CU1 - Notification of premises to be used for contained use - guidance notes

Activity Notification

THE GENETICALLY MODIFIED ORGANISMS (CONTAINED USE) REGULATIONS 2000 NOTIFICATION OF INTENTION TO CONDUCT INDIVIDUAL CONTAINED USE ACTIVITIES

Data Protection Act 1998

This Act requires the Health and Safety Executive (HSE) to inform you that this form may include information about you (this is called "personal data" in the Act) and that we are a "data controller" for the purposes of the Act. HSE will process the data for health, safety and environmental purposes. HSE may disclose these data to any person or organisation for the purposes for which they were collected or where the Act allows disclosure. As data subject, you have the right to ask for a copy of the data and to ask for any inaccurate data to be corrected.

All the information given in sections 1 to 15 of this form will be placed on HSE's public register of notifications within 14 days of receipt. You may consider that there is information relevant to these sections whose disclosure would harm your organisation's competitive position or which you wish to keep confidential on other grounds referred to in regulation 22(2); please see paragraph 126 of the Guide to the Regulations. If so, you should enter such information in section 17 with a full justification for its exemption from disclosure.

Subject to the following paragraph, there are some sections for which you must provide at least some information for disclosure. This is because the Regulations specify certain categories of information for which information from disclosure cannot be claimed on any grounds other than, exceptionally, harm to intellectual property rights. It should always be possible to provide information in these categories without risk of harm to competitive position or any of the other grounds referred to in regulation 22(2). If there are particular details, necessary for evaluation of the notification, for which you wish to claim confidentiality, these should be entered in section 17 with the necessary justification.

You may request exemption from disclosure for any information if you can demonstrate that it is necessary to protect your intellectual property rights. Such information should be entered in section 17 with a full justification for its exemption from disclosure.

Personal information will not be disclosed unless the individual concerned has given his or her explicit written permission.

Compliance with other legislation

It is important to note that compliance with the provisions of the Contained Use Regulations does not constitute compliance with other relevant legislation. For example, you may also need to apply separately for licences or permits under legislation controlling plant health, animal health, animal scientific procedures, or the introduction of non-indigenous species. For clinical trials involving gene therapy you will need approval from the Gene Therapy Advisory Committee.

Even if you have fulfilled the requirements of the Contained Use Regulations, and have any necessary consents or approvals under that legislation, you cannot begin the activity unless you also have the relevant licences / permit under any other applicable legislation

This will normally be the University, Institution, Company or Organisation. Only rarely will it be necessary to include an individual's name.
If you have previously notified your premises, indicate the date of the notification and the HSE reference number assigned (eg GM111). If you have not notified your premises, you will not have a reference - so leave blank. Note that, if not previously notified, you will also need to complete a premises notification - using the form provided if you wish - and submit it at the same time as this activity notification. The fee payable in such cases will only be that related to the activity notification.
It is permissible to notify a connected programme of work using this form. However, you must included details of all of the component activities in sections 4 - 15. The fee payable in relation to connected programmes is the fee for the highest Class of activity involved. (Notifiable activities involving GM animals and plants are equivalent to Class 2 for this purpose).
Please tick all applicable boxes on the grid. Confidentiality in relation to the Class of activities involving GMMs may not be claimed - unless disclosure would harm intellectual property rights. Any information claimed as confidential should be entered in section 17 together with justification.
Any information claimed as confidential should be entered in section 17 together with justification.
For activities involving GMMs, this section cannot be left blank unless you have a justified claim in respect of protection of intellectual property rights (IPR). If you are not making a claim in respect of IPR, you must at least include general characteristics of the GMMs involved in the intended activity. Where there are no justifiable claims for confidentiality, you must include precise details. An evaluation of the foreseeable effects must also be included, in as precise detail as possible. The evaluation of foreseeable effects should include the identity and characteristics of the GMMs indicated by the risk assessment. Include information on hazards to human health and the environment with particular reference to those arising from the modification as opposed to being inherent properties of the host micro-organism. (A fuller account of these details will be included in the risk assessment).

