Health and Safety Executive

What’s new in the

2014 Regulations?

Genetically Modified Organisms (Contained Use) Regulations 2014

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

Sector description

Containment LevelNumber of GM

CentresPercentage

CL1 342 57%

CL2 179 30%

CL3 71 12%

CL4 6 1%

Total 598 100%

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

• 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

Public consultation

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

Measure2000

regulations2014

regulations

Biohazard sign (89%)

Required where RA shows required

Not required

Inactivation of waste (88%)

RequiredRequired where

RA shows required

Use of isolators (90%)

Required where RA shows required

Not required

Changes to CL2 containment measures

Measure2000

regulations2014

regulations

Inward airflow (84%)

Required where RA shows required

Not required

Written procedures

(92%)Not required

Required where RA

shows required

Changes to CL3 containment measures

Measure2000

regulations

2014

regulations

Inward airflow (74%)

Required

Required except for activities where

transmission does not occur via airborne route

HEPA filters (67%)

Required

Required except for activities where

transmission does not occur via airborne route

Observation window (70%)

RequiredRequired where RA

shows required

Changes to CL4 containment measures

Measure2000

regulations2014

regulations

Requirement for incinerator on site

(84%)

Required to be on site

Removed from the table

Prescriptive requirement for Class III MSC

(89%)

Class III cabinet required

Required and all procedures with

infective materials required to be

contained within a cabinet/enclosure

Purpose built facility (90%)

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