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The Regulation of Genetic Modifications

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The Regulation of Genetic Modifications The GMO Controversy – PowerPoint PPT presentation

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Title: 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
  1. Preventative anticipation
  2. Safeguarding ecological spaces
  3. Proportionality of response
  4. Duty of Care
  5. Promoting the cause of natural rights
  6. 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
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