The Regulation of Genetic Modifications

1. The Regulation of Genetic Modifications “The GMO Controversy”

2. Terminology • Genetically Modified Organisms (GMOs) • Genetically Modifications • Genetic Engineering • Transgenic Technology • Recombinant DNA Technology (rDNA) • Biotechnology • Bio-Engineering • “Frankenfoods”

3. An Example: • BT Corn • Species of corn containing transplanted gene from B. Thuringiensis • Resulted in 20% decline in sales of insecticides in area • 1999 Cornell University study said Bt corn kills Monarch butterfly • Doomsday Cornkiller • Caterpillar resistant to insecticides

4. The Science of GMOs • Random genetic variation occurs naturally in all living things • Is the basis of evolution of new species through natural selection • Selective breeding of wild plants, animals and microorganisms such as yogurt cultures and yeasts, to produce domesticated variants better suited to the needs of humans.

5. The Science of GMOs • The most recent application of biotechnology to food is genetic modification • Term “GMOs” used in regulatory documents and in the scientific literature to describe • plants, animals and microorganisms which have had DNA introduced into them by means other than by combination of an egg and a sperm or by natural bacterial conjugation.

6. The Science of GMO’s • Selective breeding methods are based on the transfer of genetic material between individuals of the same species • Today, gene technology makes it possible to move genes between different species • Geneticist “speed up” natural selection and transfer beneficial characteristics from one species to another. • Resistance, grow speed, grow conditions, climate tolerance, yield, etc.

7. The History of GMO’s • 1971 Paul Berg inserted DNA from cancer tumor into E-coli strain • Opponents (Jeremy Rifkin) feared release of human cancer agent that would replicate in human organs and cause “public disaster” • Berg suspended his experiments after public outcry and Rifkin’s use of judicial process (Injunction)

8. The History Law of GMOs • Sparked series of scientific conferences resulting in “Berg letter” which declared moratorium on rDNA research until adequate controls were developed • Recombinant DNA Advisory Committee (RAC) formed to compose guidelines for rDNA research. • Guidelines only applied to Government funded labs.

9. Legislative Action • Senator’s Ted Kennedy and Jacob Javits (1976) • Proposed separate Bills to place rDNA research under control of Department of Health • Result was inaction by Congress (couldn’t make the call)

10. Judical Action • Ananda Charkarbarty (GE Microbiologist) filed application for a patent on pseudomonas bacteria that was believe to degrade crude oil spills • Bacteria did not previously exist in nature. Created by cell fusion • PTO rejected application on basis of Patent Act section 101 that bacteria were “living things are not the proper subject of a patent under US law” Diamond v. Chakarbarty

11. Genetic Modifications • 13 countries produced GM crops in 2000 • 68% of all GM crops grown by US • 82% of all GM crops are soybeans • Cotton next • 74% of all soybean crops were modified for herbicide tolerance • GM crop production increased from 4.3 million acres in 1996 to 109 million acres in 2000

12. Genetic Modifications • Maize with 2 herbicide tolerance • 23 varieties may tested w/o strict regulation • FAO says food output must increase 60% over next 25 years to meet projected demand • UCS says GM could improve food yields by 25%

13. GMO Crops Approved for Sale • soybeans • corn, not blue corn • canola • papaya • potatoes (Russett Burbank) • tomatoes

14. Approved GMO Products • Yellow crook-neck squash • red-hearted chicory (radicchio) • cotton • dairy products from cows injected with the genetically altered hormone • recombinant bovine growth hormone (rBGH)

15. Impacts of Genetic Modification • 1.4 billion farmers in developed countries depend on “saved seeds” and seed exchanges (50% of crops) • 1998 Monsanto sued 100 US soybean growers and hired “Pinkerton” agents to track down “seed savers” • “Pineland Seed Company” was granted patent in 1998 for “terminator technology” • seeds do not germinate if planted for second time

16. Impacts of Genetic Modification • WR Grace patent on extracts from “Neem” tree destroyed southern Indian farmers market • Locals could no longer not grow Neem w/o license from Grace • 1995 attempt by 2 Doctors to patent “tumeric” as healing powder opposed by India b/c discovery not original. In traditional Indian texts

