The Health Risks of DNA Nanobiothechnology

US GM crops Soy 94% Corn 88% Cotton 93% Canola 90% (Canada) Sugar beets 95% Alfalfa (hay, not sprouts) ?%

Minor Food Crops Hawaiian papaya virus resistantZucchini crookneck squash virus resistant

How do we avoid GMOs?  Buy organic  Buy products that are labeled non-GMO  Buy products listed on a Non-GMO Shopping Guide Non-GMO Shopping Guide  Avoid at-risk ingredients NonGMO ShoppingGuide. www. NonGMO ShoppingGuide.com for shopping guides and tips See

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? Rate yourself

cells nucleus chromosome DNA gene T A AA C C C G GG T TT A Basepairs: A-T & C-G (nucleotides)

1. Isolate a gene with a desired trait* desired trait* 2. Change the gene so it will work in plants* work in plants* 3. Prepare plant cells or tissue 4. Transform plant cells using a gene gun or bacteria infection method* or bacteria infection method* 5. Re-grow cells to plants via tissue culture (cloning)* How does Genetic Engineering work? * Steps that contain scientific uncertainties and risk potential

Gene construct Promoter: on switch Gene sequence Stop signal e.g. Bt toxin gene from soil bacterium often CaMV (virus) e.g. from pea

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

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 Products

Allergens Toxins New diseases Nutritional problems Agency scientists warned of:

GM plants could “contain unexpected high concentrations of plant toxicants.” 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.” “The possibility of unexpected, accidental changes in genetically engineered plants justifies a limited traditional toxicological study.” FDA Toxicology Group 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 of nutrients.” They 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 uniform way.” Food and Drug Administration “Statement of Policy” May 29, 1992

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 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.” Linda Kahl, FDA compliance officer

“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.” “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

Michael Taylor In charge of FDA policy Former Monsanto attorney Later Monsanto vice president Now US Food Safety Czar Who overruled the scientists?

‘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...’” FDA Letter to Monsanto, 1996

First GM Crop FlavrSavr Tomato

Yuk! Rats refused to eat the tomato

Many animals avoided GM feed when given a choice

Mice avoided GM corn

After 28 days 7 of 20 rats developed stomach lesions7 of 20 rats developed stomach lesions Another 7 of 40 died within 2 weeksAnother 7 of 40 died within 2 weeks Industry study

First possible cause of problems The process of creating a GM crop creates unpredicted changes in DNA and plant composition

Mutations (2-4% of DNA)Mutations (2-4% of DNA) Deletion of genesDeletion of genes Permanently on or offPermanently on or off Altered gene expressionAltered gene expression (up to 5%) (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. 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. 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. Yet to date, every attempt to challenge safety claims for biotech products has been categorically dismissed, or derided as unscientific.

Changes in Mon 810 corn “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 … exhibited truncated forms having molecular masses significantly lower than the native ones.” (Zolla)

GM soy has increased soy allergen Trypsin inhibitor (soy allergen) up to 7 times higher in cooked GM soy (Not denatured from cooking!)

Altered nutrients Increased:  Anti-nutrient (soy lectin)  Allergen (trypsin inhibitor)  Lignin (disease related?) Reduced:  Protein  A fatty acid  An essential amino acid  Phytoestrogens

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

UK attempts to create long-term safety studies

Dr. Arpad Pusztai

Rats fed GM potato (GNA lectin) Lining of the small intestine showed elevated lymphocyte counts Thymus and spleen showed changes White blood cells responded more slowly (Ewen and 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-GMGM

Stomach lining Non-GMGM