Genetically Engineered Foods: How Altering the DNA of Our Food May Be Altering Our Health

Beth Ellen DiLuglio, MS, RDN, CCN, LDN Nutrition Is Your Best Health Insurance!® NutritionMission® NutritionMission.org 561-881-9999

©Beth Ellen DiLuglio, MS, RDN, CCN, LDN Genetically Engineered Foods Outline & Objectives

Define genetic engineering Describe the history and Identify potential and Explain how to clinically and genetically modified regulation of genetic proposed benefits of GMOs as assess patients for well as potential health organisms (GMOs) engineering and GMOs complications of consuming suspected adverse GMOs and associated reactions to GMOs. pesticides WHO definition of GMOs Early concerns of FDA Aspiration to create high Assess for adverse scientists (allergens, yield, more nutritious reactions such as Genetic engineering versus toxins, nutritional crops gastrointestinal traditional effects, new disease) breeding/hybridization complications, immune Use of GMOs to produce reactions, toxin Lack of long-term pharmaceuticals and Genetically engineered exposure, micronutrient human safety studies vaccines foods and animals deficiencies, metabolic abnormalities Current GMO foods/ traits “Substantial Potential complications -Production of Bt pesticide equivalence” and of GMOs and associated within GMO plant (regulated as Generally Recognized as pesticides Consider eliminating a pesticide) Safe (GRAS) and reintroducing -Resistance/tolerance to GMO designation Early animals studies associated pesticides GMOs suggest health Be aware of where GMOs Introduction of GMOs complications are found in the food into food supply Gastrointestinal Test urine levels of supply Disruption of gut microbiome herbicides (e.g. Immunological/allergenic Controversial aspects of glyphosate) Antibiotic resistance GMOS and Metabolic Labeling of GMOs 2 Genetically Engineered Foods Outline & Objectives Define genetic engineering, genetically modified organisms

 WHO definition of genetically modified organisms (GMOs)

 Genetic engineering vs traditional breeding/hybridization

 Genetically engineered foods and animals

 Current GMO foods/traits

 Production of Bt pesticide within GMO plant (plant regulated as pesticide)

 Resistance/tolerance to GMO associated pesticides

 Be aware of where GMOs are in food supply

3 What is genetic engineering? World Health Organization definition

According to The World Health Organization (WHO)

“Genetically modified (GM) foods are foods derived from organisms whose genetic material (DNA) has been modified in a way that does not occur naturally, e.g. through the introduction of a gene from a different organism.”

World Health Organization. Food, Genetically Modified. Retrieved April 12, 2016 from http://www.who.int/topics/food_genetically_modified/en/

4 Further defining GMOs

“Combining genes from different organisms is known as recombinant DNA technology and the resulting organism is said to be ‘Genetically modified (GM)’, ‘Genetically engineered’ or ‘Transgenic’” Bawa, A. S., & Anilakumar, K. R. (2012). Genetically modified foods: Safety, risks and public concerns—a review. J Food Sci Technol Journal of Food Science and Technology, 50(6), 1035-1046. doi:10.1007/s13197-012-0899-1. Retrieved April 6, 2016 from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3791249/pdf/13197_2012_Article_899.pdf

Genetically modified (GM) plants are produced by altering the DNA of the plant genome, mitochondria or chloroplasts through the introduction, rearrangement or removal of DNA.” (chloroplasts are the food producers of the plant“) Metcalfe, D. D. (2005). Genetically modified crops and allergenicity. Nature Immunology Nat Immunol, 6(9), 857-860. doi:10.1038/ni0905- 857 Retrieved April 16, 2016 from http://faculty.jsd.claremont.edu/emorhardt/159/pdfs/2006/Metcalfe.pdf

5 Genetic engineering vs traditional breeding/hybridization Genetic engineering

 Alters the blueprint of a plant or organism, fundamentally changing it

 Uses gene insertion, often forcibly combines DNA from two unrelated species (e.g. splices bacterial genes into a plant or human genes into an animal)

 Is profoundly different than traditional breeding or hybridization as it inserts genetic material from different species, families, and kingdoms; also can insert “custom-designed genes” that don’t occur naturally

 Creates novel, often patented GMOs

 Can disrupt natural biodiversity and have unpredictable consequences

World Health Organization. Frequently asked questions on genetically modified foods. Retrieved April 6, 2016 from http://www.who.int/foodsafety/areas_work/food-technology/faq-genetically-modified-food/en/ FDA. Genetically Engineered Animals. Retrieved April 12, 2016 from http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/default.htm Phillips T. Genetically modified organisms (GMOs): Transgenic crops and recombinant DNA technology. Nature Education. 2008;1(1):213. Retrieved April 12, 2016 from http://www.nature.com/scitable/topicpage/genetically- modified-organisms-gmos-transgenic-crops-and-732 Samsel, A., & Seneff, S. (2013). Glyphosate’s Suppression of Cytochrome P450 Enzymes and Amino Acid Biosynthesis by the Gut Microbiome: Pathways to Modern Diseases. Entropy, 15(4), 1416-1463. doi:10.3390/e15041416 Retrieved April 16, 2016 from http://groups.csail.mit.edu/sls/archives/root/publications/2013/Seneff_Entropy-15-01416.pdf Hansen MK. GENETIC ENGINEERING IS NOT AN EXTENSION OF CONVENTIONAL PLANT BREEDING; How genetic engineering differs from conventional breeding, hybridization, wide crosses and horizontal gene transfer. Consumers Union. January 2000. Retrieved April 6, 2016 from http://consumersunion.org/wp-content/uploads/2013/02/Wide-Crosses.pdf 6 Genetic Engineering in a Brave New World Scientists can now

 Create trans-species organisms

 Switch genes on and off

 Manipulate metabolic pathways within a plant, animal, or microorganism by altering its DNA

7 Current GMO Traits GMO Crops

 Resist /tolerant to industrial herbicides

 Produce pesticides (e.g. insecticide)

 Produce proteins to be used in pharmaceutical drugs

 “Stacked” trait crops produce one or more insecticides and/or tolerate one or more herbicides GMO Microbes & Animals

 Genetically engineered bacteria produce specific amino acids, enzymes, proteins, and vaccines

 Genetically engineered animals produce pharmaceuticals and therapeutic proteins

 Animals genetically engineered with “humanized” genes produce specific nutrients, reduce risk of organ rejection for transplant patients GMO Future Aspirations

 Creation of crops that produce a higher yield

 Production of crops with increased nutritional value

 Production of crops with increased resistance to environmental stress

 Reduction in overall pesticide use 8 Current GMO Traits: Insecticide-producing crops Bacterial genes are spliced into food and cotton crops so that the plant itself constantly produces an active insecticidal toxin (e.g. Bt toxin)

Bt toxin is a “microbial disruptor of insect midgut membranes”

Plant Sciences UC Davis. Retrieved April 12, 2016 from http://www.plantsciences.ucdavis.edu/gepts/GeptsGMOsandtheEnvironmentb.pdf

9 Bt in crops Built-in insecticide

.Thousands of times more concentrated than the spray

.Designed to be more toxic

.Has properties of a known allergen

Slides used with permission of The Institute for Responsible Technology http://responsibletechnology.org/

10 Current GMO Traits: Herbicide Tolerance (HT) GMO crops that are tolerant to herbicides have been genetically engineered with bacterial genes that confer

resistance to specific herbicides[i] [ ii]

 “Roundup Ready®” and “LibertyLink® seeds/crops tolerate substantial amounts of corresponding herbicide* without killing off the GMO HT plant *Monsanto’s glyphosate-based Roundup® or Bayer’s glufosinate-based Liberty® respectively

 These herbicides will decimate non-GMO crops[iii] [iv]

[i] ISAAA. Herbicide Tolerance Technology: Glyphosate and Glufosinate.Retrieved April 12, 2016 from http://isaaa.org/resources/publications/pocketk/10/default.asp [ii] Staub JM, Brand L, Tran M, et al. Bacterial glyphosate resistance conferred by overexpression of an E. coli membrane efflux transporter. J IndMicrobiol Biotechnol. 2012 Apr;39(4):641-7. doi: 10.1007/s10295-011-1057-x. Epub 2011 Nov 17. PubMed PMID: 22089966. [iii] Bayer CropScience. United States. Retrieved April 12, 2016 from https://www.bayercropscience.us/products/traits/libertylink Updated January 15, 2015. [iv] Monsanto Crop Protection Update. The Science of Roundup Ready Technology, Glyphosate and Micronutrients. Part 1 – Glyphosate Chemistry, Efficacy and Interaction with Micronutrient Foliar Applications. Retrieved April 12, 2016 from http://www.monsanto.com/newsviews/documents/cpu_roundup_ready_crops_glyphosate_and_micronutrients.pdf

11 Genetic engineering of animals Bioreactors Transgenic animals are called “bioreactors”

 Created through genetic engineering to produce biopharmaceuticals, vaccines, or nutraceuticals

 Some have been crossed with human genes to produce organs

with decreased potential for rejection.[i] [ii] [iii] [iv] [v] [vi]

 Pigs with “humanized genes” developed to produce “cloned transgenic heart-healthy pork” with more omega-3 fatty

acids, creating a heart-healthy delight (!?)[vii]

[i] Wells DJ. Genetically modified animals and pharmacological research. Handb Exp Pharmacol. 2010;(199):213-26. doi: 10.1007/978-3-642-10324-7_9. Review. PubMed PMID: 20204589. [ii] Samiec M, Skrzyszowska M. Transgenic mammalian species, generated by somatic cell cloning, in biomedicine, biopharmaceutical industry and human nutrition/dietetics--recent achievements. Pol J Vet Sci. 2011;14(2):317-28. Review. PubMed PMID: 21721422. [iii] Le Bas-Bernardet S, Anegon I, Blancho G. Progress and prospects: genetic engineering in xenotransplantation. Gene Ther. 2008 Sep;15(18):1247-56. doi: 10.1038/gt.2008.119. Review. PubMed PMID: 18762806. [iv] Ormandy EH, Dale J, Griffin G. Genetic engineering of animals: ethical issues,including welfare concerns. Can Vet J. 2011 May;52(5):544-50. PubMed PMID: 22043080. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3078015/. Accessed June 17, 2015. [v] World Health Oganization. Frequently asked questions on genetically modified foods.http://www.who.int/foodsafety/areas_work/food-technology/faq-genetically-modified-food/en/. Accessed June 17, 2015. [vi] Houdebine LM. Transgenic animal bioreactors. Transgenic Res. 2000;9(4-5):305-20. Review. PubMed PMID: 11131009. [vii] Prather RS. Cloned transgenic heart-healthy pork? Transgenic Res. 2006 Aug;15(4):405-7. Review. PubMed PMID: 16906441. 12 USDA recognizes profit potential of animal pharming

According to the USDA

 “Animal pharming, the process of using transgenic animals to produce human drugs, is staking its claim in a lucrative world market.

 Transgenic animals are animals which have been genetically transformed by splicing and inserting foreign animal or human genes into their chromosomes.

 The inserted gene, when successful, enables an animal to make a certain pharmaceutical protein in its milk, urine, blood, sperm, or eggs, or to grow rejection-resistant organs for transplant…one transgenic animal can produce, in its lifetime, $200 to $300 million worth of pharmaceuticals.”[i]

The anti-thrombin drug ATryn® is the first drug produced by genetically engineered animals (goats) to be approved by the FDA.[ii] [iii]

[i] USDA Animal and Plant Health Inspection Service. Animal Pharming: The Industrialization of Transgenic Animals. http://www.aphis.usda.gov/animal_health/emergingissues/downloads/animal_pharming.pdf. Accessed June 18, 2015. [ii] Ormandy EH, Dale J, Griffin G. Genetic engineering of animals: ethical issues, including welfare concerns. Can Vet J. 2011 May;52(5):544-50. PubMed PMID: 22043080. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3078015/. Accessed June 17, 2015. [iii] Atryn. http://www.atryn.com/recombinant.php. Accessed July 6, 2015.

13 Genetically engineered animals “Pharm animals” Genetic engineering of animals & crops

 Both animals and crops designed to produce pharmaceutical proteins

 Has become routine although not highly regulated

Pigs genetically engineered with spinach desaturase gene (converts saturated fat to unsaturated linoleic acid)- high degree of mortality

 Dona, A., & Arvanitoyannis, I. S. (2009). Health Risks of Genetically Modified Foods. Critical Reviews in Food Science and Nutrition, 49(2), 164-175. doi:10.1080/10408390701855993 PMID: 18989835

Transgenic GMO pigs produced at University of Florida stolen and made into sausage…

 Loftus, R. (2005). Traceability of biotech-derived animals: application of DNA technology. Revue scientifique et technique (International Office of Epizootics),24(1), 231-242. Retrieved April 6, 2016 fromhttp://www.oie.int/doc/ged/D1940.PDF GMO fluorescent lamb enters food supply.

