Wien.arbeiterkammer.at Revision of the Carcinogens and Mutagens Directive – Why do we need it? Christoph Streissler Arbeiterkammer Wien (Chamber of Labour,

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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

wien.arbeiterkammer.atChristoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

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

wien.arbeiterkammer.atChristoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

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

wien.arbeiterkammer.atChristoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

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)

wien.arbeiterkammer.atChristoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

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)

wien.arbeiterkammer.atChristoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

Dose response relationship

Source: Factsheet Grenzwerte am Arbeitsplatz – Grundlagen und Anwendung. SUVA 2012, modified

wien.arbeiterkammer.atChristoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

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)

wien.arbeiterkammer.atChristoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

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

wien.arbeiterkammer.atChristoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

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

wien.arbeiterkammer.atChristoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

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

wien.arbeiterkammer.atChristoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

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)

wien.arbeiterkammer.atChristoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

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

wien.arbeiterkammer.atChristoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

Risk based OELVs

Source: Henning Wriedt, modified

wien.arbeiterkammer.atChristoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

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 = categoryCLP 1A

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

wien.arbeiterkammer.atChristoph Streissler: Revision of the Carcinogens and Mutagens Directive. Stockholm, 27-28 June 2013

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)