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Biotechnology, GMOs 2009 What is Biotechnology? The application of technology to improve a biological organism. or Modification of the biological function of an organism by adding genes (from another organism?) Is biotechnology necessary? •A rich source of variation already exists in nature. •But is there all of the diversity we need (want?) World Food Supply: We will have to double it by 2050 75% of future growth must come from lands already in use Most of the production growth must occur in countries where it is consumed, including in marginal areas where many of the poor reside Limited potential for land expansions, except in the Americas and SubSaharan Africa Irrigation expansion crucial to meeting food demand What Happened to Early GE Crops and Why Who’s In Charge (1989-1990)? • NIH – only agency with policies specific to biotechnology. • FDA, USDA, EPA & OSHA competing for jurisdiction. • Discovered: no agency w/clear jurisdiction over transgenic crops. • With its first submittal in November 1990 for approval of the nptII selectable marker, Calgene did not want the confidentiality usually maintained by the FDA. Instead, the company requested that all findings and issues be made public. Result: Interagency group management of transgenic crops • USDA given primary responsibility for regulation of specific research, product development and commercial applications. • FDA given principal jurisdiction over products for human and animal food (CFSAN enforces policy). • CFSAN – Center for Food Safety and Applied Nutrition. • Calgene formally requested FDA advisory opinion on “marker gene” – even before CFSAN had developed appropriate regulatory path. Petitions to consider it an “additive.” • EPA given jurisdiction for products that potentially contain pesticide residues. • In May 1991, the FDA published its findings and called for comments on the marker gene (note that the first filing was for the marker, not the whole product, sort of a "straw man" for things to come). Only 43 public comments were received. • In August 1991, Calgene submitted a second filing for the whole tomato. • In May 1992, the FDA published a policy on genetically engineered foods and concluded that the technology did not make a difference. However, rather than coming directly from the FDA, this policy came via Dan Quayle's Council on Competitiveness, possibly not the most appropriate medium for such an important message. May 1992 FDA states that it will regulate biotechnology-derived food products in the same manner as conventional food products. Will not require special testing or labeling unless major modifications (e.g., GRAS) or foreign genes had been inserted. (GRAS = Generally Regarded As Safe, i.e. no detectable significant differences of major components from a the non-transformed parent.) Public Reaction • Jeremy Rifkin (Foundation on Economic Trends) • Argues FDA’s standards are too lax • Primarily concerned with marker gene • Rifkin actions • Foundation - lengthy statement to FDA • “Pure Foods Campaign” – boycott • “Education materials” to 140,000 teachers • In January 1993, the advisory opinion was converted to a food additive petition, which requires more rigorous scrutiny but leads to the highest level of formal FDA approval for this type of product. At that time, an approval was expected in August 1993. • In March 1993, Calgene submitted its final data package, including a toxicity test. The FDA informed Calgene that its submission was complete. • In June 1993, Calgene resubmitted its environmental assessment. Twenty days later, the FDA's opinion was published in the Federal Register, calling for comments within 30 days. No comments were received. • In November 1993, bovine somatotropin (BST) was approved by the FDA. It is likely that this approval created a controversy that would not have existed if Calgene's tomato was approved first: tomato growers will sell an estimated $1 billion more tomatoes and thus support the genetically engineered product, whereas many milk producers are in fear of BST. • In February 1994, a Food Advisory Committee Hearing to approve the tomato was scheduled. This hearing was called off and rescheduled. Calgene had to fire a number of its staff due to the delays. • Subsequently, the FDA held a 3-day hearing, and the Center for Food Safety published their opinion that the tomato was safe. • Final approval came May 18, 1994 by fax. This was the first time that the FDA