Transcript Researcher - Flagler Hospital St. Augustine, FL

Action Research Study by
Celina Makowski (Principle Investigator)
and the
Flagler Hospital CME Committee
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 Research
Researcher: Celina Makowski; employee of Flagler Hospital as Manager, CPPD/CME
Researcher contact information: [email protected] 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 [email protected]. 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 postpost 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 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.
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 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.
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.
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.
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
 Click 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
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 [email protected]
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.
 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
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.
Celina Makowski, MBA
Manager, CPPD/CME
Flagler Hospital, Inc.
Contact Number: 904-819-4409
E-mail: [email protected]
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.
* 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.
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
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/FedUp-GeneticEngineeringIndustrialAgricultureAndSustainable
Video
Sacerdote, A. (n.d.) Fed up!-genetic engineering, industrial agriculture and sustainable alternatives. Retrieved from
https://archive.org/details/FedUp-GeneticEngineeringIndustrialAgricultureAndSustainable
 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, (3rd 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
 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
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
 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-Cas9 1
 CRISPR-Clustered regularly-interspaced short palindromic repeats
 Cas9 – 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/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), 37053727. Retrieved fromhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC55916/
 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/FoodScienceResearch/GEPlants/ucm461805.htm
 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 CropScience
 Others2,3:
* 2, 4-D tolerant
Soybean and Corn
Developed by Dow AgroSciences
* ACCase Inhibitor tolerant
Corn
Developed by Dow AgroSciences
* ALS-Inhibitor tolerant
* Dicamba tolerant
Cotton
Monsanto Company
* Imidazolinone tolerant
Soybean
BASF
* Isoxaflutole tolerant
Soybean and Corn
Pioneer Hi-Bred
Soybean
Bayer CropScience
* Bromoxynil tolerant
* Sulfonylurea tolerant
Cotton
Developed by Calgene
Cotton - DuPont
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/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
 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 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
GM Food Supply Impact
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
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
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
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/s13197-012-0899-1
GMO Compass. (2016). Pest resistant crops. Retrieved from http://www.gmocompass.org/eng/agri_biotechnology/breeding_aims/147.pest_resistant_crops.html
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, AgrEvo,
DeKalb, 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, AgrEvo, 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
CropScience, 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
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
AquaBounty
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?
 Enhanced productivity under abiotic stress
 Drought, sunlight, wind, & flood resistance
1
2
 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(OsNAS2) for enhanced iron availability3
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? 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
 Apple, banana, camelina, cassava, citrus, chickpea, cowpea, groundnut,
mustard, pigeon pea, potato, rice, safflower, sugarcane, wheat1
 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/Health-News/gmo-foods-tomatoes-pineapple/2015/04/01/id/635711
 Alternate terms in literature:
 Molecular farming
 Molecular pharming
 Biopharming
 PharmaPlant
 PharmaCrop
 Cost-effective cultivation, replication, and distribution
 PharmPlants 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/AboutFDA/WhatWeDo/History/ProductRegulation/SelectionsFromFDLIUpdateSeriesonFDAHistory/u
cm081964.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
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)
Bayer: Icon Genetics
Tobacco plant family
Non-Hodgkin’s lymphoma
Mapp
Biopharmaceutical
Tobacco
Ebola (currently FDA testing)
GmbH
2
Zmapp 1
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
Product
Manufacturer
Purpose
Chicken1 – 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
Rabbit2 – approved 2014
production of drug in milk
Pharming Group N.V.
Ruconest for hereditary
angioedema
Goat3 – 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/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/fractionatedplasmaproduc
ts/ucm134048.htm
ARE
GMOs
BAD?
 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=1.259296591.452587964.1456712714
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
 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
1,4
of glyphosate.
 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
 Glyphosate-resistant weeds found in 36 states
4
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/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.
 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
 1940s 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
 1960s herbicide, linked to non-Hodgkin’s lymphoma
1. Dow AgroSciences 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-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.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/NEJMp1505660
4. Roundup Ready Xtend Crop System. (2015). Retrieved fromhttp://www.monsanto.com/products/pages/roundup-ready-xtend-crop-system.aspx
 January 6, 2016 Dow AgroScience 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 WideStrike® 3 Insect Protection
 Enlist Soybean a part of field test within Dow AgroSciences 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 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.pdf
2. Dow AgroSciences 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
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
Potential allergenicity
 Addition of novel proteins in plant – protein transference
1
 Cry9C protein from Bt StarLink Corn
 Approved for animal feed only
 Found in taco shells and other products after people complained of allergic reactions
3
 Protein 2S albumin from Brazil Nut
 Found in GMO Soybean
 People with nut allergy reacted to soybean
 No standardized test or methodology for testing of genetically engineered
plant2
 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/PMC4209668/
2. Magaña-Gómez, J., & Barca, A. (2009). Risk assessment of genetically modified crops for nutrition and health. Nutrition Reviews, 67(1), 116. 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/#
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 technology2, 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/20questions/en/#
Potential Outcrossing
 Occurrence
 Cross contamination of seeds (GMO mixed with traditional)
 DNA from Bt StarLink corn approved for animal feed contaminated human corn
2
supply – found in taco shells and other products
 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/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.
