Outcome of consultations - on CD156 & 157

CD156 European Commission Directive under the Chemical Agents Directive 98/24/EC to establish a First Consolidated List of Indicative Occupational Exposure Limit Values at European Community level

CD157 Control of Substances Hazardous to Health Regulations 1999 Proposals for Maximum Exposure Limits, and Occupational Exposure Standards

The CDs were distributed to consultees in a number of ways:

CD156 CD157 No. of copies distributed direct to consultees 800 1300 No. of copies obtained through HSE Books 440 1073 No. of Internet site 'hits' 1088 1211

HSE received 21 replies to CD 156 and 39 replies to CD157. In the latter case only 19 related to the IOELV proposals. In respect of CD 156 just over 50% of the respondents represented industry, 5 represented professional associations, 2 represented trades unions, 2 represented government and 1 was an independent consultant.

In addition to substance specific responses, a number of general comments were made. Principally:

1. Concern was expressed by 2 professional associations that in the case of a good many of the proposed limits, no identified analytical method is available. One of these suggested that HSE model exposures using the EASE software package, or exposure measurements from scientific publications. A major association representing the chemical industry is also concerned about this issue;
   
2. Concern was expressed that, in view of the fact that Member States had already voted in favour of the directive, the scope for disagreement was limited;
   
3. One respondent representing Trades Unions in England and Wales urged HSE to ensure that limits are applied in other safety regimes such as the Maritime and Coast guard Agency;
   
4. One multinational company commented that they value European legislation because it makes it easier for them to apply standards throughout Europe. It added that it would have been useful if the European Commission had been able to take on board more of the UK's comments so that the UK and other Member States would then have the same limits;
   
5. A professional association representing occupational hygienists expressed concern that there are potential inconsistencies in the way that skin notation is assigned in the UK. and for IOELVs. This respondent suggested that HSE take note of the views of Sartorelli et al (1998) who have suggested that the use of physico-chemical models of dermal uptake could be used to provide sounder basis for assigning skin notation to chemicals. This method should be used to help scrutinise any IOELV skin notations.
   
6. one employer and one consultant electrical engineer expressed concern about the practice of withdrawing OESs before a MEL is in place. They were not convinced that a Chemical Hazard Alert Notice (CHAN) offered an adequate level of control. They were also concerned about issuing CHANs for substances currently being consulted upon on the grounds that such an approach might be prejudicial to the outcome of the consultation exercise.
   
7. one trade association detailed the effects of changes to OELs and R phrases on environmental protection controls and the resulting additional burdens for industry. The respondent argued that either the costs associated with complying with these additional environmental controls should be incorporated into future RIAs or the link between OEL/R phrases changes and Environmental Protection legislation should be broken.

Dealing with these comments in order, HSE's response is:

1. Unlike MELs, testing air concentrations against OESs is not obligatory and so HSE is not obliged to offer a measurement method. OESs are just one way that employers can demonstrate the adequacy of control of airborne exposure; if they chose this route, it is up to them to find suitable measurement methods. That said, HSE/HSL has done a lot of work over the years developing suitable methods and validating them. The respondents have not said methods don't exist, just that we should identify a validated method. There is no positive evidence of measurement difficulties and in most cases we consider that a suitable method is available. However, we do intend to raise these concerns with DG Employment and during development of EU proposals for future IOELVs;
   
2. HSE is considering how consultation on any proposals for future IOELV Directives could take place at an earlier stage;
   
3. Duties under COSHH, and hence OELs, are disapplied to masters or crew of a sea-going ship, or their employer in relation to normal shipboard activities. We have forwarded this comment to the Maritime and Cost guard Agency of DETR (who observe at ACTS) who have responsibility for implementation of CAD and IOELVs on board ships;
   
4. HSE agrees that common standards throughout Europe are important; this is why it supports the EC's IOELV programme. Having said that, HSE will continue to seek to put its views across to the Commission effectively with the aim of ensuring the best possible IOELV limit for the UK;
   
5. HSE has not seen and therefore cannot comment on this particular paper and the physico-chemical models it proposes. WATCH and SCOEL use their own agreed criteria to assign a Skin notation; any attempt to improve these criteria and reduce inconsistencies would need to involve both expert committees. Ultimately, however, assigning a Skin notation is a matter of expert judgement and so even if similar criteria are applied WATCH and SCOEL may reach different conclusions .
   
6. HSE is committed to informing employers, safety representatives, users and suppliers of chemicals as rapidly as possible of an ACTS/WATCH recommendation not to set/retain an OES for a substance, so that they can take any necessary steps to modify their approach to securing adequate control of exposure. HSE's chosen mechanism is the issue of CHANs, which provide interim advice on a substance while a MEL is being developed. It is standard practice for a CHAN to be issued as soon as ACTS has recommended the development of a MEL. This is to minimise the delay in alerting employers, safety representatives, and suppliers that it is not possible to identify with confidence a level of exposure which is judged to be both safe and realistically achievable. While CHANs only have the status of guidance, the COSHH Regulations and the General COSHH ACOP can still be applied to ensure that exposure of workers to hazardous substances is adequately controlled by employers (Regulation 7(1) and ACOP paragraph 38). In addition, EH40 provides references to previous OES figures for substances covered by CHANs (indicated in lighter type in Table 2 of EH40) since this represents at least a level of exposure that is practically achievable. This approach was outlined in ACTS/14/97 and agreed by members in March 1997. The fact that a CHAN is issued before the completion of a consultation exercise on the proposed withdrawal of an OES does not pre-judge the issue. The CHAN can be subsequently reviewed by HSE in the light of additional information arising from the consultation.
   
7. OELs are set for personal occupational exposure and are not directly applicable to environmental exposures. However, the Environment Agency continues to use fractions of OESs and MELs as a guide to setting environmental assessment levels (EALs) where it does not have its own standards. Since the link between OELs and EALs is discretionary rather than automatic, HSE considers that the responsibility both for evaluating the impact that new/revised OELs may have on EALs, and for considering whether to remove this link, rests with the EA. HSE accepts, however, that it may be sensible to outline in its own RIAs that there is a discretionary link with environmental protection legislation. [Subject to ACTS members' endorsement, HSE proposes in future RIAs on new/revised OELs to include an explanation about the discretionary link with EALs, and that there may be downstream costs and benefits.]