Jada M. Hueber 2002

1. Biotechnology: reading between the lines of science and safetyWhy has regulation proved to be so difficult? Jada M. Hueber 2002

2. Biotechnology: reading between the lines of science and safety • Where did genetic engineering come from? • Where can we find genetically modified organisms today? • What are some reasons for support / concern? • Are genetically modified organisms regulated by the government? • Is biotechnology safe?

3. Genetic Engineering:background • 1966 Marshall Nirenberg & Har Gobind Khorana finished unraveling the genetic code. • 1973 Herbert Boyer & Stanley Cohen performed the first recombinant DNA cloning experiment using restriction enzymes to insert DNA into a plasmid and use the transgenic plasmid (a circular bacterial 'chromosome') to transform bacteria. • 1980 U.S. Supreme Court rules that living organisms can be patented. • 1983 First transgenic plant (tobacco). • 1985 First transgenic plant produced-- resistant against a definite insect species. • 1987 A transgenic plant produced resistant to a particular kind of herbicide.

4. GMO History continued... • 1988 First transgenic plant producing a pharmaceutical. • 1994 Transgenic tomatoes contain a softening inhibition gene. These FlavrSavr tomatoes are sold in stores for a short time before being taken off the market. • 1998 April, a UK supermarket chain bans use of GMOs in its products, a move which over the following 18 months is followed by the other UK supermarket chains. May, widespread contamination of the UK canola crop by GM oilseed rape contaminated seed imported from Canada by Advanta. • Some sources cite Gregor Mendel, the Austrian Monk who studied genetics in pea plants, as the first genetic engineer. This brings to question, what is the difference between the modern science of biotechnology and plant breeding for desired traits which has been going on for centuries? Keep this question in mind...

5. The Science of Genetic Engineeringmaking a modified gene Isolate desired gene (increased shine) Isolate plasmid DNA (apple) Gene inserted into plasmid. Grow in culture to replicate. Insert modified plasmid into bacterium for replication.

6. Making the transgenic cell… ...and growing GMOs! Bacterium inserts DNA into plant cell. Transfer copies into carrier bacterium. A. tumefaciens (agrobacterium) Grow cells in culture to form plantlets. Transgenic cell Cell division Transgenic plants with new traits! Transfer to soil…

7. Where can I find GMOs? • All of these brands, and many more, have been identified as using GMOs in their ingredients. Sometimes, as in the case of Gerber baby foods, the product is found to contain GMOs despite company efforts to discontinue the use of GM crops. Kellogg’s, Kraft, McDonald’s, Nestle USA, and Quaker Oats all sell foods with GM ingredients in the U.S. but not in their products overseas where consumer opposition is strong.

8. The growing popularity of GE crops • In January, the International Service for the Acquisition of Agri-biotech Applications (ISAAA) announced that global acreage of GE crops increased 19% in 2001 (130 million acres). • From 1998 to 1999, global GE crop acreage grew 143%.

9. Who grows GE crops? • Three countries produce more than 95% of the GE crops in the world; Argentina, Canada, and the United States. • Only four crops are currently beinggrown on a large scale: canola, corn, cotton, and soybeans.

10. What good are GMOs? Imagine medicinal fruits that help prevent illness... “Golden Rice” is engineered to contain beta-carotene, a vital nutrient that can prevent blindness in malnourished children. Crops can defend themselves against pests and viruses, decreasing the amount of chemicals used by farmers. Crops can be engineered to thrive in previously inhospitable soils, giving farmers in developing nations a livelihood. Produce can be designed to be healthier, less fattening, etc... Imagine food enough to feed the world... Photos: www.thebiggestpixel.com/people01.html & www.picturesof.net

11. Substantial Equivalence: a new variety of food must be as safe as traditionally bred varieties and foods. Summary of safety assessment: • Compositionally equivalent to conventional varieties • Nutritionally equivalent and perform comparably to conventional varieties in food production and for livestock and poultry feed. • Contains protein that is proven safe for consumption.

12. Regulation jurisdiction: the Coordinated Framework system A) If the biotech product is amicrobe, the EPAregulates it. B) If the biotech product is aplant or insect, USDA-APHIS regulates it. C) If the biotech product is afood or medicine, the FDA regulates it. D) If theresearch was funded by the federal government, the National Institutes of Health (NIH) or USDA regulates the product of the research.

