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Feb 20, 2024

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BIOL 360 Tutorial 1 Marking Scheme Tutorial 1: Group Questions: (You have 45 minutes) e mail to TA Go to: http://diffen.com/difference/Ethics_vs_Morals (10 marks) Using this website as a starting point, describe the differences between Ethics and Morals. a. 2 points for defining each b. 8 points for describing min 4 examples with strong explanations on the differences between morals/ethics (2 marks for each ex) i. Needs to touch on ICE rubric aspects ii. Need to make overarching societal extensions 2. (10 marks) How is biotechnology affected by the society it is in? a. Need to have 5 examples of a biotech, and need to explain how societal ethics and individual morals impact each product/industry (2 marks for each example)
BIOL 360 Tutorial 1 Marking Scheme Tutorial 1: Individual Student Questions: Written answers handed to TA by end of tutorial. 1. (10 marks) Discuss conflicts that may occur in an individual between her or his morals and ethics. Give and explain two examples. a. Give 2 examples worth 5 marks each- touch on 5 perspectives/points per example, ie state legality ethics, workplace ethics, personal morals, societal/religious ethics, etc. 2. (10 marks) Describe 5 general areas of biotechnology. a. Need to have 5 examples/points, each defining/describing an area of biotech (1st point) and giving examples/applications of it (2nd point)
Participation: 1. Qlicker Quizzes and Short Reports (10%, attendance and participation ongoing in lectures as well as short written reports) Qlicker Personal Response System used for quizzes; MANDATORY ATTENDANCE to all lectures. - Qlicker Access to BIOL 360 - 001 - W24 Enrolment Code: 16MHGI 2. OnQ Forum (10%, due week 3,5,7,9), 2/4 will be marked, 5% each. This week.
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Agricultural Biotechnology Altering Nutritional Content • Golden Rice • Dupont TopCross Technology Delayed Fruit Ripening • FLAVR SAVR Non-Browning • Arctic Apples
Please view the Expert Talk on Performance Plants Inc. posted in Week 3 in onQ.
Learning Objectives Identify the need/reason for creating each technology Understand the process of which each technology is created List the advantages and disadvantages of each technology Identify specific ethical, legal and social concerns
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Golden Rice The project began in 1990, by Ingo Potrykus and his colleague Peter Beyer, of the University of Freiburg. https://foreignpolicy.com/2019/10/17/gold en-rice-genetically-modified-superfood- almost-saved-millions/
Narrated by Z. Baron http://www.goldenrice.org/
Vitamin A Deficiency Prevalent among those whose diets are based mainly on carbohydrate-rich, micronutrient-poor sources Causes impaired vision In extreme cases irreversible blindness increased mortality due to weakened immune system
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Vitamin A deficiency http://mic.com/articles/86107/this-food-could-help-save-2-million-lives-but-now-people-are-fighting-to-block-it Most severe in Southeast Asia and Africa
Vitamin A Deficiency 250 million preschool children are affected by VAD (WHO 2012) 2.7 million children could be saved (WHO 2012) Providing those children with vitamin A could prevent about a third of all under- five deaths
A solution through rice? Promising solution of Golden Rice Rice is a staple food 3.5 billion people consume over 80% of their daily calories from rice Golden Rice is infused with a high amount of vitamin A Low-cost Efficient way to incorporate vitamin A into the daily routine.
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Golden Rice http://en.wikipedia.org/wiki/Golden_rice#mediaviewer/File:Golde ce.jpg Oryza sativa produced through genetic engineering Biosynthesize beta-carotene, a precursor of vitamin A
Creation Designed to produce beta-carotene, a precursor of vitamin A, in the endosperm of the seed. The rice plant can naturally produce beta-carotene in its leaves The plant does not normally produce the pigment in the endosperm.
