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Celina Makowski Principle Investigator and the Flagler Hospital CME Committee Genetically Modified Organisms Good Bad or Both Study Title Evaluating the Change in Knowledge Clinical Practice and Behavior Outcomes of a Community Hospitals Enduring Continuing Medical Education A ID: 686174

retrieved food genetically www food retrieved www genetically http gmo modified activity crops amp cme 2016 labeling study foods 2015 org health

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Slide1

Action Research Study by Celina Makowski (Principle Investigator)and theFlagler Hospital CME Committee

Genetically Modified Organisms: Good, Bad, or Both?Slide2

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 ResearchResearcher: Celina Makowski; employee of Flagler Hospital as Manager, CPPD/CME Researcher contact information: celina.makowski@flaglerhospital.org or 819-4409IntroductionThis 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 e-mail 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.

Informed ConsentSlide3

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 employeeHow 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-post activity evaluation provided three weeks after activity completion.Slide4

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 SurveyMonkey® 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 SurveyMonkey® 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 SurveyMonkey® link will be e-mailed to you approximately three weeks after completing the CME activity. Slide5

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 pre-test questions by accessing the SurveyMonkey® 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 SurveyMonkey® link provided at the end of the CME activity . * Reminder, you can stop the CME activity at any time and complete later. Slide6

Will I be recorded?The information you provide by answering the pre/post test questions, demographic information, and evaluations will be recorded within SurveyMonkey® 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. Slide7

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 SurveyMonkey® 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 SurveyMonkey® 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 SurveyMonkey® 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 SurveyMonkey® 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. Slide8

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 e-mail 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.Slide9

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 activityTo obtain a study consent formClick the consent form link within the CME activity folder OR Contact the researcher, Celina Makowski, at 904-819-4409 or e-mail celina.makowski@flaglerhospital Signed consent forms can be submitted to the researcher via:Inter-office mail or drop off in Medical Staff Library E-mail to celina.makowski@flaglerhospital.org Fax to 904-819-5290Do 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. Slide10

Please answer the pre-test questions before starting the CME activity by clicking the Pre-Test link within the CME activity folderorat

https://www.surveymonkey.com/r/GMOpretest

Pre-TestSlide11

Release Date: xx/xx/2016Expiration Date: xx/xx/2016Target Audience

: All physicians, physicians’ assistants, nurse practitioners and other healthcare professionals and hospital employees interested in genetically

modified organisms.Disclosures: No Commercial InterestNo relevant financial interest by faculty or CME Committee PlannersNo investigational products/products not labeled for use is mentioned within the CME activity.Genetically Modified Organisms: Good, Bad, or Both?Slide12

Celina Makowski, MBA Manager, CPPD/CME Flagler Hospital, Inc.

Contact Number: 904-819-4409

E-mail: celina.makowski@flaglerhospital.orgFacultySlide13

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.

CME ObjectivesSlide14

* 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 SurveyMonkey® link.* Complete the Sustained Knowledge question and post-activity evaluation via SurveyMonkey® link emailed to you approximately 3 weeks after activity completion. How To Obtain CME/CEU CreditSlide15

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 Accreditation/Credit StatementSlide16

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.

DisclaimerSlide17

Sacerdote, A. (n.d.) Fed up!-genetic engineering, industrial agriculture and sustainable alternatives. Retrieved from https://archive.org/details/FedUp-GeneticEngineeringIndustrialAgricultureAndSustainable

VideoSlide18

Sacerdote

, A. (n.d.) Fed up!-genetic engineering, industrial agriculture and sustainable alternatives.

Retrieved from https://archive.org/details/FedUp-GeneticEngineeringIndustrialAgricultureAndSustainableVideoSlide19

What is

GMO?Slide20

The American Heritage® Abbreviations Dictionary“An organism or microorganism whose genetic material has been altered by means of genetic

engineering.”