approved a whole food made by biotechnology. This approval reaffirmed the FDA's May 1992 policy. Initial Public Concerns about FlavrSavr • Bacterium used to introduce gene (possible incorporation of bacterial genes). • Randomness of insertion process. • Side effects? • Use of kanamycin resistance as marker. • Allergen? Calgene Failures with Flavr Savr • Failure to develop tomato varieties that could be grown in adequate quantities in different regions. • Failure to foresee that existing equipment (for green tomatoes) could not handle Flavr Savr© tomatoes. • Failure to anticipate costs and time of regulatory process. Demise of the Flavr Savr • Consumer Issues • Consumers did not perceive quality in tomato • Rising consumer backlash to GMO’s • Existence of Alternatives • Israeli varieties (e.g., ‘Long Keeper’) • Pioneer – ‘Super Life’ (commercial growers) • DNA Plant Technology – other similar varieties • Patent infringement suit by Monsanto • Calgene “sells” technology Zenaca Seed / Safeway Tomato Paste Similar to FlvarSavr, additional benefits for Processing, less water, more pulp • 1994 Campbell Soup, Calgene and Zeneca settle IP dispute and FDA approves production • 1995 UK grants food approval • 1996 Safeway/Sainsbury begin UK sales of California grown and processed GE tomato paste • GE paste becomes on of the best selling in UK market estimated 60% share of canned market • GE Paste at a 20% cost savings, priced at 29 pence for 170 gms vs 29 pence for 142 grms • 1999 July, Paste no longer available for sale in UK Stocks exhausted •1986 – Federal “Coordinated Framework” for regulating biotech •1993 – FDA approves rBGH •1994 – First biotech food approved (Flavr Savr tomato) •1996 – First GM corn seed is sold; GM crops enter the food supply •1996 – Mad cow disease linked to human brain disease •1997 – European consumers protest US shipments; Monsanto targeted •1999 – Activists get violent; Secretary Glickman is pummeled in Italy; Monsanto PR campaign backfires in the EU; Brazil, Australia and China threaten ban; Monarch butterfly scare •2000 –Starlink corn crisis •2001 – Application for GM fish is submitted to FDA; EU says labeling will be mandatory, trade war lingers; Mexican maize contamination reported; Monsanto abandons New Leaf potato •2002 –Prodigene episode •2003 – SubSaharan African nations reject US food aid with GM corn; US sues EU in WTO •2004 – New EU rules go in effect; Monsanto shelves GM wheat; Glofish released unregulated Lessons Learned from Setbacks • Unforeseen product related problems can occur, • like shipping and handling attributes, growing • conditions in various regions present special problems. • Government policies can change as well as consumer • preferences and company marketing strategy • Intellectual property rights are valuable and contestable •Development to market process is expensive and lengthy • Scientific success does not guarantee commercial success •Do what you do best, don’t go where you don’t belong “What if we’re wrong?” “There are known knowns; there are the things we know we know. We also know there are known unknowns; that is to say there are some things we do not know. But there are also unknown unknowns – the ones we don’t know we don’t know.” -- Secretary of Defense Donald Rumsfeld, 2002 Papayas • 1992 devastating outbreak of papaya ring spot virus in Hawaii • 40% reduction in production in 5 years • 1996 Cornell University and University of Hawaii develop virus resistant “ SunUp and Rainbow “ using coat protein-mediated resistance • 1998 Hawaiian Papaya Administrative Papayas Committee Negotiates with Patent Holders To allow GE seeds to be given to Growers, First Commercial plantings were made • Over 50% of Hawaii acreage now planted to GE varieties • Fortunately efforts to develop a virus-resistant variety had been underway since 1986 • Timely approval of GE papaya saved the industry • Papaya not labeled as GE, just Hawaiian, Hawaii 17% of Total US market of about $55 million mostly from Mexico The RoundUp Ready Story • Glyphosate is a broad-spectrum herbicide • Active ingredient in RoundUp herbicide • Kills all plants it comes in contact with • Inhibits a key enzyme (EPSP synthase) in an amino acid pathway • Plants die because they lack the key amino acids • A resistant EPSP synthase gene allows crops to survive spraying RoundUp Sensitive Plants Shikimic acid + Phosphoenol pyruvate + Glyphosate Plant EPSP synthase X 3-Enolpyruvyl shikimic acid-5-phosphate (EPSP) Without amino acids, plant