
bacteria
is •The gene’s
promoter
optimized works in
bacteria
Nature Biotechnology, 2004
 What
can
Promoter transfer?
Antibiotic
resistant marker

Roundup Ready
genes
Viral genes
Summary:
Possible Sources of
Problems
1. Disruption of
DNA
2. GM protein

3. Changes in the
protein
4. Herbicide
residues
Case Study: Roundup Ready
Soy
1.Disrupted DNA
Damaged section
near transgene

Extra transgene
European Food Research and Technology

fragments
Altered nutrients
Increased:
 Anti-nutrient (soy lectin)
 Allergen (trypsin
inhibitor)
Reduced:
Lignin (disease related?)
 Protein
 A fatty acid
 An essential amino
acid
GM soy has higher lignin
content
“Components of this
same biochemical
pathway also
produce… rotenone,
a plant-produced
insecticide that may
cause Parkinson’s
disease.”
David Schubert, PhD, Salk
Institute
2. Protein may be harmful

Properties of
a known
allergen (dust
mite)
3. GM protein may be altered

 RNA was longer than intended

 Further processed into four
variants, which may create
unintended proteins
4. Increased herbicide
138 million pounds more in the US in the first 9
years
In 2004, approximately 86% more Roundup on GM
soy
Increased fusarium on crops (wheat, soy roots)
 Herbicide use is
accelerating
Estimated 120 million pound increase in 2 years
In 1 year, 2005-2006, the increase was 38%
Usage of the more toxic 2,4-D was up 237% 2004-2006
5. Gene transfer
Soy transgenes were
confirmed in human gut
Evidence of GM soy-
related problems
 Soon after
GM soy
was
introduced
into the UK,
soy
allergies
skyrockete
York Laboratory
d
by 50%.
Skin prick test
“One patient had
a positive skin
test
result to GMO
soybeans only.”
Allergy and Asthma Proceedings, 2005
Mice fed GM
soy
Pancreas
 Reduced digestive
enzymes
 Altered cell structure
Journal of Anatomy, 2002
European
Altered gene
Journal of expression
Histochemistry, 2003
 Possible causes for increase
allergies

 Digestion impaired
 New allergen created
 Known allergen increased
 Herbicide residues increased
 Roundup Ready (RR) protein may be
allergenic
 RR protein continuously produced inside
our intestines
Rabbits Fed Roundup Ready
Soy
(For 40 days)

 Increased cell
metabolism
 Changed enzyme
levels in the kidneys,
Animal Science, 2006

hearts and livers

Mice fed GM
soy
Liver
 Cells damaged
 Altered gene expression
 Higher
Cell metabolic
Structure and Function, activity
(suggesting toxic insult)
2002
 Mice livers
Hepatocyte Nuclei

Control GM-fed
 Mice livers
Hepatocyte Nuclei

Control GM-fed
 Rat
А, B – control group
Livers
C, D – GM-soy group

A C

B D

Dr. Irina Ermakova

Mice fed GM
soy
Testicular cells had altered
structure and
European Journal of Histochemistry, 2004

function
 Rat testicles
Control GM soy fed

Control GM-soy
Offspring of Mice
Fed GM
Soy
Young embryos from GM-fed
temporary
parents had
decrease in gene
expression
In
 First Generation
Mortality of rat pups

Irina Ermakova, 2005-2007

Control GM-soy Non-GM soy
 GM-soy
group
Mortalit
y of rat
offsprin
g for
Control Non- one day
GM-soy
GM
soy

Ermakova Irina, 2005-2007

 Rat litters Non-GM soy
group
at
9-days from
mothers
fed
non-GM
or GM
GM-soy group
soy.

Irina Ermakova, 2005-2007

 19-day old rats
Larger rat is from control group;
smaller from GM-soy group.
Irina Ermakova,
Preliminary evidence
Rat offspring did not
conceive
 When the entire
Russian facility began using
GM soy-based feed,
infant mortality
for all rats hit 55.3%.
GM crops are so bad, why don’t we see more problems
 L-tryptophan produced by GM
bacteria
Killed about 100 and
caused
5,000-10,000 to fall sick
The epidemic
was discovered
because the
disease
• Was new, with unique
symptoms
• Acute
• Came on quickly
 Current No post-marketing
Assessments surveillance

No human
clinical trials
No proper evaluation
of plant changes
or effects
Approvals based on
disproved or untested
assumptions
Industry
studies
Rate yourself 1-100
• 1-100, How vigilant to avoid GM food when eating out?
• How vigilant will you be to avoid bringing GM food
home?
• How active do you plan to be helping to stop this?
How do we stop
the genetic
engineering of
our food supply?
 Landslide among
manufacturers

Removed GMOs from EU!

Dr. Arpad
Pusztai
Limited expansion
• 4 major crops
• 2 major traits
• 6 countries
• 2.4% of global agricultural
land
 GM Sugar Beet
Alert!
Harvest planned for fall, 2008
www.DontPlantGMOBeets.org
US awareness is
low
As far as you know, have you
ever eaten genetically
modified foods?
•No........................................60%

•Don’t Know...........................15%
•Yes.......................................25%
Tipping point for US
rejection of GM
crops may be quite
soon
Campaign for Healthier
Eating in America

www.ResponsibleTechnology.org
 General
population
School
Under
meals intense
scrutiny
Removin
g junk
foods
 Health
professionals
“I used to test for soy
allergies all the time, but
now that soy is genetically
engineered, it is so
dangerous that I tell
people never to eat it—
unless it says organic.”
—John H. Boyles, MD, ear, nose,
and throat, and allergy specialist
Religious groups
Health-
conscious
shoppers
 28 million adults are
“high usage” organic
buyers
 54 million are
“temperate” organic
shoppers
Health and Wellness Trends
Database
 Tipping point against
rBGH
 September 2006, Boston
Globe
“Dairies are rushing to rid
their bottled milk of artificial
growth hormones. . . it could
October
 be 2006,
a tipping New York
point.”
Times
“It seems to be an explosion
in
 Wal-Mart, Kroger, Starbucks,
andthe industry.”
about 40 of the top 100
dairies
Education is Key!
 How do we avoid
 GMOs?
Buy organic
 Buy products that are labeled non-
GMO
 Buy products listed on a
Non-GMO Shopping Guide
 Avoid at-risk ingredients
See
www. responsibletechnology.o