1World 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.” 2Monsanto 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.” 3Definitions1. GMO. (n.d.) The American Heritage® Abbreviations Dictionary, (3rd ed). (2005). Retrieved March 12, 2016, from http://www.dictionary.com/browse/gmo 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 Slide21

Feeding the World of 2050Current population is approximately 7.2 billion people879 million people are currently chronically hungry

2 billion people are malnourished

Farmer benefitsIncrease worldwide food supplyIncreased crop protection to yield improved productivityResistant to diseases from pests and virusesResistant to herbicides for improved weed controlClimate change challengesMore severe droughts – agriculture uses 70% of fresh water in worldConsumer benefitsIncreased food supply equals lower costIncreased durability of crops reduce food wastePlanned improved nutritional valuePurpose of Genetic Modified CropsJames, 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.aspSlide22

Traditional Methods

Genetic alteration of plants and animals

PlantsAccording 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.” 1Dates back to ancient times when people domesticated plants for foodFarmers saved plant seed that had best characteristics for new cropsAnimals According to Encyclopaedia Britannica, “animal breeding is controlled propagation of domestic animals in order to improve desirable qualities.”Domestication of animalsPig, to provide food for human consumption Dog, used as a societal tool, i.e. hunting, protection, companionshipCross breeding of animalsCows, to develop stronger, more viable herds Fish, for increased productionRandom trait selection No direct control of DNAAllard, R. (2015, December 2). Plant breeding. Encyclopaedia Britannica. Retrieved fromhttp://www.britannica.com/science/plant-breedingFreeman, A. (2016). Animal breeding. Encyclopaedia Britannica. Retrieved fromhttp://www.britannica.com/science/animal-breeding Slide23

Genetic EngineeringAccording 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 technology1968 – Werner Arber, Swiss microbiologist, discovered restriction enzyme1969-1971 – Hamilton O. Smith & Daniel Nathans, U.S. microbiologists, isolated and refined restriction II enzymes, the beginning of DNA mapping 31973 – Stanley N. Cohen & Herbert W. Boyer pioneered the use of cutting DNA in to fragments, recombining fragments, and adding foreign genes into E. Coli bacteria1980 – Newly designed microorganisms through technology were determined patentable1986 – U.S. Department of Agriculture approved the sale of genetically altered organismVirus used as a pseudorabies vaccine2005-current – Gene EditingUse of new technology, CRISPR-Cas9 1CRISPR-Clustered regularly-interspaced short palindromic repeatsCas9 – a nuclease, an enzyme specialized for cutting DNACustomization of genetic sequencing by adding genes to an organisms DNA structureModern Methods1. Bortesi, L. & Fischer, R. (2015). The CRISPR/Cas9 system for plant genome editing and beyond. Biotechnology Advances, 33

(1), 41-52.

Retrieved

from http

://www.sciencedirect.com/science/article/pii/S0734975014001931

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), 3705-3727.

Retrieved fromhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC55916/ Slide24

Alternate terms found in literature and news articles used to describe plants that have had their genetics alteredBioengineered 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.” 3American Medical Association Prefers specific term of “bioengineered” as found in Policy H-480.958 (Bioengineered (Genetically Engineered) Crops and Foods) 1The 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””. 2Alternate TermsAmerican 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.htm3. U.S. Food and Drug Administration. (2015, October 19). Consumer info about food from genetically engineered plants. Retrieved from http://www.fda.gov/Food/FoodScienceResearch/GEPlants/ucm461805.htmSlide25

First Generation of Bioengineering

Herbicide

tolerant crops 1Roundup® Ready – Alfalfa, Canola, Corn, Cotton, Soybean, SugarbeetsTolerant to Glyphosate-based herbicidesDeveloped by Monsanto Company – 1996Liberty Link – Canola, Corn, Cotton, SoybeanTolerant to Glufosinate herbicidesDeveloped by Bayer CropScienceOthers2,3:* 2, 4-D tolerant * Dicamba tolerant Soybean and Corn CottonDeveloped by Dow AgroSciences Monsanto Company* ACCase Inhibitor tolerant * Imidazolinone tolerantCorn SoybeanDeveloped by Dow AgroSciences BASF* ALS-Inhibitor tolerant * Isoxaflutole tolerantSoybean and Corn SoybeanPioneer Hi-Bred Bayer CropScience* Bromoxynil tolerant * Sulfonylurea tolerantCotton Cotton - DuPont

Developed by Calgene Flax – University of Saskatchewan

1. GMO Compass. (2016).

Herbicide resistant crops

.

