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‘Taxonomy of Risks and Risk Assessment’
Ries de Visser (PRI – Wageningen UR)
Partners: PRI, UCM, ATO, Dupont 6.5 person month Nov. ‘03 - May ‘04
BREW – Plenary Meeting Jan. 2004
WP4 - Taxonomy of Risks and Risk
Assessment Objectives Prepare a taxonomy of risks (Part of ‘Generic Strategy’*) Make a risk assessment of a process covered by BREWUse of available knowledge + identification of gaps (input by
partners!)
Final product A 25-page report (in prep.) Contribute to overall evaluation
*: e.g. Wilkinson ea 2003 Trends in Plant Science 8: 208-212
Inspiration
“White Biotech will make Chemistry Green”*
www.EuropaBio.org; OECDJoop van der Laan, Genencor Ltd, Leiden:
Biorefineries
Maize dextrose + E.coli with 26 gene modifications 1,3-propanediol Polyester ‘Sorona’ by DuPont
* Van ‘t Hoog 2003 (‘Bionieuws’ article - August 29)
WP4 - Taxonomy of risks– Generic
strategy Lessons
Nuclear Energy Debate Rachel Carson’s ‘Silent Spring’ - pesticides Social debates – GM food
Generic framework Risk identification: experts
• Chemistry, Biotechnology, Ecology, …..• Social sciences, Humanics
Risk communication: actors Risk assessment: experts ↔ actors
(incl.regulators) Risk management: actors
WP4 - Taxonomy of risks– Lessons General
Acceptance or rejection based on judgement
Judgement depends on philosophy of life and requires knowledge
Outcome GM food debateLack of knowledge on risks of
biotechnologyDifferent interpretations of available
knowledge
WP4 – 1. Taxonomy of Risks
Terminology & definitions Approach
Inventory of knowledge (gaps) about risks Questions – Nat. Adv. Committees (e.g. UK:
ACER; NL: COGEM; International: OECD) Decision trees
Risk T & A - Terminology & definitions Bulk Chemical, Biotechnology : see WP
1 Potential Effect - Risk or Benefit : WP 4, 5 Effect, impact, chance; hazard, danger : WP 4, 5 Perception (philosophy, values, interests): WP 5
Natural Sciences: Risk = Hazard x Chance (anal.: Benefit)
Social Sciences: Perceived Risk = Risk x Weighing factor-Actors
Politics: Benefit-Risk Balance = -Perceived Risks + Perceived Benefits
WP4, Risks: actors
Chemical companies Biotechnology companies Scientists Farmers organizations Processing industry Retailers Consumer organizations NGO’s Government
WP4 – Risks Values-
Stakeholders Food allergies health-public, market-company
Non-food Invasiveness biodiversity,
society Gene flow, out-crossing biodiversity, farmers Non-target effects (insect resistance)
biodiversity Crop diseases farmer, industry
Risk & Actor: Crop diseases and the
farmer
leaf necrosis
transgenic trA
transgenic trB
Wildtype W
transformed
tr-
trA
trB
W
tr
WP4 – Risk taxonomies in the
literature Direct/indirect effects of GMO’s (Hails 2002) Natural Science / Public Perception (e.g.
Slovic 2002, Vlek 1996) Non-GM ‘baseline’ / GM – Comparisons (e.g.
‘Agrogen’ scenario study; long-term field studies)
Decision tree
Question 1
Stop or redirect development
Question 2
Question 3
Question 4
Question 5Continue
Decision trees - levels
Molecular Organism Ecosystem
Human society - health, economy, etc.,
Baseline, conventional risks GMO risks
INPUT from legal supervising boards, biological safety boards, . . . . . .?
Decision trees: assumptions and
questions1. Assumptions Transposition does not occur in the crop
species concerned, or at a very low frequency The databases used contain reliable
information Effects of gene stacking do not occur
Decision trees: assumptions and
questions2. Examples of questions
A. Risks at Gene/construct level Is transgene expression stable during vegetative and
generative development of the GM? If no then STOP further development
Are any genes present in the construct that are coding for products like allergens or toxins which are harmful to people and/or animals? If ‘yes’ then STOP
other questions: metabolic side-effects; antibiotic resistance present?
