Risk Management Measures in the real world

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At the end of October, I travelled over to Helsinki for a few days. I’d been invited to deliver a short course on “Risk management measures in a REACH context”  to personnel working for the European Chemicals Agency* (ECHA) who are responsible for evaluating the dossiers chemical manufacturers have to submit under the European REACH Regulation. Over 30 people attended the course, a much bigger number than I’d normally prefer. However, they were a really nice group of people who were keen to listen and contribute to the discussion making it an enjoyable experience for me, and, I hope, for the attendees. It was good to have the opportunity to put forward my perspective on how effective risks from hazardous substances are controlled in practice in the “real world of industry.

The principle objective of REACH is to protect human health and environment from chemical hazards, ensuring that risks from the use of chemicals are properly controlled. To achieve this, manufacturers have to undertake risk assessments for all “exposure scenarios” where their products are used and produce “extended safety data sheets” for substances, which must include appropriate “risk management measures”. We’re now starting to see these new style data sheets coming through to users.

During the training session, we looked at how exposures to chemicals vary and the practicalities of obtaining adequate data for the risk assessment process. However, the main discussion centred on the realities of how “risk management measures” are implemented in industry, based on my experiences helping companies to control the risks from using hazardous substances.

I think that there is a widespread impression that controls are much more effective than they are in practice. There are lots of reasons for this, which I’ve discussed in some previous posts. Problems can occur during all the key steps involved in the design and implementation of controls – see my Slideshare presentation and this post for some examples.

It’s a particular problem with local exhaust ventilation systems. In my experience they are rarely well designed and, in practice,  their influence on exposure is considerably less than the users (and designers/suppliers) believe. The “lower tier” exposure models commonly used to prepare the REACH risk assessments can assume that LEV is up to 90% effective. The system would have to be well designed and properly used and maintained for this to be the case and I think that it is rare for it to be achieved in practice. Consequently, exposure modelling with lower tier models can considerably overestimate the reduction in exposure achieved by LEV.

Manufacturers and importers of chemicals need to make judgements about the effectiveness of controls when carrying out their risk assessments and also when deciding on what risk management measures are needed. The danger of overestimating how good they are could compromise their risk assessments and result in risk management measures being specified that won’t adequately control exposure. It’s important, then, to have a realistic appreciation of the “real world” effectiveness of common controls.

Those extended data sheets I’ve seen so far seem to specify realistic controls for the exposure scenarios. However, they are phrased in very general terms. Again this is likely to be a particular problem with LEV. For many industrial organisers “LEV” means a captor hood – often the flexible “swinging arm” type. As I’ve discussed in a previous post, these are largely ineffective at controlling contaminants. But in many cases if a company follows a general recommendation to install LEV, this is what they’ll buy.  I think that if REACH is really to achieve it’s objective of improving control, then we need to ensure that the advice on risk management measures is as specific as practicable. So with LEV enough details needs to be provided to make sure that the design of the extraction hood is appropriate.

Milling polyurethane blocks at semi automated machine
Inappropriate application of a captor hood

Another problem I’ve noticed with the new style safety data sheets I’ve seen is that where personal protective equipment is recommended the advise is too general. For example, recommending “wear suitable gloves”. This really isn’t any improvement on the older style sheets. Downstream users need more specific advice on what type of gloves are needed, particularly what they should be made of. The reality is that most users don’t have the expertise to select “suitable gloves” and in most cases the gloves used are made of an inappropriate material and are not used and managed properly.  This point is also relevant to other types of personal protective equipment. Again, I’d like to see more specific details provided.

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For me a good model for user friendly control advice is the COSHH Essentials control sheets. These provide good, concise advice on control for common processes on a maximum of 2 sides of A4. Where LEV is recommended specific details on the hood design, including an outline diagram, is provided. These sheets aren’t perfect – their advice on personal protection is too vague, for example – but I think that overall they strike the right balance between brevity and the usefulness of the information.

A lot of work has to go into carrying out the risk assessments. It’s important that the output – i.e. the information on risk management measures – should be detailed enough to ensure that controls are properly designed and implemented. Unless this happens there’s a real danger that all the effort will be in vain and an opportunity to substantially improve control of hazardous substances at work will have been missed.

*ECHA’s role is to manage and coordinate the registration, evaluation, authorisation and restriction processes and to ensure consistency in the management of chemicals across the European Union.

REACH – Regulating chemicals in Europe

I’ve recently produced a brief presentation summarising the main requirements of REACH

A version with some explanatory notes is available on Slideshare.

