Regulation and oversight of alkaline hydrolysis
22. Extending the application of the 2016 Act to alkaline hydrolysis is one of a number of regulatory frameworks that will collectively ensure that the process is safe and that it appropriately protects public health. It will be for those intending to offer alkaline hydrolysis to ensure they have complied with all relevant legislation and to be able to demonstrate this before being able to operate.
23. It is proposed that once operational, providers will be required to work on an ongoing basis in accordance with the requirements of the 2016 Act and related regulations, all other relevant legislation, and any codes of practice and guidance. (Question 3)
24. As set out above any operator will be required to identify how they intend to deal with the liquid produced and obtain consent from the relevant authority before commencing operations. For example, where the intention is to release the liquid to public sewer, Scottish Water would need to grant trade effluent consents as well as oversee and monitor the liquid from alkaline hydrolysis. This requirement is set out in section 26 of the Sewerage (Scotland) Act 1968. Scottish Water, rather than SEPA, will be the regulator where consent is granted for a discharge of the liquid to the drain.
Scottish Environmental Protection Agency (SEPA)
25. SEPA is responsible for dealing with any issues relating to the protection of the environment. They would regulate discharge of the liquid to the environment, rather than the public sewer, from alkaline hydrolysis should that be the method appropriate to the location of the facility. SEPA have advised that discharge to the water environment would only be considered where there is no public sewer available.
26. It will be for each operator to liaise with SEPA and Scottish Water and agree which method of dealing with the liquid is most appropriate for the location. The operator will then need to ensure that they have obtained the necessary consents in order to make their planning application to the local authority.
27. Any person or business intending to offer alkaline hydrolysis will first need to acquire premises or adapt existing premises to house the equipment. Generally a planning application will need to be submitted to the relevant planning authority for the area where the premises are/will be situated. The planning application process will consider whether the proposed development is appropriate in terms of its location, visual impact, impact on local infrastructure such as access and transport links, etc. Applications may also be subject to Environmental Impact Assessments if required as part of the planning process. Statutory consultees, which could for example include SEPA, Scottish Water, Scottish Natural Heritage or the Health and Safety Executive may also be asked to comment depending on the specific circumstances of the development.
The Burial and Cremation (Scotland) Act 2016
28. As noted above, the 2016 Act provides a modern, comprehensive legislative framework for burial and cremation. It allows Scottish Ministers to develop measures related to the whole of the funeral sector, including licensing funeral directors; developing codes of practice; and inspecting and regulating the practices and procedures of burial authorities, cremation authorities and funeral directors. It is appropriate that those offering alkaline hydrolysis should be subject to the same level of scrutiny and record keeping requirements.
Opening a facility providing alkaline hydrolysis
29. It is proposed that operators of premises that will offer alkaline hydrolysis will be required to go through a procedure similar to the procedure that applies when a new crematorium is to be opened (section 59 of the 2016 Act). In addition to acquiring planning permission the operator will be required to give the Inspector of Burial, Cremation and Funeral Directors notice of their intention to open. It is proposed that they will need to demonstrate to the Inspector that they have obtained all necessary consents. Section 59 states that no applications for cremation can be accepted until the Inspector has consented. The alkaline hydrolysis regulations will require the same consent from the Inspector to operate alkaline hydrolysis facilities. (Question 4)
30. It is possible that funeral directors or cremation authorities will install alkaline hydrolysis equipment in existing premises. In order to do so they will need to comply with the same obligations as any provider setting up a new facility and ensure that all regulatory requirements are complied with. This includes giving notice to the Inspector.
Regulating the process – the Cremation (Scotland) Regulations 2019
31. It is our view that this process should be regulated in a very similar way to cremation. This means that alkaline hydrolysis procedures would be subject to the same legislative requirements and regulations which apply to cremation as set out in 2016 Act and the Cremation (Scotland) Regulations 2019 ("the 2019 Regulations").
32. It is proposed that the operators, premises and the process itself will also fall within the scope of the wider funeral sector inspection regime which is being developed under the 2016 Act. Any operators of alkaline hydrolysis would be subject to ongoing inspection in the same way as cremation authorities. (Question 5)
33. The 2019 Regulations require each cremation authority to:
- prepare and maintain a management plan for each crematorium for which it is the cremation authority. The plan should contain at least the minimum detail set out in regulation 2, including:
- operating procedures
- contingency plans
- maintenance of equipment.