 In France a lamb whose mother had been genetically modified with a jellyfish protein as part of a medical experiment sold as meat. It is illegal to sell genetically modified food in France.

US News and World Report. Associated Press. Press June 23, 2015. France probes GMO lamb with jellyfish protein, used in medical experiment, sold as meat. Retrieved April 6,2016 from http://www.usnews.com/news/world/articles/2015/06/23/gmo- lamb-with-jellyfish-protein-sold-for-meat-in-france 14 Where are GMOs found? Canadian Biotechnology Action Network (CBAN)

4 GMO crops account for almost 99% of GMO crops across the globe: corn soy cotton canola

Majority of GMOs contain at least 1 of two traits:

 Herbicide tolerance (85% of all GMO crops)

 Insect resistant

10 countries account for 98% of all GMO acres globally

 Top 3 GMO countries account for 75% of global GMO acres: USA Argentina Brazil

Slater, A., & Holtslander, C. Canadian Biotechnology Action Network. (2015). Where in the world are GM crops and foods? Retrieved April 5, 2016 from http://www.indiaenvironmentportal.org.in/files/file/where-in-the-world-gm-crops-foods.pdf

17 IMPORTANT GE CROPS IN 2003 Herbicide-tolerant soybean was the dominant transgenic crop, grown commercially in 7 countries in 2003

 USA, Argentina, Canada, Mexico, Romania, Uruguay South Africa

Insect-resistant maize was 2nd most dominant crop, planted in nine countries

 USA, Canada, Argentina, South Africa, Spain, Philippines, Honduras, Uruguay, Germany

Herbicide-tolerant canola was 3rd most dominant crop

 planted in two countries- Canada and USA Bt cotton is increasingly important in countries such as China, India, South Africa

James, C. 2003. Preview: Global Status of Commercialized Transgenic Crops: 2003. ISAAA Brief No. 30. Ithaca, NY. Retrieved April 12, 2016 from http://absp2.cornell.edu/resources/briefs/documents/warp_briefs_eng_scr.pdf

18 Approved for U.S. market as of 2006

Herbicide resistance corn, soy, cotton, canola, rice, alfalfa, beet, flax

Insect resistance corn, cotton, potato, tomato

Sterile pollen corn, chicory (radicchio) Virus resistance papaya, squash, plum

Delayed ripening tomato

Altered oil canola, soy

Altered protein composition corn

Reduced nicotine tobacco Lotter D. The genetic engineering of food and the failure of science–Part 1: The development of a flawed enterprise. Int Jrnl of Soc of Agr & Food. 2009;16(1):31-49. Retrieved April 12, 2016 from http://ijsaf.org/archive/16/1/lotter1.pdf f Soc of Agr & Food. 2009;16(1):31- 49. Retrieved April 12, 2016 from http://ijsaf.org/archive/16/1/lotter1.pdf

19 GMO stats In 2012 Worldwide biotech GMO crops accounted for 170 million planted acres

In the USA major GMO food crops are soy and corn

 GMO soybeans accounted for 93% of all soybeans planted in USA (mostly herbicide tolerant)

 GMO corn accounted for 88% of all corn planted in USA (mostly insecticide producing)

FDA's Role in Regulating Safety of GE Foods. http://www.fda.gov/forconsumers/consumerupdates/ucm352067.htm Retrieved April 16, 2016 from https://njfb.org/wp- content/uploads/2013/07/FDA-GE-Answers.pdf

20 GMO Bt Crop proliferation (% U.S. crop)[i] Bt is an insecticidal toxin

GMO Bt corn

 1997 = 8% of U.S.

 2001 = 19%

 2003 = 29%

 2015 = 81% GMO Bt Cotton

 1997 = 15%

 2001 = 37%

 2015 = 84% GMO Bt Soy

 Deregulated/approved in 2014[ii]

USDA. Recent Trends in GE Adoption. Retrieved April 12, 2016 from http://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-crops- in-the-us/recent-trends-in-ge-adoption.aspx Updated July 9, 2015. Keller R. Dow two-Bt soybean insect-resistant trait approved. Ag Professional. May 1, 2014. Retrieved April 12, 2016 from http://www.agprofessional.com/news/Dow-two-Bt-soybean-insect-resistant-trait-approved-257548091.html

21 GMOs in the United States 2015 GMO crops currently on the U.S. market include

 Soy, corn, canola, cotton, sugar beets, squash, alfalfa, Hawaiian papaya FDA has had “consultations” (requests for consideration) for

 Genetically engineered cantaloupe, flax, plum, potato, radicchio, tomato, and wheat[i] Most processed foods contain at least one GMO ingredient

 e.g. high fructose corn syrup, soybean oil, soy protein, soy lecithin, sugar from sugar beets, canola oil, etc.[ii] [iii]

[i] FDA Facts: Food from Genetically Engineered Plants. http://www.fda.gov/downloads/Food/PopularTopics/UCM385844.pdf Accessed June 17, 2015. Retrieved April 16, 2016 from http://www.fda.gov/downloads/NewsEvents/MeetingsConferencesWorkshops/UCM472504.pdf Biotechnology Consultations on Food from GE Plant Varieties. http://www.accessdata.fda.gov/scripts/fdcc/?set=Biocon. Updated March 20, 2015. Accessed June 30, 2015. [ii] Byrne P, Pendall D, Graff G. Colorado State University Extension. Labeling of Genetically Modified Foods. April 2002. Revised October 2014. http://www.ext.colostate.edu/pubs/foodnut/09371.html. Accessed June 22, 2015. [iii] MacDonald RS. Safety of Genetically Modified Foods and Food Ingredients. Animal and Plant Health Inspection Service. http://www.aphis.usda.gov/stakeholders/downloads/2015/coexistence/Ruth- MacDonald.pdf. Accessed June 25, 2015.

22 USDA: Adoption of Genetically Engineered Crops in the United States 1996-2015

http://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-crops-in-the-us/recent-trends-in-ge-adoption.aspx 23 International Service for the Acquisition Of Agri-biotech Applications (ISAAA) Hosted by Cornell University

Used with permission. Permission granted to use ISAAA slide data, unaltered and correctly sited to ISAAA, C.James 2014, for education purposes only; no commercial value/purpose, resale allowed. 24 ISAAA's GM Approval Database http://www.isaaa.org/gmapprovaldatabase/

 Easy to use database of Biotech/GM crop approvals for various biotechnology stakeholders.

 Features Biotech/GM crop events & traits

 approved for commercialization and planting

 and/or for import for food and feed use

 Provides short description of crop and trait

25 ISAAA's GM Approval Database GM Plants (can also see breakdown by trait, country, developer, etc.) http://www.isaaa.org/gmapprovaldatabase/default.asp

Alfalfa Eggplant Plum Squash Apple Eucalyptus Polish Sugar Beet Argentine Flax canola Sugarcane Canola Maize Poplar Sweet Bean Melon Potato pepper Carnation Papaya Rice Tobacco Chicory Petunia Rose Tomato Cotton Soybean Wheat

26 Biotech Crop Countries & Mega-Countries* 2014 isaa.org

Bangladesh, one of the smaller and poorest countries in the world, approved and commercialized Bt brinjal in record time in 2014. Vietnam and Indonesia moved towards planting their first biotech crops in 2015, for a total of 9 biotech countries in Asia.

http://isaaa.org/resources/publicati ons/briefs/49/executivesummary/de fault.asp

Used with permission. Permission granted to use ISAAA slide data, unaltered and correctly sited to ISAAA, C.James 2014, for education purposes only; no commercial value/purpose, resale allowed. 30 Global GM Crop area dips in 2015 in first-ever decline Biotech/GM crops planted on 2 Billion hectares 1996-2015

 Global increase in biotech hectarage from 1.7 million hectares in 1996 to 179.7 million hectares in 2015 ( = >2x land mass of China or USA)

 100-fold increase in 20 yrs makes biotechnology fastest adopted crop technology in recent times, reflecting farmer satisfaction with biotech crops (?)

 It is estimated that farmers in up to 28 countries have reaped more than US $150 billion in benefits from biotech crops since 1996. This has helped alleviate poverty for up to 16.5 million small farmers and their families annually totaling about 65 million people, who are some of the poorest people in the world.

 http://news.agropages.com/News/NewsDetail---17686.htm

 http://www.isaaa.org/resources/publications/briefs/51/executivesummary/ However Global GM crop area dips in 2015 in first-ever decline

 “The world scaled back biotech crop planting for the first time ever in 2015, led by a decline in the United States, which has fueled rapid expansion of genetically modified crops since their commercial launch two decades ago, according to an annual report released recently. The decline was blamed largely on lower crop plantings overall due to lower commodity prices, the International Service for the Acquisition of Agri-biotech Applications (ISAAA), the group that released the report, said. Planting area was unchanged or lower in eight of the top 10 biotech crop-producing countries, including a 5.4 million acre drop in the United States, the world’s largest grower, according to data from the ISAAA, which promotes the use of biotechnology in agriculture.”

 http://news.agropages.com/News/NewsDetail---17678.htm 31 On the horizon March 2015 FDA approves new GMO foods

 2 GMO apples from Okanagan Specialty Fruits, Inc.

 “Arctic Apples” resist browning due to reduced levels of certain enzymes

 6 varieties of GMO potatoes from J. R. Simplot Company

 Potatoes are genetically engineered to reduce bruise spots and reduce content of the amino acid asparagine and reducing sugars which can be converted to acrylamide at high temperatures

 Both use RNA interference (RNAi), a process that may lead to unintended or unwanted consequences.[i]

The FDA concludes that these foods are “as safe and nutritious as their conventional counterparts”

 HOWEVER “In certain circumstances, characteristics of these varieties of apples and potatoes that differ from their conventional counterparts may require disclosure to the consumer. Both companies are encouraged to consult with the FDA about potential labeling requirements.”[ii]

[i] Center for Food Safety. http://www.centerforfoodsafety.org/press-releases/3811/geneticallyengineered-botox-apples-and-concealer-potatoes-coming-to-supermarket- near-you. March 23 2015. Accessed August 28, 2015. [ii] FDA News Release. FDA concludes Arctic Apples and Innate Potatoes are safe for consumption. Retrieved April 12, 2016 from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm439121.htm 33 Bananas that produce vaccines

 “Bananas are expected to be used for the production of vaccines…

 By consuming these bananas, the immune system builds antibodies to the pathogen proteins and accrues protection by vaccination.

 Research for vaccine bananas against hepatitis B, jaundice, cholera, polio, rubella/measles and diarrhoea is being done.”

GMO Compass. Retrieved April 15, 2016 from http://www.gmocompass.org/eng/database/plants/20.banana.html

34 Genetically Engineered Salmon

 Genetically engineered AquAdvantage® salmon

 produce growth hormone year round resulting in unnaturally rapid growth.

 It will be the first GMO animal intended and approved for human consumption.[i] [ii] [iii]

 Estimated growth rates of GMO salmon are

 2-6 times greater than non-GMO salmon

 Scientists concerned in potentially fertile GMO salmon can escape and disrupt wild salmon populations.

 Genetically engineered tilapia and carp are being created as well[iv]

[i] Center for Food Safety. AquAdvantage® Salmon. http://www.centerforfoodsafety.org/issues/309/ge-fish/aquadvantage-salmon. Accessed June 17, 2015. [ii] FDA Draft: AquAdvantage® Salmon. Draft Environmental Assessment. http://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/UCM333102.pdf. Accessed June 17, 2015. [iii] Polish Academy of Sciences, Institute of Genetics and Animal Breeding, Jastrzębiec, Poland. Biopharmaceuticals and food from transgenic animals: present state and the future. http://lhu.emu.ee/downloads/Welfood/WP3T3L1.pdf. Accessed June 17, 2015. [iv] Union of Concerned Scientists. Are there risks associated with the production and consumption of genetically engineered (GE) salmon? Fall 2011. http://www.ucsusa.org/publications/earthwise/dialogue-earthwise-fall-2011.html. Accessed July 5, 2015.

35 Center for Food Safety challenges approval of GMO salmon

CFS Lawsuit Challenges FDA’s Approval of Genetically Engineered Salmon March 31st, 2016

 “Fishing communities would be devastated, and the environmental consequences of GE salmon could be extreme.

