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WORKING FOR A HEALTHY FUTURE




Updating the European
Carcinogens Directive

John Cherrie




INSTITUTE OF OCCUPATIONAL MEDICINE . Edinburgh . UK                www.iom-world.org
Europe’s dirtiest factory…

•    Malcolm Carhart died
     from lung cancer
•    Fred Richards had
     bladder cancer and
     survived
•    300 other men who
     worked at the Phurnacite
     plant in South Wales had
     their health damaged by
     their work
                                Mr Fred Richards
Summary…

•    Workplace cancers are a concern
•    In Europe the Carcinogens and Mutagens Directive
     is the key piece of legislation
    •   It has generic requirements with specific targets, e.g. vinyl
        chloride
•    The current occupational cancer burden is mostly
     caused by a small number of agents
•    Exposures have been decreasing steadily over time
•    Occupational cancer burden is still high and the
     Directive really needs updating
Phurnacite: a coal carbonization plant
Mortality in the plant…

•    We carried out a mortality study
     in the plant in 1987
     •    17 year follow-up
     •    620 men included
•    Increased mortality
            Lung   Stomach   Prostate   Bladder   Pneumonia   COPD
    SMR     146     160        152       270        189       139



•    Non-melanoma skin cancer commonly reported
The Carcinogens Directive…

•    DIRECTIVE 2004/37/EC OF THE EUROPEAN
     PARLIAMENT AND OF THE COUNCIL of 29 April
     2004
•    This Directive has as its aim the protection of
     workers against risks to their health and safety,
     including the prevention of such risks, arising or
     likely to arise from exposure to carcinogens or
     mutagens at work
Carcinogens Directive…

•    Article 4    Reduction and replacement
•    Article 5    Prevention and reduction of exposure
•    Article 6    Information for the competent authority
•    Article 7    Unforeseen exposure
•    Article 8    Foreseeable exposure
•    Article 10   Hygiene and individual protection
•    Article 11   Information and training of workers
•    Article 14   Health surveillance
Annex III
Doll and Peto assessed cancer burden

•    In 1981, they were commission by the US
     government to assess the relative
     importance of the “environment” in causing
     cancer
•    Their aim was to identify the proportion of
     cancer that is preventable
Attributable fractions…


                    About 4% (2 – 8%)
Cancer burden in the UK…

•    Designed to update Doll and Peto’s estimate for
     occupational cancer burden
     •   Current burden (2010)
     •   Future burden (to 2060)
•    Method based on:
     •   Risk of Disease (relative risk from published literature)
     •   Proportion of Population Exposed
•    Estimation for IARC groups 1 (definite) and 2A
     (probable) carcinogens and occupational
     circumstances
Attributable fraction…
                             Men = blue
                             Women = red



                         5.3% (4.6 – 6.6%)
Cancer registrations…
              85% of the cancer cases come
              from the top ten chemical agents

              - excluding ETS, which is already
              banned
Exposure decreases over time…

                                                                      Aerosols




          Creely KS et al. (2007) Trends in inhalation exposure--a review of the data in
          the published scientific literature. Ann OccupHyg.; 51(8): 665-678.
Exposure decreases over time…

                                                                    Gases and
                                                                    vapours




          Creely KS et al. (2007) Trends in inhalation exposure--a review of the data in
          the published scientific literature. Ann OccupHyg.; 51(8): 665-678.
VCM levels in a English PVC plant

                           1000
                                            y = 2E+30e-2.00x
 VCM concentration (ppm)




                                               R² = 0.740



                           100



                            10



                             1
                              1973   1974                 1975


                                                                 16
Burden should be decreasing…

•    If exposure is decreasing then it seems
     likely that the future burden will also be
     lower
•    Assumes
    •   Risk is related to exposure
    •   Prevalence of exposure is not increasing
    •   The aging population is not
        distorting the picture
So what does the future hold?