Retrieved from http://

www.gmo-compass.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/PMC3105486

/

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 Slide26

Toxin producing crops 1, 4

Corn, Potato,

Cotton, SoybeanBt crops (Bacillus thuringiensis)Bacteria found in soil, dessert, and tundra toxic to herbivorous insectsInsect consume Bt, converted to active toxin delta endotoxinDelta endotoxin destroy insect gutProtects 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 -1995Pathogen resistant crops1Papaya Virus, Bacterial, FungalStacked 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

GMO

Compass. (2016).

Pest

resistant crops

. Retrieved from http://

www.gmo-compass.org/eng/agri_biotechnology/breeding_aims/147.pest_resistant_crops.html

2. Gene stacking. (2016).

Plant & Soil Sciences

eLibrary

.

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 Slide27

Countries Growing GMOAs of 2014 in million hectares:

USA

– 73.1Brazil – 42.2Argentina – 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 – 0.8Australia – 0.5Burkina Faso – 0.5Myanmar – 0.3Mexico – 0.2Spain – 0.1Colombia – 0.1Sudan – 0.1Honduras – <0.1Chile – <0.1Portugal – <0.1Cuba – <0.1Czech Republic – <0.1Romania – <0.1Slovakia – <0.1Costa Rica – <0.1Bangladesh – <0.1James, 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

/

GM Food Supply ImpactSlide28

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.aspSlide29

Over 90% percent of corn, soybeans, and cotton produced in the United StatesSlide30

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.aspxSlide31

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.aspxSlide32

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.aspxSlide33

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/s13197-012-0899-1GMO Compass. (2016). Pest resistant crops. Retrieved from http://www.gmo-compass.org/eng/agri_biotechnology/breeding_aims/147.pest_resistant_crops.htmlSlide34

Crop

Company(s)

PhenotypeCorn – whole food, animal feed, biofuel, & oil found in processed foods, such as high fructose corn syrup and corn starchMonsanto, Bayer/Genective, Dow, Pioneer, Stine Seed, Syngenta, AgrEvo, DeKalb, Northrup King, Ciba Seeds, Plant Genetic Systems33 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 chocolateMonsanto, Dow, Bayer/Syngenta, BASF, Pioneer, AgrEvo, Du Pont20 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 margarineMonsanto, Bayer, Syngenta, Bayer CropScience, Mycogen/Dow, Aventis, Calgene, Du Pont16 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

GMO Crops in USSlide35

Crop/Product

Company(s)

PhenotypePotatoesJ.R. Simplot, Monsanto6 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 Okanagan2 Genetically Modified Varieties: Non-browningSalmon – currently banned from being imported to U.S. until labeling guidelines are finalizedAquaBounty1 Genetically Modified Variety: faster growing-3 years to 18 monthsNewly Approved GMO Products Soon to be Available to ConsumersUSDA. (n.d.) Petitions for determination of nonregulated status. Retrieved

from https

://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml#not_reg Slide36

ARE

GMOs

GOOD?Slide37

Enhanced productivity under abiotic stressDrought, sunlight, wind, & flood resistance2Disease resistant

1Maximize crop viability and eliminate crop extinctionPapaya -papaya ringspot virusPotato-potato late blightBio-fortificationImproved nutritional value or quality Golden rice with addition of vitamin A (Beta-carotene)4Rice nicotianiamine synthase 2(OsNAS2) for enhanced iron availability3Rice and cassava enhanced protein storage4Tomato enhanced with increased Folic acidAlternative energy sourceEnogen – GM corn to make Ethanol fuel5Second Generation of Bioengineering1. 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-073009-1144302. Jefferson-Moore, K. (2005). Second-generation GMOs: Where to from here? AgBioForum, 8(2&3), 143-150.

