WORKING FOR A HEALTHY FUTURE

INSTITUTE OF OCCUPATIONAL MEDICINE . Edinburgh . UK www.iom-world.org

Updating the European Carcinogens Directive

John Cherrie

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

• Non-melanoma skin cancer commonly reported

Lung Stomach Prostate Bladder Pneumonia COPD

SMR 146 160 152 270 189 139

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

Sir Richard Doll

Sir Richard Peto

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…

5.3% (4.6 – 6.6%)

Men = blueWomen = red

Cancer registrations…85% of the cancer cases come from the top ten chemical agents

- excluding ETS, which is already banned

Exposure decreases over time…

Creely KS et al. (2007) Trends in inhalation exposure--a review of the data in the published scientific literature. Ann Occup Hyg.; 51(8): 665-678.

Aerosols

Exposure decreases over time…

Creely KS et al. (2007) Trends in inhalation exposure--a review of the data in the published scientific literature. Ann Occup Hyg.; 51(8): 665-678.

Gases and vapours

16

1973 1974 19751

10

100

1000

f(x) = INF exp( − 2.00333226615499 x )R² = 0.740621920392391

VC

M c

on

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ntr

ati

on

(p

pm

)VCM levels in a English PVC plant

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 1,100,000

SHEcan considered…

In Annex III

OELs Suggested by EC

Process generated

Typical OELs

My priority for action…

Respirable crystalline silica

Chrome VI

Hardwood dust

Diesel engine exhaust

Rubber fume

Benzo[a]pyrene

Trichloroethylene

Hydrazine

Epichlorohydrin

O-Toluidine

Mineral oils as used engine oil

MDA

Diesel engine exhaust

Strong case

A case

A limited case

Uncertainty

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…

John.Cherrie@iom-world.org

www.OH-world.org