‘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’