Transcript Folie 1

Introduction and Overview of
ICCA GPS
Risk Assessment Guidance
Responsible Care
Metrics and GPS Workshop
Dubai
24 and 25 September 2012
Volker J. Soballa, Evonik Industries AG
Copyright© 2012 ICCA All Rights Reserved
Chemicals Policy and Health (CP&H)
Global Product Strategy - Contribution to SAICM
Promote knowledge
and skills transfer
Training Workshops
Guidance materials
GPS Network of experts
Improve the availability
of information
Base Set of information
GPS Safety Summary
Web-based IT-Portal
Increase awareness on
chemical management
ICCA Principles for
Chemical Management
Systems
Research on existing
and emerging issues
ICCA Long Range
Research Initiative (LRI)
Volker J. Soballa, Evonik Industries AG
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Chemicals Policy and Health (CP&H)
GPS Risk Assessment Guidance Pilot – Feedback
Africa &
Saudi Arabia
(Sasol, Sabic)
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Europe
(BASF,
Evonik)
South America
(Braskem)
North America
(Dow,
ExxonMobil)
Asia Pacific
(Sumitomo,
Mitsubishi)
The Guidance is a valuable tool and will help companies to meet
their commitments to GPS as well as regulatory requirements but
there is opportunity for improvement.
» Simplify language, add examples to illustrate processes and
harmonized the guidance with the GHS classification
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After technical revision the document was revised by a professional
communicator.
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Rollout of first version in July 2010,
Volker J. Soballa, Evonik Industries AG
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Chemicals Policy and Health (CP&H)
Improve performance – Risk Assessment Guidance
•
The target audience are emerging economies and small and
medium sized companies (SMEs) with no or very limited
experience in risk assessment and related methodologies.
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Our goal was to come up with an easy to use step wise process as
a first step to bridge gaps in current performance.
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Based on the comments from the pilot project we’ve decreased
the level of details to keep it simple and straightforward.
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The guidance has its limitations, it will be a living document to be
updated / improved in the years to come.
Volker J. Soballa, Evonik Industries AG
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Chemicals Policy and Health (CP&H)
Status GPS Risk Assessment Guidance
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Revised by OECD, ICAPO, ACI
Additions / New Chapters
 Industry perspective on
Assessment factors
 Evaluation of preparation
(Mixtures)
 Occupational Health
Assessment
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Actual version since July 2011
SMEs in Focus: First Step to Perform a Risk Assessment
Volker J. Soballa, Evonik Industries AG
Chemicals Policy and Health (CP&H)
Improve performance – Risk Assessment Guidance
OECD / REACH Guidance
“PhD Level”
Expert knowledge
ICCA GPS Guidance
“Bachelor Level”
Advanced knowledge
“College Level”
Little to no experience
Volker J. Soballa, Evonik Industries AG
The GPS guidance is intended to be simple
and pragmatic: a first step for beginners in
risk assessment. More detailed guidance
can be obtained from other sources
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Chemicals Policy and Health (CP&H)
Improve Industry Performance – GPS Guidance
Section One: Preparation
• Step 1: Select chemicals for assessment
• Step 2: Gather information
• Step 3: Prioritize chemicals into Tiers
• Step 4: Develop “Base Set of Information”
Section Two: Implementation
• Step 5: Characterize Hazard
• Step 6: Assess Exposure
• Step 7: Conduct Risk Characterization
• Step 8: Document Safety Summary
SMEs in Focus: First Step to Perform a Risk Assessment
Volker J. Soballa, Evonik Industries AG
Chemicals Policy and Health (CP&H)
Step 1: Select substances for assessment
GPS risk assessments should be performed for industrial chemicals:
» Sold (“in commerce”) or transported world-wide in quantities of more
than 1 metric ton per year by company and those that
» Pose a major threat to human health and/or the environment (e.g.
known carcinogens, etc.) even if they are sold or transported in smaller
amounts than 1 metric ton per year
The inventory should be kept strictly company internal due to
antitrust / competition law compliance
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Chemicals Policy and Health (CP&H)
Step 2: Gather information
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How to obtain the information: sources to access information on
GHS information, Phys/Chem, Hazard and Exposure Information
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Evaluate the quality of the Information: Reliability, Relevance and
Adequacy of data for assessment
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Close data gaps: As long as the information is considered reliable,
alternative sources are accepted e.g
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Route-to-route extrapolation / Read-across from related substances
In vitro methods / (Quantitative) Structure Activity Relationships
Animal tests should always be the "last resort"
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Chemicals Policy and Health (CP&H)
Step 3: Prioritize substances into Tiers
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Under GPS the prioritization of chemicals into “Tiers” is based on
an initial evaluation of their hazard and / or exposure potential.
1. Identify if your chemical has intrinsic hazard.
2. Identify use, dissemination and exposure control of chemical
3. Allocate chemicals into Tiers
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Each Tier is associated with a specific set of information. Chemicals
with higher hazard and / or exposure potential require more
information and are assessed first.
Just because a chemical is identified as high priority for RA does not mean
that the RA outcome will show the chemical is of highest risk. Even a
hazardous substance can be safely used in accepted applications.
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Chemicals Policy and Health (CP&H)
Step 3: Prioritize substances into Tiers
Doesthe
thechemical
chemicalhave
haveintrinsic
intrinsichazard?
hazard?
