Response 592705025

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Are you responding as an individual or an organisation?

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What is your organisation?

Organisation
NHS Grampian - Responding for radioactive substances

Part 2: Policy Overview

1. Do you agree with the benefits set out here?

Please select one item
Ticked Yes
No

Part 3: Key features of the new framework for authorisation holders.

4. Do you agree that the framework should include a set of universal outcomes?

Please select one item
Ticked Yes
No

5. If so, are the outcomes proposed the right ones?

Please select one item
Ticked Yes
No

6. Do you see any opportunities within your sector for industry- led guidance to be produced to support this approach and how could it support you to deliver better?

Please select one item
Ticked Yes
No
Comments:
Key here is the definition of harm, in the radioactive sector this could be defined as the level of dose to the most exposed individual. Clearly such a dose level will have to be consistent will have to be set at a level of acceptable risk (not 20uSv). In addition the definition of accident - would this be a situation that has the potential to cause harm? This highlights importance of define an appropriate harm level. I support the sentiment in section 3.3.1 & 3.3.2

9. Do you agree that SEPA should consult on the guidance setting out the likely tier of authorisation for particular activities?

Please select one item
Ticked Yes
No

10. Do you agree that standard rules will deliver the benefits we have set out?

Comments:
Standard rules have the potential to ensure that consistent conditions apply to all authorisations. Considerable effort should be made to ensure that they cover as many of the conditions for a full permit as possible. One example would be the production of radionuclides in a medical cyclotron – even though this quite a specialist practice standard rules should apply as far as possible. My worry is that if bespoke permits could contain too many bespoke rules then there is a great risk of inconsistency between permits.

11. Do you agree with the procedure for making standard rules?

Please select one item
Ticked Yes
No
If not, why not?
It is very important that there is full consultation

12. Do you agree that SEPA and Scottish Ministers should have the ability to make GBRs?

Please select one item
Ticked Yes
No
Comments:
Yes in principle. For radioactive substances I would have thought that GBR should be made following to a suitable and credible assessment of risk.

13. Do you agree that all regulated activities should have an authorised person responsible for overall compliance and that this person should be named in a permit and registration?

If not why not?
As I understand it the term “authorised person” can refer to an individual or an organisation and therefore is misleading and ambiguous. In other regulations in our field IRR99/17 and IR(ME)R the term employer is used and then it is clear that it is the organisation that is responsible. Other alternatives are Authorised Holder or Authorised Body.

14. Do you think it is proportionate to require the person in control to be the person that notifies an activity in the notification tier?

Comments:
Same as the above in the medical and university sectors and other large organisations

15. Do you agree that SEPA should include more than one person as the authorised person where appropriate?

Comments:
As above, I don’t think the word person should be used. There are perhaps some circumstances where it may be appropriate to include more than one authorised employers/bodies/organisation, however presumably would this mean a joint application and payment etc. Not sure how this would work for larger organisations.

16. Do you have any views on how SEPA should decide if a person is in “control”?

Comments:
Determination of who is control should be the same as for other legislation – i.e. the employer. It would be for the applicant to state who this is.

17. Question 17 – Do you think the core requirements set out here will deliver the right approach to FPP for the integrated authorisation framework?

Comments:
Same issues with the word “person” as set our above. I agree that the test for FPP should be set according to activity.

18. Do you think that the criteria set out above will achieve the stated purpose of the FPP test?

Comments:
Depends on the detail for each activity. For radioactive substances the technical competency could be satisfied at least in part by appoint of an suitably competent RWA.

19. Do you agree with the proposed application processes?

Please select one item
Ticked Yes
No
Comments:
YES. It would be good if the application process for each of the tiers could be carried on-line.

20. Do you agree with the proposal to have a statutory determination period of four months for the majority of permit applications?

Please select one item
Ticked Yes
No

21. Should the legislation make a clear distinction for applications for “non-standard” activities?

Comments:
I would think that it would be difficult to define non standard.

22. What other alternative arrangements would you suggest for managing non-standard applications?

Comments:
Better to agree extension to determination period at the start of the process.

