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, 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 the unintentional 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 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 Safety Assessment Protocols:
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