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
Number of GM
Centres
Percentage
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
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
2014
regulations
Biohazard
sign (89%)
Required where RA
shows required
Not required
Inactivation
Required where
Required
of waste
RA shows required
(88%)
Use of
Required where RA
Not required
isolators
shows required
(90%)
Changes to CL2 containment measures
Measure
2000
regulations
2014
regulations
Inward
airflow
(84%)
Required where
RA shows
required
Not required
Not required
Required
where RA
shows required
Written
procedures
(92%)
Changes to CL3 containment measures
Measure
2000
regulations
2014
regulations
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%)
Required
Required where RA
shows required
Inward
airflow (74%)
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%)
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