*Creation Phytoene synthase (psy) is a crucial initial step in the pathway Phytoene desaturase gene (bacterial crtI) is used to produce lycopene Lycopene is then cyclicized to beta- carotene phytoene phytoene desaturase phytoene desaturase 2 http://en.wikipedia.org/wiki/Golden_rice#mediaviewer/File:Carotenoid.svg
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Genes: • psy (phytoene synthase) from daffodil ( Narcissus pseudonarcissus ) • crtI (carotene desaturase) from the soil bacterium Erwinia uredovora phytoene phytoene desaturase phytoene desaturase 2
Creation The psy and crtI genes were transformed into the rice nuclear genome Placed under the control of an endosperm-specific promoter phytoene phytoene desaturase phytoene desaturase 2
Creation The bacterial crt1 gene completes the pathway The end product of the engineered pathway is lycopene Endogenous enzymes process the lycopene to beta-carotene in the endosperm, giving the rice a yellow color phytoene phytoene desaturase phytoene desaturase 2
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Nutritional Outcome "Golden Rice could probably supply 50% of the Recommended Dietary Allowance (RDA) of vitamin A from a very modest amount — perhaps a cup — of rice, if consumed daily” - American Society for Nutrition
Advantages Potential to improve Vitamin-A deficiency Inexpensive Effective No allergic properties
Potential Negative Issues Cultural acceptance GMO food debate Potential problems of biodiversity Giving out supplements, fortifying existing foods with vitamin A, and teaching people to grow carrots or certain leafy vegetables are, for now, more promising ways to fight the problem
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Controversy; please view video https://www.youtube.com/watch?v=GxSGKD50ioE#t =192 Cartagena Protocol on Biosafety had been adopted in the year 2000 by more than 100 nations, including members of the European Union (but neither the United States nor Canada). The written document, which came into force in 2003, governed the handling, packaging, identification, transfer, and use of “living modified organisms” among the parties to the agreement. https://foreignpolicy.com/2019/10/17/golden-rice- genetically-modified-superfood-almost-saved- millions/
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Nutritional Content: Corn - Nutrition Facts 100 grams: • Calories: 96 • Water: 73% • Protein: 3.4 grams • Carbs: 21 grams • Sugar: 4.5 grams • Fiber: 2.4 grams • Fat: 1.5 grams • https://www.healthline.com/nutrition/foods/c orn#nutrients
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Increasing Oil Content
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DuPont Topcross High oil corn contains 50 to 100% more oil and higher quality proteins than normal corn. High oil corn is attractive as a livestock feed because it has greater energy content than normal corn and can replace more expensive sources of fats and proteins. A gram of fat has about 9 calories, while a gram of carbohydrate or protein has about 4 calories.
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TopCross Licensed out by DuPont Quality Grains Preferred method of producing high oil corn. Can minimize the yield disadvantage associated with conventional high oil corn hybrids already commercialized Also enhancing grain nutrient composition.
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Topcross Technology Plant two types of corn One type, representing 90 to 92% of the seed in the blend, is a hybrid that is designated as the "grain parent." The grain parent is a male sterile (produces no pollen) version of an elite hybrid that may be in commercial production. The second type, representing 8 to 10% of the seed, is a special "pollinator."
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Topcross Technology The pollinator is a special line, available only from DuPont The pollen shed from these pollinator plants contain special genes that cause a kernel to produce a much larger than average germ or embryo (commonly called the xenia effect). Since most of the oil and essential amino acids are in the germ, the oil and thus the energy level, and protein quality of the grain produced by fertilization with these pollinators is enhanced.
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Topcross Technology The pollinator is a special line, available only from DuPont The pollen shed from these pollinator plants contain special genes that cause a kernel to produce a much larger than average germ or embryo (commonly called the xenia effect). Since most of the oil and essential amino acids are in the germ, the oil and thus the energy level, and protein quality of the grain produced by fertilization with these pollinators is enhanced.
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*Topcross Technology More oil: male apomixis in which the genetic identity of the male plant is transferred via pollination to the endosperm of the kernel. male traits result in a smaller endosperm. So embryo is a higher % of the kernel, it contains higher oil content, protein, and amino acids than the endosperm
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Patents Assigned to DuPont TopCross International, Inc. • Synthetic corn hybrid LP41 • Patent number: 5763756 • Abstract: A synthetic hybrid corn plant having the designation LP41, produced by crossing two proprietary Pfister Hybrid Corn Company maize synthetics, LP41A-Reid and LP41B-Lancaster. LP41 has the unique property of imparting high oil and high protein levels in the grain of certain normal and male sterile hybrids when used as a pollinator. LP41 is characterized by excellent cold tolerant seedling vigor for rapid emergence in cold soils, and excellent early- season adaptability to nick with early maize hybrids that condition fast dry- down and superior grain quality in the recipient female grain parent. This invention thus relates to the synthetic hybrid plants and seeds of LP41, i.e., the synthetic hybrid produced by crossing the two aforementioned parental synthetics and the seed thereof, including advanced generation seed, variants, mutants, and modifications of LP41. • Type: Grant • Filed: April 3, 1996 • Date of Patent: June 9, 1998 • Assignees: E.I. Du Pont de Nemours and Company, DuPont TopCross International, Inc. • Inventor: Richard R. Bergquist • Patent Validity • Duration of the patent is twenty years from the filing date.