For activities involving GMOs which are not micro-organisms (eg GM animals and plants) it is permissible to claim confidentiality for any of the required information, but the second section should still be completed in as precise detail as possible without endangering confidentiality. The evaluation of foreseeable effects is required to consider only human health and safety aspects. Any information claimed as confidential should be entered in section 17 together with justification.
For activities involving GMOs which are not micro-organisms (eg GM animals and plants), describe the containment and control measures which you will apply to the activity. These should be justified by reference to the risk assessment. Any information claimed as confidential should be entered in section 17 together with justification.
Any information claimed as confidential should be entered in section 17 together with justification.
You must not leave this section blank. For activities with GMMs confidentiality may only be claimed if disclosure would harm your intellectual property rights.
For activities involving GMMs, you will normally need to apply all the measures specified as requirements for the relevant containment level. If, however, your risk assessment indicates that any of those measures are unnecessary, you may ask for permission to omit them. Indicate any such measures with a brief justification that includes reference to the relevant parts of the risk assessment. You cannot claim confidentiality for the actual containment measures (except if your intellectual property rights might be affected) BUT the justification may be claimed as confidential. If any claim is made for confidentiality, the confidential information must be included in section 17 together with justification.
Waste management measures which will be applied to the activity must be described. You should take into consideration only the waste consisting of or containing viable GM material. You must specify the type and form of waste(s) generated, their treatment, ultimate form and fate. Include an indication of the numbers of viable GMOs remaining after treatment (if any).

For activities involving GMMs, this section cannot be left blank unless you are claiming protection for reasons of intellectual property rights. Even if this is not the case, it is permissible not to give precise details if claims for confidentiality can be justified. For instance, you could say that inactivation is by heat treatment to give 100% kill, but the precise detail of how this is achieved may be commercially confidential information. If any claim is made for confidentiality, the confidential information must be included in section 17 together with justification.
You must attach the risk assessment of the activity to this form. The risk assessment will not at present be placed on the public register, but will be open to disclosure to members of the public on request (subject to confidentiality provisions). If, as hoped, an electronic public register is set up in the future, this may allow for inclusion of the risk assessment on the register.

If you wish to claim exemption from disclosure for any sections of the risk assessment, please indicate those sections clearly on the risk assessment and set out a full justification for exemption. If you justification is accepted, the risk assessment will be disclosed with the exempt sections removed. You are advised to submit a second version of the risk assessment from which those sections have already been removed. Such a version of the risk assessment should indicate precisely where information has been removed.
NB: Remember that, as well as consulting the genetic modification safety committee on the risk assessment, you must also comply with the Safety Representatives and Safety Committees Regulations 1977 and, where any employees are not in groups covered by trade union safety representatives, you must consult such employees according to the Health and Safety (Consultation with Employees) Regulations 1996.

If any claim is made for confidentiality, the confidential information must be included in section 17 together with justification.
Please enter in this section any information, required in sections 1 - 15, which you wish to be exempt from public disclosure on grounds that:
1. disclosure would harm your organisation's competitive position;
2. disclosure would compromise your intellectual property rights; or
3. the information falls into one of the other categories for exemption in regulation 22(2) - state which.
  
  For each piece of information entered you must:
4. state clearly which of the grounds applies. In particular, state which category of exemption allowed by the Environmental Information Regulations 1992, as amended in 1998, applies, namely:
  
  international relations, national defence, public security, legal proceedings, confidentiality of deliberation, commercial / industrial confidentiality intellectual property;
  1. indicate the section of the form to which it is relevant; and
  2. provide a full justification, explaining why the stated ground for exemption applies.

You do not need to enter any personal information as this will automatically be treated as confidential.

Send the completed form to:
Notifications Officer
Health and Safety Executive
Room 443,
Magdalen House
Stanley Precinct
Bootle
Merseyside
L20 3QZ
Tel: 0151 951 4772,
Fax: 0151 951 3474