Health and Safety
Executive / Commission
Radiation
1. The Irish Presidency of the European Union developed a proposal for a Physical Agents (Optical Radiation) Directive that was subsequently presented to a European Council meeting by the Netherlands Presidency in July 2004. It is the fourth and last in a sequence of physical agents directives that amend the European Commission’s original 1993 proposal for a Physical Agents Directive covering noise, vibration, electromagnetic fields and optical radiation.
2. Negotiations in the European Council Social Questions Working Group began in July 2004 and were concluded by the Dutch Presidency before the end of that year. The text then passed to the European Parliament for its second reading. This concluded with a debate and vote on 6/7 September 2005 with amendments that subsequently changed the proposal considerably from the original Irish version.
3. The major change to the proposal has been the removal of natural radiation (sunlight) so that the proposal is now confined solely to artificial sources. There have also been some other amendments but they do not significantly alter the substance of the text. The removal of the natural radiation provisions means that the costs of implementation have been much reduced compared to those of the original proposal.
4. The proposal lays down minimum health and safety requirements regarding the exposure of workers to the risks arising from optical radiation. Optical radiation, which includes ultraviolet radiation (UV), infrared radiation, visible light and lasers, is a form of radiation that can interact with people in a way that varies according to the radiation wavelength. The objective of the proposal is to protect workers from the risks associated with this potential hazard and to achieve harmonisation of control regimes between Member States. It aims to achieve this by using the guidelines for restrictions on exposure that have been produced by the International Commission for Non-ionising Radiation Protection (ICNIRP). These scientifically based guidelines are designed to prevent the effects on health that can occur at high levels of exposure.
5. The proposal places a range of duties on employers. These include the requirements to assess and control exposure, reduce risk, and provide information and training to workers. There are also provisions on health surveillance.
6. The risk from optical radiation depends on the type of radiation and the intensity and the part of the body that is exposed. The symptoms of excessive exposure are well defined and the areas of the body most at risk are the skin and the eyes. The effects on the eye include damage to the cornea and lens whilst the effects on the skin include redness, burning and blistering and an increased risk of skin cancer. These adverse effects are rare as artificial sources of optical radiation are well controlled.
7. The ICNIRP guidelines upon which the Directive is based set out a series of exposure values – called exposure limit values (ELVs) in the Directive - that are designed to prevent adverse health effects.
8. Currently there is no UK legislation specific to optical radiation. The general duties to assess and control risks contained in the Health and Safety at Work Act 1974 and the Management of Health and Safety at Work Regulations 1999 apply. The proposal adds little to these existing requirements, but it does define more precisely what is expected. For example, it requires, for artificial sources, assessment of exposure as a means of assessing risk and compliance with ICNIRP guidelines and specific items of information and training. There are two types of optical radiation that need to be considered separately: lasers and broadband sources.
9. The former NRPB has estimated that about 2.1 million people work in places where lasers are used, though probably few are likely to come into contact with lasers where there is a risk of exposure above the ELVs. There is a hazard-based classification system for lasers and a British Standard which covers their use. The classification defines those lasers which, if misused, could result in overexposures. In most industrial applications high-powered lasers are properly controlled, while in some other applications they are not. However, misuse of a laser would be an offence under existing legislation and the Directive proposal does not add to this.
10. The former NRPB has also estimated that about 2.4 million people work in places where broadband sources are used, though only 400,000–1,300,000 of these are at any risk from possible inadequate control. Those who are actually likely to be exposed above the ELVs are considerably fewer. There are some industrial sectors and processes in which the emissions would immediately cause the ELVs to be exceeded, including those that generate or use an intense source of light such as in welding and glass manufacture, but these applications are almost universally controlled. Other applications, such as the use of high-powered lighting in entertainment, are rather less well controlled, though the risk of actual ill-health is very low.
