GMO RISK ANALYSIS. Hennie Groenewald, Jhill Johns & James Rhodes. GMASSURE Capacity Building, Windhoek, Nov 2014

Transcription

1 GMO RISK ANALYSIS Hennie Groenewald, Jhill Johns & James Rhodes GMASSURE Capacity Building, Windhoek, Nov 2014 Department: Science and Technology REPUBLIC OF SOUTH AFRICA

2 concepts IMPORTANT BACKGROUND CONCEPTS - Familiarity - Relative simplicity (evolving complexity) - Diverse perspectives - Continued reaffirmation of context 2

3 risk analysis RISK ANALYSIS AS BASIS FOR DECISION MAKING Adapted from Johnson et al Trends in Plant Science 12(1): 1-5. Setting the context & scope context Management goals Assessment endpoints Risk decision-making Threshold values management Risk management Risk assessment Test endpoints assessment Risk assessment Risk = f (hazard x exposure) Risk decision Scientific risk evaluation Risk communication communication Communication of the risk decision and how the decision was made 3

4 risk analysis 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 4

5 context & scope 1. SETTING THE CONTEXT & SCOPE Setting the context & scope for a risk assessment that is consistent with policies, strategies & protection goals may involve a process that includes risk assessors, decisionmakers & 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. 5 - Experience & history of use of the non-modified recipient and/or GMO.

6 2. RISK ASSESSMENT 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?) = Risk estimate (what is the risk?) (would it be a problem?) Step 3: Risk decision (is it an acceptable risk?) 6

7 2. RISK ASSESSMENT: SCIENTIFIC RISK EVALUATION No such thing as zero risk therefore we accept some level of uncertainty or risk the question is are the risks acceptable? 7

8 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 8

9 TIERED APPROACH TO RISK ASSESSMENT Tier 1: Laboratory Evidence of potential adverse effects of novel molecules? YES NO No additional data required Tier 2: Greenhouse Evidence of potential adverse effects or of GM plant compared to conventional counterpart? NO No additional data required YES Tier 3: Confined Field Trials Evidence of potential adverse effects on ecosystem functions or performance under field conditions? NO No additional data required 9 YES Risk management: Can risk be reduced to acceptable levels? YES NO Describe risk management strategies Fully characterise and describe risk

10 ELEMENTS IN THE SAFETY ASSESSMENT OF GM FOODS 1. Host plant & its use as food 3. Genetic modification 2. Donor organism(s) GM molecular characterisation 4. GM plant 4.2. Food safety expressed substances (toxicity & allergenicity); compositional analyses; evaluation of metabolites; food processing; nutritional modification

11 Commercial release Molecular assessment Single copy of each gene Stability of integration Develop protocol (usually PCR) to detect the event Expression analysis Lab & Greenhouse

12 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 phosphorous Minerals e.g. Ca, P, Mg, K, Na, Cl, S, Cu Examples of analytes for food and feed safety Acid and neutral detergent fibre Crude fibre Ether extract Amino acids Ether extract Nitrogen-free extract - - Minerals - - Crude fibre Ether extract Acid and neutral detergent fibre

13 LIKELIHOOD ASSESSMENT ENVIRONMENTAL RISK ASSESSMENT context risk hypothesis hazard pathways to harm harm risk estimate 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 13

14 BACKGROUND: SOCIO-ECONOMIC IMPACTS 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 restrictions Individual countries to decide 3

15 SOUTH AFRICA 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 socioeconomic impact that the introduction of a genetically modified organism may have on a community living in the vicinity of such introduction. 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; 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. 3

16 3 TOWARDS DEVELOPING SEIA FRAMEWORK

17 TOWARDS DEVELOPING SEIA FRAMEWORK Example: Ex-ante assessment of SEIA of Bt Maize 10

18 TOWARDS DEVELOPING SEIA FRAMEWORK Example: Ex-ante assessment of SEIA of Bt Maize (contd) 10

19 CHALLENGES Socio-economics not adequately defined Many approaches to assessing socioeconomic impact assessments Data requirements, measurable criteria & thresholds Appropriate experience for conducting socio-economic impact assessments is lacking 10

20 CONCLUDING REMARKS Sustainability balances environmental safety, food and feed safety, and socio-economic impacts Socio-economic Impact Assessments i. is highly complex ii. is context dependent Proactive AND Inclusive Systems Approach 3

21 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 More general communication 21

22 THE ACCEPTANCE OF GMO FOODS % Outright support Risk tolerant Oppose Gene therapy Pharmacogenetics GM Food Nanotechnology Source: Eurobarometer 2006 Background People s beliefs about risk are shaped by their core values education alone is not enough. The credibility of the source of information is very important even balanced views can be polarizing. No one is any longer seen as independent or unbiased. The risk / benefit ratio Tangible benefits need to reach the end consumer. Sustainability one of the keys Credible biosafety data and products that benefit targeted communities. Ethical considerations should exceed legal requirements. 22

23 ASSESSING THE RISKS OF A CONTROVERSIAL TECHNOLOGY February 2011 GM Glyphosate Toxic Chemicals in 5% of non-pregnant found in pregnant women at women 73.6ng/ml. and fetuses! 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] 23

24 COMMUNICATION VS. THE GMO DEBATE The nature of the GMO debate o Worldview/dogma perspective (NOT facts ). determines 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 nonfact based rhetoric and it doesn t evolve. 24 In contrast a strategic communications plan should focus on: o Increase awareness and engage with all stakeholders. o Build strategic relationships, e.g. with regulators. o Solicit support and build confidence. o Pre-empt potential difficulties and manage them pro-actively. o Ensure GM discussions are fact-based.

25 Thank You! 25 Dr Hennie Groenewald