Health and Safety Executive

Genetically Modified Organisms (Contained Use) Regulations 2014

Implements 2009/41/EC (GM Contained Use Directive)

What’s new in the 2014 Regulations?

Sector description

Containment Level CL1 CL2 CL3 CL4 Total Number of GM Centres

342 179 71 6 598

Percentage

57% 30% 12% 1% 100% Breakdown of employers and premises by class of activity (1 Aug 2013)

Background to consolidation

Löfstedt review - ‘Reclaiming health and safety for all’

(

November 2011) • Consolidation (4 sets of regulations into 1 consolidated regulations) • Reflect working practices, new technologies, simplify (e.g. duplication), remove unnecessary gold plating, involve/inform business of changes, evidence based policy Government committed to deliver by end 2014 • Maintain health and safety standards • Will come into force on 1 October 2014

What we needed to achieve

• • • • •

Key objectives for the new regulations

Deliver the consolidation but not re-write (evolution rather than revolution) Take the opportunity to make regulations more risk based and proportionate Ensure any changes maintain the level of protection of human health and the environment (maintain health and safety standards) Where possible, remove barriers to development of a future single regulatory framework Apply the new rules from the Better Regulation Executive (e.g. impact assessment)

Engagement with stakeholders

Fact finding questionnaire circulated to flag up issues with regulations – scientists, safety professionals, unions, other government departments etc.

Consulted other European regulators (European Enforcement Project) – Interpretation of directive – Alternative approaches taken Development of proposed changes – Used feedback to inform options and approaches

Public consultation

• • • • • Consultative Document 268 (CD268) published on HSE website Consultation ran between 28 October and 20 December 2013 (8 weeks) >5000 stakeholders alerted to CD268, from which ~800 stakeholders downloaded the consultation document and 42 stakeholders responded Proposals in two parts: – Part 1 – containment measures; – Part 2 – restructure & technical tidy up Overall support for the proposed changes – ~83% support for Part 1 – ~88% support for Part 2

Changes in 2014 Regulations

Part 1 – containment measures

- Several measures removed from the containment tables Number of changes to specific measures at a particular containment level Change to source of advice on risk assessment Laboratory work

Changes to containment measures

• Removing duplication • Measures removed from the table: – Disinfection procedures (66%) – Hand washing facilities (76%)

Bottom line

–

Requirement for both disinfection procedures and hand washing facilities remain (Reg 18(2) schedule 7)

Changes to CL1 containment measures

Measure 2000 regulations

Biohazard sign (89%) Required where RA shows required

2014 regulations Not required

Inactivation of waste (88%) Use of isolators (90%) Required Required where RA shows required

Required where RA shows required Not required

Changes to CL2 containment measures

Measure

Inward airflow (84%)

2000 regulations 2014 regulations

Required where RA shows required

Not required

Written procedures (92%) Not required

Required where RA shows required

Changes to CL3 containment measures

Measure

Inward airflow (74%) HEPA filters (67%)

2000 regulations

Required Required

2014 regulations Required except for activities where transmission does not occur via airborne route Required except for activities where transmission does not occur via airborne route

Observation window (70%) Required

Required where RA shows required

Changes to CL4 containment measures

Measure 2000 regulations 2014 regulations

Requirement for incinerator on site (84%) Required to be on site

Removed from the table

Prescriptive requirement for Class III MSC (89%) Purpose built facility (90%) Class III cabinet required

Required and all procedures with infective materials required to be contained within a cabinet/enclosure

Required and required to be purpose built

Required

Key changes - Genetic modification safety committee (GMSC)

• Requirement for competent advice on risk assessments • Person with expertise or GMSC for class 1 • • • GMSC for class 2 and above Workload of GMSC Broader remit

Changes in 2014 Regulations

• • • Part 2 – restructure & technical tidy up Layout and language Terminology Procedures

Changes to format of the regulations

• • Layout and language – Modern legal language – Better delineation of requirements of users and competent authority – Key regulations to remain the same (e.g. risk assessment) – On-line version of public register version only Terminology – Larger GMOs, contained use, user, person responsible

Change to administrative arrangements

• Administrative arrangements/procedures Class 2 notification - full risk assessment to accompany notification Emergency plan – risk based requirement Appeals procedure – grounds for appeal retained but the procedure replaced with on-line guidance

Guide to the Regulations (L29)

• • • • Redrafted the guide to the regulations to reflect the changes in the legislation Redrafted to reflect better regulation principles for guidance Restrict to explaining the meaning of the regulation – some technical content to be moved to Compendium of Guidance Compendium revision is underway – the current on-line version does not reflect the changes in the 2014 regulations

Changes to L29

• • • • Key areas highlighted from consultation – waste inactivation, GMSC, significant changes, connected programmes, synthetic biology, consistency with COSHH Institute for Safety in Technology and Research (ISTR) developing separate industry guidance on examples of significant change Electronic version only On-line community used to provide feedback on draft L29

Transitional arrangements

• • • Transfer of notifications made under 2000 Regulations (including conditions, derogations) Two possible exceptions where the risk classification may increase - GM centres should review their existing assessments in relation to use of isolators at CL1; and inward airflow at CL2 Where risk class increases notification to HSE is required within 90 day transitional period – No fee – Contained use can continue if risks remain the same – Derogation requests at the same time

Further information

• HSE website contains the following information and links ( http://www.hse.gov.uk/pubns/books/l29.htm

) – Further details of changes – Revised version of L29 – guide to the regulations – Additional GM and biosafety guidance – Link to ISTR guidance on significant change