11. During the negotiations, UK officials were keen to ensure that the proposal did little more than adopt the international ICNIRP guidelines for the control of exposure as compliance with these guidelines affords sufficient protection and control to prevent ill health. This has been achieved and when the Directive is eventually published in the Official Journal, it will have to be transposed into UK law within four years.
12. Most of the information used in this RIA was sourced from two NRPB reports commissioned by HSE1. Many assumptions have been based on judgements applied by HSE’s technical experts. Costs have been discounted at an annual rate of 3.5% (in line with Treasury guidance) and earnings have been uprated by 1.8% to account for real annual increases. Prices are expressed in 2003 values.
13. In determining the correct level of resources to devote to promoting and enforcing the proposals, HSE must take a proportionate approach. In the great majority of cases, the risk to human health from optical radiation is low and so HSE has not attached a high priority to optical radiation and is unlikely to do so in the future. The number of employers who are likely fully to comply with current duties as expressed in the new proposals is assumed to rise by 10%2. The effect of varying this assumption is examined in the “uncertainties” section.
14. At or below the limit values in the draft Directive, there will be no adverse health effects for workers. If workers were to be exposed at levels substantially in excess of these values, adverse health effects could well be observed either to the eye or the skin. For example, in the case of the eye, ultraviolet radiation can damage the cornea, infrared radiation can produce cataracts and laser radiation can cause severe damage that may result in blindness. In the case of the skin, UV radiation can produce a range of symptoms from reddening to burning and blistering and an increased risk of skin cancer. Powerful lasers can cause skin burns.
15. HSE has received few reports of ill-health or injury from exposure to optical radiation. Most reports of harm relate to the misuse of lasers, and these are occasionally serious. There will be benefits if such injuries are eliminated, but this is a function of compliance with existing law.
16. The draft Directive calls for "particular attention, when carrying out the risk assessment, to… any effects concerning the health and safety of workers belonging to particularly sensitive risk groups". Although HSE has some broad information from previous NRPB reports on the number of workers that may be subject to any such risk, we lack accurate information on levels of exposure and dose response relationships. Consequently no attempt has been made to estimate the health benefit.
17. There would be unquantifiable benefits to trade in providing a harmonised level of protection of workers to exposure to optical radiation across Europe. A harmonised level of protection would ensure that there was a ‘level playing field’ across the European Union.
18. The proposals will affect many sectors. Principal among these are; entertainments, research, medical, engineering, manufacturing and communication. NRPB estimates suggest that approximately a maximum of 4.5 million employees work in areas where there might be exposure to optical radiation, although few of these would be at risk of exceeding the ELVs as previously stated.
Familiarisation with the proposals
19. The average length of time that employers spend familiarising themselves with the proposed regulatory changes is assumed to be thirty minutes. Unfortunately, HSE does not have any direct information on how many employers will be affected by the proposals. However given the estimate of 4.5 million affected employees we can derive an estimate of how many firms will be affected by making assumptions about the average number of affected employees per firm. HSE assumes the latter figure lies between 7 and 203. The labour cost per hour is assumed to be £234. Under these assumptions, the one-off costs of familiarisation lie in the range of £0.27 million to £0.79 million.
Determination and assessment of risk
20. The NRPB report W35 suggests that 3,484,000 workers are exposed to some risk from broadband and optical radiation. Of these, HSE judges that between 174,000 and 348,000 are exposed to high risk, and between 3,136,000 and 3,310,000 are exposed to low risk. Risk assessments do not have to be conducted on each worker and HSE assumes that on average a risk assessment covers between 10 and 15 workers. For high-risk environments, HSE assumes that a production manager (£23 an hour) must spend an extra 3 to 5 hours conducting proper assessments. For low-risk environments, the corresponding extra time spent on risk assessments is 0.5 to 1 hour. The estimated costs of laser and broadband risk assessments are between £0.64 million and £0.85 million. Assessments are assumed to recur on average every three years5. This yields ten-year present values of between £2.40 million and £3.14 million.
