Revision of the Carcinogens and Mutagens Directive – Why do we need it?

1. Revision of the Carcinogens and Mutagens Directive – Why do we need it? Christoph Streissler Arbeiterkammer Wien (Chamber of Labour, Vienna, Austria) christoph.streissler@akwien.at

2. Overview • hazard – exposure – risk • starting point: a high level of protection • dose-response-relationship • threshold  non-threshold effects • health based limit values  risk based limit values • revision of the carcinogens directive (CMD): what lies ahead Christoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

3. Terms • chemical agent: any chemical element or compound, on its own or admixed […], used or released […] by any work activity, whether or not produced intentionally and whether or not placed on the market; • hazard: intrinsic property of a chemical agent with the potential to cause harm; • risk: likelihood that the potential for harm will be attained under the conditions of use and/or exposure. • exposure: concentration of an agent with which a person or population comes into contact (chemical agents: inhalation and dermal exposure) • risk = hazard × exposure Christoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

4. High level of protection • “A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities.” (TFEU, Article 168) • A high level of protection – in the context of chemicals – means to: • “ … ensure that, under reasonably foreseeable conditions, human health and the environment are not adversely affected.” (REACH Regulation, recital 16) • “… the objective in establishing OELs is to set limits for exposure via the airborne route such that exposure, even when repeated on a regular basis throughout a working life, will not lead to adverse effects on the health of exposed persons and/or their progeny at any time (as far as can be predicted from the contemporary state of knowledge).” (SCOEL: Methodology for the Derivation of Occupational Exposure Limits, v.6) Christoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

5. Can zero risk be achieved? • “… although in some cases scientific knowledge may not be such that a level of exposure to a chemical agent can be established below which risks to health cease to exist, a reduction in exposure to these chemical agents will nonetheless reduce these risks.” (CAD, recital 20) • “… the risk to humans and the environment can be considered to be adequately controlled if the estimated exposure levels do not exceed the appropriate DNEL. For those human effects for which it was not possible to determine a DNEL, a qualitative assessment of the likelihood that effects are avoided when implementing the exposure scenario shall be carried out.” (REACH regulation, Annex I, para 6.4 and 6.5, abridged) Christoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

6. Dose response relationship Source: Factsheet Grenzwerte am Arbeitsplatz – Grundlagen und Anwendung. SUVA 2012, modified Christoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

7. Threshold versus non-threshold effects of chemical agents • Chemicals which exhibit adverse effects only if their uptake exceeds a certain amount are said to have a threshold.This threshold value may be high (e.g. Acetone) or low (e.g. Chlorine), but in any case, exposure below the threshold value does not lead to adverse effects.(typically: acutely toxic or corrosive chemicals) • Chemicals which damage the genetic material of cells do not exhibit such a threshold. Already one single molecule can lead to a damage that develops into a cancer. However the potential to cause cancer may be stronger or weaker.(typically: carcinogenic and mutagenic chemicals) Christoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

8. Chemicals exhibiting a threshold effect dose effect relationship based on experimental values LOAEL: Lowest Observed Adverse Effect Level – lowest dose at which some adverse effect could be detected. NOAEL: No Observed Adverse Effect Level Source: as above Christoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

9. Chemicals exhibiting no threshold effect dose effect relationship based on experimental values, but only at comparatively high risks POD: Point Of Departure extrapolation to dose 0 (linear by default) Source: as above Christoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

10. Mode of action of carcinogenesis • Experimentally, only risks above about 10% can be observed; hence extrapolation to lower doses and lower risks is necessary • Some carcinogens exhibit threshold behaviour. In order to decide if this is the case for a given carcinogen, the mode of action (mechanism of carcinogenesis) has to be known • genotoxic action: no safe level • other modes (e.g. via chronic inflammation) may exhibit a threshold and hence a safe level • If mode of action is not well established, genotoxic carcinogenesis and hence no existence of a threshold should be assumed by default Christoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

11. Threshold versus non-threshold effects: OSH directives • OSH directives do not explicitly distinguish between threshold and non-threshold effects but between carcinogens and mutagens on the one hand and “other” chemical agents on the other hand. • CAD (Chemical Agents Directive): indicative occupational exposure limit values for the protection of workers from chemical risks, based on scientific data (health based values) • CAD: Binding Occupational Exposure Limit Values (BOELV): in addition reflect feasibility factors: only lead and its inorganic compounds. • CMD (Carcinogens and Mutagens Directive): binding occupational exposure limit values – BOELV (irrespective of mode of action) Christoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

12. Threshold versus non-threshold effects: REACH regulation • in theory: REACH regulation makes a more precise distinction • if a threshold value exists: the risk to humans and the environment can be considered to be adequately controlled if the estimated exposure levels do not exceed the appropriate DNEL:health based limit value = zero risk • If it was not possible to determine a DNEL [= no threshold value exists], a qualitative assessment of the likelihood that effects are avoided when implementing the exposure scenario [= applying the risk management measures appropriately] shall be carried out:risk based approach, but obscure • German and Dutch risk based concepts are more precise Christoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

13. Risk based OELVs Source: Henning Wriedt, modified Christoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

14. CMD in a nutshell • Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (= CMD) • covers carcinogens and mutagens (category 1 and 2 = categoryCLP1A and 1B) and substances or processes listed in annex I • obligations of employer: determination and assessment of risks; replacement (“substitution”) of substances or reduction; prevention of exposure following a hierarchy of steps; information and training for workers • health surveillance, keeping of records • annex I: additional substances or processes covered • annex III: binding occupational exposure limit values: 3 substances Christoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

15. Revision of the CMD: what lies ahead • current situation: • three BOELVs that take into consideration feasibility as of 25 years ago; • benzene: BOELV of 3,25 mg/m3: risk approx. 5 in 1000 • vinyl chloride monomer: BOELV of 7,77 mg/m3: risk approx. 3 in 1000 • what lies ahead: • methodology for deriving limit values (NOT based on cost benefit analysis) • more BOELVs, risk based • better monitoring in order to reduce discrepancies between MS • inclusion of reprotoxic substances (workers’ demand) Christoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013