17. Other Impacts • 1997 “Ricetec, Inc.” granted patent for crossing Indian basmati rice with semi-dwarf varities. Patent covered Basmati rice grown “anywhere” in Western Hemisphere. Patent gave Ricetec exclusive right to market any blend of the 22 farmer-bred varieties of Pakistan or Indian basmati rice with Ricetec’s other seeds and right to use Basmati names. • Indian Government challenged Ricetec’s claim which threatened 277 million dollar Indian rice market and Punjabi farmers.

18. Chymosin • First approved use of recombinant DNA-developed food ingredient. (March 1990) • Milk clotting enzyme used to make cheese and other dairy products (Rennet) • Chymosin was GRAS affirmation petition

19. Chymosin Approval Manufacturer had to prove: • Chymosin gene encoded a protein with same function and structure as animal derived Chymosin • Manufacturing process removed most impurities • Production organisms destroyed or removed during production and are non-toxigenic, and non pathogenic • Antibiotic-resistance markers are destroyed in the manufacturing process

20. Criticisms of GM • Bio Pollution • Food Allergens • Patents and Bio piracy • Patenting genetic material taken without consent • Cloning

21. Criticisms of GM • Species crossing diseases • Ethics and Eugenics • Monopolization of world food supply by multinationals protected by patents • Loss of biodiversity • Power over reproductive process • Human engineering

22. GMO Regulation in the US • NIH initially responsible for biotechnology regulation • Established safety protocols for biotech labs • 1986 Coordinated Framework for Regulation of Biotechnology • primary blueprint for the regulation of biotechnology • Redistributed responsibility for biotechnology regulation to FDA, USDA and the EPA • 1992 Statement of Scope • Speed up and simplify the process of bringing products, developed through biotech to consumers, food processors and farmers

23. GMO Regulation in the US • FDA Responsibility: • oversees the safety of all foods and animal feeds for consumption, including both GM and non-GM products • producers of new foods have an obligation under the HACCP to ensure that the foods they offer consumers are safe and in compliance with applicable legal requirements • Voluntary consultation with FDA prior to marketing

24. GMO Regulation in the US • Scientific evidence shows that bioengineered food ingredients are not materially different from the non-engineered versions • 1992 Statement of Policy: Foods Derived from New Plant Varieties, said GM products are GRAS • Courts have concluded that the FDA's decision to accord bioengineered food a presumption of GRAS status was neither arbitrary nor capricious

25. GMO Regulation in the US • FDA • January 17, 2001- new proposal to expand the FDA's regulatory control by making pre-market consultation mandatory • Food producers must notify the FDA at least 120 days in advance of their intent to market GM product • Must show that the GM product is as safe as its conventional counterpart and no potential safety, labeling or adulteration issues • increase the transparency of the FDA's safety review process for GM foods

26. GMO Regulation in the US • USDA Responsibility: • conducted primarily under the Federal Plant Pest Act and Animal and Plant Health Inspection Service (APHIS) • Oversees field testing of GM seeds and plants • Places inspectors in biotechnology plants • Current USDA Secretary is “pro GMO” • Ann Veneman

27. GMO Regulation in the US • EPA Responsibility: • Authority over GMOs comes from Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) • Evaluates the pesticide properties of transgenic plants • Virus resistance • Insect protection • herbicide tolerance

28. Substantial Equivalence • A GM food will be considered to be “substantially equivalent” to the natural product if after a comparison of several different characteristics, no difference is shown.

