1. 1 Crystalline Silica: The EU Regulatory Approach Dr. Michelle Wyart - Remy, IMA - Europe / EUROSIL Crystalline Silica and Oncogenesis Bologna, 24 October 2000 - EuropeIMA

2. 2 The IARC Overall Evaluation Crystalline silica inhaled in the form of quartz or cristobalite from occupational sources is carcinogenic to humans (group 1 ) IARC Monographs 68, “Silica, silicates, dusts and organic dusts” (1997) - EuropeIMA

3. 3 Mines Safety & Health Commission - ISSA Mining Section International Workshop, Luxembourg 10-12 April 2000 Are quartz dusts carcinogenic? - EuropeIMA P.H. Hessel et al, JOEM 42 (7) 704-720 (2000) A response to a recent working group report

4. 4 The IARC Overall Evaluation IARC Monographs 68, “ Silica, silicates, dusts and organic dusts” (1997) In making the overall evaluation, the Working Group noted that carcinogenicity was not detected in all industrial circumstances studied. Carcinogenicity may be dependent on inherent characteristics of the crystalline silica or on external factors affecting its biological activity or distribution of its polymorphs Crystalline silica inhaled in the form of quartz or cristobalite from occupational sources is carcinogenic to humans (group 1) Coal dust cannot be classified as to its carcinogenicity to humans - EuropeIMA

5. 5 IARC Crystalline Silica Evaluation is UNIQUE in certain circumstances at work not in the general environment not in coal mining exposure to some forms of CS could probably lead to cancer CS exhibits a variable toxicity CS is a variable entity - EuropeIMA

6. 6 “It is surely for regulators and employers to work at the most cost-effective strategies for risk prevention, not for scientific agencies to fiddle with the evidence to make it more easy for them” - EuropeIMA C. McDonald & N. Cherry Crystalline silica and lung cancer: the problem of conflicting evidence Indoor Built Environment 8 121-6 (1999)

7. 7 Possible regulatory scenarios in the EU IARC + Scientific Evidence Classification Workers Protection EU DG Environment EU DG Employment & Social Affairs Member States - EuropeIMA

8. 8 Classification?  carcinogen category 1 or 2  labelling  marketing & use restriction  dangerous transport regulations  dangerous waste regulations  preparations containing > 0.1% of it R49 may cause cancer by inhalation + Dangerous Substances Directive 67/548/EEC - 92/32/EEC EU DG Environment - European Chemical Bureau - EuropeIMA ban from public products

9. 9 "If man wishes to live in silica free environment he must move to another planet" Brian Coope A Socio-Economic Review of Crystalline Silica Usage September 1997 - EuropeIMA

10. 10 CS is not a single substance CS exhibits a variable toxicity Are there grounds for appropriate legislative measures? Classification is not a priority DG XI-ECB, Ispra October 1998 - EuropeIMA

11. 11 Grounds for Prevention - EuropeIMA Silicosis is the leading effect DECOS, MAK Commission, WHO CICAD, OSHA Risks limited to occupational exposure Silicotics at higher risks of cancer Relative risks silicosis/lung cancer: 12/1  C. A. Soutar & B.G Miller (IOM), SCOEL hearing March 2000 IARC, 1997

12. 12 - EuropeIMA Workers Protection DG Employment & Social Affairs/Member States Labour Ministries Occupational Exposure Limit (OEL) Carcinogens Directive 90/394/EEC Chemical Agents Directive 98/24/EC SubstitutionRisk assessment

13. 13 EU Council of Social Affairs 1 December 1998 invited the Commission to consider on the basis of the latest scientific evidence whether crystalline silica OEL in 98/24/EC chemical agents OEL in Annex III of 90/394/EEC carcinogens - EuropeIMA ? in which regulatory framework ? which OEL SCOEL

14. 14 - EuropeIMA Carcinogens Directive Scenario Protection of workers from risks related to exposure to carcinogens at work 90/394/EEC - 97/42/EC - 99/38/EC  substance  preparation  process Agents Obligations  replacement  exposure reduction  information of Authority  workers information & training  hygiene & health surveillance  medical record-keeping (40 years) Risk assessment

15. 15 - EuropeIMA Carcinogens Directive in which industrial circumstances? how exempting non carcinogenic circumstances ? which agent? crystalline silica? Belgium respirable crystalline silica? Denmark - the Netherlands or processes exposing to respirable crystalline silica? French Decree proposal Questions?

16. 16 Inhaled quartz is carcinogenic to man and mediates its carcinogenicity by a non-stochastic genotoxic mode of action, which implicates the existence of an exposure level of quartz below which the cancer risk can be considered nil - EuropeIMA The Dutch Example DECOS evaluation of Quartz carcinogenicity and genotoxicity publication no. 1998/02 WGD Dutch MAC value: 0.075 mg/m 3 BUT RCS is a carcinogen at work whatever the exposure level!

17. 17 - EuropeIMA Chemical Agents Directive Scenario 98/24/EC Article 5.4 When risk assessment shows because of quantitiesslight risk + preventive measures taken reduce this risk specific protection measures shall not apply including substitution

18. 18 - EuropeIMA Chemical Agents Directive a solution?  not yet implemented in MS ( 5 May 2001 )  risk assessment guides not yet available  CS risk assessment not trivial specific guidance imperative

19. 19 Which Quartz OEL? Most of current regulatory limits ~ 0.1 mg/m 3 reduction? ACGIH recommends 0.05 mg/m 3 Inspection reports (1990, France, UK, USA) 30 - 50% of samplings > 0.1 mg/m 3 Compliance is essential to prevention

20. 20 Crystalline Silica discussion CS RCS Opinion Cat. 3 RCS 3 fronts of discussion EU Commission France Germany EUSCOEL process RCS