of Genetically Engineered Food

By Jeffrey M. Smith, Executive Director, Institute for Responsible Technology Author

The Documented Health Risks

Seeds of Deception & Genetic Roulette

Hawaiian papaya
virus resistant

Zucchini crookneck squash
virus resistant

Minor Food

US GM crops
Soy Corn Cotton Canola 91% 73% 87% 80% (Canada)

How do we avoid GMOs? Buy organic

 Buy products that are labeled non Buy products listed on a

Non-GMO Shopping Guide  Avoid at-risk ingredients See


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?



chromosome DNA gene







T Basepairs: A-T & C-G (nucleotides) A

How does Genetic Engineering work?

Isolate a gene with a desired trait* Change the gene so it will work in plants* Prepare plant cells or tissue Transform plant cells using a gene gun or bacteria infection uncertainties * Steps that contain scientific method* and risk potential




Gene construct
Regulatory sequence: on/off switch Coding sequence of a gene Regulatory sequence: Termination signal Plasmid backbone DNA,
often CaMV (virus) e.g. Bt toxin gene from soil bacterium

e.g. from pea

Identify cells with incorporated genes
Test for markers Add antibiotic Only transformed cells survive

Grow transformed GM cells via cloning (tissue

Antibiotic Resistant Genes

Director, Division of Anti-infective Drug

Agency scientists warned of:

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


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 of nutrients.” They recommended testing every GM
food “before it enters the marketplace.” Division of Food Chemistry and

“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)

“The agency is not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way.” “Statement of Policy”
May 29, 1992
Food and Drug Administration

FDA declares GMOs no different

Secret FDA documents confirmed that the facts contradicted the statement

“The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks.”
officer Linda Kahl, FDA compliance

What was said within FDA

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
Industry study •Another 7 of 40 died within 2 weeks

•7 of 20 rats developed stomach lesion

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 networksYork Times: July 1, 2007, New

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 precancerous 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



Stomach lining



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%)

Industry claims Bt:
• Has a history of safe use • Is destroyed during digestion • Is not active in mammals

•People react to Bt spray •Bt survives digestion

In reality

•Mice react to Bt-toxin


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 respirator y


Overal l

sneezing water itching Bt burning Spray runny nose y asthma red


Bt cotto n

sneezing water runny nose y red

inflammatio some n in red, swelling hospita l itching fever burning 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 respirator y Bt sneezing Spray runny nose asthma Bt corn polle n sneezing asthma coughs nose bleeds



watery Itching, red burning inflammation, red, swelling swelling

fever some in hospital fever some in hospital

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


Indicators for Liver and kidney toxicity Blood pressure problems, allergies, infections or disease, higher blood sugar and anemia Monsanto study


Third reason for The proteinproblems than may be different

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 Food Chemistry, pea 2005 protein

Fourth possible problem

More herbicide residues in herbicide tolerant

Chickens fed Liberty Link corn died at twice the rate

Industry study

Fifth possible problem

Gene transfer to gut bacteria or

Transfer of transgen es to gut bacteria is optimized

•Bacterial sequences are easier to transfer to bacteria •The gene’s promoter works in bacteria

Nature Biotechnology, 2004

Promoter Antibiotic resistant marker Roundup Ready genes Viral genes

What can transfer?

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

section near transgene

Extra transgene and Technology European Food Research


Altered nutrients
 Anti-nutrient (soy lectin)  Allergen (trypsin
inhibitor)  Lignin (disease related?) Reduced:

 Protein  A fatty acid  An essential amino

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.” PhD, Salk David Schubert,

2. Protein may be harmful
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 Estimated 120 million pound increase in 2 years accelerating In 1 year, 2005-2006, the increase was 38%
Usage of the more toxic 2,4-D was up 237% 2004-2006

Soy transgenes were confirmed in human gut

5. Gene transfer

Evidence of GM soyrelated 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
 Reduced digestive
enzymes  Altered cell structure Journal of Anatomy, 2002  Altered of Histochemistry, 2003 European Journal gene expression

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)

metabolism  Changed enzyme Animal Science, 2006 levels in the kidneys, hearts and livers

 Increased cell

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

Mice livers
Hepatocyte Nuclei

Control GM-fed

Mice livers
Hepatocyte Nuclei

Control GM-fed

Rat Livers А, B – control group

C, D – GM-soy group



Dr. Irina Ermakova

Mice fed GM soy
structure and function

Testicular cells had altered
European Journal of Histochemistry, 2004

Rat testicles
Control GM soy fed



Offspring of Mice Fed GM Soy embryos from GM-fed Young
temporary decrease in gene expression
parents had

Mortality of rat pups

First Generation

Irina Ermakova, 2005-2007


GM-soy Non-GM soy

GM-soy group


NonGM soy

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

Ermakova Irina, 2005-2007

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

Non-GM soy group

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

Killed about 100 and caused 5,000-10,000 to fall sick

L-tryptophan produced by GM bacteria

The epidemic was discovered because the disease
• Was new, with unique symptoms • Acute • Came on quickly

Current Assessments

No post-marketing 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
• How vigilant will you be to avoid bringing GM food home? • How active do you plan to be helping to stop this?

• 1-100, How vigilant to avoid GM food when eating out?

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! 2008 Harvest planned for fall,

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


General population

School meals
Under intense scrutiny Removin g junk foods

Health professionals to test for soy “I used
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

Healthconscious shoppers are  28 million adults
“high usage” organic buyers  54 million are “temperate” organic Health and Wellness Trends shoppers Database

Tipping point against rBGH
 September 2006, Boston Globe “Dairies are rushing to rid their bottled milk of artificial growth hormones. . . it could  be a tipping point.” York October 2006, New Times “It seems to be an explosion inWal-Mart, Kroger, Starbucks,  the and industry.”

about 40 of the top 100 dairies

Education is Key!

How do we avoid GMOs? Buy organic

 Buy products that are labeled non Buy products listed on a

Non-GMO Shopping Guide  Avoid at-risk ingredients See


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