Volker J. Soballa, Evonik Industries AG Introduction and Overview of ICCA GPS Risk Assessment Guidance Copyright© 2012 ICCA All Rights Reserved Responsible

Volker J. Soballa, Evonik Industries AG

Introduction and Overview of ICCA GPS

Risk Assessment Guidance

　　　　　

Copyright© 2012 ICCA All Rights Reserved

Responsible CareMetrics and GPS Workshop

Dubai24 and 25 September 2012

Chemicals Policy and Health (CP&H)


Promote knowledge and skills transfer

Improve the availability of information

Increase awareness on chemical management

Research on existing and emerging issues

Training WorkshopsGuidance materials GPS Network of experts

Base Set of informationGPS Safety SummaryWeb-based IT-Portal

ICCA Principles for Chemical Management Systems

ICCA Long Range Research Initiative (LRI)

Global Product Strategy - Contribution to SAICM

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GPS Risk Assessment Guidance Pilot – Feedback

• 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

• After technical revision the document was revised by a professional communicator.

• Rollout of first version in July 2010,

North America(Dow,

ExxonMobil)

Asia Pacific(Sumitomo, Mitsubishi)

South America(Braskem)

Europe(BASF,Evonik)

Africa &Saudi Arabia(Sasol, Sabic)

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• 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.

• Our goal was to come up with an easy to use step wise process as a first step to bridge gaps in current performance.

• Based on the comments from the pilot project we’ve decreased the level of details to keep it simple and straightforward.

• The guidance has its limitations, it will be a living document to be updated / improved in the years to come.

Improve performance – Risk Assessment Guidance

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Status GPS Risk Assessment Guidance

SMEs in Focus: First Step to Perform a Risk Assessment

• Revised by OECD, ICAPO, ACI

• Additions / New Chapters Industry perspective on

Assessment factors

Evaluation of preparation(Mixtures)

Occupational Health Assessment

• Actual version since July 2011



Improve performance – Risk Assessment Guidance

“College Level”Little to no experience

“Bachelor Level”Advanced knowledge

“PhD Level”Expert knowledge

OECD / REACH Guidance

ICCA GPS Guidance

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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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



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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Step 2: Gather information

• How to obtain the information: sources to access information on GHS information, Phys/Chem, Hazard and Exposure Information

• Evaluate the quality of the Information: Reliability, Relevance and Adequacy of data for assessment

• Close data gaps: As long as the information is considered reliable, alternative sources are accepted e.g

» 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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Step 3: Prioritize substances into Tiers

• 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

• 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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Step 3: Prioritize substances into Tiers

Does the chemical have intrinsic hazard?Does the chemical have intrinsic hazard?

Yes No

Chemical has wide and dispersive

industrial, professional or endconsumer use?



Chemical has limitedindustrial or

professional use?


professional use?

Chemical has wide and dispersiveindustrial, professional or endconsumer use?


Yes No

Tier 1Top Priority for

Assessment


Assessment

Tier 22nd Priority for

Assessment


Assessment

YesNo

Tier 33rd Priority for

Assessment


Assessment


Assessment


Assessment

Tier 4No immediate further actions


Conditions of use can be strictly controlled


Does the chemical have intrinsic hazard?Does the chemical have intrinsic hazard?

Yes No






professional use?


professional use?



Yes No


Assessment


Assessment


Assessment


Assessment

YesNo


Assessment


Assessment


Assessment


Assessment





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Step 4: Base Set – Standard Parameters (for all)

Substance Identity

• CAS Number(s)• Name(s)• Structural Formula• Composition being

assessed • Use Pattern

(categories types)• Sources of Exposure

Phys / Chem

• Physical state

• Melting Point

• Boiling Point

• Relative Density

• Vapour Pressure

• Partition Co-efficient

• Water Solubility

• Ignition temperature

• Explosiveness

Tox / Ecotox

• Acute toxicity data (relevant route of exposure e.g. oral, dermal, inhalation)

• Acute Toxicity (most sensitive species: fish, daphnia or algae)

• Biodegradability

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Step 4: Base Set – Tiered Information

Tier 4

Irritation

Tier 3

Irritation

Mutagenicity

Sensitization

Tier 2

Irritation

Mutagenicity

Sensitization

Repeated Dose

Tier 1

Irritation

Mutagenicity

Sensitization

Repeated Dose

Repro / Develop

Top Priority for RA2nd Priority for RA3rd Priority for RA

Increased priority for RA =Higher information

requirement

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Section One: Preparation• 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• Step 5: Characterize Hazard • Step 6: Assess Exposure• Step 7: Conduct Risk Characterization• Step 8: Document outcome

(GPS Safety Summary)

GPS Guidance on Risk Assessment

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Step 5: Characterize Hazard

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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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Step 7: Conduct Risk Characterization

Risk Characterization Ratio (RCR)

• Threshold or non-threshold effect

» RCR = EXPOSURE / DNEL

» RCR = EXPOSURE / DMEL

• Environmental

» RCR = PEC / PNEC

Margin of Exposure (MoE)

• MOE = NOAEL or NOAEC Exposure

»If MOS > Overall Assessment Factor → No concern

»If MOS < Overall Assessment Factor → Concern

RCR ≥ 1 Risk is highDetailed assessment and RMMs required RCR < 1 Risk is controlled No further action required

MOE > 100 No concerns MOE < 100 ConcernRefine analysis or control exposures MOE < 1 Cause for high concern Direct measures needed

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Step 8: Document outcome

• 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 co-producers 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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Step 8: GPS Safety Summary - Template

• Summary • Chemical identity• Uses and Benefits• Physical/chemical properties• Health Effects• Environmental Effects• Exposure• Risk Management

Recommendations• First aid measures‐• Fire fighting measures‐

• 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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GPS versus REACH: Similarities and Differences

REACHInformation requirement (high) based on production volume

AssessHazard Derive

e.g. DNEL

Similar

Calculate Safe UseDocument in CSR

AssessExposure

GPSInformation requirement equivalent to risk potential

AssessHazard Derive

e.g. DNEL Calculate Safe UseDocument internally

AssessExposure

Communicate relevant information to the publicDifferences



Thank you very much for your attention!

Documents

Volker J. Soballa, Evonik Industries AG Introduction and Overview of ICCA GPS Risk Assessment Guidance Copyright© 2012 ICCA All Rights Reserved Responsible