IMA - Europe Crystalline Silica: The EU Regulatory Approach Dr. Michelle Wyart - Remy, IMA - Europe / EUROSIL Crystalline Silica and Oncogenesis Bologna, 24 October 2000
IMA - Europe 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)
IMA - Europe Mines Safety & Health Commission - ISSA Mining Section International Workshop, Luxembourg10-12April2000 Are quartz dusts carcinogenic? P.H. Hessel et al, JOEM 42 (7) 704-720 (2000) A response to a recent working group report
IMA - Europe The IARC Overall EvaluationIARC 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 fromoccupational sources is carcinogenic to humans (group 1) Coal dust cannot be classified as to its carcinogenicity to humans
IMA - Europe 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 is a variable entity CS exhibits a variable toxicity
IMA - Europe “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” C. McDonald & N. Cherry Crystalline silica and lung cancer: the problem of conflicting evidence Indoor Built Environment 8 121-6 (1999)
IMA - Europe Possible regulatory scenarios in the EU IARC + Scientific Evidence EU DG Employment & Social Affairs EU DG Environment Member States Classification Workers Protection
IMA - Europe Classification? Dangerous Substances Directive 67/548/EEC - 92/32/EEC EU DG Environment - European Chemical Bureau • carcinogen category 1 or 2 • preparations containing > 0.1% of it • labelling R49 may cause cancer by inhalation + • marketing & use restriction ban from public products • dangerous transport regulations • dangerous waste regulations
IMA - Europe "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
IMA - Europe Classification is not a priority DG XI-ECB, Ispra October 1998 CS is not a single substance CS exhibits a variable toxicity Are there grounds for appropriate legislative measures?
IMA - Europe Grounds for Prevention Risks limited to occupational exposure Silicotics at higher risks of cancer IARC, 1997 Relative risks silicosis/lung cancer: 12/1 C. A. Soutar & B.G Miller (IOM), SCOEL hearing March 2000 Silicosis is the leading effect DECOS, MAK Commission, WHO CICAD, OSHA
IMA - Europe 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 Substitution Risk assessment
IMA - Europe 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 ? which OEL SCOEL ? in which regulatory framework
IMA - Europe CarcinogensDirective Scenario Protection of workers from risks related to exposure to carcinogens at work 90/394/EEC- 97/42/EC - 99/38/EC Obligations Risk assessment • replacement • exposure reduction • information of Authority • workers information & training • hygiene & health surveillance • medical record-keeping (40 years) Agents • substance • preparation • process
IMA - Europe Carcinogens Directive Questions? which agent? crystalline silica? Belgium respirable crystalline silica? Denmark - the Netherlands or processes exposing to respirable crystalline silica? French Decree proposal in which industrial circumstances? how exempting non carcinogenic circumstances?
IMA - Europe The Dutch Example DECOS evaluation of Quartz carcinogenicity and genotoxicity publication no. 1998/02 WGD 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 DutchMAC value: 0.075 mg/m3 BUT RCS is a carcinogen at work whatever the exposure level!
IMA - Europe Chemical Agents Directive Scenario 98/24/EC Article 5.4 When risk assessment shows because of quantities slight risk + preventive measures taken reduce this risk includingsubstitution specific protection measures shall not apply
IMA - Europe 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
Which Quartz OEL? Most of current regulatory limits ~ 0.1 mg/m3 reduction? ACGIH recommends 0.05 mg/m3 Inspection reports (1990, France, UK, USA) 30 - 50% of samplings > 0.1 mg/m3 Compliance is essential to prevention
Crystalline Silica EU SCOEL 3 frontsof discussion Opinion Cat. 3 RCS EU Commission France Germany RCS CS discussion RCS discussion process