13. 1) federal government regulatory oversight should focus on the characteristics and risks of the biotechnology product and not the process by which it is created; The Four Principles of Regulatory Review 2) for biotechnology products that require review, regulatory review should be designed to minimize regulatory burden while assuring protection of public health and welfare; 3) regulatory programs should be designed to accommodate the rapid advances in biotechnology; and 4) in order to create opportunities for the application of innovative new biotechnology products, all regulation in environmental and health areas should use performance standards rather than specific rigid controls or specific designs for compliance.

14. Federal regulators seek to protect human safety, intellectual property rights of individuals and corporations, and the genetic integrity of existing plant and animal species... In 1980, the U.S. Supreme Court allows patents of living organisms because biotechnology procedures had made possible a human invention from a naturally-occurring organism. the conundrum Genetically modified organisms are “substantially equivalent” to conventional varieties. Therefore, they don’t require labeling. Genetically modified organisms are not “products of nature,” but “human invention.” Therefore, they are able to be patented. &

15. Corporate v. Consumer Demands: labeling The New York Times reported that a “biotech industry poll” showed that 93% of Americans wants genetically engineered foods labeled. The American Government and the biotech industry are concerned that labeling will be misleading to consumers, since they claim traditional crops and GE crops substantially equivalent. Consumer Advocates claim that the popularity of GMOs has to do with the fact that consumers are not given the choice, because they are not fully informed about what they are purchasing. H.R. 3377 “Genetically Engineered Food Right to Know Act” label: United States Government Notice: This product contains a genetically engineered material, or was produced with genetically engineered material.

16. Environmental issues The biotech industry claims that genetically modified organisms will be good for the environment. So why are environmentalists worried?

17. “Biotechnology has the potential to create more and better sources of food, to reduce pesticide use, increase yields, and improve nutrition and quality of life.” Dr. Sally McCammon, USDA Animal and Plant Health Inspection Service Studies reported by the Monsanto Corporation suggest that crops engineered to be herbicide-tolerant reduce the use of agricultural chemicals, and therefore, contamination of the environment. This practice of choosing the best combination of tools to control crop pests is called Integrated Pest Management (IPM). Percent of samples Total major corn herbicide concentration

18. “When I started farming 23 years ago we didn’t use the most powerful chemicals on the market, we didn’t flood the land with fertilizer, and we still made a good living...Our gross revenue to expense ratio was 3 to 1. Today, we are on the cutting edge, using GMOs, changing crop varieties almost yearly, using chemicals as if we farmed in Europe, and our revenue to expense ratio has dropped to 1.25 to 1, on a good year, just enough to pay the grocery bill.”Lloyd FearRed River Valley, Manitoba • Growers planting RR crops have three choices regarding weed control: • Apply early to avoid early-season yield losses from fast growing grasses, possibly suffering yield losses from late season weeds; • Delay applications until most weeds have germinated, risking loss of yield to early weeds; or, • Apply Roundup twice or more, and/or a residual herbicide at planting or when Roundup is applied.

19. “It is not clear which are greater – the successes of modern high-intensity agriculture, or its shortcomings…A greener revolution is needed – a revolution that incorporates accumulated knowledge of ecological processes and feedbacks, disease dynamics, soil processes and microbial ecology” (Tilman 1998). In one situation, after the first two applications of Roundup Ultra (total of 60 oz/A) weeds had survived. They were eventually controlled by a third application of 48 oz/A. Further tests were done involving RR crops and weed management. The effective rates were at or above typical field use rates (32 oz). “Everyone expects that a higher percentage of soybean acres will be planted to GMO varieties and that most farmers doing sowill need to apply two or three applications of two or more herbicides.” Charles M. Benbrook, PhD.

20. Spread = the combined result of survival, reproduction, and dispersal. Without a quantitative estimate of spread, risk analysis is doomed to anecdotal status Asymptotic Rate of Spread (ARS)-- in units of distance/time, the rate at which an gene’s aerial range increases in radius. “Virtually all spread models predict that at first the observed rate of spread will be slow and will gradually accelerate to some asymptotic maximum rate. Thus, without some form of quantitative analysis, it is not wise to conclude spread will be negligible simply because after one generation, most genetically engineered organism or genes are discovered close to their initial point of release” (Kareiva, et al. 1991).

21. Gene-Spread model:yellow circles spread and increase in frequency as a result of dispersal and selection. Spatial distribution of genotypes Disperse pollen Mating & seedling production Selection in favor of to get next generation

22. Spread is of particular concern regarding biodiversity and the creation of “superweeds”... Superweeds develop if herbicide-tolerant modified crops cross-breed with weedy relatives. The resulting plants would be resistant to the herbicide. S The concern is similar for insects. Will natural selection lead to a population of insects unharmed by modern pesticides? In the field, nature’s predisposition to adaptation has made things more complicated.