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Delayed Fruit Ripening http://forcechangecom.c.presscdn.com/wp-content/uploads/2011/12/1412_1_3802.jpg
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Flavr Savr A tomato that won’t soften while ripening Allow tomatoes to be shipped safely, keep their colour and maintain their natural flavours. Increase shelf life
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FLAVR SAVR Tomato was developed by Calgene Process employed to avoid practice of picking green fruits and then ripening them with ethylene treatments just before they reach consumers Ethylene treatment gives a ripe tomato color but not the full array of vine-ripened tomato flavors.
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FLAVR SAVR FLAVR SAVR tomatoes remained ripe without rotting for longer than normal tomatoes, so they could be shipped ripe over long distances and arrive ready for market http://images.huffingtonpost.com/2010-12-31-tomatoballoon.png
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Development In the1980s, the tomato fruit enzyme polygalacturonase (PG) discovered PG has the ability to dissolve cell-wall pectin which is important for fruit softening. Researchers at Calgene, Inc. proposed to suppress PG accumulation in ripening tomatoes by introducing an “antisense” copy Prevent or reduce the formation of PG.
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http://en.wikipedia.org/wiki/Flavr_Savr#mediaviewer/File:Tomatoes_ARS.jpg At UC Berkeley, Athanasios Theologis and colleagues had blocked the polygalacturonase (PG) gene responsible for ripening
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Development In1987, Calgene researchers identified and cloned a tomato fruit PG gene Developed methods for tomato transformation and regeneration, and produced tomato plants with inserted PG antisense DNA constructions. Some of the resulting tomato lines generated as little as 1% of the PG found in conventional tomatoes. Not a “plant-pest” risk so did not require permits for field testing or transport.
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Development The FLAVR SAVR tomato was created by Agrobacterium -mediated transformation in which the transfer-DNA (T-DNA) contained a copy of the tomato PG encoding gene in the antisense orientation. In addition, the T-DNA contained sequences encoding the enzyme neomycin phosphotransferase II (NPTII). (Kanamycin resistance) The expression of NPTII activity was used as a selectable trait as a marker to see the presence of the antisense-PG gene. Transcription of the antisense-PG gene stopped PG production and did not result in the expression of any novel protein.
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http://files.umwblogs.org/blogs.dir/7799/files/2013/03/2zztombig.jpg
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Nutrition, Health & Safety Health Canada's review of the information presented in support of the food use of reduced polygalacturonase activity FLAVR SAVR tomato concluded that this novel variety does not raise concerns related to human food safety. Health Canada is of the opinion that the products from the FLAVR SAVR tomato are as safe and nutritious as those available from current commercial tomato cultivars.
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FLAVR SAVR A FLOP Calgene initially selected inferior tomatoes that weren’t as tasty This created a blander taste than other non-GM tomatoes Calgene was inexperienced and inefficient in the production and transportation of tomatoes. FLAVR SAVR was not successful as a product
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Arctic Apples http://modernfarmer.com/2014/01/arctic-apple/
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Arctic Apples How do Arctic apples stay fresher longer? Most apples begin browning within minutes of the apple being bitten, sliced or bruised. This is because the damage causes an enzyme called polyphenol oxidase (PPO) to react with the fruit’s phenolic content. This results in a brown-toned melanin that stains the fruit and consumes the fruit’s Vitamin C and antioxidant content. Arctic apples do not release this enzyme, allowing the apples to maintain their natural flavor, appearance and nutrition. https://arcticapples.com/about/
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Arctic Apples Apples that contain a non-browning trait (when the apples are sliced or bruised, the apple retains its original color) Normally chemical treatments e.g. carotene, Vit C A process of genetic engineering and precision breeding by Okanagan Specialty Fruits Inc (OSF). Gene silencing is used to turn down the expression of polyphenol oxidase (PPO), thus preventing the fruit from browning. In February 2015, the apples were approved by the USDA, becoming the first genetically modified apple approved for sale in the United States.
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Fruit Browning When cutting an apple the cell wall ruptures A chemical reaction is triggered between the apple’s polyphenol oxidase (PPO) and phenolics that turns the apple flesh brown. That reaction burns up the apple's health- promoting phenolics in the process. Polyphenol oxidase (PPO) mixes with polyphenolics found in another part of the cell. (PPO is a plant enzyme. Polyphenolics are one of the many types of chemical substrates that serve various purposes, including supplying its aroma and flavor. When PPO and polyphenolics mix, brown-toned melanin is left behind.
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Prevention of Browning 4 genes that control polyphenol oxidase (PPO) production were identified when the apple’s genome was mapped. To create a non-browning Arctic version of an existing apple variety, gene silencing turned down the expression of PPO, which virtually eliminates PPO production, so the fruit doesn't brown.