 Over two million salmon escape open-water net pens into the North Atlantic every year, and these GE salmon could drive native wild salmon to extinction.”

http://www.centerforfoodsafety.org/press-releases/4317/lawsuit-challenges-fdas-approval-of-genetically- engineered-salmon#

36 National Geographic 2002 “Consumers are unaware…”

“Most people in the United States don't realize that they've been eating genetically engineered foods since the mid 1990s.

More than 60 percent of all processed foods on U.S. supermarket shelves

 including pizza, chips, cookies, ice cream, salad dressing, corn syrup, and baking powder— contain ingredients from engineered soybeans, corn, or canola.”

National Geographic. Altered Food, GMOs, Genetically Modified Food. Retrieved April12, 2016 from http://environment.nationalgeographic.com/environment/global-warming/food-how- altered/

37 www.NonGMOShoppingGuide.com

Non-GMO Shopping Guide

Slides used with permission of The Institute for Responsible Technology http://responsibletechnology.org/

38 Summary: What is Genetic Engineering?

 Artificially inserts genes from one organism, usually of a different species (e.g. bacteria, viruses, animals, humans), into another organism

 Creates organisms (genetically engineered organisms or “GMOs”) that would not otherwise occur in nature

 Is fundamentally different than natural/traditional breeding or hybridization

 GMO food crops contain bacterial genes that either produce an insecticide within the plant or confer resistance or tolerance to specific herbicides

 Current U.S. GMOs: soy, corn, canola, cotton, sugar beets, summer squash/zucchini, alfalfa, and Hawaiian papaya, and recently approved GMO apples and potatoes (new type of genetic engineering called RNA interference (RNAi)

 FDA has had requests for consideration of GMO cantaloupe, flax, plum, potato, tomato, and wheat as well. China & India developing Bt rice and chickpeas

 Most processed foods contain at least one GMO ingredient

 Transgenic animals are called “bioreactors” and are used to produce pharmaceuticals, nutraceuticals, vaccines, and organs less likely to be rejected by humans. The practice is called “animal pharming.”

 A number of health professionals, scientists, and consumer groups have raised questions and concerns about safety, regulation, containment, and ethical issues surrounding genetic engineering and GMOs. 39 Genetically Engineered Foods Outline & Objectives Describe history and regulations of GMOs

 Early concerns of FDA scientists (allergens, toxins, nutritional effects, new diseases)

 Lack of long-term human safety studies

 “Substantial equivalence” and GRAS designation

 Introduction of GMOs into food supply

 Controversial aspects of GMOS

 Labeling of GMOs

40 The History of Genetically Engineered Foods Generally Recognized as Safe (GRAS)

FDA granted GRAS status to GMOs as they were released into the food supply (no human testing required) [i]

 FDA’s Statement of Policy by David Kessler (documented in 1992 before release of GMO foods into food supply) declared that the

 “FDA believes that the new techniques are extensions at the molecular level of traditional methods and will be used to achieve the same goals as pursued with traditional plant breeding. 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, or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding.

 For this reason, the agency does not believe that the method of development of a new plant variety (including the use of new techniques including recombinant DNA techniques) is normally material information within the meaning of 21 U.S. C. 321(n) and would not usually be required to be disclosed in labeling for the food.”[ii]

[i] Kessler D. FDA Guidance to Industry for Foods Derived from New Plant Varieties. Policy Statement 22984. FDA Federal Register. May 29, 1992;(57):4. http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/biotechnology/ucm096095.htm. Updated August 15, 2013. Accessed June 30, 2015. [ii] Kessler D. FDA Guidance to Industry for Foods Derived from New Plant Varieties. Policy Statement 22984. FDA Federal Register. May 29, 1992;(57):4. http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/biotechnology/ucm096095.htm. Updated August 15, 2013. Accessed June 30, 2015.

41 Do GMOs meet the requirements of GRAS?

Many disagree that GMOs meet GRAS standards

 Point out that they can and do produce novel proteins and substances with unknown and unpredictable effects TECHNICALLY to be considered GRAS

 “the use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food.”[i] HOWEVER

 GMOs had never been in the food supply so had no history of safe consumption by humans or animals

 nor did they have substantial safety testing done

 They were considered to be on the market illegally and the FDA was sued FDA. Generally Recognized as Safe (GRAS). Page updated June 4, 2015 Retrieved April 15, 2016 http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/. 43 Do GMOs meet the requirements of GRAS? FDA scientists did not think so…

Lawsuit revealed substantial disagreement among FDA scientists themselves regarding regulation and safety of GMO foods as well as the process of genetic engineering itself.[i] [ii] [iii]

 Such a lack of consensus among experts should have disqualified GMO foods from ever being considered GRAS

FDA scientists declared that

 “transgenic crops can have unpredictable, hard-to-detect side- effects – allergens, toxins, nutritional effects, new diseases. They had urged their superiors to require long-term studies.”[iv]

[i] Druker SM. The Illegality of FDA Policy on GE Foods. http://www.biointegrity.org/. Accessed June 30, 2015. [ii] Druker, Steven M. Altered Genes, Twisted Truth: How the Venture to Genetically Engineer Our Food Has Subverted Science, Corrupted Government, and Systematically Deceived the Public. Salt Lake City, UT: Clear River, 2015. [iii] Freese, W., & Schubert, D. (2004). Safety Testing and Regulation of Genetically Engineered Foods. Biotechnology and Genetic Engineering Reviews, 21(1), 299-324. doi:10.1080/02648725.2004.10648060 Retrieved April 16, 2016 from http://www.tandfonline.com/doi/pdf/10.1080/02648725.2004.10648060 [iv] Lotter D. The genetic engineering of food and the failure of science–Part 1: The development of a flawed enterprise. Int Jrnl of Soc of Agr & Food. 2009;16(1):31-49. Retrieved April 12, 2016 from http://ijsaf.org/archive/16/1/lotter1.pdf f Soc of Agr & Food. 2009;16(1):31-49. http://ijsaf.org/archive/16/1/lotter1.pdf. Accessed June 19, 2015.

44 In reality, agency scientists warned of: Allergens Toxins New diseases Nutritional problems

Slides used with permission of The Institute for Responsible Technology http://responsibletechnology.org/ 45 “Substantial equivalence”

 Early 1990s FDA declared that genetically engineered foods (referred to as bioengineered foods) were

 “substantially equivalent” to their natural counterpart and required no human safety testing

 DESPITE the fact these foods had never been in human food supply prior to 1990s

 Scientists challenge premise of “substantial equivalence” as it

 “overlooks all the interactions between genes, and the direct or indirect potential metabolic consequences of insertional mutagenesis. This implies that GMOs are insufficiently evaluated.”

46 Assuring safety of genetically modified foods – Monsanto publication 2002

 “ Genetic modification (GM) is a recent development which allows specific genes to be identified, isolated, copied and inserted into other plants with a high level of specificity.

 Overall safety evaluation is conducted under the concept known as substantial equivalence which is enshrined in all international crop biotechnology guidelines

 Conclusion has been that foods and feeds derived from genetically modified crops are as safe and nutritious as those derived from traditional crops.

 The lack of any adverse effects resulting from the production and consumption of GM crops grown on more than 300 million cumulative acres over the last 5 years supports these safety conclusions.” Cockburn, A. (2002). Assuring the safety of genetically modified (GM) foods: The importance of an holistic, integrative approach. Journal of Biotechnology, 98(1), 79-106. doi:10.1016/s0168-1656(02)00088-3

47 Political pressure and corporate influence

Lobbying by the biotech industry and pressure from the White House prevailed

 Concept of substantial equivalence and GRAS status of GMOs was maintained though it was acknowledged that ongoing monitoring and testing of complex changes in food was warranted[i] [ii]

Confounding factor that warrants substantial concern:

 Conflict of interest with the government’s “revolving door” policy

 Allows industry affiliates to work in government positions (e.g. USDA, FDA, EPA)

 Then return to work in the industry… at times even returning again to a government post[iii]

[i] Hollingworth RM, Bjeldanes LF, Bolger M, et al. The safety of genetically modified foods produced through biotechnology. Toxicol Sci. 2003 Jan;71(1):2-8. Review. PubMed PMID: 12520069. Retrieved April 15, 2016 from http://toxsci.oxfordjournals.org/content/71/1/2.long [ii] Kuiper HA, Kleter GA, Noteborn HP, et al. Assessment of the food safety issues related to genetically modified foods. Plant J. 2001 Sep;27(6):503-28. Review. PubMed PMID: 11576435. [iii] Druker, Steven M. Altered Genes, Twisted Truth: How the Venture to Genetically Engineer Our Food Has Subverted Science, Corrupted Government, and Systematically Deceived the Public. Salt Lake City, UT: Clear River, 2015.

48 1st genetically engineered foods

1st genetically engineered food Calgene’s Flavr Savr™ tomato (delayed ripening). Calgene was later bought by Monsanto

 Marketed in the 1994

 Approved by the FDA despite the fact that it contained antibiotic resistant genes as well as genetic material from pathogenic bacteria and despite the fact that GMO foods had never been tested on humans.[i] [ii]

 Flavr Savr utilized RNA interference technology[iii]

Genetically engineered Bt potato on market in late 1990s but production dropped off sharply when McDonald’s, Burger King, and other fast food companies pledged to source only non-Bt potatoes[iv]

[i] Agency Summary Memorandum Re: Consultation with Calgene, Inc., Concerning FLAVR SAVR™ Tomatoes. Retrieved April 15, 2016 from http://www.fda.gov/Food/FoodScienceResearch/Biotechnology/Submissions/ucm225043.htm http://www.fda.gov/Food/FoodScienceResearch/Biotechnology/Submissions/ucm225043.htm#out10 [ii] Bawa, A. S., & Anilakumar, K. R. (2012). Genetically modified foods: Safety, risks and public concerns—a review. J Food Sci Technol Journal of Food Science and Technology, 50(6), 1035-1046. doi:10.1007/s13197-012-0899-1. Retrieved April 6, 2016 from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3791249/pdf/13197_2012_Article_899.pdf [iii] Krieger, E. K., Allen, E., Gilbertson, L. A., Roberts, J. K., Hiatt, W., & Sanders, R. A. (2008). The Flavr Savr tomato, an early example of RNAi technology. HortScience, 43(3), 962- 964. Retrieved April 10,2016 from http://hortsci.ashspublications.org/content/43/3/962.full.pdf+html [iv] Freese, W., & Schubert, D. (2004). Safety Testing and Regulation of Genetically Engineered Foods. Biotechnology and Genetic Engineering Reviews, 21(1), 299-324. doi:10.1080/02648725.2004.10648060 Retrieved April 16, 2016 from http://www.tandfonline.com/doi/pdf/10.1080/02648725.2004.10648060

49 Recombinant Bovine Growth Hormone (rbGH) (1990s) aka recombinant bovine somatotropin (rBST) Approved as a veterinary drug not a food

Produced by splicing bovine genes into a bacterium that then produces the hormone

 Analogues of rbGH have an amino acid sequence that is clearly different than naturally occurring bovine growth hormone produced in the pituitary of cows.[i] According to the FDA

 Treated cow’s experienced a “small but significantly greater incidence of mastitis”

 Increased levels of insulin-like growth factor 1 (IGF-1) were found in milk from treated cows

 FDA and General Accounting Office (GAO) concluded that rbGH “did not appear to represent a direct human health risk” [ii] [iii] [i] Wingfield PT, Graber P, Buell G, et al. Preparation and characterization of bovine growth hormones produced in recombinant Escherichia coli. Biochem J. 1987 May 1;243(3):829- 39. Erratum in: Biochem J 1987 Aug;245(3):following 934. PubMed PMID: 3311023. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1147932/. Accessed July 30, 2015. [ii] FDA Report on the Food and Drug Administration's Review of the Safety of Recombinant Bovine Somatotropin. Updated April 23, 2009. http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm130321.htm. Accessed July 15, 2015 [iii] Collier RJ, Bauman DE. Update on human health concerns of recombinant bovine somatotropin use in dairy cows. J Anim Sci. 2014 Apr;92(4):1800-7. doi: 10.2527/jas.2013-7383. Epub 2014 Feb 10. PubMed PMID: 24663163. 50 Politics of rbGH

 Former Monsanto affiliate attorney Michael Taylor is current deputy commissioner for food at the FDA (as of 2010)[i]

 In a position at FDA in the 1990s to approve rbGH and write the guidelines for it

 Essentially made it illegal to simply label milk as “recombinant bovine growth hormone free” fearing it may mislead consumers to think that non-GMO milk was of higher quality than treated milk.[ii]

[i] FDA. Meet Michael R. Taylor, J.D., Deputy Commissioner for Foods and Veterinary Medicine. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/ucm196721.htm. Accessed September 1, 2015. [ii] FDA. Federal Register. Interim Guidance on the Voluntary Labeling of Milk and Milk Products From Cows That Have Not Been Treated With Recombinant Bovine Somatotropin. February 10, 1994. 59(28). http://www.gpo.gov/fdsys/pkg/FR-1994-02-10/html/94-3214.htm. Accessed July 30, 2015.

