Genetically Modified Organisms Good Bad or Both Action

Genetically Modified Organisms: Good, Bad, or Both? Action Research Study by Celina Makowski (Principle Investigator) and the Flagler Hospital CME Committee

Informed Consent Study Title: Evaluating the Change in Knowledge, Clinical Practice, and Behavior Outcomes of a Community Hospital’s Enduring Continuing Medical Education Activity on the Topic of Genetically Modified Organisms. Study type: Action Researcher: Celina Makowski; employee of Flagler Hospital as Manager, CPPD/CME Researcher contact information: celina. makowski@flaglerhospital. org or 819 -4409 Introduction This enduring continuing medical education (CME) activity was created in partnership by the CME Coordinator and CME Committee as part of a doctoral action research study affiliated with Capella University in the School of Public Service Leadership. The Researcher is employed by Flagler Hospital as the Coordinator of Continuing Medical Education/Medical Librarian. If the professional association causes you discomfort you may decline expressing an interest in this study. The information in these next few slides is provided as a reminder of the informed consent form that was sent to you attached to the Genetically Modified Organisms: Good, Bad, or Both? CME activity announcement/study recruitment flyer. As a reminder, if you have any questions or did not understand something within the consent form, you should stop this CME activity and contact the researcher, Celina Makowski, by calling 819 -4409 or via email celina. makowski@flaglerhospital. org. Do not agree to participate in the study unless your questions have been answered. What is this study about? The researcher wants to learn about the changes in knowledge, clinical practice and behavior of physicians, physicians’ assistants, nurse practitioners, and hospital staff that complete the continuing medical education activity.

Why am I being asked to be in the study? *You are a physician (MD, DO, DDS, DMD, or DPM) *You are a physician’s assistant or advanced registered nurse practitioner that has hospital privileges *You are an interested clinical or non-clinical hospital employee How many people will be in this study? As many credentialed physicians, physicians’ assistants, nurse practitioners and other allied health practitioners, nurses and clinical and non-clinical hospital employees that participate in the enduring CME activity within a three month study period. Who is paying for this study? The Researcher is not being paid to conduct this study. Will it cost anything to be in the study? You do not have to pay to be in the study. How long will I be in the study? *Approximately 1. 25 hours to complete pre-test to determine knowledge of GMO, CME activity, post-test to determine knowledge gained and potential changes in behavior resulting from CME activity through activity evaluation; *Approximately 10 minutes to complete post-test and CME activity evaluation about personal and professional behavior changes, and *Approximately 10 minutes to complete the sustained knowledge test and post activity evaluation provided three weeks after activity completion.

What will happen during the study? If you decide to participate in the study you will do the following things: *complete the pre-test questions prior to the CME activity topic by accessing the Survey. Monkey® link provided prior to the start of the CME activity. *complete the continuing medical education activity and review the patient hand-out attached to this enduring CME activity. *provide demographic information that includes your name, degree, and Florida state license number for continuing education credit reporting, answer post-test questions to evaluate the change in knowledge about the activity topic, and answer the continuing medical education evaluation questions about the activity content, effectiveness of activity, reported change in your knowledge, competence, practice, or patient outcomes as a result of completing the CME activity by accessing the Survey. Monkey® link provided at the end of the CME activity. *answer the post-continuing medical education sustained knowledge and change in practice or behavior evaluation questions. The Survey. Monkey® link will be e-mailed to you approximately three weeks after completing the CME activity.

If you decide not to participate in the study you will do the following things: *answer no to the consent question included within the CME activity pretest questions by accessing the Survey. Monkey® link provided prior to the start of the CME activity. *complete the continuing medical education activity and review the patient hand-out attached to this enduring CME activity. *provide demographic information that includes your name, degree, and Florida state license number for continuing education credit reporting, answer post-test questions to evaluate the change in knowledge about the activity topic, and answer the continuing medical education evaluation questions about the activity content, effectiveness of activity, reported change in your knowledge, competence, practice, or patient outcomes as a result of completing the CME activity by accessing the Survey. Monkey® link provided at the end of the CME activity. * Reminder, you can stop the CME activity at any time and complete later.

Will I be recorded? The information you provide by answering the pre/post test questions, demographic information, and evaluations will be recorded within Survey. Monkey® for analysis. Will being in the study help me? You may not be helped by this study. Are there risks to me if I am in the study? No study is completely risk-free. However, it is not anticipated that you will be harmed or distressed during this study. You may stop being in the study at any time if you become uncomfortable. Will I get paid? You will not be paid a monetary value to complete the study. If you are qualified to earn continuing education credit, you may complete the CME activity and the accompanying pre/post test questions and activity evaluation to earn one (1) AMA PRA Category 1 Credit™ or one (1) CE/U credit. Do I have to be in this study? Your participation in this study is voluntary. You can decide not to be in the study and you can change your mind about being in the study by not completing the components of the enduring CME activity, which include the pre/post tests and activity evaluation. The researcher can remove you from the study at any time. This could happen if: *the researcher believes it is best for you to stop being in the study. *you do not follow directions about the study. *you no longer meet the inclusion criteria to participate.

Who will use and share the information about my being in this study? Any information you provide in this study that could identify you, such as your name, demographics, or license number will be kept confidential within the confines of the CME Committee’s Survey. Monkey® password protected account accessible only by the Continuing Medical Education (CME) personnel. Since the non-researchers (CME personnel or CME Committee members) do have access to the CME Committee’s Survey. Monkey® account, your name, demographics, and license number has the potential risk of being revealed as a participant of the CME activity and/or study. All printed documentation from the CME Committee’s Survey. Monkey® account will be maintained in a locked file drawer within the CME Coordinator’s office located in the hospital on a closed floor accessible by badge only. The provided personal information will only be used to report continuing medical education credits to the state of Florida. Your name, demographics or license number will not be revealed in any written reports or publication; only aggregated information will be utilized. The researcher will keep the information you provide in a password protected hospital network folder for seven years and the researcher, researcher’s supervisor, dissertation committee , CME personnel and CME committee will have access to the study data. Additionally, Capella University’s IRB, the Research Compliance Committee (RCC), or its designee may review the research records. Even if you leave the study early by not answering the Survey. Monkey® post-continuing medical education sustained knowledge question and evaluation e-mailed to you approximately three weeks after completing the CME activity, the researcher may still be able to use the data provided during the pre/post tests and activity evaluation.

Who can I talk to about this study? You can ask questions about the study at any time. You can contact the researcher if you have any concerns or complaints. You should either e-mail or call the researcher at the email address or phone number listed on slide 2 if you have questions about the study procedures, study costs (if any), study payment (if any), or if you get hurt or sick during the study. Capella University’s Institutional Review Board (IRB) has been established to protect the rights and welfare of human research participants. Please contact us at 1 -888 -227 -3552, extension 6313, for any of the following reasons: *You have questions about your rights as a research participant. *You wish to discuss problems or concerns. *You have suggestions to improve the participant experience. *You do not feel comfortable talking with the researcher. You may contact the IRB without giving us your name. We may need to reveal information you provide in order to follow up if you report a problem or concern.

Participating in the research study is voluntary. Do you want to be in the research study? � Submit a signed consent form prior to completing the Pre-test and CME activity o To obtain a study consent form q Click the consent form link within the CME activity folder OR q Contact the researcher, Celina Makowski, at 904 -819 -4409 or e-mail celina. makowski@flaglerhospital o Signed consent forms can be submitted to the researcher via: o Inter-office mail or drop off in Medical Staff Library o E-mail to celina. makowski@flaglerhospital. org o Fax to 904 -819 -5290 Do you have additional questions about the study? • Contact the researcher, Celina Makowski, at 904 -819 -4409 or e-mail celina. makowski@flaglerhospital As a reminder, you may complete the following CME activity to earn credits without participating in the research study.

Pre-Test � Please answer the pre-test questions before starting the CME activity by clicking the Pre-Test link within the CME activity folder or � at https: //www. surveymonkey. com/r/GMOpretest

Genetically Modified Organisms: Good, Bad, or Both? Release Date: xx/xx/2016 Expiration Date: xx/xx/2016 Target Audience: All physicians, physicians’ assistants, nurse practitioners and other healthcare professionals and hospital employees interested in genetically modified organisms. Disclosures: o No Commercial Interest o No relevant financial interest by faculty or CME Committee Planners o No investigational products/products not labeled for use is mentioned within the CME activity.

Faculty Celina Makowski, MBA Manager, CPPD/CME Flagler Hospital, Inc. Contact Number: 904 -819 -4409 E-mail: celina. makowski@flaglerhospital. org

CME Objectives At the conclusion of this activity, participants will be able to: � 1. Define genetically modified organisms (GMO) and the various types of genetic modifications utilized in plants and animals. � 2. Consider the historical and future impact of GMO on the food and pharmaceutical supply. � 3. Discuss the controversial benefits, health risks and conflicts of interest associated with GMO products. � 4. Summarize the various positions and viewpoints of medical and governmental organizations, scientists, and consumers.

How To Obtain CME/CEU Credit * Complete Pre-Test * Complete the CME Activity & read the patient education handout * Complete the Post-Test with a passing score of 80% and activity evaluation via Survey. Monkey® link. * Complete the Sustained Knowledge question and post-activity evaluation via Survey. Monkey® link emailed to you approximately 3 weeks after activity completion.