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No differences but PPO Arctic apple trees grow, flower and fruit the same way, and react to pests and weather the same way. Harvested, packed, stored and shipped just as other apples are. Arctic apple trees and fruits are identical to their conventional counterparts in every way – until you bite, cut or bruise the fruit.
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Commercialized 2015 Non-browning apple. Arctic Apple developed by Okanagan Specialty Fruits using RNAi. Arctic Golden, Granny Smith and Fuji apples are approved. Galas are in development.
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Arctic Apples: Current Marketing A Cut Above Customers buy with their eyes. That’s why Arctic offers a wide range of attractive, flexible cuts — and the ability to customize cuts to your specifications. https://arcticapples.com/about/
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Break Time 15 minutes….
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Regulations and Legal Aspects of GM Food
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Regulations - Canada GM foods considered a class of “novel foods” Regulated under the Food and Drugs Regulations through a pre-market notification requirement 7-10 year process to research, develop, test and assess the safety of the GM food Data for new GM food submitted to Health Canada
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Regulation - Canada Steps in Regulatory Process: 1. Pre-submission consultation 2. Pre-market notification 3. Scientific assessment a. Development of the modified organism including the molecular biological data b. Composition of and nutritional info about the GM food c. Potential production of new toxins, allergic reactions and any unintended or secondary effects d. Key nutrients and toxicants e. Major and minor constituents (fats, proteins, carbohydrates, minerals and vitamins)
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Steps in Regulatory Process Continued … 4. Requests for additional information 5. Summary report of findings 6. Preparation of food rulings proposal 7. Letter of no objection - sent to the product proponent 8. Decision document on Health Canada Web Site Describing the novel food and summarizing the safety information http://www.hc-sc.gc.ca/fn-an/gmf-agm/appro/index-eng.php
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Labeling Regulations - Canada Responsibility shared between Health Canada and the Canadian Food Inspection Agency (CFIA) under the Food and Drugs Act Labeling: Mandatory if health or safety issue with a food, which might be mitigated through labeling Voluntary for other GM food products
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Gene Edited Crops - Canada Gene-edited seeds allowed! May, 2023 Updated seed rules now allow seeds created through gene-editing that are not spliced with foreign DNA or altered to make them pesticide-resistant. Seeds will be allowed without an independent safety assessment by the government, as they are already considered safe. https://www.cbc.ca/news/canada/gene-edited-foods-fears-1.6836623
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Regulations - United States GM crops divided among 3 regulatory agencies 1. Environmental Projection Agency (EPA) 2. Food and Drug Administration (FDA) 3. U.S. Department of Agriculture (USDA) FDA = responsible for regulating GM crops that are eaten by humans and animals GM plants must adhere to the same safety requirements under the Federal Food, Drug and Cosmetic Act that apply to food and food ingredients derived from traditionally bred plants Process similar to that in Canada but not as well outlined and defined
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Regulations - European Union GM food must pass strict evaluation and safety assessment requirements on a case-by-case basis 2001 - EU moratorium on GMO approvals, but approvals before this: Spain stopped cultivating GM maize in 2004 2013 - Maize hybrid accepted (only GM crop commercially permitted in the EU) New law (2014) gave member state governments the power to decide to plant GM crops
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Special Rules in Europe: - No mixing of GM and conventional crops (maize) - Food and feed must be labelled GM • (2014). Restriction on Genetically Modified Organisms: European Union . Accessed from https://enveurope.springeropen.com/articles/10.1186/s12302- 020-00325-6 • (2015). EU changes rules on GM crop cultivation. BBC News Europe . Accessed from http://www.bbc.co m/news/world- europe-30794256
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Intellectual Property Rights Patent Act (Canada ) Stops others from making, using or selling your invention from the day the patent is filed for a max of 20 years Canadian patent rights extend throughout Canada, not other countries Patents cover new inventions (process, machine, manufacture, composition of matter), or any new and useful improvement to an existing invention
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Patent Act (Canada) Continued Basic criteria: 1. Invention must show novelty* 2. Must show utility 3. Must show inventive ingenuity Patent granted only for the physical embodiment of an idea or for a process that produces something tangible or that can be sold You cannot patent a scientific principle, an abstract theorem, an idea, some method of doing business, or a computer program per se * no prior art, not obvious to someone skilled in the art
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Can you patent genetic material? USA • Can genes be patented? • A gene patent is the exclusive rights to a specific sequence of DNA (a gene) given by a government to the individual, organization, or corporation who claims to have first identified the gene. Once granted a gene patent, the holder of the patent dictates how the gene can be used, in both commercial settings, such as clinical genetic testing, and in noncommercial settings, including research, for 20 years from the date of the patent. Gene patents have often resulted in companies having sole ownership of genetic testing for patented genes. http://ghr.nlm.nih.gov/handbook/testing/genepatents
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Landmark Case • On June 13, 2013, in the case of the Association for Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court of the United States ruled that human genes cannot be patented in the U.S. because DNA is a “product of nature.” The Court decided that because nothing new is created when discovering a gene, there is no intellectual property to protect, so patents cannot be granted. Prior to this ruling, more than 4,300 human genes were patented. The Supreme Court’s decision invalidated those gene patents, making the genes accessible for research and for commercial genetic testing.