51 The National Academy of Sciences

SAFETY OF GENETICALLY ENGINEERED FOODS APPROACHES TO ASSESSING UNINTENDED HEALTH EFFECTS 2004

“In response to its charge, the committee has developed a framework to identify appropriate scientific questions and methods for determining unintended changes in the levels of nutrients, toxins, toxicants, allergens, or other compounds in foods from GMOs, in order to assess potential short- and long-term human health consequences of such changes. Although the array of analytical and epidemiological techniques available has increased, there remain sizeable gaps in our ability to identify compositional changes that result from genetic modification of organisms intended for food; to determine the biological relevance of such changes to human health; and to devise appropriate scientific methods to predict and assess unintended adverse effects on human health.” http://www.nap.edu/read/10977/chapter/1 52 Regulation and Safety

 Process, patenting, and marketing of genetic engineering foods originated in the United States

 GMO foods regulated by a “coordinated framework”of U.S. governmental agencies including the FDA, USDA, and EPA.

 The coordinated framework from 1992 will be updated in 2015 in order to better “assess efficiently any risks associated with the future products of biotechnology.”

White House Office of Science and Technology Policy. Improving Transparency and Ensuring Continued Safety in Biotechnology. Retrieved April 16, 2016 from https://www.whitehouse.gov/blog/2015/07/02/improving-transparency-and-ensuring-continued-safety-biotechnology

53 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.” “Statement of Policy” May 29, 1992

Food and Drug Administration

Slides used with permission of The Institute for Responsible Technology http://responsibletechnology.org/

54 FDA regulation of GMO foods Foods from genetically engineered plants must meet the same requirements, including safety requirements, as foods from traditionally bred plants

REMEMBER 1992 FDA Kessler Statement of Policy (before release of GMOs into food supply)

 Extensions at the molecular level of traditional methods

 same goals as pursued with traditional plant breeding

 FDA not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way or present different or greater safety concern than foods developed by traditional breeding

 Would not usually be required to be disclosed in labeling for the food” Kessler D. FDA Guidance to Industry for Foods Derived from New Plant Varieties. Policy Statement 22984. FDA Federal Register. May 29, 1992;(57):4. http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/biotechnology/ucm096095.htm. Updated August 15, 2013. Accessed June 30, 2015.

YET 1999 congressional testimony of James Maryanski, Ph.D., FDA Biotechnology Coordinator states that genetic engineering techniques:

 “give breeders the power to cross biological boundaries that could not be crossed by traditional breeding.

 For example, they enable the transfer of traits from bacteria or animals into plants…

 Because FDA determined that bioengineered foods should be regulated like their conventional counterparts, FDA has not to date established any regulations specific to bioengineered food.”

Maryanski JH. FDA. Genetically Engineered Foods. Congressional testimony. 1999. Retrieved April 16,2016 from http://www.fda.gov/newsevents/testimony/ucm115032.htm

55 The Precautionary Principle Several countries recommend a more comprehensive, science-based approach to regulation based on the “precautionary principle” which states

 “Where there is a lack of certainty about safety, a technology should be avoided or at least limited.[i]

Many scientists in U.S. & abroad recommend the U.S. adopt the precautionary principle as well.

 In 2004 The National Research Council recognized that GMO foods warranted greater scrutiny and should be assessed for “unintended compositional changes that could result from genetically modified foods and research avenues to fill the knowledge gaps.”[ii]

[i] Marden E. Risk and Regulation: U.S. Regulatory Policy on Genetically Modified Food and Agriculture. 2003; 44 B.C.L. Rev. 733. http://lawdigitalcommons.bc.edu/bclr/vol44/iss3/2. Accessed June 30, 2015. [ii] National Research Council (US) Committee on Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human Health. Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects. Washington (DC): National Academies Press (US); 2004. PubMed PMID: 25009871. http://www.ncbi.nlm.nih.gov/books/NBK215773/. Accessed June 17, 2015.

56 FDA procedure for approving GMO foods is VOLUNTARY In lieu of human safety studies, the FDA

 “set up a voluntary consultation process to engage with the developers of genetically engineered plants to help ensure the safety of food from these products.”[i] [ii]

 According to Commissioner Kessler, “Ultimately, it is the food producer who is responsible for assuring safety.”[iii]

[i] FDA Q&A FDA Genetically Engineered Foods Q&A_2015 http://www.fda.gov/food/foodscienceresearch/biotechnology/ucm346030.htm. Updated June 5, 2015. Accessed June 11, 2015. [ii] Biotechnology Consultations on Food from GE Plant Varieties. http://www.accessdata.fda.gov/scripts/fdcc/?set=Biocon. Updated March 20, 2015. Accessed June 30, 2015. [iii] Kessler D. FDA Guidance to Industry for Foods Derived from New Plant Varieties. Policy Statement 22984. FDA Federal Register. May 29, 1992;(57):4. http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/biotechnology/ucm096095.htm. Updated August 15, 2013. Accessed June 30, 2015. 57 FDA procedure for approving GMO foods Encourages consultations FDA consultation process “encourages” developers of genetically engineered plants to consult with FDA before marketing their products.

 Generally, the developer identifies the distinguishing attributes of new genetic traits and assesses whether any new material that a person consumed in food made from the genetically engineered plants could be toxic or allergenic

 The developer also compares the levels of nutrients in the new genetically engineered plant to traditionally bred plants. This typically includes such nutrients as fiber, protein, fat, vitamins, and minerals

 The developer includes this information in a safety assessment, which FDA’s Biotechnology Evaluation Team then evaluates for safety and compliance with the law

FDA Facts: Food from Genetically Engineered Plants. http://www.fda.gov/downloads/Food/PopularTopics/UCM385844.pdf. Accessed June 17, 2015.

58 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

Slides used with permission of The Institute for Responsible •industry studies Technology http://responsibletechnology.org/ 59 The World Health Organization weighs in “All GM foods should be assessed before being allowed on the market and provides guidelines

 to determine toxicity, allergenicity, nutritional impact, stability of inserted genes, and any unintended side effects resulting from gene insertion.”[i] [ii]

Codex Alimentarius Commission (a joint WHO/FAO intergovernmental body)[iii] recommends pre-market safety assessments that specifically take into account

 intended and unintended effects

 new or altered hazards

 identification of any changes in key nutrients relevant to human health

 The FDA’s declaration of GMOs as GRAS (requiring no testing) appears to disregard these recommendations

[i] World Health Organization. Food, Genetically Modified. http://www.who.int/topics/food_genetically_modified/en/. Accessed June 17, 2015. [ii] FAO/WHO. Safety aspects of genetically modified foods of plant origin. Report of a Joint FAO/WHO Expert Consultation on Foods Derived from Biotechnology. 2000. http://apps.who.int/iris/bitstream/10665/66575/1/WHO_SDE_PHE_FOS_00.6.pdf. Accessed July 2, 2015. Codex Alimentarius. Principles for the risk analysis of foods derived from modern biotechnology. CAC/GL 44-2003. http://www.codexalimentarius.org/download/standards/10007/CXG_044e.pdf. Accessed August 31, 2015. 60 Scientists & Physicians Support the Precautionary Principle

Scientists and physicians in the USA

 have asked companies and government agencies to err on the side of caution, investigate apparent negative health effects, and label GMO foods so that adverse reactions can be tracked.[i] [ii] [iii]

The Federation of Scientists (FAS) (founded 1945 by Manhattan Project Scientists)

 Question validity of a voluntary consultation process and whether it can assess and assure the safety of GMO foods.[iv]

[i] Union of Concerned Scientists. Retrieved April 16,2016 from http://www.ucsusa.org/our-work/food-agriculture/our-failing-food- system/genetic-engineering-agriculture#.VXYkH89Viko, http://www.ucsusa.org/food_and_agriculture/our-failing-food-system/genetic- engineering/risks-of-genetic-engineering.html#.VXYkK89Viko, http://www.ucsusa.org/sites/default/files/legacy/assets/documents/food_and_agriculture/failure-to-yield.pdf [ii] American Academy of Environmental Medicine. Genetically Modified Foods. https://www.aaemonline.org/gmo.php, https://www.aaemonline.org/gmo-pressrelease.php. Accessed June 9, 2015. [iii] Physicians for Social Responsibility Support Labeling of GMO Foods. http://www.psr.org/resources/psr-supports-labeling-gmo-foods.html. Accessed June 8, 2015. [iv] Federation of American Scientists. http://fas.org/biosecurity/education/dualuse-agriculture/2.-agricultural-biotechnology/prodigene- incident.html. Accessed June 17, 2015.

61 Academy of Environmental Medicine (AAEM) Physicians and healthcare practitioners

“Because GM foods pose a serious health risk in the areas of toxicology, allergy and immune function, reproductive health, and metabolic, physiologic and genetic health and are without benefit,

 the AAEM believes that it is imperative to adopt the precautionary principle, which is one of the main regulatory tools of the European Union environmental and health policy and serves as a foundation for several international agreements.”

American Academy of Environmental Medicine. Genetically Modified Foods. Retrieved April 12, 2016 from https://www.aaemonline.org/gmo.php

62 Consumers & Consumer Groups Weigh In

GMOs are not allowed in USDA certified organic or in Non-GMO Project verified foods[i] [ii]

 Core requirements for Non-GMO Project verification are traceability, segregation, and testing of high-risk ingredients at critical control points.

[i] National Organic Program. Genetically Modified Organism (GMO). Retrieved April 16, 2016 from http://www.ams.usda.gov/sites/default/files/media/GMO%20Policy%20Training%202012.pdf [ii] Non-GMO Project Product Verification. Retrieved April 16, 2016 from http://www.nongmoproject.org/product-verification/

63 GMO pesticide-producing plants regulated as pesticides The Environmental Protection Agency (EPA) oversees regulation of GMO crops that produce pesticides (referred to as plant-incorporated protectants or “PIPs”)

 “EPA regulates pesticides, including those bioengineered into food crops”[i] under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

 For additional information about EPA's regulation of bioengineered foods that contain a pesticidal substance, see EPA's site https://www.epa.gov/pesticides/biopesticides

 “If a crop is genetically engineered to carry a gene for a Bt toxin, EPA requires the developer to verify that the toxin is safe for the environment and conduct a food-safety analysis to ensure that the foreign protein is not allergenic.” [ii]

 This system failed when unapproved Starlink® GMO Bt corn was released into the food supply; consumption of the GMO corn was associated with dozens of allergic reactions (more details to follow).[iii]

[i] FDA's Role in Regulating Safety of GE Foods. http://www.fda.gov/forconsumers/consumerupdates/ucm352067.htm Retrieved April 16, 2016 from https://njfb.org/wp- content/uploads/2013/07/FDA-GE-Answers.pdf [ii] Federation of American Scientists. http://fas.org/biosecurity/education/dualuse-agriculture/2.-agricultural-biotechnology/prodigene-incident.html. Accessed June 17, 2015. [iii] Bucchini L, Goldman LR. Starlink corn: a risk analysis. Environ Health Perspect. 2002 Jan;110(1):5-13. Review. PubMed PMID: 11781159.

