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WORKING FOR A HEALTHY FUTURE




Prioritizing action on occupational
carcinogens in Europe

The McCallum Lecture
JW Cherrie, M Gorman Ng, A Shafrir, M van Tongeren, A Searl, A Sanchez-Jimenez (IOM)
R Mistry, M Sobey, C Corden (AMEC UK)
L Rushton and S Hutchings (Imperial College)

Other project team members: J Lamb (IOM), O Warwick and M-H Bouhier (AMEC UK),
T Kaupinnen and P Heikkila (Finnish Institute of Occupational Health),
H Kromhout (IRAS, University of Utrecht), L Levy (IEH, Cranfield University)



 INSTITUTE OF OCCUPATIONAL MEDICINE . Edinburgh . UK                  www.iom-world.org
Robert Ian McCallum, CBE
b.14 Sept 1920 d.15 Feb 2009

  “Robert Ian McCallum, former
  professor of occupational
  health at the University of
  Newcastle, was probably the
  most distinguished
  occupational physician of his
  era.”

  Royal College of Physicians




                                http://munksroll.rcplondon.ac.uk/   2
A quote from Marx…

“It is better to remain silent and be thought
   a fool, than to open your mouth and
   remove all doubt.”

Groucho Marx




                                                3
Background…

•    Over 1 million cancer deaths in Europe each year
     and about 5% may be due to work
•    The commonest cancers are:
    •    breast cancer (13.5% of all cancer cases and 29% of
        cancer cases in women)
    •   colorectal cancers (12.9%) and
    •   lung cancer (12.1%)
•    Important differences incidence between countries
    •   e.g. about a two fold difference for men between the
        highest (Hungary) and the lowest (Bulgaria)

                                                               4
Workplace causes

•    Lag between first exposure and diagnosis may be
     40-50 years
•    IARC lists 107 agents that have been classified as
     carcinogenic to humans (Group 1)
    •   59 agents classified as probably carcinogenic to
        humans (Group 2a) and 267 classified as possibly
        carcinogenic to humans (Group 2b)
•    Main occupational carcinogens are asbestos, shift
     work, mineral oils, solar radiation, silica, diesel
     engine exhaust plus coal tars and pitches

                                                           5
Revision of the EU Carcinogens Directive

•    The European Commission are considering
     amending directive 2004/37/EC on the protection of
     workers from the risks related to exposure to
     carcinogens or mutagens at work
•    Before the EC proposes new initiatives it has to
     assesses the potential economic, social and
     environmental consequences.
•    It is a process that prepares evidence for political
     decision-makers on the advantages and
     disadvantages of possible policy options by
     assessing their potential impact.
               http://ec.europa.eu/governance/impact/index_en.htm
                                                                    6
Process generated substances…

•    For the process generated substances there is
     a two step process as they are currently not in
     the scope of the directive since not classified
     as EU category 1 or 2 carcinogen
•    Can be brought into scope by including them in
     Annex I.
•    Then as a secondary consideration, ask
     whether we need an OEL and of „yes‟ at what
     numerical value?


                                                       7
Outline of the talk…

•    Outline the SHEcan project to carryout a
     Socioeconomic, Health and Environmental
     impact assessment for 25 carcinogenic
     substances
•    Describe the main results from the work in
     relation to prioritizing interventions
•    Discuss some of the issues that have arisen
     in doing the work



                                                   8
The SHEcan project…

                                 Management and stakeholder consultation




                                                                 Manufactured
 Review OEL setting procedures




                                                     generated
                                                     4 Process
                                     Hardwood




                                                                  chemicals
                                     and VCM




                                                                                Review exposure control
                                                                     19
                                   Socioeconomic/Environment impact

                                                 Assess risk

                                           Estimate exposure levels

                                          Estimate number exposed

                                                                                                          9
Substances considered…

                         In Annex III

                         OELs Suggested by EC

                         Process generated




                                                10
Methods…

•    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


                                                          11
Exposure assessment…




                       12
Exposure decreases over time…




          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.         13
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


                                                                 14
Health impact…

•    Aims to provide estimates of current cancer deaths and
     registrations due to occupation and future trends under
     different scenarios of change
•    Measure of burden used is the AF - proportion of cases
     attributable to exposure; needs:
    •   risk of disease associated with the exposure of concern (e.g.
        relative risk (RR) – obtained form epidemiological literature
    •   proportion exposed in the population
•    To take into account latency we defined the risk exposure
     period (REP) for:
    •   Solid tumours: 10-50 years; e.g. 1961-2000 for 2010
    •   Haematopoietic cancers: up to 20 years; e.g. 1991-2010

