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Current risk assessment approaches for
environmental and food & feed safety
Jeffrey D Wolt
Iowa State University
OECD Geno...
Plan of presentation
• History of risk and safety assessment approaches for
GEOs/GMOs
• Current application of risk and sa...
Key foundational documents
• OECD (1986) rDNA safety considerations “Blue Book”
• WHO (1991) Strategies for assessing the ...
Technical information
• CAC (2003a) Principles for the risk analysis of foods derived
from modern biotechnology (CAC/GL 44...
Key foundational documents
• OECD (1986) rDNA safety considerations “Blue Book”
• WHO (1991) Strategies for assessing the ...
Risk analysis context
• Risk assessments for rDNA organisms are in principle no
different than for traits developed throug...
Underlying scientific principles
• No new risks
• environmental impacts similar in principle to introductions
of existing ...
Paradigm for risk/safety assessment
• Proceeds from an established baseline
• Involves characterization of
• the organism ...
Comparative risk
• Risk/safety is understood by comparison to what is familiar &
that which has a history of safe use
• In...
Risk to the environment
• Caution regarding “premature” implementation of guidance
for emerging technology
• Management pr...
Safety of food for human consumption
• Demonstrates reasonable certainty that no harm results from
intended uses under the...
Current application of risk/safety assessment
to GEOs/GMOs
• OECD/WHO/Codex provide a RA/SA paradigm & sound
scientific gu...
Spiraling study complexity
unrelated to probable harm
OECD Genome Editing 28-29 Jun 2018
The problem of 2nd order risk
• Risk of the risk/safety assessment being wrong
• Miss a significant risk
• Overanalyze a n...
A need for sound problem formulation
• “review of potential risks should be conducted on a case-by-
case basis, prior to a...
Implications for RA/SA of genome edited
plants
• No new risks
• deep experience with assessing traditional, mutational,
an...
Implications for RA/SA of genome edited
plants
• Problem Formulation
• Use risk analysis that implements sound problem for...
Summary points –
Historical risk/safety assessment paradigm
• GEOs/GMOs as a class do not represent new risks relative
to ...
Summary points –
Risk/safety assessment current practice
• OECD/WHO/Codex describe a workable RA/SA paradigm &
sound scien...
Summary points –
Risk assessment for genome edited plants
• No new risks
• Explicit problem formulation guides the need fo...
Current risk assessment approaches for
environmental and food & feed safety
Jeffrey D Wolt
Iowa State University
OECD Geno...
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Current risk assessment approaches for environmental and food & feed safety - Jeffrey Wolt

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This presentation highlights the history of risk and safety assessment approaches for GEOs/GMOs, the current application of risk and safety assessment approaches for GEOs/GMOs and the Implications for emerging applications of genome editing and their assessment.

Published in: Environment
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Current risk assessment approaches for environmental and food & feed safety - Jeffrey Wolt

  1. 1. Current risk assessment approaches for environmental and food & feed safety Jeffrey D Wolt Iowa State University OECD Genome Editing 28-29 Jun 2018
  2. 2. Plan of presentation • History of risk and safety assessment approaches for GEOs/GMOs • Current application of risk and safety assessment approaches for GEOs/GMOs • Implications for emerging applications of genome editing and their assessment OECD Genome Editing 28-29 Jun 2018
  3. 3. Key foundational documents • OECD (1986) rDNA safety considerations “Blue Book” • WHO (1991) Strategies for assessing the safety of foods produced by biotechnology • OECD (1993a) Safety considerations for biotechnology: scale-up of crop plants • OECD (1993b) Safety evaluation of foods derived by modern biotechnology: concepts and principles • OECD (1993c) Traditional crop breeding practices • WHO (2000) Safety aspects of genetically modified foods of plant origin OECD Genome Editing 28-29 Jun 2018
  4. 4. Technical information • CAC (2003a) Principles for the risk analysis of foods derived from modern biotechnology (CAC/GL 44-2003) • CAC (2003b) Guideline for the conduct of food safety assessment of foods derived from rDNA plants (CAC/GL 45- 2003) • OECD Harmonization of Regulatory Oversight in Biotechnology Consensus Documents • OECD Safety of Novel Foods and Feeds Consensus Documents • CBD (2016) Guidance on risk assessment of living modified organisms (UNEP/CBD/BS/COP-MOP/8/8/1) OECD Genome Editing 28-29 Jun 2018
