Regulation of GMOs in Contained Use facilities in Ireland by the EPA
Regulations
S.I. No 73 of 2001 (Contained Use of GMOs)
transposes Directive 98/81/EC amending Directive
90/219/EEC-Contained use of GMM.
S.I. No 54 of 2004 (Transboundary Movement)-Reg.
1946/03
Dr Tom McLoughlin
Senior Inspector
Office of Climate Change, Licensing & Resource Use
EPA
Aims and Objectives
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Government Policy
Definitions
Interpretations
Legislation
Obligations on the GMO user
Classification of GMM
Risk Assessment
Requirements for GMM/GMO Notifications
Biological Safety Committee/BSO
Cartegena Protocol
Enforcement by the EPA
Duties and Power of the Agency
Future Trends
Definitions
Micro-organism means ‘any microbiological entity, cellular or non
cellular, capable of replication or of transferring genetic
material, including viruses, viroids, animal and plant cells in
culture’
Genetically Modified Micro-organisms-GMM
• bacteria,
• viruses,
• fungi,
• plant & animal cells,
capable of replication or of transferring genetic material in
which the genetic material has been altered in a way that does
not occur naturally by mating or natural recombination.
Definitions
 Genetically Modified Organisms
means any organism in which the genetic material
has been altered in a way that does not occur
naturally by mating or natural recombination or by a
combination of both
e.g. plants & animals
GMOs inclusive of Genetically Modified Microorganisms (GMMs).
Definitions
Contained use
‘any activity in which organisms are genetically
modified or in which such organisms are cultured, stored,
transported, destroyed, disposed of or used in any other way
and for which specific containment and other protective
measures are used to limit their contact with the general
public and the environment'.
Containment measures/barriers can be physical, biological or
chemical or a combination of these.
Contained Use (CU) Directive 98/81/EC amending 90/219/ECC
Objectives of Directive:
Preventive action be taken - protect the environment & human
health
 CU of GMMs - classified in relation to the risks - present
for human health & environment
 Classification - based on RA
 Containment and other protective measures – correspond -
classification of CU
 Adopt appropriate measures for the disposal of waste - from
CU of GMM
GMO (Contained Use) Regulations, 2001-S.I. No. 73 of 2001
(60 Articles + 8 Schedules)
Part I General
Part II Contained use of GMMs
Part III Contained use of GMOs
Part IV Fees & charges
Part V - Enforcement & regulation
Part VI Advisory Committee on GMOs,
Monitoring & Reporting etc.
Obligations
Article 5- A user or any other person carrying out
an activity involving a contained use shall ensure
that all appropriate measures are taken to avoid
adverse effects on human health and the
environment.
Article 13-Before commencing a Contained UseRA must be carried out –human health and the
environment-which may be associated with such
use.
What we don’t want…
“Probe after Scots
student’s smallpox
accident”
The Sunday Post
17th December 2000
“SARS spreads in China:
Investigation launched
into lab safety.”
27 April 2004
Nature Science Update
'Pirbright link' to farm outbreak
What is Regulated/Not Regulated?
 Techniques of Genetic Modification - cloning vectors plasmids & viruses-direct introduction - microinjection, macro-injection and micro-encapsulationcell fusion
 Techniques which are not considered to be GMO - In
vitro fertilisation-conjugation, transduction,
transformation, mutagenesis, cell fusion, self cloning
 Oct 2007 - Working Group to be set at EU level up to
look at ‘newer’ techniques of GE to ascertain if they
should be included or excluded from the remitt of EU
Directives-CU/DR?
 Exemption of safe organisms - Annex II, Part B?
Classification of GMM based on Risk Assessment
• Activities classified into 1 of 4 classes (Class 1, 2, 3, or 4)
Class 1 -
activities of no or negligible risk, Containment
Level 1 (CL1) is appropriate
Class 2 -
activities of low risk, CL2
Class 3 -
activities of moderate risk, CL3
Class 4 -
activities of high risk, CL4
• Classification is based on Risk Assessment (Art. 13)
• Appropriate level of containment required to control risk to
human health and the environment.