23. Do you agree with the proposals for variations?

Please select one item
Ticked Yes
No
If not, why not?
Yes, but for simple variation to permits then the 4 month determination period should be viewed as a back stop.

24. Do you agree with the proposals for transfer?

Please select one item
Ticked Yes
No

25. Do you agree with the proposals for surrender?

Please select one item
Ticked Yes
No

26. Do you agree with the proposed approach to enforcement notices set out above?

Please select one item
Ticked Yes
No
Comments:
Definition of harm would have to be defined.

27. Do you agree a notice used in the way set out in 3.7.10 to 3.7.12 is a different type of notice and should be therefore be called something different, such as an improvement notice?

Please select one item
Ticked Yes
No

28. What benefits and drawbacks do you foresee from SEPA using enforcement notices in the way set out at 3.7.10 to 3.7.12?

Comments:
Removing prescription from the permit or standard rules means that there will be a danger of an inconsistent approach to enforcement; very dependent on interpretation of individual inspectors. Good guidance could help here, but then if the guidance is prescriptive it means the guidance becomes the de-facto rules.

29. Do you agree we should retain suspension notices for use in circumstances where we wish to suspend an activity in order to protect the environment, but the authorised person is not being ‘enforced’ against?

Please select one item
Ticked Yes
No

30. Do you agree SEPA should have the power to revoke authorisations in these circumstances?

Comments:
Generally yes but would the revocation apply to GBRs and notifications as well?

31. Do you agree that appeals against SEPA decisions should continue to be heard by the DPEA on behalf of Scottish Ministers?

If not, which alternative body do you think should hear such appeals and why?
No view

32. Do you have any views on the proposed policy principles for transitional arrangements?

Comments:
Seems reasonable

33. Do you have any suggestions for how SEPA might manage the workload to implement integrated, and corporate, authorisations?

Comments:
No view

Part 4: Key features of the new framework for the public

34. Do you support SEPA having more flexibility in how information is made available to the public?

Please select one item
Ticked Yes
No

35. Do you agree that a consistent, flexible and proportionate approach to public participation should be adopted?

Please select one item
Ticked Yes
No
Comments:
Yes – for radioactive substances any public consultation should be accompanied by creditable and easy to interpret risk information to allow a lay person to come to an informed view. As an example our current waste licence allows us to discharge limited amount of radioactive gas into the atmosphere from our cyclotron unit. Given the bad publicity surrounding ionising radiation and the way the press can sensationalise such information in an public consultation would have to be very well managed

Part 7: Radioactive Substances

39. Do you agree that it is appropriate to have controls on radioactively contaminated materials whilst they remain on the premises where they were contaminated?

Please select one item
Ticked Yes
No

40. Do you foresee any practical implications of the proposal to have controls on radioactively contaminated materials whilst they remain on the premises where they were contaminated?

Do you foresee any practical implications of the proposal to have controls on radioactively contaminated materials whilst they remain on the premises where they were contaminated?
Will the definition of contaminated materials also include activated materials? Specifically components of medical cyclotrons and medical linear accelerators?

41. Do you agree that all substances associated with NORM industrial activities should be subject to control under the integrated authorisation framework, where they exceed the out-of-scope values, irrespective of whether or not they are classed as radioactive material or waste?

If not, why not?
No view

42. Do you foresee any significant implications of this proposed change, e.g. are there any finished products (consumer products or construction materials) that would become classified as radioactive material?

Do you foresee any significant implications of this proposed change, e.g. are there any finished products (consumer products or construction materials) that would become classified as radioactive material?
No view

43. Do you agree that we should continue to exclude the public from the scope of the radioactive substances regulatory regime?

Please select one item
Ticked Yes
No

44. Do you agree with the proposed radioactive substances regulated activities?

Please select one item
Ticked Yes
No

45. Do you agree with the proposals for applying the new regulatory regime to nuclear licensed sites?

If not, why not?
No view

46. Do you foresee any problems with removing the requirement to display certificates?

Do you foresee any problems with removing the requirement to display certificates?
No

47. Do you agree that SEPA should have the power to impose conditions in an authorisation requiring the permit holder to carry out operations off their site?

Please select one item
Ticked Yes
No