64 Controversial aspects of GMOs SUPPORTERS state OPPONENTS state

 GMOs are the same as  Potential risks and concerns (allergens, toxins, increased use of naturally occurring foods toxic herbicides, human consumption despite alterations in DNA of Bt toxin, etc.) outweigh proposed benefits, many of which have not materialized

 GMOs will increase food  Animal research on GMOs reveals production, decrease serious health concerns  Call for moratorium on human pesticide use and cost, consumption and implementation increase nutritional value of long-term human studies

 Use of associated herbicides has skyrocketed  Proposed and potential  Weeds becoming resistant also benefits outweigh potential risks  Insects becoming resistant to Bt crops, now more potent Bt toxins are being developed

65 Exposure to Environmental Toxins U of Minnesota Environmental Health MPH program

GMO: Characteristics Definition of GMO: A genetically modified organism (GMO) is an organism that has ... The genetic engineering process utilizes viruses and bacteria most often to ... enhs.umn.edu/current/5103/gm/character.html GMO: References Potential adverse health effects of genetically modified crops. Journal ... Cornell University's Genetically Engineered Organisms Public Issues Education Project ... enhs.umn.edu/current/5103/gm/references.html Genetically Modified Organisms (GMO): Harmful Effects Genetically modified organisms (GMO's) are a broad group of plants, animals, and bacteria that are engineered for a wide variety of applications ranging from ... enhs.umn.edu/current/5103/gm/harmful.html GMO: Strategies for Preventing Exposure Genetically modified foods currently sold internationally have passed risk assessments ... Cornell University's Genetically Engineered Organisms Public Issues ... enhs.umn.edu/current/5103/gm/strategies.html GMO: Methods for Monitoring in the Environment In 2000, Genetically Engineered Food Alert, a coalition of seven organizations, first reported the presence of Starlink corn in the human food supply that led to ... enhs.umn.edu/current/5103/gm/methods.html

67 Exposure to Environmental Toxins U of Minnesota Environmental Health MPH program

GMO: Methods for Measuring Exposure Measuring human exposure to genetically modified organisms is extremely difficult for ... Cornell University's Genetically Engineered Organisms Public Issues ... enhs.umn.edu/current/5103/gm/measure.html GMO: Exposure Pathway Humans are exposed to genetically modified organisms by the ingestion of ... of processed foods contain ingredients made from genetically engineered corn, ... enhs.umn.edu/current/5103/gm/exposure.html GMO: Absorption, distribution and metabolism The current scientific evidence regarding the absorption, distribution, and metabolism of a genetically modified organism is identical to that of its conventional ... enhs.umn.edu/current/5103/gm/absorb.html GMO: Fate and Transport in the Environment Genetic modifications of plants are done via one of two major processes: 1. The Ti Plasmid and Agrobacterium tumefaciens 2. The Gene Gun. The first method of ... enhs.umn.edu/current/5103/gm/fate.html GMO: Dose Response Genetically Modified Organisms (GMO) ... The most well known involves a transgenic potato engineered to produce a natural insecticide (Ewen & Pusztai, 1999). enhs.umn.edu/current/5103/gm/dose.html 68 Strong support for GMOs Physicians, healthcare practitioners, scientists, farmers, special interest groups, CSPI Center for Science in the Public Interest (CSPI), publisher of “Nutrition Action Healthletter,” praises GMOs:

 “Corn and cotton engineered with their own built-in pesticide have greatly reduced the amount of chemical insecticides sprayed by farmers in the United States, India, and China.

 Herbicide-tolerant soybeans have allowed farmers to use an environmentally safer herbicide (glyphosate), practice conservation-till agriculture, and save time.

 Corn engineered with a biological insecticide has reduced insect populations so that all corn farmers (biotech, non-GE conventional farmers, and organic farmers) benefit by using less chemical insecticide and having corn with less pest damage.”[i]

 One of CSPI’s directors is David Kessler former FDA commissioner who established FDA’s position of “substantial equivalence” for GMO foods.[ii] [iii]

[i] Center for Science in the Public Interest. Retrieved April 16, 2016 Agricultural Biotechnology Project. http://cspinet.org/images/biotechbrochure.pdf. Accessed July 5, 2015. Center for Science in the Public Interest Jaffe G. GMOs From Farm to Food. http://cspinet.org/images/maygregfpd.pdf. Accessed June 26, 2015. CSPI Biotechnology. https://cspinet.org/biotech/. [ii] CSPI Directors. https://cspinet.org/about/index.html. Accessed July 5, 2015. [iii] Kessler D. FDA Guidance to Industry for Foods Derived from New Plant Varieties. Policy Statement 22984. FDA Federal Register. May 29, 1992;(57):4. Updated Augudt 21, 2015. Retrieved April 16, 2016 from http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/biotechnology/ucm096095.htm. 69 Strong support for GMOs The Genetic Literacy Project

Founded by journalist and philosophy major John Entine, states

 “The encouraging news is that in the West, victory has been achieved on a central issue—the debate over GM food safety. While just two years ago, the global media was flooded with pictures of cancer- twisted rats, allegedly victimized by eating ‘dangerous’ GM grain, the emerging common wisdom today is that GM foods are safe.”[i]

The Genetic Literacy Project claims “scientific consensus” based on a Pew poll that ONLY polled members of the American Association for the Advancement of Science (AAAS).

 The AAAS supports GMO technology and is against mandatory labeling.[ii]

 Pew poll completely ignored nonmembers and scientists from other groups who question the safety of GMOs and associated herbicides and toxins[iii] [iv]

[i] Entine J. Can a skeptical public be persuaded to embrace GMO foods? Yes, if we want sustainable agriculture. Retrieved April 16, 2016 from http://www.geneticliteracyproject.org/2015/07/01/can-a-skeptical-public-be-persuaded-to-embrace-gmo-foods-yes-if-we-want-sustainable-agriculture/ [ii] American Association for the Advancement of Science. Statement by the AAAS Board of Directors on Labeling of Genetically Modified Foods. October 20, 2015. http://www.aaas.org/sites/default/files/AAAS_GM_statement.pdf. Accessed July 6, 2015. [iii] Entine J, Randall R. Scientific consensus on GMO safety stronger than for global warming. Retrieved April 16, 2016 from http://www.geneticliteracyproject.org/2015/01/29/pewaaas-study-scientific-consensus-on-gmo-safety-stronger-than-for-global-warming/ [iv] Pew Research Center. Public and Scientists’ View on Science and Society. http://www.pewinternet.org/2015/01/29/public-and-scientists-views-on-science-and-society/. Accessed July 6, 2015. 70 According to Bayer® they are “simply inserting new genetic material…” Genetic engineering simply introduces a “new piece of genetic material”

 “The process of making a GMO isn’t all that different from the natural process found in nature, except that it is modern, fast, precise and equally safe.”

 “Animals and humans have been consuming GMOs now for 30 years and not a single death or adverse effect has been reported” Bayer CropScience. What are GMOs Part 1. March 31, 2015. Retrieved April 16, 2016 from https://www.cropscience.bayer.us/news/blog/2015/march/033115-what-are-gmos--part-1 Bayer CropScience. What are GMOs Part 2. April 2, 2015. Retrieved April 16, 2016 from https://www.cropscience.bayer.us/news/blog/2015/april/040115-what-are-gmos-part-2

Bayer bought the Aventis company that developed Starlink products but overlooks the Starlink GMO incident when claiming no adverse effects.

NOTE: Without labeling of GMO foods, it is impossible to tell whether or not an adverse reaction is associated with a GMO ingredient

71 International Service for the Acquisition of Agri-Biotech Applications ISAAA concludes GM foods are safe Foods derived from GM plants are safe according to ISAAA

 Major issues and safety concerns on the biosafety of foods derived from GM plants have been addressed.

 Protein products of the inserted genes in the commercially available GM plants have passed the rigorous tests and showed that they are non toxic, non-allergenic, and the nutritional content is comparable to their non GM counterpart.

 GM plants being developed also undergo similar testing before they are released commercially.

 Any new ingredient added to food through biotechnology will be subject to pre-market approval in the same way a new food additive, such as a preservative or food color, must be approved before it reaches the marketplace.

Pocket K No. 3: Are Food Derived from GM Crops Safe? ISAAA. Retrieved April 12, 2016 from http://isaaa.org/resources/publications/pocketk/3/default.asp

72 Predictable unpredictable effects

 Genetic damage from the insertion of genes

 Disturbance of crucial metabolic processes

 Damage from accumulation of associated pesticide residues.

Vendômois, J. S. (2010). Debate on GMOs Health Risks after Statistical Findings in Regulatory Tests. Int. J. Biol. Sci. International Journal of Biological Sciences, 590-598. doi:10.7150/ijbs.6.590 Retrieved April 16, 2016 from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2952409 and http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2952409/figure/F1/ 73 Academy of Environmental Medicine (AAEM) Physicians and healthcare practitioners

“Because GM foods pose a serious health risk in the areas of toxicology, allergy and immune function, reproductive health, and metabolic, physiologic and genetic health and are without benefit,

American Academy of Environmental Medicine. Genetically Modified Foods. Retrieved April 12, 2016 from https://www.aaemonline.org/gmo.php

74 Center for Food Safety: 6 major new “unexpected effects” & health risks from GMOs

 Toxicity

 Allergic reactions

 Antibiotic resistance

 Immunosuppression

 Cancer

 Loss of nutrition

Center for Food Safety. GE Food and Your Health. Retrieved April 16, 2016 from http://www.centerforfoodsafety.org/issues/311/ge-foods/ge-food-and-your-health

75 GMOs are Inherently Unsafe The GM process creates massive collateral damage in the plant, which can cause side- effects

Slides used with permission of The Institute for Responsible Technology http://responsibletechnology.org/

76 Opposition’s Concerns Research Summary

 GMO foods should have undergone safety testing (prior to release into human food supply)

 GMOs never met GRAS status requirements, on the market illegally

 Animal studies and documentation in humans suggest GMOs and associated pesticides are toxic even at low doses

 ***Alteration of DNA, proteins, and amino acid sequences substantially increases potential production of allergens, toxins, and compounds with unpredictable effects

 GMOs should be labeled so that affected individuals can track symptoms and associated foods/ingredients

 Genetically engineered crops, plants, and animals can pass on traits to non-GMOs, wild plants and animals, beneficial GI bacteria

77 Opposition’s Concerns Research Summary con’t

 Produce unpredictable or undesirable proteins, prions, toxins

 Cross-pollinate non-GMO or organic crops

 Increase use of associated herbicides

 Promote herbicide-tolerant weeds, insecticide tolerant crops

 Produce new or more toxic allergens[i] [ii] [iii] [iv] [v] [vi] [vii] [viii]

 FDA scientists expressed concerns above and recommended vigorous scientific testing for GMOs

 Recommendation not heeded by government or FDA[ix]

[i] Bashshur R. FDA and Regulation of GMOs. American Bar Association. February 2013;9(6). Retrieved April 12, 2016 from http://www.americanbar.org/content/newsletter/publications/aba_health_esource_home/aba_health_law_esource_1302_bashshur.html [ii] Freese, W., & Schubert, D. (2004). Safety Testing and Regulation of Genetically Engineered Foods. Biotechnology and Genetic Engineering Reviews, 21(1), 299-324. doi:10.1080/02648725.2004.10648060 Retrieved April 16, 2016 from http://www.tandfonline.com/doi/pdf/10.1080/02648725.2004.10648060 [iii] GMO Awareness. GMO-awareness.com. Accessed July 19, 2015. [iv] Institute fro Responsible Technology. Health Risks. http://responsibletechnology.org/health-risks#1. Accessed July 21, 2015. [v] Pretty J. The rapid emergence of genetic modification in world agriculture: contested risks and benefits. Environmental Conservation. 2001;28(3):248-62. doi: 10.1017/S0376892901000261. Retreived April 12, 2016 from https://www.researchgate.net/profile/Jules_Pretty/publication/231747426_The_rapid_emergence_of_genetic_modification_in_world_agriculture_contested_risks_and_benefits/links/00b49523993314336 0000000.pdf [vi] Lotter D. The genetic engineering of food and the failure of science–Part 1: The development of a flawed enterprise. Int Jrnl of Soc of Agr & Food. 2009;16(1):31-49. Retrieved April 12, 2016 from http://ijsaf.org/archive/16/1/lotter1.pdf f Soc of Agr & Food. 2009;16(1):31-49. http://ijsaf.org/archive/16/1/lotter1.pdf. Accessed June 19, 2015. [vii] Union of Concerned Scientists. Genetic Engineering Risks and Impacts. http://www.ucsusa.org/food_and_agriculture/our-failing-food-system/genetic-engineering/risks-of-genetic-engineering.html. http://www.ucsusa.org/search/site/genetically%20engineered%20foods#.VZmGvflViko. Accessed July 6, 2015. [viii] Huber DM. Ag Chemical and Crop Nutrient Interactions- Current Update. http://www.i-sis.org.uk/pdf/Glyphosate_crop_interactions_reviewed_by_Dr_Don_Huber.pdf. http://www.fluidfertilizer.com/Forum%20Presentations/2010/D.%20Huber%20-%20Ag%20Chemical%20and%20Crop%20Nutrient%20Interactions%20%E2%80%93%20Current%20Update.pdf. Accessed July 6, 2015. [ix] Druker, Steven M. Altered Genes, Twisted Truth: How the Venture to Genetically Engineer Our Food Has Subverted Science, Corrupted Government, and Systematically Deceived the Public. Salt Lake City, UT: 78 Clear River, 2015. Economic issues

 Individual choice, food sovereignty, and biodiversity are threatened by monopolies, corporate ownership, and patenting of most commonly consumed crop seeds

 Monsanto corporation controls approximately 90% of GMO crops around the world

 GMOs are banned in some countries.[i]