•    We have estimated future cancer burden in
     Europe and socioeconomic costs of interventions
     for a number of carcinogens
     •   Exposure levels reliant on stakeholder data or when
         unavailable published sources
     •   Risk assessment reliant on epidemiological studies or
         analogy
     •   Health impact carried out using carefully reviewed
         methodology developed for British cancer burden study
     •   Socioeconomic assessment based on EC guidance
Estimates of future burden…

•    Crystalline silica in Europe as an example:
     •   720,000 people exposed in Europe
     •   41% exposed above 0.05 mg/m3
     •   Current burden 7,600 lung cancers
     •   460,000 cases between 2010 and 2069
     •   Cost of inaction between
         €190,000m to €490,000m
•    Part of the SHEcan
     project work programme
Lung cancer registrations - baseline
Lung cancer registrations - intervention
The cost and benefits of intervention…

•    Total net health benefits by 2069 from setting
     a crystalline silica OEL at 0.05 mg/m3 are
     €28,000m to €74,000m
•    Costs of compliance estimated to be
     €34,000m
     •   About half of these costs arise in construction
     •   Most costs fall on small companies
For some substances there is no problem…

•    In our assessment of current burden in Europe we
     estimate <20 cancers/year from past exposure for:
     •   Vinyl chloride monomer 14 cases
     •   1, 3 Butadiene           2 cases
     •   Beryllium                7 cases
     •   Acrylamide               7 cases
     •   MbOCA                    8 cases
     •   Ethylene oxide           0 cases
     •   Refractory ceramic fibre 2 cases
     •   1, 2-Epoxypropane        0 cases
     •   Bromoethylene            0 cases
SHEcan considered…

                     In Annex III

                     OELs Suggested by EC

                     Process generated
My priority for action…
 Respirable crystalline silica     Strong case
 Chrome VI
 Hardwood dust
 Diesel engine exhaust             A case

 Rubber fume
 Benzo[a]pyrene
 Trichloroethylene
                                   A limited case
 Hydrazine
 Epichlorohydrin
 O-Toluidine
 Mineral oils as used engine oil
 MDA                               Uncertainty
 Diesel engine exhaust             Outside project scope!
The updating process…

•    The European Advisory Committee for Safety and
     Health at Work (ACSH) adopted an opinion on 5
     December supporting the introduction of new
     occupational exposure limits.
•    Ten substances identified in the article: crystalline
     silica, refractory ceramic fibres, chromium VI,
     trichloroethylene, hydrazine, acrylamide,
     epichlorohydrin, 1,2-dibromoethane, 4,4’
     methylenedianiline (MDA) and an updated limit for
     hardwood dust.
Should we think of a different tactic?

•    The Carcinogens Directive is a “traditional”
     approach to deal with occupational health
     problems
     •   Responsibility lies with the employer to meet minimum
         standards
     •   Regulators enforce non-compliance
•    Alternatively we could do more to encourage
     steady progress (decrease in exposure) in specific
     key industries/sectors
A challenge…

•    Focus on the top ten causes of the occupational
     cancer burden
•    Ensure that exposures continue to fall by about
     10% per annum
•    With this approach we could have eliminate the
     problem when an assessment
     of future burden from
     current exposure is
     <1% of all cancers
Acknowledgements…

•    The work was in part funded by the British Health
     and Safety Executive (HSE) and the European
     Commission (EC)
•    However, the views presented here are my own
•    Collaborators include:
    •   M Gorman Ng, A Shafrir, M van Tongeren, A Searl, J
        Crawford,           A Sanchez-Jimenez, J Lamb (IOM)
    •   R Mistry, M Sobey, C Corden, O Warwick and M-H Bouhier (AMEC UK)
    •   L Rushton and S Hutchings (Imperial College)
    •   T Kaupinnen and P Heikkila (Finnish Institute of Occupational
        Health),                      H Kromhout (IRAS, University of Utrecht)
    •   L Levy (IEH, Cranfield University)
Questions…