23. Initially it was stated that it was extremely unlikely that Roundup resistance would appear in weeds. Shortly after these statements were made the first case of Roundup resistance appeared in Australia... According to Bob Hartzer of Iowa State University: Herbicide resistance is defined as the inherited ability of a weed to survive a herbicide dose that kills the wild type of that species. The two important points of this definition are 1) the ability to survive the herbicide is genetic and passed along to progeny, and 2) the native population is controlled by the herbicide.

24. RR • Researchers have documented glyphosate resistance in a rye grass species. • Waterhemp was highlighted in the 1998 edition of the Weed Control Manual as the most worrisome “Up and Coming Weed” nationwide due to the emergence of resistance to triazine and ALS herbicides and its ability to withstand Roundup applications. The Roundup Ready system cost an amazing $68.77 per acre in 1999. Fifty percent more than the cost of seed+weed management systems in recent years, largely because farmers had to use more chemicals.

25. “A pest management system that relies predominantly on one tactic is inherently vulnerable. The more generations of a pest in a season, and the longer the pest is subject to selection pressure from a single tactic, the greater the odds the pest will adapt around the tactic and adapt quickly.” Charles M. Benbrook, PhD. • When Bt-transgenic crops were introduced, Monsanto admitted that resistance was a possibility, but unlikely if a 5 percent “buffer zone” of traditional plants was planted as well. Then the following discoveries were made: • Bt endotoxin expression under field conditions is not uniform, providing some insects with a chance to avoid plant tissues delivering a lethal dose. • Resistance gene to Bt endotoxin appears to be a dominant trait. • Bt-corn can adversely impact populations of key beneficial insects. • Resistance to Bt is not as rare as previously suspected. Since the release of these studies, Monsanto increased the necessary safe buffer zone to 50 percent.

26. Antibiotic Gene Markers • AGM are used to identify transferred cells within the DNA, but many worry that the genes could inadvertently be transferred to humans, decreasing the effectiveness of some antibiotics. • Scientific studies show that this is an “unlikely,” but possible scenario, so... • The genes chosen confer resistance to a narrow range of specific antibiotics no longer considered important for medical treatment. And... • The FDA has suggested that biotech companies find alternatives to antibiotic resistance genes.

27. Allergies!?... NEW tissues The National Academy of Sciences has said that GM food might cause allergic reactions, some serious, even life-threatening. Physicians are not required to report allergic reactions observed in patients, and there is no existing registry to record such data. Therefore, without data being collected and analyzed, stable conclusions regarding the existence or possibility of new allergens cannot be made. Current testing for allergenicity often compares the new protein with known allergens such as wheat, peanuts, milk, eggs, and crustaceans.

28. In 1992, the United Nations met in Rio de Janerio for the Conference on Environment and Development. The subsequent declaration contained the following statement. Principle 15 In order to protect the environment, the precautionary approach will be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation. In short, follow the precautionary principle...

29. US and EU U.S. government agencies take a “risk-based” approach to regulating biotechnology. That is, they focus on the end product, and its risks, instead of the process by which it was created. In contrast, the EU considers GMOs to be special category of organism. A quote from the Commission of European Communities Directive on the Deliberate Release to the Environment of Genetically Modified Organisms reads, “It is evident that a case-by-case examination and an environmental risk assessment is appropriate for the use of genetically modified organisms.”

30. Why has regulation proved so difficult? • The process of policy cannot keep up with the pace of science. • The pro-business approach of U.S. regulatory agencies often conflicts with consumer sentiments. • “I have studied the linkages between technology, policy, economics and the environment during most of my career. It is clear to me that the role of traditional farm policy is greatly diminished, that the private sector now largely controls the selection of technologies that are reaching farmers, and that the discipline of the open market is being undermined by industry consolidation.” • Charles M. Benbrook, PhD.

31. Disregard for the precautionary principle by corporations, scientists, and regulators. • A national myopia that trades possible ecological problems for quick business profits. The science of biotechnology holds great possibilities that should be explored for the future. It should also be recognized, however, that biotechnology is an area of science not fully experienced by nature. Any science concerning the release of “human invention” into the environment, especially if intended for consumption, should be put to the most rigorous testing.

32. “I hope I’ve persuaded you that this particular challenge is complex, tricky, difficult, and that solving it will require much more than straightforward risk assessment or cost benefit analysis, and certainly more than…rhetorical admonitions that it’s not nice to fool with Mother Nature.” Dr. Donald Kennedy, president of Stanford University; 1992