 Monsanto considers ban on MON810 Bt corn in Europe a political versus a health or environmental issue[ii]

 Growing GMO crops associated with initial $ savings

 However cost of related equipment, increased herbicide use, increased resistant weeds may exceed that of growing conventional crops

79 Restrictions on research Scientists and consumers concerned about control of GMO research[i]

 Scientific American 2009:

 “Scientists must ask corporations for permission before publishing independent research on genetically modified crops.”[ii]

 Restricted access to seeds thwarts independent research

 Questions about environmental and health effects of GMO foods go unanswered

[i] Lotter, D. (2008). The genetic engineering of food and the failure of science–Part 2: Academic capitalism and the loss of scientific integrity. Int Jrnl of Soc of Agr & Food, 16(1), 50-68. Retrieved April 16, 2016 from http://www.ijsaf.org/archive/16/1/lotter2.pdf [ii] Scientific American, “Do Seed Companies Control GM Crop Research?” Retrieved April 16, 2016 from http://www.scientificamerican.com/article.cfm?id=do- seed-companies-control-gm-crop-research

80 Loss of biodiversity & preservation Investment in seed banks Growth of vast amounts of single crops e.g. GMO corn & soy

 Limits biodiversity

 Increases risk of widespread outbreaks of disease

 Promotes loss of tolerance to drastic environmental changes (e.g. drought or climate change)

Seed banks and “seed vaults” being created in an effort to preserve biodiversity. (e.g. Svalbard Global Seed Vault in Norway)

 HOWEVER there are concerns that seed banks/vaults are being invested in and possibly controlled by the companies creating the GMO monoculture monopolies[i] [ii] [iii]

[i] Jenkins, S. (2013). Genetic engineering and seed banks: impacts on global crop diversity. Macquarie J. Int'l & Comp. Envtl. L., 9, 67. [ii] Gertsberg D. Controversy With the Doomsday Vault. GMO Journal. March 22, 2012. http://gmo-journal.com/2012/03/22/controversy-with-the-doomsday-vault/. Accessed July 27, 2015. [iii] Sutherland Charles W. GMO Poison Handbook. ‘Genetically Modified Agriculture and Animals.’ CreateSpace Publishing. 2014.

81 Labeling of GMOs More than 60 countries require labeling of GMO foods (e.g. Germany, France, Italy, Lithuania, Russia, China, etc.).[i]

 U.S. does not require labeling though voluntary labeling is welcomed.

 Physicians for Social Responsibility poll:

 90% or more of U.S. consumers want GMO foods to be labeled

 More than 600 organizations and businesses endorse labeling (including the American Nurses Association, Consumers Union, Friends of the Earth, etc.)[ii]

 Barack Obama’s 2007 campaign pledge called for mandatory labeling of GMO foods[iii]

 1996 GMO labeling and concerns part of Natural Law Party Platform[iv]

 Took 450,000 signatures to Washington for 1999 GMO summit, requesting labeling of GMOs

[i] Center for Food Safety. Genetically Engineered Food Labeling Law. April 2, 2013. http://www.centerforfoodsafety.org/reports/1413/genetically-engineered-food-labeling-laws-map. Accessed July 26, 2015. [ii] Physicians for Social Responsibility Support Labeling of GMO Foods. http://www.psr.org/resources/psr-supports-labeling-gmo-foods.html. Accessed June 8, 2015. [iii] Van Hoesen S. White House Calls For Update to Biotech Regulation. http://www.ewg.org/release/white-house-calls-update-biotech- regulation?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+ewg_pressfeed+%28EWG%3A+Press+Feed%29. Accessed Jul5, 2015. [iv] Natural Law Party Platform- Agriculture, GMOs. http://www.natural-law.org/platform/agriculture.html. Accessed August 3, 2015.

82 Grassroots movement to label GMOs in USA By July 2015 a number of U.S. states had passed laws that would require labeling of GMO foods e.g. Maine, Vermont, Connecticut 2013-2015 nationwide labeling bill introduced by Representative Peter DeFazio of Oregon and Senator Barbara Boxer of California, never moved/enacted[i]

 February 12, 2015 bill reintroduced (bill HR913) but stalled[ii] [iii]

March 25, 2015 Alternate legislation HR1599 introduced by Rep. Mike Pompeo of Kansas

 Moving quickly through the House (July 2015)

 HR1599 is an industry-friendly bill

 “Preempts state and local restrictions on GMOs or GMO food and labeling requirements for GMOs, GMO food, non-GMO food, or “natural” food”[iv]

 Bill recognizes that GMOs have been modified through recombinant DNA techniques in a way that could not be obtained using conventional breeding techniques”

 Makes it clear GMOs are substantially different than any food derived from traditional breeding practices and contradicts industry/FDA’s original premise of substantial equivalence

[i] GovTrack. H.R. 1699 Genetically Engineered Food Right-to-Know Act (113th Congress 2013-2015). https://www.govtrack.us/congress/bills/113/hr1699. Accessed July 28, 2015. [ii] HR 913 Genetically Engineered Food Right-to-Know Act. Introduced February 12, 2015. https://www.congress.gov/bill/114th-congress/house-bill/913. Accessed July 26, 2015. [iii] Center for Food Safety. More States Support GMO Labeling Bills. May 22, 2013. http://www.centerforfoodsafety.org/press-releases/2240/more-states-support-gmo-labeling-bills. Accessed July 26, 2015. [iv] HR 1599: Safe and Accurate Food Labeling Act of 2015. Introduced March 25, 2015. https://www.congress.gov/bill/114th-congress/house-bill/1599. TRACK voting: https://www.govtrack.us/congress/votes/114-2015/h462. Accessed July 26, 2015.

83 Strong support for industry-backed HR 1599 bill Strong support for HR 1599 and strong opposition to mandatory GMO labeling from Grocery Manufacturers Association (GMA)

 The GMA is world’s largest trade association

 Represents packaged food and agribusiness companies

 e.g. Coca-Cola, PepsiCo, Kraft, Bayer, and Monsanto[i]

 Lobbying expenses for GMA over $14 million in 2013 when states were voting on labeling

The Coalition for Safe Affordable Food, a group that includes a number of farmers and the U.S. Chamber of Commerce, also strongly support HR 1599[ii]

[i] Grocery Manufacturers Association Members. https://web.archive.org/web/20131226021050/http://www.gmaonline.org/forms/MemberDirectory/viewMemberDirectoryAll. Accessed July 26, 2015. [ii] Coalition for Sage Affordable Food. Individual Letters of Support for HR 1599. http://coalitionforsafeaffordablefood.org/individual-letters-of-support-for- hr-1599/. Accessed July 26, 2015.

84 Strong opposition to HR1599 HR1599 Dubbed the “DARK” act (Denying Americans the Right-to-Know)

 Claim it denies states’ rights to develop GMO labeling laws or to regulate GMO crops

 Appears to prevent FDA from requiring labeling of foods containing GMO ingredients

 Instead continues current ineffective voluntary labeling policy[i]

 Labeling of GMOs continues to be hotly debated

 Hundreds of organizations (e.g. farm, food, health, public interest, and environmental organizations) oppose HR1599[ii]

[i] Center for Food Safety. July 23, 2015. http://www.centerforfoodsafety.org/press-releases/3994/house-of-representatives-ignores-will-of-the-people-in-passage- of-anti-labeling-dark-act. Accessed July 26, 2015. [ii] Letter to Representatives re: HR 1599 and HR 913. May 13, 2015. http://documents.foodandwaterwatch.org/doc/group_letter_dark_act_House_final.pdf. Accessed July 26, 2015.

85 LABELING AND RIGHT-TO-KNOW

Cannot track adverse reactions if unknown whether food/ingredients genetically engineered

Labeling of GMOs not required in USA despite growing consumer demand and ballot initiatives; over 60 other countries require labeling, some countries ban GMOs outright

Grocery Manufacturers Association (represents Coca-Cola, PepsiCo, Kraft, Bayer, Monsanto, etc.) spends tens of millions to thwart mandatory labeling campaigns in USA

86 Labeling of GMOs in other countries

 GMOs labeled in dozens of countries despite warnings from U.S. it would

 “Consider trade sanctions trade sanctions in response to labeling frameworks that it regards as non-scientifically based and exclusionary...

 The European Parliament voted in favor of mandatory labels on a food or food product containing 0.5% of a GM ingredient in July 2002

 United States stated that the action could "seriously impair trade in agricultural biotech products.”

Marden E. Risk and Regulation: U.S. Regulatory Policy on Genetically Modified Food and Agriculture. 2003; 44 B.C.L. Rev. 733. http://lawdigitalcommons.bc.edu/bclr/vol44/iss3/2. Accessed June 30, 2015.

87 Labeling of GMOs in Europe Straightforward & simple

 According to expert Carel du Marchie Sarvaas (Director of Agricultural Biotechnology, EuropaBio) on GMOAnswers.com

 “A concrete example of GM labeling on food products sold in supermarkets in the EU is Reese’s chocolate and peanut bar, which states: ‘produced from genetically modified sugar beets, corn and/or soybeans.’”[i]

 The method and approach to labelling is not open to interpretation. EU directives indicate precisely how labels must be worded and placed.[ii]  The use of symbols or logos is not allowed. The rules on labelling apply to virtually all foodstuffs:  processed, pre-cooked or packaged food, for which a list of ingredients must be indicated on the label  bulk or unpacked goods; and  catered food in restaurants and canteens.

[i] Du Marchie Sarvaas C. GMO Answers.com https://gmoanswers.com/ask/someone-claims-61-countries-require-gmo-labeling-what-does-gmolabel-look-likewhat-sufficient. https://gmoanswers.com/sites/default/files/gmolabel1.png. Accessed July 26, 2015. [ii] GMO Compass. GMO Labelling Guidelines: What does Labelling Look Like? Retrieved April 10, 2016 from http://www.gmo- compass.org/eng/regulation/labelling/90.gmo_labelling.html 88 What does a GMO label look like?

https://gmoanswers.com/sites/default/files/gmolabel1.png

The method and approach to labelling is not open to interpretation. EU directives indicate precisely how labels must be worded and placed. The use of symbols or logos is not allowed. The rules on labelling apply to virtually all foodstuffs: • processed, pre-cooked or packaged food, for which a list of ingredients must be indicated on the label; • bulk or unpacked goods; and • catered food in restaurants and canteens. http://www.gmo-compass.org/eng/regulation/labelling/90.gmo_labelling.html 89 GMO labeling update March 16, 2016- Institute for Responsible Technology 11:30am

The DARK Act has been manipulated and we need your phone calls and emails this morning! The text of the voluntary GMO labeling bill has been redrafted and sneakily presented as an amendment to Defund Planned Parenthood.

 There are two actions being taken on the DARK Act right now: First, Amendment 3450 to Senate Bill 764 Defund Planned Parenthood would replace the text of the Planned Parenthood bill with the new text of the DARK Act. [see text of amendments SA 3450, Section 1.] Call your Senators and tell them to vote NO on accepting Amendment 3450 to bill 764. Then, in the event Amendment 3450 is accepted, and Senate Bill 764 becomes the new DARK Act, you will want your Senators to vote NO on Bill 764.

NO on Amendment 3450 and NO on Senate Bill 764.

 Call (202) 224-3121 to leave a message for your senators.

 Contact information for senators can also be found athttp://www.senate.gov/senators/contact/

 Demand mandatory on-package GMO labeling - no compromise!

90 Amendment 3450 to Senate Bill 764 Defund Planned Parenthood would replace the text of the Sea Grant College Program Act with new text of the DARK Act.

[see text of amendments SA 3450, Section 1.]

91 GMO labeling update March 16, 2016- Institute for Responsible Technology 1:44pm

Thanks to all of your calls and emails the DARK Act was blocked this morning with a vote of 49 to 48

Dear Friends, Thanks to all of your calls and emails to US Senators the DARK Act was blocked this morning with a vote of 49 to 48-- but we expect that there will be another chance to keep fighting very soon.

92 Labeling update March 19, 2016 General Mills to label GMOs on products across the country

 “The maker of Cheerios, Yoplait and Betty Crocker joins Campbell Soup as one of the few major consumer product companies to adopt labeling amid a contentious debate in Congress about whether identifying GMOs — genetically modified organisms — should be voluntary.”

 “General Mills said Friday that it will start labeling its products that contain genetically modified ingredients in response to a law going into effect in Vermont later this year.”

 “The decision comes as General Mills and other food producers prepare to comply with a Vermont law that will require GMOs to be identified starting July 1.