Retrieved from http://

www.agbioforum.org/v8n23/v8n23a11-jefferson.htm

3. Lee

, S., Kim, Y., Jeon, U. S., Kim, Y.,

Schjoerring

, J. K., & An, G. (2012). Activation of rice

nicotianamine

synthase 2 (OsNAS2) enhances iron availability for

biofortification

. Molecules

and Cells, 33(3),

269-75. http

://dx.doi.org/10.1007/s10059-012-2231-3

4. Pocket K No27: 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/12corn.html?_r=0

Slide38

Apple, banana, camelina, cassava, citrus, chickpea, cowpea, groundnut, mustard, pigeon pea, potato, rice, safflower, sugarcane, wheat1Planned Traits:Improved drought & salinity tolerance

Yield enhancement

Efficient nitrogen utilizationIncrease nutrition & food qualityResistance to pests & diseasesResistance to virusesOthers2:Pink Pineapples by Del Monte to include lycopenePurple Tomatoes with high levels of anthocyanins (same compounds found in blueberries) Orange trees with a spinach gene to resist citrus greening diseaseFuture Biotech Crops in Field Testing Stage1. 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/Health-News/gmo-foods-tomatoes-pineapple/2015/04/01/id/635711Slide39

Third

Generation of

Bioengineering-A New FrontierSlide40

Alternate terms in literature:Molecular farmingMolecular pharmingBiopharmingPharmaPlant

PharmaCrop

Cost-effective cultivation, replication, and distributionPharmPlants can grow commercially in fields with sun and rain or in greenhouses with artificially provided light source and waterNo cold-chain requirementsHumulin insulin- first GE drug made from E. Coli bacteria requires secure cold chain 2 Pharming (genetics)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/AboutFDA/WhatWeDo/History/ProductRegulation/SelectionsFromFDLIUpdateSeriesonFDAHistory/ucm081964.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 Slide41

Product

Manufacturer

HostPurposeAntigen 3Arizona State UniversityPotatoHepatitis BAntigen 3Thomas HefersonSpinachRabies virusElelyso (taliglucerase alfa) 3PfizerCarrotsGaucher’s disease (lysosomal storage disorder)GmbH 2Bayer: Icon Genetics

Tobacco plant family

Non-Hodgkin’s lymphoma

Zmapp

1

Mapp Biopharmaceutical

Tobacco

Ebola (currently

FDA testing)

Pharming: GMO Pharmaceuticals

Examples of Genetically Engineered Human Vaccines & Medicines from plants:

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

Slide42

Product

Manufacturer

PurposeChicken1 – approved 2015; produce drug in eggsAlexion PharmaceuticalsKanuma (sebelipase alfa) for lysosomal acid lipase deficiency; inherited condition preventing body from breaking down fatty molecules in cellsRabbit2 – approved 2014 production of drug in milkPharming Group N.V. Ruconest for hereditary angioedemaGoat3 – approved 2009; production of antithrombin in a goat’s milkGTC Biotherapeutics, Inc.ATryn for blood-clotting disorders

“Farmaceuticals” – Genetically Engineered Animals Used to Produce Pharmaceuticals

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/ucm476013.htm

2. FDA approves new product to treat rare genetic disease. (2014).

Retrieved from http://

www.fda.gov/newsevents/newsroom/pressannouncements/ucm405526.htm

3. Summary Basis for Regulatory Action-A

Tryn

. (2009).

Retrieved

from http

://www.fda.gov/biologicsbloodvaccines/bloodbloodproducts/approvedproducts/licensedproductsblas/fractionatedplasmaproducts/ucm134048.htm Slide43

ARE

GMOs

BAD?Slide44

GMO/bioengineered – ingredients in US foods since 1980s

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=1.259296591.452587964.1456712714Slide45

Increased Utilization

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/recent-trends-in-ge-adoption.aspxKey:Bt – Bacillus thuringiensisHt- Herbicide TolerantSlide46

Glyphosate (Roundup®)Utilization increaseUnited States1974 –

0.4 million kg

2014 – 113 million kgGlobal increase by 10 foldListed on World Health Organizations International Agency for Research on Cancer (IARC) “probable human carcinogen” 2, 3Glyphosate 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 toxicityMultiple studies have shown that glyphosate ready GM soy crops have higher residual levels of glyphosate and AMPA 1Glyphosate found to accumulate in GM Soybeans 1Super weedsGlyphosate-resistant weeds found in 36 states 4Herbicide Utilization1. 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/pr236_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/S1470-2045(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/NEJMp1505660

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.

