The value of Occupational Hygiene in the implementation of REACH

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• The value of Occupational Hygiene in the
  implementation of REACH
• AIOH 24th Annual Conference
• Andy Gillies
• President BOHS 2006-07

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Summary of Presentation

• BOHS an introduction
• REACH - why the change?
• Nuts and Bolts of REACH
• Risk assessment under REACH
• Exposure scenarios Risk Management Measures
• Useful sources of information

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An introduction to BOHS

• A multidisciplinary, learned and professional
  society
• Established in 1953
• In 2003 merged with the British Institute of
  Occupational Hygienists (BIOH)
• Now includes the Faculty of Occupational Hygiene
  as its professional arm
• Eight grades of membership
• Individual, Affiliate (for organisations or
  corporations), Retired and Student open to all
• Licentiate, Member, Specialist Member, Fellow
  Faculty grades

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An introduction to BOHS

• The voice of the occupational hygiene community
  in the UK
• An unrivalled source of information and
  expertise for members and non-members alike
• An examining board, through the Faculty of
  Occupational Hygiene, awarding qualifications in
  occupational hygiene and allied subjects
• For anyone with an interest in occupational
  hygiene, or a need for our services

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BOHS Business Strategy 2006 -2010

• A five year strategy to focus on key areas
• Ensures that limited resources are targeted and
  used effectively
• Four Strategic themes, each with specific Aims
  and success outcomes
• Owned by BOHS Council but (hopefully) used by all
  members
• Not a detailed work plan

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Strategic themes

• EDUCATION
• Promote education and research in occupational
  hygiene
• COMPETENCY
• Assure competency of occupational hygiene
  practitioners
• INFLUENCE
• Extend influence with external stakeholders
• SUPPORT
• Enhance services to members

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Some of The Crew
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The BOHS

• The Societys aim is simple
• To help to reduce work-related ill-health
• The result is dramatic
• A healthy worker in a healthy
• working environment
• www.bohs.org

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REACHthe new EU chemicals policy
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Why is a new policy needed?

• The old system isnt working
• 100,000 substances, 99 (by volume) have
  sketchy information on properties, uses risks
• Drag on research and innovation
• Information needs for new substances far
  outweighs those for existing
• Burden of proof with authorities, not the
  manufacturers
• Concern about health risks from chemicals is
  increasing

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Perspective 1WWF DETOX campaign

• The contamination of wildlife and people with
  hundreds of chemicals that lack basic safety
  information is an unregulated global experiment
  that needs to be stopped.
• 1. PLAY IT SAFE Replace hazardous chemicals with
  safer alternatives whenever they exist.
• 2. INFORMATION improves trust Provide sufficient
  safety data to identify dangerous chemicals and
  safer alternatives.
• 3. A LEGAL GUARANTEE Ensure that the chemical
  industry has the responsibility for the safety of
  their products (Duty of Care).
• 4. TRANSPARENCY for consumer products Establish
  a right to know for citizens.
• www.detox.panda.org

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Perspective 2CIA

• REACH is also a great opportunity for our
  industry to help demonstrate its outstanding
  contribution to society.(Steve Elliott, Chief
  Executive CIA, June 2006)
• Consistent with Sustainable Development and
  Responsible Care
• Actions proportionate to risk
• One substance one registration
• www.cia.org.uk

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Who is affected?

• Any company producing, importing, using or
  placing on to the EU market a substance,
  preparation or article.
• Not just the Chemical Industry sector!!
• Manufacturers, importers, suppliers, and
  downstream users
• Estimated about 30,000 substances will be
  registered
• Some exemptions
• e.g. radioactive substances, non-isolated
  intermediates, wastes, polymers, minerals, ores,
  LPG, biocides, medicinal products

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Nuts and bolts

• Registration ?
• Document that human health environmental risks
  are adequately controlled in all identified uses
• Evaluation
• Review of registration dossiers for compliance
  and animal testing proposals
• Authorisation
• For substances of very high concern (CMR class 1
  and 2, PBT, vPvB, others, e.g. endocrine
  disrupters)
• Restriction
• The missing R for substances where risks are
  unacceptable
• ? By industry By ECA or CA

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Registration

• All substances manufactured/imported gt1
  tonne/year
• For new substances, registration is essential
  before manufacture
• For existing substances, phase-in period over 11
  years (to 2018)
• Pre-registration phase (12-18 months)
• Phase 1 gt1000 tonnes/year CMR, PBT (to 2010)
• Phase 2 100 1000 tonnes/year (to 2013)
• Phase 3 10 100 and 1 10 tonnes/year (to
  2018)
• Assuming Regulation takes effect in 2007

