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Risk Assessment and Risk Management of GMOs


Risk Assessment and Risk Management of GMOs W. De Greef, ... Environmental benefits Socio-economic benefits A regulatory strategy distinguishes between Biosafety ... – PowerPoint PPT presentation

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Title: Risk Assessment and Risk Management of GMOs

Risk Assessment and Risk Management of GMOs
  • W. De Greef, IBRS

To cover
  • Historical background
  • Why risk assessment and risk management?
  • Which risks?
  • How to conduct risk assessment and risk
  • Timing and uncertainties

Historical background
  • Questions on safety of GMOs arose from the
    earliest days of the emergence of gene
  • 1975 Asilomar conference and voluntary
    moratorium on laboratory experiments
  • 1976-1985 first generation of (national)
    regulations and guidelines on GMO work
    (essentially in laboratory)
  • 1986 Publication of the Blue Book Safety
    considerations for industrial, agricultural and
    environmental applications of organisms derived
    by recombinant DNA techniques
  • ? first major effort towards international
    harmonisation of biosafety assessment of GMOs
  • ? Focus on GMOs destined for release in the

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More history
  • 1987 1990
  • first major wave of legally binding regulation of
    activities with GMOs
  • Beginning of focus on GM crops (pressure by NGOs)
  • ALL based on the Blue Book guidelines
  • 1990 2000
  • The development and distribution of the first
    generation of GM crops
  • Putting into practice the recommendations of the
    Blue Book
  • Verifying whether any biosafety hazard has
    escaped attention of RA
  • Excellent safety record for GM crops no
    biosafety accident known
  • 1997-2005
  • Negotiation and implementation of the Cartagena
  • Ongoing, deeply flawed international instrument

Why do a Risk Assessment (RA) and organise Risk
Management (RM)?
  • Biotech was the first technology which was
    regulated before the first accident
  • Application of the Precautionary approach before
    it became enshrined in environmental policy (CBD)
  • Recognition that it is possible to do harm to
    human health and to the environment
  • Understanding that these risks can be managed to
    mitigate or eliminate risks

Potential risks of GM crops
  • Environmental
  • Impact on biodiversity through escape,
    multiplication or replacement native gene pools
    (e.g. drought tolerant plants)
  • Impact on ecosystems through toxic effects (e.g.
    insect tolerant plants) and potential elimination
    of non-target species
  • Health
  • Potential toxicity of the new gene(s)
  • Potential allergenicity of new gene products
  • Potential effect on expression of native toxins
    or allergens of the receiving plant

RA and regulatory compliance
  • Risk assessment is the first step towards a
    regulatory approval and compliance strategy.
  • It is only effective if it fits in a regulatory
  • Identify where the crop will be grown, and where
    it will be traded
  • Prepare the necessary DATA for inclusion in the
    regulatory dossiers
  • It has to be linked to a risk management strategy
    and a communication strategy

Points to consider
  • A biotech project has a number of parallel
    sub-projects the regulatory project is one of
  • Regulatory time loss can start from the day of
    concept of the project
  • Choice of a gene coding for a toxic or a stable
  • Choice of an unacceptable selectable marker
  • Regulatory compliance starts in the lab!
  • There is a difference between the biosafety
    project and the regulatory project
  • Biosafety assessment is a technical exercise
  • In regulatory clearance, cost-benefit analysis,
    including non-technical parameters will enter the

Points to consider
  • After POC, regulatory clearance is almost always
    on the critical time path of a GM crop project
  • The regulatory environment of biotechnology has
    not stabilized, and will change during a project
  • Need to stay informed about policy changes!
  • The best way to stay informed is to be actively
  • It is a good idea to develop the benefit file
    together with the regulatory file
  • Environmental benefits
  • Socio-economic benefits

A regulatory strategy distinguishes between
  • Biosafety research (an open-ended scientific
  • Biosafety assessment (the systematic evaluation
    of a number of  points to consider , according
    to standards set by a regulatory body)
  • The regulatory dossier and its management (which
    requires thorough knowledge of the regulations
    but also of trading patterns of the seed and the
    grain of the crop)
  • Product Stewardship (the collection of technical
    and management measures needed to remain in
    compliance with the conditions of permits)