Information and training for workers
21. The costs of providing information to workers who are exposed to low risks from laser and broadband optical radiation are assumed to be absorbed at insignificant cost within existing training procedures.
22. Workers at high risk from laser and broadband optical radiation are assumed to require an extra 90 minutes of instruction every year. This amounts to an annual cost of between £0.39 million and £0.78 million, which has a ten-year present value of between £3.62 million and £7.23 million.
Health surveillance
23. This Directive refers to duties in the Framework Directive that have already been transposed in the UK by the Management of Health and Safety at Work Regulations 1999. In addition, there is a requirement for the provision of appropriate health surveillance linked to the outcome of the risk assessment that can be accommodated under the existing national health structure. The Directive therefore places no new duties on industry.
Action to reduce exposure
24. The Directive requires that, for artificial sources, appropriate action should be taken and recorded if a risk assessment reveals the possibility of an ELV being exceeded.
25. HSE has assumed that insignificant costs will arise from action that has to be taken as a result of risk assessments for workers at low risk from laser and broadband optical radiation.
26. For laser and broadband optical radiation workers who are at a high risk of exceeding the ELVs (as determined by the risk assessment), the costs of developing an action plan are substantial because of the likely need to employ a consultant. HSE has assumed that between 5% and 20% of risk assessments (on high risk workers) would indicate the potential for ELVs to be exceeded, and that each action plan takes a consultant between 0.5 and 3 hours, and a production manager 1.5 hours to complete. The cost of a consultant is between £120 and £150 an hour6, while the production manager’s time costs £23 (as described above). Action plans would have to be revised every three years. These assumptions yield a first year estimated cost of £0.01 million to £0.05 million, and a ten-year present value of between £0.02 million and £0.20 million.
27. The costs of implementing the action plans are difficult to assess. In some cases, the necessary action may simply be modifications to behaviour and better use of existing shields. In other cases investment in better protective equipment may be required. HSE has assumed that half of the action plans indicate the need for investment. Furthermore, we assume that the cost of additional equipment in each case lies between £300 and £10007, and that the equipment must be replaced every three years. These assumptions yield a first year cost of between £0.01 million and £0.35 million, and a ten-year present value of between £0.03 million and £1.20 million.
28. Although enforcing the implementing Regulations will involve some cost, HSE anticipates that it would have to be absorbed within existing budgets. While this would mean a re-allocation of resources, the subsequent opportunity costs are not readily quantifiable.
29. No environmental costs have been identified
30. The estimated annualised cost8 is between £0.68 million and £1.36 million.
31. The cost of the proposals averaged across the assumed number of firms that operate in potentially high-risk environments is estimated to be between £55 and £76 in the first year, with a ten year present value of £246 to £366. However, the typical business in this category will not have to implement costly action plans, and hence the costs to such a firm will be somewhat lower.
32. The initial text was circulated to our stakeholders followed by a copy of the revised text when negotiations reached common position. Discussions and meetings also took place with representatives of manufacturing and other organisations during the early negotiations and whilst the text was under consideration by the European Parliament at second reading. There was also consultation with the International Electrotechnical Commission, an international standards organisation, and with the membership of one of its subsidiary groups dealing with laser and laser-based products. Overall, the most significant concern raised by the consultees centred on the natural sunlight provisions that are no longer in the Directive.
33. The impact of the Directive on firms is likely to be in proportion to the number of employees significantly exposed to optical radiation and the number of pieces of equipment that emit optical radiation. Assuming that employees in small firms are no more likely to be exposed to high risks than their counterparts in larger firms, and that small firms do not operate proportionately more pieces of high-risk equipment, there should be no disproportionate burden on small firms.
34. HSE has contacted a number of small firms principally involved with laser sources to assess the potential impact of the Directive. Most of the companies received support and advice from their trade association particularly in relation to risk assessments. Each company was sent a copy of the Directive. The firms generally indicated that they would continue to obtain support and advice about risk assessments etc in the same way as current practice. We did not receive any indication that they would encounter significant implementation costs. Further consultation will take place when the formal consultation exercise is undertaken.
