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 GMOs

• 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 GMOs

• 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 Rifkins 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

• Senators Ted Kennedy and Jacob Javits (1976)
• Proposed separate Bills to place rDNA research
  under control of Department of Health
• Result was inaction by Congress (couldnt 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 Ricetecs other seeds and right
  to use Basmati names.
• Indian Government challenged Ricetecs 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 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 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