external directorial board - nanocalibrate · guillaume flament, claire skentelbery and maite del...

caLIBRAte Risk models testing

Project #686239, Funded by the Horizon 2020 Framework Programme of the European Union

caLIBRAteUser testing sessions on next generation decision-making tools

for risk governance of nanomaterials

THE STOFFENMANAGER NANO AND LICARA NANOSCANMarch 15th, 2018 -13.00 CET

Organizers and presenters:

Andrea Porcari and Elisabetta Borsella, Italian Association for Industrial Research (Airi),

Guillaume Flament, Claire Skentelbery and Maite del Corte,

Nanotech Industry Association (NIA),

Remy Franken, Thies Oosterwijk, TNO – Innovation for Life

Keld Alstrup Jensen, National Research Center for the Working Environment (NRCWE)

The webinar will start at 13.00


Agenda

• Welcome (13.00)

• Andrea Porcari, Introduction to caLIBRAte

• Remy Franken, Stoffenmanager Nano: introduction and case study

• Question & Answers

Webinar break (14.15-14.30)

• Thies Oosterwijk, LICARA nanoSCAN: introduction and case study


• Concluding remarks (15.30)

Moderator: Guillaume Flament


Get insights on state-of-the-art activities on risk governance of NM

Have practical info and tailored suggestions on how to use the models in your daily working activities

Give your views and needs on how to further improve the models, and design the caLIBRAte System of Systems

Why the webinars on risk models testing


Who are we

▪ Coordinator: NRCWE (KA Jensen)

▪ 24 (+1) Partners

– 21 from Europe (2 Switzerland)

– 2 from USA

– 1 from South Africa

– 1 from Canada

▪ Budget ca. 10 Mio € – ca. 8 Mio € from the EC

▪ Duration: May 2015 to Oct 2019

Green Decisions

DIALOGIK

University of

Helsinki

Health

Canada

https://upload.wikimedia.org/wikipedia/commons/1/14/BlankMap-World-large.png


The challenges

▪ Use of manufactured nanomaterials continue to grow

▪ The risk analysis is still technically and methodologically limited, and lacking robust sources of quantitative data

▪ Uncertainties in the safety of nanomaterials are seen by stakeholders as a major limitation to market

▪ Rising demand for improved (risk and innovation) governance approaches, to:

– Inform and support researchers toward safe design of nano-related products

– Facilitate decision-making on risk uncertainties (comparative, qualitative, precautionary …)

– Support compliance with regulatory frameworks

– Provide homogenous rules for safe management of NM


The goals of caLIBRAte

Establish a versatile, nano-risk governance framework

for assessment and management of human and environmental risks of

manufactured nanomaterials (MN) and MN enabled products

➢ Approach (highlights):

• Harvesting and implementing results from state-of-the-art research on risk

governance (risk assessment, management and communication)

• Develop, improve, integrate nano-specific models and methods into a system-of

systems (SoS)

• Support decisions along the R&I value chain, from basic research to market launch.

➢ Target: research organizations, companies, insurers authorities and other stakeholders

involved in research, prioritization and management of occupational, consumer and

environmental risks of NM

➢ Ambition: quality and trust in the caLIBRAte framework models will exceed the current

level of most existing REACH tools.


Decision-making along the R&I value chain

Idea

screen

Gate 1

Scoping

Screen

Gate 2

Go to

development

Gate 3

Go to test

Gate 4

Go to Launch

Gate 5

Post-Launch

review

Gate 6

Dis

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ry

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d id

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s

Sc

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ing

Sta

ge

1

Bu

ild

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s c

as

e

Res

ea

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an

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de

ve

lop

me

nt

Te

sti

ng

an

d V

ali

da

tio

n

La

un

ch

Ho

rizo

n

Sc

an

nin

g/

Mo

nit

ori

ng

Cooper Stage-Gate® Idea to launch model

Safety?

Add Risk assessment & management to the Stage-Gate decision process

material, product and safety knowledge


Where are we in caLIBRAte?

