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					Regulatory Procedure for the
 Assessment of GM Foods
  Traditional Views of
  Food Safety
 Historically, our beliefs about the safety of foods
have been based almost entirely on tradition and cultural
experience
 In practice, very few of the foods we eat today have
been subject to any toxicological studies and yet they
are genetically accepted as safe
Even foods that contain toxins or anti-nutrients have
been considered safe through a long history of use
  What’s Changed?
          Genetically modified (GM) foods
 Scrutinized by scientists, regulators and the public
 Subject to unprecedented regulatory oversight
 Have caused us to rethink our traditional views of food
safety
 Definition of “safe”
 Approaches to systematically
evaluating safety
FOOD SAFETY


  FOOD SAFETY, involves all those
 hazards, whether chronic or acute, that
may make the food injurious to the health
             of consumers.
      IT IS NOT NEGOTIABLE

                             (FAO 2003)
Can Safety be Proven?

It is impossible to prove that something is
safe
 “Zero” risk and “Absolute” safety are
impossible to achieve in the food system
GM Foods- Safety Review

 Takes around 10-14 years:
     Laboratory research
     Contained greenhouse evaluation
     Contained small scale field trials
     Pre-commercial testing
     Commercial release
           Key Initiatives

Codex Ad Hoc Intergovernmental Task Force on
  Foods Derived from Biotechnology
 General Principles for the Risk Analysis of Foods
  Derived from Recombinant DNA Plants
 Guidelines for the Conduct of Safety Assessment of
  Foods Derived from Recombinant DNA plants and
  Microorganisms
The Comparative Approach

     Based on the principle that you can
      compare a GM food with a counterpart
      having a history of safe use
     Comparison can include an evaluation of
      the same risk factors established for the
      counterpart

     This approach is commonly referred to as
      the “Substantial Equivalence” approach
 Goals of Substantial
 Equivalence
 To structure the safety assessment
relative to the counterpart food

 To identify intended or unintended
differences on which further safety
assessment should focus

 To determine “…as safe as…”
Substantial Equivalence
is not...
 A safety assessment in itself

 A characterization of the hazard

 An endpoint in the risk assessment
 process
Limitations of Substantial
Equivalence

 Availability of a counterpart
Availability of data on agronomic /
compositional properties
Availability of data on natural variations
Availability of analytical methods
 Codex Guidelines for Foods Derived from
 Recombinant DNA Microorganisms


The Safety assessment of a food produced using a recombinant
DNA microorganism follows a stepwise process of addressing
relevant factors, including:
 Description of the rDNA microorganism
Description of recipient microorganism and its use in food
production
Description of donor organism
Description of the genetic modification(s) including vector
and construct
Characterisation of the genetic modification(s)
 Codex Guidelines for Foods Derived from
 Recombinant DNA Microorganisms


 Safety assessment:
      -Expressed substances: assessment of potential toxicity and other
      traits related to pathogenicity;
      -Compositional analyses of key components;
      -Evaluation of metabolites;
      -Effects of food processing;
      -Assessment of immunological effects; allergenicity
      -Assessment of viability and residence of microorganisms in the
      human GI tract
      -Anitibiotic resistance and gene transfer
      -Nutritional modification
 International Consensus

 Even considering its limitations, the concept of substantial
equivalence as a tool to help regulators structure the safety
assessment process has been reaffirmed on numerous occasions
internationally
 There are no alternative strategies that provide a better
assurance of safety (WHO/FAO Joint Expert Consultation,
2000)
 ‘some form of substantial equivalence, starting
with a direct comparison of the novel foodstuffs with
their unmodified counterparts, appears to be the only
practical solution’
     The goal of each safety assessment is to
     provide assurance, in the light of the best
 available scientific knowledge that the food does
not cause harm when prepares, used and/or eaten
           according to its intended use.
Questions that need to be
answered
Is the transferred DNA safe to consume?
If an antibiotic resistance marker is used, is it
safe?
Are the newly produced proteins safe to
consume?
Have potential allergens been introduced into
the food?
Are the composition and nutritional value
changed?
Questions that need to
be answered
Are there changes in the content of
important substances?
In what forms will the food or food products
isolated from it be consumed?
Do the newly introduced substances survive
processing, shipment, storage and
preparation?
What is the expected human dietary
exposure?
 BAFPS Framework on Food Safety
 Assessment of GM Foods

 Sound scientific evidence
 Pursued in accordance with recognized risk
  assessment guidelines and appropriate sampling
  techniques
 Carried out in a transparent manner
 Evaluation shall consider the safety of its
  conventional counterparts
 Shall take into account the history of safe use as
  food source from the importing country
BAFPS Assessment of GM
Foods
 Focused on
     Horizontal Gene transfer
     Safe use of Antibiotic Resistance Marker Gene
     Nutritional Composition
     Possible allergenicity
     Unintended effects
General Approach to
Biosafety

  Agriculture                   Health


                   Guidelines




                Environment
Summary


 Important components of GM regulation
 Guidelines – risk assessment, management
 Legislation – GM process, GM products
 Periodic re-evaluation of Guidelines and
  implementation procedures give the
  applicants, reviewers, administrators,
  regulators and the public an opportunity to
  assess how well the system is working
THANK YOU!

				
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posted:3/4/2013
language:English
pages:23