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Session 2: Tools and frameworks for product development available
for Safe by Design
SbD and the caLIBRAte Risk Governance Framework and
connectivity to toolsProfessor Keld Alstrup Jensen, M.Sc.; PhD.
National Research Centre for the Working Environment
Lersø Parkallé 105, DK2100 Copenhagen
DENMARK
“iNTEG Risk” Emerging Risk Management Framework
The Stage Gate Innovation Model and the (Emerging) Risk Management Framework
3
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
co
ve
ry
an
d id
ea
s
Sc
op
ing
Sta
ge
1
Bu
ild
bu
sin
es
s c
as
e
Res
ea
rch
an
d
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
Horizon scanning / Early Warnings
Pre-risk assessment
Risk assessmentRisk management
and decisionCommunication and consultation
Monitoring
Context and concernsID of risk scenariosEvaluation
AnalysisCharacterizationEvaluation
ResponsiveInnovation
The Systems-of-Systems Nano-risk (Innovation) Governance Framework
Idea screen Scoping screen Go to development Go to test
Gate 4
Go to launch Post-launch review
Dis
cove
ryan
d id
eas
Sco
pin
g
Bu
ild
b
usi
ne
ss c
ase
Re
sear
ch a
nd
d
eve
lop
me
nt
Te
stin
gan
d v
alid
atio
n
Lau
nch
Ho
rizo
n
Sca
nn
ing
/ M
on
ito
rin
g
Pre-risk assessment
Predictive risk assessment
Safe-by-design
Monitoring
Decision support
Regulatory risk assessment
Gate 1 Gate 6Gate 5Gate 3Gate 2
Technical and safety information levelModel complexity
Mo
de
llin
g
info
rmat
ion
Sta
ge
-gat
ein
no
vati
on
fu
nn
el
Model support and guidance at each Stage-Gate!
Risk Innovation Governance Interface
Decision support tool(SUNDS)
Integrated HRA Integrated Env.RA
HazardModel
ExposureModel
User-specificRisk Radar Tool
Risk mitigation planning & implementation
HazardModel
ExposureModel
Acceptance
Avoidance
Limitation
Transfer
Safety-by-DesignFRAMEWORK
NM PhysChemproperty model
Communication
Intervention
Implementation
Guidances
On a “do what you need” basis SoS risk innovation
(SbD) governance framework
Inhalation riskassessment
Dermal riskassessment
Inadvertent oral riskassessment
Tier 1: Control-banding (qualitative risk assessment)
Tier 2:Basic predictive risk assessment
Tier 3:Quantitative (predictive) risk assessment
Continuous Drop & Rotating Drum
- Dustiness index- Dustiness kinetics
- Spray- Mechanical wear- Mechanical reduction- Leaching
TEDIE.2
data library
-Surface to hand-Surface to glove-Hand to mouth-Hand to perioral area-Glove to perioral area
Inhalation hazard groupingX exposure potential
Inhalation hazard estimateX conservative exposure
model
Data-based hazardX aerosol dynamic model
Dermal hazard estimateX conservative dermal
exposure loading
Ingestion hazard estimateX conservative transfer
efficiency model
1 PROC-USE: Process and Product Use; Data based on Mackevicka and Hansen (2016) and Koivisto et al. (2017) 2 TEDIE: Transfer Efficiencies for Dermal and Ingestion Exposure v. 1.1.3 (provided by IOM). Data are not specific to NM!
PROC-USE1
Release data libraryDustiness
data library
Data-based hazardX NM dermal exposure
loading model
Data-based hazardX NM-specific transfer
model
Dermal risk hazard groupingX exposure potential
Ingestion hazard groupingX exposure potential
/
Tier 0: Risk categorization
Hazard indicatorX Likelyhood of exposure
Hazard indicatorX Likelyhood of exposure
Hazard indicatorX Likelyhood of exposure
Exposure Models
Sign up to become a caLIBRAte tool user testerwww.nanocalibrate.eu
Project #686239, Funded by the Horizon 2020
Framework Programme of the European Union
Stoffenmanager -NanoRisk banding tool
TNO
Tool and its target audience
• Freely available IT-tool for prioritization of nano-specific health risks in occupational settings
• Qualitative assessment of inhalation exposure and related health risk
• Can be used for all types of NOAA and all processes with NOAA
• Assists producers, formulators and end users
• Hazard x Exposure = Risk
• In principle everybody can use the tool
• Knowledge of the processes in the company
• Understanding of risk assessment
www.stoffenmanager.nl – Nano module
August 10, 2011Wouter Fransman
Stoffenmanager Nano 1.0
How it works: hazard x exposure = risk
Stoffenmanager
Non-Nano
Nano
E
C
D
B
A
Soluble
Insoluble
PersistentFibers
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
Hazard assessment
Hazardous properties unknown
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?