Existing modelsUser-friendliness

Sensitivity

calibrationperformance

New ModelsUser-

friendliness

Sensitivity

calibration

SoS Framework demonstration


The testing of the (existing) risk models

Models and applicationdomains

Workers(labs)

Workers(All)

Users &Consumers

Environment

Waste/end-of-life

All Life Cycle

Stoffenmanager Nano ✓

LICARA nanoscan ✓ ✓ ✓ ✓

Swiss Precautionary Matrix ✓ ✓ ✓ ✓

GUIDEnano ✓ ✓ ✓ ✓

Nanosafer CB ✓

Control banding nanotool ✓ ✓

SimpleBox4Nano (SB4N) ✓ ✓ ✓

SUNDs ✓ ✓ ✓ ✓


Agenda

• Welcome (13.00)









Stoffenmanager Nano 1.0

Remy Franken & Thies Oosterwijk


Exposure measurements are complex and therefore expensive and time-consuming

• Control banding / Risk banding: first Tier for qualitative risk assessment => Work in progress…

Assists producers, formulators and end users to prioritize health risks of working with MNO

• Hazard x Exposure = Risk Applicability domain:

• Only inhalation exposure• All types of MNO and all processes with MNO• Workers only

Education (PIMEX, good practices), community portal Result: Freely available IT-tool for prioritizing nano-specific risks

August 10, 2011

Wouter Fransman


Stoffenmanager Nano 1.0: Hazard banding

Stoffenmanager

Non-Nano

Nano

Hazard band

E

C

D

B

A

Soluble

Insoluble

Persistent

Fibers

Other MNO

Indication for

C (-M); R; T+

Indication for

M (+C); S

Harmful /

irritant

Low-

hazardous

profile

T / causes

burns / resp.

irritation

Unknown

Classification

based on data

MNO or their

parent

materials

Stoffenmanager Nano 1.0: Hazard banding

E

C

D

Hazardous

properties

unknown

E

D

Parent material

classified for CMRS?

no

yes

MNO included in

the list of most

widely used

MNO’s?

no

Expert judgment,

based on data

available and primary

particle size

yes

< 50 nm?

Stoffenmanager Nano 1.0: Exposure banding

Source domains (Schneider et al., 2011)

1. Point or fugitive emission during the production phase prior to harvesting the bulk material

2. Handling and transfer of bulk powdered MNO

3. Dispersion of (solid or liquid) intermediates or ready-to-use MNO-containing products

4. Activities resulting in fracturing and abrasion of MNO-containing end products

Stoffenmanager Nano 1.0: Exposure banding

Source Receptor

Emission

- Product

- Activity

Transmission

- Local control

- Ventilation

Immission

- Personal enclosure

- PPE

Input parameterse.g.: activity, dustiness powder, concentration

liquid, local controls

ModelBased on source-receptor approach (Schneider et al.

2011)

Multiplier Exposure band4 categories

Stoffenmanager Nano 1.0: Risk banding

Hazard band

Exposure band

A B C D E

1 3 3 3 2 1

2 3 3 2 2 1

3 3 2 2 1 1

4 2 1 1 1 1

Future plans: Stoffenmanager Nano 2.0

Exposure banding• Include semi-quantitative exposure values for benchmarking• Include different values for different size classes

Hazard banding• Hazard assessment based on phys/chem properties

Towards a quantitative risk assessment

Input from Calibrate project

Case study: Production of MWCNT

Production of MWCNT for the use of fuel cell batteries

Synthesis process through chemical vapor condensation, assumed pure product

Setting is a pilot plant Duration of the process is ~2 to 4 hours once a week 1 operator present


Agenda

• Welcome (13.00)









LICARA NANOSCANA tool for the self-assessment of benefits and risks of nanoproducts

Thies Oosterwijk, Remy Franken

LICARA PROJECT

Life Cycle Approach and human Risk Assessment, product stewardship

and stakeholder risk/benefit communication of nanomaterials

Aims to develop an approach for SMEs to assess over the life cycle

the human and environment risks

and the economic, environmental and social opportunities.

LICARA NanoScan

PRESENT SITUATION ON NANO TECHNOLOGY

DEVELOPMENT WITHIN SME’S

Nano products provide benefits and business opportunities

However, the possibility of human and environmental risks

may spoil the party

It is (too) difficult and costly to assess these risks

Risk Assessment and Life Cycle Assessment are complex

and costly to perform

data are scarce and if available highly uncertain.

it is difficult to “repair” data gaps

LICARA NanoScan

NEED TO SUPPORT SME’S ON DECISION MAKING IN

UNCERTAINTY ON NANO PRODUCT DEVELOPMENT

Including both benefits and risks

Translating present available scientific knowledge into understandable

information

Tapping on specific know-how of SMEs

To sketch the pros and cons of a nanoproduct in relation to a

conventional product and over the full life cycle

LICARA NanoScan

NEED TO SUPPORT SME’S ON DECISION MAKING IN

UNCERTAINTY ON NANO PRODUCT DEVELOPMENT

Qualitative / semi-quantitative giving the fact that little quantitative data

is available with high uncertainties

Using existing tools

Helps users to show possible benefits of their innovation using

nanomaterials

Based on tool output, users can anticipate potential risks of their

innovation

LICARA NanoScan

LICARA NANOSCAN IN CALIBRATE WP2

Tool objectively scored high for early stages of innovation (stage 2 and

3)