Accreditation/Credit Statement Flagler Hospital is accredited by the Florida Medical Association to provide continuing medical education for physicians. Flagler Hospital designates this educational activity for maximum of 1. 00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Flagler Hospital designates this educational activity for 1. 00 CE/U. CE Broker: 50 -664

Disclaimer This information in this educational activity is provided for general medical education purposes only and is not meant to substitute for the independent medical judgment of a physician relative to diagnostic and treatment options of a specific patient’s medical condition. The viewpoints expressed in this CME activity are those of the authors/faculty. They do not represent an endorsement by Flagler Hospital. In no event will Flagler Hospital be liable for any decision made or action taken in reliance upon the information provided through this CME activity.

Video Sacerdote, A. (n. d. ) Fed up!-genetic engineering, industrial agriculture and sustainable alternatives. Retrieved from https: //archive. org/details/Fed. Up-Genetic. Engineering. Industrial. Agriculture. And. Sustainable

Video Sacerdote, A. (n. d. ) Fed up!-genetic engineering, industrial agriculture and sustainable alternatives. Retrieved from https: //archive. org/details/Fed. Up-Genetic. Engineering. Industrial. Agriculture. And. Sustainable

What is GMO?

Definitions � The American Heritage® Abbreviations Dictionary � “An organism or microorganism whose genetic material has been altered by means of genetic engineering. ” 1 � World Health Organization � “Genetically modified organisms (GMOs) can be defined as organisms (i. e. plants, animals or microorganisms) in which the genetic material (DNA) has been altered in a way that does not occur naturally by mating and/or natural recombination. ” 2 � Monsanto Company � “A genetically modified organism (GMO) is any organism the genetics of which have been altered through the use of modern biotechnology to create a novel combination of genetic material. GMOs may be the source of genetically modified food ingredients and are also widely used in scientific research and to produce goods other than food. ” 3 3. 1. GMO. (n. d. ) The American Heritage® Abbreviations Dictionary, (3 rd ed). (2005). Retrieved March 12, 2016, from http: //www. dictionary. com/browse/gmo 2. World Health Organization. (n. d. ). Frequently asked questions on genetically modified foods. Retrieved from http: //www. who. int/foodsafety/areas_work/food-technology/faq-genetically-modified-food/en/ Monsanto Company. (2015). Glossary. Retrieved fromhttp: //www. monsanto. com/newsviews/pages/glossary. aspx#geneticmodification

Purpose of Genetic Modified Crops � Feeding the World of 2050 � Current population is approximately 7. 2 billion people � 879 million people are currently chronically hungry � 2 billion people are malnourished � Farmer benefits � Increase worldwide food supply � Increased crop protection to yield improved productivity � Resistant to diseases from pests and viruses � Resistant to herbicides for improved weed control � Climate change challenges More severe droughts – agriculture uses 70% of fresh water in world � Consumer benefits � Increased food supply equals lower cost � Increased durability of crops reduce food waste � Planned improved nutritional value James, C. (2015). ISAA Brief 49 -2014: Executive Summary: Global status of commercialized biotech/GM Crops: 2014. International Service for the Acquisition of Agri-Biotech Application. Retrieved March 6, 2016, from http: //www. isaaa. org/resources/publications/briefs/49/executivesummary/default. asp

Traditional Methods Genetic alteration of plants and animals � Plants � According to Encyclopaedia Britannica, “plant breeding is the application of genetic principles to produce plants that are more useful to humans. This is accomplished by selecting plants found to be economically or aesthetically desirable, first by controlling the mating of selected individuals, and then be selecting certain individuals among the progeny. ” 1 � Dates back to ancient times when people domesticated plants for food � Farmers saved plant seed that had best characteristics for new crops � Animals � According to Encyclopaedia Britannica, “animal breeding is controlled propagation of domestic animals in order to improve desirable qualities. ” � Domestication of animals � Pig, to provide food for human consumption � Dog, used as a societal tool, i. e. hunting, protection, companionship � Cross breeding of animals � � Cows, to develop stronger, more viable herds Fish, for increased production � Random trait selection � No direct control of DNA Allard, R. (2015, December 2). Plant breeding. Encyclopaedia Britannica. Retrieved fromhttp: //www. britannica. com/science/plant-breeding Freeman, A. (2016). Animal breeding. Encyclopaedia Britannica. Retrieved fromhttp: //www. britannica. com/science/animal-breeding

Modern Methods � Genetic Engineering � According to Encyclopedia Britannica, “genetic engineering is the artificial manipulation, modification, and recombination of DNA or other nucleic acid molecules in order to modify an organism or population of organisms. ” 2 � Recombinant DNA technology � 1968 – Werner Arber, Swiss microbiologist, discovered restriction enzyme � 1969 -1971 – Hamilton O. Smith & Daniel Nathans, U. S. microbiologists, isolated and refined restriction II enzymes, the beginning of DNA mapping 3 � 1973 – Stanley N. Cohen & Herbert W. Boyer pioneered the use of cutting DNA in to fragments, recombining fragments, and adding foreign genes into E. Coli bacteria � 1980 – Newly designed microorganisms through technology were determined patentable � 1986 – U. S. Department of Agriculture approved the sale of genetically altered organism � Virus used as a pseudorabies vaccine � 2005 -current – Gene Editing � Use of new technology, CRISPR-Cas 9 1 CRISPR-Clustered regularly-interspaced short palindromic repeats Cas 9 – a nuclease, an enzyme specialized for cutting DNA � Customization of genetic sequencing by adding genes to an organisms DNA structure 1. Bortesi, L. & Fischer, R. (2015). The CRISPR/Cas 9 system for plant genome editing and beyond. Biotechnology Advances, 33 (1), 41 -52. Retrieved from http: //www. sciencedirect. com/science/article/pii/S 0734975014001931 2. Genetic engineering. (2016). Encyclopaedia Britannica. Retrieved from http: //www. britannica. com/science/genetic-engineering 3. Pingoud, A. & Jeltsch, A. (2001). Structure and function of type II restriction endonucleases. Nucleic Acids Research, 29(18), 37053727. Retrieved fromhttp: //www. ncbi. nlm. nih. gov/pmc/articles/PMC 55916/

Alternate Terms � Alternate terms found in literature and news articles used to describe plants that have had their genetics altered � � Bioengineered or genetically engineered Transgenic GM Food Genetically Modified Plants (GMP) � U. S. Food and Drug Administration clarification � “While genetic engineering is sometimes referred to as “genetic modification” producing “genetically modified organisms (GMOs), ” FDA considers “genetic engineering” to be the more precise term. ” 3 � American Medical Association � Prefers specific term of “bioengineered” as found in Policy H-480. 958 (Bioengineered (Genetically Engineered) Crops and Foods) 1 � The European Commission � “In recent times, it has become possible to modify the genetic make-up of living cells and organisms using techniques of modern biotechnology called gene technology. The genetic material is modified artificially to give it a new property (e. g. a plant's resistance to a disease, insect or drought, a plant's tolerance to a herbicide, improving a food's quality or nutritional value, increased yield). Such organisms are called "genetically modified organisms" (GMOs). Food and feed which contain or consist of such GMOs, or are produced from GMOs, are called "genetically modified (GM) food or feed””. 2 1. 2. American Medical Association. (2012). Report 2 of the council on science and public health. European Commission. (2016, February 17). Genetically modified organisms. Retrieved from http: //ec. europa. eu/food/plant/gmo/index_en. htm 3. U. S. Food and Drug Administration. (2015, October 19). Consumer info about food from genetically engineered plants. Retrieved from http: //www. fda. gov/Food. Science. Research/GEPlants/ucm 461805. htm

First Generation of Bioengineering � Herbicide tolerant crops 1 � Roundup® Ready – Alfalfa, Canola, Corn, Cotton, Soybean, Sugarbeets Tolerant to Glyphosate-based herbicides Developed by Monsanto Company – 1996 � Liberty Link – Canola, Corn, Cotton, Soybean Tolerant to Glufosinate herbicides Developed by Bayer Crop. Science � Others 2, 3: * 2, 4 -D tolerant Soybean and Corn Developed by Dow Agro. Sciences * ACCase Inhibitor tolerant Corn Developed by Dow Agro. Sciences * ALS-Inhibitor tolerant Soybean and Corn Pioneer Hi-Bred * Bromoxynil tolerant Cotton Developed by Calgene * Dicamba tolerant Cotton Monsanto Company * Imidazolinone tolerant Soybean BASF * Isoxaflutolerant Soybean Bayer Crop. Science * Sulfonylurea tolerant Cotton - Du. Pont Flax – University of Saskatchewan 1. GMO Compass. (2016). Herbicide resistant crops. Retrieved from http: //www. gmocompass. org/eng/agri_biotechnology/breeding_aims/146. herbicide_resistant_crops. html 2. Green, J. M. & Owen, D. K. (2011). Herbicide-resistant crops: utilities and limitation for herbicide-resistant weed management. Journal of Agriculture and Food Chemsitry, 59(11), 5819 -5829. Retrieved fromhttp: //www. ncbi. nlm. nih. gov/pmc/articles/PMC 3105486/ 3. Herbicide tolerant crops. (2012, August, 15). Sourcewatch: The Center for Medial and Democracy. Retrieved from http: //www. sourcewatch. org/index. php/Herbicide_Tolerant_Crops

