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GMO RISK ANALYSIS
Hennie Groenewald, Jhill Johns & James Rhodes
Department:
Science and Technology
REPUBLIC OF SOUTH AFRICA
GMASSURE Capacity Building, Harare, 16-20 Mar 2015
IMPORTANT BACKGROUND CONCEPTS
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- Familiarity
- Relative simplicity (evolving complexity)
- Diverse perspectives
- Continued reaffirmation of context
con
cep
ts
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Management goals
Assessment endpoints
Threshold values Test endpoints
Risk management
Risk decision
Communication of the risk decision and how the decision was made
Risk assessment Risk = f (hazard x exposure)
Scientific risk evaluation
Setting the context & scope
Risk decision-making Risk assessment
Risk communication
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RISK ANALYSIS AS BASIS FOR DECISION MAKING
context
assessment management
communication risk
an
aly
sis
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RISK ANALYSIS
• This process is:
• science based
• performed on a case by case basis
• iterative
• comparative
and take into consideration
• the nature of the introduced sequences (the trait)
• the characteristics of the crop
• the receiving environment
and interactions between these risk
an
aly
sis
1. SETTING THE CONTEXT & SCOPE
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con
text
& s
cop
e • Setting the context & scope for a risk assessment that is
consistent with policies, strategies & protection goals may
involve a process that includes risk assessors, decision-
makers & other stake holders.
• Aspects to consider during problem formulation include, as
appropriate:
- Existing policies & strategies.
- Protection goals, assessment endpoints, risk thresholds &
management strategies.
- Review of possible mechanisms.
- Identification of methodological & analytical requirements.
- Nature & level of detail of the information required.
- Experience & history of use of the non-modified recipient
and/or GMO.
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• Risk assessment then tests these assessment endpoints by evaluating the likelihood and consequence to human health or the environment following exposure to the GMO.
• In general: Step1: Problem formulation (hazard identification - what could go wrong?)
Step 2: Risk characterisation.
Exposure assessment X Consequences assessment
(how likely?) (would it be a problem?)
=
Risk estimate
(what is the risk?)
Step 3: Risk decision (is it an acceptable risk?)
2. RISK ASSESSMENT: SCIENTIFIC RISK EVALUATION
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• No such thing as zero risk
• therefore we accept some level of uncertainty or risk
• the question is “are the risks acceptable?”
2. RISK ASSESSMENT: SCIENTIFIC RISK EVALUATION
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3. RISK DECISION MAKING (RISK MANAGEMENT)
• Uncertainty is generally highest during early stage development of a GM crop.
• the risks may not be fully characterised and are managed by reducing the likelihood of risks occurring
• manage unacceptable consequences e.g. to manage volunteers that may contain a vaccine that may mix with following crops.
• field trials enable regulators the opportunity to gain familiarity with the crop
• enables the generation of relevant biosafety data to reduce uncertainties/ characterise risks
• this can result in changes in license conditions and feed into evaluations of the same or similar GMOs
TIERED APPROACH TO RISK ASSESSMENT Tier 1: Laboratory Evidence of potential adverse effects of novel molecules?
No additional data required
Tier 2: Greenhouse Evidence of potential adverse effects or of GM plant compared to conventional counterpart?
Tier 3: Confined Field Trials Evidence of potential adverse effects on ecosystem functions or performance under field conditions?
No additional data required
No additional data required
Risk management: Can risk be reduced to acceptable levels?
Describe risk management strategies
Fully characterise and describe risk
YES
NO
NO
NO
NO
YES
YES
YES
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ENVIRONMENTAL RISK ASSESSMENT
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context
hazard
risk hypothesis
pathways
to harm harm
risk estimate
LIK
EL
IHO
OD
AS
SE
SS
ME
NT
Highly likely Low Moderate High High
Likely Low Low Moderate High
Unlikely Negligible Low Moderate Moderate
Highly unlikely Negligible Negligible Low Moderate
Marginal Minor Intermediate Major
CONSEQUENCE ASSESSMENT
risk decision
ELEMENTS IN THE SAFETY ASSESSMENT OF GM FOODS
1. Host plant &
its use as food
2. Donor
organism(s)
4. GM plant
3. Genetic
modification
4.2. Food safety
• expressed substances
(toxicity & allergenicity);
• compositional analyses;
• evaluation of metabolites;
• food processing;
• nutritional modification 4.1. GM molecular
characterisation
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Commercial release
• Single copy of each gene
• Stability of integration
• Develop protocol (usually PCR) to detect the event
• Expression analysis
Molecular assessment
Lab
&
Greenhouse
Commercial release
Juice Molasses Bagasse Sugarcane tops Mature, whole sugarcane
moisture moisture moisture moisture moisture
Total sugars Total sugars - Total sugars Total sugars
ash ash ash ash ash
Crude protein Crude protein Crude protein Crude protein
Crude protein
calcium sucrose Cellulose, lignin, hemicellulose
Crude fibre Crude fibre
phosphorous Minerals e.g. Ca, P, Mg, K, Na, Cl, S, Cu
Acid and neutral detergent fibre
Ether extract Ether extract
Amino acids Ether extract Nitrogen-free extract
Acid and neutral detergent fibre
- - Minerals - -
Examples of analytes for food and feed safety
Cartagena Protocol on Biosafety: Article 26 • “…may take into account consistent with its international
obligations, socio-economic considerations arising from
the impact of living modified organisms on the
sustainable use of biological diversity…”
• only those that arise directly from impacts on biological diversity
• compatible/consistent with other international obligations eg. WTO (SPS, TBT, GATT Agreements) - ensure no trade impacts restrictions
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BACKGROUND: SOCIO-ECONOMIC IMPACTS
Individual countries to decide
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SOUTH AFRICAN SOCIO-ECONOMIC LEGISLATION
The GMO Act (1997) R1420 Sub-regulation 5(9):
“The Council may in performing its function in terms of sub-regulation (8), consider the socio-
economic impact that the introduction of a genetically modified organism may have on a community
living in the vicinity of such introduction.”