Register of GMO users in Ireland – October 2007
• 261 registered users
• 78% contained use consents (Class 1 & 2)
8
49
0
0
58%
20%
152
52
Class 1
Class 2
Class 3
Class 4
GMO
Deliberate Release
Elements of Risk Assessment
1.
2.
3.
4.
5.
Provisional allocation to Class 1, 2, 3 or 4 as per DIRECTIVE 2000/54/EC –
Biological agents at work
Identification of potentially harmful effects associated with:
 Recipient Micro-organism
 Genetic insert
 Vector
 Donor micro-organism
 Resulting GMM
Assessment of potentially harmful effects occurring
Assign appropriate containment level (CL 1, 2, 3 or 4) and other protective
measures to control risk
Review and confirm classification in light of completed assessment
Containment Levels and Measures (4th Sched)
Table 1A –
minimum requirement for contained use
of a GMM in a laboratory
Table 1B –
in addition to Table 1A contained use of
a GMM in plant growth facilities
Table 1C –
in addition to Table 1A contained use of
a GMM in animal units
Table II –
minimum requirements for GMM in
facilities other than those covered by
tables 1A, 1B or 1C
Containment Measures
GMP (Good Microbiological Practices)
GOSH (Good Occupational Safety and Hygiene)
Training, Containment equipment & Special Installation
Design.
Advice - Biological Safety Committees, BSO
GMP & GOSH
Keep workplace & environmental exposure - GMM lowest practicable level;
Exercise engineering control measures - source
& supplement - protective clothing & equipment;
Test & maintain control measures/equipment;
Test for presence of GMM outside-primary physical
containment;
Provide training of personnel;
Establish biological safety committees/subcomm.
Formulate & implement local codes of practicesafety of personnel, display biohazard signs;
GMP & GOSH-cont.
Provide washing & decontamination facilities personnel;
Adequate records; written SOP’s to ensure safety;
Effective disinfectants - disinfection procedures -
spillage of GMMs;
Safe storage - contaminated laboratory equipment &
materials
Prohibit eating, drinking, smoking, application
of cosmetics or storage of food for human
consumption -work area; prohibit mouth pipetting.
GMM Notification Requirements
• Art. 16 states that a premises shall not be used for the first
time unless
• a notification has been submitted by user to EPA
• a consent for such use has been granted by EPA
• compliance with consent conditions
GMM Notification Requirements
Class 1, 2, 3 & 4.
First time use of a premises
GMM notification
+
Subsequent contained use
Class 2, 3 & 4.
GMM Notification requirements
First time use of the premises
Subsequent contained use
Class 1
•Information under Part A of 5th Schedule
•Risk Assessment
•Fee €250
Class 2
•Information under Part A of 5th Schedule
•Fee €1,250
•Information under Part B, 5th Schedule
•Risk Assessment
•Fee €625
Class 3
•Information under Part A of 5th Schedule
•Fee €3,000
•Information under Part C, 5th Schedule
•Risk Assessment
•Fee €1,500
•Public notice
Class 4
•Information under Part A of 5th Schedule
•Fee €15,000
•Information under Part C, 5th Schedule
•Risk Assessment
•Fee €7,500
•Public notice
GMM Notification Requirements
Timeframe for decisions
First time use of a premises
• Class 1/2 - 45 days
• Class 3/4 - 90 days
Subsequent use of a premises
• Class 2 – 10 days
• Class 3/4 - Notifier may not proceed without the EPA’s prior
approval and the EPA must revert within 45 days.
Clock Stoppage
GMM Notification Requirements
Consents (Article 26)
EPA will
• issue consent with or without conditions, or,
• refuse consent
Fees (8th Schedule)
 Receipt of fees validates notification
 Refund/waiver of up to 50% of fees payable (Article
48)
GMM Notification Requirements
Annual Reporting
User is required to carry out and maintain Risk Assessments
(RAs) and to submit to EPA with annual report.