� Toxin producing crops 1, 4 � Corn, Potato, Cotton, Soybean � Bt crops (Bacillus thuringiensis) Bacteria found in soil, dessert, and tundra toxic to herbivorous insects Insect consume Bt, converted to active toxin delta endotoxin Delta endotoxin destroy insect gut Protects crops against European corn borer, southwestern corn borer, tobacco budworm, cotton bollworm, pink bollworm, and Colorado potato beetle 2 First deregulated crops by Monsanto Company -1995 1 � Pathogen resistant crops � Papaya � Virus, Bacterial, Fungal � Stacked trait crops 2, 3 � Canola, Corn, Cotton, Soybean � Addition of two or more herbicide tolerant and toxin producing genes within plant � Crops carry multiple patented traits 1. GMO Compass. (2016). Pest resistant crops. Retrieved from http: //www. gmocompass. org/eng/agri_biotechnology/breeding_aims/147. pest_resistant_crops. html 2. Gene stacking. (2016). Plant & Soil Sciences e. Library. Retrieved fromhttp: //passel. unl. edu/pages/informationmodule. php? idinformationmodule=959009357&topicorder=8&maxto=9 3. Pocket K No. 42: stacked traits in biotech crops. (2013, March). International Service for the Acquisition of Agri-Biotech Applications. Retrieved from http: //isaaa. org/resources/publications/pocketk/42/default. asp 4. University of California San Diego. (n. d. ). Bt GM crops. Retrieved from http: //www. bt. ucsd. edu/bt_crop. html

GM Food Supply Impact Countries Growing GMO As of 2014 in million hectares: � USA – 73. 1 � Brazil – 42. 2 � Argentina – 24. 3 � India – 11. 6 � Canada – 11. 6 � China – 3. 9 � Paraguay – 3. 9 � Pakistan – 2. 9 � South Africa – 2. 7 � Uruguay – 1. 6 � Bolivia – 1. 0 � Philippines – 0. 8 � Australia – 0. 5 � � � � Burkina Faso – 0. 5 Myanmar – 0. 3 Mexico – 0. 2 Spain – 0. 1 Colombia – 0. 1 Sudan – 0. 1 Honduras – <0. 1 Chile – <0. 1 Portugal – <0. 1 Cuba – <0. 1 Czech Republic – <0. 1 Romania – <0. 1 Slovakia – <0. 1 Costa Rica – <0. 1 Bangladesh – <0. 1 James, C. (2014). Pocket K No. 16: global status of commercialized biotech/GM crops in 2014. International Service for the Acquisition of Agri-Biotech Application. Retrieved from http: //www. isaaa. org/resources/publications/pocketk/16/

James, C. (2015). ISAA Brief 49 -2014: Executive Summary: Global status of commercialized biotech/GM Crops: 2014. International Service for the Acquisition of Agri-Biotech Application. Retrieved March 6, 2016, from http: //www. isaaa. org/resources/publications/briefs/49/executivesummary/default. asp

�Over 90% percent of corn, soybeans, and cotton produced in the United States

U. S. Grown Genetically Engineered Corn USDA. (2015, July 7). Adoption of genetically engineered crops in the U. S. Retrieved from http: //www. ers. usda. gov/data-products/adoption-of-genetically-engineered-crops-in-the-us. aspx

U. S. Grown Genetically Engineered Soybean USDA. (2015, July 7). Adoption of genetically engineered crops in the U. S. Retrieved from http: //www. ers. usda. gov/data-products/adoption-of-genetically-engineered-crops-in-the-us. aspx

U. S. Grown Genetically Engineered Cotton USDA. (2015, July 7). Adoption of genetically engineered crops in the U. S. Retrieved from http: //www. ers. usda. gov/data-products/adoption-of-genetically-engineered-crops-in-the-us. aspx

�Transgenic crops include, but not limited to, potatoes, eggplant, strawberries, lettuce, cantaloupe, carrots, Hawaiian papaya, zucchini, alfalfa and sugar beets. Bawa, A. S. & Anilakumar, K. R. (2013). Genetically modified foods: safety, risks and public concerns-a review. Journal of Food Science and Technology, 50(6), 1035 -1046. doi: 10. 1007/s 13197 -012 -0899 -1 GMO Compass. (2016). Pest resistant crops. Retrieved from http: //www. gmocompass. org/eng/agri_biotechnology/breeding_aims/147. pest_resistant_crops. html

GMO Crops in US Crop Company(s) Phenotype Corn – whole food, animal feed, biofuel, & oil found in processed foods, such as high fructose corn syrup and corn starch Monsanto, Bayer/Genective, Dow, Pioneer, Stine Seed, Syngenta, Agr. Evo, De. Kalb, Northrup King, Ciba Seeds, Plant Genetic Systems 33 Genetically modified varieties: i. e. 2, 4 -D and ACCASE-Inhibitor tolerant, Herbicide tolerant, Insect resistant and Glufosinate tolerant, rootworm resistant, etc. Soybeans – animal feed, soybean oil & soy lecithin found in processed foods, such as dark chocolate Monsanto, Dow, Bayer/Syngenta, BASF, Pioneer, Agr. Evo, Du Pont 20 Genetically modified varieties: i. e. Lepidopteran-Resistant, 2, 4 -D, Herbicide, Glufosinate tolerant, insect resistant, etc. Cotton – cottonseed oil used for frying in restaurants and processed foods, such as potato chips and margarine Monsanto, Bayer, Syngenta, Bayer Crop. Science, Mycogen/Dow, Aventis, Calgene, Du Pont 16 Genetically modified varieties: i. e. Dicamba and Glufosinate tolerant, Moth and butterfly resistant, herbicide tolerant, Phosphinothericin tolerant, Bromoxynil tolerant, etc. Papaya – whole food and processed foods University of Florida, Cornell University 2 Genetically modified varieties: papaya ringspot virus resistant Squash – zucchini and summer squash Asgrow, Upjohn 2 Genetically modified varieties: i. e. resistant to cucumber mosaic virus, watermelon mosaic virus 2, and zucchini yellow mosaic virus Rapeseed (Canola) – oil for cooking, margarine, and produce emulsifiers Monsanto, Pioneer 2 Genetically modified varieties: both herbicide tolerant Alfalfa – used for hay for cattle feed Monsanto, Forage Genetics 2 Genetically modified varieties: Reduced lignin and herbicide tolerant Sugar Beets – granulated sugar Monsanto, KWS SAAT AG 1 Genetically modified variety: Herbicide tolerant

Newly Approved GMO Products Soon to be Available to Consumers Crop/Product Company(s) Phenotype Potatoes J. R. Simplot, Monsanto 6 Genetically Modified Varieties: i. e. Low-Acrylamide potential, reduced black spot, Bruises, potato leafroll virus, Colorado Potato Beetle resistant, potato Virus Y resistant, etc. Apples Okanagan 2 Genetically Modified Varieties: Non-browning Salmon – currently banned from being imported to U. S. until labeling guidelines are finalized Aqua. Bounty 1 Genetically Modified Variety: faster growing-3 years to 18 months USDA. (n. d. ) Petitions for determination of nonregulated status. Retrieved from https: //www. aphis. usda. gov/biotechnology/petitions_table_pending. shtml#not_reg

ARE GMOs GOOD?

Second Generation of Bioengineering � Enhanced productivity under abiotic stress 2 � Drought, sunlight, wind, & flood resistance 1 � Disease resistant � Maximize crop viability and eliminate crop extinction Papaya -papaya ringspot virus Potato-potato late blight � Bio-fortification � Improved nutritional value or quality 4 Golden rice with addition of vitamin A (Beta-carotene) Rice nicotianiamine synthase 2(Os. NAS 2) for enhanced iron availability 3 4 Rice and cassava enhanced protein storage Tomato enhanced with increased Folic acid � Alternative energy source 5 � Enogen – GM corn to make Ethanol fuel 1. Collinge, D. B. , Jorgensen, H. J. L. , Lund, O. S. , & Lyngkaer, M. F. (2010). Engineering pathogen resistance in crop plants: current trends and future prospects. Annual Review Phytopathology, 48, 269 -291. doi: 10. 1146/annurev-phyto-073009 -114430 2. Jefferson-Moore, K. (2005). Second-generation GMOs: Where to from here? Ag. Bio. Forum, 8(2&3), 143 -150. Retrieved from http: //www. agbioforum. org/v 8 n 23 a 11 -jefferson. htm 3. Lee, S. , Kim, Y. , Jeon, U. S. , Kim, Y. , Schjoerring, J. K. , & An, G. (2012). Activation of rice nicotianamine synthase 2 (Os. NAS 2) enhances iron availability for biofortification. Molecules and Cells, 33(3), 269 -75. http: //dx. doi. org/10. 1007/s 10059 -012 -2231 -3 4. Pocket K No 27: biotechnology and biofortification. (2007, June) International Service for the Acquisition of Agri-Biotech Application. Retrieved fromhttps: //www. isaaa. org/resources/publications/pocketk/27/default. asp 5. Pollack, A. (2011). U. S. approves corn modified for ethanol. The New York Times. Retrieved from http: //www. nytimes. com/2011/02/12/business/12 corn. html? _r=0