Chosing the unit of regulatory activity
  • By law, the unit of biosafety assessment and
    regulatory oversight is the event.
  • it is essential to use as few events as possible
    to avoid escalation of biosafety assessment and
    regulatory costs
  • Most components of a biosafety assessment (and
    their compilation in a regulatory submission) can
    only be developed using the final event
  • In most jurisdictions, stacked events require a
    new regulatory submission (exception USA)

The Biosafety package
  • There are big differences in biosafety policy
    between countries, BUT
  • There is much less difference between the
    technical requirements in a biosafety package
  • These requirements were first set by the Blue
  • They form the technical annexes of the national
    regulations of all OECD member states
  • They have been adopted by almost all other
    countries with a regulation! ( e.g. China, India,
    Brazil, Argentina, South Africa )

Components of the package
  1. Description of donor and recipient organism
  2. Characterisation of the DNA to be inserted
  3. Molecular characterisation of the event
  4. Compositional analysis of the event
  5. Assessment of health safety of the event
  6. Assessment of environmental safety of the event
  7. Development and validation of event-specific
    detection tools.

1. Donor and recipient organisms
  • This is the only part of the package which is
    essentially event-independent and
  • For most major crops, including maize, there are
    standards from which to work,
  • For Bacillus thuringiensis, the same applies
  • Ref OECD consensus documents on crop biology

2. The DNA insert
  • The requirements for molecular characterisation
    of the new DNA are very stringent
  • importance of good documentation at research
  • need to ensure that reference material of the
    original vectors remains available for future
    verification by regulators.
  • If vectors or genes come from others, ensure that
    this information is supplied as part of the MTA

3. Molecular characterisation of the event
  • Copy number
  • Insertion site(s)
  • Confirmation that the gene(s) have not inserted
    in an open reading frame
  • Confirmation that no junk DNA or incomplete
    copies remain
  • Sequencing of the insert(s) and flanking
  • Expression profile of the inserts
  • Evaluation of genetic stability of the insert(s)

4. Compositional analysis
  • Components
  • Major and minor nutrients (standards have been
    developed by OECD and by Codex alimentarius)
  • Minerals and vitamins
  • The challenge
  • The applicant must demonstrate reproducibility of
    the figures produced
  • Therefore the event has to be backcrossed in
    several germplasm backgrounds (usually 3)
  • These materials (and their non-transgenic
    isogenics) have to be grown in a properly
    replicated design over at least 2 seasons in
    several locations)

5. Assessment of human health safety
  • Nutritional trials for digestibility (on several
    animal species)
  • Suite of experiments required for confirmation of
    non-allergenicity of all newly expressed proteins
    (including selectable marker)
  • Suite of experiments for confirmation of
  • Acute and sub-chronic feeding trial
    (dose-response curve) of the expressed proteins
    on mouse
  • Acute feeding trial on a range of other
    representative animals (birds, fish, mammals,
    invertebrates) of the proteins
  • The challenge
  • produce enough materials of the proteins (in
    purified form and in a plant matrix) for the
  • Find labs to do the tests according to
    international standards.

6. Environmental safety assessment
  • Gene flow assessment in the future receiving
  • Outcrossing to other crop varieties (including
  • Outcrossing to wild relatives
  • Interactions with biota in the receiving
  • Assessment of impact on soil organisms
  • Assessment of impact on organisms living on
    vegetative parts of the crop (with special
    attention to non-target insects)
  • Assessment of impact on animals feeding on the
    seed or on the vegetative parts of the plant

7. Event-specific detection tools
  • Detection tools have to be developed for
    protein-based and DNA based detection.
  • Protein based methods have to include both
    quantitative and (usually cheaper) qualitative
  • The applicant has to demonstrate that the GM
    varieties released contain only the GM event
    which receives the regulatory permit
  • Real-time PCR has become the standard for DNA
    based detection
  • Needs to be event specific!!
  • Need to create tail-PCRs for each candidate event

From Biosafety package to Regulatory filing
  • The original regulatory submission will contain
    all the data of the biosafety package
  • In addition, it will contain (in the case of
    insect resistance)
  • An IRM strategy, validated for the environment in
    which the crop is to be introduced
  • A product stewardship programme
  • A contingency plan, validated for the
    jurisdiction in which the crop is to be
  • These are the elements of a risk management
  • No risk management strategy is complete without a
    comprehensive risk communication program