 General Mills said that it's more cost effective to adopt the practice across the country in order to keep prices from rising for customers.” USAToday.com http://www.usatoday.com/story/money/2016/03/18/general-mills-to-label-gmos-on- products/81981314/

93 General Mills on GMOs

 “Those who have approved biotech crops to be as safe and acceptable as their conventional counterparts include:”

 The U.N. World Health Organization (WHO)

 http://www.who.int/foodsafety/areas_work/food-technology/faq-genetically-modified-food/en/

 The U.N. Food and Agriculture Organization (FAO)

 http://www.fao.org/biotech/fao-statement-on-biotechnology/en/

 The European Food Safety Authority

 http://www.efsa.europa.eu/en/topics/topic/gmo.htm?wtrl=01

 The U.S. Food and Drug Administration

 http://www.fda.gov/Food/FoodScienceResearch/GEPlants/default. htm

 The U.S. Department of Agriculture

 http://www.usda.gov/wps/portal/usda/usdahome?contentid=BiotechnologyF AQs.xml&navid=AGRICULTURE  https://www.generalmills.com/News/Issues/on-biotechnology 94 General Mills on GMOs con’t

 “Those who have approved biotech crops to be as safe and acceptable as their conventional counterparts include:”

 The U.S. Environmental Protection Agency https://www.epa.gov/pesticides

 Health Canada http://www.hc-sc.gc.ca/fn-an/gmf-agm/fs-if/faq_1-eng.php#b2

The National Academy of Sciences

 http://www.nap.edu/read/10977/chapter/1

 SAFETY OF GENETICALLY ENGINEERED FOODS APPROACHES TO ASSESSING UNINTENDED HEALTH EFFECTS 2004 the American Medical Association and the British Royal Society also say there is no health risk associated with GM foods or ingredients.

https://www.generalmills.com/News/Issues/on-biotechnology

95 Summary: Regulation & Safety

A coordinated framework of FDA, USDA, EPA oversees GMOs

 Voluntary process, FDA encourages biotech companies to consult the FDA and provide a nutrient, safety, and allergenicity evaluation of the crops before market

 NOT allowed in USDA certified organic or non-GMO project verified GMOs declared “substantially equivalent” to non-GMO counterparts, granted GRAS status (though challenged in court)

 Required no safety or human testing despite their novelty FDA scientists warned GMOs can have

 Unpredictable, hard-to-detect side effects including creation of new allergens, toxins, diseases, and nutritional consequences Scientific and healthcare groups have recommended detailed human testing and labeling of GMOs to track negative health effects GMO foods that produce pesticide/insecticide regulated as pesticides Many question the potential conflict of interest associated with the “revolving door” between biotechnology companies and the governmental agencies that are tasked with regulating them. 96 Genetically Engineered Foods Outline & Objectives Identify potential and proposed benefits of GMOs as well as potential health complications of consuming GMOs and associated pesticides

 Industry aspirations to create high yield, more nutritious crops

 Use of GMOs to produce pharmaceuticals and vaccines

 Potential complications of GMOs & associated pesticides

 Early animals studies suggest health complications

 Gastrointestinal

 Disruption of gut microbiome

 Immunological/allergenic

 Antibiotic resistance

97 What health benefits or concerns are associated with genetically engineered foods?

Potential Benefits Potential Concerns  Lack of regulation and labeling  “Feed the World” with greater of GMO foods yield, reduced resources,  Revolving door between more sustainable government and industry is a conflict of interest  Decrease pesticide use  Agricultural/Environmental  Increase nutritional value  Antibiotic resistance (e.g. golden rice, high oleic  Cancer soy (which has less omega-3)  Endocrine  Crops with resistance to  Gastrointestinal viruses, pests, stress, and  Gene transfer

salinity (early GMO research,  Immunological

not currently listed by FDA)[i]  Metabolic

[i] Pretty J. The rapid emergence of genetic modification in world agriculture: contested  Multi-organ risks and benefits. Environmental Conservation. 2001;28(3):248-62. doi: 10.1017/S0376892901000261.  Neurological http://www.researchgate.net/profile/Jules_Pretty/publication/231747426_The_rapid_emer gence_of_genetic_modification_in_world_agriculture_contested_risks_and_benefits/links/  Nutritional 00b495239933143360000000.pdf. Accessed June 18, 2015.  Reproductive

98 USDA Overview of GMOs Modern biotechnology today includes the tools of genetic engineering

 GMOs that tolerate specific herbicides make weed control simpler and more efficient.

 GMOs resistant to specific plant diseases and insect pests can make pest control more reliable and effective, and/or can decrease use of synthetic pesticides.

 These crop production options can help countries keep pace with demands for food while reducing production costs.

 Biotechnology-derived crops deregulated by the USDA

 GMOs being developed for phytoremediation

 Plants detoxify pollutants in the soil or absorb and accumulate polluting substances out of the soil so that the plants may be harvested and disposed of safely. http://www.usda.gov/wps/portal/usda/usdahome?contentid=BiotechnologyFAQs.xml&navid=AGRICULTURE

99 Potential benefits Feed the world, improve crops Initial benefits from GMOs were based on

 Hopes of increasing crop yields to “feed a hungry world”

 Improving nutritional composition

 Reducing fertilizer and pesticide use

 Increasing crop tolerance to drought and stress

 Enhanced growth in fish and production of pharmaceuticals by animals and crops are additional traits developed through genetic engineering[i] [ii]

[i] World Health Organization. Frequently asked questions on genetically modified foods. http://www.who.int/foodsafety/areas_work/food-technology/faq-genetically-modified-food/en/. Accessed June 17, 2015. [ii] Monsanto. What is a GMO? http://discover.monsanto.com/posts/gmo-facts/?gclid=COq81ZDnxMYCFYsRHwodVEEHeQ.Accessed July 5, 2015.

100 Increased crop yields may feed the world

 Review by the National Academy of Sciences suggests

 overall increase in crop yield using GMO technology[i]

 up to 60 million bushels (1998)[ii]

[i] Impact of Genetically Engineered Crops on Farm Sustainability in the United States. National Research Council of the National Academies. Washington, DC: The National Academies Press, 2010. http://www.nap.edu/openbook.php?record_id=12804. Accessed June 21, 2015. [ii] Metcalfe DD. Genetically modified crops and allergenicity. Nat Immunol. 2005 Sep;6(9):857-60. Review. PubMed PMID: 16116460. http://faculty.jsd.claremont.edu/emorhardt/159/pdfs/2006/Metcalfe.pdf. Accessed June 21, 2015.

101 Potential Benefits: Increased nutritional value “Golden Rice” is genetically engineered to produce more beta-carotene

 Plant and bacterial genes spliced into the rice

 Promotes increased production and accumulation of beta-carotene in rice grain, not just leaves[i] [ii]

 Touted as solution to world blindness and malnutrition

 Not yet allowed on the market as of January 2015[iii] (not available April 2016)

 The Golden Rice project wins the Patents for Humanity Award 2015

Genetically engineered bananas (w/ soy, rice, bacterial genes)

 Contain more beta-carotene, vitamin E, and iron

 Resistant to fungus

 Produce vaccines[iv] Some GMO research alters fatty acid composition

[i] Golden Rice Project. http://www.goldenrice.org/Content2-How/how1_sci.php. Accessed June 18, 2015. [ii] Beyer P, Al-Babili S, Ye X, Lucca P, Schaub P, Welsch R, Potrykus I. Golden Rice: introducing the beta-carotene biosynthesis pathway into rice endosperm by genetic engineering to defeat vitamin A deficiency. J Nutr. 2002. Mar;132(3):506S-510S. Review. PubMed PMID: 11880581. [iii] De Steur H, Blancquaert D, Strobbe S, et al. Status and market potential of transgenic biofortified crops. Nat Biotechnol. 2015 Jan;33(1):25-9. doi: 10.1038/nbt.3110. Erratum in: Nat Biotechnol. 2015 Feb;33(2):210. PubMed PMID: 25574631. http://www.nature.com/nbt/journal/v33/n1/full/nbt.3110.html. Accessed June 18, 2015. [iv] GMO-Compass. http://www.gmo-compass.org/eng/news/339.gm_bananas_developed_enhanced_nutrients.html. http://www.gmo- compass.org/eng/grocery_shopping/fruit_vegetables/17.bananas_using_genetic_engineering_against_fungal_disease.html. http://www.gmo-compass.org/eng/database/plants/20.banana.html. Accessed July 6, 2015. 102 Proposed benefits GMO traits Herbicide resistance and plant-incorporated protectants (insecticides)

 Pesticides produced by the crop  Crops genetically plant referred to as plant- engineered with incorporated protectants or “PIPs” bacterial genes can  Pesticidal protein produced by the bacterium Bacillus thuringiensis withstand excessive  Bt toxin is an insecticide

amounts of  Previously used in spray form, even herbicide/weed killer by organic farmers  Kills off certain pests such as without being the European corn borer, corn damaged themselves. rootworm, other caterpillars and worms

103 Overview of Major Concerns

 Lack of human studies, especially long-term studies

 Alteration of DNA can alter gene expression, amino acid sequence, protein function

 GMOs may produce new allergens and toxins

 Negative health effects from associated pesticides & unintended toxins

 Use of bacterial and unrelated genes in GMO crops and animals

 Agricultural effects (contamination of crops with GMOs, weed resistance, kill off of beneficial insects)

 More potent/toxic Bt insecticide and herbicides

 Unintended genetic damage to plant

105 Exposure to Environmental Toxins University of Minnesota Environmental Health MPH program GMO: Characteristics Definition of GMO: A genetically modified organism (GMO) is an organism that has ... The genetic engineering process utilizes viruses and bacteria most often to ... enhs.umn.edu/current/5103/gm/character.html GMO: References Potential adverse health effects of genetically modified crops. Journal ... Cornell University's Genetically Engineered Organisms Public Issues Education Project ... enhs.umn.edu/current/5103/gm/references.html Genetically Modified Organisms (GMO): Harmful Effects Genetically modified organisms (GMO's) are a broad group of plants, animals, and bacteria that are engineered for a wide variety of applications ranging from ... enhs.umn.edu/current/5103/gm/harmful.html GMO: Strategies for Preventing Exposure Genetically modified foods currently sold internationally have passed risk assessments ... Cornell University's Genetically Engineered Organisms Public Issues ... enhs.umn.edu/current/5103/gm/strategies.html GMO: Methods for Monitoring in the Environment In 2000, Genetically Engineered Food Alert, a coalition of seven organizations, first reported the presence of Starlink corn in the human food supply that led to ... enhs.umn.edu/current/5103/gm/methods.html 106 Exposure to Environmental Toxins University of Minnesota Environmental Health MPH program con’t GMO: Methods for Measuring Exposure Measuring human exposure to genetically modified organisms is extremely difficult for ... Cornell University's Genetically Engineered Organisms Public Issues ... enhs.umn.edu/current/5103/gm/measure.html GMO: Exposure Pathway Humans are exposed to genetically modified organisms by the ingestion of ... of processed foods contain ingredients made from genetically engineered corn, ... enhs.umn.edu/current/5103/gm/exposure.html GMO: Absorption, distribution and metabolism The current scientific evidence regarding the absorption, distribution, and metabolism of a genetically modified organism is identical to that of its conventional ... enhs.umn.edu/current/5103/gm/absorb.html GMO: Fate and Transport in the Environment Genetic modifications of plants are done via one of two major processes: 1. The Ti Plasmid and Agrobacterium tumefaciens 2. The Gene Gun. The first method of ... enhs.umn.edu/current/5103/gm/fate.html GMO: Dose Response Genetically Modified Organisms (GMO) ... The most well known involves a transgenic potato engineered to produce a natural insecticide (Ewen & Pusztai, 1999). enhs.umn.edu/current/5103/gm/dose.html 107 Failure to Yield- Union of Concerned Scientists

Used with permission UCSUSA.org http://www.ucsusa.org/food_and_agriculture/our-failing-food-system/genetic-engineering/failure-to-yield.html#.VsY2gfkrK00

108 Failure to Yield Union of Concerned Scientists “Failure to Yield” report:

Measurable benefits increasing crop yield have not materialized

 In some cases yields have been reduced[i]

 Farmers in India sued and won $1.1 million in compensation from Bayer Cropscience for declining yields

Keshav Raj Kranthi, head of the Central Institute for Cotton Research notes that GMO cotton is

 More vulnerable to infection, requires more water and nutrients, and contributes to soil depletion[ii]

[i] Gurian-Sherman, Doug. Failure to Yield: Evaluating the Performance of Genetically Engineered Crops. Cambridge, MA: Union of Concerned Scientists, 2009. http://www.ucsusa.org/food_and_agriculture/our-failing-food-system/genetic-engineering/failure-to-yield.html#. Accessed July 5, 2015. [ii] Bouissou J. The Guardian. May 15, 2012. India loses faith in GM cotton. Maharashtra state government orders German seed company to compensate farmers as cotton hybrids fail to deliver. http://www.theguardian.com/world/2012/may/15/india-gm-cotton-bayer. Accessed July 6, 2015.