Future Biotech Crops in Field Testing Stage � Apple, banana, camelina, cassava, citrus, chickpea, cowpea, groundnut, mustard, pigeon pea, potato, rice, safflower, sugarcane, wheat 1 � Planned Traits: � Improved drought & salinity tolerance � Yield enhancement � Efficient nitrogen utilization � Increase nutrition & food quality � Resistance to pests & diseases � Resistance to viruses 2 � Others : � Pink Pineapples by Del Monte to include lycopene � Purple Tomatoes with high levels of anthocyanins (same compounds found in blueberries) � Orange trees with a spinach gene to resist citrus greening disease 1. James, C. (2015). ISAA Brief 49 -2014: Executive Summary: Global status of commercialized biotech/GM Crops: 2014. International Service for the Acquisition of Agri-Biotech Application. Retrieved March 6, 2016, from http: //www. isaaa. org/resources/publications/briefs/49/executivesummary/default. a 2. Next generation of GMOs: pink pineapples, purple tomatoes. (2015, April 1). Newsmax Health. Retrieved from http: //www. newsmax. com/Health-News/gmo-foods-tomatoes-pineapple/2015/04/01/id/635711

Third Generation of Bioengineering. A New Frontier

Pharming (genetics) � Alternate terms in literature: � Molecular farming � Molecular pharming � Biopharming � Pharma. Plant � Pharma. Crop � Cost-effective cultivation, replication, and distribution � Pharm. Plants can grow commercially in fields with sun and rain or in greenhouses with artificially provided light source and water � No cold-chain requirements � Humulin insulin- first GE drug made from E. Coli bacteria requires secure cold chain 2 1. Celebrating a milestone: FDA’s approval of first genetically engineered product. (2009). U. S. Food and Drug Administration. Retrieved from http: //www. fda. gov/About. FDA/What. We. Do/History/Product. Regulation/Selections. From. FDLIUpdate. Serieson. FDAHistory/u cm 081964. htm. 2. Peters, J. & Stoger, E. (2011). Transgenic crops for the production of recombinant vaccines and antimicrobial antibodies. Human Vaccines, 7(3), 367 -374. doi: 10. 4121/hv. 7. 3. 14303. Retrieved from http: //www. tandfonline. com/doi/pdf/10. 4161/hv. 7. 3. 14303

Pharming: GMO Pharmaceuticals Examples of Genetically Engineered Human Vaccines & Medicines from plants: Product Manufacturer Host Purpose Antigen 3 Arizona State University Potato Hepatitis B Antigen 3 Thomas Heferson Spinach Rabies virus Elelyso (taliglucerase alfa) 3 Pfizer Carrots Gaucher’s disease (lysosomal storage disorder) Gmb. H 2 Bayer: Icon Genetics Tobacco plant family Non-Hodgkin’s lymphoma Zmapp 1 Mapp Biopharmaceutical Tobacco Ebola (currently FDA testing) 1. Delude, C. (2016). Down on the pharm. Proto: Massachusetts General Hospital, Winter, 12. Retrieved from http: //protomag. com/articles/down-on-the-pharm 2. Icon Genetics. (2010). Bayer starts clinical phase 1 study with personalized vaccine from tobacco plants. Retrieved from http: //www. icongenetics. com/html/5954. htm 3. Peters, J. & Stoger, E. (2011). Transgenic crops for the production of recombinant vaccines and antimicrobial antibodies. Human Vaccines, 7(3), 367 -374. doi: 10. 4121/hv. 7. 3. 14303. Retrieved from http: //www. tandfonline. com/doi/pdf/10. 4161/hv. 7. 3. 14303

“Farmaceuticals” – Genetically Engineered Animals Used to Produce Pharmaceuticals Product Manufacturer Purpose Chicken 1 – approved 2015; produce drug in eggs Alexion Pharmaceuticals Kanuma (sebelipase alfa) for lysosomal acid lipase deficiency; inherited condition preventing body from breaking down fatty molecules in cells Rabbit 2 – approved 2014 production of drug in milk Pharming Group N. V. Ruconest for hereditary angioedema Goat 3 – approved 2009; production of antithrombin in a goat’s milk GTC Biotherapeutics, Inc. ATryn for blood-clotting disorders 1. FDA approves first drug to treat a rare enzyme disorder in pediatric and adult patients. (2015). Retrieved from http: //www. fda. gov/newsevents/newsroom/pressannouncements/ucm 476013. htm 2. FDA approves new product to treat rare genetic disease. (2014). Retrieved from http: //www. fda. gov/newsevents/newsroom/pressannouncements/ucm 405526. htm 3. Summary Basis for Regulatory Action-A Tryn. (2009). Retrieved from http: //www. fda. gov/biologicsbloodvaccines/bloodproducts/approvedproducts/licensedproductsblas/fractionatedplasmaproduct s/ucm 134048. htm

ARE GMOs BAD?

� GMO/bioengineered – ingredients in US foods since 1980 s � Products: � Corn � Rapeseed (canola oil) � Soybean (soy lecithin, soybean oil, animal crops) � Cotton (animal feed and cotton oil) � “ 70 -80% of the foods we eat in the United States, both at home and away from home, contain ingredients that have been genetically modified. If the ingredient label on any food or beverage product contains corn or soy, they most likely contain genetically modified ingredients, as a very high percentage of those crops grown in the U. S. use GM technology. In addition, a high percentage of other ingredients in the U. S. , such as sugar beets, are grown with the use of GM technology as well”. Grocery Manufacturers Association Position on GMOs. (n. d. ). The facts about GMO. Retrieved from http: //factsaboutgmos. org/disclosure-statement? _ga=1. 259296591. 452587964. 1456712714

Increased Utilization Key: Bt – Bacillus thuringiensis Ht- Herbicide Tolerant USDA. (2015, July 7). Adoption of genetically engineered crops in the U. S. Retrieved from http: //www. ers. usda. gov/dataproducts/adoption-of-genetically-engineered-crops-in-the-us/recent-trends-in-ge-adoption. aspx

Herbicide Utilization � Glyphosate (Roundup®) � Utilization increase � United States 1974 – 0. 4 million kg 2014 – 113 million kg � Global increase by 10 fold � Listed on World Health Organizations International Agency for Research on 2, 3 Cancer (IARC) “probable human carcinogen” � Glyphosate compounds contains surfactants and adjuvants to stabilize product and aid penetration into plant tissue. These additives also increases the toxicity of glyphosate. 1, 4 � Residual toxicity � Multiple studies have shown that glyphosate ready GM soy crops have higher residual levels of glyphosate and AMPA 1 1 � Glyphosate found to accumulate in GM Soybeans � Super weeds 4 � Glyphosate-resistant weeds found in 36 states 1. Bohn, T. , Cuhra, M. , Traavik, T. , Sanden, M. , Fagan, J. , & Primicerio, R. (2014). Compositional differences in soybeans on the market: glyphosate accumulated in Roundup Ready GM soybeans. Food Chemistry, 153, 207. Doi: 10. 1016/j/foodchem. 2013. 12. 054 2. IARC monographs evaluate DDT, lindane, and 2, 4 -D. (2015, June 23). World Health Organization International Agency for Research on Cancer. Retrieved from https: //www. iarc. fr/en/media-centre/pr/2015/pdfs/pr 236_E. pdf 3. Guyton, KZ. , Loomis, D. , Grosse, Y. , et al. (2015). Carcinogenicity of tetrachlorvinphos, parthion, malathion, diazinon, and glyphosate. Lancet Oncology, 16(5), 490 -491. doi: 10. 1016/S 1470 -2045(15)70134 -8: 4. Landrigan, P. & Benbrook, C. (2015). GMOs, Herbicides, and Public Health. New England Journal of Medicine, 373(8), 693. Retrieved from http: //www. nejm. org/doi/full/10. 1056/NEJMp 1505660 5. Loomis, D. , Guyton, K. , Grosse, Y. et. Al. (2015). Carcinogenicity of lindane, DDT, and 2, 4 -dicholorphenoxyacetic acid. Lancet Oncology, 16(8), 891 -892.

Next Generation Herbicides � Created to kill glyphosate resistant weeds (super weeds) � Enlist Duo® - Environmental Protection Agency (EPA) approved October of 2014 �Two herbicides in one Glyphosate 2, 4 -D 1940 s herbicide, linked to cancer Component of Agent Orange defoliant used in Vietnam War 3 EPA expects 300%-700% increase use of 2, 4 -D 4 � Roundup 2® Xtend �Two herbicides in one Glyphosate Dicamba 1960 s herbicide, linked to non-Hodgkin’s lymphoma 1. Dow Agro. Sciences Launches Enlist™ Cotton for the 2016 Season. (2016, January 6). Retrieved from http: //www. dowagro. com/en-us/usag/news-andresources/newsroom/2016/january/06/dow-agrosciences-launches-enlist-cotton-for-the-2016 -season 1. 2. Dow Agro. Sciences Petitions for determination of nonregulated status for 2, 4 -D-Resistant Corn and Soybean Varieties. (2014, August). Retrieved from https: //www. aphis. usda. gov/brs/aphisdocs/24 d_feis. pdf 3. Landrigan, P. & Benbrook, C. (2015). GMOs, Herbicides, and Public Health. New England Journal of Medicine, 373(8), 693. Retrieved from http: //www. nejm. org/doi/full/10. 1056/NEJMp 1505660 4. Roundup Ready Xtend Crop System. (2015). Retrieved fromhttp: //www. monsanto. com/products/pages/roundup-ready-xtend-crop-system. aspx

