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ANNEX B

THE PUBLIC HEALTH ETC (SCOTLAND) ACT 2008 (SUNBED) REGULATIONS 2009

DRAFT REGULATORY IMPACT ASSESSMENT ( RIA)

1. Title of proposal

1.1 The Public Health etc. (Scotland) Act 2008 (Sunbed) Regulations 2009.

2. Purpose and intended effect

Objective

2.1 To protect the public from the risk of skin damage and the increased risk of developing skin cancer as a result of sunbed use by ensuring that those who intend to use a sunbed are fully informed of these risks. This measure is part of comprehensive legislation contained in Part 8 of the Public Health etc. (Scotland) Act 2008 which regulates the use, sale and hire of sunbeds.

Background: Existing regulation of sunbed operators

2.2 The total number of commercial outlets providing sunbed usage is not known. The Royal Environmental Health Institute for Scotland ( REHIS) estimated that in 2005 there were 807 sunbed salons in Scotland, around 44 of which were unstaffed. The Sunbed Association ( TSA), founded in 1995, is the trade association for the UK sunbed industry representing manufacturers (tubes/equipment) and sunbed operators. They estimate that there are around 8,000 tanning facilities in the UK, only a fifth of whom are members of the TSA (Banks, 2006). However, a study conducted by the South West Public Health Observatory ( SWPHO 2009) identified a total of 5,350 sunbed outlets, 4,492 located in England, 484 located in Scotland, 203 in Wales and 171 in Northern Ireland. This is more consistent with the Scottish Government's current work to identify premises in Scotland for the purposes of these regulations, where it has been established that there are unlikely to be more than 650 premises. Commercial outlets are particularly concentrated in low-income areas. The industry also experiences a high turn over of premises, which adds to the difficulty of estimating numbers with any degree of accuracy.

2.3 Whilst the Health and Safety at Work Act 1974 applies to sunbed operators, in the same way that it applies to all employers, and therefore sunbed operators should carry out a risk assessment to assess the health and safety risks to employees, and persons other than employees, arising out of work activity, the legislation does not offer any scope to regulate on the minimum age of the customer, the use of unsupervised sunbeds, or the mandatory provision of health information. The Health and Safety Executive has recently updated its guidance ( INDG 209 (rev1)) entitled 'Reducing health risks from the use of ultraviolet ( UV) tanning equipment'. However, the guidance is not legally binding.

2.4 Eight local authorities operate local licensing schemes (public entertainment category) to regulate sunbed premises in their areas under the Civic Government (Scotland) Act 1982. They account for around 213 sunbed premises.

2.5 The provisions in the Public Health etc. (Scotland) Act 2008 will strengthen the regulatory position in Scotland, making good practice mandatory. The Act prohibits operators from allowing use of sunbeds on their premises by persons under 18; from allowing unsupervised use of sunbeds on their premises; prohibits the sale or hire of sunbeds to persons under 18; places a duty on operators of sunbed premises to provide information to sunbed users and to display information notices on their premises on the adverse health effects of sunbed use, the information to be provided and displayed to be set out in Regulations made by Scottish Ministers. These Regulations are the subject of this Regulatory Impact Assessment. The regulatory measures will also be backed up by a communications campaign aimed at the public, and in particular young people, highlighting the dangers of sunbed use. There will also be guidance to businesses to alert them to their obligations under the Public Health Act.

Background: Usage of sunbeds

2.6 Around a quarter of adults in the UK have used a sunbed, as have around 6% of young people aged 11-17. The fraction of young people who had used a sunbed was higher in 15-17 year olds and 11-17 year olds resident in cities (11%). 18% of young people have not used a sunbed, but would consider doing so in the future (Cancer Research UK on behalf of Department of Health, 2008). A Mintel report in 2007 on the ownership and use of beauty aids showed that 4% of a sample of adults aged 16 or over own a sunbed/solarium or sun lamp and 7% use one. There are no separate statistics for Scotland. Results of a national survey of 1,000 people in Northern Ireland in 2007, undertaken by the Irish Cancer Society, showed that 6% of those surveyed said that they use a sunbed: 20% of users use sunbeds once a month, 9% use them twice a month and 2% use them once a week.