The food/feed permits
  • Food/feed permits are the backbone of the
    procedure for rapid and hindrancefree movement
    of the crop across national borders
  • Most of the data needed are generated in the
    original biosafety package
  • Some authorities are very difficult about Mutual
    Acceptance of Data (especially for compositional
  • Many authorities require at least one year of
    growing for compositional analysis in their
    borders ? significant cost!
  • Analysis of the trading patterns in the expected
    growing markets is an essential early component
    of the regulatory strategy

Post-release stewardship
  • No large scale release comes without conditions
  • The holder of the permit is accountable for
    compliance with the conditions of the permit and
    liable for damage if something goes wrong
  • Need to upgrade all breeding and seed production
  • Need to develop a post-release management program
  • Need to ensure that reporting requirements are
  • A special problem
  • Almost all permits today are time-limited

Regulatory management
  • The development and management of a large scale
    introduction of a GM crops requires complex
  • It involves scientific, technical, legal and
    administrative expertise
  • It requires presence on the ground in several
    countries and experience with many jurisdictions

Carrying out risk management
  • Executing a risk management strategy requires
    close cooperation between practitioners and
  • Monitoring for specific and foreseeable effects
    is usually carried out by permit holder
  • Research on potential unforeseen effects is
    usually done by outside scientists, on government
  • Risk management is before all a communication

Safety the ghost issue
  • Biosafety in GMO work was an early concern for
    both scientists and governments
  • Regulation and safety assessment started in late
  • GM crops have always been regulated in all
    industrialised countries
  • Real safety concerns focused around
  • Health toxicity, allergenicity
  • Environment gene escape and invasiveness
  • These are all addressed in all regulatory systems
  • Result more than 1 billion tonnes of GM food
    produced, not a single health or environmental
    damage case

Why is biotech so safe?
  • Biotechnology is an information technology
  • The only thing new in GM crops is the information
    contained in the rDNA
  • No issues of residues
  • Products of biotech are DNA and proteins
  • All digestive systems have evolved to dismantle
    DNA and proteins

Why is biotech so safe?
  • Biotech was the first technology that was
    regulated before accidents happened
  • First guidelines for lab work in U.S. and Europe
    in 1970s
  • Harmonisation of regulations stimulated by OECD
    from 1983
  • All major developer and user countries have
    elaborate biosafety regulatory structures in
  • ? Not a single safety issue in 10 years

Safety and risk perception
  • While scientific safety assessment and management
    points to a technology with a uniquely positive
    safety record
  • Public perception is of a technology haunted by
  • Monarch butterfly (U.S.), farm scale trials (UK),
    co-existence (EU), GM food aid, Starlink, Bt10,
  • What has gone wrong?
  • Massive misunderstanding among policy makers on
    reality of risks
  • Lack of a risk-benefit approach
  • Non-safety issues reported as safety issues

Monarch Butterfly deaths from GM
pollenGenetically modified crops may kill
Monarch Butterfly                               
Reality check thanks to improved habitat
protection and lower insecticide use, the monarch
butterfly is doing well
The need for risk/benefit approach
  • Risk assessment does not consider potential
    beneficiary effects
  • Promoting zero tillage improved erosion control
    CO2 capture
  • Reduced insecticide use less non-target effects
  • Leads to quest for proof of zero risk ?
  • Considering risk apart from benefits is a poor
    basis for risk management decisions

How to connect perception with reality?
  • In many places the perception of safety issues
    with GM crops has become received wisdom
  • Very difficult to dislodge, in view of
  • Ignorance of agriculture among end users and
    policy makers
  • Risk theory fear and risk perception is mostly a
    matter of control
  • Building trust through information and dialogue

  • GM crops are rapidly becoming mainstream in the
    most important agricultural production centres
  • They have brought significant benefits to
    farmers, and new products will bring large
    consumer benefits
  • They have been embroiled in a massive public
    safety controversy, for which there is no basis
    in fact
  • The only way to restore consumer and policy maker
    confidence is quality communication.

Thank you
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