INFORMATION REQUIRED -NOTIFICATION FOR FIRST TIME USE
OF PREMISES FOR CONTAINED USE - ARTICLE 16
Name of user, persons responsible for supervision &
safety
Training & qualifications of persons - supervision &
safety
Details - biological committees/subcommittees
Address & general description of premises
Description of the nature of the work
Class of the contained use
Class 1 GMM - a summary of RA - Article 13
Information on waste management
Relevant fee - 8th Schedule
Information required for a Class 2 contained use - Article 18
 Date of submission of the notification - Article 16
 Names of persons-supervision & safety & information - training &
qualifications
 Recipient, donor &/or parental micro-organism(s) used & the host -vector
 Source(s) & intended function(s) of the genetic material - used in
modification
 Identity & characteristics of the GMM
 Purpose of contained use - expected results
 Approximate culture volumes - used
 Description of containment measures, information about waste
 Management - wastes generated – treatment, final form & destination
 A summary of the RA - Article 13
 Information - CA to evaluate any emergency response plans - Article 30.
 Relevant fee - 8th Schedule
GMO Notification Requirements
Notification of Contained Use for a GMO (GM
plants/animals) must contain
• Risk Assessment (Article 36(2), Part II of 7th Schedule)
• Information set out in Part I of 7th Schedule
• Fees – no requirement
• Activity may commence 45 days after submission of
notification
• The EPA is not required to issue consent
• Annual reporting applies
• Guidelines
Enforcement
 Under Article 26 of the CU Regulations the EPA can issue a
consent with or without conditions or refuse consent.
 Enforcement - Article 56 –‘The Agency shall carry out,
cause to be carried out or arrange for such monitoring,
inspections ….’
 To ensure - users comply – conditions - licence
 To ensure - risks to human health & environment managed properly - promote high standard of biological
safety
 Allay public concerns
 Regulator of GM technology - 3rd level; biopharma industry
Site Inspection
What we look for (use a checklist that was agreed at the European
Enforcement Project CU)
 General Information re the premises
 Containment measures in place
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Restricted access
Biohazard signs
Procedures / RA
Training / training records
Class of MSC /date of last validation
Personal protective measures
GMP / GOSH
Handwashing facilities
Segregation of write up area
General observations
Site Inspection continued
 GMM Storage
 Location /in lab?/ elsewhere? / inventory
 Waste Inactivation
 Location of autoclave relative to lab
 Last date of validation
 Procedure for decontamination of
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Solid waste
Liquid waste
Sharps
 Procedure for treatment of spillages
 Decontaminating agents
 Procedure for reporting of accidents / incidents
 Are GMOs/GMMs used for teaching purposes?
Enforcement actions
Site inspection is followed up with
 Site inspection report
 Letter of non-compliance to registered user, where applicable, for
example,
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Annual reporting
Where user has relocated activity and has not informed the Agency
SOPs
Non-notified activity
BSC-management structure
Prosecution of Offences
 HC injunction
 Notice to Take Measures
Duties & Power of the EPA
• Review of contained use activities
• Enforce Regulations - site inspections, compliance
with consent conditions
• EPA - require modification, suspension or termination
• Report - Minister-performance of functions
• Inform the EU Commission of accidents
• Notice to take measures
• Prosecution of offences
• High Court Injunction
Cartegena Protocol
UN legislation to protect biodiversity – EU Regulation
Covers all LMO’s transboundary movement outside the
EU
Reguirements for Contained Use:
Exporters need to provide documentation:
Labelling-that it contains or consists of a GMO
Unique code, if available
RA relating to the safe handling, storage and transport
Contacts for further information
Help and Guidance
www.epa.ie - under ‘What we do/Licensing and
Permitting/GMOs’
Licensing process explained
Contained Use of GMMs and GMOs,
Risk assessment - examples
Who should apply - procedures
Annual reporting guidance
Legislation
Future Trends
Move to use replicating viral vectors with altered
tropism/tissue specificity/ immune evasion
Increasing development of viral chimeras
Reverse genetics of multi-segmented ds RNA
viruses (e.g., Blue-tongue, Rotavirus)
Biopharming-to produce human medicines?
Drivers for change - e.g., SARs, Influenza H5N1,
Climate Change - Blue tongue
Concluding remarks
The overriding concern of the EPA in the
implementation of the GMO Contained Use
Regulations is to ensure that their use does not
have an adverse effect on human health or the
environment.