109 Increased crop yields?

Four-year UN and World Bank study conducted by

 Hundreds of experts from 80 countries (endorsed by 58 countries) concluded that

 Crop yields for genetically engineered foods were highly variable and in some cases decreased[i]

Agroecologist Dr. Don Lotter (UC Davis, Rodale Institute):

 Major GMO crops

 Generate lower crops yields than conventional

 Ultimately reduce net return and profit margin[ii]

[i] Druker, Steven M. Altered Genes, Twisted Truth: How the Venture to Genetically Engineer Our Food Has Subverted Science, Corrupted Government, and Systematically Deceived the Public. Salt Lake City, UT: Clear River, 2015. [ii] Lotter D. The genetic engineering of food and the failure of science–Part 1: The development of a flawed enterprise. Int Jrnl of Soc of Agr & Food. 2009;16(1):31-49. Retrieved April 12, 2016 from http://ijsaf.org/archive/16/1/lotter1.pdf f Soc of Agr & Food. 2009;16(1):31-49. http://ijsaf.org/archive/16/1/lotter1.pdf. Accessed June 19, 2015.

110 Safety of chemicals, herbicides, and pesticides challenged

Toxicity of GMO-associated herbicides and insecticidal proteins being researched

 Ingestion by humans, animals, and beneficial insects may disrupt ecosystems and human health

 “Allowable” limits of herbicides increase as planting of herbicide-tolerant crops increases[i] [ii]

 Some GMO crops are “stacked” to retain more than one GMO trait.

 Most stacked trait crops are genetically engineered to produce Bt toxin and to be herbicide tolerant

[i] Schubert D. The Coming Food Disaster. CNN. Retrieved April 16, 2016 from http://www.cnn.com/2015/01/27/opinion/schubert-herbicides-crops/ [ii] EPA. Glyphosate; Pesticide Tolerances. Federal Register. May 1, 2013;78(84);25396-401. http://www.gpo.gov/fdsys/pkg/FR-2013-05-01/pdf/2013-10316.pdf Accessed July 18, 2015.

111 Concern: Herbicide-tolerant (HT) crops e.g. Monsanto®’s Roundup Ready® Bayer®’s Liberty Link®

 More and more HT crops being developed, grown

 Greater and greater amounts of herbicide can be used because crops themselves are tolerant

 2015:

 HT soybeans account for 94% of total U.S. soybean acreage

 HT cotton accounts for 89% of cotton acreage

 HT corn makes up 89% of the U.S. corn crop.

USDA. Recent Trends in GE Adoption. http://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-crops-in-the-us/recent-trends-in-ge-adoption.aspx. Updated July 9, 2015. Accessed July 23, 2015.

112 Concerns re: Herbicide residues Farmers unable to rotate crops (helps retain nutrients) in GMO fields

 Residue would kill off traditional non-tolerant crops.

Herbicide residues can be passed on

 to animals and humans through food and water

 Can measure glyphosate residues in water, urine, breast milk Weeds become resistant to herbicide

 HT weeds on the rise

Monsanto Crop Protection Update. The Science of Roundup Ready Technology, Glyphosate and Micronutrients. Part 1 – Glyphosate Chemistry, Efficacy and Interaction with Micronutrient Foliar Applications. http://www.monsanto.com/newsviews/documents/cpu_roundup_ready_crops_glyphosate_and_micronutrients.pdf. Accessed June 30, 2015.

113 More potent herbicides to combat HT weeds Industry producing new patented GMOs & more potent

herbicide formulations to combat HT weeds[i] [ii] [iii] [iv]

 2015 EPA approved Enlist Duo™ herbicide (Dow AgroScience®)

 Combines 2,4-Dichlorophenoxyacetic acid (the 2,4-D component of Agent Orange) with glyphosate for use with GMO Enlist corn and soybeans

 The EPA claims “The Agency’s decision is protective of all, including the developing fetus, infants and children, the elderly and farmworkers.”[v]

 2014 Consumers Union urges EPA to not approve/register potent herbicide formula

 Cite association between 2,4-D and increased risk of

 Parkinson’s disease

 Hypothyroidism

 Birth defects

 Non-Hodgkin’s lymphoma

 Other cancers.[vi]

[i] Green JM, Owen MD. Herbicide-resistant crops: utilities and limitations for herbicide-resistant weed management. J Agric Food Chem. 2011 Jun 8;59(11):5819-29. doi: 10.1021/jf101286h. Epub 2010 Jun 29. Review. PubMed PMID: 20586458 [ii] Schubert D. The Coming Food Disaster. CNN. http://www.cnn.com/2015/01/27/opinion/schubert-herbicides-crops/. January 29, 2015. Accessed July 18, 2015. [iii] Impact of Genetically Engineered Crops on Farm Sustainability in the United States. National Research Council of the National Academies. Washington, DC: National Academies Press, 2010. http://www.nap.edu/openbook.php?record_id=12804. Accessed June 21, 2015. [iv] Monsanto. Roundup® Xtend. http://www.monsanto.com/products/pages/roundup-xtend.aspx. Accessed July 19, 2015. [v] EPA. Registration of Enlist Duo. http://www2.epa.gov/ingredients-used-pesticide-products/registration-enlist-duo. Accessed July 23, 2015. [vi] Consumers Union. Letter to EPA Administrator Gina McCarthy. June 30, 2014. Retrieved April 16, 2016 from https://consumersunion.org/wp-content/uploads/2014/07/2-4-D-comments.pdf 114 GMO Bt crops Combine bacterial genes with a food crop Bacterial gene is spliced into plant so that

 plant actually produces the pesticide 24/7

 Production of concentrated active toxin is substantially different than spraying Bt onto crops (spray contains inactive toxin)[i]

 GMO Bt toxin different than original Registered with EPA as pesticides Initially decreased need to spray insecticides directly on crops[ii] Insecticide resistance is on the rise, may render the technology ineffective in future[iii] [iv] [i] Freese, W., & Schubert, D. (2004). Safety Testing and Regulation of Genetically Engineered Foods. Biotechnology and Genetic Engineering Reviews, 21(1), 299-324. doi:10.1080/02648725.2004.10648060 Retrieved April 16, 2016 from http://www.tandfonline.com/doi/pdf/10.1080/02648725.2004.10648060 [ii] EPA Biopesticides. Retrieved April 16, 2016 from https://www.epa.gov/pesticides/biopesticides EPA's Regulation of Bacillus thuringiensis (Bt) Crops. 735-F-02-013. May 2002. http://www.epa.gov/pesticides/biopesticides/pips/regofbtcrops.htm. Updated February 3, 2014. Accessed June 12, 2015.0 [iii] University of California, Davis. Safety of Genetically Engineered Food. http://anrcatalog.ucdavis.edu/pdf/8180.pdf . Accessed June 21, 2015. [iv] Gassmann AJ, Petzold-Maxwell JL, Clifton EH, et al. Field-evolved resistance by western corn rootworm to multiple Bacillus thuringiensis toxins in transgenic maize. Proc Natl Acad Sci U S A. 2014 Apr 8;111(14):5141-6. doi: 10.1073/pnas.1317179111. Epub 2014 Mar 17. PubMed PMID: 24639498.

115 Pesticide-producing crops and their PIPs Pesticides produced by the crop plant referred to as plant- incorporated protectants or “PIPs”

 Bt toxin is an insecticide

 Pesticidal protein produced by the bacterium Bacillus thuringiensis

 Previously used in spray form, even by organic farmers

 Kills off certain pests such as the European corn borer, corn rootworm, other caterpillars and worms (?ladybugs, butterflies, bees) Bt toxin produced in plant through genetic engineering

 different than that naturally produced by bacteria[i] [ii] (e.g. glycosolated, truncated, etc.) EPA waives maximum permissible levels for Bt residue

 “in or on” GMO crops, making tracking exposure difficult[iii]

[i] Pryme IF, Lembcke R. In Vivo Studies on Possible Health Consequences of Genetically Modified Food and Feed— with Particular Regard to Ingredients Consisting of Genetically Modified Plant Materials. Nutrition and Health. 2003;17:1-8. http://nah.sagepub.com/content/17/1/1.short. http://stopogm.net/sites/stopogm.net/files/prymepaper.pdf. Accessed July 23, 2015. [ii] Vendômois, J. S. (2010). Debate on GMOs Health Risks after Statistical Findings in Regulatory Tests. Int. J. Biol. Sci. International Journal of Biological Sciences, 590-598. doi:10.7150/ijbs.6.590 Retrieved April 16, 2016 from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2952409 and http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2952409/figure/F1/ [iii] EPA Exemption From the Requirement of a Tolerance Bacillus thuringiensis Protein. https://www.federalregister.gov/articles/2014/02/12/2014-02932/bacillus thuringiensis-cry1f- protein-in-soybean-exemption-from-the-requirement-of-a-tolerance. http://www.gpo.gov/fdsys/pkg/FR-2012-08-08/html/2012-19319.htm. Accessed July 26, 2015

116 Concern: Genetic engineering unintentionally yet substantially changes gene expression

Research that demonstrated the genetic modification of strawberries actually made them more susceptible to mold.

 As a matter of fact “major unexplainable changes in gene expression were observed

 among them increased synthesis of newly

identified compounds.”[i]

[i] Hanhineva K, Kokko H, Siljanen H, et al. Stilbene synthase gene transfer caused alterations in the phenylpropanoid metabolism of transgenic strawberry (Fragaria x ananassa). J Exp Bot. 2009;60(7):2093-106. doi: 10.1093/jxb/erp085. PubMed PMID: 19443619.

117 Summary Slide: Health benefits and concerns associated with genetically engineered foods 1p.

Proposed benefits include increased crop yields, decreased pesticide use, increased nutritional value, increased crop resistance to environmental stress.

 Strong support for GMOs from the Genetic Literacy Project, Center for Science in the Public Interest (Nutrition Action Newsletter), David Kessler former FDA commissioner, the American Association for the Advancement of Science Opposition or strong precautionary approach to GMOs: The Academy of Environmental Medicine, the Center for Food Safety, the Union of Concerned Scientists, the Institute for Responsible Technology, and the Alliance for Biointegrity

 Major concerns with GMOS:

 Crop yields not substantially increased, in some cases decreased

 GMOs never met GRAS definition, should have undergone extensive human testing and monitoring

 Animal studies suggest GMOs and associated pesticides may be toxic even at low doses

 Alteration of DNA may produce unknown allergens, toxins, and other compounds with unpredictable effects

 GMO foods should be labeled (consumer’s right to know) in order to best track adverse reactions

 GMOs may pass traits on to wild plants, non-GMO crops, beneficial GI bacteria with detrimental consequences

 Herbicides & GMO insecticides may kill off beneficial organisms (e.g. honey bees, ladybugs, Monarch butterflies)

 Genetic engineering may damage plant genes, disturb crucial metabolic processes, silence/promote non-target genes

 GMOs can easily contaminate non-GMO crops, have devastating effects on organic farmers

 Patenting and control of the food supply by a few companies is a worldwide concern

 Patenting of GMO seeds, control of research makes it difficult to obtain objective independent research on GMOs

 GMO mono-cropping leads to loss of biodiversity

 GMO crops that contain bacterial genes account for majority of U.S. corn and soy crops

 Use of associated herbicides increased exponentially with increased use of HT GMO crops

 Herbicides themselves have detrimental effects on human health at increasing doses

 Weed and insect resistance requires increased use and creation of more potent herbicides and insecticides (e.g. 2,4- D and mutated Bt toxins respectively)

 More potent, mutated Bt toxins may have detrimental effects on human health, never tested

118 Summary Details: Health benefits and concerns Proponents & Opponents to GMOs

 Proposed benefits include increased crop yields, decreased pesticide use, increased nutritional value, increased crop resistance to environmental stress.

 Proponents:The Genetic Literacy Project, Center for Science in the Public Interest (Nutrition Action Newsletter), David Kessler former FDA commissioner, the American Association for the Advancement of Science

 Major concerns include lack of human testing, health effects from GMOs and pesticides (animal testing), contamination of wild and non-GMO crops, killing off of beneficial insects, bees, etc.

 Opponents or strong precautionary approach: The Academy of Environmental Medicine, the Center for Food Safety, the Union of Concerned Scientists, the Institute for Responsible Technology, and the Alliance for Biointegrity

119 Summary Details: Major concerns