1 Regulation 21 of the Genetically Modified Organisms (Contained Use) Regulations 2000, GMO(CU), place responsibility on centres to immediately notify the Competent Authority, CA, of accidents, as defined in the regulations, involving genetically modified organisms. There may be situations where as well as notifying the Competent Authority under GMO(CU), HSE also requires notification under the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR), for example if a person were to require hospital treatment. This guidance aims to explain what should be considered to be an accident for the purposes of the GMO(CU) legislation; what information should be included when notifying an accident to the competent authority; who to contact; and what the CA will do with the information provided in the accident notification.
2 Regulation 2(1) of GMO(CU) defines an accident as:
"…an incident involving a significant and unintended release
of genetically modified organisms in the course of an activity involving
genetic modification which presents an immediate or delayed hazard to human
health or the environment".
3 Therefore, an accident is where a GMM is released in such a way that it poses an immediate or delayed risk to human health or the environment, or where a GMO (other than GMM) is released in such a way that it poses an immediate or delayed risk to human health. Accidents which result in release of GMMs and GMOs from primary containment, but not the laboratory or building may therefore constitute an accident, depending on the nature of the GMM or GMO.
4 Situations, which might constitute an accident, depending on the organisms involved, their mode of transmission and the nature of the accident, might include:
5 Spillage or release of a class 1 GMM is unlikely to count as an accident as class 1 GMMs are unable to pose a risk to human health or the environment. If you are in any doubt as to whether you need to notify the Competent Authority, please contact the inspection team. Please note that any intention to release a GMO is subject to the Genetically Modified Organisms (Deliberate Release) Regulations 2002.
6 Regulation 21 of GMO(CU) states that 'where an accident occurs, the person undertaking the activity involving genetic modification shall forthwith notify the competent authority of the accident and shall provide the following information:
7 Appendix 4 of 'A Guide to the Genetically Modified Organisms (Contained Use) Regulations 2000' sets out the format for information to be supplied with accident notification. This form is available electronically through ACGM Newsletter 32 and through the Forms section of the HSE website: https://www.hse.gov.uk/forms/genetic/index.htm
8 Accident notifications should be sent 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 The Notifications Officer receives notifications on behalf of the CA. Although details need to be provided in writing (letter, e-mail or fax), you are advised to inform HSE immediately of any incident by telephone in the first instance.
10 The Notification Officer will circulate the information provided to all members of the CA. However, regulation 21(2) also places duties on the Competent Authority where it is informed of an accident. These include:
11 This means that HSE inspectors will need to investigate the accident to obtain all the information to make recommendations to avoid similar accidents and to share the lessons learnt with our European counterparts. HSE inspectors will therefore regard any attempt to avoid notification of an accident as a serious matter.
12 The date on which the Competent Authority receives an accident notification is added to the premises notification (CU1) and the public register. The fact that a GM accident has occurred at a premises and the date on which the Competent Authority received notification of a GM accident is thus publicly available.
13 Although the detailed information provided on the accident notification form is not placed on the public register, it is kept on our files and therefore could be made available to the public if requested. Regulation 23 sets out the confidentiality and disclosure provisions for information provided in an accident notification. These provisions are essentially the same as for other notified information and ensure that information can be made available to the public if requested, unless the CA has agreed that the information should be kept confidential. However, you must provide full information to the CA to allow them to carry out their duties under regulation 21(2). The CA will review requests that information provided in accident notifications be kept confidential on the grounds that it contains:
14 Full justification of the need to keep the information confidential must be provided with any request for confidentiality. The CA will keep the information confidential whilst a decision is made, and will only release the information 14 days after informing a centre that their confidentiality claim has been refused. Where a confidentiality claim is accepted, you are required to inform the CA of any changes in circumstances relating to that claim.
15 The following information cannot be kept confidential (other than to protect intellectual property rights):
16 Further information on confidentiality and disclosure can be found at
http://www.hse.gov.uk/dst/confid.htm.