                                                                        15
Possible future scenarios...

•    Estimates made for alternative scenarios of
     change in exposure levels or numbers exposed
     •   Baseline scenario - based on pattern of past exposure, but
         no future change in exposed numbers or levels
     •   Baseline trend scenario - based on pattern of past and
         current exposure, and on linear projections up to 20 years
         into the future, after which levels assumed constant due to
         prediction uncertainty.
     •   Intervention scenarios: introduction or reductions in
         exposure limits in 2010 (results in future changes in levels
         of exposure and proportions exposed to these.
     •   Assumed „full compliance‟ (i.e. >99% of exposures < OEL)

                                                                    16
Socioeconomic impacts…

• Assessed impact of baseline exposure (disability
  and death)
• Assigned values to those impacts based on:
  • Value of life-years lost
  • Cost of illness or willingness to pay to avoid cancer
  • Different figures for non-melanoma skin cancer versus other types

• Then assessed value of impacts avoided through
  reduced workplace exposure levels across the
  population exposed (i.e. difference from baseline)
• Based on reduction of exposure to the proposed
  OEL
                                                                        17
Discounting future costs and benefits

•    All costs and benefits
     over time in this study
     were discounted using
     a 4% discount rate as
     recommended by the
     EC Impact Guidelines
     •   Costs mostly occur
         today
     •   Benefits mostly arise
         many years in the
         future

                                            18
19
Number of people currently exposed…




                                      20
currently



% currently above the proposed OEL…




                                        21
Baseline health assessment…




                              22
Cancer cases prevented by OEL…




                                 23
Crystalline silica - Registrations




                                     24
Cost-benefit ratio…




                      Note, zero compliance costs because
                      exposure was already assessed to
                      be below the OEL investigated.




                                                     25
Strength of evidence…
•    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


                                                        26
Conclusions…

•    This approach can help guide policy
•    Focus on the occupational carcinogens that
     contribute most to the health burden, which could
     contribute importantly towards the goal of
     eliminating occupational cancer
•    Better information is needed about the extent of
     exposure to occupational carcinogens




                                                         27

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Prioritizing action on occupational carcinogens