How it works: hazard x exposure = risk
Source domains (Schneider et al., in press)
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
Exposure assessment
Model approach
Input parameterse.g.: activity, dustiness powder, concentration
liquid, local controls
ModelBased on source-receptor
approach (Schneider et al., in press)
Multiplier Exposure band4 categories
Source Receptor
Emission
- Product
- Activity
Transmission
- Local control
- Ventilation
Immission
- Personal enclosure- PPE
Stoffenmanager – Nano 1.0: risk prioritization
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
Benefit to the user
• Stoffenmanager-Nano provides insight in relative inhalation health risks caused by NOAA
• Can be used retrospective to find out where controls are needed in which priority
• Can be used prospective to identify likely health risks of new innovations that are not in place yet LICARA Nano SCAN
• For safe by design, prospective use can help to identify possible risks and control them in the design phase, while retrospective use can help to control residual risks, if any.
Future plans: Stoffenmanager-Nano 2.0
• Integrate Stoffenmanager – Nano in Stoffenmanager
• Quantify exposure assessment
• Inclusion of Nano reference Values and OELs
• Towards a quantitative risk assessment
Offer: As part of Calibrate, we offer free training on how to use Stoffenmanager-nano. Interested? E-mail: [email protected]
LICARA Nano Scan
A tool for the self-assessment of benefits and risks of nanoproducts
TNO
The aim of the tool and its target audience
Tool to support SMEs in decision making in uncertainty on nano product development
• Map benefits and risks of a nanoproduct in comparison with a non-nanoproduct over the life cycle
• Qualitative / semi-quantitative, given the fact that little quantitative data is available with high uncertainties
• Using existing tools
• Doing it yourself in a modular approach
• Target audience: experts as well as non-experts
How it works
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 NanoStoffenmanager NanoPrecautionary MatrixPrecautionary Matrix
How it works
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
How it works
Weighed results
Example: scratch and corrosion resistant nano silica coating
The product seems to have no high risks
Further research: Tier 2 LCA and/or RA
SUNDS: LICARA is tier 1 in SUNDS
Applicability in innovation chain
• Clear overview of benefits of an innovation compared to conventional
product and its points of attention facilitates better decision to continue
or not
• Transparent overview of both benefits and points of attention, for
discussions with suppliers, clients, competitors and regulators
Experiences from users
• Time to fill in 4 h
• Easy and quick to use by using drop down menu
• Stoffenmanager (STM) Nano most difficult part to fill in. However, STM nano was regarded as very relevant
• Critical: choice of appropriate reference product
• Higher tier assessment could in some cases improve the risk assessment for worker, leading to a lower risk based on available data and expert knowledge
Finally
➢LICARA nanoSCAN is available for free: https://diamonds.tno.nl/licara//
➢Scientific article: http://www.sciencedirect.com/science/article/pii/S0160412016300575
Toon van Harmelen et al. LICARA nanoSCAN - A tool for the self-assessment of benefits and
risks of nanoproducts, Environment International, 91, 2016, p150–160.
➢Please check www.tno.nl/licara for more information or contact us
➢We are thankful to the whole LICARA consortium, EU FP7, Igor Linkov (expert on
Multicriteria Decision Analysis) and Jürgen Höck (project manager Precautionary Matrix)
Offer: As part of Calibrate, we offer free training on how to use LICARA nano SCAN. Interested? E-mail: [email protected]
Maaike le FeberTNO Netherlands
[email protected]+31 8886 61530
NanoSafer v.1.1
Professor Keld Alstrup Jensen, M.Sc.; PhD.