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Registration documents

• Technical dossier for all substances
• Info. on properties, uses and classification
• Animal test data or proposals for testing
• Guidance on safe use
• gt10 tonnes/year requires a Chemical Safety Report
• Hazard classification
• Chemical Safety Assessment (human health, safety
  environmental risk assessment)
• Exposure scenarios for all identified uses

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Chemical Safety Assessment
Christensen et al 2003
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CSAhazard assessment

• Human health
• Evaluate data (animal data, epidemiology)
• Decide on classification and labelling
• Establish Derived No-Effect Level (DNEL)
• Safety (physico-chemical)
• Explosivity, flammability, oxidising potential
• Environmental
• Evaluate data, including PBT and vPvB assessment
• Decide on classification and labelling
• Establish Predicted No-Effect Concentration (PNEC)

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CSAexposure assessment

• Exposure scenarios
• Cover manufacture and intended uses throughout
  substance life cycle, incl. waste
  disposal/recycling
• Describe processes and tasks
• Operational conditions
• Risk management measures required
• Included as an appendix to enhanced SDS

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Exposure scenariossome questions

• How does the ES fit with a COSHH risk assessment?
  What if the conclusions are different?
• What if my use isnt covered by an ES??
• How can a supplier estimate the exposure levels
  at my site? ?
• Should ES be generic or specific?
• Can COSHH Essentials help?
• ? Downstream User

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Risk management measures

• Must cover workers, consumers, and general
  public. For workers, consider
• Hierarchy of control
• Principles of Good Control Practice (COSHH)
• All routes of exposure (inhalation, dermal,
  accidental ingestion)

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CONTROL of Substances Hazardous to Health

• Prevent exposure (if reasonably practicable)
• hierarchy of control
• eliminate
• substitute
• contain
• other engineering controls
• procedural controls
• PPE

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Principles of Good Control Practice

• design and operate to control emissions at source
• control all relevant routes of exposure
• controls proportionate to the health risk
• hierarchy of effective and reliable controls
• suitable PPE, only when adequate control cannot
  be achieved by other means
• check and review continuing effectiveness of
  controls
• inform and train employees
• ensure no unintended increase in overall HS risks

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Risk Management Measures some questions

• How effective are RMM? Do I need to measure
  exposure?
• A different mix of control options may achieve
  the same result are both options valid?
• Do I have to use the recommended RMM from my
  supplier? ?
• What if different suppliers give conflicting
  recommendations? ?
• Will control banding schemes like COSHH
  Essentials help?
• ? Downstream User

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Human health risk characterisation

• For each exposure scenario
• For each human population exposed (as workers,
  consumers, indirectly via the environment, or a
  combination)
• Residual risk (after RMM implemented)
• Comparison of exposure with the relevant DNEL

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Communication up/down the supply chain

• Multi-directional information flow
• Enhanced Safety Data Sheets
• Hazard data, exposure scenarios, approved uses,
  restrictions on supply

CUSTOMERS (formulators, downstream users)
SUPPLIERS (manufacturers, importers)
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REACH and Occupational Hygiene

• Fundamentally REACH is about protecting human
  health and the environment. Major role for HS
  professionals
• Multi-disciplinary team needed to address all the
  issues (commercial, technical, PR)
• Occupational hygiene is at the heart of REACH
• Exposure Scenarios
• Risk Management Measures
• Exposure monitoring and modelling
• Data interpretation and use of exposure limits
• Risk communication

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BOHS and REACH

• REACH Steering Group reporting to Council
• REACH pages on website
• Workshops/Seminars planned for 2007
• Statement of the value of OH

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Expected Timetable

• July 06 common position agreed between
  Parliament and Commission
• Dec 06 second reading in European Parliament
• Dec 06 expected adoption of Regulation
• April 07 entry into force in Member States
• 2007/08 European Chemical Agency start-up
• 2008 2018 phase-in for existing substances

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Useful information sources

• Handy websites
• European Chemical Bureau http//ecb.jrc.it/REACH/
  
• CEFIC http//www.cefic.be/
• DG Enterprise http//ec.europa.eu/enterprise/rea
  ch
• CIA REACH Ready http//www.reachready.co.uk/
• British Occupational Hygiene Society www.bohs.org.
  uk/