dies X X Aromatic amino acids X Roundup Resistant Plants Shikimic acid + Phosphoenol pyruvate + Glyphosate Bacterial EPSP synthase RoundUp has no effect; enzyme is resistant to herbicide 3-enolpyruvyl shikimic acid-5-phosphate (EPSP) With amino acids, plant lives Aromatic amino acids Most Rapid Acceptance of any Agricultural Technology since the Tractor Insect resistant cotton – Bt toxin kills the cotton boll worm • transgene = Bt protein Insect resistant corn – Bt toxin kills the European corn borer • transgene = Bt protein Normal Transgenic The Golden Rice Story • Vitamin A deficiency is a major health problem • Causes blindness • Influences severity of diarrhea, measles • >100 million children suffer from the problem • For many countries, the infrastructure doesn’t exist to deliver vitamin pills • Improved vitamin A content in widely consumed crops an attractive alternative -Carotene Pathway in Plants IPP Geranylgeranyl diphosphate Phytoene synthase Phytoene Problem: Rice lacks these enzymes Phytoene desaturase ξ-carotene desaturase Lycopene Lycopene-beta-cyclase Normal Vitamin A “Deficient” Rice -carotene (vitamin A precursor) The Golden Rice Solution -Carotene Pathway Genes Added IPP Geranylgeranyl diphosphate Daffodil gene Phytoene synthase Phytoene Vitamin A Pathway is complete and functional Phytoene desaturase Single bacterial gene; performs both functions ξ-carotene desaturase Lycopene Daffodil gene Golden Rice Lycopene-beta-cyclase -carotene (vitamin A precursor) Ordinary tomatoes do not contain genes. Genetically modified ones do. True or False ? False Don’t know True Canada 52 33 15 USA 45 45 10 Austria 34 22 44 Finland 44 27 29 France 32 39 29 Germany 36 20 44 Ireland 20 51 29 Italy 35 44 21 Netherlands 51 27 22 Spain 28 46 26 Sweden 46 24 30 UK 40 38 22 Survey published in Seed Trade News, December, 1999. Survey source: Thomas J. Hoban, North Carolina State University The Percy Schmeiser Story Monsanto sued Schmeiser for patent infringement they found their GM canola growing in his field Schmeiser's original defense: GM pollen spread and /or GM seeds blew into his field from neighboring GM canola fields Later revealed that 95% of his field was GM seed (320 hectares, 3.2 million square meters) The Percy Schmeiser Story What probably happened... •RR-canola found its way into Schmeiser’s crops in 1997, either by pollen spread or seeds •Schmeiser discovered presence of RR- canola in his fields (perhaps by spraying of Roundup along edges of field) •Seeds from these plants were saved and planted in 1998 The Percy Schmeiser Story Then what happened? •Judgment against, but no monetary punishment – legal fees? •15 minutes of fame •Web page •Interviews •Speaking engagements The Percy Schmeiser Story You Can Help! If you believe in this important cause, your assistance towards Percy's legal bills would be greatly appreciated. You can make a donation online here, or if you prefer, you can send a cheque or money order to: And the beat goes on…… Genetic Mystery: Contaminated Rice Seed March 8, 2007 There's no genetically engineered rice for sale in the U.S., but tests of conventional rice seed, starting more than a year ago, have found traces of three separate genetically engineered strains. Insiders think the contamination probably occurred at an agricultural research station near Crowley, Louisiana, (the “rice capital of America”) operated by Louisiana State University. Rice pollen doesn't usually travel from one plant to another, but a windstorm might produce a freak instance of cross-pollination. However it happened, the genetically modified material did end up in foundation seed that this research station released to seed companies. The Little-Known (Non-GMO) Rice Mutant Clearfield 131? Well, it's also a herbicidetolerant line of rice. It contains a genetic mutation that allows it to tolerate doses of certain chemical herbicides. Scientists created that genetic change by soaking rice in mutation-inducing chemicals. Similar "Clearfield" varieties have been on the market for years, and nobody outside the rice industry paid much attention. March 16 - Mexico Halts US Rice at Border GMO Seed Sales Halted March 13, 2007 The unprecedented ruling follows a hearing last week in the case brought by the Center for Food Safety against the U.S. Department of Agriculture for approving GE alfalfa without conducting the required Environmental Impact Statement April 2 - Are GM Crops Behind the Bee Colony Collapse? March 26 – “Non-GMO verified”