Slide47

Created to kill glyphosate resistant weeds (super weeds)Enlist Duo® -

Environmental Protection Agency (EPA) approved October of 2014

Two herbicides in oneGlyphosate 2, 4-D1940s herbicide, linked to cancer Component of Agent Orange defoliant used in Vietnam WarEPA expects 300%-700% increase use of 2,4-D 3Roundup 2® Xtend 4Two herbicides in oneGlyphosateDicamba1960s herbicide, linked to non-Hodgkin’s lymphomaNext Generation Herbicides 1. Dow AgroSciences Launches Enlist™ Cotton for the 2016 Season. (2016, January 6). Retrieved from http://www.dowagro.com/en-us/usag/news-and-resources/newsroom/2016/january/06/dow-agrosciences-launches-enlist-cotton-for-the-2016-season1. 2. Dow AgroSciences 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/24d_feis.pdf3. 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/NEJMp15056604. Roundup Ready Xtend Crop System. (2015). Retrieved fromhttp://www.monsanto.com/products/pages/roundup-ready-xtend-crop-system.aspx

 Slide48

January 6, 2016 Dow AgroScience announced the launch of Enlist™ Cotton for 2016 growing season 2Introduction of newly engineered cotton seeds –genetically modified to withstand herbicide and pesticideT

olerant to Enlist Duo®

Stacked with Genuity®, Roundup Ready®, and WideStrike® 3 Insect ProtectionEnlist Soybean a part of field test within Dow AgroSciences Field Forward™ programPending import approvals, Dow planning to introduce Enlist corn in 2016In Testing StageMonsanto’s Roundup Ready 2 Extend soybeans 1,3Contain Genuity®Roundup Ready 2 Yields trait technologyStacked with trait tolerance to dicamba and glyphosateNew GMO Seeds - Due to Next Generation Herbicides1. Dow AgroSciences 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/24d_feis.pdf2. Dow AgroSciences Launches Enlist™ Cotton for the 2016 Season. (2016, January 6). Retrieved from http://www.dowagro.com/en-us/usag/news-and-resources/newsroom/2016/january/06/dow-agrosciences-launches-enlist-cotton-for-the-2016-season3. Roundup Ready Xtend Crop System. (2015). Retrieved fromhttp://www.monsanto.com/products/pages/roundup-ready-xtend-crop-system.aspx Slide49

Utilization of herbicides and pesticides on GMO crops contribute to the decline of nature’s pollinators 1,2Monarch Butterfly & moths

Glyphosate and Glufosinate kill Milkweed

Monarch butterfly caterpillar eat MilkweedGlyphosate and Glufosinate kill ‘weeds’Moths and other herbivore pollinators’ larvae eat weedsPollen from Bt crops drifts on to MilkweedMonarch butterfly caterpillar ingest pollen on weed leaves causing deathHoney Bees & Beetles and other pollinatorsBt plant pollen, Glyphosate, Glufosinate, Dicamba and other herbicides and pesticides are ingestedGlyphosate and other herbicides have been shown to impair honey beeDecline of Pollinators1. 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/pdf2. 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.pdfSlide50

Potential allergenicityAddition of novel proteins in plant – protein transferenceCry9C protein from Bt StarLink Corn

1

Approved for animal feed onlyFound in taco shells and other products after people complained of allergic reactions Protein 2S albumin from Brazil Nut 3Found in GMO SoybeanPeople with nut allergy reacted to soybeanNo standardized test or methodology for testing of genetically engineered plant2People with allergies in U.S. cannot rely on food labels for list of GMO ingredientsWorld Health Organization –no known allergic effects have been linked to current marketed GM food 4WHO Concern for Human Health1. 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/PMC4209668/2. 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/NEJM199603143341103

4. The World Health Organization. (2014). 20 questions on genetically modified foods. Retrieved August 10, 2014, from http://www.who.int/foodsafety/publications/biotech/20questions/en/#

 

