1 At the outset, it is important that notifiers ensure a valid notification is submitted to the Health and Safety Executive (HSE), otherwise the notification will be returned to you and the process delayed. (HSE has lead responsibility for administration of the Genetically Modified Organisms (Contained Use) Regulations 2000). Please ask yourself the following questions before submission of the notification:
2 A CU1 should be attached for premises notifications and/or a CU2 should be attached for GM activity notifications. The use of notification forms is not a legal requirement but they have been designed to ensure that the necessary information is submitted and to clearly indicate any confidential material. Electronic copies of the forms are available from the HSE web site. The CU1 can be found at: http://www.hse.gov.uk/dst/useprem.doc, and the CU2 can be found at: http://www.hse.gov.uk/dst/conduct.doc.
3 Are all boxes in the 1st section (1-8 of the CU1 form and 1-15 of the CU2 form) of the form, marked with 'Public Register' down the margin, completed?
4 Are the personal and contact details at sections 9, 10, 11 & 13 of CU1 and sections 16 & 18 of CU2 fully completed? Please note that personal details are confidential under the Data Protection Act therefore you do not need to claim confidentiality.
5 If a confidentiality claim has been made at section 12 of CU1 or section 17 of CU2, have 'disclosable' details been provided in the 'Public Register' sections of the form?
6 Have the comments from the Genetic Modification Safety Committee (GMSC) been completed for all notifications?
7 Payment can only be accepted either by cheque or by BACS payment. Requests are sometimes received from notifiers for proformas, invoices or purchase orders. Unfortunately we are unable to issue proformas, invoices or purchase orders and cannot accept payment by credit card. Please note that the fees are updated annually. If you are unsure of what the correct fee is for your notification, please refer to the HSE web site at the address below.
8 Payment by cheque: A cheque for the correct amount, made payable to the 'Health and Safety Executive', must be submitted with the notification to: The Notifications Officer, Health and Safety Executive, Hazardous Installations Directorate, Specialised Industries Division, Biological Agents Unit, 1.2 Redgrave Court, Merton Road, Bootle, Merseyside L20 7HS
9 Payment by BACS: When the payment is by BACS, a remittance advice usually accompanies the notification. Payment should be made payable to the 'Health and Safety Executive'. The correct payment details are:
Bank: CitiBank, 25 Canada Square, Canary Wharf, London E14 5LB
Account: GBS Re Health/Safety Exec
Account no: 12316277
Sort Code: 08-33-00
10 We are also often asked if we charge VAT or for details of our VAT number. The Crown does not charge VAT for a statutory function and therefore does not have a VAT number.
Has the risk assessment been attached?
11. In cases where the submission of a full risk assessment requires the use of confidential information, the confidential information needs to be clearly identified. Although there is no set procedure for doing this, it is easiest for all concerned if you supply two separate risk assessments - one with the confidential information and one without. If this is done, sending out the version of the risk assessment that does not contain confidential information can readily satisfy any request for information from the public under Open Government provisions.
12 Most claims for confidentiality have been made in line with the Regulations. However, a few difficulties have been noted. Guidance is provided in a paper entitled 'Confidentiality and disclosure'.
13 The key point is that where it is necessary to refer to confidential material in order to provide the information that is sought in any section of the form, the confidential information should be provided in section 17. Thus, if it is necessary to provide confidential information in order to describe the purpose of the contained use, this information should be provided in section 17 under a heading such as 'Full response to section 6 which contains confidential information'. At the same time a more general response must be provided in section 6, which gives some indication of the purpose of the work without revealing the specific confidential information.
14 There has been some confusion over derogation requests. Two pieces of guidance have been published to provide important information, one entitled 'Derogations - Most common errors' and one entitled 'Guidance on derogations for autoclave facilities for containment level 3 laboratories'.
15 Some of the connected programmes of work recently submitted have not been acceptable because the scope of the proposed work is too broad. To clarify this issue a guidance document' Connected programmes of work and notification of significant and other changes' has been prepared and posted on the HSE web site in ACGM Newsletter 30. A revised version of this guidance 'Interim guidance on connected programmes' can be found in ACGM Newsletter 31.
16 Guidance is provided in 'Administrative and other changes to notified information', in ACGM Newsletter 31 to explain the duties placed on notifiers to keep the Competent Authority informed of administrative changes to notifications under regulation 15. The guidance on notification of significant changes originally issued in Newsletter 30, 'Connected programmes of work and notification of significant and other changes', is currently under review. We suggest that you contact us for technical advice on whether the changes require notifying to the Competent Authority if you are proposing to make changes to a notified project or connected programme
17 The Genetically Modified Organisms (Contained Use) Regulations 2000 require that GMMs in contaminated material and waste be inactivated by validated means. Some centres have raised the issue of the extent of validation that is required to satisfy the requirement to inactivate 'by validated means'. The guidance 'Validation of waste inactivation', provides information on this matter.
18 The only exception to inactivation by validated means is where the Competent Authority has agreed to a request for a derogation from this requirement. For the Competent Authority to consider such a derogation, a considerable amount of data would be necessary to justify the request. The guidance 'Derogations from the requirement to inactivate waste by validated means', in ACGM Newsletter 29 provides further information on this.
19 Section 6 of the CU1 form and section 12 of the CU2 form require information about waste management to be provided. This information is important, as correct handling of waste is one of the key ways to limit contact between GMMs and the environment and so ensure the health and safety of humans and the environment. The information provided in these sections is placed on the Public Register. Detailed guidance entitled 'Waste management data on notification forms' can be found in ACGM Newsletter 30.
20 The Genetically Modified Organisms (Contained Use) Regulations 2000 require that waste contaminated with GMOs be inactivated by a validated means and some centres inactivate waste through off-site incineration. Detailed guidance 'Inactivation of waste through off-site incineration' can be found in ACGM Newsletter 30.
21 Please ensure that any company carrying out incineration on your behalf has notified the Competent Authority of the premises and the activity, if notifiable. If you are unsure, please contact us.
22 We are using e-mail increasingly to reply to simple queries, to speed up the notification process and to send mail shots of urgent information, such as fees increases, to GM centres. However, we only have e-mail addresses for approximately half of our official contacts, which could mean that there is a delay in getting important information to you. Contact details are confidential information under the Data Protection Act and therefore you do not need to claim confidentiality.
23 If you don't want to miss out please send your e-mail address to: diane.fox-purday@hse.gsi.gov.uk