35. The proposals will affect a large number of industrial sectors and markets. In such cases, the Office of Fair Trading recommends that competition assessments are conducted on markets that exhibit a high degree of supplier concentration. These markets are at the greatest danger of suffering adverse impacts on competition from new interventions. However, in the case of the optical radiation Directive, there is no readily identifiable market that fits this description. Furthermore, compliance costs to individual companies are not only small but also, in the majority of cases, are incurred by all suppliers in the relevant markets, with new firms experiencing exactly the same set-up and on-going costs as existing firms. The only area of concern is that some markets are subject to high rates of technological change. However, this in itself does not present cause for concern over potential negative impacts on competition.
36. Overall, HSE does not expect negative competition effects when the proposals are transposed into UK law.
| First year | Ten year present value | ||
| £million | £million | ||
| Total Benefits | Unquantified | Unquantified | |
| Total Costs | 1.32 to 2.82 | 6.31 to 12.57 |
37. Although there are numerous uncertainties in the calculations, most have been made explicit by incorporating large ranges in key parameters. However this is not the case with the assumption on the number of extra employers that comply with the existing duties. This assumption has the greatest impact on the estimated compliance costs. Proportionate action on the part of HSE to enforce the proposals is assumed to encourage an extra 10% of relevant employers to comply. This is judged by HSE to be the likely maximum that will be attained. However, if this proved wrong and compliance with the duties increased by 50%, the first year costs would be between £6.58 million and £15.18 million, with a ten year present value of between £31.59 million and £66.88 million. Conversely, if extra compliance with the duties amounted to only 5%, first year costs would be between £0.66 million and £1.40 million, and the ten-year present value would be between £3.15 million and £6.23 million.
38. The Directive, when adopted, would need to be implemented in the UK by regulations under the Health and Safety at Work etc. Act 1974. Monitoring of the impact will be on an ad-hoc basis by feedback and information received from HSE inspectors during the course of their routine inspections and from information provided by stakeholders.
39. The proposed Directive uses existing international guidelines for the ELVs and the associated requirements for risk assessments and control of exposure are broadly identical to existing requirements under current health and safety legislation. This Directive when implemented will not generate specific enforcement action although appropriate action would be undertaken if a clear breach of health and safety responsibilities were identified.
40. We intend to issue guidance in due course that will allow employers to ascertain how they will achieve compliance with the Directive. We do not expect that the Directive will impose any significant additional burdens for those employers who are already assessing and controlling risks as part of existing duties.
1 "Review of Occupational Exposure to Optical Radiation and Electric and Magnetic Fields with Regard to the Proposed CEC Physical Agents Directive” NRPB R265
“Occupational exposure to optical radiation in the context of a possible EU Proposal for a Directive on optical radiation" NRPB-W35.
2 Current levels of full compliance with the duties set out in the proposals is not known but is thought to be low.
3 The lower bound is the average firm size of all enterprises in Great Britain, while the upper bound is the average firm size of all enterprises that have employees (ie, the figure excludes enterprises with no employees). Figures were taken from Small Business Service statistics 2003.
4 This is taken from NES 2003 and relates to a production manager (SOC 112) and includes a 30% for non-wage labour costs.
5 Risk assessments only need to be repeated when major changes are made to processes. The high-tech nature of lasers and some broadband optical radiation sources probably means that changes are relatively frequent.
6Information provided by an HSE inspector.
7 Although protection against broadband optical radiation would probably be cheaper, there are instances where this level of expenditure would not be sufficient to protect against lasers, and the costs would be significantly larger. £300 to £1000 is therefore taken as range that includes the true average.
8This is the constant annual figure that when applied and discounted over a ten-year period yields the ten-year present value.