New GMO Seeds - Due to Next Generation Herbicides � January 6, 2016 Dow Agro. Science announced the launch of Enlist™ Cotton for 2016 growing season 2 � Introduction of newly engineered cotton seeds –genetically modified to withstand herbicide and pesticide � Tolerant to Enlist Duo® � Stacked with Genuity®, Roundup Ready®, and Wide. Strike® 3 Insect Protection � Enlist Soybean a part of field test within Dow Agro. Sciences Field Forward™ program � Pending import approvals, Dow planning to introduce Enlist corn in 2016 � In Testing Stage � Monsanto’s Roundup Ready 2 Extend soybeans 1, 3 � Contain Genuity®Roundup Ready 2 Yields trait technology � Stacked with trait tolerance to dicamba and glyphosate 1. Dow Agro. Sciences Petitions for determination of nonregulated status for 2, 4 -D-Resistant Corn and Soybean Varieties. (2014, August). Retrieved from https: //www. aphis. usda. gov/brs/aphisdocs/24 d_feis. pdf 2. Dow Agro. Sciences Launches Enlist™ Cotton for the 2016 Season. (2016, January 6). Retrieved from http: //www. dowagro. com/en-us/usag/newsand-resources/newsroom/2016/january/06/dow-agrosciences-launches-enlist-cotton-for-the-2016 -season 3. Roundup Ready Xtend Crop System. (2015). Retrieved fromhttp: //www. monsanto. com/products/pages/roundup-ready-xtend-crop-system. aspx

Decline of Pollinators Utilization of herbicides and pesticides on GMO crops contribute to the decline of nature’s pollinators 1, 2 � Monarch Butterfly & moths � Glyphosate and Glufosinate kill Milkweed � Monarch butterfly caterpillar eat Milkweed � Glyphosate and Glufosinate kill ‘weeds’ � Moths and other herbivore pollinators’ larvae eat weeds � Pollen from Bt crops drifts on to Milkweed � Monarch butterfly caterpillar ingest pollen on weed leaves causing death � Honey Bees & Beetles and other pollinators � Bt plant pollen, Glyphosate, Glufosinate, Dicamba and other herbicides and pesticides are ingested � Glyphosate and other herbicides have been shown to impair honey bee 1. Bohnblust, E. W. , Vaudo, A. D. , Egan, F. , Mortensen, D. A. , & Tooker, J. F. (2016). Effects of the herbicide Dicamba on nontarget plants and pollinator visitation. Environmental Toxicology and Chemistry, 35(1), 144 -151. Retrieved from http: //onlinelibrary. wiley. com/doi/10. 1002/etc. 3169/pdf 2. Herbert, L. T. , Vazquez, D. E. , Arenas, A. A. , & Farina, W. M. (2014). Effects of field-realistic doses of glyphosate on honeybee appetite behaviour. The Journal of Experimental Biology, 217, 3457 -3464. doi: 10. 1242/jeb. 109520. Retrieved from http: //jeb. biologists. org/content/jexbio/217/19/3457. full. pdf

WHO Concern for Human Health Potential allergenicity � Addition of novel proteins in plant – protein transference 1 � Cry 9 C protein from Bt Star. Link Corn � Approved for animal feed only � Found in taco shells and other products after people complained of allergic reactions � Protein 2 S albumin from Brazil Nut 3 � Found in GMO Soybean � People with nut allergy reacted to soybean � No standardized test or methodology for testing of genetically engineered plant 2 � People with allergies in U. S. cannot rely on food labels for list of GMO ingredients � World Health Organization –no known allergic effects have been linked to current marketed GM food 4 1. Grover, A. , Ashhar, N. , & Patni, P. (2014). Why genetically modified food need reconsideration before consumption? Journal of Family Medicine and Primary Care, 3(3), 188 -190. Retrieved from http: //www. ncbi. nlm. nih. gov/pmc/articles/PMC 4209668/ 2. Magaña-Gómez, J. , & Barca, A. (2009). Risk assessment of genetically modified crops for nutrition and health. Nutrition Reviews, 67(1), 1 -16. doi: 10. 1111/j. 1753 -4887. 2008. 00130. x. 3. Nordlee, J. A. , Taylor, S. L. , Townsend, J. A. , Thomas, L. A. , & Bush, R. K. (1996). Identification of a brazil-nut allergen in transgenic soybeans. The New England Journal of Medicine, 334 (11), 688 -692. doi: 10. 1056/NEJM 199603143341103 4. The World Health Organization. (2014). 20 questions on genetically modified foods. Retrieved August 10, 2014, from http: //www. who. int/foodsafety/publications/biotech/20 questions/en/#

WHO Concern for Human Health Potential Gene Transfer � Horizontal gene transfer (HGT) is know to occur in bacteria-antibiotic resistance � Food DNA is not completely degraded by human digestion � Low risk, however WHO encourages scientists not to use antibiotic resistance gene transfer technology 2, 3 � Some studies have shown GMO plant DNA in cow’s milk, muscles, white blood cells 1 � Creates question if gene transfer is a risk for people with gastrointestinal disease 1. Dona, A. & Arvanitoyannis, I. S. (2009). Health risks of genetically modified foods. Critical Reviews in Food Science and Nutrition, 49, 164 -175. doi: 10. 1080/10408390701855993 2. Magaña-Gómez, J. , & Barca, A. (2009). Risk assessment of genetically modified crops for nutrition and health. Nutrition Reviews, 67(1), 1 -16. doi: 10. 1111/j. 1753 -4887. 2008. 00130. x 3. The World Health Organization. (2014). 20 questions on genetically modified foods. Retrieved August 10, 2014, from http: //www. who. int/foodsafety/publications/biotech/20 questions/en/#

WHO Concern for Human Health Potential Outcrossing � Occurrence � Cross contamination of seeds (GMO mixed with traditional) � DNA from Bt Star. Link corn approved for animal feed contaminated human corn supply – found in taco shells and other products 2 � Pollen drift, insect or animal pollinators from genetically modified crops to non-GMO crops 1, 3 � GM Rapeseed (canola) plants cross pollinating with non-GM – found in North Dakota � New GM wild grown Rapeseed plants contain man-made genes to resist multiple pesticides – stacked traits 1. Biello, D. (2010). Genetically modified crops on the loose and evolving in U. S. Midwest. Scientific American. Retrieved from http: //www. scientificamerican. com/article/genetically-modified-crop/ 2. Bucchini, L. & Goldman, L. R. (2002). Starlink corn: a risk analysis. Environmental Health Perspectives, 110 (1), 5 -13. Retrieved from http: //www. ncbi. nlm. nih. gov/pmc/articles/PMC 1240687/ 3. Sanchez. M. A. , Pablo, c. , Navarrete, H. , Aguirre, C. , Chacon, G. , Salazar, E. , & Prieto, H. (2015). Outcrossing potential between 11 important genetically modified crops and the Chilean vascular flora. Plant Biotechnology, 14, 625 -637. doi. 10. 1111/pbi. 12408.

Linked health Issues from Utilization of Herbicides & Pesticides with GM Crops � Glyphosate 2 � Endocrine Disruptor 4 � Shown to disrupt reproductive and sexual development 2 � Toxic � Human hepatic cell line Hep. G 2 � Human placental and embryonic cell lines, and umbilical cord cells � IARC declared “probably carcinogenic to humans (Group 2 A)” 5 � 2, 4 -Dichlorophenoxyacetic acid (2, 4 -D) 4 � Endocrine Disruptor 4 � Shown to disrupt reproductive and sexual development 1, 3 � Cry 1 Ab toxin from Bt crops � Found to have crossed the placental barrier � Residue found in maternal and fetal cord serum 1. Aris, A. & Leblanc, S. (2011). Maternal and fetal exposure to pesticides associated to genetically modified foods in Eastern Townships of Quebec, Canada. Reproductive Toxicology, 31, 528 -533. doi: 10. 1016/j. reprotox. 2011. 02. 004 2. Gasnier, C. , Dumont, C. , Benachour, N. , Clair, E. , Chagnon, M. C. , & Seralini, G. E. (2009). Glyphosate-based herbicides are toxic and endocrine disruptors in human cell lines. Journal of Toxicology, 262(3), 184 -91. Doi: 10. 1016/j. tox. 2009. 06. 006 3. Mesnage, R. , Clair, E. , Gress, S. , Then, C. , Székács, A. , & Séraline, G. E. (2011). Cytotoxicity on human cells of Cry 1 Ab and Cry 1 Ac Bt insecticidal toxins alone or with a glyphosate-based herbicide. Journal of Applied Toxicology, 33, 695 -699. doi 10. 1022. jst. 2712 4. Mnif, W. , Hassine, A. I. H. , Bouaziz, A. , Bartegi, A. , Thomas, O. , & Roig, B. (2011). Effect of endocrine disruptor pesticides: a review. International Journal of Environmental Research and Public Health, 8, 2265 -2303. doi: 10. 3390/ijerph 806225 5. World Health Organization. (2015). International Agency for Research on Cancer: IARC Monograph Volume 112: evaluation of five organophosphate insecticides and herbicides. Retrieved from https: //www. iarc. fr/en/media-centre/iarcnews/pdf/Monograph. Volume 112. pdf

Conflicts of Interest?