Rationale for government intervention

2.7 The Scottish Government is concerned at the rise in skin cancer in Scotland. Over a 20 year period (1984-2004) the reported incidence of non-melanoma skin cancers has trebled and the incidence of melanoma skin cancers has more than doubled. UK-wide, there are 8,900 cases of malignant melanoma diagnosed every year and 1,800 deaths. In the age group 20-39 years, malignant melanoma is the second most common cancer in the UK. This is an unusually young age distribution for adult cancer and emphasises the importance of preventive measures.

2.8 The increased skin cancer rate is not, of course, due entirely to the use of sunbeds, but also to direct exposure to the sun's ultraviolet rays. However, there is now substantial evidence of the increased risks caused by sunbed use. In addition to increased risks of skin cancer, medical evidence also suggests links to premature aging of the skin, eye damage, photodermatosis and photosensitivity. Just one session a month will double the average individual's annual dose of ultraviolet radiation. Using sunbeds at a young age (before the age of 35) increases the risk of getting cancer by up to 75%. Recent research (by Prof. Brian Diffey in 2003) estimates that the use of commercial sunbed parlours accounts for 100 deaths per year in the UK from malignant melanoma. Ultraviolet radiation from sunbeds has been classified as a Group 2A carcinogen by the International Association for Research into Cancer ( IARC).

2.9 The World Health Organisation ( WHO) has stated that 'there is growing evidence that the ultraviolet ( UV) radiation emitted by the lamps used in solariums may damage the skin and increase the risk of developing skin cancer'. This evidence came mainly from epidemiological studies carried out in various countries where there had been an increasing trend in the use of artificial tanning devices by white skinned people. A study of the use of sunbeds or sunlamps and malignant melanoma in Southern Sweden found that there was a generally increased risk of malignant melanoma for people who had used sunbeds and that, compared to matched controls, melanoma patients under 30 were 7 times more likely to have used a sunbed more than 10 times a year. The WHO therefore 'encourages governments to formulate and enforce effective laws governing the use of sunbeds and further recommends that of highest regulatory priority should be the restriction of use by persons under 18 years'. They consider that voluntary codes are ineffective in providing adequate health protection from sunbed use. In addition, the European Commission Scientific Committee on Consumer Products ( SCCP) has also concluded that young people under the age of 18 should not use sunbeds.

2.10 The Committee on Medical Aspects of Radiation in the Environment ( COMARE) published its 13 ^th report on 19 June 2009. This report entitled 'The Health Effects and Risks Arising from the Exposure to UV Radiation from Artificial Tanning Devices' provides further evidence and support for the regulation of sunbed use. It is supportive of the measures being implemented in Scotland including the banning of sunbeds to under 18s and the banning of unsupervised use of sunbeds, as well as recommending that the use of sunbeds is not recommended to increase vitamin D levels, given there are safe alternatives which do not carry the risks associated with exposure to artificial UV radiation.

3. Consultation

Within government

3.1 All of the evidence gathered to inform the policy to regulate sunbed use was examined by the Scottish Government Cabinet to aid their consideration of the proposals to be contained in the Public Health etc (Scotland) Bill, and those introduced at Stage 2 of the Bill's progress through the Scottish Parliament. Having weighed up all of the evidence, the Scottish Cabinet decided that comprehensive legislation was required to protect public health, including the requirement for operators to provide information to customers and to display notices on the health effects of sunbed use. In addition, NHS Health Scotland, the Health & Safety Executive and the Department of Health were also consulted on the proposals.

Stakeholders

3.2 A Stakeholder Group was set up at the beginning of 2008 and members consulted on what should be included in these Regulations. These stakeholders also participated in the Scottish Parliament's consideration of the Public Health Bill in 2008. The group included representation from the Sunbed Association, Consol Suncentres, Dundee University, Cancer Research UK, the Health & Safety Executive, the Federation of Small Businesses, COSLA and representations from local authority environmental health. The group considered and advised on issues such as the long and short term health risks of sunbed use and the health information and advice that should be given to clients. It should be noted that the information to be provided must be confined to the health risks of sunbed use, which is within the competency of the Scottish Parliament. Other advice relating to any precautions which might be taken, e.g. not to exceed the recommended time on a sunbed, or to confine to no more than one session a day, is the responsibility of the Health and Safety Executive.