B. Risks at Organism level
C. Risks at Ecosystem level
Decision trees: 2. examples of
questionsB. Risks at Organism level
Are the wildtype and/or wild relatives of the GM organism indigenous in NL and/or EU?
• Cases: oilseed rape, sugar beet, • Non-cases: maize
Is outcrossing of the GMO possible with a wild relative? (sub-questions on occurrence of flowering, pollen dispersal, pollination of non-GMO; are the hybrid seeds formed viable and fertile?)
Others, e.g. re: overwintering parts, Horizontal Gene Transfer, parts or ingredients used for feed or food?
Decision trees: 2. examples of
questionsC. Risks at Ecosystem level
Is production of the GM crop possible in many places, such that isolated areas might be used?
Can negative effects on (agro-)biodiversity be expected which differ from the case of production of non-GMO’s?
Are negative effects known or expected on non-target and/or protected plant or animal species?
Or on: food webs, soil flora & fauna, soil quality, greenhouse gas emissions?
2. Risk assessments - CASES Tools: generic approach, decision trees
Questions: ‘Need to know’ or ‘Nice to know’?
Case proposed: Potato starch ~starch value chain ~range of important platform chemicals
(glucose organic acids, PLA) ~much knowledge available
Output: Matrices
STARCH VALUE CHAIN FOR CHEMICALS
CRD/BB/Starch Value Chain for Chemicals - 10/03
Renewable Raw Materials (maize, wheat, potatoe, …)
Vegetable Proteins
Proteins based plastics
Starch
Glucose
Sorbitol
Isosorbide
PU
Ascorbic acid
PTT
Propane Diol
Other polyols (mainly for food markets
today)
MaltitolMannitolXylitol
ArabitolErythritol…
Cyclodextrines
Modified Starches
Organic acidsErythorbic acid + salts
Oxalic acid + salts
Lactic acid + salts
Succinic acid
Fumaric acid
Glucuronic acid
Arabinonic acid
Itaconic acid
Citric acid + salts
Lactate esters
PLA
Malic acid
Glucaric acid
Thermoplastic starches
Polyhydroxyalcanoates
Alkylpolyglucoside
Alkylmethylglucamide
Methylglucosideesters
Glucamine
Sorbitan esters
Dibenzylidenesorbitol and der.
Polyesterpolyols
Isosorbide esters
Dimethyl isosorbide
Polyethylene Isosorbide Modified Terephtalate
Thermo setting resins
PEIT
Current bulk productions
Productions on large pilote scale
Productions to be evaluated
Gluconic acid + salts
C = chemical process
B = biotechnological process
C
B
B
B
B
B
B
BC
C
C
C
C
C
C
C
C
C
B
C
B + C
C
C
EthanolC2 chemistry…
ETBE, fuel
BB
C
C
2 cetogulonic acid
C
Biomass Ethanol AceticAcid
Ethylene
VAM
Ethyl acetate
PVAc+ co-polymers
EVA
PVOH
EVOH
Platform green chemical 2nd derivative green chemical 3rd derivative green chemical
SugarsStarchLigno-Cellulose
Capacity >35 mtpaOutput 29.4 mtpa
Capacity 110 mtpaOutput 94 mtpa
Capacity 8.2 mtpaOutput 6.5 mtpa
Capacity 4.8 mtpaOutput 4.1 mtpa
Output ~ 1 mtpa
Output 0.1 mtpa
Output 1.3 mtpa
Output 0.3 mtpa
Output ~ 2.3 mtpa
Risk Assessments – Criteria for choice of
cases Minimum confidentiality (Industry interests; EU-report, etc.)
High scientific quality Large availability of data on
organism’s biology environmental impact, use of natural resources stakeholder perception
Potentially large impacts (positive, negative) on industry, economy, society, nature, environment
Contributes to a clear picture significance of GMO applications to sustainable chemistry
and agriculture, technological progress and environmental protection, as compared to non-GMO applications;
support the public debate on the use of GMO’s .. .. .. (suggestions invited).
