From 1 October 2014 there will be a new version of the regulations. The Genetically Modified Organisms (Contained Use) Regulations 2014 (the 2014 Regulations) will consolidate and revoke the 2000 regulations and its three sets of amending regulations (2002, 2005 and 2010). Some changes have been made to the 2014 Regulations which reflect experience of applying them since 2000, and make the regulations more risk based and proportionate. This will help businesses comply with the law. The guidance on the regulations (L29) has been amended to reflect these changes.
In 2011, Professor Löfstedt’s report Reclaiming Health and Safety for All: An independent review of health and safety legislation recommended that the Genetically Modified Organisms (Contained Use) Regulations 2000 and its amending regulations should be consolidated as part of a general process of consolidating health and safety law. This was on the basis that consolidation should not reduce the health and safety protection afforded by the current regulations. The Government accepted this recommendation, and committed to delivering the revised regulations by the end of 2014.
The consolidation process has taken the opportunity of making the regulations more risk based and proportionate, while maintaining the necessary level of protection for people and the environment. The 2014 regulations take account of advances in technology, for example synthetic biology is largely encompassed by the definitions in the regulations and is likely to remain so within the foreseeable future. The 2014 regulations incorporate changes to the provisions related to containment measures, notification and administrative arrangements. In addition, the language and layout of the regulations has been modernised and simplified. A summary of the legislative changes is provided in the table below.
|Changes to containment measures in Schedule 8|
|Table 1a||Removal of the duplicated requirement for disinfection procedures|
|Table 1a||Removal of the requirement for inward airflow containment level (CL) 2|
|Table 1a||Amendment of the requirement for inward airflow where there is non-airborne transmission at CL3|
|Table 1a||Amendment of the requirement for HEPA filtration where non-airborne transmission at CL3|
|Table 1a||Amendment of the microbiological safety cabinet (MSC) requirement at CL4 – selection of the most appropriate MSC is based on the risk assessment|
|Table 1a||Amendment of the requirement for waste inactivation at CL1|
|Table 1a||Amendment of the requirement for an observation window at CL3|
|Table 1a||Amendment of the requirement for training records at CL2|
|Table 1c||Removal of the requirement for an incinerator for animal carcasses|
|Table 1c||Removal of the requirement for isolators at CL1|
|Table 2||Removal of the duplicated requirement for decontamination facilities|
|Table 2||Removal of the requirement for the controlled area to be purpose built at CL4|
|Table 2||Removal of the requirement for biohazard sign at CL1|
|Table 2||Amendment of the requirement for waste inactivation at CL1|
|Changes to administrative arrangements|
|All||Amendments to the language/layout of the regulations|
|Regulation2||Replacement of the term ‘genetically modified organisms other than micro-organism’ with the term ‘larger genetically modified organisms’|
|Regulation 8||Amendment to the requirements for a genetic modification safety committee – advice on class 1 risk assessments can be provided by individuals with appropriate expertise|
|Regulation 21||Amendment of the requirement for an emergency plan – the requirement is risk based|
|Regulation 26||Removal of the requirement for a hard copy of the public register of notifications – provision of an online version only|
|Regulation 31||Replacement and simplification of the appeals procedure with online guidance|
|Regulation 33||Amendment of the savings and transitional arrangements|
Those working with GMOs should familiarise themselves with the 2014 regulations.
There are transitional arrangements which enable (with limited exceptions) existing contained uses notified in accordance with the 2000 Regulations to be transferred across to the 2014 Regulations without the need to re-notify. Any conditions or derogations attached to the notified contained use will also still apply.
However, the person responsible for the contained use should review all risk assessment for contained use to ascertain whether changes to the containment measures in the 2014 Regulations have resulted in an increase in class of the existing contained use(s). If the class has increased, a revised notification should be submitted to HSE within 90 days of the new Regulations coming into force. A fee will not be charged provided the notification is made within the 90 day transitional period. The information can be provided by completing a new CU2 form or by submitting a letter with a revised risk assessment. In either case, the documents should be clearly marked to indicate that the notification is being made under the transitional arrangements to avoid incurring a notification fee.
The contained use may continue in the meantime unless the risk assessment shows that the risks have increased or HSE does require the user to stop the contained use.
The transitional arrangements do not apply to new contained uses notified after the 1 October 2014.For further information please refer to a guide to the Genetically Modified Organisms (Contained Use) Regulations 2014.