REGULATING MODERN BIOTECHNOLOGY: A A PLANET OF COINCIDENCE AND PLANET OF DIVERGENCES

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REGULATING MODERN BIOTECHNOLOGY A A PLANET OF
COINCIDENCE AND PLANET OF DIVERGENCES

• Alexander Golikov
• Executive Secretary
• Black Sea Biotechnology Association

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We have recently advanced our knowledge of
genetics to a point where we can manipulate life
in a way never intended by nature. We must
proceed with the utmost caution in the
application of this new-found knowledge.
Luther Burbank
1908
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Adoption of genetically modified crops within a
couple of years could lead to 1.5 fold growth in
the global GDP with the higher increase in the
countries with lower GDP per capita (Reuters,
10 March 2003)
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Bioscience is the most attractive object for
venture capital investment. Thus in the year 2002
venture capital investment in it was 4.7 billion
US dollars (2.7 bln US in 1998) which was 22 per
cent of the whole world venture capital
market (Pricewater Coopers, Thomson Venture
Economist and National Venture Capital
Association, NYT, 24 March 2003)
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Life sciences and biotechnology are widely
recognized to be, after information technology,
the next wave of the knowledge-based economy,
creating new opportunities for our societies and
economies.
Source Commission of the European
Communities Life sciences and
biotechnology A Strategy for Europe Janu
ary 23, 2002
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Europe is faced with a major policy choice
either accept a passive and re-active role, and
bear the implications of the development of these
technologies elsewhere, or develop pro-active
policies to exploit them in a responsible manner,
consistent with European values and standards.
The longer Europe hesitates, the less realistic
this second option will be.
Source Commission of the European
Communities Life sciences and
biotechnology A Strategy for Europe Janu
ary 23, 2002
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Each Contracting Party shall take legislative,
administrative or policy measures, as
appropriate, with the aim that the private sector
facilitates access to, joint development and
transfer of technology for the benefit of both
governmental institutions and the private sector
of developing countries Convention on
Biological Diversity (Article 14.4)
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Nine most scaring words in English
Im from the government and Im here to help
Ronald Reagan
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• Increased emphasis on biosafety and supply
  security will continue as a significant trend
• There will be rapid changes in technology to
  produce and process food, pharmaceuticals, etc.
• Information overload will be a continuing
  challenge
• There is growing awareness of the world as an
  interdependent food and agricultural community,
  therefore food and agriculture will continue to
  be a large icon for special interest groups who
  challenge the validity and safety about food
  agriculture to further their own agendas

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The Concept of Safety

• . a reasonable certainty of no harm from
  intended use
• .as safe and nutritious as
• traditional counterpart

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There is no zero risk!

• We consume 10,000 natural toxins daily!
• Roasted Coffee has 1,000 chemicals. Of 27
  tested, 19 were were carcinogens!
• Potato, Celery, Beans, Peach Seeds, Cassava,
  Peanut, Triticale
• Comfort with Old and Natural
• Anxiety with New and Synthetic

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PRODUCT OF MODERN BIOTECHNOLOGY (whose genetic
make-up is unlikely to occur in nature)
REFUSE
APPROVE
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Informed Decision
Public involvement
DECISION
agree
Request
?
DRAFT DECISION
IDENTIFICATION
of needs and priorities of decision makers
preparation
COLLECT
Iterativeadaptive
datainformation to meet the needs, agree roles
and responsibilities of datainformation holders
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Make-up of regulatory mechanism
science based risk assessment
A
science based risk management
B
science based risk analysis
A B
science based decision
C
A B C
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FACTS vs FACTOIDS
Factoid A piece of unverified or inaccurate
information that is presented in the press as
factual, often as part of a publicity effort, and
that is then accepted as true because of frequent
repetition. http//www.dictionary.com
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National flavor of biosafety
USACanada Product is safe unless proven
unsafe
UK Product is unsafe unless proven safe
France Product is unsafe even if
proven safe
Austria Product is unsafe
especially if proven safe
India Product is safe even
if proven unsafe
Uganda Product is safe especially if
proven unsafe
Ethiopia Product is unsafe even if not
developed yet
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Regulating biotechnology the national flavor
AS YOU LIKE IT!
identify

• who/what is the YOU?
• what the YOU would likely like at the moment?
• how to fit what the YOU likes into existing
  regulatory acts?

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State regulation
Regulation is a means by which governments seek
to gain benefits and ameliorate the potential
negative consequences of a free market economy
The US-EU Consultative Biotechnology Forum,
December 2000
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Key stakeholders and their roles
STATE
INDUSTRY
MARKET
CONSUMER
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Key stakeholders and their roles
INDUSTRY
STATE
CONSUMER
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Common problems
Regulatory systems are largely designed to
address those concerns that can be dealt with
through science. Science, by its nature, is
provisional, always evolving, and not always
value-free. The dependence of regulatory
processes on science makes them
inherently provisional.
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Common problems

• Risk assessment - the prediction of likely
• hazard is often allowed to drift into risk
  management, where economic and socio-cultural
  factors may play a role in deciding whether to
  accept a particular level of risk.

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The individuals charged with risk assessment
should be well qualified to make decisions in the
area under review, be individuals of the highest
integrity, and meet stringent requirements for
public disclosure of actual and potential
conflicts of interest.
The US-EU Consultative Biotechnology Forum,
December 2000
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WHAT IS REGULATED?
PRODUCT USA
TECHNOLOGY EU
NOVELTY CANADA
familiarity vs precaution
a new law vs amending existing
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LABELING TRACEABILITY LIABILITY and The Cartagena
Biosafety Protocol
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LABELING AS IT STAYS NOW IS MARKETING
BUSINESS NOT SAFETY OR INFORMATION CATEGORY
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• USDA United States Department of Agriculture
• plant pests, plants, veterinary biologics
• EPA Environmental Protection Agency
• microbial / plant pesticides, new uses of
  existing pesticides, novel micro-organisms
• FDA Food and Drug Administration
• food, feed, food additives, veterinary drugs,
  human drugs and medical devices

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Advantages of the US regulatory system

• transparent
• step-by-step clearance
• fast
• review on scientific basis

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EU Novel Food Regulation

• Novel Food Definition
• A novel food is defined as a food or feed
  ingredient which does not have a significant
  history of consumption within the EU prior to May
  1997.
• Novel Foods Regulation (EC) No.258/97.
• Should a food or food ingredient be deemed novel
  it would be
• subject to a pre-market safety assessment under
  the above
• Legislation

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EU GM Food and Feed Regulation

• GMO Definition
• Organisms in which the genetic material has been
  altered in a
• way that does not occur naturally by mating
  and/or natural
• recombination.
• GM Food and Feed Regulation (EC) No. 1829/2003
  (safety assessment) and Complementary Legislation
  2001/18 (deliberate release to the environment)
• Provides the basis for ensuring a high level of
  protection of human life and health, animal
  health and welfare, environment and consumer
  interests in relation to GM food and feed..

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EU Laws Governing GM crops - Current
Perceived Regulatory gap
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EU Proposed GM Crop Laws
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