GMO Crops are GRAS-Generally Recognized as Safe -“Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act, any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the condition of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive”. � Under 21 CFR 170. 30(b), general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive and ordinarily is based upon published studies, which may be corroborated by unpublished studies and other data and information. � Under 21 CFR 170. 30(c) and 170. 3(f), general recognition of safety through experience based on common use in foods requires a substantial history of consumption for food use by a significant number of consumers. U. S. Food and Drug Administration. (2015, June 4). Generally recognized as safe (GRAS). Retrieved from http: //www. fda. gov/Food/Ingredients. Packaging. Labeling/GRAS /

Substantial Equivalence � Definition � “Substantial equivalence is a concept, first described in an OECD publication in 1993, which stresses that an assessment of a novel food, in particular one that is genetically modified, should demonstrate that the food is as safe as its traditional counterpart. ” 4 Close nutritional and elemental similarity when comparing GE crop and non-GE crop 1 � Organisation for Economic Co-operation and Development (OECD) - 1993 � “Food is considered safe if there is reasonable certainty that no harm will result from its consumption under anticipated conditions. Historically, food prepared and used in traditional ways is considered safe on the basis of long term experience, even though it may naturally contain harmful substances. In principle, food is presumed to be safe unless a significant hazard has been identified. ” 3 � OECD focus is on allergenicity and toxicity resulting from genetic engineering of crop, or unintended consequences of the bioengineering of plant and not the residues and metabolites 1 of herbicides and pesticides used within or on the GE crops � Food and Agriculture Organization of the United Nations and World Health Organization created framework of substantial equivalence acceptance based on OECD definition-2000 3 1. Bohn, T. , Cuhra, M. , Traavik, T. , Sanden, M. , Fagan, J. , & Primicerio, R. (2014). Compositional differences in soybeans on the market: glyphosate accumulated in Roundup Ready GM soybeans. Food Chemistry, 153, 207. Doi: 10. 1016/j/foodchem. 2013. 12. 054 2. GM food crops and application of substantial equivalence in the European Union. (2001). Schenkelaars Biotechnology Consultants. Retrieved from http: //www. iatp. org/files/GM_Food_Crops_and_Application_of_Substantial_E. htm 3. The concept of substantial equivalence, its historical development and current use. (2000). Joint FAO/WHO Expert Consultation on Foods Derived from Biotechnology. Retrieved from ftp: //ftp. fao. org/es/esn/food/Bio-03. pdf 4. Substantial Equivalence. (2001). Organisation for Economic Co-operation and Development. Retrieved from https: //stats. oecd. org/glossary/detail. asp? ID=2604

Statement of Policy-Foods Derived from New Plant Varieties; policy statement, 22984; FDA Federal Register, Volume 57, No. 104, 1992 p. 22984. � “…. Foods derived from new plant varieties are not routinely subjected to scientific tests for safety, although there are exceptions. For example, potatoes are generally tested for the glycoalkaloid, solanine. The established practices that plant breeders employ in selecting and developing new varieties of plants, such as chemical analyses, taste testing, and visual analyses, rely primarily on observations of quality, wholesomeness, and agronomic characteristics. Historically, these practices have proven to be reliable for ensuring food safety. The knowledge from this past experience coupled with safe practices in plant breeding has contributed to continuous improvements in the quality, variety, nutritional value, and safety of foods derived from plants modified by a range of traditional and increasingly sophisticated techniques (Ref. 1 at xvi). Based on this record of safe development of new varieties of plants, FDA has not found it necessary to conduct, prior to marketing, routine safety reviews of whole foods derived from plants. ” U. S. Food and Drug Administration. (1992, May 29). Guidance to Industry for foods derived from new plant varieties. Retrieved from http: //www. fda. gov/Food/Guidance. Regulation/Guidance. Documents. Regulatory. Information/ Biotechnology/ucm 096095. htm

Coordinated U. S. Government Regulators � FDA -regulates based on safety of food for human and animal � …”FDA has ample authority under the act's food safety provisions to regulate and ensure the safety of foods derived from new plant varieties, including plants developed by new techniques. This includes authority to require, where necessary, a premarket safety review by FDA prior to marketing of the food. Under section 402(a)(1) of the act, a food is deemed adulterated and thus unlawful if it bears or contains an added poisonous or deleterious substance that may render the food injurious to health or a naturally occurring substance that is ordinarily injurious. Section 402(a)(1) of the act imposes a legal duty on those who introduce food into the market place, including food derived from new crop varieties, to ensure that the food satisfies the applicable safety standard. ” 3 � USDA - regulates introductions of new GE organisms that have potential risk 1 � EPA -regulates based on utilization of herbicides & pesticides within plant DNA or sprayed on a plant 2 1. Coordinated framework for the regulation of biotechnology. (2016, May 3). USDA Animal and Plant Health Inspection Service. Retrieved fromhttps: //www. aphis. usda. gov/aphis/ourfocus/biotechnology/sa_regulations/ct_regulations 2. EPA’s regulation of biotechnology for use in pest management. (2016, March 11). United States Environmental Protection Agency. Retrieved from https: //www. epa. gov/regulation-biotechnology-under-tsca-and-fifra/epas-regulation-biotechnology-use-pest-management 3. U. S. Food and Drug Administration. (1992, May 29). Guidance to Industry for foods derived from new plant varieties. Retrieved from http: //www. fda. gov/Food/Guidance. Regulation/Guidance. Documents. Regulatory. Information/ Biotechnology/ucm 096095. htm

FDA Safety Evaluation � Plant Biotechnology Consultation Program �“Although the consultation program is voluntary, GE plant developers routinely participate in it before bringing a new GE plant to market. ” United States Food and Drug Administration. (2015, October 13). How FDA regulates food from genetically engineered plants. Retrieved March 8, 2016, from http: //www. fda. gov/Food. Science. Research/GEPlants/ucm 461831. htm

Self-Researching � Companies are self researching � According to the FDA, “The developer submits a summary of its safety assessment to FDA for FDA’s evaluation. When the safety assessment is received by FDA, our scientists carefully evaluate the data and information. FDA considers the consultation to be complete only when its team of scientists is satisfied that the developer’s safety assessment has adequately addressed all safety and other regulatory issues. ” United States Food and Drug Administration. (2015, October 19). How does FDA evaluate the safety of GE plants? Retrieved March 8, 2016 from http: //www. fda. gov/Food. Science. Research/GEPlants/ucm 461805. htm

Corporate Research � Corporate research parameters are set for ‘ideal’ or ‘perfect’ utilization of product and not reality � “In contrast to real-life samples from the market, transgenic crops tended for scientific studies are often produced in well-controlled small experimental plots. In most research studies, application of herbicides has been omitted or has been done at doses lower than those typically used by farmers, giving test materials that are not representative of actual conditions existing in typical agricultural operations, e. g. , with regard to glyphosate residues. ” Bohn, T. , Cuhra, M. , Traavik, T. , Sanden, M. , Fagan, J. , & Primicerio, R. (2014). Compositional differences in soybeans on the market: glyphosate accumulated in Roundup Ready GM soybeans. Food Chemistry, 153, 207. Doi: 10. 1016/j/foodchem. 2013. 12. 054

EPA Glyphosate Safety Evaluation � EPA Determined that glyphosate is not an endocrine disruptor by reviewing Monsanto, Syngenta, and Joint Glyphosate Task Force research studies � Companies and groups funded and/or conducted research � Studies dated from prior to 1990 s with many dating to the 1970 s � EPA considered only 5 other independently funded studies EDSP weight of evidence conclusions on the tier 1 screening assays for the list 1 chemicals. (2015). United States Environmental Protection Agency. Retrieved from https: //www. epa. gov/sites/production/files/2015 -06/documents/glyphosate-417300_2015 -0629_txr 0057175. pdf Lerner, S. (2015). EPA used Monsanto’s research to give Roundup a pass. The Intercept. Retrieved from https: //theintercept. com/2015/11/03/epa-used-monsanto-funded-research/

EPA’s 2014 Enlist Duo Herbicide Approval � According to EPA website: � Is Enlist Duo Safe? � When used according to label directions, Enlist Duo is safe for everyone, including infants, the developing fetus, the elderly and more highly exposed groups such as agricultural workers. � Use of Enlist Duo is safe for the environment, including endangered species. The Agency assessed risks from the 2, 4 -D choline salt to endangered species and found that there would be no effect on listed species from this active ingredient in the approved use area when the product is used according to label directions. � How did EPA assess the safety of Enlist Duo? � With Enlist Duo's large body of scientific information [sic-submitted by Dow Agroscience], EPA: Evaluated risks to all age groups, from infants to the elderly, as well as agricultural workers. Used worst-case estimates for exposures from pesticide drift or movement, food, drinking water and use around homes and public spaces. (Example: We assumed that all corn and soybeans in the United States would be treated with Enlist Duo, certainly a gross exaggeration. ) Aggregated risks, looking at total potential exposure from all these sources. Used worst-case estimates for impacts on the environment, including risks to endangered species. Registration on Enlist Duo. (2016, April 6). United States Environmental Protection Agency. Retrieved from https: //www. epa. gov/ingredients-used-pesticide-products/registration-enlist-duo