- Retain applications for cremation for at least 50 years.
- Keep a register of all cremations.
34. We propose that operators offering alkaline hydrolysis should also be required to have a management plan for each alkaline hydrolysis facility they operate/ control in the same way as cremation authorities. The plan should set out the procedures and processes which enable the premises to run effectively. This is because much of the process including applications, record keeping, registers and operation of the facility/equipment are similar.
35. One of the key reasons for development of the 2016 Act and the 2019 Regulations was the need to ensure that accurate records of the process and the handling of ashes are kept. It seems equitable that the same requirements should apply to alkaline hydrolysis.
36. The management plan should include details of working practices and procedures, including, for example:
- the name, address and contact details of the alkaline hydrolysis facility, including email;
- the procedures for:
- carrying out of alkaline hydrolysis;
- dealing with any sudden increase in demand;
- dealing with applications in an emergency;
- operation and servicing of all equipment used in the process;
- disposal of ashes (such as return to family);
- disposal of effluent;
- Other regulatory requirements (such as Scottish Water or SEPA) and what procedures are in place to meet these;
- review of the management plan: and
- resilience plan for continuity of business.
37. We have not suggested what the format of the management plan should be, and it will be for operators to decide what is appropriate for their premises. We are of the view that a period of six months from regulations coming into force will be sufficient time to have a plan in place. (Question 6)
Maintenance and operation of equipment
38. A manufacturer has advised that training on the use of alkaline hydrolysis equipment would be made available when they install the equipment, and additional training can be provided during routine maintenance and servicing. If the technology is introduced, we intend to require that the operator ensures that staff are trained in the operation of the equipment used, similar to the requirements in the 2019 Regulations for cremation authorities. Cremation authorities are obliged to ensure that staff are provided with training in the operation of crematorium equipment and that it is recorded in the management plan. We suggest it should be a requirement for all training undertaken to be recorded in the management plan to ensure that written records are prepared and maintained.
39. Part 3 of the 2016 Act sets out who can make arrangements for burial or cremation. It is proposed that this will also apply for any new procedures introduced under section99. The 2019 Regulations set out the statutory application forms which must be submitted in order to carry out a cremation in Scotland. We intend to develop similar statutory forms for alkaline hydrolysis. The application forms will clearly set out the details of the deceased, the applicant, the additional forms that should accompany an application (such as the Certificate of Registration of Death) and what is to happen to any remains (ashes). (Question 7)
Joint alkaline hydrolysis
40. Joint cremation is an option under the 2019 Regulations. The 2019 Regulations make provision in relation to the cremation of: the remains of two adults; the remains of one adult with one or more than one child, still-born child or fetus; or the remains of more than one child, still-born child or fetus. We understand that it is possible for two individuals to be processed at the same time using alkaline hydrolysis, at the discretion of the operator. This might only be requested rarely and would only be done where the premises/equipment can facilitate it and there are no other operational restrictions. As with cremation, where a joint alkaline hydrolysis procedure is to take place, it is proposed that an application form for each individual will be required and should be registered individually in the alkaline hydrolysis register (see below) and recorded as individuals who are processed together.
Shared alkaline hydrolysis
41. The 2019 Regulations provide for the shared cremation of pregnancy losses where the applicant is a health provider. Due to the way that alkaline hydrolysis is carried out, where the body is removed from any container and nothing can be put in alongside the body, we are of the view it would not be appropriate to offer alkaline hydrolysis for shared cremation of pregnancy losses.
Young children and stillborn babies
42. In countries where alkaline hydrolysis is available it has been used for adults and children over four years old. We have been informed that current providers are unlikely to offer alkaline hydrolysis for children under the age of four or stillborn babies. This is primarily because, while it is possible to perform the process, it is highly unlikely that there would be any “ashes” at the end to return to parents. It would ultimately be a decision for each provider whether they wish to offer alkaline hydrolysis for young children and stillborn babies and if offered, the informed consent of parents in relation to the process and likely outcome would be key.