Tool fills data gaps with default worst-case choice

LICARA NanoScan

LICARA NanoScan

Conceptual framework on nano benefits and risks

3. Societal benefits

7. Decision support

1. Environmental benefits

4. Public health & environmental risks of nano

5. Occupational health risks of

nano

6. Consumer health risks

of nano

0. Nanoproduct and legislation

2. Economic benefits

NanoRiskCatStoffenmanager

Nano

Stoffenmanager

Nano

Precautionary

Matrix

Precautionary

Matrix

LICARA NanoScan

Risks

Public health & environmental

System knowledge

Potential effect

Potential input environment

Occupational health

Exposure potential

Hazard

Consumer health

Exposure potential

Exposed population

Hazard

Benefits

Environmental

Manufacturing

Use

End-of-life

Economic

Market potential

Profitability

Development stage

Societal

Technological breakthrough

Highly qualified labour

Global health or food

SERIES OF QUESTIONS TO FILL IN THE TOOL

LICARA NanoScan

WEIGHED RESULTS

LICARA NanoScan

Example: scratch and corrosion

resistant nano silica coating

APPLICATIONS OF LICARA NANOSCAN

LICARA NanoScan

Competition (opportunity, performance)• Compare products against new developments/product

substitution by competitors• Examine new technologies from competitors and

whether or not to invest in such technology

Market / client (benefit, risk)• Identify customers’

benefits of using nanoproducts

• Support customers in safe and responsible nanoproduct handling

Suppliers (resource analysis)• Check which

nanoproducts perform best and have the lowest occupational health risks

Reflection (internal risk analysis)• Verify whether risks are at the very least counter-

balanced by benefits

CASE STUDY: MWCNTS IN FUEL CELLS

The present case study investigates a PEM fuel cell in which MWCNT

replace carbon black (not nano-sized).

The function of the MWCNT is conducting electricity and act as carrier

for the catalyst.

https://diamonds.tno.nl/licara/

https://nano.stoffenmanager.nl/

LICARA NanoScan


https://nano.stoffenmanager.nl/


Expected benefit

Replacing carbon black with MWCNT leads to an increased surface

available for the catalyst and a significant decrease of the amount of

Platinum.

Together with an increased electric conductivity an increased overall

efficiency can be expected.

LICARA NanoScan


Potential risks:

There is a potential release of MWCNT into the environment during

particle production.

No risks are expected during the use-phase of the fuel cell.

The CNT may end up in a municipal incineration and might be burned

as hazard waste at high temperature.

Platinum is recycled using dangerous chemicals

LICARA NanoScan

THANK YOU FOR YOUR

ATTENTION

Take a look:TIME.TNO.NL


Agenda

• Welcome (13.00)










IMPORTANT!

Test the tool and provide your feedback

Provide your comments in the online user feedback form

Quick feedback just after the webinar

More in depth feedback in case of access and use of the model

Compile the form multiple times, if needed to integrate your comments after use of the tool

https://it.research.net/r/calibrateusertesting

Note: only aggregated data will be made public - data management by Airi

Get access to the models and use it by yourself:

https://nano.stoffenmanager.nl/Default.aspx?lang=en


https://nano.stoffenmanager.nl/Default.aspx?lang=en



Overall opinion on the pros and cons of the tool

Level of usability

Barriers, road-blocks, additional features

Level of accessibility of input and output data

Relevance/usefulness of the functions

Motivation

Feedback form - contents

http://www.nanocalibrate.eu/risk-governance-models

12 questions, tick boxes and open comments, overall max 10-15 minutes compilation time


Calendar of risk models testing

webinars

Scheduled:

• GUIDEnano: February 22

• Swiss Precautionary matrix: March 8

• Stoffenmanager nano and LICARA Nanoscan: March 15

• SimpleBox4Nano: March 22

To be planned:

• Nanosafer CB and Control banding nanotool (April)

• SUNDs (April)

http://www.nanocalibrate.eu/risk-governance-models


Thank you for your participation and active contributions

www.nanocalibrate.eu

[email protected]

external directorial board - nanocalibrate · guillaume flament, claire skentelbery and maite del...

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