 Glyphosate
 Endocrine Disruptor
2
4
 Shown to disrupt reproductive and sexual development
2
 Toxic
 Human hepatic cell line HepG2
 Human placental and embryonic cell lines, and umbilical cord cells
 IARC declared “probably carcinogenic to humans (Group 2A)”
5
 2,4-Dichlorophenoxyacetic acid (2,4-D)
 Endocrine Disruptor
4
 Shown to disrupt reproductive and sexual development
1,3
4
 Cry1Ab 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 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.pdf
Conflicts of Interest?
-“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/IngredientsPackagingLabeling/GRAS
/
 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
4
modified, should demonstrate that the food is as safe as its traditional counterpart.”
 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
3
unless a significant hazard has been identified.”
 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
of herbicides and pesticides used within or on the GE crops 1
 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/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/
Biotechnology/ucm096095.htm
 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
3
food satisfies the applicable safety standard.”
 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 plant2
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/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/
Biotechnology/ucm096095.htm
 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/FoodScienceResearch/GEPlants/ucm461831.htm
 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/FoodScienceResearch/GEPlants/ucm461805.htm
 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 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 1990s with many dating to the 1970s
 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_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/
 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 files for Voluntary Vacatur with 9th 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
2
(Brady Declaration ¶¶ 4, 5, 8)”
 9th 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/ctdow-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
 Biotechnology company’s producing GMO seeds and agrochemicals hire
professors, researchers, and/or scientists to lobby for genetically modified
crops and1,4,5
the biotechnology industry in blogs, news articles, science
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
goup2,4
 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/p84/a237719
2. A Mississippi State administrator’s ties to Monsanto. (2013). Retrieved from https://www.documentcloud.org/documents/2303692-david-shawmissstateuniverdocs.html#document/p28/a237738
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/p14/a237566
6. Washington State professor allies with organic industry. (2015). Retrieved from https://www.documentcloud.org/documents/2329158-charles-benbrookwash-state.html#document/p1/a238327
 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 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.
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/ucm059098.htm
2. Labeling around the world. (2016). Just Label It! Retrieved from http://www.justlabelit.org/right-to-know-center/labeling-around-theworld/
 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-1st state pass mandatory labeling law in 2013; became effective
July 1, 2016 1
 Maine-2nd state pass mandatory labeling law in 2013 – not effective
until 5 nearby states pass similar law 2
 Connecticut-3rd 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/
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
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
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
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/
 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/114th-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
 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.”
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-newsArticle&ID=2127542%20
2. GMO labeling. (2016). ConAgra 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
 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
 The Mellman Group, Inc (11/23/15)
3
 89% of 2016 voters favor mandatory labels on foods that are genetically
engineered or contain genetically engineered ingredients
 Consumer Reports (6/9/2014)
1
 92% of consumers survey want genetically engineered foods should be
labeled
 The New York Times (7/27/2013)
2
 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://4bgr3aepis44c9bxt1ulxsyq.wpengine.netdna-cdn.com/wp-content/uploads/2015/12/15memn20-JLI-d6.pdf

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
1
genetic engineering.
1. 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.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/NEJMp1505660
 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/ssl3/ecomm/PolicyFinderForm.pl?site=www.amaassn.org&uri=/resources/html/PolicyFinder/policyfiles/HnE/H-480.958.HTM
 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=d230b549-163e-48da-9eb8-eb6f99e5ca26
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%20biotech%20compromise%20proposal.pdf
 Some companies have implemented labeling bioengineered ingredients
due to Vermont’s labeling law
Soup
Gum
Cereal
Jelly
 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%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-programs
Non-GMO Project
Shopping Guide
ipiit, the Food
Ambassador
Center for Food
Safety (CFS)
Smart phone apps. (2014). GMO Awareness. Retrieved from
https://gmo-awareness.com/shopping-list/smart-phone-apps/
Life Café Healthy Pantry
 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
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