 Slide51

Potential Gene TransferHorizontal gene transfer (HGT) is know to occur in bacteria-antibiotic resistanceFood DNA is not completely degraded by human digestionLow 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 1Creates question if gene transfer is a risk for people with gastrointestinal diseaseWHO Concern for Human HealthDona, A. & Arvanitoyannis, I.S. (2009). Health risks of genetically modified foods. Critical Reviews in Food Science and Nutrition, 49, 164-175. doi:10.1080/10408390701855993Magaña-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.x3. The World Health Organization. (2014). 20 questions on genetically modified foods. Retrieved August 10, 2014, from http://www.who.int/foodsafety/publications/biotech/20questions/en/#Slide52

Potential OutcrossingOccurrenceCross contamination of seeds (GMO mixed with traditional)DNA from Bt StarLink 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 1,3GM Rapeseed (canola) plants cross pollinating with non-GM – found in North DakotaNew GM wild grown Rapeseed plants contain man-made genes to resist multiple pesticides – stacked traitsWHO Concern for Human Health1. 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/PMC1240687/3. 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.Slide53

Glyphosate Endocrine Disruptor 2

Shown

to disrupt reproductive and sexual development4Toxic 2Human hepatic cell line HepG2Human placental and embryonic cell lines, and umbilical cord cells IARC declared “probably carcinogenic to humans (Group 2A)” 52,4-Dichlorophenoxyacetic acid (2,4-D) Endocrine Disruptor 4Shown to disrupt reproductive and sexual development4Cry1Ab toxin from Bt crops1,3Found to have crossed the placental barrierResidue found in maternal and fetal cord serumLinked health Issues from Utilization of Herbicides & Pesticides with GM Crops1. 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.2011.02.0042. 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 Cry1Ab and Cry1Ac Bt insecticidal toxins alone or with a glyphosate-based herbicide.

Journal of Applied Toxicology,33

, 695-699. doi10.1022.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/ijerph806225

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/MonographVolume112.pdfSlide54

Conflicts of Interest?Slide55

-“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. GMO Crops are GRAS-Generally Recognized as SafeU.S. Food and Drug Administration. (2015, June 4). Generally recognized as safe (GRAS). Retrieved from http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/Slide56

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.” 4Close nutritional and elemental similarity when comparing GE crop and non-GE crop 1Organisation 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.” 3OECD 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 of herbicides and pesticides used within or on the GE crops 1Food and Agriculture Organization of the United Nations and World Health Organization created framework of substantial equivalence acceptance based on OECD definition-2000 3Substantial EquivalenceBohn, 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

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

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=2604Slide57

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/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Biotechnology/ucm096095.htmSlide58

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

.”

3USDA - regulates introductions of new GE organisms that have potential risk 1EPA -regulates based on utilization of herbicides & pesticides within plant DNA or sprayed on a plant2Coordinated U.S. Government Regulators1.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/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Biotechnology/ucm096095.htmSlide59

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.”

FDA Safety Evaluation

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/FoodScienceResearch/GEPlants/ucm461831.htmSlide60

Companies are self researchingAccording 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.”

Self-Researching

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/FoodScienceResearch/GEPlants/ucm461805.htmSlide61

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.”

Corporate Research

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.2013.12.054Slide62

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 researchStudies dated from prior to 1990s with many dating to the 1970s

EPA considered only 5 other independently funded studies

EPA Glyphosate Safety EvaluationEDSP 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_2015-06-29_txr0057175.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/Slide63

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.EPA’s 2014 Enlist Duo Herbicide ApprovalRegistration on Enlist Duo. (2016, April 6). United States Environmental Protection Agency. Retrieved from https://www.epa.gov/ingredients-used-pesticide-products/registration-enlist-duoSlide64

EPA files for Voluntary Vacatur with 9th

U.S. Circuit Court of Appeals

to revoke the registration of Enlist Duo® November 25, 2015 2Reconsidered 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)” 29th U.S. Circuit Court of Appeals rejects EPA request January 2016 allowing Enlist Duo available for commercial use 1Enlist Duo is available in 15 states 2Arkansas,Illinois, Indiana, Iowa, Kansas, Louisiana, Minnesota, Mississippi, Missouri, Nebraska, North Dakota, Ohio, Oklahoma, South Dakota, Tennessee and WisconsinEPA’s Enlist Duo Approval

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/2015-11-24_EPA_Voluntary_Vacatur.pdfSlide65