  • 1. WORKING FOR A HEALTHY FUTURE Prioritizing action on occupational carcinogens in Europe The McCallum Lecture JW Cherrie, M Gorman Ng, A Shafrir, M van Tongeren, A Searl, A Sanchez-Jimenez (IOM) R Mistry, M Sobey, C Corden (AMEC UK) L Rushton and S Hutchings (Imperial College) Other project team members: J Lamb (IOM), O Warwick and M-H Bouhier (AMEC UK), T Kaupinnen and P Heikkila (Finnish Institute of Occupational Health), H Kromhout (IRAS, University of Utrecht), L Levy (IEH, Cranfield University) INSTITUTE OF OCCUPATIONAL MEDICINE . Edinburgh . UK www.iom-world.org
  • 2. Robert Ian McCallum, CBE b.14 Sept 1920 d.15 Feb 2009 “Robert Ian McCallum, former professor of occupational health at the University of Newcastle, was probably the most distinguished occupational physician of his era.” Royal College of Physicians http://munksroll.rcplondon.ac.uk/ 2
  • 3. A quote from Marx… “It is better to remain silent and be thought a fool, than to open your mouth and remove all doubt.” Groucho Marx 3
  • 4. Background… • Over 1 million cancer deaths in Europe each year and about 5% may be due to work • The commonest cancers are: • breast cancer (13.5% of all cancer cases and 29% of cancer cases in women) • colorectal cancers (12.9%) and • lung cancer (12.1%) • Important differences incidence between countries • e.g. about a two fold difference for men between the highest (Hungary) and the lowest (Bulgaria) 4
  • 5. Workplace causes • Lag between first exposure and diagnosis may be 40-50 years • IARC lists 107 agents that have been classified as carcinogenic to humans (Group 1) • 59 agents classified as probably carcinogenic to humans (Group 2a) and 267 classified as possibly carcinogenic to humans (Group 2b) • Main occupational carcinogens are asbestos, shift work, mineral oils, solar radiation, silica, diesel engine exhaust plus coal tars and pitches 5
  • 6. Revision of the EU Carcinogens Directive • The European Commission are considering amending directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work • Before the EC proposes new initiatives it has to assesses the potential economic, social and environmental consequences. • It is a process that prepares evidence for political decision-makers on the advantages and disadvantages of possible policy options by assessing their potential impact. http://ec.europa.eu/governance/impact/index_en.htm 6
  • 7. Process generated substances… • For the process generated substances there is a two step process as they are currently not in the scope of the directive since not classified as EU category 1 or 2 carcinogen • Can be brought into scope by including them in Annex I. • Then as a secondary consideration, ask whether we need an OEL and of „yes‟ at what numerical value? 7
  • 8. Outline of the talk… • Outline the SHEcan project to carryout a Socioeconomic, Health and Environmental impact assessment for 25 carcinogenic substances • Describe the main results from the work in relation to prioritizing interventions • Discuss some of the issues that have arisen in doing the work 8
  • 9. The SHEcan project… Management and stakeholder consultation Manufactured Review OEL setting procedures generated 4 Process Hardwood chemicals and VCM Review exposure control 19 Socioeconomic/Environment impact Assess risk Estimate exposure levels Estimate number exposed 9
  • 10. Substances considered… In Annex III OELs Suggested by EC Process generated 10
  • 11. Methods… • 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 11
  • 13. Exposure decreases over time… 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. 13
  • 14. 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 14
  • 15. Health impact… • Aims to provide estimates of current cancer deaths and registrations due to occupation and future trends under different scenarios of change • Measure of burden used is the AF - proportion of cases attributable to exposure; needs: • risk of disease associated with the exposure of concern (e.g. relative risk (RR) – obtained form epidemiological literature • proportion exposed in the population • To take into account latency we defined the risk exposure period (REP) for: • Solid tumours: 10-50 years; e.g. 1961-2000 for 2010 • Haematopoietic cancers: up to 20 years; e.g. 1991-2010 15
  • 16. Possible future scenarios... • Estimates made for alternative scenarios of change in exposure levels or numbers exposed • Baseline scenario - based on pattern of past exposure, but no future change in exposed numbers or levels • Baseline trend scenario - based on pattern of past and current exposure, and on linear projections up to 20 years into the future, after which levels assumed constant due to prediction uncertainty. • Intervention scenarios: introduction or reductions in exposure limits in 2010 (results in future changes in levels of exposure and proportions exposed to these. • Assumed „full compliance‟ (i.e. >99% of exposures < OEL) 16
  • 17. Socioeconomic impacts… • Assessed impact of baseline exposure (disability and death) • Assigned values to those impacts based on: • Value of life-years lost • Cost of illness or willingness to pay to avoid cancer • Different figures for non-melanoma skin cancer versus other types • Then assessed value of impacts avoided through reduced workplace exposure levels across the population exposed (i.e. difference from baseline) • Based on reduction of exposure to the proposed OEL 17
  • 18. Discounting future costs and benefits • All costs and benefits over time in this study were discounted using a 4% discount rate as recommended by the EC Impact Guidelines • Costs mostly occur today • Benefits mostly arise many years in the future 18
  • 19. 19
  • 20. Number of people currently exposed… 20
  • 21. currently % currently above the proposed OEL… 21
  • 23. Cancer cases prevented by OEL… 23
  • 24. Crystalline silica - Registrations 24
  • 25. Cost-benefit ratio… Note, zero compliance costs because exposure was already assessed to be below the OEL investigated. 25
  • 26. Strength of evidence… • 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 26
  • 27. Conclusions… • This approach can help guide policy • Focus on the occupational carcinogens that contribute most to the health burden, which could contribute importantly towards the goal of eliminating occupational cancer • Better information is needed about the extent of exposure to occupational carcinogens 27

Editor's Notes

  1. The highest occupational attributable fractions were for mesothelioma, sinonasal cancer, lung cancer, cancer of the nasopharynx and breast cancerThe largest number of attributable deaths was for lung cancer and mesotheliomaAll future occupational cancer burden could potentially be prevented
  2. Two side pillars not described in this presentation
  3. Exposure assessments based on the estimated GM/GSD and proportion in H,M,L,B
  4. 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.
  5. Also estimated DALYsPrediction out to 2069 in ten-year periods
  6. Reduction not based on a specific risk management measure