•    You can contribute to the discussion at…
     www.OH-world.org




                                  John.Cherrie@iom-world.org

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Updating the european carcinogens directive

  • 1. WORKING FOR A HEALTHY FUTURE Updating the European Carcinogens Directive John Cherrie INSTITUTE OF OCCUPATIONAL MEDICINE . Edinburgh . UK www.iom-world.org
  • 2. Europe’s dirtiest factory… • Malcolm Carhart died from lung cancer • Fred Richards had bladder cancer and survived • 300 other men who worked at the Phurnacite plant in South Wales had their health damaged by their work Mr Fred Richards
  • 3. Summary… • Workplace cancers are a concern • In Europe the Carcinogens and Mutagens Directive is the key piece of legislation • It has generic requirements with specific targets, e.g. vinyl chloride • The current occupational cancer burden is mostly caused by a small number of agents • Exposures have been decreasing steadily over time • Occupational cancer burden is still high and the Directive really needs updating
  • 4. Phurnacite: a coal carbonization plant
  • 5. Mortality in the plant… • We carried out a mortality study in the plant in 1987 • 17 year follow-up • 620 men included • Increased mortality Lung Stomach Prostate Bladder Pneumonia COPD SMR 146 160 152 270 189 139 • Non-melanoma skin cancer commonly reported
  • 6. The Carcinogens Directive… • DIRECTIVE 2004/37/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 • This Directive has as its aim the protection of workers against risks to their health and safety, including the prevention of such risks, arising or likely to arise from exposure to carcinogens or mutagens at work
  • 7. Carcinogens Directive… • Article 4 Reduction and replacement • Article 5 Prevention and reduction of exposure • Article 6 Information for the competent authority • Article 7 Unforeseen exposure • Article 8 Foreseeable exposure • Article 10 Hygiene and individual protection • Article 11 Information and training of workers • Article 14 Health surveillance
  • 9. Doll and Peto assessed cancer burden • In 1981, they were commission by the US government to assess the relative importance of the “environment” in causing cancer • Their aim was to identify the proportion of cancer that is preventable
  • 10. Attributable fractions… About 4% (2 – 8%)
  • 11. Cancer burden in the UK… • Designed to update Doll and Peto’s estimate for occupational cancer burden • Current burden (2010) • Future burden (to 2060) • Method based on: • Risk of Disease (relative risk from published literature) • Proportion of Population Exposed • Estimation for IARC groups 1 (definite) and 2A (probable) carcinogens and occupational circumstances
  • 12. Attributable fraction… Men = blue Women = red 5.3% (4.6 – 6.6%)
  • 13. Cancer registrations… 85% of the cancer cases come from the top ten chemical agents - excluding ETS, which is already banned
  • 14. Exposure decreases over time… Aerosols Creely KS et al. (2007) Trends in inhalation exposure--a review of the data in the published scientific literature. Ann OccupHyg.; 51(8): 665-678.
  • 15. Exposure decreases over time… Gases and vapours Creely KS et al. (2007) Trends in inhalation exposure--a review of the data in the published scientific literature. Ann OccupHyg.; 51(8): 665-678.
  • 16. VCM levels in a English PVC plant 1000 y = 2E+30e-2.00x VCM concentration (ppm) R² = 0.740 100 10 1 1973 1974 1975 16
  • 17. Burden should be decreasing… • If exposure is decreasing then it seems likely that the future burden will also be lower • Assumes • Risk is related to exposure • Prevalence of exposure is not increasing • The aging population is not distorting the picture
  • 18. So what does the future hold? • We have estimated future cancer burden in Europe and socioeconomic costs of interventions for a number of carcinogens • Exposure levels reliant on stakeholder data or when unavailable published sources • Risk assessment reliant on epidemiological studies or analogy • Health impact carried out using carefully reviewed methodology developed for British cancer burden study • Socioeconomic assessment based on EC guidance