EPA’s Enlist Duo Approval � EPA files for Voluntary Vacatur with 9 th U. S. Circuit Court of Appeals to revoke the registration of Enlist Duo® November 25, 2015 2 � Reconsidered approval due to potential synergistic effect of two ingredients on non-target plants “Specifically, Dow did not submit to EPA during the registration process the extensive information relating to potential synergism it cited to the Patent Office; EPA only learned of the existence of that information after the registrations were issued and only recently obtained the information. Ex. 2 (Brady Declaration ¶¶ 4, 5, 8)” 2 � 9 th U. S. Circuit Court of Appeals rejects EPA request January 2016 allowing Enlist Duo available for commercial use 1 2 � Enlist Duo is available in 15 states � Arkansas, Illinois, Indiana, Iowa, Kansas, Louisiana, Minnesota, Mississippi, Missouri, Nebraska, North Dakota, Ohio, Oklahoma, South Dakota, Tennessee and Wisconsin 1. Callahn, P. (2016). Court clears way for revival of worrisome weedkiller. Chicago Tribune. Retrieved from http: //www. chicagotribune. com/news/watchdog/ct-dow -enlist-duo-court-ruling-20160127 -story. html 2. Respondent’s motion for voluntary vacatur and remand. (2015). Retrieved from http: //www. biologicaldiversity. org/campaigns/pesticides_reduction/pdfs/2015 -1124_EPA_Voluntary_Vacatur. pdf

Paid Supporters Try to Obtain Leverage with Consumers; Instead Controversy is Created � Biotechnology company’s producing GMO seeds and agrochemicals hire professors, researchers, and/or scientists to lobby for genetically modified crops and the biotechnology industry in blogs, news articles, science 1, 4, 5 journals � Articles with identified conflict of interest had favorable outcomes for commercial interest 3 � Privatization of Knowledge - Universities accept grants/donations from biotechnology & Organic companies � In exchange for research funds/grants, professors lobby for special interest goup 2, 4 � Conflict of Interest provided through financial gain or professional association are likely to influence study outcomes 3 � Biotechnology & Organic company’s pay traveling expenses for professors, researchers, and/or scientist to testify at various legislative hearings 1, 4, 6 1. A Florida professor works with the biotech industry. (n. d. ). Retrieved from https: //www. documentcloud. org/documents/2303691 -kevin-foltauoffloridadocs. html#document/p 84/a 237719 2. A Mississippi State administrator’s ties to Monsanto. (2013). Retrieved from https: //www. documentcloud. org/documents/2303692 -david-shawmissstateuniverdocs. html#document/p 28/a 237738 3. Diels, J. , Cunha, M. , Manaia, C. , Sabugosa-Madiera, B. , & Silva, M. (2011). Association of financial or professional conflict of interest to research outcomes on health risks or nutritional assessment studies of genetically modified products. Food Policy, 36(2). 197 -2 -3. doi: 10. 1016/j. foodpol. 2010. 11. 016 4. Lipton, E. (2015). Food industry enlisted academics in GMO lobbying war, emails show. The New York Times. Retrieved from http: //www. nytimes. com/2015/09/06/us/food-industry-enlisted-academics-in-gmo-lobbying-war-emails-show. html 5. University of Illinois professor joins the fight. (2011). Retrieved from https: //www. documentcloud. org/documents/2303693 -brucechassyuofillinoisdocs. html#document/p 14/a 237566 6. Washington State professor allies with organic industry. (2015). Retrieved from https: //www. documentcloud. org/documents/2329158 -charles-benbrookwash-state. html#document/p 1/a 238327

GMO Food Labeling � 64 Countries have mandatory labeling laws for genetically modified foods 2 � The U. S. FDA has had no mandatory labeling laws to include genetically modified food ingredients on food labels � U. S. FDA provides guidance for voluntary labeling as per website � Food manufacturers may voluntarily label their foods with information about whether the foods were not produced using bioengineering, as long as such information is truthful and not misleading. In general, an accurate statement about whether a food was not produced using bioengineering is one that provides information in a context that clearly refers to bioengineering technology. Examples of such statements include: “Not bioengineered. ”; “Not genetically modified through the use of modern biotechnology. ”; “We do not use ingredients that were produced using modern biotechnology. ”; “This oil is made from soybeans that were not genetically engineered. ”; “Our corn growers do not plant bioengineered seeds. ” � FDA does not intend to take enforcement action against a label using the acronym “GMO” in a statement indicating that the product (or an ingredient) was not produced through the use of modern biotechnology, as long as the food is, in fact, not derived from a genetically engineered plant and the food’s labeling is not otherwise false or misleading, as further discussed in this guidance. 1. Guidance for industry: voluntary labeling indicating whether foods have or have not been derived from genetically engineered plants. (2015, December 3). U. S. Food and Drug Administration. Retrieved from http: //www. fda. gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm 059098. htm 2. Labeling around the world. (2016). Just Label It! Retrieved from http: //www. justlabelit. org/right-to-know-center/labeling-around-theworld/

GMO Food Labeling � Advocacy groups and consumers campaign for mandatory labeling laws for food ingredients made with genetically modified crops � “Just Label It” campaign � “Right to Know” campaign � Vermont-1 st state pass mandatory labeling law in 2013; became effective July 1, 2016 1 � Maine-2 nd state pass mandatory labeling law in 2013 – not effective until 5 nearby states pass similar law 2 � Connecticut-3 rd state pass mandatory labeling law-not effective until other Northeastern states pass similar law equaling 20 million consumers � Approximately 30 other states have introduced labeling bills 1. Consumer Protection Rule 121. (2013). Retrieved fromhttps: //consumermediallc. files. wordpress. com/2016/06/final-rule-cp-121. pdf 2. Wilson, R. (2014, January 10). Maine becomes second state to require GMO labels. The Washington Post. Retrieved from https: //www. washingtonpost. com/blogs/govbeat/wp/2014/01/10/maine-becomes-second-state-to-require-gmo-labels/

Lobbying Food and Biotechnology Companies spent to oppose mandatory labeling laws 1 � 2013 - $23. 3 million � 2014 - $63. 6 million according to Environmental Workers Group (EWG) to oppose mandatory labeling laws Example of Lobbying Expenses to Oppose H. R. 1599 & S. 2609 2 Company/Associations Bill 2013 2014 2015 Grocery Manufactures Association H. R. 1599 $60, 000 $5, 880, 347 $50, 000 Pepsi. Co H. R. 1599 $2, 600, 000 $6, 660, 000 Coca-Cola H. R. 1599 $9, 320, 000 General Mills H. R. 1599 $2, 570, 000 Bayer Corporation H. R. 1599 $4, 940, 000 $11, 070, 000 Du. Pont Company H. R. 1599 $80, 000 $7, 118, 533 Monsanto Company H. R. 1599 Dunkin’ Brands (Dunkin donuts) H. R. 1599 $2, 650, 000 2016 $170, 000 $750, 000 $120, 000 American Feed Industry Assn. S. 2609 $20, 000 DOW S. 2609 $70, 000 Heinz Both $260, 000 1. Van Hoesen, S. (2015, April 23). Food and chemical companies spent big in 2014 to defeat GMO labeling. Environmental Workers Group. Retrieved March 6, 2016, from http: //www. ewg. org/release/food-and-chemical-companies-spent-big-2014 -defeat-gmo-labeling 2. Center for Responsive Politics. (2016). Retrieved fromhttps: //www. opensecrets. org/

GMO Food Labeling � House of Representatives H. R. 1599 Bill passed 275 -150 preventing mandatory labeling laws of food made with genetically modified ingredients 1, 2 � U. S. Senate S. 2609 bill was defeated 49 to 49 votes that would have prevented States from having mandatory labeling laws 3, 4 � States continue to pass bills for mandatory labels � Advocacy groups continue mandatory label campaigns 1. H. R. 1599 -safe and accurate food labeling act of 2015. (2015, July 23). Retrieved from https: //www. congress. gov/bill/114 th-congress/house-bill/1599 2. Jalonick, M. C. (2015). House passes bill to prevent mandatory GMO food labeling. PBS Newshour. Retrieved from http: //www. pbs. org/newshour/rundown/house-passes-bill-prevent-mandatory-gmo-food-labeling/ 3. Kollipara, P. (2016). Opposition stalls U. S. senate bill aimed at blocking GMO food labels. Science. Retrieved from http: //www. sciencemag. org/news/2016/03/opposition-stalls-gmo-food-labeling-bill-us-senate 4. S. 2609. (2016). Retrieved from http: //www. agriculture. senate. gov/imo/media/doc/3450. pdf

Corporate GMO Labeling Positions 1 � Campbell Soup Company � “Campbell is prepared to label all of its U. S. products for the presence of ingredients that were derived from GMOs, not just those required by pending legislation in Vermont. ” 2 � General Mills � “General Mills, the maker of Cheerios, Progresso soups and Yoplait yogurt, said it was simply impractical to label products for sale in just one state, so the disclosures required by Vermont starting in July will be on all its products. ” 3 � Con. Agra � “Con. Agra Foods will begin adding labels to products nationwide by July 2016 to meet Vermont’s GMO labeling requirements. We stand behind the health and safety of all of our products, including those with genetically modified ingredients, and believe consumers should be informed as to what’s in their food. But addressing state-by-state labeling requirements adds significant complications and costs for food companies. With a multitude of other states currently considering different GMO labeling requirements, the need for a national, uniform approach in this area is as critical as ever. That’s why we continue to urge Congress to pass a national solution as quickly as possible. ” 1. Campbell announces support for mandatory GMO labeling. (2016, January 7). Campbell’s. Retrieved from http: //investor. campbellsoupcompany. com/phoenix. zhtml? c=88650&p=irol-news. Article&ID=2127542%20 2. GMO labeling. (2016). Con. Agra Foods. Retrieved from http: //www. conagrafoods. com/news-room/news-Statement--GMO-Labeling-2150308 3. On GMOs. (2016). General Mills. Retrieved fromhttp: //www. generalmills. com/en/News/Issues/on-biotechnology