29. Criticism: • Unexpected substances may appear in GM foods • GM foods approved on the basis of substantial equivalence are not safe because not tested rigorously enough • Safety assessment based on “SE” not scientifically based

30. Labeling GM Foods(The US Position) • Labeling of GM products necessary only when the product is materially different from its non-GM equivalent • e.g. whether the use of biotechnology has changed the: • quality • safety • nutritional composition

31. EU Consumers: • Prefer traditional food practices • safer and closer to nature • Culture and tradition affect private attitudes toward regulation of foods • Have their source in the customs of the Middle Ages • Legacy of genetic testing on humans during the Nazi era • European resistance to GM products is a function of the public's distrust of the ability of their regulators to prevent such episodes as the mad cow disease crisis

32. GMO Regulation Internationally • 1957 Treaty of Rome established EU • Silent on food safety • No central European Food Safety Authority similar to the FDA or USDA • Member States continue to possess discretion in their agri-food policies • EU has issued several important GMO directives

33. GMO Regulation Internationally • Directives 90/119 and 90/220 of 1990 • regulates theunintentional and deliberate release of GM crops into the environment • 1997 Council Regulation 258/97 on Novel Foods • novel foods and novel food ingredients are subject to a single safety assessment before they are placed on the market • Directive 1813/97 • compulsory labeling of GM soya beans and maize marketed in the EU

34. GMO Labeling Internationally • EU has developed a complex codex of labeling regulations directly addressing GMOs as a separate category of agri-food products • Regulation 258/97 created additional labeling requirements for food products which have been found to be "no longer equivalent" to their traditional counterparts, as determined by scientific assessment”

35. Labeling GM Foods(Internationally) • January 2000, an international trade agreement for labeling GM foods established • 130 countries, including the US, the world's largest producer of GM foods, signed • Exporters must be required to label all GM foods • Importing countries have the right to judge for themselves the potential risks and reject GM foods, if they so choose

36. Labeling GM Foods(Internationally) • Mandatory labeling of novel food products containing more than one percent engineered DNA or protein content • Mandatory pre-market testing • Refinement of the substantial equivalence concept • Development and implementation of GMO tracing technology • Creation of a content-based mandatory labeling requirements for products derived from GMO

37. Precautionary Principle • Evolved out of German socio-legal tradition regarding good household management • “Vorsorgeprinzip” = foresight principle • Constructive partnership between individual, economy, and government to manage change so as to improve the lot of both society and the natural world

38. Six Basic Concepts • Preventative anticipation • Safeguarding ecological spaces • Proportionality of response • Duty of Care • Promoting the cause of natural rights • Paying for past ecological debt

39. Precautionary Principle • Where scientific information is insufficient, inconclusive, or uncertain and where there are indications that the possible effects of the environment, or human, animal or plant health may be potentially dangerous and inconsistent with the chosen level of protection," action may be taken in order to prevent such negative effects

40. Precautionary Principle: • Feb 2000 - Commission produced the "Communication from the Commission on the Precautionary Principle” • outline the Commission's approach to using the precautionary principle; • establish Commission guidelines for applying it; • build a common understanding of how to assess, appraise, manage and communicate risks that science is not yet able to evaluate fully; • avoid unwarranted recourse to the precautionary principle, as a disguised form of protectionism.

41. GMO Summary • GMO Generally • Definitions (magic words) • Safety Assessment Protocols: • Substantial Equivalence • Precautionary Principle • Regulation of GMOs in US: • Substantial Equivalence (SE) • Voluntary Consultation • Presumption of GRAS status • No labeling required if SE • Regulation of GMOs internationally • By EU Directive

42. Recent Case • Alliance for Bio-Integrity v. Shalala 9/2000 • Consumer group challenged FDA lack of mandatory labeling for GM foods • Alleged: • Violation of APA • FDA failure to provide EIS • FDA presumption that GM foods are GRAS is erroneous • GM foods w/o labeling are misbranded because fail to reveal “material facts”

43. Alliance for Bio-Integrity v. Shalala • Court held: • 1992 Policy Statement was a policy statement and not a substantive rule so APA did not apply • FDA presumption of GRAS status not arbitrary or capricious because based on substantial evidence • Court will not interfere with FDA decisions regarding what information is “material” enough to be included on label

44. Alliance for Bio-Integrity v. Shalala • Court held: • Consumer interest alone is insufficient to deem the use of GM technology as “material” for purposes of labeling • Without a determination that GM foods pose inherent risks or safety consequences to consumers or differ in some way from their counterparts, FDA is without authority to mandate labeling