REACH is the most important piece of legislation on the control of chemicals for a long time, certainly since COSHH was introduced in 1988. The Regulations are going to have a major impact on what chemicals are produced and the way they are controlled. Although the driving force for their introduction was pressure from the environmental lobby, their main implications are for the use of chemicals in the workplace.

At the moment its chemical manufacturers and importers who are affected – the registration process is well underway. Industry in general aren’t affected and, in my experience, most small and medium-sized companies don’t know much about the Regulations and what they will mean for their business. This will change when the requirements on “downstream users” start to come into force.

I don’t think most occupational hygienists in the UK have been affected too much by REACH yet. A minority who work for chemical manufacturers have been involved in the registration process and some consultants have also been engaged to help with this and in carrying out risk characterisations for exposure scenarios and generation of extended data sheets. However, I’m sure that most members of the profession will be involved in helping “downstream users” to meet their obligations in the not too distant future. So its important that we make sure we know about REACH and keep up to date on the technical developments.

BOHS / NVVA conferece on REACH

REACH

Conferences ae always a “mixed bag” and this was the case with  the REACH meeting held in Brussels on 30 September/1 October. Overall, it was worthwhile attending and I certainly learned more about how the requirements of REACH relating to occupational exposures were being implemented in practice.  Some of he contributions were a little too basic, given the nature of the conference and the audience, but the majority were useful.

The key points I took away from the conference were:

  • there remains a clear conflict between the requirements of REACH and occupational health and safety legislation. The objectives are the same (i.e. protecting the health of workers and others) but there are significant differences in their approaches  which could potentially lead to conflicting perceptions of risk and requirements for control.
  • insufficient thought was given to how the REACH requirements on hazard and exposure assessment could be applied in practice before the legislation was introduced. Companies implementing the requirements are having to develop the methodologies as they go along and the timescales are too tight to allow then to be properly validated before deadlines have to be met.
  • REACH DNELs (derived no effect levels) are consistently tighter than Occupational Exposure Limits (OELs) due to the major differences in the ways they are established.  This can lead to confusion and as DNELs are used in the risk assessment process to develop “risk management measures” (RMMs) it is highly likely that the REACH process will result in tighter controls being specified than those based on a risk assessment using established OELs.  Although this problem has been known about for a number of years, it has still not been resolved.
  • The tools needed for exposure assessment, which is required to allow RMMs to be specified, are still not fully developed and validated.
  • the Advanced Reach Tool (ART) looks promising and may have wider occupational hygiene applications, but needs to be validated.
  • there are a number of “first tier” exposure assessment tools (i.e. basic exposure modelling methods). A number were described during the conference. It would have been useful to see them demonstrated, using the different tools for the same substance so that their conclusions could be compared.
  • modelling techniques are always going to have their limitations, and this is particularly true for the basic “first tier” models. They need to be used by people who understand exposure assessment and these limitations. Ideally they shoul only be used as part of the exposure assessment process. There is a real danger that this won’t happen in many cases and that RMMS will end up being specified by inexpeienced people using only the flawed, basic models. From what I saw at the conference the models tend to err “on the side of safety” (just like COSHH Essentials). This may mean that worker health won’t be adversely affected but it could have economic consequences for he employers and possibly damage employment.

The occupational hygiene community has the expertise to develop the methodologies, and also has the knowledge and experience to work out how the REACH process could be improved. Unfortunately, I doubt that we have sufficient “clout” to influence the powers that be on this and we are going to have to live with, and try to manage, the consequences once the Regulations start to impact on “downstream users”.

REACH out

EU

Tomorrow I’ll be heading off to Brussels for the meeting on REACH (REACH: Registration and Beyond: Exposure Scenarios and safe handling advice) organised jointly by BOHS and their Dutch sister organisation, NVVA.

The conference focuses on some important issues, including exposure assessment. REACH requires manufacturers and importers of substances and mixtures to develop exposure scenarios and appropriate risk management measures. This is a major requirement which, with the current methodologies available for assessing occupational, environmental and consumer exposures, would be impossible to achieve. Consequently a lot of work is going into developing exposure models and guidance for exposure assessment which manufacturers and importers will be able to use when the target dates for the exposure scenarios approaches.

I’m hoping that the conference will help to bring me up to date on what progress has been made. There are so many factors that affect exposures in the workplace, so it will be interesting to see how far these have been incorporated into the models being developed. Its a big ask.