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 journals 1,4,5Articles with identified conflict of interest had favorable outcomes for commercial

interest

3Privatization of Knowledge - Universities accept grants/donations from biotechnology & Organic companies In exchange for research funds/grants, professors lobby for special interest goup2,4Conflict of Interest provided through financial gain or professional association are likely to influence study outcomes 3Biotechnology & Organic company’s pay traveling expenses for professors, researchers, and/or scientist to testify at various legislative hearings 1,4,6Paid Supporters Try to Obtain Leverage with Consumers; Instead Controversy is Created1. A Florida professor works with the biotech industry. (n.d.). Retrieved from https://www.documentcloud.org/documents/2303691-kevin-folta-uoffloridadocs.html#document/p84/a2377192. A Mississippi State administrator’s ties to Monsanto. (2013). Retrieved from https://www.documentcloud.org/documents/2303692-david-shaw-missstateuniverdocs.html#document/p28/a2377383. 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.2010.11.0164. 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-bruce-chassyuofillinoisdocs.html#document/p14/a237566

6. Washington State professor allies with organic industry. (2015).

Retrieved from https://www.documentcloud.org/documents/2329158-charles-benbrook-wash-state.html#document/p1/a238327 Slide66

64 Countries have mandatory labeling laws for genetically modified foods 2The U.S. FDA has had no mandatory labeling laws to include genetically modified food ingredients on food labelsU.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 engineered.”; “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. GMO Food Labeling1. 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/ucm059098.htm2. Labeling around the world. (2016). Just Label It! Retrieved from http://www.justlabelit.org/right-to-know-center/labeling-around-the-world/ Slide67

Advocacy groups and consumers campaign for mandatory labeling laws for food ingredients made with genetically modified crops“Just Label It” campaign “Right to Know” campaignVermont-1

st

state pass mandatory labeling law in 2013; became effective July 1, 2016 1Maine-2nd state pass mandatory labeling law in 2013 – not effective until 5 nearby states pass similar law 2Connecticut-3rd state pass mandatory labeling law-not effective until other Northeastern states pass similar law equaling 20 million consumersApproximately 30 other states have introduced labeling billsGMO Food Labeling1. 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/Slide68

Food and Biotechnology Companies spent to oppose mandatory labeling laws 12013- $23.3 million

2014- $

63.6 million according to Environmental Workers Group (EWG) to oppose mandatory labeling lawsLobbying Example of Lobbying Expenses to Oppose H.R.1599 & S.2609 2Company/AssociationsBill2013201420152016Grocery Manufactures Association

H.R. 1599

$60,000

$5,880,347

$50,000

PepsiCo

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

$170,000

Bayer Corporation

H.R. 1599

$4,940,000

$11,070,000

DuPont Company

H.R. 1599

$80,000

$7,118,533

Monsanto Company

H.R. 1599

$2,650,000

$750,000

Dunkin’ Brands (Dunkin donuts)

H.R. 1599

$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

/ Slide69

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

3,4States continue to pass bills for mandatory labelsAdvocacy groups continue mandatory label campaignsGMO Food LabelingH.R. 1599-safe and accurate food labeling act of 2015. (2015, July 23). Retrieved from https://www.congress.gov/bill/114th-congress/house-bill/1599Jalonick, 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-senate4. S. 2609. (2016). Retrieved from http://www.agriculture.senate.gov/imo/media/doc/3450.pdf Slide70

Campbell Soup Company 1“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

.”

General Mills 2“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.”ConAgra 3“ConAgra 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.”Corporate GMO Labeling Positions1. Campbell announces support for mandatory GMO labeling. (2016, January 7). Campbell’s. Retrieved from http://investor.campbellsoupcompany.com/phoenix.zhtml?c=88650&p=irol-newsArticle&ID=2127542%202. GMO labeling. (2016). ConAgra Foods. Retrieved from http://www.conagrafoods.com/news-room/news-Statement--GMO-Labeling-21503083. On GMOs. (2016). General Mills. Retrieved fromhttp://www.generalmills.com/en/News/Issues/on-biotechnology Slide71