  5. 5. Key foundational documents • OECD (1986) rDNA safety considerations “Blue Book” • WHO (1991) Strategies for assessing the safety of foods produced by biotechnology • OECD (1993a) Safety considerations for biotechnology: scale-up of crop plants • OECD (1993b) Safety evaluation of foods derived by modern biotechnology: concepts and principles • OECD (1993c) Traditional crop breeding practices • WHO (2000) Safety aspects of genetically modified foods of plant origin OECD Genome Editing 28-29 Jun 2018
  6. 6. Risk analysis context • Risk assessments for rDNA organisms are in principle no different than for traits developed through traditional breeding • Safety assessment of any new organism relies on knowledge of the parent and differences from the parent • “There is no scientific basis for specific legislation for the implementation of rDNA techniques and applications.” OECD Genome Editing 28-29 Jun 2018 OECD, 1986
  7. 7. Underlying scientific principles • No new risks • environmental impacts similar in principle to introductions of existing species & their agricultural applications • direct & indirect effects are relevant concerns for traditional plant breeding • evaluate incremental risk associated with GEOs/GMOs • Potential environmental impacts • non-target species; ecosystem function; responses of species to each other & to their environment • Unexpected adverse impacts often a low specific concern • weediness, secondary metabolites & protein toxins in food/feed, wide area monoculture • assess as for conventionally bred crops OECD Genome Editing 28-29 Jun 2018 OECD, 1986
  8. 8. Paradigm for risk/safety assessment • Proceeds from an established baseline • Involves characterization of • the organism & its environmental release (in a way amenable to probabilistic approaches) • establishment & persistence in the environment • human & ecological effects (analyzed in principle through existing methods) OECD Genome Editing 28-29 Jun 2018 OECD, 1986
  9. 9. Comparative risk • Risk/safety is understood by comparison to what is familiar & that which has a history of safe use • Incremental risk is established relative to a baseline of plants/derived foods from traditional plant breeding • Familiarity & Substantial Equivalence • ways to establish a risk analysis baseline for determining whether/to what extent risk/safety assessment is needed • substantial equivalence is not a safety assessment per se • represents a method for hazard identification to determine safety assessment needs • uses baseline history of safe use OECD Genome Editing 28-29 Jun 2018 OECD, 1993a; WHO, 2000
  10. 10. Risk to the environment • Caution regarding “premature” implementation of guidance for emerging technology • Management principles guide initial field releases, but do not infer risk • Subsequent risk assessment • proceeds from the concept of familiarity • is case dependent • uses a stepwise approach • reflects knowledge of the crop, its environment, the trait and their interactions • comparative assessment to identify incremental risk OECD Genome Editing 28-29 Jun 2018 OECD, 1986; 1992; 1993a
  11. 11. Safety of food for human consumption • Demonstrates reasonable certainty that no harm results from intended uses under the expected conditions of consumption • Recognizes a ‘history of safe use’ of traditional foods as the benchmark for the comparative safety assessment • Uses an integrated and stepwise, case-by-case approach … • And “comparative determination of similarities and differences between the genetically modified food and its conventional counterpart” • Involves targeted evaluations, rather than conduct a standard battery of toxicological tests OECD Genome Editing 28-29 Jun 2018 OECD, 1993b; WHO, 1991
  12. 12. Current application of risk/safety assessment to GEOs/GMOs • OECD/WHO/Codex provide a RA/SA paradigm & sound scientific guidance which are internally consistent • Implementations within various regulatory regimes often depart from the spirit of this guidance • scientific guidance must be applied within the legal, social, & political constraints of a given regulatory regime • Regulatory implementations of the RA/SA paradigm have skewed to increasingly complex portfolios of studies rather than adhering to analysis which is formulated to fit the risk/safety questions relevant to a given case OECD Genome Editing 28-29 Jun 2018
  13. 13. Spiraling study complexity unrelated to probable harm OECD Genome Editing 28-29 Jun 2018
