Genetically Modified Organisms – what’s new about the 2014 regulations?

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.

Why have the regulations changed?

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.

How have they changed?

Summary of the change in the 2014 Regulations

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

What do I need to do?

Those working with GMOs should familiarise themselves with the 2014 regulations. They should review their contained use activity to make sure there is no change to the classification of that contained use. If they need to submit a revised notification to HSE, this must be done within 90 days of the new regulations coming into force.
See Notifications.

For further information please refer to Genetically Modified Organisms (Contained Use) Regulations 2014.

Article source: http://www.hse.gov.uk/biosafety/gmo/whats-new.htm