Does
Yes
Chemicalhas
haswide
wide
Chemical
anddispersive
dispersive
and
industrial,professional
professional
industrial,
endconsumeruse?
use?
ororendconsumer
No
Chemicalhas
haslimited
limited
Chemical
industrialoror
industrial
professionaluse?
use?
professional
Conditionsofofuse
usecan
can
Conditions
bestrictly
strictlycontrolled
controlled
be
No
Tier11
Tier
TopPriority
Priorityfor
for
Top
Assessment
Assessment
Tier22
Tier
nd Priority for
22nd Priority
for
Assessment
Assessment
Volker J. Soballa, Evonik Industries AG
Chemicalhas
haswide
wideand
anddispersive
dispersive
Chemical
industrial,professional
professionalororendconsumer
endconsumeruse?
use?
industrial,
Yes
No
Yes
Tier33
Tier
rd Priority for
33rd Priority
for
Assessment
Assessment
Tier22
Tier
nd Priority for
22nd Priority
for
Assessment
Assessment
Tier44
Tier
Noimmediate
immediate
No
furtheractions
actions
further
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Chemicals Policy and Health (CP&H)
Step 4: Base Set – Standard Parameters (for all)
Substance Identity
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CAS Number(s)
Name(s)
Structural Formula
Composition being
assessed
Use Pattern
(categories types)
Sources of Exposure
Volker J. Soballa, Evonik Industries AG
Phys / Chem
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Tox / Ecotox
Physical state
• Acute toxicity data
Melting Point
(relevant route of
exposure e.g. oral,
dermal, inhalation)
Boiling Point
Relative Density
Vapour Pressure
Partition Co-efficient
Water Solubility
Ignition temperature
Explosiveness
• Acute Toxicity
(most sensitive
species: fish,
daphnia or algae)
• Biodegradability
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Chemicals Policy and Health (CP&H)
Step 4: Base Set – Tiered Information
Increased priority for RA =
Higher information
requirement
Tier 1
Tier 2
Irritation
Tier 3
Irritation
Mutagenicity
Irritation
Mutagenicity
Sensitization
Tier 4
Mutagenicity
Sensitization
Repeated Dose
Irritation
Sensitization
Repeated Dose
Repro / Develop
3rd Priority for RA 2nd Priority for RA
Volker J. Soballa, Evonik Industries AG
Top Priority for RA
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Chemicals Policy and Health (CP&H)
GPS Guidance on Risk Assessment
Section One: Preparation
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Step 1: Select chemicals for assessment
Step 2: Gather information
Step 3: Prioritize chemicals into Tiers
Step 4: Develop Tier-relevant information
(“Base Set of Information”)
Section 2: Implementation
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Step 5:
Step 6:
Step 7:
Step 8:
Characterize Hazard
Assess Exposure
Conduct Risk Characterization
Document outcome
(GPS Safety Summary)
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Chemicals Policy and Health (CP&H)
Step 5: Characterize Hazard
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Chemicals Policy and Health (CP&H)
Step 6: Assess Exposure
Step-wise process
» Collect information on chemical properties
» Collect information on the uses and the typical operating conditions
and risk management (exposure control) measures applied
» Set up an Exposure Scenario for each use
» Estimate exposure for each scenario, using estimating tools (e.g.
ECETOC TRA) or measured data
Perform the respective assessment for:
» Human Exposure - Workplace and Consumer scenarios
» Environmental Exposure Assessment
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Chemicals Policy and Health (CP&H)
Step 7: Conduct Risk Characterization
Margin of Exposure (MoE)
Risk Characterization Ratio (RCR)
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»
»
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RCR = EXPOSURE / DNEL
RCR = EXPOSURE / DMEL
» If MOS > Overall Assessment Factor
Environmental
»
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MOE = NOAEL or NOAEC
Exposure
Threshold or non-threshold effect
RCR = PEC / PNEC
RCR ≥ 1 Risk is high
Detailed assessment and RMMs required
RCR < 1 Risk is controlled
No further action required
Volker J. Soballa, Evonik Industries AG
→ No concern
» If MOS < Overall Assessment Factor
→ Concern
MOE > 100 No concerns
MOE < 100 Concern
Refine analysis or control exposures
MOE < 1 Cause for high concern
Direct measures needed
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Chemicals Policy and Health (CP&H)
Step 8: Document outcome
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After the RA it is important to check the efficiency of the safety
measures adopted, document the outcomes of the assessment and
reviewing the assessment regularly to keep it updated.
As this documentation will contain data of proprietary nature it will
stay company internal and does not have to be shared with coproducers or the public (no mandatory exchange of dossiers).
ICCA has develop a GPS specific format that can be used to
communicate the essential information in a transparent way with
interested stakeholders (GPS Safety Summary).
» To provide the general public with a short easy to understand
overview of relevant information for the chemical
» Does not replace technical materials such as the (M)SDS
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Chemicals Policy and Health (CP&H)
Step 8: GPS Safety Summary - Template
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Summary
Chemical identity
Uses and Benefits
Physical/chemical properties
Health Effects
Environmental Effects
Exposure
Risk Management
Recommendations
First‐aid measures
Fire‐fighting measures
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Accidental release measures
Handling and storage
Disposal consideration
State Agency Review
Classification and Labeling
Conclusion
Contact Information within
company
Date of finalization of the
Safety Summary
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Chemicals Policy and Health (CP&H)
GPS versus REACH: Similarities and Differences
Similar
REACH
Information
requirement
(high) based
on production
volume
Assess
Hazard
GPS
Information
requirement
equivalent to
risk potential
Assess
Hazard
Derive
e.g. DNEL
Derive
e.g. DNEL
Assess
Exposure
Assess
Exposure
Differences
Volker J. Soballa, Evonik Industries AG
Calculate Safe Use
Document in CSR
Calculate Safe Use
Document internally
Communicate relevant
information to the public
Chemicals Policy and Health (CP&H)
Thank you very much for your attention!
Volker J. Soballa, Evonik Industries AG