  14. 14. The problem of 2nd order risk • Risk of the risk/safety assessment being wrong • Miss a significant risk • Overanalyze a non-significant risk • Current knowledge suggests over-analysis of non-significant risk for GEOs/GMOs • Expectation of low probability for incremental risk above the baseline of traditional plant breeding • Reasonable certainty of no harm from 2+ decades of environmental deployment & occurrence in foods/feeds • No significant or unexpected harms shown in RA/SA of products released to date OECD Genome Editing 28-29 Jun 2018 OECD, 1986; EC, 2010; Nicolia et al., 2014; Pellegrino et al., 2018
  15. 15. A need for sound problem formulation • “review of potential risks should be conducted on a case-by- case basis, prior to application. Case-by-case means an individual review of a proposal against assessment criteria which are relevant to the particular proposal; this is not intended to imply that every case will require review by a national or other authority since various classes of proposals may be excluded” (OECD, 1986). • Stepwise • Case-by-case • Comparative baseline • Developed from product history of safe use and familiarity • Uses substantial equivalence as a “a starting point from which to structure a program to demonstrate any potential differences from the comparator which, if detected, can be evaluated in terms of safety” (WHO, 2000). OECD Genome Editing 28-29 Jun 2018
  16. 16. Implications for RA/SA of genome edited plants • No new risks • deep experience with assessing traditional, mutational, and molecular breeding • Substantial interesting science questions • improved efficiency & specificity of targeted mutations • Science questions (nice to know) are not necessarily regulatory questions (need to know) • At this stage of technology development, risk management may be more effective than risk assessment • science governance mechanisms can assure best practices in gene editing design, null sergeant selection, process definition & product characterization • Avoid conflating risk management with risk assessment OECD Genome Editing 28-29 Jun 2018
  17. 17. Implications for RA/SA of genome edited plants • Problem Formulation • Use risk analysis that implements sound problem formulation to guide the need for and nature of risk/safety assessments. • Flexibility • Accommodate new knowledge in risk analysis framework • Risk analysis framework – a process map, not a list of actions/studies • Avoid genome-wide assessments as a risk paradigm • Insufficient reference genomes for comparative assessments • Plant genome plasticity – signal to noise limits • The process-product conundrum • Scientific RA/SA for plants/derived foods (product focus) • Regulatory constraints may argue otherwise (process focus) OECD Genome Editing 28-29 Jun 2018
  18. 18. Summary points – Historical risk/safety assessment paradigm • GEOs/GMOs as a class do not represent new risks relative to products of traditional plant breeding • products of traditional plant breeding have an established “history of safety use” • incremental risk of the GEO/GMO is considered on a stepwise case-by-case comparative basis • existing crops and derived-foods serve as the comparative baseline • targeted evaluations should key to identified hazards/reasonably anticipated harms OECD Genome Editing 28-29 Jun 2018
  19. 19. Summary points – Risk/safety assessment current practice • OECD/WHO/Codex describe a workable RA/SA paradigm & sound scientific guidance which are internally consistent • Problem formulation is implied but explicit application is lacking • Techniques for risk/safety evaluation are emphasized over processes for risk analysis to identify what needs evaluation • Increasingly complex dossiers of studies vs. risk analysis commensurate with recognized hazards/reasonably anticipated harms • Regulatory disconnects in intent vs. application of guidance OECD Genome Editing 28-29 Jun 2018
  20. 20. Summary points – Risk assessment for genome edited plants • No new risks • Explicit problem formulation guides the need for/nature of a subsequent risk/safety assessment • Process considerations may inform the problem formulation, but product considerations drive the risk/safety assessment • Safety and progress of emerging technologies may benefit more from scientist-driven risk management practices than from risk assessments per se … • But the determination to manage an emerging technology should not be conflated with the likelihood of harm OECD Genome Editing 28-29 Jun 2018
  21. 21. Current risk assessment approaches for environmental and food & feed safety Jeffrey D Wolt Iowa State University OECD Genome Editing 28-29 Jun 2018 Thank You

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