Corporate GMO Labeling Positions � Kellogg 1 � “We will continue to strongly urge Congress to pass a uniform, federal solution for the labeling of GMOs. In fact, we believe an agreement on one is achievable. But until a federal solution is reached, and in order to comply with Vermont’s labeling law, we will start labeling some of our products nationwide for the presence of GMOs beginning in mid-to-late April. We chose nationwide labeling because a special label for Vermont would be logistically unmanageable and even more costly for us and our consumers. ” � Mars 2 � “In 2014, the state of Vermont passed a mandatory genetically modified (GM) ingredient labeling law that requires most human food products containing GM ingredients to include on-pack labeling as of July 2016. To comply with that law, Mars is introducing clear, on-pack labeling on our products that contain GM ingredients nationwide. � We firmly believe GM ingredients are safe. Food developed through biotechnology has been studied extensively and judged safe by a broad range of regulatory agencies, scientists, health professionals, and other experts around the world. ” 1. Statement from Paul Norman, President, Kellogg North America, on GMO labeling. (2016, March 23). Kellogg. Retrieved from http: //newsroom. kelloggcompany. com/news-releases? item=131647 2. Mars’ Position on Genetically Modified Organisms. (2016, April 6). MARS. Retrieved from http: //www. mars. com/global/press-center/gmo. aspx

Consumers’ GMO Labeling Positions 3 � The Mellman Group, Inc (11/23/15) � 89% of 2016 voters favor mandatory labels on foods that are genetically engineered or contain genetically engineered ingredients 1 � Consumer Reports (6/9/2014) � 92% of consumers survey want genetically engineered foods should be labeled 2 � The New York Times (7/27/2013) � 93% of U. S. respondents say foods containing genetically modified ingredients should be identified 1. Consumer support for standardization and labeling of genetically engineered food. (2014). Consumer Reports National Research Center. Retrieved from http: //www. justlabelit. org/wp-content/uploads/2015/02/2014_GMO_survey_report. pdf 2. Kopicki, A. (2013). Strong support for labeling modified foods. The New York Times. Retrieved from http: //www. nytimes. com/2013/07/28/science/strong-support-for-labeling-modified-foods. html? _r=1 3. Nearly all voters continue to want GMO foods labeled. (2015). The Mellman Group. Retrieved from http: //4 bgr 3 aepis 44 c 9 bxt 1 ulxsyq. wpengine. netdna-cdn. com/wp-content/uploads/2015/12/15 memn 20 -JLI-d 6. pdf

Position Statements � Published NEJM: “These developments suggest that GM foods and the herbicides applied to them may pose hazards to human health that were not examined in previous assessments. We believe that the time has therefore come to thoroughly reconsider all aspects of the safety of plant biotechnology”. 3 � Dona and Arvanitoyannis (2009): "in the absence of adequate safety studies, the lack of evidence that GM food is unsafe cannot be interpreted as proof that it is safe". Covered in Europe Regulation (EC) 1829/2003 on genetically modified food and feed; Novel foods regulation (EC) No. 258/97. Stated that GM foods should be regulated like pharmaceuticals with clinical trials to determine adverse health risks. Possible risks to humans and animals include "potential to pleiotropic and insertional effects, effects on animal and human health resulting from the increase of anti-nutrients, potential effects on human health resulting from the use of viral DNA in plants, possible transfer of antibiotic resistant genes to bacteria in gastrointestinal tract, and possible effects of GM foods on allergic response". 2 � American Nurses Association (2011): The American Nurses Association (ANA) has joined a coalition urging the Food and Drug Administration (FDA) to label foods that have been genetically engineered. ANA, along with nearly 400 other groups representing health professionals, consumer and environmental advocates, parents, farmers and businesses, believes people have a right to know what’s in their food. The Just Label It campaign (www. justlabelit. org) is demanding that the FDA require labels on foods produced using genetic engineering. 1 1. ANA joins ‘just label it’ campaign. (2011). American Nurses Association. Retrieved from http: //www. nursingworld. org/Main. Menu. Categories/Workplace. Safety/Healthy-Nurse/ANA-Joins-Just-Label-It-Campaign. pdf 2. Dona, A. & Arvanitoyannis, I. S. (2009). Health risks of genetically modified foods. Critical Reviews in Food Science and Nutrition, 49, 164 -175. doi: 10. 1080/10408390701855993 3. Landrigan, P. & Benbrook, C. (2015). GMOs, Herbicides, and Public Health. New England Journal of Medicine, 373(8), 693. Retrieved from http: //www. nejm. org/doi/full/10. 1056/NEJMp 1505660

Position statements � American Medical Association: “…Our AMA supports mandatory pre-market systematic safety assessments of bioengineered foods and encourages: (a) development and validation of additional techniques for the detection and/or assessment of unintended effects; (b) continued use of methods to detect substantive changes in nutrient or toxicant levels in bioengineered foods as part of a substantial equivalence evaluation; (c) development and use of alternative transformation technologies to avoid utilization of antibiotic resistance markers that code for clinically relevant antibiotics, where feasible; and (d) that priority should be given to basic research in food allergenicity to support the development of improved methods for identifying potential allergens. The FDA is urged to remain alert to new data on the health consequences of bioengineered foods and update its regulatory policies accordingly…Our AMA urges government, industry, consumer advocacy groups, and the scientific and medical communities to educate the public and improve the availability of unbiased information and research activities on bioengineered foods. (CSA Rep. 10, I-00; Modified: CSAPH Rep. 1, A-10; Modified: CASPH Rep. 2, A-12)” H-480. 958 Bioengineered (genetically engineered) crops and foods. (n. d. ). American Medical Association. Retrieved from https: //www. amaassn. org/ssl 3/ecomm/Policy. Finder. Form. pl? site=www. amaassn. org&uri=/resources/html/Policy. Finder/policyfiles/Hn. E/H-480. 958. HTM

2016 GMO Food Labeling Law 1 � Bill S. 764 signed July 29, 2016 by President Obama to amend the Agricultural Marketing Act of 1946 � Secretary of Agriculture has two years to establish national disclosure standard of bioengineered foods either via electronic code, text label, or symbol on food label � This law overturns individual State’s law, i. e. Vermont � This law only applied to foods made with DNA additions, not by DNA deletions, i. e. CRISPER-edited mushrooms, which deleted the gene that causes browning of mushroom 1. Foly and Larner. (2016, September 22). GMO food labeling and CRISPER. Lexology. Retrieved from http: //www. lexology. com/library/detail. aspx? g=d 230 b 549 -163 e-48 da-9 eb 8 -eb 6 f 99 e 5 ca 26 2. Obama signs bill requiring labeling of GMO foods. (2016, July 29) U. S. News & World Report. Retrieved from http: //www. usnews. com/news/business/articles/2016 -07 -29/obama-signs-bill-requiring-labeling-of-gmo-foods 3. The Amendments to the Agriculture Marketing Act of 1946. (2016). Retrieved from http: //www. agriculture. senate. gov/imo/media/doc/Ag%20 biotech%20 compromise%20 proposal. pdf

Examples of labeled foods available nationally � Some companies have implemented labeling bioengineered ingredients due to Vermont’s labeling law Soup Gum Cereal Jelly

Alternatives to GMO � USDA GMO-Free 3 � Companies submit documentation and USDA auditors verify that companies do not use GMO products as food ingredients. � USDA organic 1 � The National Organic Program is United States Department of Agriculture regulated to ensure farmers follow a strict process-based certification. Farmers are prohibited to growing produce from GMO seeds, feed animals produce from GMO seeds, or utilize GMO ingredients within processed food products when labeled 100% organic. � Non-GMO Project 2 � Not-for-Profit organization that offers GMO testing and verification labeling for companies wanting to use the label on their food products. 1. Labeling organic products. (2012). United States Department of Agriculture. Retrieved from https: //www. ams. usda. gov/sites/default/files/media/Labeling%20 Organic%20 Products. pdf 2. Non-GMO projects. (2016). Retrieved from http: //www. nongmoproject. org/ 3. Process verified program. (n. d. ). United States Department of Agriculture. Retrieved from https: //www. ams. usda. gov/services/auditing/process-verified-programs

Available Smartphone Apps Non-GMO Project Shopping Guide ipiit, the Food Ambassador Life Café Healthy Pantry Center for Food Safety (CFS) Smart phone apps. (2014). GMO Awareness. Retrieved from https: //gmo-awareness. com/shopping-list/smart-phone-apps/

Grass Root organizations � Against GMO: � Center for Food Safety � http: //www. centerforfoodsafety. org/ � Food Democracy Now � http: //www. fooddemocracynow. org/about � Food & Water Watch � http: //www. foodandwaterwatch. org/campaigns � For GMO: � The Facts about GMOs � https: //factsaboutgmos. org/ � Biology Fortified � http: //www. biofortified. org/category/news/ � Neutral: � Genetic Literacy Project � https: //www. geneticliteracyproject. org/#link

Thank you for participating in this CME activity. � The next item on the list to claim CME/CEU credits, √ Complete Pre-Test via Survey. Monkey® link: √ Complete the CME Activity • Complete the post-test with a passing score of 80% and activity evaluation via Post-test link found within activity folder OR at https: //www. surveymonkey. com/r/GMOposttesteval � Approximately 3 weeks after the completion of the post-test, you will receive an e-mail with the Survey. Monkey® link to complete the Sustained Knowledge question and post-activity evaluation to complete the CME/CEU activity.