Public consultation

3.3 A proposal for a Bill to require sunbed and tanning salons to be licensed was previously lodged in the Scottish Parliament by Kenneth Macintosh MSP. He distributed a consultation document entitled 'The Regulation of Sunbed Parlours Bill' in May 2006 to a wide range of interested parties, including health boards, local authorities and representatives from the sunbed industry. In total, 54 parties responded, with strong support for the regulation of sunbeds. In addition the Scottish Government undertook a telephone survey of 16 companies which it had identified as selling or hiring sunbeds in Scotland, however only one of those contacted responded to the questionnaire and 8 had ceased trading or were not obtainable. Evidence was also sought from a number of stakeholders during the passage of the Public Health etc (Scotland) Bill in 2007/08.

3.4 The draft regulations, and this draft Regulatory Impact Assessment, will be subject to public consultation. In addition, the following groups have been consulted directly:

• Cancer Research UK
• Chief Executive, NHS Health Scotland
• Chief Officers of Environmental Health
• Chief Officers of Trading Standards
• CONSOL Suncentres Ltd
• COSLA
• Crown Office & Procurator Fiscal Service ( COPFS)
• Dermatologists in Scotland (via the Regional Cancer Network Managers)
• Directors of Public Health
• Federation of Small Businesses
• Health and Safety Executive ( HSE)
• Health Protection Agency
• Health Protection Scotland
• Kenneth McIntosh MSP
• Leisure Clubs/Solariums (with an interest)
• Local Authority Sunbed Working Group
• Melanoma Support Group
• Other UK Government Health Departments
• Royal Environmental Health Institute of Scotland ( REHIS)
• The Sunbed Association
• Scottish Inter Faith Council
• Scottish Retail Consortium
• Society of Chief Officers of Environmental Health in Scotland ( SOCOEH)
• Society of Chief Officers of Trading Standards in Scotland ( SCOTSS)
• Sunbed Operators/premises in Scotland
• Sunbed Operators Working Group
• Teenage Cancer Trust
• Voluntary organisations/cancer charities (with an interest)
• West of Scotland Cancer Network ( WSCAN)

4. Options

4.1 This RIA gives consideration to the impact, in terms of costs and benefits, of the various options available:

Option 1: Do Nothing

4.2 This would mean not developing the regulations required under sections 100 and 101 of the Public Health etc (Scotland) Act 2008, prescribing the information to be displayed on notices and given to potential users of sunbeds.

Option 2: Introduce a National Licensing Scheme

4.3 Consideration has been given to introducing a national licensing scheme. This could be developed under powers in existing legislation and would ensure a consistent approach to the regulation of sunbed premises in all 32 local authorities.

Option 3: Introduce the Public Health etc (Scotland) Act 2008 (Sunbed) Regulations 2009

4.4 This option will build on the comprehensive provisions in the Public Health Act which prohibit operators from allowing use of sunbeds on their premises by persons under 18, from allowing unsupervised use of sunbeds on their premises and prohibiting the sale or hire of sunbeds to persons under 18. The Regulations prescribe the information to be displayed on notices and to be given to potential customers on the health risks associated with sunbed use.

4.5 Details of these options and the associated costs and benefits are described in section 5.

5. Costs and benefits

Sectors and groups affected

5.1 Commercial sunbed premises would be affected by the proposals. They would be required to comply with the new Regulations, ensuring that potential sunbed users were alerted to the health effects of sunbed use. That may, in turn, affect the numbers of people who use their premises.

5.2 Suppliers and manufacturers of sunbed facilities could be affected by the proposals if people are deterred from using sunbeds.

5.3 Local authorities would be affected by the proposals as they would be required to enforce compliance with the regulations. However, this is not expected to have significant impact because of their existing duties related to sunbed premises under the Health & Safety at Work Act.

5.4 The Crown Office Procurators Fiscal ( COPFS) could be affected. However, a fixed penalty system would be in operation and therefore only persistent offenders would be referred to the COPFS.

5.5 As the measure is part of more comprehensive regulation of sunbed use (see paragraph 2.5 above), the total package should ensure a positive impact on public health in the longer term, particularly amongst young people.

5.6 There is evidence to suggest that concentration of sunbed premises is higher in deprived urban areas, even after taking into account their more densely concentrated populations. There may therefore be a small positive impact, in the longer term, on reducing health inequalities.

Option 1: Do Nothing

5.7 There are no added health benefits with this option and no added costs to the Scottish administration, local authorities or businesses.