National Research Centre for the Working Environment
Lersø Parkallé 105, DK2100 Copenhagen
DENMARK
NanoSafer (v. 1.1)www.nanosafer.org
• Aim of tool• Combined Control Banding and Risk Management tool for assessment and
recommended management of the potential occupational inhalation exposure risks associated with production and use of NM.
• Application areas (solids)• Powder handling• Transfer as well as diffuse and point where “process” release rates can be
estimated (e.g., 0.01 wt% )• Pending: mechanical reduction, spray with stable solid ingredients
• Intended users• Occupational Safety Manager/Worker representatives (own nanospecific
workplace safety assessments)• Authorities/Inspectors (assessing adequacy of risk management measures;
basis for industry-inspector dialogue) • Consultants (risk assessment and management services)
Information requirements and work-flow
Hazard assessment paradigm
Grouping and scaling of hazard potential basedon physico-chemicalproperties, OELs of analogue materials and their H/R-sentences or the nanospecfic OEL (OELnano) if it exists
CNF
QNF
Ei
QFF,in
QFF,out
V1,in
V1,out
CFF
Exposure assessment paradigm
nano
AcuteAcute
OEL
CEXP
2
nano
hourhour
OEL
CEXP
88 nano
nanoSSA
OELOEL
130
ECEL Library
Inspiration tools
Material data Hazard data Work Process Assessment E-learning Manual
NanoSafer v. 1.1 welcome: user logout
MaterialInformation
HazardInformation
Work ProcessInformation
Control BandingAssessment
Material and Scenario library
Assessnano-hazard
Assessexposure level
Introduction to control Hierarchy
Inspiration for exposure control
Sector-specificpamphlets
NanoSafer is a combined control-banding and risk management tool that enablesassessment of the risk level and recommended exposure control associated withproduction and use of manufactured nanomaterials (e.g., nanoparticles, nanoflakes,nanofibers, and nanotubes) in specific work scenarios. In addition to manufacturednanomaterials, the tool can also be used to assess and manage emissions fromnanoparticle-forming processes.
Sign up to become a caLIBRAte tool user testerwww.nanocalibrate.eu
Project #686239, Funded by the Horizon 2020
Framework Programme of the European Union
The Safe-by-Design Implementation
PlatformRealization of the SbD concept
Blanca Suarez, Til Schlotter, Karl Höhener
TEMAS AG
The aim of the SbD implementation platformAim: To identify uncertainties and risks as early as possible during the innovation process by:
To: Achieve safer nanomaterials and nano-enabled products
➢ Application of the precautionary principle
➢ Identification of uncertainties and risk potentials as early as
possible
➢ Active management for the reduction / elimination of risk
potentials
➢ Transparency regarding safety relevant data and information
SbD Implementation Platform target groups
➢ Industrial enterprises:
(safety dossiers and safety profiles of nano materials and nanoproducts, corporate social responsibility, labels, code of conduct…)
➢ Research community:
(SbD, RA, LCA, inventory of safety-related tools, concepts, databases…)
➢ Innovation support agencies:
(funded projects, instruments to support safety issues in nano material innovation projects…)
➢ Regulatory authorities:
(More inside information about innovation and R&D processes…)
➢ Society:
(transparency of information builds trust…)
The Safe by Design Implementation process –How does it work?
✓ Easy/user Friendly web-based Platform
✓ Management based on Project Phases
✓ Phase specific Safety Dossier based on
Regulation
✓ Customized outputs based on
Stakeholder requirements
✓ Go/no Go criteria per Phase
✓ Transparency of Safety Information
Resources needed to use the platform (data, timescale, in house skills etc.)
➢ Project structured into phases and milestones(Phases, gate-specifications/milestones)
➢Needs and requests of the safety aspects of a project(Defined by needs of stated regulation(s), of project-specific requests,and target groups)
➢ Inventory of harmonised concepts supporting the SbD application(Concepts, tools, procedures, data and data bases)
➢ Expertise on tools supporting the design(Information about the relation “function – safety – cost”)
➢Data to feed Sustainability analysis (up to LCA in earlier phases)
➢ Information to feed the models for the estimation of safety relevantcosts
Benefits to the user and how it can impact their product development
Links to follow uphttps://temas.taglab.ch/SbDimplementation/index.phpRequest a password: [email protected]