Risk areas:
Human Society Environment Post harvest
Heal th Acceptance Economics Gene CropPhysiology/
Biochemistry
Agro-ecosystem
Process Product
Risks-instability of expression-metabolic side effects
-gene flow-non-targets
-HGT
-allergies-toxicity
?
??
+?
?
??
??
??
+
??
??
?
??
?
??
?
?
??
Matrix of risk assessment: Potato crop
WP4 Workplan rough assessments- starting
points Risks only (benefits in other WP’s) Sources of risks: legal supervision boards, stakeholders and literature Taxonomy, form: decision trees of questions [YES/NO]
Three catagories of production systems Enzymatic systems (indoor; no living organisms present; leakage; prions?) Fermentor systems (indoor; bioreactors, living organisms, may evolve,
adapt, and/or escape) Crop systems (outdoor; free-living organisms; dispersal, gene flow).
One case, i.e. one bulk chemical, per production system category One biotechnological type per case: GM compared to non-GM
Separate the effects of GMO’s (scientific method) from the stakeholder perceptions of these effects.
WP4 Assessment of Risks -
Workplan Table: Risk assessment using decision trees based on level of
biological organization, applied to specific process cases (with/without GMO).
Risk assessment Biotechnological Decision tree
Bulk Chemical Production – CASES
(level of environmental exposure) (number of risks) A
Enzymatic
GM | non-GM
B Fermenter
GM | non-GM
C Field Crop
GM | non-GM
“Gene/construct effects”
YES
YES
YES
“Organism effects” -- YES YES
“Ecosystem effects" -- -- YES
WP4 - Risk Assessment -
processes Enzymatic
Few risks involved (which? Info sources?)
Fermentor E. coli (1,3-propanediol from maize dextrose) Baker’s yeast (bio-ethanol, ….) Lactobacillus (lactic acid) . . . (suggestions invited)
WP4 - Risk Assessment (Field
Crops)Proposed CASE (existing material; field-tested)
1. Potato with 100% amylopectin (amylose-free) !
2. Maize or potato for dextrose production ?3. Oilseed rape with a high fructan content ??4. Sugar beet with a high fructan content ???
Risk example: Side-effects of Metabolic
Changes
Risk is proportional to distance
from pathway’s end-product
Primary Carbon Metabolism Hexoses
Secondary Metabolism End-product
Intermediates
1
2 3
4
5
? ?
High risk
WP4 - Risk Assessment - Crop
process
Fructan beet cv - GM sugar beet Benefits: sustainable production of biochemicals
Risks: gene flow / ‘genetic pollution’, acceptance
Amylopectin potato cvs - (non-)GM potato Benefits: sustainable production of bioplastics Risks: non-GM: ??
GM: gene flow, HGT, public acceptance
Contributions by partners (to be discussed)All: - Development of (parts of) risk taxonomy
(regulations, both for GM- and non-GM systems?)- Choice of a bulk chemical production cases for risk assessments (criteria?)
PRI – Cell and Crop physiology and biochemistry, gene constructs, biointeractions, agro-ecosystems, data from multi-stakeholder project ‘Agrogen’ (4.5 person-months)
UCM – (Risks of) Biotransformations, esterifications (1.5 p-m)
ATO – Processes and Risks of Bioreactor/ Fermenter systems, PHA, bio-ethanol scale problems (0.3 p-m)
DuPont – Production processes? Scale problems (0.2 p-m)
WP 4 - ‘Taxonomy of Risks and Risk
Assessment’
Time schedule
Inputs from WP 1, 2 and 3 welcomed:Aug. ’03 - Biotechnological production processes selectedSept. ’03 - Technical & economic characteristicsJan. ’04 - Environmental assessments
Oct./Nov. ’03 - Start main work in WP 4
Dec. ‘03 - Interim report (behind schedule)
Jan. ’04 - 2nd Plenary Meeting Preliminary outputs (report) to WP 7 and 8
May ’04 - End report WP 4
WP 4 - ‘Taxonomy of Risks and Risk Assessment’