GMO Regulation (R. No.120) (5) 2010 states:
“(1) An assessment of socio-economic impact may include information on the impact of the activity
on the following –
(a) the continued existence and range of diversity of the biological resources in the areas
inhabited or used by indigenous or local communities,,
(b) the loss of access to genetic and other natural resources previously available to indigenous
or local communities,
(c) the loss of cultural traditions, knowledge, and practices in a particular indigenous or local
community as a result of the loss of biological diversity in their territory
(d) the loss of income, competitiveness or economic markets, and
(e) the loss of food security.
The GMO Amendment Act (2006) states in Section 5(1):
“The Council shall (a) where an applicant applies in the prescribed manner for a permit to conduct
activities in respect of genetically modified organisms determine whether that applicant must, in
addition to his or her application, submit an assessment in accordance with the relevant provisions
of the National Environmental Management Act, 1998 (Act No 107 of 1998), of the impact on the
environment and an assessment of the socio-economic considerations of such activities;”
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TOWARDS DEVELOPING SEIA FRAMEWORK
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TOWARDS DEVELOPING SEIA FRAMEWORK
Example: Ex-ante assessment of SEIA of Bt Maize
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TOWARDS DEVELOPING SEIA FRAMEWORK
Example: Ex-ante assessment of SEIA of Bt Maize (contd)
• Socio-economics not adequately defined
• Many different approaches to assess socio-
economic impacts
• Data requirements, measurable criteria &
thresholds
• Appropriate experience for conducting
socio-economic impact assessments is
lacking
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CHALLENGES
Risk vs. Benefit, limits of concern
Risks
Benefits
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RISK ASSESSMENT IN PERSPECTIVE
Theoretical basis & analysis
Variability, uncertainty, risk & harm Assessment frameworks risk
ass
essm
ent
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RISK DECISION-MAKING IN PERSPECTIVE
GM technology is a tool Case by case & Bt maize vs. GMOs
vs.
Risk estimate Monitoring 21 risk
ma
na
gem
ent
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4. RISK COMMUNICATION
• Establishes a dialogue between decision makers and stakeholders to provide open, transparent and consultative risk based regulation of GMOs
• It is an important component of risk analysis
• should include an explanation of the risk assessment findings & reasoning for any imposed risk management conditions
• Also more “general” communication required though…
COMMUNICATION VS. THE GMO “DEBATE”
The nature of the GMO “debate”
o Worldview/dogma determines perspective (NOT “facts”).
o “Science-based” vs. “ideology-based”.
o Both sides have much to gain/lose.
o No such thing as “neutral” or “independent”.
o Great majority of the publically accessible “debate” is
therefore non-fact based rhetoric and it doesn’t evolve.
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“GM Toxic Chemicals found in pregnant women and fetuses!”
February 2011
ASSESSING THE RISKS OF A CONTROVERSIAL TECHNOLOGY
• Glyphosate in 5% of non-pregnant women at 73.6ng/ml.
• Gluphosinate in 18% of non-pregnant women at 28.7ng/ml.
• Cry1Ab in 69% & 93% of non- & pregnant women at ~0.16ng/ml.
“As for glyphosate, it is interesting to note that the gluphosinate
concentrations used in these tests are very high (10ug/ml) compared to
the levels we found in this study (53.6ng/ml).” [186x higher]
A perspective on science communication
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FRAME CONTROVERSIES
per
spec
tive
communicate
Influence (acceptance, regulatory, etc.)
Frame 1 Frame 2
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WHAT ARE WE REQUIRED TO COMMUNICATE?
per
spec
tive
“Colouring in a blank canvas” vs. “erasing a wrong picture”
REQUIREMENTS OF A STRATEGIC COMMUNICATION PLAN
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o Increase awareness and engage with all
stakeholders.
oBuild strategic relationships, e.g. with regulators.
oSolicit support and build confidence.
oPre-empt potential difficulties and manage them
pro-actively.
oEnsure GM discussions are fact-based.