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.”Corporate GMO Labeling Positions1. Statement from Paul Norman, President, Kellogg North America, on GMO labeling. (2016, March 23). Kellogg. Retrieved from http://newsroom.kelloggcompany.com/news-releases?item=1316472. Mars’ Position on Genetically Modified Organisms. (2016, April 6). MARS. Retrieved from http://www.mars.com/global/press-center/gmo.aspxSlide72

The Mellman Group, Inc (11/23/15) 389% of 2016 voters favor mandatory labels on foods that are genetically engineered or contain genetically engineered ingredients

Consumer Reports (6/9/2014)

192% of consumers survey want genetically engineered foods should be labeledThe New York Times (7/27/2013) 293% of U.S. respondents say foods containing genetically modified ingredients should be identifiedConsumers’ GMO Labeling Positions1. 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://4bgr3aepis44c9bxt1ulxsyq.wpengine.netdna-cdn.com/wp-content/uploads/2015/12/15memn20-JLI-d6.pdfSlide73

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". 2American 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. 1Position Statements1. ANA joins ‘just label it’ campaign. (2011). American Nurses Association. Retrieved from http://www.nursingworld.org/MainMenuCategories/WorkplaceSafety/Healthy-Nurse/ANA-Joins-Just-Label-It-Campaign.pdf2. Dona, A. & Arvanitoyannis, I.S. (2009). Health risks of genetically modified foods. Critical Reviews in Food Science and Nutrition, 49, 164-175. doi:10.1080/104083907018559933. 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/NEJMp1505660Slide74

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

)”

Position statementsH-480.958 Bioengineered (genetically engineered) crops and foods. (n.d.). American Medical Association. Retrieved from https://www.ama-assn.org/ssl3/ecomm/PolicyFinderForm.pl?site=www.ama-assn.org&uri=/resources/html/PolicyFinder/policyfiles/HnE/H-480.958.HTMSlide75

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 mushroom2016 GMO Food Labeling Law 1 1. Foly and Larner. (2016, September 22). GMO food labeling and CRISPER. Lexology. Retrieved from http://www.lexology.com/library/detail.aspx?g=d230b549-163e-48da-9eb8-eb6f99e5ca262. 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-foods3. The Amendments to the Agriculture Marketing Act of 1946. (2016). Retrieved from http://www.agriculture.senate.gov/imo/media/doc/Ag%20biotech%20compromise%20proposal.pdfSlide76

Examples of labeled foods available nationally

Some companies have implemented labeling bioengineered ingredients due to Vermont’s labeling law

Cereal

Gum

Soup

JellySlide77

USDA GMO-Free 3Companies submit documentation and USDA auditors verify that companies do not use GMO products as food ingredients.

USDA organic

1The 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 2Not-for-Profit organization that offers GMO testing and verification labeling for companies wanting to use the label on their food products. Alternatives to GMO

1. Labeling organic products. (2012).

United States Department of Agriculture

.

Retrieved

from https

://www.ams.usda.gov/sites/default/files/media/Labeling%20Organic%20Products.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-programsSlide78

Available Smartphone Apps

Center for Food

Safety (CFS)ipiit, the Food Ambassador Non-GMO Project Shopping GuideLife Café Healthy Pantry  Smart phone apps. (2014). GMO Awareness. Retrieved from https://gmo-awareness.com/shopping-list/smart-phone-apps/Slide79

Against GMO:Center for Food Safetyhttp://www.centerforfoodsafety.org/Food Democracy Nowhttp://

www.fooddemocracynow.org/about

Food & Water Watchhttp://www.foodandwaterwatch.org/campaignsFor GMO:The Facts about GMOshttps://factsaboutgmos.org/Biology Fortifiedhttp://www.biofortified.org/category/news/Neutral:Genetic Literacy Projecthttps://www.geneticliteracyproject.org/#linkGrass Root organizationsSlide80

Thank you for participating in this CME activity. The next item on the list to claim CME/CEU credits,

Complete Pre-Test via SurveyMonkey® link: √ Complete the CME ActivityComplete 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/GMOposttestevalApproximately 3 weeks after the completion of the post-test, you will receive an e-mail with the SurveyMonkey® link to complete the Sustained Knowledge question and post-activity evaluation to complete the CME/CEU activity.