  • 19. Estimates of future burden… • Crystalline silica in Europe as an example: • 720,000 people exposed in Europe • 41% exposed above 0.05 mg/m3 • Current burden 7,600 lung cancers • 460,000 cases between 2010 and 2069 • Cost of inaction between €190,000m to €490,000m • Part of the SHEcan project work programme
  • 21. Lung cancer registrations - intervention
  • 22. The cost and benefits of intervention… • Total net health benefits by 2069 from setting a crystalline silica OEL at 0.05 mg/m3 are €28,000m to €74,000m • Costs of compliance estimated to be €34,000m • About half of these costs arise in construction • Most costs fall on small companies
  • 23. For some substances there is no problem… • In our assessment of current burden in Europe we estimate <20 cancers/year from past exposure for: • Vinyl chloride monomer 14 cases • 1, 3 Butadiene 2 cases • Beryllium 7 cases • Acrylamide 7 cases • MbOCA 8 cases • Ethylene oxide 0 cases • Refractory ceramic fibre 2 cases • 1, 2-Epoxypropane 0 cases • Bromoethylene 0 cases
  • 24. SHEcan considered… In Annex III OELs Suggested by EC Process generated
  • 25.
  • 26.
  • 27.
  • 28. My priority for action… Respirable crystalline silica Strong case Chrome VI Hardwood dust Diesel engine exhaust A case Rubber fume Benzo[a]pyrene Trichloroethylene A limited case Hydrazine Epichlorohydrin O-Toluidine Mineral oils as used engine oil MDA Uncertainty Diesel engine exhaust Outside project scope!
  • 29. The updating process… • The European Advisory Committee for Safety and Health at Work (ACSH) adopted an opinion on 5 December supporting the introduction of new occupational exposure limits. • Ten substances identified in the article: crystalline silica, refractory ceramic fibres, chromium VI, trichloroethylene, hydrazine, acrylamide, epichlorohydrin, 1,2-dibromoethane, 4,4’ methylenedianiline (MDA) and an updated limit for hardwood dust.
  • 30. Should we think of a different tactic? • The Carcinogens Directive is a “traditional” approach to deal with occupational health problems • Responsibility lies with the employer to meet minimum standards • Regulators enforce non-compliance • Alternatively we could do more to encourage steady progress (decrease in exposure) in specific key industries/sectors
  • 31. A challenge… • Focus on the top ten causes of the occupational cancer burden • Ensure that exposures continue to fall by about 10% per annum • With this approach we could have eliminate the problem when an assessment of future burden from current exposure is <1% of all cancers
  • 32. Acknowledgements… • The work was in part funded by the British Health and Safety Executive (HSE) and the European Commission (EC) • However, the views presented here are my own • Collaborators include: • M Gorman Ng, A Shafrir, M van Tongeren, A Searl, J Crawford, A Sanchez-Jimenez, J Lamb (IOM) • R Mistry, M Sobey, C Corden, O Warwick and M-H Bouhier (AMEC UK) • L Rushton and S Hutchings (Imperial College) • T Kaupinnen and P Heikkila (Finnish Institute of Occupational Health), H Kromhout (IRAS, University of Utrecht) • L Levy (IEH, Cranfield University)
  • 33. Questions… • You can contribute to the discussion at… www.OH-world.org John.Cherrie@iom-world.org

Editor's Notes

  1. Minimum requirements – CHECK other countries for benzene and wood dust
  2. Stress that this is due to continuous improvement not H&amp;S interventions
  3. The mostextreme reduction is from the PVC plants in the early 1970s when the risk of angiosarcoma of the liver was first identified as a consequence of high VCM exposure. Here over a about a year the exposure dropped by more that an order of magnitude. Interestingly, although there was not systematic monitoring data for the period prior to the dramatic change the evidence is that there were improvements taking place before this which would have given a series of modest reductions in exposure and after about 1975 the rate of decline in exposure again dropped to about 6% per annum.
  4. How do we explain tric, beryllium and rubber fume?
  5. Need to know the suggested OELs
  6. What is 1,2 dibromoethane used for?