5.8 However, not to develop regulations which prescribe the information to be displayed and given to persons who propose to use a sunbed in sunbed premises would invalidate the relevant duties placed on operators in the Act. It would not help to achieve the Scottish Government objective of protecting the public from the risk of skin damage and the increased risk of developing skin cancer as a result of sunbed use. It would mean that many sectors of the general public, especially younger members of the population, would remain unaware of the serious risks of sunbed use and the longer term implications for their health. Whilst previous publicity campaigns have helped to raise awareness on this issue, and will continue to do so in the future, many younger people, in particular, continue to use sunbeds and experience the health effects of doing so. To make it mandatory to require operators to display and provide information on the health effects directly to an individual who proposes to use a sunbed in their premises is an effective way of getting the message across.

Option 2: Introduce a National Licensing Scheme

5.9 There would be potential health benefits from a national licensing scheme, although these are difficult to quantify. The COMARE Report, published on 19 June, whilst supportive of Scotland's measures to regulate sunbed use, also recommends the licensing of sunbed premises. The Scottish Government view is that we need to assess the success of the impact of the new legislation before licensing can be considered. A number of potential licence conditions are already included as provisions in the Public Health Act, i.e. preventing the use of sunbeds by under 18s, ensuring that sunbed users are supervised, and ensuring the provision of information to users on the health effects of sunbed use. Other potential licence conditions, such as ensuring that sunbed sessions are limited or a requirement for accredited staff training, would ensure a safer environment for sunbed users. However, it would not rule out the misuse of sunbeds by individuals. The aim of Scottish Government policy, at this time, is not to establish well run sunbed premises, but to protect the public and try to change public behaviour, i.e. to associate sunbeds with increased health risks.

5.10 To establish a national licensing scheme across Scotland would have set-up administration costs for the Scottish Government and for those local authorities who do not already operate existing local licensing arrangements. These are difficult to quantify. Current legislation allows local authorities to recover the cost of operating a licensing regime from those who apply through licence fees and charges. This means that the costs of implementing the scheme are offset against this income. The cost burden would then fall directly to sunbed operators. In addition, there is the potential for small businesses to recoup the expense of the licence and administration costs by increasing the fees to their customers. Costs of licences would vary from one local authority to another. For example, for skin piercing and tattoo businesses, estimated licence costs range from £150 to £500. A national licensing scheme would entail a duty being placed on local authorities to inspect premises to ensure compliance with licence requirements. However, this would have minimal funding implications as such premises are already inspected under Health and Safety at Work legislation. The Federation of Small Businesses in Scotland, in its evidence to the Scottish Parliament on proposals to regulate sunbed parlours, was not convinced that the licensing of salons was an effective and proportionate response to the problems identified, particularly when the additional costs associated with any form of licensing regime would fall on small businesses.

Option 3: Introduce the Public Health etc (Scotland) Act 2008 (Sunbed) Regulations 2009

Health and cost benefits

5.11 See the Scottish Government Rationale for the policy set out in paragraphs 2.7 - 2.10 above. The aim of the duty in the Public Health etc (Scotland) Act 2008 to display notices and provide information to customers, as prescribed in these regulations, is to protect the public from the risk of skin damage and the increased risk of developing skin cancer as a result of sunbed use by ensuring that those who intend to use a sunbed are fully informed of these risks. This measure is part of comprehensive legislation contained in Part 8 of the Act which regulates the use, sale and hire of sunbeds.

5.12 There is substantial research published on the incidence of, and deaths arising from forms of skin cancer, although less data is available on the connection of these to prior use of sunbeds. The most recent meta-analysis of 19 studies found a positive correlation between ever-use of sunbeds and melanoma (summary relative risk of incidence 1.15, 95% confidence interval 1.00-1.31), although there was no consistent evidence of a dose-response relationship. Exposure to sunbeds before 35 years of age was found to significantly increase the risk of melanoma (summary relative risk 1.75; 95% CI 1.35-2.26). ²

5.13 Another study conducted in 2003 estimated mortality from melanoma due to sunbed use each year in the UK to be about 100 deaths. ³ This would translate to about 8.5 deaths in Scotland. To put this into perspective, GRO Scotland recorded a total 171 deaths due to malignant melanoma of the skin for Scotland in 2008.

Costs of treating those with cancer and other potential effects of sunbed use

5.14 The total annual cost of dermatology treatment costs related to cancer in the table below was calculated using ISD data for 2002 ⁴. Unfortunately, it is impossible to estimate what proportion of cancer related appointments are associated with prior use of sunbeds and to therefore place a cost value on the treatment.