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• The Supreme Court’s ruling did allow that DNA manipulated in a lab is eligible to be patented because DNA sequences altered by humans are not found in nature. The Court specifically mentioned the ability to patent a type of DNA known as complementary DNA (cDNA). This synthetic DNA is produced from the molecule that serves as the instructions for making proteins (called messenger RNA). Can you see any interpretive problems with cDNA patenting? FREE OUR GENES! https://www.nature.com/articles/d41586-021-02905-9
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Canada: Patents of Genes • USA decision based as: • Does isolation of genetic material cause it to have markedly different characteristics from the genetic material as found in nature? Canada will undoubted reassess this question. https://www.ctvnews.ca/health/status-of-gene-patents-in-canada- unresolved-despite-successful-challenge-1.2824957 Interesting in light of Canada not allowing Plant Patents and not allowing patenting of higher organisms, mammals, like the Harvard Mouse, both of which are ‘patentable’ in USA
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Gene Patents in Canada: Is There a New Legal Landscape? https://pubmed.ncbi.nlm.nih.gov/29236230/
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https://cban.ca/wp-content/uploads/Patents-on-Genome-Editing-cban-March-2022.pdf
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Plant Breeders’ Rights (PBR) (Canada) A form of intellectual property rights by which plant breeder can protect their new varieties in the same way an inventor protects a new invention With the grant of PBR for a new plant variety, the owner obtains the exclusive rights to produce for sale, and to sell, reproductive material of the variety The PBR Office is part of the Canadian Food Inspection Agency (CFIA)
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PBR (Canada) Continued All species of plants are eligible for protection by PBR, not algae, fungi and bacteria No equivalent for animals The owner of the variety will be granted PBR if it can be demonstrated that the variety is: New Distinct Uniform Stable
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Case Study: Versus Percy Schmeiser
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Overview: Case on patent rights August 1998 – January 2004 1990’s 5 farmers in Percy’s area switched to Roundup Ready Canola (RRC), which is patented by Monsanto Monsanto licenses farmers to use RRC, at a cost ($15 per acre at the time of the trial) Percy never purchased or obtained a license to plant RRC 1998 tests revealed 95-98% of his canola crop was RRC
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Qlicker Question: • Monsanto versus Percy Schmeiser
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Monsanto Contract Most Interesting Aspects: Monsanto has the right to inspect, take samples and test all of the Grower’s owned and/or leased fields and storage bins and examine and copy any records and receipts that could be relevant to Grower’s performance of this agreement; this is effective for 3 years after purchasing seed The Grower, as licensee, may not challenge the validity of the patents If there is an issue with performance or non-performance of the Monsanto Technology, Monsanto must receive a notice within 15 days after the grower first notices the issue http://www.monsanto.ca/ourcommitments/Documents/TUG_English.pdf
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Trial Process The Canadian Court found Percy guilty of “selling or otherwise depriving the plaintiffs of their exclusive right to use plants which the defendants know or ought to know are Roundup tolerant, or using the seeds from such plants” Monsanto was given the right to retrieve their patented genetic material and Percy was ordered to pay Monsanto $140,000 in damages and legal costs Appeals court upheld this ruling
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Trial Process Continued Percy appealed to the Canadian Supreme Court Its ruling, by a 5-4 decision, upheld the validity of Monsanto’s patent The trial judge stated that “none of the suggested sources could reasonably explain the concentrations or extent of RRC of a commercial quality that was ultimately present in Percy’s crop”
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But … Percy did not owe Monsanto either damages or court costs The court stated that in a case like this the amount of damages is measured by the extra profits derived from the use of the patented item He did not spray with glyphosate herbicide and therefore enjoyed no benefits from the RRC
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Industrial Biotechnology Enzyme Production Synthetic Biology Antibiotics Human Recombinant Protein Drugs Vaccines Biofuels (maybe )
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