43. Should alkaline hydrolysis be regulated, we would propose to create application forms for adults, children and stillborn babies in a similar way as has been done for cremation. These would ensure clarity, openness and transparency in relation to the process. The lack of ashes in the case of children under the age of four or stillborn babies would need to be made absolutely clear in guidance to accompany the application forms. It would also be made clear in the accompanying guidance that it would not be possible for any mementos to be put in beside an infant or stillborn baby. Following discussion with the provider and being informed that there would be no ashes, it would be for the parents to decide whether alkaline hydrolysis is their preferred option based on their own values, attitudes and beliefs.
44. One of the main drivers for the 2016 Act was ensuring that what happened to the ashes following the cremation of an infant, stillborn baby or pregnancy loss would be accounted for. We are of the view that a lack of ashes should not exclude parents from being able to choose alkaline hydrolysis based on an informed understanding of the process and its implications. It would be imperative that it be made clear to parents before applying for alkaline hydrolysis, as well as recorded on the application form, that there would be no ashes from alkaline hydrolysis of an infant or stillborn baby. (Question 8)
Deaths investigated by the procurator fiscal
45. Where the Crown Office and Procurator Fiscal Service (COPFS) has investigated a sudden or unexplained death, COPFS must issue a Form E1 giving permission for cremation to take place. The Form E1 is currently only required for cremation (and not for burial) as cremation means the body is no longer available for future examination. The intention is that, where the Crown Office has investigated the death, a form similar to a Form E1 will be required before alkaline hydrolysis can take place because the body is also destroyed by this process. (Question 9)
Handling of ashes: notices and time periods for collection of ashes
46. The 2019 regulations set out the requirements for cremation authorities and funeral directors in relation to how they ensure that the instructions of the applicant for cremation are complied with. It is proposed that similar duties to comply with requirements related to the handling and disposal of ashes from alkaline hydrolysis processes (including requirements to give written notice to applicants when ashes are available for collection and time periods for the collection of ashes) should be applied to alkaline hydrolysis providers.
Disposal of ashes
47. Sections 51 – 56 of the 2016 Act sets out responsibilities of cremation authorities and funeral directors in relation to handling ashes. These procedures were brought in to ensure that the instructions (on the cremation application form) for what is to happen to the ashes are carried out and that accurate records are kept. For example, section 51 states that the cremation authority must take steps to ascertain the ways in which ashes are to be dealt with before carrying out the cremation, so it is clear whether the ashes are to be collected, who can collect them or if they are to be disposed of by the cremation authority.
48. There are then duties on cremation authorities and funeral directors in relation to returning ashes and what their options are if ashes are not returned or collected. At set points both must contact the applicant to make them aware what is happening with the ashes, when they can be collected and what will happen if they are not collected. Our intention is that alkaline hydrolysis operators will be required to comply with similar handling and record keeping requirements in relation to the handling of ashes. (Question 10)
Alkaline hydrolysis registers
49. The 2016 Act provides that cremation authorities must prepare and maintain cremation registers, setting out information about cremations carried out in the crematorium. The contents of the cremation registers are set out in the 2019 Regulations and it is appropriate for the alkaline hydrolysis registers to contain the same or very similar information. There are registers for whole bodies and for body parts. The information held includes:
- Unique reference number
- Date of cremation of body or date of cremation of body part and of remainder of body
- Name of deceased
- Sex of deceased
- Date of birth
- Date of death
- Funeral director
- Information on the dispersal of ashes
50. There is also a cremation register for stillbirth and pregnancy losses. The information held includes:
- Unique reference number
- Date of cremation
- NHS number
- Name (if given)
- Details about applicant
- Information on the dispersal of ashes (including if none were recovered)
51. It is considered appropriate that providers of alkaline hydrolysis are required to maintain a register if they offer alkaline hydrolysis for stillborn babies. (Question 13)
Duty of local authority to arrange funerals
52. Section 87 of the 2016 Act states that a local authority must arrange a funeral where “it appears that no arrangements are being made”. This may be because there are no relatives or because there are no funds to meet the funeral costs. Local authorities currently can arrange a burial or a cremation, with cremation being the most commonly used method. Should alkaline hydrolysis become available, it is proposed that it could be an alternative method available to local authorities when arranging a burial or cremation under section 87. (Question 14)
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