Value of lives saved

5.15 Assuming that all of the 8.5 death estimated above could be prevented given appropriate information and signposting about the dangers connected to the use of sunbeds, this would equate to a Value of Life (VoL) saved of £11.84m in the first year ⁵ and a Net Present Value ⁶ of about £218m over 30 years.

Costs to Scottish Government

5.16 The notices which sunbed operators are to display and leaflets containing the information to be provided to potential users, as prescribed in the Regulations, will be developed by the Scottish Government and stocks will be issued to operators before the Regulations come into effect. This will cost no more than £10,000. After the initial distribution, information materials will be available on the Scottish Government website to download.

5.17 In addition, the Scottish Government will carry out an awareness-raising campaign, in partnership with Cancer Research UK, on the implementation of these Regulations and the other aspects of sunbed regulation contained in the Public Health Act, aimed at the public and sunbed operators. The awareness-raising campaign is estimated as costing the Scottish Government around £50,000. The full cost of the development, production and distribution of the information materials and the awareness-raising campaign will be met from existing budgets and will not be an additional cost to the Scottish Government.

Costs to local authorities

5.18 The legislation does not require a regular timetable of inspections of premises. Environmental Health Officers already have duties in respect of sunbed premises under health and safety at work legislation, and it is anticipated that inspection of premises to ensure compliance will be incorporated within this existing work, without any significant additional costs being incurred by local authorities. A fixed penalty regime will be in place for non-compliance, and any penalties may be retained by local authorities. Trading Standards Officers will also incorporate any compliance work for this legislation with other existing duties, including the enforcement of age-related products under the other provisions of Part 8 of the Act. COSLA was consulted on potential costs when the Public Health Act was progressing through the Scottish Parliament and was unable to quantify any additional costs to local authorities from the new legislation.

Costs on other bodies, individuals and businesses

5.19 There will be minimal cost to sunbed operators from these regulations as significant supplies of display notices and information materials will be provided free of charge by the Scottish Government. Thereafter, materials will be available to download from the Scottish Government website. It is difficult to estimate whether there will be any potential costs to businesses in terms of lower demand for sunbed use as a result of the health information being provided to customers.

5.20 Introduction of a fixed penalty regime is expected to free up court time and allow court resources to be diverted to the most acute of cases. It is not therefore expected that there will be any significant additional costs for prosecutors of the courts.

6. Small/Micro Firms Impact Test

6.1 The majority of sunbed premises are small, unless they are part of wider businesses. Whilst implementation of the Regulations will impact on these businesses, the impact is not likely to be significant. Further details on consultation with small businesses can be found at paragraph 3.3.

7. Legal Aid Impact Test

7.1 There are no legal aid impact test issues to consider.

8. 'Test run of business forms'

8.1 There are no business forms which require to be tested with the preferred option. If proposals for licensing were adopted, this would involve business in completing additional forms.

9. Competition Assessment

9.1 No significant competition issues have been identified with any of the options. The Regulations apply equally to all operators and therefore are unlikely to have any significant competition implications.

10. Enforcement, sanctions and monitoring

Enforcement

10.1 Compliance will be enforced by authorised officers of the local authority. In practice, this will be Environmental Health Officers and Trading Standards Officers. Enforcement guidance is being developed by the Scottish Government, with the full involvement of local authority officers. Authorised officers of a local authority have a power under the legislation to enter and inspect premises in their area in order to determine whether an offence has been or is being committed. We do not intend to insist on a regular timetable of inspections, as would be required under a licensing scheme. Officers already have duties in respect of sunbed premises under health and safety at work legislation, and it is anticipated that the duty from this legislation can be incorporated into their current duties, without additional resources being incurred.

Sanctions

10.2 The Public Health Act introduces a system of fixed penalty notices for offences under Part 8. This gives local authorities an additional tool to deal quickly and effectively with non-compliance of the legislation, without the need to go to Court. The Fixed Penalty Notice for operators failing to provide information on health risks or display notices is £50. Any penalties may be retained by local authorities. In addition, prosecution is an option for cynical or persistent offenders, whom we would expect to be reported to the Procurator Fiscal. Such offenders will be subject to fines of up to £2,500 on summary conviction.

Monitoring

10.3 There is no statutory provision in the Public Health Act for monitoring the effectiveness of the policy. However, we would expect local authorities to make information available on rates of compliance as part of the normal course of their work and other duties under Health and Safety at Work legislation. In terms of the effect on the use of sunbeds and the implications for sunbed-related harm, this can be monitored over time through external research.

CMO and Public Health Directorate

Scottish Government

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